UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 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 (S ...

Exhibit 99.1 Enliven Therapeutics Reports Second 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 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 202 ...

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 levelsStrong balance sheet with $491 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029BOULDER, Colo., Aug. 13, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ...

Group 1 - Enliven Therapeutics, Inc. (ELVN) shares have increased by 8.2% over the past four weeks, closing at $23.34, with a mean price target of $41 indicating a potential upside of 75.7% [1] - The mean estimate consists of eight short-term price targets with a standard deviation of $6.74, where the lowest estimate of $33.00 suggests a 41.4% increase, and the highest estimate of $52.00 indicates a potential surge of 122.8% [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price increases, as the Zacks Consensus Estimate for the current year has risen by 4.6% over the past month [11][12] Group 2 - ELVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential for upside [13] - While consensus price targets may not be reliable indicators of the extent of gains, they can provide a directional guide for price movement [14]

Core Viewpoint - Enliven Therapeutics, Inc. has successfully completed a public offering of approximately 9.92 million shares of common stock, raising about $230 million in gross proceeds before expenses [1]. Group 1: Offering Details - The public offering included the full exercise of underwriters' option to purchase an additional 1,526,250 shares at a price of $19.66 per share [1]. - In addition to common stock, pre-funded warrants to purchase 1,780,263 shares were offered at a price of $19.659 per warrant, reflecting the common stock price minus a nominal exercise price [1]. - The offering was managed by Jefferies, Goldman Sachs & Co. LLC, TD Cowen, and Mizuho, with LifeSci Capital serving as the lead manager [2]. Group 2: Regulatory Information - The offering was conducted under a Registration Statement on Form S-3, which was previously filed and declared effective by the SEC [3]. - A final prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are accessible through the SEC's website [3]. Group 3: Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving patient survival and overall well-being [5]. - The company employs a precision oncology approach to address unmet medical needs, leveraging insights into validated biological targets and innovative chemistry [5].

ELVN-001 Positioning and Market Opportunity - The BCR::ABL1 TKIs market has historically generated approximately $6 billion in combined annual sales, even with generic options available[10] - There is a potential $9 billion opportunity in the U S alone for differentiated TKIs, which is validated by the successful launch of Scemblix[10] - The U S branded CML market has the potential to reach approximately $9 billion based on historical sales, adjusted for current prevalence and pricing[28] CML Landscape and Treatment - Prior to imatinib, the annual CML survival rate was less than 20%[14] - The 10-year survival rate for CML improved from less than 20% to over 80%[14] - Approximately 30% of second-line patients switch therapy within the first year of treatment[22] - Approximately 25% of first-line patients switch therapy within the first year[22] - In Q1 2025, Novartis reported Scemblix NBRx of 40% in 2L and 10% in 1L in the U S, highlighting the need for improved treatment options across all lines of therapy[32] ELVN-001 Clinical Data and Development - In the Phase 1 trial, the overall MMR (BCR::ABL1 ≤ 0 1%) by 24 weeks was 47% (25/53)[68] - 80% of patients in the ELVN-001 Phase 1 trial remained on the study, with a median duration of exposure of 29 weeks[58, 59] - The company expects to initiate the first ELVN-001 head-to-head pivotal trial in 2026[10]

Enliven Therapeutics (ELVN) Update Summary Company Overview - **Company**: Enliven Therapeutics - **Program**: ELVN001, targeting chronic myeloid leukemia (CML) Industry Context - **Market Size**: CML represents a large market with significant unmet needs, with a potential $9 billion opportunity in the U.S. alone [doc id='45'] - **Current Treatment Landscape**: The treatment of CML has evolved, focusing on quality of life and tolerability, with approximately 30% of patients switching therapies within a year due to intolerance or lack of response [doc id='7'][doc id='8'] Core Points and Arguments 1. **ELVN001's Potential**: ELVN001 is designed to address unmet needs in CML and has shown a potentially best-in-class profile in heavily pretreated patients [doc id='5'][doc id='6'] 2. **Regulatory Pathway**: Historical phase one data in CML has accurately predicted success in pivotal trials, allowing for smaller and faster studies [doc id='5'] 3. **Patient Population**: The ongoing phase one trial has enrolled a heavily pretreated population, with 72% of patients having discontinued their last TKI due to lack of efficacy [doc id='20] 4. **Efficacy Results**: - 47% of patients achieved major molecular response (MMR) by 24 weeks, with 32% achieving MMR and 100% maintaining MMR [doc id='24'] - 77% of patients achieved MR2 by 24 weeks, indicating robust efficacy despite the heavily pretreated population [doc id='25] 5. **Comparison with Osiminib**: ELVN001's efficacy appears favorable compared to osiminib, with a higher MMR rate in a more heavily pretreated population [doc id='27][doc id='36'] 6. **Safety Profile**: ELVN001 has shown a favorable safety profile, with low rates of dose reductions and discontinuations due to adverse events [doc id='31][doc id='34] 7. **Dosing Convenience**: ELVN001 supports once-daily dosing with or without food, addressing key challenges with current TKIs [doc id='34][doc id='77] Additional Important Insights - **Market Dynamics**: The CML market supports multiple blockbuster drugs despite the presence of generics, with TKI switching dynamics indicating a need for better treatment options [doc id='12] - **Emerging Competition**: Osiminib has rapidly penetrated earlier lines of therapy, but high discontinuation rates (50% within two years) indicate a significant opportunity for ELVN001 [doc id='11] - **Next Steps**: Enliven Therapeutics plans to initiate a pivotal trial for ELVN001 in 2026, with a focus on both late-line and frontline settings [doc id='16][doc id='44] Conclusion - Enliven Therapeutics is optimistic about the potential of ELVN001 to become a preferred treatment option for CML, with a clear regulatory path and promising early data supporting its efficacy and safety profile [doc id='46]

