LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.

4,689,177 Shares of
Common Stock

This prospectus relates to the registration of the resale of up to 4,689,177 shares of our common stock by our stockholders identified in this prospectus, or the Registered Stockholders, in connection with our direct listing, or the Direct Listing, on the Nasdaq Capital Market, or Nasdaq. Unlike an initial public offering, the resale by the Registered Stockholders is not underwritten on a firm commitment basis by any investment bank. The Registered Stockholders may, or may not, elect to sell their shares of common stock covered by this prospectus, as and to the extent they may determine. The Registered Stockholders may offer, sell, or distribute all or a portion of the shares of common stock hereby registered publicly or through private transactions at prevailing market prices or at negotiated prices. If the Registered Stockholders choose to sell their shares of common stock, we will not receive any proceeds from the sale of shares of common stock by the Registered Stockholders.

No public market exists for our common stock. Further, the listing of our common stock on Nasdaq, without a firm-commitment underwritten offering, is a novel method for commencing public trading in shares of our common stock, and consequently, the trading volume and price of shares of our common stock may be more volatile than if shares of our common stock were initially listed in connection with an initial public offering underwritten on a firm-commitment basis.

We have engaged a financial advisor to advise and assist us with respect to certain matters relating to our listing. The services expected to be performed by the advisor will include providing advice and assistance with respect to defining objectives, analyzing, structuring, and planning the listing, and developing and assisting with our investor communication strategy in relation to this listing. On February 10, 2025, Lakewood-Amedex Biotherapeutics Inc. executed an agreement with RBW Capital Partners LLC (the “Advisor” or “RBW”) for the provision of financial advisory and financial placement agency, and investment banking services, which include assisting the company with a direct listing. Pursuant to the terms of the agreement, upon closing, the Company agreed to compensate RBW with a number of shares of the Company, equal to that certain percentage from the aggregate value of the transaction as described in the agreement. As of the date hereof, it is expected that RBW will be issued 272,219 of our shares as compensation equal to 1.75% of the current fully diluted shares outstanding (the “Advisory Shares”). The Advisory Shares will not be registered by the Company under this offering.

On the day that our shares of common stock are initially listed on Nasdaq, Nasdaq will begin accepting, but not executing, pre-opening buy and sell orders and will begin to continuously generate the indicative Current Reference Price (as defined below) on the basis of such accepted orders. The Current Reference Price is calculated each second and, during a 10-minute “Display Only” period, is disseminated, along with other indicative imbalance information, to market participants by Nasdaq on its NOII and BookViewer tools. Following the “Display Only” period, a “Pre-Launch” period begins, during which RBW, in its capacity as our financial advisor, must notify Nasdaq that our shares are “ready to trade.” Once the Advisor has notified Nasdaq that our shares of common stock are ready to trade, Nasdaq will confirm the Current Reference Price for our shares of common stock, in accordance with the Nasdaq rules. If the Advisor then approves proceeding at the Current Reference Price, the applicable orders that have been entered will be executed at such price, and the regular trading of our shares of common stock on Nasdaq will commence, subject to Nasdaq conducting validation checks in accordance with the Nasdaq rules. Under the Nasdaq rules, the “Current Reference Price” means: (i) the single price at which the maximum number of orders to buy or sell can be matched; (ii) if there is more than one price at which the maximum number of orders to buy or sell can be matched, then it is the price that minimizes the imbalance between orders to buy or sell (i.e. minimizes the number of shares that would remain unmatched at such price); (iii) if more than one price exists under (ii), then it is the entered price (i.e. the specified price entered in an order by a customer to buy or sell) at which our shares of common stock will remain unmatched (i.e. will not be bought or sold); and (iv) if more than one price exists under (iii), a price determined by Nasdaq in consultation with the Advisor in its capacity as our financial advisor. In the event that more than one price exists under (iii), the Advisor will exercise any consultation rights only to the extent that it can do so consistent with the anti-manipulation provisions of the federal securities laws, including Regulation M, or applicable relief granted thereunder. The Registered Stockholders will not be involved in Nasdaq’s price-setting mechanism, including any decision to delay or proceed with trading, nor will they control or influence the Advisor in carrying out its role as a financial adviser. The Advisor will determine when our shares of common stock are ready to trade and approve proceeding at the Current Reference Price primarily based on considerations of volume, timing, and price. In particular, the Advisor will determine,

TABLE OF CONTENTS

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus includes statements that express our opinions, expectations, beliefs, plans, objectives, assumptions, or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” All statements other than statements of historical facts contained in this prospectus may be forward-looking statements. These forward-looking statements can generally be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “continues,” “anticipates,” “expects,” “seeks,” “projects,” “intends,” “plans,” “may,” “will,” “would” or “should” or, in each case, their negative or other variations or comparable terminology. They appear in a number of places throughout this prospectus, and include statements regarding our intentions, beliefs, or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, growth, strategies, future acquisitions, and the industry in which we operate. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We believe that these risks and uncertainties include, but are not limited to, those described in the “Risk Factors” section of this prospectus. These factors should not be construed as exhaustive and should be read with the other cautionary statements in this prospectus. Although we base these forward-looking statements on assumptions that we believe are reasonable when made, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition, and liquidity, and industry developments may differ materially from statements made in or suggested by the forward-looking statements contained in this prospectus. The matters summarized under “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business,” and elsewhere in this prospectus could cause our actual results to differ significantly from those contained in our forward-looking statements. In addition, even if our results of operations, financial condition, and liquidity, and industry developments are consistent with the forward-looking statements contained in this prospectus, those results or developments may not be indicative of results or developments in subsequent periods. In light of these risks and uncertainties, we caution you not to place undue reliance on these forward-looking statements. Any forward-looking statement that we make in this prospectus speaks only as of the date of such statement, and we undertake no obligation to update any forward-looking statement or to publicly announce the results of any revision to any of those statements to reflect future events or developments, except as required by applicable law. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless specifically expressed as such, and should only be viewed as historical data.

You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this prospectus primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, and other factors described in “Risk Factors” and elsewhere in this prospectus. Moreover, we operate in a competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this prospectus. The results, events, and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events, or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this prospectus relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this prospectus to reflect events or circumstances after the date of this prospectus or to reflect the latest information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may make.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

USE OF MARKET AND INDUSTRY DATA

This prospectus includes market and industry data that has been obtained from third-party sources, including industry publications, as well as industry data prepared by our management on the basis of its knowledge and experience in the industries in which we operate (including our management’s estimates and assumptions relating to those industries based on that knowledge). Furthermore, references in this prospectus to any publications, reports, surveys, or articles prepared by third parties should not be construed as depicting the complete findings of the entire publication, report, survey, or article, including those discussed under the section entitled “Risk Factors” and elsewhere in this prospectus. Some data are also based on our good-faith estimates. The information in any such publication, report, survey, or article is not incorporated by reference in this prospectus.

TRADEMARKS

We own or have rights to various trademarks, service marks, and trade names that we use in connection with the operation of our business. This prospectus may also contain trademarks, service marks, and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names, or products in this prospectus is not intended to, and does not imply a relationship with, or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus may appear without the ®, ™ or ℠ symbols, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable owner of these trademarks, service marks and trade names.

ABOUT THIS PROSPECTUS

This prospectus is a part of a registration statement on Form S-1 that we filed with the SEC using a continuous offering process. Under this process, the Registered Stockholders may, from time to time, sell the common stock covered by this prospectus in the manner described in the section titled “Plan of Distribution.” Additionally, we may provide a prospectus supplement to add information to, or update or change information contained in, this prospectus, including the section titled “Plan of Distribution.” You may obtain this information without charge by following the instructions under the “Where You Can Find Additional Information” section appearing elsewhere in this prospectus. You should read this prospectus and any prospectus supplement before deciding to invest in our common stock.

RISK FACTORS

An investment in our common stock involves a high degree of risk. You should carefully consider the following risks and all of the other information contained in this prospectus before deciding whether to invest in our common stock. If any of the following risks are realized, our business, financial condition, and results of operations could be materially and adversely affected. In that event, the trading price of our common stock could decline, and you could lose all or part of your investment in our common stock. Additional risks of which we are not presently aware, or that we currently believe are immaterial, may also harm our business and results of operations. Some statements in this prospectus, including such statements in the following risk factors, constitute forward-looking statements. See the section entitled “Cautionary Note Regarding Forward-Looking Statements.”

The successful development of biopharmaceutical products is highly uncertain.

Successful development of biopharmaceutical products is highly uncertain and depends on numerous factors, many of which are beyond our control. Product candidates that appear promising in the early phases of development may fail to reach the market due to clinical trial results showing insufficient efficacy (e.g., failure to meet primary or key secondary endpoints) or unacceptable safety or tolerability profiles. Development may also be delayed or halted due to failure to obtain regulatory approvals or delays caused by slow enrollment, high dropout rates, lengthy timeframes to achieve endpoints, extended data analysis, additional FDA data requests, or manufacturing or safety issues. Preclinical results may reveal harmful side effects or inadequate efficacy, and post-marketing requirements or competing proprietary technologies may also hinder commercialization.

Even if we are successful in obtaining marketing approval, commercial success of approved products may also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations in the United States or country-specific governmental organizations in foreign countries, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of an approved product, to qualify for reimbursement, which could be costly and divert our resources. If government and other healthcare payors were to not provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success may be reduced. In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration and will need to continue to comply (or ensure that any third-party providers comply) with current good manufacturing practices, good clinical practices, or good clinical practices for any clinical trials that we conduct post-approval. In addition, there is always the risk that we, a regulatory authority, or a third party might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with our product candidates post-approval could adversely affect our business, financial condition, and results of operations.

We have a limited operating history, and none of our current product candidates have been approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success.

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are at the clinical stage for the development of an anti-infective pharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. None of our current product candidates is approved for commercial sale, and we have not generated any revenue from them. To date, we have primarily focused our resources on company formation, business planning, partnerships, capital raising, R&D, securing intellectual property, and conducting preclinical and clinical studies. As a result, it may be more difficult for you to accurately predict our future success or viability. In addition, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors frequently experienced by clinical-stage biopharmaceutical companies. We may also need to transition from a company with a research focus to a company capable of supporting commercial activities. If we do not adequately address these risks or successfully make such a transition, our business will suffer.

We will need to raise additional capital, which may not be available on favorable terms, if at all, potentially causing dilution to stockholders, restricting our operations, or adversely affecting our business.

Developing biopharmaceutical products is a time-consuming, expensive, and uncertain process that takes years to complete. Our operations have required substantial cash since inception, and we expect expenses to increase as we advance clinical trials and seek regulatory approvals for our current and future product candidates. Even if one or more of our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Expenses may exceed expectations if regulatory authorities such as the FDA or EMA require additional studies beyond our current plans. Other unforeseen costs may also arise. Given the uncertainty in trial design and outcomes, we cannot accurately estimate the total funding needed to complete development and commercialization. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations.

Our estimate as to how long our existing capital will fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, including factors beyond our control, could lead us to use capital more quickly than anticipated, requiring us to seek additional funding earlier than planned. Our future funding requirements will depend on many factors, including, but not limited to the following: the initiation, progress, timing, cost, and outcomes of clinical trials and preclinical studies; the advancement of our pipeline and research programs; manufacturing costs, including scale-up activities; potential program expansions for new indications; regulatory requirements and their timing and cost; expenses related to intellectual property protection; competitive developments; licensing, royalty, and milestone payments; general operating expenses; costs to establish sales, marketing, and distribution infrastructure for any approved products; and the ongoing expenses of operating as a public company.

Advancing the development of our product candidates will require a significant amount of capital. In order to fund all of the activities that are necessary to complete the development of our product candidates, we will be required to obtain further funding through equity offerings, debt financings, collaborations and licensing arrangements, or other sources, which may dilute our stockholders or restrict our operating activities. Adequate additional funding may not be available to us on acceptable terms, or at all. Our failure to raise capital would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research-stage programs, clinical trials or future commercialization efforts, grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain funds through arrangement with collaborators on terms unfavorable to us or pursue merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our stockholders.

In addition, we may seek additional capital through equity, debt financing, or strategic collaborations, even if current funds appear sufficient. This may include up-front or milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a stockholder. Such financing may also result in the imposition of debt covenants, increased fixed payment obligations, or other restrictions that may adversely affect our ability to conduct our business. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates, or grant licenses on terms that are not favorable to us.

Risks Related to Development, Regulatory Approval, and Commercialization

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

Our product candidates are subject to extensive government regulation throughout all stages of development, including research, testing, manufacturing, safety, efficacy, approval, labeling, marketing, and distribution. Rigorous preclinical studies and clinical trials, and an extensive regulatory approval process must be successfully completed in the United States and in many foreign jurisdictions before a new drug can be marketed. We are not permitted to commercialize any product candidate in the United States without obtaining marketing approval from the FDA. Foreign regulatory authorities, such as the EMA, impose similar requirements. Obtaining such approvals is unpredictable, often

takes years after clinical trials begin, and depends on factors such as the type, complexity, and novelty of the product. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during product development and may vary among jurisdictions, potentially delaying or preventing approval. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical, or other data. Even if we eventually complete clinical testing and receive approval, our product candidates may be limited to narrower uses than requested. We cannot provide any assurance that any product candidate we may develop will progress through required clinical testing and obtain the regulatory approvals necessary for us to begin selling them. We have not yet submitted or obtained approval for any product candidate, and it is possible that none of our current or future candidates will ever be approved.

Further, the development of our product candidates and/or regulatory approval may be delayed for reasons beyond our control. Regulatory applications could be denied for many reasons, including the following:

•        Regulatory authorities such as the FDA or EMA may disagree with our clinical trial design, execution, or results, or may conclude that our product candidates are unsafe, only moderately effective, or have side effects or toxicities that prevent approval or limit commercial use;

•        Trial populations may not be sufficiently broad or representative enough to support approval;

•        Regulatory authorities may disagree with our interpretation of data from preclinical or clinical studies;

•        Data from our clinical trials may be insufficient to support the submission of a New Drug Application, or NDA, or other regulatory submission for approval in the U.S. or other regions;

•        We may be unable to show regulatory authorities that a product candidate’s risk-benefit ratio is acceptable for its intended use;

•        Regulatory authorities may not approve our manufacturing processes, testing procedures, specifications, or facilities, including those of third-party manufacturers for clinical and commercial supplies; and

•        Changes in regulatory policies or regulations may render our clinical data insufficient for approval.

The lengthy and unpredictable approval process, along with the uncertainty of clinical trial results, may prevent us from obtaining regulatory approval for any product candidates, significantly harming our business and prospects. Additionally, changes in regulatory policies or new regulations could delay approval of our future candidates, impose additional compliance requirements, or restrict our ability to maintain marketing authorizations.

We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Before we can obtain marketing approval from the FDA, EMA, or other foreign regulators, we must complete preclinical studies and extensive clinical trials to demonstrate safety and efficacy. Clinical testing is expensive, difficult to design and implement, time-consuming, and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process, and results from preclinical or early-stage trials may not predict success in later phases. Clinical trials can be delayed for a variety of reasons, including delays related to:

•        Disagreements with regulatory authorities (e.g., FDA, EMA) over trial design or implementation;

•        Delays in securing regulatory approval or agreement on trial design;

•        Delays in finalizing agreements with CROs or clinical trial sites due to complex or varying terms;

•        Obtaining approval from one or more independent institutional review boards, or IRBs;

•        Delays in enrollment due to travel or quarantine policies, or other uncontrollable events;

•        Changes to clinical trial protocol;

•        Clinical sites deviating from trial protocol or dropping out of a trial;

•        Delays in manufacturing sufficient quantities of a product candidate or obtaining enough combination therapies for clinical trial use;

•        Subjects not enrolling, dropping out, or failing to return for post-treatment follow-up at expected rates;

•        Lack of adequate funding to continue the clinical trial;

•        Subjects experiencing severe or unexpected drug-related adverse effects;

•        A drug safety management board or DSMB may recommend protocol changes or early termination;

•        Occurrence of serious adverse events in trials of the same class of agents conducted by other companies;

•        Selection of clinical endpoints requiring extended observation or data analysis;

•        A manufacturing facility being ordered to shut down by regulatory authorities due to cGMP violations, or issues like infections or cross-contamination;

•        Third-party clinical investigators losing necessary licenses or failing to conduct trials on schedule or in compliance with protocols, GCP, or regulatory requirements;

•        Third-party contractors not performing data collection or analysis in a timely or accurate manner; and

•        Third-party contractors being debarred or penalized by regulatory authorities, requiring us to find substitutes and potentially invalidating their data for marketing applications;

Conducting clinical trials in foreign countries, as we may do for our product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

Additionally, if the results of our clinical trials are inconclusive or if safety concerns or serious adverse events arise, we may face delays in obtaining marketing approval, receive approval for narrower indications or patient populations than desired, or face approval with significant restrictions, safety warnings, or additional post-marketing testing. We could also be required to include warnings or contraindications on labeling, face legal action, or suffer damage to our reputation. Delays in testing or obtaining marketing approvals will increase our development costs. We cannot predict if our preclinical studies or clinical trials will start as planned, be restructured, or be completed on schedule. Any delays or termination of trials will push back NDA submissions to the FDA or similar regulatory authorities, hindering our ability to commercialize and generate revenue. Even if trials are completed on time, we cannot guarantee the results will support our claims of differentiation, effectiveness, or safety. The FDA has broad discretion and may disagree that our data support our proposed claims.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us and receive compensation in connection with such services. Under certain circumstances, we may need to report these relationships to regulatory authorities like the FDA or EMA. If authorities determine that a financial relationship creates a conflict of interest, they may question the integrity of the data and jeopardize the trial’s validity. This could result in delays, rejection, or denial of marketing approval for our product candidates.

Delays or termination of our clinical trials would harm the commercial prospects of our product candidates and delay our ability to generate revenue. These delays would also increase costs, slow development and approval, and jeopardize our ability to start product sales. In addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, factors leading to trial delays or termination could result in regulatory approval denial of a product candidate. Such delays may reduce the period of exclusivity for commercialization, allowing competitors to bring similar products to market first, further harming the commercial viability of our product candidates and our business.

