UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37766 INTELLIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-4785571 (State or other jurisdiction of incorp ...

Intellia Therapeutics, Inc. (NASDAQ:NTLA) Q4 2024 Earnings Conference Call February 27, 2025 8:00 AM ET Company Participants Brittany Chaves - Senior Manager of Investor Relations John Leonard - President and Chief Executive Officer David Lebwohl - Chief Medical Officer Edward Dulac - Executive Vice President and Chief Financial Officer Birgit Schultes - Executive Vice President and Chief Scientific Officer Conference Call Participants Mani Foroohar - Leerink Partners Maury Raycroft - Jefferies Lisa Walter ...

Core Insights - Intellia Therapeutics reported better-than-expected fourth-quarter results, driven by increased collaboration revenue [1][7] Financial Performance - The company reported a net loss of $1.27 per share, which was better than the analysts' expectation of a $1.34 loss, and revenue of $12.9 million, significantly exceeding the $7 million estimate [1][2] - R&D expenses rose to $116.9 million, a 7.3% increase from $109 million in Q4 2023 [2][8] - For the full year, collaboration revenue reached $57.9 million, up from $36.3 million in 2023 [7] Company Overview and Strategy - Intellia utilizes CRISPR/Cas9 technology to develop gene-editing treatments for genetic diseases, focusing on lead programs NTLA-2001 and NTLA-2002 [3] - The company has prioritized late-stage programs and plans to reduce its workforce by about 27% in 2025 to align resources with core priorities [4] Clinical Developments - In Q4, Intellia initiated dosing in its global Phase 3 HAELO study for NTLA-2002, aiming for a 2027 U.S. market launch [5] - The MAGNITUDE Phase 3 trial for NTLA-2001 showed promising results with a 90% mean serum TTR reduction [6] Outlook - As of December 31, Intellia had a cash position of $861.7 million, projected to sustain operations through the first half of 2027 [9]

Financial Performance - Intellia Therapeutics reported a quarterly loss of $1.24 per share, which is better than the Zacks Consensus Estimate of a loss of $1.32, and an improvement from a loss of $1.46 per share a year ago, representing an earnings surprise of 6.06% [1] - The company posted revenues of $12.87 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 45.95%, compared to revenues of -$1.92 million in the same quarter last year [2] Market Performance - Intellia Therapeutics shares have declined approximately 7.4% since the beginning of the year, while the S&P 500 has gained 1.3% [3] - The company's current consensus EPS estimate for the upcoming quarter is -$1.34 on revenues of $10.38 million, and for the current fiscal year, it is -$5.01 on revenues of $70.22 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Intellia Therapeutics belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable outlook for the sector [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Outlook - As of December 31, 2024, Intellia Therapeutics expects to report approximately $862 million in cash, cash equivalents, and marketable securities[4]. - Future financial conditions and operational funding are uncertain, posing risks to the company's stability[20]. Workforce and Organizational Changes - The company plans to implement a net workforce reduction of approximately 27% in 2025, incurring estimated charges of about $8 million primarily in the first quarter[8]. - Intellia aims to complete the buildout of its commercial leadership team by the second half of 2025[17]. - Laura Sepp-Lorenzino, Ph.D., will retire on December 31, 2025, with Birgit Schultes, Ph.D., being promoted to Executive Vice President and Chief Scientific Officer effective January 13, 2025[9]. Strategic Focus and Development - Intellia's strategic reorganization aims to extend its cash runway into the first half of 2027[7]. - The company is prioritizing resources for NTLA-2002 and nexiguran ziclumeran (nex-z), discontinuing development of NTLA-3001 and select research-stage programs[17]. - The pivotal Phase 3 HAELO study for NTLA-2002 is currently screening patients, with the first patient expected to be dosed in Q1 2025[17]. - Strong enrollment is ongoing in the Phase 3 MAGNITUDE study of nex-z, tracking ahead of target projections[17]. - The company anticipates completing enrollment in the HAELO trial in the second half of 2025 and enrolling at least 550 patients in the MAGNITUDE trial by year-end[17]. - The company plans to initiate pre-approval information exchange in 2025 to assist payers with coverage and formulary decisions[17]. Risks and Uncertainties - Intellia faces risks related to its ability to protect intellectual property and maintain relationships with third parties, which could impact future results[20]. - The company is uncertain about the outcomes of preclinical and clinical studies, which may not predict future results[20]. - Intellia is developing novel platform capabilities, including DNA writing technology and gene editing outside the liver, but faces associated risks[20]. - Collaborations with Regeneron Pharmaceuticals and other partners may not continue or succeed, adding to the risk profile[20].

Core Insights - Intellia Therapeutics reported strong operational execution and clinical data in Q4 2024, focusing on pivotal Phase 3 studies for NTLA-2002 and nex-z [2][5] - The company aims to submit a Biologics License Application for NTLA-2002 in HAE by the second half of 2026 and plans for a U.S. launch in 2027 [5][6] - Intellia's cash position at the end of 2024 was approximately $862 million, expected to fund operations into the first half of 2027 [5][15] Operational Highlights - The first patient was dosed in the global Phase 3 HAELO study for NTLA-2002, targeting lifelong control of HAE attacks after a single dose [5][6] - Enrollment in the MAGNITUDE trial for nex-z in ATTR amyloidosis is ahead of projections, with over 550 patients expected by year-end [5][6] - The company is actively screening for the Phase 3 MAGNITUDE-2 trial for hereditary ATTR amyloidosis with polyneuropathy, aiming to dose the first patient in Q1 2025 [5][6] Financial Results - Collaboration revenue for Q4 2024 was $12.9 million, a significant increase from negative $1.9 million in Q4 2023, primarily due to Regeneron agreements [15] - R&D expenses rose to $116.9 million in Q4 2024 from $109.0 million in Q4 2023, driven by advancements in lead programs [15] - The net loss for Q4 2024 was $128.9 million, slightly improved from $132.2 million in Q4 2023 [15][18] Corporate Strategy - Following a strategic review, the company will prioritize late-stage programs NTLA-2002 and nex-z, discontinuing NTLA-3001 and reducing workforce by approximately 27% [8] - Intellia expects to incur about $8 million in charges for severance and related costs in Q1 2025 [8] Upcoming Events - Intellia will participate in several conferences in Q1 2025, including the AAAAI/WAO Joint Congress and the TD Cowen Annual Health Care Conference [10]

