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Enliven Therapeutics(ELVN) - 2025 Q1 - Quarterly Report
2025-05-14 20:15
(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Address of principal executive offices) (Zip Code) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-39247 ENLIVEN THERAPEUTICS, INC. (Exact Name of Registran ...
Enliven Therapeutics(ELVN) - 2025 Q1 - Quarterly Results
2025-05-14 20:10
Exhibit 99.1 Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update 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, ...
Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML and Oral Presentation at the EHA 2025 Congress
Prnewswire· 2025-05-14 13:56
Reported cumulative MMR rate of 44% (16 of 36) by 24 weeks with 26% (7 of 27) of patients achieving MMR by 24 weeks, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all dose levels with 74 patients enrolled and a median treatment duration of ~26 weeks at cutoffPresentation at EHA will include updated data with additional patients and longer treatment durationEnliven will host a we ...
Enliven Therapeutics(ELVN) - 2024 Q4 - Annual Report
2025-03-13 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39247 ENLIVEN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Delaware | | 81-1523849 | | --- | --- | -- ...
Enliven Therapeutics(ELVN) - 2024 Q4 - Annual Results
2025-03-13 20:10
Exhibit 99.1 Enliven Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update 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 • 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 i ...
Enliven's Early Data Stands Out From Peers
Seeking Alpha· 2025-01-07 05:28
Stock Performance - Enliven Therapeutics (NASDAQ: ELVN) stock has increased by 50% since August 2023, demonstrating the potential of its lead drug's differentiated profile compared to rival molecules [1] Investment Tools and Services - The Total Pharma Tracker offers an Android app and website with tools for DIY investors, including a work-in-progress software that provides extensive curated research material for any ticker [1] - In-house experts at Total Pharma Tracker provide hands-on support by identifying the best investible stocks, along with buy/sell strategies and alerts [2] - A free trial is available for investors to access the tools and services offered by Total Pharma Tracker [2]
Enliven Therapeutics(ELVN) - 2024 Q3 - Quarterly Report
2024-11-13 21:15
Financial Performance - The company reported a net loss of $71.6 million for the year ended December 31, 2023, and an accumulated deficit of $220.3 million as of September 30, 2024 [124]. - The company has experienced a net loss of $65.8 million for the nine months ended September 30, 2024 [163]. - Total operating expenses for the nine months ended September 30, 2024, were $77.7 million, up from $60.8 million in the same period of 2023, reflecting a 28% increase [150]. - Research and development expenses increased to $21.3 million for the three months ended September 30, 2024, up from $19.6 million in the same period of 2023, representing an increase of 8.7% [146]. - General and administrative expenses rose to $5.8 million for the three months ended September 30, 2024, compared to $4.6 million in the prior year, an increase of 26.1% [148]. - Other income increased to $11.8 million for the nine months ended September 30, 2024, compared to $8.6 million in the same period of 2023, an increase of 37.2% [153]. Cash and Financing - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $291.8 million, sufficient to fund operations for at least the next 12 months [123]. - The company raised gross proceeds of $90.0 million from a private placement in March 2024 [155]. - The company received gross proceeds of $164.5 million from a financing transaction and $90.0 million from a private placement in March 2024 [162]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $56.0 million, compared to $48.8 million for the same period in 2023 [163][164]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $93.2 million, a decrease from $234.2 million in the same period of 2023 [167][168]. - The company has filed a shelf registration statement allowing for equity and debt offerings up to $400.0 million [156]. - The company anticipates needing substantial additional capital to fund ongoing operations and product development [162]. Research and Development - Research and development expenses are expected to increase substantially as the company advances its product candidates through clinical trials and expands its pipeline [138]. - The company is focused on developing small molecule inhibitors for cancer treatment, with two lead product candidates, ELVN-001 and ELVN-002, currently in development [119]. - The company expects significant increases in expenses related to advancing clinical development for its BCR-ABL and HER2 programs [158]. - The company plans to expand its pipeline of product candidates through research and development efforts and seek regulatory approvals for successful candidates [158]. - The successful development of product candidates is highly uncertain, with numerous factors affecting costs and timelines [139]. Operational Considerations - The company has not generated any revenue to date and does not expect to do so in the foreseeable future [133]. - The company relies on third parties for the manufacture of its product candidates and does not own any manufacturing facilities [121]. - The merger with Former Enliven was completed on February 23, 2023, resulting in Former Enliven's stockholders owning approximately 84% of the outstanding shares [130]. - The company is monitoring macroeconomic and geopolitical developments that could impact its operations and research timelines [131]. - The company has contractual obligations totaling $883,000 as of September 30, 2024, including operating lease obligations [171]. - The company expects to incur costs associated with hiring skilled personnel and maintaining intellectual property rights [160]. - The company is focused on developing product candidates and may require additional capital to meet future operational plans [161]. Risk Management - As of September 30, 2024, the company had no debt outstanding, eliminating exposure to interest rate risk related to debt [176]. - The company's cash, cash equivalents, and marketable securities primarily consist of U.S. Treasury securities and U.S. Treasury-backed money market funds [175]. - A hypothetical 100 basis point increase or decrease in U.S. interest rates would not have a material impact on the company's financial results due to short-term maturities of investments [175]. - The company has limited contracts with vendors for research and development services denominated in foreign currencies, including euros and British pounds [177]. - The company does not currently engage in hedging activities to mitigate foreign currency exchange risk but may consider it in the future [177]. - A hypothetical 100 basis point increase or decrease in foreign exchange rates would not have a material impact on the company's financial condition or results of operations [177].
Enliven Therapeutics(ELVN) - 2024 Q3 - Quarterly Results
2024-11-13 21:10
Exhibit 99.1 Enliven Therapeutics Reports Third Quarter Financial Results and Provides a Business Update Announced positive data from the Phase 1 clinical trial of ELVN-001 in CML, reporting a cumulative MMR rate of 44% (8/18) by 24 weeks and showing that ELVN-001 remains well-tolerated with no dose reductions Continued to progress ELVN-002 with a focus on recently initiated combination clinical trials evaluating patients with HER2+ MBC and CRC Strong balance sheet with $292 million in cash, cash equivalent ...
Enliven Therapeutics to Present at the Jefferies London Healthcare Conference
Prnewswire· 2024-11-07 21:05
BOULDER, Colo., Nov. 7, 2024 /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 announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference on Tuesday, November 19, 2024, at 9:30 a.m. GMT.The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company's we ...
Enliven Therapeutics, Inc. (ELVN) Is a Great Choice for 'Trend' Investors, Here's Why
ZACKS· 2024-10-14 13:50
Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, etc. - ...