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ELVN

Enliven TherapeuticsF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-05
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Investor releaseQuarter not tagged2026-08-05

Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update

PR Newswire
Announced positive Phase 1 clinical data for ELVN-001 in CML, demonstrating encouraging ELVN-001 efficacy data and a favorable safety and tolerability profile Reached alignment with the FDA on key Phase 3 trial design components Strong balance sheet with $895 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into 2030 BURLINGAME, Calif., Aug. 5, 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 second quarter ended June 30, 2026, and provided a business update. "The second quarter was an important period for Enliven as we announced compelling updated clinical data for ELVN-001, reached alignment with the FDA on key components of the ENABLE-2 Phase 3 2L+ trial design, and significantly strengthened our balance sheet," said Rick Fair, Chief Executive Officer of Enliven. "The updated Phase 1 data support ELVN-001's potential to become a best-in-class treatment for patients living with CML. Combined with our recent regulatory and financial progress, we are well positioned to initiate ENABLE-2 later this year and rapidly advance ELVN-001 across all lines of CML therapy." ELVN-001 Program HighlightsELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with chronic myeloid leukemia (CML). In June 2026, the Company announced positive data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377). The data were presented in an oral presentation at the European Hematology Association (EHA) Congress by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. Highlights include: Key outcomes from the End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA): FDA granted Fast Track Designation to ELVN-001. Collectively, these data and regulatory milestones continue to support advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, which the Company expects to initiate in the second half of 2026. Second Quarter 2026 Financial…Read full document

Announced positive Phase 1 clinical data for ELVN-001 in CML, demonstrating encouraging ELVN-001 efficacy data and a favorable safety and tolerability profile Reached alignment with the FDA on key Phase 3 trial design components Strong balance sheet with $895 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into 2030 BURLINGAME, Calif., Aug. 5, 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 second quarter ended June 30, 2026, and provided a business update. "The second quarter was an important period for Enliven as we announced compelling updated clinical data for ELVN-001, reached alignment with the FDA on key components of the ENABLE-2 Phase 3 2L+ trial design, and significantly strengthened our balance sheet," said Rick Fair, Chief Executive Officer of Enliven. "The updated Phase 1 data support ELVN-001's potential to become a best-in-class treatment for patients living with CML. Combined with our recent regulatory and financial progress, we are well positioned to initiate ENABLE-2 later this year and rapidly advance ELVN-001 across all lines of CML therapy." ELVN-001 Program HighlightsELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with chronic myeloid leukemia (CML). In June 2026, the Company announced positive data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377). The data were presented in an oral presentation at the European Hematology Association (EHA) Congress by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. Highlights include: Key outcomes from the End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA): FDA granted Fast Track Designation to ELVN-001. Collectively, these data and regulatory milestones continue to support advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, which the Company expects to initiate in the second half of 2026. Second Quarter 2026 Financial Results Cash position: As of June 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $895.2 million, which is expected to provide cash runway into 2030. Research and development (R&D) expenses: R&D expenses were $29.0 million for the second quarter of 2026, compared to $21.5 million for the second quarter of 2025. General and administrative (G&A) expenses: G&A expenses were $8.2 million for the second quarter of 2026, compared to $7.1 million for the second quarter of 2025. Net loss: Enliven reported a net loss of $32.5 million for the second quarter of 2026, compared to a net loss of $25.3 million for the second quarter of 2025. About Enliven TherapeuticsEnliven 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 Burlingame, California. To learn more, visit www.enliventherapeutics.com and connect with us on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential profile, safety, tolerability, efficacy and potential best-in-class profile of ELVN-001; the interpretation of data from the ongoing ENABLE trial and regulatory milestones supporting the advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, and the timing of such advancement; the continued conduct, design, objectives, endpoints, and future clinical evaluation of ELVN-001, including the planned ENABLE-2 Phase 3 trial, the potential timing of initiation of ENABLE-2; the potential timing for advancing ELVN-001 across all lines of CML therapy; the potential timing and outcome of further FDA discussions and the finalization of additional Phase 3 trial design details, including a planned End-of-Phase 2 meeting and the timing of such meeting; Enliven's expected cash runway; and statements by Enliven's Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation, the potential for interim, topline and preliminary results from Enliven's clinical trials to materially change as additional patient data become available or following more comprehensive review; the potential for results from the ongoing or any future clinical trial of ELVN-001 to differ from the results of earlier trials of ELVN-001; ELVN-001 failing to demonstrate sufficient safety, efficacy, tolerability, durability, differentiated attributes or therapeutic benefit in current or future clinical trials; risks associated with unexpected events during the remainder of the ENABLE trial including serious adverse events, toxicities, dose reductions, discontinuations or other undesirable side effects; delays or difficulties in recruiting, enrolling or maintaining patients in ELVN-001 clinical trials; the risks of delays in completing the ongoing ENABLE trial or initiating ENABLE-2; Enliven failing to complete the ongoing ENABLE trial, to present additional data, to initiate ENABLE-2 or to advance ELVN-001 through clinical development; regulatory authorities disagreeing with Enliven's clinical trial design, dose selection, endpoints or interpretation of data, or requiring additional studies or diagnostics; developments relating to Enliven's competitors and industry which may affect the development or potential market opportunity for ELVN-001; and the potential inability of Enliven to obtain regulatory approval for, or ultimately commercialize or license, ELVN-001 or other product candidates; Enliven's ability to obtain or maintain the benefits associated with Fast Track designation; Enliven's limited resources; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and Form 10-Q filed with the SEC and in Enliven's future SEC filings. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-second-quarter-financial-results-and-provides-a-business-update-302842998.html

