Maple Syrup Urine Disease

Acer Shareholders – Please Vote Today!NEWTON, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced that Institutional Shareholder Services Inc. (ISS) and Glass, Lewis & Co. LLC (Glass Lewis) recommended that Acer shareholders vote "FOR" the proposed merger with Zevra Therapeutics, Inc. and the related proposals in the Company's proxy statement and prospectus for the special meeting of its shareholders to be held on November 8, 2023 at 11:00 a.m. Eastern Time. ISS and Glass Lewis are widely recognized as the leading independent voting and corporate governance advisory firms. Their analysis and recommendations are relied on by many major institutional investment firms, mutual funds and fiduciaries throughout North America. In its report, ISS stated, among other things, that “The transaction warrants support in light of the reasonably thorough review of alternatives, the positive market reaction, the upside potential provided by the stock and CVR forms of consideration, and the downside risk of non-approval.” Glass Lewis concluded that the transaction would allow Acer shareholders to participate in a larger and better capitalized pharmaceutical company, while also retaining significant upside potential through the CVR consideration, at a time when Acer appears to have few, if any, viable alternatives. Glass Lewis also noted that the total implied value of the proposed consideration represents a substantial premium to the unaffected trading price of Acer shares and the merger consideration compares favorably with the expected outcome in a liquidation scenario, in which Acer shareholders were not expected to receive any proceeds. Commenting on the proxy advisors’ reports, Chris Schelling, CEO and Founder of Acer, said: "The ISS and Glass Lewis recommendations are consistent with our view that the merger with Zevra is in the best interest of Acer shareholders." The merger and related agreements have been unanimously approved by the boards of directors of both companies. The merger and related proposals have been unanimously approved by Acer’s board of directors. Failure to vote or an abstention from voting will have the same effect as a vote "AGAINST" the merger proposal. All shareholders are asked to vote "FOR" all proposals as soon as possible. THE MERGER WILL NOT GO FORWARD UNLESS THE MERGER AND RELATED PROPOSALS ARE APPROVED. ACER SHAREHOLDERS – PLEASE VOTE TODAY! If the merger is not approved on November 8, ACER will begin trading on OTC Pink Market starting on November 9 because of the failure by the Company to regain compliance, during the previously granted 180 calendar day grace period, with Nasdaq’s requirement of having at least $35 million in market value of listed securities, resulting in the trading suspension of ACER on Nasdaq. If the merger is not subsequently consummated, Acer will not be able to fund its business operations and will likely be forced to terminate operations, liquidate or file for bankruptcy. If you are an Acer shareholder and you have questions or require assistance in submitting your proxy or voting your shares, please contact Acer’s proxy solicitor: ADVANTAGE PROXY, INC.Toll Free: 1-877-870-8565Collect: 1-206-870-8565Email: ksmith@advantageproxy.com Additional Information about the Proposed Merger between Acer and Zevra, the Special Meeting and Where to Find ItIn connection with the proposed merger, Zevra has filed a registration statement on Form S-4 with the Securities and Exchange Commission (the "SEC"), including a proxy statement / prospectus. The registration statement was declared effective on October 10, 2023. Additionally, Acer’s proxy statement was filed on October 10, 2023. Acer shareholders are urged to read these materials because they contain important information about Acer, Zevra and the proposed merger. The proxy statement / prospectus and other relevant materials, and any other documents filed by Zevra and Acer with the SEC, may be obtained free of charge at the SEC website at www.sec.gov. In addition, Acer shareholders will be able to attend the Acer special meeting via the Internet at https://www.cstproxy.com/acertx/sm2023 and view the Acer 2023 Special Meeting Proxy Statement and the Zevra Therapeutics, Inc. Forms 10-K, 10-Qs and 8-Ks. Acer shareholders are urged to read the proxy statement / prospectus and the other relevant materials before making any voting or investment decision with respect to the proposed merger. No Offer or SolicitationThis communication is for informational purposes only and not intended to and does not constitute an offer to subscribe for, buy or sell, the solicitation of an offer to subscribe for, buy or sell or an invitation to subscribe for, buy or sell any securities or the solicitation of any vote or approval in any jurisdiction pursuant to or in connection with the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”), and otherwise in accordance with applicable law. Participants in the SolicitationAcer, Zevra and their respective directors and executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Acer is set forth in its Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on March 27, 2023, and its proxy statement for its 2023 annual meeting of shareholders, which was filed with the SEC on April 14, 2023. Information about the directors and executive officers of Zevra is set forth in its Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on March 7, 2023, and its proxy statement for its 2023 annual meeting of stockholders, which was filed with the SEC on March 15, 2023, the definitive proxy statement filed by Daniel J. Mangless, together with the other participants named therein, which was filed with the SEC on March 17, 2023, and Zevra’s Current Reports on Form 8-K, filed with the SEC on March 30, 2023, May 8, 2023, May 15, 2023, and August 7, 2023. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, is set forth in the proxy statement/prospectus and other relevant materials filed with the SEC and may be obtained free of charge from the sources indicated above. About Acer TherapeuticsAcer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. In the U.S., OLPRUVA® (sodium phenylbutyrate) is approved for the treatment of UCDs involving deficiencies of CPS, OTC, or AS. Acer is also advancing a pipeline of investigational product candidates for rare and life-threatening diseases, including: OLPRUVA® (sodium phenylbutyrate) for treatment of various disorders, including Maple Syrup Urine Disease (MSUD); and EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation. For more information, visit www.acertx.com. Forward-Looking StatementsDISCLOSURE NOTICE: This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, related to Acer, Zevra and the proposed acquisition of Acer by Zevra. All statements other than statements of historical fact are forward-looking statements for purposes of federal and state securities laws. These forward-looking statements involve uncertainties that could significantly affect the financial or operating results of Acer, Zevra or the combined company. These forward-looking statements may be identified by terms such as anticipate, believe, foresee, expect, intend, plan, may, will, could, should and would and the negative of these terms or other similar expressions. Forward-looking statements in this document include, among other things, statements about the potential benefits of the proposed acquisition; statements about contingent cash consideration and related milestones as contemplated by the CVR Agreement; the anticipated timing of closing of the acquisition; the delisting of Acer’s stock from Nasdaq and resulting move to OTC Pink Market; and that, if the merger is not subsequently consummated, Acer will not be able to fund its business operations and will likely be forced to terminate operations, liquidate or file for bankruptcy. These forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary stockholder approval) in the anticipated timeframe or at all; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; risks related to the contingent cash consideration and related milestones as contemplated by the CVR Agreement, including that such milestone may not be achieved and thus the related cash consideration would not become payable; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business, contractual and operational relationships; the unfavorable outcome of the legal proceedings that have been or may be instituted against Acer, Zevra or the combined company; the ability to retain key personnel; negative effects of this announcement or the consummation of the proposed acquisition on the market price of the capital stock of Acer and Zevra and on Acer’s and Zevra’s operating results; risks relating to the value of Zevra’s shares to be issued in the transaction; significant transaction costs, fees, expenses and charges; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; the financing of the transaction and Acer’s interim operations; the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; and competitive developments. A further description of risks and uncertainties relating to Acer and Zevra can be found in their respective most recent Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov. Neither Acer nor Zevra intends to update the forward-looking statements contained in this document as the result of new information or future events or developments, except as required by law. Corporate ContactHarry PalminChief Financial OfficerAcer Therapeutics Inc.investors@acertx.com+1-844-902-6100

Acer Therapeutics buys Relief Therapeutics' stake in OLPRUVA™ worldwide, excluding geographical Europe, providing an upfront payment of $10 million in cash to Relief Therapeutics with the potential for an additional $46.5 million in milestone and royalty payments The transition from a profit-based to a revenue-based royalty stream model is expected to deliver earlier returns and enhanced predictability to Relief Therapeutics GENEVA, SWITZERLAND / ACCESSWIRE / August 30, 2023 / RELIEF THERAPEUTICS Holding SA (SWX:RLF), (OTCQB:RLFTF, RLFTY) (Relief Therapeutics), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it has entered into a new exclusive definitive licensing agreement with Acer Therapeutics Inc. (Acer Therapeutics) for the development and commercialization of OLPRUVA™ (sodium phenylbutyrate, ACER-001) for the treatment of certain urea cycle disorders (UCDs) and other potential indications. This agreement supersedes the March 2021 collaboration and license agreement between the companies, which has been cancelled as part of this new agreement. "We are very happy to have re-structured our collaboration with Acer Therapeutics which includes provisions that we believe will benefit both parties, and ultimately those suffering from UCDs and other potential rare metabolic conditions," said Jack Weinstein, chief executive officer of Relief Therapeutics. "Our