Acer Therapeutics Inc (fka ACER)

[alchemytrader]

Swinging 2.30. Goal: 3.00.

[INFINITI]

Wow Amazing

[TheFinalCD]

Acer Therapeutics and Relief Therapeutics today announced FDA acceptance for filing of New Drug Application for ACER-001 to treat Urea Cycle Disorders. PDUFA target action date set for June 5, 2022. https://tinyurl.com/ymd4nbmd #AcerTherapeutics #UCDs #investigational

Acer Therapeutics and Relief Therapeutics today announced FDA acceptance for filing of New Drug Application for ACER-001 to treat Urea Cycle Disorders. PDUFA target action date set for June 5, 2022. https://t.co/6EFdcJhsYU #AcerTherapeutics #UCDs #investigational

— Acer Therapeutics (@AcerTherapeutic) October 6, 2021

[INFINITI]

Oops wrong board sorry

[INFINITI]

Voyager said it will receive $30 million upfront and is entitled to receive up to $20 million in exercise fees for two options, exercisable by Pfizer within 12 months of signing. The company said it will also be eligible to earn up to $580 million in total development, regulatory, and commercial milestones associated with licensed products incorporating the two undisclosed Pfizer transgenes together with a Voyager licensed capsid. Voyager is eligible to receive mid- to high-single-digit tiered royalties based on net sales of Pfizer's products incorporating the licensed capsids.

Voyager shares were up 44% to $3.56 in premarket trading.

[duderaja]

What suddenly happened? Just jumped from 2.8 to 3.05, now drifting back down. Games!!!

[INFINITI]

Looks good here $$$$

[jedijazz]

$ACER Acer Therapeutic's pipeline includes the program ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) & Maple Syrup Urine Disease (MSUD)

https://acertx.com/rare-disease-research/

[jedijazz]

Good morning $ACER!

[jedijazz]

“This quarter marks significant, meaningful progress across our entire pipeline, including the very recent submission of our NDA for ACER-001 for the treatment of UCDs,” said Chris Schelling, CEO and Founder of Acer. “As we anticipate working closely with the FDA on the review process for ACER-001, we continue to make significant progress across the rest of our pipeline, including preparation of two IND submissions targeted for Q4 of this year. These INDs are expected to support initiating a dose-ranging Phase 2a study for ACER-801 (osanetant) for the treatment of vasomotor symptoms, and a pivotal Phase 3 study for EDSIVO™ for the treatment of COL3A1+ vEDS. On the corporate front, we have enhanced our management team with four important senior-level hires across their respective disciplines, including program and alliance management, marketing, and clinical development. I warmly welcome our new team members, who bring deep industry knowledge and tremendous experience, and look forward to their contributions as we position ourselves for growth.” $ACER

[jedijazz]

News: Acer Therapeutics Reports Q2 2021 Financial Results and Provides Corporate Update
Acer Therapeutics Inc.
Tue, August 10, 2021, 4:05 PM·11 min read

NEWTON, Mass., Aug. 10, 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 second quarter ended June 30, 2021 and provided an update on the Company’s recent corporate developments.

“This quarter marks significant, meaningful progress across our entire pipeline, including the very recent submission of our NDA for ACER-001 for the treatment of UCDs,” said Chris Schelling, CEO and Founder of Acer. “As we anticipate working closely with the FDA on the review process for ACER-001, we continue to make significant progress across the rest of our pipeline, including preparation of two IND submissions targeted for Q4 of this year. These INDs are expected to support initiating a dose-ranging Phase 2a study for ACER-801 (osanetant) for the treatment of vasomotor symptoms, and a pivotal Phase 3 study for EDSIVO™ for the treatment of COL3A1+ vEDS. On the corporate front, we have enhanced our management team with four important senior-level hires across their respective disciplines, including program and alliance management, marketing, and clinical development. I warmly welcome our new team members, who bring deep industry knowledge and tremendous experience, and look forward to their contributions as we position ourselves for growth.”

