BiomX Inc.

Good morning, and welcome to the Biomix Full Year 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 Biomix. Please go ahead.

Thank you, and welcome to the Biomix 2022 Financial Results and Corporate Update Conference Call. The news release became available just after 6.30 a.m. ET 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 in 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 to close on the second part of the PIPE transaction, and the potential safety, efficacy, and other benefits of our product candidates. 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 booking 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. 2023 is shaping up to be a very exciting year for our company. our Cystic Fibrosis Program with lead candidate BX004 continues to gain momentum based on the positive results announced back in late February in Part 1 of our ongoing Phase 1 B2A study. Without question, this was a watershed moment for our company and for our technology, as these results demonstrated that an optimized phage cocktail product developed utilizing a bulk platform such as BX004 could potentially reduce the presence of life-threatening bacteria in the lungs of CF patients after a short period of treatment. The Part I results also represented the first placebo-controlled study evaluating a cocktail-based phage product to show notable reductions in bacterial burden in cystic fibrosis patients. As a reminder, BX004 is a phage cocktail that has been designed to combat chronic pulmonary infections caused by pseudomonas argininosus, or PSA, which is a main contributor to morbidity and mortality in CF patients. Despite the availability of CFTR-directed therapies, CF patients continue to suffer from intractable persistent infections, such as those caused by PR-genosa. New treatment options are therefore needed to address the significant unmet need that impacts thousands of CF patients each year. Our ongoing Phase I B2A trial is comprised of two parts. Part one desired the safety, pharmacokinetics, and microbiologic activity of BX004 in nine CF patients in a single ascending dose and multiple dose design. On February 22nd, we reported these exciting results and also held a conference call with investors to review the data. For today's call, I plan on providing a high-level overview of the overall study results. However, a more detailed presentation of our data can be accessed on the Biomics website under our Industrial Relations, News Events sections. Part 2 of the trial will evaluate the safety and efficacy of BX004 in a larger group of patients with 16 patients receiving nebulized BX004 therapy and 8 receiving placebo in a 2-to-1 randomization. Importantly, treatment duration will be extended over a 10-day period with twice-daily administration of the high dose versus the seven-day period of escalating doses in Part 1. We have already started dosing patients in Part 2 of the study, and we remain on track to report results in the third quarter of this year. I'd now like to briefly recap the exciting results in Part 1 of our CF study. The primary goal of Part 1 was to assess the safety and tolerability of BX004. Bage therapies are generally considered safe, And that proved to be the case with BX004, maintaining an excellent safety profile throughout the course of treatment. However, we're also highly encouraged to see preliminary evidence of efficacy in patients treated with BX004, despite the small sample size and short duration of treatment during this first part of the trial. At day 15, patients treated with BX004 had a mean reduction in PSA colony forming units, or CFUs, compared to baseline of 1.42 log. while the mean reduction of PSA CFUs was only 0.48 log for placebo-treated patients. As noted on our conference call last month, we were surprised by the magnitude of reduction in material load, and these results exceeded our internal expectations, particularly considering the shorter course of treatment of just seven days of escalating dose. Not surprising, the X004 maintained an excellent safety and tolerability profile with no treatment-related adverse effects observed in the study. Phage-based treatments are generally regarded as safe, and results from the study serve to reinforce this view, providing us with additional comfort that BX004 can be administered at a higher dose and over a longer treatment period, as specified in Part 2 of the CF study. Phage were detectable in several BX004-treated patients up to day 15, or one week after the end of the seven-day treatment period. and there's no emerging resistance to BX004 during or after treatment. As expected, there was no change in lung function as measured by FEV1, which we attribute to the shorter course of therapy specified in part one of the study. In summary, we believe BX004 is emerging as one of the most promising development stage therapies for treatment of chronic PSA infections in patients with cystic fibrosis. In canvassing both the development stage landscape and the compassionate use program, BX004 appears to be highly competitive with respect to a number of key product attributes, including safety, tolerability, and reducing pathogenic bacteria. In addition, we also believe BX004 to be further differentiated from its potential to address resistance strain with BSA, given its unique design to confer orthogonal-based coverage across pathogenic strains. I'd now like to turn the call over to Marina to review our financial results for the full year 2022.