BiomX Inc.

or as pathogen, but in an earlier stage of disease where infection remains localized to the ulcer. The program advances toward an off-the-shelf formulation intended for broad outpatient use in diabetic foot infections, while also offering dual-use potential as a rapidly deployable solution for treating combat-related wound infection as an approach well aligned with the priorities of the U.S. Defense Health Agency, or DHA, for future conflict environments. I want to take a minute to explain why we're targeting DFI initially. The DFI indication addresses a critical unmet medical need. Approximately 160,000 lower limb amputations occur in diabetic patients in the U.S. annually, with 85% stemming from diabetic foot infection or osteomyelitis. Despite this urgent need, no new drugs have been approved for DFI in the U.S. in over two decades. Additionally, BFI patients represent a large addressable patient population with significant commercial opportunity with a regulatory pathway that's clearly supported by established FDA guidance. These factors make BFI a strategically compelling indication for our program to focus on while leveraging the strong clinical data we already have. The FDA provided detailed constructive guidance for BX011, outlining the clear potential pathway toward a BLA biologics license application. Notably, no additional non-clinical studies were requested and their CMC comments are aligned with our established manufacturing approach. This feedback confirms our development plan harmonizes with current FDA guidance for DFI product development. BX011 will be applied topically and includes proprietary phage previously evaluated in our successful BX211 study. We plan to advance BX011 in coordination with ongoing discussion with the DHA and subject to securing necessary financial resources. Looking more broadly at the landscape, we're seeing strong momentum across the phage therapy field, alongside rising global attention to antimicrobial resistance. We think this underscores the growing validation of phage-based approaches, such as ours. This broader progress across the industry validates biomics precision phage therapy and strengthen our confidence as we look ahead for the upcoming VX004 phase 2b readout. I'd like to now pass you to Marina to review our third quarter 2025 financial results.

Thank you, Jonathan. As a reminder, the financial information for the company's third quarter 2025 is available in the press release that we issued earlier today, as well as in more detail in our form thank you, which we will file later today. I will now proceed with the highlights of our third quarter financial results. Our cash balance and restricted cash as of September 30th, 2025 were $8.1 million compared to $18 million as of December 31st, 2024. The decrease was primarily due to net cash used in operating activities. Biomics estimates its cash, cash equivalents, and restricted cash are sufficient to fund its operations into the first quarter of 2026. Research and development expenses net were $6.1 million for the third quarter of 2025 compared to $7.3 million for the third quarter of 2024. The decrease was primarily driven by reduced salary expenses due to workforce reduction, lower rent expenses following a right of use asset impairment in 2024, and decreased expenses related to the CF product candidate, primarily due to the significantly higher manufacturing costs that were incurred in 2024. Such decrease was partially offset by an increase in depreciation expenses attributable to an accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Israel, as well as by decreased grant funding from the Medical Technology Enterprise Consortium under the DAA and the Israeli Innovation Authority. General and administrative expenses were $2.4 million for the third quarter of 2025, compared to $3.2 million for the third quarter of 2024. The decrease was primarily driven by reduced salary and share-based compensation expenses and lower legal and other professional service fees. The decrease was partially offset by an increase in depreciation expenses attributable to the accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Israel. Net loss was $9.2 million for the third quarter of 2025 compared to net income of $9.6 million for the third quarter of 2024. The decrease was mainly due to the change in the fair value of warrants issued as part of the company's March 2024 financing. Net cash used in operating activities for the nine months ended September 30, 2025, with $22 million compared to $30.7 million for the same period in 2024. I'll now return the call to Jonathan for his closing remarks.

Thanks, Marina. To summarize, our focus remains strongly on clinical and regulatory execution, advancing both BX004 and BX011 through key upcoming milestones. We anticipate feedback imminently on the BX004 clinical hold in the U.S., which could enable the resumption of enrollment in the near term. In parallel, encouraging FDA guidance has outlined a clear Phase III development pathways for BX004 and strengthened the regulatory and commercial opportunity for BX011, which will focus on diabetic-prone infection patients. large and commercially significant population. With increasing validation across the phage therapy space, Biomics looks forward to the upcoming BXO4 trial readout in the coming months and the continued progress toward bringing precision phage therapies to patients in need. Thank you all for joining today's earning call. And with that, we'd like to open up for questions.