Avenue Therapeutics(ATXI) - 2024 Q3 - Quarterly Report

Financial Performance - For the nine months ended September 30, 2024, the company reported a net loss of approximately $10.1 million, compared to a net loss of $11.1 million for the same period in 2023, resulting in an accumulated deficit of approximately $101.0 million[106]. - Net loss for Q3 2024 was $3.1 million compared to a net income of $0.5 million in Q3 2023, representing a decrease of 702%[126]. - Net cash used in operating activities was $8.3 million for the nine months ended September 30, 2024, compared to $7.1 million in 2023[146]. - The loss on settlement of common stock warrant liabilities was $0.8 million for the nine months ended September 30, 2024, with no comparable expense in 2023[141]. - The change in fair value of warrant liabilities resulted in a gain of $0.2 million for the nine months ended September 30, 2024, down from a gain of $1.5 million in 2023, a decrease of 87%[142]. Research and Development - The company expects to continue incurring research and development costs and general administrative expenses, leading to operating losses for at least the next several years[107]. - Research and development expenses increased to $2.3 million in Q3 2024 from $0.9 million in Q3 2023, a rise of 157%[128]. - For the nine months ended September 30, 2024, research and development expenses were $6.1 million, up from $5.1 million in the same period of 2023, an increase of 18%[137]. - The Phase 1b/2a trial for AJ201, which enrolled 25 patients, is expected to provide top-line data readout around year-end 2024[114]. - BAER-101, a novel GABA A positive allosteric modulator, demonstrated full suppression of seizure activity in preclinical data with a minimal effective dose of 0.3 mg/kg[118]. Administrative Expenses - General and administrative expenses decreased to $0.8 million in Q3 2024 from $1.2 million in Q3 2023, a decline of 29%[130]. - General and administrative expenses for the nine months ended September 30, 2024, were $3.6 million, compared to $3.0 million in 2023, an increase of 19%[139]. Capital and Financing - The company plans to obtain additional capital through the sale of debt or equity securities, but there is no assurance that necessary capital will be raised under acceptable terms[108]. - The company had $2.6 million in cash and cash equivalents as of September 30, 2024, and anticipates needing additional financing to support its operations beyond the first half of 2025[143]. Regulatory and Licensing - The company entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. for the exclusive rights to AJ201, paying an initial cash license fee of $3.0 million and agreeing to additional payments of up to $10.8 million for clinical trial reimbursements[111]. - The company reached a final agreement with the FDA on the Phase 3 safety study protocol for IV tramadol, which will involve approximately 300 post bunionectomy patients[116]. Company Structure and Governance - The company is a majority-controlled subsidiary of Fortress Biotech, Inc., which holds significant voting power over the company's outstanding capital stock[109]. - The company anticipates continued reliance on third parties for various operational aspects, including clinical data and regulatory approvals[108]. - The company is classified as a "smaller reporting company," which allows for reduced disclosure obligations and the option to delay the adoption of certain recent accounting standards[122].