View ValuationThis company has been acquiredThe company may no longer be operating, as it has been acquired. Find out why through their latest events.See Latest EventsAcer Therapeutics 将来の成長Future 基準チェック /56Acer Therapeuticsは、66.2%と50.8%でそれぞれ年率66.2%で利益と収益が成長すると予測される一方、EPSはgrowで70.9%年率。主要情報66.2%収益成長率70.86%EPS成長率Pharmaceuticals 収益成長14.6%収益成長率50.8%将来の株主資本利益率n/aアナリストカバレッジLow最終更新日05 Sep 2023今後の成長に関する最新情報Major Estimate Revision • May 23Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$2.25 to -US$2.52 per share. Revenue forecast of US$6.19m unchanged since last update. Pharmaceuticals industry in the US expected to see average net income growth of 9.5% next year. Consensus price target down from US$10.00 to US$9.67. Share price rose 9.7% to US$2.26 over the past week.Major Estimate Revision • Mar 09Consensus revenue estimates fall by 29%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$8.73m to US$6.19m. Forecast losses increased from -US$0.92 to -US$2.12 per share. Pharmaceuticals industry in the US expected to see average net income growth of 17% next year. Consensus price target down from US$10.33 to US$10.00. Share price was steady at US$2.42 over the past week.Breakeven Date Change • Jan 14No longer forecast to breakevenThe 2 analysts covering Acer Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$4.77m in 2023. New consensus forecast suggests the company will make a loss of US$11.0m in 2023.Major Estimate Revision • Aug 12Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$6.00m to US$2.67m. EPS estimate unchanged from -US$1.06 per share at last update. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 3.8% to US$2.44 over the past week.Major Estimate Revision • May 25Consensus revenue estimates increase to US$8.00mThe consensus outlook for revenues in 2021 has improved. 2021 revenue forecast increased from US$4.50m to US$8.00m. Forecast losses expected to reduce from -US$1.50 to -US$1.30 per share. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 6.7% to US$2.86 over the past week.すべての更新を表示Recent updatesお知らせ • Nov 30Acer Therapeutics Inc. Files Form 15Acer Therapeutics Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.0001 per share.お知らせ • Nov 21+ 2 more updatesAcer Therapeutics Inc. Announces Executive ChangesIn connection with the consummation of the Merger, at the Effective Time, pursuant to the terms of the Merger Agreement, Stephen J. Aselage, Jason Amello, John M. Dunn, Michelle Griffin and Chris Schelling each resigned and ceased serving as directors of Acer. On November 17, 2023, R. LaDuane Clifton and Joshua Schafer became the directors of the surviving corporation. On November 17, 2023, each of Chris Schelling, Acer's President ceased to be an executive officer of Acer Therapeutics Inc.お知らせ • Nov 18Nasdaq to Delist the Securities of Acer TherapeuticsNasdaq announced that it will delist the securities of Acer Therapeutics Inc. The company’s securities were suspended on November 9, 2023, and have not traded on Nasdaq since that time.お知らせ • Nov 15Acer Therapeutics Inc. announced delayed 10-Q filingOn 11/14/2023, Acer Therapeutics Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Nov 13Acer Therapeutics Inc.(OTCPK:ACER) dropped from S&P TMI IndexAcer Therapeutics Inc.(OTCPK:ACER) dropped from S&P TMI Indexお知らせ • Sep 01Zevra Therapeutics, Inc. (NasdaqGS:ZVRA) entered into definitive Agreement to acquire Acer Therapeutics Inc. (NasdaqCM:ACER) for $91 million.Zevra Therapeutics, Inc. (NasdaqGS:ZVRA) entered into definitive Agreement to acquire Acer Therapeutics Inc. (NasdaqCM:ACER) for $91 million on August 30, 2023. Under the consideration terms, Zevra will issue an aggregate of 2,960,507 shares of Zevra Common Stock for 22,463,726 shares of Acer Common Stock, the exchange ratio being 0.121. Zevra In addition, Acer stockholders of record as of immediately prior to the effective time of the merger would receive non-transferable CVRs entitling the holders to receive up to $34 million in cash upon the achievement of certain commercial milestones for OLPRUVA, and up to an additional $42 million in cash upon the achievement of certain regulatory milestones for OLPRUVA and EDSIVO. Post completion, Acer Therapeutics Inc. will operate as wholly-owned subsidiary of Zevra Therapeutics, Inc. In the event of termination, a buy-side and sell-side termination fee of $3 million is applicable.The transaction is subject to regulatory approval and waiting period under HSR Act, approval of Acer shareholders, Lock-up agreements, stockholders agreement, Voting and support agreement and execution of CVR agreement. The board of directors of both companies has approved the merger. As a condition to enter into merger agreement, Acer and Relief Therapeutics Holding SA entered into an exclusive license agreement on August 30, 2023 and and a termination agreement terminating the collaboration and license agreement , dated March 19, 2021, by and between Acer and Relief. The transaction is expected to close in fourth quarter of 2023. Stephanie Hosler of Bryan Cave Leighton Paisner LLP acted as legal advisor to Zevra and Canaccord Genuity Group Inc. acted as financial advisor as well as fairness opinion provider to Zevra for the transactions. Mike Hird of Pillsbury Winthrop Shaw Pittman LLP acted as legal advisor to Acer, and William Blair & Company, LLC acted as financial advisor as well as fairness opinion provider to Acer. Daniel Sadeh and Zachary Halper of Halper Sadeh LLC and Guri Ademi of Ademi & O'Reilly, LLP are acting as fairness opinion providers to Acer shareholders.お知らせ • Jun 09Acer Therapeutics Receives a Letter from Nasdaq Indicating the Company Is Not in Compliance with the $1.00 Minimum Bid Price Requirement Set in Nasdaq Listing Rule 5550(a)(2) for Continued Listing on the Nasdaq Capital MarketOn June 5, 2023, Acer Therapeutics Inc. (the Company) received a letter (the Bid Price Deficiency Notice) from the listing qualifications department staff of The Nasdaq Stock Market (Nasdaq) indicating that the Company isnot in compliance with the $1.00 minimum bid price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the Bid Price Requirement). The Bid Price Deficiency Notice has no immediate effect on the listing of the Company's common stock, and the Company's common stock continues to trade on the Nasdaq Capital Market under the symbol ACER. In accordance with Nasdaq listing rule 5810(c)(3)(A), the Company has 180 calendar days from the date of the Bid Price Deficiency Notice, or until December 4, 2023, to regain compliance with respect to the Bid Price Requirement. The Bid Price Deficiency Notice states that to regain compliance with the Bid Price Requirement, the closing bid price of the Company's common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during the compliance period ending December 4, 2023. If the Company fails to regain compliance with the Bid Price Requirement by December 4, 2023, the Company may be eligible for an additional 180-day compliance period to demonstrate compliance with the Bid Price Requirement. