What changed in this filing

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Item 1A. Risk Factors

2026-06-15 compared with 2025-06-17 · 352 added, 300 removed, 1170 unchanged (36% of the section changed)

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See the section titled “Cautionary Note Regarding Forward-Looking Statements.”

• failures of ongoing or future nonclinical or clinical trials of our product candidates, or material delays in the completion and/or commencement of our ongoing or planned nonclinical or clinical trials, could result in increased costs to us and could delay, prevent or limit our ability to generate revenue and continue our business;

• we have incurred significant net losses since inception, and we will continue to incur substantial operating losses for the foreseeable future;

• we require substantial additional financing to execute our long-term business plan, including further development and commercialization of our pherine product candidates, and to continue to operate as a going concern;

• we are a clinical-stage biopharmaceutical company with no approved products or revenues from product sales, and limited experience developing and commercializing new product candidates, which makes it difficult to assess our future viability;

• we depend heavily on the success of our product candidates, and we cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates;

• we are focused on neuroscience drug development, a field that has seen very limited success.

• we have incurred significant net losses since inception, and we will continue to incur substantial operating losses for the foreseeable future;

• if we fail to regain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted;

• we depend heavily on the success of fasedienol and, to a lesser extent, our other pherine product candidates, and we cannot be certain that ongoing clinical trials, including PALISADE-4, will produce successful results or that we will be able to obtain regulatory approval for fasedienol or any of our current or future product candidates;

• failures of ongoing or future nonclinical or clinical trials of our product candidates, such as our PALISADE-1 and PALISADE-3 clinical trials, or material delays in the completion and/or commencement of our ongoing or planned nonclinical or clinical trials, could result in increased costs to us and could delay, prevent or limit our ability to generate revenue and continue our business;

• we are focused on novel neuroscience drug development, a field that has seen very limited success.

The ability to successfully develop product candidates in this field is extremely difficult and is subject to a number of unique challenges;

• the successful completion of nonclinical studies and/or clinical trials in any of our product candidate development programs may not be sufficient to cause the FDA to approve any NDA that we may submit, or cause any other agency to provide regulatory approval of any of our product candidates, and, even if approved, does not ensure acceptance of such product candidates by clinicians leading to a revenue stream to support our operations;

• we have experienced rapid growth since early 2021.

If we fail to effectively manage our growth, we may not be able to execute on our business objectives;

• the successful completion of nonclinical studies and/or clinical trials in any of our product candidate development programs, including the PALISADE Program, may not be sufficient to cause the FDA to approve any NDA that we may submit, or cause any other agency to provide regulatory approval of any of our product candidates, and, even if approved, does not ensure acceptance of such product candidates by clinicians leading to a revenue stream to support our operations;

• if we are unable to retain or attract key management and scientific personnel, or effectively manage the impact of our recent workforce reduction, we may be unable to successfully produce, develop, and commercialize our product candidates;

• we rely on third party collaborators to assist in conducting our nonclinical studies and clinical trials and if they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed;

• we require substantial additional financing to execute our business plan, including further nonclinical and clinical development, contract manufacturing and potential commercialization of our product candidates;

• raising additional capital in equity-based financing transactions will cause substantial dilution to our existing stockholders, may restrict our operations or require us to relinquish rights to our product candidates, and may require us to seek stockholder approval to authorize additional shares of our common stock;

• if we are unable to retain or attract key management and scientific personnel, we may be unable to successfully produce, develop, and commercialize our product candidates;

• we operate in highly competitive and rapidly changing industries, which may result in others discovering, developing or commercializing competing products before or more successfully than we do;

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• we face significant competition, and if we are unable to compete effectively, we may not be able to achieve or maintain significant market penetration or improve our results of operations;

• if we are unable to adequately protect our proprietary technology and product candidates, or obtain and maintain issued patents that are sufficient to protect our product candidates, others could compete against us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects;

• Reduction in staffing, large staff turnover and/or inadequate funding for the FDA or other government agencies could hinder those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business;

• reduction in staffing, large staff turnover, changes to key personnel on applicable regulatory review teams and/or inadequate funding for the FDA or other government agencies, including those resulting from reduced staffing levels, could hinder those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business;

• other risks and uncertainties, including those described below.

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• clinical trial results may show the product candidates to be less effective than expected (for example, a clinical trial could fail to meet its primary or key secondary endpoint(s)) or have an unacceptable safety or tolerability profile;

• failure to receive the necessary regulatory approvals or a delay in receiving such approvals, which, among other things, may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up, length of time to achieve trial endpoints, additional time requirements for data analysis, review of IND, NDA or similar foreign applications, preparation, discussions with the FDA or foreign regulatory authorities, an FDA or foreign regulatory authority request for additional preclinical or clinical data (such as long-term toxicology studies) or unexpected safety or manufacturing issues;

• the FDA or other equivalent non-U.S.

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• preclinical study results may show the product candidate to be less effective than desired or to have harmful side effects;

• post-marketing approval requirements;

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If government and other healthcare payors were not to provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success would 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 our third-party providers comply) with current cGMPs and similar foreign requirements, and GCPs for any clinical trials that we conduct post-approval.

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 our third-party providers comply) with current good manufacturing practices (cGMPs) and similar foreign requirements, and good clinical practices (GCPs) 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.

Our business is highly dependent on the success of our product candidates.

If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed.

To date, as an organization, we have not completed the development of any of our product candidates.

Our future success and ability to generate revenue from our product candidates is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our product candidates.

Our business is highly dependent on the success of fasedienol and, to a lesser extent, our other product candidates.

If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize fasedienol or one or more of our other product candidates, or if we experience delays in doing so, our business will be materially harmed.

To date, as an organization, we have not completed the development of any of our product candidates, including fasedienol, our most advanced product candidate.

Our future success and ability to generate revenue from fasedienol or any of our other product candidates is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our product candidates.

All of our product candidates will require substantial additional investment for clinical development, regulatory review and approval in one or more jurisdictions.

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Our nonclinical and clinical programs have experienced delays and may experience additional delays or may never advance, which would adversely affect our ability to obtain regulatory approvals or commercialize our product candidates on a timely basis or at all, which could have an adverse effect on our business.

We may not have the financial resources to continue development of or commercialize our product candidates if we experience any issues that further delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:

• our inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and effective;

• insufficiency of our financial and other resources to complete the necessary preclinical studies, clinical trials and regulatory submissions or necessary to fund pre-commercial and commercial activities to establish sales, marketing and distribution capabilities needed to successfully commercialize an approved product;

We do not have the financial resources to continue development of our product candidates other than fasedienol, or capital required to commercialize any of our product candidates.

Moreover, we may experience issues that delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:

• negative or inconclusive results from our preclinical studies, clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical studies, clinical trials or abandon a program;

• product-related adverse events experienced by subjects in our clinical trials, including unexpected toxicity results, or by individuals using drugs or therapeutic biologics similar to our product candidates;

• delays in submitting an IND or comparable foreign applications or delays or failure in obtaining the necessary approvals or allowances from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial once commenced;

• conditions imposed by the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials;

• poor effectiveness of our product candidates observed during clinical trials;

• better than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from our clinical trials;

• delays in enrolling subjects in our clinical trials;

• delays in enrolling and randomizing subjects in our clinical trials;

• high drop-out rates of subjects from our clinical trials;

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• higher than anticipated clinical trial or manufacturing costs;

• delays in submitting an IND, comparable foreign applications or delays or failure in obtaining the necessary approvals or allowances from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial once commenced;

• our inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and effective;

• conditions imposed by the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials;

• unfavorable FDA or comparable regulatory authority inspection and review of our clinical trial sites;

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Our net losses totaled $69.7 million and $51.4 million for the years ended March 31, 2026 and 2025, respectively.

We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, and commercialization of our product candidates.

We anticipate that our expenses will increase substantially if, and as, we:

We expect to continue to incur significant losses for the foreseeable future.

We anticipate that our expenses will increase substantially in the event we:

• advance our product candidates through clinical development, including as we advance these candidates into and through later-stage clinical trials;

• seek regulatory approvals for any product candidates that successfully complete clinical trials;

• hire additional clinical, quality control, medical, scientific and other technical personnel to support the clinical development of our product candidates;

• experience an increase in headcount as we expand our research and development organization and market development and pre-commercial planning activities;

• undertake any pre-commercial and commercial activities to establish sales, marketing and distribution capabilities;

• advance our preclinical-stage product candidates into clinical development;

• maintain, expand and protect our intellectual property portfolio.

approval, secure market access and reimbursement, and become commercially viable, and therefore any investment in us is highly speculative.

Accordingly, before making an investment in us, you should consider our prospects, factoring in the costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially clinical-stage biopharmaceutical companies such as ours.

Any predictions you make about our future success or viability may not be as accurate as they would otherwise be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products.

• undertake any commercialization-related activities;

• advance preclinical-stage product candidates into clinical development;

• maintain, protect and seek to expand our intellectual property portfolio.

Biopharmaceutical product development entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, secure market access and reimbursement, and become commercially viable, and therefore any investment in us is highly speculative.

Accordingly, before making an investment in us, you should consider our prospects, factoring in the high costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially small clinical-stage biopharmaceutical companies such as ours.

Any predictions you make about our future success or

viability may not be as accurate as they would otherwise be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products.

We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives.

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If we continue to incur losses as we have since our inception, investors may not receive any return on their investment and may lose their entire investment.

We will need substantial additional financing to execute our business plan, and if we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our research and development programs, pre-commercialization or commercialization efforts.

We will need substantial additional capital to execute our business plan, and if we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our research and development programs, personnel, pre-commercialization or commercialization efforts.

Our operations have consumed substantial amounts of cash since inception.

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We will need to raise substantial additional capital to complete certain of our currently planned preclinical and clinical development programs, including future late-stage clinical trials.

If we are able to gain marketing approval for any product candidates that we develop, we will require significant amounts of additional capital in order to launch and commercialize such product candidates.

As the outcome of our ongoing research and development activities, including the outcome of future anticipated preclinical studies and clinical trials, is highly uncertain, w e cannot reasonably estimate the actual amounts of additional capital necessary to successfully complete the development and commercialization of any product candidate we develop.

We do not expect to generate sustainable positive operating cash flows until, and unless, we obtain approval from the FDA and other regulatory authorities and successfully commercialize one or more of our product candidates.

As a result of these and other factors, we will need to seek additional capital to meet our future operating plans and requirements, including capital necessary to develop, obtain regulatory approval for, and commercialize fasedienol and our other product candidates, and may seek additional capital in the event there exists favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans and requirements.

If we are able to gain marketing approval for any product candidates that we develop, we will require significant amounts of additional capital in order to prepare to launch and commercialize such product candidates.

As a result of these and other factors, we will need to seek additional capital to fund our future operations, operating plans and requirements, including capital necessary to develop, obtain regulatory approval for, and commercialize our product candidates, alone or with one or more collaborators, and may seek additional capital in the event there exists favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current operations or future operating plans and requirements.

Our future need for additional funding depends on many factors, including:

• the number and characteristics of future product candidates we pursue and their development requirements;

• the scope, progress, results and costs of researching, developing and commercializing our product candidates and any other additional product candidates we may develop and pursue in the future;

• the scope, progress, results and costs of researching, developing and commercializing our product candidates, alone or with one or more collaborators, and any other additional product candidates we may develop and pursue in the future;

• the timing of, and the costs involved in, obtaining marketing approvals for our product candidates and any other additional product candidates we may develop and pursue in the future;

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• subject to receipt of regulatory approval, revenue, if any, received from commercial sales of our product candidates or any other additional product candidates we may develop and pursue in the future;

• the cost of formulating and manufacturing our product candidates;

• the cost of formulating and manufacturing our product candidates, and our reliance on third-party contract development and manufacturing organizations (CDMOs) to do so;

• the extent to which we establish and maintain strategic partnerships, licensing or other collaborative arrangements necessary for the development and commercialization of our product candidates, on favorable financial terms, if at all;

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• the effect of competing technological and market developments;

• our headcount growth and associated costs as we expand our research and development, market development, pre-commercial and commercial activities;

• our headcount growth and associated costs if we expand our research and development, market development, pre-commercial and commercialization activities;

• the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights, including enforcing and defending intellectual property related claims;

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We may also seek funds through arrangements with collaborative partners in certain territories, including the U.S., or at an earlier stage than otherwise would be desirable or aligned with our business plan, and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

When necessary, if we are unable to obtain additional funding on a timely basis and on acceptable terms, we may be required to significantly curtail, delay or terminate one or more of our research or product development programs, our pre-commercialization efforts or be unable to continue or expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

When necessary, including if we are unable to obtain additional funding on a timely basis and on acceptable terms, we may be required to significantly curtail, delay or terminate one or more of our research or product development programs or be unable to continue our current level of operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others.

