RVPH 10-K & 10-Q changes, risk factors and insider trading

Brilaroxazine has not been approved for marketing in the United States and may never receive such approval. AlthoughWe need to conduct our planned RECOVER-2 Phase 3 Trial, which will be expensive and require substantial resources to complete. Additionally, further resources will be required in connection with regulatory processes to seek approval of brilaroxazine for schizophrenia and, if approved, to prepare for product launch and marketing. Further, although RP1208 may be in IND enabling studies for depression and may be in animal efficacy studies for obesity within a short time frame following the receipt of adequate additional financing, it is not currently in an IND-enabling study or animal efficacy study, respectively, and may never meet the requirements for filing an IND. As a result, we are uncertain when or if we will achieve profitability and, if so, whether we will be able to sustain it. Our ability to produce revenue and achieve profitability is dependent on our ability to complete the development of our product candidates, obtain necessary regulatory approvals, and have our product candidates manufactured and successfully marketed. We cannot assure you that we will be profitable even if we successfully commercializes our product candidates. If we do not successfully obtain regulatory approval to market our product candidates, our revenues will be dependent, in part, upon, among other things, the size of the markets in the territories for which we gain regulatory approval, the number of competitors in such markets, the accepted price for our product candidates and whether we own the commercial rights for that territory. If the indication approved by regulatory authorities is narrower than we expects, or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of our product candidates, even if approved. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Failure to become and remain profitable may adversely affect the timing of our clinical results and our ability to raise capital and continue operations.

Further, we will require substantial additional capital to proceed with the planned research described above. See "Risks Related to Our Business, Financial Position and Capital Requirements — We will require substantial additional capital to fundfinance our operations,operations and ifachieve our goals. If we failare unable to obtainraise necessarycapital financing,when needed or on terms acceptable to us, we may not be able to complete the development and commercialization of brilaroxazine or RP1208 and RP1208.”we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations."

The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate some or all of our planned clinical trials or research and development programs or make changes to our operating plan, or curtail or cease operationsoperations. These factors among others create a substantial doubt about our ability to continue as a going concern.

We face risks related to health epidemics and outbreaks, including any future health crises, pandemics or other widespread health crises or similar events, which could adversely impact our business, including our clinical trials.

As a result of the COVID-19 pandemic, we previously experienced, and in the event of any future outbreaks, epidemics or widespread health crises,crises or similar events, may experience disruptions that could severely impact our business and clinical trials. The effects of any health crises in the future, such as future resurgence or new strains or outbreaks, and the potential effects on our business and operations are uncertain. The impacts of potential future health crises could pose the risk that we or our employees, suppliers, future customers in the event of product approval, and others may be restricted or prevented from conducting business activities for indefinite or intermittent periods of time, including as a result of employee health and safety concerns, shutdowns, shelter in place orders, travel restrictions and other actions and restrictions that may be prudent or required by governmental authorities. This could disrupt our ability to operate our business, including producing drug product and administering our preclinical and clinical studies. In addition, fluctuations in demand and other implications associated with the COVID-19 pandemic previously resulted in, and similar crises could in the future result in, certain supply chain constraints and challenges in the broader markets and economy generally, which could impact our business and supply sources.

We will require substantial additional capital to fundfinance operations and achieve our operations,goals. and ifIf we failare unable to obtainraise necessarycapital financing,when needed or on terms acceptable to us, we may not be able to complete the development and commercialization of brilaroxazine or RP1208.RP1208 and we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations, or make changes to our operating plan, or curtail or cease operations.

We expect to spend substantial amounts to complete the development of, seek regulatory approvals for, and commercialize brilaroxazine and RP1208. We will require substantial additional capital toto, completeamong other things, further advance the brilaroxazine program, including conducting additional clinical and regulatory development activities (including our planned RECOVER-2 Phase 3 trial for brilaroxazine in schizophrenia and planned filing of an NDA thereafter) and potential commercialization ofactivities necessary to potentially bring brilaroxazine to market for the treatment of schizophreniaacute and maintenance schizophrenia, if approved, and to continue the development of brilaroxazine for PAH, IPF, BD, MDD, AD, PD, ADHD/ADD and other potential indications, and to continue the development of RP1208 for the treatment of depression and obesity. No assurance can be given that such additional capital will be available on terms acceptable to us, if at all. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our planned development programs or any future commercialization efforts. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our product candidate development efforts. Because the length of time and activities associated with successful development of brilaroxazine and RP1208 is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

We expect that significant additional capital will be needed in the future to continue our planned operations. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements in connection with any collaborations. We do not have any committed external source of funds. To the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership may experience substantial dilution, the trading price of our common stock may decline, and the terms of these securities may include liquidation or other preferences that adversely affect then-existing stockholders’ interests. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

