
Financial Data and Key Metrics Changes - As of June 30, 2022, cash balance and short-term deposits were $46.7 million, down from $63.1 million as of December 31, 2021, primarily due to net cash used in operating activities [29] - Research and development expenses net were $4.6 million for the three months ended June 30, 2022, compared to $3.8 million for the same period in 2021 [30] - General and administrative expenses were $2.4 million for the three months ended June 30, 2022, down from $3.1 million for the same period in 2021 [31] - Net cash used in operating activities was $16.4 million for the six months ended June 30, 2022, compared to $12.8 million for the same period in 2021 [32] Business Line Data and Key Metrics Changes - The cystic fibrosis program, specifically BX004, has dosed the first two patients in its Phase 1b/2a study, marking a significant milestone [8][10] - The company has paused the development of BX003 and discontinued BX001, which has affected R&D expenses [30] Market Data and Key Metrics Changes - The opportunity to address lung infections in cystic fibrosis remains substantial, with approximately 70,000 to 80,000 patients in the US and EU, and over 60% of adults with cystic fibrosis infected with Pseudomonas aeruginosa [12] Company Strategy and Development Direction - The company is focusing on advancing the BX004 program as a clinical development priority, addressing the unmet medical need in cystic fibrosis [21] - A second collaboration with Boehringer Ingelheim was announced to identify biomarkers for a pathogenic bacterium associated with inflammatory bowel disease [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of phage therapy for treating lung infections in cystic fibrosis, highlighting the need for new therapies [33] - The company aims to generate solid clinical data to rebuild investor enthusiasm and is preparing for initial clinical results for BX004 [33] Other Important Information - A restructuring was completed to extend the company's cash runway until at least mid-2024 [27] - The company has published research supporting its inflammatory bowel disease program and technology platform [23][24] Q&A Session Summary Question: Current supply and manufacturing efficiencies - The company has in-house manufacturing to control the supply chain and has capacity to support Phase 2 needs [34] Question: Predictability factors for infections with Trikafta - There is limited data, but initial findings suggest a drop in Pseudomonas levels followed by a resurgence [43] Question: Thoughts on the upcoming FDA panel for another microbiome company - There is a growing comfort in the approval process for microbiome products, and surrogate endpoints may expedite approvals [46][48] Question: Enrollment of patients for BX005 - The study has not started yet, and the focus remains on BX004 due to restructuring [57] Question: Plans to broaden BX003 - BX003 is not prioritized in the next 12 months, but a broader cocktail is being considered [60] Question: Use of microbiome as a screener for patients - The collaboration with Boehringer Ingelheim aims to identify biomarkers to better stratify patients for treatment [62]