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Company does not qualify for the second compliance period or fails to regain compliance with the Bid Price Requirement during the second 180-day period, Nasdaq will notify the Company of its determination to delist the common stock, at which point the Company would have an opportunity to appeal the delisting determination to a Hearings Panel. The Company intends to actively monitor the closing bid price of the Company's common stock between now and December 4, 2023 and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the Bid Price Requirement. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with Nasdaq listing standards.お知らせ • May 05Acer Therapeutics Inc. Receives Non-Compliance Notice From NasdaqOn May 3, 2023, Acer Therapeutics Inc. (the “Company”) received a letter from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the last 30 consecutive business days, the Company’s minimum Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq listing rule 5550(b)(2). The notice has no immediate effect on the listing of the Company’s common stock, and the Company’s common stock continues to trade on the Nasdaq Capital Market. In accordance with Nasdaq listing rule 5810(c)(3)(C), the Company has 180 calendar days, or until October 30, 2023, to regain compliance. The notice states that to regain compliance, the Company’s MVLS must close at $35 million or more for a minimum of ten consecutive business days (or such longer period of time as the Nasdaq staff may require in some circumstances, but generally not more than 20 consecutive business days) during the compliance period ending October 30, 2023. The Company believes that it can also regain compliance by meeting the continued listing standard of a minimum stockholders’ equity of at least $2.5 million. If the Company does not regain compliance by October 30, 2023, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a Hearings Panel. The Company intends to actively monitor the Company’s MVLS between now and October 30, 2023 and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the MVLS rule. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with Nasdaq listing standards.お知らせ • Feb 15Acer Therapeutics Announces Full Enrollment of Phase 2A Trial of Acer-801 (Osanetant) for Treatment of Moderate to Severe Vasomotor Symptoms Associated with MenopauseAcer Therapeutics Inc. announced full enrollment of its Phase 2a proof of concept trial of ACER-801 (osanetant), a novel, non-hormonal, neurokinin 3 receptor (NK3R) antagonist, being investigated as a potential treatment option for moderate to severe Vasomotor Symptoms (VMS) associated with menopause. Topline results from this trial are expected in mid-March 2023. The Phase 2a randomized, double-blind, placebo-controlled, dose-ranging trial of ACER-801 is designed to evaluate the safety, pharmacokinetics (PK) and efficacy of ACER-801 in 48 postmenopausal women aged 40-65 who experience moderate to severe hot flashes. Subjects were randomized 1:1:1:1 and receive twice daily doses of either 50mg, 100mg, 200mg of ACER- 801 or placebo over a 14-day treatment period, followed by a 14-day safety follow-up assessment. Results from this trial could provide proof of concept data in postmenopausal women and could inform ACER-801 dosing and a development path forward in patients with induced Vasomotor Symptoms (iVMS). About VMS, iVMS and ACER-801 VMS are caused by a disruption in sex hormone signaling in the brain, resulting in menopausal-like symptoms (hot flashes, night sweats, etc.) and most often occur in women during menopausal transition or in menopause (MR-VMS). VMS leads to significant impact on patient quality of life, including sleep deprivation, lack of focus, and anxiety/depression. VMS can also be induced (iVMS) by anti-androgen and anti-estrogen cancer therapies and surgical procedures altering sex hormone production.(1) (,) (2) VMS are caused by low estrogen levels leading to increased stimulatory signaling of NKB on the Kisspeptin/Neurokinin B/Dynorphin (KNDy) neurons in the hypothalamus. A non-hormonal treatment to manage VMS is needed, especially in patients where estrogen is contraindicated or not well tolerated. iVMS are well documented with the use of cancer therapies and certain surgical procedures. Symptoms such as hot flashes can appear immediately and be severe. Cancer therapy side effects can lead to treatment non-adherence which increases the mortality risk and/or shortens the time to recurrence. Acer also believes a treatment for iVMS is needed to help certain cancer patients to be more likely to start and stay on critical cancer therapies. ACER-801 (osanetant) is a novel, non-hormonal, NK3R antagonist that could offer a potential treatment option with meaningful improvement of VMS for patients with iVMS by blocking the stimulatory signaling of NKB on the KNDy neurons. Direct human safety evidence is available from 23 completed Phase 1 and 2 studies in which approximately 400 healthy subjects and 820 patients were treated with osanetant for schizophrenia, depression and other indications. Data from these studies indicated no major safety concerns after single-dose and repeat-dose administration.(3) ACER-801 is orally bioavailable(4) and readily crosses the blood-brain barrier.(5) Acer believes that several disorders involving the hypothalamus-pituitary-gonadal axis could be investigated for potential benefit from treatment with an NK3R antagonist. ACER-801 is an investigational product candidate which has not been approved by FDA or any other regulatory authority. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for any indications.