Announcement • Nov 30
Acer Therapeutics Inc. Files Form 15 Acer 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. Announcement • Nov 18
Nasdaq to Delist the Securities of Acer Therapeutics Nasdaq 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. Announcement • Nov 15
Acer Therapeutics Inc. announced delayed 10-Q filing On 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. Announcement • Nov 13
Acer Therapeutics Inc.(OTCPK:ACER) dropped from S&P TMI Index Acer Therapeutics Inc.(OTCPK:ACER) dropped from S&P TMI Index Announcement • Sep 01
Zevra 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. Announcement • Jun 09
Acer 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 Market On 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. Announcement • May 05
Acer Therapeutics Inc. Receives Non-Compliance Notice From Nasdaq On 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. Announcement • Feb 15
Acer Therapeutics Announces Full Enrollment of Phase 2A Trial of Acer-801 (Osanetant) for Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause Acer 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. Announcement • Jan 06
Acer Therapeutics Inc. Announces Initiation of Two Investigator-Sponsored Trials of ACER-801 (Osanetant) in Men with Adenocarcinoma of the Prostate Acer 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 17
Third 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 16
Insufficient new directors No 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. Reported Earnings • Aug 17
First 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. Major Estimate Revision • May 23
Consensus forecasts updated The 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 18
First quarter 2022 earnings: EPS and revenues miss analyst expectations First 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 27
Insufficient new directors No 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 09
Consensus 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 14
No longer forecast to breakeven The 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 12
Consensus forecasts updated The 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 25
Consensus revenue estimates increase to US$8.00m The 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. Is New 90 Day High Low • Jan 16
New 90-day high: US$3.85 The 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.