Reviva Pharmaceuticals Holdings, Inc.: Form 10-Q for the period ended Sep 30, 2025

The information in this Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with our unaudited condensed consolidated financial statements and the related notes set forth in Item 1 of Part I of this Quarterly Report on Form 10-Q, our MD&A set forth in Item 7 of Part II of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and our consolidated financial statements and related notes set forth in Item 8 of Part II of such Annual Report on Form 10-K. See Part II, Item 1A, “Risk Factors,” below and “Cautionary Note Regarding Forward-Looking Statements,” and the information referenced therein, for a description of risks that we face and important factors that we believe could cause actual results to differ materially from those in our forward-looking statements. All amounts and percentages are approximate due to rounding and all dollars in the text are in millions, except per share amounts or where otherwise noted. When we cross-reference to a “Note,” we are referring to our “Notes to Condensed Consolidated Financial Statements (Unaudited)” included in Part I, Item 1, of this Quarterly Report on Form 10-Q, unless the context indicates otherwise.

All statements other than statements of historical fact included in this section regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. When used in this section, words such as “anticipate,” “believe,” “estimate,” “expect,” “intend” and similar expressions, as they relate to our management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those contemplated by the forward- looking statements as a result of certain factors detailed herein. All subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are qualified in their entirety by this paragraph.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

• the success of our current or planned clinical trials through all phases of clinical development, including our ability to conduct and complete clinical trials in accordance with projected timelines, our ability to achieve the desired results, and our ability to successfully complete requisite regulatory review and approval processes;
• our ability to obtain the necessary financing to continue to conduct our business operations as planned, and to conduct our ongoing and planned trials, and continue and complete the planned development and commercialization of our product candidates;
• our ability to grow and manage growth economically;
• our ability to retain key executives and medical and science personnel;
• the possibility that our products in development succeed in or fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable authorities;
• the possibility that we could be forced to delay, reduce or eliminate our planned clinical trials or development programs;
• our ability to obtain approval from regulatory agents in different jurisdictions for our current or future product candidates;
• changes in applicable laws or regulations;
• changes to our relationships within the pharmaceutical ecosystem;
• the performance of third-party suppliers and manufacturers and our ability to find additional suppliers and manufacturers and obtain alternative sources of raw materials;
• our current and future capital requirements to support our development and commercialization efforts and our ability to satisfy our capital needs;
• our ability to access capital on acceptable terms in a rising interest rate and tighter credit environment;
• expectations regarding our ability to continue as a going concern;
• the accuracy of our estimates regarding expenses and capital requirements, including estimated costs of our clinical studies;
• our limited operating history;
• our history of operating losses in each year since inception and expectation that we will continue to incur operating losses for the foreseeable future;
• the valuation of our private common warrants could increase the volatility in our net income (loss);
• changes in the markets that we target;
• our ability to maintain or protect the validity of our patents and other intellectual property;
• our exposure to any liability, protracted and costly litigation or reputational damage relating to data security;
• the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements;
• any disruption to our business that may occur on a longer-term basis should we be unable to remediate the material weaknesses we have identified in our internal controls;
• our ability to regain (as applicable) and maintain compliance with the continued listing requirements of The Nasdaq Capital Market and maintain the listing of our common stock on Nasdaq; and
• the possibility that we may be adversely affected by other economic, business, and/or competitive factors.

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in such forward-looking statements. Please see “Part II-Item 1A-Risk Factors” for additional risks which could adversely impact our business and financial performance.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaims any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.

Company Overview

We are a late-stage pharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing significant unmet medical needs and burdens to society, patients, and their families. Our current pipeline focuses on the central nervous system, inflammatory, and cardiometabolic diseases. We use a chemical genomics driven technology platform and proprietary chemistry to develop new medicines. Our pipeline currently has two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. We have been granted composition of matter patents for both brilaroxazine and RP1208 in the United States (U.S.), Europe, and several other countries.

Our lead drug candidate, brilaroxazine, is in clinical development and is intended to treat multiple neuropsychiatric indications. These include schizophrenia, bipolar disorder (“BD”), major depressive disorder (“MDD”), attention-deficit/hyperactivity disorder (“ADHD”), behavioral and psychotic symptoms of dementia and Alzheimer’s disease (“BPSD”), and Parkinson’s disease psychosis (“PDP”). Furthermore, brilaroxazine is also ready for clinical development for two respiratory indications - pulmonary arterial hypertension (“PAH”) and idiopathic pulmonary fibrosis (“IPF”). The U.S. Food and Drug Administration ("FDA") granted Orphan Drug Designation to brilaroxazine for the treatment of PAH in November 2016 and IPF in April 2018. Brilaroxazine also is in preclinical development for the treatment of psoriasis.

Our primary focus is to complete the clinical development of brilaroxazine for the treatment of acute and maintenance schizophrenia.

On October 30, 2023, we announced positive topline results from our Phase 3 RECOVER 1 trial (the “RECOVER-1 Trial”), which is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. On December 16, 2024, we announced positive preliminary topline data from, and on June 2, 2025, we announced a positive full dataset and successful completion of, our Phase 3 RECOVER open label extension (the “OLE” or the “OLE Trial”) a 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia. See “Recent Developments – Open Label Extension (OLE) Trial Results” below for information about the OLE Trial results, and our other filings from time to time with the SEC for more details on our brilaroxazine development program.

Subject to the receipt of additional financing, we may also continue the clinical development of brilaroxazine for the treatment of BD, MDD, ADHD, BPSD, PDP, PAH and IPF. Moreover, subject to the receipt of additional financing, we may also advance the development of our second drug candidate, RP1208, for the treatment of depression and obesity.

