BiomX(PHGE) - 2025 Q2 - Quarterly Results

Executive Summary Overall Highlights 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][3] - 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][3] - The Phase 2b trial of BX004 in Cystic Fibrosis (CF) has successfully commenced patient dosing, with topline results expected in Q1 2026[1][3] - 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] Clinical Program Updates BX211 Program Update 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][12] - 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][12] - 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][12] - The Company is in continued discussions with the U.S. Defense Health Agency regarding next steps for the BX211 program[6] BX004 Program Update 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] - Topline results from the Phase 2b study are expected in the first quarter of 2026[6] - 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] - 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] Second Quarter 2025 Financial Results Cash Position 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] - BiomX estimates its cash, cash equivalents and restricted cash are sufficient to fund its operations into the first quarter of 2026[7] Operating Expenses 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] - 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] Net Loss and Cash Flow 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] - 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] Company Information & Forward-Looking Statements Conference Call and Webcast Details 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] - Links for registration and webcast replay were provided[12] About BX211 (Program Overview) 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] - 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] About BX004 (Program Overview) 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] - 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] - BX004 has received FDA Fast Track and Orphan Drug Designations[13] About BiomX (Company Overview) 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] - 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] Safe Harbor Statement 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] - 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] Financial Statements Condensed Consolidated Balance Sheets 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 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 |