Intellia Therapeutics Reports Financial Results for Second Quarter 2016
05 August 2016 - 6:10AM
Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing
company focused on the development of potentially curative
therapeutics using CRISPR/Cas9 technology, today reported financial
results and recent company highlights for the quarter ended June
30, 2016.
“Intellia has made substantial progress with our
science, financing and operations in the first half of 2016,” said
Nessan Bermingham, Ph.D., Chief Executive Officer and Founder,
Intellia Therapeutics. “Our product focus, therapeutic discovery
and development strength, delivery expertise and intellectual
property portfolio make Intellia well positioned to advance
CRISPR/Cas9 into clinically meaningful genome editing therapeutics
for patients with severe and life-threatening diseases.”
Recent Highlights
- On April 11, 2016, Intellia signed a multi-year research and
development collaboration and licensing agreement with Regeneron
Pharmaceuticals to advance CRISPR/Cas9 genome editing technology
for in vivo therapeutic development. Regeneron has the exclusive
rights to discover and develop CRISPR-based products against up to
10 targets, focused primarily on therapies for a broad range of
diseases that may be treated by editing genes in the liver.
Transthyretin amyloidosis (TTR) is the first target to be jointly
developed and potentially commercialized by the companies.
- The Company also strengthened its leadership team with the
addition of Perry Karsen as the Chairman of Intellia’s Board of
Directors. Mr. Karsen brings decades of biopharmaceutical
leadership experience to his role as Chairman. He most recently
held senior leadership positions at Celgene Corporation, including
Chief Operations Officer and Executive Vice President as well as
Chief Executive Officer of Celgene's cellular therapeutics
division.
- The Company, since its inception, has raised an aggregate of
$350.5 million, of which $170.5 million is from the initial public
offering and concurrent private placements in May 2016, $95 million
is through collaboration agreements, and $85 million is from the
sale of convertible preferred stock.
Second Quarter 2016 Financial
Results
As of June 30, 2016, Intellia had $300.7 million in
cash and cash equivalents, which includes net proceeds from its
initial public offering. Net loss for the second quarter 2016 was
$6.9 million, compared to $3.0 million in the same period in
2015.
Collaboration revenue was $4.2 million in the
second quarter 2016, compared to $1.4 million in the same period of
2015. The increase in collaboration revenue is primarily
attributable to the inclusion of amounts recognized under the
Regeneron collaboration in 2016.
Research and development expenses in the second
quarter 2016 were $7.4 million, compared to $2.0 million in the
same period in 2015. This increase in expenses is primarily
attributable to the growth of the Company’s research and
development organization to accelerate the development of the
CRISPR/Cas9 platform and Intellia’s proprietary and partnered
pipeline candidates.
General and administrative expenses were $3.7
million in the second quarter of 2016, compared to $2.8 million for
the same period in 2015. The increase in general and administrative
expenses is primarily driven by incremental expenses to support the
Company’s operations as a new public company, as well as increased
headcount-based expenses to support the Company's overall
growth.
Research & Development
Highlights
Intellia is advancing its pipeline through a
risk-mitigated approach focused on sentinel indication development,
platform delivery expansion, and preclinical and clinical scale up.
The Company is focused on developing the following programs:
Programs |
Partnerships |
Type of Edit |
|
|
Delivery |
Upcoming Milestones |
In Vivo |
Transthyretin Amyloidosis (ATTR) |
Co-developing with Regeneron |
Knockout |
|
|
LNP to Liver |
Select 1 to 2 development candidates and advance to
IND enabling studies in 2H2017/1H2018 |
Alpha-1 Antitrypsin Deficiency (AATD) |
Proprietary |
Knockout |
|
|
LNP to Liver |
Repair |
|
|
Hepatitis B Virus (HBV) |
Proprietary |
Knockout |
|
|
LNP to Liver |
Inborn Errors of Metabolism (IEMs) |
Proprietary |
Knockout |
|
|
LNP to Liver |
Repair |
|
|
Insertion |
|
|
Ex Vivo |
Hematopoietic Stem Cells (HSCs) |
Selectively partnered with Novartis; proprietary |
Knockout |
|
|
Electroporation |
First Novartis IND expected to be submitted in
2018 |
Repair |
|
|
Insertion |
|
|
CAR T Cells |
Partnered with Novartis |
Knockout |
|
|
Electroporation |
Advance preclinical development |
Insertion |
|
|
Upcoming Events
- Intellia will present delivery data utilizing CRISPR/Cas9 at
the Cold Spring Harbor Laboratory Meeting, taking place from August
17-20, 2016. The oral presentation, Robust In Vivo Gene Editing in
Mouse Hepatocytes with Systemic Lipid Nanoparticle Delivery of
CRISPR/Cas9 Components, will be presented by Intellia’s Chief
Technology Officer, David Morrissey, Ph.D.
