Financial Data and Key Metrics Changes - The cash balance and restricted cash as of September 30, 2025, were $8.1 million, down from $18 million as of December 31, 2024, primarily due to net cash used in operating activities [11] - Research and development expenses net were $6.1 million for Q3 2025, compared to $7.3 million for Q3 2024, driven by reduced salary expenses and lower rent expenses [12] - General and administrative expenses were $2.4 million for Q3 2025, down from $3.2 million for Q3 2024, mainly due to reduced salary and share-based compensation expenses [13] - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million for Q3 2024, primarily due to changes in the fair value of warrants [13] Business Line Data and Key Metrics Changes - The BX004 program for cystic fibrosis patients made significant progress despite regulatory challenges, with first patient dosing in the phase IIB trial [5] - The BX011 program targeting Staphylococcus aureus infections in diabetic foot infections received positive FDA feedback, supporting its development as an off-the-shelf formulation [8][9] Market Data and Key Metrics Changes - Approximately 160,000 lower limb amputations occur annually in diabetic patients in the U.S., with 85% stemming from diabetic foot infections or osteomyelitis, highlighting a significant unmet medical need [9] Company Strategy and Development Direction - The company is focused on advancing both BX004 and BX011 through key upcoming milestones, with a clear phase III development pathway for BX004 and a strong regulatory opportunity for BX011 [14] - The strategy includes leveraging existing clinical data and addressing critical unmet medical needs in the diabetic foot infection market [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about resuming enrollment in the BX004 trial following FDA feedback, viewing the clinical hold as a technical challenge rather than a fundamental concern [6][7] - The company sees strong momentum in the phage therapy field and increasing validation of phage-based approaches, which strengthens confidence in upcoming trial readouts [10] Other Important Information - The FDA provided constructive guidance for BX011, outlining a clear potential pathway toward a biologics license application without the need for additional non-clinical studies [9] Q&A Session Summary Question: Clarification on the defense potential for BX011 - Management indicated that the U.S. Defense Health Agency supports the approval of BX011 through a commercial indication first, with potential expansion later [17][19] Question: Outstanding questions regarding DFI design or inclusion criteria - Management confirmed that there are some fine-tuning aspects but generally good clarity on the clinical study design and endpoints [21][22] Question: Speculation on the FDA's initial clinical hold for BX004 - Management speculated that the hold was due to new requirements for the nebulizer device, viewing it as a technical issue rather than a concern about the drug itself [34] Question: General ideas on the size and duration of the potential phase III study for BX004 - Management indicated that while specifics are still being defined, there is a clear understanding of the phase III study's direction, pending positive data from the phase IIB trial [36]

Financial Performance - Net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024, primarily due to changes in the fair value of warrants[10] - The operating loss narrowed to $8,536 million in Q3 2025 from $11,328 million in Q3 2024, a reduction of approximately 24.7%[22] - Net loss increased to $9,166 million in Q3 2025, compared to a net income of $9,642 million in Q3 2024[22] - Basic loss per share was $0.29 in Q3 2025, compared to a loss of $0.31 per share in Q3 2024[22] - Loss before tax was $9,163 million in Q3 2025, compared to a loss of $9,642 million in Q3 2024[22] - The company reported a loss from change in fair value of warrants of $730 million in Q3 2025, compared to a gain of $20,559 million in Q3 2024[22] Cash Position - Cash balance as of September 30, 2025, was $8.1 million, down from $18 million as of December 31, 2024, primarily due to net cash used in operating activities[6] - BiomX's cash, cash equivalents, and restricted cash are estimated to be sufficient to fund operations into the first quarter of 2026[6] Research and Development - Research and development expenses for Q3 2025 were $6.1 million, a decrease from $7.3 million in Q3 2024, driven by reduced salary expenses and lower rent expenses[8] - R&D expenses decreased to $6,122 million in Q3 2025 from $7,279 million in Q3 2024, a reduction of approximately 15.9%[22] - BiomX plans to prioritize diabetic foot infections as the lead indication for regulatory development, following positive Phase 2 results from BX211[7] - The FDA has provided positive feedback on BX011, confirming a clear clinical development path for the treatment of diabetic foot infections[3] - BiomX expects to report topline results from the Phase 2b study of BX004 in the first quarter of 2026[7] General and Administrative Expenses - General and administrative expenses for Q3 2025 were $2.4 million, down from $3.2 million in Q3 2024, mainly due to reduced salary and share-based compensation expenses[9] - General and administrative expenses fell to $2,414 million in Q3 2025 compared to $3,248 million in Q3 2024, representing a decrease of about 25.6%[22] Other Financial Metrics - Interest expenses remained stable at $5 million for both Q3 2025 and Q3 2024[22] - Goodwill impairment was recorded at $801 million in Q3 2024, with no impairment in Q3 2025[22] Funding and Collaborations - The company received approximately $40 million in non-dilutive funding from the DHA and Department of Navy for the development of phage therapies[14] - The company is in discussions with the U.S. Defense Health Agency regarding the utilization of phage therapy for S. aureus-driven infections[7]

