As filed with the Securities and Exchange Commission on January 29, 2026.

Registration No. 333-292059

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

________________________________________________

AMENDMENT NO. 1

TO

FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

________________________________________________

STARTON HOLDINGS, INC.
(Exact name of registrant as specified in its charter)

DELAWARE
(Jurisdiction of incorporation or organization)

________________________________________________

215 College Road, Suite 300, Paramus, NJ 07652
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

(800) 449-5405
(Registrant’s telephone number, including area code)

________________________________________________

Pedro Lichtinger Waisman
Chairman and Chief Executive Officer
215 College Road, Suite 300
Paramus, NJ 07652
(800) 449-5405
(Name, address and phone number of agent for service)

________________________________________________

Copies of Communications to:

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Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☐

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933 OR UNTIL THIS REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

TABLE OF CONTENTS

You should rely only on the information contained in this Prospectus. We have not authorized anyone to provide you with different information. We are not making an offer of these securities in any state where the offer is not permitted.

Neither we nor any of the underwriters have authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses we have prepared. Neither we nor any of the underwriters take responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date, regardless of the time of delivery of this prospectus or of any sale of our shares of common stock.

Trademarks, Service Marks, and Trade Names

We do not own or have rights to use common law trademarks, service marks, or trade names in connection with our business in the U.S. or in certain foreign jurisdictions.

Solely for convenience, the trademarks, service marks, logos, and trade names referred to in this prospectus are without the ® and ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names. This prospectus contains additional trademarks, service marks and trade names of others, which are the property of their respective owners. All trademarks, service marks and trade names appearing in this prospectus are, to our knowledge, the property of their respective owners. We do not intend our use or display of other companies’ trademarks, service marks, copyrights, or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

GLOSSARY OF DEFINED TERMS

As used in this Prospectus, unless otherwise noted or the context otherwise requires:

“we”, “our”, “us”, “our business”, the “Company”, “Starton” and similar references refer to Starton Holdings, Inc. and its subsidiaries.

“ACA” means the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act.

“AUC” means area under the curve.

“ANDA” means Abbreviated New Drug Application.

“API” means active pharmaceutical ingredients.

“AWP” means Average Wholesale Price.

“BA” means bioavailability.

“BCL-2i” mean B-cell lymphoma 2 inhibitors.

“BTKi” means Bruton’s Tyrosine Kinase inhibitors.

“CARES Act” means Coronavirus Aid, Relief, and Economic Security Act.

“CAR-T” means chimeric antigen receptor — T cell.

“CLL” means chronic lymphocytic leukemia.

“Code” means the Internal Revenue Code of 1986, as amended.

“CR” means complete response.

“CMC” means chemistry, manufacturing, and controls.

“Cmax” means maximum plasma concentration.

“CMS” means U.S. Centers for Medicare and Medicaid Services.

“cGMP” means Current Good Manufacturing Practices.

“CRO” means contract research organizations.

“CTM” means Clinical Trial Materials.

“DEA” means the U.S. Drug Enforcement Administration.

“DGCL” means the Delaware General Corporation Law, as amended.

“DIA” means Drug-in-adhesive.

“DOJ” means U.S. Department of Justice.

“ECG” means Electrocardiogram.

“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended.

“FDA” means United States Food and Drug Administration.

“FDC Act” means the United States Federal Food, Drug, and Cosmetic Act.

“FINRA” means Financial Industry Regulatory Authority, Inc.

“FTC” means Federal Trade Commission.

“GAAP” means U.S. generally accepted accounting principles.

“GCPs” means Good Clinical Practices.

“GLP” means good laboratory practice.

“HIPAA” means Health Insurance Portability and Accountability Act of 1996.

“HITECH” means U.S. Health Information Technology for Economic and Clinical Health Act of 2009.

“IIT” means Investigator Initiated Trial.

“IMiD” means immunomodulatory imide drugs.

“IND” means Investigational New Drug.

“IRB” means institutional review board.

“LLD” means lenalidomide.

“MM” means multiple myeloma.

“Nasdaq” means the Nasdaq Stock Market.

“NCCN” means National Comprehensive Cancer Network guidelines.

“NCE” means new chemical entity.

“NDA” means New Drug Application

“NOAEL” means no-observed adverse event level.

“NOLs” means net operating loss carryforwards.

“OCR” means oral controlled release.

“ODA” means Orphan Drug Act.

“ODD” means Orphan Drug Designation.

“OTC” means over the counter.

“ORR” means objective tumor response rate.

“PCT” means Patent Cooperation Treaty of 1970.

“PDUFA” means Prescription Drug User Fee Act.

“PFS” means progression free survival rate.

“PREA” means Pediatric Research Equity Act.

“PTO” means Patent and Trademark Office.

“REMS” means Risk Evaluation and Mitigation Strategy.

“RRMM” means Relapsed Refractory Multiple Myeloma.

“SC” means subcutaneous.

“SCID” means severe combined immunodeficiency.

“SEC” means the U.S. Securities and Exchange Commission.

“Securities Act” means the Securities Act of 1933, as amended.

“STAR-LLD” means any and all possible formulations of low-dose lenalidomide.

“STAR-LLD-OCR” means oral controlled release formulation of low-dose lenalidomide.

“STAR-LLD-SC” mean a subcutaneous formulation of low-dose lenalidomide.

“TDS” means transdermal delivery systems.

“T1/2” means half-time.

“TCJA” means Tax Cuts and Jobs Act of 2017.

“TEAE” means treatment-emergent adverse event.

“Transfer Agent” means Computershare.

“TTF” means time to total treatment failure.

RISK FACTORS

Investing in our common stock is speculative and involves a high degree of risk. You should carefully consider the risks and uncertainties described below, the section of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes appearing at the end of this prospectus, before investing in shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks occur, our business, operating results and prospects could be materially harmed. In that event, the price of our common stock could decline, and you could lose part or all of your investment. This prospectus also contains forward-looking statements that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below.

Risks Related to Our Financial Condition and Capital Requirements

We are a clinical stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred net losses since our inception, we anticipate that we will incur significant losses for the foreseeable future, and we may never achieve or maintain profitability.

We were established and began operations in 2017. Our operations to date have been limited to financing and staffing our company, formulating and developing potential product candidates, licensing product candidates, and conducting preclinical and clinical studies of (i) STAR-LLD for the treatment of RRMM, CLL and complications resulting from the disease. We have successfully completed Phase 1and 1b clinical studies for STAR-LLD-SC in MM. We have entered a Phase 2a study for STAR-LLD-SC in MM, primarily due to the availability of funds. If successful, and subject to our ability to raise sufficient additional funds, we intend to pursue a Phase 3 clinical study and obtain an NDA for commercialization. In addition, subject to our ability to raise sufficient additional funds, we intend to run clinical trials and commercialize STAR-LLD-OCR in CLL and Lymphoma.

Clinical studies have risks inherent to their FDA regulatory process, clinical study design, and execution. In addition, there are risks related to the manufacturing of clinical supplies, active pharmaceutical ingredients, and to manufacture a commercial scale product, arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may prove to be inaccurate.

Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early stages of development, especially early-stage clinical pharmaceutical companies such as ours. Potential investors should carefully consider the risks and uncertainties that a company with a limited operating history will face. In particular, potential investors should consider that we cannot assure you that we will be able to, among other things:

•        Successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound;

•        Successfully manufacture or engage contract manufacturers to manufacture our clinical product candidates and establish commercial supply;

•        Successfully complete the clinical trials necessary to obtain regulatory approval for the marketing of our product candidates;

•        Secure market exclusivity and/or adequate intellectual property protection for our product candidates;

•        Attract and retain an experienced management team and advisors.

•        Secure acceptance of our product candidates in the medical community and with third-party payors and consumers;

•        Raise sufficient funds in the capital markets or otherwise to effectuate our business plan; and

•        Utilize the funds that we do have and/or raise in the future to efficiently execute our business strategy.

If we cannot successfully execute any of the foregoing, our business may fail, and your investment will be adversely affected.

Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a “going concern.”

We incurred a net loss of $9.5 million and $15.0 million for the years ended March 31, 2025 and 2024, respectively. We had a working capital deficit of $5.9 million and $9.1 million in the years ended March 31, 2025 and 2024, respectively. Net cash used in operating activities was $8.3 million and $6.5 million in the years ended March 31, 2025 and 2024, respectively. Additionally, we had an accumulated deficit of $73.8 million and $64.3 million as of March 31, 2025 and 2024, respectively. We expect to continue to incur net losses and expect significant cash outflows for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern for the one year period from the date the financial statements are issued. Furthermore, our independent registered public accounting firm’s report included an explanatory paragraph that there was substantial doubt about our ability to continue as a going concern.

We identified a material weakness in our internal control over financial reporting relating to the preparation and review of our financial statements. If the remediation of this material weaknesses is not effective, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business.

As a privately-held company, we were not required to evaluate our internal control over financial reporting in a manner that meets the standards of publicly traded companies as required by Section 404(a) of the Sarbanes-Oxley Act, or Section 404. In the course of preparing the financial statements that are included in this prospectus, our management determined that a material weakness existed within our internal controls over financial reporting. The material weakness identified relates to the lack of accounting resources to properly prepare and review our financial statements. We concluded that the material weakness in our internal control over financial reporting occurred because we were a private company and did not have the necessary business processes, systems, personnel, and related internal controls necessary to satisfy the accounting and financial reporting requirements of a public company. In order to remediate the material weakness, we will continue to expend a substantial amount of effort and resources for the remediation and improvement of our internal control over financial reporting.

Even if this offering is successful, we will require substantial additional capital to finance our operations, and failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.

The development of biopharmaceutical product candidates, including conducting preclinical studies and clinical trials, is a very time-consuming, capital-intensive and uncertain process. Our operations have consumed substantial amounts of cash since inception. We expect our expenses to substantially increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned clinical trials and potentially seek regulatory approval for our leading candidates and any future product candidates we may develop. In addition, if we are able to progress through development and commercialization, we expect to be required to make milestone and royalty payments pursuant to various license or collaboration agreements with third parties. If we obtain regulatory approval for either of our leading candidates or any future product candidates, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution. Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of capital necessary to successfully complete the development and commercialization of either of our leading candidates or any future product candidates. Furthermore, following the completion of this offering, we expect to incur additional costs associated with operating as a public company.

Based on our current operating plan, we believe that the net proceeds from this offering, together with our existing cash, will be sufficient to fund our operations through 2026, including funding our working capital needs and a Phase 2 study for STAR-LLD in MM and a Phase 1 study in CLL. We have based these estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands for our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned.

The net proceeds of this offering, together with our existing capital, may not be sufficient to complete the development of either of our leading candidates in any form, or any future product candidates, and after this offering, we will require substantial capital in order to advance such development efforts for either of our leading candidates

and any future product candidates through clinical trials, regulatory approval and commercialization. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Our ability to raise additional funds may be adversely impacted by global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, or even cease operations. We expect to finance our cash needs through public or private equity or debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop either of our leading candidates or any future product candidates.

Our future capital requirements will depend on many factors, including without limitation:

•        the initiation, type, number, scope, progress, expansions, results, costs and timing of clinical trials and preclinical studies of either of our leading candidates and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans (including an increase in the number, size, duration and/or complexity of a trial) based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials;

•        the costs and timing of manufacturing for either of our leading candidates or any future product candidate, including commercial manufacturing at sufficient scale and encountering higher than expected costs to manufacture our current and future active pharmaceutical ingredients, if any product candidate is approved, including as a result of inflation, any supply chain issues or component shortages;

•        slower than expected progress in developing either of our leading candidates or a future product candidate, including without limitation, additional costs caused by such program delays;

•        the costs, timing and outcome of regulatory meetings and reviews of either of our leading candidates and developing certain formulations of either of our leading candidates or any future product candidates in any jurisdictions in which we or our current or any future collaborators may seek approval for either of our leading candidates or any future product candidates;

•        our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting;

•        the timing and payment of milestone, royalty or other payments we must make pursuant to our existing and potential future license or collaboration agreements with third parties;

•        the costs and timing of establishing or securing sales and marketing capabilities and commercial compliance programs if either of our leading candidates or any future product candidate is approved;

•        higher than expected personnel, consulting or other costs, such as adding personnel or industry expert consultants or pursuing the licensing/acquisition of additional assets;

•        higher than expected costs to obtain, maintain, enforce and protect our patents and other intellectual property and proprietary rights;

•        our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;

•        our ability and strategic decision to develop future product candidates other than either of our leading candidates, and the timing of such development, if any;

•        patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;

•        the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and

•        our ability to raise sufficient funds when and if required.

Conducting clinical trials and preclinical studies and potentially identifying future product candidates is a time-consuming, expensive, and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize either of our leading candidates or any future product candidates. If approved, either of our leading candidates and any future product candidates may not achieve commercial success. We expect that our commercial revenue, if any, will initially be derived from sales of either of our leading candidates, which we do not expect to be commercially available for several years, if at all. Commercial success in the United States may depend upon acceptance and coverage by federal healthcare program and third-party payors, and it can be time consuming and costly to demonstrate that any of our products should be covered.

Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability, market-wide liquidity shortages, geopolitical events or otherwise.

We may not be able to raise enough capital to fund our operations for the long term.

There can be no assurance that the offering will yield sufficient proceeds to provide enough funding to support its operations for the long term. We may not be able to raise additional debt or equity financing on favorable terms or at all going forward.

If we are unable to successfully develop or commercialize new products, or to do so on a timely or cost effective basis, our operating results will suffer.

Developing and commercializing a new product is time consuming and costly and is subject to numerous factors that may delay or prevent development and commercialization. Our future results of operations will depend to a significant extent upon our ability to successfully gain FDA approval of and commercialize new products in a timely and cost effective manner. There are numerous difficulties in developing and commercializing new products, including:

•        The ability to develop products in a timely and cost effective manner and in compliance with regulatory requirements;

•        The success of the pre-clinical and clinical testing processes to ensure that new products are safe and effective or chemically identical and bioequivalent to the branded reference listed drug;

•        The risk that any of our products presently under development, if and when fully developed and tested, will not perform as expected;

•        Delays or unanticipated costs, including delays associated with the completion of clinical trials for our branded products;

•        Delays associated with FDA registration, listing and approval processes and the ability to obtain in a timely manner, and maintain, required regulatory approvals;

•        Legal actions against our products brought by brand competitors, and legal challenges to our branded products or branded product intellectual property;

•        The availability, on commercially reasonable terms, of raw materials, including API and other key ingredients;

•        Our ability to scale up manufacturing methods to successfully manufacture commercial quantities of products in compliance with regulatory requirements; and

•        Acceptance of our products by physicians, patients, payors and the healthcare community.

As a result of these and other difficulties, products currently in development may or may not receive necessary regulatory approvals on a timely basis or at all and we may not succeed in effectively managing our development costs. Further, if we are required by the FDA or any equivalent foreign regulatory authority to complete clinical trials in addition to those we currently expect to conduct, to repeat a clinical trial that has already been completed, or if there are any delays in completing preclinical studies, filing an investigational new drug application, or completing clinical trials, our expenses could increase. This risk exists particularly with respect to the introduction of branded products because of the uncertainties, higher costs, and lengthy time frames associated with research and development of such products and the inherent unproven market acceptance of such products.

Our future profitability depends, in part, upon our ability to introduce, on a timely basis, new products.

The timeliness of our product introductions is dependent upon, among other things, the timing of regulatory approval of our products, which to a large extent is outside of our control, as well as the timing of competing products. As additional suppliers introduce comparable pharmaceutical products, price competition intensifies, market access narrows and product sales prices and gross profit percentage decline, often significantly and rapidly. Accordingly, our total revenues and future profitability are dependent, in part, upon our ability to file NDA’s with the FDA and gain approvals timely and effectively. No assurances can be given that we will be able to develop and introduce successful products in the future within the time constraints necessary to be successful. If we are unable to continue to timely and effectively file NDA’s with the FDA, our total revenues, gross profit percentage, and operating results may decline significantly, and our prospects and business may be materially adversely affected.

If any of our products, when developed and approved, cannot be successfully or timely commercialized, our operating results could be adversely affected. We cannot guarantee that any investment we make in developing products will be recouped, even if we are successful in commercializing those products.

We will need to expend a significant amount of resources on research and development, which may not lead to successful product introductions.

We expend resources on research and development primarily to enable us to manufacture and market FDA approved products in accordance with FDA regulations. As we continue to develop new products, we will likely incur increased research, development and licensing expenses. Because of the inherent risk associated with research and development efforts in our industry, our research and development expenditures may not result in the successful introduction of new FDA approved products. Also, after we submit an NDA, the FDA may request that we conduct additional clinical trials for an NDA and conduct post-marketing surveillance of our products if approved. Although manufacturing for our products uses well established technologies, we may encounter delays or technology barriers that delay or even make our products unviable. As a result, we may be unable to reasonably determine the total research, development, and manufacturing costs required to develop a particular product. Finally, we cannot be certain that any investment made in developing products will be recovered, even if we are successful in commercializing the product. To the extent that we expend significant resources on research and development efforts and are not ultimately able to introduce successful new products as a result of those efforts or cost effectively commercialize new products, our business, financial position and results of operations may be materially adversely affected.

We will incur operating losses for the foreseeable future.

Our net loss was approximately $9.5 million and $15.0 million for the years ended March 31, 2025 and 2024, respectively. Our net losses may fluctuate significantly from quarter to quarter and year to year.

We devote significant amounts of financial resources to the research and development of our preclinical and clinical programs. We may incur significant expenses in the future. Some of these expenses will be made in connection with our ongoing activities, as we:

•        Launch new products into the marketplace;

•        Conduct clinical trials and seek regulatory approval for products;

•        Continue development of our pipeline product candidates;

•        Conduct preclinical studies for product candidates;

•        Add personnel to continue clinical and preclinical product development efforts; and

•        Continue our research and development efforts for new product opportunities, including business development and acquisitions.

To become profitable, we must succeed in developing or acquiring products, obtaining regulatory approval for them, and manufacturing, marketing, and selling those products for which we may obtain regulatory approval. Even if we achieve profitability for any period in the future, we may not be able to sustain profitability in subsequent periods. Our failure to become profitable would depress our market value and could impair our ability to raise capital, expand our business, discover, or develop other products or continue our operations. A decline in the value of our company could cause you to lose all or part of your investment.

We face intense competition from development companies including startups and large pharmaceutical companies that could limit or even make obsolete our market objectives. This could significantly limit our growth and materially adversely affect our financial results.

The pharmaceutical industry is highly competitive. The principal competitive factors in the pharmaceutical industry include:

•        Introduction of other brand or generic drug manufacturers’ products in direct competition with our products;

•        Ability of generic competitors to quickly enter the market after the expiration of patents or exclusivity periods, diminishing the amount and duration of significant profits;

•        Company’s reputation as a manufacturer and distributor of quality products;

•        Product appearance and labeling; and

•        A company’s breadth of potential product offerings.

We face, and will continue to face, competition from pharmaceutical, biopharmaceutical, and biotechnology companies developing similar products and technologies. Many of our competitors have longer operating histories and greater financial, research and development, marketing, and other resources than we do. Consequently, many of our competitors may be able to develop products or processes competitive with, or superior to, our own. Furthermore, we may not be able to differentiate our products from those of our competitors, to successfully develop or introduce new products, on a timely basis or at all, that are less costly than those of our competitors, or to offer payment and other commercial terms to customers as favorable as those offered by our competitors. The markets in which we compete and intend to compete are undergoing, and are expected to continue to undergo, rapid and significant change. We expect competition to intensify as technological advances and consolidations continue. New developments by other manufacturers and distributors could render our products uncompetitive or obsolete.

Our branded pharmaceutical expenditures may not result in commercially successful products.

We have made significant investments in the development of branded products. We cannot be certain that these development costs will result in the successful development or launch of branded products or will improve the long term profitability of our business. While we endeavor (with our relevant development and manufacturing partners, as applicable) to protect our branded assets by incorporating specialized manufacturing processes and by securing regulatory exclusivities and intellectual property protections, such exclusivities and protections can be subject to legal challenges that might result in a reduction of the exclusivity period or a loss of exclusivity.

We continue to expand our product line. The success of our branded products will be based largely on the successful identification and future development of our product opportunities. We cannot be certain that our branded product expenditures will result in successful research and development of our products leading to the commercially successful launches of these products or will improve the long term profitability of our business.

A business interruption at our contract manufacturing facilities or at lab facility operated by a related party that we rely on could have a material adverse effect on our business, financial condition, and results of operations.

We produce all of the products we use in research and development at contract manufacturing facilities. These facilities, or the related party lab facility that we rely on for the development, could be subject to earthquakes, power shortages, telecommunications failures, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or manmade disasters, or FDA interventions, or business interruptions. A significant disruption at any of these facilities, even on a short term basis, could impair our ability to produce and develop products on a timely basis, which could have a material adverse effect on our business, financial condition, and results of operations.

We depend to a large extent on third-party suppliers for the raw materials for our products, particularly the chemical compounds comprising the API used in the research and development of our products. Although there are multiple sources of these API’s a prolonged interruption in the supply of such products could have a material adverse effect on our business, financial position, and results of operations.

We may purchase raw materials, including API from both U.S. and non-U.S. companies. If we experience supply interruptions or delays, we may have to obtain substitute materials or products, which in turn would require us to obtain amended or additional regulatory approvals, subjecting us to additional expenditures of significant time and resources. We may source raw materials or API from a single source, which increases the risk to our business if supply from that source is interrupted.

In addition, changes in our raw material suppliers, including suppliers of API, could result in significant delays in production and higher raw material costs, because regulatory authorities must generally approve raw material sources for pharmaceutical products, which may be time consuming. Any significant supply interruption could have a material adverse effect on our business, research and development programs, financial condition, prospects, and results of operations. Because the federal drug approval application process requires specification of raw material suppliers, if raw materials from a specified supplier were to become unavailable, FDA approval of a new supplier may be required. A delay in the manufacture and marketing of the drug involved while a new supplier becomes approved by the FDA and its manufacturing process is determined to meet FDA standards could, depending on the particular product, have a material adverse effect on our results of operations and financial condition. Generally, we attempt to mitigate the potential effects of any such situation by providing for, where economically and otherwise feasible, two or more suppliers of raw materials for the drugs that we manufacture. In addition, we may attempt to enter into a contract with a raw material supplier in an effort to ensure adequate supply for certain of our products.

Further, purchasing raw materials from non-U.S. companies involves numerous factors and uncertainties beyond our control including increased shipping costs, the imposition of additional import or trade restrictions, increased custom duties and tariffs, unforeseen delays in customs, currency exchange rates, transportation delays, foreign government regulations, political instability and economic uncertainties in the countries from which we purchase our raw materials. These and other issues affecting our non-U.S. suppliers could have a material adverse effect on our business, financial condition, and results of operations.

Our future success depends on our ability to attract and retain key employees and consultants.

Our future success depends, to a substantial degree, upon the continued service of the key members of our management team. These include Pedro Lichtinger Waisman, Chairman and CEO, Scott Kahn, Chief Financial Officer, Jamie Oliver, Chief Medical Officer, Rod Hartwig, Vice President Research and Development and Manufacturing, and Shannon Wisniewski, Executive Director of Business Development and Program Management. The loss of the services of key members of our management team, or their inability to perform services on our behalf, could have a material adverse effect on our business, financial condition, prospects, and results of operations. Our success also depends, to a large extent, upon the contributions of the staff within our lab facility operated by a related party. We compete for qualified personnel against other biotechnology companies that may offer more favorable employment or contract opportunities. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we could experience constraints that would adversely affect our ability to support our research and development programs. Although we believe that we have been successful in attracting and retaining skilled personnel in all areas of our business, we cannot provide assurance that we can continue to attract, train and retain such personnel. Any failure in this regard could limit our ability to develop new products. We do not have key person insurance on any of our key employees or consultants.

