Avenue Therapeutics

Avenue Therapeutics, Inc. is a specialty pharmaceutical company, which engages in acquiring, licensing, and commercializing products for use in the intensive care hospital setting. It focuses on the development of intravenous tramadol, a potential alternative that could reduce the use of conventional opioids for patients suffering from acute pain. The company was founded on February 9, 2015 and is headquartered in New York, NY.

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Avenue Therapeutics, Inc. is a specialty pharmaceutical company, which engages in acquiring, licensing, and commercializing products for use in the intensive care hospital setting. It focuses on the development of intravenous tramadol, a potential alternative that could reduce the use of conventional opioids for patients suffering from acute pain. The company was founded on February 9, 2015 and is headquartered in Bay Harbor Islands, FL.

- Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024 - Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024

Avenue Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

MIAMI, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will participate in a fireside chat at Maxim Group's 2024 Healthcare Virtual Summit on Tuesday, October 15, 2024 at 1:30 PM ET.

Avenue Therapeutics to Participate in Maxim Group's 2024 Healthcare Virtual Summit

MIAMI, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will participate in the following upcoming investor conferences:

Avenue Therapeutics to Participate in Upcoming Investor Conferences

- Last patient visit complete in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data anticipated in second half of 2024 –

Avenue Therapeutics Reports Second Quarter 2024 Financial Results and Recent Corporate Highlights

MIAMI, June 20, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference. The presentation will be available to registered attendees for on-demand viewing on Thursday, June 27, 2024 starting at 7:00 a.m. ET.

Avenue Therapeutics to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference

Topline results of the Phase 1b/2a clinical trial anticipated mid-year 2024 Topline results of the Phase 1b/2a clinical trial anticipated mid-year 2024

Avenue Therapeutics 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)

– Raised a total of $9.4 million in gross proceeds from warrant exercise transactions since January 2024 – MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2024. “The first quarter was incredibly productive for Avenue, as we've successfully executed on key milestones across our pipeline of CNS treatments,” said Alexandra MacLean, M.D.

Avenue Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Highlights

MIAMI, April 29, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase an aggregate of 689,680 shares of the Company's common stock. The exercised warrants are comprised of warrants to purchase shares of common stock originally issued by Avenue on October 11, 2022, each having an exercise price of $116.25 per share, Series A and Series B warrants to purchase shares of common stock originally issued by Avenue on November 2, 2023, each having an exercise price of $22.545 per share, and warrants to purchase shares of common stock originally issued by Avenue on January 9, 2024, each having an exercise price of $22.545 per share. The warrant holders agreed to exercise these warrants for cash at a reduced exercise price of $6.20 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form S-1 (File Nos. 333-267206 and 333-274562) and Form S-3 (No. 333-276671). The gross proceeds to Avenue from the exercise of the warrants are expected to be approximately $4.4 million, prior to deducting placement agent fees and offering expenses. The closing of the warrant exercise transaction is expected to occur on or about May 1, 2024, subject to satisfaction of customary closing conditions.

Avenue Therapeutics Announces Exercise of Warrants for $4.4 Million in Gross Proceeds

MIAMI, April 24, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it will effect a 1-for-75 reverse split of its issued and outstanding common stock. Avenue expects its common stock to begin trading on a split-adjusted basis on the Nasdaq Capital Market as of the commencement of trading on April 26, 2024 with a new CUSIP number of 05360L403. The ticker symbol for the Company's stock will remain “ATXI.”

Avenue Therapeutics Announces Reverse Stock Split

MIAMI, March 25, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it will host a virtual key opinion leader (“KOL”) event highlighting expert perspectives on spinal bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease, on Thursday, April 4, 2024 at 11:00am ET.

Avenue Therapeutics to Host Virtual Key Opinion Leader (KOL) Event on April 4, 2024

- Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 -

Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights

MIAMI, March 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that by decision dated March 11, 2024, the Nasdaq Hearings Panel granted the Company's request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders' equity requirements, through May 20, 2024. The Company is considering all available options that may enable it to timely evidence compliance with the continued listing criteria and maintain its listing on Nasdaq; however, there can be no assurance that the Company will be able to do so.

Avenue Therapeutics Receives Positive Listing Determination from Nasdaq

BAER-101 demonstrated full suppression of seizure activity in SynapCell's GAERS model of absence epilepsy, a proven indicator of efficacy in anti-seizure drug development with high predictability of response in humans

Avenue Therapeutics to Present BAER-101 Preclinical Data at American Society for Experimental Neurotherapeutics (ASENT) 2024 Annual Meeting

-In vivo data supports BAER-101's unique ability to significantly suppress seizures using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy- -In vivo data supports BAER-101's unique ability to significantly suppress seizures using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy-

Avenue Therapeutics Announces Publication in Drug Development Research Highlighting First-In-Class Preclinical Data of BAER-101 in a Translational Model of Absence Epilepsy

MIAMI, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the Sidoti January Micro-Cap Investor Conference on Thursday, January 18, 2024 at 10:00 a.m. EST.

