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

Core Insights - Avenue Therapeutics has completed the last patient visit in its Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy, with topline data expected in the second half of 2024 [1][2][3] - The company raised $4.4 million in gross proceeds from a warrant exercise transaction in May 2024 [1][6] Clinical Development - AJ201 is the most advanced investigational treatment for spinal and bulbar muscular atrophy in the U.S., with a 12-week, multicenter, randomized, double-blind trial involving 25 patients [2][3] - The primary endpoint of the AJ201 trial is to assess safety and tolerability, while secondary endpoints include pharmacokinetic and pharmacodynamic data [3] - Avenue plans to initiate a Phase 2a clinical trial of BAER-101 for focal epilepsy, pending additional financing, with promising preclinical results [4] Financial Performance - As of June 30, 2024, cash and cash equivalents increased to $4.9 million from $3.2 million at March 31, 2024, and $1.8 million at December 31, 2023 [8] - Research and development expenses for Q2 2024 were $1.4 million, down from $3.0 million in Q2 2023, while general and administrative expenses rose to $1.5 million from $0.9 million [8][15] - The net loss attributable to common stockholders for Q2 2024 was $2.7 million, or $6.43 per share, compared to a net loss of $4.0 million, or $38.74 per share, in Q2 2023 [8][15] Corporate Actions - Avenue executed a 1-for-75 reverse stock split effective April 26, 2024, and received notice of compliance with Nasdaq listing criteria [7] - The company is developing three assets: AJ201 for spinal and bulbar muscular atrophy, BAER-101 for CNS diseases, and IV tramadol for acute postoperative pain management [9]