Moreover, we may fail to expend our limited resources on product candidates or indications that may have been more profitable or for which there is a greater likelihood of success.

Currently, we are developing or have development plans in place for the five clinical-stage pherine product candidates currently in our neuroscience pipeline.

We seek to maintain a process of prioritization and optimal capital allocation to maintain an appropriate balance between the development of our most advanced product candidates and indications and

ensuring the development of additional potential product candidates and indications, on our own or with strategic collaborators.

Due to the significant resources required for the development of our product candidates, we must decide which product candidates and indications to pursue and advance and the amount of resources to allocate to each.

Currently, our neuroscience pipeline includes five clinical-stage intranasal pherine product candidates and AV-101.

We seek to maintain a process of prioritization and optimal capital allocation to maintain an appropriate balance between the

development of our most advanced product candidates and indications and ensuring the development of additional potential product candidates and indications, on our own or with strategic collaborators.

Due to the significant resources required for the development and commercialization of our pharmaceutical product candidates, we must decide which of our product candidates and indications to pursue and advance, as well as the amount of resources to allocate to each, if any.

Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular product candidates, therapeutic areas or indications may not lead to the development of viable commercial products and may divert resources away from better opportunities.

If we make incorrect determinations regarding the viability or market potential of any of our product candidates or misread trends in the pharmaceutical industry, in particular for psychiatric and neurological disorders, our business, financial condition and results of operations could be materially and adversely affected.

As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other disorders that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercialization rights.

If we make incorrect determinations regarding the viability or market potential of any of our product candidates or misread trends in the pharmaceutical industry, in particular for psychiatric, neurological and women's health conditions and disorders, our business, financial condition and results of operations could be materially and adversely affected.

As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other conditions or disorders that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercialization rights.

We may not realize the expected benefits from our workforce reduction and we may incur additional costs implementing it or other difficulties.

In March 2026, we implemented a workforce reduction.

The objective of the reduction was to provide for disciplined cash management while prioritizing efficient execution of ongoing placebo-controlled clinical trials and real-world open label clinical studies in our PALISADE Program for fasedienol, including, but not limited to, PALISADE-4 and the Repeat Dose Study.

However, the reduction in workforce may yield unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond our intended workforce reduction, a reduction in morale among our remaining employees, and the risk that we may not achieve the anticipated benefits, all of which may have an adverse effect on our development activities, ability to progress our product candidate development, and results of operations or financial condition.

We may also incur other charges, costs, future cash expenditures or impairments not currently contemplated due to events that may occur as a result of, or in connection with, workforce reduction.

In addition, we may be unsuccessful in distributing the duties and obligations of departed employees among our remaining employees.

We may also discover that the workforce reduction and cost cutting measures will make it difficult for us to pursue new opportunities and initiatives and require us to hire qualified replacement personnel, which may require us to incur additional and unanticipated costs and expenses.

Our failure to successfully accomplish any of the above activities and goals may have a negative impact on our business, financial condition, results of operations and growth prospects.

Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish significant rights to our technologies or product candidates.

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To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interest of our stockholders may be substantially diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of our common stockholders.

In addition, royalty-based financing or debt financing, if available, may result in our relinquishing significant rights to valuable future revenue streams or fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business.

In addition, royalty-based financing or debt financing, if available, may result in our relinquishing significant rights to potentially valuable future revenue streams or fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business.

In addition, securing financing could require a substantial amount of time and attention from our management team and may divert a disproportionate amount of our attention away from day-to-day activities, which may adversely affect our management team’s ability to oversee the development and commercialization of our product candidates, if approved.

If we raise additional capital through collaborations, strategic alliances or marketing, distribution or licensing arrangements, or royalty-based financings 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 may not be favorable to us.

If we raise additional capital through collaborations, strategic alliances or marketing, distribution or licensing arrangements, or royalty-based financings with third parties, we may have to relinquish potentially valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain capital through arrangement with collaborators on terms unfavorable to us or pursue other strategies, all of which could adversely affect the holdings or the rights of our stockholders.

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The time required to obtain approval by the FDA and comparable foreign authorities is inherently unpredictable, but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including substantial discretion of the regulatory authorities and such factors may vary among jurisdictions.

For instance, jurisdictions outside of the U.S., such as China, the European Union (EU) or Japan, may have different requirements for regulatory approval, which may require us to conduct additional clinical, nonclinical or chemistry, manufacturing and control studies.

In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development.

To date, we have not submitted a NDA to the FDA or similar drug approval submissions to comparable foreign regulatory authorities for any product candidate.

We must complete additional preclinical studies

and clinical trials to demonstrate the safety and efficacy of our product candidates in humans before we will be able to seek or obtain these approvals.

Nonclinical studies and clinical trials are expensive, difficult to design and implement, can take many years to complete and are inherently uncertain as to outcome.

We cannot guarantee that any nonclinical studies or clinical trials will be conducted as planned or completed on schedule, if at all.

For instance, jurisdictions outside of the U.S., such as China, the European Union (EU) or Japan, may have different requirements for regulatory approval of a product candidate, which may require us to conduct additional clinical, nonclinical or chemistry, manufacturing and control studies.

In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical developm ent.

For example, certain early-stage clinical trials of our pherine product candidates were conducted outside of the U.S.

Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country.

Although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of these data is subject to conditions imposed by the FDA, and there can be no assurance that the FDA will accept data from trials conducted outside of the U.S.

If the FDA does not accept the data from any trial that we conduct outside the U.S., it would likely result in the need for additional trials, which would be costly and time-consuming.

Moreover, to date, we have not submitted a NDA to the FDA or similar drug approval submissions to comparable foreign regulatory authorities for any product candidate.

We must complete required nonclinical studies and clinical trials to demonstrate the safety and efficacy of our product candidates in humans before we will be able to seek or obtain any regulatory approval.

Nonclinical studies and clinical trials are expensive, difficult to design and implement, can take many years to complete.

All nonclinical studies and clinical trials are inherently uncertain as to outcome.

We cannot guarantee that any nonclinical studies or clinical trials will be conducted as planned, completed on schedule, if at all, or, if completed, be successful.

The clinical development of our product candidates is susceptible to the risk of failure inherent at any stage of development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of adverse events that are severe or medically or commercially unacceptable, failure to comply with protocols or applicable regulatory requirements and determination by the FDA or any comparable foreign regulatory authority that a product candidate may not continue development or is not approvable.

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Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability caused by, such product candidate, or mistakenly believe that our product candidates are toxic or not well tolerated when that is not in fact the case.

Serious adverse events or other adverse events, as well as tolerability issues, could hinder or prevent market acceptance of the product candidate at issue.

This lengthy approval process, as well as the unpredictability of nonclinical studies and clinical trial results, may result in our failing to obtain regulatory approval to market any product candidate we develop, which would substantially harm our business, results of operations and prospects.

The FDA and other comparable foreign authorities have substantial discretion in the approval process and determining when or whether regulatory approval will be granted for any product candidate that we develop.

Even if we believe the data collected from future clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA or any other regulatory authority.

In addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

Serious adverse events or other adverse events, as well as tolerability issues, could hinder or prevent market approval and acceptance of the product candidate at issue.

This lengthy regulatory approval process, as well as the unpredictability of nonclinical study and clinical trial results, may result in our failing to obtain regulatory approval to market any product candidate we develop, which would substantially harm our business, results of operations and prospects.

The FDA and other comparable foreign authorities have substantial discretion in the regulatory approval process and determining when or whether regulatory approval will be granted for any product candidate that we develop.

Even if we believe the data collected from completed or future clinical trials of our product candidates are promising, such data may not be sufficient to support regulatory approval by the FDA or any other regulatory authority.

In addition, even if we were to obtain regulatory approval of our product candidate, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization

of that product candidate.

Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

The FDA or comparable foreign regulatory authorities may disagree with our regulatory plan for our product candidates.

The FDA or comparable foreign regulatory authorities may disagree with our regulatory plan for the development and potential approval of our product candidates.

In order to obtain FDA approval of our product candidates, we must, among other things, demonstrate substantial evidence of the effectiveness of such product candidates.

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Adequate and well-controlled clinical trials typically involve a large number of patients, have significant costs and take years to complete.

The FDA or other regulatory authorities may disagree with us about whether a clinical trial is adequate and well-controlled or may request that we conduct additional nonclinical studies or clinical trials prior to granting any regulatory approval.

In addition, there is no assurance that the doses, endpoints and trial designs that we intend to use for our ongoing and/or future clinical trials, including trials developed based on feedback from the FDA or other regulatory agencies or those that have been used for the approval of similar drugs, will be acceptable for future approvals.

For example, while we have designed our U.S.

registration-directed PALISADE program for fasedienol for the acute treatment of SAD after receiving input and feedback from the FDA, there can be no assurance that the design of our planned clinical trials will be satisfactory to the FDA or that the FDA will not require us to modify our trials or conduct additional clinical trials, or that completing these trials will result in regulatory approval.

The FDA or other regulatory authorities may disagree with us about whether a clinical trial is adequate and well-controlled or may request or provide feedback to suggest that we conduct additional nonclinical studies or clinical trials prior to granting any regulatory approval.

In addition, there is no assurance that the doses, dosing strategy, endpoints and trial designs that we use for our clinical trials, including trials developed based on feedback from the FDA or other regulatory agencies or those that have been used for the approval of similar drugs, will be acceptable for future approvals.

For example, while we have designed the Phase 3 public speaking challenge studies in our U.S.

registration-directed PALISADE Program for fasedienol for the acute treatment of SAD using a public speaking challenge with SUDS as the primary efficacy endpoint based on FDA communications, the FDA has also communicated that additional studies or data are needed to support approval.

For example, the Repeat Dose Study was designed to incorporate FDA feedback to evaluate the effect of repeat dosing of fasedienol, potential dosing interval for repeat dose, as well as potential dose response and duration of effect, but the FDA may ultimately determine that the study or its results are not adequate to support approval.

Moreover, we plan to generate additional evidence recommended by the FDA to further characterize the clinical meaningfulness of the duration and magnitude of effect of fasedienol, but there can be no assurance that the design of our completed, ongoing and/or planned clinical trials or other activities to address FDA feedback on the development program will be satisfactory to the FDA or that the FDA will not require us to modify our trials or conduct additional clinical trials, generate additional information, or that completing these trials and other activities will result in regulatory approval, particularly given that the FDA has not granted regulatory approval to a drug on the basis of SUDS as a primary efficacy endpoint.

Even if our ongoing and/or future clinical trials achieve their primary efficacy endpoint, there can be no assurance that the FDA will find them sufficient to support approval.

Moreover, there are limited precedents for trial design, trial endpoints and regulatory pathway for the acute treatment of SAD and certain other therapeutic indications we are pursuing through the development of our product candidates, including fasedienol for the acute treatment of SAD, itruvone for the treatment of MDD and PH80 for the management of VMS (hot flashes) associated with menopause, which may make clinical development and regulatory approval for those product candidates more challenging.

Moreover, there are limited precedents for trial design, trial endpoints and regulatory pathway for the acute treatment of SAD and certain other therapeutic indications we are pursuing through the development of our product candidates, including fasedienol for the acute treatment of SAD, itruvone for the treatment of MDD and refisolone for the management of VMS (hot flashes) due to menopause, which may make clinical development and regulatory approval for those product candidates more challenging.

Our clinical trial results may not support approval of our product candidates.

