BiomX(US:PHGE)2023-08-09 13:59Financial Data and Key Metrics Changes - As of June 30, 2023, cash balance and short-term deposits were $30.7 million, down from $34.3 million as of December 31, 2022, primarily due to cash used in operating activities, partially offset by proceeds from PIPE financing [20] - Research and development expenses net were $3.8 million for Q2 2023, compared to $4.6 million for the same period in 2022, attributed to a reduction in workforce and deprioritization of certain activities [21] - Net loss for Q2 2023 was $6.4 million, an improvement from $7.5 million in Q2 2022 [23] - Net cash used in operating activities was $9.1 million for the first half of 2023, compared to $16.4 million for the same period in 2022 [23] Business Line Data and Key Metrics Changes - The BX004 program continues to show promise, with positive feedback from the cystic fibrosis (CF) community regarding its potential to treat life-threatening infections [5][8] - Patient screening for Part 2 of the Phase Ib/IIa study has been completed, with enrollment exceeding original estimates, indicating strong execution by the clinical operations team [14] Market Data and Key Metrics Changes - BX004 has received Fast Track designation from the FDA, recognizing its potential to address significant unmet medical needs in the CF community [15] - The company anticipates holding a meeting with the FDA to plan the next stage of BX004's clinical development, assuming positive results from the ongoing study [3] Company Strategy and Development Direction - The company aims to leverage the Fast Track designation to expedite the drug development process, including potential rolling submission and priority review for the Biologics License Application [16][17] - The focus remains on addressing the unmet medical needs of CF patients, particularly in treating Chronic Pseudomonas aeruginosa infections [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of the BX004 program and the positive reception from stakeholders in the CF community [5][14] - The company is preparing for discussions with regulatory authorities regarding future studies, contingent on the outcomes of Part 2 of the trial [34] Other Important Information - The company completed a $7.5 million private placement in May 2023 to support the BX004 program and other R&D activities [4] - The management highlighted the importance of gathering more data from the ongoing study to better prepare for future discussions with the FDA [36] Q&A Session Summary Question: What are the logistics around the delay in Part 2 data? - Management indicated that the delay is due to exceeding enrollment expectations and operational issues, but no endpoints have changed [32] Question: What is the wish list for upcoming discussions with regulatory authorities? - Management mentioned pursuing orphan breakthrough and accelerated approval, contingent on positive data from the ongoing studies [42] Question: How much data has been reviewed along the way for Part 2? - Management confirmed that they are blinded to the data and have not seen any results yet, but noted increased patient referrals and screening success [36] Question: Will there be a need for 6-month data before the end of Phase II meeting with the FDA? - Management indicated that they feel comfortable proceeding without needing 6-month data, given the FDA's acknowledgment of the safety of the modality [37]