UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 7, 2024, Intellia Therapeutics, Inc. announced its financial results and business updates for the quarter ended September 30, 2024. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 on this Current Report on Form 8-K.
The information in this report furnished pursuant to Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 2.02 of this report.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Intellia Therapeutics, Inc. |
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Date: |
November 7, 2024 |
By: |
/s/ John M. Leonard |
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Name: John M. Leonard |
Exhibit 99.1
Intellia Therapeutics Announces Third Quarter 2024 Financial Results and Highlights Recent Company Progress
CAMBRIDGE, Mass., Nov. 7, 2024 – Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today reported operational highlights and financial results for the third quarter ended September 30, 2024.
“Our third quarter and recent period have been marked by outstanding progress in advancing our pipeline of CRISPR-based gene editing therapies,” said Intellia President and Chief Executive Officer John Leonard, M.D. “A key achievement was the initiation of the HAELO Phase 3 study, which we believe will demonstrate what we’ve seen in the first-in-human study — a one-time treatment of NTLA-2002 has the potential to be a functional cure for hereditary angioedema. In addition, we are very pleased the strong pace of enrollment has continued in the ongoing MAGNITUDE Phase 3 study of nex-z for people living with ATTR amyloidosis with cardiomyopathy. Following the recent IND clearance from the FDA for the MAGNITUDE-2 Phase 3 study of nex-z in polyneuropathy patients, we are on track to initiate our third Phase 3 study in the weeks ahead. We look forward to the AHA annual meeting next week, where we will be sharing the first biomarker and functional capacity data from the Phase 1 study of nex-z, and further build upon Intellia’s industry-leading position in ushering in a new era of medicine.”
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Third Quarter 2024 and Recent Operational Highlights
Transthyretin (ATTR) Amyloidosis
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Hereditary Angioedema (HAE)
Alpha-1 Antitrypsin Deficiency (AATD)-Associated Lung Disease
In Vivo Platform Expansion
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Ex Vivo Program Updates
Upcoming Events
The Company will participate in the following events during the fourth quarter of 2024:
Third Quarter 2024 Financial Results
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Conference Call to Discuss Third Quarter 2024 Results
The Company will discuss these results on a conference call today, Thursday, November 7 at 8 a.m. ET.
To join the call:
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com, beginning on November 7 at 12 p.m. ET.
About Intellia Therapeutics
Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. The company’s in vivo programs use CRISPR to enable precise editing of disease-causing genes directly inside the human body. Intellia’s ex vivo programs use CRISPR to engineer human cells outside the body for the treatment of cancer and autoimmune diseases. Intellia’s deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at intelliatx.com and follow us @intelliatx.
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 concerning: the safety, efficacy, success and advancement of its clinical programs for NTLA-2001, also known as nexiguran ziclumeran or “nex-z”, for transthyretin (“ATTR”) amyloidosis, NTLA-2002 for the treatment of hereditary angioedema (“HAE”), and NTLA-3001 for the treatment of alpha-1 antitrypsin deficiency (“AATD”)-associated lung disease, pursuant to its clinical trial applications (“CTA”) and investigational new drug (“IND”) submissions, including the expected timing of data releases, regulatory feedback, regulatory filings, and the initiation, enrollment, dosing and completion of clinical trials, such as the presentation of additional data from the Phase 1 clinical trial of nex-z in 2024, its ability to rapidly enroll the Phase 3 MAGNITUDE study, the planned initiation of the Phase 3 trial MAGNITUDE-2 by year-end, the plan to
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dose the first patient in the global pivotal Phase 3 study of NTLA-2002 in 2024, its ability to dose the first patient in its NTLA-3001 Phase 1 study in 2024, the potential of NTLA-2001 to halt and reverse disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose, the potential of NTLA-2002 to be a functional cure for patients with HAE and to demonstrate lifelong control of HAE attacks after a single dose, and the potential of NTLA-3001 to restore permanent expression of functional alpha-1 antitrypsin protein to normal levels after a single dose; the expansion of its CRISPR/Cas9 technology and related novel technologies, including advancing gene editing programs in tissues outside of the liver, such as bone marrow, brain, muscle, lung and eye, and the potential of those programs to dramatically expand the opportunities for CRISPR-based treatments; its ability to advance multiple ex vivo programs utilizing its allogeneic platform, which is designed to avoid both T cell- and NK cell-mediated rejection, for the treatment of immuno-oncology and autoimmune diseases, and to combine its allogeneic platform with edits to enhance cell function and offer a new approach to target both hematological and solid tumors; its ability to advance additional in vivo and ex vivo development candidates and timing expectations of advancing such development candidates and releasing data related to such technologies and development candidates; its ability to optimize the impact of its collaborations on its development programs, including, but not limited to, its collaboration with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and their co-development programs for ATTR amyloidosis; and its growth as a company and expectations regarding its uses of capital, expenses, future accumulated deficit and financial results, including its ability to fund operations into late 2026.
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 contract manufacturers, collaborators, 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 preclinical and clinical studies and other development requirements for its product candidates, including uncertainties related to regulatory approvals to conduct clinical trials; risks related to the ability to develop and commercialize any one or more of Intellia’s product candidates successfully; risks related to the results of preclinical studies or clinical studies not being predictive of future results in connection with future studies; the risk that clinical study results will not be positive; risks related to the potential delay of planned clinical trials due to regulatory feedback or other developments; and risks related to Intellia’s collaborations with Regeneron, or its other collaborations not continuing or not being 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
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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, including its quarterly report on Form 10-Q. 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)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Collaboration revenue |
$ |
9,111 |
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$ |
11,992 |
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$ |
45,003 |
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$ |
38,192 |
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Operating expenses: |
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Research and development |
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123,380 |
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113,696 |
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349,434 |
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326,088 |
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General and administrative |
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30,501 |
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29,403 |
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93,385 |
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87,503 |
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Total operating expenses |
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153,881 |
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143,099 |
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442,819 |
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413,591 |
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Operating loss |
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(144,770 |
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(131,107 |
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(397,816 |
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(375,399 |
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Other income (expense), net: |
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Interest income |
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12,122 |
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12,740 |
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37,176 |
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37,373 |
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Change in fair value of investments, net |
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(3,064 |
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- |
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(29,483 |
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- |
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Loss from equity method investment |
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- |
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(3,857 |
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- |
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(10,905 |
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Change in fair value of contingent consideration |
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- |
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- |
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- |
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(100 |
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Total other income, net |
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9,058 |
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8,883 |
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7,693 |
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26,368 |
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Net loss |
$ |
(135,712 |
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$ |
(122,224 |
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$ |
(390,123 |
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$ |
(349,031 |
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Net loss per share, basic and diluted |
$ |
(1.34 |
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$ |
(1.38 |
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$ |
(3.99 |
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$ |
(3.96 |
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Weighted average shares outstanding, basic and diluted |
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101,002 |
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88,645 |
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97,842 |
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88,204 |
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INTELLIA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
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September 30, 2024 |
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December 31, 2023 |
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Cash, cash equivalents and marketable securities |
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$ |
944,681 |
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$ |
1,012,087 |
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Total assets |
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1,173,351 |
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1,300,977 |
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Total liabilities |
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210,736 |
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250,808 |
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Total stockholders’ equity |
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962,615 |
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1,050,169 |
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Intellia Contacts:
Investors:
Lina Li
Senior Director, Investor Relations and Corporate Communications
lina.li@intelliatx.com
Media:
Matt Crenson
Ten Bridge Communications
media@intelliatx.com
mcrenson@tenbridgecommunications.com
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