お知らせ • Jan 06Acer Therapeutics Inc. Announces Initiation of Two Investigator-Sponsored Trials of ACER-801 (Osanetant) in Men with Adenocarcinoma of the ProstateAcer Therapeutics Inc. announced the initiation of two Phase 2, single-arm investigator-sponsored trials evaluating ACER-801 (osanetant) in men with adenocarcinoma of the prostate. The POSH-MAP (Pilot of Osanetant for Severity of Hot Flashes in Men with Adenocarcinoma of the Prostate) and PORT-MAP (Pilot of Osanetant to Reduce Testosterone in Men with Adenocarcinoma of the Prostate) trials are being sponsored and conducted by The University of Kansas Cancer Center in partnership with Acer. POSH-MAP Trial: The POSH-MAP trial will evaluate the ability of ACER-801 to reduce hot flash frequency and severity and improve quality of life measures in men with prostate cancer following 28 days of therapy. Approximately 10 participants will receive 200mg of osanetant twice daily. Following the completion of treatment on day 28 participants will re-test hormone levels and report final patient outcome measures. PORT-MAP Trial: The second trial, PORT-MAP, will evaluate the ability of ACER-801 to suppress testosterone production in men with prostate cancer within 28 days prior to a planned prostatectomy. Approximately 10 participants will receive 200mg of osanetant twice daily for 28 days, followed by a one week wash out period. Following the one week wash out period, patients will undergo a prostatectomy between days 35-39. The overall effect of osanetant on testosterone levels and the proportion of men achieving castrate levels of testosterone (<50ng/ml) will be assessed, with hormone level assessment occurring on days 2, 3, 14, 28 and day 77. Rationale for ACER-801 (osanetant) NK3R Antagonist Evaluation in Prostate Cancer: Prostate cancer is a hormonally driven cancer, and the management of this disease for many men is through suppression of testosterone production – called androgen deprivation therapy (ADT). Currently, most men on ADT are treated with medications that suppress hormone production which can cause dysfunctional thermoregulation and development of vasomotor symptoms (VMS), also known as hot flashes. Up to 75% of men on ADT experience VMS, resulting in high rates of distress and ADT treatment noncompliance, with approximately 20% of men with high-risk prostate cancer prematurely discontinuing ADT.3 Early pharmacokinetic studies in men and women with various NK3R antagonists have shown an inhibitory effect on the levels of luteinizing hormone and testosterone. However, the degree of effect relative to a therapeutic goal of castrate levels of testosterone (= 50ng/mL) remains unexplored.1,2 A non-hormonal treatment to lower testosterone levels and manage induced VMS is needed as estrogen is contraindicated for the management of VMS in patients with hormone-positive tumors, including breast and prostate tumors. ACER-801 is an investigational product candidate which has not been approved by FDA or any other regulatory authority. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for any indications.Reported Earnings • Nov 17Third quarter 2022 earnings released: US$0.31 loss per share (vs US$0.23 loss in 3Q 2021)Third quarter 2022 results: US$0.31 loss per share (further deteriorated from US$0.23 loss in 3Q 2021). Net loss: US$5.01m (loss widened 53% from 3Q 2021). Revenue growth is forecast to be higher than the Pharmaceuticals industry in the US during the next 2 years. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has fallen by 29% per year, which means it is significantly lagging earnings.Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. No highly experienced directors. Independent Chairman of the Board Steve Aselage was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Seeking Alpha • Oct 05Acer Therapeutics to develop ACER-801 for post-traumatic stress disorder treatmentAcer Therapeutics (NASDAQ:ACER) said on Wednesday it was expanding ACER-801 into a new indication, to reduce the frequency and severity of acute stress disorder and post-traumatic stress disorder. (ACER) is trading 3.5% higher premarket. In a study conducted in thousands of genes that were activated in the brains of mice following fear conditioning events showed the drug was able to block fear memory consolidation shortly after exposure to a trauma. ACER-801 is a non-hormonal drug designed as a selective non-peptide neurokinin 3 receptor (NK3R) antagonist. "While the role of the NK3R pathway in the hypothalamus to manage thermoregulation is well-established in clinical trials, this opportunity explores an entirely different mechanism of action for the drug. We look forward to presenting our clinical development plan for ACER-801 for the reduction of frequency and severity of PTSD in the near future," the company said. Acute stress disorder refers to the body’s immediate response to trauma, whereas PTSD is defined as the long-term effects of trauma. The company is also developing the drug for induced Vasomotor Symptoms, which is hot flashes, flushing, and night sweats — that tend to occur in or around menopause.Reported Earnings • Aug 17First half 2022 earnings released: US$0.80 loss per share (vs US$0.54 loss in 1H 2021)First half 2022 results: US$0.80 loss per share (down from US$0.54 loss in 1H 2021). Net loss: US$11.8m (loss widened 54% from 1H 2021). Over the next year, revenue is forecast to grow 3,513%, compared to a 23% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has fallen by 14% per year, which means it is significantly lagging earnings.Seeking Alpha • Aug 12Acer, Relief's metabolic disorder therapy ACER-001 gets orphan drug status in EUThe European Commission granted orphan medicinal product designation to Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics' (OTCQB:RLFTF) (OTCQB:RLFTY) ACER-001 (sodium phenylbutyrate) to treat patients with Maple Syrup Urine Disease (MSUD). ACER-001 was had received the U.S. Food and Drug Administration's (FDA) orphan drug designation for MSUD in 2014, the companies said in an Aug. 12 press release. MSUD is a rare genetic metabolic disorder characterized by deficiency of an enzyme complex which is required to break down certain amino acids in the body. In the EU, the orphan drug status is granted to therapies aimed at treating or preventing a serious or life-threatening disease which affects not more than five in 10K people in the EU. The designation has benefits, including up to 10 years of market exclusivity for the product, if approved. ACER +6.76% to $1.58 premarket Aug. 12Seeking Alpha • Jul 28FDA accepts Acer's resubmitted U.S. marketing application for urea cycle disorder therapyAcer Therapeutics (NASDAQ:ACER) and partner Relief Therapeutics (OTCQB:RLFTF) (OTCQB:RLFTY) on Thursday said the U.S. Food and Drug Administration (FDA) had accepted the companies' resubmission of their new drug application for their ACER-001 treatment for patients with urea cycle disorders. The FDA designated the new drug application (NDA) as a class 2 resubmission and said it would review the application by Jan. 15, 2023, or the so-called Prescription Drug User Fee Act date. Despite the news, ACER stock had fallen 4.2% to $1.37 in premarket trading. The FDA's acceptance of the NDA comes 10 days after ACER and RLFTF resubmitted the application. The NDA had been initially declined by the FDA in June as the agency's field investigator had been unable to complete inspection of ACER's third-party contract packaging manufacturer.Seeking Alpha • Jul 18Acer resubmits U.S. marketing application for urea cycle disorder therapyNewton, Massachusetts-based Acer Therapeutics (NASDAQ:ACER) announced on Monday that the company resubmitted its New Drug Application (NDA) seeking FDA approval of ACER-001 oral suspension for the treatment of patients with urea cycle disorders (UCDs). Also known as sodium phenylbutyrate, ACER-001 is undergoing studies as a treatment for various inborn errors of metabolism such as UCDs. In June, Acer (ACER) announced that the FDA issued a Complete Response Letter (CRL), rejecting the marketing approval of the drug, citing the need for satisfactory inspection of its third-party contract packaging manufacturer. In the resubmission, the company has informed the FDA that the contract manufacturer in question is ready for inspections. In addition to labeling and other standard updates to the original filing, the resubmitted NDA included the nonclinical info that the FDA requested but categorized as “not an approvability issue” in the CRL. A decision on the acceptance of the NDA is expected within 14 calendar days of the submission. Last month, the shares of Acer (ACER) and its partner Relief Therapeutics (OTCQB:RLFTF) fell on the announcement of FDA rejection of ACER-001.Major Estimate Revision • May 23Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$2.25 to -US$2.52 per share. Revenue forecast of US$6.19m unchanged since last update. Pharmaceuticals industry in the US expected to see average net income growth of 9.5% next year. Consensus price target down from US$10.00 to US$9.67. Share price rose 9.7% to US$2.26 over the past week.Reported Earnings • May 18First quarter 2022 earnings: EPS and revenues miss analyst expectationsFirst quarter 2022 results: US$0.64 loss per share (down from US$0.33 loss in 1Q 2021). Net loss: US$9.18m (loss widened 99% from 1Q 2021). Revenue missed analyst estimates by 100%. Earnings per share (EPS) also missed analyst estimates by 129%. Over the next year, revenue is forecast to grow 3,535%, compared to a 13% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings.Board Change • Apr 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. No highly experienced directors. Independent Chairman of the Board Steve Aselage was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Major Estimate Revision • Mar 09Consensus revenue estimates fall by 29%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$8.73m to US$6.19m. Forecast losses increased from -US$0.92 to -US$2.12 per share. Pharmaceuticals industry in the US expected to see average net income growth of 17% next year. Consensus price target down from US$10.33 to US$10.00. Share price was steady at US$2.42 over the past week.分析記事 • Feb 11Companies Like Acer Therapeutics (NASDAQ:ACER) Can Afford To Invest In GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...Breakeven Date Change • Jan 14No longer forecast to breakevenThe 2 analysts covering Acer Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$4.77m in 2023. New consensus forecast suggests the company will make a loss of US$11.0m in 2023.Seeking Alpha • Aug 31Acer Therapeutics: Deriving Value By Developing Therapies For Rare DiseasesAcer Therapeutics is a pharmaceutical company that acquires, develops and seeks to commercialize therapies for serious, rare, and life-threatening diseases. Acer submitted an NDA for its lead drug candidate ACER-001 for treatment of UCDs in early August. Acer expects notification regarding potential acceptance for filing from the FDA approximately 60 days after NDA submission and subsequent substantive review. If approved, Acer could launch ACER-001 in mid-2022. Other than UCDs, Acer is developing therapies for MSUD, iVMS, vEDS, and infectious diseases. All these diseases have a market that is niche and untapped, characterized by low competition. Assuming a base case revenue of $40 million in 2022 and a P/S ratio of 5.0x, the company’s intrinsic value would be ~$122 million or $8.70 per share, indicating an upside close to 3.5x.Major Estimate Revision • Aug 12Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$6.00m to US$2.67m. EPS estimate unchanged from -US$1.06 per share at last update. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 3.8% to US$2.44 over the past week.Major Estimate Revision • May 25Consensus revenue estimates increase to US$8.00mThe consensus outlook for revenues in 2021 has improved. 2021 revenue forecast increased from US$4.50m to US$8.00m. Forecast losses expected to reduce from -US$1.50 to -US$1.30 per share. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 6.7% to US$2.86 over the past week.分析記事 • May 20We're Not Very Worried About Acer Therapeutics' (NASDAQ:ACER) Cash Burn RateWe can readily understand why investors are attracted to unprofitable companies. For example, although...分析記事 • Feb 25Need To Know: Acer Therapeutics Inc. (NASDAQ:ACER) Insiders Have Been Buying SharesWe often see insiders buying up shares in companies that perform well over the long term. Unfortunately, there are also...Is New 90 Day High Low • Jan 16New 90-day high: US$3.85The company is up 33% from its price of US$2.90 on 16 October 2020. The American market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 8.0% over the same period.業績と収益の成長予測OTCPK:ACER - アナリストの将来予測と過去の財務データ ( )USD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/202511028N/AN/A112/31/2024484N/AN/A212/31/20239-22N/AN/A26/30/2023N/A-39-32-32N/A3/31/2023N/A-33-36-36N/A12/31/2022N/A-26-30-30N/A9/30/20220-21-23-23N/A6/30/20220-20-22-22N/A3/31/20220-20-6-6N/A12/31/20211-1500N/A9/30/20211-17-3-3N/A6/30/20211-2011N/A3/31/20211-23-9-9N/A12/31/2020N/A-23-17-17N/A9/30/2020N/A-22-17-17N/A6/30/2020N/A-21-20-20N/A3/31/2020N/A-26-25-25N/A12/31/2019N/A-29-30-30N/A9/30/2019N/A-33-30-30N/A6/30/2019N/A-31-28-27N/A3/31/2019N/A-25-23-23N/A12/31/2018N/A-21-17-17N/A9/30/2018N/A-17-16-16N/A6/30/2018N/A-17-17-17N/A3/31/2018N/A-15-15-15N/A12/31/2017N/A-14-14-14N/A9/30/2017N/A-12-12-12N/A6/30/2017N/A-11-9-9N/A3/31/2017N/A-9N/A-9N/A12/31/2016N/A-7N/A-7N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: ACERは今後 3 年間で収益性が向上すると予測されており、これは 貯蓄率 ( 2.2% ) よりも高い成長率であると考えられます。収益対市場: ACER今後 3 年間で収益性が向上すると予想されており、これは市場平均を上回る成長と考えられます。高成長収益: ACER今後 3 年以内に収益を上げることが予想されます。収益対市場: ACERの収益 ( 50.8% ) US市場 ( 12.1% ) よりも速いペースで成長すると予測されています。高い収益成長: ACERの収益 ( 50.8% ) 20%よりも速いペースで成長すると予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: ACERの 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2023/11/20 19:09終値2023/11/17 00:00収益2023/06/30年間収益2022/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Acer Therapeutics Inc. 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。8 アナリスト機関Kumaraguru RajaBrookline Capital MarketsConstantine DavidesD. Boral Capital LLC.Vernon BernardinoH.C. Wainwright & Co.5 その他のアナリストを表示
Major Estimate Revision • May 23Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$2.25 to -US$2.52 per share. Revenue forecast of US$6.19m unchanged since last update. Pharmaceuticals industry in the US expected to see average net income growth of 9.5% next year. Consensus price target down from US$10.00 to US$9.67. Share price rose 9.7% to US$2.26 over the past week.