Recent Developments

Phase 3 RECOVER-1 Data

On October 30, 2023, we announced positive topline results and successful completion of our pivotal RECOVER-1 Trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin dopamine signaling modulator in adults with schizophrenia. Brilaroxazine is a novel serotonin dopamine signaling modulator with multi-faceted direct and indirect activities on critical pathways implicated in schizophrenia. The trial successfully met its primary endpoint at the 50 mg dose, with brilaroxazine at that dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 4. Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo. The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints, and reached statistical significance on two key secondary endpoints.

Key statistically significant and clinically meaningful improvements with brilaroxazine vs. placebo in patients (n = 411) with schizophrenia and a mean PANSS total score of 97-99 at baseline include:

Key clinical safety and tolerability findings of brilaroxazine support a well-tolerated safety profile:

• No drug related serious adverse events (SAEs) or treatment-emergent SAEs (TESAEs) observed or major safety concerns reported for brilaroxazine after 4 weeks of treatment;
• No incidence of suicidal ideation;
• No significant change in bodyweight and blood glucose levels compared to placebo;
• Significant decrease in cholesterol, LDL and increase in HDL compared to placebo;
• Significant decrease in prolactin and no change in thyroid levels compared to placebo;
• Akathisia and extrapyramidal symptoms <1% reported for brilaroxazine 50 mg and none for 15 mg;
• Common brilaroxazine treatment-emergent adverse events (TEAEs) were headache (<6%) and somnolence (<7.5%) generally transient in nature; and
• Low discontinuation rates with brilaroxazine that were less than placebo (16% in brilaroxazine 50mg and 19% in brilaroxazine 15mg vs. 22% placebo).

Open Label Extension (OLE) Trial Results

On June 2, 2025, we announced a positive full dataset and successful completion of our Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia. Once daily brilaroxazine led to robust broad-spectrum efficacy that was sustained over 1-year and was generally well tolerated with a discontinuation rate of 35% in this long-term study.

We announced the full data of the Phase 3 RECOVER trial OLE on June 2, 2025 and summarized herein are the results:

• 446 patients enrolled in the OLE trial
• 159 patients completed 1-year (12 months) of treatment
• 303 patients completed 6 months of treatment
• Biomarkers designed to independently support safety and efficacy
• Long-term safety data from 100 patients who have completed 12 months of treatment is a requirement for brilaroxazine’s NDA submission to the FDA

4

Key efficacy, biomarkers and compliance results for pooled analysis of brilaroxazine 15, 30, and 50 mg over 1 year treatment in RECOVER trial OLE (N=446)

Key safety and tolerability results for pooled analysis of brilaroxazine 15, 30, and 50 mg over 1 year treatment in RECOVER trial OLE (N=446)

Brilaroxazine: Strong Efficacy & Well-Tolerated Safety with Low Discontinuation Over 1-Year RECOVER Phase 3 trials in acute and stable schizophrenia patients (total patients enrolled, N=857)

Ongoing clinical activities related to closing the OLE trial involve closeout of clinical sites globally and preparation of the RECOVER study report, with such activities currently in progress.

Potential Path to NDA Submission

In addition to the successfully completed Phase 3 RECOVER-1 and OLE trials, we also have positive data from the Phase 2 REFRESH trial. Our original clinical development plan called for a second, larger, Phase 3 trial identified as RECOVER-2. However, given the quantity and quality of positive data we have gathered so far on the use of brilaroxazine to treat acute schizophrenia, we believe that we have met the statutory clinical data requirement needed for NDA submission and approval. We therefore have a planned meeting with the FDA in Q4-2025 to discuss the submission of an NDA based solely on the data gathered to date. If the FDA response is positive, we will target NDA submission in Q2-2026.

May 2025 ATM Sales Agreement

On May 30, 2025, we entered into an at market issuance sales agreement (the “May 2025 ATM Sales Agreement”) with B. Riley Securities, Inc. and Alliance Global Partners serving as agents (the “Agents”), with respect to an at-the-market (ATM) offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50 million through the Agents. During the three months ended September 30, 2025, we sold 1,183,506 shares of common stock pursuant to the May 2025 ATM Sales Agreement for net proceeds of approximately $0.5 million after deducting sales agent commissions and other offering expenses of approximately $30.8 thousand. During the nine months ended September 30, 2025, we sold 2,447,170 shares of common stock pursuant to the May 2025 ATM Sales Agreement for net proceeds of $1.2 million after deducting sales agent commissions and other offering expenses of approximately $0.4 million.

June 2025 Public Offering

On June 26, 2025, we entered into a placement agency agreement (the “June 2025 Placement Agency Agreement”) with A.G.P./Alliance Global Partners, as the placement agent (the “Placement Agent”), pursuant to which we sold in a public offering (i) an aggregate of 20,000,000 shares of our common stock, (ii) Series C warrants exercisable for an aggregate of up to 20,000,000 shares of common stock (the “Series C Common Warrants”) and (iii) Series D warrants exercisable for an aggregate of up to 20,000,000 shares of common stock (the “Series D Common Warrants” and together with the Series C Common Warrants, the “June 2025 Warrants”), for aggregate gross proceeds of $10.0 million (the “June 2025 Public Offering”). Each share of common stock was sold together with (i) a Series C Common Warrant to purchase one share of common stock and (ii) a Series D Common Warrant to purchase one share of common stock, at a combined public offering price of $0.50 per share of common stock and accompanying June 2025 Warrants. The Series C Common Warrants are exercisable immediately upon issuance, have a term of five years from the date of issuance and have an exercise price of $0.50 per share. The Series D Common Warrants are exercisable immediately upon issuance, have a term of twelve months from the date of issuance and have an exercise price of $0.50 per share. The net proceeds to us from the June 2025 Public Offering were approximately $9.0 million, after deducting Placement Agent fees and expenses and other offering expenses payable by us.

