BiomX(US:PHGE)2021-05-24 18:09Financial Data and Key Metrics Changes - Cash balance and short-term deposits as of March 31, 2021, were $53.6 million compared to $57.1 million as of December 31, 2020, indicating a decrease [40] - Research and development expenses increased to $5.8 million in Q1 2021 from $3.5 million in the same period of 2020, primarily due to stock-based compensation and increased clinical activities [41] - General and administrative expenses rose to $2.5 million in Q1 2021 from $2.1 million in Q1 2020, attributed to stock-based compensation and increased operational costs [42] - Net loss was $8.4 million in Q1 2021 compared to $5.9 million in Q1 2020, while net cash used in operating activities was $6.4 million for the three months ended March 31, 2021, compared to $6.9 million for the same period in 2020 [43] Business Line Data and Key Metrics Changes - The company is advancing phage cocktail candidates in five indications, with expected clinically meaningful readouts in four different indications within the next 14 months [9] - BX001 in acne-prone skin has completed enrollment of 140 subjects, with results expected in Q3 and Q4 2021 [13] - BX002 in Inflammatory Bowel Disease (IBD) showed positive Phase 1a results, demonstrating safety and high concentrations of viable phage delivered to the gastrointestinal tract [15] Market Data and Key Metrics Changes - The company is focusing on the microbiome space, which is believed to hold significant promise for novel therapies targeting pathogenic bacteria [7] - The BOLT platform allows for rapid generation and screening of phage libraries, enhancing the company's ability to develop diverse treatment options [11] Company Strategy and Development Direction - The company aims to deliver novel phage therapies targeting pathogenic bacteria in patients with unmet medical needs, emphasizing the importance of restoring the microbiome's natural balance [7][8] - The strategy includes advancing multiple clinical trials and leveraging the BOLT platform to optimize phage therapy development [11][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of phage therapy to address chronic conditions while avoiding the pitfalls of antibiotic resistance [48] - The company anticipates meaningful clinical readouts in the next 14 months, which could significantly impact its growth trajectory [36][77] Other Important Information - A virtual KOL event highlighting BX003 for IBD is scheduled for May 26, 2021, featuring a discussion led by a renowned academic expert [37] Q&A Session Summary Question: How has microbiome composition changed over time? - Management acknowledged the loss of microbiome diversity and emphasized the need for engineered solutions to avoid antibiotic resistance [47] Question: What is the current status of the phage bank and expansion efforts? - The company is investing in infrastructure and sample collection rather than a large phage bank, which has led to rapid development of phage cocktails [50][52] Question: What are the gating items before advancing BX003, BX004, and BX005 into clinical studies? - Management indicated that the phage approach allows for direct patient studies without the need for healthy volunteer studies, expediting the process [57] Question: What dose range is expected in the CF study? - The Phase 1a study will start with a lower single dose, followed by higher doses based on safety and efficacy evaluations [69] Question: How will the company work with other therapies in the atopic dermatitis study? - The study will not exclude patients on existing therapies, with some adjustments for washout periods based on prior treatments [74]