In addition, our product candidates could fail to receive regulatory approval, or regulatory approval could be delayed, for many reasons, including the following:

• the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials;

• the FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials, including with respect to the dosing regime utilized in a particular trial or the statistical analysis plan used to analyze trial data;

• the FDA or comparable foreign regulatory authorities may not file or accept our NDA or marketing application for substantive review;

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regulatory authorities may find the chemistry, manufacturing and controls, or data insufficient to support the quality of our product candidates;

• the FDA or comparable foreign regulatory authorities may disagree with the dosing regimen, design or implementation of our clinical trials;

• we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and effective for any of their proposed indications;

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• we may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks;

• the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from our preclinical studies or clinical trials;

• the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from our nonclinical studies or clinical trials;

• the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a NDA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the U.S.

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We are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical studies and clinical trials that were previously conducted for our product candidates.

We have acquired our pherine product candidates from Pherin, now our wholly-owned subsidiary, and Pherin undertook research and development of such product candidates prior to our acquisitions.

We have acquired our pherine product candidates from Pherin Pharmaceuticals, Inc.

(Pherin), now our wholly-owned subsidiary, and Pherin undertook research and development of such product candidates prior to our acquisitions.

We had no involvement with or control over the preclinical and clinical development of our pherine product candidates prior to acquiring or licensing them from Pherin.

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Moreover, there is a high failure rate for drugs candidate proceeding through clinical trials and there can be no assurance that any of our clinical trials will ultimately be successful.

We, and many other companies in the pharmaceutical and biotechnology industries, have suffered significant setbacks in late-stage clinical trials after achieving positive results in earlier-stage development, such as the failure of our PALISADE-1 Phase 3 clinical trial of fasedienol to meet its primary endpoint, and we cannot be certain that we will not face similar setbacks in the future.

In addition to the risk of ongoing or

planned clinical trials failing to meet primary endpoints, setbacks may also be caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events.

We, and many other companies in the pharmaceutical and biotechnology industries, have suffered significant setbacks in late-stage clinical trials after achieving positive results in earlier-stage development, such as the failure of our PALISADE-1 and PALISADE-3 Phase 3 clinical trials of fasedienol to meet its primary or secondary endpoints, and we cannot be certain that we will not face similar setbacks in the future.

In addition to the risk of ongoing or planned clinical trials failing to meet primary endpoints, setbacks may also be caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events.

Such failures or setback may have a material adverse effect on our ability to develop, obtain regulatory approval for or ultimately commercialize any of our product candidates.

We may incur unexpected costs or experience material delays in completing, or ultimately be unable to complete, the contract manufacturing, nonclinical and clinical development and commercialization of our product candidates.

To obtain the requisite regulatory approvals to commercialize any of our product candidates, we must demonstrate through extensive nonclinical studies and clinical trials that our product candidates are safe and effective in humans.

To obtain regulatory approvals to commercialize any of our product candidates, we must demonstrate through extensive nonclinical studies and clinical trials that our product candidates are safe and effective in humans.

We have experienced, and may further experience delays in completing our contract manufacturing, clinical trials or nonclinical studies and initiating or completing additional clinical trials or nonclinical studies, including as a result of regulators not allowing or delay in allowing clinical trials to proceed under an IND or similar approval we need to initiate a clinical trial.

We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive marketing approval or commercialize the product candidates we develop, including:

• regulators, IRBs, or other reviewing bodies such as ethics committees may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site;

• we may not reach agreement on acceptable terms with prospective contract research organizations (CROs) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

• we may experience further challenges or delays in recruiting principal investigators or study sites to lead our clinical trials;

We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize the product candidates we develop, including:

• regulators, institutional review board (IRBs), or other reviewing bodies such as ethics committees may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site;

• we may not reach agreement on acceptable terms with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

• we may experience further challenges or delays in recruiting principal investigators or clinical trial sites to lead our clinical trials;

• the number of subjects or patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or materially slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate;

• our third-party contractors, including contract development and manufacturing organizations (CDMOs), CROs, clinical research sites or other third-parties acting on our behalf or in connection with our studies, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

• we may have to amend clinical trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in regulatory requirements or guidance, which may be required to resubmit to an institutional review board (IRB) and regulatory authorities for re-examination;

• our third-party contractors, including CDMOs, CROs, clinical research sites or other third-parties acting on our behalf or in connection with our nonclinical studies and clinical trials, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

• regulators or other reviewing bodies may find deficiencies with, fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies, or the supply or quality of any product candidate or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply;

• the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.

Regulators or IRBs of the institutions in which clinical trials are being conducted may suspend, limit or terminate a clinical trial, or data monitoring committees may recommend that we suspend or terminate a clinical trial, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Regulators or IRBs of the institutions in which clinical trials are being conducted may suspend, limit or terminate a clinical trial, or data monitoring committees may recommend that we suspend or terminate a clinical trial, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a clinically meaningful benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Negative or inconclusive results from our clinical trials or preclinical studies could mandate repeated or additional clinical trials and, to the extent we choose to conduct clinical trials in other indications, could result in changes to or delays in clinical trials of our product candidates in such other indications.

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Our clinical development activities could be materially delayed or otherwise adversely affected by difficulties enrolling and randomizing patients in our clinical trials.

We have, and may continue to experience difficulties in patient enrollment and randomization in our clinical trials for a variety of reasons, including the stringent entry criteria for our clinical trials.

We have experienced, and may continue to experience, difficulties in patient enrollment and randomization in our clinical trials for a variety of reasons, including the stringent entry eligibility criteria for our clinical trials.

The timely completion of clinical trials requiring rigorous adherence to clinical trial protocols depends, among other things, on our ability to enroll and randomize a sufficient number of patients who qualify for and remain in the trial until its conclusion.

Patient enrollment and randomization is affected by many factors, including:

• the patient eligibility criteria defined in the protocol;

• the size and nature of the patient population required for analysis of the trial’s primary endpoints;

• the severity of the disease or condition under investigation;

• the proximity of patients to trial sites;

Patient enrollment and randomization in a clinical trial is affected by many factors, including:

• the patient eligibility criteria defined in the protocol for such clinical trial;

• the size and nature of the patient population required for analysis of the trial’s primary efficacy endpoints;

• the severity of the disease or condition under investigation in such clinical trial;

• the proximity of patients to clinical trial sites;

• the design of the trial;

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• our ability to obtain and maintain patient consents;

• the risk that patients enrolled in our clinical trials will drop out of the trials before completion.

• the risk that patients enrolled in our clinical trials will drop out before completion.

We may also experience challenges in recruiting principal investigators and patients to participate in ongoing and future clinical trials for our product candidates if we are unable to sufficiently demonstrate the potential of such product candidates to them.

In addition, our clinical trials may compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.

Since the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site.

Furthermore, if significant adverse events or other side effects are observed in any of our clinical trials, we may have difficulty recruiting patients to our trials and patients may drop out of our trials.

Since the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available to participate in our clinical trials at such clinical trial site.

Furthermore, if significant adverse events or other side effects are observed in any of our clinical trials that are related to or deemed to be caused by any of our product candidates, we may have difficulty recruiting patients to our trials and patients may drop out of our trials.

Finally, business disruptions, including those relating to natural disasters (including as a result of climate change), geopolitical incidents, pandemics or macroeconomic conditions, may disrupt our clinical trials.

Our inability to enroll and randomize a sufficient number of patients for our clinical trials would result in significant delays or might require us to abandon one or more clinical trials or our development efforts altogether.

Material delays in patient

enrollment and randomization may result in increased costs, affect the timing or outcome of ongoing or planned clinical trials and the public disclosure of trial results, product candidate development and approval process and jeopardize our ability to raise additional capital and seek and obtain the regulatory approval required to commence product sales and generate revenue, which could prevent completion of these trials, adversely affect our ability to advance the development of our product candidates, cause the value of the Company to decline and limit our ability to obtain additional financing if needed.

Material delays in patient enrollment and randomization may result in increased costs, affect the timing or outcome of ongoing or planned clinical trials and the public disclosure of trial results, product candidate development and regulatory approval process and jeopardize our ability to raise additional capital and seek and obtain the regulatory approval required to commence product sales and generate revenue, which could prevent completion of these trials, adversely affect our ability to advance the development of our product candidates, cause the value of the Company to decline and limit our ability to obtain additional financing if needed.

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As product candidates proceed through preclinical studies and clinical development trials towards potential approval and commercialization, it is common that various aspects of the development program, such as the vendors used to manufacture drug product or manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results.

As product candidates proceed through preclinical studies and clinical trials towards potential regulatory approval and commercialization, it is common that various aspects of the development program, such as the vendors used to manufacture drug product or manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results.

Such changes carry the risk that they will not achieve these intended objectives.

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Such changes may also require additional testing, FDA or comparable foreign regulatory authorities' notification or approval.

This could delay or prevent completion of clinical development, require conducting bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay or prevent approval of our product candidates and jeopardize our ability to commence sales and generate revenue.

Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our product candidates.

This could delay or prevent completion of clinical development, require conducting bridging clinical trials or the repetition of one or more clinical trials, increase clinical development costs, delay or prevent regulatory approval of our product candidates and jeopardize our ability to commence sales and generate revenue.

Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining regulatory approvals for the commercialization of our product candidates.

Any product candidate we develop, and the activities associated with its development and commercialization, including its design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the U.S.

and by comparable authorities in other countries.

Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction.

We have not received approval to market any product candidates from regulatory authorities in any jurisdiction and it is possible that none of the product candidates we are developing or may seek to develop in the future will ever obtain regulatory approval.

We have no experience in submitting and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs and regulatory consultants to augment our internal personnel and assist us in this process.

Failure to obtain regulatory approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction.

We have not received regulatory approval to market any of our product candidates from regulatory authorities in any jurisdiction and it is possible that none of the product candidates we are developing or may seek to develop in the future will ever obtain regulatory approval.

We have no experience in submitting and supporting the applications necessary to gain regulatory approvals and expect to rely in large part on third-party CROs and regulatory consultants to augment our internal personnel and assist us in this process.

Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy.

Securing regulatory approval also requires the submission of extensive information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority.

Any product candidates we develop may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude its obtaining marketing approval or prevent or limit commercial use.

The process of obtaining marketing approvals, both in the U.S.

Any product candidates we develop may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude its obtaining regulatory approval or prevent or limit commercial use.

The process of obtaining regulatory approvals to market our product candidates, both in the U.S.

and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved.

Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory personnel and review processes for each submitted product application, may cause delays in the approval or rejection of an application.

The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies.

Changes in regulatory approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory personnel and review processes for each submitted NDA, may cause delays in the approval or rejection of an application.

The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any NDA or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies.

In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit, or prevent marketing approval of a product candidate.

Any marketing approval that we may ultimately obtain could be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

If we experience delays in obtaining approval or if we fail to obtain approval of any product candidates we may develop, the commercial prospects for those product candidates may be harmed, and our ability to generate revenues will be materially impaired.

Any regulatory approval that we may ultimately obtain could be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

If we experience delays in obtaining regulatory approval or if we fail to obtain regulatory approval of any product candidates we may develop, the commercial prospects for those product candidates may be harmed, and our ability to generate revenues will be materially impaired.

Interim, topline and preliminary data from our nonclinical studies or clinical trials that we may announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.

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In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, if we publicly disclose certain information, you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, strategies, views, activities or otherwise regarding a particular product candidate or our business.

If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the development and commercialization of our product candidates may be delayed, and our business and results of operations may be harmed.

For planning purposes, we sometimes estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development activities or objectives.

These milestones may include our expectations regarding the commencement or completion of scientific studies and clinical trials, the submission of regulatory filings, the timing of regulatory review or approvals, or initiation of commercialization activities or objectives.

From time to time, we may publicly announce the expected timing of some of these milestones, such as the completion of an ongoing clinical trial of a product candidate, the initiation of other clinical programs, receipt of marketing approval or a commercial launch of a product.

These milestones may include our expectations regarding the commencement or completion of scientific studies and clinical trials, the submission of regulatory filings, the timing of regulatory meetings, review or approvals, or initiation of commercialization activities or objectives.

From time to time, we may publicly announce the expected timing of some of these milestones, such as the completion of an ongoing clinical trial of a product candidate, the initiation of other clinical programs, outcomes of regulatory meetings, receipt of regulatory approval or a commercial launch of a product.

