Intellia Therapeutics Announces Third Quarter 2019 Financial Results
31 Octobre 2019 - 12:30PM
Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported operational
highlights and financial results for the third quarter ended
September 30, 2019.
“In 2019, we continued to leverage the breadth of our genome
editing platform to advance our in vivo and engineered cell therapy
programs. We have demonstrated that we can knock out a
disease-causing gene as well as introduce a functional gene to
restore normal protein production. Now, we have achieved
consecutive editing in vivo by combining both these edit types,
further highlighting the versatility of our modular platform,” said
Intellia President and Chief Executive Officer, John Leonard, M.D.
“Our full-spectrum strategy and platform capabilities are enabling
Intellia’s development of a robust pipeline to address a range of
severe diseases. We look forward to the planned nomination of our
first engineered cell therapy development candidate for acute
myeloid leukemia by year-end and the submission of our first IND
application for NTLA-2001 for the treatment of transthyretin
amyloidosis in mid-2020.”
Third Quarter 2019 and More Recent Operational
Highlights
- ATTR Program: Intellia remains on track to
submit in mid-2020 an investigational new drug (IND) application
for NTLA-2001 for the treatment of transthyretin amyloidosis
(ATTR). NTLA-2001 is anticipated to be the first systemically
delivered CRISPR/Cas9 therapy to enter the clinic. As part of an
ongoing durability study of its lead lipid nanoparticle (LNP)
formulation in support of NTLA-2001, Intellia has demonstrated 10
months of durable liver editing with sustained reduction of
circulating transthyretin (TTR) protein (average reduction >95%)
following a single dose in non-human primates. In preparation for
the submission of the IND application, the Company announced today
it has commenced clinical-scale manufacturing for Phase 1
materials. NTLA-2001 is part of a co-development/co-promotion
(Co/Co) agreement with Regeneron Pharmaceuticals, Inc., with
Intellia as the lead development and commercialization party.
- WT1-TCR for AML Program: Intellia is on track
to nominate its first T cell receptor (TCR)-directed engineered
cell therapy development candidate by the end of 2019. The initial
application of the in-locus TCR-based approach consists of
autologous T cells directed towards the intracellular antigen
Wilms’ Tumor 1 (WT1) for the treatment of acute myeloid leukemia
(AML). During the third quarter and more recently, Intellia
continued to generate data from ongoing studies of multiple lead
TCRs in patient-derived xenograft models to support the nomination
of a development candidate for AML. Concurrently, the Company
advanced GMP manufacturing-related development activities in
support of a Phase 1 clinical trial.
- In Vivo Platform: At the
recent 2019 European Society of Gene and Cell Therapy (ESGCT)
Annual Meeting, Intellia presented the first demonstration of
consecutive in vivo gene knockout and targeted insertion in an
alpha-1 antitrypsin deficiency (AATD) mouse model. The consecutive
edits led to >98% reduction of the disease-causing protein and
sustained restoration of the normal protein to therapeutically
relevant circulating levels throughout the study.The novel genome
editing strategy is enabled by the ability to sequentially dose
with LNPs, one of the key advantages to Intellia’s non-viral
delivery system.
Upcoming Milestones
The Company has set forth the following for pipeline
progression:
- ATTR:
- Submit IND application for NTLA-2001 in mid-2020
- AML:
- Nominate first engineered cell therapy development candidate by
the end of 2019
Upcoming Events
The Company will participate in the following investor
events:
- Credit Suisse Healthcare Conference, November 12, Scottsdale,
Arizona
- Barclays Gene Editing and Gene Therapy Summit, November 13, New
York City
Third Quarter 2019 Financial Results
- Cash Position: Cash, cash
equivalents and marketable securities were $295.8 million as of
September 30, 2019, compared to $314.1 million as of December 31,
2018. The decrease was driven by cash used to fund operations of
approximately $90.5 million, which was offset in part by $54.1
million of net equity proceeds raised from the Company's "At the
Market" (ATM) agreement, $8.0 million of funding received under the
Novartis collaboration, $7.3 million of ATTR cost reimbursements
made by Regeneron, and $2.8 million in proceeds from employee-based
stock plans.