September 2025 Public Offering

On September 18, 2025, we entered into a placement agency agreement (the “September 2025 Placement Agency Agreement”) with A.G.P./Alliance Global Partners, as the placement agent (the “Placement Agent”), relating to the offering, issuance and sale of (i) an aggregate of 27,000,000 shares of our common stock, (ii) Series E warrants exercisable for an aggregate of up to 27,000,000 shares of common stock (the “Series E Common Warrants”) and (iii) Series F warrants exercisable for an aggregate of up to 27,000,000 shares of common stock (the “Series F Common Warrants” and together with the Series E Common Warrants, the “September 2025 Warrants”), for aggregate gross proceeds of $9.0 million (the “September 2025 Offering”). Each share of common stock was sold together with (i) a Series E Common Warrant to purchase one share of common stock and (ii) a Series F Common Warrant to purchase one share of common stock, at a combined public offering price of $0.335 per share of common stock and accompanying Common Warrants. The Series E Common Warrants are exercisable immediately, will have a term of five years from the date of issuance and have an exercise price of $0.335 per share. The Series F Common Warrants are exercisable immediately, will have a term of twelve months and have an exercise price of $0.335 per share. The net proceeds to us from the September 2025 Public Offering were approximately $8.1 million, after deducting Placement Agent fees and expenses and other offering expenses payable by us.

One Big Beautiful Bill Act

On July 4, 2025, the One Big Beautiful Bill Act (the “Act”) was signed into law. The Act makes permanent key elements of the Tax Cuts and Jobs Act, including 100% bonus depreciation, domestic research cost expensing, and the business interest expense limitation. We are currently evaluating the impact of the Act on our consolidated financial statements.

Intellectual Property Overview

We are the sole owner of our patent portfolio that includes issued patents and pending patent applications covering compositions of matter and methods of use of our product candidates RP5063 (brilaroxazine) and RP1208, as well as related compounds. As of November 6, 2025 our portfolio of intellectual property consists of 72 granted patents and 25 pending patent applications in the United States and in over 20 foreign countries.

Brilaroxazine is our first intended commercial product. The original brilaroxazine patents include composition of matter, and methods of use in treating acute mania, autism, BD, depression, psychosis, and schizophrenia. One brilaroxazine original patent (U.S. Patent No. 8,188,076) and its 7 divisional/continuation patents have been granted in the U.S. The original brilaroxazine patents have also been granted in the following foreign countries: Australia, Brazil, Canada, Germany, Spain, France, Great Britain, Hong Kong, Israel, India, Italy, Japan, S. Korea, Liechtenstein, Mexico, Russia, Slovakia, and Thailand; and pending in Colombia. We believe that our patent portfolio provides good protection of brilaroxazine. All of the U.S. and foreign original brilaroxazine granted patents and pending patent applications will expire or are expected to expire in 2030, if a patent term extension is not obtained. If and when brilaroxazine receives regulatory approval, we intend to apply for patent term extensions on patents covering brilaroxazine in any jurisdiction where patent term extension is available. For example, the expiration date of the first U.S. original brilaroxazine patent may be extendable up to 2035.

We also own additional brilaroxazine granted patents and pending patent applications for additional indications. We own attention hyperactivity disorder patents in the U.S., which will expire in 2035. We own pulmonary arterial hypertension patents in the U.S., Europe, China, Japan, and Hong Kong; all of which will expire in 2036. We own pulmonary fibrosis patents in the U.S., China, Japan, and Hong Kong, and pending applications in Brazil and Europe, which are all expected to expire in 2038.

We have one family of pending applications directed to a formulation of brilaroxazine, which are filed in Brazil, Canada, China, Europe, India, Japan, Korea, Mexico, and the U.S.

We have one family of pending applications directed to a method of using brilaroxazine for treating psoriasis, which are filed in Brazil, Canada, China, Europe, Japan, Korea, Mexico, and the U.S.

We have one U.S. pending application directed to a brilaroxazine composition.

We also have three U.S. provisional applications pending: one directed to using brilaroxazine for treating a specific symptom, and two directed to brilaroxazine compositions.

Financial Overview

We are a clinical-stage biopharmaceutical company and have not generated any revenues from the sale of products. We have never been profitable and have incurred losses since inception. As of September 30, 2025, we had a working capital surplus of approximately $3.8 million, an accumulated deficit of $180.8 million and cash and cash equivalents on hand of approximately $13.2 million. Our net loss for the three months ended September 30, 2025 and 2024, was approximately $4.0 million and $8.4 million, respectively. Our net loss for the nine months ended September 30, 2025 and 2024, was approximately $16.5 million and $23.7 million, respectively. We expect to incur significant expenses and increased operating losses for the next several years. We expect our expenses to increase in connection with our ongoing activities to research, develop and commercialize our product candidates. Furthermore, we continue to expect to incur additional costs associated with operating as a public company, which may increase now that we have exited emerging growth company status as of December 31, 2023, and as we continue our efforts to remediate the material weaknesses in our internal control over financial reporting that we identified as more particularly described in Part II, Item 9A of our fiscal year 2024 Annual Report on Form 10-K, and in this Quarterly Report on Form 10-Q below in Part I, Item 4. Controls and Procedures. We will need to generate significant revenues to achieve profitability, and we may never do so.