Core Insights - BiomX received positive FDA feedback confirming a clear clinical development pathway for BX011, a multi-phage cocktail targeting S. aureus in diabetic foot infections, building on prior Phase 2 success [1][3] - The company anticipates imminent FDA feedback regarding the clinical hold on BX004, a fixed phage cocktail for chronic Pseudomonas aeruginosa infections in cystic fibrosis patients [1][3] - BiomX plans to prioritize diabetic foot infections (DFI) for regulatory development, leveraging positive Phase 2 results from BX211 in diabetic foot osteomyelitis [6][14] Clinical Program Updates - BX004 is currently under a clinical hold by the FDA while the company reviews data on a third-party nebulizer; however, patient enrollment and dosing outside the U.S. continue [6][8] - The Phase 2b trial for BX004 involves approximately 60 cystic fibrosis patients and aims to measure efficacy endpoints such as bacterial burden reduction and lung function improvement [6][13] - BiomX plans to initiate a Phase 2a trial for BX011 following FDA feedback, with no additional non-clinical studies required [6][14] Financial Results - As of September 30, 2025, BiomX reported a cash balance of $8.1 million, down from $18 million at the end of 2024, primarily due to operating cash usage [8] - Research and development expenses for Q3 2025 were $6.1 million, a decrease from $7.3 million in Q3 2024, attributed to reduced salary and lower rent expenses [9] - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024, mainly due to changes in the fair value of warrants [11][21]

Core Insights - BiomX Inc. will report its third quarter 2025 financial results and program updates on November 12, 2025, before the U.S. financial markets open [1] - A conference call and live audio webcast will be held at 8:30 a.m. ET on the same day to discuss the financial results and program updates [1][2] Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria for chronic diseases with significant unmet needs [4] - The company utilizes its BOLT ("BacteriOphage Lead to Treatment") platform to customize phage compositions against proprietary bacterial targets [4]

Core Insights - BiomX has received positive feedback from the FDA regarding the clinical development pathway for its phage therapy product BX011, which targets Staphylococcus aureus in diabetic foot infections (DFI) [1][2][4] - The decision to focus on DFI is based on a broader patient population, significant unmet medical needs, and a clear regulatory path supported by FDA guidance [2][4] - BX011 includes multiple proprietary phages and is supported by approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency and Department of Navy [3][4] Company Development - BiomX plans to initiate a Phase 2a clinical trial for BX011 in DFI, following the successful Phase 2 study of BX211 for diabetic foot osteomyelitis [2][3] - The FDA's guidance indicates that no additional non-clinical studies are required, aligning with BiomX's existing manufacturing and quality strategy [4] - The CEO of BiomX emphasized the goal of bringing phage therapy into mainstream infectious disease care by targeting earlier stages of infection [5] Financial and Regulatory Support - The development of BX011 is backed by significant funding and ongoing discussions with the U.S. Defense Health Agency [3] - The FDA's feedback supports a potential Biologics License Application (BLA) for BX011, confirming the development plan is in accordance with current FDA guidance [4]

Core Insights - BiomX Inc. has received positive feedback from the FDA regarding the clinical development pathway for BX011, a multi-phage cocktail targeting Staphylococcus aureus in diabetic foot infections [1][4] - The decision to focus on diabetic foot infections (DFI) is based on a broader patient population, significant unmet medical need, and a clear regulatory path [2][4] - BiomX plans to initiate a Phase 2a clinical trial for BX011, supported by approximately $40 million in funding from the U.S. Defense Health Agency and the Department of Navy [3][5] Company Development - BX011 includes multiple proprietary phages, some of which were previously evaluated in the BX211 study targeting diabetic foot osteomyelitis [3] - The FDA's guidance indicates no additional non-clinical studies are required, aligning with BiomX's existing manufacturing and quality strategy [4] - The CEO of BiomX emphasized the goal of integrating phage therapy into mainstream infectious disease care by targeting earlier stages of disease [5] Financial and Regulatory Support - BiomX has received around $40 million in non-dilutive funding to support the development of its phage therapies [3] - The FDA's feedback supports the potential for a Biologics License Application (BLA) for BX011, confirming the development plan is in accordance with current FDA guidance [4]

