BiomX Inc.

Good morning and welcome to the Biomex second quarter 2023 financial results and corporate update conference call. Currently all participants are on 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 Biomex. Please proceed.

Thank you and welcome to the Biomex second quarter 2023 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 next stages in development, the sufficiency of our existing cash, cash equivalents, and short-term deposits, the potential benefits of our product candidates, the expected benefits from FDA fast-track designation, 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, and good morning, everyone. I am pleased to report that we continue to make significant progress in our BX004 program. We are delighted to update that patient screening for Part 2 of our Phase 1 B2A study has been completed with patient enrollment expected to exceed original estimates, reflecting solid execution by our clinical operations team, along with a growing awareness among physicians and patients within the cystic fibrosis community and the potential of this innovative program. I'm also pleased to announce that BXL-004 has just received FASTRAC designation from the FDA which provides further recognition that the BX004 program is addressing one of the most serious and challenging unmet medical needs facing the CF community. The FDA defines addressing a significant unmet medical need as providing a therapy when none exists or providing a therapy which may be potentially better than available therapies. The benefit of fast track designation includes but are not limited to early and frequent communication with the FDA throughout the entire drug development and review process. In addition, FASA designation means that BX004 may also be eligible for rolling submission and prior review of biological license application and or new drug application, which assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. As a reminder, BX004 is being developed for the treatment of chronic pseudomonas aeruginosa, or PSA, pulmonary infections in patients with cystic fibrosis. In February 2023, we announced positive results from Part 1 of the trial, which came in better than expected based on the treatment arm displaying notable reductions in PSA bacterial burden. Following this announcement in June, we had the opportunity to formally present these data during the late-breaking session at the 46th European Cystic Fibrosis Conference, or the ECFC, which is an important international conference that attracts a wide audience of CF thought leaders, advocacy groups, and patients. I can say unequivocally that physicians were excited with the notable reduction in bacterial burden displayed in Part 1 of our study that we came away from the eCFC meeting with the impression that chronic PSA pulmonary infections continue to pose a challenging, unmet need for CF patients today. We therefore believe that BX004 is one of the few and most promising early clinical candidates for treating these infections in CF patients. With our patient screening efforts now complete, we estimate a four to six week delay in our top line results for part two of the study, now expected to be announced in November of this year. Under the part two study design, at least 24 CF patients received BX004 twice a day, but over a longer 10-day treatment period compared to part one. Similar to part one, results from part two are intended to provide additional data on safety and reduction in PSA bacterial burden, along with other exploratory endpoints. Assuming positive results from this larger CF study group, we anticipate holding a meeting with the FDA to plan the next stage of BX004's clinical development. In addition, in May 2023, we announced the second closing of a $7.5 million private placement, or the PIPE, with a select group of institutional and individual investors, which provided additional funding to support the BX004 program and other R&D activities. We also added two highly accomplished pharmaceutical executives to our board who collectively bring to Biomic's considerable business and legal experience. In summary, we are very pleased with the continued progress in the BX004 program. The feedback we're receiving from physicians, patients, and other stakeholders within the CF community has been highly positive and constructive, reinforcing our view in the therapeutic potential of BX004 to treat life-threatening infection CF patients are facing. I'd like now to turn the call to Marina to review our financial results for the second quarter of 2023.