ELVN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Enliven Inc. (formerly, Enliven Therapeutics, Inc.) (“Former Enliven”) was incorporated in the State of Delaware in June 2019, and we are headquartered in Boulder, Colorado. We devote substantially all of our resources to research and development activities of our breakpoint cluster region – Abelson…

• equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Form 10-Q.

• incur costs related to our decision not to develop the HER2 program beyond 2025;

• establish a sales, marketing, medical and distribution infrastructure to commercialize any approved product candidates;

• contract to manufacture any clinical product candidates as well as approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries including countries in Europe, which may increase the cost of manufacturing our product candidates;

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• The following table summarizes our ELVN-001 and ELVN-002 programs:

• Enliven Inc. (formerly, Enliven Therapeutics, Inc.) (“Former Enliven”) was incorporated in the State of Delaware in June 2019, and we are headquartered in Boulder, Colorado. Since its inception, Former Enliven has devoted substantially all of its resources to research and development activities, inc…

• aggregate gross proceeds of $230.0 million. Through September 30, 2025, we have sold shares of our common stock pursuant to the Sales Agreement (as defined below) and received gross proceeds of $40.0 million. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $477.6…

• incur costs related to our decision not to develop the HER2 program beyond 2025;

• establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates;

Text added vs the prior filing · source: 10-Q · 2026-05-07

• future. We believe a hypothetical 100 basis point increase or decrease in foreign exchange rates during any of the periods presented would not have had a material impact on our financial condition or results of operations.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future …

• to have an adverse effect on our working capital, our ability to fund the development of our product candidates and our ability to achieve and maintain profitability and the performance of our stock.

• Any changes in the manufacturing process, suppliers, or facilities will require further comparability analysis and approval by the FDA before implementation, which could delay our clinical trials and product candidate development, and could require additional clinical trials, including bridging stud…

• undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Treatment-related side effects have resulted, and could result in additional patients dropping out of our trials, and could affect patient recruitment and the ability…

• We are a clinical-stage biopharmaceutical company aiming to address existing and emerging unmet needs with a precision medicine approach. If we are required by the FDA or comparable regulatory authorities to obtain approval of a companion diagnostic in connection with approval of any of our product …

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may

• not be a good indication of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our workin…

• our ability to maintain or further our research and development efforts, raise additional necessary capital, grow our business and continue our operations.

• Any changes in the manufacturing process, suppliers, or facilities will require further comparability analysis and approval by the FDA before implementation, which could delay our clinical trials and product candidate development, and could require additional clinical trials, including bridging stud…

• We are a clinical-stage biopharmaceutical company aiming to address existing and emerging unmet needs with a precision oncology approach. If we are required by the FDA or comparable regulatory authorities to obtain approval of a companion diagnostic in connection with approval of any of our product …

Text added vs the prior filing · source: 10-Q · 2026-05-07

• On January 3, 2026, Anish Patel, Pharm.D., our Chief Operating Officer and, until February 12, 2026, an officer as defined in Rule 16a-1(f), as trustee for The Patel/Dong Family Trust, dated August 24, 2017, terminated the “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408 that …

• On March 6, 2026, Lori Kunkel, M.D., a director, adopted a “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408 providing for the sale from time to time of an aggregate of up to 20,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defen…

• On March 18, 2026, Benjamin Hohl, our Chief Financial Officer and an officer as defined in Rule 16a-1(f), adopted a “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408 providing for the sale from time to time of an aggregate of up to 43,090 shares of our common stock. The trading…

• No other officers or directors, as defined in Rule 16a-1(f), adopted and/or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as defined in Regulation S-K Item 408, during the last fiscal quarter.