Major Estimate Revision • Mar 09Consensus revenue estimates fall by 29%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$8.73m to US$6.19m. Forecast losses increased from -US$0.92 to -US$2.12 per share. Pharmaceuticals industry in the US expected to see average net income growth of 17% next year. Consensus price target down from US$10.33 to US$10.00. Share price was steady at US$2.42 over the past week.
Breakeven Date Change • Jan 14No longer forecast to breakevenThe 2 analysts covering Acer Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$4.77m in 2023. New consensus forecast suggests the company will make a loss of US$11.0m in 2023.
Major Estimate Revision • Aug 12Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$6.00m to US$2.67m. EPS estimate unchanged from -US$1.06 per share at last update. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 3.8% to US$2.44 over the past week.
Major Estimate Revision • May 25Consensus revenue estimates increase to US$8.00mThe consensus outlook for revenues in 2021 has improved. 2021 revenue forecast increased from US$4.50m to US$8.00m. Forecast losses expected to reduce from -US$1.50 to -US$1.30 per share. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 6.7% to US$2.86 over the past week.
お知らせ • Nov 30Acer Therapeutics Inc. Files Form 15Acer Therapeutics Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.0001 per share.
お知らせ • Nov 21+ 2 more updatesAcer Therapeutics Inc. Announces Executive ChangesIn connection with the consummation of the Merger, at the Effective Time, pursuant to the terms of the Merger Agreement, Stephen J. Aselage, Jason Amello, John M. Dunn, Michelle Griffin and Chris Schelling each resigned and ceased serving as directors of Acer. On November 17, 2023, R. LaDuane Clifton and Joshua Schafer became the directors of the surviving corporation. On November 17, 2023, each of Chris Schelling, Acer's President ceased to be an executive officer of Acer Therapeutics Inc.
お知らせ • Nov 18Nasdaq to Delist the Securities of Acer TherapeuticsNasdaq announced that it will delist the securities of Acer Therapeutics Inc. The company’s securities were suspended on November 9, 2023, and have not traded on Nasdaq since that time.
お知らせ • Nov 15Acer Therapeutics Inc. announced delayed 10-Q filingOn 11/14/2023, Acer Therapeutics Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Nov 13Acer Therapeutics Inc.(OTCPK:ACER) dropped from S&P TMI IndexAcer Therapeutics Inc.(OTCPK:ACER) dropped from S&P TMI Index
お知らせ • Sep 01Zevra Therapeutics, Inc. (NasdaqGS:ZVRA) entered into definitive Agreement to acquire Acer Therapeutics Inc. (NasdaqCM:ACER) for $91 million.Zevra Therapeutics, Inc. (NasdaqGS:ZVRA) entered into definitive Agreement to acquire Acer Therapeutics Inc. (NasdaqCM:ACER) for $91 million on August 30, 2023. Under the consideration terms, Zevra will issue an aggregate of 2,960,507 shares of Zevra Common Stock for 22,463,726 shares of Acer Common Stock, the exchange ratio being 0.121. Zevra In addition, Acer stockholders of record as of immediately prior to the effective time of the merger would receive non-transferable CVRs entitling the holders to receive up to $34 million in cash upon the achievement of certain commercial milestones for OLPRUVA, and up to an additional $42 million in cash upon the achievement of certain regulatory milestones for OLPRUVA and EDSIVO. Post completion, Acer Therapeutics Inc. will operate as wholly-owned subsidiary of Zevra Therapeutics, Inc. In the event of termination, a buy-side and sell-side termination fee of $3 million is applicable.The transaction is subject to regulatory approval and waiting period under HSR Act, approval of Acer shareholders, Lock-up agreements, stockholders agreement, Voting and support agreement and execution of CVR agreement. The board of directors of both companies has approved the merger. As a condition to enter into merger agreement, Acer and Relief Therapeutics Holding SA entered into an exclusive license agreement on August 30, 2023 and and a termination agreement terminating the collaboration and license agreement , dated March 19, 2021, by and between Acer and Relief. The transaction is expected to close in fourth quarter of 2023. Stephanie Hosler of Bryan Cave Leighton Paisner LLP acted as legal advisor to Zevra and Canaccord Genuity Group Inc. acted as financial advisor as well as fairness opinion provider to Zevra for the transactions. Mike Hird of Pillsbury Winthrop Shaw Pittman LLP acted as legal advisor to Acer, and William Blair & Company, LLC acted as financial advisor as well as fairness opinion provider to Acer. Daniel Sadeh and Zachary Halper of Halper Sadeh LLC and Guri Ademi of Ademi & O'Reilly, LLP are acting as fairness opinion providers to Acer shareholders.