Investor releaseQuarter not tagged2026-05-31

This $5.5 Million Exit Raises Questions After Wave Life Sciences' Rough First Quarter

Motley Fool
On May 15, 2026, Exome Asset Management reported selling out of Wave Life Sciences (NASDAQ:WVE), liquidating 421,488 shares in an estimated $5.49 million trade based on quarterly average pricing. According to an SEC filing dated May 15, 2026, Exome Asset Management sold its entire stake of 421,488 shares in Wave Life Sciences. The estimated value of the transaction is $5.49 million, calculated using the average closing price during the first quarter of 2026. The quarter-end value of Exome’s position in the company dropped by $7.17 million, a figure that includes both trading activity and price fluctuations. Exome Asset Management LLC fully exited its Wave Life Sciences position, which was previously 3.4% of the fund’s AUM. Top holdings after the filing: As of May 14, 2026, shares of Wave Life Sciences were priced at $6.90, up 8% over the past year, underperforming the S&P 500 by nearly 20 percentage points. Wave Life Sciences develops stereopure oligonucleotide therapies targeting neurological, hepatic, and genetic disorders, with clinical candidates including WVE-004 (ALS/FTD), WVE-003 (Huntington's disease), and WVE-N531 (Duchenne muscular dystrophy). The firm operates a clinical-stage biotechnology business model focused on proprietary drug discovery and development, leveraging its PRISM platform and strategic collaborations to advance a pipeline of RNA-targeted medicines. It serves pharmaceutical partners, research institutions, and patients with rare and serious genetic diseases, primarily in neurology and hepatology. Wave Life Sciences is a clinical-stage biotechnology company specializing in the design and development of stereopure oligonucleotide therapeutics. It leverages its proprietary PRISM platform and strategic partnerships to advance a diversified pipeline targeting neurological and hepatic indications. The company’s focus on precision genetic medicines positions it to address unmet medical needs in rare and complex diseases, supported by collaborations with leading global pharmaceutical and academic partners. The performance of early-stage biotechs is highly contingent on clinical execution, meaning investment outcomes can hinge on a handful of data releases and regulatory decisions rather than steady operating performance. That’s notable here because Wave shares took a massive tumble in late March, collapsing roughly 50% in one day after new…Read full document

