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Editas Medicine(EDIT) - 2023 Q1 - Earnings Call Transcript
2023-05-05 18:30
Editas Medicine, Inc. (NASDAQ:EDIT) Q1 2023 Results Conference Call May 5, 2023 8:00 AM ET Company Participants Cristi Barnett - Corporate Communications and IR Gilmore O’Neill - CEO Baisong Mei - Chief Medical Officer Michelle Robertson - CFO Conference Call Participants Joon Lee - Truist Securities Samantha Semenkow - Citi Dae Gon Ha - Stifel Steve Seedhouse - Raymond James Yanan Zhu - Wells Fargo Ernie Rodriguez - Cowen Rick Bienkowski - Cantor Fitzgerald Rich Law - Credit Suisse Ry Forseth - Guggenheim ...
Editas Medicine(EDIT) - 2023 Q1 - Quarterly Report
2023-05-04 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) Delaw ...
Editas Medicine(EDIT) - 2022 Q4 - Earnings Call Transcript
2023-02-22 17:43
Editas Medicine, Inc. (NASDAQ:EDIT) Q4 2022 Results Conference Call February 22, 2023 8:00 AM ET Company Participants Ron Moldaver - Investor Relations Gilmore O’Neill - Chief Executive Officer Michelle Robertson - Chief Financial Officer Baisong Mei - Chief Medical Officer Conference Call Participants Samantha Semenkow - Citi Dae Gon Ha - Stifel Phil Nadeau - Cowen & Company Rick Bienkowski - Cantor Fitzgerald Jay Olson - Oppenheimer Brian Cheng - JP Morgan Luca Issi - RBC Capital Markets Greg Harrison - B ...
Editas Medicine(EDIT) - 2022 Q4 - Annual Report
2023-02-21 16:00
Table of Contents 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, 2022 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) Delaware ( ...
Editas Medicine, Inc. (EDIT) EDIT-301 Clinical Update 2022 - (Transcript)
2022-12-06 17:11
Industry/Company Involved * **Company**: Editas Medicine, Inc. (NASDAQ:EDIT) * **Industry**: Biotechnology, Gene Editing, Hematology Key Points and Arguments 1. **EDIT-301 Clinical Update**: Editas Medicine presented early clinical data from the RUBY study evaluating EDIT-301 for severe sickle cell disease (SCD) [6][7]. 2. **Safety Profile**: The initial safety profile of EDIT-301 was consistent with myeloablative busulfan conditioning and autologous hematopoietic stem cell transplant. Both dose participants showed successful engraftment and stopped red blood cell transfusions without any vaso-occlusive events (VOEs) [6]. 3. **Efficacy**: The first patient achieved a fetal hemoglobin (HBF) level of 45.4% and a total hemoglobin of 16.4 g/dL five months after EDIT-301 treatment. This suggests clinical proof of concept and potential for robust clinical benefit in SCD patients [7][8]. 4. **Mechanism of Action**: EDIT-301 uses a novel CRISPR nuclease, AsCas12a, to target the promoter region of the gamma globin gene 1 and 2, increasing fetal hemoglobin expression and mimicking the natural mechanism of hereditary persistence of fetal hemoglobin [12]. 5. **RUBY Study**: The RUBY study is a Phase 1/2 study designed to evaluate the safety, tolerability, and efficacy of EDIT-301 in severe SCD patients. The study will recruit up to 40 patients aged 18-50 years with a history of at least two VOEs per year [13]. 6. **Future Plans**: Editas Medicine plans to provide more data from the RUBY study, including data from additional patients, in the middle of 2023 [19]. Other Important Points * **Regulatory Pathway**: Editas Medicine is actively engaging with regulators and expects to have greater clarity on the required patient data set and follow-up for a BLA submission in the coming year [36]. * **Alternative Conditioning Therapies**: Editas Medicine is exploring alternative conditioning regimens beyond busulfan to reduce treatment burden for patients and treatment sites [38]. * **Clinical Differentiation**: Editas Medicine believes that its unique therapeutic strategy, including the use of AsCas12a and targeting the gamma globin promoter, could lead to significant differentiation from other SCD therapies [31]. * **Patient Engagement**: Editas Medicine values engagement with investigators, clinicians, and patient communities and believes that patient education and understanding of the science behind EDIT-301 are crucial [82].