Company Overview - Enliven Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics aimed at improving survival and overall well-being through a precision oncology approach [5]. Offering Details - Enliven has priced its public offering of 8,394,737 shares of common stock at $19.66 per share, with an option for investors to purchase pre-funded warrants for an additional 1,780,263 shares at $19.659 each [1]. - The gross proceeds from the offering are expected to be approximately $200 million before deducting underwriting discounts and commissions [1]. - The offering is expected to close on or about June 16, 2025, subject to customary closing conditions [1]. - Enliven has granted underwriters a 30-day option to purchase up to an additional 1,526,250 shares at the public offering price [1]. Underwriters - Jefferies, Goldman Sachs & Co. LLC, TD Cowen, and Mizuho are acting as joint book-running managers for the offering, with LifeSci Capital serving as the lead manager [2]. Regulatory Compliance - The offering is being made pursuant to a Registration Statement on Form S-3, which has been filed with and declared effective by the SEC [3]. - A final prospectus supplement and accompanying prospectus will be filed with the SEC [3]. Strategic Focus - Enliven aims to address unmet medical needs with a focus on developing potentially first-in-class or best-in-class therapies through insights in clinically validated biological targets and differentiated chemistry [5].

Core Viewpoint - Enliven Therapeutics, Inc. has initiated an underwritten public offering of $200 million in common stock and pre-funded warrants, with an additional option for underwriters to purchase up to $30 million more [1][2]. Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving survival and overall well-being through precision oncology [5]. - The company is based in Boulder, Colorado, and aims to address unmet medical needs with potentially first-in-class or best-in-class therapies [5]. Offering Details - The offering is being conducted under a Registration Statement on Form S-3, which has been declared effective by the SEC [3]. - The offering includes common stock and pre-funded warrants, with the final terms subject to market conditions [1][3]. - Jefferies, Goldman Sachs & Co. LLC, TD Cowen, and Mizuho are acting as joint book-running managers for the offering, with LifeSci Capital as the lead manager [2].

Core Insights - Enliven Therapeutics announced positive data from the Phase 1 ENABLE clinical trial for ELVN-001, a treatment for chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 47% and an achieved MMR rate of 32% by 24 weeks [1][11] - The trial demonstrated a favorable safety and tolerability profile, with only 3.4% of patients experiencing dose reductions due to treatment-emergent adverse events (TEAEs) and 4.6% discontinuing treatment due to TEAEs [11] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving the quality of life and survival for patients [13] - The company is based in Boulder, Colorado, and aims to address unmet needs in precision oncology [13] Clinical Trial Details - The ENABLE trial is a Phase 1 study evaluating ELVN-001 in previously treated CML patients, with a focus on safety, tolerability, and determining the recommended dose for further evaluation [9] - As of April 28, 2025, 90 patients were enrolled, with a median treatment duration of approximately 29 weeks [5] Efficacy Data - Among 53 evaluable patients, 25 (47%) achieved MMR by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR [5][11] - The trial included heavily pretreated patients, with 67% having received three or more prior TKIs [5] Safety Profile - ELVN-001 was well tolerated across all evaluated doses, with low levels of dose reductions and discontinuations [11] - The maximum tolerated dose was not reached, and the pharmacokinetic profile supports once-daily dosing [11][12] Future Outlook - Enliven plans to initiate a head-to-head Phase 3 pivotal trial for ELVN-001 in 2026, leveraging insights from historical Phase 1 data to guide regulatory pathways [7][9]