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Intellia Therapeutics(NTLA) - 2020 Q2 - Quarterly Report
2020-08-06 20:29
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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 o ...
Intellia Therapeutics(NTLA) - 2020 Q2 - Earnings Call Transcript
2020-08-06 17:17
Financial Data and Key Metrics Changes - The company's cash, cash equivalents, and marketable securities increased to $436.8 million as of June 30, 2020, compared to $284.5 million as of December 31, 2019, driven by net proceeds from financing activities and the expanded Regeneron collaboration [25][26]. - Collaboration revenue increased by $5.1 million to $16.3 million during Q2 2020 compared to $11.1 million during Q2 2019, primarily due to a one-time cumulative catch-up adjustment related to the expanded Regeneron collaboration [26]. - R&D expenses rose by approximately $12.3 million to $37.8 million during Q2 2020 compared to $25.5 million during Q2 2019, driven by IND-enabling activities and personnel growth [27]. Business Line Data and Key Metrics Changes - The lead program NTLA-2001 for ATTR is expected to dose the first patient by year-end, with a focus on a single ascending dose study to assess safety and pharmacokinetics [30][14]. - NTLA-5001, targeting acute myeloid leukemia, is progressing towards a regulatory application submission in the first half of next year [21]. - NTLA-2002, for hereditary angioedema, is on track for a regulatory application submission in the second half of 2021, with promising preclinical data showing sustained reduction in protein levels [16]. Market Data and Key Metrics Changes - The collaboration with Regeneron has been extended until April 2024, with the potential for further renewal, indicating a strong partnership in developing treatments for hemophilia A and B [9]. - The company is actively pursuing regulatory applications in multiple countries for NTLA-2001, with plans to expand its clinical trial sites [33]. Company Strategy and Development Direction - The company aims to leverage its CRISPR technology to develop curative genome editing treatments for life-threatening diseases, focusing on both in vivo and ex vivo approaches [6][7]. - The expansion of the Regeneron collaboration is seen as a strategic move to enhance capabilities in targeted gene insertion and to address the limitations of traditional gene therapies [9][51]. - The company is committed to advancing its pipeline and enhancing its modular platform, despite challenges posed by the COVID-19 pandemic [10][23]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of NTLA-2001 to reverse the course of ATTR with a single treatment, addressing unmet needs in the market [55]. - The company remains focused on navigating the challenges of COVID-19 while ensuring the timely progression of its clinical trials [46]. - Management highlighted the importance of a stable transgene for long-term durability in treating hemophilia, positioning their approach as superior to existing options [51]. Other Important Information - The company has made significant progress in its research programs, including advancements in engineered T cell therapies and collaborations to expand its capabilities [22][23]. - The first regulatory application for NTLA-2001 has been submitted to the U.K.'s MHRA, marking a key milestone for the company [8]. Q&A Session Summary Question: Plans for submitting additional regulatory applications - Management confirmed active plans to submit applications in other countries, with updates to follow as the process unfolds [33]. Question: Timing for trial data release - Management indicated that data release timing will depend on patient enrollment and observation, with expectations for meaningful information to be disclosed at appropriate times [40]. Question: Evaluation of WT1 for solid tumors - Management noted that while the focus is currently on AML, there are plans to explore solid tumors where WT1 is applicable [36]. Question: Considerations for the U.K. regulatory submission - Management expressed confidence in the strong filing and the supportive regulatory environment in the U.K. for gene-based therapies [44]. Question: Impact of COVID-19 on clinical trials - Management acknowledged the challenges posed by COVID-19 but emphasized that the trial's small size and first-in-human nature would facilitate patient enrollment [46]. Question: Rationale for filing with MHRA first - Management explained that the decision was based on familiarity with the agency and its efficient processes for gene-based medicine [48]. Question: Durability of gene editing versus gene therapies - Management highlighted that their approach anticipates lifelong durability, which is a key advantage over traditional gene therapies [51].
Intellia Therapeutics(NTLA) - 2020 Q1 - Earnings Call Transcript
2020-05-08 02:30
Intellia Therapeutics, Inc. (NASDAQ:NTLA) Q1 2020 Earnings Conference Call May 7, 2020 8:00 AM ET Company Participants Lina Li - Associate Director of Investor Relations John Leonard - Chief Executive Officer Laura Sepp-Lorenzino - Chief Scientific Officer Glenn Goddard - Chief Financial Officer Jos?? Rivera - General Counsel Conference Call Participants Timur Ivannikov - Raymond James Maury Raycroft - Jefferies Rick Bienkowski - SVB Leerink Madhu Kumar - R.W. Baird Tony Butler - ROTH Capital Jay Olson - Op ...
