Acer Therapeutics Reports Q3 2021 Financial Results and Provides Corporate Update
NEWTON, Mass., Nov. 19, 2021 (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 reported financial results for the third quarter ended September 30, 2021 and provided an update on Acer’s recent corporate developments.
“This quarter was all about preparing regulatory filings to advance our pipeline products,” said Chris Schelling, CEO and Founder of Acer. “For ACER-001, we successfully submitted a 505(b)(2) NDA in August and received FDA’s acceptance for filing and substantive review of our NDA in October, setting up a PDUFA target action date in June 2022. For ACER-801 and EDSIVO™, our team has been working diligently to prepare INDs, with the goal to submit both to the FDA in Q4. Additionally, we further enhanced the value in the company through the issuance of a key formulation patent by the USPTO related to ACER-001 with an expiration date of 2036, and expansion of our leadership team with the recent addition of Alka Chawla, M.D., Vice President, Medical Director.”
Q3 2021 and Recent Highlights
ACER-001, ACER-801 and EDSIVO™ (celiprolol) are investigational product candidates that have not been approved by FDA. There is no guarantee that these product candidates will receive regulatory authority approval in any territory or become commercially available for the indications under investigation.
Q3 2021 Financial Results
Cash position. Cash and cash equivalents were $14.2 million as of September 30, 2021, compared to $5.8 million as of December 31, 2020. Acer believes its cash and cash equivalents available as of September 30, 2021, plus the $10.0 million Second Development Payment in two tranches following FDA acceptance for filing and review of an NDA for ACER-001 in a UCD per the Collaboration Agreement with Relief, will be sufficient to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-801 and EDSIVO™ clinical trials.
Research and Development Expenses. Research and development expenses were $1.4 million, net of collaboration funding of $3.5 million for the three months ended September 30, 2021, as compared to $3.2 million for the three months ended September 30, 2020. This decrease of $1.8 million was primarily due to the recognition of the $3.5 million of collaboration funding from the Collaboration Agreement with Relief, partially offset by increases in contract manufacturing expenses and employee-related expenses. Research and development expenses for the three months ended September 30, 2021 were comprised of $3.6 million related to ACER-001, offset by $3.5 million of collaboration funding; $0.9 million related to ACER-801; $0.3 million related to EDSIVOTM; and $0.1 million related to other development activities.
General and Administrative Expenses. General and administrative expenses were $1.8 million, net of collaboration funding of $1.0 million for the three months ended September 30, 2021, as compared to $2.7 million for the three months ended September 30, 2020. This decrease of $0.9 million was primarily due to the recognition of the $1.0 million of collaboration funding from the Collaboration Agreement with Relief, as well as a decrease in legal expenses, partially offset by increases in precommercial expenses and employee-related expenses.
Net Loss. Net loss for the three months ended September 30, 2021 was $3.3 million, or $0.23 net loss per share (basic and diluted), compared to a net loss of $5.9 million, or $0.51 net loss per share (basic and diluted), for the three months ended September 30, 2020.
For additional information, please see Acer’s Quarterly Report on Form 10-Q filed today with the SEC.
Completion of Financial Restatement
Acer has completed the restatement of its previously issued financial statements for the fiscal quarters ended March 31, 2021 and June 30, 2021 (Restated Periods), and has filed amended Quarterly Reports on Form 10-Q/A for the Restated Periods with the SEC. As previously disclosed in its Current Report on Form 8-K filed November 16, 2021, a non-cash error was made in the application of certain complex accounting guidance for collaboration agreements, and the revenue recognition associated with the previously disclosed collaboration and license agreement between Acer and Relief, which was entered into on March 19, 2021. The correction of this non-cash error resulted in a restatement of Acer’s unaudited condensed interim financial statements and financial data for the Restated Periods. The restatement had no impact on Acer’s cash position or operating expenses or its ongoing operations or future plans.
About Acer Therapeutics Inc.
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. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.
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