Core Viewpoint - BiomX Inc. is addressing FDA follow-up information requests to lift the clinical hold on its Phase 2b trial for BX004, a treatment targeting Pseudomonas aeruginosa in cystic fibrosis patients, with topline results now expected in Q2 2026 [1][4][5] Company Updates - The FDA is continuing its evaluation of the nebulizer device used for BX004 administration, and BiomX is collaborating with the third-party manufacturer to provide the necessary information [1][2] - An independent Data Monitoring Committee (DMC) has completed a safety review of the BX004 Phase 2b trial and recommended that the study continue with an adjusted dosing regimen [3][4] - The trial protocol will be updated accordingly, and pending financial resources, the company expects to enroll approximately 60 patients in the Phase 2b trial [5] Product Information - BX004 is a fixed multi-phage cocktail designed to target Pseudomonas aeruginosa, which significantly impacts morbidity and mortality in cystic fibrosis patients [5] - Positive results from earlier phases of the trial indicated safety, tolerability, and improvement in pulmonary function associated with reduced bacterial load [5] Future Expectations - The company remains optimistic about the path forward for BX004 and looks forward to reporting topline results in the second quarter of 2026 [4][5]

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]

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 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 Insights - BiomX announced positive topline results from the Phase 2 trial of BX211 for diabetic foot osteomyelitis, indicating significant progress in their clinical pipeline [1][2] - The company is preparing for a Phase 2/3 trial of BX211 pending FDA feedback and anticipates topline results for BX004 in cystic fibrosis in Q1 2026 [4][6] Clinical Program Updates - BX211 demonstrated safety and significant reduction in ulcer size with a p-value of 0.046 at week 12 and 0.052 at week 13, showing over 40% improvement by week 10 compared to placebo [3][12] - Statistically significant improvements were also observed in ulcer depth and area expansion, with p-values of 0.048 and 0.017 respectively [3][12] - The program has received approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency to address antibiotic-resistant infections [2] Business Update - Shareholders approved the exercise of warrants related to $12 million in financing, providing operational runway into Q1 2026 [6] - The company’s cash balance increased to $21.2 million as of March 31, 2025, up from $18.0 million at the end of 2024, primarily due to recent financings [7] Financial Results - Research and development expenses rose to $5.3 million in Q1 2025 from $4.1 million in Q1 2024, driven by preparations for clinical trials [8] - General and administrative expenses decreased to $2.5 million in Q1 2025 from $2.7 million in Q1 2024 [9] - The net loss for Q1 2025 was $7.7 million, a significant reduction from $17.3 million in Q1 2024, attributed to changes in the fair value of warrants [10][25]