An offering statement pursuant to Regulation A relating to these securities has been filed with the Securities and Exchange Commission. Information contained in this Preliminary Offering Circular is subject to completion or amendment. These securities may not be sold nor may offers to buy be accepted before the offering statement filed with the Commission is qualified. This Preliminary Offering Circular shall not constitute an offer to sell or the solicitation of an offer to buy nor may there be any sales of these securities in any state in which such offer, solicitation or sale would be unlawful before registration or qualification under the laws of any such state. We may elect to satisfy our obligation to deliver a Final Offering Circular by sending you a notice within two business days after the completion of our sale to you that contains the URL where the Final Offering Circular or the offering statement in which such Final Offering Circular was filed may be obtained.

WUND Healing BioPharmaceuticals, Inc.

8683 W. Sahara Avenue, Suite 280

 Las Vegas, NV 89117

(702) 800-0030 

www.wundbio.com

$10,000,000

$10.00 per Share

1,000,000 Shares,

Minimum Investment 500 Shares ($5,000)

This is the public offering of securities of WUND Healing BioPharmaceuticals, Inc., a Nevada Corporation. We are offering up to 1,000,000 shares of our common stock, par value $0.001 (“Common Stock”), at an offering price of $10.00 per share (the “Offered Shares” or “Shares”) by the Company, pursuant to Tier 2 of Regulation A of the United States Securities and Exchange Commission (the “SEC”).

This offering is being conducted on a “best-efforts” basis, which means that there is no minimum number of Shares that must be sold by us for this offering to close; thus, we may receive no or minimal proceeds from this offering. None of the proceeds received will be placed in an escrow or trust account. All proceeds from this offering will become immediately available to us and may be used as they are accepted. Purchasers of the Shares will not be entitled to a refund and could lose their entire investments.

We estimate that this offering will commence within two days of SEC qualification; this offering will terminate at the earliest of (a) the date on which the maximum offering has been sold, (b) one year from the date of SEC qualification, or (c) the date on which this offering is earlier terminated by us, in our sole discretion. See “Plan of Distribution”.

There is no minimum target for this offering and the Company may accept investor subscriptions on a rolling basis. After each acceptance of subscriptions, funds tendered by investors will be available to the Company for its use.

There is no public market for the Shares, provided that following the closing of this offering, the Company currently plans to apply for quotation on the OTCQB Market maintained by OTC Markets; however, there can be no assurance that we will obtain such quotation, or as to the level of trading that might occur if we do.

These securities are speculative securities. Investment in the Company’s stock involves significant risk. You should purchase these securities only if you can afford a complete loss of your investment. See the “Risk Factors” section on page 16 of this Offering Circular.

Subscriptions are irrevocable and the purchase price is non-refundable as expressly stated in this offering circular. The Company, by determination of the Board of Directors, in its sole discretion, may issue the Shares under this offering for cash, promissory notes, services, and/or other consideration without notice to subscribers. Any of the foregoing non-cash consideration received by the Company shall be valued according to the Note to Rule 251(a)(1) of Regulation A.

In the event that we become a reporting company under the Securities Exchange Act of 1934, we intend to take advantage of the provisions that relate to “Emerging Growth Companies” under the JOBS Act of 2012. See “Offering Circular Summary–Implications of Being an Emerging Growth Company.”

You should carefully consider the risk factors set forth under “Risk Factors”, beginning on page 16 of this offering circular before you make your decision to invest in our common stock.

The United States Securities and Exchange Commission does not pass upon the merits of or give its approval to any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering circular or other solicitation materials. These securities are offered pursuant to an exemption from registration with the Commission; however, the Commission has not made an independent determination that the securities offered are exempt from registration.

Generally, no sale may be made to you in this offering if the aggregate purchase price you pay is more than 10% of the greater of your annual income or net worth. Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(C) of Regulation A. For general information on investing, we encourage you to refer to www.investor.gov.

We are offering to sell, and seeking offers to buy, our shares only in jurisdictions where such offers and sales are permitted. You should rely only on the information contained in this offering circular. We have not authorized anyone to provide you with any information other than the information contained in this offering circular. The information contained in this offering circular is accurate only as of its date, regardless of the time of its delivery or of any sale or delivery of our Shares. Neither the delivery of this offering circular nor any sale or delivery of our Shares shall, under any circumstances, imply that there has been no change in our affairs since the date of this offering circular. This offering circular will be updated and made available for delivery to the extent required by the federal securities laws.

This offering circular follows the disclosure format of Form S-1, pursuant to the General Instructions of Part II(a)(1)(ii) of Form 1-A.

TABLE OF CONTENTS

ABOUT THIS OFFERING CIRCULAR

No dealer, salesperson or other individual has been authorized to give any information or to make any representation other than those contained in this offering circular in connection with the offer made by this offering circular and, if given or made, such information or representations must not be relied upon as having been authorized by us. This offering circular does not constitute an offer to sell or a solicitation of an offer to buy any securities in any jurisdiction in which such an offer or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so, or to any person to whom it is unlawful to make such offer or solicitation. Neither the delivery of this offering circular nor any sale made hereunder shall, under any circumstances, create any implication that there has been no change in our affairs or that information contained herein is correct as of any time subsequent to the date hereof.

For investors outside the United States: We and the placement agents have not done anything that would permit this offering or possession or distribution of this offering circular in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this offering circular must inform themselves, and observe any restrictions relating to, the offering of the Shares of our common stock and the distribution of this offering circular outside the United States.

Our logo and some of our trademarks and tradenames are used in this offering circular. This offering circular also includes trademarks, tradenames and service marks that are the property of others. Solely for convenience, trademarks, tradenames, and service marks referred to in this offering circular may appear without the ®, ™ and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

The market data and certain other statistical information used throughout this offering circular are based on independent industry publications, reports by market research firms or other independent sources that we believe to be reliable sources; however, we have not commissioned any of the market or survey data that is presented in this offering circular. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We are responsible for all of the disclosures contained in this offering circular, and we believe these industry publications and third-party research, surveys and studies are reliable. While we are not aware of any misstatements regarding any third-party information presented in this offering circular, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “Risk Factors” beginning on page 16 of this offering circular. These and other factors could cause our future performance to differ materially from our assumptions and estimates. Some market and other data included herein, as well as the data of competitors as they relate to WUND Healing BioPharmaceuticals, Inc., is also based on our good faith estimates.

The timelines, expected dates, and milestones discussed in this document, including anticipated investigational new drug filings, clinical studies, and other future events, are preliminary and subject to change. These timelines may be affected by numerous factors, including, without limitation, costs, economic conditions, outcomes of prior studies, feedback from regulatory authorities, and other factors outside our control and the control of Zhittya Genesis Medicine, Inc., who we have contracted with as discussed below. All information regarding such timelines, filings, and studies has been provided to us by Zhittya Genesis Medicine, Inc. and we have no control over such timelines or whether or not Zhittya Genesis Medicine, Inc. moves forward with any such currently planned filings, activities or studies. To the extent circumstances change, the projected timelines and expected dates described herein may not be met and may change significantly. Expected filings, including investigational new drug filings and other regulatory submissions, as well as clinical studies, may not occur as anticipated, and Zhittya Genesis Medicine, Inc. may experience delays or may be unable to obtain regulatory approval for its drug candidates. Such changes could have a material adverse effect on our business, financial condition, cash flows, prospects, and operations. Investors should not place undue reliance on any forward-looking information regarding expected timelines or future events described in this document.

Unless the context otherwise requires, references in this offering circular to “we,” “us,” “our,” the “Registrant”, the “Company,” “WUND” and “WUND Healing BioPharmaceuticals, Inc.” refer to WUND Healing BioPharmaceuticals, Inc.

In addition, unless the context otherwise requires and for the purposes of this offering circular:

INFORMATION REGARDING FORWARD-LOOKING STATEMENTS

We make forward-looking statements under the “Offering Circular Summary,” “Risk Factors,” “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other sections of this offering circular. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “should,” “would,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or “continue,” and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the numerous risks and uncertainties described under “Risk Factors.”

While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this offering circular describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Except as required by U.S. federal securities law, we are under no duty to update any of these forward-looking statements after the date of this offering circular to conform our prior statements to actual results or revised expectations, and we do not intend to do so.

Forward-looking statements include, but are not limited to, statements about:

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this offering circular may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this offering circular to conform these statements to actual results or to changes in our expectations.

You should read this offering circular and the documents that we reference in this offering circular and have filed with the Securities and Exchange Commission as exhibits to this offering circular with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

RISK FACTORS

An investment in our common stock involves a high degree of risk. Before making an investment decision, you should give careful consideration to the following risk factors, in addition to the other information included in this offering circular, including our financial statements and related notes, before deciding whether to invest in our securities. The occurrence of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects. You may lose all or part of your investment.

Risks Related to our Business

We will need to raise substantial additional investment capital, which may be unavailable to us or, if raised, will cause dilution of our existing investors and could place significant restrictions on our ability to operate.

Even upon the completion of this offering, we will still need to raise substantial additional equity or debt financing to provide sufficient capital required to fully execute our business plan and expand our operations. Disruptions in the financial markets in general and more recently due to trade wars and tariffs may make equity and debt financing more difficult to obtain and may have a material adverse effect on our ability to meet our fundraising needs. We do not currently have any arrangements or credit facilities in place as a source of funds, and there can be no assurance that we will be able to raise sufficient capital in this offering or additional capital on acceptable terms, if at all. If such financing is not available on satisfactory terms, or is not available, we may be required to delay, scale back, or eliminate the development of business opportunities and our operations and financial condition may be materially adversely affected. If we raise additional capital by issuing equity securities, the percentage ownership of our existing stockholders will be reduced, and these stockholders may experience substantial dilution. We may also issue equity securities that provide for rights, preferences, and privileges senior to those of our common stock. Debt financing, if obtained, may involve agreements that include liens on our assets and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, would increase our expenses and could require that our assets be provided as security for such debt. Debt financing would also be required to be repaid regardless of our operating results. There are no assurances that we will have sufficient funds to pay the debt off, or that we will not default on its debt. If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish some rights to our technologies or product candidates, or to grant licenses on terms that are not favorable to us. Funding from any source may be unavailable to us on acceptable terms, if at all. If we do not have sufficient capital to fund our operations and expenses, this could lead to the failure of our business and the loss of your investment.

Our business is dependent on Zhittya’s success in developing the drug candidates which we plan to sell, and we are restricted from undertaking any other business activities other than the marketing, and distribution of Zhittya’s products in the United States and Canada during the term of the License Agreement, and Zhittya’s failure to develop those drug candidates would materially and adversely affect our business.

Pursuant to the License Agreement with Zhittya, we may not engage in any business other than the promotion, marketing, and distribution of Zhittya’s products in the United States and Canada from the date of FDA approval of Zhittya’s first product through the end of the term of the License Agreement (through January 1, 2053, along with an additional automatic 30 year renewal term), subject to certain early termination rights in the License Agreement. In addition, we may not thereafter commercialize, promote, or support any third-party drug, treatment, or device that competes with any licensed use of Zhittya’s drugs. As a result, we will be solely dependent on Zhittya and Zhittya’s efforts to obtain FDA approval of its drug candidates for our other income/revenues and operations, and we will not have any control over such efforts.

We are entirely dependent on the success of Zhittya’s drug candidates, which are still under clinical development, and if any such drug candidates do not receive regulatory approval for any reason (including Zhittya’s inability to obtain the funding necessary for clinical trials or otherwise), our business may be materially adversely affected. Zhittya does not have any products that have gained regulatory approval in the U.S. and Canada. Zhittya plans to seek approval of its drug candidates with the U.S. FDA before pursuing approval in Canada. We cannot market and sell any of Zhittya’s products in the United States or Canada without Zhittya first obtaining regulatory approval from the FDA and Health Canada. The Company believes that the earliest possible timeframe in which FDA approval could be obtained, if at all, is approximately three to seven years. This estimate reflects a minimum projected period based on current assumptions and is subject to substantial uncertainty and numerous factors beyond the Company’s control, including the scope and outcomes of clinical trials, regulatory review timelines, requests for additional data, and changes in regulatory requirements. The actual time required to obtain FDA approval, if ever obtained, may be significantly longer than three to seven years or may not occur at all. As a result, our business is dependent on Zhittya’s ability to successfully complete clinical development of and obtain regulatory approval in a timely manner and we are planning our operations and capital needs accordingly, recognizing that FDA approval may be delayed for an extended period or may never be achieved. Before obtaining regulatory approvals for the commercial sale of Zhittya’s drug candidates for a target indication, Zhittya must demonstrate with substantial evidence gathered in clinical trials, generally including adequate and well-controlled clinical trials, and, with respect to approval in the United States, to the satisfaction of the FDA, that Zhittya’s drug candidates are safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate. Even if Zhittya’s drug candidates were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements, which may further materially adversely affect our business and other income/revenues, and may cause any investment in the Company to become worthless.

Zhittya has conducted, and may continue to conduct, human studies relating to neurological indications without first obtaining an IND authorization from the FDA.

Although Zhittya obtained Institutional Review Board approval, physician approval of the study protocol, and informed consent from participating patients, the FDA may determine that such studies that Zhittya has conducted without first obtaining an IND authorization from the FDA, should not have been conducted without an effective IND.

If the FDA were to conclude that Zhittya’s prior or future human studies violated applicable regulatory requirements, the FDA could refuse to accept, place a clinical hold on, delay, limit, or otherwise adversely affect one or more of Zhittya’s future IND applications. Any such action could significantly delay or prevent the development, regulatory approval, or commercialization of products based on Zhittya’s technology. In addition, the FDA could require additional preclinical or clinical studies, impose other regulatory sanctions, or take enforcement action against Zhittya.

If Zhittya is unable to obtain or maintain the regulatory approvals necessary to continue development of its products, the Company may be required to modify its business strategy, including seeking alternative development, licensing, marketing, or commercialization partners. Suitable alternative partners may not be available on acceptable terms, or at all, which could materially and adversely affect the Company's business, prospects, financial condition, and results of operations.

We are dependent on Zhittya’s ability to conduct clinical trials, which could delay or prevent development of certain licensed product candidates.

Our License Agreement with Zhittya provides that Zhittya is responsible for conducting development activities, including filing investigational new drug applications and conducting clinical trials for certain licensed product candidates.

However, the FDA has broad discretion in determining whether the data submitted in support of an IND are sufficient to permit a sponsor to proceed directly to a particular phase of clinical development. Zhittya may not have the right to reference all relevant third-party data, and publicly available information may be insufficient for FDA purposes. The FDA may require Zhittya to conduct additional Phase I clinical trials before permitting Phase II trials to begin, even if Zhittya believes such studies are unnecessary.

If the FDA requires additional studies, or if Zhittya is unable to successfully navigate the regulatory process, development of these product candidates could be significantly delayed, incur substantial additional costs, or be abandoned. Any such outcomes could materially and adversely affect our business, financial condition, results of operations, and prospects, including our ability to realize the potential value of our License Agreement with Zhittya.

Clinical development timelines are uncertain, and regulatory requirements could delay or prevent approval of licensed product candidates.

The timelines, expected dates, and milestones discussed in this offering circular, including anticipated IND filings, clinical studies, and other future events, are preliminary and subject to change. These timelines may be affected by numerous factors, including, without limitation, costs, economic conditions, outcomes of prior studies, feedback from regulatory authorities, and other factors outside our control and the control of Zhittya, who we have contracted with as discussed below. All information regarding such timelines, filings, and studies has been provided to us by Zhittya and we have no control over such timelines or whether or not Zhittya moves forward with any such currently planned filings, activities or studies. To the extent circumstances change, the projected timelines and expected dates described herein may not be met and may change significantly. Expected filings, including IND filings and other regulatory submissions, as well as clinical studies, may not occur as anticipated, and Zhittya may experience delays or may be unable to obtain regulatory approval for its drug candidates. Such changes could have a material adverse effect on our business, financial condition, cash flows, prospects, and operations. Investors should not place undue reliance on any forward-looking information regarding expected timelines or future events described in this offering circular.

