As filed with the Securities and Exchange Commission on February 13, 2026.

Registration No. 333-292816

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT No. 1

FORM F-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

MEDIKRA INC.

(Exact name of registrant as specified in its charter)

Unit 1.02, The Bousteador 10,

Jalan PJU 7/6, Mutiara Damansara

47800 Petaling Jaya

Selangor, Malaysia

+603 2380 0319

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Puglisi & Associates

850 Library Ave., Suite 204

Newark, Delaware 19711

(302) 738-6680

(Name, address, including zip code, and telephone number, including area code, of agent for service)

With a Copy to:

Approximate date of commencement of proposed sale to the public: Promptly 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 an emerging growth company as defined in Rule 405 of the Securities Act of 1933

Emerging growth company ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to such Section 8(a), may determine.

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

SUBJECT TO COMPLETION

PRELIMINARY PROSPECTUS DATED FEBRUARY 13, 2026

4,545,455 Ordinary Shares

MEDIKRA INC.

This is an initial public offering of our ordinary shares, par value $0.0001 (“Ordinary Shares”). Prior to this offering, there has been no public market for our Ordinary Shares. We expect the initial public offering price of our Ordinary Shares to be in the range of $5 to $6 per share.

We have reserved the symbol “MDKR” for purposes of listing our Ordinary Shares on the Nasdaq Global Market (“Nasdaq”), and applied to list our Ordinary Shares on the Nasdaq. It is a condition to the closing of this offering that our Ordinary Shares qualify for listing on a national securities exchange. There is no assurance that our Nasdaq application will be approved, and if our application is not approved, this offering will not be completed.

Investing in our Ordinary Shares involves a high degree of risk, including the risk of losing your entire investment. See “Risk Factors” beginning on page 19 to read about factors you should consider before buying our Ordinary Shares.

We are an “emerging growth company” and a “foreign private issuer” as defined under the federal securities laws and will be subject to reduced public company reporting requirements. Please read the disclosures beginning on page 15 of this prospectus for more information.

We have agreed to issue a warrant to the representative of the underwriters to purchase a number of Ordinary Shares equal to five percent (5%) of the total number of Ordinary Shares sold in this offering (including any Ordinary Shares sold pursuant to the exercise of the underwriters’ over-allotment option), at an exercise price equal to 110% of the initial public offering price of the Ordinary Shares sold in this offering. The registration statement of which this prospectus is a part also registers the offer and sale of the Representative’s Warrant (as defined herein) and the Ordinary Shares issuable upon exercise thereof.

We have granted a 45-day option to the underwriters to purchase up to an aggregate of 681,818 additional Ordinary Shares, representing 15% of the Ordinary Shares sold in the offering, solely to cover over-allotments, if any, at the per share price for this initial public offering, less underwriting discounts and commissions. If the underwriters exercise the option in full, the total underwriting discounts will be $2,012,500 and the additional proceeds to us, before expenses, from the exercise of the over-allotment option will be $3,750,000.

This offering is being conducted on a firm commitment basis. The underwriters are obligated to take and pay for all of the Ordinary Shares if any such Ordinary Shares are taken. The underwriters expect to deliver the Ordinary Shares against payment in U.S. dollars in New York, New York on or about [●], 2026.

Neither the Securities and Exchange Commission nor any state securities commission nor any other regulatory body has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Brookline Capital Markets,

a division of Arcadia Securities, LLC

Prospectus dated [●], 2026

TABLE OF CONTENTS

Neither we nor 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 prepared by us or on our behalf or to which we have referred you. We take no 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 Ordinary Shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. We are not making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted or where the person making the offer or sale is not qualified to do so or to any person to whom it is not permitted to make such offer or sale. For the avoidance of doubt, no offer or invitation to subscribe for Ordinary Shares is made to the public in the Cayman Islands. The information contained in this prospectus is current only as of the date on the front cover of the prospectus. Our business, financial condition, results of operations, and prospects may have changed since that date.

No person is authorized in connection with this prospectus to give any information or to make any representations about us, the securities offered hereby or any matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or representation is given or made, such information or representation may not be relied upon as having been authorized by us.

For investors outside the United States: Neither we nor the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.

MARKET DATA

Market data and certain industry data and forecasts used throughout this prospectus were obtained from internal company surveys, internal estimates, market research, consultant surveys, publicly available information, reports of governmental agencies and international organizations, and industry publications and surveys. We believe that industry surveys, publications, consultant surveys and forecasts referred to herein have been obtained from reliable sources. To our knowledge, third-party industry data that includes projections for future periods does not take into account all potential factors that could affect such projections. Accordingly, those third-party projections should not be given undue weight. We have not independently verified any of the data from third party sources, nor have we ascertained the underlying economic assumptions relied upon therein. Similarly, internal surveys, industry forecasts and market research, which we believe to be reliable based on our management’s knowledge of the industry, have not been independently verified. We assume liability for the accuracy and completeness of such information to the extent included in this prospectus. Statements as to our market position are based on the most currently available data. Our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this prospectus.

TRADEMARKS

The logos, and other trade names, trademarks, and service marks of Medikra Inc. and its subsidiaries appearing in this prospectus are the property of Medikra Inc. and its subsidiaries. Other trade names, trademarks, and service marks appearing in this prospectus are the property of their respective holders. Trade names, trademarks, and service marks contained in this prospectus may appear without the “®” or “™” symbols. Such references are not intended to indicate, in any way, that we, or the applicable owner or licensor, will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable owner or licensor to those trade names, trademarks, and service marks. 

Conventions that Apply to this Prospectus

Unless otherwise indicated or the context requires otherwise, references in this prospectus to:

Unless the context indicates otherwise, all information in this prospectus assumes no exercise by the underwriters of their over-allotment option and no exercise of the Representative’s Warrant (as defined herein).

Medikra Inc. is a Cayman Islands holding company. Our business will be conducted by our subsidiaries, Medika Natura Sdn Bhd and Medikra Malaysia Sdn Bhd in Malaysia using MYR. Our financial statements are presented in U.S. dollars. In this prospectus, we refer to assets, obligations, commitments, and liabilities in our financial statements in U.S. dollars. These dollar references are based on the exchange rate of MYR to U.S. dollars, determined as of a specific date or for a specific period. Changes in the exchange rate will affect the amount of our obligations and the value of our assets in terms of U.S. dollars which may result in an increase or decrease in the amount of our obligations (expressed in dollars) and the value of our assets, including accounts receivable (expressed in dollars).

Prior to our Corporate Reorganization, we conducted our business through Medika Natura Sdn. Bhd., and therefore certain historical financial statements present the results of operations of Medika Natura Sdn. Bhd. Following the Corporate Reorganization, our financial statements are prepared on a consolidated basis and present the consolidated results of operations of Medikra Inc. and its subsidiaries (the shares and per share information is presented on a retroactive basis to reflect the Corporate Reorganization).

GLOSSARY OF CERTAIN TERMS

Considering that we are a biopharmaceutical company, the description of our business involves several technical terms and acronyms. We provide the following glossary to assist readers with certain technical terms and acronyms to understand key terminology frequently used herein in this prospectus:

RISK FACTORS

An investment in our Ordinary Shares involves a high degree of risk. Before deciding whether to invest in our Ordinary Shares, you should consider carefully the risks described below, together with all of the other information set forth in this prospectus, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes. If any of these risks actually occurs, our business, financial condition, results of operations, or cash flow could be materially and adversely affected, which could cause the trading price of our Ordinary Shares to decline, resulting in a loss of all or part of your investment. The risks described below and discussed in other parts of this prospectus are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business. You should only consider investing in our Ordinary Shares if you can bear the risk of loss of your entire investment.

Risks Relating to our Business and Industry

We are a clinical-stage biopharmaceutical company with no approved pharmaceutical products, limited operating history, and no revenue from drug sales.

We are a clinical-stage biopharmaceutical company incorporated in the Cayman Islands on August 30, 2024. Through our wholly owned subsidiaries, Medika Natura and Medikra Malaysia, we operate a dual-track commercialization model that integrates near-term revenue generation from nutraceutical formulations with the longer-term development of pharmaceutical-grade botanical therapeutics.

We have no approved prescription pharmaceutical products and have not yet generated revenue from drug sales, and have a limited operating history. There can be no assurance that our drug candidates will receive regulatory approval or achieve commercial success, or that we will be able to expand nutraceutical operations into additional international markets.

We have incurred losses in the past and we do not expect to generate meaningful product revenue until we commercialize one or more product candidates.

Our wholly owned Malaysian subsidiary, Medika Natura, commenced operations in 2006. As a biotechnology company with a dual-segment model—comprising clinical-stage pharmaceutical development and revenue-generating nutraceutical operations—we have incurred a net loss of approximately $0.23 million in 2024.

Even though, for the year 2023 the Company generated a net profit of approximately $0.019 million due to higher sale of nutraceutical products, based on the historical background, ongoing clinical-stage pharmaceutical development, and current market scenario, we do not expect to generate meaningful product revenue unless the current market volatility improves and until we obtain marketing approval for one or more pharmaceutical product candidates and are successful in commercializing them, either directly or through license or collaboration agreements with third parties. Our ability to achieve and sustain profitability is dependent on successful clinical development, regulatory approvals, commercial uptake, and prudent cost management. Our current and future development plans remain subject to ongoing assessments of global macroeconomic trends and evolving regulatory landscapes across our target markets. There can be no assurance that we will achieve profitability or that our development and commercialization efforts will be successful.

While we have initiated commercial sales of standardized botanical nutraceutical products, we have not yet generated revenue from pharmaceutical drug sales. We expect to continue allocating capital toward advancing our lead candidate, SKF7®, through Phase II/III clinical trials, initiating regulatory filings, expanding our manufacturing infrastructure, and developing our pipeline candidates including KPH1™ and MKS-5®.

We believe this investment-focused approach is aligned with long-term value creation, but it may result in continued operating losses over the near term. Our ability to achieve sustained profitability will depend on multiple factors, including:

We remain confident that our platform, pipeline, and commercialization roadmap position us well to unlock future value. However, there can be no assurance that we will achieve sustained profitability within a specific timeframe, or that unforeseen challenges will not arise.

Investors should consider that any potential returns may be subject to timing uncertainties and industry-related risks. Nonetheless, we believe our current strategy offers a compelling foundation for sustainable growth and scalable impact in the biopharmaceutical and health innovation sectors.

We and our contract manufacturers are subject to extensive regulatory oversight in the United States and internationally. Non-compliance with applicable regulations may materially impact our business operations and product development timelines.

Our operations, including those of our contract manufacturers and distribution partners, are subject to comprehensive regulatory requirements across all jurisdictions in which we operate or intend to introduce our products. This includes oversight by the FDA, the European Medicines Agency (“EMA”), the MFDS in South Korea, the National Pharmaceutical Regulatory Agency (“NPRA”) in Malaysia, and other relevant authorities.

As a clinical-stage biotechnology company developing botanical-based therapeutics alongside commercial-stage nutraceuticals, our regulatory pathway involves several stages of evaluation. This includes preclinical research, Phase I–III clinical trials, and, where applicable, New Drug Applications (NDAs), IND submissions, or regulatory filings under nutraceutical or food-based frameworks such as the FDA’s NDI and EFSA’s Novel Food processes.

The regulatory landscape governing biotechnology, pharmaceuticals, and functional botanicals is highly complex and continues to evolve. Regulatory changes or shifts in agency expectations may increase the time and cost associated with product development and commercialization. Furthermore, our products may be subject to varying classifications and approval requirements depending on the jurisdiction, therapeutic indication, and delivery format.

While we have initiated commercial sales of nutraceutical formulations, our prescription drug candidates remain under clinical evaluation and are not yet approved for sale. Advancing these candidates through regulatory review involves scientific, operational, and compliance challenges. Delays or failure to obtain regulatory approvals for our investigational products could hinder our ability to generate pharmaceutical revenues and achieve profitability.

Additionally, regulatory authorities such as the FDA may require post-market studies, surveillance, or risk management programs even after approval. These obligations can be resource-intensive, and failure to comply may lead to adverse actions such as product recalls, market withdrawals, or suspension of manufacturing or sales.

Regulatory enforcement actions may include, but are not limited to:

We are committed to maintaining regulatory compliance across all levels of our operations. However, any regulatory enforcement or compliance failure could negatively impact our ability to market and distribute products, delay development timelines, affect brand reputation, and materially and adversely impact our business, financial performance, and strategic objectives.

Regulatory acceptance for nutraceutical products mitigate certain risks, but do not eliminate all regulatory uncertainties

Our lead nutraceutical product, SKF7®, has received regulatory acceptance as a NDI by the FDA and Novel Food authorization by the European Food Safety Authority (EFSA). In addition, all of our currently commercialized nutraceutical formulations are registered with Malaysia’s NPRA and are in the process of being submitted for regulatory recognition in other key markets including South Korea, Germany, and Saudi Arabia. The FDA’s acceptance of SKF7® as a New Dietary Ingredient does not mean that the FDA has determined that SKF7® is safe or efficacious; such determinations can only be made through adequate and well-controlled clinical studies. While we believe that these acceptances and registrations provide an important regulatory foundation for future commercialization, there can be no assurance that our products will be successfully introduced or achieve market acceptance in these or any other jurisdictions.

However, despite these regulatory milestones, we remain subject to ongoing and evolving regulatory requirements across all jurisdictions where we operate or plan to commercialize our products. Local regulations, enforcement priorities, and interpretations may differ, which could result in unexpected delays, costs, or restrictions. While the registration status of our products may help mitigate certain risks, compliance obligations, labeling rules, product classification frameworks, and post-market surveillance requirements may still pose challenges, particularly as we expand globally.

Furthermore, our pharmaceutical development programs, including those for SKF7® and KPH1™, are still in the clinical stage and remain subject to lengthy and rigorous regulatory review processes (e.g., IND, NDA/CTX). The receipt of early-stage regulatory acceptance for nutraceutical use does not guarantee success under pharmaceutical pathways or ensure future approval for therapeutic indications.

We may not be able to submit INDs or IND amendments, or comparable foreign applications, to commence additional clinical trials on the timelines we expect, and even if we are able to do so, the FDA, EMA or comparable foreign regulatory authorities may not permit us to proceed.

We currently expect to submit an IND for SKF7® in obesity and metabolic syndrome in 2026. However, we may not be able to ultimately submit either INDs or comparable foreign applications for SKF7®, or for our other drug candidates, on the timelines we expect. For example, we may experience delays with IND-enabling studies. Moreover, we cannot be sure that submission of an IND or a comparable foreign application will result in the FDA, EMA or a comparable foreign regulatory authority allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials. Additionally, even if such regulatory authorities ultimately agree with the design and implementation of the clinical trials set forth in an IND or in a comparable foreign application, we cannot guarantee that such regulatory authorities will not change their requirements in the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs or to a new IND, or to comparable existing or new foreign applications. Any failure to submit INDs or comparable foreign applications on the timelines we expect or to obtain permission for our trials to proceed may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.

Due to the significant resources required to develop our multiple product candidates and our dependence on available capital, we must prioritize certain programs over others. We may allocate resources to candidates or indications that ultimately fail, or we may overlook opportunities that could prove more profitable or have a greater likelihood of success.

We have multiple product candidates in development, each requiring significant capital investment. Because of the substantial resources required, we must focus on selected diseases and indications and determine which candidates to advance and how to allocate resources. Our current strategy is to pursue indications where we believe proof-of-concept data may be generated efficiently, such as abdominal obesity, type 2 diabetes, polycystic ovary syndrome, and menopause-associated metabolic dysfunction. We intend to expand into additional areas, including oncology and neuroinflammatory disorders, if sufficient data and resources permit. However, even if we are able to obtain regulatory approval for one indication, there is no assurance that we will achieve success in others, and we may expend significant resources without achieving regulatory approval or commercial viability.

Our decisions regarding resource allocation may not yield viable products and could divert focus from more promising opportunities. We may reprioritize, delay, terminate, or seek collaborative arrangements for certain programs, and such decisions could later prove to be suboptimal. If we incorrectly assess clinical viability, market potential, or industry trends, we may miss valuable opportunities, forego development of more attractive programs, or relinquish rights in circumstances where sole development and commercialization would have been more advantageous.

We may not be able to successfully implement our growth strategy, although early regulatory acceptance and commercial momentum support our strategic direction. 

Our future growth, profitability, and cash flow depend on our ability to effectively execute our dual-track commercialization strategy, which includes expanding sales of our registered nutraceutical products and advancing botanical therapeutics through clinical development. While we have made meaningful progress—including the receipt of FDA NDI and EFSA Novel Food acceptance for our lead product SKF7®, as well as NPRA registrations for our current nutraceutical offerings—there can be no assurance that we will successfully scale or sustain this trajectory.

Our ability to execute our strategy depends on several factors, including our capacity to:

While we believe our foundation—including early commercial traction and an established regulatory framework—positions us well for future growth, there can be no assurance that we will achieve all strategic milestones within the anticipated timelines. Additionally, implementation will require sustained investment, which may result in short-term operating losses and fluctuations in margin performance. If we are unable to execute key components of our growth plan, our business, financial condition, and operational results could be materially affected.

We rely on a limited number of third-party manufacturers and may face supply chain risks, but existing quality systems and regulatory compliance frameworks support continuity and scalability.

Our operations, including ongoing clinical programs and commercial nutraceutical production, depend on contract manufacturers to supply, formulate, and package our products in accordance with applicable quality standards and regulatory requirements. In many cases, we work with a small number of third-party manufacturers, including single-source suppliers and those operating from a single geographic location. While this strategic focus enhances consistency and oversight, it also increases our exposure to potential disruptions.

Our contract manufacturers are subject to extensive regulatory oversight in the United States, Malaysia, and other jurisdictions where we operate or intend to expand. These manufacturers must comply with GMP standards and are assessed under relevant quality frameworks, such as PIC/S, ICH, NPRA, and CFR 21 Part 210/211 where applicable. Our lead product, SKF7®, has already achieved NDI acceptance from the FDA and Novel Food approval from EFSA, and our nutraceutical products are registered with Malaysia’s NPRA. These regulatory milestones indicate that our current manufacturing and documentation standards meet the requirements of major health authorities.

However, risks inherent in a third-party manufacturing model remain:

We take proactive steps to mitigate these risks by maintaining documentation for regulatory compliance, developing internal SOPs and contingency plans, and assessing alternative manufacturing partners in key markets. Where possible, we also diversify our supplier base and maintain active dialogue with our contract manufacturers to anticipate and address potential disruptions.

Nonetheless, there is no guarantee that our supply chain will remain uninterrupted, particularly as we scale operations or introduce new products. Any significant failure by our contract manufacturers to meet demand—either for clinical trial supply or commercial fulfillment—could delay our programs, damage customer relationships, or impact revenue generation. Furthermore, in the event of a catastrophic incident at a primary manufacturing site, insurance coverage may not fully compensate for loss of production or reputational harm.

If our contract manufacturers are unable to meet quality or volume requirements in a timely and cost-effective manner, or if we are unable to secure alternative manufacturing partners when needed, it could materially and adversely affect our business, financial condition, and results of operations.

As our sales grow, our contract manufacturers may face challenges in scaling production or meeting regulatory expectations, which could affect product availability and impact our commercial performance.

To support both our current commercial nutraceutical operations and our future prescription drug programs, we rely on contract manufacturers to deliver consistent, regulatory-compliant supply at scale. As demand for our products increases, particularly across international markets, our contract and component manufacturers will need to expand capacity while maintaining quality and adherence to evolving regulatory standards.

