[8-K] BiomX Inc. Reports Material Event

Rhea-AI Filing Summary

BiomX Inc. (PHGE) updated its Phase 2b BX004 program for cystic fibrosis. The FDA sent additional, narrow questions focused solely on the third‑party nebulizer used to deliver BX004, with no concerns raised about the drug itself. BiomX believes it has fully addressed these device-related queries.

Enrollment and dosing in the European portion of the study are proceeding ahead of plan, and topline results remain on track for the first quarter of 2026. The FDA also provided new written feedback recognizing the unmet need in chronic Pseudomonas aeruginosa infection and outlined potential development pathways, including refined inclusion criteria and approaches to enrich patient populations for a potential Phase 3 program.

BiomX plans to incorporate the FDA’s recommendations, as appropriate and subject to future study data, regulatory alignment, and resources, and anticipates an End-of-Phase 2 meeting after completion and review of the Phase 2b results.

Insights

Biotech regulatory strategist

FDA queries limited to device; EU study progress continues.

The FDA’s additional questions are described as narrow and limited to the nebulizer, with no issues raised about BX004 itself. That distinction matters: drug-safety or efficacy concerns often carry greater risk, while device questions can be addressed with technical data.

Operationally, BiomX notes enrollment and dosing in Europe are ahead of plan, and topline results are targeted for Q1 2026. The agency’s written feedback acknowledges unmet need and outlines potential pathways, including refined inclusion criteria and Phase 3 population enrichment approaches.

Next steps hinge on Phase 2b results and later regulatory dialogue at an End‑of‑Phase 2 meeting. Actual impact will depend on whether the FDA lifts the U.S. hold and on the strength of the topline data once available.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

Form 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 17, 2025

BiomX Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-38762		82-3364020
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

22 Einstein St., Floor 4 Ness Ziona, Israel		7414003
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: +972 723942377

n/a

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value		PHGE		NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

As previously disclosed by BiomX Inc. (“BiomX” or the “Company”) on August 19, 2025, the U.S. Food and Drug Administration (“FDA”) had placed a clinical hold on the Company’s Phase 2b study (the “Study”) that is design to test the Company’s drug candidate BX004 (“BX004”) in treating Cystic Fibrosis (“CF”) as the FDA reviews data submitted by the Company on a third-party nebulizer used in the Study to deliver BX004. Following the FDA’s hold notification the Company submitted additional requested data.

On October 17, 2025, BiomX updated that it had received additional questions from the FDA, which questions were narrow in scope and pertained solely to the nebulizer device, with no concerns raised regarding the BX004 drug product itself. BiomX believes it has fully addressed the FDA queries relating to the third-party nebulizer. Enrollment and dosing in the European portion of the Study continue ahead of plan, and the Study remains on track to report topline results in the first quarter of 2026.

In addition, the Company reported receiving new written feedback from the FDA recognizing the continued unmet medical need for therapies addressing chronic Pseudomonas aeruginosa infection in CF patients and outlining potential development pathways for BX004, including refined inclusion criteria for future studies and approaches to enrich patient populations in a Phase 3 program.

BiomX plans to incorporate the FDA’s recommendations, as appropriate and subject to future data from the Study, regulatory alignment, and resources, into ongoing development plans and anticipates further discussion with the FDA at an End-of-Phase 2 meeting following completion and review of the Phase 2b trial results.

Forward-Looking Statements

This Current Report 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 the possibility that the data BiomX provided will allow the FDA to lift the clinical hold, the timing of topline results for the Study, the impact of the FDA clinical hold on the Study, FDA feedback recognizing the continued unmet medical need for therapies addressing chronic Pseudomonas aeruginosa infection in CF patients and potential pathways outlined and results of potential future discussions with the FDA, 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.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	BIOMX INC.
October 17, 2025	By:	/s/ Jonathan Solomon
		Name:	Jonathan Solomon
		Title:	Chief Executive Officer

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FAQ

What did BiomX (PHGE) announce about the FDA clinical hold on BX004?

BiomX received additional FDA questions that were narrow and pertained only to the third‑party nebulizer, with no concerns raised about the BX004 drug product.

Is the BX004 Phase 2b study timeline affected for BiomX (PHGE)?

The company states the study remains on track to report topline results in the first quarter of 2026.

What is the status of the European portion of BiomX’s Phase 2b study?

Enrollment and dosing in Europe are continuing ahead of plan.

Did the FDA provide development guidance for BiomX’s BX004 program?

Yes. The FDA recognized the unmet need and outlined potential pathways, including refined inclusion criteria and approaches to enrich patient populations for Phase 3.

What are BiomX’s next regulatory steps for BX004?

BiomX plans to incorporate FDA recommendations as appropriate and anticipates an End‑of‑Phase 2 meeting after completion and review of Phase 2b results.

Does the FDA’s feedback raise any concerns about the BX004 drug itself?

No. The update states the FDA raised no concerns regarding the BX004 drug product; questions were limited to the nebulizer device.