Evelo Biosciences(US:EVLO)2022-08-12 03:55Financial Data and Key Metrics Changes - The company is focused on capital preservation and cost-saving measures due to the current financial environment, having already implemented several cost control measures to ensure cash availability for critical clinical milestones [21][22] - The company anticipates moving EDP1815 into registration trials next year based on expected feedback from health authorities [21][22] Business Line Data and Key Metrics Changes - EDP1815 is progressing towards registration trials in psoriasis and is in Phase 2 for atopic dermatitis, with data readouts expected in the first and second quarters of 2023 [5][17] - EDP2939, the first microbial extracellular vesicle product candidate, is expected to provide Phase 1 and Phase 2 data for psoriasis in the second half of 2023 [17][18] Market Data and Key Metrics Changes - The company sees a significant opportunity to expand beyond dermatological conditions into arthritis, inflammatory bowel disease, asthma, and other inflammatory diseases due to the broad applicability of its platform [6][10] - There is a strong demand for oral treatments among patients, as evidenced by the success of Otezla, which has significant tolerability issues but is still being adopted [35][36] Company Strategy and Development Direction - The company aims to create a volume-driven business model focused on treating previously overlooked patient populations with effective, safe, and affordable oral therapies [10][36] - The management emphasizes the importance of safety and tolerability for both adults and children, which is a critical parameter for clinicians [7][10] Management's Comments on Operating Environment and Future Outlook - The management is optimistic about the future, highlighting the potential of EDP1815 and SINTAX medicines to revolutionize treatment for inflammatory diseases [18][31] - The company is committed to understanding the durability and deepening responses observed in clinical studies, which is a unique aspect compared to other therapies [31][33] Other Important Information - The company announced a succession plan for CEO Simba Gill, who will transition to the role of Chair while continuing to support the new CEO [9][11] - The company has engaged an executive search firm to assist in finding a suitable successor for the CEO position [14] Q&A Session Summary Question: What types of activities might be expected in terms of capital preservation or cost-saving measures? - The company is focused on cost control and has already taken measures to bring costs under control while prioritizing core investments [21] Question: Is there a go/no-go decision expected from health authorities regarding pivotal trials? - The company expects guidance on Phase 3 clinical design and does not anticipate substantive issues, aiming to move towards registration trials next year [21] Question: What formulation and dosing profile are being considered for the Phase 3 trial of EDP1815? - The company plans to use the original formulation with once-daily dosing, but may consider a faster-release capsule if it shows significant improvement in upcoming data [24][25] Question: What EASI50 response is needed to move forward into a pivotal program for atopic dermatitis? - The company is looking for a 20% or greater separation in EASI50 responders compared to placebo to consider moving forward [25] Question: What differential efficacy impact is expected from EDP2939 compared to EDP1815? - The company anticipates that EDP2939 may provide significant improvement in efficacy and responder rates compared to EDP1815, with the potential for antibody-like efficacy [28] Question: What work is being done to understand durable and deepening responses observed in clinical studies? - The company is investigating the mechanism of action and plans to include longer duration treatments and open-label extensions in clinical studies to assess durability [31][33] Question: Are patients expressing interest in switching to oral therapies? - There is clear feedback indicating a strong demand for oral treatments, which supports the company's strategy to offer affordable oral therapies for inflammatory diseases [35][36]