We depend on our ability to protect our intellectual property and proprietary rights. We may not be able to keep our intellectual property and proprietary rights confidential and protect such rights.

Our success depends on our ability to protect and defend the intellectual property rights associated with our current and future product opportunities. If we fail to protect our intellectual property adequately, competitors may develop, manufacture and market products similar to, or that may be confused with, our products, and our competitors may obtain regulatory approval to make and distribute other versions of our products. We cannot be certain that patents will be issued with respect to any of our patent applications or that any existing or future patents issued to or licensed by us will provide competitive advantages for our products or will not be challenged, invalidated, circumvented, or held unenforceable in proceedings commenced by our competitors or other third parties. Furthermore, our patent rights may not prevent or limit our present and future competitors from developing, making, importing, using, or commercializing products that are functionally similar to our products. Some of our products, including some of our promoted products, are not protected by patents at all.

We also rely particularly on trade secrets, unpatented know-how and proprietary expertise and continuing innovation to develop and maintain our competitive position. We generally enter into confidentiality agreements with licensees, suppliers, employees, consultants, and other parties. This is done in part because not all our products are protected by patents. We cannot provide assurance that these agreements will not be breached. We also cannot be certain that we will have recourse to adequate remedies in the event of a breach. Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality agreements. We cannot be sure that our trade secrets and proprietary platform will not be independently developed or otherwise become known by our competitors or, if patents are not issued with respect to internally developed products, if we will be able to maintain the confidentiality of information relating to these products. Efforts to enforce our intellectual property rights can be costly, time consuming, and ultimately unsuccessful. Any failure to adequately prevent disclosure of our know-how, trade secrets and other propriety information could have a material adverse impact on our business and our prospects.

We may not be able to protect our intellectual property rights throughout the world.

The patent position of companies in the pharmaceutical industry generally involves complex legal and factual questions and has been and remains the subject of significant litigation in recent years. Legal standards relating to scope and validity of patent claims are evolving and may differ in various countries. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Any patents we have obtained, or may obtain in the future, may be challenged, invalidated, or circumvented. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.

Proceedings to enforce patent rights could: result in substantial costs and divert our efforts and attention from other aspects of our business; put our patents at risk of being invalidated or interpreted narrowly; put our patent applications at risk of not issuing; and provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded to us, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on any issued patent are due to be paid to the PTO and foreign patent agencies in several stages over the lifetime of the patent. The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse may, in many cases, be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, nonpayment of fees and failure to properly

prepare and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our products or product candidates, our competitors might be able to enter the market, which would harm our business, prospects, and financial position.

Our competitors or other third parties may allege that we, our suppliers, or partners are infringing their intellectual property, forcing us to expend substantial resources in litigation, the outcome of which is uncertain. Any unfavorable outcome of such litigation, including losses related to “at risk” product launches, could have a material adverse effect on our business, financial position, and results of operations.

Pharmaceutical, biotechnology and development startups are ready to enforce their intellectual property protection from entities selling or seeking regulatory approval to manufacture and market generic or other copies of their branded products, or products related to their branded products or technologies. These companies or other patent holders, including patent holders who do not have related products, may allege patent infringement or other violations of intellectual property rights. Patent holders may also bring patent infringement suits against companies that are currently marketing and selling an approved product, including an approved generic product. Litigation often involves significant expense and can delay or prevent introduction or sale of our generic or other products. For example, a certain period of delay may be statutorily prescribed, or a court could grant a patent holder injunctive relief for the period of the litigation. If third party patents are held valid, enforceable, and infringed by our products, we may, unless we could obtain a license from the patent holder, need to delay selling our corresponding product, pay damages, and, if we are already selling our product, cease selling and potentially destroy existing product stock. These risks apply to our product candidates. Third parties, including our competitors, may allege that one of our product candidates violates their patent rights, which would expose us to the same risks. A license may not be available from the patent holder on commercially reasonable terms, or at all. If available, we may choose to take a license under a third party’s patent rights to resolve a dispute, even in the absence of a finding by a court that a patent is valid, enforceable, and infringed.

There may be situations in which we may make business and legal judgments to manufacture, market or sell products that are subject to claims of alleged patent infringement prior to final resolution of those claims by the courts, based upon our belief that such patents are invalid, unenforceable, or are not infringed by our manufacturing, marketing, and sale of such products. This is referred to in the pharmaceutical industry as an “at risk” launch. The risk involved in an at risk launch can be substantial because, if a patent holder ultimately prevails against us, the remedies available to such holder may include, among other things, permanent injunctive relief preventing the sale of the product and damages measured as a reasonable royalty or by the profits lost by the patent holder, which can be significantly higher than the profits we make from selling our product. We could face substantial damages from adverse court decisions in such matters. We could also be at risk for the value of such inventory that we are unable to market or sell.

We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.

We may be subject to claims that our employees or we have inadvertently or otherwise used intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. We may also in the future be subject to claims that we have caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these potential claims.

In addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, such employees and contractors may breach the agreement and claim the developed intellectual property as their own.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A court could prohibit us from using technologies or features that are essential to our products if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and could be a distraction to our management team. In addition, any litigation or threat thereof may adversely affect our ability to hire employees or contract with independent service providers. Moreover, a loss of key personnel or their work product could hamper or prevent our ability to commercialize our products.

We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary course of business, we collect, store, and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. The size and complexity of our information technology systems, and those of our third party vendors with whom we contract, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners, or vendors, from attacks by malicious third parties, or from intentional or accidental physical damage to our systems infrastructure maintained by us or by third parties. Maintaining the secrecy of this confidential, proprietary, or trade secret information is important to our competitive business position. While we have taken steps to protect such information and invested in information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud, trickery, or other forms of deception, or for any other reason, could enable others to produce competing products, use our proprietary technology or information, or adversely affect our business or financial condition. Further, any such interruption, security breach, loss, or disclosure of confidential information, could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on our business, financial position, results of operations or cash flow. See also our “Risk Factor” below entitled “We and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs, and our actual or perceived failure to comply with such laws and obligations could subject us to potentially significant liability, fines or penalties and otherwise harm our business.”

Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations.

Our NOLs, and certain other tax attributes could expire unused and be unavailable to reduce future income tax liabilities because of their limited duration or because of restrictions under U.S. tax law. As of March 31, 2025 and 2024, we had NOLs of approximately $36.7 million and $35.4 million, respectively, for federal, and $36.2 million and $29.8 million, respectively, for state income tax purposes. Our federal NOLs do not expire; however, they are only available to offset up to 80% of taxable income for the year they are carried forward to. Our state NOLs begin to expire during the years 2037 through 2043. In addition, as of March 31, 2025 and 2024, we had Canadian NOLs of approximately $2.1 million and $2.0 million, which begin to expire during the years 2037 through 2043. In addition to our NOLs we have U.S. research tax credit carryforwards of approximately $2.4 million, which expire during the years 2037 through 2043.

Under TCJA, federal NOLs generated in tax years ending after December 31, 2017 may be carried forward indefinitely. Under the CARES Act, NOLs carryforwards arising in tax years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the 5 tax years preceding the tax year of such loss. Due to our cumulative losses, we do not anticipate that such provision of the CARES Act will be relevant to us. The deductibility of federal NOLs, particularly for tax years beginning after December 31, 2020, may be limited. It is uncertain if and to what extent various states will conform to TCJA or the CARES Act.

In addition, our NOLs are subject to review and possible adjustment by the IRS and state tax authorities. In general, under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change NOLs to offset future taxable income. Ownership changes as defined under Sections 382 and 383 will affect our ability to use our NOLs and tax credits in future years. Furthermore, our ability to use the NOLs and credits of companies that we may acquire in the future may also be subject to the same use limitations. For these reasons, we may or may not be able to use a material portion of business credits and state NOLs prior to their statutory expiration, even if we attain profitability.

We and our manufacturing partners are subject to extensive governmental regulation, and we face significant uncertainties and potentially significant costs associated with our efforts to comply with applicable regulations. Any noncompliance may result in fines or other sanctions, including debarment, product seizures, product recalls, injunctive actions, and criminal prosecutions, which could result in material adverse effects to our business, financial position, and results of operations.

The pharmaceutical industry operates in a highly regulated environment subject to the actions of courts and governmental agencies that influence the ability of a company to successfully operate its business and is subject to regulation by various governmental authorities at the federal, state and local levels with respect to the development, manufacture, labeling, sale, distribution, marketing, advertising and promotion of pharmaceutical products. As a continuous delivery startup, we are subject to extensive regulations by the federal government, principally the FDA and the DEA as well as by state governments.

The FDC Act and other federal, state, and local statutes and regulations govern the testing, manufacture, safety, labeling, storage, disposal, tracking, recordkeeping, approval, advertising, and promotion (including to the healthcare community) of our product candidates. If we, our products, the manufacturing facilities for our products, our CROs, or other persons or entities working on our behalf fail to comply with applicable regulatory requirements either before or after marketing approval, a regulatory agency, such as the FDA, may, depending on the stage of product development and approval, revoke, withdraw, or suspend approvals of previously approved products for cause, debar companies and individuals from participating in the drug approval process, request or in certain circumstances mandate recalls of allegedly violative products, seize allegedly violative products, issue Warning Letters or Untitled Letters, mandate modifications to promotional materials or require the provision of corrective information to healthcare practitioners, amend and update labels or package inserts, suspend or terminate any ongoing clinical trials, refuse to approve pending applications or supplements to applications filed, refuse to allow entry into government contracts, obtain injunctions to close manufacturing plants allegedly not operating in conformity with FDA’s cGMP requirements, stop shipments of allegedly violative products, impose import restrictions on any ingredients or components, including any APIs, that are imported from outside the U.S., impose fines perhaps significant in amount, require entry into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance and other sanctions imposed by courts or regulatory bodies, including criminal prosecutions. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions relative to that product or the manufacturing facility, including requiring product recall, notice to physicians, withdrawal of the product from the market or suspension of manufacturing.

We also cannot predict the likelihood, nature or extent of adverse government regulation that may arise from pending or future legislation or administrative action, either in the U.S. or abroad. Because of these adverse government actions our business may be negatively impacted, and if we are not able to achieve and maintain regulatory compliance, we may not be permitted to market our products or product candidates, which would adversely affect our ability to generate revenues and achieve or maintain profitability.

We are subject to extensive environmental laws and regulation, and we face significant uncertainties and potentially significant costs associated with our efforts to comply with applicable regulations.

Because of the chemical ingredients of pharmaceutical products and the nature of the manufacturing process, the pharmaceutical industry is subject to extensive environmental laws and regulation and the risk of incurring liability for damages and the costs of remedying environmental problems. These requirements include regulation of the handling, manufacture, transportation, storage, use and disposal of materials, including the discharge of hazardous materials and pollutants into the environment. In the normal course of our business, we are exposed to risks relating to possible releases of hazardous substances into the environment, which could cause environmental or property damage or personal injuries, and which could result in (i) our noncompliance with such environmental and occupational health and safety laws and regulations and (ii) regulatory enforcement actions or claims for personal injury and property damage against us. If an unapproved or illegal environmental discharge or accident occurred or if we were to discover contamination caused by prior operations, including by prior owners and operators of properties we acquire, then we could be liable for cleanup, damages, or fines, which could have a material adverse effect on our business, financial position, results of operations and cash flow. In the future, we may be required to increase expenditures in order to remedy environmental problems or comply with changes in applicable environmental laws and regulations. We could also become a party to environmental remediation investigations and activities. These obligations may relate to sites

that we currently or in the future may own or lease, sites that we formerly owned or operated, or sites where waste from our operations was disposed. Additionally, if we fail to comply with environmental regulations to use, discharge or dispose of hazardous materials appropriately or otherwise to comply with the provisions of our operating licenses, the licenses could be revoked, and we could be subject to criminal sanctions or substantial civil liability or be required to suspend or modify our manufacturing operations. We currently operate from our leased space in New Jersey and we are required to comply with the laws and regulations of New Jersey in addition to any federal laws and regulations. We may in the future establish or acquire operations in other U.S. and/or overseas jurisdictions subject to equally or more stringent laws and regulations. We may in the future establish or acquire operations in other jurisdictions subject to equally or more stringent laws and regulations. Stricter environmental, safety and health laws and enforcement policies could result in substantial costs and liabilities to us, and could subject our handling, manufacture, use, reuse or disposal of substances or pollutants to more rigorous scrutiny than is currently the case. Consequently, compliance with these laws could result in significant capital expenditures, as well as other costs and liabilities, which could materially adversely affect us.

These risks, along with others, have the potential to materially and adversely affect our business, financial position, results of operations and prospects. Although we have developed compliance programs to address the regulatory environment, there is no guarantee that these programs will meet regulatory agency standards now or in the future. Additionally, despite our efforts at compliance, there is no guarantee that we may not be deemed to be deficient in some manner in the future. If we are deemed to be deficient in any significant way, our business, financial position, and results of operations could be materially affected.

The drug regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable and typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.

Our product candidates could fail to receive regulatory approval for many reasons. For example:

•        The FDA or comparable foreign regulatory authorities may disagree that our product candidates meet the criteria for the NDA or ANDA regulatory pathway or foreign regulatory pathways;

•        We may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective or chemically identical and bioequivalent to its branded reference product for its proposed indication;

•        The results of any clinical trials we conduct may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

•        We may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

•        The FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third party manufacturers with which we contract for clinical and commercial supplies; and

•        The approval policies or regulations of the FDA or comparable foreign regulatory authorities may change significantly in a manner rendering our clinical data insufficient for approval.

This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market certain of our product candidates, which would harm our business, results of operations and prospects significantly. In addition, even if we obtain approval for our product candidates, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request or may grant approval contingent on the performance of costly post marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could harm the commercial prospects for our product candidates.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or product candidate and could substantially increase the costs of commercializing our products and product candidates.

If we are found to have improperly promoted our products, we may be subject to restrictions on the sale or marketing of our products and significant fines, penalties and sanctions, and our image and reputation within the industry and marketplace could be harmed.

The FDA and other regulatory agencies, including regulatory authorities outside the U.S., strictly regulate the marketing and promotional claims that are made about drug products. In particular, promotion for a product must be balanced, truthful, non-misleading, and consistent with its labeling approved by the FDA or by regulatory agencies in other countries. We cannot prevent physicians from prescribing our products for indications or uses that are inconsistent with the approved package insert. If, however, we are found to have promoted such unapproved uses prior to the FDA’s approval for an additional indication, we may, among other consequences, receive Untitled or Warning Letters and become subject to significant liability, including False Claims Act liability, which would materially harm our business. Both the U.S. federal government and foreign regulatory authorities have levied significant civil and criminal fines against companies and individuals for alleged improper promotion and have entered into settlement agreements with pharmaceutical companies to limit inappropriate promotional activities. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would materially harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred, and our reputation could be damaged.

Manufacturing or quality control problems may damage our reputation for quality production, require costly remedial activities and negatively impact our business, results of operations, and financial condition.

As a continuous delivery startup, we are subject to substantial regulation by various governmental authorities. For instance, we must comply with requirements of the FDA and other healthcare regulators with respect to the manufacture of pharmaceutical products. We must register our facilities, whether located in the U.S. or elsewhere, with the FDA as well as regulators outside the U.S. Also, our products, including our investigational products, must be made in a manner consistent with applicable cGMP regulations, or similar standards in each territory in which we manufacture. The failure of one of our facilities, or a facility of one of our third party suppliers, to comply with applicable laws and regulations may lead to breach of representations made to our customers or to regulatory or government action against us related to products made in that facility.

Our employees and independent contractors, including consultants, vendors and any third parties we may engage in connection with development and commercialization may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could harm our business.

Misconduct by our employees and independent contractors, including consultants, vendors and any third parties we may engage in connection with development and commercialization, could include intentional, reckless or negligent conduct or unauthorized activities that violate: (i) the laws and regulations of the FDA and other similar regulatory authorities, including those laws that require the reporting of true, complete and accurate information to such authorities; (ii) manufacturing standards; (iii) data privacy, security, fraud and abuse and other healthcare laws and regulations; or (iv) laws that require the reporting of true, complete and accurate financial information and data. Specifically, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, creation of fraudulent data in preclinical studies or clinical trials or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations.

Risks Related to Development, Clinical Testing, Manufacturing, and Regulatory Approval

Results of preclinical studies, early clinical trials, or analyses may not be indicative of results obtained in later trials, and even if we complete all planned clinical trials in the future, there is no guarantee that at the time of submission the FDA will accept our new drug application (NDA).

The results of preclinical studies, early and mid-stage clinical trials or analyses of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biotechnology industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. In addition, conclusions based on promising data from analyses of clinical results may be shown to be incorrect when implemented in prospective clinical trials.

In the U.S., we are not permitted to market our product candidates until we receive regulatory approval of an NDA from the FDA. The process of obtaining such regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications and patient population. Approval policies or regulations may change, and the FDA and comparable regulatory authorities have substantial discretion in the approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval of a product candidate is never guaranteed. Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized.

Failures of or delays in clinical trials are common and have many causes, and such failures or delays could result in increased costs to us and could prevent or delay our ability to obtain regulatory approval and commence product sales for new products. We may also find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our product candidates. Moreover, we can also find unexpected or unforeseen or unexpected side effects that can delay or make the product unviable.

We may experience failures of or delays in clinical trials of our product candidates. Our planned clinical trials may not begin on time, have an effective design, enroll a sufficient number of patients, or be completed on schedule, if at all and may not meet primary or secondary endpoints. Our clinical trials may fail or be delayed for a variety of reasons, including, among others: delays in obtaining regulatory approval to commence a trial; delays in reaching agreement with the FDA or equivalent foreign regulatory authorities on final trial design; imposition of a clinical hold for safety reasons or following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities; delays in reaching agreement on acceptable terms with prospective CROs, and clinical trial sites, or failure by such CROs to carry out the clinical trial at each site in accordance with the terms of our agreements with them; delays in obtaining required institutional review board approval at each site; difficulties or delays in having patients complete participation in a trial or return for post treatment follow up, or clinical sites electing to terminate their participation in one of our clinical trials, which would likely have a detrimental effect on subject enrollment; time required to add new clinical sites; or delays or failure by us or our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.

In addition, identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends on the speed at which we can recruit patients to participate in testing our product candidates as well as completion of required follow up periods. We may not be able to identify, recruit, and enroll a sufficient number of patients, or those with required or desired characteristics or to complete our clinical trials, in a timely manner. Patient enrollment and completion of the trials is affected by factors including: the severity of the disease under investigation; the design of the trial protocol; the size of the potential patient population; the eligibility criteria for the trial in question; the perceived risks and benefits of the product candidate under trial; the proximity and availability of clinical trial sites for prospective patients; the availability of competing therapies and clinical trials; efforts to facilitate timely enrollment in clinical trials; patient referral practices of physicians; acceptance of our delivery system by patients, and the ability to monitor patients adequately during and after treatment.

If we are unable to initiate or complete our planned clinical trials or any such clinical trial is delayed for any of the above reasons or other reasons, our development costs may increase, our regulatory approval process could fail or be delayed and our ability to commercialize and commence sales of our product candidates could be materially harmed, which could have a material adverse effect on our business.

The testing required to support our clinical trials for the regulatory approval of our products is conducted primarily by independent third parties. Any failure by any of these third parties to perform this testing properly and in a timely manner may have an adverse effect upon our ability to obtain regulatory approvals.

Our applications for the regulatory approval of our products, incorporate the results of testing and other information that is conducted or gathered primarily by independent third parties (including, for example, manufacturers of raw materials, testing laboratories, CROs, or independent research facilities). Our ability to obtain and maintain regulatory approval of the products being tested is dependent, in part, upon the quality of the work performed by these third parties, the quality of the third parties’ facilities and the accuracy of the information provided by third parties. Our control over any of these factors may be limited. We rely on these parties for execution of our preclinical studies and clinical trials, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of all of our regulatory responsibilities. We and our CROs are required to comply with FDA laws and regulations regarding cGCP guidelines for all of our products in clinical development. Regulatory authorities enforce GCP through periodic inspections of trial sponsors, principal investigators and trial sites.

If we or any of our CROs fail to comply with applicable GCP, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We also rely on contract laboratories and other third parties, such as CROs, to conduct or otherwise support our nonclinical laboratory studies properly and on time, which are subject to GLP requirements. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with applicable GCP and GLP regulations. In addition, our clinical trials must be conducted with products produced under the FDA’s cGMP regulations. While we have agreements governing activities of our CROs, we have limited influence over their actual performance. In addition, portions of the clinical trials for our product candidates may be conducted outside of the U.S., which will make it more difficult for us to monitor CROs and perform visits of our clinical trial sites and will force us to rely heavily on CROs to ensure the proper and timely conduct of our clinical trials and compliance with applicable regulations, including GCP and GLP requirements.

Our products or product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved package insert or market acceptance or result in significant negative consequences during development or following marketing approval.

Treatment with our products or product candidates may produce undesirable side effects or adverse reactions or events. Although many of our products or product candidates contain active ingredients that have already been approved, meaning that the side effects arising from the use of the active ingredient or class of drug in our products or product candidates is generally known, our products or product candidates may still cause undesirable or unknown side effects. These could be attributed to the active ingredient or class of drug or to our unique formulation and delivery method of such products or product candidates, or other potentially harmful characteristics. Such characteristics could cause us, our IRBs, clinical trial sites, the FDA, or other regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay, denial, or withdrawal of regulatory approval, which may harm our business, financial condition, and prospects significantly.

Further, if any of our products cause serious or unexpected side effects during development or after receiving market approval, a number of potentially significant negative consequences could result. For example, regulatory authorities may impose a clinical hold, withdraw their approval of the product or impose restrictions on its distribution, the FDA may require implementation of risk evaluation and mitigation strategies, regulatory authorities may require the addition of labeling statements, such as warnings or contraindications, we may be required to change the way the product is administered or conduct additional clinical studies, we could be sued and held liable for harm caused to patients, and our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or product candidate and could substantially increase the costs of commercializing our products and product candidates.

If our products or product candidates do not produce the effects intended or if they cause undesirable side effects, our business may suffer.

If our products or product candidates do not have the effects intended or cause undesirable side effects, our business may suffer. In addition, our products may not have the effect intended if they are not used in accordance with applicable instructions. Furthermore, there can be no assurance that any of the products, even when used as directed, will have the effects intended or will not have harmful side effects in an unforeseen way or on an unforeseen patient population. If any of our products or products we develop or commercialize in the future are shown to be harmful or generate negative publicity from perceived lack of effect or harmful effects, our business, financial condition, results of operations and prospects could be harmed significantly. If the products do not offer a noticeable benefit over the currently marketed formulations, then adoption may also be affected. Further, if the products are equivalent but no better than what’s on the market, FDA may delay or deny approval.

