Acer Therapeutics Reports Q3 2022 Financial Results and Provides Corporate Update | Media Pyro

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Acer Therapeutics Inc.

Acer Therapeutics Inc.

NEWTON, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the discovery, 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, 2022 and provided an update on Acer’s recent corporate developments.

“I am pleased with our team’s progress in the third quarter, which was highlighted by the timely rebuilding of our New Drug Application (NDA) following the Final Response Letter (CRL) issued by the US Food and Drug Administration (FDA ) in response to ACER- submission NDA 001,” said Chris Schelling, CEO and Founder of Acer. “As the FDA continues its review of our reissued NDA for UCDs, we remain focused on advancing ACER-001 for the treatment of Map Syrup Urine Disease (MSUD), after we submitted our IND application (Drug New Investigational) to be submitted to the FDA in Phase. 2a trial and receive Orphan Drug Designation (ODD) from the European Commission.”

“In addition to advancing ACER-001, we made significant progress with the ongoing development of our other pipeline programs, including the initiation of our pivotal, Phase 3 DiSCOVER trial of EDSIVO™ (celiproolol) for the treatment of vascular COL3A1- positive Patients with Ehlers-Danlos Syndrome (vEDS) — the only ongoing clinical trial in this patient population, to our knowledge — and the expansion of our ACER-801 program for the treatment and prevention of Post-Traumatic Stress Disorder (PTSD) through investigator-sponsored trial to be conducted at the University of North Carolina (UNC),” Schelling continued. “And early next year, we expect to report top-line results from our ongoing Phase 2a clinical trial of ACER-801 for the treatment of moderate to severe Vasomotor Symptoms (VMS) in postmenopausal women.”

Q3 and Recent Highlights

Projected Milestones (Subject to Available Capital)

Q3 2022 Financial Results

Money Status. 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 that its cash and cash equivalents available as of September 30 are sufficient , 2022 to fund its current operating and projected capital. requirements into, but not through, the fourth quarter of 2022.

Research and Development Costs. Research and development expenses were $2.7 million, net of collaboration funding of $2.2 million, for the three months ended September 30, 2022, 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 clinical study costs related to ACER-801 and EDSIVO™, contract research, and employee-related costs, which were offset in part by reductions in costs associated with contract manufacturing. Research and development expenses related to ACER-001 decreased in the three months ending September 30, 2022, which resulted in a decrease in the recognition of collaboration funding from the Relief Cooperation Agreement. Research and development expenses for the three months ended September 30, 2022 consisted of $2.3 million related to ACER-001, offset by $2.2 million of collaboration funding; $1.2 million went to ACER-801; $1.0 million went 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, compared to $1.8 million, net of collaboration funding of $1.0 million, for the three months ended ended September 30, 2021. This increase of $0.8 million was primarily due to increases in employee-related costs, pre-commercial expenses, and audit and consulting fees, partially offset by an increase in the recognition of collaboration funding from Cooperation 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 ending 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 the Financial Statement
Acer completed the restatement of its previously issued financial statements for the fiscal quarter ended June 30, 2022 (Restrated Period), and filed an amended Quarterly Report on Form 10-Q/A for the Restated Period with the SEC. A non-monetary error was made when applying certain interpretive accounting guidance related to ASC 260, Earnings per Share, which affected the Company’s presentation of its calculation of diluted earnings per share. The correction of this non-cash error resulted in the restatement of Acer’s unaudited interim consolidated 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 Therapeutics
Acer is a pharmaceutical company focused on the discovery, 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 the treatment of various metabolic errors in the fetus, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS) and post-traumatic stress disorder (PTSD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed collagen type III (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against various 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 the purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release on face. -seek statements. Examples of such statements include, but are not limited to, statements regarding the adequacy and duration of our cash and cash equivalents, our projected milestones, and our plans for future clinical trials, the results and timing of tests for ACER 001, ACER 801 and EDSIVO™. Our pipeline products (including ACER-801) are investigational 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 be available commercial for the uses under investigation. We may not achieve the plans, fulfill the intentions or meet the expectations or projections expressed 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. funding as well as drug related risks. development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intention or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date they are 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 our Quarterly Reports on Form 10-Q. You can access these documents free of charge at http://www.sec.gov.

ACER THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Completed

September 30,

2022

2021

Operating costs:

Research and development (in the three months ending 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 ending 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:

Debt issue costs

(122,400

)

Changes in the 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

Other comprehensive 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 DETAILS (Unaudited):

September 30,

December 31,

2022

2021

Cash and cash equivalents

$

6,377,923

$

12,710,762

Cooperation available

$

$

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 contacts
Corporate contact:
Jim Denike
Acer Therapeutics Inc.
jdenike@acertx.com
+1-844-902-6100

Investor contact:
Nick Colangelo
The Gilmartin Group
nick@gilmartinIR.com
+1-332-895-3226

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