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 Insights - Armata Pharmaceuticals has reported positive results from its Phase 2a diSArm study of AP-SA02, a bacteriophage therapy for complicated Staphylococcus aureus bacteremia, presented at IDWeek 2025 [1][2][3] Study Overview - The diSArm study was a randomized, double-blind, controlled trial comparing AP-SA02 combined with best available antibiotic therapy (BAT) against a placebo group receiving BAT alone [2][14] - A total of 42 patients were enrolled, with 29 receiving AP-SA02 and 13 receiving placebo, with methicillin-resistant S. aureus (MRSA) identified in approximately 38% of both groups [4][14] Efficacy Results - At day 12, clinical response rates were significantly higher in the AP-SA02 group, with 88% responding compared to 58% in the placebo group (p = 0.047) [6][17] - No patients in the AP-SA02 group experienced non-response or relapse at one week post-BAT or at the end of the study, while the placebo group had a non-response/relapse rate of approximately 25% [7][17] Safety Profile - AP-SA02 was well-tolerated, with treatment-emergent adverse events occurring in 6% of patients in the AP-SA02 group compared to 0% in the placebo group [8][17] - Serious adverse events related to the study drug were not reported [8] Mechanism and Future Directions - The study highlighted the potential of AP-SA02's defined genomic variants to provide rapid, strain-specific responses to S. aureus isolates, suggesting a flexible and adaptive therapeutic approach [10][17] - The results support advancing AP-SA02 into a pivotal Phase 3 trial planned for 2026, pending FDA review [17] Company Background - Armata Pharmaceuticals focuses on developing high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant infections, with a pipeline that includes candidates for various pathogens [16] - The Phase 1b/2a study was partially funded by a $26.2 million award from the Department of Defense [15]

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]

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]

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]

Core Insights - Armata Pharmaceuticals announced positive topline results from its Phase 1b/2a diSArm trial for AP-SA02, a novel bacteriophage therapeutic for Staphylococcus aureus bacteremia, demonstrating significant clinical improvements over best available antibiotic therapy [1][2][3] Group 1: Trial Overview - The diSArm study was a multicenter, randomized, double-blind, placebo-controlled trial assessing the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy [3] - The intent-to-treat population included 50 subjects who received at least one dose of AP-SA02 or placebo [3] Group 2: Efficacy Results - A statistically significant increase in the responder rate was observed at the Test of Cure (TOC) for AP-SA02 treated subjects (88%) compared to placebo (58%) with a p-value of 0.047 [6] - At TOC for best available therapy (BAT) and at the end of study (EOS), 100% of AP-SA02 treated subjects clinically responded, while only 25% of placebo subjects were considered responsive [6] - All subjects infected with methicillin-resistant S. aureus (MRSA) treated with AP-SA02 cleared their infection by TOC for BAT with no evidence of relapse [6] Group 3: Safety Profile - AP-SA02 was well-tolerated with no treatment-related serious adverse events reported during the trial [1][4] - Two subjects experienced adverse events possibly related to the study drug, which were manageable [4] Group 4: Manufacturing and Future Plans - Armata has developed the capacity to manufacture over 10,000 full courses of phage therapy annually at its cGMP facility in California [9] - The company aims to move rapidly towards initiating a pivotal trial based on the favorable safety and efficacy results of AP-SA02 [9]

Core Insights - Armata Pharmaceuticals is advancing its bacteriophage therapeutic AP-SA02 for complicated Staphylococcus aureus bacteremia, with topline data expected in Q2 2025 to support future pivotal trials [1][5] Funding and Support - The company has received an additional $4.65 million in non-dilutive funding from the Department of Defense, bringing the total award to $26.2 million to support the clinical development of AP-SA02 [1][2] Clinical Trial Details - The diSArm study is a Phase 1b/2a trial evaluating the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy for adults with complicated Staphylococcus aureus bacteremia [3][4] - The trial achieved full enrollment of 50 subjects by November 2024, with the last patient visit in January 2025, and demonstrated the ability to dose escalate to 5e10 PFU every six hours without significant adverse events [4][5] Manufacturing and Development Commitment - Armata is focused on demonstrating the potential of phage therapy through rigorously designed clinical trials and has developed a proprietary manufacturing process to support both clinical development and future commercial production [2][7]

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]