Acer Therapeutics

Acer Therapeutics, Inc. is a pharmaceutical company. engages in 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. The company was founded on March 15, 1991 and is headquartered in Newton, MA.

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Acer Therapeutics is a pharmaceutical company that focuses on the acquisition, development, and commercialization of therapies for serious, rare, and life-threatening diseases with unmet medical needs. Its 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).  The company was founded in 2013 and is headquartered in Newton, Massachusetts.

POSH-MAP and PORT-MAP investigator-sponsored trials to evaluate ability of ACER-801 (osanetant) to reduce hot flashes and as neoadjuvant therapy in men with prostate cancer POSH-MAP and PORT-MAP investigator-sponsored trials to evaluate ability of ACER-801 (osanetant) to reduce hot flashes and as neoadjuvant therapy in men with prostate cancer

Acer Therapeutics Announces Initiation of Two Investigator-Sponsored Trials of ACER-801 (Osanetant) in Men with Adenocarcinoma of the Prostate

NEWTON, Mass., Dec. 29, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that The Nasdaq Stock Market LLC has formally notified Acer that the company has regained compliance with the $35 million market value of listed securities requirement, and otherwise satisfies all other criteria necessary, for continued listing on The Nasdaq Capital Market. Accordingly, the listing matter is now closed and the previously-scheduled hearing before the Nasdaq Hearings Panel has been cancelled.

Acer Therapeutics Compliant with All Nasdaq Listing Criteria

Acer Therapeutics Inc. (ACER) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).

Acer Therapeutics Inc. (ACER) Upgraded to Strong Buy: What Does It Mean for the Stock?

The FDA approves Acer Therapeutics' (ACER) Olpruva (sodium phenylbutyrate) to treat certain patients with urea cycle disorders. Share price falls 33.3% following the announcement.

ACER Down Despite FDA Nod for Urea Cycle Disorders Drug

New FDA-approved formulation for patients living with urea cycle disorders

Acer Therapeutics and Relief Therapeutics Announce U.S. FDA Approval of OLPRUVA™ for Patients with Urea Cycle Disorders

Here is how Acer Therapeutics Inc. (ACER) and Cardinal Health (CAH) have performed compared to their sector so far this year.

Is Acer Therapeutics (ACER) Stock Outpacing Its Medical Peers This Year?

NEWTON, Mass., Nov. 30, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced that it has entered into definitive agreements with its CEO as well as its Chairman for a private placement of its securities for gross proceeds of $1.5 million.

Acer Therapeutics Announces $1.5M Private Placement

NEWTON, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2022 and provided an update on Acer's recent corporate developments.

Acer Therapeutics Reports Q3 2022 Financial Results and Provides Corporate Update

Notice of allowance of celiprolol method of treatment of vEDS patent application strengthens proprietary position in U.S. until 2038 Notice of allowance of celiprolol method of treatment of vEDS patent application strengthens proprietary position in U.S. until 2038

Acer Therapeutics Receives Notice of Allowance of Key US Patent Application Covering EDSIVO™ (celiprolol)

$3 million awarded to University of North Carolina (UNC) to support a proposed 180-patient, randomized, placebo-controlled trial in trauma patients

Acer Therapeutics Announces University of North Carolina Receives Department of Defense Grant to Support the Proposed Investigator Sponsored OASIS Trial of ACER-801 (Osanetant) to Reduce the Frequency and Severity of Post-Traumatic Stress Disorder

Licensed exclusive worldwide rights from Emory University to patents and patent applications for certain methods of treating or preventing post-traumatic stress disorder (PTSD) with osanetant

Acer Therapeutics Announces Expansion of ACER-801 (osanetant) Development Indications to Include Post-Traumatic Stress Disorder

Notice of allowance covering these claims further strengthens ACER-001 proprietary position in US; patent expected to be issued in Q4 2022 and expire in 2038 Notice of allowance covering these claims further strengthens ACER-001 proprietary position in US; patent expected to be issued in Q4 2022 and expire in 2038

Acer Therapeutics and Relief Therapeutics Announce Receipt of Notice of Allowance of US Patent Application Covering a Kit Comprising Phenylbutyrate and Sodium Benzoate

NEWTON, Mass., Aug. 23, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced that Acer's management team will virtually present at, and participate in, the upcoming Gilmartin Group Emerging Growth Company Showcase and H.C. Wainwright 24th Annual Global Investment Conference.

