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Enliven Therapeutics(ELVN) - 2021 Q4 - Earnings Call Transcript
2022-03-15 15:06
Imara Inc. (IMRA) Q4 2021 Earnings Conference Call March 15, 2022 8:30 AM ET Company Participants Rahul Ballal - President, Chief Executive Officer Mike Gray - Chief Financial Officer, Chief Operating Officer Ken Attie - Chief Medical Officer Conference Call Participants Yigal Nochomovitz - Citigroup Joseph Schwartz - SVB Securities Operator Ladies and gentlemen, thank you for standing by, and welcome to the Imara Inc. Q4 and 2021 earnings conference call and webcast. At this time, all participants are in ...
Enliven Therapeutics(ELVN) - 2021 Q4 - Annual Report
2022-03-14 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 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 001-39247 IMARA INC. (Exact name of Registrant as specified in its charter) Delaware 81-1523849 (State or other jurisdiction of incorpora ...
Enliven Therapeutics(ELVN) - 2021 Q3 - Earnings Call Transcript
2021-11-09 21:48
Financial Data and Key Metrics Changes - Research and development expenses increased to $10.4 million in Q3 2021 from $9.5 million in Q3 2020, primarily due to clinical trial costs and personnel-related expenses [28] - General administrative expenses rose to $3.3 million in Q3 2021 compared to $3 million in Q3 2020, attributed to increased personnel and operating costs [29] - Net loss attributable to common stockholders was $13.6 million or $0.55 per share for Q3 2021, compared to a net loss of $12.4 million or $0.72 per share in Q3 2020 [29] - Cash, cash equivalents, and investments totaled $102.8 million as of September 30, 2021, up from $88.2 million as of December 31, 2020, providing sufficient funds for operations into Q1 2023 [30] Business Line Data and Key Metrics Changes - The Ardent Phase 2b clinical trial for sickle cell disease has completed patient enrollment, with interim data expected this quarter focusing on safety and biomarkers [6][7] - The Forte Phase 2b clinical trial for beta-thalassemia has also reached enrollment in both transfusion-dependent and non-transfusion-dependent cohorts, with interim data anticipated this quarter [13][14] Market Data and Key Metrics Changes - The Ardent study has enrolled approximately 115 subjects globally, including regions such as Europe, the U.S., the Middle East, and Africa [7] - The company plans to present updated safety and VOC data from the Phase 2a open-label extension trial at the American Society of Hematology annual meeting in December [8] Company Strategy and Development Direction - The company is expanding its development pipeline with a focus on tovinontrine for heart failure with preserved ejection fraction (HFpEF) and has initiated a new program, IMR-261, an oral Nrf2 activator [5][22] - IMARA aims to interact with the FDA regarding the HFpEF program and has appointed a new Vice President of Clinical Development to lead these efforts [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts and the progress made in core programs, indicating a productive period for the company [26] - The company believes that tovinontrine may be a promising treatment option for patients with HFpEF based on independent literature and internal data [19] Other Important Information - IMR-261 is positioned as a clinic-ready asset with promising preclinical data in sickle cell disease and beta-thalassemia, with plans for clinical development in 2022 [25] - The company has made substantial progress in enabling the HFpEF program, with a focus on clinical trials and regulatory interactions [16] Q&A Session Summary Question: Will the company consider indications in kidney disease for the Nrf2 activator? - The company is currently focused on red blood cell disorders, particularly hemoglobinopathies, but acknowledges that Nrf2 activation is implicated in various diseases, including renal diseases [32] Question: What can be expected from the 12-month VOC data from the ongoing Phase 3 OLE study? - The 12-month data will provide a clearer annualized VOC rate for approximately 20 patients, minimizing the need for annualization from shorter data periods [38] Question: How did the company decide to advance IMR-261, and what challenges are anticipated? - The decision was based on existing literature and preclinical data showing significant efficacy in sickle cell models, with challenges primarily related to drug product manufacturing [41][44] Question: What doses are being tested for IMR-261, and what is the expected safety profile? - The company plans to test doses based on previous studies, with preclinical data indicating that the drug was well tolerated at higher doses [46][47] Question: What is the potential development pathway for IMR-261 given the available data? - The company is evaluating various clinical paths forward, leveraging existing data and previous INDs to expedite the development process [52]
Enliven Therapeutics(ELVN) - 2021 Q3 - Quarterly Report
2021-11-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 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: 001-39247 IMARA INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81-1523849 ...
Enliven Therapeutics(ELVN) - 2021 Q2 - Earnings Call Transcript
2021-08-08 18:44
IMARA Inc. (IMRA) Q2 2021 Earnings Conference Call August 6, 2021 8:30 AM ET Company Participants Mike Gray – Chief Financial and Chief Operating Officer Rahul Ballal – President and Chief Executive Officer Ken Attie – Chief Medical Officer Conference Call Participants Costa Sean – Morgan Stanley Joseph Swartz – SVB Leerink Operator Good day. Thank you for standing by, and welcome to the IMARA Inc. Q2 Earnings Conference Call and Webcast. [Operator Instructions] I would now like to hand the conference over ...
Enliven Therapeutics(ELVN) - 2021 Q2 - Quarterly Report
2021-08-05 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 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: 001-39247 IMARA INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81-1523849 (Sta ...
IMARA (IMRA) EHA Investor Presentations - Slideshow
2021-06-18 22:17
Advancing Novel Treatments for Hemoglobin Disorders Investor Call: June 11, 2021 CONFIDENTIAL Forward-Looking Statements and Disclaimer 2 This presentation may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, (i) the clinical trial design and timing with respect to reporting of data from the Ardent and Forte Phase 2b clinical trials in patients with sickle cell disease and beta-thalassemia, (ii) t ...
Enliven Therapeutics(ELVN) - 2021 Q1 - Earnings Call Transcript
2021-05-11 19:02
Call Start: 08:30 January 1, 0000 9:02 AM ET Imara, Inc. (IMRA) Q1 2021 Earnings Conference Call May 11, 2021 08:30 ET Company Participants Michael Gray - Chief Financial Officer & Chief Operating Officer Rahul Ballal - President, Chief Executive Officer & Director Conference Call Participants Yigal Nochomovitz - Citigroup Matthew Harrison - Morgan Stanley Joseph Schwartz - SVB Leerink Operator Ladies and gentlemen, thank you for standing by, and welcome to the Imara Inc. Q1 Earnings Conference Call and Web ...
Enliven Therapeutics(ELVN) - 2021 Q1 - Quarterly Report
2021-05-10 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 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: 001-39247 IMARA INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81-1523849 (St ...
Enliven Therapeutics(ELVN) - 2020 Q4 - Earnings Call Transcript
2021-03-05 17:39
Imara, Inc. (IMRA) Q4 2020 Earnings Conference Call March 5, 2021 8:30 AM ET Company Participants Michael Gray - CFO & COO Rahul Ballal - President, CEO & Director Conference Call Participants Matthew Harrison - Morgan Stanley Kelly Girskis - SVB Leerink Operator Ladies and gentlemen, thank you for standing by, and welcome to the IMARA Inc. Fourth Quarter Earnings Conference Call and Webcast. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Mr. Mike Gray. Thank yo ...