collective goal with Acer is to maximize the global commercialization of OLPRUVA™ to ensure as many patients as possible will access to this much needed, differentiated and convenient treatment alternative." Under the terms of the new agreement, Acer Therapeutics will retain development and commercialization rights for OLPRUVA™ worldwide for the treatment of UCDs and any potential additional indications in the U.S. and other countries worldwide, excluding geographical Europe. Acer Therapeutics will provide Relief Therapeutics with a non-contingent $10 million upfront cash payment and an additional non-contingent $1.5 million cash payment on the one-year anniversary of the agreement. Relief Therapeutics will also receive a 10 percent continuing royalty calculated on the net sales of OLPRUVA™ in the Acer Therapeutics territory, and 20 percent of any value received by Acer Therapeutics from licensing or divestment transactions relating to OLPRUVA™, up to a cumulative amount of an additional $45 million. At the same time, Relief Therapeutics will retain development and commercialization rights for OLPRUVA™ in geographical Europe, which includes the European Union, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia. Acer Therapeutics will receive from Relief Therapeutics a variable, continuing royalty up to a maximum of 10 percent of the net sales of OLPRUVA™ and 20 percent of any value received by Relief Therapeutics from sublicensing transactions relating to OLPRUVA™ in geographical Europe, which going forward exclusively remains Relief Therapeutics' territories to develop and commercialize OLPRUVA™. "Relief Therapeutics remains an ideal partner for OLPRUVA™ in Europe and we are eager to continue the development and commercialization of our innovative treatment option for those suffering from rare metabolic disorders like UCDs," said Chris Schelling, founder and chief executive officer of Acer Therapeutics. In addition to the immediate cash influx strengthening Relief Therapeutics' capital position, the transition from a profit-based model to a revenue-based royalty stream model is expected to offer Relief Therapeutics earlier returns, reduce certain associated risks and increase predictability in its royalty income. This will also support Relief Therapeutics' ongoing operations, extending the cash runway and bolster investments in the Company's pipeline, including its efforts to seek approval to commercialize OLPRUVA™ in geographical Europe. ABOUT OLPRUVA™ The U.S. Food and Drug Administration (FDA) approved ACER-001 (sodium phenylbutyrate) for the treatment of certain UCDs in December 2022 and it is now marketed in the U.S. under the brand name OLPRUVA™. OLPRUVA™ is also being studied as an investigational treatment for patients with maple syrup urine disease (MSUD), a rare metabolic genetic disease that leads to toxic build-up of leucine and other branched-chain amino acids. Please see Important Safety Information and full Prescribing Information, including Patient Information. ABOUT RELIEF THERAPEUTICS Relief Therapeutics is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief Therapeutics' portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic™ and TEHCLO™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas, which include rare metabolic, rare dermatology and rare respiratory diseases. In addition, Relief Therapeutics is commercializing several legacy products via licensing to distribution partners. Relief Therapeutics' mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief Therapeutics is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy. Relief Therapeutics is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, please visit our website or follow Relief Therapeutics on LinkedIn and Twitter. CONTACT: RELIEF THERAPEUTICS Holding SA Catherine Day Vice President, Investor Relations & Communications catherine.day@relieftherapeutics.com DISCLAIMER This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors, including (i) whether Relief Therapeutics and Acer Therapeutics will be successful in their respective development and commercialization efforts for OLPRUVA™, (ii) whether the new transaction structure will prove more or less profitable to Relief Therapeutics than the transaction structure included in the original Collaboration Agreement between the parties, (iii) whether Relief Therapeutics will ultimately be successful in obtaining the right to commercialize OLPRUVA™ in geographical Europe, and (iv) those factors described in Relief Therapeutics' filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), all of which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Copies of Relief Therapeutics' filings with the SEC are available on the SEC EDGAR database at Relief Therapeutics does not undertake any obligation to update the information contained herein, which speaks only as of this date. SOURCE: RELIEF THERAPEUTICS Holding SA View source version on accesswire.com:

