Enliven Therapeutics(ELVN) - 2021 Q3 - Earnings Call Transcript

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]