We may seek to enter into strategic alliances or collaborative arrangements with pharmaceutical companies or other industry participants in order to advance our development of brilaroxazine or, in the future, RP1208 or other product candidates, and to reduce our costs of development. If we seek such alliances or collaborative arrangements, we may not be able to negotiate such alliances or collaborative arrangements on acceptable terms, if at all. We face significant competition from other biopharmaceutical companies for appropriate partners in such alliances or arrangements. Furthermore, if we are successful in entering strategic alliances or collaborative arrangements, we may not be able to maintain such alliances or arrangements for a sufficient amount of time to commercialize brilaroxazine, RP1208 or other product candidates, or such alliances or arrangements may not result in successful development of our products. If we seek suitable alliances or arrangements but then fail to create or to maintain these, we may have to limit the size or scope of, or delay, our development of brilaroxazine, RP1208 or other future product candidates. If we elect to fund our development or research programs on our own, we will have to increase our expenditures and will need to obtain additional funding, which may be unavailable or available only on unfavorable terms. See "Risks Related to Our Business, Financial Position and Capital Requirements — We will require substantial additional capital to fundfinance operations and achieve our operations,goals. and ifIf we failare unable to obtainraise necessarycapital financing,when needed or on terms acceptable to us, we may not be able to complete the development and commercialization of brilaroxazine or RP1208 and RP1208.”we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations, or make changes to our operating plan, or curtail or cease operations.

We have identified material weaknesses in our internal control over financial reporting as of December 31, 2024.2025. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our Commoncommon Stock and listed Warrants.stock.

As more particularly described in this Annual Report on Form 10-K below in “Part II. Item 9A. Controls and Procedures.” we have identified material weaknesses in our internal control over financial reporting as of December 31, 2024,2025, including (i) an entity-level material weakness involving 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 not maintaining the other components of the Committee of Sponsoring Organizations of the Treadway Commission framework, including appropriate risk assessment, control activities, information and communication, and certain monitoring activities components, and (ii) the entity-level material weaknesses contributed to other material weaknesses within our system of internal control over financial reporting, including (a) we did not design and maintain effective information technology (IT) general controls for certain information systems supporting our key financial reporting processes, and (b) 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 disclosure. We are committed to continuing to improve our internal control over financial reporting. As of the date hereof, we have commenced procedures to remediate the material weaknesses. We will continue to monitor the design and effectiveness of these procedures and controls and make any further changes we determine appropriate. However, these material weaknesses will not be considered remediated until the applicable remedial actions have been fully implemented and we have concluded that these controls are operating effectively for a sufficient period of time.

Specifically, prior to and in connection with the closing of our Business Combination, our predecessor company, Tenzing, issued public warrants to purchase 6,325,000316,250 shares (the "Public Warrants”) and liability classified private-placement warrants to purchase 556,31327,816 shares (the "Private Warrants”). For a full description of the Public Warrants and the Private Warrants, refer to (i) the registration statement on Form S-4 (File No. 333-245057), filed in connection with the Business Combination, declared effective by the SEC on November 10, 2020 and (ii) our "Description of Securities” included as Exhibit 4.1 to this Annual Report on Form 10-K. Each of the Public Warrants and Private Warrants entitles the holder to purchase one share of our common stock at a price of $11.50$230 per share, subject to adjustment. We originally classified the Public Warrants and the Private Warrants as equity in our previously issued audited consolidated balance sheet as of December 31, 2020, and the related consolidated statements of operations, stockholders' equity (deficit),equity, and cash flows for the year then ended, and the related notes (collectively, referred to as the "Financial Statements") included in our Annual Report on Form 10-K filed on March 22, 2021.

We have reviewed the Statement and the terms of our Public Warrants and Private Warrants with our third-party technical accounting advisor and our independent auditors and management has concluded that the Private Warrants should be reclassified as liabilities measured at fair value, which will result in non-cash gains or losses from changes in fair value reported each period in earnings. Management notes the above referenced Public Warrants and Private Warrants expired on December 14, 2025 and are no longer outstanding as of December 31, 2025.