お知らせ • Jun 09Acer Therapeutics Receives a Letter from Nasdaq Indicating the Company Is Not in Compliance with the $1.00 Minimum Bid Price Requirement Set in Nasdaq Listing Rule 5550(a)(2) for Continued Listing on the Nasdaq Capital MarketOn June 5, 2023, Acer Therapeutics Inc. (the Company) received a letter (the Bid Price Deficiency Notice) from the listing qualifications department staff of The Nasdaq Stock Market (Nasdaq) indicating that the Company isnot in compliance with the $1.00 minimum bid price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the Bid Price Requirement). The Bid Price Deficiency Notice has no immediate effect on the listing of the Company's common stock, and the Company's common stock continues to trade on the Nasdaq Capital Market under the symbol ACER. In accordance with Nasdaq listing rule 5810(c)(3)(A), the Company has 180 calendar days from the date of the Bid Price Deficiency Notice, or until December 4, 2023, to regain compliance with respect to the Bid Price Requirement. The Bid Price Deficiency Notice states that to regain compliance with the Bid Price Requirement, the closing bid price of the Company's common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during the compliance period ending December 4, 2023. If the Company fails to regain compliance with the Bid Price Requirement by December 4, 2023, the Company may be eligible for an additional 180-day compliance period to demonstrate compliance with the Bid Price Requirement. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Company does not qualify for the second compliance period or fails to regain compliance with the Bid Price Requirement during the second 180-day period, Nasdaq will notify the Company of its determination to delist the common stock, at which point the Company would have an opportunity to appeal the delisting determination to a Hearings Panel. The Company intends to actively monitor the closing bid price of the Company's common stock between now and December 4, 2023 and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the Bid Price Requirement. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with Nasdaq listing standards.
お知らせ • May 05Acer Therapeutics Inc. Receives Non-Compliance Notice From NasdaqOn May 3, 2023, Acer Therapeutics Inc. (the “Company”) received a letter from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the last 30 consecutive business days, the Company’s minimum Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq listing rule 5550(b)(2). The notice has no immediate effect on the listing of the Company’s common stock, and the Company’s common stock continues to trade on the Nasdaq Capital Market. In accordance with Nasdaq listing rule 5810(c)(3)(C), the Company has 180 calendar days, or until October 30, 2023, to regain compliance. The notice states that to regain compliance, the Company’s MVLS must close at $35 million or more for a minimum of ten consecutive business days (or such longer period of time as the Nasdaq staff may require in some circumstances, but generally not more than 20 consecutive business days) during the compliance period ending October 30, 2023. The Company believes that it can also regain compliance by meeting the continued listing standard of a minimum stockholders’ equity of at least $2.5 million. If the Company does not regain compliance by October 30, 2023, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a Hearings Panel. The Company intends to actively monitor the Company’s MVLS between now and October 30, 2023 and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the MVLS rule. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with Nasdaq listing standards.
お知らせ • Feb 15Acer Therapeutics Announces Full Enrollment of Phase 2A Trial of Acer-801 (Osanetant) for Treatment of Moderate to Severe Vasomotor Symptoms Associated with MenopauseAcer Therapeutics Inc. announced full enrollment of its Phase 2a proof of concept trial of ACER-801 (osanetant), a novel, non-hormonal, neurokinin 3 receptor (NK3R) antagonist, being investigated as a potential treatment option for moderate to severe Vasomotor Symptoms (VMS) associated with menopause. Topline results from this trial are expected in mid-March 2023. The Phase 2a randomized, double-blind, placebo-controlled, dose-ranging trial of ACER-801 is designed to evaluate the safety, pharmacokinetics (PK) and efficacy of ACER-801 in 48 postmenopausal women aged 40-65 who experience moderate to severe hot flashes. Subjects were randomized 1:1:1:1 and receive twice daily doses of either 50mg, 100mg, 200mg of ACER- 801 or placebo over a 14-day treatment period, followed by a 14-day safety follow-up assessment. Results from this trial could provide proof of concept data in postmenopausal women and could inform ACER-801 dosing and a development path forward in patients with induced Vasomotor Symptoms (iVMS). About VMS, iVMS and ACER-801 VMS are caused by a disruption in sex hormone signaling in the brain, resulting in menopausal-like symptoms (hot flashes, night sweats, etc.) and most often occur in women during menopausal transition or in menopause (MR-VMS). VMS leads to significant impact on patient quality of life, including sleep deprivation, lack of focus, and anxiety/depression. VMS can also be induced (iVMS) by anti-androgen and anti-estrogen cancer therapies and surgical procedures altering sex hormone production.(1) (,) (2) VMS are caused by low estrogen levels leading to increased stimulatory signaling of NKB on the Kisspeptin/Neurokinin B/Dynorphin (KNDy) neurons in the hypothalamus. A non-hormonal treatment to manage VMS is needed, especially in patients where estrogen is contraindicated or not well tolerated. iVMS are well documented with the use of cancer therapies and certain surgical procedures. Symptoms such as hot flashes can appear immediately and be severe. Cancer therapy side effects can lead to treatment non-adherence which increases the mortality risk and/or shortens the time to recurrence. Acer also believes a treatment for iVMS is needed to help certain cancer patients to be more likely to start and stay on critical cancer therapies. ACER-801 (osanetant) is a novel, non-hormonal, NK3R antagonist that could offer a potential treatment option with meaningful improvement of VMS for patients with iVMS by blocking the stimulatory signaling of NKB on the KNDy neurons. Direct human safety evidence is available from 23 completed Phase 1 and 2 studies in which approximately 400 healthy subjects and 820 patients were treated with osanetant for schizophrenia, depression and other indications. Data from these studies indicated no major safety concerns after single-dose and repeat-dose administration.(3) ACER-801 is orally bioavailable(4) and readily crosses the blood-brain barrier.(5) Acer believes that several disorders involving the hypothalamus-pituitary-gonadal axis could be investigated for potential benefit from treatment with an NK3R antagonist. ACER-801 is an investigational product candidate which has not been approved by FDA or any other regulatory authority. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for any indications.
