BiomX Inc.

Good morning, and welcome to the Biomics Full Year 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'd now like to turn the conference over to Avi Gabay, Interim Chief Financial Officer of Biomics. Avi, please proceed, sir.

Thank you, and welcome to the Biomics Full Year 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 in our website at www.biomics.com. A replay of this call will also be available in the investor section for 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 are using forward-looking statements when we discuss on the conference call the sufficiency of the combined company's financing, potential stockholders' approval of certain matters related to the securities issue and related matters in connection with the adaptive phage therapeutics or APT acquisition, potential market opportunities, the ability to drive value for stockholders, the design, aim, expected timing, and interim and final results of our preclinical and clinical trials, the regulatory process and discussion with the FDA, the potential benefits and commercial opportunities for product candidates, and the potential safety or efficacy of BX004 and BX211. In addition, past and current preclinical and clinical results, as well as compassionate cues, 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 risk 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.

Good morning, everyone. The fourth quarter of 2023 proved to be one of the most significant and exciting periods of our company, highlighted by the positive results from Part 2 of our Phase 1 B2A study of BX004. Soon after achieving this major clinical milestone, we announced the transformational acquisition of APT in March, adding to our pipeline a second Phase 2 product candidate, BX211, for the treatment of diabetic foot osteomyelitis. In connection with this acquisition, we also raised $50 million in a private placement led by affiliates of Deerfield Management AMR Active Fund with the participation of additional existing and new investors, including the Cystic Fibrosis Foundation, OrbiMaid, and Nottingham Hollow Capital. We deeply value and appreciate the support from these widely respected institutional investors. Including net proceeds from the financing and our existing capital, Biomics now expects to have sufficient funding to reach multiple clinical milestones over the next two years. including expected data readouts for BX211 and BX004 in the first quarter of 2025 and third quarter of 2025, respectively. With approximately 80 compassionate use cases, multiple clinical studies, and INDs, the combined company possesses an extraordinary depth of clinical experience in developing phage products, along with the expertise in regulatory FERS to help further advance these programs into pivotal testing. The acquisition created a leading phage company with one of the most advanced pipelines of phage-based therapeutics, which includes two clinical stage products, each having the potential to advance the standard of care in their respective disease area. As noted, the combined company has two significant Phase II readouts anticipated in 2025, which, if successful, could potentially drive significant value for stockholders. I would like to spend More time today focusing on our new program in diabetic foot osteomyelitis, or DFO, and our ongoing Phase II clinical study. The study has already surpassed 70% of our target enrollment, and we remain on track to report the Week 13 treatment results in the first quarter of 2025. Ulcers in patients with diabetes are a complication caused by a combination of poor blood circulation, susceptibility to infection, and nerve damage from high blood sugar levels. When there is limited blood flow to the wounded area, the body struggles to heal its wounds, so these wounds develop into diabetic ulcers. Once an infected ulcer deepens to the extent that it spreads into the bone, the condition is classified as DFO, which is a very serious condition that could lead to lower lymph amputation. DFO standard of care often includes offloading of pressure from the foot, debridement surgery, and up to a six-week course of topical, oral, or IV antibiotic therapy. Unfortunately, 30 to 40% of DFO cases fail, leading to amputations. Depending upon the location of the infected bone, amputations often result in the loss of a toe or, in more severe cases, the loss of a limb below or above the ankle. With a staggering number of approximately 160,000 lower limb amputations in diabetic patients and only in the U.S. alone, 85% of which are caused by DFO, according to the Center of Disease Control and Literature This remains an area of a high unmet need. One of the main reasons for the limited effectiveness of antibiotic therapy is poor delivery of the therapy to the infected bone. Biofilm, a polysaccharide mesh secreted by bacteria infecting the bone and ulcer, creates a barrier that inhibits antibiotic penetration in these patients who already suffer from poor blood circulation. Beyond delivery, antibiotic resistance is an additional contributing factor to the limited effectiveness of antibiotic treatment. For example, according to literature, approximately 40% of staphylococcus aureus infections are MRSA, a methylene-resistant staphylococcus aureus. Phage therapy has the potential to address these key drivers for treatment failure. When properly selected, phage effectively target and kill antibiotic-resistant bacterial strains and have the capacity to break down biofilm. For example, phage were selected for the treatment of patients under our current DFL study were found when sequenced of multiple domains of catalytic activity against staphylococcal biofilm components. Moreover, a main factor that supports phage risk therapeutic approach to improve treatment outcomes in BFO are the positive results from numerous compassionate cases using phage therapy. Out of 12 cases reported in the scientific literature, 11 resulted in positive outcome of wound healing and avoiding amputation. PX211, developed under APT's technology platform, is based on a personalized approach which utilizes one of the largest phage banks in the world to optimally pair individualized phage therapy to the specific strains of bacteria as biopsied from the patient. The treatment targets Staphylococcus aureus, which is considered the most common bacterial infection in DFO, compromising approximately 50% of cases and is considered the most pathogenic bacteria due to its rapid doubling time and arsenal of viral factors. We estimate that BX211 represents a commercial opportunity of $1 billion in the U.S. and over $2 billion worldwide. We are now conducting a randomized, double-blind, placebo-controlled, multicenter Phase II study investigating the safety, tolerability, and efficacy of BX211 in subjects with DSO associated with staph aureus. Approximately 45 subjects are planned to be randomized at a 2 to 1 ratio to BX211 or placebo. BX211, or placebo, is administered weekly by topical and IV RAT at week 1 and by the topical RAT only at each of weeks 2 to 12. Over the 12-week period, all subjects continue to be treated in accordance with the standard of care, which includes antibiotic treatment, as appropriate. As of now, we have enrolled 32 patients in the study, which amounts to over 70% of the target enrollment. and are on track to report results at week 13 evaluating healing of the wound associated with osteomyelitis in the first quarter of 2025. We then expect to report a second readout in the first quarter of 2026, which is planned to evaluate amputation rates and resolution of osteomyelitis based on X-ray clinical assessment and established biomarkers such as ESR and CRP at week 52. With respect to cystic fibrosis, or CF program, in the second quarter of 2024, we expect to hold a Type C meeting with the FDA to discuss our clinical development plan for BX004. Assuming alignment with the FDA and the completion of our CMC work, we intend to submit a protocol to all relevant regulatory authorities, and following approval, begin patient enrollment in Phase 2B study. As already noted, we estimate releasing top-line results from this study in the third quarter of 2025. And now I'll pass it over to Avi to review our fourth quarter and full year 2023 financial results.