The achievement of many of these milestones may be outside of our control.

All of these milestones are based on a variety of assumptions which, if not realized as expected, may cause the timing of achievement of the milestones to vary considerably from our estimates, including:

• our available capital resources or capital constraints we experience;

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• our receipt of approvals by the FDA and other regulatory authorities and the timing thereof;

• other actions, decisions or rules issued by regulators;

• other actions, decisions or rules issued by the FDA and other regulators;

• our ability to access sufficient, reliable and affordable supplies of materials used to manufacture our product candidates;

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• the securing of costs related to, and timing issues associated with, product manufacturing as well as sales and marketing activities.

If we fail to achieve announced milestones in the timeframes we expect, the development and commercialization of our product candidates may be delayed, and our business and results of operations may be harmed.

We depend heavily on the success of one or more of our current product candidates and we cannot be certain that we will be able to obtain regulatory approval for or commercialize any of our product candidates.

We are not permitted to market our product candidates in the U.S.

until we receive approval of a NDA from the FDA, or in any foreign countries until we receive the requisite approval from such countries.

until we receive FDA approval of an NDA, or in any foreign countries until we receive the requisite approval from such countries.

Obtaining FDA approval of a NDA is a complex, lengthy, expensive and uncertain process.

The FDA may refuse to permit the filing of our NDA, delay, limit or deny approval of a NDA for many reasons, including, among others:

The FDA may refuse to permit the submission of our NDA, delay, limit or deny approval of a NDA for many reasons, including, among others:

• if we submit a NDA and it is reviewed by a FDA advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional nonclinical or clinical studies, limitations on approved labeling or distribution and use restrictions;

• a FDA advisory committee may recommend, or the FDA may require, a Risk Evaluation and Mitigation Strategies (REMS) safety program as a condition of approval or post-approval;

• a FDA advisory committee or the FDA or applicable regulatory agency may determine that there is insufficient evidence of overall effectiveness or safety in a NDA and require additional clinical studies;

• the FDA or the applicable foreign regulatory agency may determine that the manufacturing processes or facilities of third-party contract manufacturers with which we contract do not conform to applicable requirements, including cGMPs;

• a FDA advisory committee may recommend, or the FDA may require, a Risk Evaluation and Mitigation Strategy (REMS) safety program as a condition of approval or post-approval;

• a FDA advisory committee or the FDA or applicable regulatory agency may determine that there is insufficient evidence of effectiveness or safety of our product candidate in an NDA and require additional clinical studies or other information;

• the FDA or comparable foreign regulatory authorities may determine that the manufacturing processes or facilities of third-party contract manufacturers with which we contract do not conform to applicable requirements, including cGMPs;

• the FDA or applicable foreign regulatory agency may change its approval policies or adopt new regulations.

Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and commercialize any current or future drug product candidate we may develop.

Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and commercialize any current or future product candidate we may develop.

Any such setback in our pursuit of regulatory approval for any product candidate would have a material adverse effect on our business and prospects.

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Although we do not contemplate doing so, if marketed individually, each component would be subject to different regulatory pathways and reviewed by different centers within the FDA.

As drug-device combination candidates, each will require review and coordination by FDA’s drug and device centers prior to approval, which may delay approval.

In the U.S., a combination product with a drug primary mode of action generally would be reviewed and approved pursuant to the drug approval processes under the Federal Food, Drug and Cosmetic Act of 1938.

In reviewing the NDA application for such a product, however, FDA reviewers in the drug center could consult with their counterparts in the device center to ensure that the device component of the combination product met applicable requirements regarding safety, effectiveness, durability and performance.

Under FDA regulations, combination products are subject to cGMP requirements applicable to both drugs and devices, including the Quality System regulations applicable to medical devices.

Problems associated with the device component of the combination product candidate may delay or prevent approval.

As drug-device combination candidates, each will require review and coordination by FDA’s drug and device centers prior to regulatory approval, which may delay approval.

In the U.S., a combination product with a drug primary mode of action generally would be reviewed and approved pursuant to the drug approval processes under the FDCA.

In reviewing the NDA for such a product, however, FDA reviewers in the drug center could consult with their counterparts in the device center to ensure that the device component of the combination product met applicable requirements regarding safety, effectiveness, durability and performance.

Under FDA regulations, combination products are subject to cGMP requirements applicable to both drugs and devices, including the Quality Management System Regulations (QMSR) applicable to medical devices.

Problems associated with the device component of the combination product candidate may delay or prevent regulatory approval.

Any such delay would have a material adverse effect on our business and prospects.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if obtained.

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We may also observe safety or tolerability issues with our product candidates in ongoing or future clinical trials.

Many compounds that initially showed promise in clinical or earlier-stage testing are later found to cause undesirable or unexpected side effects that prevent further development of the compound.

Many product candidates that initially showed promise in clinical trials or earlier-stage testing are later found to cause undesirable or unexpected side effects that prevent further development of the product candidate.

Results of future clinical trials of our product candidates could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics, despite a favorable tolerability profile observed in earlier-stage testing.

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Consequently, it is possible that our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.

If unacceptable side effects arise in the development of our product candidates, we, the FDA or comparable foreign regulatory authorities, the IRBs, or independent ethics committees at the institutions in which our trials are conducted, could suspend, limit or terminate our clinical trials, or the independent safety monitoring committee could recommend that we suspend, limit or terminate our trials, or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.

Treatment-emergent side effects that are deemed to be drug-related could delay recruitment of clinical trial subjects or may cause subjects that enroll in our clinical trials to discontinue participation in our clinical trials.

In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.

We may need to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates.

Inadequate training in recognizing or managing the potential side effects of our product candidates could result in harm to patients that are administered our product candidates.

If unacceptable side effects arise in the development of our product candidates, specifically those deemed to be caused by or directly related to any of our product candidates, we, the FDA or comparable foreign regulatory authorities, the IRBs, or independent ethics committees at the institutions in which our trials are conducted, could suspend, limit or terminate our clinical trials, or the independent safety monitoring committee could recommend that we suspend, limit or terminate our trials, or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.

Treatment-emergent adverse events that are deemed to be drug-related could delay recruitment of clinical trial subjects or may cause subjects that enroll in our clinical trials to discontinue participation in our clinical trials.

In addition, these adverse events may not be appropriately recognized or managed by the treating medical staff.

We may need to train medical personnel using our product candidates to understand the adverse event and side effect profiles for our clinical trials and upon any commercialization of any of our product candidates.

Inadequate training in recognizing or managing the potential adverse events or side effects of our product candidates could result in harm to patients that are administered our product candidates.

Any of these occurrences may adversely affect our business, financial condition and prospects significantly.

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• our reputation may suffer.

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 our product candidates, if approved by the FDA or other regulatory authorities.

If any of our product candidates are ultimately regulated as controlled substances, we, our CDMOs, as well as future distributors, prescribers, and dispensers will be required to comply with additional regulatory requirements which could delay the marketing of our product candidates, and increase the cost and burden of manufacturing, distributing, dispensing, and prescribing our product candidates.

Before we can commercialize our product candidates in the U.S.

If our product candidates are approved by the FDA or other regulatory authorities, any of these events could diminish the usage or otherwise limit the commercial success of our products and prevent us from achieving or maintaining market acceptance of our products.

If any of our product candidates are ultimately approved and regulated as controlled substances, we, our CDMOs, as well as future distributors, prescribers, and dispensers will be required to comply with additional regulatory requirements which could delay the marketing of our product candidates, and increase the cost and burden of manufacturing, distributing, dispensing, and prescribing our product candidates.

Before we can commercialize a product candidates in the U.S.

or any market outside the U.S., the U.S.

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Although we currently do not know whether the DEA or any foreign counterpart will consider any of our current or future product candidates to be controlled substances, we cannot yet give any assurance that such product candidates will not be regulated as controlled substances.

If any of our product candidates are regulated as controlled substances, depending on the DEA controlled substance schedule in which the product candidates are placed or that of its foreign counterpart, we, our CDMOs, and any future distributors, prescribers, and dispensers of the scheduled product candidates may be subject to significant regulatory requirements, such as registration, security, recordkeeping, reporting, storage, distribution, importation, exportation,

inventory, quota and other requirements administered by the DEA or a foreign counterpart of the DEA as the case may be.

distributors, prescribers, and dispensers of the scheduled product candidates may be subject to significant regulatory requirements, such as registration, security, recordkeeping, reporting, storage, distribution, importation, exportation, inventory, quota and other requirements administered by the DEA or a foreign counterpart of the DEA as the case may be.

Moreover, if any of our product candidates are regulated as controlled substances, we and our CDMOs would be subject to initial and periodic DEA inspection.

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Individual states also independently regulate controlled substances.

We have concentrated a significant portion of our research and development efforts on the treatment of neuropsychiatric and neurological disorders, a field that faces certain challenges in drug development.

We have focused a significant portion of our research and development efforts on addressing neuropsychiatric and neurological disorders.

We have concentrated a significant portion of our research and development efforts on the treatment of neuropsychiatric disorders, a field that faces certain challenges in drug development.

We have focused a significant portion of our research and development efforts on addressing neuropsychiatric disorders.

Efforts by pharmaceutical companies in this field have faced certain challenges in drug development.

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Even if any of our product candidates receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.

We have never commercialized a product, and even if any of our product candidates is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to achieve sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.

We have never commercialized a product, and even if any of our product candidates is approved by the FDA or other regulatory authorities for marketing and sale, it may nonetheless fail to achieve sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.

Certain of the indications for our product candidates have well-established standards of care that physicians, patients and payors are familiar with and, in some cases, are available generically.

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Although the development and commercialization of our most advanced pherine product candidate, fasedienol, is currently our primary focus, as part of our longer-term growth strategy, we plan to develop other of our clinical stage pherine product candidates.

We intend to evaluate internal opportunities from our existing pherine pipeline, and also may choose to in-license or acquire other product candidates to treat patients suffering from other disorders with significant unmet medical needs and limited treatment options.

These other potential product candidates will require additional, time-consuming development efforts prior to commercial sale, including manufacturing, preclinical studies, clinical trials and approval by the FDA and applicable foreign regulatory authorities.

These other potential product candidates will require additional, time-consuming development efforts prior to regulatory approval and commercial sale, including manufacturing, preclinical studies, clinical trials and approval by the FDA and comparable foreign regulatory authorities.

All product candidates are prone to the risks of failure that are inherent in pharmaceutical product development, including the possibility that the product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities.

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In addition, we intend to devote substantial capital and resources for basic research to discover and identify additional pherine product candidates.

These research programs require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified.

Our research programs may initially show promise in identifying potential pherine product candidates, yet fail to yield product candidates for clinical development for many reasons, including the following:

These research programs require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified and advanced in preclinical and clinical development.

Our research programs may initially show promise in identifying potential pherine product candidates, yet fail to yield product candidates for preclinical and clinical development for many reasons, including the following:

• the research methodology used may not be successful in identifying potential product candidates;

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We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure.

Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts.

Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the

anticipated benefits of such efforts.

We may not be able to acquire the rights to additional product candidates on terms that we find acceptable, or at all.

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If we are unsuccessful in identifying and developing additional product candidates, either through internal development or licensing or acquisition from third parties, our potential for growth and achieving our strategic objectives may be impaired.

The number of patients with the neuroscience disorders for which we are developing our product candidates has not been established with precision.

If the actual number of patients with the disorders we elect to pursue with our product candidates is smaller than we anticipate, we may have difficulties in enrolling patients in our clinical trials, which may delay or prevent development of our product candidates.

The number of patients with the neuroscience conditions and disorders for which we are developing our product candidates has not been established with precision.

If the actual number of patients with the conditions and disorders we elect to pursue with our product candidates is smaller than we anticipate, we may have difficulties in enrolling patients in our clinical trials, which may delay or prevent development of our product candidates.

Even if such product candidates are successfully developed and approved, the markets for our products may be smaller than we expect and our revenue potential and ability to achieve profitability may be materially adversely affected.

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There is no precise method of establishing the actual number of patients with any of these conditions and disorders in any geography over any time period.

