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Sep 30, 2021
Editas Q3 2021 Earnings Report
Editas reported a net loss with EDIT-101 showing favorable safety profile and EDIT-301 continuing enrollment
Key Takeaways
Editas Medicine reported its third quarter 2021 results, highlighting initial EDIT-101 clinical data demonstrating a favorable safety profile and preliminary evidence of clinical benefit, as well as the ongoing enrollment in the EDIT-301 Phase 1/2 RUBY trial for sickle cell disease. The company's cash, cash equivalents, and marketable securities totaled $657.0 million as of September 30, 2021. Net loss attributable to common stockholders was $39.1 million, or $0.57 per share.
EDIT-101 Phase 1/2 BRILLIANCE trial showed favorable safety profile and preliminary evidence of clinical benefit.
Enrollment is ongoing in adult high-dose and pediatric mid-dose cohorts for EDIT-101.
EDIT-301 Phase 1/2 RUBY trial for sickle cell disease is currently enrolling study participants.
Preclinical data on SLEEK gene editing technology was presented, enabling high efficiency, multi-transgene knock-in.
Editas
Editas
Forward Guidance
Editas Medicine anticipates completing dosing of both the adult high-dose and pediatric mid-dose cohorts in the first half of 2022. The company also plans to begin patient dosing in the RUBY trial in the first half of 2022. Editas expects to file an IND for EDIT-301 for the treatment of transfusion-dependent beta thalassemia by the end of 2021.
Positive Outlook
- Completing dosing of adult high-dose and pediatric mid-dose cohorts in the first half of 2022
- Beginning patient dosing in the RUBY trial in the first half of 2022
- Filing an IND for EDIT-301 for the treatment of transfusion-dependent beta thalassemia by the end of 2021
- Advancing alpha-beta T cell medicines with Bristol Myers Squibb (BMS)
- Existing cash, cash equivalents, and marketable securities will enable it to fund its operating expenses and capital expenditures well into 2023.
Challenges Ahead
- Uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials
- Availability and timing of results from pre-clinical studies and clinical trials
- Whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials
- Expectations for regulatory approvals to conduct trials or to market products
- Availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements