Avenue Therapeutics(ATXI) - 2025 Q1 - Quarterly Report

Financial Performance - The net loss for the three months ended March 31, 2025, was approximately $1.9 million, compared to a net loss of $4.3 million for the same period in 2024, resulting in an accumulated deficit of approximately $104.4 million[103]. - The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future[104]. - As of March 31, 2025, the company reported an accumulated deficit of $104.4 million, indicating ongoing financial challenges[128]. - The net loss for the three months ended March 31, 2025, was $1.9 million, a 49% improvement from a net loss of $3.7 million in the same period in 2024[129]. - Net cash used in operating activities was $1.2 million for the three months ended March 31, 2025, compared to $3.1 million in the same period in 2024, reflecting improved cash management[140][141]. - The company had $3.5 million in cash and cash equivalents as of March 31, 2025, and anticipates needing additional financing to support ongoing operations[137][138]. Research and Development - Avenue expects to continue incurring research and development costs and general and administrative costs, leading to operating losses for at least the next several years[104]. - For the three months ended March 31, 2025, research and development expenses decreased by 83% to $0.4 million from $2.4 million in the same period in 2024, primarily due to reduced clinical development costs[129][131]. - BAER-101 demonstrated full suppression of seizure activity in a preclinical model with a minimal effective dose of 0.3 mg/kg[120]. - The company reached a final agreement with the FDA on the Phase 3 safety study protocol for IV tramadol, designed to assess the risk of opioid-induced respiratory depression[115]. - The company is exploring strategic alternatives for Baergic and/or BAER-101, which may include engaging a development partner or initiating a Phase 2a study if financing is secured[121]. Licensing and Agreements - The company entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. for the exclusive rights to the AJ201 product candidate, paying an initial cash license fee of $3.0 million[111]. - The AnnJi License Agreement was terminated on April 24, 2025, with the company transferring all rights related to AJ201 back to AnnJi[112]. - Future milestone payments under license agreements could total approximately $232.5 million, including $81.5 million for development milestones and $151.0 million for commercial milestones[144]. Capital and Financing - The company intends to obtain additional capital through the sale of debt or equity securities, but there is no assurance that necessary capital can be raised under acceptable terms[105]. - The company has obligations under a share repurchase agreement requiring payment of 7.5% of future financing proceeds, with $0.2 million paid in the three months ended March 31, 2025[146]. - The company reported a net cash inflow of $2.1 million from financing activities for the three months ended March 31, 2025, primarily from the sale of common stock[142]. Stock Market and Compliance - On March 17, 2025, Nasdaq notified the company of its delisting due to a violation of the stockholders' equity requirement of at least $2,500,000[107]. - General and administrative expenses increased by 14% to $1.5 million for the three months ended March 31, 2025, compared to $1.3 million in 2024, driven by higher legal expenses[133].