The outcome of preclinical studies or early clinical trials may not predict the success of later trials, and the results may not meet the requirements of the FDA, the EMA, or other regulatory authorities.

Positive results from preclinical studies and early clinical trials do not mean that future clinical trials will be successful. Failure can occur at any time during the clinical trial process. We do not know whether any of our product candidates will perform in current or future clinical trials as they have performed in preclinical studies and early clinical trials. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, the EMA, and other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences in adherence to the dosing regimen and other trial protocols, and the rate of dropout among clinical trial participants. Patients treated with our product candidates may also be undergoing surgical, radiation, and chemotherapy treatments and may be using other approved products or investigational new drugs, which can cause side effects or adverse events that are unrelated to our product candidate. As a result, assessments of efficacy can vary widely for a particular patient, and from patient to patient and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes. We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval to market our product candidates. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

Additionally, some of our planned clinical trials may utilize an “open-label” or “single-blinded” trial design. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving either the investigational product candidate or an existing approved pharmaceutical or placebo. In a single-blinded trial, the patient does not know which dose is applied. Most typically, open-label as well as single-blinded clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Both open-label and single-blinded clinical trials are subject to various limitations that may exaggerate any therapeutic effect, as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably, given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates, for which we include an open-label clinical trial when studied in a controlled environment with a placebo or active control.

In a single-blinded clinical trial, the investigator is aware of the type of treatment and dosing. These designs are vulnerable to an “investigator bias” in which beliefs and expectations of the investigator can influence the interpretation of observations and hence falsely influence a trial outcome. In addition, the investigator’s knowledge of the treatment and the respective beliefs and expectations may carry over to the patients and influence the true perception of, for example, adverse events.

Moreover, preclinical and clinical data are often susceptible to varying interpretations, and many companies with positive trial results have still failed to obtain regulatory approval. We cannot guarantee that the FDA, the EMA, or other regulatory authorities will interpret our results favorably, and additional trials may be required. This is particularly true for clinical trials in rare diseases, where the small patient population makes traditional trials challenging and regulatory flexibility is often needed. If the results do not meet regulatory standards, we may need to conduct more trials, which could require significant resources. Even if approval is granted, the terms may limit the scope of use and commercial potential. Additionally, changes in regulatory policies could render our clinical data insufficient, delaying or denying approval.

Interim, topline, and preliminary data from our clinical trials may change as more patient data becomes available and undergoes audit and verification, potentially leading to material changes in the final results.

We may periodically disclose interim, preliminary, or topline data from our preclinical studies or clinical trials based on the available data at the time. However, these results are subject to change following further analysis, and the final data could differ significantly due to additional data review, assumptions, or verification. As such, interim and preliminary results should be viewed with caution until final data is available. Differences between preliminary and final data

may impact our business prospects. Moreover, regulatory agencies or others may not agree with our assumptions, calculations, or conclusions, which could affect the program’s value, approval, or commercialization. The information we disclose may not always align with what others consider material, and if preliminary data diverges from actual results or regulatory interpretation, our ability to obtain approval and commercialize our product candidates could be jeopardized, impacting our business, results, and prospects.

Our current or future product candidates may cause adverse events, toxicities, or undesirable side effects, either alone or in combination with other drugs. These issues could hinder regulatory approval, market acceptance, and commercial potential, or lead to significant negative consequences.

As with most biopharmaceuticals, our product candidates may cause side effects or adverse events. If clinical trial results reveal unacceptable severity or prevalence of these side effects, we may need to delay or halt trials, face a restrictive label, or experience delays or denials of regulatory approval. Adverse events could also affect patient recruitment, retention, or lead to product liability claims, which could harm our business and prospects. If our product candidates show undesirable side effects or unexpected characteristics, we may need to limit their development to specific populations or conditions where the risks are more acceptable. Adverse side effects may also impact the recruitment and retention of patients and could lead to trial termination or abandonment. Any of these occurrences may prevent us from achieving or maintaining market acceptance of the affected product candidate and may harm our business, financial condition, and prospects significantly.

If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting patients to the clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether. Even if a product candidate is approved, the emergence of new side effects could lead to serious regulatory consequences. These include adoption of a Risk Evaluation and Mitigation Strategy (REMS), additional labeling requirements, restricted access, post-marketing studies, or even market withdrawal. We could also face penalties, lawsuits, or reputational damage. Any of these outcomes could limit commercial potential, reduce product usage, and prevent us from achieving or maintaining market acceptance. Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of the affected product candidate, if approved by applicable regulatory authorities.

Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.

Even if our product candidates receive regulatory approval, they may not achieve adequate market acceptance among physicians, patients, healthcare payors, or others in the medical community. Market acceptance will depend on various factors, including: demonstrated efficacy and safety relative to existing treatments; timing of launch versus competing products; approved indications; any restrictions such as boxed warnings, contraindications, or REMS not required of alternatives; perceived advantages over current therapies; cost and pricing relative to alternatives; coverage and reimbursement by payors; ease of administration; willingness of patients and physicians to adopt new treatments; the effectiveness of our marketing efforts; public perception and media coverage; and the emergence of new competing therapies. If any of our product candidates is approved but does not achieve an adequate level of acceptance, we may not generate sufficient revenue from that product candidate, and our financial results could be negatively impacted.

Refrigerated product candidates require specific storage, handling, and administration at the clinical sites.

Our products may require refrigeration or need to be stored at low temperatures in specialized refrigerated containers until immediately prior to use. The handling, warming, and administration of the antimicrobial product would need to be performed according to specific instructions. Failure to properly store, prepare, or administer them according to instructions could compromise their safety or efficacy.

We may develop our current and future product candidates in combination with other therapies, which exposes us to additional risks, and certain of our product candidates are regulated as combination products.

We may develop our current and future product candidates in combination with one or more other approved or unapproved therapies. We may also develop certain product candidates as biologic/drug combination products. These combination approaches may require additional development time and regulatory coordination, particularly within the

FDA and comparable foreign agencies. Although the FDA and similar foreign regulatory agencies have systems in place for the review of combination products, we may experience delays in the development and commercialization of our product candidates due to regulatory timing constraints and uncertainties in the approval process.

In addition, even if any product candidate were to receive marketing approval or be commercialized for use in combination, we would continue to face risks that the FDA, the EMA, or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those existing therapies. Changes in the standard of care may also require us to conduct additional trials. The occurrence of any of these risks could result in our own product candidates, if approved, being removed from the market or being less successful commercially.

We will not be able to market and sell our product candidates that we develop in combination with an unapproved therapy for a combination indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product candidate. Unapproved therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials, and lack of FDA approval. If these therapies are not approved or later face regulatory issues, we may be unable to obtain approval or commercialize our combination products.

We may allocate our limited resources to a specific product candidate or indication and miss opportunities to pursue others that could be more profitable or more likely to succeed.

Because we have limited financial and managerial resources, we focus on research programs, therapeutic platforms, and product candidates that we identify for specific indications. As a result, we may forego or delay the pursuit of opportunities with other therapeutic platforms or product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs, therapeutic platforms, and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights.

Risks Related to Our Business

The sizes of the markets for our product candidates are estimates, and these markets may be smaller than estimated.

The estimates in this prospectus of the annual addressable markets for our product candidates are based on a number of third-party estimates. While we believe the assumptions and the data underlying the estimates are reasonable, these assumptions and estimates may not be correct, and the conditions supporting the assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, the estimates of the annual addressable market for our product candidates may prove to be incorrect.

Our long-term prospects depend in part on the successful discovery and development of additional product candidates, which may fail or be delayed in development, adversely affecting their commercial viability.

Our future operating results are dependent on our ability to successfully discover, develop, obtain regulatory approval for, and commercialize product candidates beyond those we currently have in clinical development. A product candidate can unexpectedly fail at any stage of preclinical or clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care, and other unpredictable variables. The results from preclinical studies or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.

The success of our future product candidates depends on several factors, including: generating sufficient data to support clinical trials; obtaining regulatory permission to initiate clinical trials; contracting with the necessary parties to conduct clinical trials; successful enrollment of patients in, and the completion of, clinical trials on a timely basis; the timely manufacture of sufficient quantities of the product candidate and other key materials needed for use in clinical trials; and adverse events in the clinical trials. Even if we successfully advance any other product candidates

into clinical development, their success will be subject to all of the clinical, regulatory, and commercial risks described elsewhere in this “Risk Factors” section. Accordingly, we cannot assure you that we will ever be able to discover, develop, obtain regulatory approval of, commercialize, or generate significant revenue from our product candidates.

We have never commercialized anti-infective pharmaceuticals before and may lack the necessary expertise, personnel, and resources to successfully commercialize any product candidates.

We have no experience commercializing anti-infective pharmaceuticals and currently lack a sales force, marketing, or distribution capabilities. To achieve commercial success for our current product candidates, we will rely on the assistance and guidance of those collaborators. For any approved product candidates for which we retain commercialization rights, we will have to develop our own sales and marketing organization or outsource these activities to a third party or enter into a formal partnership agreement with an established pharmaceutical entity.

Our ability to commercialize product candidates depends on factors like recruiting sales and marketing personnel, gaining physician access, and managing the costs of building a sales organization. Developing these capabilities will be expensive and time-consuming and could delay the launch of our product candidates, if approved. If we are unable to build our own distribution and marketing capabilities or to find suitable partners for the commercialization of our product candidates, we may not generate revenues from them or be able to reach or sustain profitability.

We may face significant competition, and if our competitors develop superior, safer, or more cost-effective products, our commercial opportunities could be negatively impacted.

Biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary and novel products and product candidates. Our competitors have developed, are developing, or may develop products, product candidates, and processes competitive with our product candidates. Our product candidates will compete with existing therapies and new therapies that may become available in the future. We believe that a small number of products are currently under development and may become commercially available in the future, for the treatment of conditions for which we may attempt to develop product candidates. See “Business — Competition” for additional details. Our products may also need to compete with off-label drugs used for similar indications, making it difficult to replace existing therapies with our products.

Many of our current and potential competitors, especially large pharmaceutical and biotechnology companies, have significantly greater financial, manufacturing, marketing, drug development, technical, and human resources, and commercial expertise than we do. These companies have extensive experience in clinical testing, regulatory approvals, patient recruitment, and product manufacturing. Established pharmaceutical and biotechnology companies may also invest heavily to accelerate the discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete. Smaller companies, particularly those with strong partnerships, could also pose significant competition. As a result, our competitors may succeed in obtaining approval and commercializing products in our field before we do.

Our commercial opportunity could be diminished if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe effects, are more convenient, have a broader label, are marketed more effectively, are reimbursed, or are less expensive than any product candidates that we may develop. They may also obtain marketing approval for their products more rapidly than we may obtain approval for ours, which could result in them establishing a strong market position before we are able to enter the market. Even if the product candidates achieve marketing approval, they may be priced at a significant premium over competitive products. Technological advances by competitors could render our products obsolete or less viable. If we cannot compete effectively, our ability to generate revenue could be negatively impacted.

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives. We will be subject to financial reporting and other requirements for which our systems and resources may not be adequately prepared.

As a public company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting, and other expenses that we did not incur as a private company. In addition, the federal securities laws, including the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and rules and regulations subsequently implemented by the SEC and Nasdaq, have imposed various requirements on public companies, including requirements to file annual, quarterly, and event driven reports with respect to

their business and financial condition, and to establish and maintain effective disclosure and financial controls and corporate governance practices. These rules and regulations will increase our legal and financial compliance costs, make certain activities more time-consuming and costly, and require our management and other personnel to devote a substantial amount of time to compliance initiatives. Despite our best efforts, we may not be able to produce reliable financial statements or file such financial statements as part of a periodic report in a timely manner with the SEC or comply with Nasdaq listing requirements. We also expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

Pursuant to Section 404 of the Sarbanes-Oxley Act, we will be required to furnish a report by our management on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm, beginning with the first full year after we become a public company. However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 of the Sarbanes-Oxley Act, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. We will need to continue to dedicate internal resources, potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley Act. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. We could also become subject to investigations by the SEC or other regulatory authorities, which could require additional financial and management resources.

As a public company, we will also be required to maintain disclosure controls and procedures. Disclosure controls and procedures mean our controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported, within the time periods specified in the rules and forms of the SEC. We do not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. We believe 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. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and any design may not succeed in achieving its stated goals under all potential future conditions. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

We have identified material weaknesses in its internal controls over financial reporting, The material weaknesses identified include the following: (i) the Company’s documentation of its system of internal controls (including specific control policies and procedures) is limited, (ii) Segregation of duties in the handling of cash, cash receipts, and cash disbursements is limited primarily based on the small number of employees that comprise the Company’s workforce, (iii) Lack of adequate management review controls over significant accounting areas, including calculations of investments, earnings per share, stock-based compensation, income tax provision, and ROU lease schedules, and (iv) Information technology general controls are not designed and operating effectively to ensure that access to applications and data were adequately restricted to appropriate personnel, ensure segregation of duties, and appropriately monitor the activities of the individuals with access to modify data.

Neither the Company nor its independent registered public accounting firm undertook a comprehensive assessment of its internal control under the Sarbanes-Oxley Act for purposes of identifying and reporting any material weakness in its internal control over financial reporting. The Company is required to do so only after it becomes a public company and it is exempt from the auditor attestation requirements as long as it is an emerging growth company. Had we performed a formal assessment of its internal control over financial reporting or had our independent registered public accounting firm performed an audit of the effectiveness of its internal control over financial reporting, additional material weaknesses may have been identified.

We plan to begin the process of remediating such material weaknesses but there can be no assurance as to when or if we will fully remediate such material weaknesses.

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

Our audited financial statements for the year ended December 31, 2025 include an explanatory paragraph from our independent registered public accounting firm expressing substantial doubt about our ability to continue as a going concern. As of December 31, 2025, we had cash of approximately $0.2 million and a working capital deficit of approximately $2.1 million. Further, we have incurred and expect to continue to incur significant costs in pursuit of our financing and the pursuit of our business objectives.

Management’s plan to address this uncertainty includes raising additional capital beyond the proceeds from this offering, which is discussed in the section of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” However, we cannot assure you that we will be successful in obtaining such financing on favorable terms, or at all. If we are unable to raise additional capital as and when needed, we may be forced to delay or reduce our business activities, scale back or eliminate planned initiatives, or, in a worst-case scenario, cease operations entirely.

These factors, among others, raise substantial doubt about our ability to continue as a going concern. The financial statements contained elsewhere in this prospectus do not include any adjustments that might result from our inability to consummate this offering or our inability to continue as a going concern.

Risks Relating to Our Dependence on Third Parties

We rely, and expect to continue to rely, on third parties for preclinical studies, clinical trials, and manufacturing. If these third parties fail to fulfill their duties, comply with applicable regulations, or meet expected deadlines, it could delay regulatory approval or commercialization of our product candidates, harming our business.

We have relied upon and plan to continue to rely upon third parties, including independent clinical investigators and third-party CROs, to conduct certain aspects of our preclinical studies and clinical trials. While we control only certain aspects of their activities, we remain responsible for ensuring trials comply with protocols, legal and regulatory standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. All parties must adhere to Good Clinical Practice (GCP) guidelines enforced by the FDA and foreign regulatory authorities through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable, and additional clinical trials before approving our marketing applications may be required. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Our business may be adversely affected if any of these third parties violate federal or state fraud and abuse or false claims laws and regulations, or healthcare privacy and security laws. For the risk to manufacturing, see the section on Risks Related to Manufacturing.

Further, there is no guarantee that any such CROs, investigators, or other third parties on which we rely will devote adequate time and resources to our development activities or perform as contractually required. If these parties fail to meet obligations, adhere to protocols, or produce reliable data, our clinical trials may be extended, delayed, or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Consequently, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenues could be delayed or halted entirely.

Our CROs have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our CROs have the ability to terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the subjects participating in our clinical trials warrants such termination, if we make a general assignment for the benefit of our creditors, or if we are liquidated. If any of our relationships with these third-party CROs terminate, finding a replacement on reasonable terms may be difficult and time-consuming. Transitioning to a new CRO can cause delays, increase costs, and divert management focus. Capacity limitations among CROs may also hinder timely support. Despite our efforts to manage these relationships, future disruptions could materially impact our development timelines, business, financial condition, and prospects.

If we decide to establish additional collaborations but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.

Developing and potentially commercializing our product candidates will require significant additional funding. To support these efforts, we may pursue selective collaborations to enhance our capabilities, potentially accelerate research and development activities, and enable commercialization activities by third parties. Such collaborations could involve upfront costs, increased expenditures, equity dilution, or operational disruption.

We face significant competition in identifying and securing suitable collaborators, and the negotiation process can be complex and time-consuming. Whether we reach a definitive collaboration agreement will depend on several factors, including the collaborator’s resources, expertise, and assessment of our product candidates’ clinical data, regulatory prospects, market potential, manufacturing challenges, competing therapies, and intellectual property. Potential collaborators may choose alternative opportunities they view as more promising or may consider our programs too early-stage. In addition, mergers among large biopharmaceutical companies may result in a reduced number of potential future collaborators. Even if we are successful in entering into a collaboration, the terms and conditions of that collaboration may restrict us from entering into future agreements on certain terms with potential collaborators. Even if we enter a collaboration, we may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to secure collaborations on acceptable terms, we may need to delay or scale back development or commercialization efforts, or assume full responsibility for these activities, which would increase our costs and could require additional funding. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.

Misconduct or Regulatory Noncompliance by Employees or Third Parties Could Adversely Affect Our Business.

We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers, and vendors may engage in misconduct or other improper activities. This may include noncompliance with FDA regulations or other regulatory requirements. In particular, sales, marketing, and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing, and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing, promotion, sales commission, customer incentive programs, and other business arrangements. Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by these parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks. If any actions are taken against us and we cannot successfully defend ourselves, it could significantly impact our business, resulting in penalties (civil, criminal, or administrative), fines, reputational harm, exclusion from government healthcare programs, and potential damage to profits, future earnings, or operations.

Risks Related to Manufacturing

Complexities in manufacturing and supply of our anti-infective products could delay clinical trials or commercial availability.

The manufacture of anti-infective, antimicrobial products is complex and requires significant expertise and capital investment, including advanced techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production and sourcing, particularly in scaling up, validating the production process, and assuring high reliability of the manufacturing processes (including the absence of contamination), in light of variations and supply constraints of critical components. These problems include logistics and shipping, difficulties with production costs and yields, quality control, including consistency, stability, purity, and efficacy of the product, product testing, operator error, and availability of qualified personnel, as well as compliance with strictly enforced federal, state, and foreign regulations. Furthermore, if contaminants are discovered, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stability, purity, and efficacy failures, deficiencies, or other issues relating to manufacturing our product candidates will not occur in the future. Additionally, we may fail to manage the logistics of shipping the product candidate to the relevant parties. Logistical and shipment delays and problems caused by us, our vendors, or other factors not in our control, including business interruptions, global supply chain issues, and weather, could prevent or delay the delivery of product candidates to patients.

Changes in product candidate manufacturing or formulation methods may lead to increased costs or delays.

As product candidates proceed through development towards potential commercialization, it is common that various aspects of the development program, such as manufacturing methods, formulation, materials, and processes, are altered along the way in an effort to optimize processes and product characteristics. Such alterations can also occur due to changes in manufacturers. These changes carry the risk that they will not achieve their intended objectives. Any such changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with product candidates produced using the modified manufacturing methods, materials, and processes. Such changes may also require additional testing, FDA notification, or FDA approval. This could delay the completion of clinical trials, require the conduct of bridging clinical trials, or the repetition of one or more clinical trials beyond those we currently anticipate, increase clinical trial costs, delay approval of our product candidates, and jeopardize our ability to commercialize our product candidates if approved. In addition, we may be required to make significant changes to our upstream and downstream processes across our pipeline, which could delay the development of future product candidates.

If we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by us and our third-party manufacturers. Although we outsource all manufacturing to third parties, we and our manufacturers must comply with federal, state, and local regulations governing the handling, storage, and disposal of these materials. Despite adherence to legal standards, we cannot eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability, or local, city, state, or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not currently have any insurance for liabilities arising from medical or hazardous materials, and compliance with applicable environmental laws and regulations is expensive. Current and future regulations could further impair our research, development, and production efforts, negatively affecting our business.

We rely on third parties for manufacturing and may continue to depend on them for future product candidates, and this increases the risk related to the timely and sufficient production of our product candidates.

We depend on third-party manufacturers for compliance with cGMP regulations in producing our product candidates. If these third-party manufacturers fail to comply with the FDA, EMA, or other regulatory standards, they will not be able to secure and/or maintain marketing approval for their manufacturing facilities. We do not have control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance, and qualified personnel. Failure to comply with regulations by us or our third-party manufacturers could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension, or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Furthermore, the raw materials for our product candidates may be sourced, in some cases, from a single-source supplier. If we were to experience an unexpected loss of supply of any of our current and future product candidates for any reason, we could experience delays, disruptions, suspensions, or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials.

We rely on third-party manufacturers for the production of our product candidates under the guidance of members of our organization. If these manufacturers fail to meet quality, timing, or other requirements, or if there are supply disruptions, we may be forced to enter into an agreement with another third party, which we may not be able to do on commercially reasonable terms, if at all. Any replacement of our third-party manufacturers could require significant effort and expertise because there may be a limited number of qualified replacements. In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to us or the third-party manufacturer. We may have difficulty transferring such skills or technology to another third party, and a feasible alternative may not exist. Any need to switch manufacturers would require significant effort, and ensuring the new manufacturer meets the required standards may lead to delays in product development. Failure to meet manufacturing requirements or comply with cGMP regulations could adversely affect our business in a number of ways, including:

•        Inability to meet our product specifications and quality requirements consistently;

•        Inability to initiate or continue clinical trials of our product candidates under development;

•        Delays in submitting regulatory applications or receiving marketing approvals for our product candidates;

•        Inability to commercialize any product candidates that receive marketing approval on a timely basis;

•        Loss of the cooperation of future collaborators;

•        Increased inspections by regulatory authorities;

•        Potential recalls or ceasing development; and

•        Inability to meet market demand, if approved.

Risks Related to Legal and Regulatory Compliance Matters

Our relationships with healthcare professionals, clinical investigators, CROs, and third-party payors may be subject to healthcare fraud and abuse laws, exposing us to criminal sanctions, civil penalties, damages, exclusion from government programs, reputational harm, and financial losses.

Healthcare providers and third-party payors play a key role in recommending and prescribing our product candidates. Our arrangements with healthcare professionals, investigators, CROs, payors, and customers may be subject to healthcare laws and regulations, which could limit our marketing, sales, and distribution efforts. Restrictions under applicable federal and state healthcare laws and regulations include the following:

•        The federal Anti-Kickback Statute, which prohibits, among other things, offering or receiving remuneration to induce the purchase of goods or services paid for by federal healthcare programs, with penalties including fines, imprisonment, and exclusion from such programs;

•        The federal civil and criminal false claims laws and civil monetary penalty laws, such as the federal False Claims Act, which penalizes submitting false or fraudulent claims to the government, with whistleblower actions allowed for civil recovery;

•        The Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, schemes to defraud healthcare programs and mandates strict privacy and security standards for health information, with penalties for violations;

•        HIPAA, as further amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose new penalties and extend liability to business associates handling health data;

•        Federal government price reporting laws, which require manufacturers to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

•        Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

•        The Affordable Care Act, or ACA, which requires reporting of payments and transfers of value to healthcare providers and disclosing ownership interests of physicians and family members; and

•        State privacy laws that govern the privacy of personal information in specified circumstances, such as the California Consumer Privacy Act or the CCPA, which establishes new data privacy rights and penalties for violations related to personal information.

Additionally, we are subject to state and foreign equivalents of each of the healthcare laws and regulations described above, among others, some of which may be broader than federal regulations. Many U.S. states have adopted laws similar to the federal Anti-Kickback Statute and False Claims Act, and may apply to our business practices, including, but not limited to, research, distribution, sales, or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental payors, including private insurers. Some states have passed laws that require biopharmaceutical companies to comply with the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and/or the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals. Several states also impose other marketing restrictions or require biopharmaceutical companies to make marketing or price disclosures to the state and require the registration of biopharmaceutical sales representatives. Privacy and data protection laws from outside of the United States, including,

for example, the European Union General Data Protection Regulation and the UK Data Protection Act 2018, or, collectively, the GDPR, also govern the privacy and security of personal information, including health information in some circumstances, and many of these laws differ from each other in significant ways, thus complicating compliance efforts. In addition, in the United States, there are a number of states that have enacted laws that govern the privacy and security of personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

The scope and enforcement of each of these laws is uncertain and subject to rapid change, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions, and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare and privacy laws can be time and resource-consuming and can divert a company’s attention from the business. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. Authorities may determine that our practices violate current or future statutes, regulations, or guidance, which could result in administrative, civil, or criminal penalties, including fines, damages, exclusion from federal and state healthcare programs, reputational harm, individual imprisonment, or forced restructuring of our operations. We could also face heightened oversight and reporting obligations under a corporate integrity agreement. Defending against enforcement actions can be costly and time-consuming, even if successful, and may impair our operations. Additionally, if our partners, such as physicians or other providers, are found non-compliant, they may face sanctions, including program exclusion and imprisonment, which could negatively impact our business and financial results.

Our business entails a significant risk of product liability, and if we are unable to obtain sufficient insurance coverage, such inability could have an adverse effect on our business and financial condition.

Our business involves significant product liability risks related to the development, testing, manufacturing, and marketing of therapeutic treatments. Product liability claims could delay or halt our development programs and, if we commercialize products, may trigger investigations by the FDA, EMA, or other regulatory bodies into product safety, manufacturing processes, or marketing practices. These investigations could lead to recalls, enforcement actions, or even suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims can damage our reputation, reduce demand, divert management attention, incur high legal costs, and result in substantial financial liability. We currently do not have product liability insurance, but we may need to obtain product liability insurance prior to marketing any of our product candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trials and product liability insurance are becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our business.

Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.

The availability and extent of coverage and adequate reimbursement by third-party payors, including government health administration authorities, private health coverage insurers, managed care organizations, and other third-party payors, is essential for most patients to be able to afford expensive treatments. Our ability to successfully commercialize any product candidates that receive marketing approval, both in the United States and internationally, will largely depend on whether these payors cover and adequately reimburse the cost of our therapies. If reimbursement is unavailable or insufficient, we may not be able to commercialize our products or achieve a return on investment. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs.

There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors, and coverage and reimbursement levels for products can differ significantly from payor to payor. Although the Medicare

and Medicaid programs are increasingly used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics, one third-party payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for the product candidate. As a result, the coverage determination process is often time-consuming and costly, which will require us to provide scientific and clinical support for the use of our product candidates to each third-party payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Factors payors consider in determining reimbursement are based on whether the product is: (i) a covered benefit under its health plan; (ii) safe, effective, and medically necessary; (iii) appropriate for the specific patient; (iv) cost-effective; and (v) neither experimental nor investigational. In addition, third-party payors are increasingly demanding predetermined discounts and scrutinizing drug prices, medical necessity, and cost-effectiveness. This may lead to delays in coverage and reimbursement for newly approved drugs. Coverage may be restricted to specific products on formularies, which might exclude some FDA-approved drugs. We may need to conduct expensive pharmacoeconomic studies to justify the value of our product candidates, but there is no guarantee they will be deemed medically necessary or cost-effective. Even if reimbursement is available, the level may be insufficient for a viable return on investment.

Our international operations are subject to extensive governmental price controls and other market regulations. We believe the increasing emphasis on cost containment initiatives in many countries has and will continue to put pressure on the pricing and usage of therapeutics such as our product candidates. Many countries, particularly in the European Union, subject medical product prices to varying price control mechanisms as part of their national health systems, often requiring lengthy pricing negotiations. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our product candidates may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.

If we cannot secure or maintain adequate reimbursement from third-party payors, the adoption of those product candidates and sales revenue will be adversely affected, which could adversely affect the ability to market or sell those product candidates, if approved. Moreover, reimbursement policies may change at any time, and favorable coverage obtained today may not persist in the future.

We face potential liability related to the privacy of health information obtained from our sponsored clinical trials.

Most healthcare providers, including research institutions from which we obtain patient health information, are subject to HIPAA privacy and security regulations. While we are not currently classified as a covered entity or business associate under HIPAA, we could face significant criminal penalties if we knowingly receive health information from a HIPAA-covered entity that has not complied with its disclosure requirements. In addition, we may handle sensitive personal and health information throughout clinical trials, research collaborations, and patient assistance programs, making us subject to state laws requiring breach notifications to affected individuals and regulators. Certain health privacy laws, data breach notification laws, consumer protection laws, and genetic testing laws may apply directly to our operations and/or those of our collaborators, imposing restrictions on our use and dissemination of health information. Patients and providers may have rights limiting how we can use or disclose this information. We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, and even unsubstantiated claims of privacy violations or contractual breaches could be costly to defend and harm our reputation.

Failure to comply with applicable regulatory requirements by us or our third-party contractors could lead to regulatory actions that hinder our ability to develop, commercialize, or sell our product candidates, which may also increase development and marketing costs. Government enforcement actions could generate negative publicity and divert resources from other business areas. Additionally, growing social media use could lead to liability, data breaches, or reputational damage.

If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.

We are subject to numerous environmental, health, and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment, and disposal of hazardous materials and wastes. While our operations do not involve the use of hazardous and flammable materials and do not produce hazardous

waste products, we generally contract with third parties for all operations that handle, use, store, and dispose of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials managed by our vendors. In the event of contamination or injury resulting from their use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We could also incur significant costs associated with civil or criminal fines and penalties. Although we maintain workers’ compensation insurance, we may incur costs due to injuries to our employees resulting from the use of hazardous materials; this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of hazardous and flammable materials. In addition, we may incur substantial costs to comply with current or future environmental, health, and safety laws and regulations. These current or future laws and regulations may impair our research, development, or commercialization efforts, and noncompliance may result in substantial fines, penalties, or other sanctions.

The FDA, the EMA, and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.

If we choose to conduct international clinical trials, the FDA, the EMA, or other regulatory authorities may not accept foreign study data unless it meets certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practice; (ii) the trials are performed by clinical investigators of recognized competence and pursuant to current GCP requirements; and (iii) the FDA is able to validate the data through an on-site inspection or other appropriate mean. Additionally, the trials must meet the FDA’s clinical trial requirements, including adequate patient population and statistical power. There can be no assurance that the FDA, the EMA, or any applicable foreign regulatory authority will accept data from trials conducted outside of its applicable jurisdiction. If the data is not accepted, additional trials may be required, which could cause delays, increased costs, and potentially prevent approval for commercialization.

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee approval in any other jurisdiction. For example, even if the FDA or the EMA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion, and reimbursement of the product candidate in those countries. A failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties, and costs that may prevent or delay the introduction of our product candidates. Failure to comply with international regulatory requirements could reduce our market potential and hinder commercialization.

Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight. For example, the FDA may require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician training, and 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, the EMA, or foreign regulatory authorities approve our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export, and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with cGMPs and GCP for any clinical trials that we conduct post-approval. Manufacturers of drug products and their facilities are also subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility, or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

Failure to comply with FDA, the EMA, or other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions, including delays or denials of product approvals; restrictions on clinical trials, manufacturing, or specific products; warning or untitled letters; civil or criminal penalties; injunctions; suspension or withdrawal of approvals; product seizures, import bans, recalls, or detentions; and operational restrictions, such as costly new manufacturing mandates or partial shutdowns. The occurrence of any event or penalty may inhibit our ability to commercialize our product candidates and generate revenue, and could require us to expend significant time and resources in response, and could generate negative publicity.

The FDA and other regulatory agencies enforce laws and regulations prohibiting the promotion of off-label uses.

If any of our product candidates are approved and we are found to have improperly promoted them for off-label uses, we may become subject to significant liability. Regulatory agencies like the FDA strictly limit promotional claims to those consistent with a product’s approved labeling. A product may not be promoted for uses that are not approved by the FDA, the EMA, or such other regulatory agencies as reflected in the product’s approved labeling. If we receive marketing approval for a product candidate, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. government has imposed substantial fines and legal actions, including injunctions and consent decrees, on companies for allegedly promoting off-label uses. If we fail to manage compliant promotion of our products, we could face serious legal and financial consequences that may adversely impact our business.

We may face difficulties from changes to current regulations and future legislation.

Existing regulatory policies may change, and new government regulations could delay or prevent approval of our product candidates. We cannot predict the nature or impact of future legislation or administrative action in the United States or abroad. If we fail to adapt to changing requirements or maintain compliance, we may lose marketing approval and fail to achieve or sustain profitability. For example, the ACA substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the U.S. biopharmaceutical industry. Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These changes include aggregate reductions to Medicare payments and may result in additional reductions in Medicare and other healthcare funding, all of which could have a material adverse effect on customers for our product candidates, if approved, and accordingly, our financial operations.

There have also been several changes and challenges to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities. It is unclear how these developments could affect covered hospitals that might purchase our future product candidate and affect the rates we may charge such facilities for our approved product candidates in the future, if any. Moreover, there has been heightened governmental scrutiny in recent years over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products. The U.S. Congress has indicated that it will continue to seek new legislative measures to control drug costs. Further, on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new product candidates that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a drug manufacturer to make its products available to eligible patients as a result of the Right to Try Act.

We expect that healthcare reforms may result in stricter coverage criteria and downward pricing pressure, particularly from government programs like Medicare, which may influence private payors as well. Cost containment efforts may hinder our ability to generate revenue, achieve profitability, or successfully commercialize our products. Further, proposals to expand post-approval requirements or restrict promotional activities could delay marketing approvals or impose new obligations. Increased congressional scrutiny of FDA processes may also result in more stringent approval standards, labeling, and post-marketing requirements.

Risks Related to Our Intellectual Property

Our success depends on our ability to protect our intellectual property and our proprietary technologies.

Our commercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for our product candidates, proprietary technologies, and their uses, and to operate without infringing the proprietary rights of others. If we are unable to adequately protect our intellectual property rights, our competitive position could be adversely affected. We generally seek to protect our proprietary position by filing patent applications related to our product candidates in the United States and abroad. However, these applications cannot be enforced unless and until patents are issued, and only to the extent that the issued claims cover the technology. There is no assurance that our applications will result in issued patents, that any patents obtained will provide sufficient protection, or that they will not be challenged, circumvented, or found invalid or unenforceable. Even issued patents may later be found invalid or may be modified or revoked in proceedings before various patent offices or in courts. As such, the scope and effectiveness of future protection for our intellectual property remain uncertain and may not be adequate to secure or maintain a competitive advantage. These uncertainties and/or limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.

The patent application process involves numerous risks and uncertainties, and there is no assurance that we will successfully obtain or defend patents to protect our product candidates, which include the following:

•        Compliance requirements from the USPTO and foreign patent offices; failure to meet procedural, documentary, or fee-related obligations can result in abandonment or loss of rights;

•        Patent applications may not lead to issued patents;

•        Issued patents may be challenged, invalidated, revoked, circumvented, or found unenforceable, and may not provide a competitive advantage;

•        Uncertainty about the scope and strength of any issued patents, including whether third parties can circumvent or invalidate them;

•        Potential for others to file or obtain patents on similar technologies;

•        Risk that our patents may not cover our product candidates or their uses in the U.S. or abroad;

•        Competitors with greater resources may already hold or seek patents that block or interfere with our development and commercialization efforts;

•        Public policy pressures may lead to reduced patent protection for successful treatments, especially in the context of global health concerns; and

•        Foreign patent laws may be less favorable than U.S. laws, giving competitors in other countries a greater ability to develop and market similar products.

The patent prosecution process is costly and time-consuming, and we may not be able to pursue all desirable patent applications in a timely or cost-effective manner, or in all jurisdictions where protection could be commercially beneficial. Additionally, we may fail to identify patentable aspects of our research and development efforts before it becomes too late to secure protection. As a result, our patents and applications may not be prosecuted or enforced in a way that best serves our business interests. In addition, although we enter into non-disclosure and confidentiality agreements with employees, collaborators, CROs, manufacturers, consultants, advisors, licensors, and other third parties who have access to patentable aspects of our research and development output, any of these parties may breach such agreements and disclose information before a patent application is filed, thereby jeopardizing our ability to seek patent protection.

