edit_Current_Folio_8K

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 8-K


 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 16, 2016

 


 

Editas Medicine, Inc.

(Exact Name of Registrant as Specified in its Charter)

 


 

Delaware

 

001-37687

 

46-4097528

(State or Other Jurisdiction
of Incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

300 Third Street, First Floor
Cambridge, Massachusetts

 

02142

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (617) 401-9000

 

(Former Name or Former Address, if Changed Since Last Report)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


 

 

Item 2.02.       Results of Operations and Financial Condition

 

On May 16, 2016, Editas Medicine, Inc., a Delaware corporation (the “Company”), issued a press release announcing financial results for the fiscal quarter ended March 31, 2016. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information contained in Item 2.02 in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.

 

Description

99.1

 

Press release issued by the Company on May 16, 2016*

 

*  This exhibit shall be deemed to be furnished and not filed.

 


 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

EDITAS MEDICINE, INC.

 

 

 

Date: May 16, 2016

By:

/s/ Katrine S. Bosley

 

 

Katrine S. Bosley

 

 

President and Chief Executive Officer

 


 

 

EXHIBIT INDEX

 

Exhibit
No.

 

Description

99.1

 

Press release issued by the Company on May 16, 2016*

 

*  This exhibit shall be deemed to be furnished and not filed.

 


edit_Ex99_1

Exhibit 99.1

 

Picture 2

Editas Medicine Announces First Quarter 2016 Results and Update

 

 

Advancing pipeline and platform demonstrated by data presented at medical and scientific conferences as well as achievement of Juno Therapeutics milestone

 

Strengthened effort to develop medicines for cystic fibrosis through agreement with Cystic Fibrosis Foundation Therapeutics

 

Robust foundation of intellectual, financial, and human capital positions Editas for long-term success

 

 

CAMBRIDGE, Mass., May 16, 2016 – Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today reported financial results for the first quarter ended March 31, 2016, and provided an update on recent accomplishments and upcoming events.

 

“We have made significant progress this year in building Editas as a company and in advancing both our pipeline and platform,” said Katrine Bosley, President and Chief Executive Officer of Editas Medicine. “We are excited by the new data from our Duchenne muscular dystrophy program, as well as the additional results from our LCA10 program and our new data in hematopoietic stem cells. In addition, we were also delighted to announce our agreement with Cystic Fibrosis Foundation Therapeutics to discover and develop genomic medicines aimed at correcting the underlying mutations in this debilitating disease.”

 

 

Recent Highlights

 

·

Announced a three-year agreement with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, pursuant to which CFFT will pay up to $5 million to Editas Medicine to support the discovery and development of CRISPR/Cas9-based medicines for the treatment of cystic fibrosis (CF).  In addition, Editas will access CFFT’s extensive network of CF scientific advisors and clinical researchers.   

 

·

Presented data on Editas’ cancer, hematology, ophthalmology, and neuromuscular disease programs at two scientific conferences, the Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting and the 19th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), including:

 


 

-

Leber congenital amaurosis 10 (LCA10) program: Demonstration of Cas9-mediated editing of primary fibroblasts derived from LCA10 patients resulted in elimination of the target CEP290 gene mutation as well as restoration of full-length protein expression.  Evidence of guide RNAs with no detectable off-targets was also presented.

 

-

Duchenne muscular dystrophy (DMD) program:  The first data from the Company’s program to discover medicines to treat the underlying genetic cause of DMD showing that pairs of guide RNAs have the ability to remove exon 51 of the dystrophin gene with greater than 30% efficiency. These data demonstrated the potential for a genome editing approach to address the genetic changes responsible for causing the disease in approximately 10-15% of patients.

 

-

Hematopoietic stem/progenitor cells (HSPCs):    New data demonstrating long-term, robust engraftment in vivo after Cas9-mediated genome editing.  Importantly, the data also show that editing did not alter hematopoietic reconstitution or differentiation properties in comparison to untreated control HSPCs.

 

·

Announced that the Company has achieved a $2.5 million milestone under its collaboration with Juno Therapeutics, Inc. (NASDAQ: JUNO) for technical progress in a research program to create engineered T cells with chimeric antigen receptors and T cell receptors to treat cancer. 

