Core Viewpoint - BiomX Inc. has announced a private placement financing expected to raise approximately $3.0 million to support its bacteriophage programs and evaluate strategic alternatives [1][7]. Group 1: Private Placement Details - The private placement involves the issuance of Series Y Convertible Preferred Stock with a stated value of $1,000 per share, along with warrants, for a total purchase price of $3.0 million [3]. - Each share of Series Y Convertible Preferred Stock will accrue dividends at a rate of 15% per annum, payable quarterly, and has a maturity of one year from the closing date [4]. - The company will issue warrants to acquire up to 3,300,000 shares of common stock, with an initial exercise price of $2.00 and a five-year term [5]. Group 2: Use of Proceeds - The net proceeds from the private placement will be used to assess opportunities in the company's bacteriophage programs, particularly BX011 for Staphylococcus aureus infections related to diabetic foot infections, and for general corporate purposes [7]. Group 3: Regulatory and Closing Information - The securities sold in the private placement have not been registered under the Securities Act and were offered in reliance on exemptions from registration requirements [6]. - The private placement is expected to close on or about December 30, 2025, subject to customary closing conditions [5]. Group 4: Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies to target harmful bacteria for chronic diseases with significant unmet needs [9]. - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [9].

Core Viewpoint - BiomX Inc. has announced a private placement financing expected to raise approximately $3.0 million to support its bacteriophage programs and general corporate purposes [1][7]. Private Placement Details - The private placement involves the issuance of Series Y Convertible Preferred Stock with a stated value of $1,000 per share, along with warrants, for a total purchase price of $3.0 million [3]. - Each share of Series Y Convertible Preferred Stock will accrue dividends at a rate of 15% per annum, payable quarterly, and has a maturity of one year from the closing date [4]. - The company will issue warrants to acquire up to 3,300,000 shares of common stock, with an initial exercise price of $2.00 and a five-year term [5]. Use of Proceeds - The net proceeds from the private placement will be used to assess opportunities in bacteriophage programs, including BX011 for Staphylococcus aureus infections, and for general corporate purposes [7]. Regulatory and Compliance Information - The securities sold in the private placement have not been registered under the Securities Act of 1933 and were offered in reliance on exemptions from registration requirements [6]. - The company plans to file a registration statement with the SEC to register the resale of shares issuable upon conversion of the Series Y Convertible Preferred Stock and exercise of the warrants [6]. Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies to target harmful bacteria for chronic diseases with significant unmet needs [9]. - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [9].

Core Insights - BiomX has decided to discontinue the Phase 2b trial of BX004 for cystic fibrosis due to high rates of adverse events identified in a safety review by the Data Monitoring Committee [1][2] - The company is focusing on its phage program BX011 for Staphylococcus aureus infections related to diabetic foot infections while implementing cost-cutting measures, including workforce reduction [1][2][3] Company Overview - BiomX is a clinical-stage company developing natural and engineered phage therapies aimed at treating chronic diseases with significant unmet medical needs [4] - The company utilizes its BOLT platform to customize phage compositions targeting specific bacterial pathogens [4]

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 received positive FDA feedback confirming a clear clinical development pathway for BX011, a multi-phage cocktail targeting S. aureus in diabetic foot infections, building on prior Phase 2 success [1][3] - The company anticipates imminent FDA feedback regarding the clinical hold on BX004, a fixed phage cocktail for chronic Pseudomonas aeruginosa infections in cystic fibrosis patients [1][3] - BiomX plans to prioritize diabetic foot infections (DFI) for regulatory development, leveraging positive Phase 2 results from BX211 in diabetic foot osteomyelitis [6][14] Clinical Program Updates - BX004 is currently under a clinical hold by the FDA while the company reviews data on a third-party nebulizer; however, patient enrollment and dosing outside the U.S. continue [6][8] - The Phase 2b trial for BX004 involves approximately 60 cystic fibrosis patients and aims to measure efficacy endpoints such as bacterial burden reduction and lung function improvement [6][13] - BiomX plans to initiate a Phase 2a trial for BX011 following FDA feedback, with no additional non-clinical studies required [6][14] Financial Results - As of September 30, 2025, BiomX reported a cash balance of $8.1 million, down from $18 million at the end of 2024, primarily due to operating cash usage [8] - Research and development expenses for Q3 2025 were $6.1 million, a decrease from $7.3 million in Q3 2024, attributed to reduced salary and lower rent expenses [9] - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024, mainly due to changes in the fair value of warrants [11][21]

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]