Avenue Therapeutics Announces Q2 2024 Financial Results and Corporate Highlights

Avenue Therapeutics, Inc. (Nasdaq: ATXI), a specialty pharmaceutical company, announced its financial results and corporate highlights for the second quarter ending June 30, 2024. The company focuses on developing and commercializing therapies for neurologic diseases.

CEO Alexandra MacLean, M.D., stated that Avenue has made significant progress in its development pipeline for neurologic disease treatments. The company completed the last patient visit in its Phase 1b/2a trial of AJ201 for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s Disease. AJ201 is the leading investigational treatment for SBMA in the U.S., and Avenue aims to present topline data from the trial in the second half of 2024. The trial, a 12-week multicenter, randomized, double-blind study, involved 25 patients divided between AJ201 and a placebo. The study aims to assess the safety and tolerability of AJ201, as well as its pharmacokinetic and pharmacodynamic characteristics. Secondary endpoints include measuring changes in mutant AR protein levels and Nrf2-activated gene expression in skeletal muscles. Exploratory objectives include changes in fat and muscle composition as indicated by MRI scans. These measurements are considered potential biomarkers for longer-term clinical improvement.

On another front, Avenue is planning a Phase 2a clinical trial of BAER-101, subject to further financing. BAER-101 is designed for patients with focal epilepsy and other seizure disorders. Preclinical studies have shown that BAER-101 can effectively suppress seizure activity quickly and consistently. Earlier this year, data from these studies were presented at the American Society for Experimental Neurotherapeutics' Annual Meeting and published in Drug Development Research.

Avenue has also reached a final agreement with the U.S. Food and Drug Administration (FDA) on the safety study protocol and statistical analysis for its Phase 3 study of intravenous (IV) tramadol. This study will test IV tramadol for acute post-operative pain in a controlled medical setting. Approximately 300 post-bunionectomy patients will be randomized to receive either IV tramadol or IV morphine for pain management over a 48-hour period, with IV hydromorphone available for breakthrough pain.

Financially, Avenue raised $4.4 million through a warrant exercise transaction in May 2024. The company also executed a 1-for-75 reverse stock split in April 2024 and has met all listing criteria for continued listing on the Nasdaq Capital Market. As of June 30, 2024, Avenue reported $4.9 million in cash and cash equivalents, up from $3.2 million at the end of March 2024 and $1.8 million at the end of December 2023.

Regarding financial performance, Avenue's research and development expenses for Q2 2024 were $1.4 million, compared to $3.0 million for the same period in 2023. General and administrative expenses were $1.5 million, up from $0.9 million in Q2 2023. The company's net loss attributable to common stockholders for Q2 2024 was $2.7 million, or $6.43 per share, down from a net loss of $4.0 million, or $38.74 per share, in the same quarter of the previous year.

Avenue Therapeutics continues to develop three main assets: AJ201 for SBMA, BAER-101 for central nervous system diseases, and IV tramadol for acute postoperative pain. The company is headquartered in Miami, Florida, and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO).