Reviva Pharmaceuticals Holdings Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

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CURRENT REPORT 

 

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 

 

Date of Report (Date of earliest event reported): April 15, 2026

 

 

 

 

Registrant’s telephone number, including area code: (408) 501-8881

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

 

 

 

Securities registered pursuant to Section 12(b) of the Act.

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

On April 15, 2026, Reviva Pharmaceuticals Holdings, Inc. (“Reviva” or the “Company”) issued a letter to shareholders announcing certain business updates, including in connection with the Company’s program for the development of brilaroxazine for the treatment of schizophrenia and regarding the Company’s intellectual property strategy. A copy of the letter to shareholders is attached hereto as Exhibit 99.1.

 

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

 

 

 

As described in Item 7.01 of this Current Report on Form 8-K, on April 15, 2026, the Company issued a letter to shareholders announcing certain business updates, including in connection with the Company’s program for the development of brilaroxazine for the treatment of schizophrenia and regarding the Company’s intellectual property strategy.

 

The Company announced certain efforts centered on extending the long-term value of the brilaroxzine program and preparing for the next phase of development. A component of that strategy is the Company’s effort to extend patent life and commercial exclusivity for brilaroxazine, potentially through 2046. To support this objective, the Company has filed a composition of matter patent application on a new form of brilaroxazine and will be pursuing an accelerated review process for that application.

 

Based on the preclinical development package for this new form of brilaroxazine, the Company is preparing to seek U.S. Food & Drug Administration (“FDA”) alignment on using this new form of brilaroxazine product in the Company’s future new drug application (“NDA”) submission. This would include switching the active pharmaceutical ingredient (API) of brilaroxazine and its formulation in the second Phase 3 trial in schizophrenia. The Company believes 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. The Company is optimistic about receiving FDA alignment on this strategy, with feedback expected mid-year 2026.

 

If successful, this initiative has the potential to meaningfully extend the commercial exclusivity of brilaroxazine and strengthen the Company’s ability to realize the full value of the program over time. Importantly, a longer exclusivity runway could enhance the opportunity to develop brilaroxazine not only in schizophrenia, but also in bipolar disorder, major depressive disorder, and other potential high-value indications. The Company believes this strategy could materially increase the long-term value of the asset and further improve its attractiveness in future investment and strategic partnering discussions.

 

At the same time, the Company is moving forward with preparations for the second Phase 3 trial of brilaroxazine in schizophrenia, RECOVER-2. The Company expects to initiate trial related activities in Q2 2026 and begin patient enrollment in the United States in Q3 2026. As previously reported, the FDA has already cleared the protocol for this trial, and the Company currently expects study completion in Q4 2027.

 

 

The Company hereby updates and supplements its Risk Factor disclosure, as set forth in Part I, Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 30, 2026, by adding the below updated supplemental Risk Factor as follows:

 

The Company is heavily dependent on the success of brilaroxazine, its only advanced product candidate, which is still under clinical development, and if brilaroxazine does not receive regulatory approval or is not successfully commercialized, the Company’s business will be harmed.

 

The Company currently has no products that are approved for commercial sale and may never be able to develop marketable drug products. The Company expects that a substantial portion of its efforts and expenditures in the foreseeable future will be devoted to brilaroxazine. The Company’s only other product candidate is RP1208, which is in the pre-clinical phase. The Company does not expect to allocate a significant portion of its efforts or resources to the clinical trials or development of this product candidate in the foreseeable future. Accordingly, the Company’s business currently depends heavily on the successful development, regulatory approval and commercialization of brilaroxazine. The Company cannot be certain that brilaroxazine will receive regulatory approval or be successfully commercialized even if the Company receives regulatory approval. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of drug products are and will remain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries that each have differing regulations. The Company is not permitted to market brilaroxazine in the United States until it receives approval of a new drug application, or NDA, from the FDA, or in any foreign countries until it receives the requisite approval from such countries. The Company has not submitted an NDA to the FDA or comparable applications to other regulatory authorities and does not expect to be in a position to do so for the foreseeable future. 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 the Company’s other product candidates for many reasons, including:

 

 

 

 

 

This Current Report on Form 8-K, including Exhibit 99.1 hereto, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to statements regarding the Company’s expectations for future periods, anticipated business and financial performance, projections, trends; statements regarding the Company's positioning, its strategies, future progress, plans, goals, focuses and initiatives, and the expected timing and potential benefits thereof; and including statements regarding Company’s efforts to strengthen its capital position, balance sheet and cash position, preserve strategic flexibility, focus on long-term value, and support the Company’s development priorities; statements about the Company’s estimated cash position and projected cash runway; statements about brilaroxazine, including realizing the full potential thereof in schizophrenia and potentially other indications, and advancing the product through key regulatory and clinical milestones; statements about evaluating strategic alternatives as the Company seeks to maximize the value of brilaroxazine and preserve optionality for stockholders; statements about opportunity ahead and the clinical profile of brilaroxazine and its potential; statements about the Company’s plans and intentions for extending the long-term value of the brilaroxazine program and preparing for the next phase of development, including with respect to extending patent life and commercial exclusivity; statements about plans and intentions for switching to a new form of brilaroxazine product, seeking FDA alignment, future NDA submission, and expected timing, results and benefits of the Company’s strategy; and statements about the planned RECOVER-2 Phase 3 trial of brilaroxazine in schizophrenia, and the anticipated timing thereof; statements regarding the Company’s expectations about the anticipated clinical profile of its product candidates, including anticipated efficacy or safety profile; the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines and expenses, planned or potential additional trials and the timing thereof, planned or intended regulatory submissions and the timing thereof, the timing of availability of additional data or initiation of additional trials, trial results, market opportunity, costs of additional trials including statements about estimated costs, and the risk that the actual cost of trials and the Company’s actual expenses may be higher than the Company projects in its estimates; statements about ability to raise sufficient funding, including in an amount sufficient to support the Company’s intended additional trials, statements about expected approvals or the timing at which approval might be anticipated; statements about competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature; and other statements about the Company’s goals, plans, strategies, initiatives, and projections about future performance and expected results. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and management’s current beliefs and assumptions.

 

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, on the Company’s operations, clinical development and clinical trial plans, timelines and estimates, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

 

 

 

The following Exhibit 99.1 is furnished with this report:

 

 

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.