1. NEWTON, Mass., March 29, 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 announced that Acer's management team will present and host one-on-one investor meetings at the upcoming 20th Annual Needham Virtual Healthcare Conference April 12-15, 2021.

    Conference: 20th Annual Needham Virtual Healthcare Conference
    Format: Virtual presentation and one-on-one meetings
    Presentation: April 15, 2021
    Time: 11 a.m. Eastern Time
    Webcast: https://acertx.com/investor-relations/events-presentations/

    About Acer Therapeutics Inc.
    Acer is a pharmaceutical company…

    NEWTON, Mass., March 29, 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 announced that Acer's management team will present and host one-on-one investor meetings at the upcoming 20th Annual Needham Virtual Healthcare Conference April 12-15, 2021.

    Conference: 20th Annual Needham Virtual Healthcare Conference
    Format: Virtual presentation and one-on-one meetings
    Presentation: April 15, 2021
    Time: 11 a.m. Eastern Time
    Webcast: https://acertx.com/investor-relations/events-presentations/

    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 the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); 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 U.S. FDA. On March 19, 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for worldwide development and commercialization of ACER-001. For more information, visit www.acertx.com.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100



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  2. Relief to potentially pay Acer up to $36 million and royalties in exchange for net profit share and territory rights

    ACER-001 pre-NDA meeting with U.S. FDA scheduled in Q2 2021

    GENEVA and NEWTON, Mass., March 22, 2021 (GLOBE NEWSWIRE) -- RELIEF THERAPEUTICS Holding AG ((SIX: RLF, OTCQB:RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100™ (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (NASDAQ:ACER)("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 announced that the companies entered into a Collaboration and…

    Relief to potentially pay Acer up to $36 million and royalties in exchange for net profit share and territory rights

    ACER-001 pre-NDA meeting with U.S. FDA scheduled in Q2 2021

    GENEVA and NEWTON, Mass., March 22, 2021 (GLOBE NEWSWIRE) -- RELIEF THERAPEUTICS Holding AG ((SIX: RLF, OTCQB:RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100™ (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (NASDAQ:ACER)("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 announced that the companies entered into a Collaboration and License Agreement ("CLA") for worldwide development and commercialization of ACER-001. ACER-001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB) designed to be both taste-masked and immediate release.

    Under the terms of the CLA, Acer will receive an approximately $10 million cash payment within 15 business days of CLA execution (originally $14 million, to be offset by repayment of the $4.0 million outstanding balance of the prior loan, plus interest, from Relief to Acer). Relief will also pay Acer up to $20 million in U.S. development and commercial launch costs for the UCDs and MSUD indications. Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey, and Japan. The companies will split net profits from Acer's territories 60%:40% in favor of Relief. In addition, Relief has licensed the rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all revenues received in Relief's territories. Acer may also receive a total of $6 million in development milestone payments following the first European (EU) marketing approvals for UCDs and MSUD.

    Jack Weinstein, Chief Financial Officer and Treasurer of Relief, said, "We are excited to continue moving forward with the Acer team to develop and commercialize ACER-001 around the globe to address important unmet needs for patients suffering from these rare diseases. This collaboration is an important step in Relief's plan to build a diversified late-stage pipeline beyond our lead candidate, RLF-100™, which is currently in development for the treatment of respiratory illnesses due to COVID-19 infection. We are pleased to have been able to conclude this agreement, as the advanced stage of development and market opportunity with ACER-001 make this compound a perfect fit for Relief's strategy."

    Chris Schelling, Acer's CEO and Founder, said, "Our collaboration with Relief will provide important resources and additional expertise to advance the development of ACER-001 toward our goal of bringing this product candidate to patients suffering from UCDs and MSUD. We look forward to partnering with the team at Relief to advance this program and to potentially provide a much-needed treatment option for patients with these rare and debilitating diseases."

    An ACER-001 pre-NDA meeting with the U.S. FDA is scheduled to occur in the second quarter of 2021. Acer expects to receive official meeting minutes approximately 30 days after the meeting.

    ACER-001 is an investigational product being studied for the treatment of patients with UCDs and MSUD and has not been approved by the U.S. FDA or any regulatory agency outside the U.S. for any indication. There can be no assurance that if submitted, a New Drug Application or equivalent will be accepted by the U.S. FDA or any other regulatory agency for filing and review or, if filed, that it will be approved.

    About Urea Cycle Disorders (UCDs)

    UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

    Current medical treatments for UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.3

    About Maple Syrup Urine Disease (MSUD)

    MSUD is a rare inherited disorder caused by defects in the mitochondrial branched-chain ketoacid dehydrogenase complex, which results in elevated blood levels of the branched-chain amino acids (BCAA), leucine, valine, and isoleucine, as well as the associated branched-chain ketoacids (BCKA) in a patient's blood. Left untreated, this can result in neurological damage, mental disability, coma or death. There are currently no approved pharmacologic therapies in the U.S. or the European Union for MSUD. Treatment of MSUD consists primarily of a severely restricted diet to limit the intake of BCAA, with aggressive medical interventions when blood-levels of BCAA or BCKA become elevated.

    About ACER-001

    ACER-001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB). The formulation is designed to be both taste-masked and immediate release. ACER-001 is being developed using a microencapsulation process for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach, to avoid a bitter taste while still allowing for rapid systemic release. If ACER-001 is approved, its taste-masked properties could make it a compelling alternative to existing NaPB-based treatments, as the unpleasant taste associated with NaPB is cited as a major impediment to patient compliance with those treatments.3 Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product candidate will receive U.S. FDA approval or become commercially available for the uses being investigated.

    About RELIEF THERAPEUTICS Holding AG

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, In March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease.

    RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

    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 the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); 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 U.S. FDA. On March 19, 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for worldwide development and commercialization of ACER-001. For more information, visit www.acertx.com.

    References

    1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
    3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    Relief Forward-Looking Statements

    This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the ongoing clinical trials of Relief's lead compound, RLF-100™ (aviptadil) in advanced clinical development to treat respiratory deficiency due to COVID-19, will be successful. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the benefits and results of the Collaboration and License Agreement between Acer and Relief with respect to ACER-001; the potential for ACER-001 to target diseases; the adequacy of Acer's capital to support its future operations and its ability to successfully continue its development programs; Acer's ability to secure the additional capital necessary to fund its various product candidate development programs; and the development and commercial potential of any of Acer's product candidates including ACER-001. Acer 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 and uncertainties associated with Acer's ability to benefit from and achieve the results contemplated by the Collaboration and License Agreement with Relief, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund Acer's various product candidate development programs and to meet its business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Acer's intellectual property, risks related to the drug discovery and the regulatory approval process and the impact of competitive products and technological changes. Acer disclaims 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 Acer makes in its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and its Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    CORPORATE CONTACTS

    RELIEF THERAPEUTICS Holding AG:

    Jack Weinstein

    Chief Financial Officer and Treasurer

    ACER Therapeutics:

    Jim DeNike

    Acer Therapeutics Inc.

    +1 844-902-6100

    MEDIA CONTACTS

    Relief (Europe):

    Anne Hennecke / Brittney Sojeva

    MC Services AG



    +49 (0) 211-529-252-14

    INVESTOR RELATIONS CONTACTS

    Relief (Europe):

    Anne Hennecke / Brittney Sojeva

    MC Services AG



    +49 (0) 211-529-252-14

    Acer Therapeutics:

    Hans Vitzthum

    LifeSci Advisors

    +1 617-430-7578



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  3. NEWTON, Mass., March 01, 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 fourth quarter and full year ended December 31, 2020 and provided an update on the Company's recent corporate developments.

    "In spite of the challenges presented by a global pandemic in 2020, we continued to advance our existing programs while expanding our pipeline," said Chris Schelling, CEO and Founder of Acer. "As a result, we anticipate a number of key milestones next quarter, including a proposed ACER-001 pre-NDA meeting with…

    NEWTON, Mass., March 01, 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 fourth quarter and full year ended December 31, 2020 and provided an update on the Company's recent corporate developments.

    "In spite of the challenges presented by a global pandemic in 2020, we continued to advance our existing programs while expanding our pipeline," said Chris Schelling, CEO and Founder of Acer. "As a result, we anticipate a number of key milestones next quarter, including a proposed ACER-001 pre-NDA meeting with FDA, continuing to work toward a potential ACER-001 collaboration and license agreement with Relief Therapeutics pursuant to the existing option agreement between the companies, and a Type B meeting with the FDA to discuss a possible path forward for EDSIVO™. We are also working toward initiation of a Phase 2 clinical trial of osanetant in BRCA-positive patients with induced vasomotor symptoms in the fourth quarter of 2021, subject to successful IND filing and additional capital, and continuing to seek non-dilutive capital to advance emetine development."

    Fourth Quarter 2020 and Recent Highlights

    • ACER-001
      • Signed an Option Agreement with Relief Therapeutics Holding AG on January 25, 2021 providing Relief with exclusivity until June 30, 2021 for the right to pursue a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. In return, Acer received a $1.0 million upfront nonrefundable payment and a $4.0 million secured loan from Relief
      • Announced in February 2021 topline results from Acer's bioequivalence trial in which ACER-001 showed similar relative bioavailability compared to BUPHENYL® (sodium phenylbutyrate) under fed conditions



    • EDSIVO™ (celiprolol)
      • Announced in December 2020 publication by Swedish investigators of additional long-term data from COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS) patients in the European Journal of Vascular and Endovascular Surgery entitled "Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome" (https://www.ejves.com/action/showPdf?pii=S1078-5884%2820%2930930-8)

      • Submitted a Type B meeting request to the FDA in February 2021 to discuss Acer's proposed plan to collect additional data and provide confirmatory evidence in support of celiprolol's potential benefit in treating COL3A1-positive vEDS patients



    • ACER-801 (osanetant)
      • Completed active pharmaceutical ingredient (API) manufacturing and advanced other development activities to support an Investigational New Drug Application (IND) submission



    • Corporate
      • Promoted Jefferson Davis to Chief Business Officer in February 2021. A veteran life science executive and transaction specialist with over 25 years of experience in business and corporate development, Mr. Davis has led or supported over 40 transactions with an aggregate value of more than $2 billion across all major therapeutic platforms, including antibodies, small molecules, aptamers, gene therapy, vaccines, and proteins

      • Ended the fourth quarter with $5.8 million in cash and cash equivalents. Acer believes its cash position as of December 31, 2020, combined with an additional $3.2 million of net proceeds subsequently received from the sales of common stock under its ATM facility and through its equity line purchase agreement with Lincoln Park Capital, along with the $1.0 million nonrefundable payment and $4.0 million secured loan received from Relief Therapeutics following the signing of the ACER-001 Option Agreement, will be sufficient to fund its operations into the third quarter of 2021

    Upcoming Milestones

    • ACER-001
      • Q2 2021: Targeting a pre-New Drug Application (NDA) meeting with the FDA in the second quarter of 2021, assuming successful completion of the ongoing development activities

      • Mid-2021: ACER-001 NDA submission for treatment of patients with Urea Cycle Disorders (UCDs) is anticipated in mid-2021, provided that no additional data is requested by the FDA during Acer's pre-NDA meeting and ongoing development activities are successfully completed (including evaluation of long-term product stability data)



    • EDSIVO™
      • Q2 2021: Obtain FDA feedback from a Type B meeting in the second quarter of 2021 regarding Acer's proposed plan to collect additional data which, if discussions are successful and the collected data is sufficient, could potentially satisfy the substantial evidence of effectiveness needed to support a resubmission of the EDSIVO™ NDA (although neither EDSIVO™ NDA resubmission nor approval is assured)
    • ACER-801 (osanetant)
      • Q3 2021: IND submission for osanetant is anticipated in the third quarter of 2021

      • Q4 2021: Initiation of a Phase 2 clinical trial of osanetant in BRCA-positive patients who have undergone a prophylactic bilateral salpingo-oophorectomy (PBSO) is expected in the fourth quarter of 2021, dependent upon successful IND filing and subject to additional capital



    • ACER-2820 (emetine)
      • Ongoing: Further advancement of the emetine program for infectious diseases, including COVID-19, is dependent on Acer's ability to raise non-dilutive capital

      • Ongoing: The Company believes that most of the emetine IND-enabling work is in progress or complete, and intends to minimize future emetine spending as it continues to work with federal agencies and private research organizations toward the goal of securing non-dilutive funding

    Financial Results for the Fourth Quarter and Full Year 2020

    Cash position. Cash and cash equivalents were $5.8 million as of December 31, 2020, compared to $12.1 million as of December 31, 2019. Acer believes its cash and cash equivalents available as of December 31, 2020, combined with an additional $3.2 million of net proceeds subsequently received from the sales of common stock under its ATM facility and through its equity line purchase agreement with Lincoln Park Capital, along with the $1.0 million nonrefundable payment and $4.0 million secured loan received from Relief Therapeutics following the signing of the ACER-001 Option Agreement, will be sufficient to fund its operations into the third quarter of 2021.

    Research and Development Expenses. Research and development expenses were $3.5 million for the three months ended December 31, 2020, compared to $2.8 million for the three months ended December 31, 2019. Research and development expenses for the three months ended December 31, 2020 were comprised of $1.3 million related to ACER-001, $1.5 million related to emetine, $0.6 million related to osanetant, and $0.1 million related to EDSIVO™. Research and development expenses were $11.8 million for the year ended December 31, 2020, compared to $13.9 million for the year ended December 31, 2019. This decrease of approximately $2.1 million was primarily due to decreases in employee-related expense and in spending related to clinical and other consulting services, partially offset by an increase in contract research expenses.

    General and Administrative Expenses. General and administrative expenses were $2.7 million for the three months ended December 31, 2020, compared to $2.4 million for the three months ended December 31, 2019. General and administrative expenses were $11.0 million for the year ended December 31, 2020, compared to $16.0 million for the year ended December 31, 2019. This decrease of $5.0 million was primarily due to decreases in employee-related expenses and precommercial activities expenses, partially offset by an increase in legal expenses. This decrease in employee-related expenses resulted from a decrease in headcount as a consequence of the restructuring initiative undertaken after receipt of the Complete Response Letter from the FDA for EDSIVO™ in June 2019.

    Net Loss. Net loss for the three months ended December 31, 2020 was $6.2 million, or $0.50 net loss per share (basic and diluted), compared to a net loss of $5.2 million, or $0.51 net loss per share (basic and diluted), for the three months ended December 31, 2019. Net loss for the year ended December 31, 2020 was $22.9 million, or $2.06 loss per share (basic and diluted), compared to a net loss of $29.4 million, or $2.91 loss per share (basic and diluted), for the year ended December 31, 2019.

