[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) This section provides an executive summary of Enliven Therapeutics' positive Phase 1 ELVN-001 trial data, strong financial position, and CEO commentary on future plans [Executive Summary](index=1&type=section&id=1.1%20Executive%20Summary) Enliven Therapeutics reported positive Phase 1 clinical trial data for ELVN-001 in CML, showing a 47% cumulative Major Molecular Response (MMR) rate and a favorable safety profile. The company maintains a strong financial position with $491 million in cash, providing a runway into the first half of 2029 - Enliven Therapeutics, a clinical-stage biopharmaceutical company, reported positive data from the Phase 1 clinical trial of ELVN-001 in CML[1](index=1&type=chunk) - The ELVN-001 trial showed a cumulative MMR rate of **47%**, with **32%** of patients achieving MMR by 24 weeks, and demonstrated a favorable safety and tolerability profile across all dose levels[1](index=1&type=chunk) Cash Position and Runway | Metric | Value | | :------------------------------------ | :--------------------------------------------------- | | Cash, cash equivalents, and marketable securities | $491 million | | Expected cash runway | Into the first half of 2029 | [CEO Commentary](index=1&type=section&id=1.2%20CEO%20Commentary) CEO Sam Kintz highlighted ELVN-001's differentiated efficacy and tolerability, positioning it as a potential best-in-class CML therapy, with a Phase 3 trial planned for 2026 and a strengthened balance sheet - CEO Sam Kintz stated that ELVN-001's differentiated efficacy, tolerability, and convenience position it to be a potential best-in-class therapy for CML[2](index=2&type=chunk) - The company expects to initiate its first Phase 3 pivotal trial for ELVN-001 in **2026**[2](index=2&type=chunk) - Enliven strengthened its balance sheet through a recent public offering that generated approximately **$230 million** in gross proceeds, extending its cash runway into the first half of **2029**[2](index=2&type=chunk) [Pipeline Updates: ELVN-001 Program](index=1&type=section&id=Pipeline%20Updates%3A%20ELVN-001%20Program) This section details the ELVN-001 program, including its mechanism of action, positive Phase 1 clinical trial results, and future development plans [ELVN-001 Program Description](index=1&type=section&id=2.1%20ELVN-001%20Program%20Description) ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to target the BCR::ABL gene fusion, the oncogenic driver for chronic myeloid leukemia (CML) - ELVN-001 is a potent, highly selective, small molecule kinase inhibitor[3](index=3&type=chunk) - It is designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML)[3](index=3&type=chunk) [ENABLE Phase 1 Clinical Trial Results](index=1&type=section&id=2.2%20ENABLE%20Phase%201%20Clinical%20Trial%20Results) Updated positive data from the ENABLE Phase 1 clinical trial for ELVN-001 in previously treated CML patients demonstrated a 47% cumulative Major Molecular Response (MMR) rate, favorable tolerability, and comparative efficacy - Positive updated data from the ongoing ENABLE Phase 1 clinical trial (NCT05304377) for ELVN-001 in previously treated CML patients were announced in June 2025[3](index=3&type=chunk) ELVN-001 ENABLE Phase 1 MMR Rates (as of April 28, 2025) | Metric | Rate | | :------------------------------------------------ | :--- | | Evaluated patients in Major Molecular Response (MMR) | 47% (25 of 53) | | Patients achieving MMR by 24 weeks | 32% (13 of 41) | | Patients maintaining MMR | 100% (12 of 12) | - ELVN-001 remained well-tolerated across all evaluated doses and its achieved MMR rate by 24 weeks (**32%**) compared favorably with historical data from asciminib (**24-25%**) in less heavily pretreated patients[3](index=3&type=chunk) [Future Development Plans](index=2&type=section&id=2.3%20Future%20Development%20Plans) Following positive Phase 1 results, Enliven Therapeutics plans to initiate a Phase 3 pivotal trial for ELVN-001 in 2026 - The Company plans to initiate a Phase 3 pivotal trial for ELVN-001 in **2026**[4](index=4&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section presents Enliven Therapeutics' financial performance for Q2 2025, highlighting cash position, operating expenses, and net loss [Key Financial Highlights](index=2&type=section&id=3.1%20Key%20Financial%20Highlights) Enliven Therapeutics reported a strong cash position of $490.5 million as of June 30, 2025, extending its cash runway into the first half of 2029, with increased operating expenses and net loss Cash Position (as of June 30, 2025) | Metric | Value | | :------------------------------------ | :------------ | | Cash, cash equivalents, and marketable securities | $490.5 million | | Expected