BiomX Inc.

Good morning, and welcome to the Biomix second quarter 2025 financial results and business and program update conference call. Currently, all participants are in listen-only mode. At the end of this call, there will be a question and answer session. As a reminder, this conference call is being recorded. I would now like to turn the call over to Marina Wolfson, Chief Financial Officer of Biomix. Please proceed.

Thank you. And welcome to the Biomics conference call to review the company's second quarter 2025 financial results and provide an update on our business and programs. Later today, we will file 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 Investors 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 in the conference call the sufficiency of the company's cash, our pipeline, momentum, and milestones, the design, recruitment, aim, expected timing, and interim and final results of our clinical trials, expected feedback from the FDA and additional regulatory agencies and results thereof, the potential benefits of our product candidates, the potential safety or efficacy of our product candidates, BX004 and BX211, and the potential markets and partnering opportunities for our product candidates. In addition, past and current 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 Biomics Chief Executive Officer Jonathan Solomon, to whom I will now turn over the call.

Thank you, Marina, and thank you all for joining Biomics' second quarter 2025 update today. The second quarter of 2025 has been a productive period for Bionics as we continue to advance our clinical programs and build scientific validation for our phage therapy platform. During the quarter, we made important progress on both our BX004 and BX211 programs and have positioned ourselves well for the upcoming milestones. Since the end of the quarter, we achieved a critical milestone with a successful initiation of patient dosing in our Phase 2B clinical trial of BX004 for cystic fibrosis patients. An important step as we advance toward top-line results expected in the first quarter of 2026. We also published additional data from our BX004 Phase 1B2A study in Nature Communication in July, providing further validation of our phage therapy platforms. Let me start by reviewing the recent progress across our clinical pipeline. We launch into the second quarter with a virtual key opinion leader event to discuss the positive top line phase two results for BX211 that were reported in March 2025. The event received resounding endorsement from key opinion leaders, physician and industry experts highlighting the enthusiasm surrounding the strength of the data and the significant of its potential addressing the needs of patients living with diabetic foot osteomyelitis, or DFO. To recap, those MARSH results demonstrated that BX211 was safe and well-tolerated and produced sustained and statistically significant percent area reduction of ulcer size, with a p-value of 0.046 at week 12 and 0.052 at week 13. We saw separation from placebo starting at week seven with a difference greater than 40% by week 10. The results showed statistically significant improvement in both ulcer death at week 13 in patients with ulcer death defined as bone at baseline with a p-value of 0.048, reducing the expansion of ulcer area with a p-value of 0.017 compared to placebo. As background on the significance of this program, DFO is an extremely challenging indication with substantial unmet patient need. Each year, there are approximately 160,000 lower limb amputations in diabetic patients in the U.S. alone, with 85% estimated to be caused either by DFO or diabetic foot infections. No therapeutics have been approved in the United States specifically for the treatment of DFO in over 20 years. Following the positive Phase II results, we are now engaged in continued discussion with the U.S. Defense Health Agency, a key financer and supporter driving the development of BX211 program. And in parallel, we're currently planning for BX211 registrational study pending discussion and feedback from the FDA. The second quarter also marked with continuous advancement for a Phase IIb trial of BX004, which included the successful initiation of patient dosing in this Phase IIb trial. a critical milestone for our Cystic Fibrosis, or CF, program, aligning with our timeline of expected top-line results from the Phase 2b results in the first quarter of 2026. We are encouraged by the high-level enthusiasm for enrollment in the Phase 2b CF trial across the board from both patients and investigators, driven by the strength of our prior Phase 1b2a data, in which 14.3% of patients cleared infections completely after 10 days of treatment. The design of the Phase 2B trial of BX004 for the treatment of patients with cystic fibrosis infection associated with pseudomonas aeruginosa is designed as a randomized, double-blind, placebo-controlled, multi-center study in approximately 60 cystic fibrosis patients with chronic pseudomonas aeruginosa infections. Patients in the trial will be randomized at a 2 to 1 ratio to receive either BX004 or placebo via inhalation twice daily for eight weeks. The trial is designed to measure multiple efficacy endpoints, including reduction in bacterial burden, improvement in lung function, and enhanced quality of life as measured by patient questionnaires. In July, we published in the highly acclaimed Nature Communication publication. The paper included new findings from our Phase 1b2a trial showcasing previously unreported antimicrobial efficacy data, that demonstrated BX004 achieving a substantially greater improvement of approximately 500-fold. That's a 2.7 log reduction in bacterial reduction compared to placebo in CF patients. Importantly, the data also highlights no bacterial resistance to BX004 emerged during the trial. The article also details our innovative approach to large-scale data analysis in order to optimize bacteriophage cocktails. We believe that this publication in one of the highly prestigious scientific journals represents an important validation for a phage platform and methodology from broader scientific community. We continue to press forward with the execution of the BX004 trial, and in parallel, we expect to receive feedback from the US FDA regarding the potential investigation and use of real-world evidence linking material reduction to clinical outcomes during the second half of 2025, bringing us closer to addressing the urgent unmet need of patients with Pseudomonas aeruginosa CF infections sooner. The combined progress across the clinical pipeline during the second quarter, in addition to recent achievement in July, reinforces our approach and gives us strong momentum as we advance towards our next milestones. I'd like to now pass you on to Marina to review our second quarter 2025 financial results.