    For additional information, please see Acer's Annual Report on Form 10-K 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 programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); 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. For more information, visit www.acertx.com.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100



    ACER THERAPEUTICS INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

     Three Months Ended  Years Ended 
     December 31,  December 31, 
     2020  2019  2020  2019 
               
      (unaudited)        
    Operating expenses:              
    Research and development$3,481,200  $2,829,767  $11,847,902  $13,851,018 
    General and administrative 2,691,246   2,362,572   10,954,923   16,046,423 
    Loss from operations (6,172,446)  (5,192,339)  (22,802,825)  (29,897,441)
                   
    Other (expense) income, net:              
    Interest and other (expense) income, net (4,095)  50,919   13,578   471,267 
    Foreign currency transaction (loss)/gain (61,143)  (14,864)  (96,202)  8,205 
    Total other (expense) income, net (65,238)  36,055   (82,624)  479,472 
                   
    Net loss$(6,237,684) $(5,156,284) $(22,885,449) $(29,417,969)
                   
    Net loss per share - basic and diluted$(0.50) $(0.51) $(2.06) $(2.91)
                   
    Weighted average common shares outstanding - basic and diluted 12,487,688   10,095,176   11,121,039   10,092,179 



    SELECTED BALANCE SHEET DATA: 

      December 31,  December 31, 
      2020  2019 
             
    Cash and cash equivalents $5,761,568  $12,077,640 
             
    Prepaid expenses and other current assets $679,461  $807,356 
             
    Property and equipment, net $130,081  $193,974 
             
    Total assets $14,613,688  $21,465,511 
             
    Total liabilities $6,389,354  $3,095,195 
             
    Total stockholders' equity $8,224,334  $18,370,316 


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  4. NEWTON, Mass., March 01, 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 announced that Acer's management team will present and host one-on-one investor meetings at the upcoming H.C. Wainwright Global Life Sciences Virtual Conference and the 33rd Annual Roth Virtual Conference.

    Conference:H.C. Wainwright Global Life Sciences Virtual Conference
    Dates:March 9-10, 2021
    Format:One-on-one virtual meetings
      
    Conference:33rd Annual Roth Virtual Conference
    Format:Panel Presentation and one-on-one virtual meetings
    Panel:Therapeutics Against SARS-CoV-2

    NEWTON, Mass., March 01, 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 announced that Acer's management team will present and host one-on-one investor meetings at the upcoming H.C. Wainwright Global Life Sciences Virtual Conference and the 33rd Annual Roth Virtual Conference.

    Conference:H.C. Wainwright Global Life Sciences Virtual Conference
    Dates:March 9-10, 2021
    Format:One-on-one virtual meetings
      
    Conference:33rd Annual Roth Virtual Conference
    Format:Panel Presentation and one-on-one virtual meetings
    Panel:Therapeutics Against SARS-CoV-2
    Date:Monday, March 15, 2021
    Time:12 p.m. Eastern Time
    Webcast:https://acertx.com/investor-relations/events-presentations/

    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 the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); 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. For more information, visit www.acertx.com.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100



    Primary Logo

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  5. NEWTON, Mass., Feb. 11, 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 announced topline results from its bioequivalence trial in which ACER-001 showed similar relative bioavailability compared to BUPHENYL® (sodium phenylbutyrate) under fed conditions. ACER-001 powder is a proprietary, taste-masked, immediate release formulation of sodium phenylbutyrate (NaPB) in development for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).

    The single-center, single-blind…

    NEWTON, Mass., Feb. 11, 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 announced topline results from its bioequivalence trial in which ACER-001 showed similar relative bioavailability compared to BUPHENYL® (sodium phenylbutyrate) under fed conditions. ACER-001 powder is a proprietary, taste-masked, immediate release formulation of sodium phenylbutyrate (NaPB) in development for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).

    The single-center, single-blind, randomized, single-dose crossover trial evaluated bioequivalence (BE) of ACER-001 compared to BUPHENYL® when administered under fed conditions in 36 healthy adults. The topline data from this trial showed ACER-001 to have similar pharmacokinetic (PK) profiles for both phenylbutyrate (PBA) and phenylacetate (PAA) compared to BUPHENYL® under fed conditions. Acer is initially developing ACER-001 for the treatment of patients with UCDs under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, which provides a potentially streamlined path for sponsors that have developed drug products that rely upon data from drug products previously approved by the FDA.

    "With topline data now in hand, we are moving forward with our plans to conduct a pre-NDA meeting with the FDA in the second quarter of 2021, assuming successful and timely completion of the ongoing development activities, including evaluation of long-term product stability data," said Chris Schelling, CEO and Founder of Acer. "Assuming no additional data is requested by the Agency during our pre-NDA meeting, we will plan to submit an NDA for ACER-001 for the treatment of UCDs in mid-2021. If ACER-001 is approved by the FDA, we believe its unique formulation will provide clinicians with an alternative to existing sodium phenylbutyrate-based treatments."

    ACER-001 is an investigational product being studied for the treatment of patients with UCDs and MSUD and has not been approved by FDA for any indication. There can be no assurance that if submitted, a New Drug Application will be accepted by the FDA for filing and review or, if filed, that it will be approved.

    About UCDs

    UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

    Current medications for UCDs include nitrogen scavengers RAVICTI® and BUPHENYL® in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.3

    About ACER-001

    ACER-001 is a powder formulation of sodium phenylbutyrate (NaPB). The proprietary formulation is designed to be both taste-masked and immediate release. ACER-001 is being developed using a microencapsulation process for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. We believe that if ACER-001 is approved, its taste-masked properties will make it a viable alternative to existing NaPB-based treatments, as the unpleasant taste associated with NaPB is cited as a major impediment to patient compliance with those treatments.3 Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product candidate will receive FDA approval or become commercially available for the uses being investigated.

    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 the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); 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. For more information, visit www.acertx.com.

    References

    1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
    3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100



    Primary Logo

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  6. Acer to receive $1 million payment to obtain exclusivity and a $4 million loan from Relief

    Companies working toward negotiation and execution of a definitive collaboration and license agreement by June 30, 2021

    GENEVA, SWITZERLAND, and NEWTON, MA / ACCESSWIRE / January 25, 2021 / RELIEF THERAPEUTICS Holding AG ((SIX:RLF, OTCQB:RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (NASDAQ:ACER)("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 announced that the companies…

    Acer to receive $1 million payment to obtain exclusivity and a $4 million loan from Relief

    Companies working toward negotiation and execution of a definitive collaboration and license agreement by June 30, 2021

    GENEVA, SWITZERLAND, and NEWTON, MA / ACCESSWIRE / January 25, 2021 / RELIEF THERAPEUTICS Holding AG ((SIX:RLF, OTCQB:RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (NASDAQ:ACER)("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 announced that the companies have signed an Option Agreement providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. ACER-001 (sodium phenylbutyrate) powder is a taste-masked, immediate release proprietary formulation in development for the treatment of urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).

    Under the terms of the Option Agreement, Acer will receive from Relief a $1 million non-refundable payment in return for exclusivity until June 30, 2021 to negotiate and enter into a definitive collaboration and license agreement between Acer and Relief for the development of ACER-001. Further, in connection with entering into the Option Agreement, Relief will make a $4.0 million loan to Acer. The loan, which will be secured by a lien on all of Acer's assets, will bear interest at the rate of 6% per annum and will be due in one year.

    Under the terms of the proposed collaboration and license agreement, the key terms of which are set forth in the Option Agreement, if a definitive agreement is executed pursuant to these terms and closed by June 30, 2021, Acer will receive $15 million in cash (net $10 million, inclusive of the $1 million payment and offset by a repayment of the $4 million loan from Relief). In addition, Relief will agree to pay up to $20 million in U.S. development and commercial launch costs for the UCDs and MSUD indications. Further, Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer's territories 60:40 in favor of Relief. Relief will also license the rights for the rest of the world, where Acer will receive from Relief a 15% net sales royalty on all revenues received in Relief's territories. Acer could also receive a total of $6 million in milestones based on the first European (EU) marketing approvals for UCDs and MSUD. There can be no assurance, however, that a definitive agreement will be successfully negotiated and executed between the parties on these terms, on other mutually acceptable terms, or at all. Except for the $1.0 million upfront payment to Acer and the $4.0 million one-year secured loan from Relief to Acer, the remaining proposed terms of the collaboration are not binding and are subject to change as a result of further diligence by Relief and negotiation of a definitive collaboration and license agreement between the parties.

    Jack Weinstein, Relief's CFO and Treasurer, said, "We are excited about the opportunity to work with the Acer team to potentially develop and commercialize ACER-001 worldwide. This partnership is Relief's first initiative to build a pipeline of drugs beyond RLF-100(TM). While our core focus remains squarely on the rapid advancement of RLF-100(TM) for treatment of respiratory conditions, primarily acute respiratory distress syndrome (ARDS) due to COVID-19 infection, we are committed to establishing a diversified marketed product portfolio. ACER-001's stage of maturity fits perfectly within our strategic plan."

    Chris Schelling, Acer's CEO and Founder, said, "I believe Relief shares the same values and vision that Acer has in supporting the rare disease community. This potential collaboration could provide important resources and additional expertise to help bring ACER-001 to patients worldwide suffering from debilitating diseases like UCDs and MSUD. We very much look forward to the possibility of working with the Relief team."

    ###

    ABOUT UREA CYCLE DISORDERS (UCDS)
    Urea Cycle Disorders (UCDs) are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

    Current medical treatments for UCDs include nitrogen scavengers RAVICTI(R) and BUPHENYL(R) in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.2

    ABOUT MAPLE SYRUP URINE DISEASE
    Maple Syrup Urine Disease (MUSD) is a rare but serious inherited condition whereby the human body cannot process certain amino acids, causing a harmful build-up of substances in the blood and urine. The human body breaks down protein foods such as meat and fish into amino acids. Other than a highly restricted diet of branched-chain amino acid (BCCA) free synthetic foods and formula, there are no currently approved treatments for MSUD.

    ABOUT ACER-001
    ACER-001 is a powder formulation of sodium phenylbutyrate (NaPB). The formulation is designed to be both taste-masked and immediate release. ACER-001 is being developed using a microencapsulation process for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. If ACER-001 is approved, its taste-masked properties could make it a compelling alternative to existing NaPB-based treatments, as the unpleasant taste associated with NaPB is cited as a major impediment to patient compliance with those treatments.3 Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product candidate will receive FDA approval or become commercially available for the uses being investigated.

    ABOUT RELIEF THERAPEUTICS HOLDING AG
    Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100TM (aviptadil) is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Relief holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM.

    RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit: www.relieftherapeutics.com.

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    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 the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO(TM) (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); 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. For more information, visit www.acertx.com.

    REFERENCES

    1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
    3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    RELIEF FORWARD-LOOKING STATEMENTS
    This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, Inc. and its businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the ongoing clinical trials of Relief's lead compound, RLF-100(TM) (aviptadil) in advanced clinical development to treat severe COVID-19 patients, will be successful. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the structure, terms, timing and entry into a definitive agreement for the proposed collaboration between Acer and Relief with respect to ACER-001; the shared values, vision and results of the potential collaboration of Acer and Relief; the potential for ACER-001 to target diseases; the adequacy of Acer's capital to support its future operations and its ability to successfully continue its development programs; Acer's ability to secure the additional capital necessary to fund its various product candidate development programs; and the development and commercial potential of any of Acer's product candidates including ACER-001. Acer 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 and uncertainties associated with Acer's ability to successfully negotiate and execute a definitive collaboration agreement with Relief on the proposed terms, on other mutually acceptable terms, or at all, Acer's ability to repay the $4 million secured loan from Relief, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund Acer's various product candidate development programs and to meet its business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Acer's intellectual property, risks related to the drug discovery and the regulatory approval process and the impact of competitive products and technological changes. Acer disclaims 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 Acer makes in its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and its Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    CORPORATE CONTACTS

    RELIEF THERAPEUTICS Holding AG:

    Jack Weinstein
    Chief Financial Officer and Treasurer


    ACER Therapeutics:
    Jim DeNike
    Acer Therapeutics Inc.
    +1 844-902-6100
    jdenik
    MEDIA CONTACTS
    Relief (Europe):

    Anne Hennecke / Brittney Sojeva
    MC Services AG

    +49 (0) 211-529-252-14
    INVESTOR RELATIONS CONTACTS

    Relief (Europe):
    Anne Hennecke / Brittney Sojeva
    MC Services AG

    +49 (0) 211-529-252-14


    Acer Therapeutics:
    Hans Vitzthum
    LifeSci Advisors
    +1 617-430-7578

    SOURCE: Relief Therapeutics Holdings AG



    View source version on accesswire.com:
    https://www.accesswire.com/625666/Relief-Therapeutics-and-Acer-Therapeutics-Sign-Option-Agreement-for-Exclusivity-to-Negotiate-a-Collaboration-and-License-Agreement-for-the-Worldwide-Development-and-Commercialization-of-ACER-001-for-the-Treatment-of-Urea-Cycle-Disorders-and-Maple-Syrup

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  7. NEWTON, Mass., Dec. 22, 2020 (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 announced full enrollment of its pivotal trial evaluating the bioequivalence (BE) of ACER-001 compared to BUPHENYL® (sodium phenylbutyrate). Acer is developing ACER-001 for the treatment of urea cycle disorders (UCDs).

    The single-center, single-blind, randomized, single-dose crossover trial is designed to demonstrate the BE of ACER-001 compared to BUPHENYL® under fed conditions, in approximately 36 healthy adults. Results of the trial are expected in the first quarter…

    NEWTON, Mass., Dec. 22, 2020 (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 announced full enrollment of its pivotal trial evaluating the bioequivalence (BE) of ACER-001 compared to BUPHENYL® (sodium phenylbutyrate). Acer is developing ACER-001 for the treatment of urea cycle disorders (UCDs).

    The single-center, single-blind, randomized, single-dose crossover trial is designed to demonstrate the BE of ACER-001 compared to BUPHENYL® under fed conditions, in approximately 36 healthy adults. Results of the trial are expected in the first quarter of 2021.

    "We completed the first bridging study in the first quarter of 2020, the results of which demonstrated bioequivalence to BUPHENYL® under fasted conditions, but we also confirmed a significant food effect with sodium phenylbutyrate,"1 said Chris Schelling, CEO and Founder of Acer. "After meeting with the FDA in the third quarter of this year to discuss the development plan, it was determined that in light of the food effect a second BE study conducted under fed conditions would be needed to bridge to BUPHENYL® under a 505(b)(2) application. This was a challenging request in the face of COVID-19, and I am pleased to say that our partners at PPD, the global contract research organization, did an incredible job getting this trial fully enrolled before the end of the year."

    Upon successful completion of ongoing development activities, Acer intends to submit a request to the U.S. Food and Drug Administration (FDA) in the first quarter of 2021 for a pre-NDA meeting on ACER-001.

    About UCDs

    UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.2,3

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

    Current medical treatments for UCDs include nitrogen scavengers RAVICTI® and BUPHENYL® in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.3

    About ACER-001

    ACER-001 is a taste-masked, immediate-release proprietary powder formulation for oral administration of sodium phenylbutyrate (NaPB) via suspension. ACER-001 is being developed using a microencapsulation process for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. We believe that if ACER-001 is approved, its taste-masked properties will make it a compelling alternative to existing NaPB-based treatments, as the unpleasant taste associated with NaPB is cited as a major impediment to patient compliance with those treatments.4 Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product will receive FDA approval or become commercially available for the uses being investigated.

    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 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); emetine hydrochloride, a host-directed therapy against a variety of infectious diseases, initially for the treatment of patients with COVID-19; EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and osanetant for the treatment of induced Vasomotor Symptoms (iVMS). 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. For more information, visit www.acertx.com.

    References

    1. Nakano S, et al. Effect of food on the pharmacokinetics and therapeutic efficacy of 4-phenylbutyrate in progressive familial intrahepatic cholestasis. Sci Rep 9, 17075 (2019).
    2. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    3. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).

    4. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100



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  8. NEWTON, Mass., Dec. 17, 2020 (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 announced the publication of additional long-term data from COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS) patients in the European Journal of Vascular and Endovascular Surgery (EJVES). The publication, entitled "Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome,"1 can be found at https://www.ejves.com/action/showPdf?pii=S1078-5884%2820%2930930-8.

