Announcement • Nov 07
Axsome Therapeutics, Inc. (NasdaqGM:AXSM) entered into an agreement to acquire Baergic Bio, Inc. from Avenue Therapeutics, Inc. (OTCPK:ATXI) for $79.3 million. Axsome Therapeutics, Inc. (NasdaqGM:AXSM) entered into an agreement to acquire Baergic Bio, Inc. from Avenue Therapeutics, Inc. (OTCPK:ATXI) for $79.3 million on November 6, 2025. A cash consideration of $0.3 million will be paid by Axsome Therapeutics, Inc. Baergic Bio, Inc. is eligible to receive milestone payments of up to $2.5 million upon the occurrence of certain development and regulatory events for the first indication and $1.5 million for each indication thereafter, up to $79 million in potential sales-based milestones. Announcement • Jul 14
The Nasdaq Stock Market to Delist the Common Stock of Avenue Therapeutics The Nasdaq Stock Market announced that it will delist the common stock of Avenue Therapeutics, Inc. Avenue Therapeutics’ stock was suspended on March 19, 2025 and has not traded on Nasdaq since that time. Announcement • Mar 21
Avenue Therapeutics, Inc.(OTCPK:ATXI) dropped from S&P TMI Index Avenue Therapeutics, Inc.(OTCPK:ATXI) dropped from S&P TMI Index Announcement • Mar 19
Avenue Therapeutics, Inc.(OTCPK:ATXI) dropped from NASDAQ Composite Index Avenue Therapeutics, Inc. has been dropped from trhe NASDAQ Composite Index . Announcement • Mar 18
Nasdaq Determines to Delist Common Stock of Avenue Therapeutics On March 17, 2025, The Nasdaq Stock Market LLC (Nasdaq") notified Avenue Therapeutics, Inc. (the Company") that the Nasdaq Hearings Panel (the Panel") has determined to delist the Company's common stock and that trading of the Company's common stock will be suspended at the open of trading on March 19, 2025. As previously reported, the Company was in violation of Nasdaq Listing Rule 5550(b)(1), which requires companies listed on The Nasdaq Capital Market to maintain stockholders' equity of at least $2,500,000. Also as previously reported, on November 26, 2024, the Company received a delist letter from the Listing Qualifications Department (the Staff") of Nasdaq notifying the Company that it was not in compliance with this rule. In that letter, the Staff formally notified the Company that it would move to delist the Company's securities from Nasdaq unless the Company timely requested a hearing before the Panel. The Company timely requested a hearing, and as a result of the hearing, was granted an exception to permit the continued listing of the Company's common stock on the Nasdaq Capital Market, subject to certain conditions, including that on or before March 14, 2025, the Company had to make public disclosure describing any transactions undertaken by the Company to increase its equity. Because the Company did not regain compliance with Nasdaq's rules as required by the Panel decision, the Panel determined to delist the Company's securities from Nasdaq. The Company expects that Nasdaq will file a Form 25-NSE with the Securities and Exchange Commission (the SEC"), which will remove the Company's common stock from listing and registration on Nasdaq. In the interim, the Company's common stock is expected to begin trading under its current trading symbol (ATXI") on the OTC Markets system effective with the open of the markets on March 19, 2025. The Company plans to continue to file its required periodic reports and other filings with the SEC. The Company can provide no assurance that its common stock will continue to trade on this market, whether broker-dealers will continue to provide public quotes of its common stock on this market, or whether the trading volume of its common stock will be sufficient to provide for an efficient trading market for existing and potential holders of its common stock. New Risk • Jan 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Shareholders have been substantially diluted in the past year (284% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.61m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Announcement • Nov 30
Avenue Therapeutics Receives Delist Letter from Nasdaq Regarding Non-Compliance with the Minimum Stockholders’ Equity Requirement On November 26, 2024, Avenue Therapeutics, Inc. (the ‘Company’) received a delist letter (the ‘Letter’) from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC notifying the Company that it was not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1). Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the ‘Stockholders’ Equity Requirement’). The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024 reported stockholders’ equity of $1,652,000. In a decision dated June 3, 2024, a Nasdaq Hearings Panel (the ‘Panel’) previously had confirmed that the Company regained compliance with the Stockholders’ Equity Requirement. In the decision, the Panel imposed a Mandatory Panel Monitor for a period of one year or until May 21, 2025, which would require Staff to issue a Delist Determination Letter in the event that the Company failed to maintain compliance with the Stockholders’ Equity Requirement (the ‘Panel Monitor’). Due to the Panel Monitor, the Company is not eligible to submit a plan to the Staff to request an extension of up to 180 calendar days in which to regain compliance with the Stockholders’ Equity Requirement and as a result, the Staff has determined to delist the Company’s securities from The Nasdaq Capital Market. Neither the Letter nor the Company’s noncompliance have an immediate effect on the listing or trading of the Company’s common stock, which will continue to trade on The Nasdaq Capital Market under the symbol ‘ATXI.’ Pursuant to the Letter, under Nasdaq Listing Rules, the Company may request a hearing before an independent Hearings Panel (the ‘Panel’) by December 3, 2024. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. While the Company’s Form 10-Q reported stockholders’ equity of $1,652,000 as of September 30, 2024, as noted in Note 9 of the Form 10-Q, the Company believes that as of the date of the filing of the Form 10-Q, the Company had regained compliance with the $2,500,000 stockholders’ equity requirement. At the hearing, the Company intends to demonstrate its current compliance with the stockholders’ equity requirement and its ability to sustain long term equity compliance. New Risk • Aug 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$14m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Shareholders have been substantially diluted in the past year (over 7x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.33m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Price Target Changed • Jun 09
Price target increased by 1,500% to US$900 Up from US$56.25, the current price target is provided by 1 analyst. New target price is 26,527% above last closing price of US$3.38. Stock is down 96% over the past year. The company is forecast to post a net loss per share of US$431 next year compared to a net loss per share of US$73.48 last year. Announcement • May 18
Avenue Therapeutics, Inc Announces Last Patient Last Visit in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease) Avenue Therapeutics, Inc. announced the completion of the last patient’s final visit in the Company’s Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease. Topline data are expected to be reported mid-year 2024. The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 enrolled 25 patients, randomly assigned to AJ201 (600 mg/day) or placebo (3:1). The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacokinetic and pharmacodynamic data measuring change from baseline in mutant AR protein levels in skeletal muscle and changes from baseline in expression of Nrf2-activated genes in skeletal muscle. Exploratory objectives of the study include changes in the fat and muscle composition as seen on MRI scans. These endpoints are believed to be biomarkers indicating likelihood for longer term clinical improvement. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603). In April 2024, Avenue hosted a virtual key opinion leader (“KOL”) event highlighting expert perspectives on SBMA. The event featured Christopher Grunseich, M.D., Lasker Clinical Research Scholar and Investigator and Head of the Inherited Neuromuscular Diseases Unit at the National Institute of Neurological Disorders and Stroke, and Tahseen Mozaffar, M.D., Professor of Neurology, Pathology and Laboratory Medicine, Director of the Division of Neuromuscular Diseases and Director of the ALS and Neuromuscular Center at the University of California, Irvine. The two featured speakers discussed the characteristics and treatment landscape of SBMA, as well as the trial design and potential of AJ201 in SBMA. Announcement • May 08
Avenue Therapeutics, Inc., Annual General Meeting, Jun 24, 2024 Avenue Therapeutics, Inc., Annual General Meeting, Jun 24, 2024, at 09:30 US Eastern Standard Time. Agenda: To Elect six directors for a term of one year until 2025 Annual Meeting of Stockholders or until their successors are duly elected and qualified in accordance with Second Amended and Restated Bylaws; to Ratify the appointment of KPMG LLP as independent registered public accounting firm for the year ending December 31, 2024; to Approve an amendment to the 2015 Plan to increase the number of authorized shares issuable thereunder by 5,000,000 shares, which will extend the term of the 2015 Plan to June 24, 2034, increase the limit of shares that may be issued upon the exercise of incentive stock options by 5,000,000 shares, and increase the annual share limit for awards granted to non-employee directors to 500,000; and to consider other business matters. Buy Or Sell Opportunity • Apr 25
Now 570% overvalued after recent price rise Over the last 90 days, the stock has risen 5,750% to US$8.78. The fair value is estimated to be US$1.31, however this is not to be taken as a sell recommendation but rather should be used as a guide only. New Risk • Mar 19