The global credit and financial markets are currently, and have from time to time experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, rising interest and inflation rates,rates or fluctuations in these metrics, declines in consumer confidence, declines in economic growth, increases in unemployment rates, uncertainty about legal and regulatory changes, including potential changes to tax laws, and new or increased tariffs and the potential for retaliatory tariffs and “trade wars” and consequential effects on the economy, and uncertainty about economic stability. The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the ongoing conflict between Russia and Ukraine, the ongoing military conflict in the Middle East, terrorism or other geopolitical events. Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

We and our current and future third-party collaborators may rely on government programs or agencies, such as the NIH, as a source of grant funding for scientific research relevant to our product candidates. Funding from government agencies such as the NIH can fluctuate and is subject to the political process, which is often unpredictable. For example, on February 7, 2025, the NIH issued Notice Number NOT-OD-25-068, a guidance document pronouncing that funding in NIH grants to cover certain indirect costs would be capped at 15% for existing and future grant recipients, a rate that is substantially lower than the existing rates. As of February 2026, it remains uncertain how indirect costs will be handled in NIH grants. Reductions in NIH grants to us and our third-party collaborators may adversely impact our ability to develop our existing product candidates and our ability to identify new product candidates.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make or the first to file the inventions claimed in our owned patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. In connection with the patent position, we initiated and are currently a party of a derivation proceeding in the Patent Trial and Appeal Board, or PTAB, of the U.S. Patent and Trademark Office, or USPTO, against a third party, in which we claim that an earlier application filed by a third party claiming a brilaroxazine form was derived from us and was filed without our authorization. Moreover, in the future, we may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, or become involved inopposition, opposition,additional derivation, reexamination, inter parties review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigationlitigation, including the current derivation proceeding, could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. We are aware of a pending patent application filed by a third party claiming a brilaroxazine form, which we initiated and are currently a party of a derivation proceeding in PTAB of USPTO, in which we claim that the related claims in the third-party patent application were derived from us and the third-party patent application was filed without our authorization.

An active trading market for our common stock or warrants may not be sustained.

An active trading market for our common stock or warrants may not develop or continue or, if developed, may not be sustained. The lack of an active market for our common stock or warrants may impair investors’ ability to sell their common stock or warrants at the time they wish to sell themtheir securities or at a price that they consider reasonable, may reduce the fair market value of their shares of common stock or warrantssecurities and may impair our ability to raise capital to continue to fund operations by selling securities and may impair our ability to acquire additional intellectual property assets by using our securities as consideration. If our common stock were to be delisted from Nasdaq and were to then commence trading on the over-the-counter markets, it may be more difficult for an active trading market in our common stock to develop, and if developed, to be sustained.

A sale of a substantial number of shares of our common stock or warrants in the public market could cause the market price of our common stock or warrants to drop significantly, even if our business is doing well.

The price of our common stock or warrants could decline as a result of sales of a large number of shares of our common stock or warrants or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

In addition, in the future, we may issue additional shares of common stock, warrants or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. Any such issuance could result in substantial dilution to our existing stockholders and could cause the price of our common stock or warrants to decline.

If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our common stock or warrants,stock, the price of our common stock or warrants could decline.

The trading market for our common stock and warrants relies in part on the research and reports that equity research analysts publish about us and our business. We do not control these analysts. The price of our common stock could decline if one or more equity analysts downgrade our common stock or warrants or if analysts issue other unfavorable commentary or cease publishing reports about us or our business.

The price of our common stock or warrants may be volatile, which could subject us to securities class action litigation and our stockholders could incur substantial losses.

The market price for our common stock or warrants may be volatile and subject to wide fluctuations in response to factors including the following:

These and other market and industry factors may cause the market price and demand for our common stock and warrants to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their shares of common stock or warrants and may otherwise negatively affect the liquidity of our common stock or warrants.stock. In addition, the stock market in general and Nasdaq have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. In the past, when the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management.

As a result, included on our consolidated balance sheet as of December 31, 2024 contained elsewhere in this Annual Report on Form 10-K, are derivative liabilities related to embedded features contained within our Private Warrants. Accounting Standards Codification 815, Derivatives and Hedging ("ASC 815”), provides for the remeasurement of the fair value of such derivatives at each balance sheet date, with a resulting non-cash gain or loss related to the change in the fair value being recognized in other incomeincome, (expense)net in the statements of operations. As a result of the recurring fair value measurement, our consolidated financial statements and results of operations may fluctuate quarterly, based on factors, which are outside of our control. Due to the recurring fair value remeasurement, we expect that we will recognize non-cash gains or losses on our Private Warrants each reporting period and that the amount of such gains or losses could be material.

We have never declared or paid cash dividends on our common stock and do not anticipate paying any cash dividends to holders of our common stock in the foreseeable future. Consequently, investors must rely on sales of their common stock and warrants after price appreciation, which may never occur, as the only way to realize any future gains on their investments. There is no guarantee that shares of our common stock or warrants will appreciate in value or even maintain the price at which the stockholders have purchased their shares or warrants.securities.

The information in this Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with the Company’sour consolidated financial statements and the related notes set forth in Item 1 of Part I of this Annual Report on Form 10-K, 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 the Company’s 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,I, Item 1A, “Risk Factors,” belowabove 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 Consolidated Financial Statements” included in Part I, Item 1, of this Annual Report on Form 10-K, unless the context indicates otherwise.