    This published study describes outcomes in 40 patients with COL3A1-positive vEDS that were clinically…

    NEWTON, Mass., Dec. 17, 2020 (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 announced the publication of additional long-term data from COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS) patients in the European Journal of Vascular and Endovascular Surgery (EJVES). The publication, entitled "Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome,"1 can be found at https://www.ejves.com/action/showPdf?pii=S1078-5884%2820%2930930-8.

    This published study describes outcomes in 40 patients with COL3A1-positive vEDS that were clinically monitored and treated with celiprolol in a single center retrospective study at Uppsala University Hospital, a national referral center for vEDS patients in Sweden, between the years 2011 and 2019. Patients were followed for a median of 22 months (range 1-98 months) with a total follow up of 106 patient years. Assessments were conducted by a multidisciplinary team, including vascular surgeons, angiologists and clinical geneticists. Celiprolol was administered twice daily and titrated up by 100 mg steps to a maximum of 400 mg per day. Some patients were treated concomitantly or separately with other medications. Sixty-five percent of the patients reached the target dose of 400 mg and the medication was generally well tolerated.

    The annual risk of a major vascular event was 4.7% in this study, noted as being similar to that observed in the celiprolol treatment-arm of the BBEST2 trial (5%) and lower than in the BBEST trial control arm (12%). Five patients suffered major vascular events, four of which were fatal. No significant predictor of vascular events was identified by the authors.

    "The results from this long-term registry study and the increasing length of follow up provide further evidence of celiprolol's potential protective effect in COL3A1-positive vEDS patients," said Martin Björck, MD, PhD, Professor Emeritus of Vascular Surgery, Department of Surgical Sciences at Uppsala University.

    "Dr. Björck is an incredibly well-respected vascular specialist in Europe. We are encouraged by his team's results that add to the growing body of evidence in support of celiprolol's potential benefit in treating COL3A1-positive vEDS patients," said Chris Schelling, CEO and Founder of Acer Therapeutics. "Since our meeting with the FDA's Office of New Drugs (OND) last February, we have been working diligently to evaluate various forms of confirmatory evidence needed to meet the substantial evidence standard. With our partners, we believe we have identified a plan to collect additional data that supports the results from the COL3A1-positive analysis from the BBEST trial and could help meet the standard. As such, we intend to submit a request to the FDA in the next several weeks for a meeting to discuss the appropriateness of our approach."

    An infographic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f7935f3b-34a5-4373-881a-dee9b971a174

    About EDSIVO™

    Ehlers-Danlos Syndrome (EDS) is a group of hereditary disorders of connective tissue. vEDS is the most severe subtype where patients suffer from life threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. The median age of death in the U.S. is 51 years.3 An Acer-commissioned patient-finder study phenotypically identified 4,169 vEDS patients in the U.S. from an analysis of a commercially available patient claims database with data of approximately 190 million unique patient lives. Based on that information, Acer estimates the prevalence of phenotypically-defined vEDS in the U.S. could be greater than 1 in 45,000. Currently, there are no FDA-approved therapies for vEDS.

    Acer is advancing EDSIVO™, a new chemical entity (NCE), for the treatment of COL3A1-positive vEDS based on published results from a randomized controlled clinical trial of celiprolol (BBEST).2 In addition, long-term data has now been published from separate French4 and Swedish1 vEDS patient registries.

    The FDA granted a priority review of the EDSIVO™ NDA and subsequently issued a Complete Response Letter (CRL) in June 2019. The CRL stated that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS. In March 2020, Acer received a response to its Formal Dispute Resolution Request (FDRR) from the OND of the FDA stating that it had denied its appeal of the CRL in relation to the NDA for EDSIVO™. In its Appeal Denied letter, the OND described possible paths forward for Acer to explore that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO™ NDA for the treatment of patients with vEDS with a confirmed COL3A1 mutation. The OND referred to the FDA Guidance document issued in December 20195, where substantial evidence of effectiveness can be provided by two or more adequate and well-controlled studies demonstrating efficacy, or a single positive adequate and well-controlled study plus confirmatory evidence. Neither resubmission nor the prospect of approval of the EDSIVO™ NDA is assured. EDSIVO™ received FDA Orphan Drug Designation for the treatment of vEDS in 2015. EDSIVO™ is an investigational drug candidate that has not been approved by the FDA for any indication.

    References

    1. Baderkhan, H, et al. Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome. European Journal of Vascular and Endovascular Surgery. November 20, 2020.
    2. Ong KT, et al. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010;376(9751):1476-1484
    3. Pepin M, et al. Clinical and genetic features of Ehlers-Danlos syndrome type IV, the vascular type. N Engl J Med. 2000; 342:673-80
    4. Frank M, et al. Vascular Ehlers-Danlos Syndrome: Long-Term Observational Study. J Am Coll Cardiol. 2019 Apr, 73 (15) 1948–1957
    5. FDA guidance "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products", December 2019

    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 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); emetine hydrochloride, a host-directed therapy against a variety of infectious diseases, initially for the treatment of patients with COVID-19; EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and osanetant for the treatment of induced Vasomotor Symptoms (iVMS). 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. For more information, visit www.acertx.com.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100



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  9. NEWTON, Mass., Nov. 10, 2020 (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, 2020, and provided an update on the Company's recent corporate developments.

    "This quarter, we continued to make important progress in the advancement of our four programs," said Chris Schelling, CEO and Founder of Acer. "We received valuable feedback from the FDA regarding our regulatory strategy for ACER-001 for urea cycle disorders patients, and assuming all our development activities stay…

    NEWTON, Mass., Nov. 10, 2020 (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, 2020, and provided an update on the Company's recent corporate developments.

    "This quarter, we continued to make important progress in the advancement of our four programs," said Chris Schelling, CEO and Founder of Acer. "We received valuable feedback from the FDA regarding our regulatory strategy for ACER-001 for urea cycle disorders patients, and assuming all our development activities stay on track, we anticipate having a pre-NDA meeting in the mid-first half of 2021. Regarding our emetine program, several in vivo studies are currently being conducted to evaluate the drug's safety and its specific activity against SARS-CoV-2 in the Syrian Golden hamster and ferret models. Coupled with the drug's in vitro data and emetine's long history of use in humans for other indications, we should have a good understanding of this candidate's potential as a therapeutic against COVID-19 relatively soon."

    Third Quarter 2020 and Recent Highlights

    • Emetine
      • Animal studies ongoing to further evaluate emetine's safety and antiviral activity against COVID-19, the disease caused by infection with the SARS-CoV-2 virus
      • Obtained additional pre-Investigational New Drug (IND) feedback from the Division of Antivirals (DAV) at the U.S. Food and Drug Administration (FDA)
      • Progressing toward U.S.-based cGMP synthetic active pharmaceutical ingredient (API) manufacturing in 2021
      • Continued to work with federal agencies and private research organizations toward the goal of securing non-dilutive funding in support of emetine development
    • ACER-001
      • Received feedback on the Type C meeting with the FDA regarding requirements for the planned ACER-001 505(b)(2) New Drug Application (NDA) submission for treatment of urea cycle disorders (UCDs)
      • Planning to conduct a single-center, single-blind, randomized, single-dose crossover trial designed to demonstrate bioequivalence (BE) of ACER-001 compared to BUPHENYL® under fed conditions, in approximately 36 healthy adults
      • Gained insight from market research with key stakeholders – geneticists, dietitians and UCDs patients – to better understand the reaction to ACER-001's value proposition and begin quantifying the potential market opportunity in UCDs
    • EDSIVO™
      • Developing a plan to generate confirmatory evidence needed to support the potential resubmission of the EDSIVO™ NDA (although neither EDSIVO™ NDA resubmission nor approval is assured)
    • Osanetant
      • Continued to advance active pharmaceutical ingredient (API) manufacturing and other necessary steps to support IND submission
    • Corporate
      • Ended the third quarter with $6.2 million in cash and cash equivalents. Acer believes its cash position at the end of the third quarter, combined with an additional $1.0 million of proceeds subsequently received through October 26, 2020 from the sales of common stock under its ATM facility and through its equity purchase agreement with Lincoln Park Capital, will be sufficient to fund its current operations into the first quarter of 2021, excluding support for the planned emetine Phase 2/3 clinical trial, which is also subject to ongoing discussions with the FDA

    Upcoming Milestones

    • Emetine
      • Anticipate in vivo efficacy results from ongoing animal studies evaluating emetine's anti-viral activity against COVID-19 by the end of the fourth quarter 2020
      • Targeting IND submission and potential initiation of the planned Phase 2/3 trial evaluating emetine in high-risk COVID-19 outpatients in the first half of 2021, subject to ongoing discussions with the FDA and additional capital
    • ACER-001
      • Targeting completion of a BE trial of ACER-001 compared to BUPHENYL® under fed conditions, in approximately 36 healthy adults, in the first quarter of 2021
      • Anticipate holding a pre-NDA meeting with FDA in mid-first half of 2021, assuming successful and timely completion of the ongoing development activities (including the planned BE fed trial, nonclinical work and evaluation of long-term product stability data) and subject to additional capital
    • EDSIVO™
      • Expect to submit a meeting request with FDA to discuss Acer's proposed plan to provide sufficient confirmatory evidence by the end of the fourth quarter of 2020
      • If successful, potentially satisfy the substantial evidence of effectiveness needed to support a possible resubmission of the EDSIVO™ NDA (although neither EDSIVO™ NDA resubmission nor approval is assured)
    • Osanetant
      • Targeting IND submission in the second quarter of 2021 subject to discussions with FDA
      • Plan to initiate a Phase 1/2 pharmacokinetic/pharmocodynamic and safety trial evaluating osanetant in patients with medically and/or surgically induced vasomotor symptoms (iVMS) in the second half of 2021, subject to additional capital

    Financial Results for the Third Quarter 2020

    Cash position. Cash and cash equivalents were $6.2 million as of September 30, 2020, compared to $12.1 million as of December 31, 2019. Acer believes its cash position at the end of the third quarter, combined with an additional $1.0 million of proceeds subsequently received through October 26, 2020 from the sales of common stock under its ATM facility and through its purchase agreement with Lincoln Park Capital, will be sufficient to fund its current operations into the first quarter of 2021, excluding support for the planned emetine Phase 2/3 clinical trial, which is also subject to ongoing discussions with the FDA.

    Research and Development Expenses. Research and development expenses were $3.2 million for the three months ended September 30, 2020, compared to $2.8 million for the three months ended September 30, 2019. This increase of $0.4 million was primarily due to an increase in expenses for contract research related to preclinical studies, partially offset by decreases in regulatory consulting and contract manufacturing expenses. Research and development expenses for the three months ended September 30, 2020 were primarily comprised of $1.8 million related to emetine, $1.1 million related to ACER-001, and $0.3 million related to osanetant.

    General and Administrative Expenses. General and administrative expenses were $2.7 million for the three months ended September 30, 2020, compared to $2.5 million for the three months ended September 30, 2019. This increase of $0.2 million was primarily due to an increase in expenses for consulting and professional services, partially offset by decreases in expenses related to travel and information technology.

    Net Loss. Net loss for the three months ended September 30, 2020 was $5.9 million, or $0.51 net loss per share (basic and diluted), compared to a net loss of $5.3 million, or $0.52 net loss per share (basic and diluted), for the three months ended September 30, 2019.

    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 programs: emetine hydrochloride for the treatment of patients with COVID-19; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and osanetant for the treatment of induced Vasomotor Symptoms (iVMS). 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. For more information, visit www.acertx.com.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100

    ACER THERAPEUTICS INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

     Three Months Ended 
     September 30, 
      2020   2019  
       
       
            
    Operating expenses:       
    Research and development$3,227,048  $2,828,787  
    General and administrative 2,661,989   2,533,678  
    Loss from operations (5,889,037)  (5,362,465) 
            
    Other (expense) income, net:       
    Interest and other (expense) income, net (4,129)  91,321  
    Foreign currency transaction (loss) gain (35,092)  19,671  
            
    Total other (expense) income, net (39,221)  110,992  
            
    Net loss$(5,928,258 $(5,251,473) 
            
    Net loss per share - basic and diluted$(0.51 $(0.52) 
            
    Weighted average common shares outstanding - basic and diluted 11,514,254   10,095,176  



    SELECTED BALANCE SHEET DATA (Unaudited): 



      September 30,  December 31, 
      2020  2019 
             
    Cash and cash equivalents $6,157,448  $12,077,640 
             
    Prepaid expenses and other current assets $846,399  $807,356 
             
    Property and equipment, net $143,145  $193,974 
             
    Total assets $15,366,903  $21,465,511 
             
    Total liabilities $4,863,391  $3,095,195 
             
    Total stockholders' equity $10,503,512  $18,370,316 

     

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  10. NEWTON, Mass., Oct. 01, 2020 (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 announced that Acer's management team will provide a virtual corporate overview at, and participate in, the BIO Investor Forum Digital taking place on October 13-15, 2020. The presentation will be available on-demand during the conference.

    More information on Acer and a replay of the presentation can be found in the "Events and Presentations" section of Acer's website at https://www.acertx.com/investor-relations/events-presentations/.

    About Acer Therapeutics Inc.
    Acer…

    NEWTON, Mass., Oct. 01, 2020 (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 announced that Acer's management team will provide a virtual corporate overview at, and participate in, the BIO Investor Forum Digital taking place on October 13-15, 2020. The presentation will be available on-demand during the conference.

    More information on Acer and a replay of the presentation can be found in the "Events and Presentations" section of Acer's website at https://www.acertx.com/investor-relations/events-presentations/.

    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 clinical-stage candidates: emetine hydrochloride for the treatment of patients with COVID-19; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and osanetant for the treatment of induced Vasomotor Symptoms (iVMS). 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. For more information, visit www.acertx.com.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100

     

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    View Full Article Hide Full Article
  11. Advanced expanded pipeline of clinical stage product candidates, including emetine for COVID-19 and ACER-001 for Urea Cycle Disorders

    NEWTON, Mass., Aug. 13, 2020 (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, 2020, and provided an update on the Company's recent corporate developments.

    "The second quarter of 2020 was marked by significant progress in two of our lead programs – emetine and ACER-001," said Chris Schelling, CEO and Founder of Acer. "The need…

    Advanced expanded pipeline of clinical stage product candidates, including emetine for COVID-19 and ACER-001 for Urea Cycle Disorders

    NEWTON, Mass., Aug. 13, 2020 (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, 2020, and provided an update on the Company's recent corporate developments.

    "The second quarter of 2020 was marked by significant progress in two of our lead programs – emetine and ACER-001," said Chris Schelling, CEO and Founder of Acer. "The need for a therapeutic to treat confirmed COVID-19 patients before they progress and become hospitalized remains a global priority. The team has been working diligently for the past several months to advance emetine from a concept to a pre-IND opportunity and we look forward to the clinical evaluation of emetine, subject to the availability of the required capital. Regarding ACER-001, we reported encouraging new data showing that when ACER-001 is administered in a fasted state it may provide better disease management over currently approved therapies for UCDs that require administration with food. To that end, we submitted a Type C briefing package to the FDA to discuss these results and are expecting feedback later in the third quarter. We continue to target an ACER-001 NDA filing in the first half of 2021, subject to additional capital."

