Full Press Release Details
Intellia Therapeutics Announces Second Quarter 2021 Financial Results and Highlights Recent Company Progress
CAMBRIDGE, Mass., Aug. 05, 2021 - Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, today reported financial results for the second quarter ended June 30, 2021, and recent operational highlights.
"This quarter marked an exciting new chapter for Intellia. We presented the first clinical data in history supporting precision editing of a disease-causing gene within the body following a single, systemic dose of CRISPR/Cas9. These data open a new era of medicine - one that holds the potential of curing genetic disease. The interim data from our ongoing Phase 1 trial of NTLA-2001 support its potential to halt and even reverse the relentless progression of ATTR amyloidosis with one dose. More broadly, they offer proof of concept for our LNP-based platform for systemic in vivo delivery. With these results, we believe we are unlocking the treatment of diseases that originate in the liver and introducing a rapid and reproducible development path that accelerates our in vivo portfolio," said Intellia President and Chief Executive Officer John Leonard, M.D.
"In addition, together with Blackstone and Cellex, we launched a new company combining our allogeneic cell engineering platform with a clinically validated switchable, universal CAR-T construct. This new venture confers numerous benefits to Intellia, extending the reach of our technology beyond our core internal focus and giving us a meaningful stake in the company's success, even as we retain our rights across a diverse ex vivo landscape. This transaction also fortified our leading cell engineering capabilities by securing access to high-quality donor cells and dedicated manufacturing capacity to support the development of our wholly-owned ex vivo programs."
Dr. Leonard continued, "We are well-positioned to build on this quarter's momentum as we close in on a number of upcoming milestones. We look forward to initiating Phase 1 trials this year for our next two candidates, NTLA-2002 for HAE and NTLA-5001 for AML. We will also share additional interim data from NTLA-2001 later this year. With a strong financial position and a well-validated platform, we intend to expand and accelerate development across our full-spectrum pipeline."
Second Quarter 2021 and Recent Operational Highlights
The Company plans to participate in the following events during the third quarter of 2021:
The Company has set forth the following guidance for pipeline progression:
Second Quarter 2021 Financial Results
Intellia expects that its cash, cash equivalents and marketable securities as of June 30, 2021, along with the proceeds from the July 2021 public offering of common stock, will enable the Company to fund its robust R&D plans, anticipated operating expenses and capital expenditure requirements beyond the next 24 months. This expectation excludes any strategic use of capital not currently in the Company's base-case planning assumptions.
Conference Call to Discuss Second Quarter Earnings
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 August 5, 2021 at 12 p.m. ET.
About Intellia Therapeutics
Intellia Therapeutics, a leading clinical-stage genome editing company, is developing novel, potentially curative therapeutics using CRISPR/Cas9 technology. To fully realize the transformative potential of CRISPR/Cas9, Intellia is pursuing two primary approaches. The company's in vivo programs use intravenously administered CRISPR as the therapy, in which proprietary delivery technology enables highly precise editing of disease-causing genes directly within specific target tissues. Intellia's ex vivo programs use CRISPR to create the therapy by using engineered human cells to treat cancer and autoimmune diseases. Intellia's deep scientific,
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 complete clinical studies for NTLA-2001 for the treatment of transthyretin ("ATTR") amyloidosis pursuant to its clinical trial applications ("CTA"), including submitting additional regulatory applications in other countries; clinical data from the ongoing single-ascending dose portion of the Phase 1 study evaluating NTLA-2001; expectations of approvals of its CTAs to regulatory authorities in New Zealand for NTLA-2002 for the treatment of hereditary angioedema ("HAE") and the United Kingdom for NTLA-5001 for the treatment of acute myeloid leukemia ("AML"); identification and nomination of new development candidates; expectations for the new universal CAR-T cell company launched in collaboration with Blackstone Life Sciences Advisors L.L.C. and Cellex Cell Professionals GmbH; 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; statements regarding the timing of regulatory filings regarding its development programs; plans to attend and present data at scientific conferences later this year; and our expectations regarding our use of capital and our ability to fund operations beyond the next 24 months.
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 authorization, 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; risks related to the COVID-19 pandemic including the effects of the Delta variant; and the risk that Intellia's collaborations with Regeneron or its other 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 ("SEC"). 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.
Senior Vice President, Investor Relations and Corporate Communications
Director, Investor Relations
Ten Bridge Communications