 

 

Upcoming Events

 

·

Editas management will present a company overview and host meetings with investors at the Jefferies Healthcare Conference to be held June 7-10 and the JMP Securities Life Sciences Conference to be held June 21-22.

 

 

First Quarter 2016 Financial Results

 

Cash and cash equivalents at March 31, 2016 were $229.2 million, compared to $143.2 million at December 31, 2015. This includes total net proceeds of approximately $97.7 million from the Company's initial public offering of its common stock in February 2016. 

 

For the first quarter 2016, net loss attributable to common stockholders was $17.8 million, or $0.80 per share, compared to $5.4 million, or $2.75 per share, for the same period in 2015.

 

·

Collaboration revenue for the first quarter 2016 was approximately $0.8 million, resulting from reimbursement for research and development expenses under our collaboration with Juno Therapeutics entered into in May 2015.  No collaboration revenue was recognized in the first quarter of 2015.

 


 

·

Research and development expenses for the first quarter 2016 were approximately $8.9 million, compared to $1.9 million for the same period in 2015.  The increase was largely due to employee and non-employee related expenses, as well as process and platform development expenses.

 

·

General and administrative expenses were $9.8 million for the first quarter 2016, compared to $3.3 million for the same period in 2015.  The increase was largely due to legal fees to support our patents and patent applications, as well as employee compensation.

 

 

Conference Call

 

The Editas management team will host a conference call and webcast today at 8:30 a.m. ET to provide and discuss a corporate update and first quarter 2016 financial results. To access the call, please dial 877-809-6321 (domestic) or 615-247-0223 (international) and provide the passcode 97848711. A live webcast of the call will be available on the Investors & Media section of the Editas website at www.editasmedicine.com.  

 

 

About Editas Medicine

 

Editas Medicine is a leading genome editing company dedicated to treating patients with genetically-defined diseases by correcting their disease-causing genes. The Company was founded by world leaders in genome editing, and its mission is to translate the promise of genome editing science into a broad class of transformative genomic medicines to benefit the greatest number of patients.

 

 

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. 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 Quarterly Report on Form 10-Q, which is on file 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 speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 


 

 

EDITAS MEDICINE, INC.

Consolidated Statement of Operations

(amounts in thousands, except per share and share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2016

 

2015

 

Collaboration revenue

    

$

805 

    

$

-

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

 

8,882 

 

 

1,888 

 

General and administrative

 

 

9,762 

 

 

3,273 

 

Total operating expenses

 

 

18,644 

 

 

5,161 

 

Operating loss

 

 

(17,839)

 

 

(5,161)

 

Other income (expense), net:

 

 

 

 

 

 

 

Other expense, net

 

 

(30)

 

 

(99)

 

Interest income (expense), net

 

 

124 

 

 

(31)

 

Total other income (expense), net

 

 

94 

 

 

(130)

 

Net loss and comprehensive loss

 

$

(17,745)

 

$

(5,291)

 

Accretion of redeemable convertible preferred stock to redemption value

 

 

(47)

 

 

(95)

 

Net loss attributable to common Stockholders

 

$

(17,792)

 

$

(5,386)

 

 

 

 

 

 

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.80)

 

$

(2.75)

 

Weighted-average common shares outstanding, basic and diluted

 

 

22,280,797 

 

 

1,957,378 

 

 

 


 

 

EDITAS MEDICINE, INC.

Selected Consolidated Balance Sheet Items

(amounts in thousands)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

    

March 31,

    

December 31,

 

 

 

2016 

 

2015 

 

Cash and cash equivalents

 

$

229,204 

 

$

143,180 

 

Working capital

 

 

221,964 

 

 

138,060 

 

Total assets

 

 

248,808 

 

 

149,363 

 

Deferred revenue

 

 

25,479 

 

 

25,321 

 

Redeemable convertible preferred stock

 

 

-

 

 

199,915 

 

Total stockholders' equity (deficit)

 

 

201,363 

 

 

(83,114)

 

 

 

 

 

 

Media Contact

Dan Budwick

Pure Communications, Inc.

(973) 271-6085

dan@purecommunicationsinc.com 

 

Investor Contact

Jesse Baumgartner

Stern Investor Relations, Inc.

(212) 362-1200

jesse@sternir.com