MayMarch 20242026 Registered DirectPublic Offering

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 December 31, 2024,2025, we had a working capital surplus of approximately $0.1$7.8 million, an accumulated deficit of $164.3$184.1 million and cash and cash equivalents on hand of approximately $13.5$14.4 million. Our net loss for the yearsyear ended December 31, 20242025 and 2023,2024, was approximately $29.9$19.9 million and $39.3$29.9 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 additionalmaterial and significant costs associated with operating as a public company, which may continue to 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 this Annual Report on Form 10-K below in “Part II, Item 9A. Controls and Procedures”.Procedures. We will need to generate significant revenues to achieve profitability, and we may never do so.

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

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

** 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.

Our significant accounting policies are more fully described in Note 2, Summary of Significant Accounting Policies and Basis of Presentation, to the consolidated financial statements included in Item 8 of this Annual Report on Form 10-K, we believe that the following accounting policies are the most critical to assist stockholders and investors reading the consolidated financial statements in fully understanding and evaluating our financial condition and results of operation..operations.

We record clinical trial costs as they are incurred. For any unbilled costs as of each reporting date, we determine the amounts to accrue by obtaining reports from theour Company’svendors, CRO’sincluding CROs, and communicating with our personnel and suppliers to identify services that have been performed, but not yet billed. We further validate the completeness of our accruals by reconciling payments and invoices, and reviewing vendor contracts and purchase orders. As necessary, we obtain milestones and percentage completion reports from vendors and will estimate the level of service performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of the actual cost.

OurDuring estimatedthe accruedyear-ended expensesDecember are31, 2025 all patient visits concluded and clinical sites were closed. Clinical trial costs were therefore recorded based on factsactual and circumstances knowncosts to usdate atprovided thatby time.our WeCRO, will confirmas the accuracyclinical oftrials ourin estimatesprogress withare in the servicewind-down providersphase. and adjust if necessary. The significant estimates inPreviously, our accrued clinical trial costs includefor patients and sites included the calculation of patient visits incurred, but not yet reported by the vendor. The calculation involvespreviously involved the use of key inputs and assumptions such as estimated budget, estimated unreported costs based on historical trending of reported costs to date, and projected costs remaining until the conclusion of the trials which is no longer necessary given the status of the clinical trials.

In determining the fair value of awards, we utilize the Black-Scholes-Merton model using assumptions regarding volatility of the Company'sour common share price, expected term, expected divided rate, and risk-free interest rates as described below:

In determining the fair value of all equity classified warrants, thewe Company utilizesutilize the Black-Scholes-Merton model using assumptions regarding volatility of the Company'sour common share price, expected term of the warrants, expected divided rate, and risk-free interest rates. In determining the fair value of liability classified warrants, the Companywe utilizesutilize a Lattice model using assumptions regarding volatility of the Company'sour common share price, expected term of the warrants, expected dividend, and risk-free interest rates. The assumptions are described as:

For the years ended December 31, 20242025 and 2023,2024, research and development expenses were approximately $22.9$11.7 million and $31.4$22.9 million, respectively. Specifically, during the years ended December 31, 20242025 and 2023,2024, 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, namelywhich during such periods consisted primarily of our OLE and RECOVER-1 TrialsTrial 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 $2.3 million andin $3.3each million, respectivelyperiod; (ii) internal share-basedstock-based compensation expenses with respect to employees involved in research and development activities, of approximately $1.0$0.8 million and $1.5 million, respectively; (iii) other research and development related costs, of an insignificant amount and $0.1$1.0 million, respectively; and (iviii) external research and development expenses,expenses of approximately $19.6$8.6 million and $26.6$19.6 million, respectively (which includes clinical (including clinical consulting) research and development costs of approximately $15.5$6.9 million and $22.3$15.5 million, respectively, non-clinical safety related costs of approximately $1.3$0.8 million and $1.9$1.3 million, respectively, non-clinical manufacturing related costs of approximately $2.4$0.6 million and $1.7$2.4 million, respectively, and non-clinical consulting and other related costs of approximately $0.4$0.3 million and $0.6$0.4 million, respectively).

The decrease in research and development expenses for the year ended December 31, 20242025 as compared to the year ended December 31, 20232024 was primarily attributed to a decrease in external clinical research and development costs, includingpartially clinical consulting, due to completion of the RECOVER-1 Trial on October 31, 2023, offset by additional external research and development costs relatedattributed to a changedecrease orderin enteredcosts intoassociated onwith Septemberpatient 25,visits 2024 which increasedas the scopeOLE Trial proceeded toward completion during the 2025 period with remaining OLE activities thereafter consisting of certainpost-data servicesreadout providedactivities byand atrial clinicalwind-down research organization.matters.

