BiomX(PHGE) - 2024 Q1 - Quarterly Results

Report Overview and Business Highlights BiomX acquired Adaptive Phage Therapeutics and secured $50 million in financing, strategically positioning itself as a leader in phage therapy Key Business Developments In a transformative year, BiomX acquired Adaptive Phage Therapeutics (APT) in March 2024, positioning itself as a leader in phage therapy, adding a second Phase 2 asset, BX211, to its pipeline, and securing $50 million in private placement financing to advance its lead programs, BX004 and BX211, through key clinical data readouts expected in 2025 - Acquired Adaptive Phage Therapeutics (APT) in March 2024, creating a leading phage therapy company with two Phase 2 assets: BX004 for Cystic Fibrosis and BX211 for Diabetic Foot Osteomyelitis (DFO)[4] - Closed a concurrent $50 million private placement financing led by investors including Deerfield Management, the AMR Action Fund, the Cystic Fibrosis Foundation, and Orbimed[1][4] - The financing is expected to fund the company through key clinical milestones, including Phase 2b results for BX004 (Q3 2025) and Phase 2 results for BX211 (Q1 2025)[4] - The CEO highlighted 2023 as a year of great progress, emphasizing the positive Phase 1b/2a results for BX004 in treating chronic P. aeruginosa infections in Cystic Fibrosis patients[3] Clinical Program Updates BiomX provides clinical updates on its pipeline, highlighting progress for BX004 and BX211, and the strategic reprioritization of BX005 Cystic Fibrosis (BX004) The BX004 program for Cystic Fibrosis (CF) achieved significant milestones, including receiving Orphan Drug Designation from the FDA in January 2024, with positive topline results from the Phase 1b/2a trial demonstrating that BX004 was safe and well-tolerated, showing 14.3% of patients in the treatment arm converted to sputum culture negative for P. aeruginosa, compared to 0% in the placebo arm, and a subgroup with reduced lung function showed clinical improvement - BX004 was granted Orphan Drug Designation by the FDA for treating chronic pulmonary infections caused by P. aeruginosa in CF patients[7] - The Phase 1b/2a trial showed the drug was safe and well-tolerated, with no related serious adverse events[7] - Efficacy data showed 14.3% (3 out of 21) of patients in the BX004 arm converted to sputum culture negative for P. aeruginosa, versus 0% (0 out of 10) in the placebo arm[7] - In a predefined subgroup with reduced baseline lung function (FEV1<70%), the BX004 group showed a relative FEV1 improvement of 5.67% compared to placebo[7] - No evidence of treatment-related phage resistance was observed in patients treated with BX004[7] Diabetic Foot Osteomyelitis (BX211) BX211, a personalized phage therapy for Diabetic Foot Osteomyelitis (DFO) associated with S. aureus, was added to the pipeline through the acquisition of APT, with a Phase 2 randomized, double-blind, placebo-controlled trial currently underway, having enrolled 32 of the targeted 45 patients, and initial topline results anticipated in the first quarter of 2025 - BX211 is a personalized phage treatment acquired from APT for DFO associated with S. aureus[8] - A Phase 2 clinical trial is actively enrolling, with 32 out of a target of 45 patients enrolled to date[8] - Initial top-line results from the Phase 2 trial are expected in the first quarter of 2025[1][8] Atopic Dermatitis (BX005) The company has paused development efforts for its Atopic Dermatitis candidate, BX005, to prioritize resources towards the more advanced clinical programs for Cystic Fibrosis (BX004) and Diabetic Foot Osteomyelitis (BX211) - Development of BX005 has been paused to prioritize resources for the CF and DFO programs[9] Detailed Clinical Program Information Detailed clinical program information outlines development plans for BX004's Phase 2b trial and BX211's personalized approach with key readouts About BX004 BX004 is a fixed multi-phage cocktail designed to treat chronic pulmonary infections from P. aeruginosa in CF patients, with a pivotal Phase 2b trial set to begin in Q4 2024, enrolling approximately 60 patients, and the 8-week study assessing safety, reduction in bacterial load, and clinical outcomes like FEV1, with results expected in Q3 2025, and the candidate holding both Fast Track and