Intellia Therapeutics, Inc. (NTLA)

—

$8.70

+0.03 (0.29%)

Data provided by IEX. Delayed 15 minutes.

Market Cap

$933.4M

Enterprise Value

$520.3M

P/E Ratio

N/A

Div Yield

0.00%

Rev Growth YoY

+59.6%

Rev 3Y CAGR

+20.5%

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Valuation Measures

P/E Ratio N/A

P/B Ratio 1.2

Dividend Yield 0.00%

PEG Ratio 0.1

Financial Highlights

Revenue (TTM) $57.5M

Net Income (Annual) $-519.0M

Profit Margin -902.2%

ROE -64.1%

Balance Sheet Strength

Total Cash $193.4M

Total Debt $98.0M

Debt/Equity 0.13

Current Ratio 6.21

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Intellia Therapeutics: Unlocking Curative Potential with CRISPR's Edge (NASDAQ:NTLA)

By BeyondSPX Research | Published on November 16, 2025

Intellia Therapeutics (TICKER:NTLA) is a clinical-stage biotechnology company specializing in CRISPR/Cas9-based gene editing therapies. It develops innovative, potentially one-time curative treatments targeting severe genetic diseases such as hereditary angioedema and transthyretin amyloidosis, utilizing proprietary lipid nanoparticle delivery technology.

Executive Summary / Key Takeaways

Intellia Therapeutics is at the forefront of gene editing, leveraging its proprietary CRISPR-based platform to develop potentially curative, one-time treatments for severe genetic diseases, notably hereditary angioedema (HAE) and transthyretin (ATTR) amyloidosis.
The company's lead HAE program, lonvo-z, has successfully completed Phase 3 enrollment ahead of schedule and is on track for a Biologics License Application (BLA) submission in the second half of 2026, with a U.S. commercial launch anticipated in the first half of 2027.
A significant challenge has emerged with nex-z, Intellia's ATTR amyloidosis program, which is currently under a clinical hold by the FDA following a Grade 4 liver transaminase elevation and patient death in the MAGNITUDE trial. This event has suspended dosing and screening, creating near-term uncertainty for the program's timeline.
Despite the nex-z setback, Intellia maintains a solid financial position, with cash, cash equivalents, and marketable securities of $669.9 million as of September 30, 2025, projected to fund operations into mid-2027, supported by strategic restructuring and collaboration revenue.
Intellia's competitive advantage lies in its differentiated CRISPR/Cas9 technology and lipid nanoparticle (LNP) delivery, aiming for superior efficacy, rapid onset, and the transformative "one-and-done" treatment paradigm, which could redefine standards of care and offer significant pharmacoeconomic benefits.

Setting the Scene: Pioneering Gene Editing's Frontier

Intellia Therapeutics is a clinical-stage gene editing company dedicated to revolutionizing medicine through its advanced CRISPR-based therapies. Since its inception in mid-2014, Intellia has focused on building a comprehensive gene editing platform to develop both in vivo and ex vivo treatments for diseases with high unmet medical needs. The company's mission is to transform the lives of people with severe diseases by developing potentially curative genome editing treatments.

The biotechnology and pharmaceutical industries are intensely competitive, characterized by rapid technological change. Intellia operates within this dynamic landscape, facing competition from other gene editing companies, traditional pharmaceutical firms, and academic institutions. The broader industry is also witnessing significant trends, such as the increasing integration of artificial intelligence (AI) in genomic analysis and drug development, which could enhance computational tools and improve efficiency in research and development.

Intellia's strategic journey has been marked by both ambitious collaborations and necessary realignments. Key partnerships, such as the co-development and co-promotion agreement with Regeneron Pharmaceuticals for ATTR amyloidosis, have been instrumental in advancing its pipeline. However, the company has also undertaken strategic restructuring in 2025, including an approximate 27% reduction in employee headcount and the discontinuation of certain programs like NTLA-3001, to streamline operations and prioritize its late-stage, high-value assets. This strategic pivot aims to focus resources on programs with the clearest path to commercialization, positioning Intellia to become a commercially ready company with an anticipated three product launches between 2027 and 2030.

Technological Differentiation and Innovation: The CRISPR Advantage

Intellia's core differentiated technology centers on its CRISPR/Cas9 gene editing system, delivered primarily via lipid nanoparticles (LNPs). This modular platform allows for precise editing of disease-causing genes directly inside the human body (in vivo) or engineering human cells outside the body (ex vivo) for therapeutic purposes. The LNP delivery system, which is consistent across both lonvo-z and nex-z, is a critical enabler for systemic administration, allowing the CRISPR machinery to reach target tissues like the liver efficiently.

