Group 1 - Enliven Therapeutics, Inc. (ELVN) shares have increased by 0.8% over the past four weeks, closing at $19.92, with a mean price target of $41.13 indicating a potential upside of 106.5% [1] - The average of eight short-term price targets ranges from a low of $33.00 to a high of $52.00, with a standard deviation of $6.66, suggesting a potential increase of 65.7% to 161% from the current price [2] - Analysts show strong agreement in revising earnings estimates higher, with two estimates moving up in the last 30 days and the Zacks Consensus Estimate increasing by 8.8% [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 upside [13] - The consensus price target, while not entirely reliable, suggests a positive direction for price movement, which could guide further research into the stock's fundamentals [14]

Core Viewpoint - Enliven Therapeutics, Inc. (ELVN) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - For the fiscal year ending December 2025, Enliven Therapeutics is expected to earn -$1.95 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 15.2% over the past three months [8]. Institutional Investor Influence - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4][5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Enliven Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Viewpoint - Enliven Therapeutics, Inc. (ELVN) shows significant upside potential with a mean price target of $41.13, indicating a 102.4% increase from its current trading price of $20.32 [1][2]. Price Targets and Analyst Estimates - The mean estimate consists of eight short-term price targets with a standard deviation of $6.66, suggesting variability in analyst predictions. The lowest estimate is $33.00 (62.4% increase), while the highest is $52.00 (155.9% increase) [2]. - A low standard deviation among price targets indicates strong agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [9]. Earnings Estimates and Analyst Optimism - Analysts have shown growing optimism regarding ELVN's earnings prospects, as evidenced by a positive trend in earnings estimate revisions. The Zacks Consensus Estimate for the current year has increased by 5.3% over the last 30 days, with two estimates moving higher and no negative revisions [11][12]. - ELVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for upside in the near term [13]. Caution on Price Targets - While price targets are often sought after by investors, they can be misleading. Empirical research suggests that price targets rarely indicate actual stock price movements, and analysts may set overly optimistic targets due to business incentives [7][8][10].

Core Insights - Enliven Therapeutics, Inc. announced the presentation of data from its ENABLE Phase 1a/1b clinical trial of ELVN-001 at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting [1] - The presentation will include both an oral and a poster session, showcasing the company's focus on chronic myeloid leukemia treatment [2] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of small molecule therapeutics aimed at improving patient survival and overall well-being [3] - The company employs a precision oncology approach to address unmet medical needs, leveraging insights into clinically validated biological targets and innovative chemistry [3]

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 ...

[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]