BiomX Inc.

Greetings and welcome to the Biomix first quarter 2025 financial results conference call. At this time, all participants are in a listen-only mode. The 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. Please note this conference is being recorded. I will now turn the conference over to Marina Wolfson, Chief Financial Officer. Thank you. You may begin.

Thank you. And welcome to the Biomics conference call to review the company's first 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 in 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, the design, recruitment, aim, expected timing, and interim and final results of our clinical trials, expected discussions with 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 trials 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 fossil carbon 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 afternoon is Biomics Chief Executive Officer Jonathan Solomon, to whom I will now turn over the call.

Thank you, Marina, and good afternoon, everyone. We appreciate you taking the time to join Biomics Quarterly Update today. During the last quarter, the company advanced significantly, both across the corporate fund and with our clinical pipeline. Pivotal landmark events included in our March announcement of positive top-line results from the company's Phase II trial evaluating BX211 for the treatment of diabetic foot osteomyelitis, or DFO, associated with Staphylococcus aureus. Also, during the first quarter, we announced a $12 million financing, which received the remaining shareholder approval in a special meeting last month. We expect the financing will provide a runway for us in the first quarter of 2026, aligned with a planned top-line readout of the Phase IIb study of BX004 in cystic fibrosis, which remains on track. I'll review our trial of BX211 in DFO first. DFO is an extremely challenging indication. No therapeutics have been approved in the United States for the treatment of DFO, and as such, this disease represents a substantial unmet patient need. As background, each year there's a staggering number of approximately 160,000 lower limb amputations in diabetic patients in the U.S. alone, and the great majority, 85%, are estimated to be caused by either ESO or diabetic foot infections, ESI. The approximate direct cost for each amputation is $50,000, and the total financial burden on the U.S. healthcare system due to diabetic amputations is approximately $8 billion annually, a staggering figure. Sadly, BFO patients or patients with diabetic foot infections or DFI who have undergone amputations have a high five-year mortality rates between 30% to 50%. This figure is worse than the five-year survival of most cancers. Additionally, prior lower limb amputations is a major risk factor for subsequent amputations. We believe that the top-line results of a Phase II trial in BFO mark a potential turning point in how we can address this unmet need for patients. The press release, including results from the trial, can be found on our website. However, highlights from the Phase II trial of BX211 include the following findings. We demonstrated safety and tolerability of BX211. In terms of activity, we saw with BX211 a sustained and statistically significant percent error reduction, or PAR, ulcer size, with a separation from placebo starting at week 7 with a difference greater than 40% by week 10. There are also statistical significant improvement in ulcer death at week 13 in patients where ulcer death were defined as bone at baseline. And this p-value equaled 0.048. We also saw significant statistical improvement with VIX211 in reducing the expansion of ulcer area. This p-value equaled 0.017. We hosted a KOL event reviewing our top line results on April 3rd, and the link to the webcast can be found in this morning's press release. The KOL event itself received resounding endorsements from key opinion leaders, physician, and industry experts, highlighting the enthusiasm surrounding the strength of the data and the significance of its potential in addressing the needs of patients living with DFO. We are eager to share more of our subsequent analysis of the data at a scientific conference later this year. As for next steps, pending feedback from the FDA and additional regulatory agencies, we are planning a potential Phase 2-3 trial, and we are exploring potential funding and partnering opportunities for further advanced BX211 clinical development. The U.S. Defense Health Agency, DHA, has continued to support the development of BX211, and to date, they have contributed approximately $40 million in non-dilutive funding. The rise in antibiotic-resistant infections reported from ongoing global conflicts underscores the urgent need to protect combatants and noncombatants from antibiotic-resistant infections in current and potential future conflict environments. Bacteriophage therapy may offer a critical treatment option in these cases where antibiotics are no longer effective. Recently, in April, Biomics held a special meeting of shareholders which approved the exercise of certain warrants issued as part of our $12 million financing that we announced this past February. The funds from the financing and warrant exercise are expected to ensure the continued development of the company's pipeline ahead of the results of a Phase 2B trial, evaluating the BX004 as a treatment for cystic fibrosis patients with chronic pulmonary infections associated with pseudomonas aeruginosa. We'd like to take this opportunity to thank again Deerfield Management Company, the Cystic Fibrosis Federation, Napanhala, and the additional investors that participated in the financing for their continued support of the company. Looking ahead, we remain confident in the strength of our clinical pipeline and our ability to advance the potentially life-changing therapeutics addressing high unmet needs in patients. The strength of the recent Phase II DFO readout further reinforces our approach and gives us strong momentum as we advance toward our next milestones, including our upcoming cystic fibrosis trial readout, which remains on track to read out top-line results in the first quarter of 2026. I'd like now to pass you on to Marina to review our first quarter 2025 financial results.