BiomX (NYSEAM:PHGE) Q3 2025 Earnings Call November 12, 2025 08:30 AM ET Speaker1Good morning and welcome to BiomX's third quarter 2025 financial results and program update conference call. Currently, all participants are in a 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 BiomX. Please proceed.Speaker3Thank you and welcome to the ...

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 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]

Financial Data and Key Metrics Changes - Cash balance and restricted cash as of June 30, 2025, were $15.2 million, down from $18 million as of December 31, 2024, primarily due to net cash used in operating activities [13] - Research and development expenses were $5 million for 2025, compared to $6.9 million for 2024, driven by reduced salary expenses and lower rent expenses [14] - General and administrative expenses were $2.4 million for 2025, down from $2.8 million for 2024, attributed to reduced legal and professional service fees [15] - Net loss was $6 million for Q2 2025, compared to income of $4.5 million for 2024, mainly due to changes in the fair value of warrants issued [15] Business Line Data and Key Metrics Changes - The BX004 program for cystic fibrosis saw successful initiation of patient dosing in its phase 2b clinical trial, with top-line results expected in 2026 [5][9] - The BX211 program demonstrated statistically significant results in reducing ulcer size in diabetic foot osteomyelitis patients, with a p-value of 0.046 at week twelve [7][9] Market Data and Key Metrics Changes - Approximately 860,000 lower limb amputations occur annually in diabetic patients in the US, with 85% attributed to diabetic foot osteomyelitis or infections [8] - No therapeutics have been approved in the US specifically for diabetic foot osteomyelitis in over 20 years, indicating a significant unmet need in the market [9] Company Strategy and Development Direction - The company is focused on advancing its clinical programs and building scientific validation for its phase therapy platform, with multiple upcoming milestones [5][12] - Ongoing discussions with the US Defense Health Agency are aimed at supporting the BX211 program, which has received substantial funding [9][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in clinical trials, noting increased interest from sites and patients for the BX004 and BX211 studies [20][35] - The company is preparing for discussions with the FDA regarding the registrational study for BX211, with a focus on infection resolution endpoints [25][42] Other Important Information - The company estimates that its cash and equivalents are sufficient to fund operations into 2026 [14] - A publication in Nature Communications provided further validation for the BX004 program, showcasing significant antimicrobial efficacy data [11] Q&A Session Summary Question: Interest in bacteriophage studies - Management noted significant excitement from sites and patients regarding the studies, indicating a shift in recruitment dynamics compared to previous trials [20][21] Question: Registrational study for BX211 - Management discussed the promising data for BX211 and the ongoing preparations for discussions with regulatory agencies regarding the study design [23][25] Question: Real-world evidence for BX004 - Management highlighted efforts to gather real-world data and align with historical data to support discussions with the FDA [28][39] Question: Enrollment status for BX004 - Management indicated strong interest and excitement from patients and sites, suggesting that enrollment is progressing well [35] Question: Timeline for discussions with the FDA - Management aims to have discussions with the FDA regarding the registrational study framework by the end of the year [42]

Core Insights - BiomX Inc. reported positive Phase 2 results for BX211, showing over 40% wound size reduction in diabetic foot osteomyelitis patients compared to placebo, with plans for a potential registrational study [1][3][7] - New data for BX004 published in Nature Communications demonstrated approximately 500-fold bacterial reduction versus placebo, with no emergence of resistance, underscoring the capabilities of BiomX's platform [1][3][7] - The Phase 2b trial of BX004 in cystic fibrosis patients has commenced, with topline results expected in Q1 2026 and FDA feedback on real-world evidence strategy anticipated in H2 2025 [1][3][7] Clinical Program Updates - BX211 is a phage therapy targeting diabetic foot infections associated with Staphylococcus aureus, showing significant improvements in ulcer size and depth [4][13] - BX004 is a fixed phage cocktail for chronic Pseudomonas aeruginosa infections in cystic fibrosis patients, with a Phase 2b trial now underway [5][14] Financial Results - As of June 30, 2025, BiomX reported a cash balance of $15.2 million, down from $18 million at the end of 2024, sufficient to fund operations into Q1 2026 [8] - Research and development expenses for Q2 2025 were $5.0 million, a decrease from $6.9 million in Q2 2024, attributed to reduced salary and rent expenses [9] - General and administrative expenses were $2.4 million for Q2 2025, down from $2.8 million in Q2 2024, mainly due to lower legal fees [10] - The net loss for Q2 2025 was $6.0 million, compared to a profit of $4.5 million in Q2 2024, primarily due to changes in the fair value of warrants [11]