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Share price has been highly volatile over the past 3 months (33% average weekly change). Negative equity (-US$4.5m). Earnings are forecast to decline by an average of 1.5% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (492% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$7.08m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Announcement • Feb 23
Avenue Therapeutics, Inc. Announces Publication in Drug Development Research Highlighting First-In-Class Preclinical Data of BAER-101 in A Translational Model of Absence Epilepsy Avenue Therapeutics, Inc. announced the publication of preclinical in vivo data in Drug Development Research highlighting BAER-101’s full suppression of seizure activity using the Genetic Absence Epilepsy Rats from Strasbourg (“GAERS”) model of absence epilepsy. Data published showcase BAER-101’s ability to selectively target GABAA a2 and a3 subtypes more than a1 and a5, potentially improving anti-convulsant and anxiolytic activity while minimizing the risk of tolerance and abuse associated with existing treatments in this drug class. The publication describes the extent of anti-seizure activity of BAER-101 in the GAERS model, a widely used and translationally relevant animal model. The study demonstrated full suppression of seizure activity with a minimal effective dose (MED) of 0.3 mg/kg. The effect of BAER-101 was fast in onset and stable throughout the duration of testing. Results from the testing showed that the number of spike-wave discharges were dose-dependently reduced by BAER-101, and no adverse safety events were observed up to a dose 300x the MED. BAER-101 is the first clinical candidate which is selective for only a2,3 and not for a1 or a5, a pharmacology consistent with anti-seizure activity that avoids the adverse side effects common to the GABAA positive allosteric modulators (PAM) class. Specifically, the a1-subtype of GABAAR is associated with dizziness and somnolence in both animal and human studies, and the a5-subtype of GABAAR is thought to play a key role in synaptic plasticity, cognition, and memory, suggesting that engagement of a5 risks anti-cognitive effects. The pharmacology of BAER-101 lacks activity at both the a1- and a5-subtypes of GABAAR, and these findings indicate that BAER-101’s on-target engagement with a selective subset of synaptic GABAARs is sufficient to suppress absence seizures while avoiding adverse side effects common to the GABAA PAM class. Subject to obtaining the necessary financing, which could be provided through a strategic partnership, Avenue plans to initiate a Phase 2a clinical trial of BAER-101 to further study its anti-seizure properties in patients with common or rare epilepsies. Announcement • Jan 02
Avenue Therapeutics, Inc. Announces Completion of Enrollment in Phase 1b/2a Clinical Trial of AJ201 for Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease) Avenue Therapeutics, Inc. announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease. AJ201 is currently the lead drug candidate in the clinic for SBMA, and topline data are anticipated in the second quarter of 2024. The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 enrolled 25 patients, randomly assigned to AJ201 (600 mg/day) or placebo. The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Although the disease is slow in progression, limiting the potential to demonstrate clinical efficacy over 12 weeks, Avenue has included as secondary endpoints various biomarkers addressing proof of target engagement, which could reflect the likelihood of clinical success. These biomarkers include the pharmacodynamic data measuring change from baseline in mutant androgen receptor protein levels in skeletal muscle and changes in the fat and muscle composition as seen on MRI scans. New Risk • Dec 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 20% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-US$4.5m). Earnings are forecast to decline by an average of 20% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (177% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.80m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$19m net loss in 3 years). Announcement • Nov 25
the Staff of Nasdaq Determines to Delist Avenue Therapeutics’ Securities from Nasdaq Based Upon its Continued Non-Compliance with the Rule As previously disclosed on July 21, 2023, the Staff of the Listing Qualifications Department of The Nasdaq Stock Market LLC granted Avenue Therapeutics, Inc. an extension through November 15, 2023, to regain compliance with the $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(b)(1). The Company was unable to demonstrate compliance with the Rule by that date. Accordingly, on November 20, 2023, the Staff formally notified the Company that it had determined to delist the Company’s securities from Nasdaq based upon the Company’s continued non-compliance with the Rule unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company intends to timely request a hearing before the Panel, which request will stay any further action by Nasdaq at least pending completion of the hearing and the expiration of any