お知らせ • Jan 06Acer Therapeutics Inc. Announces Initiation of Two Investigator-Sponsored Trials of ACER-801 (Osanetant) in Men with Adenocarcinoma of the ProstateAcer Therapeutics Inc. announced the initiation of two Phase 2, single-arm investigator-sponsored trials evaluating ACER-801 (osanetant) in men with adenocarcinoma of the prostate. The POSH-MAP (Pilot of Osanetant for Severity of Hot Flashes in Men with Adenocarcinoma of the Prostate) and PORT-MAP (Pilot of Osanetant to Reduce Testosterone in Men with Adenocarcinoma of the Prostate) trials are being sponsored and conducted by The University of Kansas Cancer Center in partnership with Acer. POSH-MAP Trial: The POSH-MAP trial will evaluate the ability of ACER-801 to reduce hot flash frequency and severity and improve quality of life measures in men with prostate cancer following 28 days of therapy. Approximately 10 participants will receive 200mg of osanetant twice daily. Following the completion of treatment on day 28 participants will re-test hormone levels and report final patient outcome measures. PORT-MAP Trial: The second trial, PORT-MAP, will evaluate the ability of ACER-801 to suppress testosterone production in men with prostate cancer within 28 days prior to a planned prostatectomy. Approximately 10 participants will receive 200mg of osanetant twice daily for 28 days, followed by a one week wash out period. Following the one week wash out period, patients will undergo a prostatectomy between days 35-39. The overall effect of osanetant on testosterone levels and the proportion of men achieving castrate levels of testosterone (<50ng/ml) will be assessed, with hormone level assessment occurring on days 2, 3, 14, 28 and day 77. Rationale for ACER-801 (osanetant) NK3R Antagonist Evaluation in Prostate Cancer: Prostate cancer is a hormonally driven cancer, and the management of this disease for many men is through suppression of testosterone production – called androgen deprivation therapy (ADT). Currently, most men on ADT are treated with medications that suppress hormone production which can cause dysfunctional thermoregulation and development of vasomotor symptoms (VMS), also known as hot flashes. Up to 75% of men on ADT experience VMS, resulting in high rates of distress and ADT treatment noncompliance, with approximately 20% of men with high-risk prostate cancer prematurely discontinuing ADT.3 Early pharmacokinetic studies in men and women with various NK3R antagonists have shown an inhibitory effect on the levels of luteinizing hormone and testosterone. However, the degree of effect relative to a therapeutic goal of castrate levels of testosterone (= 50ng/mL) remains unexplored.1,2 A non-hormonal treatment to lower testosterone levels and manage induced VMS is needed as estrogen is contraindicated for the management of VMS in patients with hormone-positive tumors, including breast and prostate tumors. ACER-801 is an investigational product candidate which has not been approved by FDA or any other regulatory authority. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for any indications.
Reported Earnings • Nov 17Third quarter 2022 earnings released: US$0.31 loss per share (vs US$0.23 loss in 3Q 2021)Third quarter 2022 results: US$0.31 loss per share (further deteriorated from US$0.23 loss in 3Q 2021). Net loss: US$5.01m (loss widened 53% from 3Q 2021). Revenue growth is forecast to be higher than the Pharmaceuticals industry in the US during the next 2 years. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has fallen by 29% per year, which means it is significantly lagging earnings.
Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. No highly experienced directors. Independent Chairman of the Board Steve Aselage was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Seeking Alpha • Oct 05Acer Therapeutics to develop ACER-801 for post-traumatic stress disorder treatmentAcer Therapeutics (NASDAQ:ACER) said on Wednesday it was expanding ACER-801 into a new indication, to reduce the frequency and severity of acute stress disorder and post-traumatic stress disorder. (ACER) is trading 3.5% higher premarket. In a study conducted in thousands of genes that were activated in the brains of mice following fear conditioning events showed the drug was able to block fear memory consolidation shortly after exposure to a trauma. ACER-801 is a non-hormonal drug designed as a selective non-peptide neurokinin 3 receptor (NK3R) antagonist. "While the role of the NK3R pathway in the hypothalamus to manage thermoregulation is well-established in clinical trials, this opportunity explores an entirely different mechanism of action for the drug. We look forward to presenting our clinical development plan for ACER-801 for the reduction of frequency and severity of PTSD in the near future," the company said. Acute stress disorder refers to the body’s immediate response to trauma, whereas PTSD is defined as the long-term effects of trauma. The company is also developing the drug for induced Vasomotor Symptoms, which is hot flashes, flushing, and night sweats — that tend to occur in or around menopause.
Reported Earnings • Aug 17First half 2022 earnings released: US$0.80 loss per share (vs US$0.54 loss in 1H 2021)First half 2022 results: US$0.80 loss per share (down from US$0.54 loss in 1H 2021). Net loss: US$11.8m (loss widened 54% from 1H 2021). Over the next year, revenue is forecast to grow 3,513%, compared to a 23% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has fallen by 14% per year, which means it is significantly lagging earnings.