Composition of matter patents for pharmaceutical products, such as small molecule product candidates, often offer strong intellectual property protection regardless of their use. However, we cannot guarantee that the USPTO or foreign patent offices will find the claims in our pending composition of matter applications patentable, or that issued claims will be deemed valid and enforceable by courts. Product formulation patents for pharmaceutical products, such as small molecule product candidates, often offer strong intellectual property protection regardless of their use.

However, we cannot guarantee that the USPTO or foreign patent offices will find the claims in our pending product formulation applications patentable, or that issued claims will be deemed valid and enforceable by courts. Method of use patents, while useful for protecting specific therapeutic uses, do not prevent competitors from producing identical products for non-patented indications. Furthermore, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label” for our targeted indications. Although off-label prescriptions may infringe our method of use patents, enforcement is difficult as off-label prescribing is both common and challenging to police. The patent landscape for biopharmaceutical companies is highly uncertain and complex, involving intricate legal and factual issues, and has been subject to extensive litigation. As a result, the existence, scope, validity, enforceability, and commercial value of our patent rights are inherently uncertain. Our current and future patent applications may not result in issued patents that adequately protect our product candidates or prevent competitors from commercializing similar products.

Furthermore, the scope of claims in a patent application can be significantly narrowed during prosecution or reinterpreted post-issuance. Even issued patents may not offer meaningful protection or prevent competitors or other third parties from entering the market. Any patents that we file may be challenged or circumvented by third parties or may be narrowed or invalidated because of challenges by third parties. Consequently, we cannot guarantee our product candidates will be protected by valid, enforceable patents. Our competitors or other third parties may develop similar or alternative technologies in a non-infringing way, which could materially impact our business, financial condition, results of operations, and prospects.

The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability. Our patents may not cover our product candidates and may be challenged in courts or patent offices in the United States and abroad. We may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review, or PGR, and inter partes review, or IPR, or other similar proceedings in the USPTO or foreign patent offices challenging our patent rights. The outcome of such proceedings is unpredictable and may narrow, invalidate, or render our claims unenforceable, potentially enabling third parties to commercialize competing products without compensation to us. We cannot ensure all relevant prior art has been identified or correctly assessed, and unknown unknown or underestimated prior art could negatively affect our patents’ validity or enforceability. Adverse outcomes in these proceedings could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our product candidates and compete directly with us, without payment to us. Such loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our product candidates. These proceedings may also be costly and time-consuming, diverting key resources even if resolved in our favor. Additionally, any perceived weakening of our patent portfolio could deter potential collaborators or licensors from partnering with us on the development or commercialization of our product candidates.

Specifically, obtaining and enforcing patents in the biopharmaceutical industry involves a high degree of technological and legal complexity. Therefore, obtaining and enforcing biopharmaceutical patents is costly, time-consuming, and inherently uncertain. Changes in the patent laws or in the interpretations of patent laws in the United States and other countries may diminish our ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights, which could affect the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. We cannot predict the scope of claims that will be allowed in our patents or third-party patents. Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us or narrows the scope of our owned and licensed patents. Recent U.S. Supreme Court rulings have limited patent protection in some cases, creating uncertainty regarding the value of existing patents. Unpredictable changes in patent laws, regulations, or decisions by the U.S. Congress, federal courts, or the USPTO could further weaken our ability to obtain and enforce patents.

We may not identify relevant third-party patents or may misinterpret their relevance, scope, or expiration, which might adversely affect our ability to develop and market our product candidates.

We cannot guarantee that any of our patent searches or analyses, including identifying relevant patents, interpreting the scope of patent claims, or determining the expiration of relevant patents, are complete or thorough. It is possible that we have not identified all third-party patents or pending applications that may be relevant or necessary for the commercialization of our product candidates. The scope of a patent claim depends on legal interpretation, the written disclosure in a patent, and its prosecution history. Our interpretation of the scope or relevance of existing or

pending patents may be incorrect, potentially impairing our ability to develop or commercialize our products. We may mistakenly conclude that our product candidates do not infringe a third-party patent or fail to anticipate that a pending application will issue with claims of relevant scope. Additionally, we may miscalculate the expiration of a relevant patent, which could also adversely affect our commercialization plans. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our product candidates.

The patentability of our inventions partly depends on the scope and content of the “prior art,” or information available to a person of skill in the relevant art prior to the priority date of the claimed invention. There may be prior art of which we are not aware that could impact the patentability of our patent claims or, if issued, affect the validity or enforceability of a patent claim. Additionally, we may not fully understand or identify all third-party intellectual property rights relevant to our product candidates or their uses. Additionally, we may not fully understand or identify all third-party intellectual property rights relevant to our product candidates or their uses. Since patent applications in the United States and many other countries are confidential for typically a period of 18 months after filing, or may not be published at all; we cannot be certain that we were the first to file a patent application for our product candidates. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain.

Our patents or pending applications may also be challenged in courts or patent offices in the United States and abroad. For example, we could face third-party pre-issuance submission of prior art to the USPTO or become involved in PGR procedures, oppositions, derivations, reexaminations, or IPR proceedings, challenging our patent rights or the patent rights of others. An adverse determination in any such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated, or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents covering our product candidates may expire before or soon after commercialization. Any failure to obtain or maintain robust patent protection could materially and adversely affect our business, financial condition, results of operations, and prospects.

Some of our future intellectual property may result from government-funded programs and therefore, be subject to federal regulations, including reporting requirements and U.S. manufacturing preferences. These obligations could limit our exclusive rights and restrict our ability to engage non-U.S. manufacturers.

Some of the intellectual property rights we may acquire or license in the future may be generated through the use of U.S. government funding and thus be subject to federal regulations. These regulations grant the government certain rights, including a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. Under certain limited circumstances, the government may require us to grant exclusive, partially exclusive, or non-exclusive licenses to third parties for these inventions if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is needed to address public health or safety needs; or (iii) action is necessary to meet public use requirements under federal regulations (commonly referred to as “march-in rights”). The government may also claim ownership if an invention is not properly disclosed or if patent applications are not timely filed. Additionally, inventions developed under government funding are subject to certain reporting requirements, compliance with which may require us to expend substantial resources. The government generally requires that all products embodying these inventions, or produced through the use of any of these inventions, be manufactured substantially in the United States. While this requirement may be waived if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible, this preference may limit our ability to contract with non-U.S. product manufacturers. To the extent any of our future intellectual property is also generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

Intellectual property disputes, including derivation proceedings and litigation, may result in loss of rights, require us to seek licenses from third parties, or lead to reputational harm that could harm our business and stock price.

Derivation or interference proceedings, whether initiated by us or third parties, may be necessary to resolve patent priority or inventorship issues. An unfavorable outcome could result in the loss of patent rights or force us to cease using the related technology or license it from the prevailing party. If a license is not offered on commercially reasonable terms, or if we are unsuccessful in defending such proceedings, it could lead to significant costs, management distraction, and harm to our ability to secure funding, continue clinical trials, or form necessary partnerships for our

product candidates. Derivation or interference proceedings provoked by third parties or brought by us or declared by the USPTO or similar proceedings in foreign patent offices may be necessary to determine the priority of inventions with respect to, or correct the inventorship of, our patents or patent applications. In addition, any such intellectual property litigation, including derivation or interference proceedings, may lead to public announcements, rulings, and other interim proceedings that could negatively affect investor perception and the value of our product candidates. Such announcements could also harm our reputation or the market for our future product candidates, which could have a material adverse effect on our business.

Patent terms may not provide sufficient protection for our competitive position on product candidates, and if we do not obtain patent term extension for our product candidates, our business may be materially harmed.

Patents have a limited lifespan, typically 20 years from the first effective filing date in the United States, subject to timely maintenance fees. Although extensions may be available, the term of a patent and the protection it affords are limited. Patents for our product candidates may expire before or shortly after commercialization, so our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Additionally, while a patent’s lifespan can be extended due to delays caused by the USPTO, any delays caused by the patent applicant during prosecution may reduce or eliminate this extension.

Depending on the timing and specifics of FDA marketing approval, one or more of our U.S. patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments, which can extend patent life by up to five years. However, a maximum of only one patent may be extended per FDA-approved product. The extension cannot exceed 14 years from the date of product approval, and only those claims covering such approved drug product, a method for using it, or a method for manufacturing it may be extended. Patent term extensions may also be available in certain foreign countries. We may not be granted an extension if we fail to meet deadlines or other requirements, and the extension term could be shorter than requested. If we cannot obtain a patent term extension or if the extension is shorter than requested, our competitors may launch similar products after our patent expires and leverage our data to launch their products earlier. If we do not have sufficient patent life to protect our products, our business and results of operations will be adversely affected.

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

Filing, prosecuting, and defending patents globally would be prohibitively expensive, and our intellectual property rights in some countries may be less extensive than those in the United States, particularly in developing countries with less robust protections. Consequently, we may struggle to prevent third parties from using our inventions in regions where we lack patent protection or where enforcement is weaker, potentially allowing competitors to develop similar products and export them into patent-protected areas, undermining our competitive position.

Protecting and enforcing our intellectual property in foreign jurisdictions can be difficult and costly, as many foreign legal systems do not favor the enforcement of patents, trade secrets, and other intellectual property protection. Enforcing our rights abroad could result in significant costs, potential invalidation of our patents, and even provoke third-party claims. We may not succeed in legal actions we initiate, and any damages awarded may not be commercially meaningful. Additionally, if our trade secrets are disclosed internationally, competitors worldwide could have access to our proprietary information, and such disclosure could have a material adverse effect on our business. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. Certain countries, like China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. In addition, many countries limit the enforceability of patents against government agencies or government contractors, which could materially diminish the value of such a patent. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business may be adversely affected.

Because of the expense and uncertainty of litigation in certain foreign jurisdictions, we may determine that enforcing our patents or other intellectual property rights, even in cases of infringement, is not practical or in the best interest of our company or shareholders. Our competitors or other third parties may be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature intellectual property portfolios. As a result, we might opt to monitor the situation or pursue non-litigious

solutions instead. In addition, ongoing or potential litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal research programs, in-license needed technology or other product candidates, or enter into development partnerships that would help us bring our product candidates to market.

Failure to protect our trade secrets could harm our business and competitive position.

In addition to the protection afforded by other types of intellectual property, we rely on the protection of our trade secrets, including unpatented know-how, technology, and other proprietary information, to maintain our competitive position. Although we have taken steps to protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with employees, consultants, advisors, and third parties such as contractors and collaborators, we cannot guarantee that all such agreements have been duly executed, and any of these parties may not breach and disclose our proprietary information, and we may not be able to obtain adequate remedies for such breaches. We require our employees to enter into written confidentiality agreements that assign to us any inventions or developments made during their employment, and third-party contractors are also typically bound by non-disclosure agreements limiting their use and disclosure of our confidential information. Enforcing trade secret claims can be difficult, costly, time-consuming, and unpredictable, and some courts inside and outside the United States are less willing or unwilling to protect trade secrets. We may need to share our proprietary information, including trade secrets, with our current and future business partners, collaborators, and contractors located in countries where there is an elevated risk of misappropriation, including from private or state-affiliated actors.

Moreover, competitors may independently discover or otherwise gain access to our trade secrets, and we would have no right to stop them from using the information to compete with us. Loss of trade secret protection could significantly reduce the value of our proprietary information and harm our competitive position. If we fail to seek patent protection before public disclosure or cannot maintain confidentiality, our ability to secure patents or protect trade secrets may be compromised. We may also face claims that we wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information of their former employers.

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.

As is common in the biopharmaceutical industry, we engage consultants in addition to our employees to support the development of our product candidates. Many of these individuals have previously worked for, or are currently providing services to, other biopharmaceutical companies, including potential competitors. As a result, we may face claims that we, our employees, contractors, or consultants have inadvertently or improperly used or disclosed trade secrets or proprietary information of their former or current clients. Litigation may be necessary to defend against these claims. In addition to paying monetary damages, an adverse outcome could result in the loss of valuable intellectual property rights or personnel, which could adversely affect our business. Even if we prevail, litigation could result in substantial costs and be a distraction to our management team and other employees.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.

Our current or future trademarks or trade names may be challenged, infringed, circumvented, deemed descriptive or generic, or found to infringe on other marks. If we are unable to protect or continue using these trademarks and trade names, we may lose valuable brand recognition among partners and customers. Trademark applications may be rejected by the USPTO or foreign agencies, and even if accepted, they can be opposed or cancelled by third parties. Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In the USPTO and similar agencies abroad, third parties can oppose pending trademark applications or seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively, and our business may be adversely affected. We may license our trademarks and trade names to third parties, but any misuse or breach of terms on these license agreements could weaken our rights in or diminish the goodwill associated with our trademarks and trade names.

Moreover, any name we have proposed to use with product candidates in the United States may need FDA approval, regardless of whether we have registered it or applied to register it as a trademark, and similar requirements exist in Europe. If the FDA (or an equivalent administrative body in a foreign jurisdiction) objects to any of our proposed proprietary product names, we may need to invest significant time and resources to secure an acceptable alternative

that complies with trademark laws, avoids third-party conflicts, and is acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. Competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, we could face trade name or trademark infringement claims from owners of registered or unregistered marks that are similar to ours. If we assert trademark infringement claims, a court may find our marks invalid, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Risks Related to This Offering and Ownership of Our Common Stock

The direct listing process differs from an initial public offering underwritten on a firm commitment basis.

We are pursuing a direct listing of our common stock on Nasdaq, which differs from a traditional underwritten initial public offering in several significant ways.

There are no underwriters engaged on a firm commitment basis in connection with our direct listing. As a result, prior to the opening of trading on Nasdaq, there will be no traditional book building process and no price at which underwriters initially sold shares to the public to guide price discovery with respect to the opening trades on Nasdaq. Buy and sell orders submitted prior to and at the opening of trading of our common stock on Nasdaq will not be informed by a price range or initial public sale price, as is typical in a firm commitment underwritten offering. Moreover, there will be no underwriters engaged on a firm-commitment underwritten basis, assuming risk in connection with the initial resale of shares of our common stock, or engage in market-stabilizing activities such as “covered” short sales or open-market purchases to support the stock price. As a result, we may experience greater volatility in the trading price of our common stock following the listing. Since our shares of common stock have no prior public market, an active trading market may not develop or continue to be liquid, and the market price of our shares of common stock may be volatile.

In addition, there is no fixed number of shares of common stock available for sale. Therefore, there can be no assurance that any Registered Stockholders or other existing stockholders will sell any or all of their common stock, and there may initially be a lack of supply of, or demand for, our common stock on Nasdaq. Alternatively, we may have a large number of Registered Stockholders or other existing stockholders who choose to sell their common stock in the near term, potentially resulting in an oversupply of our common stock, which could adversely impact the public price of our common stock once listed on Nasdaq and thereafter.

Furthermore, we will not conduct a traditional “roadshow” with underwriters prior to the opening of trading on Nasdaq. Instead, we intend to host an investor day and may engage in other investor presentations and educational meetings to build brand awareness and investor recognition. The date of such events will be announced through financial news outlets in a manner consistent with typical corporate outreach, and we will prepare an electronic presentation publicly available without restriction on a website, which will have content similar to a traditional roadshow presentation. However, there can be no assurance that these efforts will have the same impact on investor education or market demand as a traditional roadshow conducted in connection with a firm-commitment underwritten initial public offering. As a result, there may not be efficient price discovery with respect to our common stock or sufficient demand among investors immediately after our listing, which could result in a more volatile public price of our common stock.

The differences discussed could result in a volatile trading price for our common stock and uncertain trading volume, which may adversely affect your ability to sell any common stock that you may purchase.

Our shares of common stock currently have no public market. An active trading market may not develop or continue to be liquid, and the market price of shares of our common stock may be volatile.

We expect our common stock to be listed and traded on Nasdaq. Prior to the listing on Nasdaq, there has not been a public market for any of our securities, and an active market for our common stock may not develop or be sustained after the listing, which could depress the market price of shares of our common stock and could affect the ability of our stockholders to sell our common stock. In the absence of an active public trading market, investors may not be able to liquidate their investments in our common stock. An inactive market may also impair our ability to raise capital by selling shares of our common stock, our ability to motivate our employees through equity incentive awards, and our ability to acquire other companies, products, or technologies by using shares of our common stock as consideration.

We cannot predict the prices at which our shares of common stock may trade on Nasdaq following the listing of our shares of common stock, and the market price of our shares of common stock may fluctuate significantly in response to various factors, some of which are beyond our control. In particular, as this listing is taking place through a novel process that is not a firm-commitment underwritten initial public offering, there will be no traditional book building process and no price at which traditional underwriters initially sold shares to the public to help inform efficient price discovery with respect to the opening trades on Nasdaq. On the day that our shares of common stock are initially listed on Nasdaq, Nasdaq will begin accepting, but not executing, pre-opening buy and sell orders and will begin to continuously generate the indicative Current Reference Price (as defined below) on the basis of such accepted orders. The Current Reference Price is calculated each second and, during a 10-minute “Display Only” period, is disseminated, along with other indicative imbalance information, to market participants by Nasdaq on its NOII and BookViewer tools. Following the “Display Only” period, a “Pre-Launch” period begins, during which the Advisor, in its capacity as our financial advisor, must notify Nasdaq that our shares are “ready to trade.” Once the Advisor has notified Nasdaq that our shares of common stock are ready to trade, Nasdaq will confirm the Current Reference Price for our shares of common stock, in accordance with the Nasdaq rules. If the Advisor then approves proceeding at the Current Reference Price, the applicable orders that have been entered will be executed at such price, and regular trading of our shares of common stock on Nasdaq will commence, subject to Nasdaq conducting validation checks in accordance with Nasdaq rules. The Advisor will determine when our shares of common stock are ready to trade and approve proceeding at the Current Reference Price primarily based on considerations of volume, timing, and price. In particular, the Advisor will determine, based primarily on pre-opening buy and sell orders, when a reasonable amount of volume will cross on the opening trade such that sufficient price discovery has been made to open trading at the Current Reference Price. If the Advisor does not approve proceeding at the Current Reference Price (for example, due to the absence of adequate pre-opening buy and sell interest), the Advisor will request that Nasdaq delay the open until such a time that sufficient price discovery has been made to ensure a reasonable amount of volume crosses on the opening trade. For more information, see “Plan of Distribution.”