    Second Quarter 2020 and Recent Highlights

    • Emetine
      • Announced a research collaboration agreement with the National Center for Advancing Translational Sciences (NCATS), one of the National Institutes of Health (NIH), to develop emetine hydrochloride as a potential treatment for COVID-19, the disease caused by infection with the SARS-CoV-2 coronavirus
      • Working with federal agencies and private research organizations in an effort to secure non-dilutive funding in support of emetine development
      • Obtained multiple rounds of pre-Investigational New Drug (IND) feedback from the Division of Antivirals (DAV) at the U.S. Food and Drug Administration (FDA)
      • Secured active pharmaceutical ingredient (API) from extract for initiation of the planned Phase 2/3 trial evaluating emetine in high-risk COVID-19 outpatients, assuming the availability of capital. In parallel, we successfully established a fully synthetic development pathway for API exclusively in the U.S.
    • ACER-001
      • Announced results from a food effect study in healthy volunteers showing that administration of ACER-001 in fasted state increased systemic exposure of phenylbutyrate (PBA) levels compared to fed state, which according to in silico modeling may provide improved disease management in patients with urea cycle disorders (UCDs) when compared to currently approved treatments requiring administration with food
      • Submitted a Type C briefing package to the FDA
    • EDSIVO™
      • Continued to assess possible paths forward that could provide the confirmatory evidence needed to demonstrate the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO™ NDA
    • Osanetant
      • Advanced API manufacturing and other steps to support IND submission
    • Corporate
      • Hired Stacey Bain, Ph.D. as Vice President, Clinical Operations, who brings 22 years of international clinical operational and drug development experience in pharmaceutical, biotechnology, and clinical research organization settings
      • Ended the second quarter with $5.9 million in cash and cash equivalents. Acer believes its cash position at the end of the second quarter, combined with an additional $4.7 million of net proceeds subsequently received from sales of common stock from the ATM facility and the insider private placement of common stock, will be sufficient to fund its current operations into the first quarter of 2021, excluding support for the planned emetine Phase 2/3 clinical trial

    Upcoming Milestones

    • Emetine
      • Seek to obtain potential non-dilutive funding
      • Targeting in the first half of 2021 an IND submission and clearance, followed by potential initiation of the planned Phase 2/3 trial evaluating emetine in high-risk COVID-19 outpatients, subject to ongoing discussions with the FDA and additional capital
    • ACER-001
      • Anticipate submitting NDA for urea cycle disorders (UCDs) in the first half of 2021, subject to additional capital, and assuming successful completion of nonclinical work and evaluation of long-term product stability data
    • EDSIVO™
      • Expect to request a meeting with FDA by the end of fourth quarter of 2020 to discuss Acer's proposed plan to provide sufficient confirmatory evidence and, if successful, potentially satisfy the substantial evidence of effectiveness needed to support a possible resubmission of the EDSIVO™ NDA. Neither EDSIVO™ NDA resubmission nor approval is assured
    • Osanetant
      • Anticipate submitting osanetant IND in the first quarter of 2021
      • Targeting initiation of Phase 1/2 pharmacokinetic/pharmocodynamic and safety trial in the first half of 2021, subject to additional capital, that will evaluate osanetant in patients with medically and/or surgically induced vasomotor symptoms (iVMS)

    Financial Results for the Second Quarter 2020

    Cash position. Cash and cash equivalents were $5.9 million as of June 30, 2020, compared to $12.1 million as of December 31, 2019. Acer believes its cash position at the end of the second quarter, combined with an additional $4.7 million of net proceeds subsequently received from sales of common stock under the ATM facility and the insider private placement of common stock, will be sufficient to fund its current operations into the first quarter of 2021, excluding support for the planned emetine Phase 2/3 clinical trial.

    Research and Development Expenses. Research and development expenses were $2.8 million for the three months ended June 30, 2020, compared to $4.2 million for the three months ended June 30, 2019. This decrease of $1.4 million was primarily due to decreases in employee-related expenses and clinical and regulatory consulting as a direct result of the Complete Response Letter for EDSIVO™ received from the FDA in June 2019, partially offset by increases in contract research and contract manufacturing expenses. Research and development expenses for the three months ended June 30, 2020 were primarily comprised of $1.0 million related to emetine, $0.9 million related to ACER-001, and $0.8 million related to osanetant.

    General and Administrative Expenses. General and administrative expenses were $3.0 million for the three months ended June 30, 2020, compared to $6.9 million for the three months ended June 30, 2019. This decrease of $3.9 million was primarily due to decreases in precommercial and employee-related expenses as a direct result of the Complete Response Letter for EDSIVO™ received from the FDA in June 2019, partially offset by costs related to implementing Acer's equity line purchase agreement with Lincoln Park Capital Fund, LLC.

    Net Loss. Net loss for the three months ended June 30, 2020 was $5.8 million, or $0.56 net loss per share (basic and diluted), compared to a net loss of $11.0 million, or $1.09 net loss per share (basic and diluted), for the three months ended June 30, 2019.

    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 clinical-stage candidates: emetine hydrochloride for the treatment of patients with COVID-19; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and osanetant for the treatment of induced Vasomotor Symptoms (iVMS). 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. For more information, visit www.acertx.com.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund the emetine program; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

     

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100

     

     
     
    ACER THERAPEUTICS INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)
      
     Three Months Ended
     June 30,
     2020  2019 
            
            
    Operating expenses:       
    Research and development$2,816,749  $4,246,244 
    General and administrative 2,953,137   6,919,476 
    Loss from operations (5,769,886)  (11,165,720)
            
    Other (expense) income, net:       
    Interest and other (expense) income, net (2,317   143,884 
    Foreign currency transaction gain (loss) 1,402   (19,671)
            
    Total other (expense) income, net (915   124,213 
            
    Net loss$(5,770,801) $(11,041,507)
            
    Net loss per share - basic and diluted$(0.56) $(1.09)
            
    Weighted average common shares outstanding - basic and diluted 10,365,767   10,090,883 
            



    SELECTED BALANCE SHEET DATA (Unaudited): 
          
      June 30,  December 31,
      2020  2019
            
    Cash and cash equivalents $5,880,861  $12,077,640
            
    Prepaid expenses and other current assets $475,005  $807,356
            
    Property and equipment, net $158,555  $193,974
            
    Total assets $14,791,229  $21,465,511
            
    Total liabilities $3,572,858  $3,095,195
            
    Total stockholders' equity $11,218,371  $18,370,316

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  12. Model suggests ACER-001, Acer's taste-masked, immediate release formulation of sodium phenylbutyrate, may offer improved disease management in patients with Urea Cycle Disorders compared to current treatments

    Anticipate submitting ACER-001 NDA in H1 2021 assuming successful completion of additional nonclinical work and long-term stability data, and subject to additional capital

    NEWTON, Mass., July 08, 2020 (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 announced data from a food effect study in healthy volunteers showing that administration…

    Model suggests ACER-001, Acer's taste-masked, immediate release formulation of sodium phenylbutyrate, may offer improved disease management in patients with Urea Cycle Disorders compared to current treatments

    Anticipate submitting ACER-001 NDA in H1 2021 assuming successful completion of additional nonclinical work and long-term stability data, and subject to additional capital

    NEWTON, Mass., July 08, 2020 (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 announced data from a food effect study in healthy volunteers showing that administration of ACER-001 in a fasted state increased systemic exposure of phenylbutyrate (PBA), phenylacetate (PAA) and phenylacetylglutamine (PAGN) levels compared to fed state, and therefore based on modeling data may improve disease management in patients with urea cycle disorders (UCDs) when compared to currently approved treatments requiring administration with food.

    Results from Part B of the ACER-001 bioequivalence (BE) trial in healthy volunteers (n=36) announced in February 2020 showed that ACER-001 was bioequivalent to BUPHENYL® (sodium phenylbutyrate) and were within the parameters recommended by the FDA's Guidance for Industry, "Statistical Approaches to Establishing Bioequivalence." The BE trial included a food effect study, which evaluated the pharmacokinetics (PK) of sodium phenylbutyrate (NaPBA) showing that administration of ACER-001 in a fasted state achieved more than two times the maximum concentration (Cmax) of PBA compared to administration of the same dose of ACER-001 in a fed state. These results are consistent with previously published data by Nakano, et al1 that evaluated PK of NaPBA in patients with progressive familial intrahepatic cholestasis, also demonstrating that administration of NaPBA in a fasted state significantly increased PBA peak plasma concentration compared to administration of NaPBA in a fed state.

    Currently approved therapies for UCDs, including BUPHENYL®2 and RAVICTI®3 (glycerol phenylbutyrate), are required to be administered with food. BUPHENYL® is required to be administered in a fed state due to its aversive odor and taste, with side effects including nausea, vomiting and headaches, which often lead to discontinuation of treatment.4 Additionally, prescribing information states that BUPHENYL® food effect is unknown. RAVICTI® PK and pharmacodynamic (PD) properties were determined to be indistinguishable in fed or fasted states.5 ACER-001 is uniquely formulated with its multi-particulate, taste-masked coating to allow for administration in a fasted state, while still allowing for rapid systemic release.

    Based on the results from the food effect study within the ACER-001 BE trial, Acer commissioned Rosa & Co. LLC to create a PhysioPD® PK model to evaluate the potential food effect on exposure, tolerability and efficacy of ACER-001 in UCDs patients. Results from this in silico model suggest that administration of ACER-001 in a fasted state required approximately 30% less PBA to achieve comparable therapeutic benefit in a fed state. In addition, the model predicted that administration of ACER-001 in a fasted state compared to administration of BUPHENYL® or RAVICTI® (same amounts of PBA) in their required fed states is expected to result in higher peak blood PBA, PAA and PAGN concentrations, predicting a 43% increase in urinary PAGN levels (a negative correlation between blood ammonia area under the curve and 24-hour urinary PAGN amount has been demonstrated6).

    "For nearly a quarter century, phenylbutyrate has been prescribed to UCD patients with food while its effect on phenylbutyrate absorption was never determined. The results of the ACER-001 food effect study, published literature and in silico modeling suggest that ACER-001 administered in a fasted state, and likely just 10 minutes prior to meals, could offer UCD patients a safe and better disease management option compared to currently approved products that are required to be taken with food," said Chris Schelling, CEO and Founder of Acer. "We formulated ACER-001 to specifically improve palatability and tolerability, and we expect that this formulation should allow ACER-001 to be successfully administered without food. We look forward to discussing these findings with the FDA later in the third quarter." Schelling continued "Interestingly, the increased exposure seen under fasted conditions may have benefit in other patient populations we intend to study, such as Maple Syrup Urine Disease (MSUD), where the Cmax of phenylbutyrate is the active moiety."

    About UCDs

    UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.7,8

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

    Current medical treatments for UCDs include nitrogen scavengers RAVICTI® and BUPHENYL® in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPBA) and sodium phenylbutyrate (NaPBA), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons given for non-compliance include the unpleasant taste associated with available medications, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.9

    About ACER-001

    ACER-001 is a taste-masked, immediate-release proprietary formulation of sodium phenylbutyrate developed by Acer using a microencapsulation process. ACER-001 is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. This taste-masked formulation may result in better patient tolerability allowing for administration in a fasted state, and likely prior to a meal. Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product will receive FDA approval or become commercially available for the uses being investigated.

    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 clinical-stage candidates: emetine hydrochloride for the treatment of patients with COVID-19; EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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. For more information, visit www.acertx.com.

    References

    1. Nakano S, et al. Effect of food on the pharmacokinetics and therapeutic efficacy of 4-phenylbutyrate in progressive familial intrahepatic cholestasis. Sci Rep 9, 17075 (2019).
    2. https://www.hzndocs.com/BUPHENYL-Prescribing-Information.pdf
    3. https://www.hzndocs.com/RAVICTI-Prescribing-Information.PDF
    4. Pena-Qintana L, et al. Profile of sodium phenylbutyrate granules for the treatment of urea-cycle disorders: patient perspectives. Patient Preference and Adherence Volume 11:1489-1496, September 2017.
    5. United States Patent number US8642012B2.
    6. Lee et al. Phase 2 Comparison of A Novel Ammonia Scavenging Agent With Sodium Phenylbutyrate In Patients With Urea Cycle Disorders: Safety, Pharmacokinetics And Ammonia Control. Mol Genet Metab. 2010 July; 100(3): 221–228.
    7. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    8. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
    9. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund the ACER-001 program; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100

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  13. The Law Offices of Frank R. Cruz is investigating potential claims against the board of directors of Acer Therapeutics Inc. ("Acer" or the "Company") (NASDAQ:ACER) concerning whether the board breached its fiduciary duties to shareholders.

    If you are a shareholder, click here to participate.

    On June 25, 2019, the Company disclosed receipt of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration rejecting its new drug application for EDSIVO, a medication for the treatment of Ehlers-Danlos syndrome. According to the CRL, "an adequate and well-controlled trial" was required to determine whether EDSIVO "reduces the risk of clinical events" in patients with vascular Ehlers-Danlos syndrome.

    On this news, the Company's…

    The Law Offices of Frank R. Cruz is investigating potential claims against the board of directors of Acer Therapeutics Inc. ("Acer" or the "Company") (NASDAQ:ACER) concerning whether the board breached its fiduciary duties to shareholders.

    If you are a shareholder, click here to participate.

    On June 25, 2019, the Company disclosed receipt of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration rejecting its new drug application for EDSIVO, a medication for the treatment of Ehlers-Danlos syndrome. According to the CRL, "an adequate and well-controlled trial" was required to determine whether EDSIVO "reduces the risk of clinical events" in patients with vascular Ehlers-Danlos syndrome.

    On this news, the Company's share price fell $15.16, or nearly 79%, to close at $4.12 on June 25, 2019, thereby injuring investors.

    Our investigation concerns whether the Company's board of directors breached its fiduciary duties to shareholders and/or grossly mismanaged the Company in connection with the above alleged misconduct.

    Follow us for updates on Twitter: twitter.com/FRC_LAW.

    If you purchased Acer shares and wish to discuss this matter with us, or have any questions concerning your rights and interests with regards to this matter, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to , or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

    This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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  14. NEWTON, Mass., May 14, 2020 (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 first quarter ended March 31, 2020 and provided an update on the Company's recent corporate developments.

    "Over the last several months, we made significant progress in the expansion and further diversification of our product pipeline with the recent addition of emetine, a broad-acting and potent antiviral for the treatment of COVID-19 patients," said Chris Schelling, CEO and Founder of Acer. "We are very pleased to be collaborating…

    NEWTON, Mass., May 14, 2020 (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 first quarter ended March 31, 2020 and provided an update on the Company's recent corporate developments.

    "Over the last several months, we made significant progress in the expansion and further diversification of our product pipeline with the recent addition of emetine, a broad-acting and potent antiviral for the treatment of COVID-19 patients," said Chris Schelling, CEO and Founder of Acer. "We are very pleased to be collaborating with NCATS on the development of emetine and look forward to advancing this important program. We continued to advance our ACER-001 program for UCDs following the successful completion of our pivotal bioequivalence trial and are targeting NDA submission in early 2021, subject to additional capital. In addition, we are preparing to submit an IND for osanetant by the end of the year, and we intend to initiate a Phase 1/2 trial in patients with induced vasomotor symptoms in the first quarter of next year, subject to additional capital. To that end, we entered into a stock purchase agreement with Lincoln Park Capital."