Intellia Therapeutics(NTLA) - 2020 Q1 - Quarterly Report
2020-05-07 20:31
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 Delaware 36-4785571 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 40 Erie Street, Suite 130, Cambridge, Massachusetts 02139 (Address of Principal Executive Offices) (Zip Code) 857-285-6200 (Registrant's Telephone Number, Including Area Code) For the quarterly period ended March 31, 202 ...
Intellia Therapeutics(NTLA) - 2019 Q4 - Annual Report
2020-02-27 21:34
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, 2019 ☐ 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) - 2019 Q4 - Earnings Call Transcript
2020-02-27 20:44
Financial Data and Key Metrics Changes - As of December 31, 2019, the company's cash, cash equivalents, and marketable securities were $284.5 million, a decrease from $314.1 million as of December 31, 2018, primarily due to approximately $125 million used for operations [30] - Collaboration revenue for Q4 2019 was $10.9 million, up from $7.9 million in the same period in 2018, driven mainly by the ATTR program collaboration with Regeneron [31][32] - R&D expenses increased to $31.7 million in Q4 2019 from $19.9 million in Q4 2018, attributed to IND-enabling activities for NTLA-2001 and research efforts for NTLA-5001 [33] Business Line Data and Key Metrics Changes - The company advanced its first development candidate, NTLA-2001, for transthyretin amyloidosis (ATTR) and is on track for an IND submission in mid-2020 [10][11] - NTLA-5001, targeting acute myeloid leukemia (AML), is also progressing with IND-enabling activities expected to lead to an IND submission in the first half of 2021 [22][26] - The HAE program aims to utilize a knockout approach for hereditary angioedema, with a development candidate nomination expected in the first half of 2020 [16][20] Market Data and Key Metrics Changes - The ATTR program targets a progressive and fatal disease with significant unmet medical need, as it is often underdiagnosed [13] - The HAE program is designed to address a rare genetic disease affecting approximately 1 in 50,000 people, with existing therapies having significant treatment burdens [17][18] Company Strategy and Development Direction - The company is focused on advancing a full spectrum genome editing strategy, with both in vivo and ex vivo programs aimed at addressing life-threatening diseases [7][8] - The modular approach allows for rapid development and adaptation of therapies based on prior experiences, enhancing the potential for successful outcomes [11][20] - The company aims to leverage its CRISPR technology to create engineered cell therapies for cancer and genetic diseases, with a strong emphasis on safety and efficacy [21][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of CRISPR-based therapies to provide curative options for patients, particularly in the context of ATTR and HAE [11][15] - The company anticipates a significant year ahead with multiple milestones, including the initiation of clinical trials for NTLA-2001 and NTLA-5001 [36][37] - Management highlighted the importance of collaboration with key opinion leaders and patient groups to inform clinical development and ensure alignment with patient needs [45][46] Other Important Information - The company reaffirmed that its current cash balance is expected to fund operations through at least the end of 2021 [34] - The collaboration with Regeneron involves shared development costs and future commercial profits for the ATTR program, enhancing financial stability [32] Q&A Session Summary Question: Can you elaborate on consecutive editing and potential safety concerns? - The company explained that consecutive editing involves multiple LNP administrations targeting different genetic targets, with safety assessments similar to single administrations [39][42] Question: What feedback are you receiving regarding NTLA-2001 and its potential as a one-time treatment? - Management noted broad enthusiasm from key opinion leaders and patients for a one-time curative approach compared to chronic therapies [45][46] Question: What are your thoughts on the target TTR knockdown levels for the ATTR program? - The company aims for knockdowns in excess of 60% to achieve therapeutic value, with ongoing assessments to refine this target [55][56] Question: Can you provide an update on the alpha-1 antitrypsin program? - The company is actively working on optimizing the alpha-1 antitrypsin program and plans to share updates at future scientific meetings [60] Question: How will you approach the clinical development of the HAE program? - Management indicated that the clinical program will be designed to meet and improve upon existing standards of care, with a focus on patient safety [71][72]
Intellia Therapeutics(NTLA) - 2019 Q3 - Quarterly Report
2019-10-31 21:17
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, 2019 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) - 2019 Q2 - Quarterly Report
2019-08-01 21:16
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 June 30, 2019 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 o ...
Intellia Therapeutics(NTLA) - 2019 Q1 - Quarterly Report
2019-05-02 21:00
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, 2019 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 ...
Intellia Therapeutics(NTLA) - 2018 Q4 - Annual Report
2019-02-27 13:23
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, 2018 ☐ 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 jurisdictio ...