[8-K] BiomX Inc. Reports Material Event

Rhea-AI Filing Summary

BiomX Inc. (PHGE) reported an update on its Phase 2b study of BX004 for treating cystic fibrosis. The U.S. FDA is continuing its clinical hold while it evaluates a third-party nebulizer device used to deliver BX004, and BiomX is working with the device manufacturer to answer follow-up FDA information requests in order to lift the hold. The company believes the remaining items are readily addressable and expects U.S. enrollment to resume once this process is complete and subject to available financing. An independent Data Monitoring Committee completed a safety review of the study, including participants who experienced adverse events, and recommended the trial continue with an adjusted dosing regimen. BiomX is updating the protocol accordingly and, depending on financial resources and other factors, now expects topline results in the second quarter of 2026.

Positive

• None.

Negative

• BX004 Phase 2b delayed: FDA clinical hold on the nebulizer device continues, and topline results are pushed to the second quarter of 2026, contingent on financing.

Insights

Biotech clinical and regulatory analyst

Ongoing FDA clinical hold and dosing change delay BX004 Phase 2b data to Q2 2026.

BiomX confirms that its Phase 2b study of BX004 in cystic fibrosis remains on FDA clinical hold while the agency continues to evaluate the third-party nebulizer device used for drug delivery. The company is supplying additional data with the device manufacturer and describes the remaining issues as readily addressable, but any restart of U.S. enrollment depends on successful resolution and adequate financing.

An independent Data Monitoring Committee completed a safety review that included participants who experienced adverse events and advised the trial should continue with an adjusted dosing regimen. BiomX is amending the protocol to reflect this change, which may help align the risk–benefit profile but also adds operational steps.

As a result of the hold and protocol update, topline results are now expected in the second quarter of 2026, later than previously indicated. Future progress will hinge on FDA feedback on the nebulizer device, implementation of the new dosing regimen, and the company’s ability to secure sufficient financial resources to run the study through completion.

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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): November 25, 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. Furthermore, as previously disclosed by the Company on October 17, 2025, the Company received additional questions from the FDA relating to the third-party nebulizer device.

On November 25, 2025, BiomX updated that the FDA is continuing its evaluation of the third-party nebulizer device used for drug administration in the Study, and the Company is working with the third-party manufacturer to address these FDA follow-up information requests in order to lift the FDA’s clinical hold with respect to the Study. BiomX considers the outstanding items readily addressable while maintaining productive ongoing dialogue with the FDA and expects enrollment in the U.S. to resume once this process is complete and pending availability of financing resources.

In addition, on November 25, 2025, BiomX announced that an independent Data Monitoring Committee (“DMC”) has conducted a safety review of the Study. The review included participants who experienced adverse events, and following its evaluation, the DMC recommended that the Study continue with an adjusted dosing regimen. In accordance with the recommendations, BiomX is updating the trial protocol, and pending availability of financial resources and other factors, topline results are now expected in the second quarter of 2026.

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 provides will allow the FDA to lift the clinical hold, sufficiency of financial resources, resumption of patient enrollment and timing thereof, the expected timing of topline results for the Study, the impact of the FDA clinical hold on the Study, and the potential impact of the adjustment to the dosing regimen recommended by the DMC on the Study, 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.
November 25, 2025	By:	/s/ Jonathan Solomon
		Name:	Jonathan Solomon
		Title:	Chief Executive Officer

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