BiomX(US:PHGE)2024-04-03 16:26Financial Data and Key Metrics Changes - As of December 31, 2023, cash balance and short-term deposits were $15.9 million, down from $34.3 million as of December 31, 2022, primarily due to net cash used in operating activities [30] - R&D expenses net for 2023 were $16.7 million, compared to $16.2 million in the previous year, mainly due to increased expenses related to the CF clinical trial [31] - Net loss for 2023 was $26.2 million, compared to $28.3 million for the prior year, with net cash used in operating activities for 2023 at $21.3 million, down from $29.1 million in 2022 [32] Business Line Data and Key Metrics Changes - The acquisition of APT added a second Phase 2 product candidate, BX211, for the treatment of diabetic foot osteomyelitis, enhancing the company's pipeline [22] - BX004 has demonstrated safety and proof-of-concept efficacy in the Phase 1b/2a study, with data readouts expected in 2025 for both BX004 and BX211 [35] Market Data and Key Metrics Changes - The estimated commercial opportunity for BX211 in the U.S. is $1 billion and over $2 billion worldwide, targeting Staphylococcus aureus infections, which compromise approximately 50% of diabetic foot osteomyelitis cases [9] Company Strategy and Development Direction - The company is focused on advancing its clinical programs, particularly BX004 and BX211, with significant milestones expected in the coming years [40] - The company plans to hold a Type C meeting with the FDA in the second quarter of 2024 to discuss the clinical development plan for BX004 [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2024 being a substantial year for the company, with the completion of the APT acquisition and a $50 million investment from institutional investors [40] - There is a recognition of the high unmet need in diabetic foot osteomyelitis, with approximately 160,000 lower limb amputations in diabetic patients annually in the U.S. [27] Other Important Information - The company has sufficient cash and equivalents to fund its current operating plan for at least the next 12 months, despite a note of substantial doubt about its ability to continue as a going concern [33] - General and administrative expenses decreased to $8.7 million for 2023 from $9.5 million in the prior year, primarily due to a reduction in directors and officer insurance premiums [37] Q&A Session Summary Question: Update on efficiencies post-merger - Management indicated that the integration process is ongoing, with evaluations of redundancies taking place, and expressed satisfaction with the APT team's work [43] Question: Insights on DFO and amputation rates - Management acknowledged that amputation is a complex endpoint and emphasized a focus on shorter-term outcomes like ulcer shrinkage in the current study [45] Question: Additional data analysis from Phase 2 for BX004 - Management stated that no new guidance is available yet but mentioned plans to present data at top conferences and highlighted the importance of the upcoming FDA meeting [51]