BiomX Inc.

Good morning and welcome to Biomics second quarter 2022 financial results and corporate update conference call. Currently all participants are in a listen only mode. There will be a question and answer session at the end of this call. I would now like to turn the call over to Marina Wolfson, Chief Financial Officer of Biomics. Please proceed.

Thank you and welcome to the Biomics second quarter 2022 financial results and corporate update conference call. The news release became available just after 6.30 a.m. Eastern time today and can be found on our website at biomics.com. A replay of this call will be available on the investors section of our website. Before we begin, I'd like to review the safe harbor provision. All statements on this call that are not factual historic statements may be deemed forward-looking statements. For instance, we're using forward-looking statements when we discuss on the conference call potential market opportunities, the design, aim, expected timing, and interim and final results of our preclinical and clinical trials, the sufficiency of our existing cash, cash equivalents, and short-term deposits, the potential receipt of additional funds if milestones are met, the potential benefits of our product candidates, and potential growth in shareholder value. In addition, past preclinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of our clinical trials. Except as required by law, we do not undertake to update forward-looking statements. The full safe harbor provision, including risks that could cause actual results to differ from these forward-looking statements, are outlined in today's press release. which is noted earlier, is on our website. Joining me on the call this morning is Jonathan Sellerman, Chief Executive Officer of Biomics. With that, I will turn the call over to Jonathan.

Thank you, Marina. Good morning, everyone. The second quarter of 2022 proved to be a highly productive period for our company. We dosed the first patients in our Cystic Fibrosis Program, announced a second collaboration with Boehringer Ingelheim, published important new research supportive of our inflammatory bowel disease program and technology platform, and successfully completed a restructuring to further extend our cash runway. Let me first provide an update on our cystic fibrosis program. In June, we announced the dosing of the first two patients in the company's Phase 1 B2A study, evaluating BX004 for the treatment of chronic respiratory infections in patients with cystic fibrosis. This was clearly a very important milestone for the CF program, and I am pleased to report that despite the challenges facing many companies with respect to patient recruitment, we continue to make steady progress with respect to enrollment in this study. As a reminder, Biomics is developing BX004 for the treatment of CF patients with chronic respiratory infections caused by pseudomonas aeruginosa, or PSA, a main contributor to morbidity and mortality in patients with CF. The Phase 1b2a study of BX004 is composed of two parts. Part 1 will evaluate the safety, pharmacokinetics, and microbiologic clinical activity of BX004 in eight patients in a single ascending dose and multiple dose design. And provided that the pace of enrollment for the study will continue as expected, we anticipate the results from the first part of the study by the end of the third quarter of 2022. Part 2 of the study will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2 to 1 ratio, and results from Part 2 are expected in the first quarter of 2023. As a reminder, the opportunity to address lung infections in CF remains substantial given both the size of the patient population and how few treatment options are currently available. Between the U.S. and EU alone, there are approximately 70,000 to 80,000 patients living with CF, and it is estimated that more than 60% of adults with CF are infected with this bacteria. PSA infections are the leading cause of loss of lung function in people with CF, and after patients have been infected with the PSA in their lungs, the infection is exceptionally difficult to fully eradicate. We are encouraged to see a growing body of clinical research and scientific publications that provide evidence supporting the use of phage therapy for the treatment of lung infections in CF. At the 2021 North American Cystic Fibrosis Conference, researchers from the Yale School of Medicine presented data on six patients with multidrug-resistant pseudomonas arginosa who were treated with inhaled phage twice daily for seven to ten days. The purpose of the study was to interrogate the mechanism by which phage-suppressed pure arginosa pyocyanin production and the effect on lung inflammation. Results showed that the phage therapy was safe and showed significant reduction in pseudomonas agonosa titers. In addition, phage therapy also led to an improvement in lung function. As noted in our past calls, Yale University has been the forefront of developing phage-based treatment to help address multidrug-resistant lung infections in CF patients. And through its ongoing compassionate use study, valuable clinical evidence is being generated to support this treatment approach. In June 2022, researchers from UCSD and other academic institutions published a paper in the journal Clinical Infectious Disease entitled Phage Therapy of Microbacterium Infections and Patient Use of Phage in 20 Patients with Drug-Resistant Microbacterial Disease. In the study, microbacterium isolates from 200 culture-positive patients with symptomatic disease were screened for phage susceptibilities. One or more lytic phage were identified for 55 isolates. Phage therapy was then administered to 20 patients on a compassionate use basis, and patients were monitored for adverse reactions, clinical and microbiological responses, the emergence of phage resistance, and phage neutralization in serum sputum and bronchial valvular lavage fluid. Results from the trial showed favorable clinical or microbiological response in 11 patients, and no adverse reactions were attributed to therapy in any patients regardless of the pathogen, phage administered, or the route of delivery. Awareness surrounding the Biomics CF program is also continuing to grow. On May 12th, we hosted a KOL webinar to discuss the treatment landscape for CF patients with chronic lung infections and the potential of BX004 to address patients with chronic BSA infections. The webinar featured presentations from key opinion leaders, Dr. Dave Nichols and Dr. Sain Aslam, who discussed phage therapy, the current treatment landscape, and the unmet medical need in CF patients with chronic PSA pulmonary infections. We then presented the X004 as a potential treatment solution, providing a review of the phage candidate's preclinical activity and an overview of the ongoing clinical development plan. A recording of the webinar is accessible through the investor section of our corporate website. We believe that enthusiasm appears to be building for exploring the potential of phage therapy in treating CF patients struggling with multi-drug resistant bacterial infections. With so few treatment options available, we are very pleased to see a growing body of clinical evidence and published research that points toward the potential of phage therapy to play an important role in helping CF patients combat these persistent, difficult to treat infections. Given its significant unmet medical needs for these patients, BX004 program remains our clinical development priority at Biomics, and we look forward to presenting our initial clinical findings in the near future. Turning to our recent partner activity, we were also very pleased to announce a second collaboration with Berger Ingelheim during the quarter. Under the new collaboration agreement, Biomics will utilize its X-Marker microbiome-based biomarker discovery platform to identify biomarkers for pathogenic bacterium thought to be associated with IBD. Such biomarkers could help identify IBD patients that would benefit from the potential therapies targeted at the microbiome. As a reminder, we entered our first collaboration with Berger Ingelheim back in September 2020, which focused on identifying biomarkers associated with patient phenotypes in IBD. Collaborative research is an integral part of the biomics culture, and industry-based partnerships, such as those with BI, will likely generate important new insights to help direct our future research efforts in IBD. but we also seek to build strong relationship with academic and independent research institutes. And earlier this month, we're proud to announce the publication of a research paper in the renowned scientific journal Cell, entitled Targeted Suppression of Human IBD-Associated Gut Microbiota Commensals by Phage Consortia for the Treatment of Intestinal Inflammation. The research was conducted across several organizations, including Scientists in Biomics, the Weizmann Institute of Science, and K University School of Medicine. The paper presented positive results from a proof-of-concept assessment in preclinical model of IBD. More specifically, researchers demonstrated proof-of-concept assessment of Klebsiella pneumonia targeting phage by generating an orally administered lytic 5-phage combination product specifically designed to target sensitive and resistant IBD-associated KP clade members through a distinct mechanism. The lytic 5-phase treatment enabled effectively KP suppression in the colitis-prone mice and drove attenuated inflammation and disease severity. Collaborative research with our academic partners can provide invaluable insights and external scientific validation for our company's program. In April, we announced the publication of a paper in the Journal of Bioinformatics. The research was conducted by scientists in biomics and specifically relates to the development of an algorithm named Exotos. that has enabled us to consistently generate hyper-accurate next-generation sequencing data for a single-mix analysis, thereby providing a more detailed genetic understanding of our phage product candidates. Importantly, Exotis is now being leveraged across our entire R&D platform, and because of the open-source nature of the algorithm, other researchers external to biomics can also use this algorithm to conduct analysis on various genome-related projects. Turning to corporate news, we announced the restructuring during the second quarter, which allowed us to further extend our cash runway through until at least mid-2024. Obviously, such decisions are never easy, but given the prevailing conditions within the capital markets, we must ensure that our company is well-prepared with more than sufficient resources to navigate through this challenging period. I'd now like to turn the call over to Marina Wolfson, our Chief Financial Officer, to cover our financial results for the quarter.