Achieving profitability depends on our ability to ensure that contract manufacturers can produce our products in sufficient quantities, at acceptable costs, and in full compliance with applicable regulatory frameworks. This includes FDA (CFR 21 Parts 210/211), NPRA, EFSA Novel Food, and other jurisdiction-specific requirements. Our lead asset, SKF7®, has already been cleared as a NDI by the FDA and as a Novel Food by the EFSA. Additionally, all of our commercial nutraceutical products are registered with Malaysia’s NPRA, and we intend to pursue similar registrations in other priority markets, reinforcing our commitment to regulatory alignment across our manufacturing partners.

As we scale, our contract manufacturers may encounter challenges such as:

Recent policy developments in the United States reflect a broader push to relocate pharmaceutical manufacturing domestically and expand FDA oversight of foreign facilities, including increased international inspections. These measures could increase compliance costs, create inspection-related delays, or disrupt global supply chains.

Failure to resolve these challenges may result in supply constraints, quality deviations, or delays that could impair our ability to meet commercial demand. This, in turn, could negatively affect our revenue growth, delay product launches, or erode market confidence—especially if customers choose alternative products.

We have established a proactive quality assurance strategy that includes oversight of contract manufacturing operations, regulatory audit preparedness, and the development of scale-up protocols aligned with future IND-enabling studies. Nonetheless, disruptions in supply, failure to meet regulatory or market expectations, or inability to scale efficiently could materially affect our commercial progress.

We may face barriers in driving market adoption of our products, which could delay commercialization and reduce long-term growth potential.

The successful adoption of our nutraceutical and pharmaceutical candidates depends on market acceptance, consumer confidence, healthcare provider endorsement, and competitive differentiation. If we are unable to effectively educate and engage our target audiences—including consumers, prescribers, and regulatory stakeholders—there could be lower-than-anticipated uptake of our products, particularly in new markets.

Adoption may be influenced by factors such as:

While we believe our dual-track model—comprising regulated nutraceuticals and late-stage pharmaceutical candidates—positions us well to meet unmet needs across metabolic-endocrine indications, we acknowledge that slow adoption in certain markets or segments could delay our growth trajectory. We further note that our clinical trials for prescription-grade programs may not be successful and that the Company may not be successful in obtaining regulatory approval or in commercializing its product candidates. There can be no assurance that our business model will achieve the intended level of market acceptance or that our development and commercialization efforts will be successful.

We continue to invest in medical education, strategic KOL engagement, and scientific publications to enhance visibility and trust in our platform. However, if market uptake of our products is slower than expected or if our commercialization efforts do not generate meaningful traction, it could materially and adversely affect our financial performance, market share, and investor returns.

The results of our current and future clinical trials may not support our product candidate claims or could reveal unexpected adverse effects, potentially delaying or limiting our development plans.

We rely on the generation of robust clinical and scientific data to support the development, regulatory approval, and eventual commercialization of our botanical candidates, particularly SKF7®, which is currently under clinical investigation for obesity, metabolic syndrome, and women’s health indications.

Although we have completed two randomized, placebo controlled Phase II trials in Malaysia and Indonesia and a Phase I pharmacokinetic study in India conducted under ICH GCP conditions, as well as comprehensive GLP compliant toxicology studies, there can be no assurance that future trials, including planned Phase III studies, will replicate or confirm these findings. Regulatory authorities may not accept ex U.S. trial data, and delays in patient recruitment, trial execution, or data analysis could affect our development timelines and regulatory submissions.

It is also possible that future trials may reveal:

Although our nutraceutical formulations—based on the same active extract—have achieved certain regulatory acceptance from the FDA (NDI), EFSA (Novel Food), and NPRA Malaysia, the clinical requirements for pharmaceutical approval are significantly more stringent. Any safety concerns, clinical failures, or ambiguous outcomes in future trials may hinder our ability to advance SKF7® or other candidates to regulatory approval.

Failure to demonstrate compelling clinical benefit could limit our ability to secure payer coverage or reduce commercial adoption.

In parallel with clinical efficacy and safety, real-world adoption will also depend on cost-effectiveness, competitive positioning, and payer acceptance—particularly in more regulated pharmaceutical markets. Even if our candidates demonstrate statistically significant clinical benefits, they may not meet evolving standards for coverage, reimbursement, or health technology assessment in some jurisdictions.

Additionally, concerns about botanical variability or lack of familiarity with botanical drugs in certain regulatory or medical communities may also pose hurdles to broad adoption, despite increasing international recognition of standardized phytomedicine.

We are proactively addressing these risks through:

If we encounter delays or setbacks in the development of SKF7® or our other candidates, our growth trajectory and business prospects may be adversely affected.

As a biotechnology company with a dual-track model, our long-term value creation is significantly tied to the successful development, regulatory approval, and commercialization of prescription candidates like SKF7®. Any delays—whether from clinical, regulatory, or supply chain bottlenecks—could materially impact our ability to meet development milestones, expand into new therapeutic categories, or compete in target markets.

For example, if required bridging studies, expanded safety trials, or additional pharmacokinetic data are needed due to manufacturing scale-up or formulation adjustments, this could increase development costs and delay regulatory filings.

We remain committed to advancing our pipeline with scientific and operational rigor. However, given the inherent uncertainties in clinical research, we cannot guarantee that SKF7® or other candidates will achieve regulatory approval, meet our targeted timelines, or attain commercial success. 

If our contract manufacturers or suppliers fail to comply with environmental, health, and safety laws and regulations, we may be exposed to regulatory liability or supply chain disruption that could adversely affect our business.

We rely on a network of qualified contract manufacturers and suppliers to support both our nutraceutical and pharmaceutical development programs. These partners are subject to numerous environmental, health, and safety (EHS) laws and regulations at the federal, state, and local levels—including those governing laboratory practices, waste disposal, and the handling and transport of regulated or hazardous materials.

While we select reputable partners with robust compliance systems, we cannot guarantee full elimination of EHS-related risks. Any accidental non-compliance, material release, or regulatory breach by a third-party manufacturer or supplier could result in:

Though our contract partners are primarily responsible for maintaining compliance, we may still be affected by enforcement actions taken by authorities, including fines, permitting restrictions, or operational suspensions. This is particularly relevant as we scale up manufacturing for late-stage trials and enter new geographies with evolving environmental standards.

We are actively implementing quality agreements, regular audits, and environmental risk assessments across our contract manufacturing network to mitigate these risks. Nonetheless, the occurrence of any significant compliance failure could have a material adverse effect on our operations and financial condition.

As we expand our operations, we may face challenges managing growth effectively, particularly across geographies, product categories, and regulatory jurisdictions.

Our future success depends not only on scientific and clinical progress, but also on our ability to scale operations in a controlled and efficient manner. With planned growth across both our pharmaceutical pipeline and international nutraceutical business, we must continually improve our operational, financial, and information systems while also building and retaining high-performing teams.

Key areas of focus include:

Failure to scale these operational components in tandem with our clinical and commercial ambitions may strain internal resources, delay execution timelines, or reduce responsiveness to market shifts. While we are actively investing in team development and system enhancements, the complexity of managing multi-segment international growth could still pose challenges.

By maintaining strategic discipline and prioritizing risk-adjusted expansion, we aim to minimize operational bottlenecks while continuing to build a durable, innovation-led biotechnology business.

We have previously received grant awards from Malaysian government, which may not be available to us in the future.

We have received funding under grant award programs supported by several Malaysian ministries and agencies, including the Ministry of Agriculture and Food Security (MAFS), the Ministry of Investment, Trade and Industry (MITI), the Ministry of Science, Technology and Innovation (MOSTI), the Malaysian Trade Development Corporation (MTDC), Bioconomy Corporation, SME Corp., and the Academy of Sciences Malaysia. To fund a portion of our future research and development programs, we may apply for additional grant funding from these or similar Malaysian ministries and agencies in the future. However, funding by these, and other, governmental agencies may be significantly reduced or eliminated in the future for various reasons. In addition, we may not receive full funding under current or future grants because of budgeting constraints of the agency administering the program or unsatisfactory progress on the study being funded. Therefore, we cannot provide any assurance that we will receive any future grant funding from any government agencies, or, that if received, we will receive the full amount of the particular grant award. Any such reductions could delay the development of our product candidates and the introduction of new products.

We may not be able to achieve or maintain profitability in the near term.

For the fiscal years ended December 31, 2024, and 2023, we incurred a net loss of approximately US$0.28 million, and net profit of approximately US$0.019 million, respectively. For the six months ended June 30, 2025, and 2024, we incurred net loss of approximately US$0.628 million, and net loss of approximately US$0.131 million, respectively.  While we have commenced commercial sales of nutraceutical formulations and continue to make progress across our clinical development programs—including our lead candidate SKF7®, which has received both FDA NDI and European Novel Food acceptance—we cannot assure you that we will be able to generate net income or positive cash flow from operating activities in the near term.

Our ability to achieve and sustain profitability will depend on multiple factors, including:

We anticipate that our operating expenses will continue to increase as we:

While we are confident in our dual-track model and recent regulatory progress, our path to profitability remains subject to various uncertainties—such as clinical outcomes, market adoption, competitive pressures, global economic conditions, and evolving regulatory environments. In the interim, we plan to fund our operations through various sources, including, but not limited to, proceeds from this offering, future financing rounds, equity contributions from existing shareholders, non-dilutive public sector grants, and strategic partnerships and collaborations.

If we are unable to generate sufficient revenue or manage costs effectively, our business, financial condition, and results of operations may be materially and adversely affected. We believe that the strategic investments we are making today are essential to building long-term value; however, these investments may not immediately translate into profitability.

The markets for our drug candidates that we are developing or we may develop may be smaller than we expect for one or more indications.

Our estimates of the potential market opportunity for the drug candidates that we are developing or we may develop, for one or more indications, include several key assumptions based on our industry knowledge, industry publications and third-party research reports. There can be no assurance that any of these assumptions are, or will remain, accurate. If the actual market for any of the drug candidates that we are developing or we may develop, is smaller than we expect for one or more indications, our revenue, if any, may be limited and it may be more difficult for us to achieve or maintain profitability.

We operate in a highly competitive and rapidly evolving industry, and may face resistance to the adoption of new therapies by physicians, healthcare providers, and payers.

The biotechnology and pharmaceutical industries are intensely competitive, marked by rapid technological advancements and evolving standards of care. We compete with a broad range of established multinational pharmaceutical and biotechnology companies, as well as emerging growth-stage players, many of which have significantly greater financial resources, clinical development experience, commercial infrastructure, and market presence.

While we believe our botanical-based therapeutic approach, including our proprietary SKF7® platform, offers differentiated value—particularly for patients underserved or intolerant to conventional pharmacotherapies—we may still face competitive challenges on multiple fronts:

Speed to market: Other companies may complete clinical trials, obtain regulatory approvals, or achieve commercial launch faster than we can, thereby securing first-mover advantages, broader reimbursement access, and greater physician adoption.

In addition to external competitive pressures, we may encounter internal market resistance, particularly among:

Payers and reimbursement bodies that may be slow to recognize the value of botanical drugs or natural-origin therapeutics in disease areas typically dominated by synthetic pharmaceuticals, especially where pharmacoeconomic data is still emerging.

We believe our dual-track model comprising both commercialized nutraceuticals and investigational botanical therapies offers a strategic advantage by enabling us to generate early revenue, assess consumer and clinical interest, and build awareness across markets. However, there can be no assurance that we will be successful in defending or growing our market share, accelerating adoption among prescribers, or outperforming incumbent or future competitors.

Failure to respond effectively to technological disruption, market resistance, or competitive pressures could adversely impact our growth trajectory, business operations, and financial performance.

Our operating results could be adversely affected if we are unable to accurately forecast consumer demand for our nutraceutical products or effectively manage inventory and pricing dynamics.

Efficient inventory planning and demand forecasting are critical to our ability to deliver high-quality nutraceutical products at scale, manage working capital, and sustain healthy gross margins. As a company that commercializes proprietary formulations derived from botanical ingredients, our inventory and sourcing models are informed by seasonality, ingredient availability, consumer demand trends, and channel-specific logistics.

We rely on internal forecasts, data analytics, and market intelligence to estimate demand and guide inventory decisions. However, actual demand may differ materially from forecasts due to a variety of factors, including evolving consumer preferences, economic conditions, pricing changes, seasonality, and the introduction of new products or competing alternatives.

Inventory misalignment may expose us to several risks:

Moreover, our ability to return unsold goods to suppliers is generally limited, and raw material sourcing—particularly for plant-based APIs—may be constrained by agricultural cycles, climate conditions, and supplier capacity. As we scale operations across additional international markets, our exposure to these risks may increase.

To mitigate these risks, we continue to invest in digital inventory systems, supply chain analytics, and agile procurement frameworks to better align demand forecasting with production. Nonetheless, our ability to accurately anticipate demand remains a key determinant of operational efficiency and financial performance.

Our growth and market positioning depend on the strength of our brands and reputation, which could be negatively impacted by adverse events, quality concerns, or inconsistent pricing.

Brand equity is fundamental to our consumer engagement, channel penetration, and long-term success—especially as we expand awareness of our nutraceutical offerings derived from patented botanical actives like SKF7®. Given our smaller size relative to large pharmaceutical and wellness players, we are particularly reliant on building trust, education, and visibility among both consumers and healthcare professionals.

Negative publicity—whether related to our products, management, third-party suppliers, or distribution practices—could damage consumer trust, reduce demand, or affect our ability to secure partnerships. Even unfounded safety concerns or isolated quality issues may require significant time and cost to remediate and could result in reputational harm.

As we continue to broaden our product portfolio and geographic reach, maintaining brand consistency and customer experience across markets will be critical to supporting our premium positioning and global credibility.

Changes to the pricing of our nutraceutical products may affect profitability and revenue growth.

We aim to offer high-quality, clinically supported nutraceuticals at prices accessible to our target segments. Our pricing strategy is influenced by input costs, manufacturing and logistics expenses, channel markups, consumer insights, and market-specific dynamics.

While we leverage data analytics to guide pricing decisions, external factors—such as inflation, exchange rates, raw material volatility, or competitive promotions—may require us to adjust prices. Price increases may limit affordability and reduce volume, while discounts or promotional pricing (such as during product launches or seasonal campaigns) may compress margins and affect perceived value.

In some instances, we may implement pricing changes to reduce inventory buildup or align older products with market expectations. Although these adjustments are part of our agile commercialization approach, there is no guarantee they will always drive incremental demand or be margin-neutral.

Additionally, sales made to distribution partners at discounted rates could be resold into the market at lower prices, creating potential channel conflicts and pricing distortions. We monitor such risks closely and implement contractual and operational controls where feasible, but we may not be able to eliminate this risk entirely.

Any sustained pricing pressure, inventory inefficiencies, or reputational challenges could adversely impact our margins, revenue growth, and financial condition.

We have incurred, and expect to continue to incur, significant costs for a variety of sales and marketing efforts, including mass advertising and heavy promotions to attract customers through multiple channels. If we are unable to conduct our sales and marketing efforts in a cost-effective and efficient manner, our results of operations and financial condition may be materially and adversely affected.

We will allocate substantial financial and operational resources to our sales and marketing activities. These include expanding our sales teams, investing in brand campaigns, and developing omnichannel marketing strategies aimed at strengthening brand visibility, engaging our customer base, and driving product adoption. For the fiscal years ending December 31, 2024, and 2023, our selling and marketing expenses were $766, and $3,875, respectively, representing approximately 3%, and 6% of our total net revenues. These expenditures primarily reflect test marketing efforts and brand validation campaigns conducted in selected pilot markets, and not full-scale commercialization. As we pursue broader market penetration, we expect these expenses to increase and remain significant in support of our dual-track commercialization strategy.

For the six months ended June 30, 2025, and 2024, our selling and marketing expenses were $3,565 and $436, respectively, representing approximately 45% and 2% of our total net revenues. The higher percentage in the current period primarily reflects lower sales compared with the corresponding period of the prior year, as full-scale commercialization has not yet commenced. Sales during this period were limited in nature and conducted under a controlled early-access and test-marketing initiative to assess product–market fit and obtain early feedback from selected healthcare providers. No budget was allocated for commercial team expansion, salesforce deployment, or promotional campaigns during the period. These activities were strategically focused on strengthening brand visibility and market readiness, positioning the company for potential growth as it transitions toward broader commercialization.

Selling and marketing expenditures are expected to increase in 2026 as we advance toward full-scale market entry. The timing and magnitude of these expenditures will depend on operational execution, regulatory milestones, and capital availability, and there can be no assurance that commercialization will proceed as currently planned or that we will not need to scale down, defer, or adjust our marketing initiatives based on funding or market conditions.

Our near- and mid-term strategy includes continued investments in awareness and distribution initiatives, particularly in Malaysia, the United States, South Korea, the European Union, ME, and other targeted geographies. These efforts are designed to support both our nutraceutical portfolio and our pharmaceutical development programs, including future launches of prescription botanical therapeutics subject to regulatory approval.

However, our marketing and branding activities may not always be successful, well-received, or cost-efficient. We may face challenges in maintaining the effectiveness of existing strategies or adapting to evolving consumer trends, digital platforms, or market expectations. For instance, we may not be able to rapidly identify or implement new marketing approaches that resonate with target consumers or efficiently convert interest into product demand.

In addition, failure to comply with applicable consumer protection, advertising, or promotional regulations—either in the U.S. or internationally—could result in regulatory scrutiny, fines, or restrictions that may delay or inhibit our ability to sell products in certain markets. If we are unable to optimize our sales and marketing operations or align our promotional activities with consumer behavior and legal requirements, it could materially affect our business, financial performance, and future growth prospects.

Our business is subject to complex and evolving product safety laws, regulations and standards. If we fail to comply with these laws, regulations and standards or our products otherwise have defects, we may be required to recall products and may face penalties and product liability claims, either of which could result in unexpected costs and damage our reputation.

Our operations are subject to complex and evolving product safety laws, regulations, and industry standards across the jurisdictions in which we operate. These laws govern the sourcing, manufacturing, packaging, labeling, distribution, importation, and exportation of our nutraceutical products, and require rigorous adherence to safety and quality control measures. We have implemented internal procedures and partner oversight protocols aimed at ensuring compliance with applicable regulations and standards, including collaboration with third-party testing centers and periodic consultation with regulatory and legal experts.

Despite these measures, we may not be able to guarantee continuous compliance, particularly as applicable laws, regulations, and interpretations evolve. In addition, as we expand our operations into new markets, we may encounter different or more stringent compliance frameworks that require additional internal controls or certifications.

We rely on third-party manufacturers and raw material suppliers—such as Herbal Science Sdn. Bhd.—for our nutraceutical production, and although we require compliance with relevant safety standards and mandate documentation such as Certificates of Analysis and safety reports, we do not have full operational control over the upstream procurement or manufacturing processes. While our quality assurance team monitors conformance to internal and regulatory expectations, we cannot fully eliminate the risk of supply chain deviations, defects, or contamination events.

As our commercial footprint grows, we may also face increased exposure to product liability claims. Even when products comply with safety requirements and labeling guidance, individual users may experience unexpected adverse reactions due to underlying medical conditions, allergies, or interactions with other medications. While we provide warnings, usage guidance, and contraindications where applicable, there is a risk that adverse events could still occur.

In the event of a substantiated safety concern, we may be required to initiate voluntary or regulatory product recalls or face temporary suspensions of market access. Such events could lead to administrative actions, fines, legal proceedings, or reputational harm. Any resulting disruptions or liabilities could materially affect our operations, financial condition, and prospects.

Complying with numerous health, safety and environmental regulations is both complex and costly.