Core Insights - BiomX Inc. is presenting positive topline results from its Phase 2 trial evaluating BX211 for the treatment of Diabetic Foot Osteomyelitis (DFO) at the Biomed Israel 2025 conference [1][2] - BX211 is a phage therapy targeting DFO associated with Staphylococcus aureus, a significant cause of amputation in diabetic patients [3][4] Presentation Details - The oral presentation titled "Precision Phage Therapy for Chronic Diabetic Foot Infections" will take place on May 21, 2025, from 12:15 to 2:15 pm IST at the InterContinental David Tel Aviv [2] - The session focuses on immunology and inflammation, highlighting opportunities in biopharma [2] BX211 Trial Results - The Phase 2 trial demonstrated 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) [3] - A separation from placebo was observed starting at week 7, with a difference greater than 40% by week 10 [3] - Statistically significant improvements were also noted in ulcer depth (p=0.048) and reduction of ulcer area expansion (p=0.017) [3] - The treatment period lasted 12 weeks, during which all patients received standard care, including systemic antibiotic therapy [3] Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies for chronic diseases with unmet medical needs [4] - The company utilizes its BOLT platform to customize phage compositions targeting specific bacterial pathogens [4]

Group 1 - The conference call is focused on BiomX's first quarter 2025 financial results and updates on business and programs [3] - The quarterly report on Form 10-Q will be filed with the Securities and Exchange Commission, and a press release was made available at 6:30 a.m. Eastern time [3] - A replay of the conference call will be accessible in the Investors section of the company's website [3] Group 2 - The call includes forward-looking statements regarding the company's cash sufficiency, pipeline, clinical trial designs, expected discussions with regulatory agencies, and potential benefits of product candidates [4] - The company emphasizes that past and current clinical trials do not guarantee future results [5]

Financial Data and Key Metrics Changes - As of March 31, 2025, the cash balance and restricted cash were $21.2 million, an increase from $18 million as of December 31, 2024, primarily due to funds raised in February 2025 financings [14] - Research and development expenses for Q1 2025 were $5.3 million, up from $4.1 million in Q1 2024, attributed to preparations for clinical trials and increased expenses related to the DFO product candidate [15] - The net loss for Q1 2025 was $7.7 million, a decrease from $17.3 million in Q1 2024, mainly due to changes in the fair value of warrants issued [17] Business Line Data and Key Metrics Changes - The company reported positive top-line results from the Phase 2 trial of BX211 for diabetic foot osteomyelitis, indicating a significant unmet patient need [5][9] - The Phase 2 trial of BX211 showed a statistically significant reduction in ulcer size, with a difference greater than 40% from placebo by week ten [10] Market Data and Key Metrics Changes - Approximately 160,000 lower limb amputations occur annually in diabetic patients in the U.S., with 85% estimated to be caused by diabetic foot infections [6][7] - The total financial burden on the U.S. healthcare system due to diabetic amputations is approximately $8 billion annually [7] Company Strategy and Development Direction - The company plans to discuss potential Phase 2/3 trials for BX211 with regulatory agencies later this year, aiming for breakthrough and orphan designations [22] - The company is exploring funding and partnering opportunities to advance BX211's clinical development [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the pipeline and the ability to advance therapeutics addressing high unmet needs [13] - The company anticipates a top-line readout of the Phase 2b study of BX004 in cystic fibrosis in the first quarter of 2026, which remains on track [6][33] Other Important Information - The U.S. Defense Health Agency has contributed approximately $40 million in non-dilutive funding for the development of BX211 [12] - The company held a KOL event that received positive feedback from industry experts regarding the strength of the data from the Phase 2 trial [11] Q&A Session Summary Question: Regulatory interactions and plans for DFO program - Management is gearing up for discussions with regulatory agencies later this year, considering options for breakthrough and orphan designations [22] Question: Expansion of physician interest in DFO program - There has been significant interest from various centers in the U.S. and Europe regarding participation in the next steps of the DFO program [25] Question: Timeline for CF Phase 2 trial - The CF Phase 2 trial is on track, with no impediments expected, and centers are eager to enroll patients [33] Question: Potential for moving directly to Phase 3 for BX211 - There is a chance to pursue a pivotal study for BX211, pending confirmation from regulatory agencies [35] Question: Prospects for publications and medical conferences - The company is working on presenting data at medical conferences and aims to publish findings due to the quality of the data [37] Question: Safety database size for Phase therapy - Historically, around 300 patients are targeted for orphan indications, but the company hopes to reduce this number based on the safety profile of the product [40]