Even if Zhittya successfully files INDs, the FDA may require additional data, including Phase I clinical trials, before allowing Phase II trials to commence. Regulatory review processes are inherently unpredictable, and the timing and outcome of FDA decisions cannot be assured. Any delays or additional requirements imposed by the FDA could increase development costs, slow the progress of clinical programs, or prevent the commercialization of certain licensed product candidates. Such delays or failures could materially and adversely affect our business, financial condition, results of operations, and prospects.

We depend entirely on the successful and timely production by Zhittya of its drug candidates.

We rely exclusively on Zhittya for the manufacture of its drug candidates, and our ability to generate other income/revenues depends on Zhittya’s ability to produce these drugs in sufficient quantities, on a timely basis, and in compliance with regulatory requirements. Zhittya currently manufactures its drug candidates through both a contract manufacturing organization (“CMO”) and its laboratory facilities in Reno, Nevada. The manufacture of biologics is inherently complex and involves specialized processes, including fermentation and purification steps, that are difficult to scale consistently and are subject to variability, contamination, and other technical challenges. Even minor deviations in the manufacturing process can result in production failures, batch losses, delays, or increased costs.

Furthermore, all facilities engaged in the manufacture of drug products must adhere to current good manufacturing practices (“cGMP”) and are subject to ongoing inspection and approval by the FDA and comparable foreign regulatory authorities. If Zhittya or its CMO fails to maintain compliance with cGMP requirements, experiences regulatory enforcement actions, or is unable to pass inspections, drug supply could be delayed, interrupted, or halted entirely. In addition, Zhittya’s reliance on a CMO exposes it to risks outside of its direct control, including the potential for supply chain disruptions, capacity constraints, quality failures, or termination of the manufacturing relationship.

Any further delay or inability by Zhittya to manufacture its drug candidates to appropriate quality standards, at sufficient scale, or in compliance with regulatory requirements could prevent or delay preclinical or clinical studies, regulatory submissions, and commercialization efforts, and would negatively affect our ability to generate revenue through the sale of Zhittya’s products. If Zhittya cannot produce its drug candidates in the quantities required and on acceptable terms, our business, financial condition, and results of operations could be materially and adversely affected.

We depend entirely on the successful and timely regulatory approval and development of Zhittya’s product candidates, and if Zhittya’s product candidates are unable to be successfully developed and/or fail to obtain regulatory approval, it would significantly harm our business.

We are currently dependent on Zhittya’s success in developing its product candidates and receiving regulatory approval. We have no control over the development of Zhittya’s product candidates or its ability to obtain regulatory approval. We entered into the License Agreement with Zhittya in 2016, knowing that it would take Zhittya some time to put its manufacturing capabilities in place, to submit INDs and hopefully obtain FDA approval of its drugs in development. However, since 2026, Zhittya has faced numerous unavoidable delays due to failures of its contracted manufacturers of FGF-1, and later in order to set up its own manufacturing facility, and, after much work, successfully producing its own FGF-1. In addition, COVID-19 slowed Zhittya’s development progress as well. We have no products currently approved for sale, and if Zhittya’s product candidates are unable to be successfully developed and/or fail to obtain regulatory approval or experience significant delays in doing so, we will not have available products to commercialize, which will significantly harm our business and other income/revenues, and may cause any investment in the Company to become worthless. Additionally, in the event Zhittya is further delayed in producing FGF-1, performing studies, submitting INDs, obtaining approval from the FDA of such INDs, and/or otherwise delayed further from obtaining FDA approval for FGF-1, which it anticipates will take at least three to seven years, our ability to generate cash flow and support our operations will be negatively affected, we may need to raise additional funds, and we may never be able to generate sufficient funds to support our operations.

Our revenue from operations may be lower than expected due to the tiered payment structure and other factors.

Under our License Agreement with Zhittya, revenues from certain clinical study or treatment operations are shared according to a tiered “waterfall” of Operating Profits. Operating Profit is defined as net revenues (gross revenues minus returns) minus all direct costs of commercialization, such as direct sales, marketing, product costs, and product support. Operating Profit does not include executive salaries or general corporate overhead that is not directly related to commercialization. The Company receives all of the fees generated on the first $3 million of Operating Profit (which totaled $2,047,793 as of March 31, 2026), 50% of Operating Profit between $3 million and $10 million, and only 20% of Operating Profit above $10 million. As operations grow and Operating Profit increases, the Company’s share of revenue decreases, which may result in lower-than-expected revenue over time, even if total activity increases.

In addition, the amount of revenue the Company receives depends on factors outside its control, including Zhittya’s management of operations, product availability, patient demand, and the timing and volume of participation from patients outside licensed territories. Any reductions in payments, whether due to the tiered structure or other factors, could materially and adversely affect the Company’s business, financial condition, results of operations, and prospects.

We will be required to purchase certain minimum quantities of drugs from Zhittya under the License Agreement. Zhittya may set certain minimum prices for products which we will not be able to exceed.

The License Agreement requires us to purchase certain minimum quantities of drugs from Zhittya and provides Zhittya the right to set the minimum sales price of products we sell under the License Agreement. In the event such minimum quantities are greater than the demand for the products purchased, or such minimum prices are greater than the amount customers are willing to pay, we may be unable to sell such products, such products may expire or become worthless, and we may not have sufficient funds to pay Zhittya for such purchased products. The occurrence of any of the above may have a material adverse effect on our operations and stock price.

Our business is dependent on our License Agreement with Zhittya, which provides us with the exclusive rights to commercialize and market Zhittya’s product candidates in the United States and Canada. Any breach, including non-payment of clinical progress and regulatory milestone payments when due, could lead to termination of the License Agreement. Any termination or loss of significant rights under the License Agreement would materially and adversely affect our business.

On May 17, 2016, we entered into the License Agreement with Zhittya which was amended on February 24, 2022 and amended and restated on December 21, 2022. Pursuant to the License Agreement, we obtained the exclusive right to market and sell drugs from Zhittya’s portfolio in the United States and Canada if the requisite regulatory approval is obtained, if ever. Zhittya plans to seek approval of its drug candidates with the U.S. FDA before pursuing approval in Canada. The Company believes that the earliest possible timeframe in which FDA approval could be obtained, if at all, is approximately three to seven years. This estimate reflects a minimum projected period based on current assumptions and is subject to substantial uncertainty and numerous factors beyond the Company’s control, including the scope and outcomes of clinical trials, regulatory review timelines, requests for additional data, and changes in regulatory requirements. The actual time required to obtain FDA approval, if ever obtained, may be significantly longer than three to seven years or may not occur at all. The Company is planning its operations and capital needs accordingly, recognizing that FDA approval may be delayed for an extended period or may never be achieved. The License Agreement may be terminated by Zhittya in the event a breach by us, including non-payment of clinical progress and regulatory milestone payments when due, is not cured within thirty days, and/or if we seek bankruptcy protection or are brought into involuntary bankruptcy proceedings, subject to certain limited cure rights. If the License Agreement were to be terminated by Zhittya upon a breach by us, we would lose our most significant asset and would no longer be able to commercialize and market Zhittya’s product candidates, which would have a material adverse effect on our operations as we do not anticipate having any additional method of generating revenue at that time, and would likely force us to cease operations and possibly seek bankruptcy protection. The termination of the License Agreement could also cause the value of our common stock to become worthless.

The License Agreement is not assignable by us without Zhittya’s consent.

The License Agreement provides that it is not assignable without Zhittya’s written consent. Such prohibition on assignment may prohibit our ability to monetize the license provided by the License Agreement, prevent a change of control or business combination which would otherwise be favorable to stockholders.

We are currently dependent on revenues derived from U.S. and Canadian patients traveling to foreign clinics to be treated with Zhittya’s drug candidates and on patient sponsored studies relating to Type 2 Diabetes taking place in the United States and in the event the number of such patients declines in the future or stops, our other income/revenues will be materially affected.

Currently, and until such time, if ever, as Zhittya’s drug candidates obtain FDA and/or Canada Health approval in the United States and Canada, respectively, our sole income comes from, and is expected to come from, U.S. and Canadian patients traveling to foreign clinics to be treated with Zhittya’s drug candidates and on a patient sponsored study relating to Type 2 diabetes taking place in Las Vegas, Nevada. Any decline in the number U.S. or Canadian patients willing or able to travel to other jurisdictions to be treated with Zhittya’s drug candidates, whether due to (1) increases in the cost of travel; (2) travel restrictions, including as a result of pandemics or epidemics, terrorism or immigration policies; (3) inflation; (4) trade wars; (5) reduction in the volume of, or effectiveness of, Zhittya’s marketing efforts; (6) alternative and more widely available drugs, or other events, or any declines in the number of patients in the U.S. who are willing to pay to participate in Zhittya’s Type 2 diabetes study, whether due to the cost of such study, alternative available drugs or otherwise, could cause our other income/revenues to decline significantly. Currently, Zhittya primarily uses Google to market its services to patients and in the event Google prohibited the use of its services by Zhittya, raised its pricing significantly or ceased or modified such services, it could have a material adverse effect on the number of U.S. and Canadian citizens travelling to other jurisdictions to be treated with Zhittya’s drug candidates and/or who are willing to pay to participate in Zhittya’s Type 2 diabetes study taking place in Las Vegas, Nevada, and in turn our other income/revenues. Additionally, we and Zhittya are reliant on such alternative jurisdictions continuing to allow Zhittya to treat patients using its drug candidates, and in the future such jurisdictions could limit or prevent Zhittya’s ability to treat patients, which in turn would reduce our other income/revenues and ability to generate other income/revenues. We have no control over Zhittya’s marketing efforts or expenditures.

We may not be able to satisfy certain contractual clinical progress and regulatory milestone obligations and the satisfaction of such milestone obligations may have a material adverse effect on our cash flows and ability to support our operations.

Pursuant to the License Agreement with Zhittya, we are contractually obligated to remit certain clinical progress and regulatory milestone payments to Zhittya upon the occurrence of various events during clinical development and the FDA approval process of Zhittya’s products. The milestone payments for wound healing drugs range from $100,000 to $10,000,000 and will not exceed $75,000,000 in total for the entire class of wound healing drugs. The milestone payments for injectable and infusion drugs range from $100,000 to $25,000,000 and will not exceed $300,000,000 in total for the entire class of injectable/infusion/intranasal drugs. No milestone payments are currently due, and it is anticipated that it will be over 18 months before a milestone is reached and it will be paid out of profits or we will need to raise significant additional capital to make such milestone payments. There can be no assurance that we will raise sufficient capital to pay the milestone payments, or complete the offering at all, thus potentially causing a material adverse effect on our business.

Our results of operations will be affected by the level of clinical progress and regulatory milestone payments that we are required to pay to Zhittya, the royalty and other payments we are required to pay to Zhittya or other royalty payments to third parties.

We are a party to the License Agreement which requires us to remit milestone payments related to certain Zhittya product candidates that we may decide to market and sell. The milestone payments for wound healing drug candidates range from $100,000 to $10,000,000 and will not exceed $75,000,000 in aggregate for the entire class of wound healing drugs. The clinical progress and regulatory milestone payments for injectable and infusion drug candidates range from $100,000 to $25,000,000 and will not exceed $300,000,000 in aggregate for the entire class of injectable/infusion/intranasal drugs. Any cross-border operations are also subject to the payment of the following fees for such use of the products; (a) no fee on the first $3 million of cross-border Operating Profit; (b) A fee equal to 50% of the Company’s portion of Operating Profit from $3 million to $10 million; and (c) a fee equal to 80% of the Company’s fee on Operating Profit above $10 million. We have also agreed to pay Zhittya royalties based on the future sale of licensed products of 50% for topical drugs and 80% for injection/infusion/intranasal drugs. Any failure on our part to pay milestone payments, of which none are currently due, or other amounts due to Zhittya could lead to us losing rights under our license and could thereby adversely affect our business. If product sales increase, we may, from time-to-time, disagree with Zhittya as to the appropriate royalties owed and the resolution of such disputes may be costly and may consume management’s time. Furthermore, we may enter into additional license agreements in the future once the term of the License Agreement has expired, which may also include royalty payments.

The regulatory history of the Chief Executive Officer of Zhittya, with whom we rely substantially for our revenues and prospects, may adversely affect our business, reputation, and ability to execute our business plan.

From 1981 until 2004, Mr. Daniel C. Montano, the Chief Executive Officer of Zhittya, was a member of the Board of Directors of Helen of Troy, Ltd, a corporation whose shares are publicly traded. Mr. Montano also ran Montano Securities and was its president from 1985 to 1995. In 1992, Mr. Montano agreed to the SEC issuing an order against him and Gold Properties Restoration Co., a company which he served as Chairman of the Board and Chief Executive Officer of (“Gold Properties”), providing for Mr. Montano and the entity to cease-and-desist from violating Sections 5(b)(1) and 17(a)(2) and (3) of the Securities Act. The order contained findings that Gold Properties and Mr. Montano violated Section 17(a)(2) and (3) by disseminating materially false and misleading statements contained in promotional materials that were used in connection with Gold Properties' private placement during the fall of 1990 through the spring of 1991 and an initial public offering of securities filed with the Commission on February 1, 1991. The Order also contained findings that Gold Properties and Montano violated Section 5(b) (1) of the Securities Act by engaging in various activities, which constituted offers to sell Gold Properties common stock, that were undertaken in connection with Gold Properties’ initial public offering. Mr. Montano was also sanctioned by the Massachusetts Securities Division in 1993 and the Missouri Secretary of State in 1996. In connection with matters that occurred in 1994, Mr. Montano agreed in 1997 to a settlement with the National Association of Securities Dealers, Inc. (NASD) pursuant to which he was fined $102,500 and suspended by the NASD from associating with any NASD members for a period of two years. Mr. Montano consented to the findings that he had engaged in a course of conduct that resulted in the mishandling or misuse by his firm, Montano Securities Corporation, of funds entrusted to it by applicants to the company. Montano Securities Corporation was also found to have carried out securities transactions without maintaining sufficient net capital. In May 1998, the NASD suspended Mr. Montano’s registration as a registered securities broker for an unspecified time due to his failure to pay an arbitration award. In July 1998, the SEC entered an order affirming a decision by the NASD that Mr. Montano was found to have violated certain rules of the NASD, including not accurately and sufficiently discussing the mechanism of short-selling or the risks associated with implementing the strategy using a particular stock, making improper references to prior recommendations, making exaggerated and inappropriate presentations of prior recommendations and making improper projections.

Although the enforcement actions did not involve Zhittya or our Company and occurred prior to our relationship with Zhittya, investors, business partners, regulators, prospective customers, and other stakeholders may nevertheless view these matters negatively. Such perceptions could adversely affect the reputation and credibility of Zhittya and, by extension, our Company, impair our ability to attract investors, strategic partners, customers, or financing, increase regulatory scrutiny, and negatively impact the market's perception of our business. Because we are substantially dependent on the License Agreement and Zhittya, any adverse impact on Zhittya or its management could materially and adversely affect our business, financial condition, results of operations, and prospects.

Having only recently commenced operations, we are a development stage business and subject to the many risks associated with new businesses.

The Company was incorporated in May 2016. Accordingly, we have only a limited history by which you can assess our prospects. Consequently, any predictions about our future success, performance or viability may not be as accurate as they could be if we had a longer operating history or an approved product on the market. In addition, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in the drug development and marketing field. We are, and expect for the foreseeable future to be, subject to all the same risks and uncertainties inherent in a new business enterprise and in the further development of our technology. No assurances can be given as to our ability to operate profitably. If we do not generate positive cash flow in the future and hence become profitable, we may not be able to remain in business.

