ACER - Acer stock slumps ~45% as ACER-801 paused after hot flashes trial disappoints; cash woes

2023-03-17 09:16:37 ET

Acer Therapeutics ( NASDAQ: ACER ) is pausing a program for its drug ACER-801 (osanetant) after the medicine failed to meet the efficacy goals of a phase 2a trial to treat hot flashes in postmenopausal women.

The proof of concept trial was evaluating ACER-801 to treat  moderate to severe Vasomotor Symptoms (VMS) linked with menopause.

VMS is also called as hot flashes and night sweats are common symptoms of menopause.

The company said ACER-801 was safe and well-tolerated but did not achieve statistical significance in decreasing the frequency or severity of hot flashes in postmenopausal women.

The study included 49 women who received either twice daily 50 mg, 100 mg, 200 mg of ACER-801 or placebo over 14 days, followed by a 14-day safety follow-up. Main goals were safety and pharmacokinetics, with efficacy compared to placebo as a secondary goal, according to the company.

Acer added that it is pausing the ACER-801 program until it conducts a review of the full data.

"We intend to conduct a comprehensive analysis of the totality of the clinical trial data – including the pharmacokinetic data, which has not yet been analyzed – which will inform our path forward for the program, including our collaborations for prostate cancer and post-traumatic stress disorder (PTSD)," said Acer Founder and CEO Chris Schelling.

In December 2018, Acer had signed an exclusive license agreement with Sanofi ( NASDAQ: SNY ) to acquire worldwide rights to ACER-801.

Acer believes that its existing cash and cash equivalents will be sufficient to fund its operating and capital requirements into early in Q2 2023. The company noted that it will require more financing to commercialize Olpruva (sodium phenylbutyrate).

The company noted that it is focusing on preparation for commercial launch of Olpruva, and an ongoing phase 3 trial of Edsivo (celiprolol) for vascular Ehlers-Danlos Syndrome (vEDS) in patients with a confirmed type 3 collagen (COL3A1) mutation, subject to availability of additional capital beyond early in Q2 2023.

The company said that there can be assurance that it will be able to get more capital. In case of failing, the company may delay, limit, reduce or terminate its product development, other operations or sales efforts or to suspend or restructure its business.

ACER -45.55% to $0.84 premarket March 17

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