Full Press Release Details
Intellia Therapeutics Announces
Second Quarter 2019 Financial Results and Company Update
CAMBRIDGE, Mass., Aug. 1, 2019 (GLOBE NEWSWIRE) Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported operational
highlights and financial results for the second quarter ended June 30, 2019.
We continue to build our in vivo and engineered cell
therapy pipeline in support of our mission to develop curative genome editing therapies for patients, said Intellia President and Chief Executive Officer John Leonard, M.D. With IND-enabling
toxicology studies underway for NTLA-2001, we are well-positioned to submit an IND in mid-2020 for the first systemically delivered CRISPR/Cas9-based therapy for transthyretin amyloidosis. Additionally, by the
end of this year, we plan to select our first engineered cell therapy development candidate to treat acute myeloid leukemia.
and More Recent Operational Highlights
The Company has set forth the
following for pipeline progression:
Second Quarter 2019 Financial Results
Intellia expects that its cash, cash equivalents, marketable securities and proceeds due from the ATM offerings as of June 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 Second Quarter 2019 Earnings
The Company will discuss these results on a conference call today, August 1, 2019, at 8 a.m. ET.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section of the Company s website at
www.intelliatx.com, beginning on August 1, 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
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 ability to conduct successful investigational new drug application ( IND )-enabling toxicology studies of NTLA-2001; its plans to
commence related manufacturing efforts of Phase 1 materials for NTLA-2001; its planned submission of an IND application for NTLA-2001 in mid-2020; its plans to generate preclinical and other data necessary to
nominate a first engineered cell therapy development candidate for its 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 presententation of additional data at upcoming scientific conferences regarding CRISPR-mediated, targeted transgene insertion in the liver of NHPs, using F9 as a model gene, via the Company s proprietary LNP-AAV delivery technology, 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 collaboration with Regeneron
Pharmaceuticals, Inc.; 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 second
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 will
not be predictive of future results in connection with future studies; 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.
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENT OF OPERATIONS (unaudited)
(Amounts in thousands, except per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Collaboration revenue | $ | 11,118 | $ | 7,677 | $ | 21,551 | $ | 15,146 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 25,460 | 23,467 | 49,169 | 45,960 | ||||||||||||
| General and administrative | 13,118 | 7,805 | 23,651 | 15,211 | ||||||||||||
| Total operating expenses | 38,578 | 31,272 | 72,820 | 61,171 | ||||||||||||
| Operating loss | (27,460 | ) | (23,595 | ) | (51,269 | ) | (46,025 | ) | ||||||||
| Interest income | 1,777 | 1,376 | 3,646 | 2,450 | ||||||||||||
| Net loss | $ | (25,683 | ) | $ | (22,219 | ) | $ | (47,623 | ) | $ | (43,575 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.56 | ) | $ | (0.52 | ) | $ | (1.05 | ) | $ | (1.03 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 45,814 | 42,836 | 45,526 | 42,441 |
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands)
| June 30, 2019 | December 31, 2018 | |||||||
| Cash, cash equivalents and marketable securities | $ | 275,838 | $ | 314,059 | ||||
| Total assets | 352,441 | 347,315 | ||||||
| Total liabilities | 75,575 | 69,395 | ||||||
| Total stockholders equity | 276,866 | 277,920 |
Jennifer Mound Smoter
Senior Vice President
External Affairs & Communications