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Editas Medicine Remains on Track

By Steve Symington - Aug 6, 2019 at 9:10PM

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With a new CEO in place and a groundbreaking "in vivo" dosing study approaching, the gene-editing leader is rightly excited for the future.

Editas Medicine (EDIT 6.89%) announced second-quarter 2019 results on Tuesday after the market closed, once again confirming its on track to move forward with a historic dose-escalation trial for its primary drug candidate, EDIT-101, while advancing its agenda for future experimental medicines. The genome-editing specialist also named a permanent CEO to stand at the helm following the surprise departure of its last chief executive earlier this year.

Let's slice deeper, then, to better understand how EDITAS ended the first half, as well as its plans for coming quarters.

Gloved hand using medical tweezers to remove a piece of an illustrated DNA strand.

IMAGE SOURCE: GETTY IMAGES.

Editas Medicine results: The raw numbers

Metric

Q2 2019

Q2 2018

Year-Over-Year Growth

Collaboration and other R&D revenue

$2.330 million

$7.372 million

(68.4%)

GAAP net income (loss)

($33.786 million)

($38.723 million)

N/A

GAAP net income (loss) per share

($0.69)

($0.82)

N/A

Data source: Editas Medicine. R&D = research and development; GAAP = generally accepted accounting principles. 

What happened with Editas Medicine this quarter?

  • Editas' revenue decline was primarily driven by lower revenue recognized under its collaboration agreement with Celgene (NASDAQ: CELG), as well as an out-licence agreement it entered during last year's second quarter.
  • R&D expenses declined 28% to $23.6 million, primarily because of lower sub-licensing and success-payment expenses relative to last year's second quarter.
  • Editas ended the quarter with cash, cash equivalents, and marketable securities of $317.9 million, down from roughly $342 million three months earlier. Still, Editas reminded investors that's good for "at least 24 months" of funding operations and capital expenditures.
  • Patient screening has been initiated for Editas' EDIT-101 treatment for Leber congenital amaurosis type 10 (LCA10). The company continues to expect to enroll 18 patients, ages 3 and above, in a phase 1/2 open-label, dose-escalation study in the second half of 2019 -- marking the first-ever trial of an in-vivo (editing inside the body) CRISPR medicine.
  • Editas expects to be ready for IND-enabling studies (an "IND" is an Investigational New Drug) by the end of 2019 for an experimental medicine to treat Usher syndrome type 2A (USH2A).
  • IND-enabling activities are also under way for EDIT-301, a potential treatment for Sickle Cell Disease and Beta-thalassemia. Editas plans to present pre-clinical in vivo data on EDIT-301 at a 2019 medical conference.
  • Editas is also building a Good Manufacturing Practice facility in Boulder, Colorado, to supply guide RNA and ribunucleoprotein in support of EDIT-301. The facility should be commissioned in 2020.
  • Editas is moving forward engineered cell medicines for cancer including engineered T-cells in collaboration with Celgene's Juno Therapeutics, as well as its own wholly owned engineered NK cell programs.
  • Today, Editas formally named Cynthia Collins as its permanent CEO. Collins had previously served as Editas' interim CEO since Katrine Bosley stepped down in early March.

What management had to say

Collins stated she's "pleased and honored to be appointed CEO at this exciting time for the company," adding:

Our team is making history with enrollment under way 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.

Looking forward

Editas does not provide specific quarterly revenue or earnings guidance. But the company effectively told investors everything they could have hoped to hear in these early stages, from EDIT-101's dosing trial remaining on track to the continued allocation of capital to support its growing portfolio of other experimental medicines.

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