Avenue Therapeutics(ATXI) - 2025 Q3 - Quarterly Report

Financial Performance - For the nine months ended September 30, 2025, Avenue Therapeutics reported a net loss of approximately $2.2 million, compared to a net loss of $10.1 million for the same period in 2024, indicating a significant reduction in losses [107]. - As of September 30, 2025, Avenue Therapeutics had an accumulated deficit of approximately $104.8 million, primarily due to research and development and general administrative costs [107]. - For the three months ended September 30, 2025, total operating expenses decreased by 77% to $724,000 from $3.2 million in the same period of 2024 [133]. - The net loss for the three months ended September 30, 2025, was $692,000, a reduction of 78% compared to a net loss of $3.1 million in 2024 [133]. - For the nine months ended September 30, 2025, total operating expenses were $3.7 million, a decrease of 61% from $9.7 million in 2024 [140]. - General and administrative expenses for the nine months ended September 30, 2025, were $3.0 million, down 18% from $3.6 million in 2024 [147]. - The company reported a net cash decrease of $979,000 from operating activities for the nine months ended September 30, 2025, compared to a decrease of $8.3 million for the same period in 2024 [153]. Research and Development - Avenue Therapeutics plans to continue incurring operating losses for the foreseeable future as it develops its product candidates [108]. - Avenue Therapeutics is currently evaluating the feasibility of a Phase 3 safety study for IV tramadol, which is subject to obtaining necessary financing or partnerships [121]. - The FDA has agreed on the majority of the proposed protocol items for the IV tramadol study, which will assess the risk of opioid-induced respiratory depression [120]. - The company expects a decrease in research and development activities due to no further development obligations for certain products, while continuing efforts to gain regulatory approval for existing candidates [136][146]. - Research and development expenses for the three months ended September 30, 2025, were $177,000, down 92% from $2.3 million in 2024, primarily due to reduced clinical development costs [133][135]. Financing and Capital Structure - The company intends to raise additional capital through the sale of debt or equity securities, but there is no assurance that it will be able to do so on acceptable terms [109]. - As of September 30, 2025, the company had $3.7 million in cash and cash equivalents, requiring additional financing to sustain operations beyond 12 months [152]. - Financing activities provided $2.1 million in cash for the nine months ended September 30, 2025, primarily from the sale of common stock [156]. - The common stock was suspended from trading on the Nasdaq Capital Market on March 17, 2025, and subsequently delisted on July 18, 2025, affecting funding opportunities [152]. - The company is evaluating various financing alternatives to enhance its capital structure amid liquidity challenges [152]. Licensing and Agreements - Avenue Therapeutics entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. for the AJ201 product candidate, paying an initial cash license fee of $3.0 million and agreeing to additional payments of up to $10.8 million [115]. - The company terminated the AnnJi License Agreement on April 24, 2025, transferring all rights related to AJ201 back to AnnJi [116]. - Avenue Therapeutics sold its former product candidate BAER-101 to Axsome for an upfront payment of $0.3 million and is eligible to receive approximately 74% of future payments and royalties under the Baergic Agreement [124][125]. - The company has contractual obligations totaling approximately $81.5 million in development milestones and up to $151.0 million in commercial milestones related to licensing agreements [159]. - A regulatory milestone payment of $3.0 million is due upon approval of IV tramadol, with royalties payable on net sales in the low to high single digits [160]. Other Financial Metrics - The company generated $1.4 million in net revenue for the nine months ended September 30, 2025, related to the AnnJi license termination, with no revenue recognized in the same period of 2024 [143]. - Interest income for the three months ended September 30, 2025, was $34,000, a decrease of 33% from $51,000 in 2024 [138]. - The change in fair value of warrant liabilities resulted in a loss of approximately $2,000 for the three months ended September 30, 2025, compared to a gain of $18,000 in 2024 [139]. - The company has paid $0.2 million and $0.7 million towards a share repurchase agreement with InvaGen for the nine months ended September 30, 2025, and 2024, respectively [161].