Our operations are subject to extensive environmental, health, and safety (EHS) regulations in Malaysia and other jurisdictions where we conduct or intend to conduct business. These laws govern a broad range of activities, including air emissions, wastewater discharge, solid and hazardous waste management, and the handling, storage, use, transport, and disposal of hazardous materials and chemical substances.

As regulatory expectations evolve—often becoming more stringent over time—ongoing compliance may require the implementation of enhanced systems, technologies, or operational practices. While we believe that our facilities and operational partners currently operate in compliance with applicable requirements, continued compliance may entail capital expenditures, staff training, and investment in safety and monitoring systems.

In addition, some environmental regulations impose strict liability for remediation, regardless of fault. As such, we may face exposure to claims or enforcement actions related to events outside our direct control or arising from historical activities. Although we take a proactive approach to EHS risk management and engage qualified third-party experts where appropriate, we cannot guarantee that future regulatory developments or inspections will not lead to findings of noncompliance or result in unforeseen costs.

Any violations or alleged noncompliance could lead to administrative or legal proceedings, including fines, mandatory corrective actions, or temporary disruption of operations. Furthermore, liability related to personal injury, environmental contamination, or property damage—whether through litigation or regulatory enforcement—could adversely affect our financial condition, business operations, and reputation.

Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new product candidates and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new product candidates can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes, including changes to the FDA’s priorities or processes. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for our product candidates or product candidates to be reviewed or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. federal government has shut down several times and certain regulatory agencies, such as the FDA have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, or if the FDA is otherwise hindered by inadequate funding, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a newly public company, future government shutdowns or similar funding issues could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Changes in tariffs and trade policies, and any retaliatory measures by other countries or other trade tensions, could increase business costs, impact supply chains and cause business uncertainty, any of which may adversely impact our operations, supply chain, cash flows and profitability.

Escalating trade tensions have led to increased tariffs and trade restrictions. Since taking office in January 2025, the current U.S. presidential administration has issued numerous executive orders implementing or revising tariffs and international trade policies, seeking to prioritize U.S. domestic industry and rebalance global trade dynamics.

For example, the “Liberation Day” tariffs announced on April 2, 2025 included universal tariffs on imported goods, along with additional “reciprocal” tariffs on dozens of named countries. Although these tariffs include certain pharmaceutical product exemptions, the tariffs may nevertheless have a direct and/or indirect impact on products or components that we import. Subsequently, President Trump indicated that various additional changes in U.S. tariffs and trade policies may be forthcoming, including tariffs on pharmaceutical imports, including potential tariffs pursuant to Section 232 of the Trade Expansion Act of 1962. Other countries have implemented retaliatory tariffs in response and may announce additional tariffs or trade restrictions in the future.

Any trade policy change, through the implementation of tariffs or otherwise, or uncertainty regarding their implementation or final rates or retaliatory measures or other trade tensions, can create a volatile business environment, affecting strategic planning and investment decisions, and may have a material adverse effect on global trade, macroeconomic and geopolitical conditions and the stability of global financial markets.

Any of the foregoing developments could increase our cost of goods, including the availability and costs of active pharmaceutical ingredients and raw materials. Depending upon shape and form in which any such developments are ultimately implemented or otherwise occur, these could result in higher business decision complexity, additional operational expenses, tax complexity and profit margin pressure. They can also complicate supplier management and adversely impact supply chain flexibility and supply chain traceability.

Changes in laws or policies related to pricing for prescription drugs, including most-favored-nation (“MFN”) requirements, could adversely affect our product prices and profit margins, and thereby our operations, revenues and profits.

The adoption in new jurisdictions of laws and policies that reduce, establish or mandate price controls or establish prices paid by government entities or programs for our products, or the implementation of more restrictive controls in existing jurisdictions, could adversely affect our product prices and profit margins, and thereby our operations, revenues and profits. The failure to establish or maintain timely or adequate pricing may also adversely impact operations, revenues and profits. We expect that pricing pressures to continue globally.

For example, on May 12, 2025, the current U.S. presidential administration directed federal government agencies to pursue most-favored-nation price targets with pharmaceutical manufacturers through an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” On July 31, 2025, the administration followed this executive order with letters to seventeen manufacturers requesting lower existing prescription drug prices in Medicaid, and to guarantee lower pricing for newly-launched drugs for Medicare, Medicaid, and commercial payers to match the lowest price offered in other developed nations. Starting in late September 2025, some drug manufacturers have announced agreements with the federal government to offer most-favored-nation pricing on certain existing and future products. On November 6, 2025, the Centers for Medicare & Medicaid Services (“CMS”) announced the availability of the “Generating Cost Reductions for U.S. Medicaid (GENEROUS) Model,” a limited duration payment model conducted through the CMS Innovation Center to allow drug manufacturers to voluntarily provide coordinated supplemental rebates to state Medicaid agencies that match international prices in a basket of developed market countries. Failure to participate in the model could result in less favorable Medicaid coverage against market competitors that choose to participate.

On December 19, 2025, CMS issued two additional notices of proposed rulemaking to establish mandatory, limited duration Medicare drug pricing models known as the “Global Benchmark for Efficient Drug Pricing (GLOBE) Model” for certain Medicare Part B drugs and the “Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model” for certain Medicare Part D drugs. Under these proposals, CMS would replace existing domestic inflation-based rebate calculations with new rebate obligations tied to international reference pricing benchmarks in a basket of economically comparable countries. If finalized, the models could require the Company to pay additional rebates for certain of its products, depending on CMS selection criteria and international price levels.

Moreover, on February 6, 2026, the administration announced the launch of “TrumpRx.gov,” an online portal through which the public can search for their prescription medications and determine whether their drug is available through a cost-saving program offered by a pharmaceutical manufacturer’s own direct-to-consumer website. If the drug is part of such a program, consumers will be redirected to the manufacturer’s direct-to-consumer page, where they can purchase the drug directly using a cash-based payment system rather than through their insurance.

While we are not currently subject to any of these programs, we will continue to monitor their potential impact on our business.

We may be subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations. 

As we expand internationally, our operations and product shipments are increasingly subject to complex and evolving import and export control laws, trade restrictions, and economic sanctions administered by the Malaysian government and other regulatory authorities in jurisdictions where we do business, including the United States, the European Union, South Korea, and countries in ME and ASEAN.

These laws and regulations may restrict the export or import of certain technologies, botanical extracts, active ingredients, or finished products to or from specific countries, persons, or entities. They may also impose licensing, reporting, or recordkeeping obligations that vary by region. We have implemented internal compliance mechanisms, including screening protocols and third-party due diligence processes, to identify high-risk counterparties and ensure compliance with applicable trade and customs laws.

However, given the dynamic nature of international regulations, there remains a risk of inadvertent non-compliance. If we or any of our subsidiaries or partners were to violate applicable export control or sanctions laws—whether through oversight or as a result of evolving interpretations—our business could be subject to enforcement actions, including civil or criminal penalties, regulatory fines, loss of export privileges, or reputational damage.

In addition, any regulatory investigations into alleged violations—even if ultimately resolved without penalty—could result in significant distraction to our management, increased legal costs, and negative publicity. While we believe our current protocols are robust, continued expansion into new jurisdictions may necessitate additional resources to manage compliance risks across global supply chains, distribution networks, and licensing partnerships.

Failure to maintain full compliance with export-import regulations could materially impact our ability to compete in international markets, delay the availability of our products in certain countries, and adversely affect our financial condition and business operations.

Fluctuations in exchange rates in the MYR could adversely affect our business and the value of our securities.

The value of the MYR against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in Malaysia’s political and economic conditions. The value of our Ordinary Shares will be indirectly affected by the foreign exchange rate between U.S. dollars and MYR and between those currencies and other currencies in which our revenue may be denominated. Appreciation or depreciation in the value of the MYR relative to the U.S. dollar would affect our financial results reported in U.S. dollar terms without giving effect to any underlying change in our business or results of operations. As we rely to a large extent on revenues earned in Malaysia, any significant revaluation of MYR may materially and adversely affect our cash flows, revenues and financial condition. For example, to the extent that we need to convert U.S. dollars we receive from an offering of our securities into MYR for our operations, appreciation of the MYR against the U.S. dollar could cause the MYR equivalent of U.S. dollars to be reduced and therefore could have a material adverse effect on our business, financial condition and results of operations. Conversely, if we decide to convert our MYR into U.S. dollars for the purpose of making dividend payments on our Ordinary Shares or for other business purposes and the U.S. dollar appreciates against the MYR, the U.S. dollar equivalent of the MYR we convert would be reduced. In addition, the depreciation of significant U.S. dollar denominated assets could result in a change to our operations and a reduction in the value of these assets.

Malaysia is experiencing inflationary pressures, which may prompt the government to take action to control the growth of the economy and inflation that could lead to a significant decrease in our profitability.

While we believe that the Malaysian economy has experienced rapid growth over the last two decades, it has also experienced inflationary pressures. As governments take steps to address inflationary pressures, there may be significant changes in the availability of bank credit, interest rates, limitations on loans, restrictions on currency conversions and foreign investment. There also may be imposition of price controls. If our revenues rise at a rate that is insufficient to compensate for the rise in our costs, it may have an adverse effect on our profitability. If these or other similar restrictions are imposed by a government to influence the economy, it may lead to a slowing of economic growth, which may harm our business, financial condition and results of operations.

If inflation increases significantly in ASEAN countries, our business, results of operations, financial condition and prospects could be materially and adversely affected.

If inflation in ASEAN countries, including Malaysia, increases significantly, our costs, including our staff costs and other operational costs, are expected to increase. Furthermore, high inflation rates could have an adverse effect on economic growth and the business climate within ASEAN countries, and dampen consumer purchasing power. As a result, a high inflation rate in ASEAN countries, including Malaysia, could materially and adversely affect our business, results of operations, financial condition and prospects.

We rely on third-party service providers for logistics services. If these service providers fail to provide reliable services, our business and reputation may be adversely affected.

We depend on external couriers and logistics providers (e.g. DHL, FEDEX, PosMalaysia) for key services like collecting products, storing them, shipping to customers, and managing returns. This reliance allows us to concentrate on our core business but means we have less control over the delivery services our customers receive. These logistics can be disrupted by various uncontrollable events, such as bad weather, disasters, health epidemics, IT system failures, transportation issues, labor problems, or political and economic changes. If our providers face disruptions or stop their services, finding new ones that meet our standards for quality and cost in a timely manner may be difficult or impossible.

The delivery staff from these third-party providers represent us to our customers, so managing them well is crucial for maintaining service quality. If our products do not arrive in good condition, on time, or if other delivery issues occur, it could negatively affect our products, customer satisfaction, and damage our business reputation. Additionally, if these providers increase their fees, we might face extra costs, and we may not be able to pass these increases on to our customers.

We may incur future product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses.

Our business exposes us to potential product candidate liability claims that are inherent in the testing, design, manufacture, and sale of pharmaceutical and nutraceutical products.

In its contractual dealings with third parties, it is not always possible for the Company to limit its potential exposure to products liability claims and, in any event, such contractual dealings may be of limited (if any) effect as a result of existing or future laws or regulations or unfavorable judicial decisions The distribution, sale and support of the Company’s future products may entail the risk of such claims, which is likely to be substantial in light of the use of its products in the treatment of medical conditions.

We could become the subject of product liability lawsuits alleging that product defects, or inadequate disclosure of product-related risks or product-related information resulted in an unsafe condition or injury to patients. Product liability lawsuits and claims, safety alerts, or product recalls, regardless of their ultimate outcome, could have a material adverse effect on our business and reputation, our ability to attract and retain customers and our results of operations or financial condition.

A successful product liability claim could result in significant monetary liability and could seriously harm the Company’s business, operations, financial position and/or reputation.

It is possible that claims against us may exceed the coverage limits of our third-party product liability insurance policies or cause us to record a self-insured loss. Even if any product liability loss is covered by an insurance policy, these policies typically have substantial retentions or deductibles that we are responsible for. Product liability claims in excess of applicable insurance coverage could have a material adverse effect on our business, results of operations, and financial condition.

In addition, any future product liability claim brought against us, with or without merit, could result in an increase of our product liability insurance rates. Insurance coverage varies in cost and can be difficult to obtain, and we cannot guarantee that we will be able to obtain insurance coverage in the future on terms acceptable to us or at all.

Failure to maintain or renew our current leases or locate desirable alternatives for our facilities could materially and adversely affect our business.

We lease properties for our executive offices and for our operations. If we need to terminate a lease early and relocate before the lease ends, we might face termination fees or be liable for breaching the contract. Additionally, when we wish to continue our presence at certain locations, there is no guarantee that we can successfully extend or renew those leases on terms that are acceptable to us, or at all.

Expansion into international markets will expose us to significant risks.

Building on our success in Malaysia, we intend to expand into Southeast Asia and other international markets. Expansion into international markets requires significant resources and management attention and subjects us to regulatory, economic, and political risks in addition to those we already face in Malaysia. There are significant risks and costs inherent in doing business in international markets, including:

Our experience with international regulatory environments and market practices is limited, which might hinder our ability to penetrate and operate successfully in the markets we are entering and aim to enter. Additionally, our international expansion could bring significant expenses, and there’s no guarantee of success. Our products and services might not be as quickly or widely accepted in new markets as we hope, partly due to our limited brand recognition in some parts of the world. Furthermore, if our third-party manufacturers or raw material suppliers are perceived as not adhering to the ethical, social, product, labor, and environmental standards of these markets, it could impact acceptance of our products. Failure to effectively navigate these risks could negatively impact our international operations and consequently have an adverse effect on our business, financial health, and operational outcomes.

Additionally, the laws in the countries in which we potentially may operate may change and their interpretation and enforcement may involve significant uncertainties that could limit the reliability of the legal protections available to us. We cannot predict the effects of future developments in the legal regimes in the countries in which we may potentially operate.

We gather, store, process and use various types of data, including clinical trial data, personal health information, real-world evidence and business partner records, to support our research, development and commercialization efforts. This data helps improve our products, inform regulatory submissions and enhance clinical and operational decision-making. All clinical data collection follows established international standards, including the ICH-GCP guidelines.

However, handling and protecting this data involves inherent risks. Specifically, we face challenges related to

We expect that data privacy and cybersecurity compliance will continue to draw increasing attention from regulators and the public. This may lead to higher compliance costs and greater operational complexity. Failure to effectively manage these risks could result in regulatory penalties, disruption of clinical or commercial activities, reputational damage or other adverse effects on our business and long-term prospects.

Complying with data protection laws, which are constantly evolving, can be costly and can attract negative publicity.

Many data protection laws are relatively new, and their interpretation by regulators is still evolving. If we handle data that requires extra scrutiny, we might need to implement stricter data management and protection measures. Complying with these laws, as well as future regulations related to data security and personal information protection, can be expensive and increase our operational costs. This compliance could also attract negative publicity, potentially harming our reputation and business operations. The implementation and interpretation of these laws remain uncertain.

Moreover, regulatory authorities worldwide are considering or have already adopted new data protection legislation. These, if enacted, along with their uncertain interpretations and applications, could lead to fines or orders for us to change our data practices and policies, negatively impacting our business and operations.

Any security and privacy breach may lead to leak and unauthorized disclosure of data and information we aggregate, which may hurt our brand image, our business and results of operations.

We store and analyze customer and operations data, and despite our security measures, we face risks of data loss, litigation, and potential liability due to security breaches. Our data is encrypted and stored on cloud-based servers, isolated from the internet, secured with access control, and further backed up on long-distance servers to minimize the risk of data loss or breach.

Despite the security measures we have implemented, we could still face cyber-attacks, including attempts to hack our cloud or intranet and steal customer and business information. Such attacks might also aim to extort economic benefits from us. Our security measures could also be compromised due to employee error, intentional misconduct, or other failures. Moreover, outsiders might fraudulently induce our employees to reveal sensitive information, gaining unauthorized access to our data.

Any breach or unauthorized access can lead to significant legal and financial consequences, damage our reputation, and erode customer confidence in our information security. This could deter customers from interacting with us and negatively impact our business and operations. The constantly evolving nature of security threats means we might not be able to foresee or prevent all types of attacks. A real or perceived breach could harm our reputation, lead to the loss of customers and business partners, reduce customer and partner engagement, and expose us to legal and financial risks, including lawsuits and regulatory fines. Any of these outcomes could materially and adversely affect our business and operational results.

We are dependent on information technology, and if we are unable to protect against service interruptions, data corruption, cyber-based attacks or network security breaches, our operations could be disrupted.

We rely on information technology networks and systems to market and sell our products, to process, transmit and store electronic and financial information, to manage and monitor a variety of business processes and activities and to comply with regulatory, legal and tax requirements. We are dependent on a variety of information systems to effectively process and fulfill customer orders. We also depend on our information technology infrastructure for digital marketing activities, for managing our various distribution channels, for electronic communications among our personnel, customers, manufacturers, and suppliers and for synchronization with our manufacturers and logistics providers on demand forecast, order placements and manufacturing and service status and capacity. These information technology systems, some of which are managed by third parties, may be susceptible to damage, disruptions or shutdowns due to failures during the process of upgrading or replacing software, databases or components, power outages, hardware failures, computer viruses, attacks by computer hackers, telecommunication failures, user errors or catastrophic events. Any material disruption of our systems, or the systems of our third-party manufacturers, e-commerce platforms or service providers, could disrupt our ability to track, record and analyze the products that we sell and could negatively impact our operations, shipment of goods, ability to meet customer requests, ability to process financial information and transactions, and ability to receive and process orders or engage in normal business activities. If our information technology systems suffer damage, disruption or shutdown, we may incur substantial cost in repairing or replacing these systems, and if we do not effectively resolve the issues in a timely manner, our business, financial condition and results of operations may be materially and adversely affected, and we could experience delays in reporting our financial results.

If we fail to maintain and upgrade our information technology systems, it may have a material adverse effect on our business, financial condition and results of operations.

As our business expands, we plan to continue investing in and upgrading our information technology systems and processes. Without these enhancements, we might face unexpected system disruptions, slow data processing, unreliable service, compromised quality, or delays in reporting accurate information. Such issues could harm our reputation and our ability to attract and retain customers.

However, these system upgrades come with inherent costs and risks, including potential disruptions to our internal controls, increased administrative and operating expenses, and the challenge of acquiring or retaining skilled personnel to implement and operate these new systems. These upgrades also demand significant management attention, along with the risks and costs of delays or difficulties in integrating new systems with our existing ones.

Furthermore, improving our information technology systems and infrastructure will require substantial financial, operational, and technical resources. There’s no guarantee that these investments will lead to increased business. If we are unable to adapt to technological changes or fail to maintain and upgrade our systems and infrastructure in response to evolving business needs efficiently and cost-effectively, our business could suffer adverse effects.

Compliance with Malaysia’s Personal Data Protection Act 2010, Personal Data Protection Order 2013, and any such existing or future data-privacy related laws, regulations, and governmental orders may entail significant expenses and could materially affect our business.

Our business and operations in Malaysia are subject to laws and regulations regarding data privacy and data protection pursuant to the Personal Data Protection Act 2010 (the “PDPA 2010”). In particular, the PDPA 2010 applies to any person who processes or has control over, or authorizes the processing of, any personal data regarding commercial transactions, except for any personal data processed outside of Malaysia and not intended to be further processed in Malaysia. Under the PDPA 2010, any person engaged in processing personal data shall take measures to protect the personal data from any loss, misuse, modification, unauthorized or accidental access, or disclosure, alteration, or destruction of personal data and to maintain the integrity and competence of the personnel having access to the personal data processed. Such personal data should not be kept longer than necessary for the fulfilment of the purpose for which it was to be processed and shall be destroyed or permanently deleted if it is no longer required. In addition, a data user who belongs to any of the classes of data users prescribed under the Personal Data Protection (Class of Data Users) Order 2013 (the “Order 2013”) shall be registered under the PDPA 2010 in order to process personal data.

Interpretation, application, and enforcement of such laws, rules, regulations, and governmental orders, such as the PDPA 2010 and the Order 2013, evolve from time to time and their scope may continually change, through new legislation, amendments to existing legislation, and changes in enforcement. Compliance with the PDPA 2010 and/or related implementing regulations and governmental orders could significantly increase the cost of providing our service offerings, require significant changes to our operations, or even prevent us from providing certain service offerings in Malaysia. Despite our efforts to comply with applicable laws, regulations, and other obligations relating to privacy, data protection, and information security, it is possible that our practices could fail to meet all of the requirements imposed on us by the PDPA 2010 and/or related implementing regulations and government orders. Any failure on our part to comply with such laws, rules, regulations, governmental orders, or any other obligations relating to privacy, data protection, or information security, or any compromise of security that results in unauthorized access, use or release of personally identifiable information or other data, or the perception or allegation that any of the foregoing types of failure or compromise has occurred, could damage our reputation, discourage new and existing counterparties from contracting with us or result in investigations, fines, suspension, or other penalties by Malaysian government authorities and private claims or litigation, any of which could materially adversely affect our business, financial condition, and results of operations. Even if our practices are not subject to legal challenges, the perception of privacy concerns, whether or not valid, may harm our reputation and brand and adversely affect our business, financial condition, and results of operations. Moreover, the legal uncertainty created by the PDPA 2010 and/or related implementing regulations and governmental orders could materially and adversely affect our ability, on favorable terms, to raise capital, including engaging in offerings of our securities in the U.S. market.

Inaccuracies or perceived inconsistencies in our clinical or operational metrics may harm our reputation and impact our business.

We rely on internally generated and third-party data to evaluate clinical progress, inform regulatory submissions, guide product development and support our commercialization strategy. These metrics include clinical trial outcomes, real-world evidence, biomarker responses, AI-generated analyses and other scientific or operational indicators. While we apply rigorous quality control procedures, these metrics are not independently audited unless required by regulatory authorities, and may differ from external assessments or industry benchmarks.

Any material inaccuracies, inconsistencies or perceived lack of transparency in the reporting or interpretation of our data could negatively affect our credibility with regulators, scientific partners, investors or healthcare providers. This may delay approvals, disrupt partnerships or harm our reputation, which could adversely impact our business and future prospects.

We rely on third-party payment processors for certain transactions, and any disruptions, errors, or compliance issues could affect our ability to collect revenue.

While most of our transactions are conducted through institutional agreements, we may also receive payments through third-party payment platforms or financial intermediaries. Any failure, delay, or fraud in these systems, or non-compliance with applicable financial regulations, could result in delayed collections, increased costs or operational disruption, which may affect our cash flow and financial performance.

If our cash from operations is not sufficient to meet our current or future operating needs and expenditures, our business, financial condition and results of operations may be materially and adversely affected.

As a clinical-stage company, we have historically incurred net losses and expect to continue incurring significant expenses as we advance our research and development programs, conduct clinical trials, pursue regulatory approvals, expand manufacturing capabilities and invest in commercialization. We may require additional cash resources due to changes in business conditions or strategic initiatives, including new clinical programs, market entry efforts, licensing arrangements, or acquisitions. In addition, other unanticipated costs may arise in the course of our development efforts. Because the design and outcome of our planned and anticipated clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any drug candidates we develop, and changing circumstances, some of which may be beyond our control, such as heightened inflation and interest rates, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

Our ability to fund our operations will depend on many factors, including our future financial performance, regulatory progress, market acceptance of our products, manufacturing scalability, and overall economic conditions. If our operating cash flow is insufficient to support these activities, we may need to delay or scale back critical programs, reduce investments, or seek additional financing.

We cannot be certain that external financing will be available on acceptable terms, in a timely manner or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our drug candidates or other research and development initiatives. Failure to obtain sufficient funding could materially and adversely affect our business, financial condition and future growth prospects.

Raising additional capital may cause dilution to holders of our Ordinary Shares, restrict our operations or require us to relinquish rights to our technologies or drug candidates.

We expect our expenses to continue to increase in connection with our planned operations. Until such time, if ever, that we can generate substantial product revenues, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, convertible debt financings, strategic collaborations and licensing arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans.

To the extent we raise capital through the sale of equity or convertible debt securities, such issuances may dilute existing shareholders, while incurring debt could impose restrictive covenants and repayment obligations that limit our flexibility. In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our drug candidates.

We may be subject to claims that we have infringed, misappropriated, or otherwise violated the intellectual property rights of third parties, which could be costly to defend and disrupt our business and operations.

Our success depends in part on our ability to develop and commercialize products without infringing the intellectual property rights of others. While we have implemented internal controls and licensing procedures to avoid unauthorized use of third-party technologies or proprietary information, we cannot guarantee that all uses will be fully compliant or free of claims. As we expand into new markets and competitors increase, the likelihood of third parties asserting intellectual property rights against us may grow.

We rely on proprietary extraction technologies, bioactive standardization methods, clinical data, and formulation innovations that could become the subject of third-party patent challenges or infringement allegations, particularly in jurisdictions with differing patent rules or enforcement standards. Additionally, we use third-party software, research tools, and technology platforms under license. If any of these licenses are terminated, unavailable on commercially reasonable terms, or found to infringe third-party rights, our ability to operate effectively may be impacted.

We may also face risks that employees, consultants, suppliers, or research partners unintentionally infringe, misappropriate, or disclose confidential information, trade secrets, or proprietary compounds belonging to third parties. Even if we are not ultimately found liable, defending against such claims may involve significant legal costs and divert management attention.

If any third-party intellectual property claims are successfully asserted against us, we could be required to pay substantial damages, enter into costly or restrictive license agreements, cease development or commercialization of certain products, or comply with injunctive orders. Any of these outcomes could materially and adversely affect our business, financial condition, and future prospects.

Our ability to protect our intellectual property is uncertain, and failure to do so could materially harm our business, financial condition, and prospects.

We rely on a combination of patent protection, trade secrets, proprietary know-how, and contractual agreements to safeguard our core technologies, extraction methods, standardized formulations, and clinical data. Our intellectual property portfolio includes granted and pending patents in several jurisdictions, including the United States, Europe, and Asia. However, there can be no assurance that our current or future patent applications will result in issued patents, or that any granted patents will provide sufficient protection against competitors.

Patent protection is limited to specific territories and is subject to challenge at both the patent office and in court. Third parties may claim that our patents are invalid or unenforceable, or that our technologies infringe on their intellectual property rights. Even if our patents are upheld, we may need to engage in costly and time-consuming litigation to enforce our rights. Unfavorable outcomes could lead to loss of exclusivity, monetary damages, or restrictions on our operations.

In addition to patents, we rely on trade secrets, proprietary technical knowledge, and confidential information, especially for areas not covered by formal intellectual property rights. While we take precautions, such as confidentiality and IP assignment agreements with employees, consultants, and partners, we cannot guarantee these protections will be effective. Unauthorized use, disclosure, or independent discovery of our trade secrets could reduce our competitive advantage.

We also depend on third-party licenses for certain technologies and research tools. If these licenses are terminated, disputed, or not adequately enforced by the licensors, we may lose access to critical components of our R&D platform or pipeline. License agreements may also impose ongoing obligations, such as milestone payments or diligence requirements, which, if unmet, could result in termination or legal disputes.

Our business also depends on the expertise and institutional knowledge of our management, scientific team, and external collaborators. Although we use contractual measures to protect this know-how, no assurance can be given that these measures will prevent misappropriation or ensure adequate remedies in the event of a breach.

Any failure to obtain, maintain, protect, or enforce our intellectual property rights could materially and adversely affect our ability to develop and commercialize our products, diminish our market position, and negatively impact our business and financial condition.

Our failure to maintain, enforce, or adequately protect our patents and intellectual property rights may adversely affect our business, financial condition, and prospects.

Our business depends on our ability to protect and maintain our intellectual property portfolio, which includes patents, trade secrets, trademarks, and other proprietary technologies. The timely payment of renewal, annuity, and maintenance fees is essential to preserve our patent rights across jurisdictions. Failure to do so may result in the lapse or abandonment of patents, limiting our ability to assert or defend our rights and making us vulnerable to third-party infringement or competitive entry.

In addition to our own patents, we rely on licenses from third parties and collaborations that require ongoing diligence to protect and preserve jointly developed or licensed intellectual property. If we or our partners fail to maintain these rights, our ability to enforce or leverage such IP in key markets may be compromised.

Enforcing our intellectual property rights, particularly patents, can be complex, costly, and time-consuming. Even if we identify infringing activity, litigation may not always be practical due to resource constraints or limited strategic benefit. Conversely, our patents may be subject to challenge or invalidation by third parties through administrative or court proceedings. If we are unable to successfully defend our IP, or if the scope of protection is narrowed, it may erode our competitive advantage and impact our long-term value.

We also rely on trade secrets and proprietary know-how, including extraction methods, formulation processes, and clinical data. Although we implement confidentiality and assignment agreements with employees, contractors, and partners, we cannot guarantee complete protection from unauthorized use or disclosure. If our trade secrets are misappropriated or independently developed by others, our position in the market may be weakened.

Any material failure to secure, maintain, or enforce our intellectual property rights could result in a loss of exclusivity, reputational harm, diminished product differentiation, or disruption of clinical or commercial activities, each of which could have a material adverse effect on our business, financial condition, and future growth.

Misconduct or compliance failures by our employees, contractors, or business partners could harm our reputation, disrupt our operations, and adversely affect our results.

We rely on the integrity and compliance of our employees, consultants, contract research organizations, manufacturers, logistics providers, and other partners in the conduct of our operations. Any misconduct or failure to comply with applicable laws, regulations, industry standards, or internal policies by these parties could expose us to regulatory investigations, civil or criminal liability, reputational damage, or business disruptions.

Such misconduct may include violations of anti-corruption, fraud, or abuse laws, breaches of environmental or product safety standards, inaccurate reporting of research or clinical trial data, or failure to meet ethical, labor, and supply chain standards. While we implement compliance protocols and require contractual commitments from our partners, we cannot guarantee full adherence in all circumstances.

If our third-party manufacturers, service providers, or collaborators fail to comply with regulatory requirements—such as those related to cGMP, environmental laws, or product quality—it could result in production delays, product recalls, enforcement actions, or suspension of operations. Similarly, misconduct by employees or advisors, including falsification of data, insider misconduct, or violations of confidentiality obligations, could compromise regulatory approvals, trigger liability, or damage our scientific and commercial credibility.

Any such incidents may divert management resources, lead to costly remediation efforts, or negatively impact our business, financial condition, and results of operations.

If we fail to obtain or maintain the licenses, permits, registrations, or regulatory filings required for our operations, our business and results may be materially and adversely affected.

Our operations are subject to extensive regulation by governmental authorities in each jurisdiction where we conduct research, manufacture, or intend to commercialize our pharmaceutical-grade botanical products. These include clinical trial authorizations, manufacturing licenses, product registrations, export and import permits, and compliance with health, safety, and environmental laws.

Although we have not received any warnings, penalties, or disciplinary actions as of the date of this prospectus, there can be no assurance that we will not face future administrative or enforcement actions. Any failure to obtain, maintain, or renew required approvals in a timely manner could result in suspension of clinical activities, product recalls, shipment delays, fines, or the loss of market access.

As we expand into new markets and advance new product candidates, we may be required to secure additional licenses or approvals. New or changing regulations, evolving interpretations of existing laws, or stricter enforcement policies may also increase our compliance burden or delay regulatory timelines. There is no guarantee that we will be able to obtain the necessary authorizations promptly, or at all, in every jurisdiction where we operate.

Any regulatory delays, rejections, or failures to comply with licensing obligations could materially and adversely affect our business operations, financial condition, and future growth prospects.

Our potential acquisition activities and other strategic transactions may present managerial, integration, operational and financial risks, which may prevent us from realizing the full intended benefit of the acquisitions we undertake.

We may pursue acquisitions to strengthen our competitive position in key segments, expand into adjacent product categories and emerging markets, or align with our strategic goals. However, the process of identifying and completing such acquisitions can be costly, and there is no guarantee that we will find suitable candidates or secure acquisitions on favorable terms. Additionally, obtaining approvals from government authorities may incur high compliance costs and introduce uncertainty.

Furthermore, investments and acquisitions may lead to management distractions, unexpected liabilities and expenses, undiscovered issues in due diligence, substantial cash outflows, potentially dilutive equity issuances, and significant amortization expenses related to goodwill or intangible assets. Impairment of goodwill or intangible assets could result in substantial changes to our financial results.

Assumptions made during the evaluation of acquisition opportunities may not materialize as expected, and the integration of acquired businesses can be costly and disruptive to our existing operations, particularly given our lack of experience with acquiring and integrating businesses. Integration involves inherent risks, some beyond our control, and there’s no assurance that we will achieve anticipated benefits, synergies, cost savings, or efficiencies. If our investments and acquisitions do not succeed, our financial condition and results of operations may be significantly and adversely affected.

Disruptions in the financial markets and economic conditions could affect our ability to raise capital.

Global economies could suffer dramatic downturns as a result of deteriorating credit markets, related financial crises, and various other factors, including extreme volatility in security prices, severely diminished liquidity and credit availability, ratings downgrades of certain investments, and declining valuations of others. Some governments may take unprecedented actions in an attempt to address and rectify these extreme market and economic conditions by providing liquidity and stability to the financial markets. If these actions are not successful, the return of adverse economic conditions may significantly impact our ability to raise capital, if needed, in a timely manner and on acceptable terms, or even at all.

Any catastrophe, including natural catastrophes, health epidemics and other outbreaks and extraordinary events, could disrupt our business operations.

Our business could be significantly harmed by natural disasters, health epidemics, or public safety concerns affecting Malaysia, Southeast Asia, and other regions where we operate or intend to operate. Natural disasters may lead to server interruptions, system failures, technology platform issues, or internet outages, affecting both our operations and those of our manufacturers, suppliers, and service providers. This could result in data loss, software or hardware malfunctions, and disruptions in daily operations, product manufacturing, and delivery. Health epidemics affecting our employees or partners could also have adverse effects. Furthermore, any health epidemic harming the Malaysian economy or our target customers could negatively impact our financial results.

Our headquarters are in Malaysia, where most of our management and employees are based. Consequently, if natural disasters, health epidemics, or other public safety concerns affect Malaysia, it could cause significant disruptions to our operations, leading to material adverse effects on our business, financial condition, and results of operations.

The continued and collaborative efforts of our senior management and key employees are crucial to our success, and our business may be harmed if we lose their services.

Our success hinges on the valuable contributions of our senior management and key employees, including, in particular, Abdul Razak Mohd Isa, and Mustadza Muhamad, and losing their services could harm our business. Effective collaboration among our senior management is crucial, as any inefficiency or discord could severely disrupt our operations. Furthermore, if any of our key executives or personnel are unable or unwilling to continue working with us, finding suitable replacements may be challenging due to intense competition and a limited pool of qualified candidates. Retaining our current talent and attracting experienced replacements may prove difficult, even if we offer higher compensation and benefits.

Our ability to succeed in the future also depends on attracting and retaining highly skilled individuals in research and development, technical, managerial, finance, marketing, sales, and customer service roles. Given the high demand for qualified individuals, we may need to offer competitive compensation and benefits. However, even with these incentives, successfully recruiting, integrating, and retaining the talent we require may be a challenge.

Moreover, there is a risk that if any of our executive officers or employees were to join a competitor or start a competing business, they could disclose sensitive business information, trade secrets, customer lists, and other valuable resources. While we have entered or expect to enter upon the closing of this offering into employment agreements, as the case may be, with our senior management and key employees, disputes could arise, leading to significant costs and expenses to enforce these agreements or potentially rendering them unenforceable. Any failure to attract or retain key management and personnel could severely disrupt our business and hinder our growth.

We may from time to time become a party to litigation, legal disputes, claims or administrative proceedings that may materially and adversely affect us.

From time to time, we may find ourselves involved in various forms of litigation, legal disputes, claims, or administrative proceedings as a normal part of our business operations. Predicting the outcomes of these legal matters can be challenging. In the event of an unfavorable verdict or if we choose to settle, we may incur financial damages or other liabilities. Even when we successfully defend ourselves, these legal proceedings can still demand significant financial resources, time, and effort. Negative publicity related to such legal matters could harm our reputation and negatively impact our brand and services.

Moreover, it’s worth noting that the significance of litigation, legal disputes, claims, or administrative proceedings may change over time due to factors such as evolving circumstances, the complexity of the cases, the likelihood of winning or losing, the monetary value involved, and the parties involved. This means that even cases initially considered less important could become more significant in the future. As a result, ongoing or future legal matters have the potential to affect our business, financial condition, and operating results materially and adversely.

Our performance is dependent on the performance of the economy and consumer spending patterns in the countries in which we operate.

The expenditures on our nutraceutical products is contingent upon consumers’ discretionary spending, significantly influenced by prevailing economic conditions and disposable income availability. Adverse economic scenarios in our operational countries might curtail consumers’ purchasing power, resulting in a substantial negative impact on our business, financial standing, and operational outcomes. While our pricing strategy aims to cater to a broad consumer base resilient to economic downturns, there remains a risk that a downturn in the economic conditions of our operational countries could materially and adversely affect our business, financial standing, and operational results.

Our financial performance is subject to political, economic, social, regulatory and other developments in the countries in which we operate.

Our business faces exposure to various risks arising from political, economic, social, regulatory, and other developments. These risks encompass the burdens associated with complying with diverse laws and regulations, political and economic instability, fluctuations in interest rates, economic downturns, and the fiscal and monetary policies of governments such as foreign exchange controls, inflation, deflation, taxation methods and policies, natural disasters, trade restrictions, imposition of government controls, tariffs, customs duties, product classifications by governing bodies, logistics, sourcing challenges, military conflicts, acts of terrorism, and factors influencing consumer confidence and spending. The occurrence of any of these risks has the potential to adversely impact our business, thereby affecting our overall business and financial condition.

Our use of AI technologies involves emerging risks, including regulatory uncertainty, algorithmic bias, and data privacy concerns, which could adversely affect our business, reputation, or compliance status

We currently leverage, and intend to increasingly integrate, AI and machine learning (ML) technologies into various aspects of our business operations, including clinical data analysis, product development, precision health modeling, microbiome and biomarker analysis, and digital health engagement platforms. While we believe these technologies offer significant potential to improve efficiency, innovation, and patient-specific outcomes, their use also exposes us to novel and evolving risks.

AI-related regulatory frameworks are nascent and fragmented across jurisdictions. In particular, regulators in the United States (such as the FDA), European Union (under the proposed AI Act), and other countries are actively developing rules that may affect the approval, marketing, and oversight of AI-assisted diagnostic, therapeutic, or digital health tools. As regulatory standards become more stringent, we may be required to undertake additional validation studies, modify our AI models, or submit new filings to regulatory bodies. This may delay product deployment, increase compliance costs, or require changes to our digital or clinical workflows.

Furthermore, AI models—particularly those trained on large, heterogeneous datasets—may produce unintended outputs due to algorithmic bias, incomplete data, or technical flaws. If our AI-enabled tools generate inaccurate recommendations or fail to perform as intended, we may face risks of patient harm, reputational damage, or potential liability. We may also be subject to ethical scrutiny and public criticism if our AI systems are perceived to lack transparency, fairness, or accountability.

Our use of AI requires access to large volumes of structured and unstructured data, some of which may be derived from clinical research, partner institutions, or de-identified health records. We must ensure that all data used to train or operate AI systems is collected and processed in full compliance with applicable data protection and privacy laws, including HIPAA (in the United States), GDPR (in the European Union), PDPA (in Malaysia), and other local data regulations. Failure to do so could lead to enforcement actions, fines, or contractual disputes with data providers.

Lastly, reliance on third-party AI platforms or software vendors—whether cloud-based or integrated into our systems—may expose us to cybersecurity vulnerabilities, intellectual property conflicts, or service interruptions beyond our direct control. These risks may be exacerbated as we scale operations, particularly if we expand digital or AI-enabled offerings to international users or clinical settings.

While we believe that our current AI strategy is grounded in ethical safeguards, expert oversight, and scientific rigor, any failure to anticipate, detect, or respond to emerging AI risks could materially impact our development timelines, regulatory standing, reputation, and long-term viability.

Risks Relating to our Ordinary Shares and Trading Market

There has been no public market for our Ordinary Shares prior to this offering, and you may not be able to resell our Ordinary Shares at or above the price you pay for them, or at all.

Prior to this offering, there has not been a public market for our Ordinary Shares. We applied to have our Ordinary Shares listed on the Nasdaq. An active public market for our Ordinary Shares, however, may not develop or be sustained after the offering, in which case the market price and liquidity of our Ordinary Shares will be materially and adversely affected.

The market price of our Ordinary Shares may be volatile or may decline regardless of our operating performance, and you may not be able to resell your shares at or above the initial public offering price.

The initial public offering (“IPO”) price for our Ordinary Shares will be determined through negotiations between the underwriters and us. This price may differ from the market price of our Ordinary Shares after the IPO. Purchasing our Ordinary Shares in the IPO does not guarantee the ability to resell them at or above the IPO price. We cannot assure you that the IPO price or the post-IPO market price will match or exceed prices in privately negotiated transactions that occurred prior to the IPO. The market price of our Ordinary Shares may undergo significant fluctuations due to various factors, many of which are beyond our control, including:

Furthermore, stock markets have witnessed extreme price and volume fluctuations that have impacted and continue to affect the market prices of equity securities in many companies. These fluctuations are sometimes unrelated or disproportionate to a company’s actual operating performance. Historically, stockholders have initiated securities class action lawsuits following periods of market volatility. If our company becomes involved in securities litigation, it could result in substantial costs, divert resources and management attention away from our core business activities, and adversely affect our overall business.

You will experience immediate and substantial dilution in the net tangible book value of Ordinary Shares purchased.

The initial public offering price of our Ordinary Shares is substantially higher than the (pro forma) net tangible book value per share of our Ordinary Shares. Consequently, when you purchase our Ordinary Shares in the offering, upon completion of the offering you will incur immediate dilution of $4.86 per share if the underwriters do not exercise the over-allotment option and $4.78 if the underwriters exercise the over-allotment option in full, assuming an initial public offering price of $5.50, which is the midpoint of the estimated range of the initial public offering price shown on the front cover of this prospectus, and total gross proceeds of approximately $20 million (without giving effect to the exercise by the underwriters of their overallotment option). See “Dilution.” In addition, you may experience further dilution upon the exercise of outstanding options we may grant from time to time.

If securities or industry analysts cease to publish research or reports about our business, or if they adversely change their recommendations regarding our Ordinary Shares, the market price for the Ordinary Shares and trading volume could decline.

The trading market for our Ordinary Shares will be influenced by research or reports that industry or securities analysts publish about our business. If one or more analysts who cover us downgraded our Ordinary Shares, the market price for our Ordinary Shares would likely decline. If one or more of these analysts cease to cover us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for our Ordinary Shares to decline.

Techniques employed by short sellers may drive down the market price of our Ordinary Shares.

Short selling is a practice where an individual or entity sells securities they do not own, having borrowed them from a third party. The aim is to buy identical securities later at a lower price to return to the lender, thus profiting from a decline in the securities’ value between the sale and the purchase. Short sellers often hope to benefit from a decrease in the security’s price, and they may publish or arrange for the publication of negative opinions about the issuer and its business to create negative market sentiment, potentially generating profits for themselves by selling the security short. These actions have historically resulted in the selling of shares in the market.

The impact of such negative publicity on our company is uncertain. If we were to become the target of unfavorable allegations, whether true or false, we might need to allocate significant resources to investigate and defend against these allegations. While we would vigorously defend ourselves, there may be limitations on how we can respond to the relevant short seller due to freedom of speech principles, state laws, or commercial confidentiality concerns. Such a situation could be financially and temporally burdensome and divert our management’s attention from our core business growth efforts. Even if the allegations against us are ultimately proven baseless, they could have a significant adverse effect on our business operations and shareholder’s equity, potentially leading to a substantial reduction in the value of our Ordinary Shares for investors.

We currently do not expect to pay dividends in the foreseeable future, and you must rely on price appreciation of our Ordinary Shares for return on your investment.

We currently plan to retain the majority, if not all, of our available funds and future earnings to support the development and expansion of our business. Consequently, we do not anticipate paying cash dividends in the foreseeable future. Therefore, it is not advisable to consider an investment in our Ordinary Shares as a potential source of future dividend income.

Our board of directors holds complete discretion when it comes to deciding whether to distribute dividends, while adhering to specific requirements of Cayman Islands law. Under Cayman Islands law, a company may distribute dividends from either profits or the share premium account, provided that the Company remains able to pay its debts as they fall due in the ordinary course of business following the making of any such payment. Even if our board of directors decides to declare and pay dividends, the timing, amount, and form of such dividends, if any, will rely on various factors, including our future financial performance, capital needs, surplus, subsidiary distributions, financial health, contractual obligations, and other factors deemed relevant by our board of directors.

Consequently, the return on your investment in our Ordinary Shares will primarily depend on the potential future appreciation in the value of these shares. There is no guarantee that our Ordinary Shares will increase in value or maintain their purchase price in the future. You may not realize any returns on your investment in our Ordinary Shares, and there is a possibility that you could even lose your entire investment.

Substantial future sales or perceived potential sales of our Ordinary Shares in the public market could cause the price of our Ordinary Shares to decline.

Sales of our Ordinary Shares on the public market or the perception that these sales could occur, could cause the market price of our Ordinary Shares to decline. Such sales, or the perception thereof, also might make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we deem appropriate. We cannot predict what effect, if any, market sales of securities held by a principal shareholder or any other shareholder or the availability of these securities for future sale will have on the market price on our Ordinary Shares. In addition, if we issue additional Ordinary Shares, either through private transactions or in the public markets in the United States or other jurisdiction, your ownership interests in our company would be diluted and this, in turn, would have an adverse effect on the price of our Ordinary Shares.

You may face difficulties in protecting your interests, and your ability to protect your rights through U.S. courts may be limited, because we are incorporated under Cayman Islands law.

We are an exempted company incorporated under the laws of the Cayman Islands with limited liability, and conduct all of our operations through our subsidiaries, Medika Natura and Medikra Marketing, outside the United States. All of our assets are located, and our officers and directors reside, and the assets of such persons are located, outside the United States. As a result, it could be difficult or impossible for you to bring an action against us or against these individuals outside of the United States in the event that you believe that your rights have been infringed upon under the applicable securities laws or otherwise. Even if you are successful in bringing an action of this kind, the laws of the Cayman Islands and Malaysia could render you unable to enforce a judgment against our assets or the assets of our directors and officers. In addition, our corporate governance is governed by our memorandum and articles of association, the Companies Act (As Revised) of the Cayman Islands, and the common law of the Cayman Islands. It’s essential to understand that the rights of our shareholders, their ability to take action against our directors, actions by minority shareholders, and the fiduciary duties of our directors are primarily determined by the common law of the Cayman Islands. The Cayman Islands’ common law draws from limited judicial precedent within the Cayman Islands and is also influenced by the common law of England, with English court decisions having persuasive, but not binding, authority in the Cayman Islands.

The legal framework for shareholder rights and director fiduciary duties in the Cayman Islands may not be as well-defined as in some U.S. jurisdictions with more developed statutes and judicial precedents. Additionally, the Cayman Islands has a less extensive body of securities laws compared to the United States. In particular, Cayman Islands companies may not have the legal standing to initiate shareholder derivative actions in U.S. federal courts. There is no statutory recognition in the Cayman Islands of judgments obtained in the United States, although the courts of the Cayman Islands will generally recognize and enforce a non-penal judgment of a foreign court of competent jurisdiction without retrial on the merits.

Under Cayman Islands law, shareholders of exempted companies like ours have limited rights to inspect corporate records, typically limited to the memorandum and articles of association, register of directors, and register of mortgages and charges. The discretion to grant access to other corporate records rests with our directors under our articles of association, and they are not obligated to make such records available to shareholders. This could potentially create challenges for shareholders in gathering information necessary for shareholder motions or proxy solicitations in proxy contests.

As a result of these factors, our public shareholders may face more challenges in safeguarding their interests in response to actions taken by our management, board members, or controlling shareholders compared to the protections available to shareholders of U.S.-incorporated companies.

Certain judgments obtained against us by our shareholders may not be enforceable.

We are an exempted Cayman Islands company and substantially all of our assets are located outside of the United States. Substantially all of our current operations are conducted in Malaysia. In addition, most of our current directors and officers are nationals and residents of countries other than the United States. As a result, it may be difficult or impossible for you to bring an action against us or against these individuals in the United States in the event that you believe that your rights have been infringed under the U.S. federal securities laws or otherwise. Even if you are successful in bringing an action of this kind, the laws of the Cayman Islands and of Malaysia may render you unable to enforce a judgment against our assets or the assets of our directors and officers.

If we cannot continue to satisfy the listing requirements and other rules of the Nasdaq, our securities may be delisted, which could negatively impact the price of our securities and your ability to sell them.

We applied to have our Ordinary Shares listed on the Nasdaq upon consummation of this offering. It is a condition to the closing of this offering that our Ordinary Shares qualify for listing on a national securities exchange. Following this offering, in order to maintain our listing on the Nasdaq, we will be required to comply with certain rules of the Nasdaq, including those regarding minimum stockholders’ equity, minimum share price, minimum market value of publicly held shares, and various additional requirements. Even if we initially meet the listing requirements and other applicable rules of the Nasdaq, we may not be able to continue to satisfy these requirements and applicable rules. If we are unable to satisfy the Nasdaq criteria for maintaining our listing, our securities could be subject to delisting.

Because we are a foreign private issuer and are exempt from certain Nasdaq corporate governance standards applicable to U.S. issuers, you will have less protection than you would have if we were a domestic issuer.

Nasdaq listing rules require listed companies to have, among other things, a majority of its board members be independent. As a foreign private issuer, however, we are permitted to, and we may follow home country practice in lieu of the above requirements, or we may choose to comply with the above requirement within one year of listing. The corporate governance practice in our home country, the Cayman Islands, does not require a majority of our board to consist of independent directors. Thus, although a director must act in the best interests of the Company, it is possible that fewer board members will be exercising independent judgment and the level of board oversight on the management of our company may decrease as a result. In addition, Nasdaq listing rules also require U.S. domestic issuers to have a compensation committee, a nominating and corporate governance committee composed entirely of independent directors, and an audit committee with a minimum of three members. We, as a foreign private issuer, are not subject to these requirements. Nasdaq listing rules may require shareholder approval for certain corporate matters, such as requiring that shareholders be given the opportunity to vote on all equity compensation plans and material revisions to those plans, certain ordinary share issuances. We intend to comply with the requirements of Nasdaq listing rules in determining whether shareholder approval is required on such matters and to appoint a nominating and corporate governance committee. We may, however, consider following home country practice in lieu of the requirements under Nasdaq listing rules with respect to certain corporate governance standards which may afford less protection to investors.

We are a foreign private issuer within the meaning of the rules under the Exchange Act, and as such we are exempt from certain provisions applicable to U.S. domestic public companies.

Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the securities rules and regulations in the United States that are applicable to U.S. domestic issuers, including:

We are required to file an annual report on Form 20-F within four months of the end of each fiscal year. In addition, we intend to publish our results on a quarterly basis as press releases, distributed pursuant to the rules and regulations of Nasdaq. Press releases relating to financial results and material events are also furnished to the SEC on Form 6-K. However, the information we are required to file with or furnish to the SEC is less extensive and less timely compared to that required to be filed with the SEC by U.S. domestic issuers. As a result, you may not be afforded the same protections or information that would be made available to you if you were investing in a U.S. domestic issuer.

We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses to us.

As discussed above, we are a foreign private issuer under the Exchange Act, and therefore, we are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act. The determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter. In the future, we would lose our foreign private issuer status if (1) more than 50% of our outstanding voting securities are owned by U.S. residents and (2) a majority of our directors or executive officers are U.S. citizens or residents, or we fail to meet additional requirements necessary to avoid the loss of foreign private issuer status. If we lose our foreign private issuer status, we will be required to file with the SEC periodic reports and registration statements on U.S. domestic issuer forms, which are more detailed and extensive than the forms available to a foreign private issuer. We will also have to comply with U.S. federal proxy requirements, and our officers, directors and 10% shareholders will become subject to the short-swing profit disclosure and recovery provisions of Section 16 of the Exchange Act. In addition, we will lose our ability to rely upon exemptions from certain corporate governance requirements under the listing rules of Nasdaq. As a U.S. listed public company that is not a foreign private issuer, we will incur significant additional legal, accounting, and other expenses that we will not incur as a foreign private issuer.

As an exempted company incorporated in the Cayman Islands, we are permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance listing standards.

As an exempted company incorporated in the Cayman Islands, we are permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from the corporate governance listing requirements of the Nasdaq. These practices may afford less protection to shareholders than they would enjoy if we complied fully with corporate governance listing requirements of the Nasdaq. Following this offering, we will rely on home country practice to be exempted from certain of the corporate governance requirements of the Nasdaq, including, but not limited to:

If we are classified as a passive foreign investment company, United States taxpayers who own our Ordinary Shares may have adverse United States federal income tax consequences.

A non-U.S. corporation such as ourselves will be classified as a passive foreign investment company, which is known as a PFIC, for any taxable year if, for such year, either:

Passive income generally includes dividends, interest, rents and royalties (other than rents or royalties derived from the active conduct of a trade or business), and gains from the disposition of passive assets.

If we are determined to be a PFIC for any taxable year (or portion thereof) that is included in the holding period of a U.S. taxpayer who holds our Ordinary Shares, the U.S. taxpayer may be subject to increased U.S. federal income tax liability and may be subject to additional reporting requirements.

Depending on the amount of cash we raise in this offering, together with any other assets held for the production of passive income, it is possible that, for our 2025 taxable year or for any subsequent year, more than 50% of our assets may be assets that produce passive income, in which case we would be deemed a PFIC, which could have adverse U.S. federal income tax consequences for U.S. taxpayers who are shareholders. We will make this determination following the end of each taxable year. Based on our income and the composition of our assets for the taxable year ended December 31, 2025, we do not believe we were a PFIC for such year. However, because PFIC status is a factual determination that must be made annually after the close of each taxable year, and because the value of our assets for purposes of the PFIC asset test will generally be determined by reference to the market price of our Ordinary Shares, which may fluctuate, there can be no assurance that we will not be considered a PFIC for the 2026 taxable year or any future taxable year.

For purposes of the PFIC analysis, in general, a non-U.S. corporation is deemed to own its pro rata share of the gross income and assets of any entity in which it is considered to own at least 25% of the equity by value.

For a more detailed discussion of the application of the PFIC rules to us and the consequences to U.S. taxpayers if we were or are determined to be a PFIC, see “Material Income Tax Consideration—United States Federal Income Taxation—PFIC.”

We will incur substantial increased costs as a result of being a public company.

Upon consummation of this offering, we will incur significant legal, accounting, and other expenses as a public company that we did not incur as a private company. The Sarbanes-Oxley Act of 2002, as well as rules subsequently implemented by the SEC and Nasdaq, impose various requirements on the corporate governance practices of public companies.

Compliance with these rules and regulations increases our legal and financial compliance costs and makes some corporate activities more time-consuming and costlier. We will incur additional costs in obtaining director and officer liability insurance. In addition, we incur additional costs associated with our public company reporting requirements. It may also be more difficult for us to find qualified persons to serve on our board of directors or as executive officers.

We are an “emerging growth company,” as defined in the JOBS Act and will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of this offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our Ordinary Shares that is held by non-affiliates exceeds $700 million as of the applicable determination date, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting and other requirements that are otherwise applicable generally to public companies. These provisions include exemption from the auditor attestation requirement under Section 404 in the assessment of the emerging growth company’s internal control over financial reporting and permission to delay adopting new or revised accounting standards until such time as those standards apply to private companies.

After we are no longer an “emerging growth company,” or until five years following the completion of our initial public offering, whichever is earlier, we expect to incur significant additional expenses and devote substantial management effort toward ensuring compliance with the requirements of Section 404 and the other rules and regulations of the SEC. For example, as a public company, we have been required to increase the number of independent directors and adopt policies regarding internal controls and disclosure controls and procedures.

We are currently evaluating and monitoring developments with respect to these rules and regulations, and we cannot predict or estimate with any degree of certainty the amount of additional costs we may incur or the timing of such costs.

If we fail to implement and maintain an effective system of internal controls, we may fail to meet our reporting obligations or be unable to accurately report our results of operations or prevent fraud, and investor confidence and the market price of our Ordinary Shares may be materially and adversely affected.

Prior to this offering, we have been a private company with limited accounting personnel and other resources with which to address our internal controls and procedures. Our independent registered public accounting firm has not conducted an audit of our internal control over financial reporting. Our failure to discover and address any material weaknesses or control deficiencies that may arise could result in inaccuracies in our financial statements and could also impair our ability to comply with applicable financial reporting requirements and related regulatory filings on a timely basis. As a result, our business, financial condition, results of operations and prospects, and the trading price of our Ordinary Shares, may be materially and adversely affected. Moreover, ineffective internal control over financial reporting significantly hinders our ability to prevent fraud.

In connection with the preparation of the Company’s consolidated financial statements for fiscal years 2024 and 2023 and preparation of the Company’s unaudited condensed consolidated financial statements for the six months ended June 30, 2025, the Company identified material weaknesses in its internal control over financial reporting, as defined in the standards established by the PCAOB. These include the material weaknesses related to: (i) a lack of appropriate levels of accounting knowledge and experience to address complex U.S. GAAP accounting issues and related disclosures, in accordance with U.S. GAAP and SEC financial reporting requirements; and (ii) lack of formal internal control policies and internal independent supervision functions to establish formal risk assessment process and internal control framework.

The Company intends to implement measures designed to improve the internal control over financial reporting to address the underlying causes of these material weaknesses, including: (i) hiring additional accounting and financial reporting personnel with GAAP and SEC reporting experience; (ii) mandate continuing professional requirements for accounting staff to stay current with changes in U.S. GAAP; and (iii) setting up a financial and system control framework with formal documentation of polices and controls in place. Implementing any appropriate changes to our internal controls may distract our officers and employees from day-to-day business operations, entail substantial costs to modify our existing processes, and take significant time to complete. These changes may not, however, be effective in remediating the identified material weaknesses or maintaining the adequacy of our internal controls, and any failure to remediate the identified material weaknesses, maintain that adequacy or consequent inability to produce accurate financial statements on a timely basis, could increase our operating costs and harm our business. In addition, investors’ perceptions that our internal controls are inadequate or that we are unable to produce accurate financial statements on a timely basis may harm the price of our Ordinary Shares.

Upon completion of this offering, we will become a public company in the United States subject to the Sarbanes-Oxley Act of 2002. Section 404 of the Sarbanes-Oxley Act of 2002 will require that we include a report of management on our internal control over financial reporting in our annual report on Form 20-F beginning with our annual report for the fiscal year ending December 31, 2025. In addition, once we cease to be an “emerging growth company,” as such term is defined in the JOBS Act, our independent registered public accounting firm must attest to and report on the effectiveness of our internal control over financial reporting. Our management may conclude that our internal control over financial reporting is not effective. Moreover, even if our management concludes that our internal control over financial reporting is effective, our independent registered public accounting firm, after conducting its own independent testing, may issue a report that is qualified if it is not satisfied with our internal controls or the level at which our controls are documented, designed, operated, or reviewed, or if it interprets the relevant requirements differently from us. In addition, after we become a public company, our reporting obligations may place a significant strain on our management, operational, and financial resources and systems for the foreseeable future. We may be unable to complete our evaluation testing and any required remediation in a timely manner.

Our management has broad discretion to determine how to use the funds raised in the offering and may use them in ways that may not enhance our results of operations or the price of our Ordinary Shares.

We anticipate that we will use the net proceeds from this offering to commercialize nutraceutical formulations in key markets, to expand our manufacturing capacity and scale regulatory-compliant production, to find clinical development of our lead candidate, SKF7®, to support preclinical and IND-enabling studies for KPH1™ and MKS5®, as well as for working capital and general corporate purposes. Our management will have significant discretion as to the use of the net proceeds to us from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the market price of our Ordinary Shares. Pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.

We are an “emerging growth company” within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies, this will make it more difficult to compare our performance with other public companies.

We are an “emerging growth company” within the meaning of the Securities Act, as modified by the JOBS Act. Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such an election to opt out is irrevocable. We have elected not to opt out of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This will make comparison of our financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

Because we are an “emerging growth company,” we may not be subject to requirements that other public companies are subject to, which could affect investor confidence in us and our Ordinary Shares.

For as long as we remain an “emerging growth company,” as defined in the JOBS Act, we will elect to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of shareholder approval of any golden parachute payments not previously approved. Because of these lessened regulatory requirements, our shareholders would be left without information or rights available to shareholders of more mature companies. If some investors find our Ordinary Shares less attractive as a result, there may be a less active trading market for our Ordinary Shares and our share price may be more volatile. See “Implications of Our Being an ‘Emerging Growth Company.’”

Future sales of our securities by existing shareholders could depress the market price of our Ordinary Shares.

25,555,160 of our Ordinary Shares are issued and outstanding as of the date of this prospectus. A substantial percentage of our Ordinary Shares outstanding prior to this offering are subject to the six (6) month contractual lockup. See “Underwriting”. The holders of these Ordinary Shares and our other Ordinary Shares outstanding prior to this offering may be able to sell their Ordinary Shares under Rule 144 after such contractual lock-up and other legal restrictions on resale lapse. See “Shares Eligible for Future Sale” below. Because these shareholders have paid a lower price per Ordinary Share than participants in this offering, when they are able to sell their pre-IPO shares, they may be more willing to accept a lower sales price than the IPO price, which could impact the future trading price of our Ordinary Shares, to the detriment of participants in this offering.

Our shareholders may be held liable for claims by third parties against us to the extent of distributions received by them upon a subsequent liquidation of the company.

If Medikra is placed into liquidation within 6 years following the payment of a distribution, there is a risk that the payment would be voidable by a liquidator if the liquidator can establish that it was made with the intent to defraud creditors (regardless of whether Medikra was solvent at the time of making the distribution). In addition, if Medikra is placed into liquidation at any time, and it appears that the distribution was paid with intention to defraud creditors, then there is a risk that any persons who were knowingly parties to such fraud may be personally liable to contribute to the company’s assets (regardless of whether Medikra was solvent at the time of paying the dividend).

We may not have sufficient funds to satisfy indemnification claims of our directors and officers.

We have agreed to indemnify our officers and directors to the fullest extent permitted by law, including for any liability incurred in their capacities as such, except through their own actual fraud, willful default or dishonesty. Our obligation to indemnify our officers and directors may discourage shareholders from bringing a lawsuit against our officers or directors for breach of their fiduciary duty. These provisions also may have the effect of reducing the likelihood of derivative litigation against our officers and directors, even though such an action, if successful, might otherwise benefit us and our shareholders. Furthermore, a shareholder’s investment may be adversely affected to the extent we pay the costs of settlement and damage awards against our officers and directors pursuant to these indemnification provisions.

Cayman Islands economic substance requirements may have an effect on our business and operations. 

Pursuant to the International Tax Co-operation (Economic Substance) Act (Revised) (the “ES Act”) together with the Guidance Notes published by the Cayman Islands Tax Information Authority from time to time, if a company is considered to be a “relevant entity” and is conducting one or more of the nine “relevant activities” then that company will be required to satisfy the economic substance test and comply with the economic substance requirements in relation to the relevant activity as set out in the ES Act. All companies whether a relevant entity or not are required to file an annual report in the Cayman Islands with the Registrar of Companies in the Cayman Islands confirming whether or not it is carrying on any relevant activities.

DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that reflect our current expectations and views of future events, all of which are subject to risks and uncertainties. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. You can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may,” or other similar expressions in this prospectus. These statements are likely to address our growth strategy, financial results, and product and development programs. You must carefully consider any such statements and should understand that many factors could cause actual results to differ from our forward-looking statements. These factors may include inaccurate assumptions and a broad variety of other risks and uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and actual future results may vary materially. Factors that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited to:

We describe certain material risks, uncertainties, and assumptions that could affect our business, including our financial condition and results of operations, under “Risk Factors.” We base our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may, and are likely to, differ materially from what is expressed, implied or forecast by our forward-looking statements. Accordingly, you should be careful about relying on any forward-looking statements. Except as required under the federal securities laws, we do not have any intention or obligation to update publicly any forward-looking statements after the distribution of this prospectus, whether as a result of new information, future events, changes in assumptions, or otherwise.

Industry Data and Forecasts

This prospectus includes market data and industry forecasts relating to the global markets for metabolic disease therapeutics, cardiovascular therapeutics, women’s health, chronic inflammation, oncology, the botanical pharmaceutical industry, and the nutraceutical industry. We have obtained this information from industry publications, third-party research reports, and publicly available sources that we believe to be reliable, but we have not independently verified the data. Forecasts and projections are inherently uncertain and are based on assumptions that may prove to be incorrect. As a result, these industries may not grow at the rates projected, or at all, and actual results may differ materially from those expressed or implied by such forecasts. Any such shortfall could materially and adversely affect our business, financial condition, results of operations, and the market price of our Ordinary Shares.

ENFORCEABILITY OF CIVIL LIABILITIES

We are incorporated under the laws of the Cayman Islands as an exempted company with limited liability. We are incorporated under the laws of the Cayman Islands because of certain benefits associated with being a Cayman Islands company, such as political and economic stability, an effective judicial system, a favorable tax system, the absence of foreign exchange control or currency restrictions, and the availability of professional and support services. The Cayman Islands, however, has a different body of securities laws as compared to the United States and provides less protection for investors than the United States. Additionally, Cayman Islands companies may not have standing to sue before the Federal courts of the United States.

Substantially all of our assets are located in Malaysia. In addition, most of our directors and officers are nationals or residents of Malaysia and all or a substantial portion of their assets are located outside the United States. As a result, it may be difficult for investors to effect service of process within the United States upon us or these persons, or to enforce against us or them judgments obtained in the United States courts, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States. See “Risk Factors—Risks Relating to our Ordinary Shares and Trading Market—You may face difficulties in protecting your interests, and your ability to protect your rights through U.S. courts may be limited, because we are incorporated under Cayman Islands law”.

We have appointed Puglisi & Associates as our agent to receive service of process with respect to any action brought against us in the United States District Court for the Southern District of New York under the federal securities laws of the United States or of any state in the United States or any action brought against us in the Supreme Court of the State of New York in the County of New York under the securities laws of the State of New York.

Harney Westwood & Riegels (Cayman) LLP, our counsel with respect to the laws of the Cayman Islands, has advised us that the courts of the Cayman Islands are unlikely (i) to recognize or enforce against us, judgments of courts of the United States predicated upon the civil liability provisions of the securities laws of the United States or any State; and (ii) in original actions brought in the Cayman Islands, to impose liabilities against us predicated upon the civil liability provisions of the securities laws of the United States or any State, so far as the liabilities imposed by those provisions are penal in nature. In those circumstances, although there is no statutory enforcement in the Cayman Islands of judgments obtained in the United States, the courts of the Cayman Islands will recognize and enforce a foreign money judgment of a foreign court of competent jurisdiction without retrial on the merits based on the principle that a judgment of a competent foreign court imposes upon the judgment debtor an obligation to pay the sum for which judgment has been given provided certain conditions are met. For a foreign judgment to be enforced in the Cayman Islands, such judgment must be final and conclusive, given by a court of competent jurisdiction (the courts of the Cayman Islands will apply the rules of Cayman Islands private international law to determine whether the foreign court is a court of competent jurisdiction), and must not be in respect of taxes or a fine or penalty, inconsistent with a Cayman Islands judgment in respect of the same matter, impeachable on the grounds of fraud or obtained in a manner, and or be of a kind the enforcement of which is, contrary to natural justice or the public policy of the Cayman Islands (awards of punitive or multiple damages may well be held to be contrary to public policy). A Cayman Islands Court may stay enforcement proceedings if concurrent proceedings are being brought elsewhere.

Adnan Sundra & Low, our counsel with respect to Malaysian law, has advised us that there is uncertainty as to whether the courts of Malaysia would (i) recognize or enforce judgments of United States courts obtained against us or our directors or officers predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States or (ii) entertain original actions brought in Malaysia against us or our directors or officers predicated upon the securities laws of the United States or any state in the United States.

Adnan Sundra & Low has further advised us that there are currently no statutes, treaties, or other forms of reciprocity between the United States and Malaysia providing for the mutual recognition and enforcement of court judgments. Under Malaysian laws, a foreign judgment cannot be directly or summarily enforced in Malaysia. The judgment must first be recognized by a Malaysian court either under applicable Malaysian laws or in accordance with common law principles. For Malaysian courts to accept the jurisdiction for recognition of a foreign judgment, the foreign country where the judgment is made must be a reciprocating country expressly specified and listed in the Reciprocal Enforcement of Judgment Act 1958 (“REJA”) and Maintenance Orders (Facilities for Enforcement) Act 1949. As the United States is not one of the countries specified under the statutory regime where a foreign judgment can be recognized and enforced directly in Malaysia, a judgment obtained in the United States must be enforced through the principle of common law by commencing fresh proceedings in a Malaysian court by way of a writ of summons. At common law, a foreign judgment is treated as an implied obligation to pay a debt which provides a cause of action on which the debtor can be sued in another country. Typically, the Malaysian court may award summary judgment in favor of the creditor without the need for the parties to go through the process of trial.

The requirements for enforcing a foreign judgment in Malaysia under common law must fulfill certain conditions, which includes the following: (i) the judgment must be a monetary judgment for a definite sum, which excludes other reliefs such as declaratory orders, specific performance, injunctions and claims in rem; (ii) the foreign court exercised a jurisdiction which the Malaysian courts will recognize; (iii) the judgment was not obtained by fraud; (iv) the enforcement of the judgment must not contravene public policy in Malaysia; (v) the proceedings in which the judgment was obtained were not opposed to natural justice, and (vi) the judgment must be final and conclusive. Additionally, Section 78(1)(f) and Section 86 of the Malaysian Evidence Act require that the original copy of the foreign judgment be produced, or if a copy is relied upon, then the copy must be duly notarized or legalized by the relevant officer and certified with proof of the character of the document according to the law of the foreign country.

USE OF PROCEEDS

We estimate that we will receive net proceeds from this offering, after deducting the estimated underwriting discounts and the estimated offering expenses payable by us, of approximately $21.71 million if the underwriters do not exercise their over-allotment option, and approximately $25.19 million if the underwriters exercise their over-allotment option in full, in each case based on an assumed initial public offering price of $5.50 per share, which is the midpoint of the estimated initial public offering price range set forth on the cover page of this prospectus.

We intend to allocate the net proceeds from this offering to advance our strategic priorities across clinical development, manufacturing, commercialization, and innovation, as set forth below:

We may also use a portion of the net proceeds from this offering to acquire or invest in complementary technologies, products, intellectual property, or businesses that align with our strategic objectives. While we do not currently have any agreements, commitments, or understandings with respect to any such acquisitions or investments, we believe this flexibility is important to support long-term innovation and competitive positioning.

The foregoing represents our current intentions based on our existing business strategy and operational outlook. However, the actual allocation of the net proceeds will depend on a variety of factors, including our future revenues, cash flows, and evolving business needs. As such, our management will have broad discretion in applying the net proceeds from this offering, we may reallocate funds among the planned uses if our priorities or market conditions change, and investors will be relying on our judgment regarding the application of the net proceeds of this offering.

To the extent that the net proceeds are not immediately deployed for the purposes described above, we intend to invest them in short-term, interest-bearing, investment-grade securities, bank deposits, or other liquid instruments in accordance with our treasury management policies and applicable regulations.

DIVIDEND POLICY

Since our inception, we have not declared or paid cash dividends on our Ordinary Shares. Any decision to pay dividends in the future will be subject to a number of factors, including our financial condition, results of operations, the level of our retained earnings, solvency, capital demands, general business conditions, and other factors our board of directors may deem relevant. We currently intend to retain most, if not all, of our available funds and any future earnings after this offering to fund the operation, development, and growth of our business, and, as a result, we do not expect to pay any dividends in the foreseeable future. Consequently, we cannot give any assurance that any dividends may be declared and paid in the next few years.

Under Cayman Islands law, a Cayman Islands exempted company may pay a dividend on its shares out of either profit or share premium, provided that it is permitted to do so by its articles of association (which our articles of association permit) and in no circumstances may a dividend be paid if following such payment the company would be unable to pay its debts as they fall due in the ordinary course of business.

If we determine to pay dividends on any of our Ordinary Shares in the future, as a holding company, the declaration of dividends will be dependent on receipt of funds from our Malaysia subsidiaries, Medika Natura and Medikra Malaysia. Under the Malaysian Companies Act 2016, whilst it is not necessary for a private limited company to declare dividends, but if it does, dividends must be paid out of existing profit and no dividend shall be paid out if the payment will cause the company to be insolvent. As a result, in the event that Medika Natura and Medikra Malaysia incur debt of their own in the future, the instruments governing the debt may restrict any such entity’s ability to pay dividends or make other distributions to Medikra.

Cash dividends, if any, on our Ordinary Shares will be paid in U.S. dollars. Malaysia is under a single-tier tax system, where dividends are exempted from income tax in the hands of shareholders. In other words, our Malaysia subsidiaries are not required to deduct tax from dividends paid to their foreign corporate shareholder, Medikra, and no tax credits will be available for offsetting against the recipient’s tax liability. Also, Malaysia does not impose any withholding tax (i.e., 0%) on dividends paid by Malaysian companies to non-residents. Hence, our Malaysian subsidiaries are not required to withhold any sum from its dividends for tax withholding purposes.

Payments of dividends and capital in respect of our Ordinary Shares will not be subject to taxation in the Cayman Islands and no Cayman Islands withholding will be required on the payment of a dividend or capital to any holder of the Ordinary Shares nor will gains derived from the disposal of the securities be subject to Cayman Islands income or corporate tax. 

EXCHANGE RATE INFORMATION

Our business is conducted by our subsidiary, Medika Natura, in Malaysia utilizing MYR as our primary currency. For financial reporting purposes, capital accounts presented in our financial statements are translated into U.S. dollars using historical exchange rates prevailing at the time of capital transactions. No representation is made that the MYR amounts could have been, or could be, converted into U.S. dollars at the rates used in translation. The following table provides information concerning exchange rates between MYR and the U.S. dollar for the periods indicated. Assets and liabilities are translated at the exchange rates as of the balance sheet date.

Items in the statements of operations and comprehensive income (loss), and statements of cash flows are translated at the average exchange rate of the period.

Our reporting currency is the U.S. Dollar. This prospectus also contains translations of certain foreign currency amounts into U.S. dollars for the convenience of the reader. Assets and liabilities denominated in foreign currencies are translated at year-end exchange rates, income statement accounts are translated at average rates of exchange for the year and equity is translated at historical exchange rates.

CAPITALIZATION 

The following table sets forth our capitalization as of June 30, 2025: 

The pro forma information set forth in the table below is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

You should read this capitalization table in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the financial statements and the related notes appearing elsewhere in this prospectus.

A $1.00 increase (decrease) in the assumed initial public offering price of $5.50 (the midpoint of the price range on the cover page of this prospectus) per share would increase (decrease) each of additional paid-in capital, total shareholders’ equity and total capitalization by $4,215,909 if the underwriters’ over-allotment option is not exercised or $4,848,295 if the underwriters’ over-allotment option is exercised in full, assuming the number of Ordinary Shares offered by us remains the same and after deducting the estimated underwriting discounts, and estimated expenses payable by us.

DILUTION 

If you invest in our Ordinary Shares, your interest will be diluted immediately to the extent of the difference between the initial public offering price per Ordinary Share you will pay in this offering and the pro forma net tangible book value per Ordinary Share after this offering.

As of June 30, 2025, we had a net tangible book value of $1,088,105, corresponding to a net tangible book value of $0.04 per Ordinary Share. Net tangible book value per share or per Ordinary Share represents the amount of our total tangible assets less our total liabilities, divided by 25,555,160, the total number of Ordinary Shares issued and outstanding on June 30, 2025.

After giving effect to the sale of the 4,545,455 Ordinary Shares offered by us in this offering, at an assumed public offering price of $5.50 per Ordinary Share, which is the midpoint of the price range set forth on the cover page of this prospectus, assuming no exercise of the underwriter’s option to purchase additional Ordinary Shares and after deducting the estimated underwriting discounts and commissions and management fees and estimated offering expenses payable by us, our pro forma net tangible book value estimated at June 30, 2025 would have been approximately $23,128,526 representing $0.77 per Ordinary Share based on 30,100,615 Ordinary Shares deemed outstanding after this offering assuming no exercise of the underwriters’ over-allotment option. At the assumed public offering price for this offering of $5.50 per Ordinary Share, which is the midpoint of the price range set forth on the cover page of this prospectus, this represents an immediate increase in historical net tangible book value of $0.73 per Ordinary Share to existing shareholders and an immediate dilution in net tangible book value of $4.73 per Ordinary Share to purchasers of Ordinary Shares in this offering. Dilution for this purpose represents the difference between the price per Ordinary Share paid by these purchasers and pro forma d net tangible book value per Ordinary Share immediately after the completion of this offering. Pro forma information discussed above is illustrative only.

The following table illustrates such dilution on a per Ordinary Share basis to purchasers of Ordinary Shares in this offering:

A $1.00 increase or decrease in the assumed initial public offering price of $5.50 (the midpoint of the price range on the cover page of this prospectus) per Ordinary Share would increase (decrease) our pro forma net tangible book value per Ordinary Share after this offering by $4,215,909 and the dilution per Ordinary Share to new investors by $5.59, assuming the number of Ordinary Shares offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 500,000 Ordinary Shares would increase or decrease our pro forma net tangible book value per Ordinary Share after this offering by $2,550,626 and the dilution per Ordinary Share to new investors by $4.66, assuming the assumed initial offering price of $5.50 (the midpoint of the price range on the cover page of this prospectus) per Ordinary Share, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The following table summarizes, on a pro forma basis as of June 30, 2025, the differences between the number of Ordinary Shares acquired from us, the total amount paid and the average price per Ordinary Share paid by the existing holders of our Ordinary Shares and by investors in this offering and based upon an assumed public offering price of $5.50 (the midpoint of the price range on the cover page of this prospectus) per Ordinary Share, which is the midpoint of the price range set forth on the cover page of this prospectus before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The number of Ordinary Shares purchased from us by existing shareholders is based on 25,555,160 Ordinary Shares issued and outstanding as of June 30, 2025 and assumes no exercise of the underwriter’s over-allotment option and no exercise of the Representative’s Warrant.  

The pro forma information as discussed above is illustrative only. Our net tangible book value following the completion of this offering is subject to adjustment based on the actual initial public offering price of our Ordinary Shares and other terms of this offering determined at the pricing.

CORPORATE HISTORY AND STRUCTURE

Our Corporate History

Medika Natura was originally established as Orchid Life Sdn Bhd, a limited liability company under the laws of Malaysia on December 1, 2006. Orchid Life Sdn Bhd rebranded as Medika Natura Sdn Bhd on July 5, 2019.

Medika Natura’s wholly owned subsidiary, Medikra Malaysia was originally established as Medikra Marketing Sdn Bhd, as a private company limited by shares under the laws of Malaysia on April 26, 2022. Medikra Marketing Sdn Bhd changed its name to Medikra Malaysia Sdn Bhd on November 5, 2024.

In connection with this offering, we have undertaken a reorganization of our corporate structure (the “Reorganization”) in the following steps:

Our Corporate Structure

As of the date of this prospectus, all of the outstanding equity interests of Medika Natura are owned by Medikra, with 34.78% of the issued and outstanding Ordinary Shares of Medikra held by Abdul Razak Mohd Isa, 34.98% of the issued and outstanding Ordinary Shares held by Mustadza Muhamad, 17.91% of the issued and outstanding Ordinary Shares held by Datuk Ali Bin Abdul Kadir, the chairman of Medikra, and the remaining 12.33% of the issued and outstanding Ordinary Shares held by eight minority shareholders.

The following chart depicts our organizational structure as of the date of this prospectus:

Upon completion of this offering based on a proposed number of 4,545,455 Ordinary Shares being offered (assuming an initial public offering price of $5.50, which is the midpoint of the estimated range of the initial public offering price shown on the front cover of this prospectus, and total gross proceeds of approximately $25,000,000), assuming no exercise of the underwriters’ over-allotment option, all of the outstanding equity interests of Medika Natura will be owned by Medikra, with the outstanding Ordinary Shares of Medikra being held by the following: Abdul Razak Mohd Isa - 8,888,630 Ordinary Shares (29.53%), Mustadza Muhamad - 8,938,620 Ordinary Shares (29.70%), Datuk Ali Bin Abdul Kadir – 4,577,920 (15.21%) Ordinary Shares, the pre-IPO non-controlling shareholders of Medikra – 25,555,160 Ordinary Shares, and the public shareholders of Medikra who purchase Ordinary Shares in this offering – 4,545,455 Ordinary Shares.

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

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the section of this prospectus titled “Summary Selected Consolidated Financial and Other Data” and the Company’s consolidated financial statements, and related notes, appearing elsewhere in this prospectus. In addition to historical information, this discussion and analysis contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Disclosure Regarding Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. The Company’s actual results and the timing of events may differ materially from those discussed in our forward-looking statements as a result of many factors, including, but not limited to, those set forth under “Risk Factors” and elsewhere in this prospectus.

On August 30, 2024, Medikra was incorporated as a Cayman Islands exempted company with limited liability to become the ultimate holding company for our business pursuant to our Corporate Reorganization. See “Corporate History and Structure.” Prior to the Corporate Reorganization, Medikra only engaged in activities incidental to its formation and the Corporate Reorganization. Accordingly, a discussion and analysis of the results of operations and financial condition of Medikra for the period of its operations prior to the Corporate Reorganization would not be meaningful and are not presented.

Overview

Medikra is the parent company of Medika Natura, a clinical-stage biopharmaceutical company headquartered in Malaysia. Through our wholly owned subsidiary, we are focused on the discovery, development, and commercialization of pharmaceutically standardized botanical therapeutics and bioactive ingredients derived from the botanical biodiversity of Malaysia and Southeast Asia. Our therapeutic programs target unmet medical needs in obesity, metabolic dysfunction, inflammation, and immune-endocrine disorders.

Medika Natura also fully owns Medikra Malaysia, which was incorporated on April 26, 2022 (formerly Medikra Marketing Sdn Bhd, renamed on November 5, 2024). Medikra Malaysia serves as the Company’s and its subsidiaries’ (collectively, the “Group”) dedicated marketing and distribution entity for Southeast Asia and select international markets.

SKF7®: Development Overview and Therapeutic Strategy

Our lead product candidate, SKF7®, is a patented, pharmaceutically standardized extract of Labisia pumila, a medicinal plant indigenous to Malaysia. SKF7® is in clinical development for the treatment of abdominal obesity and metabolic dysfunction. It has been evaluated in randomized, double blind, multicenter, placebo-controlled Phase II clinical trials in Malaysia and Indonesia, and in a pharmacokinetic study in healthy adults in India.

Of the 133 participants enrolled in the Malaysian Phase II trial, 132 provided consent for optional plasma proteomic analysis. The exploratory aptamer-based plasma proteomic analysis quantified more than 10,000 human proteins, with approximately 2,300 significantly modulated following treatment and 99 reproducibly regulated across within-group and between-group comparisons, forming a consistent proteomic signature of SKF7® activity. The analysis identified molecular networks associated with inflammation, lipid metabolism, cholesterol biosynthesis, and apoptosis related signaling, which are pathways implicated in abdominal obesity and metabolic dysfunction.

Based on preclinical and clinical findings, SKF7® is currently being evaluated for its potential to support the management of central obesity, metabolic dysfunction, inflammation associated conditions, and endocrine-related imbalances. These mechanistic observations are hypothesis generating and suggest potential applications in women’s health, cardiometabolic risk modification, and oncology. These exploratory areas remain at an early stage of research and development. Our other pipeline assets are either in preclinical development or commercialized as nutraceuticals. We have not yet submitted an IND application in the United States or a clinical trial application in Europe for SKF7®, and there can be no assurance that we will do so, or that any such application, if submitted, will be successful.

Scientific Foundation and Translational Advancement of SKF7®

The scientific foundation for the Labisia pumila anti-obesity program was established through preclinical research led by Professor Emeritus Dr. Zhari Ismail at Universiti Sains Malaysia (USM). Funded by Malaysia’s NKEA Research Grant Scheme (NRGS, 2012–2014) under the Ministry of Agriculture and Food Industry (MAFI), the program reflected national recognition of its strategic importance.

This research demonstrated statistically significant weight management and metabolic benefits in preclinical models conducted in Sprague Dawley rats. The Labisia pumila Standardized Extract (LPSE) produced reductions in body weight, adiposity measures, and key lipid parameters, including total cholesterol, triglycerides, and low-density lipoprotein (LDL) cholesterol, together with improvements in high-density lipoprotein (HDL) cholesterol and preservation of normal hepatic architecture. In comparative studies against reference anti-obesity agents, LPSE showed comparable outcomes in selected metabolic parameters under controlled laboratory conditions.

Mechanistic investigations revealed multiple biological pathways known to be relevant to obesity management, including inhibition of pancreatic lipase and suppression of adipocyte differentiation and lipid accumulation. Advanced nanoformulation strategies (LPSE-Liposome) were explored to enhance delivery efficiency and broaden potential applications. These pre-clinical findings support the potential for differentiated product development in the weight-management category, with formulation options designed for optimized delivery and efficacy.

Beyond metabolic disorders, Professor Zhari’s investigations also generated preliminary evidence of potential applications in oncology and women’s health, particularly in uterine-fibroid models. These additional investigational outcomes may indicate that there are potential opportunities for future pipeline expansion within the broader Labisia pumila platform. However, pre-clinical study results are not indicative of likelihood of potential clinical research outcomes and predicting additional future applications is difficult.

Building on this scientific foundation, Medika Natura advanced the active pharmaceutical ingredient (API), SKF7®, into full-scale translational development. This progression was supported by a grant awarded in 2015 by MAFI under the National Key Economic Area (NKEA) Malaysian initiative, underscoring governmental recognition of the therapeutic potential of this indigenous botanical resource. The initiative funded comprehensive preclinical studies, regulator-approved clinical trials in Malaysia, Indonesia, and India, and subsequent commercialization activities. The resulting data formed part of dossiers submitted to the U.S. Food and Drug Administration (FDA) under accepted New Dietary Ingredient (NDI) Notifications and to the European Food Safety Authority (EFSA) under the Novel Food framework.

To secure global commercialization rights, Medika Natura obtained match funding from the Malaysian Technology Development Corporation (MTDC) to acquire the intellectual-property rights from USM. This enabled the formal transfer to Medika Natura of all relevant data and exclusive ownership of LPSE and LPSE-Liposome for further development and international expansion. LPSE refers to the Labisia pumila Standardized Extract, the laboratory-scale prototype of SKF7®, while LPSE-Liposome denotes its nanoliposomal variant, serving as the prototype of SKF7® Liposome.

All intellectual-property rights to these formulations were acquired by Medika Natura from USM and are protected under Malaysian Patent No. MY-193591-A, granted on October 19, 2022, titled “Standardised Extract of Labisia pumila for Weight Reduction and Nanoformulation Thereof.” The patent provides composition-of-matter and process protection for both the extract and its nanoformulated derivatives, establishing foundational exclusivity for SKF7® across key therapeutic areas.

In subsequent phases of development, additional funding was secured from the Ministry of International Trade and Industry (MITI) through the Malaysian Industrial Development Finance Berhad (MIDF) under the 11th Malaysia Plan (RMK-11) High-Value Added and Complex Product Development Program in 2019. This initiative supported preclinical studies that evaluated SKF7®’s therapeutic potential in type 2 diabetes and oncology. Collaborative research with Universiti Kebangsaan Malaysia (UKM) and Universiti Putra Malaysia (UPM) evaluated efficacy in type 2 diabetes models, cervical-cancer in vivo xenograft models, and breast-cancer in vitro assays. Complementary proteomics-based studies conducted by the Forest Research Institute Malaysia (FRIM) investigated the anti-cancer potential of SKF7® in HeLa cervical-cancer cells, encompassing mechanisms of action, differential protein expression, pathway mapping, and apoptosis profiling.

The program also facilitated international patent filings in these therapeutic areas, several of which remain pending, and supported global regulatory activities, including FDA acceptance of SKF7® as a New Dietary Ingredient (NDI) and EFSA recognition as a Novel Food.

PCT filings and related national applications for Labisia pumila extract have been made across several jurisdictions. In Malaysia, PI2021006446, “Labisia pumila Extract Composition and Its Pharmaceutical Formulation” (composition and method of extraction), was filed on November 2, 2021 and remains under examination, while MY-193591-A, “Standardised Extract of Labisia pumila for Weight Reduction and Nano-Formulation Thereof,” was granted on October 19, 2022, and PCT/MY2022/000010 was filed on December 15, 2022. In the United States, U.S. Application No. 17/961,940, “Labisia pumila Extract Composition and Its Pharmaceutical Formulation,” filed on October 7, 2022, led to U.S. Patent No. 12,403,166 B2, which was granted on September 2, 2025, while a divisional application, U.S. Application No. 19/220,442, was filed on May 28, 2025 and remains under examination. In the European Union, Application No. 22859531.0 was filed on May 31, 2024 and is pending examination, and in South Korea, Application No. 10-2024-7018373 was filed on May 31, 2024 and is also pending examination. With the exception of the granted patents in Malaysia (MY-193591-A) and the United States (U.S. 12,403,166 B2), all applications remain under examination. All resulting datasets and associated rights have been transferred to Medika Natura, which holds exclusive global ownership of the API and its related intellectual property.

In June 2022, Medika Natura entered into a Memorandum of Understanding (the “Memorandum of Understanding”) with the Government of Malaysia, represented by the Ministry of Health’s National Institutes of Health, the research body under the Ministry of Health Malaysia (MOH), to establish a formal framework for collaboration in medical research. Under this agreement, the National Institutes of Health (“NIH”) serves as the designated authority for collaborative scientific activities on behalf of the Government of Malaysia.

The Memorandum of Understanding outlines cooperation in areas including joint research, data generation, scientific exchange, and publication of collaborative findings, and does not obligate either party to undertake any specific project. Any specific collaborative activity is implemented on terms and conditions mutually decided by the parties. Each party retains ownership of its respective intellectual property and intellectual property arising from jointly developed research outputs is jointly owned on terms to be mutually agreed by the parties. Publications and public disclosures of results and data from collaboration projects require written approval of both parties, and use of a party’s name, logo, or official emblem on any publication, document, or paper requires prior written approval from that participant.

The Memorandum of Understanding does not include quantified payment obligations. Each party is responsible for its own costs and expenses in the preparation of the Memorandum of Understanding, and any financial arrangements to cover expenses for cooperative activities are mutually decided on a case-by-case basis, subject to the availability of funds and resources. The Memorandum of Understanding does not specify any royalty payments or milestone payments. The Memorandum of Understanding includes confidentiality obligations regarding documents, information, and other data received from the other parties, and these confidentiality obligations survive expiry or termination of the agreement. The Government of Malaysia also reserves the right to suspend temporarily, either in whole or in part, implementation of the Memorandum of Understanding for reasons of national security, national interest, public order, or public health, by written notification.

The Memorandum of Understanding generally serves as a record of the participants’ intentions and is not intended to create legally binding obligations, except that specified provisions, including those relating to financial arrangement, intellectual property, confidentiality, suspension, amendment, and dispute settlement, are binding. The Memorandum of Understanding came into effect on June 10, 2022, and remained in effect for a period of three years. After that it was automatically extended and will continue to automatically extend for further three-year periods indefinitely until terminated at the request of either participant. Either party may terminate the Memorandum of Understanding by providing at least six months’ prior written notice to the other party, and termination will not affect on-going projects or programs agreed before termination.

The Institute for Medical Research (“IMR”), the biomedical research arm of the Ministry of Health and one of Malaysia’s longest-standing national research institutes. IMR’s mandate includes advancing national health priorities through biomedical and translational research, generating evidence for disease prevention and control strategies, and supporting the evaluation of diagnostics and health-related technologies.

In response to the COVID-19 pandemic, Medika Natura co-funded and independently supported a study conducted by the IMR. IMR’s research programs are aligned with national health priorities and aim to generate evidence for informed decision-making, support disease prevention and control strategies, and contribute to evaluate the development of diagnostics and health technologies. The IMR study evaluated the antiviral activity of SKF7® against the wild-type (Wuhan) and Omicron variants of SARS-CoV-2. The research, titled “In vitro study on efficacy of SKF7®, a Malaysian medicinal plant product against SARS-CoV-2,” demonstrated antiviral and immunomodulatory activity in vitro and was published in BMC Complementary Medicine and Therapies in 2024.

IMR also independently conducted exploratory preclinical initiatives involving SKF7®. In an established model of estrogen deficiency, SKF7® was associated with non-hormonal endocrine-related findings, antioxidant observations, and hepatoprotective effects. The endocrine investigations included evaluation of hormonal parameters and estrogen-related receptor expression patterns. Microbiome profiling using 16S rRNA sequencing demonstrated shifts in microbial composition and diversity metrics across treatment groups. Whole-transcriptome mRNA sequencing identified differential gene-expression patterns involving metabolic, stress-response, and inflammatory pathways in SKF7®-treated groups, with functional enrichment analysis revealing involvement of multiple biological processes.

In addition, an in vitro study using mouse microglial cells evaluated the immunological response to SKF7® under neuroinflammatory stimulation. The study observed dose-dependent effects on selected inflammatory mediators and associated signaling pathways. These exploratory findings are being used to support internal hypothesis generation and to guide the prioritization of future non-clinical research directions related to neuroinflammation, oxidative stress, and vascular-associated biology. Some of the biological pathways examined in this work are also relevant to early-stage scientific inquiry in neurodegenerative conditions such as Alzheimer’s disease; however, SKF7® has not been evaluated for safety or efficacy in Alzheimer’s disease or any other neurological disorder in humans, and no conclusions can be drawn regarding potential clinical benefit.

Translating a broad body of preclinical and toxicology data into human studies, SKF7® has been evaluated in multicenter, randomized, placebo-controlled Phase II clinical trials conducted in Malaysia and Indonesia in subjects with overweight or central obesity, and in a Phase I single-dose pharmacokinetic study in healthy adults in India.

In the Malaysian Phase II study, a four-month randomized, placebo-controlled trial evaluated daily SKF7® doses of 375 mg, 562.5 mg, and 750 mg, conducted without standardized lifestyle or behavioral interventions. Participants receiving the 750 mg daily dose demonstrated statistically significant reductions in abdominal obesity, reflected by decreases in body weight, body-mass index, waist circumference, and waist-to-height ratio. No deaths or serious adverse events were reported, and the study was completed under Good Clinical Practice (“GCP) conditions.

In the Indonesian Phase II study, a three-month trial in 120 adults evaluated daily SKF7® doses of 750 mg, 1,125 mg, and 1,500 mg versus placebo, also conducted without lifestyle or behavioral interventions. No deaths or serious adverse events were reported. The study generated dose-response data indicating differential effects across treatment groups, which are being used to guide formulation assessment and future trial design.

In the Indian Phase I pharmacokinetic study, 12 healthy adult volunteers received a single 1,500 mg oral dose under fed conditions. The study characterized the absorption and systemic exposure of SKF7® and reported no deaths or treatment-related serious adverse events, and the PK findings informed dose selection for subsequent clinical development

Exploratory molecular analyses from the Malaysian Phase II study, performed with aptamer-based proteomic technologies in the United States, analyzed 132 paired plasma samples. Out of 10,788 quantified proteins, 2,284 were statistically modulated and 99 were reproducibly regulated across within-group and between-group comparisons. Enrichment analysis identified protein networks associated with immune regulation, inflammation, lipid metabolism, cholesterol biosynthesis, and hemostasis.

In this context, human omics refers to large-scale molecular profiling of patient samples that evaluates thousands of proteins to provide an integrated view of biological pathways. These findings are exploratory and hypothesis-generating, require further validation, and are not predictive of clinical outcomes. Quantitative details are withheld for intellectual property considerations and future confirmatory studies.

SKF7® has undergone nonclinical and human testing to characterize its toxicological and tolerability profile. These evaluations include proprietary cell-based assays, studies using human blood samples, rodent and non-rodent models, and formal toxicological assessments such as dose-range-finding and maximum-tolerated-dose studies conducted in compliance with applicable guidelines.

In addition, the EFSA has authorized SKF7® as a novel botanical ingredient under the EU Novel Food framework following a toxicological review, allowing its use in food and dietary applications within the European Union. SKF7® has also been accepted by the FDA as an NDI for use in dietary-supplement formulations. These regulatory determinations relate solely to the ingredient’s use in foods or supplements and do not constitute approval for any therapeutic indication or claim of efficacy or safety.

Collectively, these assessments provide nonclinical and human data describing exposure, tolerance, and use parameters. SKF7® continues to be evaluated in ongoing and planned clinical studies intended to further characterize its pharmacology and tolerability in metabolic and endocrine-related conditions. The outcomes of these or future studies may differ, and there can be no assurance that SKF7® will demonstrate comparable findings in later-stage trials or obtain regulatory approval for therapeutic use.

Global Regulatory Progress

We have advanced SKF7® through several regulatory frameworks across key global markets. These achievements demonstrate our commitment to quality and compliance with internationally recognized standards:

These regulatory milestones represent steps in the Company’s dual-path development approach encompassing nutraceutical and pharmaceutical programs, although there can be no guarantee that such efforts will result in successful regulatory outcomes or commercialization.

Intellectual Property Portfolio

SKF7® is supported by a robust and geographically diversified intellectual property portfolio designed to ensure long-term exclusivity and defensibility of our lead asset and its future derivatives:

This comprehensive strategy enhances our ability to pursue global market entry while protecting innovation across several disease areas.

KPH1™: Development Overview and Therapeutic Strategy

Following the advancement of SKF7®, Medika Natura is expanding its development pipeline with KPH1™, a proprietary standardized extract of Kaempferia parviflora designed for ischemic heart disease and aging. KPH1™ builds upon the Company’s established botanical-drug platform and leverages the same integrated preclinical, clinical, and omics-based development framework used for SKF7®. The program reflects the Company’s broader strategy to extend its therapeutic reach beyond metabolic disorders to cardiovascular and aging-related health.

KPH1™ is a proprietary standardized extract of Kaempferia parviflora developed by Medika Natura for ischemic heart disease and aging. The program is supported through a collaboration between Medika Natura and the Academy of Sciences Malaysia (“ASM”) under the Ministry of Science, Technology and Innovation’s (“MOSTI”) i-Connect Program. The initiative focuses on the premiumization of HALAL-certified nutraceuticals with potential therapeutic claims under the Malaysian Collaborative Network Platform for Disruptive Innovation (i-Connect) within the HALAL supply-chain sector. The collaboration agreement was signed on April 5, 2022.

On October 17, 2024, Medika Natura appointed the Faculty of Medicine at Universiti Malaya as the lead preclinical investigator for the KPH1™ program. As of October 2025, the team has successfully completed preclinical studies evaluating the pharmacology, tolerability, and cardioprotective potential of KPH1™ in ischemic and aging models under internationally recognized laboratory standards. Oral administration improved cardiac function, reduced oxidative stress, and preserved mitochondrial integrity without treatment-related toxicity. Multi-omics analyses using single-nucleus and single-cell RNA sequencing platforms conducted in the United States and Singapore identified molecular patterns associated with mitochondrial and vascular homeostasis.

Where applicable, the preclinical toxicology studies were conducted in accordance with OECD GLP, FDA CFR 21, and ICH M3 (R2) guidelines in AAALAC-accredited facilities. A 90-day repeated-dose toxicity and toxicokinetic study in rats showed no adverse findings and established a no-observed-adverse-effect level (NOAEL) of the highest dose tested. The Company is not conducting animal studies in the United States at this time, but selected analyses of preclinical data have been performed in the United States and Singapore using accredited laboratories.

These findings are exploratory and intended to guide future clinical evaluation, and there can be no assurance that subsequent clinical studies will be successful. Quantitative and mechanistic details remain confidential pending ongoing and future patent filings. 

Global Regulatory Progress

Intellectual Property Portfolio

Strategic Areas of Investigation

In addition to SKF7®’s lead indication in obesity and metabolic dysfunction, we are pursuing exploratory research across several high-impact therapeutic areas. These early-stage investigations are intended to guide future development strategies and are not yet the subject of clinical claims or regulatory submissions. They include:

Exploratory studies are ongoing to evaluate the potential role of SKF7® in modulating neuroinflammatory and redox-related pathways that may be relevant in cognitive and neurodegenerative conditions.

Non-hormonal mechanisms of interest have been observed in estrogen-deficient models, supporting continued evaluation of SKF7® in the context of menopausal metabolic and endocrine alterations.

16S rRNA microbiome profiling has revealed composition changes in microbial communities, which may support hypotheses related to metabolic regulation, immune balance, and microbiome-host interactions.

In vitro assays are being used to evaluate potential biological activity of SKF7® in hormone-sensitive cell lines, including models relevant to breast and cervical epithelial biology. These studies are ongoing and intended to inform future preclinical development.

These areas of investigation remain early-stage and are intended to inform future therapeutic hypothesis generation and potential expansion of the SKF7® platform.

Preclinical and Clinical Development Readiness

SKF7® (Labisia pumila)

SKF7® is supported by GLP–compliant toxicology, pharmacokinetic, and pharmacodynamic studies conducted in cellular, rodent, and non-rodent models. No treatment-related serious adverse findings were identified. A Phase II/III clinical trial in abdominal obesity and metabolic dysfunction, including type 2 diabetes, is planned for initiation in 2026, subject to Pre-IND meetings and regulatory review with the FDA and Malaysia’s NPRA. Medikra has not yet submitted an IND application to the FDA and NPRA. Although prior studies were conducted under ICH-GCP standards outside the United States, FDA acceptance of these data for Phase III progression remains to be determined.

KPH1™ (Kaempferia parviflora)

KPH1™ is supported by GLP-compliant preclinical and toxicokinetic studies evaluating cardiovascular and aging-related mechanisms. An early-stage Phase I/II clinical trial in cardiovascular aging and ischemic heart disease is planned for 2026, subject to Pre-IND meetings and regulatory review with the FDA and NPRA, to assess tolerability, pharmacokinetics, and exploratory efficacy endpoints. Medikra has not yet submitted an IND application to the FDA and NPRA. FDA acceptance of non-U.S. study data for subsequent clinical progression remains to be determined.

Both programs are expected to advance following completion of site selection and regulatory submissions. Additional financing will be required to complete these trials, and our clinical trials for prescription-grade programs may not be successful. The Company may not obtain regulatory approval or achieve successful commercialization, and there can be no assurance of regulatory acceptance or development success.

Pipeline Expansion: Additional Botanical Therapeutics

In addition to SKF7® and KPH1™, we are advancing a robust pipeline of botanical candidates with potential applications across cardiovascular, endocrine, and immuno-inflammatory conditions. These programs are grounded in clinically relevant research collaborations and developed under strict regulatory and quality frameworks.

MKS-5® (Orthosiphon stamineus)

MKS5® is a proprietary botanical formulation developed from Orthosiphon stamineus, targeting chronic inflammation and autoimmune conditions such as rheumatoid arthritis. The formulation, branded as Starpril®, is manufactured under GMP in accordance with Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards. MKS5® is registered with the NPRA of Malaysia under the traditional medicine category and is commercially marketed as Starpril®. The formulation is currently undergoing regulatory evaluation in Germany and Saudi Arabia, with ongoing development supported by Medika Natura’s internal research and development resources.

Next-Generation Therapeutic Candidates

Advances the development of new compositions, formulations, and delivery approaches derived from lead assets. These programs are guided by preclinical evidence and data from ongoing development to expand into new therapeutic indications and enhance differentiation, intellectual property, and clinical value.

Factors Affecting Our Results of Operations

Our results of operations are influenced by a range of internal and external factors that reflect the complexity of developing, commercializing, and scaling pharmaceutical-grade botanical therapeutics and nutraceutical products. Key factors include:

These factors, individually and aggregated, shape the trajectory of our business operations, revenue generation, and long-term value creation.

Finance operation overview

Revenues

Revenue from Nutraceutical Products

The table above reflects revenue generated from the sale of our nutraceutical products manufactured under GMP standards —Labeesity SKF7® and Pervira®, each derived from standardized botanical active ingredients currently undergoing advanced clinical evaluation. These products are manufactured in compliance with GMP PIC/S and MS2424: Halal Pharmaceutical standards and are registered with Malaysia’s NPRA under the traditional medicine framework. While not yet approved as therapeutic drugs, they have been commercialized in Malaysia on a limited basis as part of our broader regulatory and commercialization strategy.

Labeesity SKF7®, which contains the SKF7® extract of Labisia pumila, has been available since 2017 under a controlled early access and test marketing initiative. This initiative was designed to collect real-world data on product usage, tolerability, and quality in parallel with formal clinical trial activities. Information obtained from this program has been used to support regulatory submissions, including notifications accepted by the U.S. Food and Drug Administration (FDA) under the New Dietary Ingredient (NDI) framework and by the European Food Safety Authority (EFSA) under the Novel Food regulation. These clearances are limited to dietary supplement use and do not constitute, or guarantee, acceptance of any future Investigational New Drug (IND) application or pharmaceutical development approval.

Sales for the six months ended June 30, 2025, totaled US$8,075, compared to US$18,152 for the six months ended June 30, 2024, reflecting a decrease of US$10,077 or 55.5%. The lower revenue reflects our continued focus on clinical and regulatory development activities rather than commercialization, consistent with our status as a clinical-stage biopharmaceutical company, and also reflects the emphasis in the first half of 2025 on production capacity relocation, regulatory submissions, and patent filings.

Sales for the year ended December 31, 2024, totaled US$26,176, compared to US$68,381 for the year ended December 31, 2023, reflecting a decrease of US$42,205 or 61.7%. This variance was primarily due to a strategic reallocation of production capacity and inventory to support ongoing preclinical and clinical studies for regulatory advancement. No dedicated commercial budget was allocated during the reporting periods, as our primary focus remained on data generation, regulatory submissions, and patent filings.

Sales for Labeesity SKF7® for the years ended December 31, 2024 and 2023 were US$21,874 and US$58,208, respectively. Sales for Pervira® for the years ended December 31, 2024 and 2023 were US$4,302 and US$10,173, respectively. Sales for Labeesity SKF7® for the six months ended June 30, 2025 and 2024 were US$7,758 and US$8,347, respectively, and sales for Pervira® were US$317 and US$9,805, respectively.

Although revenue from nutraceutical sales remains supplementary at this stage, these activities have provided valuable market validation, customer insights, and real-world usage data that strengthen the overall clinical and regulatory positioning of our product candidates. Additionally, a portion of manufactured batches continues to be allocated for use in preclinical research and clinical trials, further reinforcing the scientific and intellectual property value of our pipeline.

Other Income, Net

Other income for the six months ended June 30, 2025, totaled US$8,952, compared to US$1,623 for the six months ended June 30, 2024, representing an increase of US$7,329 or 451.6%. The increase was primarily due to higher bank interest income earned on current account balances maintained with CIMB Bank, reflecting increased cash balances during the period.

Other income for the year ended December 31, 2024, totaled US$88,972, compared to US$98,182 for the year ended December 31, 2023, representing a decrease of US$9,210 or 9.4%. The decrease was primarily attributable to lower net government grant income recognized during the year.

Cost of Revenues

Cost of revenues primarily consists of direct costs incurred in the production of our nutraceutical products manufactured under GMP standards, Labeesity SKF7® and Pervira®. These costs include raw material extraction, GMP PIC/S and Halal Pharmaceutical standards compliant manufacturing, quality control and laboratory testing, regulatory compliance, and packaging.

For the six months ended June 30, 2025 and 2024, cost of revenues amounted to US$1,654 and US$3,957, respectively. This decrease of US$2,303, or 58.2% was co-related with the decrease in total revenue. The decrease was consistent with lower revenue and was primarily attributable to reduced production in the first half of 2025, as resources were directed toward relocation of production capacity, regulatory submissions, and patent filings

For the years ended December 31, 2024, and 2023, cost of revenues amounted to US$5,559 and US$20,175, respectively. The decrease of US$14,616, or 72.4%, was primarily attributable to a reduction in commercial production volume, consistent with the Group’s strategic emphasis on preclinical and clinical development activities during the reporting periods.

Sales recorded in 2023 and 2024 were limited in nature and conducted under a controlled early access and test marketing initiative. These sales were demand-driven and intended to assess product-market fit and gather early feedback from selected healthcare providers. No budget was allocated for commercial team expansion, salesforce deployment, or promotional campaigns during the period.

While commercial sales volume declined, a portion of extract production was allocated to support non-commercial objectives. Specifically, Pervira® extract was produced to supply ongoing preclinical research, while SKF7® extract was manufactured in support of regulatory registration requirements in international markets. As such, not all production during the period was attributable to revenue-generating activity.

The Group employs a Just-In-Time (“JIT”) production model, aligning procurement and manufacturing schedules with confirmed purchase orders and operational requirements. This approach allowed for reduced production output in 2024 while maintaining sufficient extract availability for clinical and regulatory purposes. The model also contributed to lower raw material consumption, reduced manufacturing overheads, and minimized inventory-related storage and handling costs.

This production approach is intended to improve cost efficiency, enhance inventory turnover, and mitigate risks associated with degradation or regulatory non-compliance—particularly relevant for high-standard botanical formulations. By integrating production planning with clinical development and regulatory strategy, the Group maintains operational flexibility and financial discipline as it progresses toward late-stage development milestones.

Gross profit and gross profit margin

Gross profit represents revenues less cost of revenues. Gross profit margin represents gross profit as a percentage of revenues. Gross profit was US$6,421 and US$14,195 for the six months ended June 30, 2025 and 2024, respectively. Gross profit margin was 79.5% and 78.2% for the six months ended June 30, 2025 and 2024, respectively.

Gross profit was US$20,617 and US$48,206 for the years ended December 31, 2024 and 2023, respectively. Gross profit margin was 78.8% and 70.5% for the years ended December 31, 2024 and 2023, respectively. The increase of the gross profit margin is due to the decrease of the cost of production as a result of an improved production efficiency.

The gross profit margin will decrease if there is an increased in production cost, such as raw material costs, exchange rates, production costs, import tariffs or other related costs.

The decrease in gross profit from US$48,206 in 2023 to US$20,617 in 2024 was primarily attributable to lower revenue generated in 2024, as the Company was still in the pilot phase. During the year, the Company concentrated its efforts on research and development activities, patent filings, trademark applications, and preparatory work for this offering.

Government Grant income

Governmental grant income represents grant income derived from contracts with government entities without the expectation of direct repayment. Grant income is recognized in the consolidated statements of operations and comprehensive loss on a systematic basis over the periods in which we recognized the related expenses for which the grant is intended to compensate.

Below is the grant received from the government recognized as income for the years ended December 31, 2024 and 2023:

For the six months ended June 30, 2025 and 2024, grant income recognized in the consolidated statement of operations and comprehensive loss amounted to US$5,236 and US$4,354, respectively. The overall increase of US$882 is primarily due to the increase in the grant income recognized in the first half of the year 2025 for SKF7®, where the Company has received its claim on the international patent filing fee from MIDF.

For the years ended December 31, 2024 and 2023, grant income recognized in the consolidated statement of operations and comprehensive loss amounted to US$95,636 and US$116,615 respectively. The overall decrease of US$20,979 is primarily due to the decrease in the grant income recognized for SKF7® as Medika Natura completed both its preclinical studies in type 2 diabetes and cancer and has submitted the regulatory dossier to U.S FDA and EFSA. Concurrently, for the year ended December 31, 2024, Medika Natura has also started to focus developing KPH1™, a proprietary standardized extract of Kaempferia parviflora, where the research was co-funded by ASM.

Below is the summary of the grant income received by Medika Natura from 2015 through the year ended December 31, 2024.

Ministry of Agriculture and Food Industry (“MAFI”)

In 2015, Medika Natura was awarded with a ceiling grant of RM19.55 million which is equivalent to approximately US$4,439,187. The government grant received from MAFI was fully utilized for qualifying expenditures and recognized as income in full on a systematic basis for the period the expenses is incurred before the financial year ended December 31, 2023. Accordingly, no deferred grant balance remains from MAFI as of years ended December 2023 and 2024 respectively.

Malaysian Trade Development Corporation (“MTDC”)

In 2018, Medika Natura managed to secure funding for the sum of RM1,659,400 which is approximately US$376,797 under the Commercialization of Research and Development Fund to fund the approved commercialization activities. The initial funding comprises of the following:

The fund was used to acquire the patent filed by USM on the ’Standardized extract of Labisia pumila for weight reduction and nanoformulation thereof,’ as well as related technical knowledge and research data, and to develop the e-commerce website for Labeesity. This patent was granted on October 19, 2022, under Patent No. MY-193591-A. By the end of the project, Medika Natura had utilized only US$185,363, of which US$129,574 was awarded as a grant and the remaining US$55,609 was converted into a debt facility. The grant income was fully recognized before the financial year ended December 31, 2023, as and when the corresponding expenses were incurred. Currently, Medika Natura is servicing only the debt facility, with full settlement expected in the first quarter of 2026. For further information on the debt facility, please refer to the Notes to the Consolidated Financial Statements for the financial years ended December 31, 2023, and 2024

Ministry of Investment, Trade and Industry (MITI) via Malaysian Industrial Development Finance Berhad (“MIDF”)

In 2020, Medika Natura received a grant of RM950,000 which is equivalent to US$215,715 under the Market Development Program, a funding program under the 11^th Malaysia Plan (RMK-11) for High Value Added and Complex Product Development and Market Program. MIDF, a mandated agency under the Ministry of International Trade and Industry (“MITI”) was appointed to facilitate the grant disbursement.

For the years ended December 31, 2024 and 2023, Medika Natura received US$1,614 and US$116,615, respectively. These funds were utilized for the preparation and submission of regulatory dossiers, including the NDI notification to the FDA and a Novel Food application to the EFSA. The funds were also applied to international patent and trademark filings through the PCT and the MyIPO, covering jurisdictions in the United States (U.S. Patent Application No. 17/961,940), Malaysia (PCT/MY2022/000010 and PI2021006446), South Korea (Application No. 10-2024-7018373), and European Union (Application No. 22859531.0). 

Academy of Sciences Malaysia (“ASM”)

In 2022, Medika Natura entered into an agreement with ASM, the Implementing Agency appointed by the Ministry of Science, Technology and Innovation (“MOSTI”) for the grant under the i-Connect Program. Medika Natura, together with the collaborators from Universiti Malaya (UM) embarked on a project for the commercialization of Kaempferia parviflora (KPH1™) with the goal to produce a HALAL standardized extract of KPH1™ and filing the product to regulatory bodies. Currently, KPH1™ is under pre-clinical study for its tolerability and efficacy. This is the first grant that was awarded for KPH1™.

As of December 31,2024, Medika Natura has received RM528,750 which is approximately US$115,951 in advance, where US$94,022 has been charged to the statement of operations and comprehensive loss for the financial year ended December 31,2024 to match against the expenses incurred during the research and development activities. We expect to utilize the remaining amount in the upcoming financial years.

Research and Development (R&D) Expenses

Our research and development (R&D) strategy is focused on advancing pharmaceutical-grade botanical therapeutics that are clinically evaluated for tolerability, efficacy, and regulatory compliance. SKF7®, our lead compound derived from Labisia pumila, is a patented botanical active pharmaceutical ingredient (API) developed to address obesity, metabolic dysfunction, and associated endocrine disorders. While initially developed for weight management, accumulated preclinical and clinical data have revealed broader therapeutic applications across inflammatory and metabolic disease pathways.

The development of SKF7® began with academic research at USM and progressed under the MAFI’s Entry Point Project 1 (EPP1) in 2015, which supported its reformulation and the development of a comprehensive regulatory blueprint. This foundational work established the pharmacological rationale, therapeutic dosing, and manufacturing reproducibility necessary for regulatory advancement. SKF7® subsequently advanced through GLP-compliant preclinical studies and multi-center, ICH-GCP-compliant Phase 1 and 2 clinical trials conducted in Malaysia, Indonesia, and India.

These efforts culminated in key global regulatory milestones, including: