BiomX Inc.

Greetings. Welcome to Biomix fourth quarter and full year 2021 financial results and corporate update conference call. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. I'll now turn the conference over to Marina Wolfson, Senior Vice President of Finance. Ms. Wolfson, you may now begin.

Thank you, and welcome to the Biomics fourth quarter and full year 2021 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 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, 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 cash if milestones are met, the potential benefits of our product candidates, and potential growth in shareholder value. 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 Solomon, Chief Executive Officer of Biomics. With that, I will turn the call over to Jonathan.

Thank you, Marina, and good morning, everyone. Let me begin by saying that I believe biomics is now entering the most exciting period in our company's seven-year history. With proof-of-concept data expected within the next 12 months in both our cystic fibrosis and atopic dermatitis programs, we are poised to generate readouts that could have significant impact on the value of our company. At the same time, with the recent equity investment from Maruhu and the Cystic Fibrosis Foundation, We are also well-positioned financially, with existing cash expected to take us at least until the end of 2023. Additional tranches of up to $15 million under our existing loan agreement may further extend our cash runway into mid-2024. Let me now provide a brief update on each program, starting with BX004 and cystic fibrosis. BX004 is our novel phage candidate that is being developed for the treatment of chronic respiratory infection caused by pseudomonas arginosa, or P. arginosa, a main contributor to morbidity and mortality in patients with CF. Chronic P. arginosa infection leads to epithelial surface damage and airway plugging, progressively impairing pulmonary function. CF patients chronically infected by P. arginosa show a steeper lung function decline, a higher number of pulmonary exacerbations, more hospital admissions, and a higher mortality than PR-Ginosa-free patients. PR-Ginosa infections usually start in childhood and following prolonged and repeated broad-spectrum antibiotic courses, enhanced resistant to antibiotics develops and leads to the appearance of multidrug-resistant strains, MDR. Studies have shown that about 80% of CF patients are chronically colonized by PR-Ginosa by the age of 20. And the eight-year risk of death was found to be 2.6 times higher in patients with pyrogynosis versus those without it. Research has also shown that continued colonization of pyrogynosis eventually results in a point where the infection can no longer be controlled, which is further characterized by the expression of biofilm-forming genes within the bacteria itself. Biofilm and its assemblage of surface-associated microbial cells enclose an extracellular polymetric substance and one of the leading causes for antibiotic resistance. In preclinical studies, BX004 not only demonstrated activity against antibiotic-resistant strains of pyuridinosa, but also showed the ability to penetrate biofilm. We therefore believe BX004 holds significant potential to address this life-threatening infection in CF patients. the opportunity to address this unmet medical need is also significant. With an estimated 30,000 CF patients in the U.S. and 80,000 worldwide, chronic antibiotic-resistant bacterial infection remains one of the most challenging medical conditions in CF patients. P. aeruginosa is the most common and detrimental bacteria in lung infections of CF patients, and it is estimated that approximately 30 to 50 percent of these patients suffer from chronic infection due to this bacterium. Part 1 of this trial will evaluate the safety, pharmacokinetics, and microbiological clinical activity of BX004 in 8 CF patients in a single ascending dose and multiple dose design. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients who will be randomized to receive treatment or placebo cohort in a 2 to 1 ratio. Sites are now open, though we are seeing slower enrollment due to the recent COVID wave. So to be conservative, we now expect the readout from part one of the study in third quarter of 2022 and the readout from part two in first quarter of 2023. We are also proud to have the support of the Cystic Fibrosis Foundation for the development of BX004. In January, we announced a therapeutic development award from the foundation in support of our ongoing phase one B2A study. The award is structured as an equity investment And in December, the foundation made its initial investment of $3 million in Biomics common stock. Upon completion of patient dosing in Part 1 of the study, Biomics would have the right to receive the second tranche of $2 million. Now let me turn to the atopic dermatitis program. We are developing BX005 as a topical phage product candidate targeting staphylococcal oris, or staph oris, a bacterium associated with the development and exacerbation of inflammation in atopic dermatitis. By reducing staph aureus burden, we believe BX005 has the potential to shift the skin microbiome composition to its baseline state, leading to clinical improvement. Atopic dermatitis not only represents a significant unmet need, but the commercial opportunity remains attractive, with the current therapeutic market valued at $5 billion, which is expected to triple over the next few years. Given the size of the market opportunity, we recognize the importance of developing strategic relationships to maximize the value of this program. Last quarter, we announced an agreement with Maruhu for BX005. As the largest dermatology-focused company in Japan, Maruhu brings exceptional expertise in this therapeutic area, and we are very pleased to have their support for our program. Similar to the CF Foundation, Maruhu's financial support for BX005 program came in the form of an equity investment in biomics. Maruhu purchased $3 million of our common stock at a premium to the market share price. Funding from this investment is intended primarily to support the planned Phase 1-2 study. We anticipate initial data in the fourth quarter of 2022. With respect to our other programs, our IBD product candidate is expected to enter the clinic next year, and we also expect to build out a preclinical effort surrounding our colorectal cancer product candidate in 2023 as well. I'd now like to turn over the call to Marina Wilson, our Senior Vice President of Finance and Operations, to cover our financial results for the fourth quarter and full year results.