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Editas Medicine Makes Steady Progress in Another Solid Quarter

By Steve Symington – Nov 8, 2018 at 8:00AM

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From filing its IND filing for EDIT-101 to new data on new engineered cell treatments, the genome editing company delivered just as promised in Q3.

Editas Medicine (EDIT -4.22%) announced third-quarter 2018 results on Wednesday after the market closed. The genome editing pioneer offered the latest details regarding its financial position and a crucial step for its key EDIT 101 drug candidate for treating Leber Congentical Amaurosis type 10 -- the leading cause of childhood blindness -- and progress moving forward various other earlier-stage medicines in its pipeline.

With shares up modestly in response as of this writing, let's dig deeper to see what Editas Medicine had to say.

Strand of DNA with a missing section being inserted

IMAGE SOURCE: GETTY IMAGES.

Editas Medicine results: The raw numbers

Metric

Q3 2018

Q3 2017

Year-Over-Year Growth

Collaboration and other R&D revenue

$14.5 million

$6.3 million

%

GAAP net income (loss)

($15.2 million)

($26.6 million)

N/A

GAAP net income (loss) per share

($0.32)

($0.62)

N/A

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

What happened with Editas Medicine this quarter?

  • Revenue growth was driven by a $10.6 million increase in revenue recognized under Editas' strategic alliance with Allergan -- under which the two companies will co-develop and share equal profits and losses from EDIT-101 in the United States -- and $0.1 million in revenue under a license agreement with Beam Therapeutics.
  • R&D expenses declined 14.7% year over year to $20.4 million, primarily driven by lower reimbursable sublicensing, process and platform development expenses under the Allergan profit-sharing agreement.
  • Editas ended the quarter with $337.5 million of cash, cash equivalents, and marketable securities, good for at least 24 months of funding for operating expenses and capital expenditures without any future cash received from milestones or financing.
  • In October, Editas filed an investigational new drug (IND) application for EDIT-101 with the U.S. Food and Drug Administration. Editas is also eligible to receive a $25 million milestone payment from Allergan upon clearance of this IND application.
  • The National Institutes of Health determined a recombinant DNA advisory committee review of the protocol for the phase 1 and 2 trials of EDIT-101 was unnecessary, so the protocol is now registered with the NIH. Editas plans to treat 10 to 20 patients in a dose escalation study to "evaluate the safety and efficacy of EDIT-101."
  • A Federal Appeals Court upheld the U.S. Patent and Trademark Office's "no interference-in-fact decision" for certain CRISPR/Cas9 patents, which Editas exclusively licenses from Broad Institute. These patents contain foundational IP that Editas believes is "essential to making CRISPR medicines."

What management had to say

Editas CEO Katrine Bosley stated:

The filing of the IND for EDIT-101 for the treatment of LCA10 marks a significant milestone for Editas and brings us closer to helping people living with this devastating disease. We have also made important progress on our engineered cell medicines and we look forward to presenting data from our novel program to treat Sickle Cell Disease and Beta-Thalassemia in an oral presentation at the American Society of Hematology meeting next month.

Looking forward

Editas does not offer specific quarterly financial guidance. But there were no big surprises this quarter, which is a great thing for the early-stage genome editing specialist. Rather, the company filed its IND for EDIT-101 last month just as it said it would -- and this while simultaneously moving forward with other promising medicines and maintaining a balance sheet with plenty of wiggle room to continue its quest for upending the world of serious-disease treatment as we know it.

Steve Symington has no position in any of the stocks mentioned. The Motley Fool recommends Editas Medicine. The Motley Fool has a disclosure policy.

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