BiomX outlines imminent FDA feedback and targets BX004 Phase IIb data in Q1 2026 while advancing BX011 for diabetic foot infections [Seeking Alpha]
BiomX Inc. COmmon Stock (PHGE)
Company Research
Source: Seeking Alpha
Jonathan Solomon, CEO, stated that the third quarter of 2025 was an important period for BiomX, highlighting that "we began the quarter strongly with first patient dosing in our Phase IIb trial, a significant milestone Quick Insights The main regulatory risk is an FDA clinical hold at U.S. trial sites due solely to a third-party nebulizer delivery device, not the drug, with FDA feedback on resolution pending. European sites continue unaffected and management is optimistic about resuming U.S. enrollment soon. BiomX has $8.1 million in cash as of September 30, 2025, sufficient to fund operations into Q1 2026; continued progress, especially for BX011, depends on securing additional financing. BX004 Phase IIb data is expected in Q1 2026 with potential Phase III design to be shaped by recent FDA feedback; BX011 has received clear guidance for BLA submission, targeting diabetic foot infections first, and development depends on ongoing Defense Health Agency discussions and securing
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News
- BiomX Provides Update on BX004 Phase 2b Trial in Cystic FibrosisGlobeNewswire
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- BiomX Inc (PHGE) Q3 2025 Earnings Call Highlights: Strategic Advances Amid Financial Challenges [Yahoo! Finance]Yahoo! Finance
- BiomX Inc. (PHGE) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- BiomX Reports Third Quarter 2025 Financial Results and Provides Program Updates [Yahoo! Finance]Yahoo! Finance
PHGE
Earnings
- 11/12/25 - Beat
PHGE
Sec Filings
- 11/25/25 - Form 8-K
- 11/17/25 - Form 8-K
- 11/12/25 - Form 10-Q
- PHGE's page on the SEC website