Enliven Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

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 pretreated patient population, the efficacy data below, which shows MMR rates by 24 weeks, highlights that ELVN-001 continues to demonstrate the profile of a best-in-class ATP-competitive inhibitor.

Dose (number of patients)

80 mg QD (n=19)

60/120 mg QD (n=41)

Cumulative Major Molecular Response (MMR)

47% (n=19)

69% (n=26)

Achieved MMR

38% (n=16)

53% (n=17)

Maintained MMR

100% (n=3)

100% (n=9)

Deep Molecular Response (DMR)

16% (n=19)

35% (n=26)

• Upcoming ELVN-001 Milestones Mid-year presentation of additional Phase 1 data from the ongoing ENABLE trial Regulatory alignment with the FDA on dose selection and Phase 3 trial design Initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, in the second half of 2026

Additional Company Updates

• The strength of the ELVN-001 data to-date and the Company's clear path forward to the initiation of its planned Phase 3 pivotal trial and potential commercialization have driven recent leadership and Board changes, including the appointment of Rick Fair as Chief Executive Officer in December 2025 and the addition of Scott Garland to the Board in January 2026.
• These changes underscore Enliven's commitment to aligning experienced leadership and governance with its transition into late-stage development and future commercialization.

Fourth Quarter and Full Year 2025 Financial Results

• Cash Position: As of December 31, 2025, the Company had cash, cash equivalents and marketable securities totaling $462.6 million, which is expected to provide cash runway into the first half of 2029.
• Research and development (R&D) expenses: R&D expenses were $21.2 million for the fourth quarter of 2025, compared to $20.7 million for the fourth quarter of 2024. R&D expenses were $85.9 million for the full year 2025, compared to $80.8 million for the full year 2024.
• General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2025 were $13.0 million, compared to $6.2 million for the fourth quarter of 2024, mainly driven by stock-based compensation related to the CEO transition announced in December 2025. G&A expenses were $33.8 million for the full year 2025, compared to $23.8 million for the full year 2024.
• Net Loss: Enliven reported a net loss of $29.7 million for the fourth quarter of 2025, compared to a net loss of $23.2 million for the fourth quarter of 2024. Total net loss for the full year 2025 was $103.7 million, compared to $89.0 million for the full year 2024.

About Enliven Therapeutics

Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. To learn more, visit www.enliventherapeutics.com and connect with us on LinkedIn and X.

Enliven Therapeutics, Inc. Selected Condensed Consolidated Financial Information (in thousands, except per share data) (unaudited)

Statements of Operations

Three Months Ended December 31,

Year Ended December 31,

2025

2024

2025

2024

Operating expenses:

Research and development

$ 21,245

$ 20,724

$ 85,856

$ 80,778

General and administrative

13,040

6,172

33,802

23,776

Total operating expenses

34,285

26,896

119,658

104,554

Loss from operations

(34,285)

(26,896)

(119,658)

(104,554)

Other income (expense), net

4,618

3,716

15,964

15,530

Net loss

$ (29,667)

$ (23,180)

$ (103,694)

$ (89,024)

Net loss per share, basic and diluted

$ (0.48)

$ (0.46)

$ (1.83)

$ (1.89)

Weighted-average shares outstanding, basic and diluted

62,213

49,858

56,664

47,073

Balance Sheets

December 31,

2025

2024

Assets

Current assets:

Cash, cash equivalents and marketable securities

$ 462,621

$ 313,440

Restricted cash

—

54

Prepaid expenses and other current assets

12,257

4,633

Total current assets

474,878

318,127

Property and equipment, net

34

458

Operating lease right-of-use assets

383

—

Deferred offering costs

217

—

Other long-term assets

656

7,175

Total assets

$ 476,168

$ 325,760

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$ 2,159

$ 1,342

Accrued expenses and other current liabilities

14,409

14,573

Total current liabilities

16,568

15,915

Total liabilities

16,568

15,915

Stockholders' equity

459,600

309,845

Total liabilities and stockholders' equity

$ 476,168

$ 325,760