Q2 2021 and Recent Highlights

ACER-001 (sodium phenylbutyrate)

Following completion of a Q2 2021 pre-NDA meeting with the U.S. Food and Drug Administration (FDA), submitted a New Drug Application (NDA) in August 2021 for ACER-001 for the treatment of Urea Cycle Disorders (UCDs)

Reached agreement with FDA on the Company’s initial Pediatric Study Plan (iPSP) which outlines an approach that addresses the needs of pediatric patients with UCDs

ACER-801 (osanetant)

Continued to advance toward an Investigational New Drug Application (IND) submission for the treatment of vasomotor symptoms (VMS)

EDSIVO™ (celiprolol)

Following completion of a Type B meeting with FDA, in June 2021 Acer announced plans to conduct a pivotal Phase 3, randomized, double-blind, placebo-controlled, decentralized clinical trial for EDSIVO™ for patients with COL3A1+ vascular Ehlers-Danlos Syndrome (vEDS), subject to available capital

The DiSCOVER (Decentralized Study of Celiprolol on vEDS-related Event Reduction) trial is estimated to take approximately 3.5 years to complete, once fully enrolled

FDA indicated agreement with Acer’s plans to submit a proposed protocol under the IND Special Protocol Assessment (SPA) process with possible breakthrough designation

Launched www.discoverceliprolol.com as an outreach tool for interested parties

Corporate

Hired Tanya Hayden, Vice President of Program and Strategic Alliance Management, in June 2021. During her nearly 20-year tenure at Lonza (formerly Bend Research/Capsugel), Ms. Hayden was responsible for oral drug delivery technologies, clinical and commercial contract manufacturing, operational excellence and client-focused project management

Hired John Hilton, Vice President of Marketing and Strategic Insights, in July 2021. Mr. Hilton brings over 20 years of biopharmaceutical industry experience including marketing, sales, KOL development, pipeline marketing, and access strategy functions, as well as oversight of launch planning for ten new products in the last ten years

Hired Terrie Kellmeyer, Ph.D., Vice President of Clinical Development, in August 2021. Dr. Kellmeyer brings to Acer over 23 years of experience in the pharmaceutical industry spanning the areas of Clinical Development, Regulatory Affairs, Medical Writing and Medical Affairs

Hired Jeffrey Edwards, Ph.D., Vice President of Clinical Sciences, in August 2021. Dr. Edwards brings to Acer over 16 years of pharmaceutical experience in clinical and preclinical studies and support for regulatory submissions

Ended Q2 2021 with $22.1 million in cash and cash equivalents. Acer believes its cash and cash equivalents available as of June 30, 2021, plus a $10.0 million Second Development Payment conditioned upon FDA accepting an NDA for ACER-001 in a UCD for filing and review per the Collaboration Agreement with Relief Therapeutics, will be sufficient to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for the planned ACER-801 and EDSIVO™ clinical trials

Anticipated Milestones

ACER-001 (sodium phenylbutyrate)

Q4 2021: Based on standard FDA review timelines, Acer expects to receive notification from FDA on the potential acceptance of the NDA for filing within 60 days of submission and subsequent substantive review

ACER-001 is an investigational product candidate which has not been approved by FDA. There is no guarantee that this product candidate will be accepted for substantive review, or if accepted, receive regulatory authority approval in any territory, or become commercially available for the indications under investigation

ACER-801 (osanetant)

Q4 2021: IND submission for the treatment of VMS is anticipated in Q4 2021

Q1 2022: Phase 2a clinical trial initiation is expected in Q1 2022 designed to evaluate ACER-801’s PK, efficacy and safety in postmenopausal women and to identify the optimal dosing strategy for subsequent efficacy studies in certain cancer patients with induced vasomotor symptoms (iVMS), dependent upon successful IND submission and clearance, and subject to additional capital

EDSIVO™ (celiprolol)

Q4 2021: Submission of the proposed EDSIVO™ pivotal trial protocol and IND, request for breakthrough therapy designation, coordination with FDA on SPA agreement, and beginning to identify COL3A1+ vEDS patients for potential trial participation are anticipated in Q4 2021

Q1 2022: Initiation of the EDSIVO™ DiSCOVER pivotal clinical trial is expected in Q1 2022 subject to successful IND submission and clearance, FDA SPA agreement, and obtaining additional capital required to conduct and complete the trial