extension that may be granted by the Panel to the Company. The Company is considering all options available to it to regain compliance with the Rule; however, there can be no assurance that the Panel will grant the Company’s request for continued listing or that the Company will be able to evidence compliance with the Rule within any extension period that may be granted by the Panel. Neither the Staff’s notification nor the Company’s noncompliance with the Rule have an immediate effect on the listing or trading of the Company’s common stock, which will continue to trade on The Nasdaq Capital Market under the symbol “ATXI”. New Risk • Nov 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$13m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Negative equity (-US$4.5m). Shareholders have been substantially diluted in the past year (169% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.55m market cap). Announcement • Nov 04
Avenue Therapeutics, Inc. has completed a Composite Units Offering in the amount of $5 million. Avenue Therapeutics, Inc. has completed a Composite Units Offering in the amount of $5 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 16,633,400
Price\Range: $0.3006
Discount Per Security: $0.02405
Security Name: Pre-Funded Warrant
Security Type: Equity Warrant
Securities Offered: 16,633,400 New Risk • Nov 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Negative equity (-US$6.1m). Shareholders have been substantially diluted in the past year (98% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.92m market cap). Announcement • Sep 29
Avenue Therapeutics Receives Letter from Nasdaq Regarding Non-Compliance with Minimum Bid Price Requirement for Continued Listing on The Nasdaq Capital Market On September 27, 2023, Avenue Therapeutics, Inc. (the ‘Company’) received a letter from the Staff of the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) stating that the bid price of the Company’s common stock (‘Common Stock’) had closed below $1.00 per share for 30 consecutive business days, and that, therefore, the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum-Bid Price Requirement’), which sets forth the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Nasdaq’s notice has no immediate effect on the listing of the Common Stock on The Nasdaq Capital Market. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company is afforded a 180-calendar day grace period, through March 25, 2024, to regain compliance with the bid price requirement. Compliance can be achieved by evidencing a closing bid price of at least $1.00 per share for a minimum of ten (10) consecutive business days, although the Staff may, in its discretion, require compliance for a longer period of time (generally no more than 20 consecutive business days) during the 180-calendar day grace period. If the Company does not regain compliance with the bid price requirement by March 25, 2024, the Company may be eligible for an additional 180-calendar day compliance period so long as it satisfies the criteria for initial listing on The Nasdaq Stock Market, other than the market value of publicly held shares requirement, and the continued listing requirement for market value of publicly held shares and the Company provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company is not eligible for the second grace period, the Nasdaq staff will provide written notice that the Common Stock is subject to delisting; however, the Company may request a hearing before the Nasdaq Hearings Panel (the ‘Panel’), which request, if timely made, would stay any further suspension or delisting action by the Staff pending the conclusion of the hearing process and expiration of any extension that may be granted by the Panel. There can be no assurance that the Company would be successful in its efforts to maintain the Nasdaq listing. The Company intends to closely monitor the closing bid price of the Common Stock and consider all available options to remedy the bid price deficiency, but no decision regarding any action has yet been made. Recent Insider Transactions • Sep 13
Executive Director recently bought US$251k worth of stock On the 8th of September, Lindsay Rosenwald bought around 349k shares on-market at roughly US$0.72 per share. This transaction increased Lindsay's direct individual holding by 62x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Announcement • Aug 02
