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 ...

Positive FDA feedback confirms clear clinical pathway for BX011 targeting S. aureus in Diabetic Foot Infections, building on Company’s prior Phase 2 success BiomX expects FDA feedback on BX004 clinical hold imminently; Enrollment and dosing of patients outside the U.S. are continuing in accordance with protocol Positive FDA feedback received in October provided guidance for potential Phase 3 development pathways of BX004 BiomX will host a conference call and webcast today at 8:30 AM ET NESS ZIONA, Israel, ...

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 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]

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 - The initiation of patient dosing in BiomX's Phase 2b trial for BX004 represents a significant milestone in the development of phage therapy targeting antibiotic-resistant lung infections in cystic fibrosis (CF) patients [1][2] - Topline results from the trial are expected in Q1 2026, with the potential for BX004 to become a leading phage-based therapy for CF patients suffering from chronic Pseudomonas aeruginosa infections [1][2] Company Overview - BiomX Inc. is a clinical-stage company focused on developing natural and engineered phage therapies aimed at specific pathogenic bacteria, particularly for chronic diseases with substantial unmet needs [4] - The company has received FDA Fast Track and Orphan Drug designations for BX004, which is a fixed multi-phage cocktail designed to treat chronic pulmonary infections caused by P. aeruginosa in CF patients [3][4] Clinical Trial Details - The Phase 2b trial is a randomized, double-blind, placebo-controlled study involving approximately 60 CF patients, with a 2:1 randomization to receive either BX004 or placebo via inhalation twice daily for 8 weeks [2][3] - The trial aims to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and enhanced quality of life metrics [2][3] Previous Findings - Prior Phase 1b/2a trials demonstrated that 14.3% of patients achieved complete bacterial clearance after just 10 days of treatment, including patients with chronic infections lasting over a decade [1][2] - Positive topline results from Part 2 of the Phase 1b/2a trial indicated improvements in pulmonary function associated with reduced P. aeruginosa burden compared to placebo in a predefined subgroup of patients [3]

Core Insights - BiomX's phage therapy platform has received validation through a peer-reviewed article published in Nature Communications, showcasing the results of a first-in-human Phase 1b/2a trial for treating antibiotic-resistant P. aeruginosa infections [1][2] - The trial demonstrated a significant bacterial reduction of 2.7 log₁₀ (approximately 500-fold) compared to placebo, with no emergence of bacterial resistance and preservation of a healthy microbiome [1][9] - BiomX is advancing its Phase 2b trial of BX004, with topline results expected in Q1 2026 [1][2] Company Overview - BiomX Inc. is a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria, particularly for chronic diseases with substantial unmet needs [7] - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [7] Clinical Trial Highlights - The Phase 1b/2a study evaluated the safety, tolerability, pharmacokinetics, and anti-microbiologic activity of BX004 over a 7-day treatment period in nine cystic fibrosis patients [4] - BX004 demonstrated a strong safety profile with no treatment-related safety events and achieved a 2.7 log₁₀ reduction in P. aeruginosa bacteria compared to placebo [4][9] - Therapeutic phages were successfully detected and persisted at the infection site in treated patients, indicating effective delivery and activity [4] Scientific Validation - The study employed large-scale genomic analysis and bacterial defense mechanisms to optimize bacteriophage cocktails for chronic infections associated with cystic fibrosis [3] - The publication details the translational path from laboratory discovery to clinical testing, confirming the absence of known antibiotic resistance or virulence genes in the phages used [5] Future Developments - BiomX is currently enrolling patients in a randomized, placebo-controlled Phase 2b trial of BX004, which will assess lung function, bacterial load, and quality of life metrics over an 8-week period [6] - BX004 has received Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration, indicating its potential significance in treating chronic pulmonary infections [6]

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]