If side effects are identified with our marketed products, or if manufacturing problems occur, changes in labeling of products may be required, which could have a material adverse effect on our sales of the affected products. We or regulatory authorities, including the FDA, could decide that changes to the product labeling are needed to ensure the safety and effectiveness of the products. Label changes may be necessary for a number of reasons, including the identification of actual or potential safety or efficacy concerns by regulatory agencies or the discovery of significant problems with a similar product that implicates an entire class of products. Any significant concerns raised about the safety or efficacy of the products could also result in the need to reformulate those products, to conduct additional clinical trials, to make changes to the manufacturing processes, or to seek re approval of the relevant manufacturing facilities. Significant concerns about the safety and effectiveness of a product could ultimately lead to the revocation of its marketing approval. Under the Food and Drug Administration Amendments Act of 2007, the FDA has broad authority to force drug manufacturers to take any number of actions if previously unknown safety or drug interaction problems arise, including but not limited to, mandating labeling changes to a product based on new safety information (safety labeling changes). New safety issues may require us to, among other things, provide additional warnings or restrictions on product package inserts, even including boxed warnings in the U.S. or similar warnings outside of the U.S., directly alert healthcare providers of new safety information, narrow our approved indications, alter or terminate current or planned trials for additional uses of products, or even remove a product from the market, any of which could have a significant adverse impact on potential sales of the products or require us to expend significant additional funds. The revision of product labeling or the regulatory actions described above could have a material adverse effect on our sales of the affected products and on our business and results of.

Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim “top-line” or preliminary data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

Our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings, or otherwise limit their sales.

Serious adverse events or undesirable side effects caused by STAR-LLD or any other product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Any clinical trials for our drug product candidates that include STAR-LLD may fail to demonstrate acceptable levels of safety and efficacy which could prevent or significantly delay their regulatory approval or result in a more restrictive label by the FDA or other comparable foreign authorities.

If unacceptable side effects arise in the development of our product candidates, we, the FDA or the IRBs at the institutions in which our studies are conducted, or the DSMB, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications. In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Any of these occurrences may harm our business, financial condition, and prospects significantly.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:

•        Regulatory authorities may withdraw approvals of such product;

•        Regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication;

•        Additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

•        We may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients;

•        We could be sued and held liable for harm caused to patients;

•        The product may become less competitive; and

•        Our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of a product candidate, if approved, and could significantly harm our business, results of operations, and prospects.

The market opportunities for STAR-LLD may be smaller than we anticipate.

Our estimates of market potential have been derived from a variety of sources, including scientific literature, patient foundations, and market research, and may prove to be incorrect. Even if we obtain significant market share for any product candidate, following approval, if the potential target populations are smaller than we anticipate, we may never achieve profitability, for example, by obtaining marketing approval for additional indications.

Even if we obtain regulatory approval for any product candidate, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties.

Even if our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, distribution, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and comparable requirements outside of the United States. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, quality of product or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring recall or withdrawal of the product from the market.

In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP, regulations and standards. If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may

impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may:

•        issue safety alerts, “Dear Healthcare Provider” letters, press releases or other communications containing warnings about such product;

•        mandate modification to promotional materials or require us to provide corrective information to healthcare practitioners;

•        require that we conduct post-marketing studies;

•        require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific action and penalties for noncompliance;

•        seek an injunction or impose civil or criminal penalties or monetary fines;

•        suspend marketing of, withdraw regulatory approval of or recall such product;

•        suspend any ongoing clinical studies;

•        refuse to approve pending applications or supplements to applications filed by us;

•        suspend or impose restrictions on operations, including costly new manufacturing requirements; or

•        seize or detain products, refuse to import or export products or require us to initiate a product recall.

The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue.

Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

The use of STAR-LLD and/or any other product candidates we may develop in clinical trials and the sale of any products for which we obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by patients, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

•        Impairment of our business reputation and significant negative media attention;

•        Withdrawal of participants from our clinical trials;

•        Significant costs to defend the litigation;

•        Distraction of management’s attention from our primary business;

•        Substantial monetary awards to patients or other claimants;

•        Inability to commercialize STAR-LLD, and/or any other product candidate;

•        Product recalls, withdrawals, or labeling, marketing, or promotional restrictions;

•        Decreased market demand for any product; and

•        Loss of revenue.

Risks Related to Commercialization

The successful commercialization of STAR-LLD, and/or any other product candidate we develop will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels, and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the U.S., third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models in the U.S. for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

Therefore, the availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford newly approved prescription medications such as STAR-LLD if approved. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on our ability to successfully commercialize our drug and any other product candidates we develop. Assuming we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the U.S. or elsewhere will be available for our product candidates or any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

We may also be subject to extensive governmental price controls and other market regulations outside of the U.S., and we believe the increasing emphasis on cost-containment initiatives in other countries have and will continue to put pressure on the pricing and usage of medical products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own prices for medical products but monitor and control company profits.

Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the U.S., the reimbursement for our product candidates may be reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenue and profits. The downward pressure on healthcare costs in general, particularly prescription drugs and biologics and surgical procedures and other treatments, has become intense. As a result, increasingly high barriers are being erected to the entry of new products.

Moreover, increasing efforts by governmental and third-party payors in the U.S. to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the sale of our product candidates due to the trend toward managed health care, the increasing influence of health maintenance organizations and additional legislative changes.

For example, federal policymakers have intensified efforts to align U.S. prices for branded prescription drugs and biologics with the lowest prices paid in certain foreign markets (often referred to as “most-favored nation” or “MFN” pricing). Recent executive actions have directed federal agencies to communicate MFN-aligned price targets to manufacturers, explore rulemaking to impose MFN pricing where voluntary compliance is not achieved, facilitate direct-to-consumer purchasing channels, and consider additional measures, including importation pathways, enhanced antitrust scrutiny, and export controls on pharmaceuticals products or inputs. Any MFN initiative could reduce our realized net prices in the United States, which we anticipate will be our largest market for our future products. Because MFN constructs typically reference the lowest price available in a basket of developed countries (with or without adjustment for purchasing power), they can create a binding ceiling materially below prevailing U.S. net prices for certain products. The impact could be magnified if MFN benchmarks are set on net (confidential) prices rather than list prices, if MFN prices are extended beyond Medicare or Medicaid into other federal or commercial channels, or if government purchasers condition formulary access, coverage, or contracting on MFN compliance.

MFN-aligned policies may also intersect with other federal drug pricing initiatives, including Medicare negotiation under Inflation Reduction Act, inflationary rebate provisions, and potential demonstration models under the Center for Medicare and Medicaid Innovation. The cumulative effect of overlapping policies could be materially greater than the effect of any single program, and the timing, scope, and mechanics of these interactions remain uncertain. The ultimate scope, timing, and enforceability of MFN or MFN-like initiatives are uncertain and may be subject to legal challenge, congressional action, administrative discretion, and changes in Administration policy. We cannot predict whether, when, or how MFN pricing or related measures will be implemented, expanded, or enforced, or the extent to which third parties (including payers, PBMs, wholesalers, pharmacies, group purchasing organizations, hospital systems, and international health authorities) will adopt MFN-aligned expectations in their dealings with us if we are successful in commercializing any product. Any of the foregoing, individually or in the aggregate, could have a material adverse effect on our business, financial condition, cash flows, results of operations, and ability to execute our strategy.

It may be difficult for us to profitably sell our products, if and when approved, if coverage and reimbursement for our product candidates are limited by third-party payor policies.

Third-party payors increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs or biologics when an equivalent generic drug, biosimilar, or a less expensive therapy is available. It is possible that a third-party payor may consider our product candidates as substitutable and offer to reimburse patients only for the less expensive product.

Even if we show improved efficacy or improved convenience of administration with our product candidates, pricing of existing drugs may limit the amount we will be able to charge for our product candidates. These payors may deny or revoke the reimbursement status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return on our investment in our product candidates. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our product candidates.

Moreover, no uniform policy for coverage and reimbursement for products exists among third-party payors in the U.S. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we believe that changes in these rules and regulations are likely.

Even if STAR-LLD, and/or any product candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

If STAR-LLD, and/or any product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community. If it does not achieve an adequate level of acceptance, we may not generate significant product revenues or become profitable. The degree of market acceptance of our product candidates, if approved, will depend on a number of factors, including but not limited to:

•        The efficacy and potential advantages compared to alternative treatments;

•        Effectiveness of sales and marketing efforts;

•        The cost of treatment in relation to alternative treatments, including any similar generic treatments;

•        Our ability to offer our products for sale at competitive prices;

•        The convenience and ease of administration compared to alternative treatments;

•        The willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•        The strength of marketing and distribution support;

•        The availability of third-party coverage and adequate reimbursement;

•        The prevalence and severity of any side effects; and

•        Any restrictions on the use of our product together with other medications.

Because we expect sales of our product candidates, if approved, to generate substantially all of our revenues for the foreseeable future, the failure of our product candidates to find market acceptance would harm our business and could require us to seek additional financing.

If we are unable to establish sales, marketing, and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing STAR-LLD.

We do not have any infrastructure for the sales, marketing, or distribution of STAR-LLD, and the cost of establishing and maintaining such an organization may exceed the cost-effectiveness of doing so. In order to market and successfully commercialize our drug or any product candidate we develop, we must build our sales, distribution, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. We expect to build a focused sales, distribution, and marketing infrastructure to market STAR-LLD/in the U.S. There are significant expenses and risks involved with establishing our own sales, marketing, and distribution capabilities, including our ability to hire, retain, and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact the commercialization of that product. For example, if the commercial launch of STAR-LLD for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our product candidates on our own include:

•        Our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

•        The inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe our products; and

•        Unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If we are unable to build our own sales force or negotiate a collaborative relationship for the commercialization of STAR-LLD we may be forced to delay the potential commercialization of the drug or reduce the scope of our sales or marketing activities. If we need to increase our expenditures to fund commercialization activities for STAR-LLD we will need to obtain additional capital, which may not be available to us on acceptable terms, or at all. We may also have to enter into collaborative arrangements for STAR-LLD at an earlier stage than otherwise would be ideal and we may be required to relinquish rights to it or otherwise agree to terms unfavorable to us. Any of these occurrences may have an adverse effect on our business, operating results, and prospects.

If we are unable to establish adequate sales, marketing, and distribution capabilities, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates and may never become profitable. We will be competing with many companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

Risks Related to Healthcare Laws and Other Legal Compliance Matters

Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.

In both the United States and certain foreign countries, there have been a number of legislative and regulatory changes or proposed changes to the healthcare system, many of which have focused on prescription drug pricing and lowering overall healthcare costs, that could impact our ability to sell our products profitably and support future innovation. We expect prescription drug pricing and other healthcare costs to continue to be subject to intense political and social pressures on a global scale.

In the United States, the President, federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of healthcare and addressing public concern over access and affordability of prescription drugs. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), made significant changes to the U.S. healthcare system, which included expanding healthcare coverage through Medicaid and implementation of the individual health insurance mandate; changing coverage and reimbursement of drug products under Medicare, Medicaid and 340B government programs; imposing an annual fee on manufacturers of branded drugs; and expanding government enforcement authority. The ACA has been the subject of legislative and litigation challenges. We cannot predict what effect, if any, further changes to the ACA would have on our business, if any.

In the current U.S. administration, we are uncertain of the impact or outcome of potential Executive Orders, rescission of rules and policy statements, or new legislation including the imposition of tariffs, especially any relative impact on the healthcare regulatory and policy landscape, or the impact they may have on our business. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs, or any significant taxes or fees imposed as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, or otherwise, could have an adverse impact on our anticipated product revenues.

There have been several recent U.S. Congressional inquiries and proposed and enacted legislation designed to bring more transparency to drug pricing, reduce the cost of prescription drugs, and reform government health care program reimbursement methodologies for prescription drugs. On September 20, 2024, CMS issued a final rule titled “Medicaid Program; Misclassification of Drugs, Program Integrity Updates Under the Medicaid Drug Rebate Program” which may impact our reimbursement and rebate strategy. We expect that health care reform measures that may be adopted in the future may result in increased manufacturer financial liability and additional downward pressure on the price that we may receive for any of our product candidates, if approved. Any reduction in reimbursement from Medicare or other government health care programs may result in a similar reduction in payments from private payors.

The Inflation Reduction Act of 2022 (IRA) included, among other provisions, several measures intended to lower the cost of prescription drugs and related healthcare reforms. Specifically, the IRA authorizes and directs the Centers for Medicare and Medicaid Services (CMS) to set drug prices for certain Medicare Part B and Part D qualified drugs with the greatest expense to the program, with the first year of maximum price applicability to begin in 2026 and an expanding list of selected drugs each year after. The Act further authorizes CMS to levy a financial penalty on pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part D drugs faster than the rate of inflation. Finally, the IRA creates significant changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025 and creating new financial liabilities for drug manufacturers and health plans providing Part D benefits. We cannot be sure whether additional or related legislation or rulemaking will be issued or enacted, or what impact, if any, such changes will have on our reimbursement strategy and the profitability of any of our drug candidates, if approved for commercial use, in the future.

Furthermore, legislative and regulatory proposals have been made to expand post-approval requirements, make changes to the Orphan Drug Act and related guidance, reform the 340B Drug Pricing Program, and restrict sales and promotional activities for drugs. With respect to the 340B Drug Pricing Program, recent legislative proposals, as well as judicial challenges to DHHS’s policies, present both opportunities and challenges for drug manufacturers participating in the program. Further, we cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

In many international markets, including the European Union, the government regulates prescription drug prices, patient access, and/or reimbursement levels to control the biopharmaceutical budget of their government-sponsored healthcare system. The European Union and some individual countries have announced or implemented measures and may in the future implement new or additional measures, to reduce biopharmaceutical costs to contain healthcare expenditures. These measures vary by country and may include, among other things, non-coverage decisions, patient access restrictions, international price referencing, mandatory discounts or rebates, and cross-border sales of prescription drugs. These measures may impact our reimbursement strategy and could adversely affect our ability to generate revenues or commercialize STAR-LLD or other product candidates in certain international markets.

At the state level, individual states are experiencing significant economic pressure within their respective Medicaid programs and responding to public concern over the cost of healthcare. States, including California, Florida, Nevada and Maine, among others, have responded to these pressures with a range of legislative enactments and policy proposals designed to control prescription drug prices by, for example, allowing importation of pharmaceutical products from jurisdictions outside the U.S., imposing Prescription Drug Affordability Boards, some with the ability to impose price controls on state drug purchases and imposing transparency measures around prescription drug prices and marketing costs. These measures, which vary by state, could adversely impact our coverage and reimbursement of our product candidates, reduce the ultimate demand for our products, if approved, and put pressure on our product net pricing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for STAR-LLD and any future product candidates, if approved, or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

We expect that these new laws and other healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. There likely will continue to be pressure on prescription drug prices globally and legislative and regulatory proposals, including at the federal and state levels in the U.S., directed at broadening the availability of health care and containing or lowering the cost of health care products and services. The implementation of these cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize STAR-LLD and any future product candidates, if approved, impact our ability to set a price that we believe is fair for our products, the level of taxes we are required to pay, and the availability of capital.

Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our product candidates, if approved. Such laws include:

•        The U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving, or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order, or recommendation of, any good, facility, item, or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. The U.S. federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. Although there are several statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution, they are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending or arranging for the prescription or purchase of any drug product may be subject to scrutiny if they do not qualify for an exception or safe harbor. This law applies to our marketing practices, educational programs, pricing policies and relationships with healthcare providers. We continue to evaluate what effect, if any, these rules will have on our business;

•        The U.S. federal false claims and civil monetary penalties laws, including the civil FCA which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly

making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute or the Federal Food, Drug, and Cosmetic Act (FDC Act) constitutes a false or fraudulent claim for purposes of the FCA. A claim includes “any request or demand” for money or property presented to the federal government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims;

•        HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

•        HIPAA, as amended by the HITECH, and their respective implementing regulations, which impose, among other things, specified requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;

•        The FDC Act, and its implementing regulations, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;

•        A wide range of federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers, including those related to privacy;

•        The U.S. federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services (CMS), information related to payments and other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiology assistants and certified nurse-midwives), and teaching hospitals and other healthcare providers, as well as ownership and investment interests held by such healthcare professionals and their immediate family members;

•        Federal laws, including the Medicaid Drug Rebate Program, that requires pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs and the 340B Drug Discount Pricing Program which requires pharmaceutical manufacturers offering their products through the Medicaid program to offer discounts on those drugs to certain 340B covered entities;

•        The Drug Supply Chain Security Act (DSCSA), which imposes obligations on entities in the commercial product supply chain, including manufacturers, to identify and track prescription drugs as they are distributed in the U.S

•        Analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance

promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business activities, including our consulting agreements and other relationships with physicians and other healthcare providers, some of whom receive stock or stock options as compensation for their services, could be subject to challenge under one or more of such laws. Ensuring that our current and future internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid, and other federal healthcare programs, individual imprisonment, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. If any of the physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect our ability to operate our business. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products and product candidates.

As is the case with other biotechnology and pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biotechnological and pharmaceutical industries involve both technological complexity and legal complexity. Therefore, obtaining and enforcing patents is costly, time-consuming, and inherently uncertain. In addition, the America Invents Act (“AIA”), which was passed in September 2011, resulted in significant changes to the U.S. patent system.

An important change introduced by the AIA is that, as of March 16, 2013, the U.S. transitioned to a “first-to-file” system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that files a patent application in the PTO after that date but before us could therefore be awarded a patent covering an invention of ours even if we made the invention before it was made by the third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application, but circumstances could prevent us from promptly filing patent applications on our inventions.

Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent before the PTO. This applies to all of our U.S. patents, even those effectively filed before March 16, 2013. Because of a lower evidentiary standard in PTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a PTO proceeding sufficient for the PTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.

Accordingly, a third party may attempt to use the PTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. It is not clear what, if any, impact the AIA will have on the operation of our business. However, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned and in-licensed patent applications and the enforcement or defense of our owned and in-licensed patents.

Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the federal courts and the PTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. Similarly, the complexity and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is relatively stringent in the type of amendments that are allowed during prosecution. Complying with these laws and regulations could limit our ability to obtain new patents in the future that may be important for our business.

If we do not obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for our products, our business may be materially harmed.

Patents have a limited lifespan. In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our products are obtained, once the patent life has expired for a product, we may be open to competition from competitive medications, including generic medications. Given the amount of time required for the development, testing and regulatory review of new products, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from using or commercializing technologies or products similar or identical to ours.

Depending upon the timing, duration, and conditions of FDA marketing approval of our product candidates, we may be able to extend the term of a patent covering each product candidate under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act, and similar legislation in the EU. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent that is applicable to and covers an approved drug may be extended. Similar provisions are available in Europe, such as supplementary protection certificates, and in certain other non-U.S. jurisdictions to extend the term of a patent that covers an approved drug. However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of a patent term extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced, possibly materially.

Further, under certain circumstances, the term of a patent covering our products may be extended for time spent during the pendency of the corresponding patent application in the PTO (referred to as Patent Term Adjustment (“PTA”)). The laws and regulations underlying how the PTO calculates the PTA is subject to change and any such PTA granted by the PTO could be challenged by a third party. If we do not prevail under such a challenge, the PTA may be reduced or eliminated, resulting in a shorter patent term, which may negatively impact our ability to exclude competitors.

Because PTA added to the term of patents covering pharmaceutical products has particular value, our business may be adversely affected if the PTA is successfully challenged by a third party and our ability to exclude competitors is reduced or eliminated.

We and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs, and our actual or perceived failure to comply with such laws and obligations could subject us to potentially significant liability, fines or penalties and otherwise harm our business.

We and our service providers maintain and will maintain a large quantity of sensitive information, including confidential business and patient health information, in connection with our preclinical studies and clinical trials, and are subject to laws and regulations governing the privacy and security of such information. The global data protection

landscape is rapidly evolving, and we and our service providers may be affected by or subject to new, amended or existing laws and regulations in the future, including as our operations continue to expand or if we decide to operate in foreign jurisdictions. These laws and regulations may be subject to differing interpretations, which adds to the complexity of processing personal data. Guidance on implementation and compliance practices is often updated or otherwise revised. This may create uncertainty in our business, affect our ability to operate in certain jurisdictions or to collect, store, transfer, use, share and otherwise process personal information, necessitate the acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us. These laws are rapidly changing, such that tracking, analyzing, and complying with these laws requires significant time and expenses and can materially impact our business, as it may require investing in additional security system technical upgrades, updating contracts, consent forms, internal policies and procedures, external privacy notices, and other protocols. Any failure or perceived failure by us to comply with federal, state or foreign laws or regulation, our internal policies and procedures or our contracts governing our processing of personal information could result in negative publicity, government investigations and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

As our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities. In the United States, numerous federal and state laws and regulations, including health information privacy laws, data breach notification laws and consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, storage, transfer, disclosure, protection and other processing of health-related and other personal information could apply to our operations or the operations of our collaborators and third-party providers. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA. While we are not currently a covered entity under HIPAA, our future operations could subject us to HIPAA as a business associate, or even a covered entity. Depending on the facts and circumstances, we could be subject to significant penalties if we violate HIPAA.

In addition, certain state laws govern the privacy and security of health-related and other personal information in certain circumstances, some of which may be more stringent, broader in scope or offer greater individual rights with respect to protected health information than HIPAA, many of which may differ from each other, thus, complicating compliance efforts. These laws are evolving rapidly and may differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. By way of example, the California Consumer Privacy Act (CCPA), which went into effect on January 1, 2020, gives California residents individual privacy rights to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that are expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability and many similar laws have been proposed at the federal level and in other states. Further, the California Privacy Rights Act (CPRA) imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It also created a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. The majority of the provisions of the CPRA went into effect on January 1, 2023. Other states are exploring their own laws, which may or may not be similar to the CCPA or the CPRA. Other states have followed California, including, but not limited to, Colorado, Connecticut, Utah, Virginia, and Washington. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.

There also are a wide variety of privacy laws in other countries that may impact our operations, now or in the future. For example, in Europe, the General Data Protection Regulation (GDPR) imposes stringent requirements regarding the collection, use, disclosure, storage, transfer or other processing of personal data of individuals within the European Economic Area (EEA), including providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches and taking certain measures when engaging third-party processors. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenue of the

noncompliant company, whichever is greater. The GDPR also confers a private right of action in some circumstances on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR. Among other things, the GDPR requires the establishment of a lawful basis for the processing of data, imposes requirements relating to the consent of the individuals to whom the personal data relates, including detailed notices for clinical trial subjects and investigators, as well as requirements regarding the security of personal data and notification of data processing obligations to the competent national data processing authorities. In addition, the GDPR increases the scrutiny of transfers of personal data from the EEA to the United States and other jurisdictions that the European Commission does not recognize as having “adequate” data protection laws. Recent legal developments in Europe have created complexity and uncertainty regarding transfers of personal data from the EEA to the United States. For example, on July 16, 2020, the Court of Justice of the European Union (CJEU) invalidated the EU-US Privacy Shield Framework (Privacy Shield) under which personal data could be transferred from the EEA to United States entities that had self-certified under the Privacy Shield scheme. While the CJEU upheld the adequacy of the standard contractual clauses (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism, and potential alternative to the Privacy Shield), it made clear that reliance on the standard contractual clauses alone may not necessarily be sufficient in all circumstances. Use of the standard contractual clauses must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals, and additional measures and/or contractual provisions may need to be put in place, however, the nature of these additional measures is currently uncertain. The European Commission issued revised standard contractual clauses on June 4, 2021 to account for the decision of the CJEU and recommendations made by the European Data Protection Board. The revised standard contractual clauses must be used for relevant new data transfers beginning on September 27, 2021 and existing standard contractual clauses arrangements must be migrated to the revised clauses by December 27, 2022. The new standard contractual clauses apply only to the transfer of personal data outside of the EEA and not the United Kingdom; the United Kingdom’s Information Commissioner’s Office launched a public consultation on its draft revised data transfers mechanisms in August 2021 and the United Kingdom standard contractual clauses came into force in March 2022, with a two-year grace period. There is some uncertainty around whether the revised clauses can be used for all types of data transfers, particularly whether they can be relied on for data transfers to non-EEA entities subject to the GDPR. As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the standard contractual clauses cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.