Avenue Therapeutics to Present at Sidoti January Micro-Cap Investor Conference

MIAMI, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into warrant exercise agreements with existing accredited investors for the immediate exercise of certain outstanding warrants to purchase an aggregate of 16.5 million shares of the Company's common stock. These warrants for immediate exercise include: (i) November 2023 Series B warrants to purchase an aggregate of 14.6 million shares of common stock issued by Avenue on November 2, 2023, each having an exercise price of $0.3006 per share, and (ii) January 2023 warrants to purchase an aggregate of 1.9 million shares of common stock issued by Avenue on January 31, 2023, each having an exercise price of $1.55 per share, at a reduced exercise price of $0.3006 per share as agreed upon by the Company. The gross proceeds to Avenue from the exercise of the warrants are expected to be approximately $5.0 million, prior to deducting placement agent fees and estimated offering expenses. The closing of the warrant exercise transactions is expected to occur on or about January 9, 2024, subject to satisfaction of customary closing conditions.

Avenue Therapeutics Enters into Warrant Exercise Transactions for $5.0 Million in Proceeds

MIAMI, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has reached final agreement with the U.S. Food and Drug Administration (“FDA”) on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for intravenous (IV) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The final 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.

Avenue Therapeutics Reaches Final Agreement with the U.S. FDA for the Phase 3 Safety Study for IV Tramadol

- Topline data remains on track for second quarter of 2024 - MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today 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.

Avenue Therapeutics Announces Completion of Enrollment in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)

MIAMI, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Amy Chappell, M.D., FAAN, will be presenting preclinical in vivo data evaluating BAER-101 using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy at the American Epilepsy Society (AES) 2023 Annual Meeting in Orlando, FL on December 2, 2023.

Avenue Therapeutics to Present at American Epilepsy Society 2023 Annual Meeting

Avenue Therapeutics (NASDAQ: ATXI ) stock is rising higher after the company revealed a major investment from Robert Davidow. According to a filing with the Securities and Exchange Commission (SEC), Davidow now holds a 14.5% stake in the specialty pharmaceutical company.

Why Is Avenue Therapeutics (ATXI) Stock Up 59% Today?

- Phase 1b/2a clinical trial of AJ201 remains on track to report topline data in second quarter of 2024 - - Positive BAER-101 preclinical data accepted for presentation at American Epilepsy Society (AES) Annual Meeting - - Agreement reached with U.S. FDA on study design and analysis approach for Phase 3 safety study of IV tramadol - - Raised $5 million in gross proceeds from public equity offering - MIAMI, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2023. “In the third quarter, Avenue continued to successfully execute across our pipeline of innovative CNS treatments," said Alexandra MacLean, M.D.

Avenue Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the closing of its previously announced public offering of an aggregate of 16,633,400 units (or pre-funded units in lieu thereof) at a public offering price of $0.3006 per unit (inclusive of the pre-funded warrant exercise price of $0.0001 per share). Each unit consisted of (i) one share of common stock (or one pre-funded warrant in lieu thereof), (ii) one Series A warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring five years from the date of issuance, and (iii) one Series B warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring eighteen months from the date of issuance. The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are approximately $5.0 million.

Avenue Therapeutics Announces Closing of $5.0 Million Public Offering

MIAMI, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the pricing of its public offering of an aggregate of 16,633,400 units at a public offering price of $0.3006 per unit. Each unit consists of (i) one share of common stock (or one pre-funded warrant in lieu thereof), (ii) one Series A warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring five years from the date of issuance, and (iii) one Series B warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring eighteen months from the date of issuance. The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be approximately $5.0 million.

Avenue Therapeutics Announces Pricing of $5.0 Million Public Offering

MIAMI, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the H.C. Wainwright 25th Annual Global Investment Conference scheduled to take place September 11-13, 2023. The presentation will be available for on-demand viewing starting Monday, September 11, 2023 at 7:00 a.m. ET.

Avenue Therapeutics to Present at H.C. Wainwright 25th Annual Global Investment Conference

- First patient dosed in Phase 1b/2a clinical trial of AJ201; topline data anticipated in first half of 2024 - - Positive BAER-101 preclinical data demonstrate excellent anti-seizure activity in translational animal model; Phase 2a trial in epilepsy planned to initiate in 2024 - - Agreement reached with U.S. FDA on study design and analysis approach for Phase 3 safety study of IV tramadol - MIAMI, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the second quarter ended June 30, 2023. “Avenue continues to make significant progress across our compelling pipeline of first- and best-in-class neurologic therapies for patients facing great unmet need," said Alexandra MacLean, M.D.

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