Additionally, prior to the opening trade, there will not be a price at which underwriters initially sold shares of common stock to the public, as there would be in a firm commitment underwritten initial public offering. The absence of a predetermined initial public offering price could impact the range of buy and sell orders collected by Nasdaq from various broker-dealers. Consequently, upon listing on Nasdaq, the public price of our common stock may be more volatile than in a firm commitment underwritten initial public offering and could decline significantly and rapidly.

Furthermore, because of our novel listing process on Nasdaq, Nasdaq’s rules for ensuring compliance with its initial listing standards, such as those requiring a valuation or other compelling evidence of value, are untested. In the absence of a prior active public trading market for our common stock, if the price of our common stock or our market capitalization falls below those required by Nasdaq’s eligibility standards, we may not be able to satisfy the ongoing listing criteria and may be required to delist.

In addition, because of our novel listing process, individual investors, retail or otherwise, may have greater influence in setting the opening public price and subsequent public prices of our common stock on Nasdaq and may participate more in our initial trading than is typical for a firm-commitment underwritten initial public offering. These factors could result in a public price of our common stock that is higher than other investors (such as institutional investors) are willing to pay, which could cause volatility in the trading price of our common stock and an unsustainable trading price if the price of our common stock significantly rises upon listing and institutional investors believe our common stock is worth less than retail investors, in which case the price of our common stock may decline over time. Further, if the public price of our common stock is above the level that investors determine is reasonable for our common stock, some investors may attempt to short our common stock after trading begins, which would create additional downward pressure on the public price of our common stock. To the extent that there is a lack of consumer awareness among retail investors, such a lack of consumer awareness could reduce the value of our common stock and cause volatility in the trading price of our common stock.

The public price of our common stock following the listing also could be subject to wide fluctuations in response to the risk factors described in this prospectus and others beyond our control, including:

•        The number of shares of our common stock publicly owned and available for trading;

•        Variations in our operating performance and the performance of our competitors in general;

•        Actual or anticipated fluctuations in our quarterly or annual operating results;

•        Publication of research reports by securities analysts about us or our competitors, or our industry;

•        The public’s reaction to our press releases, our other public announcements, and our filings with the SEC;

•        Our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;

•        Additions and departures of key personnel;

•        Changes in laws and regulations affecting our business;

•        Commencement of, or involvement in, litigation involving us;

•        Changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;

•        The volume of shares of our common stock available for public sale; and

•        General economic and political conditions such as recessions, interest rates, fuel prices, foreign currency fluctuations, international tariffs, social, political, and economic risks, and acts of war or terrorism.

In addition, securities exchanges have experienced price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. Stock prices of many companies have fluctuated in a manner often unrelated to the operating performance of those companies. These fluctuations may be even more pronounced in the trading market for our common stock shortly following the listing of our common stock on Nasdaq as a result of the supply and demand forces described above. In the past, stockholders have instituted securities class action litigation following periods of market volatility. If we were to become involved in securities litigation, it could subject us to substantial costs, divert resources and the attention of management from our business, and harm our business, results of operations, and financial condition.

If we fail to meet the continued listing requirements of Nasdaq, Nasdaq may delist our securities.

As a public company, we will be subject to the reporting requirements and the rules and regulations of the applicable listing standards of Nasdaq. If we fail to maintain compliance with the continued listing standards of Nasdaq, our securities may be delisted, which could negatively affect the market price and liquidity of our securities. In such a case, we may seek to regain compliance by implementing a number of available options. If in the future our securities are delisted from Nasdaq, we could face significant material adverse consequences, including: limited availability of market quotations for our securities; reduced liquidity for our shares; a determination that our shares are “penny stock,” which will require brokers trading in our shares to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our shares; a limited amount of news and analyst coverage; and decreased ability to issue additional securities or obtain additional financing in the future. In addition, as long as our shares are listed on Nasdaq, U.S. federal law prevents or preempts the states from regulating their sale, although the law does allow the states to investigate companies if there is a suspicion of fraud, and if there is a finding of fraudulent activity, then the states can regulate or bar their sale. If we were no longer listed on Nasdaq, we would be subject to regulations in each state in which we offer our shares.

The Advisor, which will own 272,219 shares of our Common Stock on the date of the Direct Listing and is acting as placement agent in connection with our private placement, may have a conflict of interest.

Given RBW’s dual role as our financial advisor under Nasdaq direct listing rules and its status as a shareholder and placement agent, it may present a conflict of interest. A conflict of interest may arise when a person or an entity has interests that may make it difficult to perform their work objectively and effectively. Conflicts of interest may also arise if a person or entity receives personal benefits as a result of their position. Nasdaq will determine the Current Price of our Common Stock in the Direct Listing price in consultation with the Advisor in its capacity as our financial advisor. The Advisor will determine when our Common Stock are ready to trade and approve proceeding at the Current Reference Price primarily based on considerations of volume, timing, and price. In particular, the Advisor will determine, based primarily on pre-opening buy and sell orders, when a reasonable amount of volume will cross on the opening trade such that sufficient price discovery has been made to open trading at the Current Reference Price. We will issue the Advisor 272,219 shares of Common Stock in connection with the Direct Listing. As the Advisor will receive substantial personal benefit as a result of the Direct Listing, the existence of such financial and personal interests may result in a conflict of interest on the part of the Advisor between what it may believe is best for the Company and its shareholders and what it may believe is best for itself.

Future sales of our Common Stock by our Registered Shareholders and other existing shareholders could cause our share price to decline.

We currently expect our Common Stock to be listed and traded on Nasdaq. Prior to listing on Nasdaq, there has been no public market for our Common Stock, and there has not been a sustained history of trading in our Common Stock in “over-the-counter” markets. While our Common Stock may be sold after our listing on Nasdaq by the Registered Shareholders pursuant to this prospectus or by our other existing shareholders in accordance with Rule 144 under the Securities Act, unlike a firm-commitment underwritten initial public offering, there can be no assurance that any Registered Shareholders or other existing shareholders will sell any of their Common Stock and there may initially be a lack of supply of, or demand for, Common Stock on Nasdaq. As described herein, certain of our Common Stock outstanding as of the date hereof will be registered under this registration statement. The Registered Shareholders and other existing shareholders may sell all of their Common Stock, resulting in an oversupply of our Common Stock on Nasdaq. In the case of a lack of supply of our Common Stock, the trading price of our Common Stock may rise to an unsustainable level. Further, institutional investors may be discouraged from purchasing our Common Stock if they are unable to purchase a block of our Common Stock in the open market due to a potential unwillingness of our existing shareholders to sell a sufficient amount of Common Stock at the price offered by such institutional investors and the greater influence individual investors have in setting the trading price. If institutional investors are unable to purchase our Common Stock, the market for our Common Stock may be more volatile without the influence of long-term institutional investors holding significant amounts of our Common Stock. In the case of a lack of market demand for our Common Stock, the trading price of our Common Stock could decline significantly and rapidly after our listing. Therefore, an active, liquid and orderly trading market for our Common Stock may not initially develop or be sustained, which could significantly depress the public price of our Common Stock and/or result in significant volatility, which could affect your ability to sell your Common Stock.

The Series C Preferred Stock that we will issue prior to the effective date of this offering contain conversion price reset provisions, which may cause significant dilution to our stockholders.

We have agreed to issue $7,500,000 of Series C Preferred Stock prior to the effective date of this offering to an unaffiliated third-party investor. The issuance of our Common Stock upon the conversion of the Series C Preferred Stock that we will issue prior to the effective date of this offering would dilute the percentage ownership interest of holders of our Common Stock and (subject to any restrictions under applicable securities laws) increase the number of our publicly traded shares, which could depress the market price of our Common Stock.

In addition, the aforementioned Series C Preferred Stock include terms under which, in the event that we in the future issue Common Stock, or securities convertible into or exercisable for Common Stock, at a price per share lower than the conversion price then in effect, the conversion price will be reduced to such lower price, subject to certain exceptions (see “Description of Share Capital”), and reset provisions relating to the conversion price based upon the trading price of our Common Stock on the date of conversion. By reducing the conversion price of such securities, such reset provisions would increase the number of shares issuable upon conversion, resulting in greater dilution to our shareholders.

A significant number of our shares are eligible for sale, and their sale or potential sale may depress the market price of our ordinary shares.

Sales of a significant number of shares of our Common Stock in the public market could harm the market price of our Common Stock. A significant number of the outstanding shares of our Common Stock will be available for immediate resale in the public market upon the Direct Listing. If a significant number of shares were sold, such sales would increase the supply of our Common Stock in the public market, thereby potentially causing a decrease in its price. Some or all of our Common Stock may be offered from time to time in the open market pursuant to effective registration statements and/or compliance with Rule 144, which sales could have a depressive effect on the market for our Common Stock. By way of example, we are required to file a resale registration statement within ten days of the Direct Listing to register the Common Stock issuable upon conversion of the Series C Preferred Stock we will be issuing prior to the Direct Listing and the Common Stock issued to our Advisor. The sale of a significant portion of such shares when such shares are eligible for public sale may cause the value of our Common Stock to decline in value.

Because we have no current plans to pay cash dividends on our common stock, you may not receive any return on investment unless you sell your common stock for a price greater than that which you paid for it.

We currently intend to retain all available funds and any future earnings to fund the development, commercialization, and growth of our business, and therefore, we do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. Any future determination to declare dividends will be made at the discretion of our Board of Directors and will depend on our financial condition, operating results, capital requirements, general business conditions, and other factors that our Board of Directors may deem relevant. Our future ability to pay cash dividends on our common stock may also be limited by the terms of any future debt securities or credit facility. As a result, capital appreciation, if any, of the common stock you purchase in this offering will be your sole source of gain for the foreseeable future.

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

We are an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of certain exemptions and relief from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including (i) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, (ii) having the option of delaying the adoption of certain new or revised financial accounting standards, (iii) reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements and (iv) exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We may take advantage of these exemptions until such time as we are no longer an emerging growth company. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock. Further, pursuant to Section 107 of the JOBS Act, we have elected to take advantage of the extended transition period for complying with new or revised accounting standards until those standards would otherwise apply to private companies. As a result, our operating results and financial statements may not be comparable to the operating results and financial statements of other companies that have adopted the new or revised accounting standards.

We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that our voting and non-voting common stock held by non-affiliates is $250 million or more measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is $700 million or more measured on the last business day of our second fiscal quarter.

It is possible that some investors will find our common stock less attractive as a result of the foregoing, which may result in a less active trading market for our common stock and higher volatility in our stock price.

General Risks

Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.

Securities research analysts may establish and publish their own periodic projections for our Company. These projections may vary widely and may not accurately predict the results we achieve. The price of our common stock may decline if our actual results do not match the projections of these securities research analysts. Similarly, if one or more of the analysts who write reports on us downgrade our stock or publish 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, our stock price or trading volume could decline.

The future issuance of shares of preferred stock with dividend or conversion rights, liquidation preferences, or other economic terms favorable to the holders of preferred stock could adversely affect the market price for our common stock by making an investment in the common stock less attractive. For example, investors in the common stock may not wish to purchase common stock at a price above the conversion price of a series of convertible preferred stock because the holders of the preferred stock would effectively be entitled to purchase common stock at the lower conversion price, causing economic dilution to the holders of common stock.

Industry and Market Data

This Prospectus contains estimates made, and other statistical data published by independent parties and by us relating to market size and growth, and other data about our industry. We obtained the industry and market data in this Prospectus from our own research as well as from industry and general publications, surveys, and studies conducted by third parties. This data involves a number of assumptions and limitations and contains projections and estimates of the future performance of the industries in which we operate that are inherently subject to a high degree of uncertainty, and actual events or circumstances may differ materially from events and circumstances reflected in this information. We caution you not to give undue weight to such projections, assumptions, and estimates. In addition, while we believe that the results and estimates from our internal research are reliable, such results and estimates have not been verified by any independent source.

USE OF PROCEEDS

The Registered Stockholders may, or may not, elect to sell shares of our common stock covered by this prospectus. To the extent any Registered Stockholder chooses to sell shares of our common stock covered by this prospectus, we will not receive any proceeds from any such sales of our common stock. See “Principal and Registered Stockholders.”

DIVIDEND POLICY

We have never declared or paid cash dividends on our common stock. We currently intend to retain all available funds and any future earnings to fund the development, commercialization, and growth of our business, and therefore, we do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. Any future determination as to the declaration and payment of dividends, if any, will be at the discretion of our Board of Directors. Any such determination will also depend upon our business prospects, operating results, financial condition, capital requirements, general business conditions, and other factors that our Board of Directors may deem relevant. Our future ability to pay cash dividends on our common stock may also be limited by the terms of any future debt securities or credit facility.

CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of December 31, 2025 and 2024:

The number of shares of our voting common stock reflected in our actual information set forth in the table above excludes:

1,151,528 shares of common stock issuable upon exercise of stock options outstanding under our 2020 Equity Incentive Plan (the Stock Plan) as of December 31, 2025;

118,244 shares of common stock issuable upon exercise of stock options outstanding not under any equity incentive plan as of December 31, 2025;

683,430 shares of our common stock reserved for future issuance under the Stock Plan as of December 31, 2025; and

266,899 shares of our common stock issuable upon the exercise of warrants outstanding at December 31, 2025.

All the shares of common stock subject to stock options and/or warrants outstanding and reserved for issuance under our equity incentive plan are expected to be registered on Form S-8 under the Securities Act, and such shares are eligible for sale in the public markets, subject to Rule 144 under the Securities Act (“Rule 144”) limitations applicable to affiliates.

The following table sets forth our cash and cash equivalents and capitalization as of December 31, 2025, on:

•        an actual basis; and

•        on an as adjusted basis to give effect to (i) the issuance of 937,500 shares of Series C Convertible Preferred Stock for gross proceeds of $7.5 million (net $6.95 million); (ii) the automatic conversion of all outstanding convertible notes and accrued interest into common stock at $8 per share; (iii) the automatic conversion of all outstanding Series A Convertible Preferred Stock into common stock; (iv) the automatic conversion of all outstanding Series B Convertible Preferred Stock and accrued dividends into common stock.

Upon completion of these transactions, no shares of Series A or Series B preferred stock and no convertible notes will remain outstanding. However, the Series C Convertible Preferred Stock will remain outstanding and will be convertible into common stock at the option of the holders from time to time, including in connection with sales of such shares following the direct listing.

Accordingly, the pro forma capitalization reflects a post-listing capital structure consisting of both common stock and Series C Convertible Preferred Stock.

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

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section titled “Risk factors,” our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. See also the section titled “Special note regarding forward-looking statements.” Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Overview and History

Lakewood-Amedex Biotherapeutics Inc. (the “Company,” “Lakewood-Amedex,” “we,” “us,” or “our”), a Nevada corporation headquartered in University Park, Florida, is a clinical-stage biopharmaceutical company focused on the discovery and development of novel antimicrobial therapeutics to address critical unmet medical needs in infectious diseases, particularly those driven by antimicrobial resistance (AMR).

The Company was originally incorporated in Delaware on July 11, 2006, under the name Nu Pharmas, Inc., following the acquisition of substantially all the assets of Renaissance Nutraceuticals, Inc., a Delaware corporation, on April 9, 2007. With an initial focus on antisense RNA technologies and the contract manufacturing of oligonucleotides, Nu Pharmas changed its name to Amedex Therapeutics, Inc. in 2007. On November 11, 2007, Amedex Therapeutics acquired substantially all of the assets of Lakewood Pharmaceuticals, Inc., a Delaware corporation. Subsequently, on February 1, 2008, the Company was renamed Lakewood-Amedex Inc. On June 5, 2025, the Company changed its name to Lakewood-Amedex Biotherapeutics Inc. and re-domiciled as a Nevada corporation. On September 29, 2025, the Company filed a certificate of amendment to its articles of incorporation effecting a 1-for-5.92 reverse stock split.

In 2012 and 2013, the Company transitioned its research focus from oligonucleotide therapeutics to small molecule antimicrobials, particularly a novel class of compounds known as Bisphosphocins®, which were discovered serendipitously during early-stage antisense RNA testing. Bisphosphocins® are synthetic antimicrobial nucleotide derivatives that exhibit broad-spectrum activity and have shown potent effects against multiple drug-resistant bacterial strains.

We are addressing the global AMR crisis, which is directly responsible for approximately 1.27 million deaths annually and contributes to nearly 5 million deaths worldwide. The rising threat of drug-resistant pathogens, including MRSA, VRE, and others, has rendered many existing antibiotics ineffective, leading to higher healthcare costs, longer hospital stays, and increased mortality. Despite the urgency of this public health challenge, innovation in antibiotic development has slowed significantly, with many recent approvals derived from existing classes that remain vulnerable to known resistance mechanisms.

Our lead product candidate, Nu-3, is a broad-spectrum Bisphosphocin® antimicrobial formulated for the topical treatment of chronically infected diabetic foot ulcers (DFUs). We have successfully completed a first-in-human exploratory clinical trial and plan to advance Nu-3 into a Phase 2a safety and dose-response trial, followed by a placebo-controlled Phase 2b study. The Phase 2b study is designed to determine the optimal dosing regimen and support the design of pivotal Phase 3 trials for future regulatory approval and commercialization.

In addition to Nu-3, we are advancing a pipeline of early-stage Bisphosphocin® compounds such as Nu-8, Nu-10, and Nu-11, targeting a range of acute and chronic infectious indications. These pipeline candidates will undergo further preclinical development to identify the best compound-indication match for advancement into clinical evaluation.

As of March 2026, we held 68 issued patents and had 36 pending patent applications covering our core technologies and product candidates in key global pharmaceutical markets.

Financial Overview

Since inception, we have devoted substantially all of our resources to research and development activities, including preclinical studies and clinical trials, corporate infrastructure development, intellectual property protection, and fundraising efforts. We have not generated any revenue from product sales. From inception through December 31, 2025, we have raised $46.1 million in gross proceeds through the issuance of convertible preferred stock, common stock, and convertible debt.

