Acquisition and Stock Transactions - The acquisition of Adaptive Phage Therapeutics LLC (APT) was completed on March 15, 2024, with BiomX issuing 9,164,968 shares of common stock and 40,470 shares of Series X Preferred Stock as part of the stock-for-stock transaction [140]. - BiomX's stockholders prior to the acquisition owned approximately 55% of the share capital, while APT's stockholders owned approximately 45% [142]. - On March 15, 2024, the company raised approximately $50 million through a PIPE transaction, involving the issuance of 216,417 Redeemable Convertible Preferred Shares and Private Placement Warrants [193]. Research and Development - The Phase 1b/2a trial for BX004 in cystic fibrosis patients showed a reduction of -1.42 log in Pseudomonas aeruginosa colony-forming units compared to -0.28 log in the placebo group at Day 15 [148]. - In Part 2 of the Phase 1b/2a trial, 14.3% of patients treated with BX004 converted to sputum culture negative for P. aeruginosa after 10 days, compared to 0% in the placebo group [153]. - BX004 received Fast Track designation from the FDA in August 2023 and orphan drug designation in December 2023 [155]. - BiomX plans to initiate a Phase 2b study for BX004 in cystic fibrosis patients in Q4 2024, enrolling approximately 60 patients and monitoring safety and microbiological reduction [156]. - The ongoing Phase 2 trial for BX211 in diabetic foot osteomyelitis has completed enrollment, with topline results expected at week 13 and further evaluations at week 52 [158]. - Development of BX005 for atopic dermatitis was discontinued in 2024 to focus resources on cystic fibrosis and diabetic foot osteomyelitis programs [162]. - The company has paused development of its personalized phage therapy for prosthetic joint infections to prioritize cystic fibrosis and diabetic foot osteomyelitis programs [160]. - The company plans to continue focusing on the development of product candidates BX004 and BX211, while exploring additional funding options to support operations [182]. Financial Performance - R&D expenses for Q3 2024 were $7.3 million, a 30% increase from $5.6 million in Q3 2023, primarily due to clinical trial preparations and increased rent expenses following the APT Acquisition [165]. - General and administrative expenses rose to $3.2 million in Q3 2024, up 45% from $2.2 million in Q3 2023, mainly due to the consolidation of expenses after the Acquisition [167]. - Goodwill impairment of $0.8 million was recorded in Q3 2024, resulting from the Acquisition and a decline in market capitalization [168]. - Operating loss for Q3 2024 was $11.3 million, compared to $7.8 million in Q3 2023, reflecting increased expenses [165]. - Net loss for Q3 2024 was $9.6 million, compared to a net income of $7.9 million in Q3 2023, with basic and diluted loss per share at $(0.31) compared to $1.30 in the prior year [172]. - For the nine months ended September 30, 2024, R&D expenses totaled $18.3 million, a 31% increase from $14.0 million in the same period in 2023 [174]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $30.7 million, compared to $15.0 million in the same period in 2023 [183]. - The company recorded $2.2 million in other income for the nine months ended September 30, 2024, a 633% increase from $0.3 million in the same period in 2023 [177]. - As of September 30, 2024, the company had liquidity resources of approximately $24.7 million, expected to fund operations into Q4 2025 [195]. - The company has accumulated a deficit of $166.2 million since inception and does not expect to generate significant revenues from product sales in the next twelve months [195]. - The company plans to fund future operations and development activities through public or private equity issuances, debt securities, loans, and possibly additional grants [196]. - For the nine months ended September 30, 2024, net cash provided by financing activities was $39.0 million, primarily from the issuance of Redeemable Convertible Preferred Shares and Private Placement Warrants totaling $49.5 million, offset by a long-term debt prepayment of $10.7 million [189]. - During the same period in 2023, net cash provided by financing activities was $4.2 million, mainly from the issuance of Common Stock of $7.2 million, offset by long-term debt repayment of $2.9 million [190]. - The company prepaid $10.4 million of the Hercules Loan on March 19, 2024, which included an end-of-term charge of $983,000 and accrued interest of $69,000 [191]. - As of September 30, 2024, all Pre-Funded Warrants have been exercised, resulting in the issuance of 1,458,638 shares of Common Stock [194]. Market and Operational Risks - The company has not experienced disruptions to its business operations due to the ongoing conflict in Israel, but the situation remains unpredictable [206]. - Political instability in Israel may adversely affect the company's operations and financial condition [209].
BiomX(PHGE) - 2024 Q3 - Quarterly Report