cash runway | Into the first half of 2029 | Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :----------------- | :----------------- | :----------------- | :--------- | | Research and development | $21.5 | $18.8 | +14.4% | | General and administrative | $7.1 | $5.8 | +22.4% | Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :------- | :----------------- | :----------------- | :--------- | | Net Loss | $(25.3) | $(20.0) | +26.5% | [Condensed Consolidated Financial Information](index=4&type=section&id=3.2%20Condensed%20Consolidated%20Financial%20Information) The condensed consolidated financial statements detail Enliven's Q2 2025 performance, showing increased operating expenses, net losses, and a significant rise in cash and total assets due to recent financing [Statements of Operations](index=4&type=section&id=3.2.1%20Statements%20of%20Operations) For Q2 2025, total operating expenses increased to $28.6 million, resulting in a net loss of $25.3 million, or $(0.49) per share, with similar trends for the six-month period Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $21,491 | $18,826 | $46,386 | $38,796 | | General and administrative | $7,093 | $5,777 | $13,891 | $11,794 | | Total operating expenses | $28,584 | $24,603 | $60,277 | $50,590 | | Loss from operations | $(28,584) | $(24,603) | $(60,277) | $(50,590) | | Other income (expense), net | $3,249 | $4,653 | $6,398 | $7,902 | | Net loss | $(25,335) | $(19,950) | $(53,879) | $(42,688) | | Net loss per share, basic and diluted | $(0.49) | $(0.41) | $(1.05) | $(0.95) | | Weighted-average shares outstanding | 52,105 | 48,075 | 51,084 | 45,060 | [Balance Sheets](index=4&type=section&id=3.2.2%20Balance%20Sheets) As of June 30, 2025, cash, cash equivalents, and marketable securities significantly increased to $490.5 million, driving total assets to $503.9 million, while liabilities remained stable and stockholders' equity grew Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :---------------- | | Cash, cash equivalents and marketable securities | $490,503 | $313,440 | | Total current assets | $495,622 | $318,127 | | Total assets | $503,887 | $325,760 | | Total current liabilities | $15,211 | $15,915 | | Total liabilities | $15,415 | $15,915 | | Stockholders' equity | $488,472 | $309,845 | | Total liabilities and stockholders' equity | $503,887 | $325,760 | [About Enliven Therapeutics](index=2&type=section&id=About%20Enliven%20Therapeutics) This section provides an overview of Enliven Therapeutics, detailing its focus on precision oncology and small molecule therapeutics [Company Profile](index=2&type=section&id=4.1%20Company%20Profile) Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics with a precision oncology approach to address unmet medical needs - Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics[6](index=6&type=chunk) - The company aims to address existing and emerging unmet needs with a precision oncology approach to improve survival and enhance overall well-being[6](index=6&type=chunk) - 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[6](index=6&type=chunk) [Legal and Disclaimers](index=2&type=section&id=Legal%20and%20Disclaimers) This section outlines important legal considerations, including forward-looking statements and disclaimers regarding cross-trial comparisons [Forward-Looking Statements](index=2&type=section&id=5.1%20Forward-Looking%20Statements) This section outlines that the press release contains forward-looking statements regarding future plans, trends, and financial conditions, which are subject to substantial risks and uncertainties - The press release contains forward-looking statements concerning Enliven and other matters that involve substantial risks and uncertainties, including goals, intentions, and expectations for future plans, trends, events, results of operations, and financial condition[7](index=7&type=chunk) - Forward-looking statements are based on current beliefs and assumptions subject to risks and uncertainties, and actual results could differ materially due to factors such as limited operating history, ability to advance product candidates, regulatory approval, and intellectual property protection[7](index=7&type=chunk)[9](index=9&type=chunk) - Enliven undertakes no obligation to revise or update any forward-looking statement, except as required by applicable law[9](index=9&type=chunk) [Cross-Trial Comparison Disclaimer](index=3&type=section&id=5.2%20Cross-Trial%20Comparison%20Disclaimer) The company explicitly states that it has not performed any head-to-head trials for ELVN-001, thus cross-trial comparisons with data from different studies are not valid - The Company has not performed any head-to-head trials for ELVN-001[11](index=11&type=chunk) - Data referenced from different clinical trials at different points in time, with differences in trial design and patient populations, means conclusions from cross-trial comparisons cannot be made[11](index=11&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) This section provides contact details for investor and media relations [Investor and Media Relations](index=3&type=section&id=6.1%20Investor%20and%20Media%20Relations) Contact information for investor and media inquiries is provided - Investors can contact ir@enliventherapeutics.com[11](index=11&type=chunk) - Media can contact media@enliventtherapeutics.com[11](index=11&type=chunk)

