Editas Medicine Announces Third Quarter 2023 Results and Business Updates
Company to provide a clinical update on the EDIT-301 RUBY trial for SCD and EdiTHAL trial for TDT in December at the
Granted
Strengthened Executive Team with appointment of
“We made significant progress advancing EDIT-301 in the third quarter, continuing to enroll and dose patients, and advancing the program towards a BLA filing. We believe EDIT-301 has the potential to be a clinically differentiated, one-time, durable medicine that can provide life changing clinical benefits to patients with sickle cell disease or beta thalassemia, specifically driving early and robust correction of anemia and sustained increases in fetal hemoglobin, and we look forward to sharing clinical data from RUBY and EdiTHAL at ASH and in a Company-sponsored webinar next month,” commented Gilmore O’Neill, M.B.,
Recent Achievements and Outlook
Ex
- EDIT-301 Clinical Data Update
- The Company will share clinical data updates from the RUBY trial for severe sickle cell disease (SCD) and the EdiTHAL trial for transfusion-dependent beta thalassemia (TDT) in a Company-sponsored webinar and in a poster at the
American Society of Hematology (ASH) Annual Meeting onMonday, December 11 .
- The Company will share clinical data updates from the RUBY trial for severe sickle cell disease (SCD) and the EdiTHAL trial for transfusion-dependent beta thalassemia (TDT) in a Company-sponsored webinar and in a poster at the
- EDIT-301 for Sickle Cell Disease
- The Company continues to enroll and dose patients in the RUBY trial for SCD.
- In October, the
U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to EDIT-301 for the treatment of SCD.
- EDIT-301 for Transfusion-dependent Beta Thalassemia
- The Company continues to enroll and dose patients in the EdiTHAL trial for TDT.
Business Development
- In August,
Editas Medicine entered into a licensing agreement withVor Bio , providingVor Bio a non-exclusive Cas9 license for the development of ex vivo Cas9 gene edited hematopoietic stem cell (HSC) therapies for the treatment and/or prevention of hematological malignancies. Under this agreement,Editas Medicine received an upfront payment and is eligible for future development, regulatory, and commercial milestone payments, as well as royalties on medicines utilizing the related intellectual property.
Other Corporate Highlights
- Leadership
Caren Deardorf joined Editas as Chief Commercial and Strategy OfficerMs. Deardorf brings to Editas more than 25 years of international biotechnology leadership across a range of companies and therapeutic areas. Most recently,Ms. Deardorf served as the Chief Commercial Officer of Magenta Therapeutics. Prior to Magenta, she served as the Chief Commercial Officer of Ohana Biosciences where she was responsible for developing a commercial strategy, including planning for the company’s first product launch. Earlier in her career,Ms. Deardorf held a variety of commercial roles of increasing responsibility at Biogen, most recently serving as Vice President,Product Development & Commercialization , leading and executing a highly successful global launch of SPINRAZA®, a treatment for children and adults with spinal muscular atrophy. During her tenure at Biogen,Ms. Deardorf was instrumental in building the multiple sclerosis (MS) franchise and helping to establish Biogen’s global leadership through US and worldwide brand management, including leading the brand and launch strategy for TECFIDERA® and the US and EU launches of TYSABRI® andAVONEX ®.
Third Quarter 2023 Financial Results
Cash, cash equivalents, and marketable securities as of
- For the three months ended
September 30, 2023 , net loss attributable to common stockholders was$45.0 million , or$0.55 per share, compared to net loss of$55.7 million , or$0.81 per share, for the same period in 2022. - Collaboration and other research and development revenues increased to
$5.3 million for the three months endedSeptember 30, 2023 , compared to$42.0 thousand for the same period in 2022. The increase is primarily related to an upfront payment for the non-exclusive Cas9 license toVor Bio in the third quarter of 2023. - Research and development expenses decreased slightly by
$0.8 million to$40.5 million for the three months endedSeptember 30, 2023 , compared to$41.3 million for the same period in 2022. - General and administrative expenses decreased by
$1.2 million to$15.0 million for the three months endedSeptember 30, 2023 , compared to$16.2 million for the same period in 2022. The decrease was driven by reduced headcount related expense, including stock compensation, and reduced legal costs.
Upcoming Events
American Society of Hematology (ASH) 2023 Annual MeetingDecember 8-12, 2023 San Diego, CA
- Truist Securities BioPharma Symposium
November 8-9, 2023 New York, NY
- Stifel 2023 Healthcare Conference
November 14-15, 2023 New York, NY
- Evercore ISI’s Annual
HealthCONx Conference November 28-30, 2023 Miami, FL
Conference Call
The
About
As a clinical-stage genome editing company,
Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the initiation, timing, progress and results of the Company’s preclinical and clinical studies and its research and development programs, the timing for the Company’s receipt and presentation of data from its clinical trials and preclinical studies, including clinical data updates for the RUBY and EdiTHAL trials in
Consolidated Statement of Operations (amounts in thousands, except share and per share data) (Unaudited) |
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Three Months Ended |
Nine Months Ended |
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2023 | 2022 | 2023 | 2022 | ||||||||||||
Collaboration and other research and development revenues | $ | 5,336 | 42 | $ | 18,074 | $ | 13,176 | ||||||||
Operating expenses: | |||||||||||||||
Research and development | 40,512 | 41,326 | 108,095 | 122,960 | |||||||||||
General and administrative | 14,987 | 16,236 | 55,198 | 52,720 | |||||||||||
Total operating expenses | 55,499 | 57,562 | 163,293 | 175,680 | |||||||||||
Operating loss | (50,163 | ) | (57,520 | ) | (145,219 | ) | (162,504 | ) | |||||||
Other income, net: | |||||||||||||||
Other (expense) income, net | — | 1 | (1,590 | ) | 4 | ||||||||||
Interest income, net | 5,144 | 1,793 | 12,464 | 2,806 | |||||||||||
Total other income, net | 5,144 | 1,794 | 10,874 | 2,810 | |||||||||||
Net loss | $ | (45,019 | ) | $ | (55,726 | ) | $ | (134,345 | ) | $ | (159,694 | ) | |||
Net loss per share, basic and diluted | $ | (0.55 | ) | $ | (0.81 | ) | $ | (1.81 | ) | $ | (2.33 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 81,648,250 | 68,736,125 | 74,029,645 | 68,621,574 |
Selected Consolidated Balance Sheet Items (amounts in thousands) (Unaudited) |
|||||||
2023 | 2022 | ||||||
Cash, cash equivalents, and marketable securities | $ | 446,414 | $ | 437,371 | |||
Working capital | 300,000 | 296,644 | |||||
Total assets | 504,650 | 514,321 | |||||
Deferred revenue, net of current portion | 60,667 | 60,667 | |||||
Total stockholders' equity | 360,462 | 360,680 |
Media and Investor Contact:
(617) 401-0113
cristi.barnett@editasmed.com
Source: Editas Medicine, Inc.