BiomX(US:PHGE)2025-11-12 21:04Acquisition and Partnerships - BiomX completed the acquisition of Adaptive Phage Therapeutics (APT) on March 15, 2024, exchanging 916,497 shares of common stock and 40,470 shares of Series X Preferred Stock[128]. - BiomX is supporting an NIH study targeting Pseudomonas aeruginosa infections in CF patients under FDA emergency Investigational New Drug allowance[145]. Product Development and Trials - BX004, a therapeutic phage product candidate for chronic pulmonary infections caused by Pseudomonas aeruginosa, showed a 2.7 log₁₀ CFU/g treatment effect compared to placebo in a Phase 1b/2a trial[133]. - In Part 2 of the Phase 1b/2a trial for BX004, 23 CF patients received treatment, with no safety events related to the drug reported[134]. - The FDA granted BX004 Fast Track designation for treating chronic respiratory infections in CF patients in August 2023[135]. - BiomX initiated a Phase 2b study for BX004 in CF patients, with the first patient dosed on July 14, 2025, aiming to enroll up to 60 patients[136]. - The FDA placed a clinical hold on the Phase 2b study in October 2025, focusing on the third-party nebulizer device used for BX004 delivery[137]. - BX211 demonstrated a statistically significant percent area reduction (PAR) of ulcer size in a DFO trial, with p = 0.046 at week 12[146]. - BX211 was found safe and well-tolerated, with significant improvements in ulcer depth and area compared to placebo[146]. - BX011 is prioritized for development in diabetic foot infections (DFI) before expanding to diabetic foot osteomyelitis (DFO), pending financial resources[143]. Financial Performance - R&D expenses for Q3 2025 were $6.1 million, a decrease of 16% from $7.3 million in Q3 2024[151]. - General and administrative expenses for Q3 2025 were $2.4 million, down 25% from $3.2 million in Q3 2024[152]. - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024[150]. - Basic and diluted loss per share for Q3 2025 was $0.29, compared to earnings of $0.31 per share in Q3 2024[157]. - For the nine months ended September 30, 2025, R&D expenses were $16.4 million, a decrease of 10% from $18.3 million in the same period in 2024[159]. - General and administrative expenses for the nine months ended September 30, 2025 were $7.3 million, down 17% from $8.8 million in the same period in 2024[160]. - The net loss for the nine months ended September 30, 2025 was $22.9 million, compared to a net loss of $3.2 million in the same period in 2024[159]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $22.0 million, a decrease from $30.7 million in the same period in 2024[169]. - The company recorded a loss from the change in fair value of warrants of $1.7 million for the nine months ended September 30, 2025, compared to a loss of $24.4 million in the same period in 2024[164]. - The company believes its cash and cash equivalents will be sufficient to meet working capital needs into Q1 2026, but requires additional funds for operating expenses and capital requirements[168]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $30.7 million, primarily driven by R&D and general administrative expenses[171]. - Net cash provided by investing activities during the nine months ended September 30, 2024 was $0.7 million, mainly from cash and restricted cash acquired from the Acquisition[172]. - Net cash provided by financing activities during the nine months ended September 30, 2024 was $39.0 million, primarily from the issuance of Redeemable Convertible Preferred Shares and Private Placement Warrants[176]. - As of September 30, 2025, liquidity resources consisted of approximately $8.1 million in cash, cash equivalents, and restricted cash, expected to fund operations into Q1 2026[183]. - The company has accumulated a deficit of $203.6 million since inception and does not expect to generate significant revenues from product sales in the next twelve months[183]. - The company plans to fund operations and development activities through future public or private equity issuances, debt securities, and possibly additional grants[184]. - As of September 30, 2024, the company had outstanding foreign exchange contracts for the exchange of USD to NIS amounting to approximately $3.4 million[174]. - The company raised approximately $50 million from a private investment in public equity (PIPE) in March 2024, resulting in the issuance of Redeemable Convertible Preferred Shares and warrants[180]. - The gross proceeds from the February 2025 Securities Purchase Agreement were $5.5 million, before deducting fees and expenses[181]. - The company expects to continue incurring additional losses in the foreseeable future due to ongoing R&D activities[184].