With respect to many of the indications in which we have developed, are developing, or plan to develop our product candidates, we have estimates of the prevalence of the disease or disorder.

With respect to many of the indications in which we have developed, are developing, or plan to develop our product candidates, we have estimates of the prevalence of the condition or disorder.

Our estimates as to prevalence may not be accurate, and the actual prevalence or addressable patient population for some or all of those indications, or any other indication that we elect to pursue, may be significantly smaller than our estimates.

In estimating the potential prevalence of indications we are pursuing, or may in the future pursue, including, among others, our estimates as to the prevalence of SAD, MDD and vasomotor symptoms (hot flashes) due to menopause, we apply assumptions to available information that may not prove to be accurate.

In estimating the potential prevalence of conditions or disorders we are pursuing, or may in the future pursue, including, among others, our estimates as to the prevalence of SAD, MDD and vasomotor symptoms (hot flashes) due to menopause, we apply assumptions to available information that may not prove to be accurate.

In each case, there is a range of estimates in the published literature and in marketing studies, which include estimates within the range that are lower than our estimates.

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Even if our prevalence estimates are correct, our product candidates may be developed for only a subset of patients with the relevant disease or disorder or our products, if approved, may be indicated for or used by only a subset.

In the event the number of patients with the diseases and disorders we are studying is significantly lower than we expect, we may have difficulties in enrolling patients in our clinical trials, which may delay or prevent development of our product candidates.

If any of our product candidates are approved and our prevalence estimates with respect to any indication or our other market assumptions are not accurate, the markets for our product candidates for these indications may be smaller than we anticipate, which could limit our revenues and our ability to achieve profitability or to meet our expectations with respect to revenues or profits.

In the event the number of patients with the conditions and disorders we are studying is significantly lower than we expect, we may have difficulties in enrolling patients in our clinical trials, which may delay or prevent development of our product candidates.

If any of our product candidates are approved and our prevalence estimates with respect to any condition or disorder or our other market assumptions are not accurate, the markets for our product candidates for these conditions or disorders may be smaller than we anticipate, which could limit our revenues and our ability to achieve profitability or to meet our expectations with respect to revenues or profits.

Competitive products may reduce or eliminate the commercial opportunity for our product candidates, if approved.

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The clinical and commercial landscapes for the treatment of neuroscience disorders, including those we are pursuing, are highly competitive and subject to rapid and significant technological change.

We face competition with respect to our indications for our product candidates and will face competition with respect to any other drug candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide.

There are a number of large pharmaceutical and biotechnology companies that

currently market and sell drugs or are pursuing the development of drug candidates for the treatment of the indications that we are pursuing.

We face competition with respect to our indications for our product candidates and will face competition with respect to any other product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of product candidates for the treatment of the conditions or disorders that we are pursuing.

Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

We believe that a significant number of product candidates are currently under development for certain of the same indications we are currently pursuing, and some or all may become commercially available in the future for the treatment of conditions for which we are trying or may try to develop product candidates.

We believe that a significant number of product candidates are currently under development for certain of the same conditions or disorders we are currently pursuing, and some or all may become commercially available in the future for the treatment of conditions or disorders for which we are trying or may try to develop product candidates.

Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions, government agencies and research institutions.

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We currently have no marketing, sales or distribution capabilities.

We intend to establish a sales and marketing capabilities, either on our own or in collaboration with third parties, with technical expertise and supporting distribution capabilities to commercialize one or more of our product candidates that may receive regulatory approval in key territories.

These efforts will require substantial additional resources, some or all of which may be incurred in advance of any approval of the product candidate.

Any failure or delay in the development of our or third parties’ internal sales, marketing and distribution capabilities would adversely impact the commercialization of our product candidates.

We intend to establish sales and marketing capabilities, either on our own or in collaboration with third parties, with technical expertise and supporting distribution capabilities to

commercialize one or more of our product candidates that may receive regulatory approval in key territories.

These efforts will require substantial additional resources, some or all of which may be incurred in advance of any regulatory approval of the product candidate.

Any failure or delay in the development of our or a third party collaborator internal sales, marketing and distribution capabilities would adversely impact the commercialization of our product candidates.

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

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Deliberate attacks and attempts to gain unauthorized access to computer systems and networks, have increased in frequency and sophistication.

These threats pose a risk to the security of our, our collaborators’, CROs’, third-party logistics providers’, distributors’ and other contractors’ and consultants’ systems and networks, and the confidentiality, availability and integrity of our data.

These threats pose a risk to the security of our, our collaborators’, CDMOs', CROs’, third-party logistics providers’, distributors’, and other contractors’ and consultants’ systems and networks, and the confidentiality, availability and integrity of our data.

We may not be successful in preventing or identifying cyberattacks and may experience security breaches that may remain undetected for an extended period.

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Like other companies, we have on occasion experienced, and will continue to experience, threats to our data and systems, including malicious codes and viruses, phishing, business email compromise attacks or other cyberattacks.

Similarly, our collaborators, CROs, third-party logistics providers, distributors and other contractors and consultants may not be successful in protecting our clinical and other data that is stored on their systems.

Similarly, our collaborators, CDMOs, CROs, third-party logistics providers, distributors and other contractors and consultants may not be successful in protecting our clinical and other data that is stored on their systems.

Any cyberattack, data breach or destruction or loss of data could result in a violation of applicable U.S.

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We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our drug development programs and the potential commercialization of our product candidates will require substantial additional cash to fund expenses.

Our drug development programs and the potential commercialization of our product candidates will require substantial additional capital to fund expenses.

We may decide to collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates.

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As a result, we can expect to relinquish some or all of the control over the future success of a product candidate that we license to a third party in the territories included in the licenses.

Moreover, upfront payments received upon execution of collaborative agreements, such as the AffaMed Agreement, may be recorded as deferred revenue, in which case they would be recognized over the period of performance for the related performance obligations with the third-party collaborator pursuant to the applicable agreement.

The period of performance obligations may also be revised on a prospective basis.

Assumptions related to revenue recognition for performance obligations provided over time are reviewed in each accounting period and changes are recorded in the current period.

In certain circumstances, changes in assumptions related to the measure of progress for a performance obligation performed over time could result in negative revenue or the acceleration of revenue for an accounting period.

We face significant competition in seeking appropriate collaborators.

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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.

In addition, any future collaboration that we enter into may not be successful.

In addition, any current or future collaboration that we enter into may not be successful.

The success of our current and future collaboration arrangements will depend heavily on the efforts and activities of our collaborators.

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Collaborations with pharmaceutical or biotechnology companies and other third parties often are terminated or allowed to expire by the other party.

Any such termination or expiration would adversely affect us financially and could harm our business reputation.

Any such termination or expiration could adversely affect us financially and could harm our business reputation.

Our future growth may depend, in part, on our ability to penetrate markets outside of the U.S., where we would be subject to additional regulatory burdens and other risks and uncertainties.

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Risks Related to Managing Our Business and Operations

We depend heavily on our senior managerial personnel, third-party consultants and others and our ability to compete in the biopharmaceutical industry depends upon our ability to retain such highly qualified personnel.

We depend heavily on our key senior managerial personnel, third-party consultants and others and our ability to compete in the biopharmaceutical industry depends upon our ability to retain such highly qualified personnel.

The loss of their services or our inability to hire such personnel could materially harm our business.

Our success depends, and will likely continue to depend, upon our ability to attract and retain the services of our executive officers, senior managerial and other senior personnel within our organization.

Our executive officers and other senior employees may terminate their employment with us at any time.

The loss of their services might impede the achievement of our operational and strategic objectives.

Our success depends, and will likely continue to depend, upon our ability to retain the services of our executive officers, key senior managerial and other key senior personnel within our organization.

Our executive officers and other senior

employees may terminate their employment with us at any time.

In addition, we recently reduced employee headcount in connection with cost preservation efforts.

As a result, the loss of the services of those employees might impede the achievement of our operational and strategic objectives.

Moreover, our ability to compete in the biopharmaceutical industry depends upon our ability to attract and retain highly qualified managerial, scientific, medical, regulatory and technical personnel.

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Our industry has experienced a high rate of turnover of management personnel in recent years.

Replacing executive officers or other key employees may be difficult and may take an extended period of time because of the limited number of

individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully and the culture fit to be a leader in our organization.

Replacing executive officers or other key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully and the cultural fit to be a leader in our organization.

Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these additional key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.

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We may not be able to hire and/or retain a sufficient number of employees or employees with the required expertise to develop our product candidates or operate our business successfully.

As of March 31, 2025, we had 53 full-time employees, and two part time employees.

In March 2026, our Board of Directors approved a reduction of approximately 20% in our workforce, intended to provide disciplined cash management while prioritizing efficient execution of the ongoing clinical studies in our PALISADE Program.

As of March 31, 2026, we had 41 full-time employees.

Our focus on the development of our lead product candidates requires us to optimize cash utilization and to manage and operate our business in a highly efficient manner.

We cannot assure you that we will be able to hire and/or retain adequate staffing levels to develop our product candidates or run our operations and/or to accomplish all of the objectives that we otherwise would seek to accomplish.

If we are not able to effectively expand our organization by hiring new qualified employees, our clinical trials may be delayed or terminated, we may not be able to successfully execute the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our development and commercialization goals.

We cannot assure you that we will be able to retain adequate staffing levels to develop our product candidates or run our operations and/or to accomplish all of the objectives that we otherwise would seek to accomplish.

If we are not able to retain adequate staffing levels or effectively expand our organization by hiring new qualified employees as needed, our clinical trials may be delayed or terminated, we may not be able to successfully execute the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our development and commercialization goals.

Our employees, independent contractors, consultants, collaborators, CDMOs and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.

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Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred.

If any such actions are instituted against

us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, integrity oversight and reporting obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could have a material adverse effect on our ability to operate our business and our results of operations.

We expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We expect to continue to experience significant growth in the number of our employees and the scope of our operations.

To manage these growth activities, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel.

Our management may need to devote a significant amount of their attention to managing these growth activities.

Due to our limited financial resources, our limited operating history and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion or any necessary relocation of our operations, retain key employees, or identify, recruit and train additional qualified personnel.

Our inability to manage the expansion or any necessary relocation of our operations effectively may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees.

Our expected growth could also require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates.

If we are unable to effectively manage our expected growth, our expenses may increase more than expected, our ability to generate revenues could be reduced and we may not be able to implement our business strategy, including the successful commercialization of our product candidates.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, integrity oversight and reporting obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could have a material adverse effect on our ability to operate our business and our results of operations.

Unfavorable domestic or global economic or political conditions could adversely affect our business, financial condition or results of operations.

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Domestic and global financial and political crises cause extreme volatility and disruptions in the capital and credit markets.

A severe or prolonged economic downturn, such as the economic downturn triggered by the COVID-19 pandemic, could result in a variety of risks to our business, including, weakened demand for our product candidates and our ability to raise additional capital when needed on acceptable terms, if at all.

A severe or prolonged government shutdown and/or economic downturn, could result in a variety of risks to our business, including, weakened demand for our product candidates and our ability to raise additional capital when needed on acceptable terms, if at all.

A weak or declining domestic or global economy could also strain our suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our services.

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Techniques or software used to gain unauthorized access, and/or disable, degrade, or harm our systems may be difficult to detect for prolonged periods of time, and we may be unable to anticipate these techniques or put in place protective or preventive measures.

The damage or disruption of our systems, or the theft or compromise of our technology, data, or intellectual property, may

negatively impact our business, financial condition and results of operations, reputation, stock price and long-term value, which could adversely affect our business.

damage or disruption of our systems, or the theft or compromise of our technology, data, or intellectual property, may negatively impact our business, financial condition and results of operations, reputation, stock price and long-term value, which could adversely affect our business.

Current politics in the U.S.

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The current political environment in the U.S.

is volatile, and recent or future regulatory changes, especially at the FDA, have resulted, and may continue to result, in uncertainty throughout the pharmaceutical industry and, have an adverse effect on our business and the value of our securities.

is volatile, and recent or future regulatory changes, especially leadership at the FDA, have resulted, and may continue to result, in uncertainty throughout the pharmaceutical industry and, have an adverse effect on our business and the value of our securities.

