BiomX Announces Discontinuation of Phase 2b BX004 Trial Following Internal Review
Rhea-AI Summary
BiomX (NYSE American: PHGE) announced on December 8, 2025 that it will discontinue the Phase 2b trial of nebulized phage therapy BX004 in cystic fibrosis after an internal review and recommendations from the independent Data Monitoring Committee following unusually high rates of adverse events.
The company said it will implement cost‑cutting measures, including a significant workforce reduction, and review strategic alternatives while refocusing development efforts on its bacteriophage program BX011 for Staphylococcus aureus diabetic foot infections, subject to available resources.
Positive
- Refocus on BX011 fixed phage cocktail for S. aureus DFI
- Cost‑cutting measures intended to conserve cash and resources
Negative
- Discontinued BX004 Phase 2b due to unexpectedly high adverse events
- Significant workforce reduction announced as part of cost cuts
- Company stated required timelines and resources exceed current resources
Key Figures
Market Reality Check
Peers on Argus 1 Down
PHGE is up 8.39% while key biotech peers like ADAP, APM and PHIO show declines between roughly -4% and -18%, indicating a stock-specific move rather than a sector-wide rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 25 | BX004 trial update | Positive | +5.4% | DMC recommended BX004 Phase 2b continue with adjusted dosing despite safety events. |
| Nov 14 | Reverse stock split | Negative | +7.5% | 1-for-19 reverse stock split approved and scheduled to take effect on Nov 25. |
| Nov 12 | Q3 2025 earnings | Negative | -1.9% | Reported Q3 loss, limited cash of <b>$8.1M</b>, and going-concern uncertainty. |
| Nov 05 | Earnings call notice | Neutral | +2.0% | Announced date and webcast details for Q3 2025 results and program update. |
| Nov 04 | BX011 FDA feedback | Positive | -16.9% | Positive FDA feedback and Phase 2a plan for BX011 in diabetic foot infections. |
Recent PHGE headlines often trigger sharp, sometimes counterintuitive moves, with both positive and negative news showing a mix of aligned and divergent price reactions.
Over the last few months, BiomX has combined clinical updates with balance-sheet stress. An Aug–Nov 2025 regulatory sequence covered BX004 clinical holds, ongoing Phase 2b work, and positive FDA feedback for BX011. Corporate actions included authorization and execution of a 1-for-19 reverse split and continued use of an ATM program. Liquidity remained tight, with cash only funding operations into Q1 2026. Against that backdrop, today’s discontinuation of the BX004 Phase 2b CF trial marks a major shift away from a previously central program and toward BX011 and cost-cutting.
Market Pulse Summary
This announcement discloses discontinuation of the BX004 Phase 2b CF trial after unexpectedly high adverse events and DMC feedback, alongside workforce reductions and a focus on BX011 for diabetic foot infections. Investors may contextualize this with recent filings that highlighted limited cash into Q1 2026 and going‑concern language. Key factors to monitor include progress and timelines for BX011, execution of cost-cutting, and any updates on strategic alternatives or additional funding.
Key Terms
data monitoring committee medical
AI-generated analysis. Not financial advice.
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
FAQ
Why did BiomX (PHGE) discontinue the BX004 Phase 2b trial on December 8, 2025?
How does stopping the BX004 Phase 2b trial affect BiomX's development focus (PHGE)?
What cost actions did BiomX (PHGE) announce alongside the BX004 discontinuation?
Did BiomX (PHGE) cite patient safety in the decision to stop the BX004 trial?
Will BiomX (PHGE) resume BX004 testing with alternative dosing or strategy?
What is the near‑term development plan for BiomX (PHGE) after the BX004 setback?