- Intellia’s CEO & Founder Nessan Bermingham, Ph.D., will be
presenting at the Wedbush PacGrow Healthcare Conference in New York
on August 17, 2016, the Wells Fargo Healthcare Conference in
Boston, September 7-8, 2016, the Morgan Stanley Global Healthcare
Conference in New York on September 12, 2016, and the Leerink
Partners Rare Disease Roundtable Series in New York on September
28-29, 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. Intellia was named as one of the top 10 biotech start-ups
by Nature Biotechnology. In September 2015, Intellia was named a
“Fierce 15” biotech company by FierceBiotech. 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.
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|
|
|
|
|
|
|
|
Intellia Therapeutics, Inc. |
Consolidated Statements of
Operations |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
Six Months Ended June 30, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
Collaboration
revenue |
|
|
$ |
4,206 |
|
|
$ |
1,377 |
|
|
|
|
$ |
5,983 |
|
|
$ |
2,663 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
7,422 |
|
|
|
1,966 |
|
|
|
|
|
12,647 |
|
|
|
3,337 |
|
General and
administrative |
|
|
3,729 |
|
|
|
2,833 |
|
|
|
|
|
6,975 |
|
|
|
3,943 |
|
Total operating
expenses |
|
11,151 |
|
|
|
4,799 |
|
|
|
|
|
19,622 |
|
|
|
7,280 |
|
Operating loss |
|
|
|
(6,945 |
) |
|
|
(3,422 |
) |
|
|
|
|
(13,639 |
) |
|
|
(4,617 |
) |
Interest income |
|
|
|
46 |
|
|
|
- |
|
|
|
|
|
51 |
|
|
|
- |
|
Loss before income
taxes |
|
|
|
(6,899 |
) |
|
|
(3,422 |
) |
|
|
|
|
(13,588 |
) |
|
|
(4,617 |
) |
Income tax benefit |
|
|
|
- |
|
|
|
382 |
|
|
|
|
|
- |
|
|
|
484 |
|
Net loss |
|
|
$ |
(6,899 |
) |
|
$ |
(3,040 |
) |
|
|
|
$ |
(13,588 |
) |
|
$ |
(4,133 |
) |
|
Intellia Therapeutics, Inc. |
Consolidated Balance Sheets Data |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
|
|
June 30, 2016 |
|
|
|
December 31,
2015 |
Cash and cash
equivalents |
|
$ |
300,687 |
|
|
|
|
$ |
75,816 |
|
Total assets |
|
|
310,624 |
|
|
|
|
|
82,139 |
|
Total liabilities |
|
|
87,022 |
|
|
|
|
|
14,783 |
|
Convertible preferred
stock |
|
|
- |
|
|
|
|
|
88,557 |
|
Total stockholders'
equity (deficit) |
|
|
223,602 |
|
|
|
|
|
(21,201 |
) |
Media Contact:
Jennifer Mound Smoter
Chief External Affairs & Communications Officer
+1 224-804-4462
jenn.smoter@intelliatx.com
Investor Contacts:
John Graziano
Trout Group
646-378-2942
jgraziano@troutgroup.com
Chad Rubin
Trout Group
646-378-2947
crubin@troutgroup.com
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