ACER-2820 (emetine)

Ongoing: With most of the emetine IND-enabling work complete, further advancement of the emetine program for treatment of certain infectious diseases, including COVID-19, is dependent on Acer’s ability to raise non-dilutive capital

Q2 2021 Financial Results

Cash position. Cash and cash equivalents were $22.1 million as of June 30, 2021, compared to $5.8 million as of December 31, 2020. Acer believes its cash and cash equivalents available as of June 30, 2021, plus a $10.0 million Second Development Payment conditioned upon FDA accepting an NDA for ACER-001 in a UCD for filing and review per the Collaboration Agreement with Relief Therapeutics, will be sufficient to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-801 and EDSIVO™ clinical trials.

Research and Development Expenses. Research and development expenses were $1.5 million, net of collaboration funding of $0.9 million for the three months ended June 30, 2021, as compared to $2.8 million for the three months ended June 30, 2020. This decrease of $1.3 million was primarily due to the recognition of the $0.9 million of collaboration funding from the Collaboration Agreement with Relief, as well as a decrease in expenses for contract research and contract manufacturing, partially offset by an increase in consulting and professional fees. Research and development expenses for the three months ended June 30, 2021 were comprised of $1.1 million related to ACER-001, offset by $0.9 million of collaboration funding; $0.5 million related to emetine; $0.3 million related to ACER-801; $0.3 million related to EDSIVOTM; and $0.2 million related to other development activities.

General and Administrative Expenses. General and administrative expenses were $2.3 million, net of collaboration funding of $0.5 million for the three months ended June 30, 2021, as compared to $3.0 million for the three months ended June 30, 2020. This decrease of $0.7 million was primarily due to the recognition of the $0.5 million of collaboration funding from the Collaboration Agreement with Relief, as well as a reduction in one-time costs related to the Lincoln Park agreement recognized in 2020, partially offset by an increase in employee-related expenses.

Net Loss. Net loss for the three months ended June 30, 2021 was $3.2 million, or $0.23 net loss per share (basic and diluted), compared to a net loss of $5.8 million, or $0.56 net loss per share (basic and diluted), for the three months ended June 30, 2020.

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: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced vasomotor symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of 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. In March 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for development and commercialization of ACER-001. 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, 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
[e-mail]

Jim DeNike
Acer Therapeutics Inc.
Ph: 844-902-6100
[e-mail]

[StockHighAlert-]

$ACER News! ~ Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S. FDA for ACER-001 for Treatment of Urea Cycle Disorders https://finance.yahoo.com/news/acer-therapeutics-relief-therapeutics-announce-123000017.html

[jedijazz]

"The submission of our NDA for ACER-001 marks an important step toward bringing this potential alternative treatment option to patients with UCDs," said Chris Schelling, Chief Executive Officer and Founder of Acer . "We look forward to working with the FDA through the review process and will continue advancing our preparations for a potential launch of ACER-001, while also assisting Relief toward regulatory submissions in Europe."

Jack Weinstein, Chief Financial Officer and Treasurer of Relief Therapeutics , added, "We are excited about the progress made to date in support of a potential regulatory approval of ACER-001 for UCDs in the U.S. With the NDA now submitted, we will continue our efforts to back ACER-001's development in Europe by targeting submission of a Marketing Authorization Application (MAA) for the treatment of UCDs in Europe by the end of 2021."

$ACER

[jedijazz]

NEWS: RELIEF THERAPEUTICS Holdings AG: Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S. FDA for ACER-001 for Treatment of Urea Cycle Disorders
Mon, August 9, 2021, 1:30 AM

NEWTON, MA and GENEVA, SWITZERLAND / ACCESSWIRE / August 9, 2021 / 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, and RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs). ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

Based on standard FDA review timelines, Acer expects to receive notification from FDA on the potential acceptance of the NDA for filing within 60 days of submission and subsequent substantive review.

The 505(b)(2) NDA submission is supported by results from two previously announced bioequivalence (BE) trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to BUPHENYL(R) (sodium phenylbutyrate). Acer has also received an Agreement Letter from FDA in response to the Company's initial Pediatric Study Plan (iPSP) which outlines an agreed upon approach that addresses the needs of pediatric patients with UCDs.

