FDA clinical hold pauses BiomX (PHGE) U.S. BX004 cystic fibrosis trial

Rhea-AI Filing Summary

BiomX Inc. reports that the U.S. Food and Drug Administration has placed a clinical hold on the U.S. portion of its Phase 2b study of BX004 for treating cystic fibrosis. The FDA is reviewing data BiomX submitted on a third-party nebulizer device used to deliver BX004 and, in its notification, did not raise concerns about BX004 itself. Following the notification, BiomX provided additional requested data to the FDA, and patient screening and enrollment in the United States have been paused.

In Europe, all components of the third-party nebulizer are CE marked and have been deemed to meet applicable regulatory requirements. The Phase 2b study in the European Union has been approved, and enrollment and dosing of patients are continuing according to the study protocol.

Positive

• None.

Negative

• FDA clinical hold pauses U.S. BX004 Phase 2b enrollment, introducing uncertainty and potential delay in the cystic fibrosis trial, even though the issue is tied to the nebulizer device rather than the drug.

Insights

Biotech clinical development analyst

FDA clinical hold pauses U.S. BX004 Phase 2b, while EU trial continues.

The key event is an FDA clinical hold on the U.S. arm of the Phase 2b trial of BX004 in cystic fibrosis. The hold is tied to FDA review of data on a third-party nebulizer used to deliver the drug, and the FDA explicitly did not raise concerns about BX004 itself in the notification described.

BiomX has already submitted additional data requested by the FDA, but the timing and outcome of the FDA review are not detailed in the disclosure. During this period, U.S. patient screening and enrollment are paused, which can slow overall trial progress depending on the importance of U.S. recruitment to the study design.

In contrast, the trial in the European Union is proceeding, with the nebulizer components described as CE marked and meeting applicable regulatory requirements, and enrollment and dosing continuing under the protocol. Future updates on the FDA’s review and any change in the status of the clinical hold will be important for understanding BX004’s development path.

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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): August 19, 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.

On August 19, 2025 BiomX Inc. ("BiomX" or the "Company") announced that the U.S. Food and Drug Administration ("FDA") has 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.

The FDA did not raise concerns in the clinical hold notification regarding BX004. Following the FDA’s hold notification the Company submitted additional requested data. As a result of the FDA’s notification, patient screening and enrollment in the U.S. portion of the Study have now been paused. In Europe, all components of the third-party nebulizer device are CE marked and thus have been deemed to meet applicable regulatory requirements. The Study in the EU has been approved and enrollment and dosing of patients are continuing in accordance with the protocol of the Study.

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 clinical hold imposed by the FDA, the possibility that the data BiomX provided will allow the FDA to lift such clinical hold, that such clinical hold will be lifted soon, if at all, the timing, process and potential outcomes of review and other measures by the European regulatory authorities, resumption of patient enrollment and timing thereof and the impact of the FDA clinical hold on the BX004 Phase 2b trial, 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.
August 19, 2025	By:	/s/ Jonathan Solomon
		Name:	Jonathan Solomon
		Title:	Chief Executive Officer

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FAQ

What did BiomX Inc. (PHGE) disclose in this 8-K filing?

BiomX Inc. disclosed that the U.S. Food and Drug Administration placed a clinical hold on the U.S. portion of its Phase 2b study of BX004 for treating cystic fibrosis, due to the FDA’s review of data on a third-party nebulizer used to deliver the drug.

Does the FDA clinical hold involve safety concerns about BX004 itself?

According to the disclosure, the FDA’s clinical hold notification did not raise concerns regarding BX004 itself and is focused on reviewing data on the third-party nebulizer device used in the study.

How does the FDA clinical hold affect the BX004 Phase 2b trial in the United States?

As a result of the FDA’s clinical hold, patient screening and enrollment in the U.S. portion of the BX004 Phase 2b study have been paused while the FDA reviews the nebulizer data and the additional information submitted by BiomX.

Is the BX004 Phase 2b cystic fibrosis trial continuing in Europe?

Yes. The filing states that in Europe all components of the third-party nebulizer are CE marked and deemed to meet regulatory requirements, and that the Phase 2b study in the EU has been approved with enrollment and dosing of patients continuing according to the protocol.

What forward-looking risks does BiomX highlight related to BX004 and its clinical trials?

BiomX notes risks typical for pharmaceutical development, including the possibility of adverse results in preclinical and clinical studies, challenges enrolling patients, the risk that trials may not commence, continue or be completed on time, and the impact of decisions by the FDA, other regulators, and review boards on its development candidates.

Where can investors find more information on BiomX Inc. (PHGE) risks?

The company directs readers to the “Risk Factors” section in its Annual Report on Form 10-K filed on March 25, 2025, and to additional filings available on the SEC’s website at www.sec.gov.