NEWTON, Mass., Aug. 15, 2022 (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 second quarter ended June 30, 2022, and provided a corporate update.
“I am very pleased with our team’s quick turnaround of our New Drug Application (NDA) resubmission following receipt of the Complete Response Letter (CRL) in response to our ACER-001 NDA for urea cycle disorders (UCDs),” stated Chris Schelling, CEO and Founder of Acer. “We have already announced the U.S. Food & Drug Administration (FDA) has accepted our NDA resubmission for ACER-001 in UCDs, assigned a new PDUFA date of January 15, 2023, and we are awaiting the agency’s inspection of our third-party contract packaging manufacturer. Meanwhile, we have made additional progress on our ACER-001 program, including the submission of an Investigational New Drug (IND) application for clinical investigation in Maple Syrup Urine Disease (MSUD) patients, and the issuance of a key utility patent in China.”
Schelling continued, “In parallel to our efforts in support of ACER-001 development, we also initiated in the second quarter, our Phase 3 pivotal DiSCOVER trial of EDSIVO™ for the treatment of vascular Ehlers-Danlos Syndrome (vEDS) under our Special Protocol Assessment (SPA) agreement with the FDA. Looking ahead, we anticipate topline results in our Phase 2a clinical trial of ACER-801 for the treatment of moderate to severe Vasomotor Symptoms (VMS) in post-menopausal women in Q4 of 2022.”
Q2 2022 and Recent Highlights
Anticipated Milestones
Q2 2022 Financial Results
Cash position. Cash and cash equivalents were $14.5 million as of June 30, 2022, compared to $12.7 million as of December 31, 2021. Acer believes its cash and cash equivalents available as of June 30, 2022 will be sufficient to fund its currently anticipated operating and capital requirements through Q3 2022.
Research and Development Expenses. Research and development expenses were $3.4 million, net of collaboration funding of $1.6 million, for the three months ended June 30, 2022, as compared to $1.4 million, net of collaboration funding of $1.0 million, for the three months ended June 30, 2021. This increase of $2.0 million was primarily due to increases in expenses for clinical studies. Research and development expenses for the three months ended June 30, 2022 were comprised of $2.1 million related to ACER-801; $1.8 million related to ACER-001, offset by $1.6 million of collaboration funding; $0.8 million related to EDSIVO; and $0.3 million related to other development activities.
General and Administrative Expenses. General and administrative expenses were $3.6 million, net of collaboration funding of $3.3 million, for the three months ended June 30, 2022, as compared to $2.3 million, net of collaboration funding of $0.6 million, for the three months ended June 30, 2021. This increase of $1.3 million was primarily due to increases in precommercial expenses, audit and consulting fees, and employee-related expenses, partially offset by a decrease in the recognition of the collaboration funding from the Collaboration Agreement with Relief.
Net Loss. Net loss for the three months ended June 30, 2022 was $2.7 million, or $0.17 net loss per share (basic and diluted), compared to a net loss of $3.1 million, or $0.21 net loss per share (basic and diluted), for the three months ended June 30, 2021.
For additional information, please see Acer’s Quarterly Report on Form 10-Q filed today with the SEC.
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 investigational 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 viruses, including cytomegalovirus, Zika, dengue, Ebola and COVID-19. For more information, visit www.acertx.com.
Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, the Company’s expectations with respect to the clinical trials and anticipated milestones for ACER-001 (sodium phenylbutyrate), ACER-801 (osanetant) and EDSIVO™ (celiprolol), including timing, conditions, results, enrollment, duration and capital needs related thereto, and the Company’s expectations with respect to the sufficiency of its cash and cash equivalents and the duration thereof. Our pipeline products are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You may access these documents for no charge at http://www.sec.gov.
ACER THERAPEUTICS INC. | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
June 30, | ||||||||
2022 | 2021 | |||||||
Operating expenses: | ||||||||
Research and development (in the three months ended June 30, 2022 and 2021, net of collaboration funding of $1,648,631 and $1,025,935, respectively) | $ | 3,426,773 | $ | 1,361,287 | ||||
General and administrative (in the three months ended June 30, 2022 and 2021, net of collaboration funding of $3,257,701 and $602,534, respectively) | 3,638,073 | 2,268,508 | ||||||
Loss from operations | (7,064,846 | ) | (3,629,795 | ) | ||||
Other income (expense), net: | ||||||||
Costs of debt issuance | (200,129 | ) | — | |||||
Changes in fair value of debt instruments | 4,729,460 | — | ||||||
Interest and other (expense) income, net | (139,234 | ) | 564,914 | |||||
Foreign currency transaction gain (loss) | 7,713 | (4,156 | ) | |||||
Total other income (expense), net | 4,397,810 | 560,758 | ||||||
Net loss | $ | (2,667,036 | ) | $ | (3,069,037 | ) | ||
Net loss per share - basic and diluted | $ | (0.17 | ) | $ | (0.21 | ) | ||
Weighted average common shares outstanding - basic and diluted | 15,273,707 | 14,310,244 |
SELECTED BALANCE SHEET DATA (Unaudited): | ||||||||
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
Cash and cash equivalents | $ | 14,469,744 | $ | 12,710,762 | ||||
Collaboration receivable | $ | — | $ | 5,000,000 | ||||
Prepaid expenses | $ | 666,318 | $ | 1,094,229 | ||||
Other current assets | $ | 65,061 | $ | 9,283,625 | ||||
Property and equipment, net | $ | 101,582 | $ | 114,112 | ||||
Total assets | $ | 23,242,890 | $ | 36,256,951 | ||||
Deferred collaboration funding | $ | 14,209,169 | $ | 24,487,047 | ||||
Bridge loan payable, at fair value | $ | 4,084,709 | $ | — | ||||
Convertible note payable, at fair value | $ | 4,321,200 | $ | — | ||||
Total liabilities | $ | 32,026,432 | $ | 37,980,556 | ||||
Total stockholders’ deficit | $ | (8,783,542 | ) | $ | (1,723,605 | ) | ||
CORPORATE CONTACT
Jim DeNike
Acer Therapeutics Inc.
[email protected]
+1-844-902-6100
INVESTOR RELATIONS CONTACT
Nick Colangelo
Gilmartin Group
[email protected]
+1-332-895-3226
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