- Collaboration Revenue:
Collaboration revenue increased by approximately $3.2 million to
$10.6 million during the third quarter of 2019, compared to $7.4
million during the third quarter of 2018. The increase in
collaboration revenue in 2019 was primarily driven by amounts
recognized from the expansion of the existing collaboration with
Novartis, as well as by amounts recognized under the Company’s ATTR
Co/Co agreement with Regeneron. As previously disclosed, Regeneron
funds approximately 50% of the development costs for the ATTR
program.
- R&D Expenses: Research
and development expenses increased by approximately $4.3 million to
$27.5 million during the third quarter of 2019, compared to $23.2
million during the third quarter of 2018. This increase was driven
primarily by the advancement of Intellia’s research programs,
research personnel growth to support these programs, as well as the
expansion of the development organization.
- G&A Expenses: General and
administrative expenses increased by approximately $0.2 million to
$8.4 million during the third quarter of 2019, compared to $8.3
million during the third quarter of 2018. This increase was driven
primarily by employee-related expenses to support Intellia’s
growing research and development efforts.
- Net Loss: The Company’s net
loss was $23.6 million for the third quarter of 2019, compared to
$22.7 million during the third quarter of 2018.
Financial Guidance
Intellia expects that its cash, cash equivalents and marketable
securities as of September 30, 2019, as well as technology access
and funding from Novartis and Regeneron, will enable Intellia to
fund its anticipated operating expenses and capital expenditure
requirements into the second half of 2021. This expectation
excludes any potential milestone payments or extension fees that
could be earned and distributed under the collaboration agreements
with Novartis and Regeneron or any strategic use of
capital not currently in the Company’s base-case planning
assumptions.
Conference Call to Discuss Third Quarter 2019
Earnings
The Company will discuss these results on a conference call
today, October 31, 2019, at 8 a.m. ET.
To join the call:
- U.S. callers should dial 888-208-1711 and use conference ID#
7693636, approximately five minutes before the call.
- International callers should dial + 1 856-344-9299 and use
conference ID# 7693636, approximately five minutes before the
call.
A replay of the call will be available through the Events and
Presentations page of the Investor Relations section on Intellia’s
website, beginning on October 31, 2019 at 12 p.m. ET.
About Intellia Therapeutics
Intellia Therapeutics is a leading genome editing company
focused on developing 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, and through improved cell therapies that can treat cancer
and immunological diseases, or can replace patients’ diseased
cells. The combination of deep scientific, technical and clinical
development experience, along with its leading intellectual
property portfolio, puts Intellia 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 and follow
us on Twitter @intelliatweets.
Forward-Looking Statements
This press release contains “forward-looking statements” of
Intellia Therapeutics, Inc. (“Intellia” or the “Company”) within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements include, but are not limited
to, express or implied statements regarding Intellia’s beliefs and
expectations regarding its planned submission of an investigational
new drug (“IND”) application for NTLA-2001 for the treatment of
transthyretin amyloidosis (“ATTR”) in mid-2020; its plans to
nominate a first T cell receptor (“TCR”)-directed engineered cell
therapy development candidate for its acute myeloid leukemia
(“AML”) program by the end of 2019; its plans to advance and
complete preclinical studies, including non-human primate studies
for its ATTR program, AML program and other in vivo and ex vivo
programs; develop our proprietary LNP-AAV hybrid delivery system to
advance our complex genome editing capabilities, such as gene
insertion; its presentation of additional data at upcoming
scientific conferences, and other preclinical data by the end of
2019; the advancement and expansion of its CRISPR/Cas9 technology
to develop human therapeutic products, as well as maintain and
expand its related intellectual property portfolio; the ability to
demonstrate its platform’s modularity and replicate or apply
results achieved in preclinical studies, including those in its
ATTR and AML programs, in any future studies, including human
clinical trials; its ability to develop other in vivo or ex
vivo cell therapeutics of all types, and those targeting WT1
