Editas Medicine, Inc.
Editas Medicine, Inc. Q3 FY2022 earnings call
November 2, 2022 · fiscal period ended 2022-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-11-02
Management highlights
• Gilmore O’Neill discussed progress in transitioning from a platform company to a clinical stage therapeutics company, highlighting clinical pipeline programs like EDIT-301 for sickle cell disease and transfusion-dependent beta thalassemia, and EDIT-101 for LCA10. Also mentioned IP portfolio with exclusive licenses from Broad Institute and Harvard University covering Cas9 for human therapeutics in US. • Baisong Mei provided updates on EDIT-301, including dosing of second patient in RUBY trial and progress in EDITHAL trial for transfusion-dependent beta thalassemia; discussed EDIT-101, including BRILLIANCE study update and natural history study of LCA10 patients. • Mark Shearman talked about preclinical programs like EDIT-103 for redoxin autosomal-dominant retinitis pigmentosa and EDIT-202 iPSC-derived NK cell program for solid tumors, including preclinical data presented at scientific meetings. • Michelle Robertson reviewed financial results, noting cash position, expenses, and revenue from out-license agreement.
Segment performance
No detailed product segment financial performance with absolute revenue and contribution % provided in the transcript.
Guidance
• Look forward to providing clinical updates for EDIT-101 and EDIT-301 programs in the coming weeks. • Plan to share more information about strategic plans in the coming months.
Risks
• Forward-looking statements made during the call may differ materially from actual results due to various factors, including those discussed in the Risk Factors section of the most recent annual report on Form 10-K and subsequent filings. • No specific operational failure risks discussed in detail, but general risks associated with clinical development and regulatory approval mentioned.
Q&A highlights
Q: For EDIT-301, what will be sufficient to show clinical benefit and regarding EDIT-101, what magnitude of improvement in visual outcomes is clinically meaningful?
A: Gilmore O’Neill stated EDIT-301's 30% fetal-globin as a minimal threshold for clinical benefit, and for EDIT-101, clinical meaningfulness relates to improved functional outcomes for patients to be mobile and participate in society, with details to be shared based on natural history study.
Q: What is the level of confidence in EDIT-101 program and its potential?
A: Gilmore O’Neill said EDIT-101 program serves to develop experience with applying technology in humans and determine viable patient segments for clinical meaningful response.
Q: On RUBY trial, could data be directly comparable to other CRISPR SCD trials and about BRILLIANCE trial's FDA package submission?
A: Gilmore O’Neill stated EDIT-301 data will show competitiveness, and for BRILLIANCE, data to be shared this month will help determine next steps for regulatory study design.
Q: For EDIT-103, rate limiting step for IND and use of Cas9 vs Cas12a?
A: Mark Shearman said Cas9 used as it fits in single AAV for dual AAV approach, IND-enabling studies delayed due to analytical testing requirements.
Q: Clarification on RUBY trial data and BRILLIANCE trial pediatric cohort update?
A: Baisong Mei clarified RUBY trial data to include safety and efficacy measures, and for BRILLIANCE, IDMC recommended continuing study with review of additional pediatric data before high-dose cohort.
Q: On NK cell platform and impact of IRA on pipeline?
A: Gilmore O’Neill mentioned interest in partnerships for NK platform, and Baisong Mei stated optimism about IRA enabling development of technologies for unmet diseases.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.81 | $-0.87 | +6.9% | — |
| Revenue | — | $4.4M | — | — |
Transcript
November 2, 2022Full transcript unavailable for redistribution
The structured summary above covers the available call sections. Full transcript text is not included on this page.
Continue exploring
Prior quarters
This page presents the stored structured earnings-call summary and deterministic earnings calendar values. How this is generated. For informational purposes only; not investment advice.