Sodium Benzoate

NEWTON, Mass., March 27, 2023 (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 Q4 and full year ended December 31, 2022, and provided an update on the Company’s recent corporate developments. “2022 marked Acer’s first U.S. Food and Drug Administration (FDA) product approval, for OLPRUVA™ (sodium phenylbutyrate), an innovative and responsibly priced treatment option for certain people with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS),” commented Chris Schelling, CEO and Founder of Acer. “We remain committed to our mission to provide transformative treatments to underserved and overlooked patients with rare and life-threatening diseases and will continue to focus our resources on launch preparation for OLPRUVA™ as well as continued pivotal Phase 3 clinical trial evaluation of EDSIVO™ for vEDS, both of which are subject to additional capital.” Q4 2022 and Recent Highlights OLPRUVA™ (sodium phenylbutyrate) for oral suspension In October 2022, Acer was issued a Notice of Allowance from the US Patent and Trademark Office (USPTO) for US patent application No. 16/624,834 (now issued as US Patent No. 11,517,547) for claims related to a kit comprising a combination therapeutic product composed of sodium phenylbutyrate or glycerol phenylbutyrate and sodium benzoateIn December 2022, Acer announced FDA approval of OLPRUVA™ (sodium phenylbutyrate) for oral suspension, a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with UCDs, involving deficiencies of CPS, OTC or AS. OLPRUVA™ is not used to treat rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment. More information is available at www.OLPRUVA.comIn March 2023, Acer announced an update on its OLPRUVA™ U.S. commercial launch activities, including the ongoing addition of commercial and medical affairs resources, the introduction of its OLPRUVA™ Navigator by Acer Therapeutics patient support service, a predictable and responsible price commitment, and anticipated drug availability by early July 2023 (subject to additional capital)In March 2023, Acer announced results from a survey designed to quantify preferences of healthcare providers for Urea Cycle Disorders (UCDs) presented at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting. The authors concluded that optimizing nitrogen-binding medications for UCD treatment to facilitate and encourage increased patient adherence through masking taste/odor and/or enhancing other aspects of the patient experience may support improved outcomes in UCDs EDSIVO™ (celiprolol) In October 2022, Acer announced that the USPTO issued a Notice of Allowance for Acer’s patent application No. 16/930,208 and subsequently issued on December 13, 2022, as US Patent #11,523,997, for claims related to certain methods of treating vascular Ehlers-Danlos syndrome (vEDS) with celiprolol ACER-801 (osanetant) In March 2023, Acer announced that topline results from Acer’s Phase 2a proof of concept clinical trial to evaluate ACER-801 (osanetant) as a potential treatment for moderate to severe Vasomotor Symptoms (VMS) associated with menopause showed that ACER-801 was safe and well-tolerated but did not achieve statistical significance when evaluating ACER-801’s ability, when compared to placebo, to decrease the frequency or severity of hot flashes in postmenopausal women. As a result, Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set Corporate Ended Q4 2022 with $2.3 million in cash and cash equivalents. Acer believes its cash and cash equivalents available at December 31, 2022, together with the gross proceeds of $7.0 million from a second term loan with SWK Funding LLC which closed on January 31, 2023, $4.1 million from Acer’s ATM facility subsequent to December 31, 2022, and $2.7 million from a sale of securities (including pursuant to a registered direct offering of shares of common stock and prefunded warrants) which closed on March 24, 2023, will be sufficient to fund Acer’s anticipated operating and capital requirements into the middle of Q2 2023 Anticipated Milestones (Subject to Available Capital) Q2 2023: Acer intends to continue to add resources to establish its commercial and medical affairs presence in the U.S. in support of its OLPRUVA™ launch expected in Q2 2023 Q2 2023: Negotiations with the major commercial payers and state Medicaid organizations regarding access for OLPRUVA™ are ongoing, and representatives from Acer’s OLPRUVA™ Navigator by Acer Therapeutics patient support service are expected to begin accepting prescriptions in late Q2 2023Q2 2023: Acer expects OLPRUVA™ wholesale acquisition cost (WAC) pricing to be listed publicly in Q2 2023Early July 2023: Acer anticipates OLPRUVA™ drug availability in early July 2023Q4 2023: Acer anticipates completing enrollment in its ongoing, pivotal Phase 3 DiSCOVER trial of EDSIVO™ (celiprolol) in patients with COL3A1-positive vEDS. The double-blind portion of the DiSCOVER trial is designed to end if statistical significance is reached at an interim analysis which occurs at accrual of 28 vEDS-related events, estimated to occur as early as approximately 18 months after completion of full enrollment, or after accrual of 46 vEDS-related clinical eventsAcer intends to explore additional lifecycle opportunities for OLPRUVA™ (sodium phenylbutyrate) in various disorders where proof of concept data exists, including in Maple Syrup Urine Disease (MSUD), Pyruvate Dehydrogenase Complex Deficiency (PCDC), rare pediatric epilepsies and various liver disorders Q4 and Full Year 2022 Financial Results Cash Position. Cash and cash equivalents were $2.3 million as of December 31, 2022, compared to $12.7 million as of December 31, 2021. Acer believes its cash and cash equivalents as of December 31, 2022, together with the gross proceeds of $7.0 million from a second term loan with SWK Funding LLC which closed on January 31, 2023, $4.1 million from Acer’s ATM facility subsequent to December 31, 2022, and $2.7 million from a sale of securities (including pursuant to a registered direct offering of shares of common stock and prefunded warrants) which closed on March 24, 2023, will be sufficient to fund its currently anticipated operating and capital requirements into the middle of Q2 2023. Research and Development Expenses. Research and development expenses were $2.6 million, net of collaboration funding of $1.0 million, for the three months ended December 31, 2022, as compared to $1.7 million, net of collaboration funding of $1.3 million, for the three months ended December 31, 2021. Research and development expenses for the three months ended December 31, 2022 were comprised of $1.1 million related to ACER-001, offset by $1.0 million of collaboration funding; $1.2 million related to ACER-801; $1.0 million related to EDSIVO™; and $0.3 million related to other development activities. Research and development expenses were $11.9 million, net of collaboration funding of $7.8 million, for the year ended December 31, 2022, as compared to $6.5 million, net of collaboration funding of $6.1 million, for the year ended December 31, 2021. This increase of $5.4 million was primarily due to increases in employee-related expenses and expenses related to clinical studies, partially offset by the increase in recognition of contra-expense from the collaboration funding from Acer’s Collaboration and License Agreement with Relief Therapeutics Holding AG (Relief) for the development and commercialization of OLPRUVA™ (Collaboration Agreement). General and Administrative Expenses. General and administrative expenses were $2.6 million, net of collaboration funding of $1.2 million, for the three months ended December 31, 2022, as compared to $3.1 million, net of collaboration funding of $1.6 million, for the three months ended December 31, 2021. General and administrative expenses were $12.7 million, net of collaboration funding of $8.2 million, for the year ended December 31, 2022, as compared to $10.7 million, net of collaboration funding of $3.2 million, for the year ended December 31, 2021. This increase of $2.0 million was primarily due to increases in precommercial activities, employee-related expenses, professional services, as well as information technology, partially offset by the increase in the recognition of contra-expense from the collaboration funding from the Collaboration Agreement with Relief. Net Loss. Net loss for the three months ended December 31, 2022 was $9.4 million, or $0.54 net loss per share (basic and diluted), compared to a net loss of $4.4 million, or $0.31 net loss per share (basic and diluted), for the three months ended December 31, 2021. Net loss for the year ended December 31, 2022 was $26.2 million, or $1.66 net loss per share (basic and diluted), compared to a net loss of $15.4 million, or $1.08 net loss per share (basic and diluted), for the year ended December 31, 2021. For additional information, please see Acer’s Annual Report on Form 10-K filed today with the SEC. 