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BiomX Inc.
11/15/2022
Good morning, and welcome to the Biomix third 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 Wilson, Chief Financial Officer of BiomixX. Please proceed.
Thank you, and welcome to the Biomix third 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 biomic.com. A weekly of this call will be available on the investor 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 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 as 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 as noted earlier, is on our website. Joining me on the call this morning is Jonathan Salomon, Chief Executive Officer of Biomics. With that, I will turn the call over to Jonathan.
Thank you, Marina, and good morning, everyone. I intend to keep my remarks brief this morning, as during the third quarter, we remained largely focused on our ongoing Phase 1 B2A trial of BX004 in cystic fibrosis. I'll now provide an update on the program. As announced in our press release this morning, we made important progress with respect to enrollment during the quarter. Given the challenges enrolling CF patients in the wake of the COVID-19 pandemic, we put in place important mechanisms to improve enrollment, and these measures have produced a recent uptick and considerable acceleration of BX004 enrollment trends that will impact both parts of the trial. Based on our latest estimates, we now believe that enrollment in part one of the study will be completed by year end. Taking into consideration some modest impact from the U.S. holiday season, In the extensive data analysis that follows each patient's dosing schedule, we now expect to report results from Part 1 of the trial in the first quarter of 2023, followed by results from Part 2 in the third quarter of 2023. As a reminder, we are developing BX004 as a treatment for CF patients with chronic respiratory infection caused by pseudomonas arginosa, or PSA, a main contributor to morbidity and mortality in patients with CF. Part one of the trial will evaluate the safety, pharmacokinetics, and microbiological clinical activity of BX004 in eight patients in a single ascending dose and multiple dose design. Part two of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized through treatment or placebo cohort in a two-to-one ratio. Last quarter, we highlighted some of the positive outcomes from investigative-sponsored clinical trials that are utilizing phage-based treatment modalities to address difficult to treat infections in CF. We are pleased to see a growing data-driven support for the potential benefits of applying phase-directed therapies to address these persistence and life-threatening lung infections in CF patients. And we look forward to reporting data from the BX004 program in 2023. I'd now like to turn the call over to Marina Wolfson, our Chief Financial Officer, to cover our financial results for the third quarter.
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