BiomX Announces Discontinuation of Phase 2b BX004 Trial Following Internal Review

Following internal analysis and Data Monitoring Committee (DMC) feedback, the Company has elected to discontinue the BX004 Cystic Fibrosis (CF) Phase 2b trial

 BiomX continues to see potential in BX011, its phage program for Staphylococcus aureus (S. aureus) infections associated with diabetic foot infections (DFI). The Company is also implementing cost cutting measures, while evaluating strategic alternatives

NESS ZIONA, Israel, Dec. 08, 2025 (GLOBE NEWSWIRE) --  BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced its discontinuation of the ongoing Phase 2b clinical trial of nebulized phage therapy BX004 in patients with CF associated with chronic Pseudomonas aeruginosa infections.

The decision to discontinue the CF Phase 2b trial follows the Company’s previously announced safety review by the independent DMC on November 25, 2025. After assessing the DMC’s recommendations and conducting an internal analysis of unexpectedly high rates of adverse events, the Company has elected to discontinue the trial. Additionally, the Company plans to implement cost-cutting measures including a significant reduction in workforce while reviewing other strategic alternatives, aimed at maximizing shareholder value.

“Our first priority is the improved treatment, health and safety of patients in the cystic fibrosis community, including those who enrolled in this trial. Patients living with cystic fibrosis continue to face significant challenges and require improved treatment options, including for Pseudomonas infections” said Jonathan Solomon, Chief Executive Officer of BiomX. “Ultimately, the projected timelines and resources required to evaluate the issue and potentially proceed safely with an alternative dosing or treatment strategy were beyond the Company’s currently available resources, leading us to make the difficult decision to discontinue the program.”  

Subject to availability of sufficient financial and other resources, the focus of the Company will be the development of bacteriophage-based therapeutics and advancing BX011 its fixed phage cocktail targeting S. aureus infection in patients with DFI.

About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.

Safe Harbor
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX refers to its focus on, and the potential benefits of, BX011, sufficiency of financial and other resources and review of strategic alternatives, it is using forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX’s control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA, and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.

Contacts:

BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com

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