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. In the U.S., OLPRUVA™ (sodium phenylbutyrate) is approved for the treatment of urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). Acer is also advancing a pipeline of investigational product candidates for rare and life-threatening diseases, including: OLPRUVA™ (sodium phenylbutyrate) for treatment of various disorders, including Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-801 (osanetant) for treatment of Vasomotor Symptoms (VMS), post-traumatic stress disorder (PTSD) and prostate cancer. 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 about plans for the commercialization of OLPRUVA™ for oral suspension in the U.S. for the treatment of certain patients with UCDs involving deficiencies of CPS, OTC, or AS, including negotiations with commercial payers and Medicaid organizations regarding access as well as the timing of drug availability and the expected commercial launch, statements about plans and potential milestones for the continued clinical development of OLPRUVA™ in other indications, statements about plans and potential milestones for the continued clinical development of EDSIVO™ for treatment of vEDS in patients with a confirmed type III collagen (COL3A1) mutation, statements about plans for the development of ACER-801, statements about our anticipated 2023 milestones, and statements about our capital requirements and sufficiency and duration of our current cash and cash equivalents. Our efforts to commercialize OLPRUVA™ for oral suspension in the U.S. for the treatment of certain patients with UCDs involving deficiencies of CPS, OTC, or AS are at an early stage, we currently do not have fully developed marketing, sales or distribution capabilities, and there is no guarantee that we will be successful in our commercialization efforts. Our pipeline products (including OLPRUVA™ for indications other than UCDs as well as EDSIVO™ and 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 commercialization efforts, our pipeline product development programs and our 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 Three Months Ended Years Ended December 31, December 31, 2022 2021 2022 2021 (unaudited) Revenue$— $360,000 $— $1,260,000 Operating expenses: Research and development (in the three months ended December 31, 2022 and 2021, net of collaboration funding of $999,183 and $1,288,376, respectively, and in the twelve months ended December 31, 2022 and 2021, net of collaboration funding of $7,825,263 and $6,055,295, respectively)$2,644,745 $1,705,402 $11,924,837 $6,508,055 General and administrative development (in the three months ended December 31, 2022 and 2021, net of collaboration funding of $1,186,048 and $1,636,535, respectively, and in the twelve months ended December 31, 2022 and 2021, net of collaboration funding of $8,248,813 and $3,197,659, respectively) 2,618,378 3,074,325 12,689,422 10,700,334 Total operating expenses 5,263,123 4,779,727 24,614,259 17,208,389 Loss from operations (5,263,123) (4,419,727) (24,614,259) (15,948,389) Other (expense) income, net: Costs of debt issuance (229,500) — (1,720,094) — Changes in fair value of debt instruments (loss) gain (3,846,472) — 245,138 — Interest and other income (expense), net 21,209 (2,641) (101,432) 519,639 Foreign currency transaction (loss) gain (66,444) 1,725 (46,668) 54,757 Total other (expense) income, net (4,121,207) (916) (1,623,056) 574,396 Net loss$(9,384,330) $(4,420,643) $(26,237,315) $(15,373,993) Net loss per share - basic$(0.54) $(0.31) $(1.66) $(1.08) Weighted average common shares outstanding - basic 17,359,964 14,310,244 15,767,152 14,268,245 Net loss per share - diluted$(0.54) $(0.31) $(1.66) $(1.08) Weighted average common shares outstanding - diluted 17,359,964 14,310,244 15,767,152 14,268,245 SELECTED BALANCE SHEET DATA: December 31, December 31, 2022 2021 Cash and cash equivalents $2,329,218 $12,710,762 Collaboration receivable $— $5,000,000 Prepaid expenses $759,292 $1,094,229 Deferred financing costs $408,000 $— Other current assets $20,188 $9,283,625 Property and equipment, net $214,578 $114,112 Total assets $11,624,226 $36,256,951 Deferred collaboration funding $8,412,971 $24,487,047 Original Term Loan payable, at fair value $5,567,231 $— Convertible note payable, at fair value $6,047,532 $— Total liabilities $28,385,498 $37,980,556 Total stockholders’ deficit $(16,761,272) $(1,723,605) Corporate and IR Contact Jim DeNikeAcer Therapeutics Inc.jdenike@acertx.com+1-844-902-6100 Nick ColangeloGilmartin Groupnick@gilmartinIR.com+1-332-895-3226

