AVENUE THERAPEUTICS, INC.

Avenue Therapeutics, Inc. is a specialty pharmaceutical company focused on developing and commercializing treatments for neurologic diseases. The company's current product candidates include ATX-04 and intravenous tramadol (IV tramadol). ATX-04 is a selective β2-adrenergic agonist for Pompe disease. In February 2026, Avenue entered into an exclusive license agreement with Duke University for patents and know-how related to clenbuterol, also referred to as ATX-04, for lysosomal storage diseases with a focus on Pompe disease. IV tramadol is a schedule IV opioid intended for the treatment of post-operative acute pain, which Avenue has been developing since its inception and prior to its initial public offering in 2017. Previously, through November 5, 2025, Avenue was involved with BAER-101 for the treatment of epilepsy and panic disorders. In November 2022, Avenue completed a Stock Contribution Agreement, dated May 11, 2022, with Fortress Biotech, Inc. to acquire shares in Baergic Bio, Inc., which was developing BAER-101. As a result, Baergic became a majority-controlled and owned subsidiary of Avenue. On November 5, 2025, Avenue announced an agreement for Baergic to be acquired by Axsome Therapeutics, Inc., including the global rights to BAER-101 (also known as AZD7325), a novel oral GABAA α2,3 subtype-selective receptor positive allosteric modulator (PAM). BAER-101 was originally licensed by Baergic from AstraZeneca AB and will be referred to as AXS-17 by Axsome. Avenue and other former stockholders of Baergic are eligible to receive additional payments and royalties from Axsome based on development, regulatory, and commercial milestones and net sales. Avenue Therapeutics, Inc. is a majority-controlled subsidiary of Fortress Biotech, Inc.