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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Acer Therapeutics Inc | NASDAQ:ACER | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.90 | 0.8702 | 0.91 | 0 | 01:00:00 |
“I am pleased with our team’s progress in the third quarter, highlighted by the timely resubmission of our New Drug Application (NDA) following the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) in response to ACER-001’s NDA submission,” stated Chris Schelling, CEO and Founder of Acer. “As the FDA continues its review of our resubmitted NDA for UCDs, we remain focused on advancing ACER-001 for the treatment of Maple Syrup Urine Disease (MSUD), having submitted our (Investigational New Drug) IND application to the FDA for a Phase 2a trial and receiving Orphan Drug Designation (ODD) from the European Commission.”
“In addition to the advancement of ACER-001, we made significant progress with the continued development of our other pipeline programs, including the initiation of our pivotal, Phase 3 DiSCOVER trial of EDSIVO™ (celiprolol) for the treatment of COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS) patients -- the only ongoing clinical trial in this patient population, to our knowledge -- and expansion of our ACER-801 program into treatment and prevention of Post-traumatic Stress Disorder (PTSD) through an investigator-sponsored trial to be conducted by the University of North Carolina (UNC),” Schelling continued. “And early next year, we look forward to reporting topline results from our ongoing Phase 2a clinical trial of ACER-801 for the treatment of moderate to severe Vasomotor Symptoms (VMS) in post-menopausal women.”
Q3 and Recent Highlights
Anticipated Milestones (Subject to Available Capital)
Q3 2022 Financial Results
Cash Position. Cash and cash equivalents were $6.4 million as of September 30, 2022, compared to $12.7 million as of December 31, 2021. Acer believes its cash and cash equivalents available as of September 30, 2022 will be sufficient to fund its currently anticipated operating and capital requirements into, but not through, the fourth quarter of 2022.
Research and Development Expenses. Research and development expenses were $2.7 million, net of collaboration funding of $2.2 million, for the three months ended September 30, 2022, as compared to $1.4 million, net of collaboration funding of $3.5 million, for the three months ended September 30, 2021. This increase of $1.3 million was primarily due to increases in expenses for clinical studies related to ACER-801 and EDSIVO™, contract research, and employee-related expenses, partially offset by decreases in expenses related to contract manufacturing. Research and development expenses related to ACER-001 decreased in the three months ended September 30, 2022, resulting in a decrease in the recognition of the collaboration funding from the Collaboration Agreement with Relief. Research and development expenses for the three months ended September 30, 2022 were comprised of $2.3 million related to ACER-001, offset by $2.2 million of collaboration funding; $1.2 million related to ACER-801; $1.0 million related to EDSIVO™; and $0.4 million related to other development activities.
General and Administrative Expenses. General and administrative expenses were $2.6 million, net of collaboration funding of $1.4 million, for the three months ended September 30, 2022, as compared to $1.8 million, net of collaboration funding of $1.0 million, for the three months ended September 30, 2021. This increase of $0.8 million was primarily due to increases in employee-related expenses, precommercial expenses, and audit and consulting fees, partially offset by an increase in the recognition of the collaboration funding from the Collaboration Agreement with Relief.
Net Loss. Net loss for the three months ended September 30, 2022 was $5.0 million, or $0.31 net loss per share (basic and diluted), compared to a net loss of $3.3 million, or $0.23 net loss per share (basic and diluted), for the three months ended September 30, 2021.
For additional information, please see Acer’s Quarterly Report on Form 10-Q filed today with the Securities and Exchange Commission (SEC).
Completion of Financial RestatementAcer has completed the restatement of its previously issued financial statements for the fiscal quarter ended June 30, 2022 (Restated Period), and has filed an amended Quarterly Report on Form 10-Q/A for the Restated Period with the SEC. A non-cash error was made in applying certain interpretive accounting guidance related to ASC 260, Earnings Per Share, which affected the Company’s presentation of its diluted earnings per share calculation. 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 Period. The restatement had no impact on Acer’s cash position or operating expenses or its ongoing operations or future plans.
About Acer TherapeuticsAcer 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) and post-traumatic stress disorder (PTSD); 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 StatementsThis 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, statements regarding the sufficiency and duration of our cash and cash equivalents, our anticipated milestones, and our plans with respect to future clinical trials, results and timing thereof for ACER 001, ACER 801 and EDSIVO™. Our pipeline products (including ACER-801) 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, the availability of financing to fund our pipeline product development programs and general corporate operations as well as risks related to 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 | |||||||
September 30, | |||||||
2022 | 2021 | ||||||
Operating expenses: | |||||||
Research and development (in the three months ended September 30, 2022 and 2021, net of collaboration funding of $2,178,078 and $3,454,881, respectively) | $ | 2,681,680 | $ | 1,435,461 | |||
General and administrative (in the three months ended September 30, 2022 and 2021, net of collaboration funding of $1,432,889 and $958,590, respectively) | 2,557,370 | 1,843,360 | |||||
Loss from operations | (5,239,050 | ) | (3,278,821 | ) | |||
Other income (expense), net: | |||||||
Costs of debt issuance | (122,400 | ) | — | ||||
Changes in fair value of debt instruments | 324,550 | — | |||||
Interest and other income (expense), net | 19,431 | (2,471 | ) | ||||
Foreign currency transaction gain | 10,524 | 8,284 | |||||
Total other income (expense), net | 232,105 | 5,813 | |||||
Net loss | $ | (5,006,945 | ) | $ | (3,273,008 | ) | |
Net loss per share - basic and diluted | $ | (0.31 | ) | $ | (0.23 | ) | |
Weighted average common shares outstanding - basic and diluted | 16,089,019 | 14,310,244 | |||||
SELECTED BALANCE SHEET DATA (Unaudited):
September 30, | December 31, | ||||||
2022 | 2021 | ||||||
Cash and cash equivalents | $ | 6,377,923 | $ | 12,710,762 | |||
Collaboration receivable | $ | — | $ | 5,000,000 | |||
Prepaid expenses | $ | 920,710 | $ | 1,094,229 | |||
Other current assets | $ | 5,436 | $ | 9,283,625 | |||
Property and equipment, net | $ | 92,502 | $ | 114,112 | |||
Total assets | $ | 15,324,533 | $ | 36,256,951 | |||
Deferred collaboration funding | $ | 10,598,201 | $ | 24,487,047 | |||
Bridge loan payable, at fair value | $ | 4,478,359 | $ | — | |||
Convertible note payable, at fair value | $ | 3,603,000 | $ | — | |||
Total liabilities | $ | 27,531,350 | $ | 37,980,556 | |||
Total stockholders’ deficit | $ | (12,207,317 | ) | $ | (1,723,605 | ) | |
Acer ContactsCorporate contact:Jim DeNikeAcer Therapeutics Inc.jdenike@acertx.com+1-844-902-6100
Investor contact:Nick ColangeloGilmartin Groupnick@gilmartinIR.com+1-332-895-3226
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