The tangible benefits of this technology are evident in its lead programs. For lonvo-z in HAE, the therapy is designed to inactivate the kallikrein B1 (KLKB1) gene in the liver, aiming for a lifelong reduction in kallikrein levels after a single, one-time treatment. Clinical data from the Phase 1 trial demonstrated a mean reduction in monthly HAE attack rate of 98% over the study period, with patients remaining attack-free and treatment-free for a median of nearly two years. This represents a "functional cure," a new category of response that offers patients freedom from HAE attacks and chronic prophylaxis.

Similarly, nex-z for ATTR amyloidosis is designed to inactivate the TTR gene in the liver, leading to a deep, consistent, and potentially lifelong reduction in TTR protein after a single dose. Phase 1 data for ATTR cardiomyopathy showed absolute TTR levels dropping from 222.4 to 16.5 μg/mL in wild-type patients and from 132 to 16.6 μg/mL in variant patients. This rapid TTR reduction, with a nadir reached at 28 days, is crucial for a life-threatening illness where every day matters. For ATTR polyneuropathy, a mean serum TTR reduction of 90% was observed by Day 28, remaining virtually unchanged through at least 24 months, with 13 of 18 patients showing clinically meaningful improvements in mNIS+7 scores.

These technological advantages translate into a significant competitive moat for Intellia. The "one-and-done" nature of its therapies, coupled with the precision and depth of gene editing, offers a compelling value proposition for patients, physicians, and payers. This approach aims to reduce the administrative burden of chronic therapies for physicians and provide meaningful pharmacoeconomic advantages for payers by potentially eliminating the need for ongoing, expensive treatments. Intellia's R&D efforts also extend to new technologies like its "gene writer" approach, which could further expand its therapeutic opportunities and maintain its leadership in the evolving gene editing space.

Clinical Programs: High Stakes and High Potential

Intellia's pipeline is currently focused on three pivotal Phase 3 programs, each representing a significant market opportunity and a test of its gene editing platform.

Lonvo-z for Hereditary Angioedema (HAE)

Lonvo-z (formerly NTLA-2002) is Intellia's wholly owned investigational in vivo CRISPR-based therapy for HAE. The Phase 3 HAELO study, a global, randomized, double-blind, placebo-controlled trial involving 60 adults, completed enrollment in September 2025, ahead of schedule. This rapid enrollment underscores the high unmet need in the HAE community and the strong interest in a potential one-time treatment.

Topline data from the HAELO study are expected by mid-2026, with a BLA submission to the FDA planned for the second half of 2026. Intellia anticipates a U.S. commercial launch in the first half of 2027. The clinical profile of lonvo-z, demonstrated by 3-year follow-up data from the Phase 1 portion of the study, shows patients remaining attack-free and treatment-free for a median of 23 months after a single dose. This "functional cure" paradigm is a key differentiator, offering patients freedom from attacks and chronic prophylaxis, and simplifying treatment management for physicians. Lonvo-z has also received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, which facilitates earlier and more frequent engagement with the agency, potentially expediting the review process.

Nex-z for Transthyretin (ATTR) Amyloidosis

Nex-z (formerly NTLA-2001) is an investigational in vivo CRISPR-based therapy designed to treat ATTR amyloidosis by inactivating the TTR gene in the liver. The program includes two pivotal Phase 3 trials: MAGNITUDE for ATTR cardiomyopathy (ATTR-CM) and MAGNITUDE-2 for hereditary ATTR polyneuropathy (ATTRv-PN).

Enrollment in the MAGNITUDE study for ATTR-CM has been robust, with over 650 patients enrolled by October 2025, and the company targeting at least 650 patients cumulatively by year-end 2025. Intellia plans to expand the MAGNITUDE study from 765 to 1,200 patients to enhance statistical power, particularly in the stabilizer stratum, which is crucial for demonstrating benefit over existing standard-of-care therapies. Enrollment for MAGNITUDE is expected to be completed by early 2027. The MAGNITUDE-2 study for ATTRv-PN, with an expected enrollment of 50 patients, saw its first patient dosed in March 2025, with enrollment expected to be completed in the first half of 2026, enabling a BLA filing by 2028. Nex-z has also received RMAT designation from the FDA for both ATTR-CM and ATTRv-PN.

The Nex-z Clinical Hold: A Critical Juncture

On October 29, 2025, the FDA placed a clinical hold on the IND applications for both the MAGNITUDE and MAGNITUDE-2 Phase 3 trials. This action followed a report of Grade 4 liver transaminase elevations and increased total bilirubin in a patient dosed with nex-z in the MAGNITUDE trial, who subsequently passed away on November 5, 2025. Dosing and screening in both trials have been temporarily paused.

