BiomX Ltd.

For the first time, scientists have designed a phage combination therapy that can precisely target and suppress gut bacteria associated with inflammatory bowel diseases (IBD). The work showcases the possibility of using phages for treating diseases associated with gut microbiota. For the first time, scientists have designed a phage combination therapy that can precisely target and suppress gut bacteria associated with inflammatory bowel diseases (IBD). Presented on August 4 in the journal Cell, the work showcases the possibility of using phages for treating diseases associated with gut microbiota. "The biggest problem with applying phage therapies is that there is a constant arms race between bacteria and phages," says Eran Elinav, director of the Systems Immunology department, Weizmann Institute of Science and the Microbiome & Cancer Division, German National Cancer Center (DKFZ) and the corresponding author of the study. "If you apply a single phage on a bacterium, the bacterium would likely develop resistance mechanisms very rapidly. To our knowledge, we are the first to use an orally-administered phage combination therapy against a disease-contributing gut commensal, while tackling the huge issue of phage resistance and treating a non-communicable disease." IBD includes a group of chronic inflammatory disorders of the gut that affect millions of people in the world. While the cause of IBD remains unclear, previous research has suggested that certain bacteria in the gut are linked to the disease. Researchers have tried using antibiotics to treat IBD, but these therapies are not sufficiently specific or effective. Antibiotics kill the friendly gut bacteria along with the pathogenic ones, can cause adverse effects, and give rise to antibiotic-resistant bacteria. "This proof-of-concept study utilizes phages as a precision weapon in suppressing a group of commensal strains contributing to IBD," says Elinav. "But our vision is that this new modality could potentially be developed and applied against a number of other IBD-associated bugs, and also against commensals that are involved with other diseases, including obesity, diabetes, cancer, neurodegenerative diseases, and more." Elinav's team, in collaboration with a group of international scientists, and the Weizmann Institute of Science's spinoff phage therapy company BiomX Ltd compared the gut microbiota compositions of 537 IBD patients to healthy controls enrolled in cohort studies in France, Israel, the U.S., and Germany. The team found IBD patients, despite their differences in geography, ethnicity and diet, tend to have a group of Klebsiella pneumoniae (Kp) strains enriched in their gut, especially in those who are experiencing disease flare-ups. When transplanting the Kp into mice, the team found that mice developed a severe intestinal inflammation and tissue damage, suggesting that these Kp strains may contribute to worsening of IBD. Next, Elinav and his team scanned and isolated thousands of bacteriophages from environmental samples. Bacteriophages are viruses that can target and infect bacteria. They identified some 40 phages that appear to be effective against the IBD-contributing Kp strains, including strains that have already developed phage resistance. The team tested the phages in various groups as a potential cocktail treatment against IBD-contributing Kp strains. In these phage combinations, each of the phages uses a different receptor to enter bacteria, and kills them through different mechanisms. Even if the bacteria mutate, rendering one of their receptors resistant, there will be back-ups, Elinav says. An effective cocktail design can prevent phage-resistant bacteria from forming and spreading, he adds. Elinav and his team discovered the most effective phage combination, which contains five phages, in suppressing the Kp strains in the test tube, as well as in mice IBD models, where the phage cocktail attenuated inflammation and tissue damage. The team further tested two representative phages from this cocktail in a phase I clinical trial that involves 18 healthy volunteers. The experiment showed that the phages can survive at high levels and remain active throughout the gastrointestinal tract when taken with antacids while not impacting the surrounding microbiota. Participants had no severe treatment-related adverse events. The team plans to further test the 5-phage cocktail in a subsequent phase II trial encompassing IBD patients that harbor the disease-contributing Kp strains. In addition, Elinav and his team are working to identify bacteria associated with other diseases and to develop effective phage combination therapies against them. "What we envision is a precision medical pipeline," says Elinav. "Using it, we can characterize the pathogenic bacteria of a person suffering from a disease related to the gut microbiota, and then apply a phage therapy that would be tailored to the individual to suppress the bacteria."

BRANFORD, Conn. & NESS ZIONA, Israel--(BUSINESS WIRE)-- 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, announced today that it is voluntarily delisting its shares of common stock from trading on the Tel Aviv Stock Exchange (the “TASE”). Based upon a review of the recent trading volume of BiomX’s common stock on the TASE and the costs associated with maintaining a presence on more than one stock exchange, BiomX’s management and its Board of Directors have concluded that it would be in the best interests of shareholders to have BiomX’s common stock listed on a single stock exchange. Under applicable Israeli law, the delisting of BiomX’s shares of common stock from trading on the TASE is expected to become effective in three months, on October 6, 2022. During this time, BiomX’s shares will continue to be traded on the TASE. Following the delisting of BiomX’s shares of common stock on the TASE, BiomX’s shares will continue to be listed on the NYSE American and all BiomX shares now traded on the TASE are expected to be transferred to the NYSE American where they can continue to be traded. 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. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets. Additional information is available at , 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 benefits of delisting from TASE and expectation of continued listing on the NYSE American, 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 30, 2022 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. Source: BiomX Inc. View source version on businesswire.com: 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. View this news release online at:

Boehringer Ingelheim has forged a second inflammatory bowel disease (IBD) collaboration with BiomX. The two companies will work together to identify biomarkers for the disease using the Israel-based BiomX's XMarker discovery platform. Shares of BiomX jumped more than 23% in premarket trading following the announcement. The two companies intend to use the discovery platform, a microbiome-based technology, to identify biomarkers for a pathogenic bacterium thought to be associated with IBD, a term that includes both Crohn's disease and ulcerative colitis. IBD is a chronic inflammation of the gastrointestinal tract. The two companies hope that the XMarker platform will find biomarkers that could indicate which IBD patients would receive benefit from microbiome-targeted therapies. According to its website, Boehringer is assessing a Phase II kinase inhibitor in combination with Janssen's Stelara, a drug already approved for Crohn's disease, which could benefit patients with this form of IBD. Boehringer was also assessing studying spesolimab, a selective antibody that blocks the activation of the interleukin-36 receptor in Crohn's. However, that trial has been terminated, according to a notification on clinicaltrials.gov. Last year, the U.S. Food and Drug Administration granted priority review to spesolimab as a potential treatment for generalized pustular psoriasis flares. Carine Boustany, senior vice president and site head of discovery research in the U.S. and head of global immunology and respiratory disease research at Boehringer, said the company is developing a first-in-class pipeline to address unmet needs in IBD. Some of those needs include "complications, utilizing clinical and biomarker measures to identify these patient segments. "This collaboration will help us advance our understanding of a segment of patients with IBD that may specifically benefit from blunting the recognition of the pathogenic microbiome," Boustany continued. The collaboration announced Tuesday builds on a partnership the two companies established in 2020 that focused on identifying biomarkers associated with patient phenotypes in IBD. That collaboration also concentrated on the XMarker platform, which uses a metagenomics-based approach to discover predictive microbial genomic signatures to be further developed into biomarkers, according to company information. The platform combines ultra-high-resolution DNA analysis, AI techniques and high-scale cloud computing resources to build classifiers of high sensitivity and specificity. Jonathon Solomon, chief executive officer of BiomX, expressed excitement over the new agreement with the Germany-based life sciences company. "Inflammatory bowel disease is a heterogenous inflammatory condition that remains extremely difficult to treat. By leveraging our unique, ultra-high resolution XMarker biomarker discovery platform, we hope to identify those biomarkers that can pinpoint the presence of pathogenic bacteria associated with IBD. Through this collaboration, we may be able to develop effective biomarkers that can be used to segment patient groups within IBD which could help determine the most appropriate course of therapy," Solomon said in a statement. Under the terms of the collaboration, BiomX will be entitled to receive a research payment of an undisclosed amount of money. Additionally, Boehringer will have the option to negotiate for exclusive rights to biomarkers discovered under the deal. BiomX retains the right to use the biomarkers as companion diagnostics for phage therapy.