    First Quarter 2020 and Recent Highlights

    • Emetine
      °  Announced a research collaboration agreement with the National Center for Advancing Translational Sciences (NCATS), one of the National Institutes of Health (NIH), to develop emetine hydrochloride as a potential treatment for COVID-19, the disease caused by infection with the SARS-CoV-2 coronavirus
      °  In discussion with the Division of Antivirals (DAV) at FDA after receiving its written responses to the Company's pre-Investigational New Drug (pre-IND) package
      °  Presented at the Biomedical Advanced Research and Development Authority (BARDA) CoronaWatch meeting on May 7, 2020. BARDA CoronaWatch is a funding program providing government support for selected coronavirus projects
    • ACER-001
      °  Initiated nonclinical work and evaluation of long-term product stability following the successful completion of the pivotal trial showing that ACER-001 is bioequivalent to BUPHENYL® (sodium phenylbutyrate)
    • EDSIVO™
      °  Received appeal response from the FDA's Office of New Drugs (OND) stating it denied Acer's appeal of the Complete Response Letter (CRL) in relation to the New Drug Application (NDA) for EDSIVO™. Acer is assessing possible paths forward, as described in the OND's response, that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO™ NDA
    • Ended the first quarter with $7.0 million in cash and cash equivalents. Acer believes its cash position will be sufficient to fund its current operations into the fourth quarter of 2020, excluding support for a planned emetine clinical trial and for EDSIVO™ development and precommercial activities
    • Announced a common stock purchase agreement to potentially sell up to $15 million worth of shares to Lincoln Park Capital Fund, LLC over a 36-month period, following the filing and effectiveness of a registration statement and subject to various limitations including those under the Nasdaq listing rules

    Upcoming Milestones

    • Emetine
      °  Pursuing several potential financing options, including federally-funded research and grants, to support emetine development
      °  Working toward an IND submission in mid-2020
      °  Targeting initiation in the third quarter of 2020, subject to additional capital, an adaptive design Phase 2/3 randomized, blinded, placebo-controlled multi-center trial in high-risk, symptomatic adult COVID-19 patients not requiring hospitalization
    • ACER-001
      °  Anticipate submitting NDA for urea cycle disorders (UCDs) in the first quarter of 2021, subject to additional capital, and assuming successful completion of nonclinical work and evaluation of long-term product stability data
    • Osanetant
      °  Anticipate submitting osanetant IND in the fourth quarter of 2020
      °  Targeting initiation of Phase 1/2 pharmacokinetic/pharmocodynamic and safety trial in the first quarter of 2021, subject to additional capital, evaluating osanetant in patients with medically and/or surgically induced vasomotor symptoms (iVMS) in which Hormone Replacement Therapy (HRT) is contraindicated
    • EDSIVO™
      °  Continuing to evaluate possible next steps with the goal of resubmission of the EDSIVO™ NDA. Neither resubmission nor EDSIVO™ approval is assured

    Financial Results for the First Quarter 2020

    Cash position. Cash and cash equivalents were $7.0 million as of March 31, 2020, compared to $12.1 million as of December 31, 2019. Acer believes its cash position will be sufficient to fund its current operations into the fourth quarter of 2020, excluding support for a planned emetine clinical trial and for EDSIVO™ development and precommercial activities.

    Research and Development Expenses. Research and development expenses were $2.3 million for the three months ended March 31, 2020, compared to $3.9 million for the three months ended March 31, 2019. This decrease of approximately $1.6 million was primarily due to decreases in clinical and regulatory consulting, contract manufacturing, and employee-related expenses as a direct result of the Complete Response Letter for EDSIVO™ received from the FDA in June 2019, partially offset by an increase in contract research expenses. Research and development expenses for the three months ended March 31, 2020 were primarily comprised of approximately $0.5 million related to EDSIVO™ and approximately $1.4 million related to ACER-001.

    General and Administrative Expenses. General and administrative expenses were $2.6 million for the three months ended March 31, 2020, compared to $4.2 million for the three months ended March 31, 2019. This decrease of $1.6 million was primarily due to decreases in precommercial and employee-related expenses as a direct result of the Complete Response Letter for EDSIVO™ received from the FDA in June 2019.

    Net Loss. Net loss for the three months ended March 31, 2020 was $4.9 million, or $0.49 net loss per share (basic and diluted), compared to a net loss of $8.0 million, or $0.79 net loss per share (basic and diluted), for the three months ended March 31, 2019.

    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 clinical-stage candidates: emetine hydrochloride for the treatment of patients with COVID-19; EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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. For more information, visit www.acertx.com.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund the emetine program; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100


    ACER THERAPEUTICS INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

      Three Months Ended
      March 31,
      2020   2019 
       
       
                 
    Operating expenses:            
    Research and development $ 2,322,905     $ 3,946,220  
    General and administrative   2,648,551       4,230,698  
    Loss from operations   (4,971,456 )     (8,176,918 )
                 
    Other income, net:            
    Interest income   22,742       185,143  
    Foreign currency transaction (loss) gain   (2,993 )     23,070  
                 
    Total other income, net   22,749       208,213  
                 
    Net loss $ (4,948,707 )   $ (7,968,705 )
                 
    Net loss per share - basic and diluted $ (0.49 )   $ (0.79 )
                 
    Weighted average common shares outstanding - basic and diluted   10,097,107       10,087,363  
                   

    SELECTED BALANCE SHEET DATA (Unaudited): 

      March 31,   December 31,
      2020   2019
               
    Cash and cash equivalents $ 7,007,260   $ 12,077,640
               
    Prepaid expenses and other current assets $ 624,520   $ 807,356
               
    Property and equipment, net $ 176,265   $ 193,974
               
    Total assets $ 16,140,378   $ 21,465,511
               
    Total liabilities $ 2,051,430   $ 3,095,195
               
    Total stockholders' equity $ 14,088,948   $ 18,370,316

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  15. Targeting Q3 2020 initiation of an adaptive Phase 2/3 trial evaluating emetine in high-risk COVID-19 outpatients, following IND submission and clearance

    Acer to host conference call and webcast on Monday, May 11 at 5:30 pm Eastern Time

    NEWTON, Mass., May 11, 2020 (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 announced it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences (NCATS), one of the National Institutes of Health (NIH), to develop emetine hydrochloride as a potential treatment…

    Targeting Q3 2020 initiation of an adaptive Phase 2/3 trial evaluating emetine in high-risk COVID-19 outpatients, following IND submission and clearance

    Acer to host conference call and webcast on Monday, May 11 at 5:30 pm Eastern Time

    NEWTON, Mass., May 11, 2020 (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 announced it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences (NCATS), one of the National Institutes of Health (NIH), to develop emetine hydrochloride as a potential treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus. Under the terms of the agreement, Acer and NCATS will collaborate to accelerate the clinical development of emetine, a broad-acting and potent antiviral according to various preclinical and clinical studies.

    Acer is in ongoing discussion with the Division of Antivirals (DAV) at the FDA after receiving its initial written responses to the Company's pre-Investigational New Drug (pre-IND) package. Acer is working toward an IND submission in mid-2020 and targeting clinical trial initiation in the third quarter of 2020, subject to additional capital. The Company has proposed an adaptive design Phase 2/3 randomized, blinded, placebo-controlled multi-center trial to evaluate the safety and antiviral activity of emetine in high-risk, symptomatic adult patients with confirmed COVID-19 infection not requiring hospitalization. The trial objectives as planned are to determine the safety and efficacy of emetine via clinical status at a specific timepoint in addition to disease resolution.

    Acer is concurrently pursuing several financing options, including federally-funded research and grants, to support emetine development. For example, the Biomedical Advanced Research and Development Authority (BARDA) invited the Company to present the emetine development program at the BARDA CoronaWatch meeting on May 7, 2020. BARDA CoronaWatch is a funding program providing government support for selected coronavirus projects. While Acer plans to advance emetine through IND submission, initiation of the clinical trial of emetine is contingent on the timely availability of additional capital to fund this program.

    Emetine will be delivered as a sterile subcutaneous injection. Acer will oversee the contract synthesis and manufacturing of emetine for clinical development and potential commercialization.

    "We are very pleased to be selected by NCATS and look forward to collaborating on the development of emetine, a broad-acting and potent antiviral identified by NCATS as their best preclinical opportunity for further clinical development for the treatment of COVID-19," said Chris Schelling, CEO and Founder of Acer. "With a collaboration agreement in place, ongoing discussions with the FDA toward IND submission, and several potentially non-dilutive funding sources being pursued, we believe we are well-positioned to advance the clinical development of emetine."

    Conference Call and Webcast Details
    Interested parties can access the live call and webcast on Monday, May 11, 2020, at 5:30 pm Eastern Time (2:30 pm Pacific Time) from the Investors section of Acer's website or directly at
    http://public.viavid.com/index.php?id=139741. Participants can also access the call by dialing 800-458-4148 (US Toll Free) or 1-720-543-0206 (International Toll Number) and providing the Conference ID 8855853. A replay of the call will also be available under the Investors section of Acer's website.

    About Emetine Hydrochloride
    Acer and NCATS are working together to develop emetine for the treatment of patients with COVID-19, the disease  caused by the SARS-CoV-2 virus. Emetine is an active pharmaceutical ingredient of syrup of ipecac, given orally to induce emesis, and has also been formulated as an injectable to treat thousands of individuals with amebiasis. Several independent in vitro studies have demonstrated nanomolar potency against both DNA and RNA-replicating viruses, including Zika virus, Ebola virus1, Rabies Lyssavirus, human cytomegalovirus, human immunodeficiency virus 1, influenza A virus, Rift Valley fever virus, echovirus 1, human metapneumovirus, and herpes simplex virus type 22. Clinically, emetine has been used to treat approximately 700 patients (including pediatrics) with viral hepatitis3 and varicella-zoster virus4. Additionally, emetine is a potent inhibitor of multiple genetically-distinct coronaviruses and demonstrated in vitro the strongest anti-coronavirus activity in one study that screened and identified approved compounds with broad-spectrum efficacy against the replication of four coronaviruses5 and specifically against SARS-CoV-2.6

    Acer intends to initially seek FDA approval to market emetine in the U.S. using a regulatory pathway established under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act that allows applicants to rely at least in part on third party data for approval. The Company intends to rely in part on the existing preclinical and clinical safety data for emetine, while supplementing with the COVID-19 safety and efficacy data to be generated in the Phase 2/3 trial as well as chemistry, manufacturing and controls information. If the Phase 2/3 trial is completed successfully, following IND submission and clearance, Acer anticipates submitting to the FDA the 505(b)(2) NDA for emetine for the treatment of COVID-19. The potential initiation of the Phase 2/3 trial, its conduct and completion and NDA submission are subject to the Company's ability to generate sufficient capital resources to fund this program. Emetine is an investigational drug for COVID-19 and is not currently FDA approved for any indication.

    About the National Center for Advancing Translational Sciences
    The National Center for Advancing Translational Sciences (NCATS) — one of 27 Institutes and Centers at the National Institutes of Health (NIH) — was established to transform the translational process so that new treatments and cures for disease can be delivered to patients faster. Its focus is to advance the science of translation, which is the process of turning observations into interventions to improve health. NCATS collaborates with researchers, the public and other stakeholder groups to design new approaches and technologies that ultimately will deliver more treatments to more people more quickly.

    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 clinical-stage candidates: emetine hydrochloride for the treatment of patients with COVID-19; EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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. For more information, visit www.acertx.com.

    References

    1. Yang S, et al. Emetine inhibits Zika and Ebola virus infections through two molecular mechanisms: inhibiting viral replication and decreasing viral entry. Cell Discov (2018) 4:31. doi:10.1038/s41421-018-0034-1
    2. Andersen, P.I., et al. Novel Antiviral Activities of Obatoclax, Emetine, Niclosamide, Brequinar, and Homoharringtonine. Viruses 2019, 11, 964
    3. Del Puerto  et al. Pren. méd. argent., 55: 818, 1968
    4. Annamalai et al. Emetine Hydrochloride in the Treatment of Herpes Zoster. 1968
    5. Shen L, et al. High-Throughput Screening and Identification of Potent Broad-Spectrum Inhibitors of Coronaviruses. J Virol. 2019 May 29;93(12)
    6. Choy et al. Remdesivir, lopinavir, emetine, and homoharringtonine inhibit SARS-CoV-2 replication in vitro. Antiviral Res. 2020 Jun; 178: 104786

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund the emetine program; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100

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  16. NEWTON, Mass., April 30, 2020 (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 announced it has entered into a common stock purchase agreement for up to $15 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor.

    Under the terms of the purchase agreement and following the filing and effectiveness of a registration statement, Acer will have the right at its sole discretion, but not the obligation, to sell to LPC up to $15 million worth of shares over the 36-month term of the agreement, subject to various limitations…

    NEWTON, Mass., April 30, 2020 (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 announced it has entered into a common stock purchase agreement for up to $15 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor.

    Under the terms of the purchase agreement and following the filing and effectiveness of a registration statement, Acer will have the right at its sole discretion, but not the obligation, to sell to LPC up to $15 million worth of shares over the 36-month term of the agreement, subject to various limitations including those under the Nasdaq listing rules. There are no upper limits to the price per share LPC may pay to purchase the shares, and the purchase price of the shares will be based on the then prevailing market prices at the time of each sale to LPC. Acer controls the timing and amount of any future sales of its stock to LPC. There are no warrants, derivatives, financial or business covenants associated with the agreements, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Acer's common stock. Acer may terminate the purchase agreement at any time, at its discretion, without any cost or penalty. 

    Acer intends to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes. In consideration for LPC entering into the purchase agreement, Acer issued shares of its common stock to LPC as a commitment fee.

    Additional information regarding the purchase agreement with LPC is available in the Current Report on Form 8-K that Acer filed today with the Securities and Exchange Commission.

    The offer and sale of the securities in the above transaction have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and may not be offered or sold in the United States absent registration under the Securities Act and any applicable state securities laws or an applicable exemption from such registration.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock, nor shall there be any sale of shares of common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About Lincoln Park Capital Fund, LLC

    LPC is a long-only institutional investor headquartered in Chicago, Illinois. LPC's experienced professionals manage a portfolio of investments in public and private entities. These investments are in a wide range of companies and industries emphasizing life sciences and technology. LPC's investments range from multi-year financial commitments to fund growth to special situation financings to long-term strategic capital offering companies' flexibility and consistency. For more information, please visit www.lpcfunds.com.

    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 three clinical-stage candidates: EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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. For more information, visit www.acertx.com.

    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 regarding possible sales of common stock pursuant to the purchase agreement with LPC and our  financing needs are forward-looking statements. 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, including, without limitation, uncertainties related to our working capital, our ability to carry on our existing operations and to obtain needed financing. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. 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 Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum

    LifeSci Advisors

    Ph: 617-430-7578

    Jim DeNike

    Acer Therapeutics Inc.

    Ph: 844-902-6100

     

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  17. OND denies Acer's appeal but describes possible paths forward for EDSIVO™

    ACER-001 bioequivalence trial complete; New Drug Application submission anticipated early 2021

    Targeting osanetant Phase 1/2 trial initiation by end 2020

    NEWTON, Mass., March 18, 2020 (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 fourth quarter and full year ended December 31, 2019 and provided an update on the Company's recent corporate developments.

    "Over the last 12 months, we have made considerable progress in advancing our pipeline…

    OND denies Acer's appeal but describes possible paths forward for EDSIVO™

    ACER-001 bioequivalence trial complete; New Drug Application submission anticipated early 2021

    Targeting osanetant Phase 1/2 trial initiation by end 2020

    NEWTON, Mass., March 18, 2020 (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 fourth quarter and full year ended December 31, 2019 and provided an update on the Company's recent corporate developments.