We expect our expenses will increase in connection with our ongoing activities, as we:

• invest significantly to further research and develop, through clinical trials for brilaroxazine, including completion of OLE activities, and a potential Phase 3 RECOVER-2 Trial, if required, and pre-clinical research for RP1208, and seek regulatory approval for our product candidates brilaroxazine and RP1208;
• identify and develop additional product candidates;
• hire additional clinical, scientific and management personnel;
• seek regulatory and marketing approvals for any product candidates that we may develop;
• ultimately establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval;
• maintain, expand and protect our intellectual property portfolio;
• acquire or in-license other drugs and technologies; and
• add operational, financial and management information systems and personnel, including personnel to support our product candidate development, and any future commercialization efforts, and our ongoing compliance with and maintenance of public company controls, procedures and regulatory requirements and standards. and including in connection with our continuing efforts to remediate the material weaknesses in our internal control over financial reporting that we identified as more particularly described in Part II, Item 9A of our fiscal year 2024 Annual Report on Form 10-K, and in this Quarterly Report on Form 10-Q below in Part I, Item 4. Controls and Procedures.

In light of successful completion of the Phase 3 RECOVER-1 trial, a second large randomized double-blind trial (Phase 2 REFRESH) and a large Phase 3 RECOVER OLE trial to assess long-term safety, tolerability, sustainable efficacy and treatment adherence, we are currently assessing appropriate next steps in brilaroxazine’s path to approval. See “Research and Development Expenses” below.

Research and Development Expenses

We focus our resources on research and development activities, including the conduct of preclinical and clinical studies and product development and expense such costs as they are incurred. We have not historically tracked or recorded research and development expenses on a project-by-project basis, primarily because we use our employee and infrastructure resources across multiple research and development projects, and it is not practical for us to allocate such costs on a project-by-project basis. Our research and development expenses primarily consist of clinical trial expenses and employee-related expenses, including deferred salaries, salaries, benefits and taxes for personnel in research and development functions.

The largest recurring component of our total operating expenses has historically been research and development activities. We expect our research and development expenses will increase for the next several years as we advance our development programs, pursue regulatory approval of our product candidates in the U.S. and other jurisdictions and prepare for potential commercialization, which would require a significant investment in costs related to contract manufacturing and inventory buildup.

Our primary product candidates and their current status are as follows:

* Potential Phase 3 RECOVER-2 Trial intended initiation in early 2026, if such trial is required pending planned meeting with FDA and agency’s recommendation for brilaroxazine’s path to approval.

** We completed the Phase 1 clinical study for brilaroxazine prior to starting the Phase 2 study in schizophrenia and schizoaffective disorder, and completed our RECOVER-1 Trial double-blind part in acute schizophrenia patients for which we announced topline data in October 2023. In these three studies, we collected safety data for brilaroxazine in over 800 patients, including healthy subjects and patients with stable schizophrenia, acute schizophrenia and schizoaffective disorder. Generally, no separate Phase 1 study is required for conducting a Phase 2 study for an additional indication, provided the treatment doses in the Phase 2 study for an additional indication are within the range of doses tested in the previously completed Phase 1 study.

The successful development of our platform and product candidates is highly uncertain, and we may never succeed in achieving marketing approval for our product candidates brilaroxazine (RP5063), RP1208, or any future product candidates. In connection with the activities required to complete the development of brilaroxazine for schizophrenia, including remaining OLE activities and study wrap-up and our potential Phase 3 RECOVER-2 Trial, if required, we expect to incur substantial additional costs over the 2025-2026 period to take us through the submission of the planned NDA for brilaroxazine, together with additional costs post-NDA submission in preparation of potential commercialization if approved. We expect our clinical costs in connection with the development of brilaroxazine for schizophrenia (with our estimates including, for these purposes, expected costs of our potential Phase 3 RECOVER-2 Trial, if required), may total approximately $60 million over the next approximately two years, consisting of our estimated costs for (i) remaining OLE activities and wrap-up, (ii) our potential Phase 3 RECOVER-2 Trial, if required, and additional activities supporting the brilaroxazine program through the planned NDA submission, and (iii) additional Research & Development costs (primarily associated with consulting, scientific, research and other expenses in support of remaining OLE activities and wrap-up and our potential Phase 3 RECOVER-2 Trial, if required, through the planned NDA as well as certain activities in preparation of potential commercialization if the product attains approval). The foregoing forecasted amount of expenses is an estimate based on numerous factors and information available to management as of today, and is subject to change. The actual amount of such expenses could be materially higher or lower than the forecasted amount. The foregoing statements regarding estimates of forecasted future costs and expenses represent forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements.” At this time, other than providing reasonable estimates and forecasts based on information available to us of what we expect future costs may be in connection with the potential Phase 3 RECOVER-2 Trial, if required, and remaining OLE activities and wrap-up and certain associated expenses and other future activities needed to continue to develop brilaroxazine, we cannot reasonably estimate the nature, timing, or costs of the efforts necessary to finish developing any of our product candidates or the period in which material net cash, if any, from these product candidates may commence. We believe we have successfully completed with positive results the two randomized double blind trials, as well as the safety, pharmacology and non-clinical studies typically required for NDA approval. We therefore are preparing to meet with FDA to gain alignment on our path to NDA submission, including a discussion of whether there is a need for a second phase 3 study (RECOVER-2). If FDA tells us we need to initiate a second phase 3 study, we intend to commence it in early 2026, subject to financing. As stated previously, there are numerous risks and uncertainties associated with developing our therapeutics, including:

• the scope, rate of progress, expense, and results of clinical trials;
• the scope, rate of progress, and expense of process development and manufacturing;
• preclinical and other research activities;
• our ability to raise capital to finance our clinical trials; and
• the timing of regulatory approvals.