NEWTON, Mass., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced it has entered into definitive agreements to reacquire worldwide development, commercialization and economic rights to OLPRUVA™ (sodium phenylbutyrate) from Relief Therapeutics, excluding the European Union, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia (Geographical Europe). OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs). Under the prior Collaboration and License Agreement (CLA) between the parties, Acer would have paid Relief 60% of Acer's OLPRUVA™ net profits in the U.S., Canada, Brazil, Turkey and Japan (the Acer territories), while Acer would have received a 15% royalty on Relief’s net sales in the rest of the world (the Relief territories). Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe. In return, Relief will receive an upfront payment by Acer of $10 million, to be made within 5 business days of the signature date, with an additional payment of $1.5 million due on the first-year anniversary of the $10 million payment. Acer has also agreed to pay a 10% royalty on net sales in the Acer territories, and 20% of any value received by Acer from certain third parties relating to OLPRUVA™ licensing or divestment rights, all of the foregoing which are capped at $45 million, for total payments to Relief of up to $56.5 million. Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™. “Regaining exclusive worldwide rights to OLPRUVA™ without profit sharing, subject only to Relief's rights in the Geographical Europe, unlocks value for Acer as we continue the U.S. launch of OLPRUVA™ and begin to provide treatments to UCD patients in need,” said Chris Schelling, CEO and Founder of Acer. “Reacquiring greater economic rights to OLPRUVA™ allows Acer to reinvest more capital into potential lifecycle expansion opportunities for OLPRUVA™, in additional inborn errors of metabolism, such as Maple Syrup Urine Disease and other potential indications.” “We are very happy to have restructured our collaboration with Acer Therapeutics which we believe will benefit those suffering from UCDs and other potential rare metabolic conditions,” said Jack Weinstein, CEO of Relief Therapeutics. “Our collective goal with Acer is to maximize the global commercialization of OLPRUVA™ to ensure as many patients as possible will access this much needed, differentiated and convenient alternative.” Additional information regarding the termination of the March 2021 CLA and execution of the new ELA for European rights is available on form 8-K at . OLPRUVA™: Now Available by Prescription in U.S. ACER-001 (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and is marketed under the brand name, OLPRUVA™. OLPRUVA™ (sodium phenylbutyrate) for oral suspension is a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a BSA of 1.2 m2 or greater, with UCDs, involving deficiencies of CPS, OTC, or AS.1 Please see full Prescribing Information, including Patient Information. Important Safety Information Certain medicines may increase the level of ammonia in the blood or cause serious side effects when taken during treatment with OLPRUVA™. Tell your doctor about all the medicines you or your child takes, especially if you or your child takes corticosteroids, valproic acid, haloperidol, and/or probenecid. OLPRUVA™ can cause serious side effects, including: 1) nervous system problems (neurotoxicity) such as, sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, and/or confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA™ contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA™ is right for you. The most common side effects of OLPRUVA™ include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For additional Important Safety Information, see full Prescribing Information, Patient Package Insert and discuss with your doctor. About Acer Therapeutics Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. In the U.S., OLPRUVA™ (sodium phenylbutyrate) is approved for the treatment of UCDs involving deficiencies of CPS, OTC, or AS. Acer is also advancing a pipeline of investigational product candidates for rare and life-threatening diseases, including: OLPRUVA™ (sodium phenylbutyrate) for treatment of various disorders, including Maple Syrup Urine Disease (MSUD); and EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation. For more information, visit . References OLPRUVA™ (sodium phenylbutyrate) for oral suspension. Prescribing information. Newton, MA: Acer Therapeutics Inc. Acer Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, expected payments between Acer and Relief in connection with the ELA and terminated CLA, the impact of the revised business arrangement between Acer and Relief on the Company and the Company’s investment plans related thereto, plans with respect to the U.S. launch of OLPRUVA™, and the possible side effects of OLPRUVA™. Additionally, the Company’s effort to advance a pipeline of investigational product candidates and related plans and expectations is an example of such forward-looking statements. Our efforts to commercialize OLPRUVA™ for oral suspension in the U.S. for the treatment of certain patients with UCDs involving deficiencies of CPS, OTC, or AS are at an early stage, we currently do not have fully developed marketing and sales capabilities, and there is no guarantee that we will be successful in our commercialization efforts. Our pipeline products (including OLPRUVA™ for indications other than UCDs) are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the availability of financing to fund our commercialization efforts, our pipeline product development programs and general corporate operations as well as risks related to drug development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You may access these documents for no charge at . Corporate and IR Contacts Harry Palmin Chief Financial Officer Acer Therapeutics Inc. investors@acertx.com +1-844-902-6100 Nick Colangelo Gilmartin Group nick@gilmartinIR.com +1-332-895-3226