Core Insights - Enliven Therapeutics announced positive Phase 1 clinical trial data for ELVN-001 in chronic myeloid leukemia (CML), with a cumulative major molecular response (MMR) rate of 47% and 32% of patients achieving MMR by 24 weeks, alongside a favorable safety profile [1][2][7] - The company has a strong financial position with $491 million in cash and equivalents, expected to sustain operations into the first half of 2029 [1][2][7] Pipeline Updates - ELVN-001 is a selective small molecule kinase inhibitor targeting the BCR::ABL gene fusion, which is crucial for CML patients [3] - The company plans to initiate a Phase 3 pivotal trial for ELVN-001 in 2026, building on the positive findings from the Phase 1 trial [2][7] Financial Results - For Q2 2025, Enliven reported R&D expenses of $21.5 million, up from $18.8 million in Q2 2024, and G&A expenses of $7.1 million, compared to $5.8 million in the same period last year [7][11] - The net loss for Q2 2025 was $25.3 million, compared to a net loss of $20.0 million in Q2 2024 [7][11] Balance Sheet Highlights - As of June 30, 2025, the company had total current assets of $495.6 million, including cash, cash equivalents, and marketable securities of $490.5 million [12] - Stockholders' equity stood at $488.5 million, reflecting a significant increase from $309.8 million at the end of 2024 [12]

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]

Summary of Enliven Therapeutics (ELVN) 2025 Conference Call Company Overview - Enliven Therapeutics is a clinical stage precision oncology company based in Boulder, Colorado, focusing on kinase drug discovery and development, particularly for chronic myeloid leukemia (CML) [4][5] Key Points Discussed Product Pipeline and Clinical Trials - The lead asset, ELVN001, is a highly selective ATP competitive inhibitor of BCR ABL for treating CML [4] - A Phase I study is ongoing for patients not expected to respond to approved BCR ABL TKI therapies, with data updates expected at the EHA conference on June 13 [7][8] - Recent data showed a cumulative major molecular response (MMR) rate of 44% and a response achieved rate of 26% in heavily pretreated patients [8][9] - The number of efficacy evaluable patients increased from 36 to approximately 90, indicating a more robust dataset for analysis [11][12] Efficacy Metrics - The response achieved rate correlates well with historical pivotal studies, suggesting reliability in the efficacy metrics [8][9] - The company aims to compare ELVN001 against Osiminib, a second-generation ATP competitive inhibitor, in pivotal studies [16][18] - The data presented will include various molecular markers and response rates, including achievement of less than 1% BCR ABL, which is critical for assessing efficacy [23][24] Safety and Tolerability - Safety data indicates that the majority of adverse events (AEs) are consistent with the class, with no new concerning toxicities reported [45][49] - The company has a solid safety profile, with a focus on tolerability as a key driver for drug use in CML patients [51] Future Plans and Market Potential - The company is preparing for a pivotal study, with dose selection expected to be between 60 mg and 120 mg, likely favoring 80 mg based on target coverage [54][56] - There is a significant commercial opportunity in the second-line plus setting, potentially accessing a patient population 2.5 times larger than the third-line plus setting [68][69] - The company is excited about the potential for a more attractive comparator arm in future studies, which could enhance market positioning [60][68] Financial Position - Enliven Therapeutics has a strong cash position in the upper $200 million range, providing a runway into late 2027 [76] Additional Insights - The company is winding down two programs to prioritize resources for the lead asset, with potential updates on new clinical programs expected next year [73][74] - The upcoming data presentation at EHA is anticipated to provide further insights into the efficacy and safety of ELVN001, which could bolster investor confidence [76][78]