Intellia has initiated a comprehensive investigation, including mandated increased monitoring of patient laboratory values and a review of blinded safety data and baseline characteristics to identify potential contributors to the liver-related events. Management noted that Grade 4 liver transaminase elevations have been reported in less than 1% of all patients enrolled in MAGNITUDE, with no such elevations in MAGNITUDE-2. The company has suspended its milestone guidance for nex-z pending regulatory alignment and plans to provide an update once a path forward is finalized with regulators. This clinical hold represents a significant risk and introduces uncertainty into the development timeline and commercial prospects for nex-z.

Financial Performance and Liquidity: A Strategic Rebalancing

Intellia's financial performance reflects its stage as a clinical-stage biotechnology company with significant investments in research and development. For the three months ended September 30, 2025, collaboration revenue increased by $4.7 million to $13.8 million, primarily driven by cost reimbursements from the Regeneron collaboration. However, for the nine months ended September 30, 2025, collaboration revenue slightly decreased by $0.3 million to $44.7 million, largely due to a one-time $21 million recognition of intra-entity profit in the prior year related to the AvenCell agreement.

Operating expenses have seen a strategic reduction. Research and development (R&D) expenses decreased by $28.6 million to $94.7 million in Q3 2025 and by $49.2 million to $300.2 million for the nine months ended September 30, 2025. These reductions were primarily attributable to a $22.7 million decrease in employee-related expenses, a $20.3 million decrease in research materials and contracted services, and a $30.9 million decrease in stock-based compensation, all stemming from the January 2025 workforce reduction and strategic restructuring. These savings were partially offset by increased external costs for the advancement of lonvo-z and nex-z programs. General and administrative (G&A) expenses remained consistent at $30.5 million in Q3 2025, but decreased by $6.7 million to $86.7 million for the nine months ended September 30, 2025, mainly due to lower stock-based compensation, partially offset by increased expenses for building out the commercial infrastructure. The net loss for Q3 2025 was $101.3 million, an improvement from $135.7 million in the prior year quarter.

As of September 30, 2025, Intellia held $669.9 million in cash, cash equivalents, and marketable securities. Net cash used in operating activities for the nine months ended September 30, 2025, was $325.5 million, which included approximately $65 million in non-recurring cash payments related to the portfolio prioritization, workforce reduction, and real estate consolidation. The company also generated $128.2 million in net proceeds from at-the-market (ATM) offerings during this period. Intellia projects its cash runway to extend into mid-2027, funding operations through the anticipated U.S. commercial launch of lonvo-z. Management expects a year-over-year decline in GAAP operating expenses of at least 10% for 2025, with an estimated average cash use of approximately $95 million per quarter in 2025 and 2026. This financial outlook is supported by expected cash savings of nearly $50 million from a smaller real estate footprint following a strategic consolidation to a new Cambridge headquarters.

Competitive Landscape and Strategic Positioning

Intellia operates in a highly competitive biotechnology sector, facing both direct and indirect rivals. Direct competitors in the CRISPR gene editing space include CRISPR Therapeutics , Editas Medicine , and Beam Therapeutics , while larger pharmaceutical companies like Vertex Pharmaceuticals also have interests in gene therapies.

Intellia's competitive advantage is rooted in its proprietary CRISPR/Cas9 system and LNP delivery technology. This platform offers enhanced precision in gene editing and efficient systemic delivery, which can lead to faster development cycles for liver-targeted indications compared to competitors focused on ex vivo applications. For instance, nex-z's ability to achieve a 90% TTR reduction with a nadir at 28 days is notably faster and deeper than the approximately 80% reduction achieved by TTR silencers, which can take six months to reach their nadir. This rapid and profound TTR reduction is a critical differentiator, especially in a life-threatening illness where early intervention is paramount.

In the HAE market, lonvo-z's "one-and-done" profile is unique, offering a functional cure that eliminates attacks and the need for chronic prophylaxis. No other existing HAE therapy accomplishes this, positioning lonvo-z to redefine the standard of care and offer significant advantages over chronic treatments. For ATTR amyloidosis, Intellia aims to demonstrate a significant clinical benefit for nex-z, even in combination with existing stabilizers like tafamidis, which has not been shown by other agents. This strategy, supported by the expanded MAGNITUDE trial, seeks to differentiate nex-z in an increasingly crowded market.

