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BiomX Announces Therapeutics Development Award of up to $5 Million from the Cystic Fibrosis Foundation

By: via Business Wire

Funding Will Support Phase 1b/2a Study Evaluating BX004 for the Treatment of Chronic Respiratory Infections in CF Patients

CF Foundation to Invest up to $5 Million in BiomX Common Stock

Data Readouts from Phase 1b/2a CF Trial of BX004 Expected in 2022

BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the Company will receive a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation (“CF Foundation”).

“We are very pleased to receive the support of the Cystic Fibrosis Foundation – an organization which historically has played a role in supporting the development of innovative therapies for patients suffering from cystic fibrosis (CF),” said Jonathan Solomon, Chief Executive Officer of BiomX. “The funding provided by the CF Foundation will be used to support the development of our phage therapy product candidate for CF patients, BX004, through its Phase 1b/2a study and represents a continuation of the CF Foundation’s mission to bring potentially life-saving medicines to patients. We thank the CF Foundation for its support, and we look forward to reporting data from our Phase 1a/2b trial in 2022.”

Under the terms of the agreement with the CF Foundation, BiomX will receive up to $5 million in two tranches. In the first tranche, which closed on December 21, 2021, the CF Foundation invested $3 million as initial equity investment. Upon completion of patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004 BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.

BiomX is developing BX004 for the treatment of chronic respiratory infections in CF patients caused by Pseudomonas 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 trial in CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa.

The Phase 1b/2a trial of BX004 is composed of two parts and is expected to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the second quarter of 2022. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the third quarter of 2022.

About BiomX

BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases, such as cystic fibrosis, atopic dermatitis, inflammatory bowel disease, primary sclerosing cholangitis, and colorectal cancer. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.

Additional information is available at 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 its expectations regarding the timing and design of its Phase 1a/2b trial and reporting the results thereof, and the potential to achieve the applicable clinical milestone required to receive an additional $2 million investment from CFF, 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 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 31, 2021 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.

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