PHGE

EX-99.1

2 ea026528101ex99-1_biomx.htm

PRESS RELEASE DATED NOVEMBER 12, 2025

Exhibit 99.1

BiomX Reports Third Quarter 2025 Financial Results and Provides Program Updates

Positive FDA feedback confirms clear clinical pathway for BX011 targeting S. aureus in Diabetic Foot Infections, building on Company’s prior Phase 2 success

BiomX expects FDA feedback on BX004 clinical hold imminently; Enrollment and dosing of patients outside the U.S. are continuing in accordance with protocol

Positive FDA feedback received in October provided guidance for potential Phase 3 development pathways of BX004

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

Ness Ziona, Israel, November 12, 2025 -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced financial results for the third quarter ended September 30, 2025, and provided recent clinical and corporate updates.

“This past quarter was defined by significant advancements in our regulatory discussions with the Food and Drug Administration (FDA) across our pipeline,” said Jonathan Solomon, Chief Executive Officer of BiomX. “For BX004, we anticipate imminent FDA feedback regarding the clinical hold, and we have already received supportive guidance outlining potential Phase 3 development pathways that reflect recognition of the significant unmet need among cystic fibrosis patients treated with CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulators. In parallel, we received additional positive FDA feedback confirming a clear clinical development path for BX011, our new fixed multi-phage cocktail targeting Staphylococcus aureus (S. aureus) in diabetic foot infections, building on the success of our prior Phase 2 trial in diabetic foot osteomyelitis.”

Clinical Program Updates

BX004 – Fixed phage cocktail for chronic Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF)

●In July 2025, BiomX successfully initiated patient dosing in its Phase 2b trial of BX004, a randomized, double-blind, placebo-controlled, multicenter study in approximately 60 CF patients with chronic P. aeruginosa infections. The trial is designed to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and enhanced quality of life.

●In October 2025, BiomX received written FDA feedback recognizing the significant unmet need among cystic fibrosis patients treated with CFTR modulators. The FDA outlined potential Phase 3 development pathways, including opportunities for population enrichment and optimized trial design.

●The FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004; no concerns were raised in the clinical hold notification regarding the BX004 drug candidate. Enrollment and dosing of patients outside the U.S. is continuing in accordance with protocol. Feedback on the U.S. clinical hold of BX004 is expected imminently.

●The Company expects to report topline results from the Phase 2b study in the first quarter of 2026.

BX011 – Fixed phage cocktail for patients with diabetic foot infections (DFI) associated with S. aureus

●Earlier this month, BiomX announced that it has received positive feedback from the FDA on the proposed clinical development pathway for BX011, a next-generation fixed multi-phage cocktail targeting S. aureus in DFI. BiomX plans to prioritize DFI as the lead indication for regulatory development, ahead of the Company’s potential future development of BX211 in diabetic foot osteomyelitis (DFO).

●This plan builds on the significant positive Phase 2 results from BX211 in diabetic foot osteomyelitis (DFO), while enabling the Company to target the large DFI patient population.

●BiomX is currently planning a Phase 2a trial for BX011 following recent discussions and feedback from the FDA, with no additional non-clinical studies required, pending sufficiency of financial resources.

●The Company is in continued discussions with the U.S. Defense Health Agency (DHA) regarding next steps to support the utilization of phage therapy to target S. aureus-driven infections.

●In the third quarter, BiomX attended Infectious Disease Week 2025 in which the Company presented previously reported results targeting S. aureus during oral and poster presentations. Separately, during attendance at DFCon 2025 – Diabetic Foot Conference, the abstract accepted for poster presentation was awarded Best Clinical Abstract Award.

