Editas Medicine Announces Fourth Quarter and Full Year 2022 Results and Business Updates
Commenced parallel patient dosing in the EDIT-301 RUBY trial for SCD, following clinical proof-of-concept demonstrated last quarter
On track to provide clinical update for RUBY trial by mid-2023 and dose 20 total patients by year-end
On track to dose first patient in EDIT-301 EDITHAL trial for TDT in Q1 2023 and provide clinical update by year-end
Entered into definitive agreement to sell iNK cell franchise and out-license certain gene editing technologies to Shoreline Biosciences
“I’m proud of our team’s achievements in 2022, as we showed proof-of-concept in two clinical programs, hired a world-class CMO, and initiated our strategic transformation,” commented Gilmore O’Neill, M.B.,
Recent Achievements and Outlook
Ex
- EDIT-301 for Sickle Cell Disease (SCD)
- After completing sequential dosing of the first two patients,
Editas Medicine has commenced parallel patient dosing in the Phase 1/2 RUBY trial for severe SCD, and remains on track to dose 20 total SCD patients by year-end. - The Company remains on track to present a clinical update from the RUBY trial by mid-2023.
- In
December 2022 ,Editas Medicine announced positive safety and efficacy data from the first two patients treated in the RUBY trial, suggesting clinical proof-of-concept.
- After completing sequential dosing of the first two patients,
- EDIT-301 for Transfusion-dependent Beta Thalassemia (TDT)
Editas Medicine remains on track to dose the first patient in the Phase 1/2 EDITHAL trial for TDT in Q1 2023.- The Company remains on track to present data from the EDITHAL trial by year-end.
- Alternative HSC Transplantation Preconditioning
Editas Medicine is in early stage research for the development of non-myeloablative patient preconditioning regimens for hematopoietic stem cell (HSC) transplantations.
In
- HSCs
Editas Medicine is in the discovery stage of developing a product for in vivo editing of HSCs.
- Other Organs & Tissues
Editas Medicine is in the discovery stage of developing products for in vivo editing of other tissues.- In
November 2022 ,Editas Medicine announced clinical data demonstrating proof-of-concept of EDIT-101 from the Phase 1/2 BRILLIANCE trial for the treatment of blindness due to LCA10, an inherited retinal disease. The Company also announced it will pause enrollment in the trial and seek to identify a collaboration partner.
- iNK Cell Franchise
- In
January 2023 , the Company announced that it had entered into a definitive agreement with Shoreline Biosciences, under which Shoreline will acquire 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 will license Editas Medicine’s rights to proprietary SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies.
- In
- Alpha-Beta T Cells for Oncology
- Bristol Myers Squibb (BMS) recently opted into three additional gene editing programs under the collaboration agreement with
Editas Medicine and declared one new development candidate, further validating the Company’s technology, and marking 11 total programs opted into by BMS since the start of the collaboration.
- Bristol Myers Squibb (BMS) recently opted into three additional gene editing programs under the collaboration agreement with
Fourth Quarter and Full Year 2022 Financial Results
Cash, cash equivalents, and marketable securities as of
Fourth Quarter 2022
- For the three months ended
December 31, 2022 , net loss attributable to common stockholders was$60.7 million , or$0.88 per share, compared to net loss of$41.4 million , or$0.61 per share, for the same period in 2021. - Collaboration and other research and development revenues decreased by
$6.0 million to$6.5 million for the three months endedDecember 31, 2022 , compared to$12.5 million for the same period in 2021. The decrease was primarily attributable to a decrease in collaboration related milestones. - Research and development expenses increased by
$14.4 million to$52.0 million for the three months endedDecember 31, 2022 , from$37.6 million for the same period in 2021. The increase is principally related to increased clinical and manufacturing investment in the Company’s EDIT-301 program and a one-time charge incurred as part of the Company pausing internal investment in EDIT-101. - General and administrative expenses increased by
$1.5 million to$18.0 million for the three months endedDecember 31, 2022 , from$16.5 million for the same period in 2021. The increase was attributable to increased employee-related expenses and patent expenses in the three months endedDecember 31, 2022 .