Having only recently commenced operations, our ability to operate successfully is materially uncertain and our operations and prospects are subject to all risks inherent in a developing business enterprise. In investing in this offering, potential investors should be aware of the difficulties normally encountered by early-revenue, development stage companies and the high rate of failure of such enterprises. The likelihood of our viability and potential for revenue and profit generation must be considered in light of the significant problems, expenses, difficulties, complications, and delays that may be encountered. These potential problems and uncertainties include, but are not limited to:

There can be no assurance that we will be able to successfully address these and other challenges with which we may be confronted. If our efforts are unsuccessful, our business, financial condition, and operating results could be materially and adversely affected, in which case our value could be negatively impacted and you could lose all or a part of your investment.

Our financial situation creates doubt about whether we will continue as a going concern.

The Company was incorporated on May 16, 2016. The Company’s sole source of income is the other income received from Zhittya. As of March 31, 2026, we had a total stockholders’ deficit of $(814,712), an accumulated deficit of $125,144,816, and negative working capital of $1,010,091. As of December 31, 2025, we had a total stockholders’ deficit of $(1,125,680), an accumulated deficit of $125,452,659, and negative working capital of $1,272,378. The large accumulated deficit is mainly the result of the original 2016 license agreement with Zhittya valued at $76.5 million, as discussed in greater detail below under “Business—License Agreement with Zhittya”, that was fully written off by 2022 under a revised valuation. Another $46.5 million in expenses is related to the value of the preferred stock issued to Zhittya pursuant to the terms of the License Agreement. These two items, combined, equal $123 million of the accumulated deficit and do not reflect the results of ongoing operations. From 2023 to 2025, the Company has generated net income every year, with cumulative income of $251,597 over these three years, and net income for the three months ended March 31, 2026 of $307,844.

There can be no assurance that we will be able to achieve a level of income adequate to generate sufficient cash flow from operations or obtain funding from this offering or additional financing through private placements, public offerings, and/or bank financing necessary to support our working capital requirements. To the extent that funds generated from any private placements, public offerings, and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment. These conditions raise substantial doubt about our ability to continue as a going concern.

Zhittya faces substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than Zhittya does.

The commercialization of drugs is highly competitive. More established companies may have a competitive advantage over Zhittya due to their greater size, cash flows, and institutional experience. Compared to Zhittya, many of Zhittya’s competitors may have significantly greater financial, technical, and human resources. As a result of these factors, Zhittya’s competitors may have an advantage in marketing their approved products and may obtain regulatory approval of their product candidates before Zhittya is able to, which may limit Zhittya’s ability to develop or commercialize product candidates, and in turn limit our ability to sell such products under the License Agreement. Our competitors may also be more successful than us in marketing their products.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of Zhittya’s and our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies compete with Zhittya in recruiting and retaining qualified scientific, management, and commercial personnel, complementary to, or necessary for, Zhittya’s operations.

Zhittya’s product candidates for which it intends to seek approval may face competition sooner than anticipated.

The enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) created an abbreviated regulatory pathway for the approval of products demonstrated to be biosimilar, or “highly similar,” to or “interchangeable” with an FDA-approved innovator (original) biologic product. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing reference product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product is approved under a biologics license application (“BLA”). Although the FDA has approved 86 biosimilar products as of May 15, 2026 (according to fda.gov), complex provisions of the law are still being interpreted and implemented by the FDA. As a result, the ultimate impact, implementation, and meaning of the BPCIA are still subject to some uncertainty and FDA actions and court decisions concerning the law could have a material adverse effect on the future commercial prospects for Zhittya’s biological products.

We believe that, if any of Zhittya’s product candidates are approved as a biological product under a BLA, it should qualify for the 12-year period of exclusivity. However, there is a risk that the FDA could approve biosimilar applicants for other reference products that no longer have such exclusivity, thus potentially creating the opportunity for greater competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of Zhittya’s referenced product candidates in a way that is similar to traditional generic substitution for non-biological products is not yet clear and will depend on a number of marketplace and regulatory factors that are still developing.

There are no substantial barriers to entry into the industry and Zhittya has not obtained any registered intellectual property protection for its product candidates. There is no guarantee someone else will not duplicate its ideas and bring them to market before Zhittya does, which could severely limit our anticipated sales and other income/revenues. If we cannot generate sales and other income/revenues, it could result in the loss of your investment.

Since Zhittya’s product candidates have no registered intellectual property protection, unauthorized persons may attempt to copy aspects of its business, including its product design, functionality or marketing materials. Any encroachment upon Zhittya’s corporate information, including the unauthorized use of its brand name, the use of a similar name by a competing company or a lawsuit initiated against it for infringement upon another company’s proprietary information or improper use of their copyright, may affect its ability to create brand name recognition, cause customer confusion, and/or have a detrimental effect on its business. Litigation or proceedings before the U.S. or international patent and trademark offices may be necessary in the future to enforce Zhittya’s registered intellectual property rights, to protect its trade secrets and domain name and/or to determine the validity and scope of the proprietary rights of others. Any such infringement, litigation, or adverse proceeding could result in substantial costs and diversion of resources and could seriously harm its and our business operations and/or results of operations. As a result, an investor could lose his or her entire investment.

Our ability to sell and market licensed product candidates depends on Zhittya’s intellectual property, which is currently limited to provisional patents and has not been registered with any governmental authority.

Zhittya initially filed five provisional patent applications with the U.S. Patent and Trademark Office in 2025 relating to the use of FGF-1 to treat various diseases, including Parkinson’s disease, neurodegenerative diseases of the brain, Type 2 diabetes, lung damage, and neuropathy. Zhittya subsequently filed corresponding non-provisional patent applications based on those provisional filings. The patent applications are intended to protect Zhittya’s intellectual property relating to the therapeutic use of FGF-1 and, if issued as patents, may provide the Company with exclusive rights to the claimed inventions for the applicable patent term, subject to the requirements and limitations of U.S. patent law.

Because we rely on our license from Zhittya to sell and market these products, our ability to protect the licensed products from competition depends entirely on Zhittya’s decisions regarding patent filings and prosecution. If Zhittya does not file non-provisional patent applications, or if such applications are not granted, competitors could make, use, sell, or market the same or similar products, which could materially and adversely affect our business, financial condition, results of operations, and prospects.

The product candidates that we plan to market may fail if Zhittya is not able to successfully commercialize them and we may not ultimately generate significant other income/revenues as a result.

Difficulties often encountered in scaling up production include problems involving production yields, quality control and assurance, shortage of qualified personnel, production costs, and process controls. In addition, the drugs we plan to market under the License Agreement will be subject to inherent risks associated with new technologies and products. These risks include the possibility that any of the product candidates we market may:

We will need to license new modifications to the products and treatments that Zhittya develops under substantially the same terms as the License Agreement.

In the event that Zhittya develops or otherwise acquires any modification of its drug candidate, FGF-1, which has been shown in a clinical trial to grow small blood vessels in the ischemic areas of the heart and has been shown in trials to reduce anginal pain, or updates the formulation of the products that are licensed to us, such modifications will be the sole and exclusive property of Zhittya. The License Agreement grants us the right to become Zhittya’s exclusive licensee in the United States and Canada for such modifications under a new license agreement, which is expected to have substantially the same terms as the current License Agreement. There can be no assurance that those terms will be favorable to us under the circumstances. We estimate that with respect to any future modifications to the FGF-1 molecule it will take Zhittya at least seven years, if not longer, to develop and acquire all necessary regulatory approval to go to market, which regulatory approvals may not be received, and as such, we do not anticipate a new product release to overlap with the term of the License Agreement during which substantially same terms are required for modifications. However, our estimation may not be accurate and we may need to enter into such additional license agreements sooner.

We are generating revenue, but it may not be sustainable or enough to cover operating losses and may not be at the volume that we expect in the future.

We are generating revenue from patients who live in our licensed territory (the United States and Canda) and are traveling to other territories to be treated by Zhittya and from a patient supported study on Type 2 diabetes taking place in Las Vegas, Nevada; however, that revenue may not be sustainable in the long term. Zhittya’s efforts to find patients might become ineffective or the governments where the clinics reside might revoke their approval. We are a sales and marketing company with a limited operating history. To date, we have invested substantially all of our efforts in the commercial planning for Zhittya’s drug candidates. We have not generated any revenue from sales in the U.S. and Canadian markets to date, as Zhittya’s drug candidates are still in development. We have a limited operating history upon which to evaluate our business and prospects. Consequently, any predictions about our future success, performance, or viability may not be as accurate as they could be if we had a longer operating history or approved products on the market. Because of the various risks and uncertainties associated with developing, obtaining regulatory approvals for, and marketing new products, we are unable to predict with any certainty the extent of any future other income/revenues, cash flows, profits, or losses.

We hope to continue generating enough other income to cover our operating expenses, as our activities have consisted primarily of developing our marketing strategies. As a result, for the years ended December 31, 2025, and 2024, we recorded net income of $91,510 and $97,039, respectively, and for the three months ended March 31, 2026, we generated net income of $307,844. To date, we have financed our operations primarily through preferred stock financings, loans from related parties, sales of common stock and other income generated through our agreement with Zhittya. We have devoted substantially all of our financial resources to general and administrative expenses associated with our operations.

Following this offering, we expect that our operating expenses will continue to increase as we (i) build our commercial infrastructure, (ii) develop, enhance, and begin to commercialize, if FDA approved, Zhittya’s product candidates in the United States and Canada thereafter, (iii) make clinical progress and regulatory milestone payments to Zhittya, and (iv) incur additional operational costs associated with being a public company. For example, in anticipation of Zhittya potentially receiving FDA approval to support the commercial launch of its product candidates in the United States (not expected for 3 to 7 years) and later in Canada as Zhittya uses the data from the U.S. approval to seek approval in that market, we might need to grow our sales force over time and the number of our sales representatives at commercial launch will vary and may be higher depending on the duration of the pre-market approval review process. If Zhittya is delayed in obtaining approval of its product candidates by the FDA, we may be required to offer increased compensation to our U.S. sales team to retain them, which would further increase our operational costs. As a result, we expect to continue to incur operating losses for the foreseeable future. Our expected future operating losses, combined with our prior operating losses, may adversely affect the market price of our common stock and our ability to raise capital and continue operations.

If approved by the FDA, we expect that sales of Zhittya’s product candidates will account for the substantial majority of our future revenue. If Zhittya’s product candidates do not achieve an adequate level of acceptance by physicians, health care payors, and patients, and does not receive adequate reimbursement from third party payors, we may not generate sufficient revenue and we may not be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability in subsequent periods or on an ongoing basis. If we do not achieve or sustain profitability, it will be more difficult for us to finance our business and accomplish our strategic objectives, either of which would have a material and adverse effect on our business, financial condition, and results of operations and cause the market price of our common stock to decline.

Customers may not adopt the products we market quickly or at all.

Customers in the sector in which we operate can be generally cautious in their adoption of new products. In addition, given the relative novelty of our future planned products to be marketed, customers of those products may require education regarding their utility and use, which may delay their adoption. There can be no assurance that customers will adopt the products we sell in the future quickly, or at all.

If Zhittya’s product candidates or any of our future product candidates are approved for marketing, and we are found to have improperly promoted off-label uses, or if physicians misuse the products we sell or use the products off-label, we may become subject to prohibitions on the sale or marketing of its products, significant fines, penalties, sanctions, or product liability claims, and our image and reputation within the industry and marketplace could be harmed.

The FDA and other regulatory agencies strictly regulate the marketing and promotional claims that are made about pharmaceutical products, such as Zhittya’s product candidates, if approved. In particular, a product may not be promoted for uses or indications that are not approved by the FDA or other similar regulatory authorities as reflected in the product’s approved labeling. If Zhittya receives marketing approval for Zhittya’s product candidates such as for the treatment of foot ulcers, which is one indication that Zhittya is pursuing, physicians could use Zhittya’s product candidates on their patients in a manner that is inconsistent with the approved label, potentially including for the treatment of other aesthetic or therapeutic indications. If we are found to have promoted such off-label uses, we may receive warning letters and be subject to other enforcement actions from the FDA, Health Canada and other regulatory agencies, and become subject to significant liability, which would materially harm our business. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would materially harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred, and our reputation could be damaged. The FDA has also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed in order to resolve FDA enforcement actions. If we are deemed by the FDA to have engaged in the promotion of products for off-label use, we could be subject to FDA prohibitions or other restrictions on the sale or marketing of products and other operations or significant fines and penalties, and the imposition of these sanctions could also affect our reputation and position within the industry.

Physicians may also misuse Zhittya’s product candidates or any future product candidates, if approved, or use improper techniques, potentially leading to adverse results, side effects or injury, which may lead to product liability claims. If Zhittya’s product candidates or any future product candidates, if approved, are misused or used with improper techniques or are determined to cause or contribute to consumer harm, we may become subject to costly litigation by our customers or their patients. Product liability claims could divert management’s attention from our core business, be expensive to defend, result in sizable damage awards against us that may not be covered by insurance and subject us to negative publicity resulting in reduced sales of our marketed products. Furthermore, the use of Zhittya’s product candidates or any future product candidates, if approved, for indications other than those cleared by the FDA may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and consumers. Any of these events could harm our business and results of operations and cause our stock price to decline.

Zhittya’s product candidates or any of its future product candidates may cause serious or undesirable side effects or possess other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of approved labeling, or result in post-approval regulatory action.

Unforeseen side effects from Zhittya’s product candidates or future product candidates marketed by us could arise either during clinical development or, if approved, after marketing such product. Undesirable side effects caused by product candidates could cause us or regulatory authorities to interrupt, modify, delay, or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, Health Canada, or similar regulatory authorities. Results of clinical trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, trials could be suspended or terminated and the FDA, Health Canada, or similar regulatory authorities could order us to cease further development of or deny approval of product candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in product liability claims. Any of these occurrences may harm our business, financial condition, operating results, and prospects.

Additionally, if we or others identify undesirable side effects, or other previously unknown problems, caused by Zhittya’s product candidates, or any of our future product candidates, after obtaining regulatory approval in the United States, Canada or other jurisdictions, a number of potentially negative consequences could result, including:

Any of the above events could prevent us from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing such products. The demand for any such product candidates could also be negatively impacted by any adverse effects of a competitor’s product or treatment.

The significant level of competition for the product candidates that we market may result in pricing pressure, reduced margins, or the inability of our future product to achieve market acceptance.

The industry for the products we plan to market and sell is intensely competitive and rapidly changing. We may be unable to compete successfully, which may result in price reductions, reduced margins, and the inability to achieve market acceptance for the Zhittya’s products that we sell.

Our competitors may have longer operating histories, significantly greater resources, greater brand recognition than we do, and large customer bases. As a result, they may be able to devote greater resources to the manufacture, promotion, or sale of their products, receive greater resources and support from market partners and independent distributors, initiate or withstand substantial price competition, or more readily take advantage of acquisition or other opportunities.

Unsuccessful pre-clinical development and future Clinical Phase I/II studies for the product candidates for which we plan to market will have a material adverse effect on our business.

The successful completion of pre-clinical development and multiple clinical trials is critical to the success of the product candidates we plan to market and sell. If the pre-clinical development and clinical trials are unsuccessful or produce inconsistent results or unanticipated adverse side effects, such product candidates could be delayed and as a result Zhittya may be unable to successfully commercialize them.

The loss of our management team or other key personnel would have an adverse impact on our future development and impair our ability to succeed.