This political and regulatory uncertainty may receive increasing publicity which, in turn, may cause the investing public to reduce the perceived value of pharmaceutical companies.

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Similar requirements may exist in foreign jurisdictions.

We remain responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards.

Our failure, or the failure of our third-party contract manufacturers, to comply with applicable protocol, legal and regulatory requirements and scientific standards could result in, among other things, rejection of our clinical data, sanctions being imposed on us, including clinical holds, a refusal to file determination by the FDA, receipt of a complete response letter (CRL), 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 significantly affect our ability to achieve regulatory approval of our product candidates.

We remain responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards.

Our failure, or the failure of our third-party contract manufacturers, to comply with applicable protocol, legal and regulatory requirements and scientific standards could result in, among other things, rejection of our clinical data, sanctions being imposed on us, including clinical holds, a refusal to file determination by the FDA, receipt of a complete response letter, 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 significantly affect our ability to achieve regulatory approval of our product candidates.

If we or our third-party clinical trial providers or third-party CROs do not successfully carry out these clinical activities, our clinical trials or the potential regulatory approval of a product candidate may be delayed or be unsuccessful.

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Furthermore, at clinical trial sites, the availability of staff and trial participants has been limited due to a decrease in the number of clinical investigative sites across the globe.

Accordingly, enrollment and randomization of subjects in some of our clinical trials may be slower than expected as a result of these changes in the post-COVID clinical

trial landscape.

Accordingly, enrollment and randomization of

subjects in some of our clinical trials may be slower than expected as a result of these changes in the post-COVID clinical trial landscape.

These contractors may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could impede their ability to devote appropriate time to our clinical programs.

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As a result, delays may occur, which could negatively impact our ability to meet our expected clinical development timelines and harm our business, financial condition and prospects.

Our use of third party contract manufactures to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, raw materials, active pharmaceutical ingredients (APIs) or drug products when needed or at an acceptable cost.

Our use of third party CDMOs to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, raw materials, active pharmaceutical ingredients (APIs) or drug products when needed or at an acceptable cost.

We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do so.

Our current strategy is to outsource all manufacturing of our product candidates to third party contract manufacturers.

We currently rely on and engage third-party contract manufacturers to provide all of the API and the final filled and finished drug product formulation of all of our product candidates that are being used in our clinical trials and preclinical studies.

Our current strategy is to outsource all manufacturing of our product candidates to third party CDMOs.

We currently rely on and engage third-party CDMOs to provide all of the API and the final filled and finished drug product formulation of all of our product candidates that are being used in our clinical trials and preclinical studies.

Although we believe that there are several potential alternative manufacturers who could manufacture our product candidates, we may incur added costs and delays in identifying and qualifying any such replacement.

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There may be difficulties in scaling up to commercial quantities and formulation of our product candidates, and the costs of manufacturing could be prohibitive.

The third-party contract manufacturers we rely on from time to time may have limited or no experience manufacturing our API and final drug products.

If our third-party contract manufacturers have difficulty or suffer delays in successfully manufacturing material that meets our specifications, it may limit supply of our product candidates and could delay our clinical trials.

Even if we are able to establish and maintain arrangements with third-party contract manufacturers, reliance on third-party contract manufacturers entails additional risks, including:

• the failure of the third-party manufacturer to comply with applicable regulatory requirements and reliance on third parties for manufacturing process development, regulatory compliance and quality assurance;

• manufacturing delays if our third-party manufacturers give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreement between us;

The third-party CDMOs we rely on from time to time may have limited or no experience manufacturing our API and final drug products.

If our third-party CDMOs have difficulty or suffer delays in successfully manufacturing material that meets our specifications, it may limit supply of our product candidates and could delay our clinical trials.

Even if we are able to establish and maintain arrangements with third-party CDMOs, reliance on third-party CDMOs entails additional risks, including:

• the failure of the third-party CDMOs to comply with applicable regulatory requirements and reliance on third parties for manufacturing process development, regulatory compliance and quality assurance;

• manufacturing delays if our third-party CDMOs give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreement between us;

• limitations on supply availability resulting from capacity and scheduling constraints of third parties;

• the possible breach of manufacturing agreements by third parties because of factors beyond our control;

• the possible termination or non-renewal of the manufacturing agreements by the third party, at a time that is costly or inconvenient to us;

• the possible termination or non-renewal of the manufacturing agreements by the third party CDMO, at a time that is costly or inconvenient to us;

• the possible misappropriation of our proprietary information, including our trade secrets and know-how.

If we do not maintain our key third-party contract manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our product candidates.

If we do find replacement third-party contract manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered with the FDA and other foreign regulatory authorities.

Additionally, if any third-party contract manufacturer with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we do not and may not ever have the capabilities or resources, or enter into an agreement with a different manufacturer.

If we do not maintain our key third-party CDMO relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our product candidates.

If we do find replacement third-party CDMO, we may not be able to enter into agreements with them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered with the FDA and other foreign regulatory authorities.

Additionally, if any third-party CDMO with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we do not and may not ever have the capabilities or resources, or enter into an agreement with a different manufacturer.

In either scenario, our clinical trials supply could be delayed significantly as we establish alternative supply sources.

In some cases, the technical skills required to manufacture our product candidates may be unique or proprietary to the original third-party contract manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.

In addition, if we are required to change third-party manufacturers for any reason, we will be required to verify that the new third-party contract manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations.

In addition, if we are required to change third-party CDMOs for any reason, we will be required to verify that the new third-party CDMO maintains facilities and procedures that comply with quality standards and with all applicable regulations.

We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce our product candidate according to the specifications previously submitted to the FDA or another regulatory authority.

We may be unsuccessful in demonstrating the comparability of clinical supplies, which could require the conduct of additional clinical trials.

The delays associated with the verification of a new third-party manufacturer could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget.

Furthermore, a third-party contract manufacturer may possess technology related to the manufacture of our product candidate that such third party owns independently.

This would increase our reliance on such third-party contract manufacturer or require us to obtain a license from such third-party contract manufacturer in order to have another third party manufacture our product candidates.

If any of our product candidates is approved by any regulatory agency, we intend to utilize arrangements with third-party contract manufacturers for the commercial production of those products.

This process is difficult and time consuming and we may face competition for access to manufacturing facilities as there are a limited number of contract manufacturers operating under cGMPs that are capable of manufacturing our product candidates.

The delays associated with the verification of a new third-party CDMO could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget.

Furthermore, a third-party CDMO may possess technology related to the manufacture of our product candidate that such third party owns independently.

This would increase our reliance on such third-party CDMO or require us to obtain a license from such third-party CDMO in order to have another third party CDMO our product candidates.

If any of our product candidates is approved by any regulatory agency, we intend to utilize arrangements with third-party CDMOs for the commercial production of those products.

This process is difficult and time consuming and we may face competition for access to manufacturing facilities as there are a limited number of CDMOs operating under cGMPs that are capable of manufacturing our product candidates.

Consequently, we may not be able to reach agreement with third-party contract manufacturers on satisfactory terms, which could delay our commercialization.

Some of our third-party contract manufacturers are located outside of the U.S.

Some of our third-party CDMOs are located outside of the U.S.

There is currently significant uncertainty about the future relationship between the U.S.

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or foreign governments will act with respect to tariffs, international trade agreements and policies, further governmental action related to tariffs, additional taxes, regulatory changes or other retaliatory trade measures in the future could occur with a corresponding detrimental impact on our business and financial condition.

Our failure, or the failure of our third-party contract manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or voluntary recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly affect supplies of our product candidates.

The facilities used by our contract manufacturers to manufacture our product candidates must be evaluated by the FDA or comparable foreign regulatory authorities in connection with any NDA or other application we may submit.

Our failure, or the failure of our third-party CDMOs, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or voluntary recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly affect supplies of our product candidates.

The facilities used by our CDMOs to manufacture our product candidates must be evaluated by the FDA or comparable foreign regulatory authorities in connection with any NDA or other application we may submit.

We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with cGMPs and similar foreign requirements.

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In addition, we have no control over the ability of our third-party contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.

If the FDA finds deficiencies or a comparable foreign regulatory authority does not approve these facilities for

the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

If the FDA finds deficiencies or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product

candidates, if approved.

Third-party contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements.

Any failure to comply with cGMP and similar foreign requirements or other FDA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our product candidates and market our products, if approved.

The FDA and other foreign regulatory authorities require our third-party contract manufacturers to register manufacturing facilities.

The FDA and other foreign regulatory authorities require our third-party CDMOs to register manufacturing facilities.

The FDA and corresponding foreign regulators also inspect these facilities to confirm compliance with cGMPs and similar foreign requirements.

Failure of any third-party contract manufacturer to comply with cGMP requirements for applicable drug/device combination products could significantly affect supplies of our product candidates.

We expect each of our current clinical-stage pherine product candidates, fasedienol, itruvone, PH15, PH80 and PH284, will be considered drug-device combination products.

Third-party contract manufacturers may not be able to comply with cGMP requirements applicable to drug/device combination products, including applicable provisions of the FDA’s or a comparable foreign regulatory authority’s drug cGMP regulations, device cGMP requirements embodied in the Quality System Regulation (QSR) or similar regulatory requirements outside the U.S.

Failure of any third-party CDMO to comply with cGMP requirements for applicable drug/device combination products could significantly affect supplies of our product candidates.

We expect each of our current clinical-stage pherine product candidates, fasedienol, refisolone, itruvone, PH15 and PH284, will be considered drug-device combination products.

Third-party CDMOs may not be able to comply with cGMP requirements applicable to drug/device combination products, including applicable provisions of the FDA’s or a comparable foreign regulatory authority’s drug cGMP regulations, device cGMP requirements embodied in the QMSR or similar regulatory requirements outside the U.S.

Our failure, or the failure of our third-party contract manufacturers, to comply with applicable regulations could result in material adverse effects, including clinical holds, 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 significantly affect supplies of our product candidates.

If any third-party contract manufacturer of our product candidates is unable to increase the scale of its production of our product candidates or increase the product yield of its manufacturing, then our manufacturing costs may increase and commercialization may be delayed.

In order to produce sufficient quantities to meet the demand for clinical trials and, if approved, subsequent commercialization of our product candidates, our third-party contract manufacturers will be required to increase their production and optimize their manufacturing processes while maintaining the quality of our product candidates.

If any third-party CDMO of our product candidates is unable to increase the scale of its production of our product candidates or increase the product yield of its manufacturing, then our manufacturing costs may increase and commercialization may be delayed.

In order to produce sufficient quantities to meet the demand for clinical trials and, if approved, subsequent commercialization of our product candidates, our third-party CDMOs will be required to increase their production and optimize their manufacturing processes while maintaining the quality of our product candidates.

The transition to larger scale production could prove difficult.

In addition, if our third-party manufacturers are not able to optimize their manufacturing processes to increase the product yield for our product candidates, or if they are unable to produce increased amounts of our product candidates while maintaining the same quality then we may not be able to meet the demands of clinical trials or market demands, which could decrease our ability to generate profits and have a material adverse impact on our business and results of operations.

In addition, if our third-party CDMOs are not able to optimize their manufacturing processes to increase the product yield for our product candidates, or if they are unable to produce increased amounts of our product candidates while maintaining the same quality then we may not be able to meet the demands of clinical trials or market demands, which could decrease our ability to generate profits and have a material adverse impact on our business and results of operations.

We may need to maintain licenses for APIs from third parties to develop and commercialize some of our product candidates, which could increase our development costs and delay our ability to commercialize those product candidates.

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For example, even if the FDA grants marketing approval of a product candidate, comparable foreign regulatory authorities must also approve the manufacturing and marketing of the product candidate in those countries.

Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S.,

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 U.S., a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.

Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S., 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 U.S., a product candidate must be

approved for reimbursement before it can be approved for sale in that jurisdiction.

In some cases, the price that we intend to charge for our products is also subject to approval.

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If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

While we may in the future seek designations for our product candidates with the FDA and comparable foreign regulatory authorities that are intended to confer benefits such as a faster development process, an accelerated regulatory pathway or regulatory exclusivity, there can be no assurance that we will successfully obtain such designations.