Avenue Therapeutics, Inc. Announces High Potency and Full Efficacy in A Model of Generalized Seizures for Its Novelgaba-A Receptor Potentiator, Baer-101, Supporting Phase 2 Clinical Study Avenue Therapeutics, Inc. announced that BAER-101, the Company’s potentially best-in-class selective GABA-A a2,3 positive allosteric modulator (“PAM”), significantly suppressed seizures in a translational animal model of absence epilepsy. BAER-101 underwent preclinical in vivo evaluation in SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy. The GAERS model mimics behavioral, electrophysiological and pharmacological features of human absence seizures. The GAERS model is a proven, early, informative indicator of efficacy in anti-seizure drug development, with high predictability of response in humans. In the model, BAER-101 demonstrated full suppression of seizure activity with a minimal effective dose of 0.3 mg/kg, PO. The effect was fast in onset and stable throughout the duration of testing. BAER-101 has previously been shown to be safe with minimal side effects in clinical studies of hundreds of patients in a program targeting a different indication by AstraZeneca. The combination of safety, tolerability and efficacy in an established translationally relevant epilepsy model support BAER-101’s continued development. The selective potentiation of alpha 2,3-containing GABA-A receptors with minimal impact on a1 and a5-containing GABA-A receptors differentiates BAER-101 from competitors, and predicts a lower potential for sedation, motor incoordination, cognitive impairment and/or tolerance. Further study of the anti-seizure properties of BAER-101 is being planned in patients with focal seizures and other seizure disorders for which current treatments are not fully efficacious. Avenue is developing BAER-101 via its subsidiary Baergic Bio for epilepsy disorders. BAER-101 is a PAM of a2,3 subunit-containing GABA-A receptors with minimal activity at a1 or a5-containing receptors, which are believed to mediate many of the issues impacting the medical use of benzodiazepines such as those noted with diazepam use (tolerance, dependence, abuse, sedation and impaired cognition). As a result, BAER-101 may have the potential to treat epilepsy, anxiety and other disorders in which benzodiazepines are currently used, while minimizing the benzodiazepine associated adverse effects. BAER-101 was licensed in from AstraZeneca with a large safety database in over 700 patients and an efficacy signal in a ?subset of patients with anxiety. Announcement • Jul 28
Avenue Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease) Avenue Therapeutics, Inc. announced that the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy ("SBMA"), also known as Kennedy's Disease. A recent study used genetic analysis to estimate disease prevalence of 1:6,887 males.(1) AJ201 is currently the lead drug candidate in the clinic for SBMA and enrollment in the trial is expected to be complete by the end of 2023 or early 2024 with potential topline data in 2024. Additionally, compelling preclinical data in a mouse model showed efficacy signals, including improvement in motor function, robust degradation of mutant androgen receptors ("AR"), a disease-signaling protein, and activation of the Nrf1 and Nrf2 pathways. In this Phase 1b/2a clinical trial, the company aim to demonstrate how AJ201's novel, multi-fold mechanism of action reduces accumulation of mutant AR aggregates to potentially decrease neuroinflammation, protect cells from oxidative stress, and ultimately, improve clinical outcomes for SBMA patients. The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 is expected to enroll approximately 24 patients, randomly assigned to AJ201 (600 mg/day) or placebo. The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacodynamic data measuring change from baseline in mutant AR protein levels in skeletal muscle and changes in the fat and muscle composition as seen on MRI scans, which are believed to be biomarkers indicating likelihood for longer term clinical improvement. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603). Announcement • Jul 26
Avenue Therapeutics, Inc. Reaches Agreement with U.S. Food and Drug Administration on Key Elements of Phase 3 Safety Study for Intravenous Tramadol Avenue Therapeutics, Inc. announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on key elements of the Phase 3 safety study, including the primary endpoint and statistical analysis approach, for intravenous (IV) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine. The study will randomize post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in a Phase 3 efficacy trial. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. The primary endpoint is a composite of elements indicative of respiratory depression. Avenue is submitting the revised protocol to the FDA including the statistical plan, which reflects the now agreed upon study design, for final review. Announcement • May 24
