Editas Medicine Announces First Quarter 2023 Results and Business Updates
Company to provide a clinical update on the EDIT-301 Phase 1/2 RUBY trial for SCD in June at the
On track to dose 20 total patients by year-end in the RUBY trial
First patient in EDIT-301 EDITHAL trial for TDT dosed with successful neutrophil and platelet engraftment; Company on track to provide clinical update by year-end
“I am energized by our strong start to the year. We entered 2023 with the objective of accelerating the development of EDIT-301 and positioning Editas as a leader in programable in vivo gene editing. Following on our December EDIT-301 clinical data showing a competitive and potentially differentiated product, we have built considerable momentum with our EDIT-301 program, including dosing and engraftment of the first patient in our EDITHAL trial. We look forward to disclosing the clinical progress of EDIT-301 when we provide a RUBY trial update with safety and efficacy data from multiple patients next month in an oral presentation at the
Recent Achievements and Outlook
- EDIT-301 for Sickle Cell Disease (SCD)
Editas Medicinewill present a clinical update from the RUBY trial in June in both an oral presentation at EHA and in a Company-sponsored webinar.
- The Company remains on track to present an additional RUBY clinical update by year-end.
Editas Medicinecontinues to parallel dose patients and remains on track to dose 20 total SCD patients by year-end, with 19 patients enrolled to date.
U.S. Food and Drug Administrationgranted Orphan Drug Designation to EDIT-301 for the treatment of SCD.
- EDIT-301 for Transfusion-dependent Beta Thalassemia (TDT)
Editas Medicinedosed the first patient in the Phase 1/2 EDITHAL trial for TDT in Q1 2023. The patient had successful neutrophil and platelet engraftment.
- The Company remains on track to present data from the EDITHAL trial by year-end.
- Business Development
January 2023, the Company announced that it had entered into a definitive agreement with Shoreline Biosciences, Inc., under which Shoreline acquired Editas Medicine’s preclinical gene edited induced pluripotent stem cell (iPSC) derived natural killer cell (iNK) programs, including EDIT-202, and related manufacturing technologies. Additionally, Shoreline licensed Editas Medicine’s rights to proprietary SLEEK (Selection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies.
Emma Reeveappointed as Chair of the Editas Board of Directors, effective at the Company’s annual stockholder meeting, scheduled for June 1 Ms. Reevejoined the Editas Medicine Board of Directors in September 2021. Ms. Reeveis an accomplished biopharmaceutical executive with more than 25 years of global financial experience across pharmaceutical, medical device, and biopharmaceutical companies. Elliott Levy, M.D., appointed to the Editas Board of Directors as an independent director Dr. Levyis an accomplished biopharmaceutical executive with more than 20 years of global research and development expertise, including leading clinical strategy and development for multiple programs at all stages of development at global biopharmaceutical companies Amgen and Bristol Myers Squibb. Linea Aspesijoined Editas as Chief People Officer Ms. Aspesibrings to Editas more than 25 years experience, including 15 years in the life sciences sector, aligning talent plans to company vision, mission, and values, and partnering with senior leaders to define and drive cultural transformation strategies.
First Quarter 2023 Financial Results
Cash, cash equivalents, and marketable securities as of
- For the three months ended
March 31, 2023, net loss attributable to common stockholders was $49.0 million, or $0.71per share, compared to net loss of $50.5 million, or $0.74per share, for the same period in 2022.
- Collaboration and other research and development revenues increased by
$3.1 millionto $9.9 millionfor the three months ended March 31, 2023, compared to $6.8 millionfor the same period in 2022. The increase is related to the Company’s sale of its wholly owned oncology assets and related licenses in January 2023.
- Research and development expenses were flat at
$37.8 millionfor the three months ended March 31, 2023, compared to $38.0 millionfor the same period in 2022.
- General and administrative expenses increased by
$3.5 millionto $23.0 millionfor the three months ended March 31, 2023, from $19.5 millionfor the same period in 2022. The increase was primarily attributable to increased professional services expenses to support business development activities, partially offset by a decrease in stock compensation expense.
European Hematology Association(EHA) 2023 Congress June 8-11, 2023, Frankfurt, Germany Bank of America Securities2023 Health Care Conference May 9-11, 2023, Las Vegas, NV RBC Capital Markets Global Healthcare Conference2023 May 16, 2023, New York, NY
As a clinical stage genome editing company,
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the initiation, timing, progress and results of the Company’s preclinical and clinical studies and its research and development programs, including dosing 20 total patients by year-end in the RUBY trial, the timing for the Company’s receipt and presentation of data from its clinical trials and preclinical studies, including a clinical update for the RUBY trial in
Consolidated Statement of Operations
(amounts in thousands, except share and per share data)
|Three Months Ended|
|Collaboration and other research and development revenues||$||9,851||$||6,771|
|Research and development||37,804||37,976|
|General and administrative||23,008||19,545|
|Total operating expenses||60,812||57,521|
|Other income, net:|
|Other expense, net||(1,584||)||(234||)|
|Interest income, net||3,509||469|
|Total other income, net||1,925||235|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.71||)||$||(0.74||)|
|Weighted-average common shares outstanding, basic and diluted||68,924,180||68,484,978|
Selected Consolidated Balance Sheet Items
(amounts in thousands)
|Cash, cash equivalents, and marketable securities||$||401,778||$||437,371|
|Deferred revenue, net of current portion||60,667||60,667|
|Total stockholders' equity||317,473||360,680|
Media and Investor Contact:
Cristi Barnett(617) 401-0113 email@example.com
Source: Editas Medicine, Inc.