Acer Therapeutics to Participate in August and September 2022 Investor Conferences

NEWTON, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the second quarter ended June 30, 2022, and provided a corporate update.

Acer Therapeutics Reports Q2 2022 Financial Results and Provides Corporate Update

Orphan designation provides potential for up to 10-year market exclusivity in the EU upon regulatory approval Orphan designation provides potential for up to 10-year market exclusivity in the EU upon regulatory approval

Relief Therapeutics and Acer Therapeutics Announce that the European Commission Has Granted Orphan Drug Designation for ACER-001 in Maple Syrup Urine Disease

Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital

Acer Therapeutics and Relief Therapeutics Announce ACER-001 IND Submission for the Treatment of Maple Syrup Urine Disease

Prescription Drug User Fee Act (PDUFA) target action date set for January 15, 2023 Prescription Drug User Fee Act (PDUFA) target action date set for January 15, 2023

Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Review of NDA Resubmission for ACER-001 for Treatment of UCDs

Acer has notified the FDA in the resubmission that the third-party contract packaging manufacturer is ready for inspection Acer has notified the FDA in the resubmission that the third-party contract packaging manufacturer is ready for inspection

Acer Therapeutics Announces Resubmission of New Drug Application for ACER-001 for Treatment of UCDs

Key patent strengthens proprietary position in China until August 2031 Key patent strengthens proprietary position in China until August 2031

Acer Therapeutics and Relief Therapeutics Announce That the China National Intellectual Property Administration (CNIPA) Issued Utility Model Patent 11,202,767 Covering ACER-001 Dosage Form

Acer Therapeutics' (ACER) new drug application for ACER-001 to treat urea cycle disorders faces rejection from the FDA. Share price falls 21% following the announcement.

Acer Therapeutics (ACER) Gets CRL for Urea Cycle Disorders Drug

The FDA issued a Complete Response Letter regarding the marketing application for Acer Therapeutics Inc (NASDAQ: ACER) and its collaboration partner, Relief Therapeutics Holding SA's (OTC: RLFTF) ACER-001 (sodium phenylbutyrate), for urea cycle disorders (UCDs).

FDA Rejects Acer Therapeutics - Relief Therapeutics' Urea Cycle Disorder Candidate

NEWTON, Mass., June 21, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced the promotion of Tanya Hayden to Chief Operating Officer (COO). Harry S. Palmin, who had been serving as the Company's Chief Operating Officer as well as its Chief Financial Officer, will continue to serve as the Company's Chief Financial Officer.

Acer Therapeutics Announces Promotion of Tanya Hayden to Chief Operating Officer

Citing the need to inspect a third-party contract packaging manufacturer, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)

Acer Therapeutics and Relief Therapeutics Announce Update on U.S. FDA Review of New Drug Application (NDA) for ACER-001

NEWTON, Mass., June 07, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that it has not yet received a decision from the U.S. Food and Drug Administration (FDA) on its 505(b)(2) New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders (UCDs). The NDA for ACER-001 for UCDs was accepted for review by FDA on October 5, 2021 at which time FDA assigned a PDUFA target action date of Sunday, June 5, 2022. FDA has informed Acer that review for ACER-001 is ongoing and the agency currently does not have a set target date. Under the Prescription Drug User Fee Act (PDUFA), FDA's review performance goal is to review and act on 90 percent of NDA submissions by the target action date.

Acer Therapeutics Issues Statement Regarding PDUFA Target Action Date for ACER-001

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ACER, BBWI, and BDX have been added to the Zacks Rank #5 (Strong Sell) List on May 27, 2022.

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