While we have in the past and may in the future seek designations for our product candidates with the FDA and comparable foreign regulatory authorities that are intended to confer benefits such as a faster development process, an accelerated regulatory pathway or regulatory exclusivity, there can be no assurance that we will successfully obtain such designations.

In addition, even if one or more of our product candidates are granted such designations, we may not be able to realize the intended benefits of such designations.

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Even if we obtain such designations for our product candidates, there can be no assurance that we will realize their intended benefits.

For example, we may seek a Breakthrough Therapy designation for some of our product candidates.

A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

For a product candidate that has been designated as a Breakthrough Therapy, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.

Product candidates receiving Breakthrough Therapy designation also receive the same benefits associated with Fast Track designation, described below.

Designation as a Breakthrough Therapy is within the sole discretion of the FDA.

Accordingly, even if we believe one of our product candidates meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation.

For example, as to fasedienol for the acute treatment of SAD, the FDA has informed us that designation as a breakthrough therapy cannot be granted at this time.

In any event, the receipt of a Breakthrough Therapy designation for a product candidate may not result in a faster development process, review or approval compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

In addition, even if one or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that such product candidates no longer meet the conditions for qualification.

Furthermore, the FDA has granted Fast Track designation for fasedienol for the acute treatment of SAD, for itruvone for the treatment of MDD, and for AV-101 for the adjunctive treatment of MDD and for the treatment of neuropathic pain, and we may seek Fast Track Designation for some of our other product candidates.

For example, we have in the past and may in the future seek Fast Track designation and/or Breakthrough Therapy designation for some of our product candidates.

The FDA has broad discretion whether or not to grant these designations, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it.

The FDA has granted Fast Track designation for development of fasedienol for the acute treatment of SAD, for development of itruvone for the treatment of MDD, and for development of AV-101 for the adjunctive treatment of MDD and the treatment of neuropathic pain, and we may seek fast track designation for some of our other pherine product candidates.

If a drug or biologic is intended for the treatment of a serious or life-threatening condition and the therapy demonstrates the potential to address unmet medical needs for this condition, the therapy sponsor may be eligible for Fast Track designation.

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A NDA submitted for a Fast Track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.

The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it.

The receipt of Fast Track designation for fasedienol for acute treatment of SAD, for itruvone for the treatment of MDD and AV-101 for the

adjunctive treatment of MDD and for the treatment of neuropathic pain, and any future receipt of Fast Track designation for other product candidates, does not guarantee a faster development process, review or approval compared to conventional FDA procedures, and receiving a Fast Track designation does not provide assurance of ultimate FDA approval.

The receipt of Fast Track designation for development of fasedienol for acute treatment of SAD, for itruvone for the treatment of MDD and AV-101 for the adjunctive treatment of MDD and for the treatment of neuropathic pain, and any future receipt of Fast Track designation for other product candidates, does not guarantee a faster development process, review or approval compared to conventional FDA procedures, and receiving a Fast Track designation does not provide assurance of ultimate FDA approval.

In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program.

A Breakthrough Therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

Product candidates receiving Breakthrough Therapy designation also receive the same benefits associated with Fast Track designation, described above.

Designation as a Breakthrough Therapy is within the sole discretion of the FDA.

Accordingly, even if we believe one of our product candidates meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation.

For example, the FDA

has declined to grant our requests for Breakthrough Therapy designation for fasedienol for the acute treatment of SAD.

In addition, even if one or more of our product candidates qualify as Breakthrough Therapy designation, the FDA may later decide that such product candidates no longer meet the conditions for qualification.

Some of our programs have been partially supported by government grant awards.

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Any exercise by the government of certain of its rights could harm our competitive position, business, financial condition, results of operations and prospects.

Our relationships with healthcare providers and physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors in the U.S.

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Federal and state healthcare laws and regulations that may affect our ability to operate include the following:

• the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for the purchase, lease, order, arrangement, or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.

A person or entity

does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation.

or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.

A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation.

Violations are subject to civil fines and criminal penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs.

In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act or federal civil money penalties;

• the federal civil and criminal false claims laws and civil monetary penalty laws, such as the federal False Claims Act, which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things:

• the federal civil and criminal false claims laws, such as the federal False Claims Act, which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things:

knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent;

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The federal False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the federal False Claims Act and to share in any monetary recovery;

• the federal Civil Monetary Penalties Law, which prohibits, among other things, the submission of false or fraudulent claims, the employment or contracting of an excluded individual or entity, and offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of reimbursable items or services;

• the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which prohibits, among other things, a person from knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious, or fraudulent statements or representations in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.

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Centers for Medicare & Medicaid Services, within the U.S.

Department of Health and Human Services, information related to payments or other transfers of value made to physicians, certain non-physician practitioners including nurse practitioners, certified nurse anesthetists, anesthesiologist assistants, physician assistants, clinical nurse specialists, and certified nurse midwives as well as teaching hospitals and to disclose ownership and investment interests held by physicians and their immediate family members;

Department of Health and Human Services, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners including nurse practitioners, certified nurse anesthetists, anesthesiologist assistants, physician assistants, clinical nurse specialists, and certified nurse midwives) as well as teaching hospitals and to disclose ownership and investment interests held by physicians and their immediate family members;

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

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Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high.

Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product candidates, once approved.

Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product candidates, if approved.

Patients are unlikely to use our product candidates, once approved, unless coverage is provided and reimbursement is adequate to cover a significant portion of their cost.

There is significant uncertainty related to insurance coverage and reimbursement of newly approved products.

There is significant uncertainty related to

insurance coverage and reimbursement of newly approved products.

It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the U.S.

Increasingly, third-party payors are requiring that drug companies provide them

with predetermined discounts from list prices and are challenging the prices charged for medical products.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.

We cannot be sure that reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of reimbursement.

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In particular, the IRA allows CMS to begin negotiating prices for certain high-cost Medicare-covered small molecule drugs after they have spent seven years on the market.

On August 29, 2023, CMS announced the list of the first ten drugs that will be subject to price negotiations.

CMS has published the negotiated prices for the initial ten drugs, which went into effect in January 2026, and the subsequent 15 drugs, which will first be effective in 2027.

CMS has also published the next set of 15 drugs that will be subject to negotiation.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.

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Congress has indicated that it will continue to seek new legislative measures to control drug costs.

continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect:

The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect:

• the demand for any of our product candidates, if approved;

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• the availability of capital.

In addition, recent and/or future policy changes may create uncertainty for our business.

The One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program.

Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect our sales of any product candidate that we commercialize.

The current administration is also pursuing a two-fold strategy to reduce drug costs in the U.S.

While it is unclear whether and how these proposals will be implemented, the current administration’s policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for our products, if approved.

On the one hand, the current U.S.

president threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S.

to the lowest price in a group of other countries.

In response, multiple manufacturers entered into confidential pricing agreements with the federal government.

Subsequently, in April 2026, the current administration issued a proclamation imposing tariffs under Section 232 of the Trade Expansion Act on imports of brand pharmaceuticals, biologics and associated pharmaceutical ingredients, beginning July 31, 2026.

Exempted from these tariffs, among others, are companies that have executed or are negotiating agreements with the federal government regarding most favored nation pricing and onshoring of production and research and development.

On the other hand, the current administration is also pursuing traditional regulatory pathways to impose drug pricing policies and published two proposed regulations in December 2025, referred to as GLOBE and GUARD.

If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing.

While the impact of the GLOBE and GUARD proposed regulations, if finalized, cannot yet be determined, it is likely to be significant.

Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S.

pharmaceutical sector and our business.

In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry.

Moreover, recent and/or future policy changes may create uncertainty for our business.

In its June 2024 decision in Loper Bright Enterprises v.

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Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

We cannot be sure whether additional legislative changes will be enacted, or whether the FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals or clearances of our product candidates, if any, may be.

We cannot be sure whether additional legislative

changes will be enacted, or whether the FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals or clearances of our product candidates, if any, may be.

Off-label use or misuse of our product candidates may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.

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In addition, government funding of other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions and personnel turnover, as a result of leadership changes, staff reductions or otherwise, at the FDA, other government agencies and comparable foreign regulatory authorities may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies and comparable foreign regulatory authorities, which would

adversely affect our business.

Disruptions and personnel turnover, as a result of leadership changes, staff reductions or otherwise, or changes to key personnel, including those on relevant regulatory review teams at the FDA, other government agencies and comparable foreign regulatory authorities may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies and comparable foreign regulatory authorities, which would adversely affect our business.

For example, in recent years, the U.S.

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Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S.

administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.

If a prolonged government shutdown occurs, or if renewed global health concerns, funding shortages or staffing limitations hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

administrative agencies, including the FDA and the USPTO, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect ability of these agencies to conduct routine activities.

If funding shortages, policy changes or staffing limitations hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Significant reductions in, or disruptions to, staffing and resources available at the USPTO could also lead to delays in the examination or approval of patent applications, or to other challenges in securing and/or enforcing our intellectual property rights.

We are subject to evolving global data protection laws and regulations, which may require us to incur substantial compliance costs, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.

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Companies that must comply with the EU GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater.

In addition, some of the personal data we process in respect of clinical trial participants is special category or sensitive personal data under the EU GDPR,

and subject to additional compliance obligations and to local law derogations.

In addition, some of the personal data we process in respect of clinical trial participants is special category or sensitive personal data under the EU GDPR, and subject to additional compliance obligations and to local law derogations.

Since the beginning of 2021, after the end of the transition period following the withdrawal of the United Kingdom from the EU (Brexit), we may also be subject to the United Kingdom General Data Protection Regulation and Data Protection Act 2018 (collectively, the UK GDPR) which imposes separate but similar obligations to those under the EU GDPR and comparable penalties, including fines of up to £17.5 million or 4% of a noncompliant company’s global annual revenue for the preceding financial year, whichever is greater.

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Case law from the Court of Justice of the European Union (CJEU) states that reliance on the standard contractual clauses - a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism - alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis.

On October 7, 2022, President Biden signed an Executive Order on ‘Enhancing Safeguards for U.S.

October 7, 2022, President Biden signed an Executive Order on ‘Enhancing Safeguards for U.S.

Intelligence Activities’ which introduced new redress mechanisms and binding safeguards to address the concerns raised by the CJEU in relation to data transfers from the EEA to the U.S.

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activities to increase in time.

We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses,

patent registrations and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

Risks Related to Our Intellectual Property Rights

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We also rely on know-how, continuing technological innovation and in-licensing opportunities to develop, strengthen and maintain the proprietary position of our product candidates.

We own patents and patent applications related to product candidates fasedienol, itruvone, PH80, PH15, and AV-101 and have licensed patents and patent applications related to certain stem cell technology.

We own patents and patent applications related to product candidates fasedienol, itruvone, refisolone, PH15, and AV-101 and nasal spray delivery devices, and have licensed patents and patent applications related to certain stem cell technologies.

Although we own and have licensed issued and patents and pending patent applications relating to our product candidates in the U.S.

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Grounds for a validity challenge include alleged failures to meet any of several statutory requirements, including lack of novelty, obviousness, and non-enablement.

Grounds for unenforceability assertions include allegations

that someone connected with the prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution.

Grounds for unenforceability assertions include allegations that someone connected with the prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution.

Third parties may also raise similar claims before administrative bodies in the U.S.

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The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant problems in protecting our proprietary rights in these countries.

Moreover, public policy, both within and outside the U.S., has become increasingly unfavorable toward intellectual property rights.

We cannot be certain that we will secure and maintain adequate patent protection for new products and technologies in the United States and other important markets.

If these developments were to occur, they could have a material adverse effect on our sales.

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Any litigation to enforce or defend our patent rights, even if we were to prevail, could be costly and time-consuming and would divert the attention of our management and key personnel from our business operations.

We may not prevail in any lawsuits we initiate, or in which we participate as a third party, and the damages or other remedies awarded if we prevailed may not be commercially meaningful.

We may not prevail in any lawsuits we initiate, or in which we participate as a third party, and the damages or other remedies awarded if we prevail may not be commercially meaningful.

In addition, proceedings to enforce or defend our patents could put our patents at risk of being invalidated, held unenforceable, or interpreted narrowly.

