Avenue Therapeutics Reports $1.9 Million Net Loss in Q1 2025, Sees Improvement Year-Over-Year

Avenue Therapeutics, Inc. reported a net loss of approximately $1.9 million for the first quarter of 2025, a significant improvement compared to a net loss of $4.3 million during the same period in 2024. The company's accumulated deficit now stands at $104.4 million. The reduction in losses is attributed to a decrease in research and development expenses, which fell to $411,000 from $2.4 million year-over-year, primarily due to the cessation of costs associated with the AJ201 program following its termination. General and administrative expenses increased slightly to $1.5 million from $1.3 million, reflecting higher legal costs.

In terms of financial position, Avenue Therapeutics reported total assets of $3.6 million as of March 31, 2025, up from $2.7 million at the end of 2024. Cash and cash equivalents increased to $3.5 million from $2.6 million, bolstered by $2.1 million in net proceeds from the sale of common stock under an At the Market Offering Agreement. Current liabilities also rose to $1.3 million from $816,000, primarily due to increased accounts payable and accrued expenses.

Strategically, Avenue faced a significant setback with the termination of its license agreement with AnnJi Pharmaceutical Co. for the AJ201 product candidate, which was intended for the treatment of spinal and bulbar muscular atrophy. The termination, effective April 24, 2025, included a transfer of rights back to AnnJi and a commitment not to develop competing products for 48 months. Despite this setback, Avenue is set to receive $2 million from AnnJi, contingent on certain milestones, and retains the potential for future royalties from any commercial sales of AJ201.

Operationally, Avenue Therapeutics continues to focus on its remaining product candidates, including intravenous tramadol for post-operative pain management and BAER-101 for epilepsy and panic disorders. The company is exploring strategic alternatives for Baergic Bio, Inc., which it acquired to enhance its neurological product pipeline. Avenue's management has indicated that additional funding will be necessary to support ongoing operations and product development, as the company is not currently generating revenue and expects to incur losses for the foreseeable future.

Looking ahead, Avenue Therapeutics acknowledges substantial doubt about its ability to continue as a going concern without securing additional financing. The company plans to pursue various funding options, including equity or debt offerings, to support its operational and developmental needs. The outlook remains uncertain, as the company navigates the challenges of product development and market conditions while striving to achieve regulatory approvals for its candidates.