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BiomX Inc.
8/15/2024
Greetings and welcome to Biomix second quarter 2024 financial results conference call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference please press star zero on your telephone keypad. As a reminder this conference is being recorded. It is now my pleasure to introduce your host, Ms. Marina Wolfson, Chief Financial Officer. Thank you, Ms. Wolfson. You may begin.
Thank you, and welcome to the Biomics Conference Call to review the second quarter 2024 financial results and provide an update on our business and program. Yesterday, we filed the quarterly report on Form 10-Q with the Securities and Exchange Commission. In addition, the press release became available at 6.30 a.m. Eastern Time today and can be found on our website at biomics.com. A replay of this call will also be available on the Investor section of our website. As 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 the efficiency of the company's cash, 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 trials, the regulatory process and discussions with the FDA, the potential benefits and commercial opportunities of our 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 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 our Chief Executive Officer, Jonathan Solomon, to whom I will now turn over the call.
Hi, everyone. Thank you for joining us on our earnings call. We're excited to discuss Bionic Status with you this morning. Earlier this year, the company took a momentous step in merging with Adaptive Phase Therapeutics, or APT, and completing a concurrent $50 million financing. Last month, we were delighted to update that an important milestone with respect to this transaction was met when our stockholders overwhelmingly voted in favor of the conversion of up to 256,000 Series X non-voting convertible preferred stock issued upon the merger and concurrent financing to up to 256 million Biomics Commons stock. The Series X preferred stock was issued to certain APT shareholders and investors who participated in the concurrent financing. As a result of the stockholder vote in favor, each share of Series X preferred stock issued converted into 1,000 shares of Biomics common stock, subject to certain beneficial ownership limitations set by certain investors. Subject to such beneficial ownership limitations to date, over 100,000 shares of Series X preferred stocks were converted to over 100 million shares of the company's common stock that were added to the company's outstanding share accounts. I'd like to now discuss why are we so excited about the clinical programs in our combined pipeline. As we previously announced, we expect to report important results for our two lead clinical assets in 2025. I'll review these anticipated readouts in just a moment. By integrating the two companies' programs, we believe we now have the leading phage-related pipeline in advanced clinical testing. Key to the strength of our combined programs is the diversity of our complementary approaches. At Biomics, we are developing six phage cocktails, which can target a broad host range of various bacterial strains and address multiple resistant mechanisms, allowing treatment of patients with the same phage cocktail. We are also developing personalized phage treatment that can address bacterial diversity and potentially polymicrobial infections, tailoring a specific phage treatment to a given patient. The Biomics pipeline demonstrates the diversity of our approaches. BX004, the company's novel fixed-stage cocktail, is advancing in development of treatment of serious chronic lung infection in cystic fibrosis patients, or CF patients, caused by pseudomonas arginosa. During the second quarter, we presented positive safety and efficacy results from the Phase 1 B2A trial of BX004, including at the 47th European Cystic Fibrosis Conference and the ASN Microbe 2024, both of which took place in June. As a quick recap, after only 10 days of treatment, 14.3% of patients in the BX004 arm of the phase 1 B2A study converted to sputum culture negative for pseudomonas aeruginosa compared to 0% of the patients in the placebo arm. BX004 versus placebo also showed signal of improved pulmonary function. We have entered into discussion with the US FDA regarding our next clinical trial for BX004 and are making progress in preparation for its initiation including completion of the remaining CMC work and finalizing Phase 2B study protocol. We expect to release top-line results from this study in the third quarter of 2025. For our second Advanced Clinical Candidate, BX211, we expect initial top-line results through Week 13 for the current Phase 2 trial in the first quarter of 2025. As most of you know, BX211 is our asset acquired through the merger with APT. BX211 is a personalized phage treatment currently being evaluated in a randomized double-blind, placebo-controlled, multicenter Phase II trial for subjects with diabetic foot osteomyelitis, or DFO, associated with staphylococcus aureus infection. The design of our ongoing Phase II study was guided in part by reports in the scientific literature of compassionate use of phage therapy, which showed positive outcome of wound healing and avoiding amputation in 11 of 12 patients. Both are lead programs we have continued to see and are grateful for the growing excitement among the clinical community. We are also grateful to our stockholders whose ongoing support has been vital for our efforts and has provided key validation for phage-based therapeutic modalities we are advancing into the clinic. We believe that both BX004 and BX211 have the potential to significantly change how we address the substantial unmet needs of patients with intractable infections. Overall, we are thrilled with the promising data already reported and with the key readouts we are anticipating from both of our lead programs. As Marina will review, based on the proceeds from the financing concurrent with the merger with ATP and existing capital, Biomics continues to expect to have sufficient funding to reach these multiple important clinical milestones, potentially driving significant value for our shareholders. Now, I will pass the call back to Marina, who will review Biomics' financial results. Marina?
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