General Administrative Expenses

General and administrative expenses primarily consist of payroll and related costs for employees in executive, business development, finance, and administrative functions. Other significant general and administrative expenses include professional fees for accounting and legal services.

We expect general and administrative expenses to increase as we expand infrastructure and continue the development of our clinical programs. Other increases could potentially include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel, and increased fees for directors, outside consultants, lawyers, and accountants. We expect to incur significant costs to comply with corporate governance, internal controls, and similar requirements applicable to public companies.

Critical Accounting Estimates

Our critical accounting estimates are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on April 3, 2025. Since the date of such Annual Report, there have been no material changes in our critical accounting estimates.

Results of Operations

Comparison of the three months ended September 30, 2025 and 2024:

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

Research and Development Expenses

Research and development costs are expensed as incurred. These expenses represent both internal and external costs.

For the three months ended September 30, 2025 and 2024, research and development expenses were approximately $2.1 million and $6.9 million, respectively. Specifically, during the three months ended September 30, 2025 and 2024, our research and development costs consisted primarily of the following costs associated with our key research and development projects for advancing the clinical development of brilaroxazine during the reporting periods, which during such periods consisted primarily of our OLE Trial for our Phase 3 clinical study for brilaroxazine: (i) internal salaries, wages and other payroll related costs for employees involved in research and development activities of approximately $0.5 million and $0.4 million, respectively (ii) internal stock-based compensation expenses with respect to employees involved in research and development activities of approximately $0.2 million and $0.3 million, respectively; and (iii) external research and development expenses of approximately $1.4 million and $6.2 million, respectively (which includes clinical (including clinical consulting) research and development costs of approximately $1.2 million and $5.6 million, respectively, non-clinical safety related costs of $0.1 million and $0.4 million, respectively, non-clinical manufacturing related costs of approximately $0.1 million and $0.2 million, respectively).

The decrease in research and development expenses for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 was primarily attributed to a decrease in external clinical research and development costs, partially attributed to a decrease in costs associated with patient visits as the OLE Trial proceeded toward completion during the 2025 period with remaining OLE activities thereafter consisting of post-data readout activities and trial wind-down matters.

We expect our research and development activities to increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs associated with our ongoing operations, including expenses associated with activities required to complete the development of brilaroxazine in schizophrenia including OLE Trial remaining activities and associated expenses and increased expenses associated with our potential Phase 3 RECOVER-2 Trial, if required, to take us through the submission of the planned NDA for brilaroxazine, together with additional costs post-NDA submission in preparation of potential commercialization if approved. For additional information, please see the discussion appearing above in the introductory section of this Part I-Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations.

General and Administrative Expenses

For the three months ended September 30, 2025 and 2024, general and administrative expenses were approximately $1.9 million and $1.6 million, respectively. Specifically, during the three months ended September 30, 2025 and 2024, our general and administrative expenses consisted primarily of: (i) stock-based compensation expense of approximately $0.3 million and $0.2 million, respectively; (ii) consultant and professional expenses of approximately $0.4 million and $0.6 million, respectively; (iii) legal expenses of approximately $0.5 million and $0.2 million, respectively; (iv) employee related expenses of approximately $0.5 million and $0.4 million, respectively; (v) D&O insurance expenses of approximately $0.1 million in both periods; and (vi) other general and administrative expenses of approximately $0.1 million in both periods.

(Loss) Gain on Remeasurement of Warrant Liabilities

We recognized a remeasurement of warrant liabilities loss of approximately $27.8 thousand for the three months ended September 30, 2025 resulting from the increase in the calculated fair value of the warrants attributed to an increase in volatility offset by a marginal decrease in stock price. For the three months ended September 30, 2024, we recognized a remeasurement of warrant liabilities gain of approximately $72.3 thousand due to the decrease in the calculated fair value of the warrants attributed to a decrease in volatility.

Interest Expense

We incurred interest expense of approximately $2.6 thousand and $5.1 thousand for the three months ended September 30, 2025 and 2024, respectively. The decrease in interest expense was primarily caused by a decrease in the corresponding short-term debt balance for the period.

Interest Income

Interest income was approximately $59.1 thousand and $53.2 thousand for the three months ended September 30, 2025 and 2024, respectively. Interest income increased by $5.9 thousand primarily due to the average higher cash and cash equivalents daily balance for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Other Expense, net

Other expense, net was approximately $6.8 thousand for the three months ended September 30, 2025 and approximately $23.7 thousand for the three months ended September 30, 2024. The decrease of approximately $16.9 thousand was primarily attributable to a lower period-over-period foreign currency transaction loss from favorable foreign currency fluctuations related to the consolidation of the Company's Indian subsidiary.

Comparison of the nine months ended September 30, 2025 and 2024:

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Research and Development Expenses

Research and development costs are expensed as incurred. These expenses represent both internal and external costs.

For the nine months ended September 30, 2025 and 2024, research and development expenses were approximately $10.0 million and $18.2 million, respectively. Specifically, during the nine months ended September 30, 2025 and 2024, our research and development costs consisted primarily of the following costs associated with our key research and development projects for advancing the clinical development of brilaroxazine during the reporting periods, which during such periods consisted primarily of our OLE Trial for our Phase 3 clinical study for brilaroxazine: (i) internal salaries, wages and other payroll related costs for employees involved in research and development activities, of approximately $2.0 million and $1.9 million, respectively; (ii) internal stock-based compensation expenses with respect to employees involved in research and development activities, of approximately $0.7 million and $0.6 million, respectively; and (iii) external research and development expenses of approximately $7.3 million and $15.7 million, respectively (which includes clinical (including clinical consulting) research and development costs of approximately $6.0 million and $12.6 million, respectively, non-clinical safety related costs of approximately $0.7 million and $0.8 million, respectively, non-clinical manufacturing related costs of approximately $0.5 million and $2.0 million, respectively, and non-clinical consulting and other related costs of approximately $0.1 million and $0.3 million, respectively).