While competitors like CRISPR Therapeutics have established partnerships and a strong presence in ex vivo oncology, Intellia's focus on in vivo systemic therapies, particularly for liver-directed indications, provides a distinct market positioning. Against larger players like Vertex Pharmaceuticals , which benefit from established commercial infrastructure, Intellia leverages its innovative technology and collaborations (e.g., with Regeneron for ATTR) to drive pipeline growth and prepare for market entry. The company's commercialization strategy for lonvo-z emphasizes the ease of outpatient infusion and the pharmacoeconomic benefits of a one-time therapy, which is expected to resonate with patients, physicians, and payers.

Conclusion

Intellia Therapeutics stands at a pivotal moment, balancing the immense promise of its pioneering CRISPR gene editing platform with the inherent challenges of clinical development. The rapid advancement of lonvo-z for HAE, culminating in completed Phase 3 enrollment and a clear path to market by early 2027, underscores the company's operational strength and the transformative potential of its one-time gene editing therapies. This program, with its potential for a "functional cure," is poised to redefine the treatment paradigm for HAE patients and offers a compelling investment thesis.

However, the recent clinical hold on the nex-z program for ATTR amyloidosis presents a significant hurdle, demanding a thorough investigation and regulatory resolution. While this introduces uncertainty, Intellia's robust financial position, bolstered by strategic restructuring and collaboration revenue, provides a buffer to navigate this challenge and continue investing in its pipeline. The company's long-term success hinges on its ability to resolve the nex-z clinical hold, continue demonstrating the superior efficacy and safety of its CRISPR-based therapies, and effectively execute its commercialization strategy, particularly for lonvo-z, to deliver on its mission of providing potentially curative treatments for severe diseases.

Step 2: Strategic Chart Placeholder Insertion

The company is determined to be revenue-generating based on the article's mention of "collaboration revenue increased by $4.7 million to $13.8 million" and "collaboration revenue slightly decreased by $0.3 million to $44.7 million."

Therefore, the following two charts are mandatory:

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25215000.0, 24626000.0, 27255000.0, 36400000.0, 35352000.0, 35043000.0, 34176000.0, 40861000.0, 39619000.0, 39617000.0, 21840000.0, 22036000.0, 19604000.0]}}">Loading interactive chart...</beyondspx-chart></div> (Rule 9)

For additional charts, the following rules are triggered by the article's content:

Rule 3 (Cash & Equivalents Trend): The article discusses "Intellia held $669.9 million in cash, cash equivalents, and marketable securities" and projects its "cash runway to extend into mid-2027." This is a significant point about liquidity.
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19604000.0]}}">Loading interactive chart...</beyondspx-chart></div>
Profit Margin Chart Consolidation (Rules 5 & 6): The article discusses "Operating expenses have seen a strategic reduction" and "The net loss for Q3 2025 was $101.3 million, an improvement from $135.7 million in the prior year quarter." This indicates discussion of operating efficiency and overall profitability.
- Candidate: <div class="beyondspx-chart-container" style="width: 100%; max-width: 700px; height: auto; display: block; margin-left: auto; margin-right: auto; border: 1px solid #ddd; padding: 3px; margin-top: 10px; margin-bottom: 10px;"><beyondspx-chart data-chart-config="{"visual_style": "line_multiple_metrics", "caption": "NTLA's Quarterly Operating Profit Margin and Net Profit Margin for the Last 20 Quarters", "data_mapping": {"date_key": "date", "value_keys": ["operatingProfitMargin", "netProfitMargin"], "series_names": ["Operating Profit Margin", "Net Profit Margin"], "common_label": "Profit Margin (%)"}, "fmp_params": {"period": "quarterly", "limit": 20}}" data-chart-data="{"annual": {"symbol": ["NTLA", "NTLA", "NTLA", "NTLA", "NTLA", "NTLA", "NTLA", "NTLA", "NTLA", "NTLA", "NTLA"], "date": ["2014-12-31", "2015-12-31", "2016-12-31", "2017-12-31", "2018-12-31", "2019-12-31", "2020-12-31", "2021-12-31", "2022-12-31", "2023-12-31", "2024-12-31"], "calendarYear": ["2014", "2015", 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We have 2 mandatory charts and 2 additional candidates. To reach a total of 4 charts (within the 2-4 range), we will select both additional candidates.

