Acer Therapeutics Inc. - ACER STOCK NEWS

Acer Therapeutics (Nasdaq: ACER) announced participation at the 20th Annual Needham Virtual Healthcare Conference from April 12-15, 2021. The management team will present on April 15, 2021, at 11 a.m. Eastern Time and will also host one-on-one investor meetings. Acer focuses on developing therapies for serious rare diseases, with several products in its pipeline, including ACER-001 for metabolic disorders and EDSIVO™ for vascular Ehlers-Danlos syndrome. The company seeks to address significant unmet medical needs in the healthcare sector.

Acer Therapeutics Inc. announced a proposed settlement related to a shareholder derivative lawsuit filed on behalf of the company in the U.S. District Court for Massachusetts. The settlement involves governance reforms and a $500,000 fee to plaintiffs’ counsel. The settlement hearing is scheduled for May 12, 2021, where the court will evaluate the fairness of the settlement and consider any objections. Current Acer shareholders as of December 29, 2020, are advised to review the details and their rights regarding this settlement.

Relief Therapeutics and Acer Therapeutics have entered into a Collaboration and License Agreement (CLA) for the development and commercialization of ACER-001, a taste-masked sodium phenylbutyrate formulation. Acer will receive an upfront payment of $10 million and may receive up to $20 million for development costs. The profit-sharing arrangement favors Relief with a split of 60% to 40%. Additionally, Relief will pay Acer royalties and milestone payments. A pre-NDA meeting with the U.S. FDA for ACER-001 is set for Q2 2021, aimed at addressing unmet needs in treating Urea Cycle Disorders and Maple Syrup Urine Disease.

Acer Therapeutics Inc. (Nasdaq: ACER) reported its financial results for Q4 and full year 2020, ending Dec 31, 2020. The company ended the year with cash and equivalents of $5.8 million, down from $12.1 million in 2019. Despite a net loss of $22.9 million for the year, Acer expects key milestones in Q2 2021, including a pre-NDA meeting with the FDA for ACER-001 and progress on EDSIVO™. The net loss per share was $2.06, an improvement from $2.91 in 2019. Total R&D expenses were $11.8 million, down from $13.9 million the previous year.

Acer Therapeutics Inc. (Nasdaq: ACER) will present at two virtual conferences in March 2021, focusing on therapies for serious rare diseases. The H.C. Wainwright Global Life Sciences Virtual Conference is scheduled for March 9-10, 2021. Acer's management will also participate in the 33rd Annual Roth Virtual Conference on March 15, 2021, with a panel presentation on therapeutics against SARS-CoV-2 at 12 p.m. Eastern Time. Acer's pipeline includes therapies for urea cycle disorders, vascular Ehlers-Danlos syndrome, and COVID-19.

Acer Therapeutics (Nasdaq: ACER) announced positive topline results from a bioequivalence trial of its investigational drug ACER-001, designed for treating urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD). The trial showed that ACER-001 has similar pharmacokinetic profiles compared to BUPHENYL® under fed conditions. The company is targeting a pre-NDA meeting with the FDA in Q2 2021, aiming to submit a New Drug Application (NDA) for ACER-001 for UCDs mid-2021, pending no further data requests. The approval of ACER-001 could provide a much-needed alternative treatment to existing options.

Acer Therapeutics has entered an Option Agreement with Relief Therapeutics for exclusive rights to negotiate a collaboration on ACER-001, aimed at treating urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD). Acer will receive a $1 million payment for exclusivity and a $4 million loan, repayable within a year. If a definitive agreement is reached by June 30, 2021, Acer stands to gain $15 million in cash (net $10 million) and up to $20 million for UCD and MSUD development costs. The agreement terms are non-binding and subject to change.

Acer Therapeutics Inc. (Nasdaq: ACER) reported full enrollment of its pivotal trial for ACER-001, aimed at treating urea cycle disorders (UCDs). The trial compares ACER-001's bioequivalence to BUPHENYL® in healthy adults under fed conditions, with results expected in Q1 2021. Following this, Acer plans to request a pre-NDA meeting with the FDA in Q2 2021. The unique formulation of ACER-001 is designed to improve patient compliance by masking the unpleasant taste of sodium phenylbutyrate, a common treatment for UCDs.

Acer Therapeutics announced new long-term data showing celiprolol may have a protective effect for patients with COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS). The study, published in the European Journal of Vascular and Endovascular Surgery, involved 40 patients treated at Uppsala University Hospital over up to 98 months. The annual major vascular event risk was 4.7%, similar to previous findings. Acer aims to collect further evidence for FDA resubmission of EDSIVO™, a treatment for vEDS, after receiving a Complete Response Letter in June 2019.