On May 15, 2026, Exome Asset Management reported selling out of Wave Life Sciences (NASDAQ:WVE), liquidating 421,488 shares in an estimated $5.49 million trade based on quarterly average pricing. According to an SEC filing dated May 15, 2026, Exome Asset Management sold its entire stake of 421,488 shares in Wave Life Sciences. The estimated value of the transaction is $5.49 million, calculated using the average closing price during the first quarter of 2026. The quarter-end value of Exome’s position in the company dropped by $7.17 million, a figure that includes both trading activity and price fluctuations. Exome Asset Management LLC fully exited its Wave Life Sciences position, which was previously 3.4% of the fund’s AUM. Top holdings after the filing: As of May 14, 2026, shares of Wave Life Sciences were priced at $6.90, up 8% over the past year, underperforming the S&P 500 by nearly 20 percentage points. Wave Life Sciences develops stereopure oligonucleotide therapies targeting neurological, hepatic, and genetic disorders, with clinical candidates including WVE-004 (ALS/FTD), WVE-003 (Huntington's disease), and WVE-N531 (Duchenne muscular dystrophy). The firm operates a clinical-stage biotechnology business model focused on proprietary drug discovery and development, leveraging its PRISM platform and strategic collaborations to advance a pipeline of RNA-targeted medicines. It serves pharmaceutical partners, research institutions, and patients with rare and serious genetic diseases, primarily in neurology and hepatology. Wave Life Sciences is a clinical-stage biotechnology company specializing in the design and development of stereopure oligonucleotide therapeutics. It leverages its proprietary PRISM platform and strategic partnerships to advance a diversified pipeline targeting neurological and hepatic indications. The company’s focus on precision genetic medicines positions it to address unmet medical needs in rare and complex diseases, supported by collaborations with leading global pharmaceutical and academic partners. The performance of early-stage biotechs is highly contingent on clinical execution, meaning investment outcomes can hinge on a handful of data releases and regulatory decisions rather than steady operating performance. That’s notable here because Wave shares took a massive tumble in late March, collapsing roughly 50% in one day after new data showed that a higher dose of its obesity candidate, WVE-007, failed to show meaningful improvement in reducing a type of belly fat.Nevertheless, the firm seemed optimistic in its latest earnings release. CEO Paul Bolno said the company is "accelerating" development of WVE-007 following encouraging early body composition data and remains on track across several pipeline programs. Financially, Wave generated $38.2 million in first-quarter revenue, up from $9.2 million a year earlier, while narrowing its net loss to $26.1 million from $46.9 million. It ended March with $544.6 million in cash and expects that funding to last into the third quarter of 2028.Ultimately, this remains a pipeline story, and Exome's exit may reflect risk management, but the next meaningful driver of returns will likely be clinical and regulatory execution rather than institutional trading activity. Before you buy stock in Wave Life Sciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Wave Life Sciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $463,900!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,294,401!* Now, it’s worth noting Stock Advisor’s total average return is 978% — a market-crushing outperformance compared to 211% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 31, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health and Ionis Pharmaceuticals. The Motley Fool has a disclosure policy. This $5.5 Million Exit Raises Questions After Wave Life Sciences' Rough First Quarter was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-05-08

Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update

PR Newswire
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…Read full document

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 2026, compared to $24.9 million for the first quarter of 2025. General and administrative (G&A) expenses: G&A expenses were $7.1 million for the first quarter of 2026, compared to $6.8 million for the first quarter of 2025. Net Loss: Enliven reported a net loss of $23.6 million for the first quarter of 2026, compared to a net loss of $28.5 million for the first quarter of 2025. 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. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven's ELVN-001 program; statements regarding the potential long-term opportunity in CML; expected milestones for ELVN-001, including the potential timing for the presentation of additional Phase 1 data from the ongoing ENABLE trial, the potential timing of regulatory interactions with the FDA on dose selection and Phase 3 trial design, and potential timing of the initiation of Phase 3 ENABLE-2; Enliven's expected cash runway; statements regarding ELVN-001's positioning as the potentially best-in-class ATP-competitive inhibitor in CML, and its positioning to strongly compete across all lines of therapy; and statements by Enliven's Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the potential for the results of the ongoing or any future clinical trial of ELVN-001 to differ from the results from earlier trials of ELVN-001; the risk of delays in completing the ongoing ENABLE trial or initiation of a Phase 3 trial of ELVN-001; risks associated with unexpected events during the remainder of the ongoing ENABLE trial, including adverse events, toxicities or other undesirable side effects; the risk of difficulties in recruiting, enrolling or maintaining patients in clinical trials of ELVN-001; the limited operating history of Enliven; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, including extrapolations or predictions regarding the safety and efficacy of ELVN-001 based on comparisons to published results of trials of other products, which may be different when evaluated in head-to-head studies; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; the risk that FDA disagrees with Enliven's clinical trial design or Enliven's interpretation of the data; the risk that regulatory authorities may require Enliven to develop and obtain approval for a companion diagnostic in connection with the approval of a product candidate; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change in the final data; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the potential market opportunity for any of Enliven's programs; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-first-quarter-financial-results-and-provides-a-business-update-302765868.html

