BiomX Inc. Files 8-K for Other Events

TL;DR

BiomX filed an 8-K for 'Other Events' - need more info to know what's up.

AI Summary

BiomX Inc. filed an 8-K on August 19, 2025, reporting "Other Events." The filing does not contain specific details about the nature of these events, dollar amounts, or definitive dates beyond the filing date itself. The company was formerly known as Chardan Healthcare Acquisition Corp. and changed its name on April 30, 2018.

Why It Matters

This 8-K filing indicates a material event has occurred for BiomX Inc., requiring disclosure to investors. However, the lack of specific details in this filing necessitates further investigation to understand the event's implications.

Risk Assessment

Risk Level: medium — The filing is for 'Other Events' without specific details, creating uncertainty about potential impacts on the company.

Key Players & Entities

• BiomX Inc. (company) — Registrant
• Chardan Healthcare Acquisition Corp. (company) — Former company name
• August 19, 2025 (date) — Date of report
• April 30, 2018 (date) — Date of name change

FAQ

Key Financial Figures

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

Filing Documents

• ea0253854-8k_biomx.htm (8-K) — 26KB
• 0001213900-25-078196.txt ( ) — 188KB
• phge-20250819.xsd (EX-101.SCH) — 3KB
• phge-20250819_lab.xml (EX-101.LAB) — 33KB
• phge-20250819_pre.xml (EX-101.PRE) — 22KB
• ea0253854-8k_biomx_htm.xml (XML) — 4KB

01 Other Events

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

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 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 th

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. August 19, 2025 By: /s/ Jonathan Solomon Name: Jonathan Solomon Title: Chief Executive Officer 2

View Full Filing

View this 8-K filing on SEC EDGAR