Full Press Release Details
Editas Medicine Announces Fourth Quarter and Full Year 2022 Results and
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
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
CAMBRIDGE, Mass., Feb. 22, 2023 - Editas Medicine, Inc. (Nasdaq: EDIT), a clinical stage genome editing company, today reported business highlights and financial results for the fourth quarter and full year 2022.
"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., M.M.Sc., President and Chief Executive Officer, Editas Medicine. "We entered 2023 with the objective of positioning Editas as a leader in programable in vivo gene editing and have begun executing on a new strategy underpinned by three pillars: sharpening our discovery and development focus; strengthening our discovery engine and technological capabilities; and expanding our business development efforts. Our team is energized by this new strategic direction as we continue to progress towards becoming a commercial-stage organization."
Recent Achievements and Outlook
Ex Vivo Hemoglobinopathies
Business Development & Other Corporate Highlights
Fourth Quarter and Full Year 2022 Financial Results
Cash, cash equivalents, and marketable securities as of December 31, 2022, were $437.4 million, compared to $478.5 million as of September 30, 2022, and $619.9 million as of December 31, 2021. The Company expects that its existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditures into 2025.
Editas Medicine plans to participate in the following investor events:
March 6, 2023 - Boston, MA
The Editas Medicine management team will host a conference call and webcast today at 8:00 a.m. ET to provide and discuss a corporate update and financial results for the fourth quarter and full year of 2022. To access the call, please dial 877-407-0989 (domestic) or 201-389-0921 (international) and ask for the Editas Medicine earnings call. A live webcast of the call will also be available on the Investors section of the Editas Medicine website at www.editasmedicine.com, and a replay will be available approximately two hours after its completion.
About Editas Medicine
As a clinical stage genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute and Harvard University's Cas9 patent estates and Broad Institute's Cas12a patent estate for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.
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 Securities and Exchange Commission, as updated by the Company's subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release represent Company's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.
EDITAS MEDICINE, INC.
Consolidated Statement of Operations
(amounts in thousands, except share and per share data)
| Three Months Ended | Twelve Months Ended | ||||||||||||
| December 31, | 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 |
EDITAS MEDICINE, INC.
Selected Consolidated Balance Sheet Items
(amounts in thousands)
| December 31, | 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 |