Seeking Alpha • Aug 12Acer, Relief's metabolic disorder therapy ACER-001 gets orphan drug status in EUThe European Commission granted orphan medicinal product designation to Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics' (OTCQB:RLFTF) (OTCQB:RLFTY) ACER-001 (sodium phenylbutyrate) to treat patients with Maple Syrup Urine Disease (MSUD). ACER-001 was had received the U.S. Food and Drug Administration's (FDA) orphan drug designation for MSUD in 2014, the companies said in an Aug. 12 press release. MSUD is a rare genetic metabolic disorder characterized by deficiency of an enzyme complex which is required to break down certain amino acids in the body. In the EU, the orphan drug status is granted to therapies aimed at treating or preventing a serious or life-threatening disease which affects not more than five in 10K people in the EU. The designation has benefits, including up to 10 years of market exclusivity for the product, if approved. ACER +6.76% to $1.58 premarket Aug. 12
Seeking Alpha • Jul 28FDA accepts Acer's resubmitted U.S. marketing application for urea cycle disorder therapyAcer Therapeutics (NASDAQ:ACER) and partner Relief Therapeutics (OTCQB:RLFTF) (OTCQB:RLFTY) on Thursday said the U.S. Food and Drug Administration (FDA) had accepted the companies' resubmission of their new drug application for their ACER-001 treatment for patients with urea cycle disorders. The FDA designated the new drug application (NDA) as a class 2 resubmission and said it would review the application by Jan. 15, 2023, or the so-called Prescription Drug User Fee Act date. Despite the news, ACER stock had fallen 4.2% to $1.37 in premarket trading. The FDA's acceptance of the NDA comes 10 days after ACER and RLFTF resubmitted the application. The NDA had been initially declined by the FDA in June as the agency's field investigator had been unable to complete inspection of ACER's third-party contract packaging manufacturer.
Seeking Alpha • Jul 18Acer resubmits U.S. marketing application for urea cycle disorder therapyNewton, Massachusetts-based Acer Therapeutics (NASDAQ:ACER) announced on Monday that the company resubmitted its New Drug Application (NDA) seeking FDA approval of ACER-001 oral suspension for the treatment of patients with urea cycle disorders (UCDs). Also known as sodium phenylbutyrate, ACER-001 is undergoing studies as a treatment for various inborn errors of metabolism such as UCDs. In June, Acer (ACER) announced that the FDA issued a Complete Response Letter (CRL), rejecting the marketing approval of the drug, citing the need for satisfactory inspection of its third-party contract packaging manufacturer. In the resubmission, the company has informed the FDA that the contract manufacturer in question is ready for inspections. In addition to labeling and other standard updates to the original filing, the resubmitted NDA included the nonclinical info that the FDA requested but categorized as “not an approvability issue” in the CRL. A decision on the acceptance of the NDA is expected within 14 calendar days of the submission. Last month, the shares of Acer (ACER) and its partner Relief Therapeutics (OTCQB:RLFTF) fell on the announcement of FDA rejection of ACER-001.
Major Estimate Revision • May 23Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$2.25 to -US$2.52 per share. Revenue forecast of US$6.19m unchanged since last update. Pharmaceuticals industry in the US expected to see average net income growth of 9.5% next year. Consensus price target down from US$10.00 to US$9.67. Share price rose 9.7% to US$2.26 over the past week.
Reported Earnings • May 18First quarter 2022 earnings: EPS and revenues miss analyst expectationsFirst quarter 2022 results: US$0.64 loss per share (down from US$0.33 loss in 1Q 2021). Net loss: US$9.18m (loss widened 99% from 1Q 2021). Revenue missed analyst estimates by 100%. Earnings per share (EPS) also missed analyst estimates by 129%. Over the next year, revenue is forecast to grow 3,535%, compared to a 13% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings.
Board Change • Apr 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. No highly experienced directors. Independent Chairman of the Board Steve Aselage was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Major Estimate Revision • Mar 09Consensus revenue estimates fall by 29%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$8.73m to US$6.19m. Forecast losses increased from -US$0.92 to -US$2.12 per share. Pharmaceuticals industry in the US expected to see average net income growth of 17% next year. Consensus price target down from US$10.33 to US$10.00. Share price was steady at US$2.42 over the past week.
分析記事 • Feb 11Companies Like Acer Therapeutics (NASDAQ:ACER) Can Afford To Invest In GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...
Breakeven Date Change • Jan 14No longer forecast to breakevenThe 2 analysts covering Acer Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$4.77m in 2023. New consensus forecast suggests the company will make a loss of US$11.0m in 2023.
Seeking Alpha • Aug 31Acer Therapeutics: Deriving Value By Developing Therapies For Rare DiseasesAcer Therapeutics is a pharmaceutical company that acquires, develops and seeks to commercialize therapies for serious, rare, and life-threatening diseases. Acer submitted an NDA for its lead drug candidate ACER-001 for treatment of UCDs in early August. Acer expects notification regarding potential acceptance for filing from the FDA approximately 60 days after NDA submission and subsequent substantive review. If approved, Acer could launch ACER-001 in mid-2022. Other than UCDs, Acer is developing therapies for MSUD, iVMS, vEDS, and infectious diseases. All these diseases have a market that is niche and untapped, characterized by low competition. Assuming a base case revenue of $40 million in 2022 and a P/S ratio of 5.0x, the company’s intrinsic value would be ~$122 million or $8.70 per share, indicating an upside close to 3.5x.
Major Estimate Revision • Aug 12Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$6.00m to US$2.67m. EPS estimate unchanged from -US$1.06 per share at last update. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 3.8% to US$2.44 over the past week.
Major Estimate Revision • May 25Consensus revenue estimates increase to US$8.00mThe consensus outlook for revenues in 2021 has improved. 2021 revenue forecast increased from US$4.50m to US$8.00m. Forecast losses expected to reduce from -US$1.50 to -US$1.30 per share. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target of US$10.00 unchanged from last update. Share price rose 6.7% to US$2.86 over the past week.
分析記事 • May 20We're Not Very Worried About Acer Therapeutics' (NASDAQ:ACER) Cash Burn RateWe can readily understand why investors are attracted to unprofitable companies. For example, although...
分析記事 • Feb 25Need To Know: Acer Therapeutics Inc. (NASDAQ:ACER) Insiders Have Been Buying SharesWe often see insiders buying up shares in companies that perform well over the long term. Unfortunately, there are also...
Is New 90 Day High Low • Jan 16New 90-day high: US$3.85The company is up 33% from its price of US$2.90 on 16 October 2020. The American market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 8.0% over the same period.