We have incurred significant net losses since our inception. For the years ended December 31, 2025 and 2024, we reported net losses of $3.8 million and $4.8 million, respectively. As of December 31, 2025, we had an accumulated deficit of $53.4 million. These losses have resulted primarily from expenditures related to our research and development programs and general and administrative expenses. We expect to continue to incur significant losses for the foreseeable future.

Manufacturing and Supply Chain

We do not own or operate any manufacturing facilities and have no current plans to establish internal manufacturing capabilities. We rely on third-party contract development and manufacturing organizations (CDMOs) to produce clinical supply materials and intend to continue this approach for commercial production, if applicable. These third parties are also responsible for packaging, labeling, storing, and distributing our clinical trial materials, and are expected to perform the same functions for any commercial products if and when we receive regulatory approval.

We believe this outsourced model enables us to remain capital-efficient and allows us to focus our resources on advancing our pipeline and enhancing our proprietary development platforms.

Future Operating Plans

We anticipate our operating expenses will increase substantially as we:

•        Advance our lead candidate, Nu-3, through ongoing and future clinical trials;

•        Finalize preclinical development activities for additional pipeline candidates and file Investigational New Drug (IND) applications

•        Conduct preclinical studies and clinical trials for new product candidates;

•        Expand our discovery research programs to identify novel antimicrobial candidates;

•        Seek regulatory approvals for candidates that successfully complete clinical trials;

•        Protect and enhance our intellectual property portfolio;

•        Hire additional clinical, regulatory, scientific, quality, and administrative personnel;

•        Advance our Quality Management System and 21CFR11 compliant Document Management System

•        Secure third-party manufacturing capabilities for future development and commercialization needs;

•        Establish commercial infrastructure for sales, marketing, and distribution;

•        Enhance internal systems and personnel to comply with public company reporting obligations.

Due to the inherent risks and uncertainties associated with pharmaceutical product development, we are unable to predict with certainty the timing or extent of future expenditures or whether we will ever achieve profitability.

Components of Our Results of Operations

Our results of operations have consisted primarily of operating expenses, which include the following components:

Operating Expenses

Our operating expenses are classified into two primary categories:

•        Research and development (“R&D”) expenses

•        General and administrative (“G&A”) expenses

Research and Development Expenses

R&D expenses represent costs incurred in connection with the discovery and development of our product candidates and our proprietary platform technologies. These expenses primarily include:

•        External costs, including fees paid to:

•        Contract research organizations (“CROs”),

•        Contract development and manufacturing organizations (“CDMOs”),

•        Third-party consultants,

•        Research laboratories and other service providers that support our preclinical and clinical development programs.

•        Internal costs, which consist primarily of:

•        Salaries, stock-based compensation, and other employee-related expenses for personnel involved in R&D activities,

•        Facility-related costs directly attributable to R&D operations.

We expense R&D costs as incurred. Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors, and analyzing the progress of our preclinical and clinical studies or other services performed. To date, a substantial majority of our R&D spending has related to external costs incurred in connection with the development of our product candidates. While we allocate internal resources toward product innovation, early discovery, preclinical development, clinical program management, and oversight of manufacturing partners, we do not currently track R&D expenses on a program-specific basis until a product candidate is designated for development in a specific therapeutic area.

The successful development of our current or any future product candidates is highly uncertain and subject to numerous risks, many of which are beyond our control. These include clinical trial design, regulatory requirements, manufacturing constraints, and evolving government policies. Product candidates at later stages of development typically incur higher costs, primarily due to increased clinical trial size, extended duration, and enhanced regulatory and safety requirements. Accordingly, we expect our R&D expenses to increase substantially in future periods as we:

•        Advance our lead product candidate, Nu-3, through clinical development;

•        Progress additional pipeline candidates through preclinical and clinical phases;

•        Expand our and discovery research programs;

•        Prepare for potential regulatory submissions and commercialization; and

•        Advance our Quality Management System and 21CFR11 compliant Document Management System.

Because of the inherent uncertainty involved in clinical development, we cannot reasonably estimate the timing or total costs required to complete the development of our existing or future pipeline candidates. Our future R&D expenses will depend on numerous factors, including but not limited to:

•        The number, scope, progress, and results of current and future preclinical studies and clinical trials;

•        Per-patient trial costs and trial size;

•        Establishing an appropriate safety profile in both preclinical studies and clinical trials;

•        Geographic scope and the number of clinical sites participating in each study;

•        Patient enrollment rates and duration of follow-up;

•        Number of treatment arms and dosing regimens;

•        Patient discontinuation or drop-out rates;

•        Regulatory feedback or new requirements imposed during development;

•        Costs and timing of clinical supply manufacturing;

•        Changes in applicable laws, regulations, or agency guidance;

•        The potential establishment of development or commercialization partnerships;

•        Obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates.

Any change in these variables could substantially impact our projected costs, timing, and likelihood of successful development.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel-related expenses for employees in executive, finance, legal, human resources, and other corporate functions. These include salaries, benefits, and stock-based compensation.

G&A expenses also include:

•        Professional fees for legal, accounting, auditing, consulting, and tax services;

•        Legal expenses related to patent filings and intellectual property protection;

•        Facilities-related costs not allocated to R&D;

•        Insurance premiums, including director and officer liability insurance;

•        Travel and other administrative costs.

We expect our general and administrative expenses to increase in future periods as we:

•        Expand our corporate infrastructure to support current and anticipated R&D activities;

•        Increase headcount to support operations as a public company;

•        Incur additional audit, legal, regulatory, compliance, investor relations, and public reporting costs associated with our transition to a publicly traded company.

Other Income (Expense), Net

Interest Income

Interest income consists of income earned from our cash and cash equivalents. We expect interest income to increase in the short term due to higher cash balances resulting from the net proceeds of the Series C convertible Preferred Stock financing outlined under the Proposed Convertible Financing section.

Other Expense

Other expense consists primarily of interest expense related to outstanding debt obligations, a one-time non-operating loss on a fraud incident, and other immaterial non-operating items.

Comparison of the years ended December 31, 2025 and 2024

The following table summarizes our results of operations for the years ended December 31, 2025 and 2024:

Research and development expenses

The following table summarizes our R&D expenses for the years ended December 31, 2025 and 2024:

Research and development expenses were approximately $1.3 million for the year ended December 31, 2025, compared to $2.1 million for the year ended December 31, 2024, representing a decrease of approximately $0.8 million. This decrease was primarily attributable to an approximately $0.6 million reduction in workforce-related expenses, driven by a voluntary reduction in employee compensation, a decrease in headcount, and the reclassification of a portion of salary expenses following the promotion of our Chief Operating Officer to Chief Executive Officer in 2025. As a result of this change in role and responsibilities, approximately 60% of this individual’s compensation was reallocated to general and administrative expenses. The reductions were partially offset by an increase in stock-based compensation of approximately $0.5 million.

In addition, research and development expenses decreased by approximately $0.2 million due to lower clinical costs and development costs, including reduced spending on clinical supplies, formulation activities, regulatory support, and preclinical contract research, consulting services, and travel.

General and administrative expenses

The following table summarizes our general and administrative expenses for the years ended December 31, 2025 and 2024:

General and administrative expenses were approximately $2.5 million for the year ended December 31, 2025, compared to approximately $1.9 million for the year ended December 31, 2024, representing an increase of approximately $0.6 million. The increase was primarily driven by an approximately $0.6 million increase in personnel-related expenses, largely attributable to higher stock-based compensation. The increase in personnel-related expenses also reflects approximately $0.1 million resulting from the reclassification of a portion of salary expenses following the promotion of our Chief Operating Officer to Chief Executive Officer in 2025, with approximately 60% of that individual’s compensation allocated to general and administrative expenses. These increases were partially offset by a reduction in workforce-related expenses, including a voluntary reduction in employee compensation and related costs of approximately $0.1 million.

Professional services expenses increased by approximately $0.1 million, primarily due to higher legal, audit, and other professional fees of approximately $0.4 million incurred in preparation for our proposed direct listing on the Nasdaq Capital Market, partially offset by a reduction in patent-related costs of approximately $0.3 million.

Corporate expenses decreased by approximately $0.1 million, primarily reflecting lower fundraising-related costs and board-related costs of approximately $0.2 million. Facility costs remained relatively consistent year over year.

Other income (expense), net

Other income (expense), net was approximately $(0.1) million for the year ended December 31, 2025, compared to approximately $(0.8) million for the year ended December 31, 2024, representing a favorable change of approximately $0.7 million. This improvement was primarily attributable to the absence of a one-time loss related to a fraud incident of approximately $1.0 million recorded during the year ended December 31, 2024. The favorable impact was partially offset by lower interest income of approximately $0.1 million, higher interest expense of approximately $0.1 million, and the absence of a one-time receipt of approximately $0.1 million recognized during the year ended December 31, 2024.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not generated revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to continue to incur substantial losses and use significant cash resources for the foreseeable future as we advance the development of our product candidates.

To date, we have financed our operations primarily through the sale of convertible preferred stock, common stock, and convertible debt. Through December 31, 2025, we have received aggregate gross proceeds of $46.1 million from these financing activities.

As of December 31, 2025, we had cash and cash equivalents of approximately $0.2 million. Based on our current operating plan, these capital resources, together with expected net proceeds from our ongoing private placement memorandum (PPM) offering, are expected to fund our operations for at least 12 months from the date of listing. However, these estimates are based on assumptions that may prove to be inaccurate, and actual results may differ materially. As such, there is substantial doubt about our ability to continue as a going concern.

Our audited financial statements for the years ended December 31, 2025 and 2024 include an explanatory paragraph from our independent registered public accounting firm stating that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern.

Our continued operations will depend on our ability to raise additional capital through equity offerings, debt financings, collaborations, or other strategic arrangements. There can be no assurance that such additional financing will be available on acceptable terms, or at all.

Future Funding Requirements

We anticipate that our expenses will increase significantly as we:

•        Advance our lead product candidate, Nu-3, through clinical development;

•        Continue preclinical development of additional pipeline candidates;

•        Seek regulatory approvals for our product candidates;

•        Build our commercial infrastructure to support future product launches, if approved;

•        Expand our operational, financial, legal, and compliance functions as a public company;

•        Strengthen our intellectual property portfolio; and

•        Hire additional personnel in research, clinical, regulatory, quality, and administrative functions.

Our future capital requirements will depend on many factors, including:

•        The scope, progress, and timing of our Nu-3 clinical trial;

•        The costs, design, and duration of any additional preclinical and clinical trials;

•        Manufacturing scale-up expenses, including establishment of commercial supply;

•        Regulatory feedback and approval pathways in the U.S. and internationally;

•        The timing and terms of any future in-licensing or acquisition transactions;

•        The costs of maintaining and protecting our intellectual property portfolio;

•        The need for additional personnel and infrastructure as we grow;

•        The level of market acceptance and third-party reimbursement of any future approved products;

•        The extent to which we enter into strategic collaborations, partnerships, or licensing arrangements; and

•        Any milestone or royalty payments required under existing or future agreements.

Until such time, if ever, that we are able to generate revenue from product sales, we expect to continue financing our operations through the sale of equity securities, debt financings, government or private grants, and/or licensing or collaboration arrangements.

Should we raise additional funds through the issuance of equity or convertible debt securities, existing stockholders may experience dilution, and the new securities may contain rights, preferences, or privileges senior to those of existing holders. Debt financing, if available, may impose restrictive covenants, and collaboration agreements may require us to relinquish valuable rights to our technologies or future revenue streams.

If we are unable to obtain adequate financing when needed, we may be required to delay, limit, reduce, or terminate our research and development programs or future commercialization efforts, or enter into strategic transactions on unfavorable terms, or cease operations entirely.

Material Cash Requirements from Known Contractual and Other Obligations

Leases

We lease office space in University Park, Florida, under a non-cancelable operating lease that expires on April 30, 2027. For additional information, refer to Note 5 to our audited financial statements included elsewhere in this filing.

Research and Development Commitments

We expect to continue to incur substantial costs related to the ongoing clinical development of Nu-3 and other pipeline candidates. We are in the final stages of entering into new contractual commitments with CROs to support clinical trial execution. Each contract typically remains in effect through the completion of the respective clinical trial. Costs will vary depending on trial size, duration, and scope of services.

We also anticipate continued investments in preclinical development, manufacturing, and regulatory activities to support our broader pipeline.

Cash flows

For the years ended December 31, 2025 and 2024

The following table provides information regarding our cash flows for the years ended December 31, 2025 and 2024:

Operating Activities

Net cash used in operating activities was approximately $1.9 million for the year ended December 31, 2025, compared to approximately $5.7 million for the year ended December 31, 2024, representing a decrease of approximately $3.8 million. The decrease was primarily due to a lower net loss and more favorable working capital changes in the current year. For the year ended December 31, 2025, cash used in operating activities was primarily driven by a net loss of approximately $3.8 million, partially offset by approximately $1.9 million in non-cash charges and favorable changes in operating assets and liabilities. Non-cash adjustments primarily consisted of stock-based compensation expense. Changes in working capital were primarily driven by an increase in trade payables and accrued liabilities, partially offset by a reduction in lease liability.

In comparison, for the year ended December 31, 2024, net cash used in operating activities of approximately $5.7 million was primarily driven by a net loss of approximately $4.8 million and unfavorable changes in operating assets and liabilities of approximately $1.2 million, mainly related to reductions in trade payables and accrued liabilities. These were partially offset by non-cash charges, primarily stock-based compensation expense.

Investing Activities

There were no investing activities during the year ended December 31, 2025.

For the year ended December 31, 2024, net cash provided by investing activities was approximately $3.9 million. These amounts primarily reflected proceeds from the maturity of short-term investments and sale of an investment, partially offset by purchases of such investments.

Financing Activities

Net cash provided by financing activities was approximately $1.5 million for the year ended December 31, 2025. These proceeds were received through a financing, initially consisting of approximately $0.2 million in short-term promissory notes bearing interest at 10% per annum. These notes were subsequently converted into short-term convertible promissory notes under the same interest terms. In total, the Company raised $1.5 million during the year through the issuance of short-term convertible promissory notes, all bearing interest at a rate of 10% per annum.

Net cash used in financing activities for the year ended December 31, 2024 was $50 thousand, attributable to the repurchase of company stock.

Proposed Convertible Financing

The Company has agreed to the terms of a financing of newly created shares of Series C Convertible Preferred Stock (the “Series C Preferred”) as set forth below:

•        Offering of $7,500,000 of Series C Convertible Preferred Stock at an original issuance price of $10.00 per share and original issue discount of 20%.

•        Each share of Preferred Stock is convertible at the option of the holder, at any time and from time to time, at a conversion price that is the lesser of $10.00 per share or a 20% discount to the trailing 5-day average closing price, with a floor of $1.00, resulting in a maximum number of Common Stock of 9,375,000.

•        The closing will take place on the date of the filing for acceleration of this Registration Statement.

•        Officers, Directors, and holders of 10% or more of the Company’s issued and outstanding shares of common stock are subject to a lockup period of the lesser of (i) 180 days from the closing date or (ii) the date of full conversion of the Series C Preferred.

•        All beneficial owners of more than 5% of the Company’s unregistered common stock are subject to a lockup period of the lesser of (i) 180 days from the closing date or (ii) the date of full conversion of the Series C Preferred.

•        The Company will be obligated to file a registration statement registering for resale the shares of common stock underlying the Series C Preferred.

•        The Company shall not issue any type of equity or equity-linked securities without the prior written consent of the Investor before (i) 180 days from the closing date or (ii) the date of full conversion of the Series C Preferred without the written consent of the Series C Preferred investor.

•        The Investor shall be entitled to receive dividends at the rate of ninety-six cents ($0.96) per share per annum, or 9.6% per annum of the liquidation preference of eight dollars ($10.00) per share on the Series C Preferred that have not been converted commencing 180 days from the closing date.

Critical Accounting Policies and Significant Judgments and Estimates

Our financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosures, including the disclosure of contingent assets and liabilities. We evaluate our estimates and assumptions on an ongoing basis. Estimates are based on historical experience, known trends, and other relevant factors believed to be reasonable under the circumstances. Actual results may differ materially from those estimates.

While our significant accounting policies are described in more detail in Note 2 to our financial statements included elsewhere in this filing, we believe that the following accounting policies involve the most significant judgments and estimates used in the preparation of our financial statements.

Research and Development Expenses and Related Prepaid and Accrued Expenses

We recognize research and development (“R&D”) expenses as incurred. These expenses consist primarily of costs incurred in connection with the development of our product candidates, including services performed by third-party contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), consultants, and other external vendors, as well as internal personnel costs.

Advance payments for goods or services to be used in future R&D activities are deferred and recognized as expenses when the related services are performed or when the goods are received.

Stock-Based Compensation

We account for stock-based compensation in accordance with ASC 718, Compensation — Stock Compensation. We recognize expense for all equity-based awards, including stock options granted to employees, directors, and consultants, based on the grant-date fair value of the awards. The fair value of stock options is estimated using the Black-Scholes option-pricing model. Compensation cost is recognized on a straight-line basis over the requisite service period, which is typically the vesting period of the respective awards.

The determination of grant-date fair value requires management to make several assumptions, including:

•        Risk-free interest rate:    Based on U.S. Treasury yields with maturities similar to the expected term of the options at the date of grant.

•        Dividend yield:    Assumed to be zero, as we have never declared or paid dividends and do not anticipate doing so in the foreseeable future.

•        Expected term:    Estimated using the simplified method, which calculates the average between the vesting date and the contractual term of the option.

•        Expected volatility:    Based on the historical volatilities of a group of comparable public companies, as we do not have sufficient trading history of our common stock.

•        Fair value of common stock:    Determined based on valuations performed by third-party valuation specialists, considering recent financings and other relevant market data.

These assumptions require significant judgment, and changes in these inputs could materially affect the fair value of future grants and related stock-based compensation expense.

Refer to Note 8 of our financial statements included elsewhere in this filing for additional information regarding the assumptions used in the Black-Scholes model and stock option activity during the periods presented.

As of December 31, 2025, there was no intrinsic value associated with the outstanding stock options.

Determination of Fair Value of Our Common Stock

Prior to the listing of our common stock on a public securities exchange, there has been no public market for our common stock, and, as such, the fair value of our common stock for financial reporting purposes has been determined by our Board of Directors with the assistance of management and third-party valuation specialists. The fair value was estimated based on a variety of factors in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation.

