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BiomX to Present Data from Ongoing Phase 1b/2a Study Evaluating BX004 for the Treatment of Chronic Pseudomonas aeruginosa Pulmonary Infections in Patients with Cystic Fibrosis at the 37th Annual North American Cystic Fibrosis Conference

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BiomX to present data from Phase 1b/2a study on BX004 for the treatment of chronic Pseudomonas aeruginosa infections in cystic fibrosis patients at the 37th Annual North American Cystic Fibrosis Conference.
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  • BiomX will present data on BX004, a novel phage product candidate, for the treatment of chronic Pseudomonas aeruginosa infections in cystic fibrosis patients. The data will be presented at the 37th Annual North American Cystic Fibrosis Conference and will be available as an e-poster on the virtual congress platform. The presentation will provide insights into the potential of BX004 as a therapeutic option for cystic fibrosis patients.
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CAMBRIDGE, Mass. and NESS ZIONA, Israel, Oct. 27, 2023 (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 that the Company will present data from Part 1 of its ongoing Phase 1b/2a study evaluating the novel phage product candidate, BX004, for the treatment of chronic Pseudomonas aeruginosa (PsA) pulmonary infections in people with cystic fibrosis (“CF”) at the 37th Annual North American Cystic Fibrosis Conference, which is being held November 2-4, 2023, in Phoenix, Arizona. The abstract was selected for an oral presentation at the conference.

The Phase 1b/2a data for BX004 will also be available as an e-poster on the virtual congress platform.

Details of the oral presentation are as follows:

Title: A phase 1b/2a randomized, double-blind, placebo-controlled, multicenter study evaluating nebulized phage therapy in cystic fibrosis subjects with chronic Pseudomonas aeruginosa pulmonary infection

Session Name: W22-What’s New in Clinical Trials in CF?
Session Date and Time: Friday November 3, 2023, 9:30 AM - 11:30 AM MST
Location: 104 AB (West)

The poster will also be made available on the publications section of the BiomX website on November 3, 2023.

About BX004

BiomX is developing BX004, utilizing its proprietary BOLT platform, 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 September 2021, BX004 was cleared by the U.S. Food and Drug Administration to initiate a Phase 1b/2a study in CF patients with chronic pulmonary infections caused by P. aeruginosa. BX004 is being developed for the treatment of chronic respiratory infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. The Phase 1b/2a trial is composed of two parts. Part 1 of the study evaluated the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in nine CF patients in a single ascending dose and multiple dose design. Part 2 of the study will evaluate the safety and efficacy of BX004 in at least 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 of the trial are expected in November 2023.

About BiomX
BiomX is a clinical-stage company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets. For more information, please visit www.biomx.com, 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 potential safety or efficacy of BX004, and the expected timing, design and patient enrollment of Part 2 of the Phase 1b/2a study, 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. 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. 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 March 29, 2023 and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. 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 Contacts:

Investor Relations:
LifeSci Advisors, LLC
John Mullaly
(617)-698-9253
jmullaly@lifesciadvisors.com

BiomX, Inc.
Anat Primovich
Corporate Project Manager
+972 (50) 697-7228
anatp@biomx.com

Source: BiomX Inc.


FAQ

What is the purpose of the study?

The purpose of the study is to evaluate the efficacy of BX004, a novel phage product candidate, in treating chronic Pseudomonas aeruginosa infections in cystic fibrosis patients.

Where will the data be presented?

The data will be presented at the 37th Annual North American Cystic Fibrosis Conference in Phoenix, Arizona.

Will the data be available online?

Yes, the data will be available as an e-poster on the virtual congress platform and on the BiomX website.

What is the potential impact of BX004?

BX004 has the potential to be a promising therapeutic option for cystic fibrosis patients with chronic Pseudomonas aeruginosa infections.

BiomX Inc.

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