Orphan Drug designations from the FDA - A randomized, double-blind, placebo-controlled Phase 2b trial is planned to initiate in Q4 2024[16] - The trial will enroll approximately 60 patients randomized 2:1 (BX004 vs. placebo) with an 8-week treatment duration[16] - Primary endpoints will assess safety, tolerability, microbiological reduction of P. aeruginosa, and clinical effects on lung function (FEV1), with trial results expected in Q3 2025[16] About BX211 BX211 is a personalized phage therapy for DFO, tailoring treatment by selecting specific phages against the S. aureus strain isolated from each patient, with the ongoing Phase 2 trial enrolling ~45 subjects who will receive weekly treatment for 12 weeks alongside standard care, and two key readouts: the first in Q1 2025 for wound healing, and a second in Q1 2026 evaluating long-term outcomes like amputation rates and resolution of osteomyelitis - BX211 is a personalized phage treatment where a specific phage is selected from a proprietary bank to match the patient's S. aureus strain[17] - The ongoing Phase 2 trial will administer BX211 or placebo weekly for 12 weeks, with all subjects also receiving standard of care, including antibiotics[19] - The trial has two primary readout points: Week 13 results on wound healing (expected Q1 2025) and Week 52 results on amputation rates and resolution of osteomyelitis (expected Q1 2026)[19] Financial Results BiomX's 2023 financial results show a reduced net loss and significant post-year-end financing, alongside a 'going concern' warning Full Year 2023 Financial Performance BiomX reported a cash balance of $15.9 million at the end of 2023, a decrease from $34.3 million at the end of 2022, primarily due to operating activities, with the company's net loss for 2023 at $26.2 million, an improvement from the $28.3 million loss in 2022, and subsequent to year-end, the company raised $50 million and repaid a $10.4 million loan, though financial statements include a 'going concern' warning related to potential stockholder approval risks for convertible preferred stock Financial Metric Summary | Financial Metric | 2023 (USD in millions) | 2022 (USD in millions) | | :--- | :--- | :--- | | Cash, short-term deposits & restricted cash | 15.9 | 34.3 | | R&D Expenses, net | 16.7 | 16.2 | | G&A Expenses | 8.7 | 9.5 | | Net Loss | 26.2 | 28.3 | | Net Cash Used in Operating Activities | 21.3 | 29.1 | - Post-year-end, the company closed a $50 million financing and fully repaid a $10.4 million loan balance with Hercules Capital[12] - Financial statements contain a 'going concern' warning due to the risk that stockholders may not approve the conversion of preferred stock issued in the APT acquisition and financing[12] Consolidated Balance Sheets The consolidated balance sheet shows total assets of $25.0 million and total liabilities of $21.9 million as of December 31, 2023, resulting in total stockholders' equity of $3.1 million, compared to total assets of $45.5 million and stockholders' equity of $21.0 million at the end of 2022 BIOMX INC. CONSOLIDATED BALANCE SHEETS | (USD in thousands) | As of Dec 31, 2023 | As of Dec 31, 2022 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | 14,907 | 31,332 | | Total current assets | 17,632 | 36,881 | | Total non-current assets | 7,397 | 8,650 | | Total Assets | 25,029 | 45,531 | | LIABILITIES & EQUITY | | | | Total current liabilities | 11,176 | 7,939 | | Total non-current liabilities | 10,772 | 16,553 | | Total Liabilities | 21,948 | 24,492 | | Total Stockholders' equity | 3,081 | 21,039 | | Total Liabilities and Equity | 25,029 | 45,531 | Consolidated Statements of Operations For the year ended December 31, 2023, the company reported an operating loss of $25.3 million and a net loss of $26.2 million, or $0.51 per share, representing a decrease in net loss compared to the $28.3 million, or $0.95 per share, reported for the full year 2022 BIOMX INC. CONSOLIDATED STATEMENTS OF OPERATIONS | (USD in thousands, except per share data) | Year ended Dec 31, 2023 | Year ended Dec 31, 2022 | | :--- | :--- | :--- | | R&D expenses, net | 16,698 | 16,244 | | General and administrative expenses | 8,650 | 9,456 | | Operating loss | 25,348 | 27,219 | | Net Loss | 26,169 | 28,317 | | Basic and diluted loss per share | 0.51 | 0.95 |