    "Over the last 12 months, we have made considerable progress in advancing our pipeline of clinical-stage product candidates," said Chris Schelling, CEO and Founder of Acer. "While the Office of New Drugs recently denied our appeal of the EDSIVO™ Complete Response Letter, we are encouraged by its description of possible paths forward. While neither resubmission nor the prospect of approval is assured, we are evaluating our possible next steps with the goal of resubmission of the EDSIVO™ NDA. Concurrently, we continue to advance our ACER-001 program for Urea Cycle Disorders following the successful completion of our pivotal bioequivalence trial and are working toward a New Drug Application submission in early 2021. In addition, we are preparing to initiate an osanetant Phase 1/2 trial in patients with induced vasomotor symptoms by the end of the year, subject to additional capital."

    Fourth Quarter 2019 and Recent Highlights

    • EDSIVO™
      • Today announced the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) denied Acer's appeal of the Complete Response Letter (CRL) in relation to the New Drug Application (NDA) for EDSIVO™. In its Appeal Denied letter, the OND describes possible paths forward for Acer to explore that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO™ NDA for the treatment of patients with vascular Ehlers-Danlos syndrome (vEDS) with a confirmed COL3A1 mutation
         
    • ACER-001
      • Announced successful completion and final data from Part B of the pivotal trial showing that ACER-001 was bioequivalent to BUPHENYL® (sodium phenylbutyrate)
      • Initiated remaining nonclinical work and evaluation of long-term product stability
         
    • Ended the fourth quarter with $12.1 million in cash and cash equivalents. Acer believes its cash position will be sufficient to fund its current operations through the end of 2020, excluding support for EDSIVO™ development and precommercial activities and the planned osanetant clinical trial

    Upcoming Milestones

    • EDSIVO™
      • While neither resubmission nor the prospect of approval is assured, evaluate possible next steps with the goal of resubmission of the EDSIVO™ NDA
         
    • ACER-001
      • Submit NDA for UCDs in early 2021, subject to additional capital, and assuming successful completion of nonclinical work and evaluation of long-term product stability data
         
    • Osanetant
      • Submit osanetant IND in 2H 2020
      • Target initiation of Phase 1/2 pharmacokinetic/pharmocodynamic and safety trial by end of 2020, subject to additional capital, evaluating osanetant in patients with medically and/or surgically induced vasomotor symptoms (iVMS) in which Hormone Replacement Therapy (HRT) is contraindicated

    Financial Results for the Fourth Quarter and Full Year 2019

    Cash position. Cash and cash equivalents were $12.1 million as of December 31, 2019, compared to $41.7 million as of December 31, 2018. Acer believes its cash position will be sufficient to fund its current operations through the end of 2020, excluding support for EDSIVO™ development and precommercial activities, and the planned osanetant clinical trial.

    Research and Development Expenses. Research and development expenses were $2.8 million for the three months ended December 31, 2019, compared to $5.3 million for the three months ended December 31, 2018. Research and development expenses for the three months ended December 31, 2019 were primarily comprised of approximately $0.3 million related to EDSIVO™ and approximately $2.4 million related to ACER-001. Research and development expenses were $13.9 million for the year ended December 31, 2019, compared to $12.5 million for the year ended December 31, 2018. This increase of approximately $1.4 million was primarily due to increases in spending related to contract manufacturing services, regulatory consulting, and medical affairs services during the first half of 2019 in preparation for the potential launch of EDSIVO™, as well as to an increase in employee-related expenses. The increase in employee-related expenses was driven by increased headcount during the first half of 2019, as well as $0.5 million restructuring expense and increased stock-based compensation expense. These increases were partially offset by a decrease in spending related to license fees.

    General and Administrative Expenses. General and administrative expenses were $2.4 million for the three months ended December 31, 2019, compared to $3.4 million for the three months ended December 31, 2018. General and administrative expenses were $16.0 million for the year ended December 31, 2019, compared to $9.3 million for the year ended December 31, 2018. This increase of $6.7 million was primarily due to a $4.6 million increase in employee-related expenses, which included $1.0 million restructuring expense, increased headcount and travel during the first half of 2019, and increased stock-based compensation expense. The remaining increase in general and administrative expenses was primarily due to an increase in expenses related to precommercial activities.

    Net Loss. Net loss for the three months ended December 31, 2019 was $5.2 million, or $0.51 net loss per share (basic and diluted), compared to a net loss of $8.5 million, or $0.85 net loss per share (basic and diluted), for the three months ended December 31, 2018. Net loss for the year ended December 31, 2019 was $29.4 million, or $2.91 loss per share (basic and diluted), compared to a net loss of $21.3 million, or $2.49 loss per share (basic and diluted), for the year ended December 31, 2018.

    For additional information, please see Acer's Annual Report on Form 10-K 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 three clinical-stage candidates: EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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. For more information, visit www.acertx.com.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100


    ACER THERAPEUTICS INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

      Three Months Ended     Years Ended  
      December 31,     December 31,  
      2019     2018     2019     2018  
        (unaudited)                  
     Operating expenses:                              
     Research and development $ 2,829,767     $ 5,312,378     $ 13,851,018     $ 12,452,424  
     General and administrative   2,362,572       3,387,147       16,046,423       9,261,570  
     Loss from operations   (5,192,339 )     (8,699,525 )     (29,897,441 )     (21,713,994 )
                                   
     Other income, net:                              
     Interest income   50,919       206,637       471,267       412,553  
     Foreign currency transaction (loss)/gain   (14,864 )     (3,398 )     8,205       20,550  
     Total other income, net   36,055       203,239       479,472       433,103  
                                   
     Net loss $ (5,156,284 )   $ (8,496,286 )   $ (29,417,969 )   $ (21,280,891 )
                                   
     Net loss per share - basic and diluted $ (0.51 )   $ (0.85 )   $ (2.91 )   $ (2.49 )
                                   
     Weighted average common shares outstanding - basic and diluted   10,095,176       10,054,482       10,092,179       8,555,039  
                                   

    SELECTED BALANCE SHEET DATA: 

        December 31,     December 31,  
        2019     2018  
                     
    Cash and cash equivalents   $ 12,077,640     $ 41,671,284  
                     
    Prepaid expenses and other current assets   $ 807,356     $ 1,075,021  
                     
    Property and equipment, net   $ 193,974     $ 130,867  
                     
    Total assets   $ 21,465,511     $ 50,663,419  
                     
    Total liabilities   $ 3,095,195     $ 5,580,261  
                     
    Total stockholders' equity   $ 18,370,316     $ 45,083,158  

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  18. NEWTON, Mass., March 18, 2020 (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 announced that the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has denied Acer's appeal of the Complete Response Letter (CRL) in relation to the New Drug Application (NDA) for EDSIVO. In its Appeal Denied letter, the OND describes possible paths forward for Acer to explore that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO NDA for the treatment of patients with vascular…

    NEWTON, Mass., March 18, 2020 (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 announced that the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has denied Acer's appeal of the Complete Response Letter (CRL) in relation to the New Drug Application (NDA) for EDSIVO. In its Appeal Denied letter, the OND describes possible paths forward for Acer to explore that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO NDA for the treatment of patients with vascular Ehlers-Danlos syndrome (vEDS) with a confirmed COL3A1 mutation.

    "We appreciate the OND's time and attention in thoughtfully considering this FDRR," said Chris Schelling, CEO and Founder of Acer. "While neither resubmission nor the prospect of approval of the EDSIVO™ NDA is assured, we are evaluating our possible next steps with the goal of resubmission of the EDSIVO™ NDA."

    Acer believes its cash position will be sufficient to fund its current operations through the end of 2020, excluding support for EDSIVO™ development and precommercial activities and the planned osanetant clinical trial.

    About vEDS and EDSIVO™ (celiprolol)
    Ehlers-Danlos Syndrome (EDS) is a group of hereditary disorders of connective tissue. vEDS is the most severe subtype where patients suffer from life threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. There is currently no approved treatment option for vEDS. The median age of death is 51 years.1 An Acer-commissioned patient-finder study phenotypically identified 4,169 vEDS patients in the U.S. from an analysis of a commercially available patient claims database with data of approximately 190 million unique patient lives. Based on that information, Acer estimates the prevalence of phenotypically-defined vEDS in the U.S. could be greater than 1 in 45,000. Currently, there are no FDA-approved therapies for vEDS. Acer is advancing EDSIVO™, a new chemical entity (NCE), for the treatment of vEDS based on published results from a randomized controlled clinical trial of celiprolol.2 The FDA granted a priority review of the EDSIVO™ NDA and subsequently issued a CRL in June 2019. The OND denied an Acer appeal of the CRL in March 2020, but made reference to the FDA Guidance document issued in December 2019, where substantial evidence of effectiveness can be provided by two or more adequate and well-controlled studies demonstrating efficacy, or a single positive adequate and well-controlled study plus confirmatory evidence3. EDSIVO™ received FDA Orphan Drug Designation for the treatment of vEDS in 2015.

    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 three clinical-stage candidates: EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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. For more information, visit www.acertx.com.

    References

    1. Pepin M, et al. Clinical and genetic features of Ehlers-Danlos syndrome type IV, the vascular type. N Engl J Med. 2000; 342:673-80
    2. Ong KT, et al. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010;376(9751):1476-1484
    3. FDA guidance "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products", December 2019

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100
     

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  19. NEWTON, Mass., Feb. 24, 2020 (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 announced successful completion and final data from Part B of its pivotal trial evaluating the bioavailability and bioequivalence of ACER-001 to BUPHENYL® (sodium phenylbutyrate). ACER-001 is a proprietary, taste-masked formulation of sodium phenylbutyrate, in development for the treatment of Urea Cycle Disorders (UCDs).

    Part B of the trial evaluated 36 healthy adults in a single-center, single-blind, randomized, single-dose crossover study designed to evaluate bioequivalence…

    NEWTON, Mass., Feb. 24, 2020 (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 announced successful completion and final data from Part B of its pivotal trial evaluating the bioavailability and bioequivalence of ACER-001 to BUPHENYL® (sodium phenylbutyrate). ACER-001 is a proprietary, taste-masked formulation of sodium phenylbutyrate, in development for the treatment of Urea Cycle Disorders (UCDs).

    Part B of the trial evaluated 36 healthy adults in a single-center, single-blind, randomized, single-dose crossover study designed to evaluate bioequivalence of ACER-001 compared to BUPHENYL®. Consistent with observations from Part A of the trial, data from Part B showed ACER-001 to be bioequivalent to BUPHENYL® and were within the parameters recommended by the FDA's Guidance for Industry, "Statistical Approaches to Establishing Bioequivalence." Acer is developing ACER-001 under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, which provides a potentially streamlined path for sponsors that have developed improvements to drug products previously approved by the FDA.

    "We are pleased to see data from the trial showing ACER-001 bioequivalence to BUPHENYL®, marking the successful completion of an important step in the advancement of ACER-001," said William Andrews, M.D., FACP, Chief Medical Officer of Acer. "These data support our belief that if approved, ACER-001 could represent a cost-effective, taste-masked, immediate-release alternative for patients suffering from UCDs. We plan to submit a New Drug Application in early 2021, subject to additional capital, and assuming successful completion of remaining nonclinical work and 12-month long-term stability data."

    About Section 505(b)(2)
    The ACER-001 pivotal trial is designed to make use of the 505(b)(2) alternative pathway to approval established in the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 505(b)(2) provides an alternative pathway for submission of an NDA, referred to as a 505(b)(2) application, when some or all of the safety and efficacy investigations relied on for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference but for which the relevant information is publicly available. The Hatch-Waxman Amendments also provide pharmaceutical products approved under Section 505(b)(2) with potential market exclusivity for three years from FDA approval.

    About UCDs
    UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms1,2.

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

    Current medical treatments for UCDs include nitrogen scavengers RAVICTI® and BUPHENYL® in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons given for non-compliance include the unpleasant taste associated with available medications, the frequency with which medication must be taken, the number of pills, and the high cost of the medication3.

    About ACER-001
    ACER-001 is a taste-masked, immediate-release proprietary formulation of sodium phenylbutyrate developed by Acer using a microencapsulation process. ACER-001 is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating which dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product will receive FDA approval or become commercially available for the uses being investigated.

    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 three clinical-stage candidates: EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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.

    References

    1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
    3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for ACER-001 to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, including our ability to raise additional capital, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results or actual outcomes, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100

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  20. Part A Successfully Completed and Optimal Formulation of ACER-001 Identified

     Results of Part B Expected in Q1 2020 with a Planned NDA Submission in Q1 2021

    NEWTON, Mass., Dec. 16, 2019 (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 announced full enrollment of Part B of its pivotal trial evaluating bioavailability and bioequivalence of ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs). Part B was initiated following successful completion of Part A and identification of an optimal ACER-001 formulation. Acer is…

    Part A Successfully Completed and Optimal Formulation of ACER-001 Identified

     Results of Part B Expected in Q1 2020 with a Planned NDA Submission in Q1 2021

    NEWTON, Mass., Dec. 16, 2019 (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 announced full enrollment of Part B of its pivotal trial evaluating bioavailability and bioequivalence of ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs). Part B was initiated following successful completion of Part A and identification of an optimal ACER-001 formulation. Acer is developing ACER-001 under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.

    Results from Part A of the trial evaluated bioavailability of three different oral suspension formulations of ACER-001 compared to BUPHENYL® (sodium phenylbutyrate) in 20 healthy adult subjects. These data, along with results from a concurrent taste assessment trial evaluating palatability of the three formulations of ACER-001 compared to BUPHENYL®, informed Acer's selection of the single, optimal formulation of ACER-001 for ongoing evaluation in Part B that will be taken through to potential commercialization. Part B of this trial is a single-center, single-blind, randomized, single-dose crossover study designed to demonstrate bioequivalence of ACER-001 compared to BUPHENYL® in 36 healthy adult subjects.

    "Successful completion of Part A and full enrollment of Part B mark important progress in the ongoing development of ACER-001," said William Andrews, M.D., FACP, Chief Medical Officer of Acer. "Over the next year, we aim to complete Part B of the bioequivalence trial in the first quarter of 2020, enroll and complete Part B of the Taste Assessment study, and per FDA feedback, conduct some additional nonclinical work while monitoring the long-term stability data of the product. Assuming successful outcomes with these activities, we should be on track to proceed with submission of a New Drug Application (NDA) in early 2021."

    About Section 505(b)(2)
    The ACER-001 pivotal trial is designed to make use of the 505(b)(2) alternative pathway to approval established in the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA). The Hatch-Waxman Amendments established Section 505(b)(2) of the FFDCA that provides an alternative pathway for submission of an NDA, referred to as a 505(b)(2) application, when some or all of the safety and efficacy investigations relied on for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference. The Hatch-Waxman Amendments also established market exclusivity to provide pharmaceutical products approved under Section 505(b)(2) with potential market exclusivity for three years from FDA approval.

    About UCDs
    UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms1,2.

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation. Current medical treatments for UCDs include nitrogen scavengers RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons given for non-compliance include the unpleasant taste associated with available medications, the frequency with which medication must be taken, the number of pills, and the high cost of the medication3.

    About ACER-001
    ACER-001 is a fully taste-masked, immediate-release proprietary formulation of sodium phenylbutyrate developed by Acer using a microencapsulation process and being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating which dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. Acer is initially developing ACER-001 as a taste-masked, cost-effective alternative treatment for patients with UCDs. If the pivotal bioavailability and bioequivalence trial is successful, Acer plans to submit an NDA under Section 505(b)(2) for ACER-001 in UCDs in the first quarter of 2021. Acer also intends to develop ACER-001 for patients with Maple Syrup Urine Disease (MSUD) and has been granted orphan drug designation by the FDA in this indication.

