Editas Medicine Announces Second Quarter 2023 Results and Business Updates
On track to dose 20 total patients in the EDIT-301 RUBY trial for SCD and provide a clinical update by year-end
Commenced parallel patient dosing in the EDIT-301 EDITHAL trial for TDT and on track to provide a clinical update by year-end
Strengthened Executive Team with Appointments of
“We continued making significant progress against our strategic plan in the second quarter, specifically the advancement of our EDIT-301 program towards a BLA filing. The promising data we shared in June signal that 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 and beta thalassemia long term, specifically driving early and robust correction of anemia and sustained increases in fetal hemoglobin. The Editas team is excited and continues driving execution towards our goals,” commented Gilmore O’Neill, M.B.,
Recent Achievements and Outlook
- EDIT-301 for Sickle Cell Disease (SCD)
Editas Medicineremains on track to dose 20 total SCD patients in the RUBY trial by year-end.
- The Company remains on track to provide an additional RUBY clinical update by year-end.
- In June,
Editas Medicinepresented positive initial clinical safety and efficacy data from the RUBY trial in an oral presentation at the European Hematology Association (EHA) Hybrid Congressin Frankfurt, Germany, and in a Company-sponsored webinar.
- EDIT-301 for Transfusion-dependent Beta Thalassemia (TDT)
Editas Medicinehas commenced parallel dosing in the EDITHAL trial for TDT.
- The Company remains on track to provide an additional EDITHAL clinical update by year-end.
- In June,
Editas Medicinepresented positive initial clinical safety and efficacy data from the first patient treated in the EDITHAL trial in a Company-sponsored webinar.
Other Corporate Highlights
Erick Lucerajoined Editas as Chief Financial Officer Mr. Lucerabrings to Editas more than 30 years of financial, operational, and investment experience in life sciences, including driving financial decision-making and identifying and successfully closing strategic partnerships in the biotechnology field. Prior to joining Editas Medicine, Mr. Luceramost recently served as Chief Financial Officer of AVEO Pharmaceuticals, where he helped scale the company from a clinical-stage entity, through FDA approval and commercial launch, to its acquisition by LG Chem. Linda C. Burklyjoined Editas as Chief Scientific Officer Dr. Burklybrings to Editas more than 35 years of experience in biotechnology as a research leader spanning the breadth of the drug discovery and development value chain. Her experience encompasses therapeutic areas of immunological, neurological, and rare genetic disorders. Linda also has a track record of contributing to the foundations of approved medicines and late-stage clinical candidates including Trogarzo®, Tysabri®, and Dapirolizumab (Phase 3), her role ranging across inventing therapeutic compositions, discovering novel pathway biology and uses of therapeutic compositions, co-authoring INDs, and leading project teams. Prior to joining Editas Medicine, Dr. Burklyheld positions of increasing responsibility over a 37-year tenure at Biogen, most recently leading neuroscience-focused research teams as Vice President and Senior Distinguished Investigator from 2014 to 2022.
Editas Medicinecontinues to advance its internal manufacturing and quality management capabilities. The Company is increasing its clean room capacity and is moving activities to a new Azzurfacility in Devens, MA, expected to be completed in 2024. This new facility and increased capacity will support the scaling of the EDIT-301 program, including manufacturing clinical supply for the RUBY and EDITHAL trials and preparing the Company for commercial readiness.
Second Quarter 2023 Financial Results
Cash, cash equivalents, and marketable securities as of
- For the three months ended
June 30, 2023, net loss attributable to common stockholders was $40.3 million, or $0.56per share, compared to net loss of $53.5 million, or $0.78per share, for the same period in 2022.
- Collaboration and other research and development revenues decreased by
$3.5 millionto $2.9 millionfor the three months ended June 30, 2023, compared to $6.4 millionfor the same period in 2022. The decrease is related to Bristol Myers Squibb’s program opt-in in the second quarter of 2022 that did not occur in the same period of 2023.
- Research and development expenses decreased to
$29.8 millionfor the three months ended June 30, 2023, compared to $43.7 millionfor the same period in 2022. The $13.9 milliondecrease is attributable to the Company’s strategic reprioritization, including a targeted clinical and manufacturing focus on EDIT-301, and reduced employee-related costs.
- General and administrative expenses remained relatively flat, slightly increasing by
$0.3 millionto $17.2 millionfor the three months ended June 30, 2023, from $16.9 millionfor the same period in 2022.
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 further clinical updates for the RUBY and EDITHAL trials by year-end, potential of, and expectations for, the Company’s product candidates, the timing or likelihood of regulatory filings and approvals, the Company’s expectations regarding commercial readiness, 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)
|Three Months Ended
||Six Months Ended
|Collaboration and other research and development revenues||$||2,887||$||6,362||$||12,738||$||13,134|
|Research and development||29,779||43,659||67,583||81,635|
|General and administrative||17,202||16,937||40,211||36,483|
|Total operating expenses||46,981||60,596||107,794||118,118|
|Other income, net:|
|Other (expense) income, net||(7||)||235||(1,590||)||1|
|Interest income, net||3,811||546||7,320||1,015|
|Total other income, net||3,804||781||5,730||1,016|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.56||)||$||(0.78||)||$||(1.27||)||$||(1.52||)|
|Weighted-average common shares outstanding, basic and diluted||71,376,678||68,640,858||70,157,204||68,563,348|
Selected Consolidated Balance Sheet Items
(amounts in thousands)
|Cash, cash equivalents, and marketable securities||$||480,033||$||437,371|
|Deferred revenue, net of current portion||60,667||60,667|
|Total stockholders' equity||399,917||360,680|
Media and Investor Contact:
Cristi Barnett(617) 401-0113 email@example.com
Source: Editas Medicine, Inc.