The decrease in research and development expenses for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily attributed to a decrease in external clinical research and development costs, partially attributed to a decrease in costs associated with patient visits as the OLE Trial proceeded toward completion during the 2025 period with remaining OLE activities thereafter consisting of post-data readout activities and trial wind-down matters.

We expect our research and development activities to increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs associated with our ongoing operations, including expenses associated with activities required to complete the development of brilaroxazine in schizophrenia including OLE Trial remaining activities and associated expenses and increased expenses associated with our potential Phase 3 RECOVER-2 Trial, if required, to take us through the submission of the planned NDA for brilaroxazine, together with additional costs post-NDA submission in preparation of potential commercialization if approved. For additional information, please see the discussion appearing above in the introductory section of this Part I-Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations.

General and Administrative Expenses

For the nine months ended September 30, 2025 and 2024, general and administrative expenses were approximately $6.7 million and $6.3 million, respectively. Specifically, during the nine months ended September 30, 2025 and 2024, our general and administrative expenses consisted primarily of: (i) stock-based compensation expense of approximately $1.1 million and $0.5 million, respectively; (ii) consultant and professional expenses of approximately $2.3 million and $2.7 million, respectively; (iii) legal expenses of approximately $1.2 million and $1.0 million, respectively; (iv) employee related expenses of approximately $1.5 million and $1.4 million, respectively; (v) Directors and Officers insurance expenses of approximately $0.3 million and $0.4 million, respectively; and (vi) other general and administrative expenses of approximately $0.3 million in both periods.

Gain on Remeasurement of Warrant Liabilities

We recognized a remeasurement of warrant liabilities gain of approximately $44.5 thousand and $728.8 thousand for the nine months ended September 30, 2025 and 2024, respectively, resulting from the decrease in the calculated fair value of the warrants, principally as a result of the decrease in our stock price during both periods.

Interest Expense

We incurred interest expense of approximately $19.0 thousand and $13.8 thousand for the nine months ended September 30, 2025 and 2024, respectively. The increase in interest expense is attributed to the interest rate on short term debt obtained by the Company related to Directors and Officers liability insurance policy premiums.

Interest Income

Interest income was approximately $0.2 million and $0.3 million for the nine months ended September 30, 2025 and 2024, respectively. The interest income decrease of approximately $0.1 million was primarily due to the average lower cash and cash equivalents daily balance for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.

Other Expense, net

Other expense, net was approximately $33.8 thousand for the nine months ended September 30, 2025 and approximately $159.2 thousand for the nine months ended September 30, 2024. The decrease of approximately $125.4 thousand was primarily attributable to a lower period-over-period foreign currency transaction loss from foreign currency fluctuations related to the consolidation of the Company's Indian subsidiary.

Liquidity and Capital Resources

14

Capital Resources

We have funded our operations to date primarily from the issuance and sale of our equity and convertible equity securities. As of September 30, 2025, we had cash and cash equivalents of approximately $13.2 million. To fund our current operating plans, we will need to raise significant additional capital. Our existing cash and cash equivalents will not be sufficient for us to complete development of our product candidates and, if applicable, to prepare for commercializing any product candidate that may receive approval. Accordingly, we will continue to require substantial additional capital beyond our existing cash to continue our clinical development and potential commercialization activities. We believe that we has adequate cash on hand to cover anticipated outlays into the second quarter of 2026 but will need additional fundraising activities and cash on hand during the 2026 fiscal year. We have based this estimate, however, on assumptions that may prove to be wrong, and could spend available financial resources much faster than we currently expect. We will need to raise additional funds to continue funding our development efforts and operations. We intend to secure such additional funding, although there are no guarantees or commitments for additional funding. These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date the consolidated financial statements are issued. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include collaborations with third parties. Without limiting the foregoing, we may issue shares of common stock from time to time pursuant to our May 2025 ATM Sales Agreement (please see further discussion in this section below). Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition, and our ability to pursue our business strategy, and our ability to continue as a going concern. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

We expect to continue to incur significant expenses and operating losses for the foreseeable future as we continue our research and preclinical and clinical development of our product candidates; expand the scope of our current studies for our product candidates; initiate additional preclinical, clinical or other studies for our product candidates; change or add additional manufacturers or suppliers; seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical studies; seek to identify, evaluate and validate additional product candidates; acquire or in-license other product candidates and technologies; maintain, protect and expand our intellectual property portfolio; attract and retain skilled personnel; add operational, financial and management information systems and personnel, including personnel to support our product candidate development, and any future commercialization efforts, and our ongoing compliance with and maintenance of public company controls, procedures and regulatory requirements and standards, including in connection with our ongoing remediation efforts regarding the material weaknesses in our internal controls as disclosed in this Quarterly Report including in Part I, Item 4 hereof; and experience any delays or encounter issues with any of the above. See also the discussion set forth under the caption “Financial Overview” appearing in this Management’s Discussion and Analysis of Financial Condition and Results of Operation section above.