"The submission of our NDA for ACER-001 marks an important step toward bringing this potential alternative treatment option to patients with UCDs," said Chris Schelling, Chief Executive Officer and Founder of Acer . "We look forward to working with the FDA through the review process and will continue advancing our preparations for a potential launch of ACER-001, while also assisting Relief toward regulatory submissions in Europe."

Jack Weinstein, Chief Financial Officer and Treasurer of Relief Therapeutics , added, "We are excited about the progress made to date in support of a potential regulatory approval of ACER-001 for UCDs in the U.S. With the NDA now submitted, we will continue our efforts to back ACER-001's development in Europe by targeting submission of a Marketing Authorization Application (MAA) for the treatment of UCDs in Europe by the end of 2021."

ACER-001 is an investigational product candidate which has not been approved by FDA or the European Medicines Agency (EMA). There is no guarantee that this product candidate will be accepted for substantive review, or if accepted, receive regulatory authority approval in any territory, or become commercially available for the indications under investigation.

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 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, 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, frequency with which medication must be taken, required number of pills, and the high cost of the medication. 3

ABOUT ACER-001
ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste in the mouth while quickly dissolving in the low pH of the stomach. ACER-001's taste-masked formulation is aimed to improve the palatability of sodium phenylbutyrate. Acer is also being developed for Maple Syrup Urine Disease (MSUD) and has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is an investigational product candidate which has not been approved by FDA or the European Medicines Agency (EMA).

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

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(TM) (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 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. In addition, Relief's recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

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 .

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.

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 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, 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 .

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(TM) (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.

CORPORATE CONTACTS

Acer Therapeutics Inc.

Jim DeNike
[phone]
[e-mail]

INVESTOR RELATION CONTACTS

Acer Therapeutics Inc.
Hans Vitzthum
LifeSci Advisors
[phone]
[e-mail]

RELIEF THERAPEUTICS Holding AG

Jack Weinstein
Chief Financial Officer and Treasurer
[e-mail]

RELIEF THERAPEUTICS Holding AG
Michael Miller
Rx Communications Group
[phone]
[e-mail]

# # #

SOURCE: Relief Therapeutics Holdings AG



View source version on accesswire.com:
https://www.accesswire.com/658900/RELIEF-THERAPEUTICS-Holdings-AG-Acer-Therapeutics-and-Relief-Therapeutics-Announce-Submission-of-a-New-Drug-Application-to-the-US-FDA-for-ACER-001-for-Treatment-of-Urea-Cycle-Disorders

[jedijazz]

Good morning. Huge news out! $ACER

[ProfitScout]

$ACER is addressing some serious, rare and life-threatening diseases where other bio-tech companies are not working. It is very encouraging to see this company's products moving forward towards clinical trials as covered in recent news here:

ACER THERAPEUTICS PLANS CLINICAL TRIAL FOR EDSIVO(TM) (CELIPROLOL) FOLLOWING TYPE B FDA MEETING

Phase 3, randomized, double-blind, placebo-controlled, decentralized clinical trial estimated to take approximately 3.5 years to complete once fully enrolled

FDA indicates agreement with submission of proposed protocol under a Special Protocol Assessment (SPA) with possible breakthrough designation

NEWTON, Mass., June 10, 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 following a recent Type B meeting with the U.S. Food and Drug Administration (FDA) regarding Acer’s proposed EDSIVO™ (celiprolol) development plan, the company is now planning a pivotal clinical trial in patients with COL3A1+ vascular Ehlers-Danlos Syndrome (vEDS).

In the Type B meeting, Acer discussed conducting a U.S.-based prospective, randomized, double-blind, placebo-controlled, decentralized clinical trial in patients with COL3A1+ vEDS, and sought the Agency’s opinion on various proposed design features of the study. The official meeting minutes Acer recently received from the FDA confirm details of that discussion, including: the acceptability of a decentralized (virtual) clinical trial design and use of an independent centralized adjudication committee; acceptability of a primary endpoint based on clinical events associated with disease outcome; agreement with modest safety data collection (based on the known safety profile of the drug 1,2,3,4 ) and no pharmacokinetic (PK) data needing to be collected; and a statistical plan that considers the rare disease classification of vEDS.