We expect our research and development activities to substantially 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 completionexpenses ofassociated with our OLEPhase Trial and our planned registrational3 RECOVER-2 Trial, expenses 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 Operation.Operations.

Our common stock will bewas delisted from trading on Nasdaq and willis tradecurrently quoted under its trading symbol “RVPH” on the OTCQB Venture Market tier of the OTC Markets Group, which involves additional risks compared to being listed on a national securities exchange.

OnAs previously disclosed, on May 12, 2026, we received notice from the Nasdaq Hearings Panel (the “Panel”) that the Panel had determined to delist our common stock from The Nasdaq Capital Market (“Nasdaq”) due to our non-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”), and as a result our common stock will bewas suspended from trading on Nasdaq as of the open of trading on May 14, 2026 (the “Nasdaq Delisting”). OurCommencing May 14, 2026, our common stock willis beginnow trading under its current trading symbol “RVPH”quoted on the OTCQB Venture Market tier of the OTC Markets Group (the “OTCQB Venture Market”), oncontinuing Mayto 14,utilize 2026.its existing trading symbol “RVPH”.

The Nasdaq Delisting has adversely impacted our Company, and may continue to materially and adversely impact us in several ways, including, without limitation, by (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing or able to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; (iii) impairing our ability to provide equity incentives to our employees; (iv) impacting our common stock as it will fall within the definition of a “penny stock,” which would cause brokers trading our common stock to adhere to more stringent rules; (v) causing analysts to limit or stop coverage of our common stock; and (vi) limiting availability of market quotations for our common stock.

Although our common stock willis becurrently available for quotation on the OTCQB Venture Market, the Nasdaqfact Delistingthat our common stock is quoted on the OTC Markets (rather than being listed on a national securities exchange), has and may continue to result in limited liquidity of the public trading market for our common stock. The lack of an active, liquid trading market for our common stock could have material adverse effects on our business, financial condition and future prospects due to, among other things, impairing the ability of holders of our common stock to sell their shares at the time they wish to sell them or at a price that they consider reasonable and reducing the trading liquidity and fair market value of the shares of our common stock, as well as our ability raise funds through the sale of equity or equity-linked securities that will be required to operate our existing and future business.

The OTC MarketMarkets system is a network of security dealers who buy and sell stock. The dealers are connected by a computer network that provides information on current “bids” and “asks,” as well as volume information. Trading in securities quoted on the OTC Markets is often thin and characterized by wide fluctuations in trading prices, due to many factors, some of which may have little to do with our operations or business prospects. This volatility could depress the market price of our common stock for reasons unrelated to operating performance. Moreover, the OTC Markets is not a stock exchange, and trading of securities on the OTC Markets is often more sporadic than the trading of securities listed on a national stock exchange. These factors may result in investors having difficulty reselling any shares of our common stock.

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 pre-clinical development for the treatment of psoriasis.

HavingAs previously disclosed, having not regained compliance with the Bid Price Requirement by such date, we received a letter from the Panel dated May 12, 2026 indicating that the Panel had determined to delist our common stock from Nasdaq. Our common stock will bewas suspended from trading on Nasdaq as of the open of trading on May 14, 2026.2026, and Nasdaq filed a Form 25 on July 10, 2026 pursuant to Rule 12d2-2(b) to strike the common stock from listing on Nasdaq and/or withdraw registration on Nasdaq.

Beginning on May 14, 2026, our common stock willis benow quoted on the OTCQB Venture Market operated by OTC Markets Group Inc. under its existing symbol “RVPH.”

OnAs previously announced, effective March 4,9, 2026, we filed an amendment to our Amended and Restated Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to effectimplemented a reverse stock split of our issued and outstanding common stock at a ratio of one-for-twenty (1:20) (the “Reverse Split”). TheIn Reverse Split became effective in accordanceconnection with the termsReverse ofSplit, theour amendmentcommon atstock 12:01is a.m. Eastern Time on March 9, 2026designated under a new CUSIP number, 76152G209. All share, common stock warrant, prefunded warrant, restricted common stock and common stock option amounts, and per share, per common stock warrant, per prefunded warrant, per restricted common stock and per common stock option amounts, in this Quarterly Report on Form 10-Q, have been retrospectively adjusted as appropriate to reflect the Reverse Split.

We plan to initiate trialpatient relatedenrollment activities forin the RECOVER-2 Phase 3 study for brilaroxazine in schizophrenia (the “RECOVER-2 Trial”) in Q2-2026 and begin patient enrollment in the Unitedfirst Stateshalf inof Q3-2026.2027. As previously reported, the FDA has already cleared the protocol for the RECOVER-2 Trial, and we currently expect study completion in Q4-2027.2028. We anticipate that the RECOVER-2 Trial will be similar in design to our completed RECOVER Phase 3 trial of brilaroxazine. We are expecting FDA feedback in the fourth quarter of 2026 on the incorporation of a new formulation of brilaroxazine into our RECOVER-2 Trial and potential NDA, as described below.