On May 30, 2025, we entered into an at the May 2025 ATM Sales Agreement with the Agents, with respect to an at-the-market (ATM) offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50 million through the Agents. During the three months ended September 30, 2025, we sold 1,183,506 shares of common stock pursuant to the May 2025 ATM Sales Agreement for net proceeds of $0.5 million after deducting sales agent commissions and other offering expenses of approximately $30.8 thousand. During the nine months ended September 30, 2025, we sold 2,447,170 shares of common stock pursuant to the May 2025 ATM Sales Agreement for net proceeds of $1.2 million after deducting sales agent commissions and other offering expenses of approximately $0.4 million.

On June 26, 2025, we entered into the June 2025 Placement Agency Agreement with the Placement Agent, relating to the offering, issuance and sale in a public offering of (i) an aggregate of 20,000,000 shares of our common stock, (ii) Series C Warrants exercisable for an aggregate of up to 20,000,000 shares of common stock and (iii) Series D Warrants exercisable for an aggregate of up to 20,000,000 shares of common stock, for aggregate gross proceeds of $10.0 million. Each share of common stock was sold together with (i) a Series C Common Warrant to purchase one share of common stock and (ii) a Series D Common Warrant to purchase one share of common stock, at a combined public offering price of $0.50 per share of common stock and accompanying June 2025 Warrants. The Series C Common Warrants are exercisable immediately upon issuance, have a term of five years from the date of issuance and have an exercise price of $0.50 per share. The Series D Common Warrants are exercisable immediately upon issuance, have a term of twelve months from the date of issuance and have an exercise price of $0.50 per share. The net proceeds to us from the June 2025 Public Offering were approximately $9.0 million, after deducting Placement Agent fees and expenses and other offering expenses payable by us.

On September 18, 2025, we entered into the September 2025 Placement Agency Agreement with the Placement Agent, relating to the offering, issuance and sale of (i) an aggregate of 27,000,000 shares of our common stock, (ii) Series E Common Warrants exercisable for an aggregate of up to 27,000,000 shares of our common stock and (iii) Series F Common Warrants exercisable for an aggregate of up to 27,000,000 shares of common stock, for aggregate gross proceeds of $9.0 million. Each share of common stock was sold together with (i) a Series E Common Warrant to purchase one share of common stock and (ii) a Series F Common Warrant to purchase one share of common stock, at a combined public offering price of $0.335 per share of common stock and accompanying Common Warrants. The Series E Common Warrants are exercisable immediately, have a term of five years from the date of issuance and have an exercise price of $0.335 per share. The Series F Common Warrants are exercisable immediately, have a term of twelve months and have an exercise price of $0.335 per share. The net proceeds to us from the September 2025 Public Offering were approximately $8.1 million, after deducting Placement Agent fees and expenses and other offering expenses payable by us.

During the nine months ended September 30, 2025, an aggregate of 160,750 of the common stock warrants, issued in our December 2024 financing were exercised at an exercise price of $1.50 per warrant share.

Until such time as we can generate substantial product revenue, if ever, we expect to finance our cash needs through a combination of equity or debt financings and collaboration agreements. We do not currently have any committed external sources of capital. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. If we raise additional funds through collaboration agreements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan, or curtail or cease operations. We will need to generate significant revenues to achieve profitability, and we may never do so.

Cash Flows

Net Cash Used in Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2025 was approximately $18.8 million, consisting primarily of a net loss of approximately $16.5 million, adjusted for non-cash items, including stock-based compensation expense of approximately $1.8 million, coupled with a decrease in our operating assets and liabilities totaling approximately $4.0 million. The $4.0 million decrease in net operating assets and liabilities was primarily due to a decrease in accrued clinical expenses and other accrued expenses and accounts payable net with a decrease in prepaid expenses and other current assets and a decrease in prepaid clinical trial costs.

Net cash used in operating activities for the nine months ended September 30, 2024, was approximately $24.4 million, consisting primarily of a net loss of approximately $23.7 million, adjusted for non-cash items, including a change in fair value of warrant liabilities gain of approximately $0.7 million, and partially offset by stock-based compensation expense of approximately $1.1 million, coupled with a decrease in our operating assets and liabilities totaling approximately $1.1 million. The $1.1 million decrease in net operating assets and liabilities was primarily due a decrease in accrued clinical expenses and other accrued expenses coupled with an increase in prepaid clinical trial costs, and an increase in prepaid expenses and other current assets, offset by an increase in accounts payable and an increase in accrued compensation.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2025 was approximately $18.5 million. Cash provided by financing activities during the nine months ended September 30, 2025 was attributable to (i) $19.0 million in gross proceeds from the sale of common stock, Series C Common Warrants and Series D Common Warrants in our June 2025 Public Offering and Series E Common Warrants and Series F Common Warrants in our September 2025 Public Offering, partially offset by transaction costs of approximately $1.9 million, approximately $0.4 million of which was not yet paid as of September 30, 2025; (ii) gross proceeds of approximately $1.6 million from the sale of common stock under our May 2025 ATM Sales Agreement, partially offset by transaction costs of approximately $0.4 million, approximately $0.1 million of which was not yet paid as of September 30, 2025; and (iii) approximately $0.2 million in proceeds from the exercise of common stock warrants. The foregoing were partially offset by repayments on the short-term debt of approximately $0.5 million.

Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $6.6 million. Cash provided by financing activities was attributable to approximately $6.6 million in proceeds from issuance of common stock, common stock warrants, prefunded warrants and from modification of existing warrants, in offerings, net of transaction costs, and approximately $0.4 million in proceeds from the issuance of short-term debt, which was offset by the repayments of short-term debt of approximately $0.3 million.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by Rule 13a-15(b) under the Exchange Act, our management, under the supervision and with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and implementation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2025. Based on such evaluation, as a result of the material weaknesses in internal control over financial reporting described below, our principal executive officer and principal financial officer have concluded that, as of September 30, 2025, our disclosure controls and procedures were not effective at the reasonable assurance level.