Further, following the withdrawal of the United Kingdom from the European Union and the EEA and the end of the transition period, we have to comply with the GDPR and separately the GDPR as implemented in the United Kingdom, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR and has the ability to fine up to the greater of €20 million/£17 million or 4% of global turnover. The relationship between the United Kingdom and the European Union and the EEA in relation to certain aspects of data protection law remains unclear, and it is unclear how United Kingdom data protection laws and regulations will develop in the medium to longer term. The European Commission has adopted an adequacy decision in favor of the United Kingdom, enabling data transfers from EU member states to the United Kingdom without additional safeguards. However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews or extends that decision, which could have implications for our transfer of personal data.

In many jurisdictions, enforcement actions and consequences for noncompliance are rising. If we experience a reportable data breach that is subject to any federal, state, or international data privacy and security laws or if our operations are found to otherwise be in violation of any data privacy and security laws, rules or regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, litigation, and the curtailment or restructuring of our operations, which could adversely affect our ability to operate our business and our financial results. In the United States, these include enforcement actions in response to rules and regulations promulgated under the authority of federal agencies and state attorneys general and legislatures and consumer protection agencies. Compliance in the event of a widespread data breach is costly. Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, rules or regulations, we cannot be certain that our program will address all areas of potential exposure and the risks in this area cannot be entirely eliminated, particularly because the requirements and government interpretations of the requirements in this space are constantly evolving. Any action

against us for violation of these laws, rules or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business, as well as damage our business or reputation. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security, fraud and reporting laws may prove costly.

Additionally, privacy advocates and industry groups have regularly proposed, and may propose in the future, self-regulatory standards that may legally or contractually apply to us. If we fail to follow these security standards, even if no personal information is compromised, we may incur significant fines or experience a significant increase in costs.

Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, store, use, transfer, disclose and otherwise process data, update our data privacy and security policies and procedures, or in some cases, impact our ability to operate in certain jurisdictions. Failure by us or our collaborators and our service providers to comply with U.S. and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose such information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend, could result in adverse publicity and adversely affect our business, financial condition, results of operations and prospects. Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to the Shares of Common Stock and this Offering

There is no active market for the Company’s securities.

Currently, no active market exists for the shares of common stock and there is no assurance that an active trading market will ever develop or, if developed, that it will be sustained. A purchaser of the shares of common stock may, therefore, be unable to resell the purchased securities. Consequently, holders of the shares of common stock may not be able to liquidate their investment in the event of an emergency or for any other reason, and the purchased securities may not be readily accepted as collateral for a loan. Therefore, proposed investors are advised that the purchase of the shares of common stock should be considered only as a long-term and speculative high-risk investment. Due to the absence of a public market for the purchased securities: (i) investors may not be able to liquidate their investment in the event of an unexpected need for cash; (ii) transferability of the purchased securities is extremely limited; and (iii) in the event of a disposition of the purchased securities, the investor could sustain a loss of all or any part of his investment.

Our management team will have immediate and broad discretion over the use of the net proceeds from this offering and may not use them effectively.

We currently intend to use the net proceeds from this offering to support our product development activities for our lead programs, STAR-LLD, including conducting clinical development and managing regulatory affairs for our product candidates; and for working capital and other general corporate purposes, including payment of certain outstanding trade payables and other amounts due and owing to related parties. See “Use of Proceeds” and “Certain Relationships and Related Transactions, and Director Independence — Deferred Consulting and Service Fees.” Our management will have broad discretion in the application of the net proceeds. Our stockholders may not agree with the manner in which our management chooses to allocate the net proceeds from this offering. The failure by our management to apply these funds effectively could have a material adverse effect on our business, financial condition, and results of operation.

We do not have any current plans to pay dividends on our shares of common stock.

We do not anticipate paying any cash dividends in the foreseeable future. If we incur indebtedness in the future to fund our future growth, our ability to pay dividends may be further restricted by the terms of such indebtedness.

Because a small number of existing stockholders own a large percentage of our voting stock, you will have minimal influence over shareholder decisions.

Existing management has significant stock ownership in the Company representing approximately 24.7% of the issued and outstanding shares of common stock prior to this offering and approximately 20.5% of the issued and outstanding shares of common stock following the consummation of this offering (or approximately 20.0% if the underwriter’s over-allotment option to purchase additional shares of our shares of common stock from us is exercised in full). As a result of such ownership concentration, these individuals will have significant influence over the management and affairs of the Company and its business. It will also exert considerable, ongoing influence over matters subject to stockholder approval, including the election of directors and significant corporate transactions, such as a merger, sale of assets or other business combination or sale of the Company. This concentration of ownership may have the effect of delaying, deferring, or preventing a change in control, impeding a merger, consolidation, takeover or other business combination involving us, or discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of the Company, even if such a transaction would benefit other stockholders.

We have operated as a private company and have no experience attempting to comply with public company obligations. Attempting to comply with these requirements will increase our costs and require additional management resources, and we still may fail to comply.

We will face increased legal, accounting, administrative and other costs and expenses as a public company. Compliance with the Sarbanes-Oxley Act of 2002, the Dodd-Frank Act of 2010, as well as rules of the Securities and Exchange Commission and Nasdaq, for example, will result in significant initial cost to us as well as ongoing increases in our legal, audit and financial compliance costs, particularly after we are no longer an “emerging growth company.” The Exchange Act will require, among other things, that we file annual, quarterly and current reports with respect to our business and financial condition. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to incur substantial costs to maintain the same or similar coverage.

As a public company, we expect to become subject to Section 404 of the Sarbanes-Oxley Act relating to internal controls over financial reporting and we expect to incur significant expense and devote substantial management effort toward ensuring compliance with Section 404. We currently do not have an internal audit group, and we will need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge. Implementing any appropriate changes to our internal controls may require specific compliance training for our directors, officers and employees, entail substantial costs to modify our existing accounting systems, and take a significant period of time to complete. Such changes may not, however, be effective in maintaining the adequacy of our internal controls, and any failure to maintain that adequacy, or consequent inability to produce accurate consolidated financial statements or other reports on a timely basis, could increase our operating costs and could materially impair our ability to operate our business. We cannot assure you that our internal controls over financial reporting will prove to be effective.

If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.

Pursuant to Section 404 of the Sarbanes-Oxley Act, our management will be required to report upon the effectiveness of our internal control over financial reporting beginning with the annual report for our fiscal year ending March 31, 2027. When and if we are a “large accelerated filer” or an “accelerated filer” and are no longer an “emerging growth company,” each as defined in the Exchange Act, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. However, for so long as we remain an emerging growth company, we intend to take advantage of an exemption available to emerging growth companies from these auditor attestation requirements. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation. To comply with the requirements of being a reporting company under the Exchange Act, we will need to upgrade our systems including information technology; implement additional financial and management controls, reporting systems, and procedures; and hire additional accounting and finance staff. If we or, if required, our auditors are unable to conclude that our internal control over financial reporting is effective, investors may lose confidence in our financial reporting, and the trading price of our common stock may decline.

We are an emerging growth company, and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act and are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including, but not limited to, only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements, exemptions from the requirements of holding non-binding advisory votes on executive compensation and seeking stockholder approval of any golden parachute payments not previously approved and not being required to adopt certain accounting standards until those standards would otherwise apply to private companies. We could be an emerging growth company until the last day of the fiscal year following the fifth anniversary of this offering, although circumstances could cause us to lose that status earlier, including if we become a large accelerated filer (in which case we will cease to be an emerging company as of the date we become a large accelerated filer, which, generally, would occur if, at the end of a fiscal year, among other things, the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter), if we have total annual gross revenue of $1.235 billion or more during any fiscal year (in which cases we would no longer be an emerging growth company as of March 31 of such fiscal year), or if we issue more than $1.0 billion in non-convertible debt during any three year period before that time (in which case we would cease to be an emerging growth company immediately). Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

Our Common Share price may be volatile and as a result you could lose all or part of your investment.

In addition to volatility associated with equity securities in general, the value of your investment could decline due to the impact of any of the following factors upon the market price of the shares of common stock:

•        disappointing results from our development efforts;

•        decline in demand for our shares of common stock;

•        downward revisions in securities analysts’ estimates or changes in general market conditions;

•        technological innovations by competitors or in competing technologies;

•        investor perception of our industry or our prospects; and

•        general economic trends.

Stock markets in general have experienced extreme price and volume fluctuations, and the market prices of securities have been highly volatile. These fluctuations are often unrelated to operating performance and may adversely affect the market price of the shares of common stock. We and the underwriters will negotiate to determine the initial public offering price. You may not be able to resell your shares at or above the initial public offering price or at all.

An active, liquid trading market for our common stock may not develop, which may limit your ability to sell your shares.

Prior to this offering, there was no public market for our common stock. Although we have applied to list our common stock on the NASDAQ Capital Market under the symbol “STA,” an active trading market for our shares may never develop or be sustained following this offering. The initial public offering price will be determined by negotiations between us and the underwriters and may not be indicative of market prices of our common stock that will prevail in the open market after the offering. A public trading market having the desirable characteristics of depth, liquidity and

requirements imposed upon U.S. broker-dealers may discourage such broker-dealers from effecting transactions in shares of our common stock, which could severely limit the market liquidity of such shares of common stock and impede their sale in the secondary market.

A U.S. broker-dealer selling penny stock to anyone other than an established customer or “accredited investor” (generally, an individual with a net worth in excess of $1,000,000 or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a special suitability determination for the purchaser and must receive the purchaser’s written consent to the transaction prior to sale, unless the broker-dealer or the transaction is otherwise exempt. In addition, the “penny stock” regulations require the U.S. broker-dealer to deliver, prior to any transaction involving a “penny stock”, a disclosure schedule prepared in accordance with SEC standards relating to the “penny stock” market, unless the broker-dealer or the transaction is otherwise exempt. A U.S. broker-dealer is also required to disclose commissions payable to the U.S. broker-dealer and the registered representative and current quotations for the securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price information with respect to the “penny stock” held in a customer’s account and information with respect to the limited market in “penny stocks”.

Stockholders should be aware that, according to the SEC, the market for “penny stocks” has suffered in recent years from patterns of fraud and abuse. Such patterns include (i) control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (iii) “boiler room” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (iv) excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, resulting in investor losses. Our management is aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities.

Delaware law and provisions in our bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the potential trading price of our common stock.

Our certificate of incorporation and bylaws that will be in effect immediately prior to the completion of this offering will contain provisions that could significantly reduce the value of our shares to a potential acquiror or delay or prevent changes in control or changes in our management without the consent of our board of directors. The provisions in our charter documents will include the following:

•        a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

•        no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

•        the exclusive right of our board of directors, unless the board of directors grants such right to the stockholders, to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;

•        the required approval of at least 66-2/3% of the shares entitled to vote to remove a director for cause, and the prohibition on removal of directors without cause;

•        the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;

•        the ability of our board of directors to alter our bylaws without obtaining stockholder approval;

•        the required approval of at least 66-2/3% of the shares entitled to vote to adopt, amend or repeal our amended and restated bylaws or repeal the provisions of our certificate of incorporation regarding the election and removal of directors;

•        a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

•        an exclusive forum provision providing that the Court of Chancery of the State of Delaware will be the exclusive forum for certain actions and proceedings;

•        the requirement that a special meeting of stockholders may be called only by the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and

•        advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of us.

We are also subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law. Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction.

Our certificate of incorporation and bylaws provide that the Court of Chancery of the State of Delaware shall be the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our certificate of incorporation and bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine; provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. Nothing in our certificate of incorporation and bylaws precludes stockholders that assert claims under the Exchange Act from bringing such claims in state or federal court, subject to applicable law. Our certificate of incorporation also provides that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. The exclusive forum provision will be applicable to the fullest extent permitted by applicable law, subject to certain exceptions. Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. It should be noted, however, that there is uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.

Any person or entity purchasing or otherwise acquiring any interest in any of our securities will be deemed to have notice of and consented to this provision. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, or could result in increased costs for a stockholder to bring a claim, particularly if they do not reside in or near Delaware, both of which may discourage lawsuits with respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choice of forum provision that will be contained in our certificate of incorporation and bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.

MARKET AND INDUSTRY DATA

We obtained the industry, market and competitive position data used throughout this prospectus from our own internal estimates and research, as well as from industry and general publications, and research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market and competitive position data included in this prospectus is reliable and based on reasonable assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.

USE OF PROCEEDS

We estimate that the net proceeds to us from the sale of shares of our shares of common stock in this offering will be approximately $37,200,000, based upon the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriter’s over-allotment option to purchase additional shares of common stock from us is exercised in full, we estimate that the net proceeds to us would be approximately $42,780,000, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the majority of the net proceeds from the offering to support product development activities for our leading drug delivery candidates, including conducting clinical development and managing our regulatory affairs for our product candidates; and for working capital and other general corporate purposes, including payment of certain outstanding trade payables and amounts due and owing to related parties.

We currently expect to use the net proceeds from this offering as follows:

•        approximately $        to advance Phase 1 clinical development of STAR-LLD-OCR in CLL;

•        approximately $        to advance Phase 2 clinical development of STAR-LLD-(SC and OCR) in high-risk RRMM;

•        approximately $        to fund several IIT studies at certain major academic centers of STAR-LLD-SC in combinations with CAR-T cell therapies in RRMM and lymphoma;

•        approximately $        to pay certain outstanding trade payables and amounts due and owing to related parties for goods and services rendered to us. See “Certain Relationships and Related Transactions, and Director Independence — Deferred Consulting and Service Fees;”

•        the balance of approximately $        to fund 1 year of working capital and other general corporate purposes.

Each $1.00 increase or decrease in the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease the net proceeds that we receive from this offering by approximately $6.7 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions payable by us. Similarly, each increase or decrease of 1.0 million in the number of shares of our shares of common stock offered by us would increase or decrease the net proceeds that we receive from this offering by approximately $6.0 million, assuming the assumed initial public offering price remains the same and after deducting the estimated underwriting discounts and commissions payable by us.

The principal purposes of this offering are to increase our capitalization and financial flexibility, create a public market for our shares of common stock, and enable access to the public equity markets for us and our stockholders.

Based on our current plans, we believe that the net proceeds from this offering, together with our existing cash, will be sufficient to fund our operations through 2026.

The net proceeds from this offering, together with our existing cash and cash equivalents, are expected to fully fund the Phase 2a multiple myeloma clinical trial in high-risk relapsed/refractory patients (second line and higher) and allow us to initiate a Phase 1 study in CLL for STAR-LLD-OCR; however, they are not expected to be sufficient to complete Phase 3 clinical studies or to seek NDA’s for commercialization for STAR-LLD-OCR or to pursue further clinical studies for other potential pipeline programs, and we will need to raise substantial additional capital to complete the development of this or any other product candidate. See section entitled “Risk Factors” starting on page 12.

STOCK SPLIT

On December 9, 2025, we effected a 1-for-3 reverse stock split. The stock split affects all of our stockholders uniformly and did not affect any stockholder’s percentage ownership interest in us. Unless otherwise indicated, and other than the consolidated financial statements and the related notes included elsewhere in this prospectus, information presented in this prospectus is adjusted to reflect our 1-for-3 reverse stock split.

DIVIDEND POLICY

We have never declared or paid cash dividends on our capital stock and have no present intention to pay cash dividends on our common stock for the foreseeable future. Any determination to pay dividends to holders of our common stock will be at the discretion of our board of directors and will depend on many factors, including our financial condition, results of operations, liquidity, earnings, projected capital and other cash requirements, legal requirements, restrictions in the agreements governing any indebtedness we may enter into, business prospects and other factors that our board of directors deems relevant. Investors should not purchase our common stock with the expectation of receiving cash dividends.

REORGANIZATION

Prior to our corporate reorganization, which was consummated on November 5, 2025, our equity owners held their ownership interests in our subsidiary (and former holding company) Starton Therapeutics Inc., a corporation incorporated under the Business Corporations Act (British Columbia) (“Starton Canada”), which in turn held all of the equity interests in our operating company, Starton Therapeutics, Inc., a Delaware corporation.

As a result of our corporate reorganization, we now own directly or indirectly, Starton Callco ULC, a British Columbia unlimited liability company (“CallCo”), Starton Exchangeco Inc., a British Columbia corporation (“Exchangeco”), Starton Canada, and Starton Therapeutics, Inc., a Delaware corporation. All of our equity owners own all of their equity interests only in our capital stock or in shares of Exchangeco that are exchangeable for our capital stock.

In connection with our corporate reorganization, Exchangeco issued 9,992,352 shares in the capital stock of Exchangeco (“Exchangeable Shares”) to certain Canadian equity owners in Starton Canada in exchange for their shares in Starton Canada with the intention of allowing the Rollover Shareholders to continue deferring tax in Canada following our corporate reorganization for as long as they continue to own Exchangeable Shares. The Exchangeable Shares are exchangeable for shares of our common stock. Holders of Exchangeable Shares also received shares of our special voting stock, which provide the holders of Exchangeable Shares with certain voting rights, by way of a voting trustee, with respect to matters on which holders of shares of our common stock are entitled to vote. The Exchangeable Shares and special voting stock are intended to be the economic and voting equivalent of shares of our common stock.

The following information describes in more detail our current capital structure immediately after our corporate reorganization. The diagrams included in this section are simplified illustrations that summarize our capital structure and are intended only as a supplement to, and not a substitute for, the following information regarding our corporate reorganization.

Post-Reorganization Capitalization

Prior to the completion of this offering, we will have outstanding and reserved for issuance:

•        32,695,939 shares of our common stock, including 9,992,352 shares of our common stock issuable in the future, if at all, upon the exchange of an equal number of exchangeable shares of Exchangeco;

•        9,992,352 shares of our special voting stock; and

•        7,488,778 shares of our common stock issuable upon the exercise, if at all, of Options to purchase 7,488,778 shares of our common stock.

The former stockholders of Starton Canada through their ownership of Exchangeable Shares of Exchangeco will be the only group of persons who will have an interest in one of our subsidiaries.

Corporate Structure

Set forth below is a diagram that graphically illustrates, in simplified form, our current corporate structure (following our November 2025 corporate reorganization), prior to the completion of this offering.

CAPITALIZATION

The following table sets forth our cash as well as our capitalization, as of September 30, 2025 as follows:

•        on an actual basis;

•        on the basis of (i) our Reorganization whereby 93,956,176 shares of Starton Therapeutics, Inc were exchanged for an equal number of shares in Starton Holdings, Inc., and (ii) our post-Reorganization 1-for-3 reverse stock split on December 9, 2025 resulting in an adjustment of 93,95,176 shares of common stock in Starton Holdings to 31,318,586 shares of common stock in Starton Holdings, Inc.; and

•        on a pro forma as adjusted basis, giving effect to the sale and issuance by us of 6,666,667 shares of our shares of common stock in this offering, based upon the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma as adjusted information set forth in the table below is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. You should read this table together with our consolidated financial statements and related notes, and the sections titled “Selected Consolidated Financial and Other Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that are included elsewhere in this prospectus.

____________

(1)      The actual capitalization data represents the historical capitalization data of Starton Therapeutics, Inc. as of September 30, 2025. In connection with the Reorganization in November 2025, Starton Holdings, Inc. became the parent company of Starton Therapeutics, Inc. and all shares of Starton Therapeutics, Inc. were exchanged for an equal number of shares in Starton Holdings, Inc.

(2)      The Reorganization adjustments give effect to our Reorganization in November 2025 whereby all shares of Starton Therapeutics, Inc. were exchanged for an equal number of shares in Starton Holdings, Inc. and our post-Reorganization 1-for-3 reverse stock split on December 9, 2025.

(3)      The offering adjustments data represents the capitalization data of Starton Holdings, Inc. and reflects the adjustments described in footnote (2) to this table and the issuance and sale by us of 6,666,667 shares of our common stock in this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, at an assumed initial public offering price of $6.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus and the payment of $461,092 in offering expenses incurred by the Company as of September 30, 2025.

(4)      The proforma as adjusted data represents the capitalization data of Starton Holdings, Inc. and reflects the pro forma adjustments described in footnote (3) to this table. Each $1.00 increase or decrease in the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the amount of our pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit), and total capitalization by $6.2 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions payable by us. An increase or decrease of 1.0 million shares in the number of shares offered by us would increase or decrease, as applicable, the amount of our pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit), and total capitalization by $5.6 million, assuming the assumed initial public offering price remains the same, and after deducting estimated underwriting discounts and commissions payable by us.

(5)      As noted in footnote (1) above, the actual outstanding common stock represents that of Starton Therapeutics, Inc. as of September 30, 2025. The pro forma as adjusted common stock represents that of Starton Holdings, Inc. after giving effect to the Reorganization in November 2025, our December 9, 2025 1-for-3 reverse stock split, the issuance of shares from this offering and the issuance of outstanding common stock subscriptions.

If the underwriters’ over-allotment option to purchase additional shares of our shares of common stock from us were exercised in full, pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit), total capitalization, and shares outstanding as of September 30, 2025 would be $37,810,056, $114,823,091, $33,850,857, $71,661,955, and 37,985,253, respectively.

The number of shares of our shares of common stock that will be outstanding after this offering, after giving effect to the Reorganization in November 2025, our December 9, 2025 1-for-3 reverse stock split, and the issuance of outstanding common stock subscriptions, is based on 39,362,606 shares of our shares of common stock outstanding as of September 30, 2025; however, it excludes the following:

•        7,488,778 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2025, issued under our 2025 Omnibus Equity Incentive Plan;

•        844,555 shares of common stock reserved for issuance pursuant to future awards under our Omnibus Equity Incentive Plan;

•        333,333 shares of common stock that may be issued upon the exercise by the underwriters’ of their warrants; and

•        9,992,352 shares of special voting stock issued in connection with our corporate reorganization equal to the number of exchangeable shares that are issued by Exchangeco in our corporate reorganization.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements, which are statements other than those of historical fact. These forward-looking statements include, among other things, statements about the parties’ ability to close the financial conditions, results of operations, earnings outlook and prospects of Starton. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would,” “will,” “seek,” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking.

These forward-looking statements are based on information available as of the date of this prospectus and on the current expectations, forecasts and assumptions of the management of Starton, involve a number of judgments, risks and uncertainties and are inherently subject to changes in circumstances and their potential effects and speak only as of the date of such statements. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed, contemplated or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in “Risk Factors,” and those discussed and identified in public filings made with the SEC by Starton.

Should one or more of these risks or uncertainties materialize or should any of the assumptions made by the management of Starton prove incorrect, actual results may vary in material respects from those projected in or contemplated by these forward-looking statements.

