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Sep 30, 2022
Evelo Q3 2022 Earnings Report
Reported third quarter financial results and business highlights.
Key Takeaways
Evelo Biosciences reported a net loss of $30.6 million for the third quarter of 2022, with cash and cash equivalents totaling $69.1 million as of September 30, 2022. The company is progressing with its clinical programs, including EDP1815 in atopic dermatitis and psoriasis, and EDP2939 in psoriasis, with multiple Phase 2 data readouts expected in 2023.
On track for multiple Phase 2 readouts for EDP1815 in atopic dermatitis in 2023, with data from first three cohorts expected in early 1Q 2023 and fourth cohort in 2Q 2023.
Phase 2 data for first extracellular vesicle product candidate EDP2939 in psoriasis anticipated in 2H 2023.
Continuing to advance regulatory discussions for registration trials for EDP1815 in psoriasis.
Cash and cash equivalents were $69.1 million as of September 30, 2022.
Evelo
Evelo
Forward Guidance
Evelo Biosciences is on track to deliver on three Phase 2 clinical milestones throughout 2023.
Positive Outlook
- Data from the first three cohorts in the Phase 2 trial of EDP1815 in atopic dermatitis is expected early in the first quarter of 2023.
- Data from the fourth cohort in the Phase 2 trial of EDP1815 in atopic dermatitis is expected in the second quarter of 2023.
- Data from patients in the Phase 2 trial of EDP2939 in psoriasis is anticipated in the second half of 2023.
- EMA and MHRA acknowledged the appropriateness of the proposed registration clinical trial design for EDP1815 in psoriasis.
- The company has the technical and manufacturing operations in place that it believes will allow for registration trials and commercial launch.
Challenges Ahead
- Received a request from the MHRA for additional information with respect to the Clinical Trial Application (CTA) submission for the EDP2939 Phase 1/2 trial.
- The lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval.
- Reliance on third parties and collaborators to expand microbial library, conduct clinical trials, manufacture product candidates, and develop and commercialize product candidates, if approved.
- Lack of experience in manufacturing, selling, marketing, and distributing product candidates.
- Potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of intellectual property.