Editas Medicine Announces Second Quarter 2018 Results and Update
Plan to file EDIT-101 Investigational New Drug (IND) application in
Strong balance sheet to advance Company through multiple value inflection points
“During the second quarter, we continued to drive towards our first IND and to advance our broader pipeline of transformative CRISPR medicines,” said
Recent Achievements and Outlook
Allergan Pharmaceuticals International Limited (Allergan ) exercises option to develop and commercialize EDIT-101 globally and Editas exercises option to co-develop and equally share profits and losses inthe United States . Editas andAllergan announced today thatAllergan has exercised its option for EDIT-101 andAllergan has paid an option exercise fee of$15 million , which will be recorded in the third quarter. In addition, Editas is eligible to receive a$25 million milestone payment fromAllergan upon clearance of an IND application for EDIT-101.
- EDIT-101 advancing towards clinical trials with NIH filing submitted in July and IND filing anticipated in
October 2018 . Editas submitted the requisite data package for human gene transfer clinical protocol registration to theUnited States National Institutes of Health (NIH) for potential review by theRecombinant DNA Advisory Committee . Editas plans to file an IND application for EDIT-101 with theUnited States Food and Drug Administration inOctober 2018 . In addition, the Company presented new pre-clinical data on EDIT-101 at theAmerican Society of Gene & Cell Therapy 21st Annual Meeting (ASGCT Meeting) demonstrating that EDIT-101 was well tolerated in a study of non-human primates (NHPs). Therapeutically relevant levels of editing were achieved in NHPs regardless of pre-existing or induced immunity to Staphylococcus aureus Cas9.
- Broader ocular pipeline moving forward. Editas is pursuing product candidates for Usher Syndrome type 2A (USH2A) and recurrent ocular Herpes Simplex Virus type 1 (HSV-1). At the ASGCT Meeting, Editas and collaborators from Massachusetts Eye and Ear presented in vitro data demonstrating that deletion of exon 13 in the human USH2A gene using CRISPR/Cas9 can restore cilia formation, providing the basis for a potential medicine. Editas also presented pre-clinical in vivo proof-of-concept data in a rabbit model for its recurrent ocular HSV-1 program at the
Association for Research in Vision and Ophthalmology 2018 Annual Meeting.
- Designing novel medicines for Sickle Cell Disease and Beta-Thalassemia. Editas reported data at the ASGCT Meeting demonstrating that lead molecules targeting the beta-globin locus drove the upregulation of fetal hemoglobin in human mobilized peripheral blood stem cells. This was achieved by editing a novel genomic site that has potential to result in a best-in-class medicine. Editas expects to present additional data on this program in the second half of 2018.
- Improving efficacy of engineered T cell medicines to treat cancer with CRISPR-based gene editing. In May, Editas expanded its collaboration with
Juno Therapeutics, Inc. , aCelgene company (Celgene ), to develop and commercialize engineered T cell medicines for cancer. The recently expanded collaboration now encompasses four programs, including checkpoint inhibitors, tumor microenvironment, T cell receptor locus editing, and an undisclosed program.
- Strong balance sheet to advance Company through multiple value inflection points. The Company held cash, cash equivalents, and marketable securities of
$344.1 million as ofJune 30, 2018 , providing at least 24 months of funding for operating expenses and capital expenditures without any assumption of future cash received from milestones or additional financings.
Upcoming Events
Editas will participate in the following investor conferences:
- Citi 13th Annual
Biotech Conference ,Gene Editing Panel ,September 5 ,1:15 p.m. ET ,Boston ; Morgan Stanley 16th Annual Global Healthcare Conference, Fireside Chat,September 12 ,4:50 p.m. ET ,New York City ;- Jefferies Gene Therapy Summit,
September 27 ,New York City ; and - Chardan 2nd Annual
Genetic Medicines Conference ,October 9 ,New York City .
Editas will also participate in the following scientific and medical conferences:
- 26th Annual
Congress of theEuropean Society of Gene & Cell Therapy ,October 16-19 , Lausanne.
Second Quarter 2018 Financial Results
Cash, cash equivalents, and marketable securities at
For the second quarter ended
- Collaboration and other research and development revenues were
$7.4 million for the quarter endedJune 30, 2018 , compared to$3.1 million for the same period in 2017. The$4.3 million increase was primarily attributable to$3.9 million in revenue recognized pursuant to a license agreement withBeam Therapeutics Inc. and a$2.8 million increase in revenue recognized pursuant to our collaboration agreement withCelgene , partially offset by a$2.4 million decrease in revenue recognized pursuant to our strategic alliance withAllergan .
- Research and development expenses were
$32.7 million for the quarter endedJune 30, 2018 , compared to$17.3 million for the same period in 2017. The$15.4 million increase was primarily attributable to$9.6 million in increased sublicensing and success payment expenses resulting from$12.5 million in research funding payments related to our sponsored research agreement with theBroad Institute which were partially offset by a decrease in sublicensing fees,$3.1 million in increased process and platform development expenses,$1.4 million in increased employee related expenses,$0.9 million in increased stock-based compensation expenses, and$0.4 million in increased facility-related expenses.
- General and administrative expenses were
$14.3 million for the quarter endedJune 30, 2018 , compared to$11.9 million for the same period in 2017. The$2.4 million increase was attributable to$1.1 million in increased stock-based compensation expenses,$0.7 million in increased employee related expenses, and$0.7 million in increased professional service expenses, partially offset by$0.2 million in decreased intellectual property and patent related fees.
Conference Call
The Editas management team will host a conference call and webcast today,
About
As a leading 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 “aim,” ‘‘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 Company planning to file an IND for EDIT-101 in
Editas Medicine, Inc. | |||||||||
Condensed Consolidated Statements of Operations | |||||||||
(unaudited) | |||||||||
(amounts in thousands, except per share and share data) | |||||||||
Three Months Ended | |||||||||
June 30, | |||||||||
2018 | 2017 | ||||||||
Collaboration and other research and development revenues | $ | 7,372 | $ | 3,097 | |||||
Operating expenses: | |||||||||
Research and development | 32,718 | 17,318 | |||||||
General and administrative | 14,311 | 11,894 | |||||||
Total operating expenses | 47,029 | 29,212 | |||||||
Operating loss | (39,657 | ) | (26,115 | ) | |||||
Other income (expense), net: | |||||||||
Other income, net | 154 | 122 | |||||||
Interest income (expense), net | 780 | (446 | ) | ||||||
Total other income (expense), net | 934 | (324 | ) | ||||||
Net loss | $ | (38,723 | ) | $ | (26,439 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.82 | ) | $ | (0.65 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 46,952,059 | 40,830,161 |
Editas Medicine, Inc. | |||||
Selected Condensed Consolidated Balance Sheet Items | |||||
(unaudited) | |||||
(amounts in thousands) | |||||
June 30, | December 31, | ||||
2018 | 2017 | ||||
Cash, cash equivalents, and marketable securities | $ | 344,080 | $ | 329,139 | |
Working capital | 324,217 | 295,492 | |||
Total assets | 393,530 | 373,260 | |||
Deferred revenue, net of current portion | 104,929 | 94,725 | |||
Construction financing lease obligation, net of current portion | 32,944 | 33,431 | |||
Total stockholders’ equity | 231,332 | 208,080 |
Media Contact
(617) 401-0113
cristi.barnett@editasmed.com
Investor Contact
(617) 401-9083
mark.mullikin@editasmed.com