All subsequent written and oral forward-looking statements concerning other matters addressed in this prospectus and attributable to Starton or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this prospectus. Except to the extent required by applicable law or regulation, Starton undertakes any obligation to update these forward-looking statements to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

You should read the following discussion of our financial condition and results of operations in conjunction with our consolidated financial statements and the notes included elsewhere in this prospectus. The consolidated financial statements and the related notes included elsewhere in this prospectus are of Starton Therapeutics, Inc., a corporation organized under the laws of British Columbia, which was formerly our holding company; however, it became a subsidiary of Starton Holdings, Inc. as part of a corporate reorganization completed in November 2025, which is described in greater detail in the section titled “Reorganization”. The consolidated financial statements and the notes included elsewhere in this prospectus do not reflect the Reorganization or the 1-for-3 reverse stock split effected following the Reorganization in December 2025, except as otherwise indicated. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this prospectus, particularly under the “Risk Factors” and “Special Note Regarding Forward-Looking Statements” sections.

Overview

We are a clinical-stage biotechnology company focused on improving standard-of-care therapies for people with cancer through application of our proprietary platform delivery technology systems. We use continuous delivery of FDA-approved, active ingredients in an attempt to develop and bring products to market in either new indications or with enhanced outcomes in existing indications. In collaboration with our consulting company, McKinsey & Company, we evaluated over 80,000 potential applications to identify those applications where we believed our continuous delivery platform would bring the most benefit to patients. Based on the results of that evaluation, we are focused initially on the treatment of hematologic malignancies (blood cancers).

Our lead programs, STAR-LLD, are continuous delivery systems of the generic form of Revlimid® (lenalidomide), which is a prescription medicine owned by Bristol Myers Squibb that is currently used to treat adults with MM and certain lymphomas. With STAR-LLD, we are seeking to develop both a subcutaneous and an oral controlled release formulation in parallel to improve the probability of success. We are pursuing multiple indications in multiple myeloma and chronic lymphocytic leukemia, and potentially expanding in other cancers, including B cell lymphomas and solid tumors as well as in combination with CAR-T therapies.

We expect to announce our second program, which is currently in the formulation development stage, within the next 12 to 18 months. It has been our practice to only disclose new programs once we have filed for provisional intellectual property protection.

Immunomodulatory drugs (IMiDs) are the mainstay of early treatment in a number of hematologic with a potential market of approximately $12 billion as of 2020. We believe our proprietary continuous delivery platform can potentially increase efficacy of approved drugs, make them more tolerable, and expand their potential use; however, we have not obtained regulatory approvals for our product candidates and there can be no assurances that we will obtain regulatory approval in the time frame we anticipate or ever. Our strategic platforms aim to provide a controlled, sustained release. The use of the continuous delivery of lenalidomide allows for lower peaks and higher troughs which provide therapeutic blood levels for the entirety of the dosing interval whereas once-daily oral dosing is associated with sub-therapeutic blood levels of lenalidomide during each day’s dosing.

We have conducted a proof-of-concept study in a mouse model of multiple myeloma, of the STAR-LLD-SC continuous infusion versus the lenalidomide standard of care. Specifically, the tumor volume increase on day 29 was 483% with standard of care versus a-81% reduction in tumor volume in the STAR-LLD-SC group. A delay in the tumor progression was also increased in the continuous infusion group as STAR-LLD-SC.

We have conducted a Phase 1b clinical trial (low-dose lenalidomide STAR-LLD) that yielded positive interim top-line data in relapsed or refractory multiple myeloma (RRMM). The Phase 1b was completed and top-line data has been presented to the FDA. The study was designed to assess the safety, pharmacokinetics, and efficacy of the Company’s STAR-LLD-SC in combination with dexamethasone and bortezomib (Velcade®), and met the primary safety objective while being administered by continuous subcutaneous (SC) infusion. All six patients achieved a partial response (PR) or better.

Since our inception in 2017, we have devoted substantially all of our resources to organizing and staffing our company, acquiring the rights to develop our leading drug delivery candidates, clinical development of our leading candidates, raising capital, identifying potential product candidates, enhancing our intellectual property portfolio and undertaking research and clinical and preclinical studies for our development programs. We do not have any products approved for sale and have not generated any product revenue. We have funded our operations to date primarily through the private placement of our common stock. As of September 30, 2025, we received gross proceeds of approximately $48.5 million from the issuance of our common stock and had cash of $1,071,148.

Financial Operations Overview

Revenue

We did not realize any revenue during the years ended March 31, 2025 or March 31, 2024.

Costs and Expenses

Our costs and expenses are primarily the result of the following activities: development of our pipeline of proprietary product candidates; and general and administrative expenses including stock-based compensation. We record our costs and expenses in the following categories:

Research and Development Expenses

The successful development of our current and future product candidates is highly uncertain. This is due to the numerous risks and uncertainties, including the following:

•        successful completion of preclinical studies and clinical trials;

•        delays in regulators or institutional review boards authorizing us or our investigators to commence our clinical trials or in our ability to negotiate agreements with clinical trial sites or CROs;

•        the number and location of clinical sites included in the trials;

•        raising additional funds necessary to complete clinical development of our product candidates;

•        obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates;

•        contracting with third-party manufacturers for clinical supplies of our product candidates

•        protecting and enforcing our rights in our intellectual property portfolio including, if necessary, litigation; and

•        maintaining a continued acceptable safety profile of the products following approval.

We expect our research and development expenses to continue to be significant over the next several years as we develop and/or acquire additional product candidates and technologies. We may hire or engage additional skilled colleagues or third parties to perform these activities, conduct clinical trials and ultimately seek regulatory approval for any product candidate that successfully completes those clinical trials.

In addition, the probability of success for each product candidate will depend on numerous factors, including regulatory approval, competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

General and Administrative Expenses

General and administrative expenses consist of salaries, benefits, stock-based compensation and other related costs. Other costs include professional fees for patent-related and other legal expenses, consulting, tax and accounting services; insurances; depreciation and general corporate expenses.

The Company expects to incur additional general and administrative costs as a result of being a publicly traded company, including expenses to comply with the rules and regulations of the SEC and NASDAQ, as well as higher expenses for corporate insurance, director and officer insurance, investor relations, and professional services.

Results of Operations

Comparison of the Year Ended March 31, 2025 and 2024

Comparison of the six months ended September 30, 2025

Research and Development Expense

The following table summarizes our research and development expenses for the years ended March 31, 2025 and 2024:

The primary focus of our research and development efforts has been on the continued testing and development of our lenalidomide program. Research and development expenses were $7.6 million for the year ended March 31, 2025, consisting of approximately $4.0 million for our lenalidomide program $1.6 million for stock based compensation and

$2.0 million for other research and development expenses that are not delineated and operating expenses associated with research and development. This compares to expenditures of $6.7 million for the year ended March 31, 2024, consisting of $4.8 million for our lenalidomide program, $1.6 million for stock based compensation and $0.3 million for other research and development expenses. The increase of $0.9 million, or 15.5%, was primarily due to costs associated with the Phase 1b clinical trial of lenalidomide.

The following table summarizes our research and development expenses for the six months ended September 30, 2025 and 2024:

Research and development expenses were approximately 3.6 million for the six months ended September 30, 2025, as compared to approximately 3.8 million for the six months ended September 30, 2024, resulting from various lenalidomide-related projects.

General and Administrative Expense

General and administrative expenses were $6.8 million for the year ended March 31, 2025, as compared to $8.3 million for the year ended March 31, 2024. The decrease of $1.5 million, or 18.1%, is due to decreased professional fees for services and facilities and other expenses.

General and administrative expenses were $3.5 million for the six months ended September 30, 2025, as compared to $3.4 million for the six months ended September 30, 2024.

Liquidity and Capital Resources

Overview

We have historically sourced our liquidity requirements primarily with cash flow from financing activities, such as equity issuances. To date, we have raised gross proceeds of approximately $48.5 million from the issuance of common stock. As of September 30, 2025, we had cash of $1,071,148.

Sources of Liquidity

Net Cash Used in Operating Activities

Net cash used in operating activities for the year ended March 31, 2025 decreased by $1.8 million compared to the same period in the prior year. The decrease was due to the realized gain on asset $(5.0) million plus lower accounts payables $(3.6 million) primarily offset by a lower net loss of $5.0 million higher stock compensation expense of $0.4 million, accrued expenses of $0.9 million and various others $0.5 million.

Net cash used in operating activities for the six months ended September 30, 2025 increased by $1.1 million compared to the same period in the prior year. Net cash outflow decreased for the six months ended September 30, 2025 compared to the same period in the prior year due to an increase in accounts payable of $1.2 million.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the year ended March 31, 2025 was $3.3 million higher than the prior year due to an increase in sales of our common stock.

Net cash provided by financing activities for the six months ended September 30, 2025 was $2.7 million lower than the prior year due to a decrease in sales of our common stock of $3.6 million partially offset by increased proceeds from management loans of $1.0 million.

Commitments and Contingencies

The Company may from time to time be involved in various legal actions arising in the normal course of business. In the opinion of the management, the Company’s liability, if any, in these pending actions would not have a material adverse effect on the financial position of the Company. The Company’s general and administrative expenses would include amounts incurred to resolve claims made against the Company, but nothing has been recorded for the years ended March 31, 2025 or 2024.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. During the periods presented, we did not engage in any off-balance sheet financing activities other than those reflected in the notes to our audited and unaudited consolidated financial statements included elsewhere in this prospectus.

Critical Accounting Policies and Estimates

The preparation of condensed financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and income and expenses during the periods reported. These estimates may change as new events occur or additional information is obtained, and we may periodically be faced with uncertainties, the outcomes of which are not within our control and may not be known for a prolonged period. Because the use of estimates is inherent in the financial reporting process, actual results may differ from these estimates under different assumptions or conditions. Actual results could materially differ from those estimates. We have identified the following critical accounting policies:

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. Accounts requiring the use of significant estimates consist of valuation of deferred taxes and stock-based compensation calculations.

Regulatory Strategy

By way of background, a new drug application to enable the commercial distribution of a new drug (NDA) also called 505(b)(1), is the format that manufacturers use to bring a formal proposal to the FDA that a new drug should be approved and made available for use by patients in the United States. The NDA includes a great deal of information about the drug being evaluated including the ingredients, how it’s made, pre-clinical (animal model) study results, clinical trial results in humans, what the drug does in the body, and how it will be packaged. It takes a lengthy amount of time and resources for a manufacturer to complete all the necessary requirements to submit a successful NDA to the FDA for review. The 505(b)(2) pathway provides manufacturers who have certain types of drugs with an opportunity to seek FDA approval without performing all the pre-clinical work required to initiate in-human clinical studies that is required with an NDA. These products target non-inferiority rather than superiority. Starton is pursuing enhanced or new indications and as result only benefits from the 505(b)(2) preclinical development activities and needs to conduct full clinical programs.

A 505(b)(2) pathway can be an option for drugs with a new aspect related to indication, dosage form or regimen, strength, combination with other products, or other unique traits. A key feature of the 505(b)(2) pathway is that it enables a manufacturer to submit their product for FDA review by including data and/or study results originally collected by another manufacturer or researcher. In the event the FDA agrees with our 505(b)(2) pathway approach for a specific product, we may rely on pre-clinical data from previous findings and will not be required to conduct additional pre-clinical studies. The manufacturer of the 505(b)(2) eligible product needs to build a connection between their version of the product, or the active ingredients in it, and the reference product. For example, this could include data and results of bioanalytical testing, pre-clinical studies, or even clinical trial results. If successful in their effort to include supporting evidence from other researchers in their submission, the manufacturer of the 505(b)(2) candidate would not have to re-run these studies themselves. While the 505(b)(2) path allows for using the research of others as a component of their FDA submission, the manufacturer of the 505(b)(2) product may still need to complete some of its own research in other areas to help fulfill all the various requirements of the FDA to earn approval.

Another appealing aspect of seeking approval through the 505(b)(2) pathway is that, if approved, the approved product is eligible for 3-5 years of market exclusivity. A drug approved via a full 505(b)(1) NDA is normally granted a 5-year market exclusivity period. A 505(b)(2) pathway may represent an appealing pathway for drug approval for manufacturers for certain products. The ability to reference previously completed research as part of the FDA submission can save a great deal of time and money compared to the traditional full NDA. Additionally, a drug being approved through this pathway is not a simple generic of a previously approved product, so it may obtain additional patients or perhaps be an improvement over a currently available treatment.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Orphan Drug Designation (ODD) by the FDA is a special status granted to drugs and biologics intended to treat rare diseases or conditions. Orphan diseases affect fewer than 200,000 people in the United States. The primary purpose of this designation is to encourage the development of treatments for rare diseases, which might otherwise be overlooked due to the small market size and high development costs. Key benefits of ODD include tax credits, waived application fees, enhanced support from FDA during the development process and market exclusivity for seven years.

The 505(b)(2) designation, orphan designation, and breakthrough designation do not increase the likelihood of drug approval, and 505(b)(2) and orphan designation may not speed up the development or review timelines for any drug or drug-device combination product. The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. The use of a surrogate endpoint enables the FDA to approve these drugs faster. Companies are still required to conduct full studies to confirm the anticipated clinical benefit but may be able to conduct a portion of the Phase 3 clinical program while making the drug available to patients at the end of the Phase 2 program provided that adequate number of patients in the Phase 3 clinical program are enrolled. We intend to apply for Accelerated Approval in both MM and CLL indications, but there is no guarantee that the FDA will grant such designations, and even if such designations are granted, there is no guarantee that this will positively affect adoption of our candidates, and may impact our ability to get reimbursed by third-party payors for our products.

We anticipate submitting an approval package that contains the following elements:

•        The FDA stipulated in the pre-IND meeting that no additional nonclinical studies would be required to support an NDA filing beyond those already completed. We will reference prior findings by the FDA of safety for lenalidomide from nonclinical studies performed with the innovator drug.

•        The FDA has several drug master files submitted and awaiting the Revlimid® patent expiration, which is expected in 2028. This will allow Starton to supply lenalidomide, the active ingredient in Revlimid®, from one of these manufacturers.

•        A Phase 1 bioavailability study in seventeen (17) healthy male volunteers between the ages of 21 to 55 has been completed as requested by the FDA. This study was executed under European authorization in the Netherlands by ICON plc. This study demonstrated that STAR-LLD-SC was greater than 92% bioavailable across all dosage groups when compared to the reference drug oral Revlimid®. Single doses of 100 μg/h (2.4 mg/day), 200 μg/h (4.8 mg/day), or 400 μg/h (9.6 mg/day) of STAR-LLD-SC administered as a continuous 24-hour SC infusion, and single doses of 5 mg, 10 mg, or 20 mg Revlimid® oral capsules were well tolerated by healthy male subjects. The rate of subjects with TEAE was 41% (7/17). There was only a single finding of a headache that was considered drug-related for all reported events. There were no adverse events of special interest or drug-related Grade 3-4 toxicities reported. There were no clinically relevant findings with respect to clinical laboratory parameters, vital signs, ECG, and physical examination. These data support the findings of the rodent toxicology study that the starting dose for Phase 1b should be 400 μg/h.

•        A Phase 1b pilot study evaluated the safety and efficacy in six (6) transplant ineligible patients age 18 or older (consisting of three (3) males and three (3) females) receiving a second-line or greater treatment for relapsed/refractory multiple myeloma with a triplet regimen containing a proteasome inhibitor, dexamethasone, and lenalidomide continuous infusion. This study signaled the safety and efficacy necessary for Starton to work with the FDA to construct a development program suitable for approval of an NDA in transplant ineligible patients with multiple myeloma and chronic lymphocytic leukemia. These signals included: (1) adverse events associated with the treatment; (2) immune biomarkers of cellular function of T-cells, B-cells, and NK-cells; (3) the objective response rate categorized by complete response, very good partial response, partial response, duration of response, and progression free survival; (4) no severe (grade >2) hematologic toxicity, which is common with oral dosing; and (5) acceptance of the use by patients of an ambulatory pump.

•        In MM, a Phase 2a study is underway in second-line or greater relapsed/refractory MM patients age 18 years or older receiving treatment with a triplet regimen containing a proteasome inhibitor, dexamethasone, and lenalidomide continuous infusion is planned. This study will evaluate four (4) cohorts of six (6) patients each (3 cohorts of different STAR-LLD-SC doses of 300 μg/h (7.2 mg/day), 500 μg/h (12 mg/day), or 600 μg/h (14.4 mg/day) and 1 cohort of Revlimid® 25 mg a day) for determining the optimal and minimal effective dose based on signals of safety and efficacy necessary to select the recommended phase 3 dose for the pivotal registration studies. An expansion group of up to forty-five (45) patients may be treated at the RP2D. These signals will be evaluated/compared by daily dose and include 1) adverse events associated with the treatment, 2) the objective response rate categorized by complete response, very good partial response, partial response, duration of response, and progression free survival. We anticipate an equivalent or better efficacy response and enhanced tolerability compared to the Revlimid® comparator cohort with the triplet.

•        To obtain marketing approval, we anticipate performing open-label two arm pivotal registration studies in the indications described above. In order to seek accelerated approval designation, the studies will have to be initiated while the Phase 2 studies are ongoing.

•        Our R&D center and laboratory in Paramus, NJ is an FDA registered facility and capable of GMP small-scale production of preclinical and certain Phase 1 Clinical Trial Materials (CTM).

•        We intend to rely on well-established global contract research organizations to execute the study under our direction.

Human Studies with STAR-LLD-SC Design and Treatments

Multiple Myeloma

Unmet medical need in multiple myeloma

A Phase 1 study was performed in seventeen (17) healthy volunteers between the ages of 21 to 55 randomly assigned to receive either, single doses of 100 μg/h (2.4 mg), 200 μg/h (4.8 mg), or 400 μg/h (9.6 mg) of lenalidomide administered as a 24-hour SC infusion, and single doses of 5 mg, 10 mg, or 20 mg Revlimid® oral capsules were well tolerated by healthy male subjects. Healthy females are not appropriate for this type of study due to the teratogenic effects of lenalidomide. The study was not powered to show differences between the groups. The rate of subjects with a TEAE was 41% (7/17). There was only a single finding of headache considered drug-related for all reported events. There were no adverse events of special interest, or no severe or drug-related Grade 3-4 toxicities reported. There were no clinically relevant findings with respect to clinical laboratory parameters, vital signs, ECG, and physical examination. These data support the findings of the rodent toxicology study that the starting dose for Phase 1b should be 400 mcg/h. The pharmacokinetic data demonstrating the effect on Cmax and AUC and “flattening the curve”.

Summary Statistics of Pharmacokinetic Parameters from Phase 1 BA Study

____________

AUC = area under the concentration-time curve from time-zero to time t; AUC = area under the concentration-time curve from time-zero to infinity; AUC = percentage of AUC obtained by extrapolation; C = last observable quantifiable plasma concentration; CL/F= apparent steady state clearance of absorbed subcutaneous/oral; C = plasma concentration at steady state following subcutaneous administration; C = maximum plasma concentration; CL/F = apparent clearance; F = fraction absorbed subcutaneous/oral; N = number of subjects; t = half-life; t = time to maximum plasma concentration; V/F = apparent volume of distribution.

Note: Values represent geometric mean (%CV), except for t and AUC where the median (range) is presented. Predicted blood levels in healthy volunteers are lower than those to be observed in MM patients. This is related to differences in clearance of lenalidomide (Chen 2017) where MM patients have a clearance of ~12 L/h and healthy volunteers have a range of 18-25 L/h.

The concentration-time curve in response to a 24-hour SC infusion of lenalidomide was notably flattened based on the data provided above compared to the concentration-time curve observed after oral administration of Revlimid®, demonstrating an absorption rate limiting phenomenon during SC administration. The Relative BA (FSC/oral) of lenalidomide was between 0.919 and 0.958 across all 3 doses tested, showing BA was similar between administration of SC lenalidomide and administration of oral Revlimid® capsules, however, dose normalized Cmax was notably higher after administration of oral Revlimid® capsules. On a mg-to-mg basis, STAR-LLD-SC and Revlimid® were bioequivalent in terms of absorbed dose. The Geometric mean Cmax was about 16-fold lower, and the geometric mean AUC0-t was about 2-fold lower after a 24-hour SC infusion of lenalidomide compared to oral administration of Revlimid®, across all 3 dose levels tested. Of note the AUC on a mg-to-mg basis is bioequivalent between the two drugs.

On December 23, 2022, we submitted a proposal to the FDA for a Phase 1b study in MM patients in first line intolerant patients. The FDA took exception to the study and a clinical hold was placed on the Phase 1b study followed by a request by Starton for a Type A oral meeting with the FDA. The disagreement was based on our selecting first-line patients for study, and the FDA recommended second line or greater treatment with RVd. We resubmitted a protocol and received written responses from the FDA that provided guidance for the Phase 1b study. Following the oral meeting, further guidance was provided by the FDA resulting in a second line Phase 1b study that was submitted during the first week of May 2023.

We received a letter of authorization on May 31, 2023 from the FDA to begin the clinical program in the U.S. with the initiation of the Phase 1b protocol. The letter stated in part, “We have completed the review of your submission and have concluded that the clinical trial protocol STAR-LLD-MM-023, titled, ‘A Phase 1b protocol to assess the safety, efficacy, and pharmacokinetics of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD-SC) for the treatment of relapsed-refractory multiple myeloma (MM)’ may be initiated.”

The study operations role was awarded and contracted to a global clinical research organization. Study oversite and responsibility was provided by our clinical operations team. Initiation of the study “start-up” process began June 5, 2023 that included study feasibility, clinical site selection, and set-up of the operational structure.

A summary of Starton’s Phase 1b clinical study

Our Phase 1b study was an open label study (N=6) of STAR-LLD-SC in patients with RRMM age 18 or older who were transplant ineligible, who met the eligibility criteria, and who were to begin a second or greater treatment line with lenalidomide/dexamethasone in combination with the proteasome inhibitor Velcade®. A total of six (6) patients (consisting of three (3) males and three (3) females) were evaluated. The dose level was 400 µg/h (9.6 mg a day) which is ~60% lower than the standard dose of lenalidomide. This dose was based on the known pharmacokinetic (PK) thresholds for immune activation and lenalidomides activity on killing MM cells. The current study was designed to demonstrate the utility of continuous, low-dose, lenalidomide (STAR-LLD-SC) using a subcutaneous (SC) infusion pump and to demonstrate its safety, PK, and efficacy in the defined population at the defined dose. Lenalidomide was delivered via an FDA 510(k)-cleared ambulatory pump (Smiths Medical CADD Solis-VIP — CE Mark 2797, FDA clearance K111275).

Target Population:    Transplant ineligible RRMM patients who are to receive lenalidomide/dexamethasone/PI in a 2nd or greater line of therapy and meet the eligibility criteria are eligible for the study.

Inclusion Criteria:

1. Male or female ≥18 years at the time of informed consent; 2. Autologous stem cell transplant (ASCT) ineligible; 3. COVID-19 negative; 4. A prior diagnosis of RRMM as defined by IMWG criteria; 5. Documented measurable disease following first line therapy; 6. Intended to be treated in 2nd line or greater with lenalidomide, dexamethasone, and a PI; 7. Proteasome inhibitor sensitive defined as progression free for > 6 months from cessation of PI or never received a prior PI; 8. Progression per IMWG criteria on the most recent line of therapy; 9. Eastern Cooperative Oncology Group performance status ≤2 (patients with a performance status of 3 based solely on bone pain secondary to MM may be eligible following consultation and approval by the Medical Monitor); 10. Willing to comply with the protocol defined Lenalidomide Pregnancy Risk Minimization Plan for the prevention of pregnancy. Females of childbearing potential (FCBP) must have a medically supervised negative serum or urine pregnancy test 4-14 days prior to planned start of treatment and again 24 hours prior to initiation of study medication. All FCBP must agree to either commit to continued abstinence from sexual intercourse or begin TWO acceptable methods of birth control AT THE SAME TIME, at least 28 days before receiving the first dose of STAR-LLD. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex or synthetic condom during sexual contact with a FCBP from the time of starting study treatment through 28 days after the last dose, even if they have had a vasectomy; 11. Able to take anti-thrombotic prophylaxis;12. Grade 2 of better laboratory results must be met during screening; 14. Able and willing to receive percutaneous ambulatory therapy;15. Has an in-home care partner willing to receive training from a nurse for assistance with pump management.