Investor releaseQuarter not tagged2026-03-04

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

PR Newswire
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…Read full document

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. 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. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven's ELVN-001 program; expected milestones for ELVN-001, including the potential timing for the presentation of additional Phase 1 data from the ongoing ENABLE trial, the potential timing of regulatory and operational catalysts including regulatory alignment with the FDA on dose selection and Phase 3 trial design, and potential timing of the initiation of ENABLE-2; statements regarding the potential commercialization of ELVN-001; Enliven's expected cash runway; and statements by Enliven's Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the potential for the results of the ongoing or any future clinical trial of ELVN-001 to differ from the results from earlier trials of ELVN-001; the risk of delays in completing the ongoing ENABLE trial or initiation of a Phase 3 trial of ELVN-001; risks associated with unexpected events during the remainder of the ongoing ENABLE trial, including serious adverse events, toxicities or other undesirable side effects; the risk of difficulties in enrolling or maintaining patients in clinical trials of ELVN-001; the limited operating history of Enliven; the ability to advance product candidates through clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; or the risk that FDA disagrees with Enliven's clinical trial design or Enliven's interpretation of the data; the risk that regulatory authorities may require Enliven to develop and obtain approval for a companion diagnostic in connection with the approval of a product candidate; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change from the final data; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-fourth-quarter-and-full-year-2025-financial-results-and-provides-a-business-update-302702806.html

Investor releaseQuarter not tagged2025-08-14

Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update

PR Newswire
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…Read full document

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 (32%) achieving and 12 of 12 (100%) maintaining MMR. ELVN-001 remains well-tolerated across all evaluated doses. These data continued to compare favorably to precedent Phase 1 MMRs for approved BCR::ABL1 tyrosine kinase inhibitors (TKIs), particularly given the more heavily pretreated patient population in the ELVN-001 clinical trial. Specifically, the achieved MMR rate by 24 weeks of 32% compares favorably with historical data from less heavily pretreated patients receiving asciminib, which showed achieved MMR rates of 24% in the Phase 1 trial and 25% in the ASCEMBL Phase 3 trial. The Company plans to initiate a Phase 3 pivotal trial in 2026. Second Quarter 2025 Financial Results Cash Position: As of June 30, 2025, the Company had cash, cash equivalents and marketable securities totaling $490.5 million, which is expected to provide cash runway into the first half of 2029. Research and development (R&D) expenses: R&D expenses were $21.5 million for the second quarter of 2025, compared to $18.8 million for the second quarter of 2024. General and administrative (G&A) expenses: G&A expenses were $7.1 million for the second quarter of 2025, compared to $5.8 million for the second quarter of 2024. Net Loss: Enliven reported a net loss of $25.3 million for the second quarter of 2025, compared to a net loss of $20.0 million for the second quarter of 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 oncology approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven's ELVN-001 program; Enliven's pipeline of product candidates; expected milestones for ELVN-001, including the expected timing for the potential start of a Phase 3 pivotal trial for ELVN-001; Enliven's expected cash runway; and statements by Enliven's Co-founder and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the limited operating history of Enliven; the ability to advance product candidates through clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the ability of Enliven to successfully pursue strategic alternatives for ELVN-002; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change from the final data; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. Head-to-Head Comparisons The Company has not performed any head-to-head trials for ELVN-001. As a result, the data referenced in this press release is derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, conclusions from cross-trial comparisons cannot be made. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-second-quarter-financial-results-and-provides-a-business-update-302529004.html SOURCE Enliven Therapeutics, Inc.

