Intellia Therapeutics Reports Financial Results for Third Quarter 2016
November 01 2016 - 4:05PM
Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing
company focused on the development of potentially curative
therapeutics using CRISPR/Cas9 technology, today reported results
for the quarter ended September 30, 2016 and provided an update on
recent highlights and upcoming events.
“We have demonstrated substantial progress in our research,
including being the first company to present data showing high
levels of in vivo editing in animal models using systemic
lipid nanoparticles to deliver CRISPR/Cas9 components,” said Nessan
Bermingham, Ph.D., Chief Executive Officer and Founder, Intellia
Therapeutics. “We continue to make further enhancements and remain
focused on advancing the development of CRISPR/Cas9-based
therapeutics for patients with severe unmet medical needs.”
Recent Highlights
- Intellia presented preclinical data demonstrating in vivo gene
editing using lipid nanoparticles (LNPs) to deliver CRISPR/Cas9.
These data were presented at the Genome Engineering: The CRISPR/Cas
Revolution meeting in Cold Spring Harbor, New York. In several
preclinical studies, the data showed:
- Progress in achieving in vivo editing, reporting an efficiency
of approximately 60 percent in mouse liver at the transthyretin
(TTR) target site after a single intravenous administration, which
was consistent across different lobes of the liver. This resulted
in an associated decrease in serum TTR protein levels of up to
approximately 80 percent;
- Dose-dependent editing by LNP delivery;
- Undetectable Cas9 mRNA and guide RNA (gRNA) in the liver at 72
hours post administration; and
- Repair patterns in mouse liver cells in vivo being best
predicted in vitro by primary mouse liver cells rather than cell
lines.
- Intellia presented four posters at the recent European Society
for Gene and Cell Therapy Congress (ESGCT) in Florence, Italy. The
data presentations included an update on the Company’s in vivo
delivery and DNA repair data and new methods for analyzing
off-target activity. In its presentation on off-target analysis,
Intellia described improved computational methods for readily
identifying guide RNAs with zero to few off-target events, an
essential step in developing CRISPR/Cas9-based therapeutics.
Third Quarter 2016 Financial Results
As of September 30, 2016, Intellia had $290.6 million in cash
and cash equivalents. Net loss for the third quarter 2016 was $7.5
million, compared to $3.0 million in the same period in 2015.
Collaboration revenue was $4.9 million in the third quarter
2016, compared to $1.7 million in the same period of 2015. For the
Novartis collaboration, Intellia recognized $2.0 million and $1.7
million in the third quarters of 2016 and 2015, respectively. The
Regeneron collaboration, announced in April 2016, for which the
Company recognized $2.9 million in the third quarter of 2016, was
the primary driver of the increase in collaboration revenue.
Research and development expenses in the third quarter 2016 were
$7.9 million, compared to $3.5 million in the same period in 2015.
This increase in expenses is primarily attributable to accelerating
the development of our CRISPR/Cas9 platform and advancing our
sentinel indications. These expenses include compensation and
benefits for employees, including equity-based compensation, and
expansion of Intellia’s facilities and laboratories.
General and administrative expenses were $4.7 million in the
third quarter of 2016, compared to $1.5 million for the same period
in 2015. The increase in general and administrative expenses is
primarily driven by expenses to support the Company's overall
growth and costs associated with being a publicly traded
company.
Upcoming Events
Intellia will present at the Fortune Brainstorm Health 2016
Conference in San Diego on November 2, 2016, the Credit Suisse
Healthcare Conference in Arizona on November 7, 2016, and the
Jefferies 2016 Healthcare Conference in London on November 16,
2016.
About Intellia Therapeutics
Intellia Therapeutics is a leading genome editing company,
focused on the development of proprietary, potentially curative
therapeutics using the CRISPR/Cas9 system. Intellia believes the
CRISPR/Cas9 technology has the potential to transform medicine by
permanently editing disease-associated genes in the human body with
a single treatment course. Our combination of deep scientific,
technical and clinical development experience, along with our
leading intellectual property portfolio, puts us in a unique
position to unlock broad therapeutic applications of the
CRISPR/Cas9 technology and create a new class of therapeutic
products. Learn more about Intellia Therapeutics and CRISPR/Cas9 at
intelliatx.com; Follow us on Twitter @intelliatweets.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward looking statements include, but are not limited
to, statements regarding our ability to advance CRISPR/Cas9 into
therapeutic products for severe and life-threatening diseases; the
potential timing and advancement of our clinical trials; the impact
of our collaborations with Novartis and Regeneron on our
development programs; the potential indications we may pursue,
including our sentinel indications; the potential timing of
regulatory filings regarding our development programs; and
potential commercialization opportunities for product candidates.
