Intellia Therapeutics(NTLA)
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Intellia Therapeutics(NTLA) - 2021 Q4 - Earnings Call Transcript
2022-02-24 18:09
Intellia Therapeutics, Inc. (NASDAQ:NTLA) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ET Company Participants Ian Karp ??? Senior Vice President-Investor Relations and Corporate Communications John Leonard ??? Chief Executive Officer Glenn Goddard ??? Chief Financial Officer David Lebwohl ??? Chief Medical Officer Laura Sepp-Lorenzino ??? Chief Scientific Officer Conference Call Participants Joon Lee ??? Truist Maury Raycroft ??? Jefferies Greco Song ??? SVB Leerink Swapnil Malekar ??? Piper ...
Intellia Therapeutics(NTLA) - 2021 Q4 - Annual Report
2022-02-23 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ 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) (State or other jurisdiction of incorporation o ...
Intellia Therapeutics(NTLA) - 2021 Q3 - Earnings Call Presentation
2021-11-04 20:45
Bill, living with transthyretin amyloidosis, and his wife, Maura o real Corporate Overview November 2021 THERAPEUTIC 2 Intellia Therapeutics' Legal Disclaimer This presentation contains "forward-looking statements" of Intellia Therapeutics, Inc. ("Intellia", "we" or "our") 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 our: abili ...
Intellia Therapeutics(NTLA) - 2021 Q3 - Earnings Call Transcript
2021-11-04 17:41
Intellia Therapeutics, Inc. (NASDAQ:NTLA) Q3 2021 Results Conference Call November 4, 2021 8:00 AM ET Company Participants Ian Karp - SVP, IR and Corporate Communications Dr. John Leonard - CEO Dr. David Lebwohl - Chief Medical Officer Dr. Laura Sepp-Lorenzino - Chief Scientific Officer Glenn Goddard - CFO Conference Call Participants Maury Raycroft - Jefferies Joon Lee - Truist Securities Rick Bienkowski - SVB Leerink Xiaobin Gao - Barclays Luca Issi - RBC Liisa Bayko - Evercore ISI Yanan Zhu - Wells Fargo ...
Intellia Therapeutics(NTLA) - 2021 Q3 - Quarterly Report
2021-11-03 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ 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 Jurisdict ...
Intellia Therapeutics (NTLA) Investor Presentation - Slideshow
2021-10-08 15:44
Bill, living with transthyretin amyloidosis, and his wife, Maura o E Corporate Overview October 2021 THERAPE 2 Intellia Therapeutics' Legal Disclaimer This presentation contains "forward-looking statements" of Intellia Therapeutics, Inc. ("Intellia", "we" or "our") 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 our: ability to co ...
Intellia Therapeutics(NTLA) - 2021 Q2 - Earnings Call Transcript
2021-08-05 19:00
Financial Data and Key Metrics Changes - As of June 30, 2021, the company's cash, cash equivalents, and marketable securities totaled $551.3 million, a decrease from $597.4 million as of December 31, 2020, primarily due to cash used for operations of approximately $115.1 million [29] - Collaboration revenue decreased by $9.7 million to $6.6 million in Q2 2021 compared to $16.3 million in Q2 2020, driven by a one-time catch-up adjustment related to a previous collaboration agreement [31] - R&D expenses increased by $21.1 million to $58.9 million in Q2 2021 compared to $37.8 million in Q2 2020, influenced by a one-time payment related to a Novartis agreement and employee-related expenses [31] Business Line Data and Key Metrics Changes - NTLA-2001 showed a mean serum TTR reduction of 87% at day 28 in the second dose level, with a maximum reduction of 96%, indicating a strong therapeutic potential for ATTR amyloidosis [9][17] - NTLA-2002 and NTLA-5001 are progressing towards clinical trials, with CTAs submitted for both candidates, aiming to begin first-in-human trials by the end of the year [10][26] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in the genetic disease treatment market, leveraging its CRISPR-based therapies to address unmet medical needs [7][11] - The collaboration with Cellex and Blackstone Life Sciences aims to enhance the development of differentiated immuno-oncology and autoimmune therapies, indicating a strategic move to broaden market reach [10][11] Company Strategy and Development Direction - The company aims to build a comprehensive toolbox for CRISPR-based medicines, focusing on both in vivo and ex vivo therapeutic applications [8] - Collaborations are seen as a key strategy to extend the reach of the company's technology while retaining rights across diverse areas [11] - The company plans to nominate at least one new development candidate by the end of the year and is working towards its first allogeneic development candidate by the first half of 2022 [28][35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of NTLA-2001 as a one-time treatment for ATTR amyloidosis, viewing the interim clinical data as a significant milestone [9][34] - The company is confident in its ability to engage with regulators regarding next steps for clinical trials without needing additional data [41][42] - Management highlighted the importance of achieving deeper TTR knockdown for improved clinical outcomes in both cardiomyopathy and polyneuropathy [73] Other Important Information - The company completed a successful follow-on offering in July, raising $648.1 million in net proceeds, strengthening its financial position to advance its pipeline [30] - The company is committed to sharing additional interim results and updates on its clinical programs at upcoming scientific and medical conferences [36] Q&A Session Summary Question: Plans for engaging with FDA regarding next step trials - Management indicated that they do not believe additional data is necessary to engage with regulators and are planning to do so soon [41][42] Question: Expectations for upcoming data from Cohorts 3 and 4 - Management stated that they will report additional data from the dose escalation portion of the trial before the end of the year [49] Question: Thoughts on re-dosing with NTLA-2001 - Management expressed confidence that one dose would be sufficient for meaningful clinical benefit, but noted that re-dosing could be an option if necessary [91] Question: Differences in T-cells from AML patients compared to B cell lymphoma patients - Management indicated that there are no expected issues with T-cell manufacturing from AML patients [95] Question: Regulatory path for 2001 in cardiomyopathy and polyneuropathy - Management stated that it is premature to conclude whether comparative studies will be required for regulatory approval [66]