Investor releaseQuarter not tagged2025-05-15

Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update

PR Newswire
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%…Read full document

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%) achieving and 9 of 9 (100%) maintaining MMR. ELVN-001 continues to demonstrate a favorable safety and tolerability profile, consistent with its selective kinase profile. These data continue to compare favorably to precedent Phase 1 trials of the approved BCR::ABL1 tyrosine kinase inhibitors (TKIs), particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial. An oral presentation will be delivered at the EHA 2025 Congress, taking place June 12–15 in Milan, Italy, and virtually, and will highlight updated results, including data from additional patients and longer treatment duration. Enliven will also host a webcast and conference call at 1:30 p.m. ET on Friday, June 13, 2025, to discuss the updated data. Details of the webcast are posted on the Upcoming Events page of the Company's website. 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 The Company dosed the first patient in its Phase 1 exploratory cohort evaluating ELVN-002 in combination with trastuzumab deruxtecan (NCT05650879) and progressed its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab in HER2+ colorectal cancer (NCT06328738). To prioritize the advancement of ELVN-001 and its upcoming pivotal trial, the Company plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025, which is expected to extend cash runway into late 2027. First Quarter 2025 Financial Results Cash Position: As of March 31, 2025, the Company had cash, cash equivalents and marketable securities totaling $289.6 million, which is expected to provide cash runway into late 2027. Research and development (R&D) expenses: R&D expenses were $24.9 million for the first quarter of 2025, compared to $20.0 million for the first quarter of 2024. General and administrative (G&A) expenses: G&A expenses were $6.8 million for the first quarter of 2025, compared to $6.0 million for the first quarter of 2024. Net Loss: Enliven reported a net loss of $28.5 million for the first quarter of 2025, compared to a net loss of $22.7 million for the first quarter of 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 oncology approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven's programs, including ELVN-001 and ELVN-002; Enliven's pipeline of product candidates; expected milestones for ELVN-001, including the expected timing of reporting data from the Phase 1 ENABLE clinical trial of ELVN-001 in CML and the timing for the potential start of a pivotal trial for ELVN-001; statements relating to Enliven's plans to pursue strategic alternatives for ELVN-002 and to discontinue the program beyond 2025; Enliven's expected cash runway; and statements by Enliven's Co-founder and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the limited operating history of Enliven; the ability to advance product candidates through clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the ability of Enliven to successfully pursue strategic alternatives for ELVN-002; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change from the final data; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Head-to-Head ComparisonsThe Company has not performed any head-to-head trials for ELVN-001. As a result, the data referenced in this press release is derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, conclusions from cross-trial comparisons cannot be made.   View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-first-quarter-financial-results-and-provides-a-business-update-302455583.html SOURCE Enliven Therapeutics, Inc.

Investor releaseQuarter not tagged2025-03-14

Enliven Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update

PR Newswire
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 expl…Read full document

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 cohort in combination with Kadcyla® (an approved HER2 antibody drug conjugate) in patients with HER2+ metastatic breast cancer (MBC) (NCT05650879). Additionally, the Company continued to enroll patients in its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in patients with HER2+ MBC and colorectal cancer (CRC) and began dosing patients in the Phase 1b trial specifically evaluating patients with CRC (NCT06328738). Enliven plans to report data from the ongoing Phase 1 trials in the second half of 2025. Fourth Quarter and Full Year 2024 Financial Results Cash Position: As of December 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $313.4 million, which is expected to provide cash runway into mid-2027. Research and development (R&D) expenses: R&D expenses were $20.7 million for the fourth quarter of 2024, compared to $17.9 million for the fourth quarter of 2023. R&D expenses were $80.8 million for the full year 2024, compared to $64.6 million for the full year 2023. General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2024 were $6.2 million, compared to $4.8 million for the fourth quarter of 2023. G&A expenses were $23.8 million for the full year 2024, compared to $19.0 million for the full year 2023. Net Loss: Enliven reported a net loss of $23.2 million for the fourth quarter of 2024, compared to a net loss of $19.4 million for the fourth quarter of 2023. Total net loss for the full year 2024 was $89.0 million, compared to $71.6 million for the full year 2023. About Enliven TherapeuticsEnliven 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 oncology approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. Forward-Looking StatementsThis press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial position, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven's programs, including ELVN-001 and ELVN-002; expected milestones for ELVN-001 and ELVN-002, including the potential timing for a start of a potential pivotal trial and the expected timing of data from the clinical trials of ELVN-001 and ELVN-002, including updated data from the Phase 1 trial evaluating ELVN-001 in patients with CML and the Phase 1 trials in ELVN-002; statements relating to Enliven's expected cash runway; and statements by Enliven's Co-founder and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the limited operating history of Enliven; the ability to advance product candidates through clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change from the final data; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.   View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-a-business-update-302401091.html SOURCE Enliven Therapeutics, Inc.

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