Enliven Therapeutics files automatic shelf with $200.0 million ATM prospectus supplement

The shelf and the sales agreement

Enliven, which trades on the Nasdaq Global Select Market as ELVN, filed an automatic shelf registration statement on Form S-3ASR on August 13, 2025. The base prospectus covers common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts and units, to be offered from time to time in one or more offerings. The filing includes a sales agreement prospectus supplement covering up to $200.0 million of common stock under an Open Market Sale Agreement dated June 23, 2023 with Jefferies LLC. Jefferies is the sales agent. It is not required to sell any specific amount and uses commercially reasonable efforts. Its compensation is up to 3.0% of the aggregate gross proceeds of shares sold. Cooley LLP, of New York, represents Jefferies in the offering. Wilson Sonsini Goodrich & Rosati, Professional Corporation, of Palo Alto, passes on the validity of the securities for Enliven. The supplement says the number of shares that may be sold is not determinable at this time. It gives 59,226,171 shares outstanding as of June 30, 2025, and excludes 9,487,212 shares issuable on options at a weighted average exercise price of $16.13, 2,851,768 shares issuable on pre-funded warrants at $0.001, and 3,718,335 shares reserved under the 2020 plan. The shelf also covers debt and other securities, and the filing does not say which of them, if any, are planned. The 2023 sales agreement predates this filing, and the filing does not say how much of the $200.0 million has been sold under it.

The strategic review and the pipeline

The company's main asset is ELVN-001, a small-molecule kinase inhibitor aimed at the BCR-ABL fusion that drives chronic myeloid leukemia. The annual report says tolerability, safety, resistance and convenience concerns have become more prominent as patients can now expect to live on therapy for decades. To prioritize ELVN-001 and its pivotal trial, the company is exploring strategic alternatives for ELVN-002, its HER2 program, and it does not intend to pursue that program's development beyond 2025. The supplement says the proceeds, together with existing cash, cash equivalents and marketable securities, would fund research and development, including a planned Phase 3 trial of ELVN-001, and working capital. The supplement gives no cash balance or runway estimate.

The data and their limits

In June 2025 the company announced updated data from the ongoing ENABLE Phase 1 trial of ELVN-001 in patients with previously treated CML. As of an April 28, 2025 cutoff, 25 of 53 evaluable patients, or 47%, had major molecular response by 24 weeks. The company also reported 13 of 41 patients (32%) achieving and 12 of 12 (100%) maintaining major molecular response. The company says ELVN-001 remains well-tolerated across all evaluated doses. The company also says these results compare favorably with precedent Phase 1 responses for approved BCR::ABL1 inhibitors, given that its patients were more heavily pretreated. That is a comparison across trials, not a controlled one. The population is small and the study is early. The company calls the upcoming ELVN-001 trial pivotal, and it has not yet reported that trial. The company says its approach is rooted in validated biology and differentiated chemistry. Both the differentiation claim and the comparison are the company's own, and the filing does not name the approved BCR::ABL1 inhibitors it compares against.

The company

Enliven Inc., formerly Enliven Therapeutics, Inc., was incorporated in Delaware in June 2019. The business combination with the former Enliven closed on February 23, 2023 under a merger agreement dated October 13, 2022, and the company effected a 1-for-4 reverse stock split at closing. The company says its team has taken four FDA-approved products through clinical trials at prior companies: Koselugo, Mektovi, Tukysa and Retevmo. The company's shares trade on the Nasdaq Global Select Market under ELVN. The offering is an at-the-market program, so each sale is priced at the market at the time. Each Jefferies confirmation lists the shares sold and the gross proceeds.

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