Exclusion Criteria

1. Pregnant or breastfeeding; 2. Received an ASCT; 3. Venous thromboembolism within 12 months of starting treatment on study; 4. Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses; 5. Currently taking any investigational therapy for the treatment of MM. A 28-day washout prior to Cycle 1 Day 1 is required for any previous investigational therapy; 6. Received a prior treatment line containing lenalidomide and failed to achieve an objective response (CR, VGPR or PR);7. Discontinued a prior line of treatment due to intolerability to lenalidomide; 8. Concomitant use of strong CYP3A inducers (see https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#table3-3); 9. Concurrent clinically significant amyloidosis or plasma cell leukemia or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes); 10. Known active infection requiring systemic anti-infective treatment (prophylactic treatment is permitted); 11. Prior malignancies within the previous 3 years, other than previously treated squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast or another malignancy that is considered cured with minimal risk of

recurrence (e.g., very low and low risk prostate cancer in active surveillance); 12. Prior major surgical procedure or radiation therapy within 4 weeks of the initiation of STAR-LLD-SC (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of STAR-LLD-SC); 13. Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the patient’s safety, as per the Investigator’s judgment.

All patients experienced a partial response (PR) or better (100%) during the study.

Safety Assessment

No drug-related grade 3-4 hematologic toxicities were observed following treatment durations as long as a year. There was no > grade 3 non-hematologic toxicity considered related to the study medication (1 patient with fatigue), Overall, the treatment regimen was well tolerated. The majority of adverse events were mild or moderate in intensity. The table below lists the adverse events which occurred in a patient and the number that were drug related vs. those not related. Due to the overlying toxicity profile of bortezomib and lenalidomide investigators used their clinical judgement to assign causality,

List of adverse events that occurred in 2 or more patients in Phase 1b

The table above lists the adverse events which occurred in more than 2 patients and those which were drug related. All six (6) patients experienced adverse events of special interest, including fatigue; diarrhea; injection site erythema and injection site reaction/erythema/injection site rash; bone pain, injection site rash, myalgia, systemic rashb; and anemia, iron deficiency anemia, injection site bruising, injection site irritation, injection site pain, muscular weakness, neck pain, and pyrexia.

A Phase 1b end of study meeting with the FDA took place in January 2025. At that meeting Starton agreed to expand the current study from a Phase 1b study to a Phase 1b/2a, Multicenter Study of Continuous Subcutaneous (SC) Low-Dose Lenalidomide (STAR-LLD-SC) in patients with RRMM, which will be an extension of the current six (6) patient RRMM phase 1b study.

Lenalidomide toxicity

The toxicity of lenalidomide is associated with the drug Cmax and AUC. Grade 3-4 hematologic toxicity can reach a combined 70% for low platelet and low neutrophil counts. In elderly patients or those with pre-existing disease, the Cmax and AUC can become too high leading to toxicity. In many cases, despite a good response to lenalidomide, these toxicities lead to treatment discontinuations.

A majority of patients with MM will relapse following first line therapy, so the disease is incurable in most cases (National Cancer Institute, 2021). Biochemical relapse, or relapse without clinical symptoms, is not uncommon during lenalidomide-based therapies. The time to symptomatic progression varies but eventually treatment is required. The International Myeloma working group suggests that biological relapses should not be treated until the

development of clinical symptoms, except in those cases with significant paraprotein relapse. It is recommended that myeloma therapy be restarted without delay in patients with a rise of absolute level of M-protein at which the benefit out-weighs the risks.

IP Protection

Revlimid® is under IP protection until April of 2028 in the US. We plan to commercialize STAR-LLD (potentially both SC and OCR) based on an FDA granting accelerated approval in both high-risk RRMM and CLL, assuming receipt of all regulatory approvals. Our intellectual property position provides protection until at least 2040. To achieve this timeline, we hope to obtain accelerated approval status based on the use of a surrogate marker in a life threatening condition where the response is superior in terms of safety or efficacy than the commercially available therapy as discussed in an FDA guidance “Expedited Programs for Serious Conditions — Accelerated Approval of Drug and Biologics — Guidance for Industry.” We may not obtain FDA approval in the timeframe we anticipate or may never obtain FDA approval. The FDA may also impose additional requirements or require additional studies or protocol amendments during any phase. We cannot guarantee that the FDA will agree with any of our trial designs, or agree to allow us to pursue an accelerated approval pathway, and may require multiple meetings to develop a pathway forward for any of our candidates in any indications.

Chronic Lymphocytic Leukemia

Unmet medical need in chronic lymphocytic leukemia (CLL)

CLL, with a prevalence of roughly 200,000 patients represents the most common form of leukemia in the U.S., accounting for about 1 in 3 new cases. It is estimated that more than 20,000 new patients are diagnosed annually (American Cancer Society 2024). Despite all the recent additions of approved new agents, CLL remains a largely incurable malignancy. Most CLL patients relapse after initial therapy. The goal in treating CLL is achievement of a high CR rate that translates into prolonged responses and possible cure of the disease (Byrd, 2003). There are four BTK inhibitors in the market and several in development, however, very few CLL patients have achieved CR despite treatment with newly approved agents, including ibrutinib, acalabrutinib, zanubrutinib and pirtobrutinib. The National Cancer Institute-sponsored working group criteria for CLL diagnosis and treatment define CR as less than 30% lymphocytes in the bone marrow. Although BTKi’s are highly effective, eventually all patients become refractory to the BTKi product class. Global Data currently projects that over 50% of patients become refractory to BTK inhibitors. Patients who progress on or cannot tolerate BTKi therapy may then transition to a BCL2 inhibitor (BCL2i). Currently, the only BCL2i treatment available for BTKi relapse is Venetoclax alone or in combination with rituximab or obinutuzumab. In the “double class-resistant” setting (i.e., patients who progressed after both a covalent BTK inhibitor and a BCL2 inhibitor), patients are left without viable proven treatment options and there are currently no products in development to address this major unmet medical need. In a real-world US database studying patients treated with both a covalent BTK inhibitor and a BCL2 inhibitor, of those who discontinued those drugs, only ~54% went on to receive subsequent therapy and the median time from discontinuation to next treatment or death was only ~4.6 months in those who had both exposures.

Lenalidomide has been studied extensively in CLL but has not gained formal regulatory approval. Its current label includes a warning contraindicating its use in CLL however, the prescribing information for Revlimid® acknowledges it may be considered for treatment in clinical trials. Based on the limited amount of available data, it appears that maintenance therapy may improve the quality of remission in CLL patients and prolong PFS (Montillo, 2006; O’Brien, 2003; Rai, 2002; Byrd, 2003; Wendtner, 2004; Schweighofer, 2006).

In addition, as the first IMiD, STAR-LLD-OCR would bring CLL patients a new mode of action that could work in combination with existing therapies. Having other modes of action would potentially result in significant PFS and overall survival improvements.

Celgene Corporation, now part of Bristol Myers Squibb, conducted two (2) randomized Phase 3 clinical studies in CLL. The CONTINUUM trial compared maintenance Revlimid® to placebo. PFS1 and PFS2 were significantly improved in the LLD treated patients. Toxicity was most pronounced in the LLD treated patients. Drug related deaths were greater in the LLD treated patients (5 vs 3) deaths. A second study (ORIGIN) evaluated Revlimid® vs

chlorambucil in first line CLL for treatment of elderly patients. There was a mathematical improvement in PFS which was not significant. OS was also no different between the groups. There was a greater number of deaths from any cause in the LLD treated patients (35 in LLD vs 21 in Chlorambucil) that lead to stopping the study by the ethics committee.

While STAR-LLD-SC has not been evaluated for safety and efficacy by the FDA, we plan to evaluate STAR-LLD-OCR intending to demonstrate the drug is both safe and effective on submission of such data to the FDA. While the IND has not yet been submitted to the FDA, we anticipate a Phase 1b study will be performed in 30 BTKi and BCL2i co-relapsed/refractory chronic lymphocytic leukemia patients using an oral controlled release formulation to assess the PK, PD, safety and efficacy. Patients will receive obinutuzumab and STAR-LLD-OCR at 3 unique doses for 6 cycles to determine the MTD/OBD as well as evidence of efficacy compared to historic data with obinutuzumab alone. We anticipate that a Phase 2 study will enroll an additional 45 patients at the optimal dose determined from the Phase 1b study. With up to 30% patients being Revlimid® intolerant in the first year of maintenance, the goal is for STAR-LLD-OCR, if approved, to address a major unmet medical need in CLL.

Competition

Our industry is highly competitive and subject to rapid and significant technological change. While we believe that the development experience and scientific knowledge of our management team provide us with competitive advantages, we may face competition from large pharmaceutical and biotechnology companies, smaller pharmaceutical and biotechnology companies, including specialty pharmaceutical companies and generic drug companies, academic institutions, government agencies and research institutions, and others, that have commercialized and/or are developing therapies for the same therapeutic areas that our product candidates target.

Many of our competitors may have significantly greater financial, technical, and human resources than we have. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Our commercial opportunity could be reduced or eliminated if our competitors develop or market products or other novel technologies that are more effective, safer or less costly than any that will be commercialized by us or obtain regulatory approval for their products more rapidly than we may obtain approval for ours. Our success will be based in part on our ability to identify, develop, and manage a portfolio of drugs that are safer and more effective in the treatment and support of patients.

Unmet medical need in chimeric antigen receptor therapies

Chimeric antigen receptor (CAR) T-cell therapy is an individualized, cell-based immunotherapy that reprograms a patient’s own T lymphocytes to recognize and eliminate malignant cells. The process begins with collection of peripheral blood mononuclear cells by leukapheresis. Patient T-cells are then isolated, activated, and genetically modified ex-vivo, typically using a viral vector, to express an engineered receptor that combines a tumor-specific antigen-binding domain with intracellular T-cell activation and costimulatory signaling domains. The resulting CAR T-cells are expanded, formulated, and returned to the patient for a single intravenous infusion following lymphodepleting chemotherapy intended to enhance in-vivo CAR T-cell expansion and persistence.

Once infused, CAR T-cells bind tumor antigens independently of major histocompatibility complex (MHC) presentation, enabling recognition of cancer cells that may evade native T-cell immunity. Clinical activity is driven by rapid in-vivo expansion, cytokine release, and targeted cytolysis, followed by memory formation in responding patients. This mechanism has produced high response rates and durable remissions in otherwise treatment-refractory hematologic malignancies, particularly B-cell lymphomas and multiple myeloma, positioning CAR-T therapy as a potentially curative modality for a subset of patients.

Commercial CAR-T therapies are currently autologous, meaning each treatment lot is manufactured specifically for an individual patient. This individualized approach introduces operational complexity, including vein-to-vein timelines, specialized manufacturing expertise, and coordinated care across accredited centers. Continued innovation seeks to address these limitations through platform optimization, next-generation constructs, and allogeneic or “off-the-shelf” cell therapy approaches designed to enhance access and scalability.

While the clinical efficacy of CAR-T therapy is transformative for eligible patients, the modality carries unique risks that require specialized monitoring and management. Cytokine release syndrome (CRS) and immune-effector cell-associated neurotoxicity syndrome (ICANS) are class-defining adverse events related to T-cell activation and

inflammatory cytokine signaling. Additional long-term considerations include cytopenias, infections, and evolving post-marketing safety monitoring for secondary malignancies. Regulatory frameworks ensure that CAR-T therapies are administered at qualified centers with real-time clinical oversight.

As real-world experience increases and earlier-line indications expand, CAR-T therapies are reshaping treatment paradigms in hematologic cancers. Ongoing development in tumor-specific targets, dual-targeting constructs, combination regimens, and allogeneic platforms highlight the continued momentum toward broader accessibility, improved durability, and a diversified cell-therapy ecosystem.

Chimeric antigen receptor T-cell (CAR-T) therapy has transformed outcomes for patients with relapsed or refractory hematologic malignancies, delivering deep and durable responses in settings where conventional therapies fail. However, despite these advances, a substantial unmet medical need persists in patients who relapse following CAR-T infusion. Across B-cell lymphomas and multiple myeloma, 40 – 60% of patients will experience disease progression within the first 12 months after treatment, and the prognosis after relapse is poor. Median overall survival following CAR-T failure is typically 6 – 9 months, underscoring the urgency for effective salvage strategies.

Biologic mechanisms underlying post-CAR-T relapse highlight the complexity of this clinical challenge. Key drivers include antigen escape, functional CAR-T cell exhaustion, immune microenvironment suppression, and tumor clonal evolution. For BCMA-directed CAR-T therapy in myeloma and CD19-targeted products in lymphoma, downregulation or loss of target antigen expression is increasingly recognized as a dominant resistance pathway. Additionally, CAR-T persistence varies considerably across patients, and limited long-term T-cell durability contributes to relapses in an otherwise responsive disease.

Current therapeutic options in the post-CAR-T setting are limited and not standardized. Clinicians often rely on salvage chemotherapy, antibody-drug conjugates, bispecific T-cell engagers, and immunomodulatory agents, though responses are often transient and toxicity can be significant in a heavily pretreated, immunologically depleted population. No therapy is currently approved specifically for patients who progress after CAR-T, and clinical trial accessibility remains limited geographically and logistically. Further challenges include limited performance status in this population and the absence of validated sequencing strategies or predictive biomarkers.

The growing use of CAR-T is expanding the pool of patients at risk for post-CAR-T relapse, and as treatment moves earlier in the disease continuum, the absolute number of patients requiring effective post-CAR-T options will increase substantially. Addressing this gap requires novel mechanisms capable of re-engaging antitumor immunity, overcoming antigen loss, and safely treating immunologically fragile patients. Therapeutics that preserve or restore immune function, target alternative tumor antigens, or deliver cytotoxic payloads with precision represent promising avenues.

Post-CAR-T progression represents a critical therapeutic frontier in hematologic oncology with high mortality, limited treatment standards, and significant scientific opportunities for innovation. Effective intervention in this setting would not only improve survival and quality of life for a rapidly expanding patient population but also strengthen the overall value proposition and durability of CAR-T-based treatment paradigms.

Unmet Need in Post-CAR-T Progression & Emerging Role of Lenalidomide

Chimeric antigen receptor T-cell (CAR-T) therapy has revolutionized treatment for relapsed/refractory hematologic malignancies, offering unprecedented response rates in late-line disease. Despite these advances, in patients with lymphoma 40 – 60% relapse within 12 months of infusion, and post-CAR-T progression is associated with poor survival, typically 6 – 9 months12. Data from MM CAR-T therapies indicates failure of 45%3 and 24%4 at 12 months with major difference between Ide-cel and Cilta-cel. These patients represent a rapidly expanding population with limited standardized treatment options.

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1        DiBlasi R et al Blood 2022: 140 (24) 2584-2593

2        Iacoboni G et al. Hematol Oncol 2024: 17 (102) 1-10

3        KarMMa Munshi NC et al. NEJM 2021;384; 705-716

4        Cartitude-4 San-Miguel et al. NEJM 2023; 389: 335-347

Mechanisms of relapse are multifactorial and include antigen escape, CAR-T cell exhaustion, failure of CAR-T persistence, and immunosuppressive microenvironment remodeling. As CAR-T moves earlier in treatment algorithms, the absolute number of patients experiencing relapse will rise, underscoring the urgency for effective and biologically rational salvage strategies.

Lenalidomide as an Emerging Salvage Approach

Lenalidomide, a cornerstone IMiD, has gained increasing attention as a strategy to salvage or amplify CAR-T activity, particularly in B-cell malignancies and multiple myeloma.

Scientific Rationale

Lenalidomide exerts complementary immune-enhancing mechanisms that align with CAR-T biology:

•        Expansion and activation of endogenous T cells

•        Augmentation of CAR-T cell function through improved cytokine signaling and metabolic fitness

•        Enhancement of NK-cell mediated cytotoxicity

•        Reversal of T-cell exhaustion markers

•        Modulation of tumor microenvironment, reducing immunosuppressive regulatory T cells and myeloid suppressor cells

Preclinical models demonstrate synergy between IMiDs and adoptive T-cell therapies, including enhanced CAR-T expansion, persistence, and antitumor function.

Emerging Clinical Evidence

Early clinical experience, including retrospective cohort studies, real-world series, and early phase evaluations suggests that lenalidomide can induce durable disease control in select patients post-CAR-T, particularly in multiple myeloma and B-cell lymphoma. Notable findings include:

•        Reports of meaningful responses when administered shortly after biochemical or radiographic relapse post-CAR-T

•        Utility as maintenance-like therapy to stabilize disease and prolong CAR-T benefit in slow biochemical relapse

•        Observations that patients receiving IMiDs post-CAR-T may exhibit extended progression-free and overall survival compared to historical expectations, particularly when used early at relapse

Importantly, lenalidomide’s immune-adjuvant properties may offer benefit independent of target antigen status, addressing antigen-loss driven relapse, a major limitation of current T-cell redirecting salvage therapies.

Future Opportunity

The integration of lenalidomide and next-generation IMiDs in the post-CAR-T setting represents a promising therapeutic avenue to:

•        Re-engage immune surveillance

•        Enhance CAR-T durability

•        Bridge to subsequent immunotherapies

•        Improve survival in a critical high-risk population

This strategy aligns with the broader need for immune-restorative and antigen-agnostic therapeutic approaches.

Post-CAR-T relapse remains one of the most pressing unmet needs in hematologic oncology, defined by rapid disease progression, limited therapeutic guidance, and poor survival. Lenalidomide offers a biologically grounded, clinically emerging approach to extend the benefit of CAR-T therapy, optimize immune function, and address relapse biology. Continued prospective evaluation will be essential to formalize dosing strategies, timing, and patient selection — positioning immune-modulation as a pivotal component of next-generation post-CAR-T care.

Starton’s approach to using continuous delivery of lenalidomide in B-cell lymphomas and MM

Starton is actively planning to fund several IIT studies at certain major academic centers in the United States in lymphoma and multiple myeloma in patients who have progressed following CAR-T therapy with lymphoma and in RRMM patients in combination with CAR-T for the first 30-days after the infusion to improve the biochemical response to treatment over CAR-T alone. These programs are currently underway in terms of protocol generation and contract negotiations. These studies, which are expected to start at the end of Q2/2026, will provide insight into the mechanisms and success rate of STAR LLD-SC in each population. They will form the basis of the Phase 1 requirements for a new drug application (NDA) for the enhancement and success of the combination in patient outcomes. We believe if the studies are successful that we will request the FDA allow us to perform a phase two registration trial based on accelerated approval in one of the two indications and will follow with the second approval subsequent to the initial NDA.

Lenalidomide Competition

We are not aware of any continuous delivery immunomodulatory drugs in development, and we expect Revlimid to continue to be the cornerstone of MM treatment. We plan to potentially build on and expand use in Revlimid-intolerant patients and replace Revlimid in key sub-populations. Notably, Revlimid is not currently labeled for use in CLL outside of a clinical trial or in combination with CAR-T therapy. If approved, we expect our STAR-LLD continuous delivery formulations to be the first immunomodulatory IMiD drug available for CLL or CAR-T patients with the capability of creating a maintenance segment.

There are multiple products in development and in the market for the treatment of multiple myeloma including bispecific antibodies, CAR-T cells, and others. The MM treatment market is highly competitive. However, lenalidomide is expected to remain a key part of treatment and successful development and approval of an improved safety and tolerability profile and delivery could offer significant benefits to patients. In the maintenance therapy market segment, currently the only registered product is lenalidomide.

Manufacturing and Supply

We do not own or operate manufacturing facilities for the commercial production of our product candidates, nor do we have plans to develop our own manufacturing operations in the foreseeable future. We have a GMP manufacturing unit that produces pre-clinical and Phase 1 clinical supplies. We currently rely, and expect to continue to rely, on third parties for the manufacturing of our product candidates or any other product candidates for Phase 2 and beyond clinical testing, as well as for commercial manufacturing. Also, we currently rely and continue to rely on third parties for the manufacturing and development of our diagnostic devices for clinical testing. There are multiple generic manufacturing suppliers of the active ingredients that we use with FDA approved drug master files. Currently, we have purchased enough material for our planned clinical studies through purchase orders.

Sales and Marketing

We currently have no marketing, sales or distribution capabilities. In order to commercialize any products that are approved for commercial sale, we must either develop a sales and marketing infrastructure or collaborate with third parties that have sales and marketing experience.

We may elect to establish our own sales force to market and sell a product for which we obtain regulatory approval in the United States. We believe that establishing our own commercial operations in our core strategic market (i.e., the U.S.) strengthens our ability to negotiate with strategic participants in the market and is an important component of our strategy. We intend to develop a network of partners and distributors to commercialize our products outside the US. If we decide to market and sell any products ourselves, we do not expect to establish direct sales capability until shortly before the products are approved for commercial sale.

We plan to seek third-party support from established pharmaceutical and biotechnology companies for those products that would benefit from the promotional support of a large sales and marketing force. In these cases, we might seek to promote our products in collaboration with marketing partners or rely on relationships with one or more companies with large established sales forces and distribution systems. We believe that through our strategic relationships with well-developed commercial payors and medical organizations we can accelerate the size and development of the market at marginal incremental cost, and therefore, we may be able to achieve faster and higher market penetrations.

Intellectual Property

We strive to protect and enhance the proprietary technologies, inventions, and improvements that we believe are important to our business, including seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties. Our policy is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the U.S. and in jurisdictions outside of the U.S. related to our proprietary technology, inventions, improvements, platforms, and our product candidates that are important to the development and implementation of our business.

As of November 21, 2025, our patent portfolio includes seven (7) issued patents: (1) US 11,197,852 for “Continuous delivery of lenalidomide and other immunomodulatory agents,” issued on December 14, 2021, which will expire in April 2040; (2) US 11,975,112 for “Treatment of vomiting and nausea with minimum dose of olanzapine,” issued on May 7, 2024, which will expire in May 2041; (3) Chinese 114901287B for “Treatment of vomiting and nausea with minimum dose of olanzapine,” issued November 29, 2024, which will expire in January 2041; (4) US 12,201,622 for “Continuous delivery of lenalidomide and other immunomodulatory agents,” issued on January 21, 2025, which will expire in July 2040; (5) Mexican 425779 for “Continuous delivery of lenalidomide and other immunomodulatory agents,” issued on July 16, 2025, which will expire in April 2040; (6) US 12,383,510 for “Treatment of vomiting and nausea with minimum dose of olanzapine,” issued on August 12, 2025, which will expire in January 2041; and (7) US 12,390,457 for “Stable solutions of immunomodulatory imide compounds for parenteral use,” issued on August 19, 2025, which will expire in March 2042; four (4) pending U.S. non-provisional patent applications; two (2) pending international patent (PCT) applications; two (2) pending U.S. provisional patent applications; and three (3) soon-to-be-filed U.S. provisional patent applications. In addition, there are twenty-nine (29) PCT national stage patent applications pending in various jurisdictions including Australia, Brazil, Canada, China, Japan, Hong Kong, Korea, and Mexico.

