Zevra Therapeutics Completes Acquisition of Acer Therapeutics in its Journey to Become a Leading Rare Disease Company

Zevra Therapeutics, Inc. recently announced the completion of its acquisition of Acer Therapeutics Inc., which marks a significant step forward in executing Zevra’s strategy to become a leader in developing and commercializing treatments for rare diseases and furthers the company’s commitment to supporting patient communities with limited or no existing therapeutic options. As previously announced on August 31, 2023, the capital-efficient transaction included approximately 2.96 million shares of Zevra stock and contingent value rights (CVRs) issued in exchange for all outstanding shares of Acer. The CVRs represent the right to receive up to $76 million payable upon the achievement of certain regulatory and net sales milestones, net of the amount payable, if any, to SWK Funding LLC, a former warrantholder of Acer. In addition, immediately prior to the signing and announcement of the merger agreement, Zevra purchased Acer’s senior secured debt for a combination of cash, Zevra stock and notes valued at $28.5 million as a condition of entering into the merger agreement with Acer.

“Today’s acquisition marks an exciting milestone for Zevra as we advance our mission to deliver therapies to the rare disease community,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra. “With our combined resources, expanded portfolio, and expert capabilities, we have the opportunity to make a tremendous impact on the lives of people with serious rare diseases. We are excited about the opportunities ahead for patients and remain focused on executing our strategic priorities to create long-term shareholder value.”

The acquisition of Acer brings multiple rare disease assets and increases Zevra’s revenue potential with the addition of OLPRUVA, which is indicated for the treatment of certain urea cycle disorders (UCDs), expands Zevra’s clinical portfolio with EDSIVO, currently in Phase 3 for vascular Ehlers-Danlos syndrome (vEDS). The acquisition brings complementary assets and bolsters Zevra’s commercial and development capabilities with the addition of key Acer personnel and existing commercial systems.

“The integration of Acer’s programs, capabilities and accomplished team complements and enhances Zevra’s portfolio, and advances our mission to bring life-changing therapies to patients with rare diseases,” said Joshua Schafer, Chief Commercial Officer and Executive Vice President of Business Development of Zevra. “Acer’s programs and capabilities are an excellent fit for Zevra, particularly OLPRUVA for UCDs, which is a serious rare genetic metabolic disorder. There is a high degree of overlap between the diagnosing physicians and Centers of Excellence where patients with UCDs and Niemann-Pick disease type C (NPC) are treated. We believe this overlap will allow us to realize synergies and scale to efficiently commercialize both programs.”

Subsequent to the closing of the Acer transaction, Zevra announced that it has agreed to sell an aggregate of 1,382,489 shares of its common stock and accompanying warrants to purchase up to 1,382,489 shares of common stock at a price of $4.34 per share to a healthcare focused investment fund (the Investor) for gross proceeds of approximately $6 million and an aggregate of 917,934 shares of its common stock to cancel a warrant held by the Investor to purchase 2,920,306 shares of common stock of Acer (the Transaction). The shares of common stock and the warrants were offered and sold to the Investor in a registered direct offering conducted without an underwriter or placement agent. The Transaction is expected to close on or about November 22, 2023, subject to customary closing conditions.

The securities described above are being sold by Zevra pursuant to a registration statement on Form S-3 (Registration No. 333-257661), which was filed with the Securities Exchange Commission on July 2, 2021, and became effective on July 12, 2021, and the prospectus contained therein, as supplemented by a prospectus supplement to be filed with the SEC. The securities will be sold only by means of a prospectus, forming a part of the effective registration statement. Electronic copies of the accompanying prospectus may be obtained, when available, by visiting the SEC’s website at http://www.sec.gov.

Bryan Cave Leighton Paisner LLP served as legal advisor to Zevra, and Canaccord Genuity LLC served as exclusive financial advisor to Zevra for the merger transactions. Pillsbury Winthrop Shaw Pittman LLP served as legal advisor to Acer, and William Blair & Company, LLC served as exclusive financial advisor to Acer.

Urea cycle disorders (UCDs) are a group of rare, genetic disorders that can cause harmful ammonia build-up in the blood, potentially resulting in brain damage and neurocognitive impairments, if ammonia levels are not controlled. Any increase in ammonia over time is serious. Therefore, it is important to adhere to any dietary protein restrictions and have alternative medication options to help control ammonia levels.

ACER-001 (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and has recently been marketed under the brand name, OLPRUVA. OLPRUVA (sodium phenylbutyrate) for oral suspension is a prescription medicine indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg (44 pounds) or greater and with a body surface area (BSA) of 1.2 m² or greater, with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). Please see Important Safety Information and full Prescribing Information, including Patient Information.

Zevra Therapeutics is a rare disease company melding science, data, and patient need to create transformational therapies for diseases with limited or no treatment options. With unique, data-driven clinical, regulatory, and commercialization strategies, the company is overcoming complex drug development challenges to bring much-needed therapies to patients. With both regulatory and clinical-stage product candidates, the company is building its commercial capability to make new therapies available to the rare disease community. For more information, visit www.zevra.com. .