BiomX Inc.

Item 1A. Risk Factors

In addition to the other information set forth in this reQuarterly Report, you should carefully considerincluding in the factors discusssection captioned in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K Cautionary Statement Regarding Forward-Looking Infor the year ended December 31, 2024.

There have been no material changes frommation above, you should carefully consider the risk factors previously disclosussed in our Annual RepoPart on ForI, Item 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 25, 2A Risk Factors of the 2025, except  10-K, as noted below.

Regulatory authorities may impose a hold on our clinical trials.

A clinical trial may be suspended or terminaupdated and supplemented by us or a collaborathe risk factor, institutionals review boards (IRBs) for the institutions in which such trials are being conducted,lating to 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 epanys strategic transition and new business focus set forth in the May 5 8-K. These risks could materially affects, failure to demonstrate a benefit from  the Companys busing a cell therapy, changes in governmentess, financial 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 tcondition, results of operations, cash flows, and the treatment of CF patients with chronic pulmonary infections due toading price of the need for additional informatiCommon regarding the manufacturing process of BX004. On OctobStock.

Other 17, 2025, we reported that we received additional questions from the FDAthan as set forth in that were narrow in scopee May 5 8-K 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 as supplemented by the FDAs queries relating to the nebulizer. Enrollment and dosing in the European portion of the studydisclosures continue ahead of plan, and the study remains on track to report topline results ained elsewhere in the first qis Quarter of 2026. While we believe we have addressed the FDAs requests, there can be no assurance that the clinical holdly Report (including will be fully lifted or that future regulatory actions will not occur, any of which could affect our development plans and timelines.

A prolonged shutdown of the U.S. federal government could adversely affect our business, financialth respect to the Companys NYSE American condition, results of operations and prospects.

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 tinued listing matters, the Companys going-concern conclusion, the future. During such shutdowns, certain regulatory agencies, including integration of 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 recently acquired operating subsidiaries, and 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 matters described in Liquidity and approvCapital of our regulatory submissions, which could adversely affect the timing of our development programs and the potential commercResources above), there have been no materialization of our product candidates. Similarly, a continued shutdown of  changes to 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 neededrisk factors set forth in the 2025 10-K.