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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 in the United States. Editas and Allerganannounced today that Allerganhas exercised its option for EDIT-101 and Allerganhas 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 millionmilestone payment from Allerganupon 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 the United States National Institutes of Health(NIH) for potential review by the Recombinant DNA Advisory Committee. Editas plans to file an IND application for EDIT-101 with the United States Food and Drug Administrationin October 2018. In addition, the Company presented new pre-clinical data on EDIT-101 at the American Society of Gene & Cell Therapy21st 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 Ophthalmology2018 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., a Celgenecompany ( 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 millionas of June 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.
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 Stanley16th 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
Congressof the European 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 millionfor the quarter ended June 30, 2018, compared to $3.1 millionfor the same period in 2017. The $4.3 millionincrease was primarily attributable to $3.9 millionin revenue recognized pursuant to a license agreement with Beam Therapeutics Inc.and a $2.8 millionincrease in revenue recognized pursuant to our collaboration agreement with Celgene, partially offset by a $2.4 milliondecrease in revenue recognized pursuant to our strategic alliance with Allergan.
- Research and development expenses were
$32.7 millionfor the quarter ended June 30, 2018, compared to $17.3 millionfor the same period in 2017. The $15.4 millionincrease was primarily attributable to $9.6 millionin increased sublicensing and success payment expenses resulting from $12.5 millionin research funding payments related to our sponsored research agreement with the Broad Institutewhich were partially offset by a decrease in sublicensing fees, $3.1 millionin increased process and platform development expenses, $1.4 millionin increased employee related expenses, $0.9 millionin increased stock-based compensation expenses, and $0.4 millionin increased facility-related expenses.
- General and administrative expenses were
$14.3 millionfor the quarter ended June 30, 2018, compared to $11.9 millionfor the same period in 2017. The $2.4 millionincrease was attributable to $1.1 millionin increased stock-based compensation expenses, $0.7 millionin increased employee related expenses, and $0.7 millionin increased professional service expenses, partially offset by $0.2 millionin decreased intellectual property and patent related fees.
The Editas management team will host a conference call and webcast today,
As a leading genome editing company,
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “aim,” ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the Company planning to file an IND for EDIT-101 in
|Editas Medicine, Inc.|
|Condensed Consolidated Statements of Operations|
|(amounts in thousands, except per share and share data)|
|Three Months Ended|
|Collaboration and other research and development revenues||$||7,372||$||3,097|
|Research and development||32,718||17,318|
|General and administrative||14,311||11,894|
|Total operating expenses||47,029||29,212|
|Other income (expense), net:|
|Other income, net||154||122|
|Interest income (expense), net||780||(446||)|
|Total other income (expense), net||934||(324||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.82||)||$||(0.65||)|
|Weighted-average common shares outstanding, basic and diluted||46,952,059||40,830,161|
|Editas Medicine, Inc.|
|Selected Condensed Consolidated Balance Sheet Items|
|(amounts in thousands)|
|June 30,||December 31,|
|Cash, cash equivalents, and marketable securities||$||344,080||$||329,139|
|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|