In the early stages of development, our business will be significantly dependent on our management team and other key personnel. Our success will be particularly dependent upon John Laub, our Chief Executive Officer. The loss of Mr. Laub or any other future key personnel could have a material adverse effect on us and our ability to further execute our intended business. The replacement of any of our key personnel would likely involve significant time and costs and may significantly delay or prevent the achievement of our business objectives, which could have an adverse effect on our business. In addition, we do not carry any “key person” insurance policies that could offset potential loss of service under applicable circumstances.

Our independent contractors, consultants, commercial collaborators, principal investigators, vendors, and other agents may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk that our independent contractors, consultants, commercial collaborators, principal investigators, vendors, and other agents may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless, and/or negligent conduct or disclosure of unauthorized activities to us that violates applicable regulations, including those laws requiring the reporting of true, complete, and accurate information to regulatory agencies, manufacturing standards, and federal and state healthcare laws and regulations. In particular, sales, marketing, and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing, and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing, and promotion, sales commissions, referrals, customer incentive programs, and other business arrangements. Misconduct by these parties could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. The precautions we take to detect and prevent misconduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal, and administrative penalties, including, without limitation, damages, fines, disgorgement, imprisonment, and the curtailment or restructuring of our operations.

We plan to rely on third-party distribution partners for the distribution of Zhittya’s products, product candidates, and services, which could delay or limit our ability to generate revenue.

With respect to certain markets for Zhittya’s product candidates and services, we plan to retain third-party service providers to perform functions related to the marketing, distribution, and sale of Zhittya’s product candidates and any future product candidates. Key aspects of those functions may be out of our direct control, including regulatory compliance, warehousing, and inventory management, distribution, contract administration, accounts receivable management, and call center management. Any future distribution partners may hold significant control over important aspects of the commercialization of Zhittya’s product candidates, including market identification, regulatory compliance, marketing methods, pricing, composition of sales force, and promotional activities.

We may not be able to control the amount and timing of resources that any future third-party distribution partners may devote to Zhittya’s product candidates, or prevent any third-party from pursuing the development of alternative technologies or products that compete with Zhittya’s products, except to the extent our contractual arrangements protect us against such activities. Also, we may not be able to prevent any other third-party from withdrawing its support of Zhittya’s products.

If third-party service providers fail to comply with applicable laws and regulations, fail to meet expected deadlines, encounter natural or other disasters at their facilities, or otherwise fail to perform their services to us in a satisfactory or predicted manner, or at all, our ability to deliver products to meet commercial demand could be significantly impaired. In addition, we may use third parties to perform various other services for us relating to sample accountability and regulatory monitoring, including adverse event reporting, safety database management, and other product maintenance services. If the quality or accuracy of the data maintained by these service providers is insufficient, our ability to continue to market Zhittya’s products could be jeopardized or we could be subject to regulatory sanctions, and any indemnity we may receive from such third-party service providers could be limited by such provider’s ability to pay and otherwise may not be sufficient to cover all losses we may experience.

We will need to increase the size of our organization, and we may experience difficulties in managing this growth.

As of June 1, 2026, we had no employees. Our chief executive officer (CEO) and chief financial officer (CFO) are independent contractors, who work approximately 40 hours per week for us. We will need to expand our managerial, operational, finance, and other resources to manage our operations and to commercialize Zhittya’s product candidates. Our management and personnel, systems, and facilities currently in place may not be adequate to support this future growth. Our need to effectively execute our growth strategy requires that we:

Due to our limited financial resources and our limited experience in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our development and strategic objectives or disrupt our operations.

If we are not able to attract and retain highly skilled employees and contractors, we may not be able to implement our business model successfully.

We will rely upon consultants/contractors to effectively establish, manage, and grow our business, until such time as we begin hiring employees. We currently rely upon our management team, who work for us as independent contractors. Consequently, we believe that our future viability will depend largely on our ability to attract and retain highly skilled personnel. In order to do so, we may need to pay higher compensation, fees, and/or other incentives to our employees or consultants than we currently expect and such higher compensation payments would have a negative effect on our operating results. Competition for experienced, high-quality employees, consultants, and contractors is intense and we cannot assure that we will be able to recruit and retain such personnel. We may not be able to hire or retain the necessary personnel to implement our business strategy. Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business effectively.

Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability, which could adversely affect our business and our reputation.

In the ordinary course of business, we expect to collect and store sensitive data, including legally protected patient health information, credit card information, personally identifiable information about our employees, intellectual property, and proprietary business information. The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we plan to take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches or interruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. We have measures in place that are designed to prevent, and if necessary, to detect and respond to such security incidents and breaches of privacy and security mandates. However, in the future, any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act (“HIPAA”) and European Union General Data Protection Regulation (“GDPR”), government enforcement actions and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process samples, provide test results, share and monitor safety data, bill payors or patients, provide customer support services, conduct research and development activities, process and prepare company financial information, manage various general and administrative aspects of our business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.

Risks Related to Government Regulation

The use of the product candidates we market may be limited by regulations, and we may be exposed to product liability and remediation claims.

The use of the product candidates we market may be regulated by various local, state, federal, and foreign regulators. Even if we are able to comply with all such regulations and obtain all necessary registrations, we cannot provide assurance that our future products will not cause injury to the environment, people or animals, and/or otherwise have unintended adverse consequences, under all circumstances. For example, the product candidates may be improperly combined with other chemicals or, even when properly combined, Zhittya’s product candidates may be blamed for damage caused by those other chemicals. The costs of remediation or products liability could materially adversely affect our results, financial condition, and operations.

We may be held liable for, or incur costs to settle, liability and remediation claims if any products we market cause injury or are found unsuitable during product testing, manufacturing, sale, or use. These risks exist even with respect to product candidates that have received, or may in the future receive, regulatory approval, registration, or clearance for commercial use. We cannot guarantee that we will be able to avoid product liability exposure.

When at the stage customary to do so, we expect to maintain product liability insurance at levels we believe are sufficient and consistent with industry standards for like companies and products. However, we cannot guarantee that our product liability insurance will be sufficient to help us avoid product liability-related losses. In the future, it is possible that meaningful insurance coverage may not be available on commercially reasonable terms or at all. In addition, a product liability claim could result in liability to us greater than our assets or insurance coverage. Moreover, even if we have adequate insurance coverage, product liability claims or recalls could result in negative publicity or force us to devote significant time and attention to these matters, which could harm our business.

Product liability claims may be brought against us by patients, healthcare providers, or others selling or otherwise coming into contact with the products we market and commercialize. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities and reputational harm. In addition, regardless of merit or eventual outcome, product liability claims may result in:

While we may attempt to manage our product liability exposure by proactively recalling or withdrawing from the market any defective products, any recall or market withdrawal of Zhittya’s products may delay the supply to our customers and may impact our reputation. We may not be successful in initiating appropriate market recall or market withdrawal efforts that may be required in the future and these efforts may not have the intended effect of preventing product malfunctions and the accompanying product liability that may result. Such recalls and withdrawals may also be used by our competitors to harm our reputation for safety or be perceived by patients as a safety risk when considering the use of the products we market, either of which could have a material adverse effect on our business, financial condition, and results of operations.

Although we plan to have product liability insurance that we believe is appropriate, this insurance is subject to deductibles and coverage limitations. Product liability insurance may not be available to us on acceptable terms, if at all, and, if available, coverage may not be adequate to protect us against any future product liability claims. If we are unable to obtain insurance at an acceptable cost or on acceptable terms or otherwise protect against potential product liability claims, we could be exposed to significant liabilities. A product liability claim, recall, or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect on our business, financial condition, and results of operations.

Our inability to comply with ongoing and changing regulatory requirements could delay or prevent sales of the product candidates we are marketing.

The testing, manufacture, sale, and use of the product candidates we market will be regulated by government agencies in the United States, and abroad. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and the products we plan to market. Any new statutes, regulations, or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of or make it more difficult to obtain approval to, manufacture, market, or distribute products we plan to market. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require: additional testing prior to obtaining clearance or approval for future product candidates, changes to manufacturing methods, recall, replacement, or discontinuance of future product candidates, or additional record keeping. These regulations substantially increase the time and cost associated with bringing future products to market. If the third-party manufacturers who develop the products that we market do not receive the necessary governmental approvals to test, or manufacture the products we plan to market, or if regulatory authorities revoke their approvals, do not grant approvals in a timely manner or grant approvals subject to restrictions on their use, we may be unable to sell these products in the United States or other jurisdictions, which could adversely affect our results and operations.

There can be no assurance that Zhittya will be able to obtain regulatory approval for marketing technologies, products, and applications it may develop. Because many of the products that may be sold by us must be registered with one or more government agencies, the registration process can be time consuming and expensive, and there is no guarantee that the product will obtain all needed registrations.

Even if Zhittya obtains all necessary regulatory approvals to market and sell products we license, they will be subject to continuing review and extensive regulatory requirements, including periodic re-registrations. Regulatory authorities could withdraw a previously approved product from the market upon receipt of newly discovered information, including an inability to comply with regulatory requirements or the occurrence of unanticipated problems with Zhittya’s products, or for other reasons.

The regulatory approval process is expensive, time-consuming, and uncertain and may prevent us from obtaining approvals for the commercialization of our future product candidates, if any.

The labeling, approval, selling, marketing and distribution of health and life-science related product candidates are subject to extensive regulation, which regulations differ from country to country.

In connection with the development of any marketing and distribution for product candidates that qualify as biopharmaceuticals, we will not be permitted to market them in the United States or other regions until Zhittya receives approval to do so by the appropriate regulatory agencies in the United States (which we don’t expect for 3-7 years) and later in Canada, of which Zhittya is under no obligation to have products approved in the United States or Canada. We have not submitted an application or premarket notification for or received marketing clearance or approval for any of Zhittya’s product candidates. Obtaining approval of any premarket approval can be a lengthy, expensive, and uncertain process. There is no guarantee that Zhittya’s products will receive regulatory approval for marketing and distribution. If the FDA or other relevant regulatory agencies do not approve our applications for marketing our biopharmaceutical product(s), then we cannot market the product(s). The regulatory agencies may seek additional information or additional data, which would further delay our ability to market the product. Furthermore, failure to comply with FDA, non-U.S. regulatory authorities, or other applicable U.S. and non-U.S. regulatory requirements may, either before or after product clearance or approval, if any, subject us to administrative or judicially imposed sanctions, including: 

The FDA and/or other regulatory agencies can delay, limit, or deny clearance or approval of a biopharmaceutical product candidate for many reasons, including:

Our future revenue from the sale of Zhittya’s licensed drugs in the U.S. and Canada depends on Zhittya obtaining regulatory approval in the United States and Canada, which may never occur.

We currently receive revenue from the Zhittya’s sales of its drugs to U.S. and Canadian residents who travel to certain countries outside the United States and Canada in order to use Zhittya’s drugs, and which we record as other income. Under our License Agreement, if and when the Zhittya’s drugs are approved for use by the FDA or Health Canada, we will be obligated to pay Zhittya 50% of our operating profits derived from such sales of topical drugs and 80% of our operating profits derived from such sales of injection/infusion/intranasal drugs. However, Zhittya is under no obligation to seek, obtain, or maintain FDA or Health Canada approval for its drugs and the process of obtaining such regulatory approvals is time-consuming, expensive, and uncertain.

As a result, Zhittya may choose not to pursue FDA or Health Canada approval, may delay such approval for extended periods, or may abandon the approval process entirely because of costs, regulatory challenges, or strategic business considerations. If Zhittya does not obtain regulatory approval in the United States or Canada for its drugs, we may never generate revenue from sales of the drugs in these markets, which could have a material adverse effect on our financial condition and results of operations.

The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if Zhittya is unable to obtain timely regulatory approval for its product candidates, our business will be substantially harmed.

We will not be permitted to market product candidates in the United States until Zhittya is able to receive approval of a new drug application, or NDA, from the FDA, or in any foreign countries until Zhittya receives the requisite approval from such countries. Prior to submitting an NDA to the FDA for approval of Zhittya’s product candidates, Zhittya will be required to have its product candidates complete initiate and complete clinical trials. Successfully completing its clinical program and obtaining approval of an NDA is a complex, lengthy, expensive, and uncertain process, and the FDA may delay, limit, or deny approval of product candidates for many reasons. This could increase costs and jeopardize Zhittya’s ability to obtain regulatory approval for and successfully market product candidates, which would in turn jeopardize our ability to generate product revenue.

Zhittya’s clinical studies are subject to numerous risks.

Zhittya is in the process of conducting, and may in the future conduct, studies evaluating our licensed product candidates, and we do not control their design, conduct, timing or interpretation. Certain studies conducted by Zhittya have been, or may be, patient-supported, open-label or otherwise not randomized, double-blind or well-controlled, which may limit the reliability, interpretability and regulatory acceptability of the resulting data.

Pre-clinical data generated by Zhittya may not be predictive of safety or efficacy in humans, and any positive signals observed in non-clinical models may not translate to clinical studies. Similarly, open-label or patient-supported clinical studies may lack appropriate control arms and blinding, increasing the risk of bias (including selection bias) and making it difficult to determine whether observed outcomes are attributable to the investigational product rather than placebo effects, disease variability or other confounding factors. Patients in such studies may also self-select for participation, resulting in study populations that are not representative of the broader disease population (Parkinson’s disease or otherwise) in the United States or Canada.

Results from Zhittya’s studies may not be replicated in future randomized, double-blind, well-controlled clinical trials, and future trials could produce materially different or less favorable results. Regulatory authorities, including the FDA and Health Canada, may determine that data from studies or from patient-supported or open-label clinical studies are insufficient, unreliable or biased, and may require additional, more rigorous studies, resulting in increased costs, delays or uncertainty regarding regulatory approval. Any such outcomes could materially adversely affect our ability to develop, obtain approval for or commercialize Zhittya’s product candidates.

We expect the product candidates Zhittya develops will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated.

The Biologics Price Competition and Innovation Act (the “BPCI Act”) was enacted as part of the Affordable Care Act to establish an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic. Under the BPCI Act, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain whether such processes intended to implement the BPCI Act may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for Zhittya’s biological products.

Notwithstanding the above, we believe that any of the product candidates Zhittya develops that are approved in the United States as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this 12 year period of exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider the subject product candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of the reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

Zhittya will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense to us, and we may be subject to penalties if Zhittya fails to comply with regulatory requirements or experience unanticipated problems with its product candidates.

Any regulatory approvals that Zhittya’s product candidates receive will require surveillance to monitor the safety and efficacy of such product candidate. The FDA may also require a risk evaluation and mitigation strategy in order to approve Zhittya’s product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves Zhittya’s product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for the product candidates will be subject to extensive and ongoing regulatory requirements, some of which are expected to be undertaken by us. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials that Zhittya conducts post-approval. As such, Zhittya and we will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing application and previous responses to inspectional observations. Accordingly, Zhittya must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. In addition, the FDA could require Zhittya to conduct another study to obtain additional safety or biomarker information. Further, we will be required to comply with FDA promotion and advertising rules, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses (known as “off-label use”), limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet and social media. Later discovery of previously unknown problems with Zhittya’s product candidates, including adverse events of unanticipated severity or frequency, or with third-party suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a risk evaluation and mitigation strategy program. Other potential consequences include, among other things:

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Zhittya’s product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. For example, certain policies of the current U.S. President’s administration may impact Zhittya’s and our business and industry. Namely, the current U.S. President’s administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. It is difficult to predict how these orders will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority. If these executive actions impose restrictions on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted. If we or Zhittya are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or Zhittya are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

Negative public opinion and increased regulatory scrutiny of Zhittya’s product candidates and treatments may damage public perception of such product candidates or adversely affect our ability to conduct our business or Zhittya’s ability to obtain regulatory approvals for its product candidates.

The technologies that Zhittya uses are novel. Public perception may be influenced by claims that such technology is unsafe, and Zhittya’s products may not gain the acceptance of the public or the medical community. In particular, our success will depend upon physicians specializing in targeted diseases prescribing the product candidates we license from Zhittya as treatments in lieu of, or in addition to, existing, more familiar, treatments for which greater clinical data may be available. Any increase in negative perceptions of the products we sell and/or Zhittya’s product candidates may result in fewer physicians prescribing such treatments or may reduce the willingness of patients to utilize such treatments or participate in clinical trials for Zhittya’s product candidates. Increased negative public opinion or more restrictive government regulations in response thereto, would have a negative effect on our business or financial condition and may delay or impair the development and commercialization of Zhittya’s product candidates or demand for such product candidates.

Even if Zhittya obtains regulatory approval of its product candidates, the products may not gain market acceptance among physicians, patients, hospitals, treatment centers and others in the medical community.

Zhittya and its technologies may not become broadly accepted by physicians, patients, hospitals, and others in the medical community. It is possible that the product candidates may result in unforeseen and unintended outcomes, which may result in unacceptable side effects, including death. Additional factors will influence whether the product candidates are accepted in the market, including:

If Zhittya’s product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, treatment centers or others in the medical community, we will not be able to generate significant revenue. Even if the products achieve market acceptance, they may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than Zhittya’s products, are more cost effective or render Zhittya’s products obsolete.

Pre-clinical data is uncertain and may not be replicated in future clinical studies.

We discuss the results of certain pre-clinical and clinical studies in this offering circular, all of which are inherently preliminary and may not be predictive of the results of future clinical trials. Findings from pre-clinical studies, including observations of biological activity, tissue response, or other potential therapeutic effects, are subject to significant limitations, including small sample sizes, limited controls, differences in study design, and the absence of the statistical rigor typically associated with well-designed randomized clinical trials. In addition, certain prior studies may not have reported adverse events, statistical analyses, or p-values, which further limits the ability to assess the significance, reproducibility, and clinical relevance of the reported findings. As a result, there can be no assurance that any positive pre-clinical observations will be replicated in future human studies or larger, controlled clinical trials, or that such trials will demonstrate comparable safety, efficacy, biological activity, or therapeutic benefit. Failure to reproduce favorable pre-clinical results in subsequent clinical development could materially harm our business, prospects, financial condition, and the market price of our securities.

Risks Related to Intellectual Property

We may be involved in lawsuits related to Zhittya’s efforts to protect or enforce its intellectual property rights, which could be expensive, time-consuming, and ultimately unsuccessful.

Zhittya does not have any patents, trademarks, or registered intellectual property. Any encroachment upon its proprietary information, including the unauthorized use of its brand name, the use of a similar name by a competing company or a lawsuit initiated either by Zhittya or against Zhittya for infringement upon proprietary information or improper use of a trademark, may affect its ability to create brand name recognition, cause customer confusion, and/or have a detrimental effect on its business due to the cost of defending any potential litigation related to infringement. If Zhittya, in the future, obtains any of such intellectual property, litigation, or proceedings before the U.S. or international patent and trademark offices may be necessary to enforce its intellectual property rights, to protect its trade secrets and domain name, and/or to determine the validity and scope of the proprietary rights of others. Any such litigation or adverse proceeding could result in substantial costs and diversion of resources and could seriously harm our business, operations, and/or results of operations.

Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain.

Our commercial success depends upon our ability to market and sell Zhittya’s products without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the life sciences industry. We cannot guarantee that Zhittya’s product candidates will not infringe third-party patents or other proprietary rights. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to Zhittya’s products and technology, including inter partes review, interference, or derivation proceedings before the United States Patent and Trademark Office (“USPTO”) and similar bodies in other countries. Third parties may assert infringement claims against us based on existing intellectual property rights and intellectual property rights that may be granted in the future.

If we are found to infringe on a third party’s intellectual property rights, we or Zhittya could be required to obtain a license from such a third party to continue developing and marketing such products. However, neither Zhittya nor we may be able to obtain any required license on commercially reasonable terms or at all. Even if Zhittya or we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We or Zhittya could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, Zhittya or we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent Zhittya from commercializing its product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

Risks Related to Our Securities and this Offering

There is no existing public market for our common stock, and an active trading market may never develop or be sustained.

Prior to this offering, there has been no public market for our common stock. We cannot predict whether investor interest in our Company generated by this offering will lead to the development of a trading market, or how liquid any such market might become. Even if a trading market develops following this offering, it may not be maintained, and investors may find it difficult or impossible to sell their Shares at any price. If an active trading market does not develop or is not sustained, the value of your investment could be adversely affected, and you may be required to hold your Shares for an indefinite period of time.

This is a “best efforts” offering; no minimum amount of Securities is required to be sold, and we may not raise the amount of capital we believe is required for our business.

There is no required minimum number of Securities that must be sold as a condition to completion of this offering. Because there is no minimum offering amount required as a condition to each closing of this offering, the actual offering amount, and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth in this offering circular. We may sell fewer than all of the Shares offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of Shares sufficient to pursue the business goals outlined in this offering circular. Thus, we may not raise the amount of capital we believe is required for our business and may need to raise additional funds, which may not be available or available on terms acceptable to us. Despite this, any proceeds from the sale of the Shares offered by us will be available for our immediate use, and because there is no escrow account and no minimum offering amount in this offering, investors could be in a position where they have invested in us, but we are unable to fulfill our objectives due to a lack of interest in this offering.

There can be no assurance that our common stock will be approved for quotation on the OTCQB Market or that we will maintain such quotation.

Following this offering, we intend to apply for quotation of our common stock on the OTCQB Market operated by OTC Markets Group Inc. However, quotation on the OTCQB is subject to a number of eligibility requirements, including, among others, a minimum bid price requirement, current SEC reporting obligations, payment of applicable fees, and compliance with OTC Markets Group’s corporate governance standards. We cannot assure you that we will satisfy all applicable requirements, that our application will be approved, or that we will be able to locate a broker-dealer willing to sponsor our quotation application. Even if our common stock is quoted on the OTCQB, we may fail to maintain continued eligibility, in which case our shares may be downgraded to the OTC Pink Market or may not be quoted on any public market at all. Any failure to obtain or maintain OTCQB quotation could significantly impair the liquidity of our common stock and your ability to sell your Shares.

We will need a broker-dealer to sponsor our application for quotation on the OTC Markets, and there is no assurance that we will secure such a sponsor.

In order to have our common stock quoted on the OTCQB or any other tier of the OTC Markets, we must have a registered broker-dealer submit an application on our behalf through the Financial Industry Regulatory Authority (FINRA). We have not yet secured a broker-dealer sponsorship commitment, and there can be no assurance that we will be able to do so on acceptable terms, or at all. If we are unable to find a broker-dealer willing to sponsor our quotation application, our common stock may not be quoted on any public market following this offering, which could render your investment illiquid.

Our common stock may be subject to the SEC’S penny stock rules, which could make transactions in our common stock more difficult and reduce the trading market for our shares.

Our common stock may be subject to the SEC’s “penny stock” rules if it trades below $5.00 per share and we do not qualify for an applicable exemption. Under these rules, broker-dealers effecting transactions in penny stocks are subject to heightened disclosure obligations and customer suitability requirements, including the delivery of standardized risk disclosure documents and the preparation of suitability determinations prior to any transaction. These requirements may discourage broker-dealers from recommending or handling our common stock, reduce the trading market for our shares, and make it significantly more difficult for investors to purchase or sell our common stock in the secondary market.

The offering price has been determined arbitrarily by us and may not reflect the market value of our common stock.

The offering price of our common stock has been determined by us and does not necessarily bear any relationship to our assets, net tangible book value, earnings, financial condition, prospects, or any other established criterion of value. The offering price should not be regarded as an indicator of the future market price of our common stock. The market price of our common stock following this offering, if a trading market develops at all, may be substantially lower than the offering price, and investors purchasing Shares in this offering may lose some or all of their investment.

We intend to become a reporting company under Tier 2 of Regulation A, and there can be no assurance that we will successfully complete or maintain that status.

Following the qualification of this offering, we will become subject to the periodic and current reporting requirements of Regulation A. We cannot assure you that we will be able to satisfy our ongoing reporting obligations once this offering is qualified. As discussed herein, there is no public market for the Shares, provided that following the closing of this offering, the Company currently plans to apply for quotation on the OTCQB Market maintained by OTC Markets; however, there can be no assurance that we will obtain such quotation, or as to the level of trading that might occur if we do. Failure to timely file required reports with the SEC could result in the loss of our ability to quote our common stock on the OTCQB (if such quotation is approved in the future), which could adversely affect the liquidity and marketability of our common stock and the ability of holders of restricted shares to rely on resale exemptions under the securities laws.

Holders of restricted shares may be unable to rely on Rule 144 if we do not become and remain a reporting company.

Shares of our common stock sold in prior exempt transactions, and shares issued to our founders, officers, directors, and employees, are “restricted securities” within the meaning of Rule 144 under the Securities Act. Rule 144 permits holders of restricted securities to resell shares in the open market without registration, subject to compliance with certain conditions, including a requirement that the issuer has been subject to the reporting requirements of the Exchange Act for at least 90 days and is current in its reporting obligations. If we fail to become or remain a reporting company, holders of restricted shares may be unable to avail themselves of the Rule 144 resale exemption and may have no other means of selling their shares absent a registered offering or another applicable exemption.

The market price of our common stock may be volatile, and you could lose all or a significant portion of your investment.

If a trading market for our common stock develops following this offering, the market price of our common stock may be subject to wide fluctuations in response to numerous factors, many of which are beyond our control. These factors may include, among others, our actual or anticipated operating results, changes in our business or prospects, developments in our industry, market conditions generally, investor perceptions, trading volume, and broad economic, political, or market conditions such as recessions or changes in interest rates. Volatility in our stock price could cause you to lose all or a significant part of the value of your investment. In addition, companies with publicly traded securities that experience significant stock price volatility are sometimes subject to securities class action litigation. Even if such litigation is without merit, it could result in substantial costs and divert management’s attention and resources from our business.

Becoming a public reporting company will significantly increase our operating costs and place demands on our management.

Upon the qualification of this offering and the effectiveness of our Exchange Act registration, we will become subject to the reporting, disclosure, and governance requirements applicable to public companies. We expect to incur significant additional costs related to legal counsel, independent audit services, financial reporting systems, investor relations, and directors’ and officers’ liability insurance that we did not incur as a private company. In addition, our management team will be required to devote substantial time and attention to our SEC reporting obligations, which may divert their focus from the operation and growth of our business. These increased costs and demands on management may adversely affect our financial condition and results of operations.

As an emerging growth company and smaller reporting company, we will be subject to reduced disclosure requirements, which may make our common stock less attractive to investors.

We expect to qualify as both an “emerging growth company” and “smaller reporting company” under SEC rules following the effectiveness of our Exchange Act registration. As an emerging growth company and smaller reporting company, we will be permitted to provide less extensive disclosures in our SEC filings than those required of larger public companies, including scaled executive compensation disclosures and relief from certain other disclosure requirements. These reduced disclosures may make it more difficult for investors to fully evaluate our business, financial condition, and prospects, and may make our common stock less attractive to institutional investors or analysts who cover public companies, which could adversely affect the trading market for our shares.

We do not expect to pay dividends in the foreseeable future.

We do not intend to declare dividends for the foreseeable future, as we anticipate that we will reinvest any and all future earnings in the development and growth of our business. Therefore, investors will not receive any funds unless they sell their securities, and holders may be unable to sell their securities on favorable terms or at all. We cannot assure you of a positive return on your investment or that you will not lose the entire amount of your investment.

Upon our dissolution, you may not recoup all or any portion of your investment.

In the event of our liquidation, dissolution or winding-up, whether voluntary or involuntary, our assets would be used to pay all of our debts and liabilities, and only thereafter would any remaining assets be distributed to our stockholders, subject to rights of the holders of our preferred stock, if any, on a pro rata basis. There can be no assurance that we will have assets available from which to pay any amounts to our stockholders upon such a liquidation, dissolution or winding-up. In such an event, you would lose all of your investment.

Purchasers in this offering will experience immediate and substantial dilution in net tangible book value.

Because the price per share of our common stock being offered is higher than the book value per share of our common stock, you will suffer substantial dilution in the net tangible book value of the common stock you purchase in this offering. Based on the public offering price of $10.00 per share, if you purchase common stock in this offering, you will suffer dilution per share in the net tangible book value of the common stock. See “Dilution” below for a more detailed discussion of the dilution you will incur if you purchase our common stock in the offering.

We have broad discretion in how we use the proceeds of this offering and may not use these proceeds effectively, which could affect our results of operations and cause our common stock price to decline.

We will have considerable discretion in the application of the net proceeds of this offering. We intend to use the net proceeds from this offering to fund our business strategy, including without limitation, new and ongoing research and development expenses, offering expenses, working capital and other general corporate purposes, which may include funding for the hiring of additional personnel. As a result, investors will be relying upon management’s judgment with only limited information about our specific intentions for the use of the balance of the net proceeds of this offering. We may use the net proceeds for purposes that do not yield a significant return or any return at all for our stockholders. In addition, pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.

A significant number of our outstanding shares will not be subject to lock-up agreements in connection with this offering. The sale of a significant number of our shares may cause the market price of our common stock to drop significantly.

Upon completion of this offering all of our directors and officers and the holders of 5% our capital stock will have signed lock-up agreements that prevent them from selling any shares of our common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock, subject to certain exceptions, for a period of not less 180 days [from the date of this offering circular] without the prior written consent of Benjamin Securities. Benjamin Securities may in its sole discretion and at any time without notice release some or all of the shares subject to lock-up agreements prior to the expiration of the period. When determining whether or not to release shares from the lock-up agreements, Benjamin Securities will consider, among other factors, the stockholder’s reasons for requesting the release, the number of shares for which the release is being requested and market conditions at the time.

If a public market exists for our securities and our stockholders sell substantial amounts of our common stock in the public market, the market price of our common stock could decrease significantly. The perception in the public market that our stockholders might sell shares of our common stock could also depress the market price of our common stock. We cannot predict the effect, if any, of future sales of our common stock on the value of our common stock. Sales of substantial amounts of our common stock by large stockholders, or the perception that such sales could occur, may adversely affect the market price of our common stock.

The market price for shares of our common stock may drop significantly when such securities are sold in the public markets. A decline in the price of shares of our common stock might impede our ability to raise capital through the issuance of additional shares of our common stock or other equity securities. 

If a public market exists for our common stock in the future, our common stock price may be volatile and could decline substantially following this offering.

If a public market exists for our common stock in the future, our common stock may be highly volatile and subject to wide fluctuations. Our financial performance, government regulatory action, tariffs, tax laws, interest rates, and market conditions in general could have a significant impact on the future market price of our common stock.

Some of the factors that could negatively affect or result in fluctuations in the future market price of our common stock include:

Other factors unrelated to our performance that may affect the price of the Company’s securities include the following: (i) the extent of analytical coverage available to investors concerning our business may be limited if investment banks with research capabilities do not follow the Company; (ii) lessening in trading volume and general market interest in the Company’s securities may affect an investor’s ability to trade significant numbers of the Company’s securities; (iii) the size of our public float may limit the ability of some institutions to invest in the Company’s securities; and (iv) a substantial decline in the price of the Company’s securities that persists for a significant period of time could cause the Company’s securities, if listed on an exchange, to be delisted from such exchange further reducing market liquidity. As a result of any of these factors, the market price of the Company’s securities at any given point in time may not accurately reflect our long-term value. Class action litigation often has been brought against companies following periods of volatility in the market price of their securities. We may in the future be the target of similar litigation. Securities litigation could result in substantial costs and damages and divert management’s attention and resources.

