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NESS ZIONA, Israel - BiomX Inc. (NYSE American:PHGE), a micro-cap biotechnology company currently valued at $15.69 million with shares trading at $0.59, reported Friday that it has addressed FDA queries regarding the third-party nebulizer used to deliver its BX004 phage therapy for cystic fibrosis (CF) patients. According to InvestingPro data, the company maintains a solid liquidity position with more cash than debt on its balance sheet.
The company stated it has responded to the FDA’s additional technical clarifications about the nebulizer, which had led to a clinical hold on the U.S. portion of BX004’s Phase 2b trial. According to BiomX, the FDA’s concerns were "narrow in scope" and focused solely on the delivery device, not the drug product itself. With a current ratio of 2.66, InvestingPro analysis shows the company’s liquid assets comfortably exceed its short-term obligations, though it faces challenges with rapid cash burn.
Despite the U.S. clinical hold, patient enrollment and dosing in Europe have continued "ahead of plan," with the company maintaining that the Phase 2b trial remains on track to report topline results in the first quarter of 2026. All nebulizer components used in the European trial are CE marked and approved for use in the EU.
In parallel developments, BiomX received written feedback from the FDA acknowledging the significant unmet need for therapies addressing chronic Pseudomonas aeruginosa infection in CF patients, even with current CFTR modulator treatments available. The agency outlined potential development pathways, including approaches to refine inclusion criteria and enrich patient populations for Phase 3 studies.
BX004 is a fixed multi-phage cocktail targeting Pseudomonas aeruginosa infections in CF patients. The therapy previously demonstrated improvement in pulmonary function associated with reduced bacterial burden in a Phase 1b/2a trial subgroup with reduced lung function.
The current Phase 2b trial aims to enroll approximately 60 patients in a randomized, double-blind, placebo-controlled study assessing lung function, bacterial load, and quality of life metrics over 8 weeks. BX004 has received FDA Fast Track and Orphan Drug Designations.
This information is based on a press release statement from BiomX. Wall Street analysts maintain an optimistic outlook with price targets ranging from $15 to $16, significantly above current trading levels. For deeper insights into BiomX’s financial health, growth prospects, and 12 additional exclusive ProTips, investors can access the comprehensive Pro Research Report available on InvestingPro.
In other recent news, BiomX announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Phase 2 trial for the cystic fibrosis treatment BX004. The hold is due to concerns about the third-party nebulizer device used to deliver the phage therapy, not the BX004 therapy itself, which previously received FDA clearance for clinical investigational use. BiomX has responded to the FDA’s request by submitting additional data from the nebulizer’s manufacturer. In other developments, BiomX has set the date for its 2025 Annual Meeting of Stockholders for October 16, 2025. The company has also established August 22, 2025, as the record date for determining shareholders eligible to vote at the meeting. This meeting date differs by more than 30 days from the previous year’s meeting, prompting the company to update the deadline for shareholder proposals.
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