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]

BiomX (PHGE) Q2 2025 Earnings Call August 13, 2025 08:00 AM ET Speaker0Good morning and welcome to the BioMix Second Quarter twenty twenty five Financial Results and Business 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 BioMix.Please proceed.Speaker1Thank ...

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'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]

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]

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]

Financial Data and Key Metrics Changes - BioMx reported a strong start to the year with total gross proceeds of approximately $12 million from financing activities, which will support the completion of the Phase 2b study of BX004 in cystic fibrosis patients [25][26] - The company anticipates that the funds will provide adequate runway to reach the readout of top line Phase 2b results expected in the first quarter of 2026 [25] Business Line Data and Key Metrics Changes - The Phase II trial of BX211 for treating staphylococcus aureus infections in patients with diabetic foot osteomyelitis (DFO) showed statistically significant results across several key parameters, marking a significant advancement in phage therapy [7][23] - The study involved 41 patients, with a randomized two-to-one ratio of control to treatment group, demonstrating a greater than 40% reduction in ulcer size by week 10 for the BX211 treatment group [16][18] Market Data and Key Metrics Changes - In the U.S., there are over 38 million individuals diagnosed with diabetes, leading to approximately 400,000 diabetic foot infection ER visits annually and around 160,000 lower limb amputations in diabetic patients [11] - The total financial burden on the U.S. healthcare system due to diabetic amputations is approximately $8 billion annually, highlighting the substantial unmet need in this market [11] Company Strategy and Development Direction - BioMx aims to address the unmet needs of patients with chronic diseases through customized stage therapies, focusing on the development of BX004 and BX211 [6][7] - The company is exploring real-world evidence in cystic fibrosis to understand the relationship between Pseudomonas aeruginosa reduction and clinical outcomes, preparing for regulatory discussions later this year [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the positive Phase II results for BX211, viewing it as a watershed moment for phage therapy and a potential game changer in managing DFO and diabetic foot infections [7][23] - The management highlighted the importance of continued support from investors and partners, including the Defense Health Agency, which is interested in phage therapy due to its potential in treating drug-resistant infections [33][34] Other Important Information - BioMx will host a virtual event on April 3 featuring key opinion leaders in bacteriophage therapy to discuss the implications of the Phase II trial results for BX211 [27][28] - The company emphasized the safety of phage therapy, noting no significant differences in severe adverse events between the phage and placebo groups [60] Q&A Session Summary Question: Potential for additional non-dilutive capital from various sources - Management indicated ongoing support from the Defense Health Agency, which has been funding the company significantly, especially in light of drug-resistant infections observed in returning troops [33][34] Question: Insights on patient demographics and natural disease progression - The patient population in the study was typical for DFO, with a median age around 60 and a significant portion facing amputation, highlighting the unmet need [37][39] Question: Thoughts on the control arm's performance - The control arm's performance was consistent with expectations, hovering around a 40% improvement, which aligns with historical data for similar patient populations [39][58] Question: Early learnings regarding dosing regimens - Management noted that while it is still early to draw conclusions, the gradual response observed in this study may differ from previous studies in cystic fibrosis, suggesting that delivery methods and infection geography play significant roles [42][44] Question: Phase III study expectations and regulatory designations - Management acknowledged it is early to define Phase III study parameters but expressed excitement about the data quality and potential regulatory consultations to strategize the best path forward [46] Question: Specific adverse events related to phage treatment - Management confirmed that no significant differences in severe adverse events were observed between the phage and placebo groups, reinforcing the safety profile of phage therapy [60] Question: Plans for publication or presentation of data - Management is consulting with key opinion leaders to determine the best context for publishing the data, emphasizing the significance of the findings [62]