    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 three clinical-stage candidates: EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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.

    References

    1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
    3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for ACER-001 to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100

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  21. NEWTON, Mass., Nov. 13, 2019 (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, 2019 and provided an update on the Company's recent corporate developments.

    "We have been very active as we continue to progress the development of our pipeline products, including continued work in support of potential EDSIVO™ approval, and the ongoing development of ACER-001," said Chris Schelling, CEO and Founder of Acer. "We have completed our EDSIVO™ Type A meeting following receipt of the Complete…

    NEWTON, Mass., Nov. 13, 2019 (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, 2019 and provided an update on the Company's recent corporate developments.

    "We have been very active as we continue to progress the development of our pipeline products, including continued work in support of potential EDSIVO™ approval, and the ongoing development of ACER-001," said Chris Schelling, CEO and Founder of Acer. "We have completed our EDSIVO™ Type A meeting following receipt of the Complete Response Letter (CRL) and are evaluating plans to appeal the decision. At the same time, we are well underway with our ACER-001 pivotal bioequivalence trial for urea cycle disorders (UCDs), and we are advancing osanetant toward clinical development for induced Vasomotor Symptoms (iVMS), both as previously announced."

    Third Quarter 2019 and Recent Events

    • EDSIVO™
      • Conducted a Type A meeting in October 2019 with the U.S. Food and Drug Administration (FDA) regarding the EDSIVO™CRL and engaged with industry experts to determine an optimal path forward
      • Presented data at the Academy of Managed Care Pharmacy (AMCP) Nexus 2019 conference from a pilot study designed to estimate the healthcare costs associated with clinical events in patients with vEDS in the United States. The poster can be found here: https://www.acertx.com/edsivo-publications-and-presentations/
         
    • ACER-001
      • Fully enrolled Part A of a two-part pivotal bioavailability and bioequivalence (BE) trial to bridge ACER-001 to BUPHENYL® for treatment of UCDs.  Part A is a single-center, single-blind, randomized, single-dose crossover trial designed to evaluate the relative bioavailability of three different oral suspension formulations of ACER-001 compared to BUPHENYL® in 20 healthy adult subjects
      • Initiated a taste assessment trial of three different formulations of ACER-001 (multi-particulate powder) assessed relative to BUPHENYL® (powder) using certified taste-testers
      • Received Type C written comments from the FDA in October 2019:
        • Proceeding with clinical trials as planned
        • The FDA stated that 12 months of long-term and 6 months of accelerated stability data would be required for submission of a 505(b)(2) New Drug Application (NDA)
    • Ended the third quarter with $16.1 million in cash and cash equivalents, which the Company believes will be sufficient to fund its current operating and capital requirements through the end of 2020

    Upcoming Milestones

    • EDSIVO™
      • Evaluating an appeal via Formal Dispute Resolution Request (FDRR) to the Office of New Drugs (OND) with potential submission by the end of 2019
         
    • ACER-001
      • Two-part pivotal BE trial:
        • Results expected for Part A in Q4 2019
        • Anticipate enrolling the first subjects in Part B in Q4 2019.  Part B is a single-center, open-label, randomized, single-dose crossover trial to demonstrate bioequivalence of the optimal formulation of ACER-001 (chosen from Part A) compared to BUPHENYL® in 36 healthy adult subjects.  Trial completion expected in Q1 2020
      •  Taste assessment trials:
        • Results expected in Q4 2019 for taste assessment trial evaluating three different formulations of ACER-001
        • Anticipate enrolling the first subjects in 1H 2020 for the taste study comparing the optimal ACER-001 formulation with BUPHENYL®. The design and size of the trial will be determined following further discussions with the FDA
      • Submit NDA for UCDs in Q1 2021, subject to additional capital, assuming successful outcome in BE trial and 12-month long-term stability data
         
    • Osanetant
      • Submit osanetant Investigational New Drug Application (IND) in Q2 2020
      • Aim to initiate Phase 1/2 trial in 2H 2020, subject to additional capital, evaluating osanetant in patients with medically and/or surgically induced VMS in which Hormone Replacement Therapy (HRT) is contraindicated

    Financial Results for the Third Quarter 2019

    Cash position. Cash and cash equivalents were $16.1 million as of September 30, 2019, compared to $41.7 million as of December 31, 2018. The Company believes its cash position will be sufficient to fund its current operating and capital requirements through the end of 2020.

    Research and Development Expenses. Research and development expenses were $2.8 million during the three months ended September 30, 2019, compared to $2.4 million during the three months ended September 30, 2018. This increase of $0.4 million was primarily due to increases in expenses related to manufacturing services, partially offset by decreases in employee-related expenses and in expenses related to research services and consulting services. Research and development expenses for the three months ended September 30, 2019 were primarily comprised of approximately $0.8 million related to EDSIVO™ and approximately $1.6 million related to ACER-001.

    General and Administrative Expenses. General and administrative expenses were $2.5 million for the three months ended September 30, 2019 compared to $1.7 million for the three months ended September 30, 2018. The increase of $0.8 million was primarily due to  increases in employee-related expenses.

    Net Loss. Net loss for the three months ended September 30, 2019 was $5.3 million, or $0.52 net loss per share (basic and diluted), compared to a net loss of $4.0 million, or $0.43 net loss per share (basic and diluted), for the three months ended September 30, 2018. The increase in loss per share (basic and diluted) was driven largely by increases in expenses related to manufacturing services, partially offset by  an increase in the number of shares outstanding at September 30, 2019 as compared to September 30, 2018.

    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 three clinical-stage pharmaceutical product candidates: EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding our capital resources; the potential for EDSIVO™ (celiprolol), ACER-001 and osanetant to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; our progress toward possible approval for EDSIVO™ in light of the Complete Response Letter we received earlier this year; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, our ability to reduce our operating expenses and conserve cash on a net basis as a result of our prior or any future corporate restructuring initiative, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100

       
    ACER THERAPEUTICS INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)
       
      Three Months Ended
      September 30,
      2019    2018 
       
       
                   
    Operating expenses:              
    Research and development $ 2,828,787     $ 2,377,916  
    General and administrative   2,533,678       1,729,446  
    Loss from operations   (5,362,465 )     (4,107,362 )
                   
    Other income, net:              
    Interest income   91,321       138,671  
    Foreign currency transaction gain   19,671       3,180  
                   
    Total other income, net   110,992       141,851  
                   
    Net loss $ (5,251,473 )   $ (3,965,511 )
                   
    Net loss per share - basic and diluted $ (0.52 )   $ (0.43 )
                   
    Weighted average common shares outstanding - basic and diluted   10,095,176       9,136,321  


    SELECTED BALANCE SHEET DATA (Unaudited):          
               
      September 30,     December 31,  
      2019     2018  
                   
    Cash and cash equivalents $ 16,121,903     $ 41,671,284  
                   
    Prepaid expenses and other current assets $ 972,064     $ 1,075,021  
                   
    Property and equipment, net $ 158,796     $ 130,867  
                   
    Total assets $ 25,541,832     $ 50,663,419  
                   
    Total liabilities $ 2,676,770     $ 5,580,261  
                   
    Total stockholders' equity $ 22,865,062     $ 45,083,158  


     

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  22. NEWTON, Mass., Oct. 28, 2019 (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 announced full enrollment of Part A in a pivotal trial evaluating bioavailability and bioequivalence of ACER-001 for the treatment of Urea Cycle Disorders (UCDs). The ACER-001 pivotal trial is designed to make use of the 505(b)(2) alternative pathway to approval established in the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA).

    The ACER-001 trial design consists of two parts. Part A is a single-center, single-blind, randomized, single-dose…

    NEWTON, Mass., Oct. 28, 2019 (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 announced full enrollment of Part A in a pivotal trial evaluating bioavailability and bioequivalence of ACER-001 for the treatment of Urea Cycle Disorders (UCDs). The ACER-001 pivotal trial is designed to make use of the 505(b)(2) alternative pathway to approval established in the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA).

    The ACER-001 trial design consists of two parts. Part A is a single-center, single-blind, randomized, single-dose crossover trial designed to evaluate the relative bioavailability of three different oral suspension formulations of ACER-001 compared to BUPHENYL® in 20 healthy adult subjects. The goal of Part A of this study is to provide data to help identify the optimal formulation of ACER-001 for further evaluation in Part B.  Part B will be a single-center, open-label, randomized, single-dose crossover trial to demonstrate bioequivalence of the optimal formulation of ACER-001 compared to BUPHENYL® in 36 healthy adult subjects.

    "The initiation of this trial represents a significant milestone as we continue to advance the development of our pipeline product candidates," said William Andrews, M.D., FACP, Chief Medical Officer of Acer. "We believe ACER-001 could represent a taste-masked, cost-effective alternative treatment for patients with UCDs.  We look forward to completion of the two-part bioequivalence trial in the first quarter of 2020, and to progressing our work on ACER-001 for this serious, rare disease."

    About Section 505(b)(2)
    The Hatch-Waxman Amendments established Section 505(b)(2) of the FFDCA that provides an alternative pathway for submission of a New Drug Application (NDA), referred to as a 505(b)(2) application, when some or all of the safety and efficacy investigations relied on for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference. The Hatch-Waxman Amendments also established market exclusivity to provide pharmaceutical products approved under Section 505(b)(2) with potential market exclusivity for three years from FDA approval. ACER-001 is being developed under Section 505(b)(2).

    About UCDs
    UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms1,2.

    The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation. Current medical treatments for UCDs include nitrogen scavengers RAVICTI® and BUPHENYL® in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage UCDs, non-compliance with treatment is common. Reasons given for non-compliance include the unpleasant taste associated with available medications, the frequency with which medication must be taken, the number of pills, and the high cost of the medication3.

    About ACER-001
    ACER-001 is a fully taste-masked, immediate-release proprietary formulation of sodium phenylbutyrate developed by Acer using a microencapsulation process, being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating which dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. Acer is initially developing ACER-001 as a taste-masked, cost-effective alternative treatment for patients with UCDs. If the pivotal bioavailability and bioequivalence trial is successful, Acer plans to submit an NDA under Section 505(b)(2) for ACER-001 in UCDs in the first quarter of 2021. Acer also intends to develop ACER-001 for patients with Maple Syrup Urine Disease (MSUD) and has been granted orphan drug designation by the FDA in this indication. The most common side effects of BUPHENYL® include absent or irregular menstrual periods, decreased appetite, body odor and bad taste.

    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 three clinical-stage candidates: EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. 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.

    References

    1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
    2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
    3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

    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 regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for ACER-001 to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:
    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-430-7578

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100

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  23. Shareholder rights law firm Robbins Arroyo LLP reminds investors that a purchaser of Acer Therapeutics Inc. (NASDAQ:ACER) filed a class action complaint for alleged violations of the Securities Exchange Act of 1934 between September 25, 2017 and June 24, 2019. Acer Therapeutics is a pharmaceutical company that focuses on the acquisition, development, and commercialization of therapies for rare and life-threatening diseases.

    If you suffered a loss as a result of Acer's misconduct, click here.

    Acer Therapeutics Inc. (ACER) Accused of Misleading Investors

    According to the complaint, in December 2016, Acer announced that it obtained exclusive rights to New Drug Application ("NDA")-enabling clinical data from the Assistance Publique—Hôpitaux…

    Shareholder rights law firm Robbins Arroyo LLP reminds investors that a purchaser of Acer Therapeutics Inc. (NASDAQ:ACER) filed a class action complaint for alleged violations of the Securities Exchange Act of 1934 between September 25, 2017 and June 24, 2019. Acer Therapeutics is a pharmaceutical company that focuses on the acquisition, development, and commercialization of therapies for rare and life-threatening diseases.

    If you suffered a loss as a result of Acer's misconduct, click here.

    Acer Therapeutics Inc. (ACER) Accused of Misleading Investors

    According to the complaint, in December 2016, Acer announced that it obtained exclusive rights to New Drug Application ("NDA")-enabling clinical data from the Assistance Publique—Hôpitaux de Paris' Ong Trial for the use of EDVISO in treating vascular Ehlers-Danlos Syndrome ("vEDS"). Throughout the relevant period, Acer touted the robust results from the Ong Trial and assured that it would support Acer's NDA for EDVISO. However, these assurances were materially false and misleading as they failed to disclose that the Ong Trial did not meet FDA standards and therefore Acer lacked sufficient data to support filing EDVISO's NDA. This became evident in June 2019, when Acer revealed that the FDA needed it to "conduct an adequate and well-controlled trial" to determine EDVISO's effects in patients. A news source then reported that the small group size of the Ong Trial had raised questions about the adequacy of EDVISO. On this news, Acer's stock price fell $15.16 per share, or over 75% to close at $4.12 per share. The stock currently trades at $2.63 per share.

    Acer Therapeutics Inc. (ACER) Shareholders Have Legal Options

    Contact us to learn more:

    Leo Kandinov

    (800) 350-6003



    Shareholder Information Form

    Robbins Arroyo LLP is a nationally recognized leader in shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested. Click here to receive free alerts from Stock Watch when companies engage in wrongdoing.

    Attorney Advertising. Past results do not guarantee a similar outcome.

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  24. NEW YORK, Aug. 29, 2019 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of Acer Therapeutics Inc. (NASDAQ:ACER) from September 25, 2017 through June 24, 2019, inclusive (the "Class Period"). The lawsuit seeks to recover damages for Acer investors under the federal securities laws.

    Rosen Law Firm, P.A. Logo

    To join the Acer class action, go to http://www.rosenlegal.com/cases-register-1611.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email or for information on the class action.

    NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU…

    NEW YORK, Aug. 29, 2019 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of Acer Therapeutics Inc. (NASDAQ:ACER) from September 25, 2017 through June 24, 2019, inclusive (the "Class Period"). The lawsuit seeks to recover damages for Acer investors under the federal securities laws.

    Rosen Law Firm, P.A. Logo

    To join the Acer class action, go to http://www.rosenlegal.com/cases-register-1611.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email or for information on the class action.

    NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR'S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

    According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Acer lacked sufficient data to support filing EDSIVO's New Drug Application ("NDA") with the FDA for the treatment of vEDS; (2) the Ong Trial, a 2004 study Acer heavily relied on its submission of EDSIVO's NDA, was an inadequate and ill-controlled clinical study by FDA standards, and was comprised of an insufficiently small group size to support EDSIVO's NDA; (3) consequently, the FDA would likely reject EDSIVO's NDA; and (4) as a result, defendants' statements about Acer's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

    A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 30, 2019. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1611.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at or .

    Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

    Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013.   Rosen Law Firm has secured hundreds of millions of dollars for investors. 

    -------------------------------

    Contact Information:

          Laurence Rosen, Esq.
          Phillip Kim, Esq.
          The Rosen Law Firm, P.A.
          275 Madison Avenue, 34th Floor
          New York, NY  10016
          Tel: (212) 686-1060
          Toll Free: (866) 767-3653
          Fax: (212) 202-3827
         
         
         
          www.rosenlegal.com

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/acer-imminent-deadline-rosen-a-top-ranked-law-firm-announces-filing-of-securities-class-action-lawsuit-against-acer-therapeutics-inc-important-august-30th-deadline--acer-300909201.html

    SOURCE Rosen Law Firm, P.A.

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  25. Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all investors that purchased Acer Therapeutics, Inc. (NASDAQ:ACER) securities between September 25, 2017 and June 24, 2019 (the "Class Period"). Investors have until August 30, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

    Click here to participate in the action.