Third Quarter 2025 Financial Results

Cash balance and restricted cash as of September 30, 2025, were $8.1 million, compared to $18 million as of December 31, 2024. The decrease was primarily due to net cash used in operating activities, partially offset by funds raised in the Company’s February 2025 financing. BiomX estimates its cash, cash equivalent

EX-99.1

2 ea025302201ex99-1_biomx.htm

PRESS RELEASE DATED AUGUST 13, 2025

Exhibit 99.1

BiomX Reports Second Quarter 2025 Financial Results and Provides Program Updates

Positive Phase 2 results for BX211 demonstrated >40% wound size reduction vs. placebo in diabetic foot osteomyelitis patients; Planning underway for potential registrational study

Nature Communications publication of new BX004 Phase 1b/2a data demonstrated further ~500-fold (2.7 log₁₀)2 bacterial reduction versus placebo with no detectable emergence of resistance observed, highlighting strength of BiomX platform capabilities

Phase 2b trial of BX004 in Cystic Fibrosis (CF) has successfully commenced patient dosing; FDA feedback on real-world evidence strategy expected in H2 2025; Company expects to report topline results in Q1 2026

BiomX will host a conference call and webcast today at 8:00 AM ET

Ness Ziona, Israel, August 13, 2025 -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced financial results for the second quarter ended June 30, 2025, and provided recent clinical and corporate updates.

“In the past few months, BiomX achieved several significant milestones that advance our pipeline and further validate our phage therapy platform,” said Jonathan Solomon, Chief Executive Officer of BiomX. “Positive Phase 2 results for BX211 in diabetic foot osteomyelitis demonstrated sustained, statistically significant improvements in wound size reduction, with over 40% reduction in ulcer size compared to placebo, and a favorable safety profile. In parallel, new peer-reviewed data for BX004, published in Nature Communications, reported approximately 500-fold (2.7 log₁₀)2 further bacterial reduction versus placebo and no detectable emergence of resistance, critical evidence supports the strength of our candidate BX004. With BX004’s Phase 2b trial now underway, FDA feedback on our real-world evidence plan expected later this year, and planning for a potential registrational BX211 study in progress, BiomX is positioned for multiple value-driving catalysts over the next 12 months.”

Clinical Program Updates

BX211 – Phage for the treatment of patients with diabetic foot infections and osteomyelitis (DFI/DFO) associated with Staphylococcus aureus (S. aureus)

●BiomX reported positive topline results from the Phase 2 trial of BX211 in March 2025 just prior to the start of the second quarter, demonstrating that BX211 was safe and well-tolerated and produced sustained and statistically significant1 percentage area reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13) with separation from placebo starting at week 7 and a difference greater than 40% by week 10.

●The Phase 2 trial results also showed that BX211 produced statistically significant improvements in both ulcer depth at week 13 in patients with ulcer depth defined as bone exposure at baseline (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo, with all patients receiving standard of care including systemic antibiotic therapy as appropriate over the 12-week treatment period.

●Planning for a potential registrational study of BX211 is underway, pending feedback from the U.S. Food and Drug Administration (FDA).

●Following strong Phase 2 results, the Company hosted a Virtual Key Opinion Leader event during the second quarter featuring leading clinical experts in diabetic foot infections and osteomyelitis. The discussion highlighted the clinical significance of the BX211 data, its potential role alongside standard of care, and perspectives on the path to registrational development. A replay of the webcast is available at the following Link, the content of which does not form a part of this press release.

●The Company is in continued discussions with the U.S. Defense Health Agency regarding next steps for the BX211 program following the positive Phase 2 results.

BX004 – Fixed phage cocktail for chronic Pseudomonas aeruginosa (P. aeruginosa) in patients with CF

●In July 2025, BiomX successfully initiated dosing of patients in its Phase 2b trial of BX004. The Phase 2b trial is a randomized, double-blind, placebo-controlled, multicenter study in approximately 60 CF patients with chronic P. aeruginosa infections. Patients are randomized 2:1 to receive either BX004 or placebo via inhalation twice daily for 8 weeks. The trial is designed to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and enhanced quality of life as measured by validated patient questionnaires.

●The Company expects to report topline results from the Phase 2b study in the first quarter of 2026.

●In the second half of 2025, BiomX expects to receive feedback from the FDA regarding the potential investigation and use of real-world evidence linking bacterial reduction to clinical

EX-99.1

2 ea024231901ex99-1_biomxinc.htm

PRESS RELEASE DATED MAY 15, 2025

Exhibit 99.1

BiomX Reports First Quarter 2025 Financial Results and Provides Business and Program Updates

In March 2025, BiomX announced positive topline results of the phase 2 trial evaluating BX211 for the treatment of diabetic foot osteomyelitis (DFO)

BX004 Phase 2b study in Cystic Fibrosis (CF) on track to report topline results in Q1 2026

In April 2025, shareholders approved exercise of warrants issued in $12 million in financings announced in February 2025; funds expected to provide runway through topline Phase 2b results for BX004 trial

The Company will host a conference call and webcast today at 2:00 PM ET

Ness Ziona, Israel, May 15, 2025 -- (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced financial results for the first quarter ended March 31, 2025, and provided program and business updates.

“The first quarter of 2025 was a period of exceptional progress for BiomX, both on the corporate front and across our clinical pipeline,” said Jonathan Solomon, Chief Executive Officer of BiomX. “The strength of the positive Phase 2 results from our BX211 program in diabetic foot osteomyelitis exceeded our expectations and received resounding endorsement from key opinion leaders and industry experts. These positive results represent a significant milestone for the field of bacteriophage therapy and further reinforce our platform’s potential to address serious, resistant infections. Notably, the BX211 program has been supported to date by approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency (DHA), which has identified an urgent need for new treatments to combat antibiotic-resistant infections in current and future conflict environments. The work received DHA and Department of Navy funding under an Other Transaction Authority (OTA) award through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD). We are currently in discussions regarding potential next steps in partnership with the DHA to further advance this program. Looking ahead, we remain focused on our next major catalyst, which is the anticipated Phase 2b readout of BX004 in cystic fibrosis in the first quarter of next year, supported by the recent financings we secured to advance this program and extend our operational runway.”

Clinical Program Updates

BX211 – phage for the treatment of DFO associated with Staphylococcus aureus (S. aureus)

●In March 2025, BiomX announced positive results from the Company’s DFO Adaptive Novel Care Evaluation (DANCE™) Phase 2 trial evaluating its BX211 phage treatment for DFO associated with Staphylococcus aureus (S. aureus).

●Key highlights from the Phase 2 trial results included:

oBX211 was found to be safe and well-tolerated.

oBX211 produced sustained and statistically significant1 Percentage Area Reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo (standard of care) starting at week 7 and a difference greater than 40% by week 10.

oCompared to placebo, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of ulcer area (p=0.017), compared to placebo.

oBX211 demonstrated favorable trends compared to placebo across several additional clinical parameters, including: proportion of visits with no clinical evidence of infection; evidence of resolving DFO by MRI/X-ray at week 12; proportion of patients with abnormal C-Reactive Protein at baseline that achieved a reduction of CRP of at least 50% at any point in the study; and greater Wagner scale improvement2.

oThrough week 13, BX211 demonstrated comparable efficacy against both Methicillin-susceptible and resistant strains, as well as against high and low biofilm producers—consistent with the orthogonal mechanism of phage therapy to antibiotics and its inherent anti-biofilm capabilities.

oA key opinion leader (KOL) event discussing the Phase 2 results took place on April 3, 2025. A replay of the webcast is available here, the content of which does not form a part of this press release.

●Pending feedback from the FDA, BiomX is planning for a Phase 2/3 clinical trial of BX211.

BX004 – fixed phage cocktail for the treatment of CF in patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa)

●During the first quarter, BiomX initiated the exploration and analysis of real-world evidence in people with CF on the relationship between P. aeruginosa reduction and clinical outcomes. Regulatory discussions with the U.S. Food and Drug Administration (“FDA”) and other regulatory au