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August 2023
June 2023
June 2023
May 2023
March 2023
Exhibit 99.1
Enliven Therapeutics Highlights Business Achievements and Reports First Quarter 2023 Financial Results
Successfully completed merger with Imara Inc., trading under the new ticker symbol on Nasdaq, ELVN
Dosed first patient in Phase 1 study of ELVN-002 in patients with HER2-altered non-small cell lung cancer (NSCLC) and other solid tumors
Enrollment progressing in Phase 1 trial with ELVN-001 in chronic myeloid leukemia (CML)
Ended the first quarter 2023 with cash and cash equivalents of approximately $292 million, which is expected to provide cash runway into early 2026
BOULDER, Colo., May 11, 2023 (GLOBE NEWSWIRE) Enliven Therapeutics, Inc. (Enliven) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today reported financial results for the first quarter ended March 31, 2023 and provided a business update.
2023 is off to a strong start with the successful completion of our merger with Imara Inc. and the concurrent private financing, dosing of the first patient in the Phase 1 study of ELVN-002, continued progression of enrollment in our Phase 1 trial for ELVN-001, and good progress on our discovery pipeline, said Sam Kintz, MBA, Enlivens Co-founder and President and Chief Executive Officer. 2023 is a critical year of execution for us as our parallel lead programs advance ahead of expected Phase 1a data for both programs in 2024.
Recent Business Highlights and Upcoming Milestones
Research and Development Highlights
| ELVN-002: Dosed the first patient in the Phase 1 clinical trial evaluating ELVN-002 in people with cancers harboring an abnormal HER2 gene (NCT05650879). ELVN-002 is a CNS penetrant, selective and irreversible HER2 inhibitor with activity against various HER2 mutations, including Exon 20 insertion mutations (E20IMs) in NSCLC, for which there are currently no approved small molecule inhibitors. The Company expects to share initial safety and efficacy data from the Phase 1a study in 2024. |
| ELVN-001: Continued progress in the dose escalation portion of the Phase 1 clinical trial evaluating ELVN-001 in adults with CML (NCT05304377). The Company expects to share initial safety and efficacy data from the Phase 1a study in 2024. |
| Pipeline: Progress toward nominating a product candidate for a third program, which is expected in the second quarter of this year. Enliven is also actively pursuing multiple additional early-stage discovery programs. |
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Enliven Therapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2023 10-K Annual Report includes:
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The increase was primarily due to an increase of $1.7 million in stock-based compensation, $1.3 million in professional services costs, $0.4 million in salaries and benefits, $0.3 million in liability insurance costs, and $0.2 million in other expenses.
This consisted primarily of a net loss of $31.4 million, net cash outflows from changes in our operating assets and liabilities of $7.2 million (primarily due to an increase in prepaids and other assets and a net decrease in accounts payable and accrued expenses and other liabilities) and non-cash amortization of premiums and discounts on marketable securities of $0.8 million, partially offset by non-cash charges for stock-based compensation of $6.5 million.
Liquidity and Capital Resources Sources of Liquidity Since our inception, we have not generated any revenue from product sales or other sources and have incurred significant operating losses and negative cash flows from our operations.
At the closing of the Merger, (a) each outstanding share of Former Enliven common stock (including common stock issued upon the conversion of its preferred stock) was converted into the right to receive a number of shares of our common stock (after giving effect to our 1-for-4 reverse stock split of our common stock (the Reverse Stock Split)) equal to the exchange ratio per the Merger Agreement; and (b) each then outstanding Former Enliven stock option that had not previously been exercised prior to the closing of the Merger was assumed by us.
The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts.
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Financial Statements, Disclosures and Schedules
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Material Contracts, Statements, Certifications & more
Enliven Therapeutics, Inc. provided additional information to their SEC Filing as exhibits
Ticker: ELVN
CIK: 1672619
Form Type: 10-Q Quarterly Report
Accession Number: 0000950170-23-041349
Submitted to the SEC: Thu Aug 10 2023 4:16:58 PM EST
Accepted by the SEC: Thu Aug 10 2023
Period: Friday, June 30, 2023
Industry: Pharmaceutical Preparations