Our pending U.S. non-provisional patent applications include: (1) US Application No. 17/831,603 for “Transdermal Drug Delivery Systems for Administration of a Therapeutically Effective Amount of Lenalidomide and Other Immunomodulatory Agents;” (2) US Application No. 18,246,190 for “Treatment of Vomiting and Nausea with Minimum Dose of Olanzapine;” (3) US Application No. 18/933,332 for “Molecular Solid Suspensions for Transdermal Drug Delivery;” and (4) US Application No. 18/978,681 for “Continuous Delivery of Lenalidomide and Other Immunomodulatory Agents.”

Our two (2) pending international patent applications that are awaiting nationalization are PCT Application No. PCT/IB2024/060778 for “Molecular Solid Suspensions for Transdermal Drug Delivery” and PCT Application No. PCT/US2025/010176 for “Solid State Active Pharmaceutical Compositions for Transdermal Drug Delivery.”

Our STAR-LLD PCT national stage applications include product and method of treatment or use claims covering STAR-LLD. Any applications, if issued, claiming priority to this PCT application are expected to expire in 2040, not including any patent term adjustment or extension.

To the extent available and feasible, it would be our expectation to expand our IP protection as we advance with development and pursue patent applications covering additional methods of use, formulation embodiments, and other product-specific claims.

Trademarks, Service Marks, and Trade Names

We do not own or have rights to use common law trademarks, service marks, or trade names in connection with our business in the U.S. or in certain foreign jurisdictions.

Solely for convenience, the trademarks, service marks, logos, and trade names referred to in this offering memorandum are without the ® and ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names. This prospectus contains additional trademarks, service marks and trade names of others, which are the property of their respective owners. All trademarks, service marks and trade names appearing in this prospectus are, to our knowledge, the property of their respective owners. We do not intend our use or display of other companies’ trademarks, service marks, copyrights, or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Employees

In light of our early stage of development, we only have a small number of full-time employees. We supplement our workforce by engaging a number of consultants, contract research organizations, contract development and manufacturing organizations and other supporting organizations.

As of January 15, 2026, we had 7 full-time employees, all of whom are engaged in critical functions including management, clinical research, manufacturing and research and development activities or operations needed to support such endeavors. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be good.

Facilities

We lease space for our corporate headquarters at 215 College Road, Suite #300, Paramus, New Jersey, which consists of transdermal delivery and analytical laboratories, a cGMP Phase 1 manufacturing facilities and office space. The corporate headquarters is approximately 9,075 square feet of space comprised of a transdermal delivery and analytical laboratories space of approximately 6,325 square feet and the balance of 2,750 square feet is office space. The lease expires on April 15, 2030. We believe that our current space is adequate for our needs. We also believe we will be able to obtain additional space, as needed, on commercially reasonable terms.

Legal Proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of business. There are currently no pending or threatened legal proceedings or claims against us that, in our opinion, are likely to have a material adverse effect on our business, operating results, financial condition or cash flows. Defending such proceedings is costly and can impose a significant burden on management and team members. The results of any future litigation cannot be predicted with certainty, but regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Government Regulation

Government authorities in the U.S., at the federal, state and local level, and other countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and import of products such as those we are developing. A new drug must be approved by the FDA through the NDA process before it may be legally marketed in the U.S.

U.S. Drug Development Process

In the U.S., the FDA regulates drugs under the FDC Act and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

The process required by the FDA before a drug may be marketed in the U.S. generally involves the following:

•        completion of preclinical laboratory tests, animal studies and formulation studies in accordance with FDA’s good laboratory practice requirements and other applicable regulations;

•        submission to the FDA of an IND, which must become effective before human clinical trials may begin;

•        approval by an independent IRB or ethics committee at each clinical site before each trial may be initiated;

•        performance of adequate and well-controlled human clinical trials in accordance with GCPs to establish the safety and efficacy to the FDA of the proposed drug for its intended use;

•        submission to the FDA of an NDA after completion of all pivotal trials;

•        satisfactory completion of an FDA advisory committee review, if applicable;

•        satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity, and of selected clinical investigation sites to assess compliance with GCPs; and

•        FDA review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the U.S.

Prior to beginning the first clinical trial with a product candidate in the U.S., we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an IND product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro studies assessing toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. Once submitted, the IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor, and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Therefore, submission of an IND may or may not result in FDA authorization to begin a clinical trial.

Human clinical trials in the U.S. generally cannot commence until an IND application is submitted and becomes effective. The exception is if the product is eligible to be tested for BA without an IND as defined by the criteria in 21 CFR § 320.31. The criteria in section 21 CFR § 320.31 state that a product is eligible to be tested for BA without an IND if the new formulation does not contain a NCE, does not contain a radioactively labeled drug product, does not contain a cytotoxic drug product, and the daily dose is not in excess of the labeled exposure of the approved product. If a new formulation does not fit these criteria, a company must submit preclinical testing results to the FDA as part of the IND, and the FDA must evaluate whether there is an adequate basis for testing the drug in initial clinical studies in human volunteers. Once human clinical trials have commenced, the FDA may stop the clinical trials by placing them on “clinical hold” because of concerns about the safety of the product being tested, or for other reasons.

Clinical trials involving the administration of the investigational product to human subjects under the supervision of qualified investigators must be done in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site and must monitor the study until completed. Regulatory authorities, the FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

•        Phase 1 — The product candidate is initially introduced into healthy human subjects, and in some cases, patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism, and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

•        Phase 2 — The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

•        Phase 3 — The product candidate is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA.

During the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND, at the end of Phase 2, and before an NDA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase of development. Sponsors typically use the meetings at the end of the Phase 2 trial to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of the new drug.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final drug. In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

While the IND is active and before approval, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report must be submitted at least annually to the FDA. Written IND safety reports must also be submitted to the FDA and investigators for serious and unexpected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.

Sponsors of certain clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information on www.clinicaltrials.gov. Information related to the product, subject population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss certain results of their clinical trials after completion. Disclosure of the results of these trials can be delayed until the new product or new indication being studied has been approved. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

U.S. Review and Approval Process

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, preclinical and other non-clinical studies, and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain limited circumstances. Additionally, no user fees are assessed on NDA’s for products designated as orphan drugs, unless the product also includes a non-orphan indication.

The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality, and purity. Under the PDUFA guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after it the application is submitted. The FDA conducts a preliminary review of all NDA’s within the first 60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing.

The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates an NDA, it will issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A Complete Response Letter usually describes the specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as an additional clinical trials or other significant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing. If a Complete Response Letter is issued, the sponsor must resubmit the NDA or, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.

The 505(b)(2) new drug application (NDA) is one of three FDA drug approval pathways and represents a one of several regulatory strategies. The pathway was created by the Hatch-Waxman Amendments of 1984. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant but instead rely on previously submitted data.

A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a less expensive and faster route to approval, compared with a traditional development path, while creating new, differentiated products with potential commercial value. However, our selection of this pathway is not guaranteed to be successful, and the FDA might not agree with our position that the 505(b)(2) pathway is appropriate for one or more of our product candidates.

The FDA regulates combinations of products that are subject to review by multiple FDA centers, such as drug, biologic or medical device components that are physically, chemically or otherwise combined into a single entity, as a combination product. The FDA center with primary jurisdiction for the combination product will take the lead in the premarket review of the product, with the other center consulting or collaborating with the lead center.

The FDA’s Office of Combination Products (OCP) determines which center will have primary jurisdiction for the combination product based on the combination product’s “primary mode of action.” A mode of action is the means by which a product achieves an intended therapeutic effect or action. The primary mode of action is the mode of action that provides the most important therapeutic action of the combination product, or the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.

It is often difficult for the OCP to determine with reasonable certainty the most important therapeutic action of the combination product. In these cases, the OCP will consider consistency with other combination products raising similar types of safety and effectiveness questions, or which center has the most expertise to evaluate the most significant safety and effectiveness questions raised by the combination product.

A sponsor may use a voluntary formal process, known as a Request for Designation, when the product classification is unclear or in dispute, to obtain a binding decision as to which center will regulate the combination product. If the sponsor objects to that decision, it may request that the agency reconsider that decision. This process can add time and delays to the regulatory approval process, and even when a reconsideration is granted, there is no guarantee that the outcome of a reconsideration will be different, or that the sponsor will receive a result that it agrees with. If our candidates receive a designation we do not anticipate, this could further delay study design, product development, and our requests for approval.

If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations or restrictions on the indicated uses for which such product may be marketed. For example, the FDA may approve the NDA with a REMS to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre-and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may also require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.

In addition, the PREA requires a sponsor to conduct pediatric clinical trials for most drugs, for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration. Under PREA, original NDA’s and supplements must contain a pediatric assessment unless the sponsor has received a deferral or waiver. The required assessment must evaluate the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The sponsor or FDA may request a deferral of pediatric clinical trials for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that the drug is ready for approval for use in adults before pediatric clinical trials are complete or that additional safety or effectiveness data needs to be collected before the pediatric clinical trials begin. The FDA must send a non-compliance letter to any sponsor that fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.

By focusing on FDA approved medicines for our continuous delivery, we will have access to pediatric indications and waivers that have been granted by the FDA to those products and will engage with the FDA to define the specific requirements, if any, for each delivery.

Expedited Development and Review Programs

The FDA has a fast-track designation program that is intended to expedite or facilitate the process for reviewing new drug products that meet certain criteria. Specifically, new drugs are eligible for fast-track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. With regard to a fast-track product, the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.

Any product submitted to the FDA for approval, including a product with a fast-track designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. A drug is eligible for priority review if it is designed to treat a serious condition, and if approved, would provide a significant improvement in safety or effectiveness compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new drug designated for priority review in an effort to facilitate the review. The FDA endeavors to review applications with priority review designations within six months of the filing date as compared to ten months for review of new molecular entity NDAs under its current PDUFA review goals.

In addition, a product may be eligible for accelerated approval. Drug products intended to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials to verify the predicted clinical benefit. Products receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required clinical trials, or if such trials fail to verify the predicted clinical benefit. In addition, the FDA currently requires pre-approval of promotional materials as a condition for accelerated approval, which could adversely impact the timing of the commercial launch of the product.

The Food and Drug Administration Safety and Innovation Act established a category of drugs referred to as “breakthrough therapies” that may be eligible to receive breakthrough therapy designation. A sponsor may seek FDA designation of a product candidate as a “breakthrough therapy” if the product is intended, alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the fast-track program features, as well as more intensive FDA interaction and guidance.

The breakthrough therapy designation is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met. If a product is designated as breakthrough therapy, the FDA will work to expedite the development and review of such drug.

The ODA provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation. For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and the FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including eligibility for market exclusivity for seven (7) years post FDA-approval and tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated. CLL is an orphan disease and any drug or biological product approved by the FDA for treatment of CLL will qualify for orphan designation.

Fast track designation, breakthrough therapy designation, priority review, accelerated approval, and orphan designation do not change the standards for approval but may expedite the development or approval process. Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. Further,

being granted any of these expedited review designations does not convey any advantages in the regulatory approval process or guarantee eventual approval by the FDA. Depending on the data generated, we believe that some of our products might qualify for fast track, orphan status or breakthrough therapy designation.

Post-approval Requirements

Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fees for any marketed products.

Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain procedural and documentation requirements upon drug manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical studies to assess new safety risks, or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

•        restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

•        fines, warning letters, or untitled letters;

•        clinical holds on clinical studies;

•        refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product approvals;

•        product seizure or detention, or refusal to permit the import or export of products;

•        consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

•        mandated modification of promotional materials and labeling and the issuance of corrective information;

•        the issuance of safety alerts, “Dear Healthcare Provider” letters, press releases and other communications containing warnings or other safety information about the product; or

•        injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising, and promotion of drug products. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising, and potential civil and criminal penalties. Physicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described in the product’s labeling and that differ from those tested and approved by the FDA. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict marketers’ communications on the subject of off-label use of their products. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined companies from

engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labelling.

Patent Exclusivity and Orange Book Listing

In seeking approval for a drug through an NDA, including a 505(b)(2) NDA, applicants are required to list with the FDA certain patents whose claims cover the applicant’s product. Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the Orange Book. Any applicant who files an ANDA seeking approval of a generic equivalent version of a drug listed in the Orange Book or a 505(b)(2) NDA referencing a drug listed in the Orange Book must certify to the FDA (i) that there is no patent listed with the FDA as covering the relevant branded product, (ii) that any patent listed as covering the branded product has expired, (iii) that the patent listed as covering the branded product will expire prior to the marketing of the generic product, in which case the ANDA will not be finally approved by the FDA until the expiration of such patent or (iv) that any patent listed as covering the branded drug is invalid or will not be infringed by the manufacture, sale or use of the generic product for which the ANDA is submitted. A notice of the Paragraph IV certification must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA or 505(b)(2) application refers. The applicant may also elect to submit a “section viii” statement certifying that its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.

If the referenced NDA holder and patent owners assert a patent challenge directed to one of the Orange Book listed patents within 45 days of the receipt of the Paragraph IV certification notice, the FDA is prohibited from approving the application until the earlier of 30 months from the receipt of the Paragraph IV certification, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the applicant. The ANDA or 505(b)(2) application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the branded reference drug has expired as described in further detail below.

Patent Term Restoration

Under the Hatch-Waxman Act, a portion of the patent term lost during product development and FDA review of an NDA, or 505(b)(2) application is restored if approval of the application is the first permitted commercial marketing of a drug containing the active ingredient. The patent term restoration period is generally one-half the time between the effective date of the IND and the date of submission of the NDA, plus the time between the date of submission of the NDA and the date of FDA approval of the product. The maximum period of restoration is 5 years, and the patent cannot be extended to more than 14 years from the date of FDA approval of the product. Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval.

The PTO, in consultation with the FDA, reviews and approves the application for patent term restoration. When any of our products are approved, we intend to seek patent term restoration for an applicable patent when it is appropriate. At present, we anticipate STAR-LLD, if approved, to qualify for patent term restoration.

Non-Patent Exclusivity

In addition to patent exclusivity, the holder of the NDA for the listed drug may be entitled to a period of non-patent exclusivity, during which the FDA cannot approve an ANDA or 505(b)(2) application that relies on the listed drug.

For example, a drug that is considered NCE at the time of approval may be awarded a five-year period of marketing exclusivity, starting at the time of product approval. An ANDA or 505(b)(2) application referencing that drug may not be approved until the five-year period expires. Also, an ANDA or 505(b)(2) application referencing that drug may not filed with the FDA until the expiration of 5 years, unless the submission is accompanied by a Paragraph IV certification, in which case the applicant may submit its application 4 years following the original product approval.

A drug, including one approved under Section 505(b)(2), may obtain a three-year period of exclusivity for a particular condition of approval, or change to a marketed product, such as a new formulation for a previously approved product, if one or more new clinical studies (other than BA or bioequivalence studies) was essential to the approval of the application and was conducted/sponsored by the applicant.

A drug granted orphan designation may obtain a seven-year period of exclusivity, with an additional six (6) months for pediatric conditions.

Pediatric Exclusivity

Section 505A of the FDC Act provides for six months of additional exclusivity and patent protection if an NDA sponsor submits pediatric data that fairly responds to a written request from the FDA for such data. The data does not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s request, additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or Orange Book listed patent protection cover the drug are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve an ANDA, or 505(b)(2) application owing to regulatory exclusivity or listed patents. When any of our products are approved, we anticipate seeking pediatric exclusivity when it is appropriate.

Orphan Drug Exclusivity

The ODA provides incentives for the development of drugs intended to treat rare diseases or conditions, which generally are diseases or conditions affecting less than 200,000 individuals annually in the U.S. If a sponsor demonstrates that a drug is intended to treat a rare disease or condition, the FDA grants orphan drug designation to the product for that use. The benefits of orphan drug designation include research and development tax credits and exemption from user fees. A drug that is approved for the orphan drug designated indication is granted seven (7) years of orphan drug exclusivity. During that period, the FDA generally may not approve any other application for the same product for the same indication, although there are exceptions, most notably when the later product is shown to be clinically superior to the product with exclusivity. We intend to seek orphan drug designation and exclusivity for our products whenever it is available.

Drug Enforcement Agency Regulation

Our product candidates may be regulated as “controlled substances” as defined in the Controlled Substances Act of 1970, as amended, which establishes registration, security, recordkeeping, reporting, storage, distribution, and other requirements administered by the DEA. The DEA is concerned with, among other things, the control of handlers of controlled substances and with the equipment and raw materials used in their manufacture and packaging, in order to prevent loss and diversion into illicit channels of commerce.

The DEA regulates controlled substances as Schedule I, II, III, IV or V substances. A pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of abuse and Schedule V substances the lowest relative risk of abuse among such substances. The manufacture, shipment, storage, sale and use of Schedule II drugs are subject to a high degree of regulation. For example, Schedule II drug prescriptions generally must be signed by a physician and may not be refilled without a new prescription. Substances in Schedule IV are considered to have a lower potential for abuse relative to substances in Schedule II. A prescription for controlled substances in Schedule IV may be issued by a practitioner through oral communication, in writing or by facsimile to the pharmacist and may be refilled if so, authorized on the prescription or by call-in. In the future, our other potential products may also be listed by the DEA as controlled substances.

Annual registration is required for any facility that manufactures, distributes, dispenses, imports, or exports any controlled substance. The registration is specific to the particular location, activity and controlled substance schedule. For example, separate registrations are needed for import and manufacturing, and each registration will specify which schedules of controlled substances are authorized.

The DEA typically inspects a facility to review its security measures prior to issuing a registration. Security requirements vary by controlled substance schedule, with the most stringent requirements applying to Schedule I and Schedule II substances. Required security measures include background checks on employees and physical control

of inventory through measures such as cages, surveillance cameras and inventory reconciliations. Records must be maintained for the handling of all controlled substances and periodic reports must be made to the DEA, including, for example, distribution reports for Schedule II controlled substances, Schedule III substances that are narcotics and other designated substances. Reports must also be made for thefts or losses of any controlled substance and authorization must be obtained to destroy any controlled substance. In addition, special authorization and notification requirements apply to imports and exports.

In addition, a DEA quota system controls and limits the availability and production of controlled substances in Schedule II. Distributions of any Schedule II controlled substance must also be accompanied by special order forms, with copies provided to the DEA. The DEA establishes annually an aggregate quota for how much of a Schedule II substance may be produced in total in the U.S. based on the DEA’s estimate of the quantity needed to meet legitimate scientific and medicinal needs. This limited aggregate amount of any particular Schedule II substance that the DEA allows to be produced in the U.S. each year is allocated among individual companies, who must submit applications annually to the DEA for individual production and procurement quotas. We and our contract manufacturers must receive an annual quota from the DEA in order to produce or procure any Schedule II substance for use in manufacturing. The DEA may adjust aggregate production quotas and individual production and procurement quotas from time to time during the year, although the DEA has substantial discretion in whether or not to make such adjustments. Our and our contract manufacturers’ quota of an active ingredient may not be sufficient to meet commercial demand or complete clinical trials. Any delay or refusal by the DEA in establishing our and our contract manufacturers’ quota for controlled substances could delay or stop our clinical trials or product launches, which could have a material adverse effect on our business, financial position, and results of operations.

To meet its responsibilities, the DEA conducts periodic inspections of registered establishments that handle controlled substances. Failure to maintain compliance with applicable requirements, particularly as manifested in loss or diversion, can result in enforcement action that could have a material adverse effect on our business, results of operations and financial condition. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In certain circumstances, violations could result in criminal proceedings.

Individual states also regulate controlled substances, and we and our contract manufacturers will be subject to state regulation on distribution of these products.

Other Healthcare Laws

Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. Such laws include, without limitation, U.S. federal and state anti-kickback, fraud and abuse, false claims, pricing reporting, data privacy and security, and physician payment transparency laws and regulations as well as similar foreign laws in the jurisdictions outside the U.S. Violation of any of such laws or any other governmental regulations that apply may result in significant penalties, including, without limitation, administrative civil and criminal penalties, damages, disgorgement fines, additional reporting requirements and oversight obligations, contractual damages, the curtailment or restructuring of operations, exclusion from participation in governmental healthcare programs and/or imprisonment.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidate for which we may seek regulatory approval. Sales in the U.S. will depend, in part, on the availability of sufficient coverage and adequate reimbursement from third-party payors, which include government health programs such as Medicare, Medicaid, TRICARE, and the Veterans Administration, as well as managed care organizations and private health insurers. Prices at which we or our customers seek reimbursement for our product candidates can be subject to challenge, reduction, or denial by third-party payers.

The process for determining whether a third-party payor will provide coverage for a product is typically separate from the process for setting the reimbursement rate that the payor will pay for the product. In the U.S., there is no uniform policy among payors for coverage or reimbursement. Decisions regarding whether to cover any of a product, the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies but also have their own methods and approval processes. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming

and costly process that can require manufacturers to provide scientific and clinical support for the use of a product to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product that receives approval. Third-party payors may not consider our product candidates to be medically necessary or cost-effective compared to other available therapies, or the rebate percentages required to secure favorable coverage may not yield an adequate margin over cost or may not enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. Additionally, decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product.

U.S. Healthcare Reform

In the U.S., there has been, and continues to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities, and affect the profitable sale of product candidates.

Among policy makers and payors in the U.S., there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the U.S., the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. In March 2010, the ACA was passed and signed into law, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical industry. The ACA increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1%; required collection of rebates for drugs paid by Medicaid managed care organizations; required manufacturers to participate in a coverage gap discount program, in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs, implemented a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; expanded eligibility criteria for Medicaid programs; created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and established a Center for Medicare Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, including the Bipartisan Budget Act of 2018, will remain in effect through 2029 unless additional Congressional action is taken. The CARES Act was signed into law on March 27, 2020 and suspended these reductions from May 1, 2020 through December 31, 2020 due to the COVID-19 pandemic, and extended the sequester by one year, through 2030. In addition, on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from 3 to 5 years. On August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law. The IRA included, among other provisions, several measures intended to lower the cost of prescription drugs and related healthcare reforms. Specifically, the IRA authorizes and directs the Centers for Medicare and Medicaid Services (CMS) to set drug prices for certain Medicare Part B and Part D qualified drugs with the greatest expense to the program, with the first year of maximum price applicability to begin in 2026 and an expanding list of selected drugs each year after. The Act further authorizes CMS to levy a financial penalty on pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part D drugs faster than the rate of inflation. Finally, the IRA creates significant changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025 and creating new financial liabilities for drug manufacturers and health plans providing Part D benefits. We cannot be sure whether additional or related legislation or rulemaking will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

Individual states in the U.S. have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, states, including California, Florida, Nevada and Maine, among others, have responded to these pressures with a range of legislative enactments and policy proposals designed to control prescription drug prices by, for example, allowing importation of pharmaceutical products from jurisdictions outside the U.S., imposing Prescription Drug Affordability Boards, some with the ability to impose price controls on state drug purchases and imposing transparency measures around prescription drug prices and marketing costs. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine which drugs and suppliers will be included in their healthcare programs. Furthermore, there has been increased interest by third party payors and governmental authorities in reference pricing systems and publication of discounts and list prices.

