Benzinga | Jan 25, 2021 08:38AM EST

Relief Therapeutics And Acer Therapeutics Sign Option Agreement For Exclusivity To Negotiate Collaboration And License Agreement For Worldwide Development + Commercialization Of ACER-001 For Treatment Of Urea Cycle Disorders And Maple Syrup Urine Disease

Acer to receive $1 million payment to obtain exclusivity and a $4 million loan from Relief



Companies working toward negotiation and execution of a definitive collaboration

and license agreement by June 30, 2021

GENEVA and NEWTON, Mass., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Relief Therapeutics Holding AG ((SIX: RLF, OTCQB:RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (NASDAQ:ACER)("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 the companies have signed an Option Agreement providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. ACER-001 (sodium phenylbutyrate) powder is a taste-masked, immediate release proprietary formulation in development for the treatment of urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).

Under the terms of the Option Agreement, Acer will receive from Relief a $1 million non-refundable payment in return for exclusivity until June 30, 2021 to negotiate and enter into a definitive collaboration and license agreement between Acer and Relief for the development of ACER-001. Further, in connection with entering into the Option Agreement, Relief will make a $4.0 million loan to Acer. The loan, which will be secured by a lien on all of Acer's assets, will bear interest at the rate of 6% per annum and will be due in one year.

Under the terms of the proposed collaboration and license agreement, the key terms of which are set forth in the Option Agreement, if a definitive agreement is executed pursuant to these terms and closed by June 30, 2021, Acer will receive $15 million in cash (net $10 million, inclusive of the $1 million payment and offset by a repayment of the $4 million loan from Relief). In addition, Relief will agree to pay up to $20 million in U.S. development and commercial launch costs for the UCDs and MSUD indications. Further, Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer's territories 60:40 in favor of Relief. Relief will also license the rights for the rest of the world, where Acer will receive from Relief a 15% net sales royalty on all revenues received in Relief's territories. Acer could also receive a total of $6 million in milestones based on the first European (EU) marketing approvals for UCDs and MSUD. There can be no assurance, however, that a definitive agreement will be successfully negotiated and executed between the parties on these terms, on other mutually acceptable terms, or at all. Except for the $1.0 million upfront payment to Acer and the $4.0 million one-year secured loan from Relief to Acer, the remaining proposed terms of the collaboration are not binding and are subject to change as a result of further diligence by Relief and negotiation of a definitive collaboration and license agreement between the parties.

Jack Weinstein, Relief's CFO and Treasurer said, "We are excited about the opportunity to work with the Acer team to potentially develop and commercialize ACER-001 worldwide. This partnership is Relief's first initiative to build a pipeline of drugs beyond RLF-100(tm). While our core focus remains squarely on the rapid advancement of RLF-100(tm) for treatment of respiratory conditions, primarily acute respiratory distress syndrome (ARDS) due to COVID-19 infection, we are committed to establishing a diversified marketed product portfolio. ACER-001's stage of maturity fits perfectly within our strategic plan."

Chris Schelling, Acer's CEO and Founder, said, "I believe Relief shares the same values and vision that Acer has in supporting the rare disease community. This potential collaboration could provide important resources and additional expertise to help bring ACER-001 to patients worldwide suffering from debilitating diseases like UCDs and MSUD. We very much look forward to the possibility of working with the Relief team."