BiomX Inc. Files 8-K

TL;DR

BiomX filed an 8-K, something happened, details TBD.

AI Summary

BiomX Inc. filed an 8-K on October 17, 2025, reporting an "Other Events" item. The filing does not contain specific details about the event, dollar amounts, or new dates beyond the reporting date.

Why It Matters

This filing indicates a material event has occurred for BiomX Inc., requiring disclosure to investors, though the specifics are not yet detailed.

Risk Assessment

Risk Level: low — The filing is a standard disclosure form without immediate financial or operational implications detailed within the provided text.

Key Players & Entities

• BiomX Inc. (company) — Registrant
• Chardan Healthcare Acquisition Corp. (company) — Former company name

FAQ

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value PHGE NYSE American Indi

Filing Documents

• ea0261617-8k_biomx.htm (8-K) — 28KB
• 0001213900-25-099752.txt ( ) — 190KB
• phge-20251017.xsd (EX-101.SCH) — 3KB
• phge-20251017_lab.xml (EX-101.LAB) — 33KB
• phge-20251017_pre.xml (EX-101.PRE) — 22KB
• ea0261617-8k_biomx_htm.xml (XML) — 4KB

01 Other Events

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

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 a

SIGNATURES

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 2

View Full Filing

View this 8-K filing on SEC EDGAR