Full Year 2022
- For the full year 2022, net loss attributable to common stockholders was
$220.4 million , or$3.21 per share, compared to$192.5 million , or$2.85 per share, for the same period in 2021. - Collaboration and other research and development revenues were
$19.7 million for 2022, compared to$25.5 million for 2021. The$5.8 million decrease was primarily attributable decreased revenue recognized in the year endedDecember 31, 2022 related to the Company’s collaboration agreement with BMS. - Research and development expenses were
$175.0 million for 2022, compared to$142.5 million for 2021. The$32.5 million increase was attributable to increases in manufacturing and clinical-related expenses, including costs related to EDIT-301, as well as employee-related expenses to support clinical programs,and a one-time charge incurred as part of the Company pausing internal investments in EDIT-101. - General and administrative expenses were
$70.7 million for 2022, compared to$76.2 million for 2021. The$5.5 million decrease was primarily attributable to decreased stock-based compensation expense related to the vesting of certain equity awards, as well as stock-based compensation expenses that were granted to the former CEO and certain other employees in 2021 that did not occur in the year endedDecember 31, 2022 .
- Cowen 43rd Annual
Health Care Conference March 6, 2023 –Boston, MA
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, including dosing 20 total patients by year-end in the RUBY trial and dosing the first patient in the EDITHAL trial in the first quarter of 2023, 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 by mid-2023 and presentation of data from the EDITHAL trial by year-end, potential of, and expectations for, the Company’s product candidates, the timing or likelihood of regulatory filings and approvals, and the Company’s expectations regarding cash runway. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials, including the RUBY and EDITHAL trials, and clinical development of the Company’s product candidates, including EDIT-301; 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 and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the
Consolidated Statement of Operations
(amounts in thousands, except share and per share data)
(Unaudited)
Three Months Ended |
Twelve Months Ended | |||||||||||||||||||
December 31, | ||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||
Collaboration and other research and development revenues | $ | 6,536 | $ | 12,469 | $ | 19,712 | $ | 25,544 | ||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | 51,998 | 37,552 | 174,958 | 142,507 | ||||||||||||||||
General and administrative | 17,984 | 16,526 | 70,704 | 76,183 | ||||||||||||||||
Total operating expenses | 69,982 | 54,078 | 245,662 | 218,690 | ||||||||||||||||
Operating loss | (63,446 | ) | (41,609 | ) | (225,950 | ) | (193,146 | ) | ||||||||||||
Other income, net: | ||||||||||||||||||||
Other income(expense), net | 1,289 | (325 | ) | 1,293 | (1,698 | ) | ||||||||||||||
Interest income, net | 1,419 | 499 | 4,225 | 2,342 | ||||||||||||||||
Total other income, net | 2,708 | 174 | 5,518 | 644 | ||||||||||||||||
Net loss | $ | (60,738 | ) | $ | (41,435 | ) | $ | (220,432 | ) | $ | (192,502 | ) | ||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.88 | ) | $ | (0.61 | ) | $ | (3.21 | ) | $ | (2.85 | ) | ||||||||
Weighted-average common shares outstanding, basic and diluted | 68,793,157 | 68,355,723 | 68,664,822 | 67,619,388 |
Selected Consolidated Balance Sheet Items
(amounts in thousands)
(Unaudited)
December 31, | |||||
2022 | 2021 | ||||
Cash, cash equivalents, and marketable securities | $ | 437,371 | $ | 619,915 | |
Working capital | 296,644 | 460,426 | |||
Total assets | 514,321 | 677,483 | |||
Deferred revenue, net of current portion | 60,667 | 60,888 | |||
Total stockholders' equity | 360,680 | 553,642 |
Media Contact:
(617) 401-0113
cristi.barnett@editasmed.com
Investor Contact:
(617) 401-9052
ir@editasmed.com

Source: Editas Medicine, Inc.