Intellia Therapeutics(NTLA) - 2021 Q2 - Quarterly Report
2021-08-04 16:00
Financial Overview - Intellia Therapeutics has raised approximately $1,166.1 million since inception, with $275.9 million from collaboration agreements and $438.3 million from follow-on public offerings[85]. - As of June 30, 2021, the company had raised approximately $1,166.1 million to fund operations, with $551.3 million in cash, cash equivalents, and marketable securities[144][145]. - The company closed a public offering in July 2021, raising estimated net proceeds of $648.1 million from the sale of 4,758,620 shares at $145.00 per share[145]. - Net cash used in operating activities was $105.4 million for the six months ended June 30, 2021, primarily due to increased research and development spending[157]. - Net cash provided by financing activities was $65.7 million during the same period, including $45.3 million from at-the-market offerings[159]. - The company expects to fund ongoing operating expenses and capital expenditures beyond the next twenty-four months with current cash and proceeds from the July 2021 offering[153]. - Interest income decreased by $1.5 million to $0.4 million for the six months ended June 30, 2021, compared to $1.9 million for the same period in 2020[143]. Research and Development - The lead in vivo candidate, NTLA-2001, has shown a mean reduction of 52% in serum TTR levels at a 0.1 mg/kg dose and 87% at a 0.3 mg/kg dose in a Phase 1 study[94]. - The ongoing Phase 1 trial for NTLA-2001 aims to enroll up to 38 participants and assess safety, tolerability, pharmacokinetics, and pharmacodynamics[93]. - The company plans to move to pivotal studies for both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis after completing the Phase 1 trial[95]. - The company is developing NTLA-5001 for acute myeloid leukemia and NTLA-2002 for hereditary angioedema, with clinical trial applications pending[79]. - NTLA-2001 is the first CRISPR/Cas9-based therapy candidate administered systemically for precision editing of a gene in humans[86]. - The company has demonstrated over 95% reduction in serum TTR protein levels in non-human primate studies after a single systemic administration of LNPs[91]. - NTLA-2002 demonstrated greater reductions in serum kallikrein protein levels and activity compared to the current standard of care, sustained over 17 months following a single dose in an ongoing study[101]. - The company plans to enroll the first patient in the Phase 1 study for NTLA-2002 by year-end and is submitting additional regulatory applications for enrollment in other countries[101]. - NTLA-5001 targets the WT1 intracellular antigen, overexpressed in >90% of AML blasts, aiming to provide a broadly applicable treatment for AML[109]. - The company submitted its first CTA for NTLA-5001 to initiate a Phase 1 study, focusing on patients with persistent or recurrent AML[110]. Collaborations - Intellia's collaboration with Regeneron Pharmaceuticals involves shared development costs and profits, with Regeneron covering approximately 25% of worldwide costs for the ATTR amyloidosis program[96]. - Through June 30, 2021, the company recorded $145.0 million in upfront payments and $35.6 million for research and development services under the Regeneron collaboration[118]. - As of June 30, 2021, the company had deferred revenue of $62.8 million related to collaboration agreements[119]. - The collaboration with Novartis focuses on developing new ex vivo CRISPR/Cas9-edited therapies using CAR-T cells and HSCs[120]. - The company entered into a collaboration agreement with NewCo to develop allogeneic universal CAR-T cell therapies, with a commitment of up to $250 million from BXLS[124]. Financial Performance - Collaboration revenue decreased by $9.7 million to $6.6 million for the three months ended June 30, 2021, compared to $16.3 million for the same period in 2020[132]. - Research and development expenses increased by $21.1 million to $58.9 million for the three months ended June 30, 2021, compared to $37.8 million for the same period in 2020[133]. - Total operating expenses rose by $26.3 million to $75.6 million for the three months ended June 30, 2021, compared to $49.3 million for the same period in 2020[131]. - Net loss increased by $36.4 million to $68.8 million for the three months ended June 30, 2021, compared to $32.4 million for the same period in 2020[131]. - Collaboration revenue decreased by $16.2 million to $13.0 million for the six months ended June 30, 2021, compared to $29.2 million for the same period in 2020[139]. - Research and development expenses increased by $25.7 million to $98.2 million for the six months ended June 30, 2021, compared to $72.4 million for the same period in 2020[140]. - General and administrative expenses increased by $7.4 million to $30.3 million for the six months ended June 30, 2021, compared to $22.8 million for the same period in 2020[142]. - The company expects research and development expenses to continue to increase through 2021 as it grows its development team and progresses clinical trials[141]. - A one-time payment of $10.0 million was made to Novartis related to the amendment of the 2014 Novartis Agreement, impacting research and development expenses[134]. Strategic Goals - The company’s strategy focuses on leveraging a modular platform to advance in vivo and ex vivo therapies for diseases with high unmet need[85]. - The company aims to transform the lives of people with severe diseases by developing curative genome editing treatments using CRISPR/Cas9 technology[83]. - HAE is estimated to affect 1 in 50,000 people, with approximately 11,000 to 21,500 diagnosed patients in the U.S. and Europe[97]. - The company anticipates increased expenses in 2021 as it continues to grow its research and development team and advance additional programs into clinical development[151]. - The company has $47.4 million in shares of common stock remaining eligible for sale under the 2019 Sales Agreement[150]. - The company’s ability to generate revenue and achieve profitability depends on successful development and commercialization of product candidates, regulatory approvals, and market acceptance[154].
Intellia Therapeutics(NTLA) - 2021 Q1 - Earnings Call Transcript
2021-05-06 18:55
Financial Data and Key Metrics Changes - As of March 31, 2021, the company's cash, cash equivalents, and marketable securities were $600.8 million, an increase from $597.4 million as of December 31, 2020, primarily driven by proceeds from various agreements and collaborations [49]. - Collaboration revenue decreased by $6.5 million to $6.4 million in Q1 2021 compared to $12.9 million in Q1 2020, attributed to a milestone payment from Novartis in the previous year [51]. - R&D expenses increased by $4.6 million to $39.3 million in Q1 2021 compared to $34.7 million in Q1 2020, driven by advancements in lead programs and expansion of the development organization [52]. - G&A expenses rose by $2.3 million to $13.6 million in Q1 2021 compared to $11.3 million in Q1 2020, related to employee-related expenses [53]. Business Line Data and Key Metrics Changes - The company received the European Union's orphan drug designation for NTLA-2001, indicating regulatory recognition of its potential benefits for ATTR patients [13][22]. - NTLA-2001 demonstrated over 95% TTR reduction in nonhuman primates after a single dose, suggesting potential for halting and reversing the disease [21]. - NTLA-5001, an engineered TCR T cell therapy for AML, is on track for a first-in-human regulatory submission mid-year [39]. Market Data and Key Metrics Changes - The global prevalence of hereditary ATTR is estimated at 50,000, with wild type ATTR affecting between 200,000 and 500,000 individuals [19]. - The treatment burden for HAE patients remains significant, with current therapies being costly and requiring ongoing management [31][113]. Company Strategy and Development Direction - The company aims to develop curative genome editing treatments, leveraging its CRISPR/Cas9 platform for both in vivo and ex vivo applications [10][11]. - Upcoming milestones include reporting interim clinical data for NTLA-2001 and submitting regulatory filings for NTLA-5001 and NTLA-2002 [18][57]. - The company is focused on expanding its pipeline and platform capabilities to deliver innovative genomic medicines [58]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of NTLA-2001 and the potential for significant clinical validation in the near future [56]. - The company remains committed to addressing unmet medical needs and believes its innovative therapies can provide substantial benefits over existing treatments [22][113]. Other Important Information - The company welcomed Dr. Georgia Keresty to its board, bringing over 35 years of pharmaceutical industry experience [15]. - The company plans to share preclinical data at the ASGCT annual meeting, including updates on its research in alpha-1 antitrypsin deficiency [46]. Q&A Session Summary Question: What data should be expected from NTLA-2001 in mid-2021? - Management indicated that substantive data will be shared, but specifics on the number of cohorts were not disclosed [60][62]. Question: What is the status of the IND for NTLA-2001 in the US? - The first-in-human study is being conducted outside the US, with plans for a US IND for future studies involving cardiomyopathy [61]. Question: Any updates on safety in the clinical study? - Management stated that safety data will be shared in the mid-year update, emphasizing the study's progress [64]. Question: Will LNP design characteristics be discussed in the mid-year update? - Management suggested that while the focus will be on clinical data, there may be opportunities to discuss platform advantages later in the year [66]. Question: What is the target knockdown level for NTLA-2001? - The target is set at 80%, with the goal to surpass it for better clinical outcomes [68][69]. Question: Will there be redosing for patients not reaching target knockdown levels? - Management indicated that provisions for suboptimal doses may be addressed in the study [102]. Question: How does the company view competition in the sickle cell disease space? - The company aims to provide a solution that avoids the need for bone marrow transplants, focusing on in vivo delivery systems [86][87].
Intellia Therapeutics(NTLA) - 2021 Q1 - Quarterly Report
2021-05-05 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ 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 ...