Editas Medicine Announces First Quarter 2018 Results and Update
Strengthened Board of Directors with addition of
Cash, cash equivalents, and marketable securities of
“We made steady progress in advancing our pipeline of CRISPR medicines toward the clinic and in building the company overall,” said
Recent Achievements and Outlook
- EDIT-101 for Leber Congenital Amaurosis type 10 (LCA10) on track for mid-2018 Investigational New Drug (IND) application filing. Editas has prepared what it believes is a strong package of preclinical data to support the IND filing. In data presented at the
Association for Research in Vision and Ophthalmology2018 Annual Meeting (ARVO Meeting), the Company demonstrated in transgenic mice that EDIT-101 caused predicted therapeutic levels of editing at adeno-associated virus doses that were safe and well tolerated in ocular gene therapy trials from other sponsors. At the American Society of Gene & Cell Therapy21st Annual Meeting (ASGCT Meeting), the Company will demonstrate that EDIT-101 was well tolerated in a study of non-human primates.
- Expanding oncology collaboration with
Juno Therapeutics, Inc., a Celgene Company(Celgene). Editas is announcing today an expansion of its collaboration with Celgeneto develop and commercialize chimeric antigen receptor and engineered T cell receptor medicines including Celgene’s lead program for human papillomavirus-associated solid tumors. As a result of the expansion and progress of the collaboration, Editas will receive an additional $10 millionin cash and will be eligible to receive a fourth independent milestone and royalty stream.
- Advancing research programs for recurrent ocular herpes simplex virus type 1 (HSV-1) and Usher syndrome type 2A (USH2A). The Company presented preclinical in vivo proof-of-concept data for its recurrent ocular HSV-1 program at the ARVO Meeting. Using the Company's CRISPR gene editing approach in rabbits, HSV-1 viral load was reduced by 75% and corneal lesions by 91% relative to control. In addition, Editas and collaborators at Massachusetts Eye and Ear will present in vitro data at the ASGCT Meeting validating the Company's approach to deletion of exon 13 to treat USH2A.
- Designing a potentially superior medicine for sickle cell disease and beta-thalassemia. Editas scientists have identified multiple sites at the beta-globin locus that regulate fetal hemoglobin induction, designed potent lead molecules, and demonstrated that these molecules drive upregulation of fetal hemoglobin in human mobilized peripheral blood stem cells. Data from this program will be presented at the upcoming ASGCT Meeting.
- Strong balance sheet to advance the Company through multiple value inflection points. The Company held cash, cash equivalents, and marketable securities of
$359 millionas of March 31, 2018, providing at least 24 months of funding for operating expenses and capital expenditures without any assumption of cash received from milestones or additional financings.
- Strengthened organization with appointment of
James C. Mullenand Jessica Hopfield, Ph.D., to Board of Directors. Mr. Mullen has been named Chairman of the Board of Directors and brings more than 30 years of experience in the biotechnology industry. He previously served as the Chief Executive Officer and President of Biogen, Inc., and as the Chief Executive officer of Patheon N.V. Dr. Hopfield is a former Partner of McKinsey & Companywith more than 20 years of experience in healthcare.
Editas will participate in the following upcoming investor conferences:
Bank of America Merrill Lynch2018 Health Care Conference, May 15-17, Las Vegas.
Editas will also participate in the following upcoming scientific and medical conferences:
- TIDES 2018: Oligonucleotide and Peptide Therapeutics,
May 7-10, Boston; and American Society of Gene & Cell Therapy21st Annual Meeting, May 16-19, Chicago.
First Quarter 2018 Financial Results
Cash, cash equivalents, and marketable securities at
For the first quarter ended
- Collaboration and other research and development revenues were
$3.9 millionfor the quarter ended March 31, 2018, compared to $0.7 millionfor the same period in 2017. The $3.2 millionincrease was attributable to a $2.9 millionincrease in revenue recognized pursuant to our strategic alliance with Allergan Pharmaceuticals International Limitedand a $0.3 millionincrease in reimbursable research and development expenses primarily resulting from the adoption of Accounting Standards Codification, Topic 606, Revenue From Contracts With Customers.
- Research and development expenses were
$21.3 millionfor the quarter ended March 31, 2018, compared to $19.0 millionfor the same period in 2017. The $2.3 millionincrease was primarily attributable to a $7.1 millionincrease in process and platform development costs and the acquisition of certain non-capitalized intangible assets, a $1.4 millionincrease in employee related expenses, a $0.3 millionincrease in stock-based compensation expenses, a $0.4 millionincrease in facility-related expenses and a $0.3 millionincrease in other expenses. This increase was partially offset by a $7.3 milliondecrease in sublicensing and success payment expenses.
- General and administrative expenses were
$14.2 millionfor the quarter ended March 31, 2018, compared to $12.3 millionfor the same period in 2017. The $1.9 millionincrease was primarily attributable to a $1.5 millionincrease in intellectual property legal expense and patent-related fees, a $0.4 millionincrease in stock-based compensation expenses, a $0.4 millionincrease in other expenses, and a $0.2 millionincrease in employee related expenses. This increase was partially offset by a $0.7 milliondecrease in professional service expenses.
The Editas management team will host a conference call and webcast today,
As a leading 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,’’ "track," ‘‘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 Company being on track to file an IND for EDIT-101 by mid-2018. 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 factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from preclinical 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
|Editas Medicine, Inc.|
|Condensed Consolidated Statements of Operations|
|(amounts in thousands, except per share and share data)|
|Three Months Ended|
|Collaboration and other research and development revenues||$||3,927||$||682|
|Research and development||21,300||19,021|
|General and administrative||14,186||12,288|
|Total operating expenses||35,486||31,309|
|Other income (expense), net:|
|Other income, net||182||140|
|Interest income (expense), net||438||(610||)|
|Total other income (expense), net||620||(470||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.67||)||$||(0.85||)|
|Weighted-average common shares outstanding, basic and diluted||45,992,008||36,485,421|
|Editas Medicine, Inc.|
|Selected Condensed Consolidated Balance Sheet Items|
|(amounts in thousands)|
|Cash, cash equivalents, and marketable securities||$||358,821||$||329,139|
|Deferred revenue, net of current portion||91,972||94,725|
|Construction financing lease obligation, net of current portion||33,190||33,431|
|Total stockholders’ equity||247,515||208,080|
Source: Editas Medicine, Inc.