NESS ZIONA, Israel, Nov. 04, 2025 (WORLD NEWSWIRE)– BiomX Inc. (NYSE: PHGE) (” BiomX” or the “Business”), a clinical-stage business advancing unique natural and crafted phage treatments targeting particular pathogenic germs, today revealed that it has actually gotten favorable feedback from the U.S. Fda (FDA) on the proposed medical developmental path for BX011, a next-generation set multi-phage mixed drink targeting Staphylococcus aureus ( S. aureus) in diabetic foot infections (DFI).
FDA feedback supports BiomX’s strategy to advance its phage-based treatment into DFI as the next medical sign, following the Business’s previous Stage 2 research study of BX211, a phage item for the treatment of diabetic foot osteomyelitis (DFO) brought on by S. aureus The choice to concentrate on DFI shows 3 essential aspects: a more comprehensive client population with a substantial unmet medical requirement, a big industrial chance, and a clear regulative course supported by recognized FDA assistance. The 2 signs share the very same S. aureus pathogen, making DFI the proper preliminary sign for regulative approval prior to possible advancement in DFO.
The brand-new solution, BX011, consists of several exclusive phages, amongst them phage formerly assessed in the BX211 research study. BiomX’s advancement of phage treatments for S. aureus has actually been supported by around $40 million in non-dilutive financing from the U.S. DHA and Department of Navy financing under an Other Deal Authority (OTA) award through the Medical Innovation Business Consortium (MTEC) and handled by the Naval Medical Research Study Command (NMRC)– Naval Advanced Medical Advancement (NAMD). BX011’s development will continue in positioning with continuous conversations with the U.S. Defense Health Company (DHA) and based on the accessibility of needed funds, with strategies to start a Stage 2a medical trial in DFI.
The FDA offered comprehensive assistance supporting a course towards a prospective Biologics License Application (BLA). No extra non-clinical research studies are anticipated, and the FDA’s talk about Chemistry, Production, and Controls (CMC) follow BiomX’s existing production and quality method. The feedback validates that the BX011 advancement strategy remains in accordance with present FDA assistance for DFI item advancement.
” By targeting what is normally an earlier phase of illness, where infection stays in the ulcer instead of advancing to the bone, we intend to reach a more comprehensive client population and take full advantage of both the industrial and healing effect of our program” stated Jonathan Solomon, President of BiomX. “The FDA’s remarks strengthen our objective of bringing phage treatment into mainstream transmittable illness care.”
In March 2025, BiomX reported statistically considerable favorable topline arises from its Stage 2 BX211 trial targeting S. aureus in DFO. BX211 was safe and well endured, attaining considerable and continual decreases in ulcer size, with a clear separation from placebo beginning at week 7, and enhancements in ulcer depth observed at week 13. All clients got requirement of care, consisting of systemic antibiotic treatment, throughout the 12-week treatment duration.
About BiomX
BiomX is a clinical-stage business leading the advancement of natural and crafted phage mixed drinks and individualized phage treatments developed to target and damage hazardous germs for the treatment of persistent illness with significant unmet requirements. BiomX finds and verifies exclusive bacterial targets and uses its BOLT (” BacteriOphage Cause Treatment”) platform to tailor phage structures versus these targets. For additional information, please see www.biomx.com, the material of which does not form a part of this news release.
Safe Harbor
This news release consists of reveal or indicated “positive declarations” within the significance of the “safe harbor” arrangements of the U.S. Personal Securities Lawsuits Reform Act of 1995. Positive declarations can be recognized by words such as: “target,” “think,” “anticipate,” “will,” “may,” “expect,” “quote,” “would,” “located,” “future,” and other comparable expressions that anticipate or show future occasions or patterns or that are not declarations of historic matters. For instance, when BiomX describes the possible advantages of BX011, the next actions in advancement of BX011, the capacity of this item prospect, consisting of BLA, any requirement for extra non-clinical research studies or other actions before medical trial (if such trials are started at all), future compliance of the advancement of BX011 with FDA assistance, conversations with the DHA and sufficiency of funding resources, it is utilizing positive declarations. Positive declarations are neither historic truths nor guarantees of future efficiency. Rather, they are based just on BiomX management’s present beliefs, expectations and presumptions. Since positive declarations associate with the future, they undergo intrinsic unpredictabilities, threats and modifications in scenarios that are tough to anticipate and much of which are beyond BiomX’s control. These threats and unpredictabilities consist of, however are not restricted to, modifications in relevant laws or policies; the possibility that BiomX might be negatively impacted by other financial, company, and/or competitive aspects, consisting of threats intrinsic in pharmaceutical research study and advancement, such as: unfavorable lead to BiomX’s drug discovery, preclinical and medical advancement activities, the threat that the outcomes of preclinical research studies and early medical trials might not be reproduced in later medical trials, BiomX’s capability to enlist clients in its medical trials, and the threat that any of its medical trials might not begin, continue or be finished on time, or at all; choices made by the FDA, and other regulative authorities; choices made by investigational evaluation boards at medical trial websites and publication evaluation bodies with regard to our advancement prospects; BiomX’s capability to get, preserve and impose copyright rights for its platform and advancement prospects; its possible reliance on cooperation partners; competitors; unpredictabilities regarding the sufficiency of BiomX’s money resources to money its scheduled activities for the durations expected and BiomX’s capability to handle unexpected money requirements; and basic financial and market conditions. For that reason, financiers must not count on any of these positive declarations and must evaluate the threats and unpredictabilities explained under the caption “Danger Elements” in BiomX’s Yearly Report on Kind 10-K submitted with the Securities and Exchange Commission (the “SEC”) on March 25, 2025, and extra disclosures BiomX makes in its other filings with the SEC, which are offered on the SEC’s site at www.sec.gov. Positive declarations are made since the date of this news release, and other than as offered by law BiomX specifically disclaims any commitment or carrying out to upgrade positive declarations.
Contacts:
BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com