Intellia Therapeutics (NTLA) incurred a fourth-quarter 2024 loss of $1.24 per share (excluding one-time expenses of change in fair value of investments), which was narrower than the Zacks Consensus Estimate of a loss of $1.32. In the year-ago quarter, Intellia had incurred a loss of $1.46 per share. Including one-time expenses, the company reported a loss of $1.27 per share in the fourth quarter of 2024.See the Zacks Earnings Calendar to stay ahead of market-making news.The company’s total revenues currentl ...

NEW YORK, Feb. 28, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Intellia Therapeutics, Inc. ("Intellia" or the "Company") (NASDAQ: NTLA) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Intellia investors who were adversely affected by alleged securities fraud between July 30, 2024 and January 8, 2025. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/intellia-therapeutics- ...

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 ...

Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash, cash equivalents, and marketable securities were approximately $861.7 million, down from $1 billion as of December 31, 2023 [31] - Collaboration revenue for Q4 2024 was $12.9 million, a significant increase from negative $1.9 million in Q4 2023, primarily driven by the Regeneron license and collaboration agreement [31] - R&D expenses increased to $116.9 million in Q4 2024 from $109 million in Q4 2023, reflecting advancements in lead programs [32] - G&A expenses rose to $32.4 million in Q4 2024 from $29 million in the prior year quarter, mainly due to stock-based compensation [32] Business Line Data and Key Metrics Changes - The company is focused on late-stage programs, particularly NTLA-2002 for hereditary angioedema (HAE) and nex-z for transthyretin amyloidosis (ATTR), with significant enrollment progress expected [8][12] - Enrollment in the Phase III study for NTLA-2002 is anticipated to be completed in 2026, while the MAGNITUDE study for ATTR is expected to exceed 550 patients by year-end 2025 [11][20] Market Data and Key Metrics Changes - The company sees substantial market opportunities in HAE and ATTR, with a focus on preparing for commercial phases as enrollment progresses [9][12] - The FDA granted nex-z Regenerative Medicine Advanced Therapy Designation (RMAT), facilitating closer collaboration as the company approaches a BLA filing in 2028 [26] Company Strategy and Development Direction - The company has prioritized resources on late-stage programs, discontinuing NTLA-3001 in favor of a second-generation approach [12] - The strategy includes building a commercial infrastructure in the U.S. for NTLA-2002, with plans for a successful launch between 2027 and 2030 [13][110] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the operational execution and the potential for near-term value creation through ongoing clinical programs [7][13] - The company anticipates a decline in GAAP operating expenses of approximately 5% to 10% year-over-year due to restructuring efforts [34] Other Important Information - The company welcomed Birgit Schultes as the new Chief Scientific Officer, bringing over 20 years of experience in drug development [14] - The company plans to present longer-term data from both ATTR-CM and ATTRv-PN patients later this year [27] Q&A Session Summary Question: Update on OpEx decline and trajectory - Management indicated that operating expenses were up 7% year-over-year, but restructuring efforts are expected to lead to a decline in OpEx over the next few years [42][48] Question: Phase III events accrual rate for nex-z - Management noted that enrollment is ahead of projections and expects favorable findings at the interim analysis [60] Question: Competition from Alnylam's next-generation TTR silencer - Management acknowledged the competitive landscape but emphasized the unique advantages of their approach and data [66][70] Question: Confidence in patient enrollment numbers for ATTR cardiomyopathy trial - Management expressed high confidence in reaching the enrollment target of 550 patients by year-end [79] Question: Commercial approach for HAE - Management highlighted the straightforward treatment regimen and the potential for a functional cure as key drivers for patient interest and reimbursement [86][88] Question: Long-term follow-up for HAE patients - Management indicated that all patients have shown improvement, and longer follow-up data will be reported later this year [95][97] Question: Preparations for BLA filing - Management confirmed that they are on track for a BLA filing in 2026, with favorable interactions with the FDA [106] Question: Sales force size for NTLA-2002 launch - Management did not disclose specific sales force size but indicated confidence in operationalizing the market opportunity [109] Question: Long-term observation data for HAE - Management plans to submit a supplemental BLA soon after initial approval, based on ongoing patient follow-up [117]

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].