Our valuations were performed using methodologies that comply with the option-pricing method (“OPM”). These methods consider a range of objective and subjective factors, including:

•        The prices of preferred stock sold to outside investors in arms-length transactions and the rights, preferences, and privileges of the preferred stock relative to common stock;

•        Our historical and projected financial performance and key milestones;

•        The development status of our product candidates, including data from clinical trials and regulatory milestones;

•        The lack of marketability of our common stock;

•        The industry outlook and performance of comparable publicly traded peer companies;

•        The likelihood and timing of a potential liquidity event, such as an initial public offering or sale of the company;

•        General U.S. and global economic and capital market conditions.

After the valuation is performed, our Board of Directors reviews and approves the estimated fair value of our common stock based on the recommendation of management and the analysis provided by our third-party valuation firm.

Following the listing of our common stock, the fair value of our common stock will be based on the quoted closing price of our shares on the applicable trading market.

We believe that the methodologies used to determine the estimated fair value of our common stock are consistent with the guidance prescribed by the Financial Accounting Standards Board under ASC 718 and are reasonable for financial reporting purposes.

Off-Balance Sheet Arrangements

We did not have, during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules, such as relationships with unconsolidated entities or financial partnerships, including structured finance or special purpose entities, that have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Recently Issued Accounting Standards

A description of recently issued accounting standards that may potentially impact our financial position, results of operations, or cash flows is included in Note 2 to our financial statements included elsewhere in this filing.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As an emerging growth company, we may take advantage of certain exemptions from various reporting and other requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

•        reduced disclosure obligations regarding executive compensation;

•        no requirement to hold nonbinding advisory votes on executive compensation or golden parachute arrangements;

•        an exemption from the auditor attestation requirement of Section 404(b) of the Sarbanes-Oxley Act; and

•        delayed adoption of new or revised accounting standards applicable to public companies until such standards are also applicable to private companies.

We have elected to take advantage of the extended transition period to comply with new or revised accounting standards. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates.

We will remain an emerging growth company until the earliest of:

•        the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more;

•        the last day of the fiscal year in which the market value of our common stock held by non-affiliates is $700 million or more as of the last business day of our second fiscal quarter;

•        the date on which we have issued more than $1.0 billion in nonconvertible debt over a three-year period; or

•        the last day of the fiscal year following the fifth anniversary of the completion of this offering.

We are also a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act, meaning that we have either (i) less than $250 million of public float, or (ii) less than $100 million in annual revenues and less than $700 million of public float. As a smaller reporting company, we may take advantage of many of the same reduced disclosure obligations available to emerging growth companies, including reduced disclosure obligations regarding executive compensation.

Quantitative and Qualitative Disclosures About Market Risk

Interest Rate Risk

We are exposed to market risk related to changes in interest rates. As of December 31, 2025, our cash and cash equivalents consisted primarily of cash held in checking and money market accounts. Because of the short-term nature of these instruments, we do not believe a sudden change in interest rates would have a material effect on our financial condition or results of operations.

Foreign Currency Exchange Risk

We currently operate primarily in the United States, and all current transactions conducted by the company are transacted in US dollars and do not have significant exposure to foreign currency exchange risk. However, as we expand clinical activities globally, our exposure to exchange rate fluctuations may increase, particularly with respect to the Euro and other non-U.S. currencies. To date, we have not entered into any foreign currency exchange contracts or other hedging strategies. We do not believe that a hypothetical 10% increase or decrease in exchange rates would have had a material effect on our financial results during the periods presented.

Effects of Inflation

Inflation may increase our cost of operations, particularly labor and research and development expenditures. While inflation has not materially affected our business or results of operations during the periods presented, we continue to monitor its potential impact on future financial performance.

BUSINESS

Stockholders should read this section in conjunction with the more detailed information about the Company contained in this prospectus, including our audited financial statements and the other information appearing in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

General

Antimicrobial resistance (AMR) represents a growing global health crisis, responsible for 1.27 million deaths annually and contributing to nearly 5 million deaths worldwide. The rapid rise of resistant pathogens has rendered many existing antibiotics ineffective, increasing the risk of severe infections, prolonged hospital stays, and substantial economic burdens. Despite this urgent need, the development of new antibiotics has slowed, with most advancements occurring within existing drug classes, leaving them vulnerable to resistance mechanisms.

Lakewood-Amedex Biotherapeutics Inc., a privately held pharmaceutical company, is addressing this crisis with the development of its Bisphosphocin® class of antimicrobial agents. Unlike traditional antibiotics, Bisphosphocin® compounds are being developed with a novel mechanism of action that is designed to destabilize bacterial membranes within minutes, potentially significantly reducing the likelihood of resistance development. This unique approach is designed to make them highly active against a broad spectrum of Gram-positive, Gram-negative, and drug-resistant pathogens, including methicillin resistant Staphylococcus aureus (MRSA) and multidrug-resistant Gram-negative bacteria. The available non-clinical data will need to be confirmed in clinical studies and evaluated by the FDA and comparable regulatory authorities.

The lead compound, Nu-3, is currently advancing through clinical trials for the treatment of infected diabetic foot ulcers (iDFU), a major complication affecting millions of diabetic patients worldwide. Nu-3 is formulated as a topical gel, and based on in vitro and in vivo non-clinical data, potentially offering several advantages over systemic antibiotics, including:

•        Rapid and potent antimicrobial action

•        Broad-spectrum activity, including against resistant bacterial strains.

•        Targeted delivery at the infection site, overcoming circulation challenges in diabetic patients.

•        No expected resistance development

•        Minimal systemic exposure, reducing side effects.

Beyond iDFU, Lakewood-Amedex Biotherapeutics Inc. is exploring additional local drug delivery applications, including complicated urinary tract infections (CAUTI) and pulmonary infections.

A.     Introduction to AMR

Antimicrobial resistance (AMR) continues to pose a significant global public health threat, ranking among the top 10 challenges faced by humanity. A Lancet publication in 2022 on the global burden of AMR, with the latest data from 2019, reported that 4.95 million deaths were associated with antimicrobial resistance and that 1.27 million deaths were directly attributable to AMR.6 The Centers for Disease Control and Prevention (CDC) reported that in the U.S. alone, more than 2.8 million AMR infections occur each year, with more than 35,000 deaths as a result.7

Antimicrobial resistance is a growing global threat and may lead to a future pandemic affecting humanity.8 Beyond its devastating impact on human lives, AMR also jeopardizes the global economy, with implications for international trade, health care expenditures, and overall productivity. If left unaddressed, by 2050, the economic toll of AMR could reach a staggering $3.8 trillion in global gross domestic product (GDP) loss. Treatment of infections caused by the six leading multi-drug-resistant germs cost more than $4.6B in 2021 in the U.S.9

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6        Antimicrobial Resistance Collaborators. (2022). Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet; 399(10325): P629-655. DOI: https://doi.org/10.1016/S0140-6736(21)02724-0.

7        Antibiotic Resistance Threats in the United States, 2019, Atlanta, GA: U.S. Department of Health and Human Services, CDC (2019 Antibiotic Resistance Threats Report | Antimicrobial Resistance | CDC).

8        World Bank. 2017. “Drug-Resistant Infections: A Threat to Our Economic Future.” Washington, DC: World Bank. License: Creative Commons Attribution CC BY 3.0 IGO

9        Nelson et al, National Estimates of Healthcare Costs Associated With Multidrug-Resistant Bacterial Infections Among Hospitalized Patients in the United States, 2021, Clinical Infectious Disease, 2021, 72, S17–26.

AMR is a natural process that happens over time through genetic changes in pathogens. Microbes have several biological mechanisms to induce resistance and promote their survival in the presence of antibiotics and antifungals, and these mechanisms are categorized into four distinct types: 1) preventing antibiotic uptake; 2) modification of the drug target; 3) inactivation of the drug; or 4) removal of the drug through efflux pumps.10

As a result of drug resistance, antibiotics and antifungal medicines become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness, disability, and death. AMR emergence and spread are accelerated by human activity, particularly in less developed countries. This situation is predominantly linked to the misuse and/or overuse of antimicrobials to treat, prevent, or control infections in humans, animals, and plants (entering the food chain). The discovery and launch of antimicrobial drugs has slowed to a trickle, while resistant organisms have emerged for most classes of drugs. It is clear that new classes of AMR drugs are urgently needed.11

The urgent need for effective antimicrobial drugs is further highlighted by increasing resistance trends. The 2022 World Health Organization (WHO) report on the Global Antimicrobial Resistance and Use Surveillance System (GLASS) report revealed alarming levels of resistance.12 The resistance rate towards cephalosporin exceeds 50% in Klebsiella pneumoniae, which typically necessitates the use of carbapenems (i.e., “Reserve” antibiotics), while over 50% resistance towards carbapenems in Acinetobacter spp. leaves patients with very few options. Over 60% of N. gonorrhoeae isolates showed resistance to ciprofloxacin, one of the most frequently prescribed oral antibacterials. Similarly, more than 20% of isolates of E. coli, the primary pathogen responsible for urinary tract infections (UTIs), demonstrate resistance to both first-line (ampicillin and co-trimoxazole) and second-line (fluoroquinolone) treatment. While some resistance trends have remained stable over the past 4 years, the rates of bloodstream infections (BSI) caused by resistant E. coli, Salmonella spp., and resistant N. gonorrhoeae infections have increased by at least 15% compared to 2017 figures. Most septic conditions originate from a localized infection that is either misdiagnosed, diagnosed too late, or progresses due to the presence of resistant pathogens. Therefore, it is crucial to prevent a locally treatable infection from becoming systemic by providing effective treatment options for local drug delivery against resistant pathogens.

So far, most new drug developments have occurred in the existing classes of antibiotics, but the new drugs in these classes are susceptible to the same drug resistance mechanisms and are therefore likely to be only temporary solutions; novel drugs from totally new mechanistic classes are urgently needed. In addition to resistance development in bacteria, an increasing concern is a similar development for fungal infections.

B.     Bisphosphocin® Overview

All the data presented in the following sections B a)- f) were obtained from non-clinical in vitro or in vivo experiments. The Company acknowledges that the results from preclinical studies may not be reproduced in clinical trials and that the outcomes of clinical trials are inherently uncertain.

Lakewood-Amedex Biotherapeutics Inc. has discovered a new class of antimicrobials, the Bisphosphocin® class, being developed with a unique mechanism of action designed to overcome the problem of resistance emergence. Several examples of the class have been extensively profiled non-clinically for their antimicrobial properties, and one member — Nu-3 — has been advanced into the clinic. The physicochemical properties of the Bisphosphocin® class make them suitable for a wide range of local drug delivery options, such as gel formulations for skin infections, solution formulations for complicated urinary tract infections (cUTI), and solution formulations as aerosols for the treatment of pulmonary infections with the use of a nebulizer. The direct application at the site of infection has the advantage of rapid antimicrobial action, limited systemic exposure, and hence avoidance of most or all systemic side-effects known from systemic antibiotic therapies, such as gastrointestinal side effects and disruptive effects on the intestinal microbiome. Most importantly, initial in vitro data suggest that the novel mechanism of action (see below) makes the possibility of resistance emergence less likely. Our goal is to develop our Bisphosphocin® compounds to become a valuable and important treatment option for locally treatable infections.

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10      Reygaert W C, An overview of antimicrobial resistance mechanisms of bacteria, AIMS Microbiology, 2018, 4 (3), 482-501.

11      Antibiotic Resistance Threats, CDC, 2019, Antibiotic Resistance Threats in the United States, 2019.

12      Global antimicrobial resistance and use surveillance system (GLASS) report 2022, ISBN 978-92-4-006270-2 (electronic version), ISBN 978-92-4-006271-9 (print version)

a)      Mechanism of Action

Figure 1: A schematic representation of the mechanism of action of the Bisphosphocin® class of compounds

The Bisphosphocin® class of compounds is rapidly cidal in vitro to bacteria through a pH and concentration dependent destabilization of the bacterial cell membrane (see Figure 1 for a schematic of the mechanism), typically achieving this effect in under one minute of exposure. As evidence for the mechanism, exposure of bacteria to increasing concentrations of Nu-3 allows SYTOX green nucleic acid stain to accumulate inside bacterial cells, which is indicative of cell membrane depolarization/destruction and is correlated with the loss of bacterial cell viability (see Figure 2).13

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13      Lakewood-Amedex Biotherapeutics Inc. data

The activity of the Bisphosphocin® class of compounds is pH dependent, with the greatest potential potency and activity at low pH values — pH 2 to 4. Compounds with a larger pH range for activity provide an opportunity to match different compounds to different indications, where the pH of the drug delivery formulation can be adjusted to suit the target organ. For example, the skin is more tolerant of lower pHs, whereas formulations designed for the bladder should be at a higher pH — typically > 3.5. Other properties of the Bisphosphocin® class may also play a role in the tolerance of various tissues to the class.

b)      Antibacterial Spectrum

Bisphosphocin® compounds exhibit a broad-spectrum in vitro antibacterial activity against gram positive, gram negative, and the most relevant resistant bacterial strains, such as MRSA and other resistant pathogens. A partial list of bacteria that are susceptible to Nu-3 and other Bisphosphocin® compounds is shown in Figure 3 (bacteria shown in red are AMR organisms).14 Research indicates that the antimicrobial properties of Bisphosphocin® compounds are effective against several biodefense pathogens, thereby potentially playing a role in national security and public health.

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14      Lakewood-Amedex Biotherapeutics Inc. data

c)      Rapid antibacterial effects

In in vitro time kill experiments where bacteria are exposed to the Bisphosphocin® class of compounds, the cidal action is rapid, with total cell death occurring within minutes at higher concentrations and lower pH values. For example, Nu-3 kills 105 E. coli bacteria within 10 minutes at 25 mg/ml (2.5% solution) and leads to complete eradication in less than 10 minutes at higher concentrations (see Figure 4). Additional bacterial time kills are shown in Figure 5, demonstrating the rapid time kill for a range of bacteria, including AMR strains.15

Figure 4: In vitro kill kinetics of Nu-3 against E. coli at three different concentrations of Nu-3

Figure 5: Time kill of Nu-3 against a range of bacteria at 1 and 10 min

The time-kill assays presented in Figures 4 and 5 were executed by incubating a bacterial culture (approximately 1.0 x 105 CFU/ml in saline) with Nu-3 at the indicated concentrations in Eppendorf tubes, which were kept at room temperature. The surviving bacteria were quantified at 1, 5, 10, and 20 minutes after the incubation period

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15      Lakewood-Amedex Biotherapeutics Inc. data

through serial dilution and plating on agar plates.16 In additional in vitro experiments with two other members of the class of antimicrobials, Nu-10 and Nu-11, both compounds showed faster times to kill 100% of E. coli and S. aureus, and at lower concentrations than Nu-3 as shown in Figure 6.

Figure 6: Time kill for 100% reduction of E. coli and S. aureus for Nu-10 and Nu-11 at a range of concentrations.

d)      Effects on Biofilm

Biofilm formation is a method used by bacteria to evade antibiotics and survive in hostile conditions. It has been identified as a major problem associated with chronic, recurrent, and resistant infections. The majority of the SOC antibiotics demonstrated reduced efficacy against bacteria that have entered a non-replicating state, commonly referred to as dormancy.17 Recent research indicates that Bisphosphocin® compounds are effective at killing bacteria even when present in a biofilm environment where bacteria are in a quiescent or dormant state (see Figure 7 for the effect of Nu-3 on S. epidermidis biofilm growth).18

Figure 7: Increasing concentrations of Nu-3 block S. epidermidis growth and biofilm. Bacteria were grown in the presence or absence of Nu-3 in glass culture tubes for 48h. After visualizing the growth, the media were removed and then stained with a crystal violet stain to visualize biofilm formation.

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16      Lakewood-Amedex Biotherapeutics Inc. data

17      Kahn et al, Challenges of Antibiotic Resistance Biofilms and Potential Combating Strategies; A Review, Biotech., 2021, 11, 169.

18      Aikiyoshi et al, 53rd ICAAC Conference, 2013

e)      No Resistance Development

The rapid membrane antimicrobial mode of action of Bisphosphocin® compounds presents a challenge to resistance development by bacteria, which has been supported by in vitro laboratory experiments using a serial passage of E. coli and MRSA in the presence of Nu-3 for 21 days. The Minimum Inhibitory Concentrations (MICs) for Nu-3 were slightly increased at the end of the experiment for E. coli and unchanged for S. aureus. In contrast, the MIC of the ciprofloxacin control had increased over 2,000-fold for E. coli and over 600-fold for MRSA (see Figure 8). The initial MIC values of 10 mg/ml for Nu-3 were unchanged when assessed against bacteria resistant to Ciprofloxacin, which implies that cross-resistance did not occur.19

Figure 8: Nu-3 exhibits minimal or no tendency to develop resistance to E. coli and MRSA, whereas ciprofloxacin showed a 2,000-fold and 600-fold decrease in activity to E. coli and MRSA.

f)      Minimal systemic exposure and side effects

The Bisphosphocin® class of compounds is designed for application at the site of infection. In addition to the advantage of being able to target the infection directly, the local application is also designed to provide for limited systemic exposure and hence avoidance of most or all systemic side-effects, such as severe allergic reactions and gastrointestinal side effects that would otherwise occur through disruption of the intestinal microbiome and disruption of gut/intestinal microbiome with subsequent impairment of the immune system. Lakewood-Amedex Biotherapeutics Inc. has demonstrated in vivo that local application produces limited systemic exposure in several animal models, including a large animal porcine toxicology study where Nu-3 was applied to the wounds, in a twice-a-day regimen, for 14 days. Systemic exposure in this study was very low and short-lived, with no adverse effects on any organ system.20 Quantitative testing (pharmacokinetics) of systemic exposure in humans is planned in the upcoming clinical trial.

g)      Manufacturing aspects

The Bisphosphocin® class of compounds is a modified nucleotide molecule and has excellent aqueous solubility, potentially making them adaptable to a range of different drug product formulations and delivery methods. Significant investment has been dedicated to the development of the manufacturing processes required to produce both the Bisphosphocin® drug substances and drug products. Drug substance manufacturing process development has been conducted for several members of the class and has been carried out on a multikilogram scale under current Good Manufacturing Practices (cGMP) guidelines with high efficiency. In addition, process improvement efforts have reduced the cost of goods and have produced bulk drug substance with improved physical chemistry characteristics. Stability testing of the lead compound — Nu-3 — has shown the bulk drug substance material to be stable for at least five years. Similarly, drug product manufacturing process development has been conducted, and multikilogram

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19      Lakewood-Amedex Biotherapeutics Inc. data

20      Lakewood-Amedex Therapeutics Inc. data

quantities of the Nu-3 gel have been manufactured under cGMP guidelines, and the product is suitable for use in clinical trials. Stability testing of the Nu-3 formulation has shown the drug product to be stable for at least twenty-four months. In addition, initial testing for sterility and antimicrobial effectiveness has demonstrated that the drug product is sterile for at least eighteen months and does not require additional preservatives to maintain sterility.