The fact that no market currently exists for the Company’s securities may affect the pricing of the Company’s securities in the secondary market, the transparency and availability of trading prices and the liquidity of the Company’s securities. The market price of the Company’s securities is affected by many other variables which are not directly related to our success and are therefore not within our control. These include other developments that affect the market for pharmaceutical products, the breadth of the public market for our Company’s securities and the attractiveness of alternative investments. The effect of these and other factors on the market price of the Company’s securities is expected to make the price of the Company’s securities volatile in the future, which may result in losses to investors.

The offering price per share of common stock offered under this offering circular may not accurately reflect the value of your investment.

The offering price per common stock share offered by this offering circular was negotiated between us and the Placement Agents. Factors considered in determining the price of our common stock include:

The offering price may not accurately reflect the value of our common stock and may not be realized upon any subsequent disposition of the common stock.

After the completion of this offering, we may be at an increased risk of securities class action litigation.

Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced significant stock price volatility in recent years. If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

We could issue “blank check” preferred stock without stockholder approval with the effect of diluting the interests of then-current stockholders and impairing their voting rights, and provisions in our charter documents and under Nevada law could discourage a takeover that stockholders may consider favorable.

Our Amended and Restated Articles of Incorporation provides for the authorization to issue up to 25,000,000 shares of “blank check” preferred stock with designations, rights, and preferences as may be determined from time to time by our Board of Directors (the “Board”), of which 3,500,000 shares have been designated as Series A-1 Convertible Preferred Stock and 3,500,000 shares have been designated as Series A-2 Convertible Preferred Stock.

Our Board is empowered, without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting or other rights which could dilute the interest of, or impair the voting power of, our common stockholders. The issuance of a series of preferred stock could be used as a method of discouraging, delaying, or preventing a change in control. For example, it would be possible for our Board to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of our company. In addition, advance notice is required prior to stockholder proposals, which might further delay a change of control.

The issuance of common stock upon conversion of our outstanding Series A-1 Convertible Preferred Stock and Series A-2 Convertible Preferred Stock will cause immediate and substantial dilution to existing stockholders and the sale of common stock upon conversion of our outstanding Series A-1 Convertible Preferred Stock and Series A-2 Convertible Preferred Stock may depress the market price of our common stock.

As of the date of this offering circular, there are 3,500,000 shares designated and 3,500,000 outstanding shares of Series A-1 Convertible Preferred Stock (“Series A-1 preferred stock”)and 3,500,000 shares designated and 3,500,000 outstanding shares of Series A-2 Convertible Preferred Stock (“Series A-2 preferred stock”)(each as discussed and with certain terms related thereto), defined below under “Description of Capital Stock—Preferred Stock— Series A-1 Convertible Preferred Stock and Series A-2 Convertible Preferred Stock”.

Each share of Series A-1 preferred stock is convertible at the option of the holders of Series A-1 preferred stock into one share of our common stock, subject to anti-dilution protections and other adjustments upon certain events. Until twenty-four (24) months have elapsed from the first underwritten public offering of the Company’s common stock, holders of our Series A-1 preferred stock are prohibited from effecting a conversion. Holders of our Series A-1 preferred stock are also prohibited from effecting a conversion that would result in a holder beneficially owning more than 4.99% of the number of shares of our common stock outstanding immediately after giving effect to the issuance of shares of common stock upon a conversion of Series A-1 preferred stock. Upon a sale of the Company, if not converted earlier, all shares of Series A-1 preferred stock will automatically convert into shares of our common stock.

Each share of Series A-2 preferred stock is convertible at the option of the holders of Series A-2 preferred stock into one share of our common stock, subject to anti-dilution protections and other adjustments upon certain events. Holders of our Series A-2 preferred stock are prohibited from effecting a conversion until (a) twenty-four (24) months have elapsed from the first underwritten public offering of the Company’s common stock and (b) the 30-day volume-weighted average price for our common stock exceeds $20.00. Holders of our Series A-2 preferred stock are also prohibited from effecting a conversion that would result in a holder beneficially owning more than 4.99% of the number of shares of our common stock outstanding immediately after giving effect to the issuance of shares of common stock upon a conversion of Series A-2 preferred stock which includes their holding of Series A-1 preferred stock together the conversion could not result in the holder of the Series A-1 and A-2 together owning more than 4.99% of the shares of our common stock outstanding immediately after giving effect to the issuance of shares of the common stock outstanding. Upon a sale of the Company, if not converted earlier, all shares of Series A-2 preferred stock will automatically convert into shares of our common stock if the sales price exceeds $20 per share.

The conversion of the Series A-1 and Series A-2 preferred stock into common stock of the Company will cause significant dilution to the then holders of our common stock.

Additionally, if conversions of our outstanding Series A-1 and Series A-2 preferred stock and sales of such converted shares take place, the price of our common stock may decline. In addition, the common stock issuable upon conversion of our outstanding Series A-1 and Series A-2 preferred stock may represent overhang that may also adversely affect the market price of our common stock. Overhang occurs when there is a greater supply of a company’s stock in the market than there is demand for that stock. When this happens the price of the Company’s stock will decrease, and any additional shares which stockholders attempt to sell in the market will only further decrease the share price. If the share volume of our common stock cannot absorb converted shares sold by the holder of the Series A Preferred Stock, then the value of our common stock will likely decrease.

Because of the speculative nature of investment risk, you may lose your entire investment.

An investment in the Company’s securities carries a high degree of risk and should be considered as a speculative investment. The Company has no history of earnings, limited cash reserves, a limited operating history, has not paid dividends and is highly unlikely to pay dividends in the immediate or near future. The likelihood of success of the Company must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the establishment of any business. An investment in the Company’s securities may result in the loss of an investor’s entire investment. Only potential investors who are experienced in high-risk investments and who can afford to lose their entire investment should consider an investment in the Company.

If paid in shares of our common stock, in our discretion, the clinical progress and regulatory milestone payments owed to Zhittya will cause significant dilution to existing stockholders.

Pursuant to our License Agreement with Zhittya, we are required to make certain milestone payments to Zhittya, upon Zhittya’s achievement of applicable clinical progress and regulatory milestones, which are based on certain recognizable achievements in the development and approval of the injectable/infusion/intranasal drug candidates and topical drug candidates with the following applications: coronary heart disease, Parkinson’s disease, stroke, diabetic foot ulcers and venous ulcers, as discussed in greater detail below under “Business—License Agreement with Zhittya”.

The clinical progress and regulatory milestone payments for wound healing drug candidates range from $100,000 to $10,000,000 and will not exceed $75,000,000 in total for the entire class of wound healing drugs. The milestone payments for injectable and infusion drug candidates range from $100,000 to $25,000,000 and will not exceed $300,000,000 in total for the entire class of injectable/infusion/intranasal drugs.

At our discretion, such clinical progress and regulatory milestone payments may be paid in the form of cash or shares of our common stock, calculated using the average closing price over the prior 20 trading days prior to issuance, provided that in the event the issuance of any shares of common stock to Zhittya would result in Zhittya owning 5% or more of the Company’s outstanding common stock, we are required to defer the stock payment until such time as the issuance of such shares will result in Zhittya’s ownership of the Company not exceeding 4.99% of the Company’s common stock.

Additionally, these clinical progress and regulatory milestone payments obligations will not begin to accrue until 90 days after the closing of our initial public offering or public sale of shares. To date, no clinical progress and regulatory milestone payments are due.

The issuance of shares of common stock in satisfaction of clinical progress and regulatory milestone payments due pursuant to the terms of the License Agreement will cause significant dilution to existing stockholders.

Future sales of our common stock, other securities convertible into our common stock, or preferred stock could cause the market value of our common stock to decline and could result in dilution of your shares.

Our Board of Directors is authorized, without your approval, to cause us to issue additional shares of our common stock or to raise capital through the creation and issuance of preferred stock, other debt securities convertible into common stock, options, warrants and other rights, on terms and for consideration as our Board of Directors in its sole discretion may determine.

If our stockholders sell substantial amounts of our common stock in the public market, the market price of our common stock could decrease significantly. The perception in the public market that our stockholders might sell shares of our common stock could also depress the market price of our common stock. If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline significantly. Benjamin Securities may waive the lock-up agreements entered into in connection with this offering. If the lock-up agreements entered into in connection with this offering are waived, shares of our common stock will become available for sale into the market, subject to applicable law, which could reduce the market price for our common stock.

We cannot predict the effect, if any, of future sales of our common stock, or the availability of our common stock for future sales, on the value of our common stock. Sales of substantial amounts of our common stock by large stockholders, or the perception that such sales could occur, may adversely affect the market price of our common stock.

The market price for shares of our common stock may drop significantly when such securities are sold in the public markets. A decline in the price of shares of our common stock might impede our ability to raise capital through the issuance of additional shares of our common stock or other equity securities. 

We have no intention of declaring dividends in the foreseeable future.

The decision to pay cash dividends on our common stock rests with our Board of Directors and will depend on our earnings, unencumbered cash, capital requirements and financial condition. We do not anticipate declaring any dividends in the foreseeable future, as we intend to use any excess cash to fund our operations. Investors in our common stock should not expect to receive dividend income on their investment, and investors will be dependent on the appreciation of our common stock to earn a return on their investment.

Risk Factors Relating to Our Organizational Documents

Your investment in us may be adversely affected by the limitation of liability and indemnification of management under the Nevada Revised Statutes and our Amended and Restated Articles of Incorporation.

The Nevada Revised Statutes and our Amended and Restated Articles of Incorporation provide for the limitation of the liability of directors for monetary damages. Such provisions may discourage stockholders from bringing a lawsuit against directors for breaches of fiduciary duty and may also have the effect of reducing the likelihood of derivative litigation against directors and officers even though such action, if successful, might otherwise be a benefit to our stockholders. In addition, a stockholder’s investment in us may be adversely affected to the extent that costs of settlement and damage awards against our officers or directors are paid by us pursuant to such provisions. Additionally, in accordance with Nevada Revised Statutes, our Amended and Restated Articles of Incorporation and our Bylaws, we will indemnify, hold harmless and provide advancement of expenses, to the fullest extent permitted by applicable law, directors, officers, employees, and agents that are made a party or threatened to be made a party to legal proceedings by reason of the fact that such parties were working at our request. We direct you to our Amended and Restated Articles of Incorporation and our Bylaws for more information.

Our Bylaws provide that the Eighth Judicial District Court of Clark County, Nevada, will be the sole and exclusive forum for certain disputes which could limit stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, future employees or agents.

Our Bylaws, to be effective immediately prior to the start of this offering, provide that unless we consent in writing to the selection of an alternative forum, the Eighth Judicial District Court of Clark County, Nevada shall be the sole and exclusive forum for state law claims with respect to: (i) any derivative action or proceeding brought in our name or right or on our behalf, (ii) any action asserting a claim for breach of any fiduciary duty owed by any of our directors, officers, future employees, or agents to us or our stockholders, (iii) any action arising or asserting a claim arising pursuant to any provision of Nevada Revised Statutes Chapters 78 or 92A or any provision of our Amended and Restated Articles of Incorporation or Bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine, including, without limitation, any action to interpret, apply, enforce, or determine the validity of our Amended and Restated Articles of Incorporation or Bylaws.

This exclusive forum provision would not apply to suits brought to enforce any liability or duty created by the Securities Act, or the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction. To the extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.

This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our or its directors, officers, other future employees, or agents, which may discourage such lawsuits against us and our directors, officers, other future employees, and agents. Alternatively, if a court were to find the choice of forum provision contained in our Bylaws to be inapplicable or unenforceable in an action, that we may incur additional costs associated with resolving such action in other jurisdictions, which could have a material adverse effect on our business, results of operations, and financial condition.

General Risk Factors

We have a short operating history in an evolving industry and, as a result, our past results may not be indicative of future operating performance.

We have a short operating history in a rapidly evolving industry that may not develop in a manner favorable to our business. Our relatively short operating history makes it difficult to assess our future performance. You should consider our business and prospects in light of the risks and difficulties we may encounter.

Our future success will depend in large part upon our ability to, among other things:

If we fail to address the risks and difficulties that we face, including those associated with the challenges listed above as well as those described elsewhere in this “Risk Factors” section, our business and our operating results will be adversely affected.

Failure to adequately manage our planned aggressive growth strategy may harm our business or increase our risk of failure.

For the foreseeable future, we intend to pursue an aggressive growth strategy for the expansion of our operations. Our ability to rapidly expand our operations will depend upon many factors, including our ability to work in a regulated environment, establish and maintain strategic relationships with suppliers, and obtain adequate capital resources on acceptable terms. Any restrictions on our ability to expand may have a materially adverse effect on our business, results of operations, and financial condition. Accordingly, we may be unable to achieve our targets for growth, and our operations may not be successful or achieve anticipated operating results.

Additionally, our growth may place a significant strain on our managerial, administrative, operational, and financial resources and our infrastructure. Our future success will depend, in part, upon the ability of our senior management to manage growth effectively. This will require us to, among other things:

As a result, we may lack the resources to deploy our services on a timely and cost-effective basis. Failure to accomplish any of these requirements could have an adverse effect on future operating results.

If we make any acquisitions, they may disrupt or have a negative impact on our business.

If we make acquisitions in the future, we could have difficulty integrating the acquired company’s assets, personnel and operations with our own. We do not anticipate that any acquisitions or mergers we may enter into in the future would result in a change of control of the Company. In addition, the key personnel of the acquired business may not be willing to work for us. We cannot predict the effect expansion may have on our core business. Regardless of whether we are successful in making an acquisition, the negotiations could disrupt our ongoing business, distract our management and employees and increase our expenses. In addition to the risks described above, acquisitions are accompanied by a number of inherent risks, including, without limitation, the following:

Our business could be severely impaired if and to the extent that we are unable to succeed in addressing any of these risks or other problems encountered in connection with an acquisition, many of which cannot be presently identified. These risks and problems could disrupt our ongoing business, distract our management and employees, increase our expenses and adversely affect our results of operations.

We may apply working capital and future funding to uses that ultimately do not improve our operating results or increase the value of our securities.

In general, we have complete discretion over the use of our working capital and any new investment capital we may obtain in the future. Because of the number and variety of factors that could determine our use of funds, our ultimate expenditure of funds (and their uses) may vary substantially from our current intended operating plan for such funds. Our management has broad discretion to use any or all of our available capital reserves. Our capital could be applied in ways that do not improve our operating results or otherwise increase the value of a stockholder’s investment.

Claims, litigation, government investigations, and other proceedings may adversely affect our business and results of operations.

We may be subject to actual and threatened claims, litigation, reviews, investigations, and other proceedings, including proceedings relating to our operations or those of third parties, and other matters. Any of these types of proceedings, may have an adverse effect on us because of legal costs, disruption of our operations, diversion of management resources, negative publicity, and other factors. The outcomes of these matters are inherently unpredictable and subject to significant uncertainties. Determining legal reserves and possible losses from such matters involves judgment and may not reflect the full range of uncertainties and unpredictable outcomes. Until the final resolution of such matters, we may be exposed to losses in excess of the amount recorded, and such amounts could be material. Should any of our estimates and assumptions change or prove to have been incorrect, it could have a material effect on our business, financial position, results of operations, or cash flows. In addition, it is possible that a resolution of one or more such proceedings, including as a result of a settlement, could require us to make substantial future payments, prevent us from offering certain products or services, require us to change our business practices in a manner materially adverse to our business, requiring development of non-infringing or otherwise altered technologies, damaging our reputation, or otherwise having a material effect on our operations.

We may incur indebtedness in the future which could reduce our financial flexibility, increase interest expense and adversely impact our operations and our costs.

As of March 31, 2026, we had $1,193,873 of liabilities. However, we may incur significant amounts of indebtedness in the future. Our level of indebtedness could affect our operations in several ways, including the following:

A high level of indebtedness increases the risk that we may default on our debt obligations. We may not be able to generate sufficient cash flows to pay the principal or interest on our debt, and future working capital, borrowings or equity financing may not be available to pay or refinance such debt. If we do not have sufficient funds and are otherwise unable to arrange financing, we may have to sell significant assets or have a portion of our assets foreclosed upon which could have a material adverse effect on our business, financial condition and results of operations.

