BiomX to Present Phase 1b/2a Clinical Trial Data for BX004 at the 47th European Cystic Fibrosis Conference and at ASM Microbe 2024

GAITHERSBURG, Md. and NESS ZIONA, Israel, May 30, 2024 (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 the Company will present at two upcoming conferences data from BiomX’s Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections. The findings will be presented in an oral presentation and an ePoster at the 47th European Cystic Fibrosis Conference, which is taking place June 5-8, 2024, in Glasgow, United Kingdom, and in a Rapid Fire oral presentation and a poster at the American Society for Microbiology (ASM) Microbe 2024 meeting, being held June 13-17, 2024, in Atlanta, Georgia.

Details of the presentations are as follows:

47th European Cystic Fibrosis Conference

Title: Safety and efficacy of a nebulized phage cocktail in cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection: a phase 1b/2a randomized, double-blind, placebo-controlled study

Abstract: WS06.06

Oral Presentation: Clinical Trials New Therapies Workshop, WS06 – Where are we with new therapeutic approaches?

Date and Time: Thursday, June 6, 2024, 18:15 - 18:30 BST

ePoster: Available via dedicated computer terminals in ePoster area for duration of Conference

Presenter: Prof. Eitan Kerem, MD, Professor of Pediatrics and former Chairman of Department of Pediatrics at the Pediatric Pulmonology Unit, Hadassah University Medical Center, Jerusalem, Israel

ASM Microbe 2024

Title: Sputum Pharmacokinetics of a Nebulized Phage Cocktail in Cystic Fibrosis Patients with Chronic Pseudomonas aeruginosa Pulmonary Infection: A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Study

Abstract: 6480

Oral Presentation: Session AAR-RF-001 – AAR Friday Rapid Fire

Date and Time: Friday, June 14, 2024, 11:45 a.m. - 12:30 p.m. ET

Poster: Session AAR-P-016 - AAR06 Friday Novel Approaches: Diagnostics/Discovery and Non-Traditional Therapies to Combat Drug-Resistant Infections; Poster Board Number: AAR-FRIDAY-459

Date and Time: Friday, June 14, 2024, poster displayed from 10:00 a.m. - 5:00 p.m. ET; presenter at poster 10:30 a.m.-11:30 a.m. and 4:00 p.m.-5:00 p.m. ET

Presenter: Urania Rappo, MD, FIDSA, BiomX Inc., Cambridge, United States

BiomX will make the presentations available on the of the Company’s website on Thursday, June 6, 2024, 1:00 p.m. ET, for the 47th European Cystic Fibrosis Conference and on Monday, June 17, 2024, 1:00 p.m. ET, for ASM Microbe 2024.

About BX004

BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial where BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<70%).

BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center Phase 2b trial in CF patients with chronic P. aeruginosa pulmonary infections in the fourth quarter of 2024. The trial is designed to enroll approximately 60 patients randomized at a 2:1 ratio to BX004 or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The trial is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. Trial results are expected in the third quarter 2025. The FDA has granted BX004 Fast Track designation and Orphan Drug Designation.

About BiomX

BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit , the content of which does not form a part of this press release.

Safe Harbor

This press release 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 discusses the expected timing of clinical trials, key data readouts and topline results and the potential benefits of BX004, BiomX is making 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. In addition, past and current pre-clinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of BiomX clinical trials. 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. Actual results and outcomes may differ materially from those indicated in the forward-looking statements, as a result of various important factors, including risks and uncertainties related to the ability to recognize the anticipated benefits of the merger with APT; the outcome of any legal proceedings that may be instituted against BiomX following the merger and related transactions; the ability to obtain or maintain the listing of the common stock of BiomX on the NYSE American following the merger; costs related to the merger; 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 any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 4, 2024, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at . Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.

BiomX, Inc.

Assaf Oron