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): August 9, 2016
Editas Medicine, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
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001-37687 |
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46-4097528 |
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(State or Other Jurisdiction |
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(Commission |
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(IRS Employer |
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300 Third Street, First Floor |
02142 |
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(Address of Principal Executive Offices) |
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(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 August 9, 2016, Editas Medicine, Inc., a Delaware corporation (the “Company”), issued a press release announcing financial results for the fiscal quarter ended June 30, 2016 and other business highlights. 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
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Exhibit |
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Description |
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99.1 |
Press release issued by the Company on August 9, 2016* |
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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.
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EDITAS MEDICINE, INC. |
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Date: August 9, 2016 |
By: |
/s/ Andrew A. F. Hack |
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Andrew A. F. Hack |
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Chief Financial Officer |
EXHIBIT INDEX
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Exhibit |
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Description |
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99.1 |
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Press release issued by the Company on August 9, 2016* |
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* |
This exhibit shall be deemed to be furnished and not filed. |
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Exhibit 99.1 |
Editas Medicine Announces Second Quarter 2016 Results and Update
Exclusive license to high-fidelity Cas9 and Cas9 PAM variants from Massachusetts General Hospital further advances leading genome editing platform
Strategic partnership with Adverum to explore delivery of genomic medicines
to treat range of genetic eye diseases
CAMBRIDGE, Mass., August 9, 2016 – Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today reported financial results for the second quarter ended June 30, 2016, and provided an update on recent accomplishments and upcoming events.
“We continue to make strong progress advancing our leadership position in genome editing and developing important new medicines for patients with a wide range of genetically-defined diseases,” said Katrine Bosley, President and Chief Executive Officer of Editas Medicine. “With our recent strategic agreements with Massachusetts General Hospital, Adverum, and San Raffaele Telethon Institute for Gene Therapy, we have significantly expanded our platform capabilities while continuing to enhance and expand our product pipeline.”
Recent Highlights
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Entered an exclusive licensing agreement with Massachusetts General Hospital for high-fidelity Cas9 and Cas9 PAM variants. These next-generation Cas9s have the potential to expand the range of genetically defined diseases that may be treated and to further improve on the specificity of the earlier versions of Cas9. |
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Established a collaboration with Adverum Biotechnologies to explore the use of Adverum's next-generation adeno-associated virus (AAV) vectors in up to five ophthalmic indications. We believe that the combination of Adverum’s vector technology and ophthalmic gene therapy expertise with our industry-leading genome editing platform has the potential to enhance and expand our pipeline of product candidates for inherited retinal diseases. |
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Formed a strategic collaboration with Fondazione Telethon and Ospedale San Raffaele, which operate a joint research collaboration known as the San Raffaele Telethon Institute for Gene Therapy, to advance genome edited hematopoietic stem cell and T cell therapies. The goal of this three-year research collaboration includes the development of gene correction strategies for the treatment of a wide range of genetically-defined diseases. |
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Appointed Akshay Vaishnaw, M.D., Ph.D., to our board of directors. Dr. Vaishnaw brings deep expertise in developing a new therapeutic modality from Alnylam Pharmaceuticals, Inc., where he currently serves as the Executive Vice President of Research & Development and Chief Medical Officer. |
Upcoming Events
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Editas management will present a company overview and host meetings with investors at the Morgan Stanley Global Healthcare Conference to be held September 12-14. |
Second Quarter 2016 Financial Results
Cash and cash equivalents at June 30, 2016 were $217.7 million, compared to $143.2
million at December 31, 2015.
For the three months ended June 30, 2016, net loss attributable to common stockholders was $19.0 million, or $0.54 per share, compared to $47.7 million, or $21.45 per share, for the same period in 2015.
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Collaboration and other research and development revenues were $3.4 million for the three months ended June 30, 2016 and represented $3.3 million of revenue recognized pursuant to our collaboration with Juno Therapeutics, Inc. including $2.5 million related to the first milestone payment, and $0.1 million of revenue recognized pursuant to our agreement with Cystic Fibrosis Foundation Therapeutics, Inc. Collaboration and other research and development revenues were $0.2 million for the three months ended June 30, 2015 and represented revenue recognized pursuant to our collaboration with Juno Therapeutics. |
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Research and development expenses increased by $3.1 million, to $10.4 million for the three months ended June 30, 2016 from $7.3 million for the three months ended June 30, 2015. The $3.1 million increase was due to a $4.8 million increase in employee and non-employee related expenses, including stock-based compensation resulting from an increase in the size of our workforce, a $1.5 million increase in our process and platform development expenses due to increased research activity, and a $0.9 million increase in facility related costs as a result of additional office and laboratory space. These increases were partially offset by a decrease of $4.1 million in license fees and expenses, resulting from our having incurred $4.1 million in fees and expenses under agreements with licensors in the three months ended June 30, 2015 as a result of our entry into our collaboration agreement with Juno Therapeutics. |
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General and administrative expenses increased by $8.9 million to $12.2 million for the three months ended June 30, 2016 from $3.3 million for the three months ended June 30, 2015. The $8.9 million increase in general and administrative expenses was primarily attributable to increases of $5.7 million in legal fees to support our intellectual property, including costs for the prosecution and maintenance of our patents as well as to procure the application for |
and issuance of additional patents in the United States and other jurisdictions, $2.3 million in employee compensation cost, $0.3 million in consulting fees and $0.6 million in other general and administrative expenses. |
Conference Call
The Editas management team will host a conference call and webcast today at 5:00 p.m. ET to provide and discuss a corporate update and second quarter 2016 financial results. To access the call, please dial 877-809-6321 (domestic) or 615-247-0223 (international) and provide the passcode 56269948. A live webcast of the call will be available on the Investors & Media section of the Editas website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.
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.
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EDITAS MEDICINE, INC. |
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Consolidated Statement of Operations |
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(amounts in thousands, except per share and share data) |
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(Unaudited) |
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Three Months Ended |
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June 30, |
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2016 |
2015 |
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Collaboration and other research and development revenues |
$ |
3,388 |
$ |
167 | |||||
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Operating expenses: |
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Research and development |
10,430 | 7,282 | |||||||
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General and administrative |
12,158 | 3,281 | |||||||
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Total operating expenses |
22,588 | 10,563 | |||||||
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Operating loss |
(19,200) | (10,396) | |||||||
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Other income (expense), net: |
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Other income (expense), net |
5 | (37,141) | |||||||
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Interest income (expense), net |
153 | (34) | |||||||
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Total other income (expense), net |
158 | (37,175) | |||||||
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Net loss and comprehensive loss |
$ |
(19,042) |
$ |
(47,571) | |||||
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Accretion of redeemable convertible |
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preferred stock to redemption value |
- |
(96) | |||||||
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Net loss attributable to common stockholders |
$ |
(19,042) |
$ |
(47,667) | |||||
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Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.54) |
$ |
(21.45) | |||||
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Weighted-average common shares |
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outstanding, basic and diluted |
35,286,719 | 2,222,064 | |||||||
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EDITAS MEDICINE, INC. |
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Selected Condensed Consolidated Balance Sheet Items |
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(amounts in thousands) |
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(Unaudited) |
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June 30, |
December 31, |
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2016 |
2015 |
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Cash and cash equivalents |
$ |
217,650 |
$ |
143,180 | |||
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Working capital |
207,497 | 138,060 | |||||
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Total assets |
249,602 | 149,363 | |||||
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Deferred revenue |
25,642 | 25,321 | |||||
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Redeemable convertible preferred stock |
- |
199,915 | |||||
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Total stockholders' equity (deficit) |
187,330 | (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