Healthcare Regulations

Pharmaceutical companies are subject to various federal and state laws that are intended to combat health care fraud and abuse and that govern certain of our business practices, especially our interactions with third-party payors, healthcare providers, patients, customers and potential customers through sales and marketing or research and development activities. These include anti-kickback laws, false claims laws, sunshine laws, privacy laws, and FDA regulation of advertising and promotion of pharmaceutical products.

Anti-kickback laws, including the federal Anti-Kickback Statute, make it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce or reward referral of an individual for, or the purchase, order or recommendation of, any good or service reimbursable by, a federal health care program (including our products). The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. Although there are several statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing, or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. The penalties for violating the federal Anti-Kickback Statute include administrative civil money penalties, imprisonment for up to 10 years, fines of up to $100,000 per violation and possible exclusion from federal healthcare programs such as Medicare and Medicaid.

The federal civil and criminal false claims laws, including the civil False Claims Act, prohibit knowingly presenting, or causing to be presented, claims for payment to the federal government (including Medicare and Medicaid) that are false or fraudulent (and, under the Federal False Claims Act, a claim is deemed false or fraudulent if it is made pursuant to an illegal kickback). Manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the False Claims Act can result in significant monetary penalties, including fines ranging from $13,946 to $27,894 for each false claim, and treble damages. The federal government is using the False Claims Act, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical companies throughout the country, for example, in connection with the promotion of products for unapproved uses and other improper sales and marketing practices. The government has obtained multi-million and multi-billion-dollar settlements under the False Claims Act in addition to individual criminal convictions under applicable criminal statutes. In addition, companies have been forced to implement extensive corrective action plans and have often become subject to consent decrees or corporate integrity agreements, severely restricting the manner in which they conduct their business. Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.

to change certain practices, pay substantial fines and operate under the supervision of a federally appointed monitor for a period of years. Due to the breadth of these laws and their implementing regulations and the absence of guidance in some cases, it is possible that our practices might be challenged by government authorities. Violations of fraud and abuse laws may be punishable by civil and criminal sanctions including fines, civil monetary penalties, as well as the possibility of exclusion of our products from payment by federal health care programs.

Government Price Reporting

Government regulations regarding reporting and payment obligations are complex, and we are continually evaluating the methods we use to calculate and report the amounts owed with respect to Medicaid and other government pricing programs. Our calculations are subject to review and challenge by various government agencies and authorities, and it is possible that any such review could result either in material changes to the method used for calculating the amounts owed to such agency or the amounts themselves. Because the process for making these calculations, and our judgments supporting these calculations, involve subjective decisions, these calculations are subject to audit. In the event that a government authority challenges or finds ambiguity with regard to our report of payments, such authority may impose civil and criminal sanctions, which could have a material adverse effect on our business. From time to time, we conduct routine reviews of our government pricing calculations. These reviews may have an impact on government price reporting and rebate calculations used to comply with various government regulations regarding reporting and payment obligations.

Many governments and third-party payors reimburse the purchase of certain prescription drugs based on a drug’s AWP. In the past several years, state and federal government agencies have conducted ongoing investigations of manufacturers’ reporting practices with respect to AWP, which they have suggested have led to excessive payments by state and federal government agencies for prescription drugs.

Drug Pedigree Laws

State and federal governments have proposed or passed various drug pedigree laws (e.g., the Drug Supply Chain Security Act), which can require the tracking of all transactions involving prescription drugs from the manufacturer to the pharmacy (or other dispensing) level. Companies are required to maintain records documenting the chain of custody of prescription drug products beginning with the purchase of such products from the manufacturer. Compliance with these pedigree laws requires implementation of extensive tracking systems as well as heightened documentation and coordination with customers and manufacturers. While we fully intend to comply with these laws, there is uncertainty about future changes in legislation and government enforcement of these laws. Failure to comply could result in fines or penalties, as well as loss of business that could have a material adverse effect on our financial results.

Federal Regulation of Patent Litigation Settlements and Authorized Generic Arrangements

As part of the Medicare Prescription Drug Improvement and Modernization Act of 2003, companies are required to file with the FTC and the DOJ certain types of agreements entered into between brand and generic pharmaceutical companies related to the settlement of patent litigation or manufacture, marketing and sale of generic versions of branded drugs. This requirement could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with brand pharmaceutical companies and could result generally in an increase in private-party litigation against pharmaceutical companies or additional investigations or proceedings by the FTC or other governmental authorities.

Other

The U.S. federal government, various states and localities have laws regulating the manufacture and distribution of pharmaceuticals, as well as regulations dealing with the substitution of generic drugs for branded drugs. Our operations are also subject to regulation, licensing requirements and inspection by the states and localities in which our operations are located or in which we conduct business.

Certain of our activities are also subject to FTC enforcement actions. The FTC also enforces a variety of antitrust and consumer protection laws designed to ensure that the nation’s markets function competitively, are vigorous, efficient, and free of undue restrictions. Federal, state, local and foreign laws of general applicability, such as laws regulating working conditions, also govern us.

In addition, we are subject to numerous and increasingly stringent federal, state and local environmental laws and regulations concerning, among other things, the generation, handling, storage, transportation, treatment and disposal of toxic and hazardous substances, the discharge of pollutants into the air and water and the cleanup of contamination. We are required to maintain and comply with environmental permits and controls for some of our operations, and these permits are subject to modification, renewal, and revocation by the issuing authorities. Our environmental capital expenditures and costs for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or increased manufacturing activities at any of our facilities. We could incur significant costs or liabilities as a result of any failure to comply with environmental laws, including fines, penalties, third-party claims and the costs of undertaking a clean-up at a current or former site or at a site to which our wastes were transported. In addition, we have grown in part by acquisition, and our diligence may not have identified environmental impacts from historical operations at sites we have acquired in the past or may acquire in the future.

MANAGEMENT

Executive Officers and Directors

The following table sets forth information regarding our executive officers and directors, including their ages as of January 15, 2026:

Background of Our Executive Officers and Directors

Executive Officers

Pedro Lichtinger Waisman has been our Chairman and Chief Executive Officer since the founding of Starton in May 2017. Prior to Starton, Mr. Lichtinger Waisman served as President and Chief Executive Officer of Asterias Biotherapeutics from June 2014 to February 2016, and as President and Chief Executive Officer of Optimer Pharmaceuticals from May 2010 to February 2013. Mr. Lichtinger Waisman also worked at Pfizer Inc. from 1995 to 2010, including as President of its Global Primary Care Business Unit from 2008 to 2009 and President of Europe Pharmaceuticals from 2006 to 2008. Mr. Lichtinger Waisman holds an MBA degree from Wharton School of Business and an engineering degree from the National University of Mexico. Mr. Lichtinger Waisman is well qualified to serve as a director because of his experience as Chairman and CEO of Starton and his extensive management experience in the pharmaceutical industry.

James C. Oliver has been our Chief Medical Officer since 2019. Prior to Starton, beginning in 2013, Dr. Oliver worked at Accelovance Inc., a global contract research organization, where, from 2018, he served as the Chief Science Officer and managing director for Europe and Asia. Dr. Oliver has more than 30 years of experience in both the public and private sectors of the life sciences industry and contract research organizations, as well as 12 years in academia. Over Dr. Oliver’s career, he has managed large cross-functional project teams with internal staff and oversaw contract research organization vendors. Dr. Oliver has significant FDA experience with both the Drug and Biologic divisions having prepared more than fifty (50) INDs and participated in seven (7) successful NDA submissions for U.S./Global pharmaceutical companies. In his tenure with public and private biotechnology companies, he advised on several series of successful fundraisings. Dr. Oliver holds a Pharm.D. and a Bachelor of Science degree in pharmacy, both from Mercer University School of Pharmacy.

Scott L. Kahn has been our Chief Financial Officer since October 2022. Mr. Kahn has more than 35 years of finance and accounting experience in diverse organizations from start-ups to Fortune 500 companies. Prior to Starton, from 2006 to 2021, Mr. Kahn served as CFO and Vice President at Diopsys, Inc, a medical device company, where he was responsible for overseeing accounting, finance, human resources and investor relations. Following Diopsys, Mr. Kahn was Chief Financial Officer for Milestone Scientific, Inc. and had consulting engagements with Aquestive Therapeutics as Corporate Controller and Phibro Animal Health as Regional Controller. Mr. Kahn received a B.A. in Accounting from Franklin and Marshall College and an M.B.A. in International Business from Rutgers University. He is a Certified Public Accountant licensed in the State of New York and a Chartered Global Management Accountant.

Directors

Eric Baum, became a director of Starton in 2018. Mr. Baum has served as Managing Director of Acquis Consulting Group, L.L.C., a management consulting firm, since 2003, and has served as Managing Director and Co-Founder of its affiliate, Solidea Capital, a venture advisory firm, since 2005. At Acquis Consulting Group and Solidea Capital, Mr. Baum advises companies in areas such as business and corporate strategy, market positioning, growth and scale strategies, trajectory management, partnering frameworks and risk evaluation. He also serves on the Board of Directors of ESGAI Technologies Inc., Diagen AI Life Sciences and BigRentz, Inc. Mr. Baum is also actively involved in the venture capital arena as an angel investor and participant in several investment-focused groups, such as the Charlotte Angel Fund. Mr. Baum received a Bachelor of Business Administration from Emory University where he graduated valedictorian from the Goizueta Business School. Mr. Baum is well qualified to serve as a director because of his experience in management and corporate strategy.

Moses Dodo, became a director of Starton in 2022. Mr. Dodo has more than 35 years of corporate development experience focused on the US and Latin America. Since April 2021, Mr. Dodo has been a Managing Partner at MD5 Capital & Strategy Consulting, LLC, a boutique healthcare management consulting firm specializing in the healthcare industry. Prior to MD5, from March 2014 to April 2021, Mr. Dodo worked for Bupa Global Latin America, a global private health insurance provider, where he served as Managing Director from 2014 and Board Chairman from June 2019, where he led corporate development and inorganic growth. Prior to Bupa Global, Mr. Dodo served as CEO and Chairman of Amedex Bermuda, a life insurance company, and as a Board member of HtH Geoblue, a partnership with Blue Cross Blue Shield offering international private medical insurance in the USA. Mr. Dodo holds a bachelor’s degree in Business Administration and Finance from Fundacao Armando Alvares Penteado, Sao Paolo, Brazil. Mr. Dodo is well qualified to serve as a director because of his regulatory and management experience in the healthcare industry.

Nitin Kaushal became a director of Starton in 2018. Mr. Kaushal has over 30 years of financial and investment experience with a focus on the life sciences industry. Mr. Kaushal is a retired Managing Director of PWC Corporate Finance Inc., serving from 2012 to 2020. In addition to Starton, Mr. Kaushal currently sits on the boards of Viemed Healthcare, Inc. (Nasdaq: VMD), High Tide Inc. (Nasdaq: HITI) (TSXV: HITI) (FSE: 2LYA), Everyday People Financial Corp. (TSX-V: EPF)(OTCQB: EPFCF), and Synergy CHC Corp. (Nasdaq: SNYR). Mr. Kaushal received his Bachelor of Science degree in Chemistry from the University of Toronto Scarborough and his CA, CPA and CF Corporate Finance Qualification from Chartered Professional Accountants of Canada (CPA Canada). Mr. Kaushal is well qualified to serve as a director because of his experience as a member of various boards of directors and as a Chartered Accountant.

Roy F. Waldron, Ph.D., J.D., became a director of Starton in 2019. From 1999 to his retirement in June 2018, Dr. Waldron served as the Senior Vice President‚ Associate General Counsel, and Chief Intellectual Property Counsel at Pfizer. At Pfizer, he led global teams of Pfizer attorneys and professionals in procuring patents‚ and worked closely with R&D‚ Business Development and Pfizer Business Units to develop and strengthen intellectual property strategies for development and acquisition targets. Dr. Waldron holds a Juris Doctorate from New York University Law School‚ a Ph.D. from Yale University, and a Bachelor of Arts from Dartmouth College. Dr. Waldron is well qualified to serve as a director because of his experience with intellectual property in the pharmaceutical industry.

There are no family relationships among our directors or executive officers.

Involvement in Certain Legal Proceedings

None of our directors, executive officers, promoters or control persons has been involved in any events requiring disclosure under Item 401(f) of Regulation S-K.

Board Composition

Number and Terms of Office of Officers and Directors

Our board of directors is comprised of five directors and is divided into three classes with staggered three-year terms. At each annual meeting of stockholders, the successors to directors whose terms then expire will be elected to serve from the time of election and qualification until the third annual meeting following election. Our directors are divided among the three classes as follows:

•        the Class I directors are Roy Waldron and Nitin Kaushal, and their terms will expire at the first annual meeting of stockholders after the completion of this offering; and

•        the Class II directors are Eric Baum and Moses Dodo and their terms will expire at the second annual meeting of stockholders after the completion of this offering; and

•        the Class III director is Pedro Lichtinger Waisman and his term will expire at the third annual meeting of stockholders after the completion of this offering.

Directors in a particular class will be elected for three-year terms at the annual meeting of stockholders in the year in which their terms expire. As a result, only one class of directors will be elected at each annual meeting of stockholders, with the other classes continuing for the remainder of their respective three-year terms. Each director’s term continues until the election and qualification of his or her successor, or the earlier of his or her death, resignation or removal. This classification of our board of directors may have the effect of delaying or preventing changes in control of our company. See the section titled “Description of Capital Stock — Anti-Takeover Provisions.”

Director Independence

In connection with this offering, we have applied to list our common stock on the NASDAQ Capital Market. Under the rules of Nasdaq, independent directors must comprise a majority of a listed company’s board of directors within a specified period after the completion of this offering. In addition, the rules of Nasdaq require that, subject to specified exceptions, each member of a listed company’s audit, compensation and nominating and governance committees be independent. Under the rules of Nasdaq, a director will only qualify as an “independent director” if, in the opinion of that company’s board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.

Additionally, compensation committee members must not have a relationship with us that is material to the director’s ability to be independent from management in connection with the duties of a compensation committee member.

Audit committee members must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act. In order to be considered independent for purposes of Rule 10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors or any other board committee: accept, directly or indirectly, any consulting, advisory or other compensatory fee from the listed company or any of its subsidiaries; or be an affiliated person of the listed company or any of its subsidiaries.

Our board of directors has undertaken a review of the independence of each director and considered whether each director has a material relationship with us that could compromise his or her ability to exercise independent judgment in carrying out his or her responsibilities. Our board of directors determined that each of Eric Baum, Moses Dodo, Nitin Kaushal and Roy Waldron is an “independent director” as defined under the applicable rules and regulations of the SEC and the listing requirements and rules of Nasdaq. In making these determinations, our board of directors reviewed and discussed information provided by the directors and by us with regard to each director’s business and personal activities and relationships as they may relate to us and our management, including the beneficial ownership of our common stock by each non-employee director and the transactions involving them described in the section titled “Certain Relationships and Related Party Transactions.”

Board Committees

Our board of directors has established an audit committee, a compensation committee and a nominating and governance committee prior to the completion of this offering, each of which will operate pursuant to a charter adopted by our board of directors and which will be effective prior to the consummation of this offering. The composition and responsibilities of each of the committees of our board of directors are described below. Members serve on these committees until their resignation or until otherwise determined by our board of directors. Our board of directors may establish other committees as it deems necessary or appropriate from time to time. Following the completion of this offering, copies of the charters for each committee will be available on our website. Reference to our website does not constitute incorporation by reference of the information contained at or accessible through our website into this prospectus or the registration statement of which it forms a part.

Audit Committee

Our audit committee oversees our corporate accounting and financial reporting process. Among other matters, the audit committee:

•        appoints our independent registered public accounting firm;

•        evaluates the independent registered public accounting firm’s qualifications, independence and performance;

•        determines the engagement of the independent registered public accounting firm;

•        reviews and approves the scope of the annual audit and pre-approves the audit and non-audit fees and services;

•        reviews and approves all related party transactions on an ongoing basis;

•        establishes procedures for the receipt, retention and treatment of any complaints received by us regarding accounting, internal accounting controls or auditing matters;

•        discusses with management and the independent registered public accounting firm the results of the annual audit and the review of our quarterly financial statements;

•        approves the retention of the independent registered public accounting firm to perform any proposed permissible non-audit services;

•        discusses on a periodic basis, or as appropriate, with our management’s policies and procedures with respect to risk assessment and risk management;

•        consults with management to establish procedures and internal controls relating to cybersecurity;

•        is responsible for reviewing our financial statements and our management’s discussion and analysis of financial condition and results of operations to be included in our annual and quarterly reports to be filed with the SEC;

•        investigates any reports received through the ethics helpline and reports to the board of directors periodically with respect to any information received through the ethics helpline and any related investigations; and

•        reviews the audit committee charter and the audit committee’s performance on an annual basis.

Our audit committee consists of Eric Baum, Moses Dodo and Nitin Kaushal. Our board of directors has determined that all members are independent under the Nasdaq Listing Rules and Rule 10A-3(b)(1) of the Exchange Act. The chair of our audit committee is Mr. Kaushal. Our board of directors has determined Mr. Kaushal is an “audit committee financial expert” as such term is currently defined in Item 407(d)(5) of Regulation S-K. Our board of directors has also determined that each member of our audit committee can read and understand fundamental consolidated financial statements, in accordance with applicable requirements.

Our audit committee will operate under a written charter, to be effective prior to the completion of this offering, that satisfies the applicable Nasdaq listing standards.

Compensation Committee

Our compensation committee oversees policies relating to compensation and benefits of our officers and employees. The compensation committee reviews and approves or recommends corporate goals and objectives relevant to compensation of our executive officers (other than our Chief Executive Officer), evaluates the performance of these officers in light of those goals and objectives and approves the compensation of these officers based on such evaluations. The compensation committee also reviews and approves or makes recommendations to our board of directors regarding the issuance of stock options and other awards under our stock plans to our executive officers (other than our Chief Executive Officer). The compensation committee reviews the performance of our Chief Executive Officer and makes recommendations to our board of directors with respect to his compensation, and our board of directors retains the authority to make compensation decisions relative to our Chief Executive Officer. The compensation committee will review and evaluate, on an annual basis, the compensation committee charter and the compensation committee’s performance.

Our compensation committee consists of Eric Baum, Moses Dodo and Nitin Kaushal. Our board of directors has determined that all members are independent under the Nasdaq Listing Rules and are “non-employee directors” as defined in Rule 16b-3 promulgated under the Exchange Act. The chair of our compensation committee is Mr. Baum.

Our compensation committee will operate under a written charter, to be effective prior to the completion of this offering, that satisfies the applicable Nasdaq listing standards.

Nominating and Corporate Governance Committee

Our nominating and governance committee consists of Eric Baum, Moses Dodo and Roy Waldron. Our board of directors has determined that each member of the nominating and corporate governance committee is “independent” as defined in the applicable rules of Nasdaq. The nominating and corporate governance committee’s responsibilities upon the closing of this offering will include:

•        identifying and recommending candidates for membership on our board of directors;

•        recommending directors to serve on our board committees;

•        reviewing and recommending our corporate governance guidelines and policies;

•        reviewing proposed waivers of the code of conduct for directors and executive officers;

•        evaluating, and overseeing the process of evaluating, the performance of our board of directors and individual directors; and

•        assisting our board of directors on corporate governance matters.

Our nominating and corporate governance committee will operate under a written charter, to be effective prior to the completion of this offering, that satisfies the applicable Nasdaq listing standards.

Compensation Committee Interlocks and Insider Participation

None of the members of the compensation committee is currently, or has been at any time, one of our executive officers or employees. None of our executive officers currently serves, or has served during the last year, as a member of the board of directors or compensation committee of any entity that has one or more executive officers serving as a member of our board of directors or on our compensation committee.

Board Diversity

The Board’s objective is that its membership be comprised of a diverse group of experienced and dedicated individuals. Our nominating and corporate governance committee will be responsible for reviewing with the board of directors, on an annual basis, the appropriate characteristics, skills and experience required for the board of directors as a whole and its individual members. In evaluating the suitability of individual candidates (both new candidates and

current members), the nominating and corporate governance committee, in recommending candidates for election, and the board of directors, in approving (and, in the case of vacancies, appointing) such candidates, may take into account many factors, including but not limited to the following:

•        personal and professional integrity;

•        ethics and values;

•        experience in corporate management, such as serving as an officer or former officer of a publicly held company;

•        professional and academic experience relevant to our industry;

•        experience as a board member of another publicly held company;

•        strength of leadership skills;

•        experience in finance and accounting and/or executive compensation practices;

•        ability to devote the time required for preparation, participation and attendance at board of directors meetings and committee meetings, if applicable;

•        background, gender, age and ethnicity;

•        conflicts of interest; and

•        ability to make mature business judgments.

Following the consummation of this offering, our board of directors will evaluate each individual in the context of the board of directors as a whole, with the objective of ensuring that the board of directors, as a whole, has the necessary tools to perform its oversight function effectively in light of our business and structure and in compliance with the rules of Nasdaq.

Code of Business Conduct and Ethics

We have adopted a written code of business conduct and ethics that applies to all of our directors, officers and employees, including those officers responsible for financial reporting. The full text of our code of business conduct and ethics will be posted on our website at www.startontx.com upon the completion of this offering. Any substantive amendment to, or waiver of, a provision of the code of business conduct and ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller or persons performing similar functions, will be disclosed on our website.

Limitation on Liability and Indemnification Matters

Our certificate of incorporation and our bylaws will limit our directors’ liability, and provide that we may indemnify our directors and officers to the fullest extent permitted under Delaware General Corporation Law, or the DGCL. The DGCL provides that directors of a corporation will not be personally liable for monetary damages for breach of their fiduciary duties as directors, except for liability for any:

•        transaction from which the director derives an improper personal benefit;

•        act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

•        unlawful payment of dividends or redemption of shares; or

•        breach of a director’s duty of loyalty to the corporation or its stockholders.

These limitations of liability do not apply to liabilities arising under federal securities laws and do not affect the availability of equitable remedies such as injunctive relief or recession.

The DGCL and our bylaws will provide that we will, in certain situations, indemnify our directors and officers and may indemnify other employees and other agents, to the fullest extent permitted by law. Any indemnified person is also entitled, subject to certain limitations, to advancement, direct payment or reimbursement of reasonable expenses (including attorneys’ fees and disbursements) in advance of the final disposition of the proceeding. We believe that these provisions in our certificate of incorporation and bylaws are necessary to attract and retain qualified persons as directors and officers.

We also maintain a directors’ and officers’ insurance policy pursuant to which our directors and officers are insured against liability for actions taken in their capacities as directors and officers.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or control persons, in the opinion of the SEC, such indemnification is against public policy, as expressed in the Securities Act and is therefore unenforceable.

Non-Employee Director Compensation

We do not pay our non-employee directors any cash compensation for serving on our Board of Directors.

Each of our non-employee directors are awarded a baseline amount of annual stock option grants based on the following formula: options to purchase 33,333 shares of our common stock for serving on our Board of Directors; options to purchase 5,000 shares of our common stock for serving as the chair of a Board committee; and options to purchase 2,500 shares of our common stock for serving as a member of a Board committee. The Board options are granted on an annual basis at the end of each of our fiscal years and are subject to an exercise price equal to the then prevailing fair market value of the shares of our common stock, as generally determined by our Board of Directors based on the pricing of our most recent financing transaction in which we sold shares of our common stock. These awards are granted at the discretion of the Board and are subject to ad hoc increases or decreases at the discretion of the Board.

The following table sets forth the total cash and equity compensation paid to our non-employee directors for service on our board of directors during the fiscal year ended March 31, 2025: