BiomX Inc.

Hello, and welcome to the Biomics first quarter 2024 financial results. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to CFO Avi Gabay. Please go ahead, Avi.

Thank you and welcome to the Biomix first quarter 2024 financial results and corporate update conference call. The press release became available just after 6.30 a.m. Eastern time today and can be found on our website at www.biomix.com. A replay of this call will also 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 historical statement may be deemed forward-looking statements. For instance, we're using forward-looking statements when we discuss in the conference call the sufficiency of the combined company's financing, potential stockholder approval of certain matters related to the securities issued and related matters in connection with the adaptive phase therapeutics or APT merger, potential market opportunities, the ability to drive value for stockholders, the design, recruitment, aim, expected timing, and interim and final results of our preclinical and clinical trial, the regulatory process and discussion with the FDA, the potential benefits and commercial opportunities of our product candidate, and the potential safety and efficacy of BX004 and BX211. In addition, past and current 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 to call this morning is Jonathan Solomon, Chief Executive Officer of Biomics. With that, I'll turn the call over to Jonathan.

Good morning, everyone. For the first time, Biomix is reporting results for a combined entity following our merger with APT in March, and Avi will elaborate more on this. Overall, the first quarter of 2024 was nothing less than transformational for Biomix. The company has now entered into a new era. With the merger with APT in March, we have expanded our mid-clinical stage programs, which we believe constitute the leading phage-related pipeline in the industry. We are now advancing diverse approaches focused on developing natural phage crocs and personalized phage treatments. With the recent merger, we've added a second Phase II product candidate, BX211, for the treatment of diabetic foot osteomyelitis, or DFO. And I'll review our progress shortly. BX004, our most advanced mid-clinical stage candidate, has already shown what we believe are promising clinical results supporting the potential of phage therapy to treat harmful bacteria underlying serious chronic infections in cystic fibrosis or CF patients. The broadening of our pipeline, the diversity of our approaches, and the data we've seen to date are all key in reducing risk inherent in biotech developments. Concurrently with the merger with APT, we raised $50 million of gross proceeds in a private placement led by affiliates of Deerfield Management and the AMR Fund with the participation of additional existing and new investors including the Cystic Fibrosis Foundation Orbimed, and Nathanael Capital Management. These important and accredited life sciences investors provide further validation for the potential of phage therapy as a new therapeutic modality and the strength of our lead candidates, each having the potential to advance the standard of care in their prospective disease area. Including net proceeds from the financing in our existing capital, Biomics now expects to have sufficient funding to reach multiple important clinical milestones through 2025, including expected data readouts for our lead candidates, BX211 and BX004, in the first quarter of 2025 and the third quarter of 2025, respectively. We believe these Phase II data readouts could potentially drive significant value for our stockholders. We are thrilled with the continuing progress of both of our Phase II programs. On our last earnings calls, I had the opportunity to take a deep dive into BX211 as part of the merger with APT. As a reminder, BX211 is a personalized phase treatment being evaluated in the randomized, double-blinded, placebo-controlled, multi-center phase 2 trial for subjects with DFO associated with Staphylococcus aureus. This is an area of high unmet need. Each year, there is a staggering number of approximately 160,000 lower limb amputations in diabetic patients in the U.S. alone, 85% of which are caused by DFO, according to the Centers for Disease Control and the literature. We believe that phage-based therapeutic approaches have the potential to greatly improve treatment outcomes in DFO. Reports in the scientific literature of compassionate use with phage therapy have shown that 11 of 12 cases resulted in positive outcomes of wound healing and avoiding amputation. Finding from these cases played an important role in the design of the ongoing phase two of BX211. With the target enrollment of 45 patients, the trial has already surpassed 70% of this target. We remain on track to report on the week 13 treatment results in the first quarter of 2025. We are also excited by the progress of BX004, our other lead mid-clinical stage candidate. BX004 is a fixed multi-stage cocktail for the treatment of CF patients with chronic pulmonary infections caused by pseudomonas arginosa, a main contributor to the mobility and mortality in these patients. In January this year, we were granted orphan drug designation by the FDA for BX004. More recently, in April, we presented positive safety and efficacy results from Part 2 of a Phase 1 B2A trial of BX004 at the European Society of Clinical Microbiology and Infectious Disease, or ESCMID, Global Congress. In fact, our presentation was selected as a top poster, ranking it among the top first-second percentile of top-rated abstracts in the category submitted and accepted at the Congress. We believe that the data for BX004 are the most promising advanced findings published to date for phage therapy for the treatment of chronic pulmonary infections in CF patients. We've shown with BX004 both conversion to sputum culture-negative pseudomonas organosa in 14.3% of patients and demonstrated signals of improved pulmonary function after only 10 days of treatment. Both findings in contrast to results in placebo. Under a Phase IIb trial, we now plan to treat for a much longer treatment duration of two months, which we believe has the potential to demonstrate a more pronounced effect on both micrological and lung functional readouts. As previously reported, by mid-2024, we anticipate holding a Type C meeting with the FDA to discuss our clinical development plans for BX004. Pending alignment with the FDA and completion of the remaining CMC work, our plan is to submit a Phase IIb study protocol to all relevant regulatory authorities and initiate the study by the end of this year. As already noted, we estimate releasing top line results on the study in the third quarter of 2025. We are thrilled to have what we believe is the broadest and most advanced phage pipeline with promising data already reported and key readouts in phase two studies in both our lead programs in 2025. On this final note, I'll now pass it over to Avi to review our first quarter 2024 financial results. Avi.