Avenue Therapeutics(US:ATXI)2024-11-14 21:10Corporate Highlights and Pipeline Update Avenue Therapeutics made significant progress in its neurologic disease treatment pipeline, with AJ201 topline data expected by year-end 2024, and other programs contingent on financing AJ201 for SBMA AJ201's Phase 1b/2a clinical trial for SBMA completed patient visits in May 2024, with topline safety and tolerability data expected by year-end - Topline data from the Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy (SBMA) is anticipated around year-end 202413 - The final patient visit for the 12-week, 25-patient trial was completed in May 2024, marking the last clinical milestone before the data announcement3 - The primary endpoint of the study is to evaluate the safety and tolerability of AJ201, with secondary endpoints measuring changes in mutant AR protein levels and Nrf2-activated genes3 BAER-101 for Epilepsy Avenue plans a Phase 2a clinical trial for BAER-101 in focal epilepsy, contingent on securing additional financing - Avenue plans to initiate a Phase 2a clinical trial of BAER-101 for patients with focal epilepsy, but this is contingent upon receiving additional financing4 IV Tramadol for Post-Operative Pain Avenue reached final FDA agreement on the IV tramadol Phase 3 safety study protocol, with initiation contingent on financing or partnership - Final agreement has been reached with the U.S. FDA on the safety study protocol for the Phase 3 trial of IV tramadol4 - The initiation of the Phase 3 study, which will compare IV tramadol to IV morphine in post-bunionectomy patients, is pending additional financing or a partnership4 Third Quarter 2024 Financial Results Avenue Therapeutics reported a net loss of $3.1 million for Q3 2024, a significant shift from prior year's net income, with increased R&D and reduced cash Q3 2024 Financial Highlights (in millions, except per share data) | Financial Metric | Q3 2024 | Q3 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $2.6 million | N/A | -$2.3M vs Q2 2024 | | R&D Expenses | $2.3 million | $0.9 million | +$1.4 million | | G&A Expenses | $0.8 million | $1.2 million | -$0.4 million | | Net (Loss) Income | ($3.1 million) | $0.5 million | -$3.6 million | | (Loss) Income Per Share | ($1.92) | $4.86 | -$6.78 | Condensed Consolidated Balance Sheets As of September 30, 2024, Avenue Therapeutics reported total assets of $2.6 million, primarily cash, and total stockholders' equity of $1.7 million Balance Sheet Summary (in thousands) | Account | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,597 | $1,783 | | Total assets | $2,625 | $1,850 | | Total current liabilities | $973 | $1,196 | | Total stockholders' equity | $1,652 | $654 | Condensed Consolidated Statements of Operations For Q3 2024, Avenue Therapeutics reported a loss from operations of $3.2 million and a net loss of $3.1 million, a significant decline from prior year Statement of Operations Summary - Three Months Ended Sep 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Research and development | $2,327 | $907 | | General and administrative | $829 | $1,161 | | Loss from operations | ($3,156) | ($2,068) | | Net (loss) income | ($3,087) | $513 | | Net (loss) income per share | ($1.92) | $4.86 | Statement of Operations Summary - Nine Months Ended Sep 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Research and development | $6,080 | $5,149 | | General and administrative | $3,607 | $3,042 | | Loss from operations | ($9,687) | ($12,421) | | Net loss | ($10,137) | ($11,105) | | Net loss per share | ($17.27) | ($115.55) |