BiomX Reports Full Year 2019 Financial Results and Provides Business Update

BiomX Inc. (NYSE: PHGE), a clinical-stage biotechnology company developing both natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results and provided a business update for the full year ended December 31, 2019.

“2019 was a landmark year for BiomX as we advanced our lead program in acne-prone individuals into the clinic and, through our merger, listed publicly on the NYSE American stock exchange,” said Jonathan Solomon, BiomX Chief Executive Officer. “Phage can target and kill specific bacteria. This property, combined with an excellent safety record, creates the potential for it to become a disruptive therapeutic modality for the treatment of chronic diseases in which bacteria play a causative role. With our phage cocktail customization capabilities, cutting-edge synthetic biology, computational biology tools, phage manufacturing facilities and a strong financial position, we believe we are well positioned to leverage phages’ unique potential and develop important and novel therapeutics. We continue to be on track to announce data from our Phase 1 study of our lead candidate BX001 in subjects with acne prone skin at the end of the first quarter of 2020 and Phase 1 data for our inflammatory bowel disease program in the fourth quarter of 2020.”

COVID-19 Update

In light of the evolving COVID-19 pandemic, BiomX has implemented all recommended measures to safeguard the health and safety of its employees and the continuity of its business operations. The Company’s research and development programs currently remain on schedule. In addition BiomX enjoys a strong cash position with over $82 million in cash, cash equivalents and short-term deposits as of the end of 2019.

Recent Highlights

Development Programs

• Completed enrollment of a Phase 1 cosmetic clinical study in subjects with acne-prone skin. BiomX completed enrollment in a first-in-human cosmetic clinical study of BX001 in 75 subjects with mild to moderate acne. BX001 is a topically administered gel comprised of a cocktail of naturally occurring phage designed to address the appearance of acne by targeting Cutibacterium acnes (or C. acnes, formerly taxonomically classified as P. acnes), a bacterium implicated in the pathophysiology of acne vulgaris.

• Pre-IND meeting held with FDA and manufacturing initiated for BX002 for the treatment of Inflammatory Bowel Disease (IBD). BX002 is a phage cocktail targeting strains of Klebsiella pneumoniae that have been shown in animal models to be pro-inflammatory and pathogenic and may have a role in the onset and aggravation of the disease in humans¹. BiomX has advanced towards the clinic with a pre-Investigational New Drug (IND) regulatory meeting and initiated manufacturing for clinical trials in this indication.

• Presented preclinical results from program targeting Primary Sclerosing Cholangitis (PSC) at AASLD conference. BiomX presented in vivo data on a phage cocktail that substantially reduced bacterial burden of pathogenic Klebsiella pneumoniae strains which are thought to be disease modifying in PSC, a rare progressive liver disorder with no FDA-approved treatment².

• Presented preclinical results from colorectal cancer program at AACR Microbiome, Viruses, and Cancer Conference. BiomX presented preclinical in vivo data on phage that target Fusobacterium nucleatum, a bacterium present in the microenvironment of colorectal cancer tumors and thought to protect tumors from the host’s immune system³. BiomX also successfully applied synthetic engineering to convert phage from temperate (lysogenic) to lytic, the state in which phage kill bacteria.

• Completed construction of in-house phage manufacturing facility. The new facility, located at the Company’s headquarters, supports clinical manufacturing of candidate phage products and in the future could be expanded to support commercial manufacturing needs.

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