We announced certain efforts centered on extending the long-term value of the brilaroxazine program and preparing for the next phase of development. A component of that strategy is our effort to extend patent life and commercial exclusivity for brilaroxazine, potentially through 2046. To support this objective, on August 11, 2026, we have filed a composition of matter provisional patent application on a new form of brilaroxazine internationally in PCT (Patent Cooperation Treaty) and will be pursuingfiled an accelerated reviewapplication processin forthe thatUnited application.States through the United States Patent and Trademark Office (USPTO) Track One Program.

Based on the pre-clinical development package for this new form of brilaroxazine, we are preparing to seek FDA alignment on using this new form of brilaroxazine product in our potential future NDA submission. This would include switching the drug substance of brilaroxazine and its formulation in the second Phase 3 trial in schizophrenia. We believe this type of change is not uncommon in the pharmaceutical industry during late-stage development and prior to NDA filing, particularly when it may strengthen lifecycle management and long-term intellectual property. We are optimistic about receivingexpecting FDA alignmentfeedback in Q4-2026 on thisthe strategy,potential withincorporation feedbackof expectedthe mid-yearnew 2026.formulation of brilaroxazine into both our RECOVER-2 Trial and our potential future NDA submission for brilaroxazine for the treatment of schizophrenia. After FDA feedback, we plan to initiate a bioequivalence study to confirm comparability of the new formulation.

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. The Company does not expect to utilize the May 2025 ATM Sales Agreement while the Company’s common stock is quoted on the OTC Markets Group. During the threesix months ended MarchJune 31,30, 2026, we sold 570,845 shares of common stock pursuant to the May 2025 ATM Sales AgreementAgreement, for net proceeds of $2.5 millionmillion, after deducting sales agent commissions and other offering expenses of approximately $0.1 million. There were no sales pursuant to the May 2025 ATM Sales Agreement during the three months ended June 30, 2026.

On March 20, 2026, we closed a public offering (the “March 2026 Public Offering”) pursuant to a placement agency agreement and a securities purchase agreements with certain investors participating in the offering, pursuant to which we issued and sold (i) an aggregate of 6,283,334 shares (the “Shares”) of our common stock, (ii) pre-funded warrants (the “March 2026 Pre-Funded Warrants”) exercisable for an aggregate of up to 383,333 shares of our common stock, (iii) Series G warrants (the “Series G Warrants”) exercisable for an aggregate of up to 6,666,667 shares of our common stock and (iv) Series H warrants (the “Series H Warrants” and together with the Series G Warrants, the “March 2026 Common Stock Warrants”) exercisable for an aggregate of up to 6,666,667 shares of our common stock, for aggregate gross proceeds of $10.0 million. Each Shareshare of common stock (or March 2026 Pre-Funded Warrant in lieu thereof) was sold together with (i) a Series G Warrant to purchase one share of common stock and (ii) a Series H Warrant to purchase one share of common stock, at a combined public offering price of $1.50 per share of common stock and accompanying March 2026 Common Stock Warrants (or a combined public offering price of $1.4999 per March 2026 Pre-Funded Warrant and accompanying March 2026 Common Stock Warrants). The March 2026 Pre-Funded Warrants have an exercise price of $0.0001 per share and will expire when exercised in full. The Series G Warrants are exercisable immediately, have a term of five years from the date of issuance and have an exercise price of $1.50 per share. The Series H Warrants are exercisable immediately, have a term of twelve months and have an exercise price of $1.50 per share. The net proceeds to us from the March 2026 Public Offering were approximately $8.9 million, after deducting placement agent fees and expenses and other offering expenses payable by us.

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 MarchJune 31,30, 2026, our portfolio of intellectual property consists of 76 granted patents and 2223 pending patent applications in the United States and in over 26 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.South Korea, Liechtenstein, Mexico, Russia, Slovakia, and Thailand. We believe that our patent portfolio provides good protection of brilaroxazine. All 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 have twoone U.S. provisional applicationsapplication pending directed to brilaroxazine composition.

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 MarchJune 31,30, 2026, we had a working capital surplus of approximately $17.4$15.2 million, an accumulated deficit of $187.3approximately $189.8 million and cash and cash equivalents on hand of approximately $22.2$19.9 million. Our net loss for the three months ended MarchJune 31,30, 2026 and 2025, was approximately $3.2$2.4 million and $6.4$6.1 million, respectively. Our net loss for the six months ended June 30, 2026 and 2025, was approximately $5.6 million and $12.5 million, respectively. 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 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 2025 Annual Report on Form 10-K, and in this Quarterly Report on Form 10-Q below in “the section of Part I captioned "Item 4. Controls and Procedures.”" We will need to generate significant revenues to achieve profitability, and we may never do so.

