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 Inc. will report its third quarter 2025 financial results and program updates on November 12, 2025, before the U.S. financial markets open [1] - A conference call and live audio webcast will be held at 8:30 a.m. ET on the same day to discuss the financial results and program updates [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 ("BacteriOphage Lead to Treatment") platform to customize phage compositions against proprietary bacterial targets [4]

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 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 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 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]

Part I. Financial Information [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents BiomX Inc.'s unaudited condensed consolidated financial statements as of June 30, 2025, reflecting a net loss of $13.7 million for the first six months and a cash position of $14.0 million Condensed Consolidated Balance Sheet Data (USD in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $14,046 | $16,856 | | Total current assets | $16,635 | $20,520 | | Total assets | $38,050 | $43,233 | | **Liabilities & Equity** | | | | Total current liabilities | $6,262 | $8,267 | | Total liabilities | $18,890 | $19,085 | | Total stockholders' equity | $19,160 | $24,148 | Condensed Consolidated Statements of Operations (USD in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | R&D expenses, net | $5,014 | $6,897 | $10,264 | $11,002 | | General and administrative expenses | $2,419 | $2,828 | $4,925 | $5,508 | | Operating loss | $7,433 | $9,725 | $15,189 | $16,510 | | Net loss (income) | $6,037 | $(4,471) | $13,696 | $12,856 | | Basic loss (earnings) per share | $0.19 | $(0.14) | $0.50 | $1.95 | Condensed Consolidated Statements of Cash Flows (USD in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,821) | $(22,593) | | Net cash provided by investing activities | $109 | $717 | | Net cash provided by financing activities | $11,884 | $38,772 | | **Net (decrease) increase in cash** | **$(2,828)** | **$16,896** | - The company has incurred significant losses, with an accumulated deficit of **$194.4 million** as of June 30, 2025, raising substantial doubt about its ability to continue as a going concern[51](index=51&type=chunk) - On March 6, 2024, BiomX acquired Adaptive Phage Therapeutics (APT), expanding its pipeline with two Phase 2 assets[45](index=45&type=chunk)[52](index=52&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, detailing business strategy, operational results, liquidity, and financial outlook, including a going concern warning [Business Overview and Clinical Developments](index=32&type=section&id=Business%20Overview%20and%20Clinical%20Developments) BiomX is a clinical-stage company developing phage therapies for chronic diseases, primarily focusing on cystic fibrosis (BX004) and diabetic foot osteomyelitis (BX211), and has discontinued its atopic dermatitis program - The company's primary focus is on developing phage therapies for chronic diseases, specifically cystic fibrosis (CF) with product candidate **BX004** and diabetic foot osteomyelitis (DFO) with **BX211**[126](index=126&type=chunk) - A Phase 2b study for **BX004** in CF patients was initiated, with the first patient dosed on July 14, 2025, and topline results expected in the **first quarter of 2026**[138](index=138&type=chunk) - The Phase 2 trial for **BX211** in DFO patients showed positive results, with statistically significant improvement in ulcer size reduction (**p=0.046 at week 12**), and the company is planning a potential registrational study[142](index=142&type=chunk)[144](index=144&type=chunk)[147](index=147&type=chunk) - The development of **BX005** for atopic dermatitis was discontinued in 2024 to focus resources on the CF and DFO programs[150](index=150&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This subsection compares the company's operating results for the three and six-month periods ended June 30, 2025, and 2024, highlighting decreased R&D and G&A expenses and a net loss in Q2 2025 Comparison of Operating Results (USD in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | R&D expenses, net | $5,014 | $6,897 | $10,264 | $11,002 | | G&A expenses | $2,419 | $2,828 | $4,925 | $5,508 | | Operating loss | $7,433 | $9,725 | $15,189 | $16,510 | | Net loss (income) | $6,037 | $(4,471) | $13,696 | $12,856 | - R&D expenses for Q2 2025 decreased by **$1.9 million (28%)** year-over-year, primarily due to workforce reduction and lower rent expenses, partially offset by costs for the new Phase 2b CF trial[152](index=152&type=chunk)[159](index=159&type=chunk) - G&A expenses for Q2 2025 decreased by **$0.4 million (14%)** year-over-year, driven by a reduction in legal and professional service fees[153](index=153&type=chunk) - For the six months ended June 30, 2025, R&D expenses decreased by **$0.7 million (6%)** and G&A expenses decreased by **$0.6 million (11%)** compared to the same period in 2024[160](index=160&type=chunk)[161](index=161&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $15.2 million in cash, expected to fund operations into Q1 2026, but faces substantial doubt about its going concern ability due to recurring losses and future funding needs - The company's cash, cash equivalents, and restricted cash of **$15.2 million** as of June 30, 2025, are expected to fund operations into the **first quarter of 2026**[169](index=169&type=chunk)[184](index=184&type=chunk) - Management has expressed substantial doubt about the company's ability to continue as a going concern and is exploring additional financing options, including equity or debt financing, grants, and collaborations[169](index=169&type=chunk)[185](index=185&type=chunk) - Net cash used in operating activities was **$14.8 million** for the first six months of 2025, a decrease from **$22.6 million** in the same period of 2024[170](index=170&type=chunk)[171](index=171&type=chunk) - The company raised gross proceeds of approximately **$50 million** from the March 2024 PIPE and a total of **$12.0 million** from the February 2025 SPA and concurrent warrant exercise[180](index=180&type=chunk)[181](index=181&type=chunk)[183](index=183&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, BiomX is exempt from providing disclosures regarding market risk under this item - As a smaller reporting company, BiomX is not required to make disclosures under Item 3 regarding market risk[186](index=186&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of the end of the reporting period, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective[188](index=188&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[189](index=189&type=chunk) Part II. Other Information [Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and XBRL data files - This section provides a list of all exhibits filed as part of the quarterly report, including officer certifications and Inline XBRL documents[191](index=191&type=chunk) Part III. Signatures [Signatures](index=46&type=section&id=Signatures) The report is duly signed and authorized by the company's Chief Executive Officer and Chief Financial Officer as of August 13, 2025 - The Form 10-Q report was signed on August 13, 2025, by Jonathan Solomon, Chief Executive Officer, and Marina Wolfson, Chief Financial Officer[197](index=197&type=chunk)[198](index=198&type=chunk)

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]