Any forward-looking statements in this press release are based on
management's current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the risk that any
one or more of our product candidates will not be successfully
developed and commercialized, the risk of cessation or delay of any
of the ongoing or planned clinical trials and/or our development of
our product candidates, the risk that the results of previously
conducted studies involving similar product candidates will not be
repeated or observed in ongoing or future studies involving current
product candidates, the risk that our collaboration
with Novartis or Regeneron will not continue or will not
be successful, and risks related to our ability to protect and
maintain our intellectual property position. For a discussion of
other risks and uncertainties, and other important factors, any of
which could cause our actual results to differ from those contained
in the forward-looking statements, see the section entitled "Risk
Factors" in our most recent quarterly report on Form 10-Q filed
with the Securities and Exchange Commission, as well as discussions
of potential risks, uncertainties, and other important factors in
our subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the
date of the release, and Intellia Therapeutics undertakes no duty
to update this information unless required by law.
INTELLIA
THERAPEUTICS, INC. |
CONSOLIDATED
STATEMENT OF OPERATIONS (UNAUDITED) |
(Amounts in
thousands) |
|
|
|
Three
Months Ended September 30, |
|
Nine Months
Ended September 30, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Collaboration
revenue |
|
$ |
4,869 |
|
|
$ |
1,688 |
|
|
$ |
10,852 |
|
|
$ |
4,351 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
7,861 |
|
|
|
3,458 |
|
|
|
20,509 |
|
|
|
6,795 |
|
General and administrative |
|
|
4,705 |
|
|
|
1,531 |
|
|
|
11,680 |
|
|
|
5,474 |
|
Total operating expenses |
|
|
12,566 |
|
|
|
4,989 |
|
|
|
32,189 |
|
|
|
12,269 |
|
Operating loss |
|
|
(7,697 |
) |
|
|
(3,301 |
) |
|
|
(21,337 |
) |
|
|
(7,918 |
) |
Interest income |
|
|
215 |
|
|
|
- |
|
|
|
266 |
|
|
|
- |
|
Loss before income
taxes |
|
|
(7,482 |
) |
|
|
(3,301 |
) |
|
|
(21,071 |
) |
|
|
(7,918 |
) |
Income tax benefit |
|
|
- |
|
|
|
282 |
|
|
|
- |
|
|
|
766 |
|
Net loss |
|
$ |
(7,482 |
) |
|
$ |
(3,019 |
) |
|
$ |
(21,071 |
) |
|
$ |
(7,152 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.22 |
) |
|
$ |
(10.27 |
) |
|
$ |
(1.16 |
) |
|
$ |
(48.65 |
) |
Weighted
average shares outstanding, basic and diluted |
|
|
34,316 |
|
|
|
294 |
|
|
|
18,098 |
|
|
|
147 |
|
|
|
|
|
|
|
|
|
|
INTELLIA
THERAPEUTICS, INC. |
CONSOLIDATED
BALANCE SHEET DATA (UNAUDITED) |
(Amounts in
thousands) |
|
|
|
September
30, 2016 |
|
December
31, 2015 |
Cash and
cash equivalents |
|
$ |
290,618 |
|
|
$ |
75,816 |
|
Total assets |
|
|
301,469 |
|
|
|
82,139 |
|
Total liabilities |
|
|
83,345 |
|
|
|
14,783 |
|
Convertible preferred
stock |
|
|
- |
|
|
|
88,557 |
|
Total stockholders'
equity (deficit) |
|
|
218,124 |
|
|
|
(21,201 |
) |
|
|
|
|
|
Media Contact:
Jennifer Mound Smoter
Chief External Affairs & Communications Officer
+1 857-706-1071
jenn.smoter@intelliatx.com
Investor Contacts:
John Graziano
Trout Group
+ 1 646-378-2942
jgraziano@troutgroup.com
Chad Rubin
Trout Group
+ 1 646-378-2947
crubin@troutgroup.com
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