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Cynthia (Cindy) Collins named President and Chief Executive Officer
Initiated Brilliance Phase 1/2 clinical trial of EDIT-101(AGN-151587) for LCA10
Patient dosing in Brilliance trial on track for 2H19
EDIT-301 for hemoglobinopathies pre-clinical in vivo data to be presented by YE19
Cash, cash equivalents, and marketable securities of $317.9 million as of June 30, 2019
CAMBRIDGE, Mass., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today reported business highlights and financial results for the second quarter of 2019.
"I am pleased and honored to be appointed CEO at this exciting time for the company," said Cynthia Collins, President and Chief Executive Officer of Editas Medicine. “Our team is making history with enrollment underway and patient dosing anticipated in the first ever clinical trial of an in vivo CRISPR medicine. As we enter this new phase in our company’s development, we are also advancing our broader pipeline of in vivo CRISPR medicines, including our Usher syndrome program, as well as engineered cell medicines for hemoglobinopathies and cancers.”
Recent Achievements and Outlook
In Vivo CRISPR Medicines
Engineered Cell Medicines
Editas Medicine plans to participate in the following investor events:
Editas Medicine plans to participate in the following scientific and medical conferences:
Second Quarter 2019 Financial Results
Cash, cash equivalents, and marketable securities at June 30, 2019, were $317.9 million, compared to $369.0 million at December 31, 2018.
For the three months ended June 30, 2019, net loss attributable to common stockholders was $33.8 million, or $0.69 per share, compared to $38.7 million, or $0.82 per share, for the same period in 2018.
The Editas Medicine management team will host a conference call and webcast today at 5:00 p.m. ET to provide and discuss a corporate update and financial results for the second quarter of 2019. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 8968723. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.
About Editas Medicine
As a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit www.editasmedicine.com.
About EDIT-101 (AGN-151587)
EDIT-101 is a CRISPR-based experimental medicine under investigation for the treatment of Leber congenital amaurosis 10 (LCA10). EDIT-101 is administered via a subretinal injection to reach and deliver the gene editing machinery directly to photoreceptor cells.
About Leber Congenital Amaurosis
Leber congenital amaurosis, or LCA, is a group of inherited retinal degenerative disorders caused by mutations in at least 18 different genes. It is the most common cause of inherited childhood blindness, with an incidence of two to three per 100,000 live births worldwide. Symptoms of LCA appear within the first years of life, resulting in significant vision loss and potentially blindness. The most common form of the disease, LCA10, is a monogenic disorder caused by mutations in the CEP290 gene and is the cause of disease in approximately 20‑30 percent of all LCA patients.
About the Editas Medicine-Allergan Alliance
In March 2017, Editas Medicine and Allergan Pharmaceuticals International Limited (Allergan) entered a strategic alliance and option agreement under which Allergan received exclusive access and the option to license up to five of Editas Medicine’s genome editing programs for ocular diseases, including EDIT-101 (AGN-151587). Under the terms of the agreement, Allergan is responsible for development and commercialization of optioned products, subject to Editas Medicine’s option to co-develop and share equally in the profits and losses of two optioned products in the United States. In August 2018, Allergan exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10. Additionally, Editas Medicine exercised its option to co-develop and share equally in the profits and losses from EDIT-101 in the United States. Editas Medicine is also eligible to receive development and commercial milestones, as well as royalty payments on a per-program basis. The agreement covers a range of first-in-class ocular programs targeting serious, vision-threatening diseases based on Editas Medicine’s unparalleled CRISPR genome editing platform, including CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a).
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. Forward-looking statements in this press release include statements regarding the Company’s plans with respect to the Brilliance Phase 1/2 clinical trial for EDIT-101 (AGN-151587), including dosing patients in the second half of 2019, and its expectations of completing a manufacturing facility in Colorado. 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 because of new information, future events or otherwise.
|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||$||2,330||$||7,372|
|Research and development||23,565||32,718|
|General and administrative||14,414||14,311|
|Total operating expenses||37,979||47,029|
|Other income, net:|
|Other (expense) income, net||(68)||154|
|Interest income, net||1,931||780|
|Total other income, net||1,863||934|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.69)||$||(0.82)|
|Weighted-average common shares outstanding, basic and diluted||49,070,574||46,952,059|
|Editas Medicine, Inc.|
|Selected Condensed Consolidated Balance Sheet Items|
|(amounts in thousands)|
|June 30,||December 31,|
|Cash, cash equivalents, and marketable securities||$||317,930||$||368,955|
|Deferred revenue, net of current portion||75,911||115,614|
|Construction financing lease obligation, net of current portion||—||32,417|
|Total stockholders’ equity||193,062||236,162|