Presentation to Focus on Positive Topline Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO)NESS ZIONA, Israel, Sept. 04, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE), a clinical-stage company advancing natural and engineered phage therapies targeting specific pathogenic bacteria, today announced that Jonathan Solomon, the Company’s Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference taking place o ...

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]

Executive Summary [Overall Highlights](index=1&type=section&id=Overall%20Highlights) BiomX reported significant clinical progress for BX211 and BX004 and anticipates multiple value-driving catalysts - Positive Phase 2 results for BX211 demonstrated **over 40% wound size reduction** versus placebo in diabetic foot osteomyelitis patients, with planning underway for a potential registrational study[1](index=1&type=chunk)[3](index=3&type=chunk) - New Phase 1b/2a data for BX004 showed **approximately 500-fold (2.7 log₁₀) bacterial reduction** versus placebo with no detectable emergence of resistance[1](index=1&type=chunk)[3](index=3&type=chunk) - The Phase 2b trial of BX004 in Cystic Fibrosis (CF) has successfully commenced patient dosing, with topline results expected in **Q1 2026**[1](index=1&type=chunk)[3](index=3&type=chunk) - BiomX is positioned for multiple value-driving catalysts over the next 12 months, including FDA feedback on BX004's real-world evidence strategy and planning for a potential registrational BX211 study[3](index=3&type=chunk) Clinical Program Updates [BX211 Program Update](index=1&type=section&id=BX211%20Program%20Update) Positive Phase 2 results for BX211 in diabetic foot infections showed significant improvements in wound healing - BX211 demonstrated a sustained and statistically significant percentage area reduction (PAR) of ulcer size with a difference **greater than 40%** by week 10 (p = 0.046 at week 12)[4](index=4&type=chunk)[12](index=12&type=chunk) - The Phase 2 trial also showed statistically significant improvements in ulcer depth (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo[6](index=6&type=chunk)[12](index=12&type=chunk) - Planning for a potential registrational study of BX211 is underway, pending feedback from the U.S. Food and Drug Administration (FDA) and availability of cash resources[6](index=6&type=chunk)[12](index=12&type=chunk) - The Company is in continued discussions with the U.S. Defense Health Agency regarding next steps for the BX211 program[6](index=6&type=chunk) [BX004 Program Update](index=2&type=section&id=BX004%20Program%20Update) Patient dosing has begun in the Phase 2b trial for BX004 in Cystic Fibrosis, with results expected in Q1 2026 - In July 2025, BiomX successfully initiated dosing of patients in its Phase 2b trial of BX004, a randomized, double-blind, placebo-controlled, multicenter study in approximately 60 CF patients[6](index=6&type=chunk) - Topline results from the Phase 2b study are expected in the **first quarter of 2026**[6](index=6&type=chunk) - BiomX expects to receive feedback from the FDA in the **second half of 2025** regarding the potential investigation and use of real-world evidence linking bacterial reduction to clinical outcomes[6](index=6&type=chunk) - New findings from the Phase 1b/2a trial showed BX004 achieved **approximately 500-fold (2.7 log₁₀) greater bacterial reduction** compared with placebo, with no bacterial resistance detected[6](index=6&type=chunk) Second Quarter 2025 Financial Results [Cash Position](index=3&type=section&id=Cash%20Position) Cash and restricted cash decreased to $15.2 million, sufficient to fund operations into Q1 2026 Cash and Restricted Cash | Metric | June 30, 2025 (USD in millions) | December 31, 2024 (USD in millions) | | :--- | :--- | :--- | | Cash and restricted cash | 15.2 | 18.0 | - The decrease in cash was primarily due to net cash used in operating activities[7](index=7&type=chunk) - BiomX estimates its cash, cash equivalents and restricted cash are sufficient to fund its operations into the **first quarter of 2026**[7](index=7&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Operating expenses decreased year-over-year due to workforce reductions and lower professional fees Operating Expenses (Q2 2025 vs. Q2 2024) | Expense Category | Q2 2025 (USD in thousands) | Q2 2024 (USD in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | Research and development | 5,014 | 6,897 | -27.3% | | General and administrative | 2,419 | 2,828 | -14.4% | - The decrease in R&D expenses was primarily driven by reduced salary expenses from workforce reductions, lower rent expenses, and increased grant funding, partially offset by higher expenses from initiating the Phase 2b clinical trial of BX004[8](index=8&type=chunk) - The decrease in G&A expenses was primarily attributed to a reduction in legal and other professional service fees, partially offset by increased share-based compensation expenses[9](index=9&type=chunk) [Net Loss and Cash Flow](index=3&type=section&id=Net%20Loss%20and%20Cash%20Flow) The company reported a net loss of $6.0 million for Q2 2025, with a year-over-year decrease in cash used for operations Net Loss and Operating Cash Flow | Metric | Q2 2025 (USD in thousands) | Q2 2024 (USD in thousands) | 6 Months 2025 (USD in thousands) | 6 Months 2024 (USD in thousands) | | :--- | :--- | :--- | :--- | :--- | | Net loss (income) | 6,037 | (4,471) | 13,696 | 12,856 | | Net cash used in operating activities | N/A | N/A | 14,800 | 22,600 | - The net loss for Q2 2025 was mainly due to the change in the fair value of warrants issued as part of the Company's March 2024 financing[10](index=10&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2025, **decreased to $14.8 million** from $22.6 million for the same period in 2024[10](index=10&type=chunk) Company Information & Forward-Looking Statements [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) BiomX hosted a conference call to discuss its Q2 2025 financial results and provide a corporate update - A conference call and webcast were held on August 13, 2025, at 8 AM ET[11](index=11&type=chunk) - Links for registration and webcast replay were provided[12](index=12&type=chunk) [About BX211 (Program Overview)](index=3&type=section&id=About%20BX211%20(Program%20Overview)) BX211 is a phage treatment targeting S. aureus in diabetic foot osteomyelitis, a leading cause of amputation - BX211 is a phage treatment for DFO associated with S. aureus, a bacterial infection of the bone that often leads to amputation in diabetic patients[12](index=12&type=chunk) - Positive Phase 2 results showed BX211 was safe and well-tolerated, producing statistically significant and sustained reduction of ulcer size (PAR) and improvements in ulcer depth[12](index=12&type=chunk) [About BX004 (Program Overview)](index=4&type=section&id=About%20BX004%20(Program%20Overview)) BX004 is a multi-phage cocktail for treating chronic P. aeruginosa infections in Cystic Fibrosis patients - BX004 is a fixed multi-phage cocktail for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a major contributor to morbidity and mortality[13](index=13&type=chunk) - Positive results from Phase 1b/2a studies demonstrated safety, tolerability, microbiologic activity, and improvement in pulmonary function associated with a reduction in P. aeruginosa burden in a predefined subgroup[13](index=13&type=chunk) - BX004 has received **FDA Fast Track and Orphan Drug Designations**[13](index=13&type=chunk) [About BiomX (Company Overview)](index=4&type=section&id=About%20BiomX%20(Company%20Overview)) BiomX is a clinical-stage company developing phage treatments to destroy harmful bacteria in chronic diseases - BiomX is a clinical-stage company developing natural and engineered phage cocktails and personalized phage treatments[14](index=14&type=chunk) - The company aims to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs, using its BOLT ("BacteriOphage Lead to Treatment") platform[14](index=14&type=chunk) [Safe Harbor Statement](index=4&type=section&id=Safe%20Harbor%20Statement) This section disclaims forward-looking statements, highlighting inherent risks and uncertainties - The press release contains forward-looking statements subject to inherent uncertainties, risks, and changes in circumstances, including adverse results in clinical development, regulatory decisions, and the sufficiency of cash resources[15](index=15&type=chunk) - Investors should not rely on these statements and are advised to review risks and uncertainties detailed in BiomX's SEC filings, particularly the Annual Report on Form 10-K[15](index=15&type=chunk) Financial Statements [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show the company's financial position as of June 30, 2025, compared to December 31, 2024 Condensed Consolidated Balance Sheets (USD in thousands) | ASSETS / LIABILITIES AND STOCKHOLDERS' EQUITY | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Current assets | 16,635 | 20,520 | | Total non-current assets | 21,415 | 22,713 | | **Total Assets** | **38,050** | **43,233** | | **LIABILITIES** | | | | Current liabilities | 6,262 | 8,267 | | Total non-current liabilities | 12,628 | 10,818 | | **Total Liabilities** | **18,890** | **19,085** | | **STOCKHOLDERS' EQUITY** | | | | Total stockholders' equity | 19,160 | 24,148 | | **Total Liabilities and Stockholders' Equity**| **38,050** | **43,233** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations detail financial performance for the three and six months ended June 30, 2025 Condensed Consolidated Statements of Operations (USD in thousands, except per share data) | 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 | | :--- | :--- | :--- | :--- | :--- | | Research and development ("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 of Common Stock | 0.19 | (0.14) | 0.50 | 1.95 | | Diluted loss per share of Common Stock | 0.19 | 0.69 | 0.50 | 1.95 |

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]

Company Overview - BiomX Inc. is a clinical-stage company focused on developing novel natural and engineered phage therapies targeting specific pathogenic bacteria [4] - The company utilizes its BOLT ("BacteriOphage Lead to Treatment") platform to customize phage compositions against proprietary bacterial targets [4] Upcoming Financial Results - BiomX will report its second quarter 2025 financial results and program updates before the U.S. financial markets open on August 13, 2025 [1] - A conference call and live audio webcast will be held at 8 a.m. ET on the same day to discuss these results [1][2] Conference Call Details - Registration for the conference call is recommended at least 5 minutes prior to the start [2] - The conference call can be accessed via a specific registration link, and a webcast will also be available [3]

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]