Biomx Inc. ((PHGE)) has held its Q3 earnings call. Read on for the main highlights of the call.
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BiomX Inc.’s recent earnings call conveyed a cautiously optimistic sentiment, highlighting significant advancements in clinical trials and positive regulatory feedback. Despite facing financial challenges and a temporary regulatory hold, the company remains hopeful about the future of phage therapy and its strategic plans for BX011 and BX004.
BX004 Phase IIb Trial Progress and FDA Feedback
The BX004 program for cystic fibrosis patients has made notable progress, with the first patient dosing in the Phase IIb trial. Although a clinical hold has been placed on U.S. trial sites due to issues with a third-party nebulizer device, the European trial continues without interruption. The FDA has acknowledged the unmet need for treatments targeting chronic Pseudomonas aeruginosa infections and provided constructive guidance for future development, including Phase III criteria.
Positive FDA Feedback for BX011 in Diabetic Foot Infections
BiomX received encouraging feedback from the FDA regarding the development plan for BX011, which targets Staphylococcus aureus infections in diabetic foot infections. The program aims to deliver an off-the-shelf formulation with potential dual-use in combat-related wound infections, aligning with U.S. Defense Health Agency priorities. The FDA has outlined a clear pathway toward a Biologics License Application, supporting the commercial potential without requiring additional nonclinical studies.
Financial Management and Reduced Expenses
BiomX has successfully reduced research and development expenses to $6.1 million in Q3 2025 from $7.3 million in Q3 2024, attributed to workforce reductions and lower rent expenses. General and administrative expenses also decreased to $2.4 million from $3.2 million. The company estimates its cash reserves are sufficient to fund operations into the first quarter of 2026.
Clinical Hold on BX004 U.S. Trial Sites
The FDA has placed a clinical hold on BX004 U.S. trial sites due to concerns with a third-party nebulizer device, not the drug candidate itself. This temporary pause affects U.S. sites while awaiting further FDA feedback, although European enrollment continues as planned.
Decreased Cash Balance and Net Loss
BiomX’s cash balance and restricted cash decreased to $8.1 million as of September 30, 2025, from $18 million at the end of 2024, primarily due to net cash used in operating activities. The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024, influenced by changes in the fair value of warrants.
Forward-Looking Guidance
During the earnings call, BiomX provided guidance on several metrics. The company reported a cash balance of $8.1 million as of September 30, 2025, with expectations to fund operations into Q1 2026. They anticipate reporting BX004 Phase IIb data in Q1 2026 and have received positive FDA feedback for BX011’s development pathway. Despite the temporary FDA clinical hold on BX004, BiomX is advancing its lead programs with regulatory engagement and clinical trial progress.
In summary, BiomX Inc.’s earnings call reflects a cautiously positive outlook with significant progress in clinical trials and regulatory feedback. While financial challenges persist, the company’s strategic advancements in phage therapy and key programs like BX011 and BX004 provide a promising future trajectory.