    The complaint, filed on July 1, 2019, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the company's business, operational and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed…

    Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all investors that purchased Acer Therapeutics, Inc. (NASDAQ:ACER) securities between September 25, 2017 and June 24, 2019 (the "Class Period"). Investors have until August 30, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

    Click here to participate in the action.

    The complaint, filed on July 1, 2019, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the company's business, operational and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) Acer lacked sufficient data to support filing EDSIVO's NDA with the FDA for the treatment of vEDS; (ii) the Ong Trial was an inadequate and ill-controlled clinical study by FDA standards, and was comprised of an insufficiently small group size to support EDSIVO's NDA; (iii) consequently, the FDA would likely reject EDSIVO's NDA; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.

    If you purchased Acer Therapeutics securities during the Class Period, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at , or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

    Bragar Eagel & Squire, P.C. is a New York-based law firm concentrating in commercial and securities litigation. For additional information concerning the Acer lawsuit, please go to https://bespc.com/Acer. For additional information about Bragar Eagel & Squire, P.C. please go to www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

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  26. The law firm of Kessler Topaz Meltzer & Check, LLP reminds Acer Therapeutics, Inc. (NASDAQ:ACER) ("Acer") investors that a securities fraud class action lawsuit has been filed on behalf of those who purchased or otherwise acquired Acer securities between September 25, 2017 and June 24, 2019, inclusive (the "Class Period").

    REMINDER: Investors who purchased Acer securities during the Class Period may, no later than August 30, 2019, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation please visit www.ktmc.com/acer-therapeutics-inc-securities-class-action.

    According to the complaint, Acer is a pharmaceutical company that focuses on the acquisition…

    The law firm of Kessler Topaz Meltzer & Check, LLP reminds Acer Therapeutics, Inc. (NASDAQ:ACER) ("Acer") investors that a securities fraud class action lawsuit has been filed on behalf of those who purchased or otherwise acquired Acer securities between September 25, 2017 and June 24, 2019, inclusive (the "Class Period").

    REMINDER: Investors who purchased Acer securities during the Class Period may, no later than August 30, 2019, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation please visit www.ktmc.com/acer-therapeutics-inc-securities-class-action.

    According to the complaint, Acer is a pharmaceutical company that focuses on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases. Acer's pipeline includes, inter alia, EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome ("vEDS") in patients with a confirmed type III collagen mutation. vEDS is a rare disease known to cause abnormal fragility in blood vessels, causing aneurysms, arteriovenous fistulas, arterial dissections, and spontaneous vascular ruptures, all of which are potentially life-threatening. In 2004, the French research hospital, Assistance Publique—Hôpitaux de Paris, Hôpital Européen Georges Pompidou ("AP-HP"), published data on vEDS patients. Based on AP-HP's research, investigators began assessing the preventive effect of celiprolol for major cardiovascular events in patients suffering from vEDS "through a multicenter, prospective, randomized, open trial with blinded evaluation of clinical events" (the "Ong Trial"). The Ong Trial was composed of fifty-three participants "randomized at eight centers in France and one center in Belgium." On December 13, 2016, Acer Therapeutics Inc. ("Private Acer") – a private Delaware corporation and Acer's predecessor – issued a press release announcing that it had signed an agreement with AP-HP, which granted exclusive rights to access and use data from the Ong Trial. Private Acer announced it would use this data to support its New Drug Application ("NDA") for celiprolol in the treatment of vEDS.

    The Class Period commences on September 25, 2017, when Acer issued a press release announcing "Positive Results From Pivotal Clinical Trial of EDSIVO" for the treatment of vEDS.

    According to the complaint, on June 25, 2019, Acer issued a press release disclosing that the U.S. Food and Drug Administration ("FDA") rejected Acer's NDA for EDSIVO. The press release cited the need for an "adequate and well-controlled trial" evaluating EDSIVO's effectiveness in reducing the risk of clinical events in patients with vEDS. That same day, Reuters published an article titled "FDA declines to approve Acer Therapeutics' rare genetic disorder treatment." In discussing the FDA's rejection of Acer's NDA, the article noted how "[t]he small group size" of the Ong Trial had "raised questions among experts about the adequacy of the trial results." Following this news, Acer's stock price fell $15.16 per share, or 78.63%, to close at $4.12 per share on June 25, 2019.

    The complaint alleges that, throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (i) Acer lacked sufficient data to support filing EDSIVO's NDA with the FDA for the treatment of vEDS; (ii) the Ong Trial was an inadequate and ill-controlled clinical study by FDA standards, and was comprised of an insufficiently small group size to support EDSIVO's NDA; (iii) consequently, the FDA would likely reject EDSIVO's NDA; and (iv) as a result, Acer's public statements were materially false and misleading at all relevant times.

    Investors who wish to discuss this securities fraud class action lawsuit and their legal options are encouraged to contact Kessler Topaz Meltzer & Check, LLP (James Maro, Jr., Esq. or Adrienne Bell, Esq.) at (844) 887-9500 (toll free) or at .

    Acer investors may, no later than August 30, 2019, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

    Kessler Topaz Meltzer & Check prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check. For more information about Kessler Topaz Meltzer & Check, please visit www.ktmc.com.

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  27. NEW YORK, Aug. 27, 2019 /PRNewswire/ -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Acer Therapeutics Inc. ("Acer" or the "Company") (NASDAQ: ACER) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Acer securities purchased between September 25, 2017 and June 24, 2019, inclusive (the "Class Period"). Such investors are encouraged to join this case by visiting the firm's site: www.bgandg.com/acer.  

    Bronstein, Gewirtz & Grossman, LLC

    This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws.

    The complaint alleges that throughout the Class Period, defendants made false and/or misleading statements…

    NEW YORK, Aug. 27, 2019 /PRNewswire/ -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Acer Therapeutics Inc. ("Acer" or the "Company") (NASDAQ: ACER) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Acer securities purchased between September 25, 2017 and June 24, 2019, inclusive (the "Class Period"). Such investors are encouraged to join this case by visiting the firm's site: www.bgandg.com/acer.  

    Bronstein, Gewirtz & Grossman, LLC

    This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws.

    The complaint alleges that throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) Acer lacked sufficient data to support filing EDSIVO's NDA with the FDA for the treatment of vEDS; (2) the Ong Trial was an inadequate and ill-controlled clinical study by FDA standards, and was comprised of an insufficiently small group size to support EDSIVO's NDA; (3) consequently, the FDA would likely reject EDSIVO's NDA; and (4) as a result, the Company's public statements were materially false and misleading at all relevant times.

    On June 25, 2019, Acer issued a press release titled "Acer Therapeutics Receives Complete Response Letter from U.S. FDA for use of EDSIVO™ (celiprolol) in vEDS Patients" (the "June 2019 Press Release").  In the June 2019 Press Release, Acer disclosed receipt of a Complete Response Letter ("CRL") from the FDA regarding its NDA for EDSIVO for the treatment of vEDS.  Acer advised investors that "[t]he CRL states that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS" and that "Acer plans to request a meeting to discuss the FDA's response." That same day, news sources reported that the small group size of the Ong Trial had raised questions among experts about the adequacy of EDSIVO's trial results. Following this news, Acer's stock price fell $15.16 per share, or 78.63%, to close at $4.12 per share on June 25, 2019.

    If you wish to review a copy of the Complaint you can visit the firm's site: www.bgandg.com/acer or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss in Acer you have until August 30, 2019 to request that the Court appoint you as lead plaintiff.  A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

    Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique.  Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients.  In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.

    Contact:
    Bronstein, Gewirtz & Grossman, LLC
    Peretz Bronstein or Yael Hurwitz
    212-697-6484 |

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/final-deadline---acer-therapeutics-inc-acer----bronstein-gewirtz--grossman-llc-reminds-shareholders-of-class-action-and-lead-plaintiff-deadline-august-30-2019-300906634.html

    SOURCE Bronstein, Gewirtz & Grossman, LLC

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  28. NEWTON, Mass., Aug. 27, 2019 (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 announced that Acer's management team will provide a corporate overview at the 21st Annual H.C. Wainwright Global Investment Conference being held at the Lotte New York Palace Hotel in New York City on Tuesday, September 10, 2019.

    21st Annual H.C. Wainwright Global Investment Conference Details
    Date: Tuesday, September 10, 2019
    Time: 2:35 pm ET
    Location: The Lotte Hotel, New York
    Webcast: http://wsw.com/webcast/hcw5/acer/

    About Acer Therapeutics
    Acer is a pharmaceutical…

    NEWTON, Mass., Aug. 27, 2019 (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 announced that Acer's management team will provide a corporate overview at the 21st Annual H.C. Wainwright Global Investment Conference being held at the Lotte New York Palace Hotel in New York City on Tuesday, September 10, 2019.

    21st Annual H.C. Wainwright Global Investment Conference Details
    Date: Tuesday, September 10, 2019
    Time: 2:35 pm ET
    Location: The Lotte Hotel, New York
    Webcast: http://wsw.com/webcast/hcw5/acer/

    About Acer Therapeutics
    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 three clinical-stage candidates: EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. Acer's product candidates are 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.

    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 regarding strategy, future operations, future financial position, future revenues, projected expenses, regulatory actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding our capital resources; the anticipated future reduction in operating and cash conservation benefits associated with our corporate restructuring initiative; the potential for EDSIVO™ (celiprolol), ACER-001 and osanetant to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; our progress toward possible approval for EDSIVO™; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. 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 and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, our ability to reduce our operating expenses and conserve cash on a net basis as a result of our prior or any future corporate restructuring initiative, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management's attention and resources which could result from securities class action litigation, risks related to the drug development and the regulatory approval process, including the timing of regulatory actions, and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

    Investor Contact:

    Hans Vitzthum
    LifeSci Advisors
    Ph: 617-535-7743

    Jim DeNike
    Acer Therapeutics Inc.
    Ph: 844-902-6100

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  29. NEW YORK, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C. reminds investors that class action lawsuits have been commenced on behalf of stockholders of Fred's, Inc. (NASDAQ:FRED), Acer Therapeutics, Inc. (NASDAQ:ACER), Diebold Nixdorf, Inc. (NYSE:DBD), and Intelligent Systems Corporation (NYSE:INS). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

    Fred's, Inc. (NASDAQ:FRED)

    Lead Plaintiff Deadline: August 26, 2019

    Class Period: December 20, 2016 to June 28, 2017

    The complaint, filed on June 27, 2019, alleges that Walgreens Boots Alliance, Inc. ("Walgreens"), the Company and certain of their respective officers…

    NEW YORK, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C. reminds investors that class action lawsuits have been commenced on behalf of stockholders of Fred's, Inc. (NASDAQ:FRED), Acer Therapeutics, Inc. (NASDAQ:ACER), Diebold Nixdorf, Inc. (NYSE:DBD), and Intelligent Systems Corporation (NYSE:INS). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

    Fred's, Inc. (NASDAQ:FRED)

    Lead Plaintiff Deadline: August 26, 2019

    Class Period: December 20, 2016 to June 28, 2017

    The complaint, filed on June 27, 2019, alleges that Walgreens Boots Alliance, Inc. ("Walgreens"), the Company and certain of their respective officers issued false and misleading statements and/or failed to disclose, among other things, the level of regulatory risk faced by the original and revised mergers pursuant to which Walgreens would acquire Rite Aid Corp. ("Rite Aid") (the "Original Merger").  Walgreens and Rite Aid had entered into an agreement with Fred's to sell 865 Rite Aid stores for $950 million in an all-cash transaction in order to complete the Original Merger (the "Fred's Asset Purchase Agreement").

    On January 30, 2017, Rite Aid and Walgreens announced that they had entered into a new merger agreement (the "Revised Merger").  On June 29, 2017, Rite Aid and Walgreens announced that they had terminated the Revised Merger.  Following the termination of the Revised Merger, Walgreens terminated the Fred's Asset Purchase Agreement.

    Defendants made materially false and misleading statements concerning the level of regulatory risk faced by the Original Merger and the Revised Merger which would ultimately cause the termination of the Fred's Asset Purchase Agreement. Specifically, defendants made false and/or misleading statements: (i) downplaying or disputing contrary reports from journalists signaling regulatory turbulence in closing the Original Merger, as well as, the Revised Merger; and (ii) representing that inside knowledge of the FTC gave confidence that the deal would close.

    On this news, Fred's stock price dropped $2.78 per share or over 22.8% from $12.20 per share to close at $9.41 per share on June 29, 2017. The Company's stock price continued to fall over the following months, closing at $6.60 per share on September 27, 2017.

    To learn more about the Fred's class action go to: https://bespc.com/fred

    Acer Therapeutics, Inc. (NASDAQ:ACER)

    Lead Plaintiff Deadline: August 30, 2019

    Class Period: September 25, 2017 to June 24, 2019

    The complaint, filed on July 1, 2019, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the company's business, operational and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) Acer lacked sufficient data to support filing EDSIVO's NDA with the FDA for the treatment of vEDS; (ii) the Ong Trial was an inadequate and ill-controlled clinical study by FDA standards, and was comprised of an insufficiently small group size to support EDSIVO's NDA; (iii) consequently, the FDA would likely reject EDSIVO's NDA; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.

    To learn more about the Acer class action go to https://bespc.com/Acer

    Diebold Nixdorf, Inc. (NYSE:DBD)

    Lead Plaintiff Deadline: September 3, 2019

    Class Period: February 14, 2017 to July 4, 2017

    The complaint, filed on July 2, 2019, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company was experiencing delays in systems rollouts as well as a longer customer decision-making process and order-to-revenue conversion cycle; (ii) the foregoing issues were negatively impacting the Company's services business and operations; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times. On July 5, 2017, Diebold disclosed that the Company expected a wider net loss than indicated in its prior guidance for fiscal 2017, from a range of $50 to $75 million to a range of $110 to $125 million net loss.

    The Company attributed the lowered expectations to a delay in systems rollouts as well as a longer customer decision-making process and order-to-revenue conversion cycle. Following this news, Diebold's stock price fell $6.40 per share, or nearly 23%, to close at $21.60 per share on July 5, 2017

    To learn more about the Diebold Nixdorf class action go to: https://bespc.com/dbd

    Intelligent Systems Corporation (NYSE:INS)

    Lead Plaintiff Deadline: September 9, 2019

    Class Period: January 23, 2019 to May 29, 2019

    The complaint, filed on July 9, 2019, alleges that throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (1) Defendant Petit, the "financial expert" on Intelligent Systems' Audit Committee engaged in accounting fraud as the CEO of MiMedx Group, Inc.; (2) Intelligent Systems' CEO, Defendant Strange, engaged in undisclosed related-party transactions with Defendant Petit and others and had an undisclosed personal relationship with the Company's auditor; (3) Intelligent Systems had its employees set up or take control of shell companies in Asia so they could partake in undisclosed related-party transactions for the purpose of either fabricating revenue for the Company and/or siphoning money out of the Company; and (4) as a result, defendants' statements about Intelligent Systems' business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

    For more information on the Intelligent Systems class action go to: https://bespc.com/INS

    Bragar Eagel & Squire, P.C. is a New York-based law firm concentrating in commercial and securities litigation. For additional information about Bragar Eagel & Squire, P.C. please go to www.bespc.com. Attorney advertising.  Prior results do not guarantee similar outcomes.

    Contacts
    Bragar Eagel & Squire, P.C.
    Brandon Walker, Esq.
    Melissa Fortunato, Esq.
    (212) 355-4648

    www.bespc.com

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