Additional manufacturing development has been conducted for Nu-10, including process development and initial scale up production to 1 kg of Nu-10 drug substance. Drug product development of a solution formulation of Nu-10 has also been initiated with preliminary stability studies showing drug product stability for at least 6 months at 0-5ºC.

h)      Indications

We believe that the Bisphosphocin® class of compounds is suitable for the treatment of a range of indications. Lakewood-Amedex Biotherapeutics Inc. has a portfolio of compounds that are being profiled for indications such as infected diabetic foot ulcer, urinary tract infections, and pulmonary infections. Figure 9 shows the MIC values for Nu-3, Nu-8, Nu-10, and Nu-11, where Nu-10 and Nu-11 show improved in vitro activity as compared to Nu-3 and Nu-8, against bacteria that are found in both urinary tract and pulmonary infections. Nu-10 and Nu-11 are being further explored in preclinical testing as potential development compounds for the CAUTI or the pulmonary indication development. The decision whether one of the compounds is suited for either of the indications will largely be determined by animal toxicology studies that need to be performed to identify the most favorable benefit-risk profile, taking into consideration the local organ specific tissue conditions.

Figure 9: MIC comparative data for Nu-3, Nu-8. Nu-10, and Nu-11 against a range of bacteria involved in urinary tract and pulmonary infections (NT = Not Tested).

Figure 10 shows a summary of the development status of the portfolio of compounds. Treatment of infected diabetic foot ulcer is the most advanced, and each indication will be further described below.

Figure 10: Current development status of the Lakewood-Amedex Biotherapeutics Inc. compounds

iDFU

Background

One compound — Nu-3 — is in the clinical phase for the selected lead indication of infected Diabetic Foot Ulcers (iDFU). Among the 830 million patients worldwide suffering from Diabetes,21 close to 40 million are in the US alone, and about one third of them will develop a diabetic foot ulcer (DFU) in their life, of which about 50% will be infected. Numerous patients experience more than one of these events in their lives. Additionally, a fifth of diabetic patients who have a foot ulcer will need amputation,22 and infections, if not contained, are an important additional risk factor alongside the presence of peripheral arterial disease, for future amputations.23 This underlines the important role of an early and effective treatment of the infection in an early stage to prevent disease progression, including these devastating complications like amputations. The cost of care for diabetic foot ulcer complications exceeds the cost of treatment of the 5 most costly forms of cancer.24

Global Data has reported the prevalence rates for DFU for many countries/regions, including the USA, Western Europe, India, China, and Brazil. (see Table 1).

Table 1: DFU Prevalence in millions of patients for the USA, Western Europe, India, China, and Brazil. Footnotes: a — calculated data; b = USA; c = France, Germany, Italy, Spain, UK; d = Canada, Australia, Brazil, China, India, Japan, Mexico, Russia, South Africa, and South Korea.

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21      WHO report on Diabetes, 2024, https://www.who.int/news-room/fact-sheets/detail/diabetes.

22      Lipsky et al., Clin Infect Dis., 2012, 54, 132-173. doi: 10.1093/cid/cis34.

23      Armstrong D., et al., Diabetes Care, 1998, 21 (5), pp 855-859; Oyibo S.O., et al., Diabetes Care, 2001, 24, 84-88; Jia L., et al. PLoS ONE, 2017, 12 (5), pp 1-15, https://doi.org/10.1371/journal.pone.0177916.

24      Armstrong D., Swerdlow M.A., Armstrong A.A., Conte M.S., Padula V., and Bus, S.A., Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer, J. Foot and Ankle Res., 2020, 13:16.

Diabetic foot ulcers (DFU) represent a complex and difficult to treat complication of diabetes mellitus. Besides external traumata, three major pathologic conditions appear to be the main contributors to the development of DFUs: ischemia, neuropathy, and infection. Consequently, the treatment of DFUs must consider all these factors and address them as applicable, in addition to proper wound care management, to heal the ulcer. Infection control is hence accepted to be a key success factor in facilitating healing and preventing disease progression to a more severe form of infection, which eventually may lead to amputation.

Curing an infection of a DFU is particularly challenging because i) the infection tends to be polymicrobial in nature, requiring a broad-spectrum antibiotic, ii) the ulcer is prone to re-infections, and iii) the pathogenic bacteria are increasingly becoming resistant to most front-line therapies. A recent meta-analysis suggests that resistant bacteria such as MRSA can be identified in 15-20% of patients with an infected diabetic foot ulcer.25 Recent studies have also estimated that approximately 60% to 80% of chronic infections also involve the formation of biofilm. This contributes to the questionable effects of traditional antibiotics in the treatment of iDFU.26

Today’s standard of care for mildly infected foot lesions includes traditional oral antibiotic therapy (empiric treatment with potential switch of therapy if suggested based on culture results) in addition to thorough wound care, including the use of off-loading restraints. Oral antibiotic therapy, however, is associated with several systemic side effects, such as allergic reactions, disturbance of the normal gut microbiome, and gastrointestinal problems. The biggest limitation, however, seems to be the limited effects of antibiotics in mild iDFU. The main reason for the development of diabetic foot ulcers is the poor perfusion due to peripheral artery disease, which affects the microcirculation in the more superficial tissue layers. For the same reason, it must be assumed that the use of oral medication like an antibiotic may not reliably lead to sufficient concentration of such an antibiotic in a peripheral and a more superficial foot ulcer. Existing guideline recommendations for the use of antibiotics are more an expression of infection stewardship, but are not supported by reliable data. To our knowledge, no data demonstrating an additive effect of oral antibiotics over proper wound care in mild iDFU are published, underlying the need for a more effective antimicrobial treatment and the benefit of local drug delivery to circumvent the problems related to poor perfusion in infection.

Lakewood-Amedex Biotherapeutics Inc.’s Lead compound Nu-3

Studies indicate that Nu-3, as a gel formulation, exhibits the most favorable combination of product features such as a broad spectrum and fast acting antimicrobial activity, including resistant strains; a very low likelihood of resistance development; a low likelihood of systemic side effects and direct effects on the infected area as a topical gel in a disease that is largely driven by poor perfusion and low susceptibility of systemic antibiotic treatments.

A rigorous phase 2 study protocol has been developed and has been fully aligned with the FDA to assess the potential use of Nu-3 gel in iDFU. These discussions resulted in a full alignment on design, eligibility criteria, as well as outcome measures/endpoints for this phase 2 b study. Recently, the Company decided, for business reasons, to first start with a smaller size phase 2a study to establish initial proof of concept in patients before moving into the originally planned phase 2b study. This single blind study will compare three different concentrations of Nu-3 gel, 2%, 5% and 10% with twice-a-day applications. Study population, eligibility criteria, and targeted endpoints are identical to the phase 2b study that has already been discussed and agreed upon with the FDA. Prior to the start of the phase 2a study, this protocol will also be added to the IND, and sufficient time for any additional FDA feedback has been built into the operational planning. Once a dose response curve has been established from this phase 2a study, which, if confirmed, would provide strong evidence for a positive proof of concept, the phase 2b study will follow and will be used to determine the final dose as well as the administration regimen (once-a-day vs twice-a-day) in comparison to placebo. (Details also disclosed on page 5)

Preclinical Bioactivity of Nu-3

Non-clinical research indicates that Nu-3 displays a broad spectrum of activity against the top ten typical microbial components of an infection of a diabetic foot ulcer. The MICs are summarized in Table 2. More recently, Nu-3 was tested against a range of recently isolated resistant and susceptible organisms, and Nu-3 showed similar MICs against

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25      Zhou et al, The Global Prevalence of Methicillin-Resistant Staphylococcus Aureus in Patients with Diabetic Foot Ulcers: A systematic Review and Meta-Analysis, Diabetes, Metabolic Syndrome and Obesity, 2024, 17, 563-574.

26      Pouget et al, Biofilms in Diabetic Foot Ulcers: Significance and Clinical Relevance, Microorganisms, 2020, 8, 1580.

the bacteria, indicating that the antibacterial activity remains robust (see Table 3). It is important to highlight that these MIC numbers were significantly lower, ranging from 8 to 50 times, than the one of the clinical doses (10% gel – 100 mg/ml) that will be studied in the clinical trial.

Table 2: MIC50 data for Nu-3 against the top 10 bacterial isolates from infections in DFU.

Table 3: MIC50 data for Nu-3 against recent clinical isolates.

VSE = Vancomycin susceptible Enterococci; VRE = Vancomycin resistant Enterococci;
MSSA = Methicillin susceptible S. aureus; MRSA = Methicillin resistant S. aureus.

Nu-3 has been profiled in several in vivo murine skin infection models. In a single-dose study comparing 10% Nu-3 solution vs. 10% Nu-3 gel, the gel outperformed the solution, showing complete inhibition at 1 and 8 hours post-infection in an infection treatment protocol using methicillin resistant S. aureus (MRSA) (see Figure 11a).27 In a multiple dose study comparing once-a-day and twice-a-day dosing of both 5% and 10% gels with a 5-day recovery period, the gel formulations demonstrated effectiveness at the end of the recovery period with little to no reinfection (see Figure 11b).28

Figure 11a: Murine in vivo MRSA single dose skin infection model: A MRSA infection was introduced to skin abrasions and allowed to establish for 4 hours before applying the treatment — 10% Nu-3 gel, 10% Nu-3 solution, or placebo. The treated sites were then analyzed for bacterial growth at 1-, 2-, 4-, and 8-hours post-infection establishment.

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27      Lakewood-Amedex Biotherapeutics Inc. data.

28      Lakewood-Amedex Biotherapeutics Inc. data.

Figure 11b: Murine in vivo MRSA multidose skin infection model: A MRSA infection was introduced to skin abrasions and allowed to establish for 4 hours before applying the treatment — 10% Nu-3 gel qd or bid, or 5% Nu-3 gel qd or bid, or placebo for 5 days, followed by 5-day observation as a recovery period. The treated sites were then analyzed for bacterial growth.

A porcine toxicology study to explore the effects of topical Nu-3 gel (up to 20%) on normal wound healing was conducted at multiples of the expected clinical doses for two weeks. No deleterious effects were seen on wound healing, and no skin sensitization was observed, clearing the way for doses of up to 10% Nu-3 to be used in the clinic.29

Nu-3 Clinical Studies

An exploratory human trial on skin sensitization was conducted with Nu-3 solutions at 1 and 2% and no significant effects were observed. The same concentrations of Nu-3 solution were also studied in a small exploratory Phase1/2 study in iDFU patients where positive trends in the reduction of infection as well as a trend in wound area reduction were observed, supporting the further development of Nu-3.30 A formulation switch from solution to gel was identified as an improvement and a gel formulation has been developed and patented which is supported by the murine data discussed in the previous section.

A new Phase 2b study in infected Diabetic Foot Ulcers has been designed and agreed upon with the FDA (NCT06020235 — ClinicalTrials.gov) comparing 2 different gel-concentrations (5% and 10%) each as either once-a-day or twice-a-day treatments in comparison to a placebo group. The study is fully blinded and primarily determines antimicrobial response and clinical infection improvement, in addition to relevant safety information and wound healing.

The Company recently decided to add a smaller Phase 2a study to the development program to establish a dose response curve in patients testing 3 different active treatments (2%, 5% and 10% gel). With all other relevant protocol components remaining identical to the Phase 2b study that has been discussed and agreed upon with the FDA, this study will allow easy transition from the Phase 2a to the Phase 2b study while at the same time providing important clinical feedback on the potential safety and efficacy of Nu-3.

Additional Indications

Beyond the lead indication of iDFU, we believe that essentially every infection of more superficial wounds could be in scope for Nu-3 gel as treatment. This includes wounds from injuries or burns as well as post-surgical wound infections. Another application for a solution formulation may be for otitis externa, which is frequently observed in children and young adults. All these additional applications would require the respective clinical testing and the subsequent review and approval process by the FDA and comparable regulatory authorities.

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29      Lakewood-Amedex Biotherapeutics Inc. data.

30      Lakewood-Amedex Biotherapeutics Inc. data.

CAUTI

Background

Complicated urinary tract infections and especially catheter-associated urinary tract infections (CAUTI) are frequently caused by drug resistant bacteria and bacterial biofilm31. The Bisphosphocin® class has demonstrated in vitro activity against a broad range of resistant bacteria, including those frequently found in UTI, such as E. coli, K. pneumoniae, and P. aeruginosa, as well as having demonstrated activity against biofilm forming organisms. In addition, in vivo activity has been demonstrated in animal models of UTI. Compounds with a larger pH range for activity provide an opportunity to match different compounds to different indications, where the pH of the drug delivery formulation can be adjusted to suit the target organ. For example, the skin is more tolerant of lower pHs, whereas formulations designed for the bladder should be at a higher pH — typically > 3.5. Lakewood-Amedex Biotherapeutics Inc. is currently screening several new agents from the Bisphosphocin® class with the goal of selecting the most promising and indication-appropriate candidate to progress into the clinic after the submission of an Investigative New Drug application (IND).

Non-clinical studies conducted as proof of concept utilizing infected rat bladders confirmed that the intravesical administration of Nu-8, as one of the potential compound candidates at a pH of 3.5, significantly reduced bladder colony-forming units (CFUs). Wistar female rats were infected with E. coli through a guided sterile catheter on day 0 and again on day 1. Four hours after the second infection, the rats received either a vehicle or a 5% or 10% Nu-8 solution for a duration of 30 minutes. Following the treatment, the urethral opening was sealed with true seal glue to ensure bladder retention, thereby simulating the clinical conditions of catheterized patients. The intravesical treatment with Nu-8 for 30 minutes demonstrated a notable antibacterial effect in the bladder at both 5% and 10% doses when compared to the vehicle control group (see Figure 12). A similar study using Nu-10 in the rat urinary tract infection model demonstrated a notable antibacterial effect in the bladder at both 2.5% and 5% doses when compared to the vehicle control group (see Figure 13). Throughout both of these studies, all animals appeared to be in normal health.32

Figure 12: The administration of Nu-8 via intravesical delivery for a period of 30 minutes exhibited a significant bactericidal effect against the urinary pathogen E. coli, demonstrating a concentration-dependent response in a rat model of urinary tract infection.

Figure 13: The administration of Nu-10 via intravesical delivery for a period of 30 minutes exhibited a significant bactericidal effect against the urinary pathogen E. coli, demonstrating a concentration-dependent response in a rat model of urinary tract infection.

Further non-clinical research with Nu-8, Nu-10, and Nu-11, and some other portfolio compounds, will be performed to identify the most suitable candidate to be advanced into early clinical development.

Pulmonary

Background

Pulmonary infections such as community acquired bronchial pneumonia (CABP), hospital acquired bronchial pneumonia (HABP), and ventilator acquired bronchial pneumonia (VABP) are frequently caused by drug resistant bacteria. In addition, patients with cystic fibrosis have recurrent bacterial and fungal lung infections with organisms such as P. aeruginosa and A. fumigatus. The Bisphosphocin® class has demonstrated in vitro activity against a broad range of resistant bacteria, including those frequently found in pulmonary infections such as H. influenzae, K. pneumoniae, and P. aeruginosa. In addition, in vivo activity has been demonstrated in animal models of pulmonary infections caused by Acinetobacter species, P. aeruginosa, and A. fumigatus. Lakewood-Amedex Biotherapeutics Inc. is currently screening several new agents from the Bisphosphocin® class with the goal of selecting a candidate to progress into the clinic after the submission of an IND.

In vivo animal data

The Bisphosphocin® Nu-8 shows high activity in the treatment of lung infections caused by a range of organisms. Figure 14 shows three such experiments where the administration of a solution of Nu-8 as an aerosol dramatically reduces the microbial counts in the lung.33

Figure 14a

Figure 14b

Figure 14c

Figure 14: Murine Pneumonia models: a) Acinetobacter model; b) Aspergillus model, and c) Pseudomonas model. Neutropenic mice were infected intranasally with the indicated microorganism. Twenty-four hours post-infection, animals were treated intra-nasally by nebulization with Nu-8 (10% nebulized for twenty minutes, twice). At 2-, 4-, and 6-hours post-treatment, animals were terminated; lung tissues were collected to determine the bacterial load. Nu-8 (10%) showed significant antibacterial activity (p<0.05) at 2-, 4-, and 6-hours post-nebulization administration when compared to the vehicle control at 2- and 4-hours.

Further non-clinical research with Nu-8, Nu-10, and Nu-11, and some other portfolio compounds, will be performed to identify the most suitable candidate to be advanced into early clinical development.

Intellectual Property

Lakewood-Amedex Biotherapeutic Inc.’s broad antimicrobial technology platform is well protected by an intellectual property portfolio. The broad patent estate comprises 104 patents, 68 of which have been allowed, with the remaining 36 being pending applications. The key patent filings provide protection through at least 2038, and the most recent patent applications will extend protection through 2044, once issued. Our patents cover compositions of matter of the Bisphosphocin® class and other related classes of compounds; formulations of Nu-3; use patents for the Bisphosphocin® class; and process patents for the class.

Trademarks

The Company has one registered trademark:

Patents

The Company has 68 issued patents originally developed by the Company and 36 pending patents originally developed by the Company. The following table outlines each of the patents, both issued and pending, with the application number, the date filed, the patent number (if applicable), the title, status, anticipated expiration date, and portfolio compound(s) associated with the patent.