* We plan to initiate trialpatient relatedenrollment activities forin the RECOVER-2 Phase 3 study for brilaroxazine in schizophrenia (the “RECOVER-2 Trial”) in Q2-2026 and begin patient enrollment in the Unitedfirst Stateshalf inof Q3-2026.2027. As previously reported, the FDA has already cleared the protocol for the RECOVER-2 Trial, and we currently expect study completion in Q4-2027.2028. We anticipate that the RECOVER-2 Trial will be similar in design to our completed RECOVER Phase 3 trial of brilaroxazine. We announced certain efforts centered on extending the long-term value of the brilaroxazine program and preparing for the next phase of development. As described above, in connection with our effort to extend patent life and commercial exclusivity for brilaroxazine potentially through 2046, we have filed a composition of matter provisional patent application on a new form of brilaroxazine internationally in PCT (Patent Cooperation Treaty) and will be pursuingfiled an accelerated reviewapplication processin forthe thatUnited application.States through the United States Patent and Trademark Office (USPTO) Track One Program. Based on the pre-clinical development package for this new form of brilaroxazine, we are preparing to seek FDA alignment on using this new form of brilaroxazine product in our future new drug application (“NDA”) submission. This would include switching the drug substance of brilaroxazine and its formulation in the RECOVER-2 Trial. We are optimistic about receivingexpecting FDA alignmentfeedback on this strategy,strategy within feedbackQ4-2026. expectedAfter mid-yearFDA 2026.feedback, we plan to initiate a bioequivalence study to confirm comparability of the new formulation.

Comparison of the three months ended MarchJune 31,30, 2026 and 2025:

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

For the three months ended MarchJune 31,30, 2026 and 2025, research and development expenses were approximately $1.4 million and $4.1$3.7 million, respectively. Specifically, during the three months ended MarchJune 31,30, 2026 and 2025, 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$0.4 million and $0.8$0.6 million in each period, respectively; (ii) internal stock-based compensation expenses with respect to employees involved in research and development activities, of approximately $0.3$0.1 million and $0.3$0.2 million, respectively; and (iii) external research and development expenses of approximately $0.6$0.9 million and $3.0$2.9 million, respectively (which includes clinical (including clinical consulting) research and development costs of approximately $0.4$0.6 million and $2.1$2.6 million, respectively, non-clinical safety related costs of an insignificant amount and approximately $0.6$0.1 million, respectively, non-clinical manufacturing related costs of approximately $0.1$0.2 million andin $0.3each million, respectively,period and non-clinical consulting and other related costs of approximately $0.1 million and an insignificant amount, respectively).respectively.

The decrease in research and development expenses for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 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 2025 with the remaining OLE activities thereafter consisting of post-data readout activities and trial wind-down matters.costs.

For the three months ended MarchJune 31,30, 2026 and 2025, general and administrative expenses were approximately $1.8$1.2 million and $2.4$2.3 million, respectively. Specifically, during the three months ended MarchJune 31,30, 2026 and 2025, our general and administrative expenses consisted primarily of: (i) stock-based compensation expense of approximately $0.3$0.1 million and $0.6$0.2 million, respectively; (ii) consultant and professional expenses of approximately $0.6$0.3 million and $0.9$1.0 million, respectively; (iii) legal expenses of approximately $0.3$0.2 million and $0.2$0.5 million, respectively; (iv) employee relatedemployee-related expenses of approximately $0.5 million in each period; and $0.6 million, respectively; (v) and Directors and Officers insurance expenses of approximately $0.1 million in each period.

We recognized a remeasurement of warrant liabilities gain of approximately $61$11.1 thousand for the three months ended MarchJune 31,30, 2025 resulting from a decrease in the calculated fair value of the warrants, principally as a result of the decrease in our stock price. Our previously outstanding liability classifiedliability-classified warrants expired in December 2025; accordingly, no gain or loss was recognized for the three months ended MarchJune 31,30, 2026.

We incurred interest expense of approximately $7$2.9 thousand and $12$4.8 thousand for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease in interest expense is attributed to the reduced interest rate on short term debt obtained by us related to Directors and Officers liability insurance policy premiums.

Interest income was approximately $89$0.2 thousand and $86 thousandmillion for the three months ended MarchJune 31,30, 2026 and 2025,an respectively.insignificant amount for the three months ended June 30, 2025. The interest income increase of approximately $3$0.2 thousandmillion was primarily due to an increase in average cash balances during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025.

