Full Press Release Details
Intellia Therapeutics Announces First Quarter 2020 Financial Results
CAMBRIDGE, Mass., May 7, 2020 (GLOBE NEWSWIRE) - Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, today reported operational highlights and financial results for the first quarter ended March 31, 2020.
"At Intellia, our mission is to develop curative, CRISPR/Cas9-based treatments for severe diseases. I am grateful to our team for remaining steadfast in our commitment to patients and putting us in the position to deliver on our goals despite the challenging circumstances presented by the global COVID-19 pandemic," said Intellia President and Chief Executive Officer John Leonard, M.D. "We look forward to advancing NTLA-2001 into clinical testing and dosing ATTR patients with the first systemically delivered CRISPR/Cas9-based therapy in the second half of 2020. Additionally, we continue to advance our full-spectrum pipeline, including IND-enabling activities for NTLA-5001, our engineered TCR-T cell therapy candidate for AML, and the nomination of NTLA-2002 as our development candidate for the treatment of HAE."
First Quarter 2020 and Recent Operational Highlights
The Company will participate in the following events during the second quarter of 2020:
The Company has set forth the following for pipeline progression:
First Quarter 2020 Financial Results
Intellia expects that its cash, cash equivalents and marketable securities as of March 31, 2020 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements at least through the end of 2021. This expectation excludes any strategic use of capital not currently in the Company's base-case planning assumptions.
Conference Call to Discuss First Quarter 2020 Earnings
The Company will discuss these results on a conference call today, May 7, 2020, at 8 a.m. ET.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia's website at www.intelliatx.com, beginning on May 7, 2020 at 12 p.m. ET.
About Intellia Therapeutics
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") or equivalent regulatory filing for NTLA-2001 for the treatment of transthyretin amyloidosis ("ATTR") in mid-2020 and its planned dosing of first patients in the second half of 2020; plans to complete manufacturing activities and submit an IND application or equivalent regulatory filing for NTLA-5001, its first T cell receptor ("TCR")-directed engineered cell therapy development candidate for its acute myeloid leukemia ("AML") program in the first half of 2021; plans to submit an IND application or equivalent regulatory filing for NTLA-2002, a development candidate for its hereditary angioedema ("HAE") program in the second half of 2021; plans to advance and complete preclinical studies, including non-human primate studies for its ATTR program, AML program, HAE program and other in vivo and ex vivo programs; development of a proprietary LNP/AAV hybrid delivery system, as well
as its modular platform to advance its complex genome editing capabilities, such as gene insertion; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2020; advancement and expansion of its CRISPR/Cas9 technology to develop human therapeutic products, as well as its ability to maintain and expand its related intellectual property portfolio; ability to demonstrate its platform's modularity and replicate or apply results achieved in preclinical studies, including those in its ATTR, AML and HAE programs, in any future studies, including human clinical trials; 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; expectations of the potential impact of the coronavirus disease 2019 pandemic on strategy, future operations and timing of its clinical trials or IND submissions; 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; ability to optimize the impact of collaborations on its development programs, including but not limited to its collaborations with Novartis or Regeneron, and a decision by Regeneron on whether to enter into a co-development and co-promotion agreement for the HAE program; statements regarding the timing of regulatory filings, actions and decisions regarding its development programs; use of capital, expenses, future accumulated deficit and other 2020 financial results or in the future; and ability to fund operations through the end 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 its intellectual property position; risks related to Intellia's relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its 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; 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 STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands, except per share data)
| Three Months Ended Mar 31, | ||||||||
| 2020 | 2019 | |||||||
| Collaboration revenue | $ | 12,916 | $ | 10,433 | ||||
| Operating expenses: | ||||||||
| Research and development | 34,650 | 23,709 | ||||||
| General and administrative | 11,314 | 10,533 | ||||||
| Total operating expenses | 45,964 | 34,242 | ||||||
| Operating loss | (33,048 | ) | (23,809 | ) | ||||
| Interest income | 1,242 | 1,869 | ||||||
| Net loss | $ | (31,806 | ) | $ | (21,940 | ) | ||
| Net loss per share, basic and diluted | $ | (0.63 | ) | $ | (0.49 | ) | ||
| Weighted average shares outstanding, basic and diluted | 50,491 | 45,234 |
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands)
| Mar 31, 2020 | December 31, 2019 | |||||||
| Cash, cash equivalents and marketable securities | $ | 250,259 | $ | 284,472 | ||||
| Total assets | 314,752 | 334,280 | ||||||
| Total liabilities | 66,993 | 64,399 | ||||||
| Total stockholders' equity | 247,759 | 269,881 |
Jennifer Mound Smoter
Senior Vice President
External Affairs & Communications