Core Viewpoint - Intellia Therapeutics, Inc. is facing a class action lawsuit due to alleged misleading statements regarding its NTLA-3001 program for treating alpha-1 antitrypsin deficiency-associated lung disease, which has been discontinued following a company reorganization [1][2]. Summary by Relevant Sections Allegations - The complaint alleges that Intellia's management provided investors with optimistic timelines for the NTLA-3001 study, claiming the first patient would be dosed in the second half of 2024. However, they failed to disclose that demand for viral-based editing was declining as non-viral methods gained preference in the scientific community [1]. - The truth emerged on January 9, 2025, when Intellia announced the halting of all NTLA-3001 research and a 27% workforce reduction, indicating a shift in focus to other pharmaceutical developments [1]. Stock Price Impact - Following the announcement of the discontinuation of NTLA-3001, Intellia's stock price dropped from $12.02 per share on January 8, 2025, to $10.20 per share on January 10, 2025, reflecting a significant loss in market value [1]. Next Steps for Shareholders - Shareholders who purchased NTLA shares during the specified class period are encouraged to register for the class action by April 14, 2025, to potentially become lead plaintiffs and receive updates on the case [2].

Core Viewpoint - A class action has been filed against Intellia Therapeutics, Inc. for allegedly misleading investors regarding the viability of its drug candidate NTLA-3001, which is intended for treating alpha-1 antitrypsin deficiency-associated lung disease [1][2]. Allegations - The complaint claims that during the class period, Intellia provided investors with optimistic information about its Phase 1/2 study for NTLA-3001, including expectations to dose the first patient in the second half of 2024 [2]. - It is alleged that Intellia failed to disclose that demand for viral-based editing was declining as non-viral delivery methods gained traction due to their cost-effectiveness and efficiency, making NTLA-3001 an inefficient program for the company [2]. Revelation of Truth - On January 9, 2025, Intellia announced a reorganization, halting all NTLA-3001 research and studies, and disclosed a workforce reduction of 27% in 2025, leading to a 15% decline in the company's stock price [3]. Next Steps for Shareholders - Shareholders may be eligible to participate in the class action and can contact Robbins LLP if they wish to serve as lead plaintiff, although participation is not required for recovery [4]. About Robbins LLP - Robbins LLP is a recognized leader in shareholder rights litigation, dedicated to helping shareholders recover losses and improve corporate governance since 2002 [5].

Core Viewpoint - Intellia Therapeutics, Inc. is facing a class action securities lawsuit due to alleged securities fraud that affected investors between July 30, 2024, and January 8, 2025 [1] Group 1: Lawsuit Details - The lawsuit aims to recover losses for Intellia investors who were impacted by the company's failure to disclose critical information regarding its Phase 1/2 study of NTLA-3001 for treating alpha-1 antitrypsin deficiency-associated lung disease [2] - Defendants allegedly misled investors by expressing confidence in the study's timeline, stating that the first patient would be dosed in the second half of 2024, while failing to reveal a significant decline in demand for viral-based editing methods [2] - On January 9, 2025, Intellia announced a reorganization, halting all NTLA-3001 research and reducing its workforce by 27%, which led to a significant drop in the company's stock price from $12.02 to $10.20 per share [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until April 14, 2025, to request to be appointed as lead plaintiff in the lawsuit [3] - Participation in the lawsuit does not require serving as a lead plaintiff, and class members may be entitled to compensation without any out-of-pocket costs [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4]

Core Viewpoint - Intellia Therapeutics, Inc. is facing a class action lawsuit due to allegations of misleading investors regarding the progress and viability of its NTLA-3001 program for treating alpha-1 antitrypsin deficiency-associated lung disease, which has now been discontinued [1][2]. Summary by Relevant Sections Allegations - The lawsuit claims that Intellia's management provided investors with optimistic timelines for the NTLA-3001 study, specifically stating that the first patient would be dosed in the second half of 2024 [1]. - It is alleged that the company failed to disclose a significant decline in demand for viral-based editing technologies, as non-viral methods gained favor for their cost-effectiveness and efficiency [1]. - The truth about the company's situation was revealed on January 9, 2025, when Intellia announced a reorganization, halting all NTLA-3001 research and reducing its workforce by 27% [1]. Stock Price Impact - Following the announcement of the discontinuation of NTLA-3001, Intellia's stock price dropped from $12.02 per share on January 8, 2025, to $10.20 per share on January 10, 2025 [1]. Next Steps for Shareholders - Shareholders who purchased NTLA shares during the specified class period are encouraged to register for the class action by April 14, 2025, to potentially become lead plaintiffs [2]. - Registered shareholders will receive updates through a portfolio monitoring software regarding the case's progress [2]. Law Firm's Commitment - The Gross Law Firm aims to protect investors' rights and seeks recovery for those who suffered losses due to misleading statements or omissions by companies [3].