in AML in particular, using CRISPR/Cas9 technology; the ability to
continue its growth and realize the anticipated contribution of the
members of its board of directors and executives to its operations
and progress; the impact of its collaborations on its development
programs, including but not limited to its collaborations with
Regeneron Pharmaceuticals, Inc. and Novartis Institutes for
BioMedical Research; statements regarding the timing of regulatory
filings regarding its development programs; its use of capital,
including ATM receivables, expenses, future accumulated deficit and
other financial results during the third quarter of 2019; and the
ability to fund operations into the second half of 2021. Any
forward-looking statements in this press release are based on
management’s current expectations and beliefs 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: risks related to
Intellia’s ability to protect and maintain our intellectual
property position, including through our arbitration proceedings
against Caribou; risks related to Intellia’s relationship with
third parties, including our licensors; risks related to the
ability of our licensors to protect and maintain their intellectual
property position; uncertainties related to the initiation and
conduct of studies and other development requirements for our
product candidates; the risk that any one or more of Intellia’s
product candidates will not be successfully developed and
commercialized; the risk that the results of preclinical studies or
clinical studies will not be predictive of future results in
connection with future studies; the risk that Novartis will not
continue to pursue programs it has selected through its
collaboration with Intellia; and the risk that Intellia’s
collaborations with Novartis or Regeneron or its
other ex vivo collaborations will not continue or will not be
successful. For a discussion of these and other risks and
uncertainties, and other important factors, any of which could
cause Intellia’s actual results to differ from those contained in
the forward-looking statements, see the section entitled “Risk
Factors” in Intellia’s most recent annual report on Form 10-K as
well as discussions of potential risks, uncertainties, and other
important factors in Intellia’s other filings with
the Securities and Exchange Commission. All information in
this press release is as of the date of the release,
and Intellia undertakes no duty to update this information
unless required by law.
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INTELLIA
THERAPEUTICS, INC. |
CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED) |
(Amounts in
thousands, except per share data) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2019 |
|
|
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2018 |
|
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2019 |
|
|
|
2018 |
|
Collaboration revenue |
|
$ |
10,616 |
|
|
$ |
7,408 |
|
|
$ |
32,167 |
|
|
$ |
22,554 |
|
Operating expenses: |
|
|
|
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|
|
|
|
|
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Research and development |
|
27,513 |
|
|
|
23,237 |
|
|
|
76,682 |
|
|
|
69,197 |
|
|
General and administrative |
|
|
8,431 |
|
|
|
8,270 |
|
|
|
32,082 |
|
|
|
23,481 |
|
|
|
Total operating expenses |
|
35,944 |
|
|
|
31,507 |
|
|
|
108,764 |
|
|
|
92,678 |
|
Operating loss |
|
|
|
(25,328 |
) |
|
|
(24,099 |
) |
|
|
(76,597 |
) |
|
|
(70,124 |
) |
Interest income |
|
|
|
1,694 |
|
|
|
1,397 |
|
|
|
5,340 |
|
|
|
3,847 |
|
Net loss |
|
|
|
$ |
(23,634 |
) |
|
$ |
(22,702 |
) |
|
$ |
(71,257 |
) |
|
$ |
(66,277 |
) |
Net loss per share, basic and diluted |
$ |
(0.49 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.53 |
) |
|
$ |
(1.55 |
) |
Weighted average shares outstanding, basic and diluted |
|
48,554 |
|
|
|
43,161 |
|
|
|
46,547 |
|
|
|
42,684 |
|
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INTELLIA
THERAPEUTICS, INC. |
CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED) |
(Amounts in
thousands) |
|
|
|
|
|
September 30, 2019 |
|
December 31, 2018 |
Cash, cash
equivalents and marketable securities |
$ |
295,790 |
|
$ |
314,059 |
Total
assets |
|
346,635 |
|
|
347,315 |
Total
liabilities |
|
70,983 |
|
|
69,395 |
Total
stockholders' equity |
|
275,652 |
|
|
277,920 |
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Intellia Contacts:
Investors:Lina LiAssociate DirectorInvestor
Relations+1 857-706-1612lina.li@intelliatx.com
Media:Jennifer Mound SmoterSenior Vice
PresidentExternal Affairs & Communications+1
857-706-1071jenn.smoter@intelliatx.com
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