Avenue Therapeutics Receives Non-Compliance Notice From The Nasdaq Stock Market LLC On May 19, 2023, Avenue Therapeutics, Inc. (the “Company”) received a deficiency letter (the “Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC notifying the Company that it was not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1). Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the “Stockholders’ Equity Requirement”). The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2023, reported stockholders’ equity of negative $2,157,000. The Letter further noted that as of the letter date, the Company did not have a market value of listed securities of $35 million, or net income from continued operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years, the alternative quantitative standards for continued listing on The Nasdaq Capital Market. The Letter has no immediate effect on the Company’s continued listing on the Nasdaq Capital Market, subject to the Company’s compliance with the other continued listing requirements. In accordance with Nasdaq rules, the Company has been provided 45 calendar days, or until July 3, 2023, to submit a plan to regain compliance (the “Compliance Plan”). If the Compliance Plan is acceptable to the Staff, it may grant an extension of 180 calendar days from the date of the Letter. If the Staff does not accept the Compliance Plan, the Staff will provide written notification to the Company that the Compliance Plan has been rejected. At that time, the Company may appeal the Staff’s determination to a Nasdaq Hearings Panel. The Company intends to submit a Compliance Plan on or before July 3, 2023. Further, the Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. However, there can be no assurance that Nasdaq will approve the Compliance Plan or that the Company will ultimately regain compliance with all applicable requirements for continued listing. Neither the Nasdaq Letter nor the Company’s noncompliance have an immediate effect on the listing or trading of the Company’s common stock, which will continue to trade on The Nasdaq Capital Market. Announcement • Feb 02
Avenue Therapeutics, Inc. announced that it has received $0.24 million in funding On January 31, 2023, Avenue Therapeutics, Inc. closed the transaction. Announcement • Nov 19
Avenue Therapeutics, Inc., Annual General Meeting, Dec 28, 2022 Avenue Therapeutics, Inc., Annual General Meeting, Dec 28, 2022, at 09:00 US Eastern Standard Time. Agenda: To elect five directors for a term of one year until the company's 2023 Annual Meeting of Stockholders or until their successors are duly elected and qualified in accordance with the company's Amended and Restated Bylaws; to ratify the appointment of BDO USA, LLP as the company's independent registered public accounting firm for the year ending December 31, 2022; to approve an amendment to the company's certificate of incorporation to increase the number of authorized shares of the company's common stock from 20,000,000 to 75,000,000; to approve an amendment to the company's 2015 Incentive Plan to increase the number of authorized shares issuable thereunder by 5,000,000 shares; and to transact any other business that may properly come before the Annual Meeting or any adjournment of the Annual Meeting. Board Change • May 19
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Faith Charles was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Feb 01
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Curt Oltmans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Breakeven Date Change • Jun 17
Forecast breakeven pushed back to 2024 The 2 analysts covering Avenue Therapeutics previously expected the company to break even in 2022. New consensus forecast suggests the company will make a profit of US$1.70m in 2024. Average annual earnings growth of 9.0% is required to achieve expected profit on schedule. Is New 90 Day High Low • Feb 09
New 90-day high: US$6.93 The company is up 121% from its price of US$3.14 on 10 November 2020. The American market is up 16% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 7.0% over the same period. Is New 90 Day High Low • Nov 03
New 90-day low: US$2.95 The company is down 71% from its price of US$10.35 on 04 August 2020. The American market is up 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Oct 13
Avenue Therapeutics, Inc. Receives Complete Response Letter from the FDA for IV Tramadol Avenue Therapeutics, Inc. announced it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the company’s New Drug Application (“NDA”) for IV tramadol. The CRL stated that although the pivotal Phase 3 clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA has determined that it cannot approve the application in its present form. The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. Specifically, if a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed. The likely choice would be another opioid, which would result in opioid “stacking” and increase the likelihood of opioid-related adverse effects. Other than this potential safety concern, the FDA did not identify a safety signal in Avenue’s clinical development program. In addition, the CRL stated that the FDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter. Is New 90 Day High Low • Oct 12
New 90-day low: US$4.53 The company is down 53% from its price of US$9.60 on 14 July 2020. The American market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Price Target Changed • Oct 12
Price target lowered to US$9.00 Down from US$12.00, the current price target is an average from 2 analysts. The new target price is 99% above the current share price of US$4.53. As of last close, the stock is down 17% over the past year.