Financial Data and Key Metrics Changes - As of March 31, 2025, the cash balance and restricted cash were $21.2 million, an increase from $18 million as of December 31, 2024, primarily due to funds raised in February 2025 financings [13] - Research and development expenses net were $5.3 million for Q1 2025, compared to $4.1 million for Q1 2024, reflecting preparations for clinical trials and increased expenses related to the DFO product candidate [14] - General and administrative expenses decreased to $2.5 million in Q1 2025 from $2.7 million in Q1 2024, attributed to prior year expenses related to an acquisition [14] - The net loss for Q1 2025 was $7.7 million, a significant decrease from $17.3 million in Q1 2024, mainly due to changes in the fair value of warrants [15] - Net cash used in operating activities was $8.7 million for Q1 2025, down from $11.4 million for the same period in 2024 [16] Business Line Data and Key Metrics Changes - The company reported positive top-line results from the Phase 2 trial of BX211 for diabetic foot osteomyelitis, indicating a significant unmet patient need [5][6] - The Phase 2 trial of BX211 showed a statistically significant reduction in ulcer size, with a difference greater than 40% from placebo by week ten [9] Market Data and Key Metrics Changes - The U.S. healthcare system incurs approximately $8 billion annually due to diabetic amputations, with a staggering number of 160,000 lower limb amputations occurring each year among diabetic patients [7] - The five-year mortality rate for patients with diabetic foot infections who undergo amputations is between 30% to 50%, highlighting the critical need for effective treatments [7] Company Strategy and Development Direction - The company plans to advance BX211 through potential Phase 2/3 trials, pending feedback from regulatory agencies, and is exploring funding and partnership opportunities [10] - The company aims to leverage the recent positive data to pursue breakthrough and orphan designations for regulatory interactions [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the clinical pipeline and the ability to advance therapeutics addressing high unmet needs, particularly in cystic fibrosis and diabetic foot osteomyelitis [12] - The company anticipates a top-line readout of the Phase 2b study of BX004 in cystic fibrosis in the first quarter of 2026, which remains on track [12][33] Other Important Information - The U.S. Defense Health Agency has contributed approximately $40 million in non-dilutive funding to support the development of BX211 [11] - The company successfully completed a $12 million financing, which is expected to ensure continued development of its pipeline [5][12] Q&A Session Summary Question: Regulatory interactions regarding the DFO program - Management indicated ongoing discussions with regulatory agencies and plans to discuss potential breakthrough and orphan designations later this year [21][22] Question: Expansion of physician interest in the DFO program - There has been significant interest from various centers in the U.S. and Europe, with plans for a global study [25][26] Question: Timeline for the CF Phase 2 trial - The trial is on track, with no impediments anticipated, and patient recruitment is expected to proceed smoothly [32][33] Question: Potential for a pivotal study for BX211 - Management is considering the possibility of moving directly to a pivotal study based on the positive data, pending discussions with regulatory agencies [37][38] Question: Publication and conference prospects for BX211 data - The company is working on presenting data at medical conferences and aims to publish findings due to the quality of the data [39][40] Question: Safety database size for regulatory approval - Management indicated that they hope to reduce the number of patients needed for the safety database based on the product's safety profile [42][43]