Core Viewpoint - BiomX has addressed the FDA's queries regarding the third-party nebulizer for BX004, and new FDA feedback highlights the significant unmet need for therapies targeting chronic Pseudomonas aeruginosa infections in cystic fibrosis patients, with the Phase 2b study on track to report topline results in Q1 2026 [1][5][8] Group 1: FDA Interaction and Clinical Trials - The FDA's initial clinical hold on the U.S. portion of the Phase 2b trial was addressed by BiomX and the nebulizer manufacturer, who provided comprehensive data to respond to the FDA's feedback [2] - The FDA issued a request for limited technical clarifications regarding the nebulizer's performance, which BiomX believes has been fully addressed [2][4] - Patient recruitment and dosing in Europe have exceeded expectations, and the Phase 2b trial is on track to report topline results in the first quarter of 2026 [3][4] Group 2: Development Pathways and Market Need - New FDA feedback acknowledges the ongoing unmet need for therapies addressing chronic Pseudomonas aeruginosa infections in cystic fibrosis patients, even with the availability of CFTR modulators [5] - The FDA outlined potential development pathways for BX004, including refining inclusion criteria and enriching patient populations for a Phase 3 program [5][6] - BiomX plans to incorporate the FDA's recommendations into ongoing development plans and anticipates further discussions at an End-of-Phase 2 meeting after the Phase 2b trial results [6] Group 3: Product Overview - BX004 is a fixed multi-phage cocktail aimed at treating cystic fibrosis patients with chronic pulmonary infections caused by Pseudomonas aeruginosa, a major contributor to morbidity and mortality in this patient population [7] - Positive results from earlier trials indicated safety, tolerability, and microbiologic activity, with improvements in pulmonary function noted in a predefined subgroup of patients [8] - BX004 has received FDA Fast Track and Orphan Drug Designations, and the company expects to enroll approximately 60 patients in the Phase 2b trial, assessing lung function, bacterial load, and quality of life metrics [8]

Core Insights - BiomX has addressed the FDA's queries regarding the third-party nebulizer used for BX004, which were narrow in scope, and has responded to an additional request for technical clarifications [1][2] - The FDA's new feedback highlights the significant unmet need for therapies targeting chronic Pseudomonas aeruginosa infections in cystic fibrosis patients and outlines potential development pathways [5][6] - Patient enrollment and dosing in Europe for the BX004 Phase 2b trial are progressing ahead of schedule, with topline results expected in the first quarter of 2026 [3][4] FDA Interaction - BiomX, in collaboration with the nebulizer manufacturer, provided comprehensive data to address the FDA's initial clinical hold on the U.S. portion of the Phase 2b trial [2] - The FDA has not raised concerns regarding the BX004 drug product itself, focusing solely on the nebulizer device [2] Clinical Trial Progress - The BX004 Phase 2b trial is on track to report topline results in Q1 2026, with all nebulizer components used in the European trial being CE marked and approved for use in the EU [3][4] - BiomX plans to enroll approximately 60 patients in a randomized, double-blind, placebo-controlled Phase 2b trial, assessing lung function, bacterial load, and quality of life metrics [8] Development Strategies - The FDA's feedback recognizes the ongoing unmet need for therapies in cystic fibrosis, suggesting opportunities to refine inclusion criteria and enrich patient populations for a Phase 3 program [5][6] - BiomX intends to incorporate the FDA's recommendations into its development plans and anticipates further discussions at an End-of-Phase 2 meeting after the Phase 2b trial results [6]

Core Insights - BiomX Inc. will present positive topline results from its Phase 2 trial evaluating BX211 for the treatment of Diabetic Foot Osteomyelitis (DFO) at the H.C. Wainwright 27th Annual Global Investment Conference [1][2] Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria for chronic diseases with significant unmet needs [4] - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [4] Product Details - BX211 is a phage treatment specifically designed for DFO associated with Staphylococcus aureus, a bacterial infection that can lead to amputation in diabetic patients [3] - The Phase 2 trial results indicated that BX211 was safe and well-tolerated, with a statistically significant reduction in ulcer size (p = 0.046 at week 12; p = 0.052 at week 13) and a difference greater than 40% from placebo by week 10 [3] - Statistically significant improvements were also observed in ulcer depth (p = 0.048) and reduction of ulcer area expansion (p = 0.017) over the 12-week treatment period [3] Future Plans - BiomX is planning a registrational trial for BX211, pending discussions and feedback from the FDA [3]

Core Viewpoint - The U.S. FDA has placed a clinical hold on BiomX's Phase 2b study of BX004 due to concerns regarding the third-party nebulizer device used for drug delivery, while the BX004 drug candidate itself has no concerns raised by the FDA [1][2][3] Group 1: Clinical Trial Status - The clinical hold is temporary, and BiomX has submitted additional data to the FDA to address the concerns regarding the nebulizer [2][3] - Patient screening and enrollment in the U.S. portion of the Phase 2b trial of BX004 have been paused, while enrollment and dosing continue in Europe where the nebulizer device meets regulatory requirements [2][4] Group 2: BX004 Development - BX004 is a fixed multi-phage cocktail targeting chronic pulmonary infections caused by Pseudomonas aeruginosa in cystic fibrosis patients [4] - Positive results from earlier studies indicate safety, tolerability, and improvement in pulmonary function associated with reduced bacterial load [4] - The Phase 2b trial aims to enroll approximately 60 patients and will assess lung function, bacterial load, and quality of life metrics over an 8-week period [4] Group 3: Company Overview - BiomX is focused on developing natural and engineered phage therapies to target specific pathogenic bacteria for chronic diseases with unmet needs [5] - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [5]