Other expense, net was approximately $3$1.0 thousand for the three months ended MarchJune 31,30, 2026 and approximately $25$1.9 thousand for the three months ended MarchJune 31,30, 2025. The decrease of approximately $22$0.9 thousand was primarily attributable to a lower period-over-period foreign currency transaction loss from foreign currency fluctuations related to the consolidation of our Indian subsidiary.

We have funded our operations to date primarily from the issuance and sale of our equity and convertibleequity-linked equitysecurities, securities.such as warrants. As of MarchJune 31,30, 2026, we had cash and cash equivalents of approximately $22.2$19.9 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 have adequate cash on hand, including the net proceeds of the March 2026 Public Offering,hand to cover anticipated outlays into earlyJuly 20272027, but will need additional fundraising activities and cash on hand prior to such time. 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. 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.

On March 20, 2026, we closed a public offering (the “March 2026 Public Offering”) conducted pursuant to a placement agency agreement (the “March 2026 Placement Agency Agreement”) and securities purchase agreements with certain investors participating in the offering (the “March 2026 Securities Purchase Agreements”),offering, pursuant to which we issued and sold (i) an aggregate of 6,283,334 shares of common stock, (ii) pre-funded warrants (the “March 2026 Pre-Funded Warrants”) exercisable for an aggregate of up to 383,333 shares of common stock (the “March 2026 Pre-Funded Warrant Shares”), (iii) Series G warrants (the “Series G Warrants”) exercisable for an aggregate of up to 6,666,667 shares of common stock (the “Series G Warrant Shares”) and (iv) Series H warrants (the “Series H Warrants” and together with the Series G Warrants, the “March 2026 Common Stock Warrants”) exercisable for an aggregate of up to 6,666,667 shares of common stock (the “Series H Warrant Shares” and together with the March 2026 Pre-Funded Warrant Shares and Series G Warrant Shares, the “March 2026 Warrant Shares”), for aggregate gross proceeds of $10.0 million. Each share of common stock (or March 2026 Pre-Funded Warrant in lieu thereof) was sold together with (i) a Series G Warrant to purchase one share of common stock and (ii) a Series H Warrant to purchase one share of common stock, at a combined public offering price of $1.50 per share of common stock and accompanying March 2026 Common Stock Warrants (or a combined public offering price of $1.4999 per March 2026 Pre-Funded Warrant and accompanying March 2026 Common Stock Warrants). The March 2026 Pre-Funded Warrants have an exercise price of $0.0001 per share and will expire when exercised in full. The Series G Warrants are exercisable immediately, have a term of five years from the date of issuance and have an exercise price of $1.50 per share. The Series H Warrants are exercisable immediately, have a term of twelve months and have an exercise price of $1.50 per share. The net proceeds to us from the March 2026 Public Offering were approximately $8.9 million, after deducting Placement Agent fees and expenses and other offering expenses payable by us.

During the threesix months ended MarchJune 31,30, 2026,2026 , we sold 570,845 shares of common stock pursuant to the May 2025 ATM Sales Agreement for net proceeds of $2.5 million after deducting sales agent commissions and other offering expenses of approximately $0.1 million. SubsequentDuring tothe Marchthree 31,months 2026ended June 30, 2026, and through the filing date of this Quarterly Report on Form 10-Q, we have not sold any shares of common stock pursuant to the May 2025 ATM Sales Agreement.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was approximately $3.8$5.9 million, consisting primarily of a net loss of approximately $3.2$5.6 million, adjusted for non-cash items, including stock-based compensation expense of approximately $0.6$0.8 million, coupled with a decrease in our operating assets and liabilities totaling approximately $1.2$1.1 million. The $1.2$1.1 million decrease in net operating assets and liabilities was primarily due to a decrease in accounts payable.payable as well as accrued expenses and other current liabilities coupled with an increase in prepaid clinical trial costs, net with a decrease in prepaid expenses and other current assets.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025, was approximately $8.2$13.2 million, consisting primarily of a net loss of approximately $6.4$12.5 million, adjusted for non-cash items, including a change in fair value of warrant liabilities gain of approximately $0.1 million, and stock-based compensation expense of approximately $0.9$1.3 million, coupled with a decrease in our operating assets and liabilities totaling approximately $2.6$1.9 million. The $2.6$1.9 million decrease in net operating assets and liabilities was primarily due to a decrease in accrued clinical expenses andexpenses, other accrued expenses and accounts payable coupled with an increase in prepaid expenses and other current assets, net with a decrease in prepaid clinical trial costs.

Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 was approximately $11.6$11.4 million. Cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026 was attributable to approximately $9.2$9.1 million in proceeds from issuance of common stock, common stock warrants, and pre-funded warrants, net of transaction costs paid, and $2.6$2.5 million in net proceeds from the issuance of common stock inpursuant to the May 2025 ATM offering,Sales Agreement, which was offset by the repayments of short-term debt of approximately $0.2 million.