In the second half of 2021, Acer intends to submit a protocol for the prospective study, along with an investigational new drug application (IND), request breakthrough therapy designation, and coordinate with FDA to reach agreement on a Special Protocol Assessment (SPA). Based on initial power calculations, Acer anticipates that the trial should enroll approximately 200 COL3A1+ vEDS patients in the U.S., and the duration of the clinical trial is estimated to be approximately 3.5 years to complete once fully enrolled.

“We appreciate the guidance and flexibility provided by FDA on the design of this proposed clinical trial,” said Chris Schelling, CEO and Founder of Acer. “This trial, along with the results from the prior BBEST trial 1 , should answer whether EDSIVO™ demonstrates substantial evidence of effectiveness by reducing vEDS-related events. Over the next six months, we intend to work closely with FDA to finalize the protocol for the pivotal trial, collaborate with vEDS advocacy groups to identify COL3A1+ patients who may be interested in participating in the trial in order to expedite enrollment, and achieve first patient dosed as quickly as possible. Our progress to date on the EDSIVO™ program is the direct result of our unwavering and ongoing commitment to patients with rare diseases. We look forward to continuing its development for treatment of vEDS patients who desperately need a therapy.”

For more information on the trial as it becomes available, please visit: www.discoverceliprolol.com .

The conduct and completion of the EDSIVO™ pivotal clinical trial is subject to Acer’s ability to obtain up to approximately $10 million of funding. Such funding may come from one or more of a number of current and future sources, including but not limited to current cash, a strategic partnership, other non-dilutive sources and potential ACER-001 revenue. Acer believes its cash and cash equivalents available as of March 31, 2021, plus up to $20.0 million of Development Payments per the ACER-001 Collaboration Agreement with Relief Therapeutics, are sufficient to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned EDSIVO™ and osanetant clinical trials.

EDSIVO™ is an investigational drug and is not currently FDA approved for any indication. There can be no assurance that the funding to conduct and complete the clinical trial will be obtained, that the clinical trial will be successful, or that the resubmission of the original New Drug Application will be approved.

About Breakthrough Therapy Designation
The FDA’s breakthrough therapy designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions. The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review. To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

About vEDS
Ehlers-Danlos syndrome (EDS) is an inherited disorder caused by mutations in the genes responsible for the structure, production, or processing of collagen, an important component of the connective tissues in the human body, or proteins that interact with collagen. EDS is a spectrum disorder where patients present with various forms, the most serious of which is vEDS, also known as EDS type IV, which is generally caused by a mutation in the COL3A1 gene. vEDS causes abnormal fragility in blood vessels, which can give rise to aneurysms, abnormal connections between blood vessels known as arteriovenous fistulas, arterial dissections, and spontaneous vascular ruptures, all of which can be potentially life-threatening. Gastrointestinal and uterine fragility or rupture also commonly occur in vEDS patients. Spontaneous arterial rupture has a peak incidence in the third or fourth decade of life in vEDS patients but may occur earlier and is the most common cause of sudden death in vEDS patients. Arterial rupture or dissection events occur in about 25% of patients before the age of 20 but increase to roughly 90% of patients by the age of 40. The median survival age of vEDS patients in the U.S. is 51 years, with arterial rupture being the most common cause of sudden death. 5

About EDSIVO™ (celiprolol)
Acer is developing EDSIVO™, a new chemical entity (NCE), for the treatment of COL3A1+ vEDS patients. Acer’s EDSIVO™ NDA was originally submitted based on data obtained from the BBEST trial 1 and accepted for filing in October 2018 with priority review. Following FDA review, Acer received a Complete Response Letter (CRL) stating 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. Acer subsequently appealed the FDA decision. While FDA denied the appeal, it described possible paths forward for Acer to explore. Following its Type B meeting with FDA in the second quarter of 2021, Acer has decided to conduct a clinical trial for EDSIVO™. There can be no assurance that the resulting data from the trial would be adequate to support approval of an NDA, although having a SPA agreement in place would indicate concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., conduct, entry criteria, dose selection, endpoints, and planned analyses) for a study intended to support a future marketing application.