The final Annotated Article Text with strategically inserted chart placeholders is below:

Intellia Therapeutics: Unlocking Curative Potential with CRISPR's Edge (NASDAQ:NTLA)

Executive Summary / Key Takeaways

Intellia Therapeutics is at the forefront of gene editing, leveraging its proprietary CRISPR-based platform to develop potentially curative, one-time treatments for severe genetic diseases, notably hereditary angioedema (HAE) and transthyretin (ATTR) amyloidosis.
The company's lead HAE program, lonvo-z, has successfully completed Phase 3 enrollment ahead of schedule and is on track for a Biologics License Application (BLA) submission in the second half of 2026, with a U.S. commercial launch anticipated in the first half of 2027.
A significant challenge has emerged with nex-z, Intellia's ATTR amyloidosis program, which is currently under a clinical hold by the FDA following a Grade 4 liver transaminase elevation and patient death in the MAGNITUDE trial. This event has suspended dosing and screening, creating near-term uncertainty for the program's timeline.
Despite the nex-z setback, Intellia maintains a solid financial position, with cash, cash equivalents, and marketable securities of $669.9 million as of September 30, 2025, projected to fund operations into mid-2027, supported by strategic restructuring and collaboration revenue.
Intellia's competitive advantage lies in its differentiated CRISPR/Cas9 technology and lipid nanoparticle (LNP) delivery, aiming for superior efficacy, rapid onset, and the transformative "one-and-done" treatment paradigm, which could redefine standards of care and offer significant pharmacoeconomic benefits.

Setting the Scene: Pioneering Gene Editing's Frontier

Technological Differentiation and Innovation: The CRISPR Advantage

Clinical Programs: High Stakes and High Potential

Intellia's pipeline is currently focused on three pivotal Phase 3 programs, each representing a significant market opportunity and a test of its gene editing platform.

Lonvo-z for Hereditary Angioedema (HAE)

Nex-z for Transthyretin (ATTR) Amyloidosis

The Nex-z Clinical Hold: A Critical Juncture

Financial Performance and Liquidity: A Strategic Rebalancing

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The net loss for Q3 2025 was $101.3 million, an improvement from $135.7 million in the prior year quarter.

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Intellia projects its cash runway to extend into mid-2027, funding operations through the anticipated U.S. commercial launch of lonvo-z. Management expects a year-over-year decline in GAAP operating expenses of at least 10% for 2025, with an estimated average cash use of approximately $95 million per quarter in 2025 and 2026. This financial outlook is supported by expected cash savings of nearly $50 million from a smaller real estate footprint following a strategic consolidation to a new Cambridge headquarters.

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Competitive Landscape and Strategic Positioning

Intellia operates in a highly competitive biotechnology sector, facing both direct and indirect rivals. Direct competitors in the CRISPR gene editing space include CRISPR Therapeutics , Editas Medicine (EDIT), and Beam Therapeutics (BEAM), while larger pharmaceutical companies like Vertex Pharmaceuticals also have interests in gene therapies.

While competitors like CRISPR Therapeutics (CRSP) have established partnerships and a strong presence in ex vivo oncology, Intellia's focus on in vivo systemic therapies, particularly for liver-directed indications, provides a distinct market positioning. Against larger players like Vertex Pharmaceuticals (VRTX), which benefit from established commercial infrastructure, Intellia leverages its innovative technology and collaborations (e.g., with Regeneron (REGN) for ATTR) to drive pipeline growth and prepare for market entry. The company's commercialization strategy for lonvo-z emphasizes the ease of outpatient infusion and the pharmacoeconomic benefits of a one-time therapy, which is expected to resonate with patients, physicians, and payers.

Conclusion

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Intellia Therapeutics: Unlocking Curative Potential with CRISPR's Edge (NASDAQ:NTLA)

Executive Summary / Key Takeaways

Setting the Scene: Pioneering Gene Editing's Frontier

Technological Differentiation and Innovation: The CRISPR Advantage

Clinical Programs: High Stakes and High Potential

Lonvo-z for Hereditary Angioedema (HAE)

Nex-z for Transthyretin (ATTR) Amyloidosis

The Nex-z Clinical Hold: A Critical Juncture

Financial Performance and Liquidity: A Strategic Rebalancing

Competitive Landscape and Strategic Positioning

Conclusion

Executive Summary / Key Takeaways

Setting the Scene: Pioneering Gene Editing's Frontier

Technological Differentiation and Innovation: The CRISPR Advantage

Clinical Programs: High Stakes and High Potential

Lonvo-z for Hereditary Angioedema (HAE)

Nex-z for Transthyretin (ATTR) Amyloidosis

The Nex-z Clinical Hold: A Critical Juncture

Financial Performance and Liquidity: A Strategic Rebalancing

Competitive Landscape and Strategic Positioning

Conclusion

Discussion (0)

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