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We also may rely upon unpatented trade secrets, unpatented know-how, and continuing technological innovation to develop and maintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our employees and our collaborators and consultants.

It is possible that technology relevant to our business will be independently developed by a person that is not a party to such an agreement.

It is possible that technology relevant to our business will be independently developed by a person who is not a party to such an agreement.

Furthermore, if the employees, collaborators, and consultants who are parties to these agreements breach or violate the terms of these agreements, we may not discover or have adequate remedies for any such breach or violation, and we could lose our trade secrets through such breaches or violations.

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Third parties may initiate legal proceedings against us, alleging that we infringe their intellectual property rights, which may prevent or delay our product development efforts and stop us from commercializing candidate products or increase the costs of commercializing them if approved.

Also, we may file counterclaims or initiate other legal proceedings against third parties to challenge the validity or scope of their intellectual property rights, the outcomes of which also would be uncertain and a failure to prevail in such proceedings could have a material adverse effect on the success of our business.

Also, we may file counterclaims or initiate other legal proceedings against third parties to challenge the validity or scope of their intellectual property rights, the outcomes of which also

would be uncertain and a failure to prevail in such proceedings could have a material adverse effect on the success of our business.

We cannot assure that our business, product candidates, and proprietary methods do not or will not infringe the patents or other intellectual property rights of third parties.

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The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance.

The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

For example, the U.S.

Supreme Court recently decided Hikma v.

Amarin (June 2026), which concerned alleged “induced” infringement by a generic manufacturer that obtained FDA approval to market a drug under a “skinny label” corresponding to an unpatented treatment method while a second indication remained under patent.

The Court found that merely stating that a product was a generic equivalent did not constitute active steps to encourage infringement of the patented treatment indication.

Although this decision will not have any direct, immediate impact on the Company, it could be relevant in the future should the Company receive FDA approval to treat multiple indications using unpatented compounds or formulations.

In addition, the coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform and is subject to change.

If we are sued for patent infringement, we would need to demonstrate that our product candidates, products, or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this.

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or other jurisdictions.

The statutory deadlines for pursuing patent protection in individual foreign jurisdictions are based on the priority filing date of each of our patent applications and the time periods allowed for filing related applications in a given country.

The statutory deadlines for pursuing patent protection in individual foreign jurisdictions are based on the priority filing date of each of our patent

applications and the time periods allowed for filing related applications in a given country.

Thus, for each of the patent families that we believe provide coverage for our lead product candidates or technologies, we must decide where and when to pursue protection outside the U.S.

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These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

In addition, we may not be able to obtain a trademark registration in the US or other countries that provides optimal brand name protection, and we may not be able to obtain the same trademark registration in the US and other countries.

Even if we pursue and obtain issued patents in particular jurisdictions, our patent claims or other intellectual property rights may not be effective or sufficient to prevent third parties from so competing.

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We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights in relevant foreign

jurisdictions may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Accordingly, our efforts to enforce our intellectual property rights in relevant foreign jurisdictions may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Some intellectual property that we have licensed may have been discovered through government-funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S.

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government has the right to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that:

(i) adequate steps have not been taken to commercialize the invention;

(i) adequate steps have not been taken to commercialize the

(ii) government action is necessary to meet public health or safety needs;

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The full impact of these decisions is not yet known.

Recent court decisions and related USPTO examination guidelines must be considered, particularly as they relate to changes in what types of inventions are eligible for patent protection.

Recent court decisions and related USPTO examination guidelines must be considered, particularly as they relate to

changes in what types of inventions are eligible for patent protection.

Foreign patent and intellectual property laws are also evolving and are not predictable as to their impact on the Company and other biopharmaceutical companies.

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Risks Related to our Securities

If we fail to regain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be

negatively impacted.

Moreover, there can be no assurance that we will be able to regain compliance with such Nasdaq continued listing standards in the future.

On February 3, 2026, we were notified by the Nasdaq Stock Market, LLC ( Nasdaq ) that we were not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market.

Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.

The notification provides that we have 180 calendar days, or until August 3, 2026, to regain compliance with Nasdaq Listing Rule 5550(a)(2).

To regain compliance, the bid price of our common stock must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days.

An additional 180 days may be granted to regain compliance, so long as we meet the Nasdaq Capital Market continued listing requirements (except for the bid price requirement) and notify Nasdaq in writing of our intention to cure the deficiency during the second compliance period by implementing a reverse stock split, if necessary.

If we do not qualify for the second compliance period or fail to regain compliance during the second 180-day period, then Nasdaq will notify us of its determination to delist our common stock, at which point we will have an opportunity to appeal the delisting determination to a hearings panel.

No assurance can be given that we will regain compliance with the Nasdaq continued listing standards.

Failure to regain compliance with all Nasdaq continued listing standards could result in a delisting of our common stock, which could cause Nasdaq to delist our shares of common stock from trading on its exchange.

If our shares of common stock were delisted from Nasdaq, we and our stockholders could face significant material adverse consequences including:

• a limited availability of market quotations for our securities;

• reduced liquidity for our securities;

• a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

• a limited amount of news and analyst coverage;

• a decreased ability to issue additional securities or obtain additional financing in the future.

Market volatility may affect our stock price and the value of your investment.

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• volatility resulting from uncertainty and general economic conditions;

• plans for, progress of or results from nonclinical and clinical development activities related to our product candidates;

• plans for, progress of or results from nonclinical studies and clinical trials of our product candidates;

• the failure of the FDA or other regulatory authority to review or approve our product candidates in a timely manner, or at all;

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We will continue to invest resources to comply with evolving laws, regulations and standards, however this investment may result in increased general and administrative expense, and a diversion of management’s time and attention from revenue-generating activities to compliance activities.

If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us, and our business may be adversely affected.

our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us, and our business may be adversely affected.

The amount of our future losses is uncertain and our quarterly and annual operating results may fluctuate significantly or fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.

Our quarterly and annual operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following:

• the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry,

• the timing and success or failure of nonclinical studies and clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry,

• our ability to successfully recruit, enroll and retain subjects who meet our eligibility criteria for participation in our clinical trials, and any delays caused by difficulties in such efforts;

• the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics that compete with our product candidates;

• our ability to obtain marketing approval for our product candidates and the timing and scope of any such approvals we may receive;

• our ability to obtain regulatory approval for our product candidates and the timing and scope of any such approvals we may receive;

• the timing and cost of, and level of investment in, research and development and commercialization activities relating to our product candidates, which may change from time to time;

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• expenditures that we will or may incur to develop additional product candidates;

• the level of demand for our product candidates should they receive approval, which may vary significantly;

• the level of demand for our product candidates should they receive regulatory approval, which may vary significantly;

• the changing and volatile U.S.

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Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.

Because of potential volatility in our trading price and trading volume, we may incur significant costs from class action securities litigation.

The stock market in general, and the Nasdaq Stock Market (Nasdaq) and biotechnology and pharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Because of potential volatility in our trading price and trading volume, we may incur significant costs from litigation, including class action securities litigation.

The stock market in general, and the Nasdaq and biotechnology and pharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Historically, securities class action litigation has often been brought against companies following periods of volatility in the market price of a company’s securities.

For example, purported stockholders of the Company filed a lawsuit in the United States District Court for the Northern District of California against the Company and certain of our executive officers, the members of our Board and certain other parties, claiming, under the U.S.

For example, purported stockholders of the Company have filed a lawsuits in the United States District Court for the Northern District of California and the District of Nevada against the Company and certain of our executive officers, the members of our Board and certain other parties, claiming, under the U.S.

federal securities laws and certain California civil statutes, among other things, allegedly false or misleading statements, and alleged omissions of material facts, related to our public disclosures.

We believe the claims are without merit and intend to vigorously defend all claims.

This type of litigation could result in substantial costs and a diversion of management’s attention and resources, which could harm our business, operating results, or financial condition.

Additionally, the dramatic increase in the cost of directors’ and officers’ liability insurance may cause us to opt for lower overall policy limits or to forgo insurance that we may otherwise rely on to cover significant defense costs, settlements, and damages awarded to plaintiffs.

Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise may, and likely will significantly dilute all other stockholders.

We expect to issue additional capital stock in the future that may, and likely will result in substantial dilution to all of our stockholders.

We believe all claims are wholly without merit and intend to vigorously defend all claims.

These types of litigation could result in substantial costs

and a significant diversion of management’s attention and resources, which could harm our business, operating results, or financial condition.

Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will significantly dilute all other stockholders.

We expect to issue additional capital stock in the future that will result in substantial dilution to all of our stockholders.

We expect to grant equity awards to employees and directors under our stock incentive plans.

We may also raise capital through equity financings in the future.

As part of our business strategy, we may acquire or make investments in complementary companies, products, or technologies and issue equity securities to pay for any such acquisition or investment.

Any such issuances of additional capital stock will cause stockholders to experience significant dilution of their ownership interests and the per share value of our common stock to decline.

We may also raise capital through equity financings in the future, as well as securities convertible into equity.

As part of our business strategy, we may acquire or make investments in complementary companies, products, or technologies and issue equity and/or debt securities to pay for any such acquisition or investment.

Any such issuances resulting in the issuance of additional equity securities likely will cause stockholders to experience significant dilution of their ownership interests and the per share value of our common stock to decline.

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.

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Adverse market or macroeconomic conditions or market volatility resulting from global economic and political developments, including those affecting the financial services industry, could adversely affect our business operations and our financial condition and results of operations.

Adverse market or macroeconomic and political conditions or market volatility resulting from global economic developments, political activity and uncertainty, high inflation, rising interest rates, the post-COVID environment or other factors, could materially and adversely affect our business operations.

Adverse market or macroeconomic and political conditions or market volatility resulting from global economic developments, political activity and uncertainty, high inflation, rising interest rates or other factors, could materially and adversely affect our business operations.

For instance, actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.

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In addition, any deterioration in the macroeconomic economy or financial services industry could lead to losses or defaults by our partners, vendors or suppliers, which in turn, could have a material adverse effect on our current and/or projected business operations and results of operations and financial condition.

For example, a partner may fail to make payments when due, default under their agreements with us, become insolvent or declare bankruptcy, or a supplier may determine that it will no longer deal with us as a customer.

For example, a partner may fail to make payments when due, default under their agreements with us, become insolvent or declare bankruptcy, or a supplier may determine

that it will no longer deal with us as a customer.

In addition, a vendor or supplier could be adversely affected by any of the liquidity or other risks that are described above as factors that could result in material adverse impacts on us, including but not limited to delayed access or loss of access to uninsured deposits or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution.

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The rules dealing with U.S.

federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S.

federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the U.S.

Internal Revenue Service and the U.S.

Treasury Department.

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Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations.

For example, on July 4, 2025, the United States enacted tax legislation commonly referred to as the One Big Beautiful Bill Act ( OBBB Act ).

In accordance with U.S.

GAAP, the Company will account for the tax effects of changes in tax law in the period of enactment which is the quarter ended September 30, 2025.

The Company is currently in the process of analyzing the tax impacts of the OBBB Act, but we do not expect a material impact on our financial statements.

We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.

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Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.

summarized and reported within the time periods specified in the rules and forms of the SEC.

We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

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These analyses and projections may vary widely and may not accurately predict the results we actually achieve.

Our share price may decline if our actual results do not match the analyses and projections of these securities research analysts.

Our share price may decline if our actual results do not match the analyses, opinions and projections of these securities research analysts.

Similarly, if one or more of the analysts who write reports on us downgrades our stock or publishes inaccurate or unfavorable research about our business, our share price could decline.

If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, our share price or trading volume could decline.

Although we are currently in compliance with all applicable Nasdaq continued listing standards, there can be no assurance that we will be able to continue to comply with such Nasdaq continued listing standards in the future.

If, in the future, Nasdaq delists our shares of common stock from trading on its exchange for failure to meet Nasdaq’s continued listing standards, we and our stockholders could face significant material adverse consequences including:

• a limited availability of market quotations for our securities;

• reduced liquidity for our securities;

• a limited amount of news and analyst coverage;

• a decreased ability to issue additional securities or obtain additional financing in the future.

The price of our common stock may be volatile.

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

• material and adverse impact of the COVID-19 pandemic and post-COVID environment on the markets and the broader global economy;

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

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors