ELVN

Phase 1 data update for ELVN-001 expected mid-2026 Initiation of the Phase 3 ENABLE-2 pivotal trial of ELVN-001 expected in the second half of 2026 Strong balance sheet with $452 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029 BOULDER, Colo., May 7, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. "Recent strategic momentum in CML validates a remaining unmet need and a compelling long-term opportunity. Against this backdrop, we remain focused on execution as we prepare to initiate the Phase 3 pivotal trial of ELVN-001 in the second half of 2026," said Rick Fair, Chief Executive Officer of Enliven. "Based on the Phase 1 data generated to date, we believe ELVN-001 has the potential to be the best-in-class ATP-competitive inhibitor in CML and that it is positioned strongly to compete across all lines of therapy." ELVN-001 Program Highlights ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML). In January 2026, the Company announced positive initial Phase 1b data for ELVN-001, reinforcing ELVN-001's positioning as the potentially best-in-class ATP-competitive inhibitor in CML Enrollment continued in the 80 mg once daily expansion cohort of the Phase 1b trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377) The Company remains on track to achieve its anticipated 2026 milestones, including: Mid-year presentation of additional Phase 1 data from the ongoing ENABLE trial Regulatory interactions with the FDA on dose selection and Phase 3 trial design Initiation of Phase 3 ENABLE-2 in the second half of 2026 First Quarter 2026 Financial Results Cash Position: As of March 31, 2026, the Company had cash, cash equivalents and marketable securities totaling $452.4 million, which is expected to provide cash runway into the first half of 2029. Research and development (R&D) expenses: R&D expenses were $20.7 million for the first quarter of...

Reported positive initial Phase 1b data for ELVN-001 in CML Initiation of the Phase 3 ENABLE-2 pivotal trial of ELVN-001 expected in the second half of 2026 Key data readout, regulatory interactions, and operational catalysts throughout 2026 Strong balance sheet with $463 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029 BOULDER, Colo., March 3, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update, including highlights of positive initial data from the ongoing Phase 1b ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377). "2025 was a year of meaningful progress as we advanced ELVN-001 toward a Phase 3 pivotal clinical trial," said Rick Fair, Chief Executive Officer of Enliven. "As we move into 2026, we're entering one of the most active and transformative periods in Enliven's history – with an important data readout, key regulatory interactions, and the planned initiation of our ENABLE-2 pivotal trial. We are focused on execution to demonstrate ELVN-001's potential as a best-in-class ATP-competitive inhibitor for people living with CML." ELVN-001 Program Highlights ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with CML. The Company announced positive initial Phase 1b data for ELVN-001 in patients with CML. As of the cutoff date of December 22, 2025, 60 patients were enrolled in the initial cohorts of the Phase 1b trial. Patients were first enrolled in the 80 mg once daily (QD) cohort. Subsequent patients were randomized to either 60 mg QD or 120 mg QD. Patients enrolled were heavily pretreated, consistent with patients from previously reported datasets. In these 60 patients: 53% of patients received four or more unique prior TKIs. 67% of patients received prior asciminib and 32% received prior ponatinib. Despite the heavily pre...

Announced positive data from the Phase 1 clinical trial of ELVN-001 in CML, reporting a cumulative MMR rate of 47% with 32% of patients achieving MMR by 24 weeks and demonstrating a favorable safety and tolerability profile across all dose levels Strong balance sheet with $491 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029 BOULDER, Colo., Aug. 13, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the second quarter ended June 30, 2025, and provided a business update, including highlights of pipeline progress. "We made tremendous progress this quarter. Notably, we reported updated positive clinical data for ELVN-001, which continue to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs despite being evaluated in a more heavily pre-treated patient population," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "These results reinforce our belief that ELVN-001 could ultimately compete across all lines of CML therapy based on its differentiated efficacy, tolerability and convenience – attributes that position it to be a potential best-in-class therapy for people living with CML. Building on the strength of these findings, we expect to initiate our first Phase 3 pivotal trial in 2026 and remain confident in ELVN-001's potential within the CML treatment landscape. We also strengthened our balance sheet through our recent public offering, which generated gross proceeds of approximately $230 million and extended our cash runway into the first half of 2029." Pipeline Updates ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML). In June 2025, the Company announced positive updated data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377) in an oral presentation at the European Hematology Association (EHA) Congress. As of the April 28, 2025, cutoff date, 25 of 53 (47%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 13 of 41...

Updated data from the Phase 1 ENABLE clinical trial of ELVN-001 in CML to be presented at the EHA 2025 Congress in June EHA abstract reported cumulative MMR rate of 44% (16 of 36) by 24 weeks with 26% (7 of 27) of patients achieving MMR by 24 weeks, and ELVN-001 remains well-tolerated with 74 patients enrolled Enliven to host a webcast and conference call following the oral presentation at EHA on Friday, June 13, at 1:30 p.m. ET Strong balance sheet with $290 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into late 2027 BOULDER, Colo., May 14, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the first quarter ended March 31, 2025, and provided a business update, including highlights of pipeline progress. "We are very pleased with the continued progress of ELVN-001 and the data that was just released in the EHA abstract. We continue to gain confidence and momentum in the program as the efficacy, safety and tolerability data consistently compare favorably to the approved BCR::ABL inhibitors. We are excited to share further updated data at EHA next month," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "Looking towards the rest of the year, we remain focused on clinical execution as we prepare for the potential start of a pivotal trial for ELVN-001 in 2026." Recent Research and Development Highlights and Upcoming Milestones ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion Today, the Company announced positive updated data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML) (NCT05304377) in an abstract that was accepted for an oral presentation at the European Hematology Association (EHA) Congress. As of the cutoff date for the abstract (January 21, 2025), 74 patients were enrolled in the trial across dose levels from 10-160 mg daily, and the vast majority of patients (82%) remain on study with a median treatment duration of ~26 weeks. 16 of 36 (44%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 7 of 27 (26%) a...

Updated Phase 1 data for ELVN-001 expected mid-2025 as positive enrollment momentum continues Expected monotherapy and combination data from the ELVN-002 Phase 1 trials in second half of 2025 Strong balance sheet with $313 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into mid-2027 BOULDER, Colo., Mar. 13, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update, including highlights of pipeline progress. "We are very pleased with the ongoing progress we are making as a Company. We continue to hear significant enthusiasm and excitement from investigators on both of our programs. The momentum of ELVN-001 has accelerated since the data presentation at the ESH-iCMLf conference," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "2025 is a big year for Enliven and we are excited for the upcoming program updates. We are focused on continued clinical execution and preparing for the potential start of a pivotal trial for ELVN-001 in 2026." Recent Research and Development Highlights and Upcoming Milestones ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion In 2024, the Company announced positive initial data from the ongoing Phase 1 clinical trial that compared favorably to the precedent Phase 1 trials for the approved BCR::ABL1 tyrosine kinase inhibitors (TKIs). The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML). The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML (NCT06787144). The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025. ELVN-002 is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations Enliven continued to enroll patients in its Phase 1 trial evaluating ELVN-002 as a monotherapy agent in patients with HER2+ and HER2 mutant tumors and its exploratory c...