Editas Medicine(EDIT) - 2022 Q3 - Earnings Call Transcript
2022-11-02 14:50
Financial Data and Key Metrics Changes - As of September 30, 2022, the company's cash, cash equivalents, and marketable securities were $479 million, down from $528 million in the previous quarter, indicating a disciplined approach to expense management with a cash runway extending into 2024 [37] - Minimal revenue was recorded for the third quarter from an out-license agreement, compared to $6.2 million in the same period last year when a collaboration with BMS was opted into [38] Business Line Data and Key Metrics Changes - R&D expenses for the third quarter were $41 million, an increase from $29 million in the same quarter last year, driven by investments in manufacturing and CMC capabilities to support ongoing clinical trials [39] Market Data and Key Metrics Changes - The company is focused on leveraging its gene editing expertise to develop new therapeutics, with updates expected in the coming months [6] Company Strategy and Development Direction - The company is transitioning from a platform company to a clinical-stage therapeutics company, emphasizing execution and clinical advancement as top priorities [6][7] - The EDIT-301 program for sickle cell disease and transfusion-dependent beta thalassemia is a key focus, utilizing a proprietary AsCas12a engineered nuclease for higher editing efficiency [8][9] - The EDIT-101 program for LCA10 aims to establish safety and efficacy in a specific patient population, with updates expected soon [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the competitive positioning of EDIT-301, anticipating that a significant portion of the patient population will remain untreated at the time of launch due to slow uptake and evolving payer landscapes [44][110] - The company is optimistic about its ability to innovate within the context of the Inflation Reduction Act, believing it can develop new technologies targeting challenging human diseases [106] Other Important Information - The company holds exclusive licenses for Cas9 therapeutic patents in the US, which could be a significant value driver as many competitors are developing products using Cas9 [15][18] - The company is actively seeking partnerships to unlock the full potential of its NK cell platform and other oncology programs [89] Q&A Session Summary Question: What will be the goal regarding the fetal-globin level for EDIT-301? - Management indicated that while 30% fetal-globin is a minimal threshold for clinical benefit, they believe their product will be competitive due to its differentiated approach using AsCas12a [43] Question: What is the level of confidence in the potential of the EDIT-101 program? - Management views EDIT-101 as both a commercial opportunity and a proof-of-concept for applying their technology to other indications, focusing on identifying the most responsive patient segments [48] Question: Are there any updates on the NK cell platform? - Management is keen to unlock the potential of the NK platform through partnerships and will share updates once agreements are signed [89] Question: What additional endpoints are being considered for the sickle cell program? - Management is considering various approaches for differentiation and will share more details in future updates [90] Question: When will data from the RUBY trial be available? - Data from the RUBY trial is expected to be shared by the end of the year, including safety and efficacy data from the first treated patients [61][97]
Editas Medicine(EDIT) - 2022 Q3 - Quarterly Report
2022-11-01 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) D ...
Editas Medicine, Inc. (EDIT) Management Presents at Morgan Stanley 20th Annual Global Healthcare Conference Call Transcript
2022-09-12 18:53
Summary of Editas Medicine, Inc. Conference Call Company Overview - **Company**: Editas Medicine, Inc. (NASDAQ:EDIT) - **Date**: September 12, 2022 - **Participants**: - Gilmore O'Neill - President and CEO - Mark Shearman - Executive VP and Chief Scientific Officer - Baisong Mei - Senior VP and Chief Medical Officer - Michelle Robertson - Chief Financial Officer Key Industry Insights - **Gene Editing Landscape**: The call discussed the competitive landscape of gene editing technologies, particularly focusing on CRISPR, base editing, and prime editing. Editas utilizes the AsCas12a enzyme, which is engineered for higher fidelity and efficiency compared to the Cas9 enzyme used by many competitors [5][6][9]. Core Technology and Differentiation - **AsCas12a Enzyme**: Editas employs the AsCas12a enzyme for its gene editing programs, which is noted for its high on-target activity and specificity. This enzyme allows for precise control over gene editing, reducing potential off-target effects [5][7][10]. - **Guide RNA**: The company uses a smaller guide RNA (41 mer) compared to the larger guide RNA (90-100 mer) used in Cas9 technologies, enhancing the quality and purity of the editing process [9][10]. - **Clinical Applications**: The AsCas12a enzyme is particularly important in Editas' cell therapy approaches, such as the EDIT-301 program for sickle cell disease, where high control over editing is crucial [7][10]. Clinical Programs - **BRILLIANCE Study**: This is a Phase 1 interventional study targeting LCA10, a rare genetic disease. The study aims to assess safety and efficacy, focusing on identifying patient segments likely to respond to treatment [24][25][28]. - **Endpoints**: The study will evaluate various endpoints, including visual acuity, quality of life, and physiological parameters, to determine treatment effectiveness [26][29][31]. - **Data Release**: Data from the study is expected to be shared in October/November 2022, with a focus on identifying patient populations that show a meaningful benefit [28][31]. Intellectual Property and Monetization - **IP Position**: Editas holds exclusive licenses from the Broad Institute for Cas9-related IP, which positions the company favorably in the gene editing market. The company is confident in its IP standing following favorable reviews by the PTAB and federal appeals court [18][19][20]. - **Monetization Strategy**: The company is considering monetizing its IP as a potential revenue stream, particularly for therapeutic applications involving Cas9 [18][19]. Financial Position - **Cash Reserves**: As of Q2 2022, Editas reported over $500 million in cash, which is expected to sustain operations into 2024 while the company explores additional financing opportunities [53]. Conclusion - Editas Medicine is positioned as a leader in the gene editing space, leveraging its proprietary AsCas12a technology to differentiate itself from competitors. The company is focused on advancing its clinical programs while maintaining a strong IP position and financial health.
Editas Medicine(EDIT) - 2022 Q2 - Quarterly Report
2022-08-02 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) Tradin ...
Editas Medicine(EDIT) - 2022 Q1 - Quarterly Report
2022-05-03 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) Tradi ...