BiomX(PHGE) - 2025 Q1 - Quarterly Report

Part I. Financial Information Financial Statements Presents BiomX Inc.'s unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, statements of operations, equity, and cash flows Condensed Consolidated Balance Sheets (unaudited) | (USD in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total current assets | 23,533 | 20,520 | | Total assets | 45,654 | 43,233 | | Total current liabilities | 7,021 | 8,267 | | Total liabilities | 21,155 | 19,085 | | Total stockholders' equity | 24,499 | 24,148 | Condensed Consolidated Statements of Operations (unaudited) | (USD in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development ("R&D") expenses, net | 5,250 | 4,105 | | General and administrative expenses | 2,506 | 2,680 | | Operating loss | 7,756 | 6,785 | | Loss (income) from change in fair value of warrants | (914) | 8,010 | | Net loss | 7,659 | 17,327 | | Basic and diluted loss per share | 0.33 | 2.78 | Condensed Consolidated Statements of Cash Flows (unaudited) | (USD in thousands) | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | (8,712) | (11,356) | | Net cash provided by investing activities | 51 | 663 | | Net cash provided by financing activities | 11,913 | 38,975 | | Increase in cash and cash equivalents | 3,252 | 28,282 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Q1 2025 financial condition and operations, covering business, clinical developments, results, liquidity, and going concern Business Overview BiomX develops phage therapies for chronic diseases like CF and DFO, utilizing fixed cocktail and personalized approaches, and acquired APT in March 2024 - The company develops phage therapies to kill specific harmful bacteria associated with chronic diseases like cystic fibrosis (CF) and diabetic foot osteomyelitis (DFO)[133] - BiomX employs two main product types: fixed cocktail therapy using its proprietary BOLT platform and personalized therapy matching optimal phage to specific patients[134][136] - On March 15, 2024, BiomX acquired Adaptive Phage Therapeutics (APT), a stock-for-stock transaction that made APT a wholly-owned subsidiary and added two Phase 2 assets to BiomX's pipeline[137][51] Clinical and Pre-Clinical Developments BiomX advances BX004 (CF) to Phase 2b, plans BX211 (DFO) Phase 2/3 after positive Phase 2 results, and discontinued BX005 (Atopic Dermatitis) - BX004 (Cystic Fibrosis): A Phase 2b study is expected to start in Q2 2025. Results are now anticipated in Q1 2026 due to manufacturing delays. The FDA has granted this program Fast Track and orphan drug designations[143][144] - BX211 (Diabetic Foot Osteomyelitis): Positive Phase 2 trial results announced in March 2025 showed the treatment was safe and produced a sustained and statistically significant percent area reduction (PAR) of the ulcer. A Phase 2/3 trial is being planned, pending FDA feedback and funding[148][150][153] - Discontinued Program: The development of BX005 for Atopic Dermatitis was discontinued in 2024 to focus resources on the more advanced CF and DFO programs[156] Results of Operations Q1 2025 net loss significantly improved to $7.7 million due to warrant fair value changes and reduced interest expense, despite increased R&D Comparison of Consolidated Results of Operations (unaudited) | (USD in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | R&D expenses, net | 5,250 | 4,105 | | General and administrative expenses | 2,506 | 2,680 | | Operating loss | 7,756 | 6,785 | | Net loss | 7,659 | 17,327 | | Basic and diluted loss per share | $0.33 | $2.78 | - R&D expenses increased by $1.1 million (27%) YoY, driven by preparations for the Phase 2b trial of BX004 (CF) and increased expenses for the DFO trial[158][165] - Interest expenses fell 99% to just $5,000 from $850,000 in Q1 2024, following the full repayment of the Hercules loan in March 2024[161] - A significant swing from an $8.0 million loss to a $0.9 million income from the change in fair value of warrants was a primary driver of the reduced net loss in Q1 2025[162] Liquidity and Capital Resources BiomX holds $21.2 million cash, sufficient until Q1 2026, but faces going concern doubts, with Q1 2025 financing raising $11.9 million - The company's cash, cash equivalents, and restricted cash of $21.2 million as of March 31, 2025, are projected to be sufficient to fund operations into the first quarter of 2026[181] - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern, citing the need for additional funds to support operating expenses[166][50] - In Q1 2025, net cash provided by financing activities was $11.9 million, mainly from the February 2025 SPA and related warrant exercises, which raised gross proceeds of $5.5 million and $6.5 million, respectively[173][178][179] - In Q1 2024, net cash from financing was $39.0 million, driven by a $50 million PIPE financing, partially offset by a $10.7 million repayment of long-term debt[174] Quantitative and Qualitative Disclosures About Market Risk BiomX is exempt from market risk disclosures as a smaller reporting company - The company is exempt from this disclosure requirement because it qualifies as a smaller reporting company[183] Controls and Procedures Management confirmed effective disclosure controls and no material changes to internal controls as of March 31, 2025 - 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[185] - There were no changes in the company's internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, these controls[186] Part II. Other Information Exhibits Lists exhibits filed with the Form 10-Q, including corporate governance documents, officer certifications, and XBRL data - The report includes a list of filed exhibits, such as corporate governance documents (Certificate of Incorporation, Bylaws), CEO/CFO certifications pursuant to SEC rules, and Inline XBRL documents[188] Signatures Signatures The report concludes with formal signatures by the CEO and CFO on May 15, 2025 - The report was duly signed and authorized on May 15, 2025, by Jonathan Solomon (Chief Executive Officer) and Marina Wolfson (Chief Financial Officer)[192][194]