BiomX Reports Third Quarter 2025 Financial Results and Provides Program Updates – BiomX (AMEX:PHGE)

Favorable FDA feedback verifies clear scientific path for BX011 targeting S. aureus in Diabetic Foot Infections, developing on Business’s previous Stage 2 success

BiomX anticipates FDA feedback on BX004 scientific hold imminently; Registration and dosing of clients outside the U.S. are continuing in accordance with procedure

Favorable FDA feedback got in October offered assistance for prospective Stage 3 advancement paths of BX004

BiomX will host a teleconference and webcast today at 8:30 AM ET

NESS ZIONA, Israel, Nov. 12, 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 monetary outcomes for the 3rd quarter ended September 30, 2025, and offered current scientific and business updates.

” This previous quarter was specified by substantial developments in our regulative conversations with the Fda (FDA) throughout our pipeline,” stated Jonathan Solomon, President of BiomX. “For BX004, we expect impending FDA feedback relating to the scientific hold, and we have actually currently gotten helpful assistance detailing prospective Stage 3 advancement paths that show acknowledgment of the substantial unmet requirement amongst cystic fibrosis clients treated with CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulators. In parallel, we got extra favorable FDA feedback verifying a clear scientific advancement course for BX011, our brand-new repaired multi-phage mixed drink targeting Staphylococcus aureus ( S. aureus) in diabetic foot infections, developing on the success of our previous Stage 2 trial in diabetic foot osteomyelitis.”

Medical Program Updates

BX004– Repaired phage mixed drink for persistent Pseudomonas aeruginosa ( P. aeruginosa) in clients with cystic fibrosis (CF)

• In July 2025, BiomX effectively started client dosing in its Stage 2b trial of BX004, a randomized, double-blind, placebo-controlled, multicenter research study in around 60 CF clients with persistent P. aeruginosa infections. The trial is created to determine several effectiveness endpoints, consisting of decrease in bacterial problem, enhancements in lung function, and improved lifestyle.

• In October 2025, BiomX got composed FDA feedback acknowledging the substantial unmet requirement amongst cystic fibrosis clients treated with CFTR modulators. The FDA described prospective Stage 3 advancement paths, consisting of chances for population enrichment and enhanced trial style.
• The FDA has actually put a medical hang on the Stage 2b research study as it examines information sent by BiomX on third-party nebulizer utilized to provide BX004; no issues were raised in the scientific hold notice relating to the BX004 drug prospect. Registration and dosing of clients outside the U.S. is continuing in accordance with procedure. Feedback on the U.S. scientific hold of BX004 is anticipated imminently.

• The Business anticipates to report topline arise from the Stage 2b research study in the very first quarter of 2026.

BX011– Repaired phage mixed drink for clients with diabetic foot infections (DFI) related to S. aureus

• Previously this month, BiomX revealed that it has actually gotten favorable feedback from the FDA on the proposed scientific advancement path for BX011, a next-generation set multi-phage mixed drink targeting S. aureus in DFI. BiomX prepares to focus on DFI as the lead indicator for regulative advancement, ahead of the Business’s prospective future advancement of BX211 in diabetic foot osteomyelitis (DFO).
• This strategy develops on the substantial favorable Stage 2 arise from BX211 in diabetic foot osteomyelitis (DFO), while allowing the Business to target the big DFI client population.
• BiomX is presently preparing a Stage 2a trial for BX011 following current conversations and feedback from the FDA, without any extra non-clinical research studies needed, pending sufficiency of funds.
• The Business remains in continued conversations with the U.S. Defense Health Company (DHA) relating to next actions to support the usage of phage treatment to target S. aureus- driven infections.
• In the 3rd quarter, BiomX went to Transmittable Illness Week 2025 in which the Business provided formerly reported outcomes targeting S. aureus throughout oral and poster discussions. Individually, throughout presence at DFCon 2025– Diabetic Foot Conference, the abstract accepted for poster discussion was granted Finest Medical Abstract Award.

3rd Quarter 2025 Financial Outcomes

Money balance and limited money since September 30, 2025, were $8.1 million, compared to $18 million since December 31, 2024. The reduction was mainly due to net money utilized in running activities, partly balanced out by funds raised in the Business’s February 2025 funding. BiomX approximates its money, money equivalents and limited money suffice to money its operations into the very first quarter of 2026.

Research study and advancement costs, internet were $6.1 million for the 3rd quarter of 2025, compared to $7.3 million for the 3rd quarter of 2024. The reduction was mainly driven by lowered income costs due to labor force decreases, lower lease costs following a right-of-use property problems in 2024, and reduced costs connected to the CF item prospect, mainly due to the considerably greater production expenses that were sustained in 2024. Such reduction was partly balanced out by a boost in devaluation costs attributable to the sped up devaluation of leasehold enhancements arising from the adjustment of our workplace lease arrangement in Ness Ziona, Israel, along with by reduced grant financing from the Medical Innovation Business Consortium (under the DHA) and the Israel Development Authority.

General and administrative costs were $2.4 million for the 3rd quarter of 2025, compared to $3.2 million for the 3rd quarter of 2024. The reduction was mainly driven by lowered income and share-based payment costs and lower legal and other expert service charge. This reduction was partly balanced out by a boost in devaluation costs attributable to the sped up devaluation of leasehold enhancements arising from the adjustment of our workplace lease arrangement in Ness Ziona, Israel.

Bottom line was $9.2 million for the 3rd quarter of 2025, compared to earnings of $9.6 million for the 3rd quarter of 2024. The reduction was primarily due to the modification in the reasonable worth of warrants provided as part of the Business’s March 2024 funding.

Net money utilized in running activities for the 9 months ended September 30, 2025, was $22.0 million, compared to $30.7 million for the exact same duration in 2024.

Teleconference and Webcast Particulars
BiomX will host a teleconference and webcast on November 12, 2025, at 8:30 AM ET to discuss its 3rd quarter 2025 monetary outcomes and to offer a business upgrade.

Teleconference
https://register-conf.media-server.com/register/BIf7434533b852452a822a8e5f48b669e2

Webcast Link
https://edge.media-server.com/mmc/p/s6tntmgo

About BX004
BiomX is establishing BX004, a repaired multi-phage mixed drink, for the treatment of CF clients with persistent lung infections triggered by P. aeruginosa, a primary factor to morbidity and death in clients with CF. In November 2023, BiomX revealed favorable topline arise from Part 2 of the Stage 1b/2a trial where BX004 showed enhancement in lung function related to a decrease in P. aeruginosa problem compared to placebo in a predefined subgroup of clients with lowered lung function (standard FEV1P. aeruginosa lung infections. The 8-week research study will evaluate lung function, bacterial load, and lifestyle metrics. BX004 has actually gotten FDA Fast lane and Orphan Drug Designations.

About BX011
BX011 is a set multi-phage mixed drink created to deal with S. aureus– associated DFI. DFI is a severe bacterial infection which often establishes from ulcers on the foot and is a leading reason for amputation in clients with diabetes. BX011 integrates several exclusive phages, consisting of phage formerly examined in the Business’s previous DFO trial, to offer broad and powerful protection versus this S. aureus in DFI clients. Following the FDA’s helpful feedback, BiomX strategies to start a Stage 2a trial of BX011 in DFI, based on offered resources.

BiomX’s advancement of phage treatments for S. aureus has actually been supported by around United States $40 million in non-dilutive financing from the 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).

About BiomX
BiomX is a clinical-stage business leading the advancement of natural and crafted phage mixed drinks and customized phage treatments created to target and ruin damaging germs for the treatment of persistent illness with considerable unmet requirements. BiomX finds and confirms exclusive bacterial targets and uses its BOLT (” BacteriOphage Result In Treatment”) platform to tailor phage structures versus these targets. To find out more, please visit www.biomx.com, the material of which does not form a part of this news release.

Safe Harbor
This news release includes reveal or suggested “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 determined by words such as: “target,” “think,” “anticipate,” “will,” “may,” “expect,” “quote,” “would,” “located,” “future,” and other comparable expressions that anticipate or suggest future occasions or patterns or that are not declarations of historic matters. For instance, when BiomX describes its expected timing for reporting outcomes for its scientific properties along with the style of scientific trials thereof, timing of raising FDA scientific hold, if at all, future drivers, prospective timing, result and repercussions of anticipated feedback from the FDA and conversations with the U.S. DHA, the prospective security, effectiveness and toleration of BX004, BX011 and BX211, the prospective advantages of BX004 and BX211, future scientific advancement of BX004, BX011 and BX211, the capacity of its drug prospects to attend to the considerable unmet requirements of clients, and the quotes of the sufficiency of its money, money equivalents and short-term deposits, 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 existing beliefs, expectations and presumptions. Since positive declarations connect to the future, they go through fundamental unpredictabilities, dangers and modifications in scenarios that are challenging to anticipate and a number of which are beyond BiomX’s control. These dangers and unpredictabilities consist of, however are not restricted to, modifications in relevant laws or guidelines; the possibility that BiomX might be negatively impacted by other financial, company, and/or competitive elements, consisting of dangers fundamental in pharmaceutical research study and advancement, such as: negative lead to BiomX’s drug discovery, preclinical and scientific advancement activities, the threat that the outcomes of preclinical research studies and early scientific trials might not be reproduced in later scientific trials, BiomX’s capability to enlist clients in its scientific trials, and the threat that any of its scientific 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 scientific trial websites and publication evaluation bodies with regard to our advancement prospects; BiomX’s capability to get, keep and implement copyright rights for its platform and advancement prospects; its prospective reliance on cooperation partners; competitors; unpredictabilities regarding the sufficiency of BiomX’s money resources to money its scheduled activities for the durations prepared for and BiomX’s capability to handle unexpected money requirements; and basic financial and market conditions. For that reason, financiers need to not count on any of these positive declarations and need to examine the dangers 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 responsibility or carrying out to upgrade positive declarations.

Contacts:
BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com

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