BiomX Inc.

Current report

Item 1A. Risk Factors

Current report

Other than as set forth in the May 5 8-K and as supplemented by the disclosures contained elsewhere in this Quarterly Report (including with respect to the Company’s NYSE American continued listing matters, the Company’s going-concern conclusion, the integration of the recently acquired operating subsidiaries, and the matters described in “Liquidity and Capital Resources” above), there have been no material changes to the risk factors set forth in the 2025 10-K.

Previous report

There have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 25, 2025, except as noted below.

Previous report

Regulatory authorities may impose a hold on our clinical trials.

Previous report

A clinical trial may be suspended or terminated by us or a collaborator, institutional review boards (IRBs) for the institutions in which such trials are being conducted, the Data Monitoring Committee for such trial, or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a cell therapy, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. On August 13, 2025, we reported that the FDA placed a clinical hold on our Phase 2b trial of BX004 for the treatment of CF patients with chronic pulmonary infections due to the need for additional information regarding the manufacturing process of BX004. On October 17, 2025, we reported that we received additional questions from the FDA that were narrow in scope and related solely to the third-party nebulizer device used in the study, with no concerns raised regarding the BX004 drug product itself. We believe we have fully addressed the FDA’s queries relating to the 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. While we believe we have addressed the FDA’s requests, there can be no assurance that the clinical hold will be fully lifted or that future regulatory actions will not occur, any of which could affect our development plans and timelines.

Previous report

A prolonged shutdown of the U.S. federal government could adversely affect our business, financial condition, results of operations and prospects.

Previous report

Congressional disagreement over the federal budget or the federal debt ceiling has resulted in a shutdown of the U.S. federal government. It is unclear how long such shutdown will continue or, even if it ends, if there could be similar shutdowns in the future. During such shutdowns, certain regulatory agencies, including the FDA and the SEC, may be required to furlough employees and suspend or significantly curtail critical activities. Our product development and regulatory activities depend in part on the continuity and capacity of the FDA and other health authorities. Although as of November 11, 2025, we have not been materially affected by the impacts of the shutdown on the FDA, disruptions at the FDA may delay the review, initiation or completion of our clinical trials, or the review and approval of our regulatory submissions, which could adversely affect the timing of our development programs and the potential commercialization of our product candidates. Similarly, a continued shutdown of the SEC could delay our ability to access the capital markets, including due to delays in the effectiveness of registration statements or other filings, which could adversely impact our liquidity and ability to raise additional funds when needed.