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ITEM 1A. RISK FACTORS.
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, 2025, as filed with the SEC on March 30, 2026. 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, 2025, as filed with the SEC on March 30, 2026, 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, 2025, as filed with the SEC on March 30, 2026, 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 Companys 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.
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We are heavily dependent on the success of brilaroxazine, our only advanced product candidate, which is still under clinical development, and if brilaroxazine does not receive regulatory approval or is not successfully commercialized, our business will be harmed.
We currently have no products that are approved for commercial sale and may never be able to develop marketable drug products. We expect that a substantial portion of our efforts and expenditures in the foreseeable future will be devoted to brilaroxazine. Our common stock only other product candidate is RP1208, which is in the pre-clinical phase. We do not expect to allocate a significant portion of our efforts or resources to the clinical trials or development of this product candidate in the foreseeable future. Accordingly, our business currently depends heavily on the successful development, regulatory approval and commercialization of brilaroxazine. We cannot be certain that brilaroxazine will receive regulatory approval or be successfully commercialized even if we receive regulatory approval. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of drug products are and will be delisted from trading on Nasdaq and will trade under its tradingremain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries that each have differing regulations. We are not permitted to market brilaroxazine in the United States until we receive approval of a new drug application, or NDA, from the FDA, or in any foreign countries until we receive the requisite approval from such countries. We have not submitted an NDA to the FDA or comparable applications to other regulatory authorities and do not expect to be in a position to do so for the foreseeable future, including with respect to brilaroxazine for schizophrenia, pending completion of all studies and trials including completion of the planned bioequivalence study for the new brilaroxazine form and our planned RECOVER-2 trial. Obtaining approval of an NDA is an extensive, lengthy, expensive and inherently uncertain process, and the FDA may delay, limit or deny approval of brilaroxazine and our other product candidates for many reasons, including:
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| we may not be able to demonstrate that brilaroxazine is safe and effective as a treatment for our targeted indications to the FDAs satisfaction; |
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| the FDA may require additional Phase 3 trials of brilaroxazine in schizophrenia, including in connection with our plan to switch to a new form of brilaroxazine in the Phase 3 RECOVER-2 trial, which would increase our costs and prolong brilaroxazines development; |
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| the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA for marketing approval; |
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| the FDA may disagree with the number, design, size, conduct or implementation of our clinical trials; |
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| the contract research organizations, or CROs, that we retain to conduct clinical trials may take actions outside of our control that materially adversely impact our clinical trials; |
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| the FDA may not find the data from preclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of brilaroxazine outweigh its safety risks; |
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| the FDA may disagree with our interpretation of data from its preclinical studies and clinical trials or may require that we conduct additional studies; |
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| the FDA may not accept data generated at our clinical trial sites; |
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| if our NDA is reviewed by an advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; |
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| the FDA may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval; |
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| the FDA may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturers; or |
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| the FDA may change its approval policies or adopt new regulations. |
Our sycommon stock was delisted from trading on Nasdaq and is currently 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.
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As 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 be as suspended from trading on Nasdaq as of the open of trading on May 14, 2026 (the Nasdaq Delisting). OCommencing May 14, 2026, our common stock will begin trading under its current trading symbol RVPH ois now quoted on the OTCQB Venture Market tier of the OTC Markets Group (the OTCQB Venture Market) on May 14, 2026, continuing to utilize its existing trading symbol RVPH.
The Nasdaq Delisting may matehas 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 will beis currently available for quotation on the OTCQB Venture Market, the Nasdaq Defact that our common stock is quoted on the OTC Markets (rather than being listing ed 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.
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Trading on the OTC Markets is volatile and sporadic, which could depress the market price of our common stock and make it difficult for our security holders to resell their common stock.
The OTC Market s 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.
If we fail to comply with the continuing listing standards of the OTC Markets system, our common stock could be delisted, which could affect the market price of our common stock and reduce our ability to raise capital.
There can be no assurance that we will be able to maintain compliance with the continued listing requirements for the OTCQB Venture Market. If we fail to maintain compliance with any such continued listing requirement, there can also be no assurance that we will be able to regain compliance with any such continued listing requirement in the future.
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