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. In March 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for development and commercialization of ACER-001. For more information, visit www.acertx.com .

References

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.
Nawarskas J, et al. Cardiology in Review 2017;25: 247–253.
Frank M, et al. Vascular Ehlers-Danlos Syndrome: Long-Term Observational Study. J Am Coll Cardiol. 2019 Apr, 73 (15) 1948–1957.
Baderkhan, H, et al. Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome. European Journal of Vascular and Endovascular Surgery. November 20, 2020.
Pepin, et al. Survival is affected by mutation type and molecular mechanism in vascular Ehlers–Danlos syndrome (EDS type IV). Genet Med. 2014 Dec;16(12):881-8.
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 for clinical study enrollment or regulatory actions, or otherwise, 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 for EDSIVO™ or our other products; 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 Contacts:

Hans Vitzthum
LifeSci Advisors
Ph: 617-430-7578
[e-mail]

Jim DeNike
Acer Therapeutics Inc.
Ph: 844-902-6100
[e-mail]

[jedijazz]

$ACER Acer Therapeutics, Inc. is a pharmaceutical company. It engages in the acquisition, development and commercialization of therapies for medical needs. Its product pipeline includes ACER-001 Edsivo and ACER-2820. The Edsivo is a type of celiprolol for Vascular Ehlers-Danlos syndrome. The ACER-001 is for the treatment of urea cycle disorders and Maple Syrup Urine diseases. https://www.marketwatch.com/investing/stock/acer?mod=quote_search

[jedijazz]

Good morning $ACER

[jedijazz]

$ACER Acer Therapeutics plans clinical trial of Edsivo in connective-tissue disorder; Following a recent Type B meeting with the FDA, Acer Therapeutics (NASDAQ:ACER), plans to conduct clinical trial of Edsivo (celiprolol) in patients with COL3A1+ vascular Ehlers-Danlos Syndrome (vEDS). https://seekingalpha.com/news/3705018-acer-therapeutics-plans-clinical-trial-of-edsivo-in-connective-tissue-disorder

[oxnous]

Seems that biotechs that have no news lose the interest of investors. They want volatility

[deri21]

$ACER 50+ Companies to Present at the Access to Giving Virtual Investor Conference on July 13th - 15th, 2021 https://finance.yahoo.com/news/50-companies-present-access-giving-133500693.html

[deri21]

$ACER 4 Small Drug Stocks Set to Escape the COVID-Led Industry Weakness https://www.zacks.com/commentary/1741634/4-small-drug-stocks-set-to-escape-the-covid-led-industry-weakness?cid=CS-ZC-HL-industry_outlook-1741634

[deri21]

$ACER Good article
https://finance.yahoo.com/news/hedge-funds-think-acer-therapeutics-181156348.html

[conix]

In the second half of 2021, Acer intends to submit a protocol for the prospective study, along with an investigational new drug application (IND), request breakthrough therapy designation, and coordinate with FDA to reach agreement on a Special Protocol Assessment (SPA).

Based on initial power calculations, Acer anticipates that the trial should enroll approximately 200 COL3A1+ vEDS patients in the U.S., and the duration of the clinical trial is estimated to be approximately 3.5 years to complete once fully enrolled.

[deri21]

$ACER Acer Therapeutics Plans Clinical Trial for EDSIVO™ (celiprolol) Following Type B FDA Meeting https://finance.yahoo.com/news/acer-therapeutics-plans-clinical-trial-123000027.html

[deri21]

$ACER What Makes Opexa Therapeutics, Inc. (ACER) a New Buy Stock
https://finance.yahoo.com/news/makes-opexa-therapeutics-inc-acer-160004683.html

[deri21]

$ACER Ownership or on my watch list. Either way I never state my position.. 3 OR 4 drugs in pipeline sparked my interest as well the partnership with $RLFTF..

[I am done]

I don't read charts well... what is this saying?

[conix]

Could you list me three things about ACER that makes you an owner of the shares?

TIA

[deri21]

$ACER Thank you..

[conix]

ACER Charts

[deri21]

$ACER Acer Therapeutics Plans NDA Submission for ACER-001 in Q3 2021 Following Pre-NDA Meeting with FDA https://finance.yahoo.com/news/acer-therapeutics-plans-nda-submission-123000292.html

[conix]

ACER Chart

[J-Belfort]

Trending up, big movement will come in time

[deri21]

$ACER Relief Provides Update on Progress and Plans with ACER-001 for the Treatment of Urea Cycle Disorders https://www.marketbeat.com/stocks/NASDAQ/ACER/?RegistrationCode=SocialMedia-StockTwits&utm_source=GeneralSocialMedia&utm_medium=Social&utm_campaign=SocialMedia

[deri21]

$ACER Acer Therapeutics Stock Forecast, Price & News
*Acer Therapeutics (NASDAQ:ACER) Receives Market Perform Rating from William Blair
https://www.marketbeat.com/stocks/NASDAQ/ACER/?RegistrationCode=SocialMedia-StockTwits&utm_source=GeneralSocialMedia&utm_medium=Social&utm_campaign=SocialMedia

[deri21]

$ACER Acer Therapeutics EPS beats by $0.30, beats on revenue
https://seekingalpha.com/news/3697410-acer-therapeutics-eps-beats-0_30-beats-on-revenue?utm_source=quotemedia.com&utm_medium=referra

[4570govt]

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS


NOTICE TO CURRENT ACER THERAPEUTICS INC. STOCKHOLDERS

TO:


ALL CURRENT OWNERS OF ACER THERAPEUTICS INC. (“ACER” OR THE “COMPANY”) COMMON STOCK (TICKER SYMBOL: ACER) AS OF DECEMBER 29, 2020, WHO CONTINUE TO OWN SUCH SHARES (“CURRENT ACER STOCKHOLDERS”).



PLEASE READ THIS NOTICE CAREFULLY AND IN ITS ENTIRETY. THIS NOTICE RELATES TO A PROPOSED SETTLEMENT AND DISMISSAL OF STOCKHOLDER DERIVATIVE LITIGATION AND CONTAINS IMPORTANT INFORMATION REGARDING YOUR RIGHTS.



IF THE COURT APPROVES THE SETTLEMENT, YOU WILL BE FOREVER BARRED FROM CONTESTING THE APPROVAL OF THE PROPOSED SETTLEMENT AND FROM PURSUING RELEASED CLAIMS.



THIS ACTION IS NOT A “CLASS ACTION.” THUS, THERE IS NO COMMON FUND UPON WHICH YOU CAN MAKE A CLAIM FOR A MONETARY PAYMENT.

[4570govt]

NOTICE to ACER stock owners

https://finance.yahoo.com/news/notice-settlement-derivative-suits-200500675.html

[4570govt]

Sold 25 Apr call contracts when the March calls expired worthless. Looks like these will expire worthless too.

I'll repeat this until it turns around. Then I'll sell puts.

[bridgrace]

JB,
Any thoughts about what the price would be for ACER by RLFTF>

[ClayTrader]

* * $ACER Video Chart 03-15-2021 * *

Link to Video - click here to watch the technical chart video

[green maschine]

I meant EOW

[green maschine]

It went to $7.38 in early morning trading. It'll return there by EOD.

[green maschine]

Nice play. We got GOLD here!

[4570govt]

I bought ACER at $4.55 and sold March $5 calls for 95¢. I'll be happy if they're called away at the end of this week.

I'll be even happier if they're not called. I'll increase my position and sell more calls.

[green maschine]

Q4 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. And in return, Acer received a $1 million upfront nonrefundable payment and a $4 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”

?- 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...

[color=greenFull Story: https://pulse2.com/acer-stock-price-nasdaq-acer-therapeutics-increases-over-100-pre-market-what-you-should-know-about-the-company/][/color]

[Spuds McKenz66]

thanks ACER

[J-Belfort]

Multiple drugs in pipeline, some near approval. Discussions about Relief therapeutics possible acquisition due to profit sharing option/agreement.

[Spuds McKenz66]

y the jump here ACER