NEWTON, Mass., Nov. 14, 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 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, 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 ACER-001 (sodium phenylbutyrate) In July 2022, Acer resubmitted its NDA for ACER-001 to the FDA following receipt of a CRL in June 2022, in which the FDA stated that satisfactory inspection of Acer’s third-party contract packaging manufacturer is required before the ACER-001 NDA may be approvedIn July 2022, the FDA accepted Acer’s NDA resubmission (Class 2) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2023In July 2022, the China National Intellectual Property Administration (CNIPA) issued a utility model patent for ACER-001 covering certain dosage form claims related to ACER-001’s polymer-coated formulation, with an expiration date of August 24, 2031In July 2022, Acer submitted its IND application to the FDA, which is now in effect, for the investigation of ACER-001 in a Phase 2a, open-label dose-ranging efficacy clinical trial that would evaluate the treatment effect of different doses of ACER-001 on blood leucine and other branched-chain amino acid (BCAA) levels in MSUD patients (initiation of this trial is subject to additional capital)In August 2022, the European Commission granted orphan medicinal product designation in the EU to ACER-001 for the potential treatment of MSUDIn October 2022, Acer received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for US patent application No. 16/624,834 for claims related to a kit comprising sodium phenylbutyrate or glycerol phenylbutyrate and sodium benzoate ACER-801 (osanetant) In October 2022, Acer announced expansion of its ACER-801 (osanetant) program into PTSD, an indication that affects over 12 million adults in the US alone. The worldwide exclusive rights, related patents and patent applications, were licensed from Emory University based on preclinical data in which osanetant was able to block fear memory consolidation in miceIn October 2022, the Department of Defense (DoD) awarded a $3 million grant to the UNC Institute for Trauma Recovery to support a proposed 180-patient, randomized, placebo-controlled trial evaluating osanetant in trauma patients EDSIVO™ (celiprolol) In October 2022, Acer announced the USPTO issued a Notice of Allowance for Acer’s patent application No. 16/930,208 for claims related to certain methods of treating vEDS with celiprolol Corporate Ended Q3 2022 with $6.4 million in cash and cash equivalents, which Acer believes will be sufficient to fund its currently anticipated operating and capital requirements into, but not through, the fourth quarter of 2022 Anticipated Milestones (Subject to Available Capital) ACER-001 (sodium phenylbutyrate) January 15, 2023: The FDA has assigned a new PDUFA target action date of January 15, 2023, on the pending NDA, following the FDA’s acceptance for review of Acer’s resubmitted NDA for ACER-001 for the treatment of patients with UCDs2023: Acer plans to initiate in 2023 its Phase 2a trial to evaluate the efficacy and safety of ACER-001 for the potential treatment of patients with MSUD ACER-801 (osanetant) Q1 2023: Acer expects to announce topline results in Q1 2023 from its ongoing Phase 2a randomized, double-blind, placebo-controlled, dose-ranging trial of ACER-801 for the treatment of moderate to severe VMS in post-menopausal womenH1 2023: UNC expects to initiate in H1 2023 the proposed investigator-sponsored trial (OASIS) to evaluate the potential for ACER-801 to reduce the frequency and severity of PTSD EDSIVO™ (celiprolol) Q4 2023: Acer anticipates the DiSCOVER trial for celiprolol in patients with COL3A1-positive vEDS will be fully enrolled in Q4 2023. Once fully enrolled, the duration of the DiSCOVER trial is currently estimated to be up to approximately 3.5 years to completion (based on statistical power calculations and number of primary events). One interim analysis (based on the number of primary events occurring) is also planned at approximately 24 months after full enrollment 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