We identified the following entity-level material weaknesses. We have an ineffective control environment, including an insufficient number of personnel with an appropriate level of knowledge and experience to create the proper environment for effective internal control over financial reporting, and did not maintain the other components of the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO), including appropriate risk assessment, control activities, information and communication, and monitoring activities components relating to (i) sufficiency of processes related to identifying and analyzing risks to the achievement of objectives, including technology, across the entity, (ii) developing general control activities over technology to support the achievement of objectives across the entity, (iii) sufficiency of selecting and developing control activities that contribute to the mitigation of risks to the achievement of objectives to acceptable levels and (iv) sufficiency of monitoring activities to ascertain whether the components of internal control are present and functioning.

The entity-level material weaknesses contributed to other material weaknesses within our system of internal control over financial reporting as follows:

• We did not design and maintain effective information technology (IT) general controls for certain information systems supporting our key financial reporting processes. Specifically, we did not design and maintain (a) change management controls to ensure that program and data changes affecting financial applications and underlying accounting records are identified, tested, authorized and implemented appropriately, (b) access controls to ensure appropriate IT segregation of duties are maintained that adequately restrict and segregate privileged access between environments which support development and production, (c) controls to monitor on an on-going basis for the proper segregation of privileged access between environments which support development and production and (d) operations controls to ensure appropriate interfacing between systems. As a result, IT application controls and business process controls (automated and manual) that are dependent on the ineffective IT general controls, or that rely on data produced from systems impacted by the ineffective IT general controls, are also deemed ineffective.
• We did not design and maintain effective process-level controls, which affects substantially all account balances and disclosures.

These material weaknesses have a pervasive impact and consequently, impact control activities over all financial statement account balances, classes of transactions, and disclosures.

Management’s Remediation Measures

We are committed to continuing to improve our internal control over financial reporting, and also our IT general controls. As of the date hereof, we have commenced procedures to remediate the material weaknesses, including engaging a third-party consulting firm to assist with the enhancement of IT general controls over information systems relevant to financial reporting, including privileged access and segregation of duties; and with continued realignment of existing personnel to strengthen management’s review and documentation over internal control over financial reporting.

We will continue to monitor the design and effectiveness of these procedures and controls and make any further changes we determine appropriate.

Notwithstanding the existence of the material weaknesses as described above, we believe that the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial position, results of operations, and cash flow as of the dates, and for the periods presented, in conformity with GAAP.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Changes in Internal Control Over Financial Reporting

Except as described above, there was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by the Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Our business is subject to substantial risks and uncertainties. An investment in our securities involves a high degree of risk. The information presented below supplements the risk factors previously disclosed in "Part I, Item 1A. Risk Factors," in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the SEC on April 3, 2025. In addition to the other information set forth in this report and in our other SEC filings from time to time, you should carefully consider the factors discussed in "Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the SEC on April 3, 2025, as supplemented by the information below, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, for the fiscal year ended December 31, 2024, as filed with the SEC on April 3, 2025, as supplemented by the information below, may not be the only risks facing the Company. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results. Except as required by the federal securities law, we undertake no obligation to update or revise any risk factor, whether as a result of new information, future events or otherwise.

We are currently listed on The Nasdaq Capital Market. If we fail to regain compliance with the continued listing requirements of Nasdaq, 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.

Our common stock is currently listed for trading on Nasdaq. On May 13, 2025, we received a notice from Nasdaq indicating that we are not in compliance with the requirement under Nasdaq Listing Rule 5550(a)(2) to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq (the “Bid Price Requirement”). We were provided a compliance period of 180 calendar days from the date of the notice, or until November 10, 2025, to regain compliance with the Bid Price Requirement, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). On November 11, 2025, we received a letter from Nasdaq indicating that, based upon our not having regained compliance with the Bid Price Requirement and our ineligibility for a second 180 calendar day compliance period, the Listing Qualifications Staff of Nasdaq had determined to delist the Company’s securities from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”). We intend to timely request a hearing before the Panel, at which hearing we will request an extension within which to evidence compliance with all applicable requirements for continued listing on Nasdaq, including compliance with the Bid Price Requirement. Our request for a hearing will stay any suspension or delisting action by the Staff pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. We intend to continue to take definitive steps in an effort to evidence compliance with the Bid Price Requirement; however, there can be no assurance that the Panel will grant our request for continued listing or that we will be able to evidence compliance with the Bid Price Requirement within any extension period that may be granted by the Panel.

We will continue to monitor the closing bid price of our common stock and may, if appropriate, consider available options, including implementation of a reverse stock split of our common stock, to regain compliance with the Bid Price Requirement. If we seek to implement a reverse stock split in order to remain listed on Nasdaq, the announcement or implementation of such a reverse stock split could negatively affect the price of our common stock and/or warrants.

We must regain compliance with Nasdaq’s Bid Price Requirement of $1.00 per share (and must continue to maintain compliance with Nasdaq’s other continued listing requirements), or risk delisting, which could have a material adverse effect on our business. If our common stock is delisted from Nasdaq, it could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock as a result of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, contractual counterparties and employees and fewer business development opportunities. If our common stock were delisted, it could be more difficult to buy or sell our common stock or to obtain accurate quotations, and the price of our common stock could suffer a material decline. Delisting could also impair our ability to raise capital on acceptable terms, if at all.

Disruptions at the FDA and other government agencies caused by funding shortages could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times - including the most recent shutdown, which began October 1, 2025 and continued until November 12, 2025 – and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.