Our business could be adversely affected by security threats, including cybersecurity threats.

We face various security threats, including cybersecurity threats to gain unauthorized access to our sensitive information, to seek initiation of unauthorized fund transfers, or to render our information or systems unusable, and threats to the security of our facilities and infrastructure or third-party facilities and infrastructure. The potential for such security threats subjects our operations to increased risks that could have a material adverse effect on our business, financial condition and results of operations. For example, unauthorized access to our seismic data, reserves information or other proprietary information could lead to data corruption, communication interruptions, or other disruptions to our operations.

Our implementation of various procedures and controls to monitor and mitigate such security threats and to increase security for our information, systems, facilities and infrastructure may result in increased capital and operating costs. Moreover, there can be no assurance that such procedures and controls will be sufficient to prevent security breaches from occurring. If any of these security breaches were to occur, they could lead to losses of, or damage to, sensitive information or facilities, infrastructure and systems essential to our business and operations, as well as data corruption, reputational damage, communication interruptions or other disruptions to our operations, which, in turn, could have a material adverse effect on our business, financial position and results of operations.

The threat and impact of terrorist attacks, cyber-attacks or similar hostilities may adversely impact our operations.

We cannot assess the extent of either the threat or the potential impact of future terrorist attacks on the energy industry in general, and on us in particular, either in the short-term or in the long-term. Uncertainty surrounding such hostilities may affect our operations in unpredictable ways, including that our facilities or those of our counterparties, could be targets of, or indirect casualties of, an act of terror, a cyber-attack or electronic security breach, or an act of war.

We may have difficulty managing growth in our business, which could have a material adverse effect on our business, financial condition and results of operations and our ability to execute our business plan in a timely fashion.

Because of our small size, growth in accordance with our business plans, if achieved, will place a significant strain on our financial, technical, operational and management resources. As we expand our activities, including our planned pharmaceutical marketing efforts, there will be additional demands on our financial, technical and management resources. The failure to continue to upgrade our technical, administrative, operating and financial control systems or the occurrence of unexpected expansion difficulties could have a material adverse effect on our business, financial condition and results of operations and our ability to execute our business plan in a timely fashion.

Failure to adequately protect critical data and technology systems could materially affect our operations.

Information technology solution failures, network disruptions and breaches of data security could disrupt our operations by causing delays or cancellation of customer orders, impeding processing of transactions and reporting financial results, resulting in the unintentional disclosure of customer, employee or our information, or damage to our reputation. There can be no assurance that a system failure or data security breach will not have a material adverse effect on our financial condition, results of operations or cash flows.

Stockholders may be diluted significantly through our efforts to obtain financing and satisfy obligations through the issuance of securities.

Wherever possible, our board of directors will attempt to use non-cash consideration to satisfy obligations. In many instances, we believe that the non-cash consideration will consist of shares of our common stock, preferred stock (which may be similar to or different than the Series A-1 and A-2 preferred stock) or warrants to purchase shares of our common stock. Our board of directors has authority, without action or vote of the stockholders, subject to the requirements of any national exchange on which our common stock is eventually traded, if any (which generally require stockholder approval for any transactions which would result in the issuance of more than 20% of our then outstanding shares of common stock or voting rights representing over 20% of our then outstanding shares of stock, subject to certain exceptions, including sales in a public offering and/or sales which are undertaken at or above the lower of the closing price immediately preceding the signing of the binding agreement or the average closing price for the five trading days immediately preceding the signing of the binding agreement), to issue all or part of the authorized but unissued shares of common stock, preferred stock or warrants to purchase such shares of common stock. In addition, we may attempt to raise capital by selling shares of our common stock, possibly at a discount to market in the future. These actions will result in dilution of the ownership interests of existing stockholders and may further dilute common stock book value, and that dilution may be material. Such issuances may also serve to enhance existing management’s ability to maintain control of us, because the shares may be issued to parties or entities committed to supporting existing management.

Securities analysts may not cover, or continue to cover, our common stock and this may have a negative impact on the market price of our securities.

The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We do not have any control over independent analysts (provided that we have engaged various non-independent analysts). We do not have any independent analysts that cover our common stock, and any future analysts which cover our common stock may discontinue coverage of our common stock at any time. If no independent securities or industry analysts cover us, the trading price for our common stock could be negatively impacted. If one or more of the future analysts who cover us, if any, downgrades our common stock, changes their opinion of our shares or publishes inaccurate or unfavorable research about our business, our stock price could decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease and we could lose visibility in the financial markets, which could cause our stock price and trading volume to decline.

There may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may materially harm us.

We do not expect that internal control over financial accounting and disclosure, even if timely and well-established, will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. Failure of our control systems to prevent error or fraud could materially adversely affect our business.

Failure to develop our internal controls over financial reporting as we grow could have an adverse impact on us.

As we mature, we will need to develop our current internal control systems and procedures to manage our growth. We are required to establish and maintain appropriate internal controls over financial reporting. Failure to establish appropriate controls, or any failure of those controls once established, could adversely impact our public disclosures regarding our business, financial condition, or results of operations. In addition, management’s assessment of internal controls over financial reporting may identify weaknesses and conditions that need to be addressed in our internal controls over financial reporting or other matters that may raise concerns for investors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting, disclosure of management’s assessment of our internal controls over financial reporting, or disclosure of our public accounting firm’s attestation to or report on management’s assessment of our internal controls over financial reporting may have an adverse impact on the price of our common stock.

The Company does not insure against all potential losses, which could result in significant financial exposure.

The Company does not have commercial insurance or third-party indemnities to fully cover all operational risks or potential liability in the event of a significant incident or series of incidents causing catastrophic loss. As a result, the Company is, to a substantial extent, self-insured for such events. The Company relies on existing liquidity, financial resources and borrowing capacity to meet short-term obligations that would arise from such an event or series of events. The occurrence of a significant incident, series of events, or unforeseen liability for which the Company is self-insured, not fully insured or for which insurance recovery is significantly delayed could have a material adverse effect on the Company’s results of operations or financial condition.

Global economic conditions could materially adversely affect our business, results of operations, financial condition and growth.

Adverse macroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs, changes to fiscal and monetary policy, tighter credit, higher interest rates, high unemployment and currency fluctuations could materially adversely affect our operations, expenses, access to capital and the market for pharmaceutical products. In addition, uncertainty about, or a decline in, global or regional economic conditions could have a significant impact on our expected funding sources, suppliers and partners. A downturn in the economic environment could also lead to limitations on our ability to issue new debt; reduced liquidity; and declines in the fair value of our financial instruments. These and other economic factors could materially adversely affect our business, results of operations, financial condition and growth.

We may be adversely affected by climate change or by legal, regulatory or market responses to such change.

The long-term effects of climate change are difficult to predict; however, such effects may be widespread. Impacts from climate change may include physical risks (such as rising sea levels or frequency and severity of extreme weather conditions), social and human effects (such as population dislocations or harm to health and well-being), compliance costs and transition risks (such as regulatory or technology changes) and other adverse effects. The effects of climate change could increase the cost of certain products, commodities and energy (including utilities), which in turn may impact our ability to procure goods or services required for the operation of our business. Climate change could also lead to increased costs as a result of physical damage to or destruction of our facilities, equipment and business interruption due to weather events that may be attributable to climate change. These events and impacts could materially adversely affect our business operations, financial position or results of operation.

We might be adversely impacted by changes in accounting standards.

Our financial statements are subject to the application of U.S. GAAP, which periodically is revised or reinterpreted. From time to time, we are required to adopt new or revised accounting standards issued by recognized authoritative bodies, including the Financial Accounting Standards Board (“FASB”) and the SEC. It is possible that future accounting standards may require changes to the accounting treatment in our financial statements and may require us to make significant changes to our financial systems. Such changes might have a materially adverse impact on our financial position or results of operations.

* * * * *

For all of the foregoing reasons and others set forth herein, an investment in our securities involves a high degree of risk.

USE OF PROCEEDS

If we sell all of the Shares being offered, our net proceeds (after our estimated offering expenses of $980,000) will be $9,020,000. We will use these net proceeds for the following:

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The precise amounts that we will devote to each of the foregoing items, and the timing of expenditures, will vary depending on numerous factors.

The expected use of net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve and change. The amounts and timing of our actual expenditures, specifically with respect to working capital, may vary significantly depending on numerous factors. The precise amounts that we will devote to each of the foregoing items, and the timing of expenditures, will vary depending on numerous factors. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering.

In the event we do not sell all of the Shares being offered, we may seek additional financing from other sources in order to support the intended use of proceeds indicated above. If we secure additional equity funding, investors in this offering would be diluted. In all events, there can be no assurance that additional financing would be available to us when wanted or needed and, if available, on terms acceptable to us.

We intend to pay our early regulatory milestone payments, such as completing animal toxicity studies and filing an IND from the cash flow from operations and not from these proceeds. The actual allocation of proceeds will be determined at our discretion and will depend on various factors, including our operational requirements and the timing and availability of other sources of capital.

The principal purposes of this offering are to strengthen our capitalization, enhance our financial flexibility, establish a public market for our common stock, and provide us and our stockholders with future access to the public equity markets. We believe that becoming a public company at this time will allow us to develop the operational infrastructure, internal controls, governance processes, and management experience necessary to operate effectively as a public reporting company. In addition, we believe that in the event we are able to obtain a public listing for our common stock, that will increase transparency for investors and provide greater potential liquidity for our existing stockholders over time. While we do not currently intend to use the net proceeds of this offering to fund significant clinical milestone payments, we believe that establishing our presence in the public markets now will better position us to raise additional capital in future periods, if needed, to support milestone payments and other development-related expenditures as Zhittya hopefully advances through its clinical trials and achieves key regulatory and clinical milestones.

We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Additionally, our management will retain broad discretion over the allocation of the net proceeds from this offering and our existing cash and cash equivalents.

In the ordinary course of our business, we expect to from time to time evaluate the acquisition of, investment in, or in-license of complementary products, technologies, or businesses, and we could use a portion of the net proceeds from this offering for such activities. We currently do not have any agreements, arrangements, or commitments with respect to any potential acquisition, investment, or license.

Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and government securities.

DIVIDEND POLICY

We plan to retain any earnings for the foreseeable future for our operations. We have never paid any dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future. Any future determination to pay cash dividends will be at the sole discretion of our Board and will depend on our financial condition, operating results, capital requirements and such other factors as our Board deems relevant.

CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of March 31, 2026:

You should read this capitalization table together with “Use of Proceeds,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our financial statements and the related notes appearing elsewhere in this offering circular.

Each increase (decrease) of 0.25 million Shares in the number of Shares of common stock offered by us would increase (decrease) each of our pro forma, as adjusted cash, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $2.5 million, after deducting estimated placement agent discounts and commissions. 

The number of shares of common stock to be outstanding after this offering is based on 2,632,000 shares outstanding as of March 31, 2026 and 3,632,000 shares outstanding on a pro forma, as adjusted basis, including the 1,000,000 maximum number of Shares of common stock offered in the offering, and does not give effect to:

DILUTION

If you invest in our common stock, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock immediately after this offering.

An early-stage company typically sells its shares (or grants options over its shares) to its founders and early employees at a very low cash cost, because they are, in effect, putting their “sweat equity” into the company. When the company seeks cash investments from outside investors, like you, the new investors typically pay a much larger sum for their shares than the founders or earlier investors, which means that the cash value of your stake is diluted because all the shares are worth the same amount, and you paid more than earlier investors for your shares.

As of March 31, 2026, we had a net tangible book value of $(1,026,663), or $(0.39) per share of common stock, based on shares of common stock outstanding at March 31, 2026. Our net tangible book value per share is the amount of our total tangible assets less our total liabilities at March 31, 2026, divided by the number of shares of common stock outstanding at March 31, 2026.

The following table illustrates dilution to new investors assuming the sale of 25%, 50%, 75% and 100% of the maximum number of Shares offered in this offering. This table is solely for illustration. Actual dilution will depend on the final number of Shares sold.

The following table illustrates this dilution on a per share basis based on the net tangible book value.

Future dilution

Another important way of looking at dilution is the dilution that happens due to future actions by the company. The investor’s stake in a company could be diluted due to the company issuing additional shares. In other words, when the company issues more shares, the percentage of the company that you own will go down, even though the value of the company may go up. You will own a smaller piece of a larger company. This increase in number of shares outstanding could result from a stock offering (such as an initial public offering, another crowdfunding round, a venture capital round, angel investment), employees exercising stock options, or by conversion of certain instruments (e.g. convertible bonds, preferred shares or warrants) into stock.

If the Company decides to issue more shares, an investor could experience value dilution, with each share being worth less than before, and control dilution, with the total percentage an investor owns being less than before. There may also be earnings dilution, with a reduction in the amount earned per share (though this typically occurs only if a company offers dividends, and most early-stage companies are unlikely to offer dividends, preferring to invest any earnings into the company).

If you are making an investment expecting to own a certain percentage of the company or expecting each share to hold a certain amount of value, it’s important to realize how the value of those shares can decrease by actions taken by the company. Dilution can make drastic changes to the value of each share, ownership percentage, voting control, and earnings per share.

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis summarizes the significant factors affecting our operating results, financial condition, liquidity and cash flows as of and for the periods presented below. The following discussion and analysis should be read in conjunction with the financial statements and the related notes thereto included elsewhere in this offering circular. The discussion contains forward-looking statements that are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. Actual results could differ materially from those discussed in or implied by forward-looking statements as a result of various factors, including those discussed below and elsewhere in this offering circular, particularly in the sections titled “Risk Factors” and “Information Regarding Forward-Looking Statements.

Going Concern Analysis

Our ability to become profitable depends on our ability to generate revenue. We are currently generating revenue as Zhittya Genesis Medicine, Inc. (Zittya) treats patients in its foreign clinics. We do not expect to generate significant revenue until our strategic partner, Zhittya, obtains FDA approval for its drug candidates and we successfully commercialize one of the product candidates in the U.S. and Canada.

The Company’s sole source of income is the other income received from Zhittya pursuant to our License Agreement with Zhittya. As of March 31, 2026, we had a total stockholders’ deficit of $(814,712), an accumulated deficit of $125,144,816, and negative working capital of $1,010,091. As of December 31, 2025, we had a total stockholders’ deficit of $(1,125,680), an accumulated deficit of $125,452,659, and negative working capital of $1,272,378. The large accumulated deficit is mainly the result of the original 2016 license agreement with Zhittya valued at $76.5 million, as discussed in greater detail under “Business—License Agreement with Zhittya”, that was fully written off by 2022 under a revised valuation. Another $46.5 million in expenses related to the value of the preferred stock issued to Zhittya pursuant to the terms of the License Agreement. These two items, combined, equal $123 million of the accumulated deficit and do not reflect the results of ongoing operations. From 2023 to 2025, the Company has generated net income every year, with cumulative income of $251,597 over these three years, and net income for the three months ended March 31, 2026 of $307,844.

In the event Zhittya is further delayed in producing FGF-1, performing studies, submitting INDs, obtaining approval from the FDA of such INDs, and/or otherwise delayed further from obtaining FDA approval for FGF-1, which it anticipates will take at least three to seven years, our ability to generate cash flow and support our operations will be negatively affected, we may need to raise additional funds, and we may never be able to generate sufficient funds to support our operations.

We expect to incur significant expenses for the foreseeable future. We expect our expenses to increase in connection with our ongoing activities. Further, we expect to incur additional costs associated with operating as a reporting company. Accordingly, we will need additional financing to support our continuing operations. We plan to seek to fund our operations through public or private equity, debt financings, or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all, or if such funding comes through the form of equity, may cause significant dilution to existing stockholders. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

The Company was incorporated on May 16, 2016 and will require significant additional capital in order to operate in the normal course of business and fund clinical progress and regulatory milestone payments related to approvals and clinical studies. As a result, these conditions have raised substantial doubt regarding our ability to continue as a going concern beyond one year. While we believe in the viability of management’s strategy to generate sufficient revenue, control costs, and the ability to raise additional funds, if necessary, there can be no assurances to that effect. Our ability to continue as a going concern is dependent upon the ability to complete clinical studies and implement the business plan, raise additional capital, generate sufficient other income/revenues, and to control operating expenses. The Company’s ability to realize its assets and discharge its liabilities is dependent upon the Company obtaining the necessary financing and ultimately upon its ability to achieve profitable operations. These material uncertainties may cast significant doubt on the Company’s ability to continue as a going concern. Failure to arrange adequate financing on acceptable terms and/or achieve profitability may have an adverse effect on the financial position, results of operations, cash flows and prospects of the Company. The financial statements do not give effect to adjustments to assets or liabilities that would be necessary should the Company be unable to continue as a going concern. These adjustments could be material.

Results of Operations

We have a limited operating history. Therefore, there is limited historical financial information upon which to base an evaluation of our performance. Our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. We have incurred significant net losses since inception. We have, however, generated net income of $91,510 and $97,039 for the years ended December 31, 2025 and 2024, respectively and net income for the three months ended March 31, 2026 of $307,844. As of March 31, 2026, we had a total stockholders’ deficit of $(814,712), an accumulated deficit of $125,144,816, and negative working capital of $1,010,091. As of December 31, 2025, we had a total stockholders’ deficit of $(1,125,680), an accumulated deficit of $125,452,659, and negative working capital of $1,272,378. The large accumulated deficit is mainly the result of the original 2016 license agreement with Zhittya valued at $76.5 million, as discussed in greater detail under “Business—License Agreement with Zhittya”, that was fully written off by 2022 under a revised valuation. Another $46.5 million in expenses related to the value of the preferred stock issued to Zhittya pursuant to the terms of the License Agreement. These two items, combined, equal $123 million of the accumulated deficit and do not reflect the results of ongoing operations. From 2023 to 2025, the Company has generated net income every year, with cumulative income of $251,597 over these three years, and net income for the three months ended March 31, 2026 of $307,844. We expect to incur additional net expenses over the next several years as we continue to maintain and expand our existing operations. The amount of future income we will achieve is uncertain.

Financial Overview

Revenue

We are generating other income from Zhittya’s cross-border operations and from a patient sponsored Type 2 diabetes research study taking place in Las Vegas, Nevada, and we expect the cross-border operations to continue and to grow, and future patient-funded studies to potentially become available in the United States. However, for the Company to make significant revenue, Zhittya, our strategic partner, needs to complete the development of its product candidates in a timely manner and obtain regulatory approval for them; otherwise, our ability to generate future revenue, and our results of operations and financial position, would be materially and adversely affected.

If our development efforts for Zhittya’s current or future product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales of such licensed products. Because of the numerous risks and uncertainties associated with product development, regulatory approval, and market acceptance, we are unable to predict the amount or timing of product revenue.

Operating Expenses

Operating expenses consist primarily of professional fees, consulting fees, office lease expenses, marketing costs, and general and administrative expenses. Operating expenses are expensed when incurred.

Professional fees include audit, legal, and outside accounting costs. Consulting fees primarily include the outsourced CEO and CFO, as well as general and business development consulting. General and administrative expenses include insurance, technology, banking, and other administrative costs.

We anticipate that our operating expenses will increase in the future to support our efforts to promote and raise awareness of the Company and to operate as a reporting company. These expenses will likely include costs related to the fees to outside consultants, lawyers, accountants, and investor relations firms.

Other income (expense)

Other income (expense) primarily consists of Income from participation in future revenues from a related party.

Income Taxes

As of December 31, 2025, and 2024 we had net operating loss (NOL) carry forwards of approximately $2,100,000. Net operating loss carryforwards of $32, and $35,310 will expire in 2036 and 2037, respectively. The remaining $2.07 million of the Company’s net operating losses have an indefinite carryforward period, but utilization for any tax year is limited to 80% of taxable income. After weighing all available and positive and negative evidence for the period, the Company determined a full valuation allowance is necessary against all net operating losses. As of March 31, 2026, the Company’s net operating loss carryforwards and related valuation allowance were not materially changed from December 31, 2025. The Company recorded no income tax expense for the three months ended March 31, 2026.

We have not recorded any net tax benefit due to uncertainty around utilizing these tax attributes within their respective carryforward periods.

Utilization of the net operating losses may be subject to a substantial annual limitation due to ownership change limitations provided by the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”).

RESULTS OF OPERATIONS

Comparison of the three months ended March 31, 2026, and 2025

Professional fees

These fees increased $227 for the three months ended March 31, 2026, due to $28,151 in additional audit fees in preparation for a potential public offering and $1,079 in legal fees, offset mostly by $29,003 in lower accounting costs with the financials now being initially prepared by the Company’s CFO.

Consulting fees

Consulting fees increased $20,021 for the three months ended March 31, 2026, as a result of the Company hiring a business development consultant for $12,000 ($4,000 over three months) and the CFO being paid $8,021 more for working a full quarter versus 75 days during the three months ended March 31, 2025.

Lease expense

Lease expense decreased $6,947 in the three months ended March 31, 2026 as the Company relocated to a less expensive office lease in mid- January 2025.

General and administrative expenses

General and administrative expenses increased $1,934 in the three months ended March 31, 2026, primarily from insurance and automobile expenses relating to the Company’s business development consultant engaged in 2026.

Income from participation in future revenues – related party

This income increased $398,543 for the three months ended March 31, 2026, due to $603,250 more in patient fees offset by $204,707 more in advertising costs and referral fees. Zhittya launched type 2 diabetes treatments in September 2025, for which the Company receives $15,000 per patient, resulting in $480,000 in new fees paid in the three months ended March 31, 2026. The Company also received $123,250 in additional fees from other treatments from Zhittya in the three months ended March 31, 2026, compared to the three months ended March 31, 2025.

Interest expense

Interest expense was $482 less in the three months ended March 31, 2026 due to $12,000 in prior related party loans that were repaid after March 31, 2025.

Income tax expense

The Company incurred $830 in income tax expense for the three months ended March 31, 2026.

Net Income (Loss)

The Company had net income of $307,844 for the three months ended March 31, 2026, compared to a net loss of $(75,115) in the three months ended March 31, 2025, primarily due to $398,543 in additional income from participation in future revenues, offset slightly by $15,236 more in operating expenses, each as discussed in greater detail above.

Comparison of the years ended December 31, 2025, and 2024:

Professional fees

These fees increased by $106,596 for the year ended 2025 versus the year ended 2024, driven by $107,133 in additional audit expenses and $16,806 in extra legal fees incurred in preparation for the anticipated public offering, offset by $(17,343) in lower accounting fees due to more efficient external support.

Consulting fees

The increase of $225,479 for the year ended December 31, 2025 versus the year ended December 31, 2024, is due to the engagement of an outsourced CFO for $184,479 in the year ended 2025, and a $41,000 increase in the remuneration of other consultants.

Lease expense

The Company relocated to a less expensive office lease in mid-January 2025. The year ended December 31, 2025 included $6,775 in final costs on the old lease in January 2025 and $29,238 in costs on the new lease. The year ended December 31, 2024 consists of twelve months on the old lease at $22,472 per quarter.

Income from participation in future revenues – related party

For the year ended December 31, 2025, this income increased over the year ended December 31, 2024, due to $300,000 in income from diabetes studies launched by Zhittya in September 2025, offset by $22,250 less income from ongoing studies.

Interest expense

Interest expense was $6,674 for the year ended December 31, 2025, versus $2,342 for the year ended December 31, 2024, was due to related party loans that averaged nearly $30,000 higher during the current year.

Net income

For the year ended December 31, 2025, the Company generated $5,530 less net income than in the year ended December 31, 2024. Higher other income of $277,750 was offset by $278,948 more in operating expenses, largely in preparation for an anticipated public offering in 2026.

LIQUIDITY, FINANCING, AND CAPITAL RESOURCES

As of March 31, 2026, we had approximately $159,906 in unrestricted cash. We believe our current unrestricted cash will not be sufficient to fund our currently anticipated operating expenses. We plan on funding this shortfall through additional borrowings from related parties, and if necessary, the sale of additional common shares of stock, including through the offering contemplated by this offering circular.

We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will incur significant losses for at least the next several years. As of March 31, 2026 and December 31, 2025, we had cash and cash equivalents of $159,906 and $176,337, respectively. For the three months ended March 31, 2026 and 2025, our net income (loss) was $307,844 and $(75,115), respectively, and our net cash provided by operating activities was $483,373 and $16,792, respectively. As of December 31, 2025 and December 31, 2024, we had cash of $176,337 and $67,434, respectively. For the years ended December 31, 2025 and 2024, our net income was $91,510 and $97,039, respectively, and our net cash provided by operating activities was $176,477 and $66,149, respectively.

We believe that funds from this offering, as well as revenues that the Company expects to receive from the ongoing Parkinson’s disease and Type 2 diabetes studies, will support our operations until such time as Zhittya obtains FDA approval for one or more of its drug candidates, and milestone payments are due. We believe that the earliest possible timeframe in which FDA approval could be obtained, if at all, is approximately three to seven years. Health Canada approval is not expected to be sought until after FDA approval is received, if at all, and the timeline for such future approval, if any, cannot be estimated at this time.

Our future liquidity and capital funding requirements are expected to depend on numerous factors, including:

We believe that our existing cash resources will not be sufficient to meet our forecasted requirements for operating liquidity, capital expenditures, and debt services for at least the next 12 months. We expect that over the next 12 months, our liquidity needs could range from none to $1 million, in the worst case. The Company does not currently have, and does not expect to have during the next 12 months, any capital expenditures or any debt service. The Company plans to address its financing requirements relating to the financial challenges as follows:

There is no certainty that the Company will be successful in raising capital and the Company currently has no committed source for borrowings. If we raise additional funds by issuing equity securities, our shareholders will experience dilution. Debt financing, if available, may involve covenants further restricting our operations or our ability to incur additional debt. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. Additional financing may not be available at all, or in amounts or on terms that we do not deem to be favorable. If we are unable to obtain additional financing when needed to satisfy our liquidity requirements, we may be required to delay the marketing of Zhittya’s drugs.

The following table provides detailed information about our net cash flows from continuing operations for the periods indicated:

CASH FLOWS

For the three months ended March 31, 2026 and 2025

Net Cash used in operating activities

In the three months ended March 31, 2026, net cash provided by operating activities was mainly the result of the Company generating $307,844 of net income, incurring $3,125 in non-cash stock-based consulting expenses, and a $156,908 increase in accounts payable, offset by a $440,000 decrease in other receivables, related party. Net cash provided by operating activities for the three months ended March 31, 2025 was mainly due to $75,115 of net loss, offset by $31,750 of increase in other receivables, related party, $28,214 of increase in accounts payable and $19,320 of increase in accrued expenses.

Net Cash used in investing activities

The Company paid a security deposit on a less expensive new office lease entered in January 2025 of $5,336, which made up the entire net cash used in investing activities for the three months ended March 2025.

Net Cash provided by financing activities

Net cash provided by financing activities for the three months ended March 31, 2026, was mainly due to the Company reducing loans payable to related parties by $12,000 and incurring $47,804 in deferred offering costs. Net cash provided by financing activities for the three months ended March 31, 2025, was mainly due to the Company borrowing a net of $33,000 from related parties in March 2025 to fund operating needs, offset by the repayment of a $916 loan and the Company incurring $25,000 in deferred offering costs.

For the years ended December 31, 2025 and 2024

Net cash provided by operating activities

For the year ended December 31, 2025, the Company had $176,477 of cash provided by operating activities, which mainly consisted of net income of $91,510, $1,360 in non-cash lease expenses, $7,722 in lease payments applied against a security deposit, and $11,979 in stock consulting expenses. The Company also collected the remaining $31,750 related party receivable, and increased accounts payable/accrued expenses by $37,776 to conserve cash, offset slightly by prepaid insurance for $5,620 for the year ended December 31, 2025. For the year ended December 31, 2024, net cash provided by operating activities was due to net income of $97,039, offset by $9,027 in non-cash lease expenses, together $37,909 in lease payments applied against a security deposit, collected $24,000 in related party receivables, and used this cash flow to reduce accounts payable/accrued expenses by $83,771. 

Net Cash used in investing activities

Net cash used in investing activities for the year ended December 31, 2025 was solely due to $5,336 paid on a security deposit for a less expensive new office lease deposit.

Net Cash used in financing activities

For the year ended December 31, 2025, net cash used in financing activities was $62,238 and related to $86,126 in deferred offering costs, $916 in external loans and a net of $24,804 received from related parties to fund operating needs. For the year ended December 31, 2024, net cash used in financing activities was $21,665 and related to $35,000 incurred in deferred offering costs, a net of $13,390 received from related-party loans, and $55 repaid on an external loan. 

OFF-BALANCE SHEET ARRANGEMENTS

We did not have any off-balance sheet arrangements during the periods presented, and we do not currently have any off-balance sheet arrangements, as defined by applicable regulations of the SEC, which are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures, or capital resources.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or US GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised, if the revision affects only that period, or in the period of the revision and future periods, if the revision affects both current and future periods.

Significant judgments, estimates and assumptions that have the most significant effect on the amounts recognized in the financial statements relate to the stock-based compensation, other receivables, and income from participation in future revenues. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.

Accounting for past equity issuances has been based on the estimated fair value at the time of issuance. Share-based compensation was based on the value of equity transactions over the past three years prior to the issuance of the Restricted Stock Units.

Recently Issued Accounting Pronouncements

In July 2025, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets (ASU 2025-05). The ASU 2025-05 relates to estimating credit losses under the calculation of current expected credit losses (CECL) for current accounts receivable and current contract assets arising from revenue transactions accounted for under ASC 606, Revenue from Contracts with Customers. The provisions of ASU 2025-05 are effective for annual reporting periods beginning after December 15, 2025, and interim reporting periods within those annual reporting periods. The Company early adopted ASU 2025-05 on January 1, 2025 on a prospective basis and elected to apply the practical expedient for accounts receivable, however, since the Company does not have any accounts receivable at December 31, 2025, there was no impact of this adoption on the accompanying financial statements or operations.

In November 2024, the FASB issued ASU 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures” to require more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact of adopting this guidance on its financial statements and related disclosures. The adoption of this pronouncement is not expected to have a material impact on the Company’s financial statements.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures related to improvements to income tax disclosures. The amendments in this update require enhanced jurisdictional and other disaggregated disclosures for the effective tax rate reconciliation and income taxes paid. The amendments in this update are effective for fiscal years beginning after December 15, 2024. The adoption of this pronouncement had no impact on the Company’s financial statements.

In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company adopted the ASU on January 1, 2024 and has expanded its disclosure.

In October 2023, the FASB issued ASU 2023-06 “Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative,” which incorporates certain SEC disclosure requirements into the FASB Accounting Standards Codification (“Codification”). The amendments in the ASU are expected to clarify or improve disclosure and presentation requirements of a variety of Codification topics, allow investors to more easily compare entities subject to the SEC’s existing disclosures with those entities that were not previously subject to the requirements, and align the requirements in the Codification with the SEC’s regulations. The effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The amendments in this ASU should be applied prospectively. The Company does not expect ASU 2023-06 will have a material impact to its financial statements or related disclosures.

Implications of Being an Emerging Growth Company