[Company Overview and Business Update](index=1&type=section&id=Company%20Overview%20and%20Business%20Update) Enliven Therapeutics provided a business update, highlighting CEO statements, pipeline progress for ELVN-001 and ELVN-002, and its precision oncology focus [Introduction and CEO Statement](index=1&type=section&id=Introduction%20and%20CEO%20Statement) Enliven reported Q4 and FY2024 results, with the CEO highlighting pipeline progress and pivotal trial preparations for ELVN-001 in 2026 - Enliven Therapeutics, a clinical-stage biopharmaceutical company, reported financial results for Q4 and full year 2024 and provided a business update, including pipeline progress[1](index=1&type=chunk) - CEO Sam Kintz highlighted ongoing progress, significant investigator enthusiasm for both programs, and accelerated momentum for ELVN-001[2](index=2&type=chunk) - The company is focused on continued clinical execution and preparing for the potential start of a pivotal trial for ELVN-001 in 2026[2](index=2&type=chunk) [Recent Research and Development Highlights and Upcoming Milestones](index=1&type=section&id=Recent%20Research%20and%20Development%20Highlights%20and%20Upcoming%20Milestones) Enliven updated on ELVN-001 and ELVN-002 clinical progress, regulatory designations, and data readouts expected mid-2025 and H2 2025 - ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion[3](index=3&type=chunk) - ELVN-002 is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor[3](index=3&type=chunk) - The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML)[4](index=4&type=chunk) - Updated Phase 1 data for ELVN-001 is expected mid-2025[1](index=1&type=chunk)[4](index=4&type=chunk) - Expected monotherapy and combination data from the ELVN-002 Phase 1 trials are anticipated in the second half of 2025[1](index=1&type=chunk)[9](index=9&type=chunk) [ELVN-001 Program Update](index=1&type=section&id=ELVN-001%20Program%20Update) ELVN-001, a BCR::ABL inhibitor, showed positive initial Phase 1 data, received FDA Orphan Drug Designation for CML, with further data expected mid-2025 - ELVN-001 is designed to specifically target the BCR::ABL gene fusion[3](index=3&type=chunk) - In 2024, the Company announced positive initial data from the ongoing Phase 1 clinical trial for ELVN-001 that compared favorably to precedent Phase 1 trials for approved BCR::ABL1 tyrosine kinase inhibitors (TKIs)[4](index=4&type=chunk) - The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML)[4](index=4&type=chunk) - The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML[4](index=4&type=chunk) - The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025[4](index=4&type=chunk) [ELVN-002 Program Update](index=1&type=section&id=ELVN-002%20Program%20Update) ELVN-002, a HER2 inhibitor, continues Phase 1 enrollment for monotherapy and combination trials, with data expected in H2 2025 - ELVN-002 is a CNS penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations[3](index=3&type=chunk) - 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[3](index=3&type=chunk) - ELVN-002 is being evaluated in combination with Kadcyla® in patients with HER2+ metastatic breast cancer (MBC)[5](index=5&type=chunk) - 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[9](index=9&type=chunk) - Enliven plans to report data from the ongoing Phase 1 trials in the second half of 2025[9](index=9&type=chunk) [About Enliven Therapeutics](index=2&type=section&id=About%20Enliven%20Therapeutics) Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology, developing small molecule therapeutics to address unmet needs - Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics[7](index=7&type=chunk) - Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being[7](index=7&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[7](index=7&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Enliven reported increased operating expenses and net losses for Q4 and FY2024, maintaining a strong cash position into mid-2027 [Summary of Financial Performance](index=2&type=section&id=Summary%20of%20Financial%20Performance) Enliven reported increased R&D and G&A expenses for Q4 and FY2024, leading to higher net losses, but maintains a strong **$313.4 million** cash position into mid-2027 - 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[1](index=1&type=chunk)[9](index=9&type=chunk) Key Financial Highlights (Q4 and Full Year 2024 vs 2023) | Metric | Q4 2024 (in millions) | Q4 2023 (in millions) | YoY Change (Q4) | FY 2024 (in millions) | FY 2023 (in millions) | YoY Change (FY) | | :---------------------- | :-------------------- | :-------------------- | :---------------- | :-------------------- | :-------------------- | :---------------- | | R&D Expenses | $20.7 | $17.9 | +15.6% | $80.8 | $64.6 | +25.1% | | G&A Expenses | $6.2 | $4.8 | +29.2% | $23.8 | $19.0 | +25.3% | | Net Loss | $(23.2) | $(19.4) | +19.6% | $(89.0) | $(71.6) | +24.3% | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Enliven's Q4 2024 total operating expenses increased to **$26.9 million**, resulting in a **$23.2 million** net loss, with FY2024 net loss at **$89.0 million** Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Dec 31, 2024 (in thousands) | Three Months Ended Dec 31, 2023 (in thousands) | Year Ended Dec 31, 2024 (in thousands) | Year Ended Dec 31, 2023 (in thousands) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------------------------- | :------------------------------------- | | Research and development | $20,724 | $17,905 | $80,778 | $64,574 | | General and administrative | $6,172 | $4,824 | $23,776 | $18,955 | | Total operating expenses | $26,896 | $22,729 | $104,554 | $83,529 | | Loss from operations | $(26,896) | $(22,729) | $(104,554) | $(83,529) | | Other income (expense), net | $3,716 | $3,359 | $15,530 | $11,945 | | Net loss | $(23,180) | $(19,370) | $(89,024) | $(71,584) | | Net loss per share, basic and diluted | $(0.46) | $(0.47) | $(1.89) | $(2.01) | | Weighted-average shares outstanding | 49,858 | 41,128 | 47,073 | 35,546 | [Balance Sheets](index=4&type=section&id=Balance%20Sheets) As of December 31, 2024, total assets increased to **$325.8 million**, driven by **$313.4 million** in cash, while liabilities decreased and equity rose significantly Balance Sheets (in thousands) | Asset/Liability/Equity | December 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | | Cash, cash equivalents and marketable securities | $313,440 | $253,148 | | Total current assets | $318,127 | $266,151 | | Total assets | $325,760 | $271,867 | | Accounts payable | $1,342 | $532 | | Accrued expenses and other current liabilities | $14,573 | $15,362 | | Contingent value right liability | — | $10,000 | | Total current liabilities | $15,915 | $25,894 | | Total liabilities | $15,915 | $25,961 | | Stockholders' equity | $309,845 | $245,906 | | Total liabilities and stockholders' equity | $325,760 | $271,867 | [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements regarding Enliven's future plans and financial position, emphasizing inherent risks and uncertainties that could materially alter actual results - The press release contains forward-looking statements concerning Enliven's future plans, trends, events, results of operations, and financial position[8](index=8&type=chunk) - These statements include expectations regarding Enliven's programs (ELVN-001 and ELVN-002), potential timing for a pivotal trial, and expected data from clinical trials[10](index=10&type=chunk) - Forward-looking statements are subject to substantial risks and uncertainties, including limited operating history, ability to advance product candidates, regulatory approval, and reliance on third parties[10](index=10&type=chunk) - Enliven undertakes no obligation to revise or update any forward-looking statement, except as required by applicable law[10](index=10&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) This section provides contact information for Enliven Therapeutics' investor relations and media inquiries - Investors can contact ir@enliventherapeutics.com[11](index=11&type=chunk) - Media can contact media@enliventherapeutics.com[11](index=11&type=chunk)

Financial Position - The company has raised a total of $140.5 million from private placements of convertible preferred stock and $164.5 million from the sale of common stock in pre-closing financing [126][133]. - As of September 30, 2024, the company reported cash, cash equivalents, and marketable securities totaling $291.8 million, sufficient to fund operations for at least the next 12 months [127]. - The accumulated deficit as of September 30, 2024, stands at $220.3 million, with net losses of $71.6 million and $37.7 million for the years ended December 31, 2023, and 2022, respectively [128]. - Cash, cash equivalents, and marketable securities as of September 30, 2024, totaled $291.8 million, providing liquidity for ongoing operations [158]. - Cash, cash equivalents, and marketable securities primarily consist of U.S. Treasury securities and U.S. Treasury-backed money market funds, with no debt outstanding as of September 30, 2024 [182][183]. - Total contractual obligations and commitments as of September 30, 2024 amount to $883,000, including operating lease obligations [178]. Revenue and Operations - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future [136]. - The company expects to require substantial additional capital to fund ongoing operations and product development, with no revenue generated to date [161]. - Future capital requirements will depend on various factors, including the costs of research and development, regulatory reviews, and the commercialization of product candidates [165]. Expenses - Research and development expenses are expected to increase substantially as the company advances its product candidates through clinical trials and expands its pipeline [140][146]. - General and administrative expenses are anticipated to increase significantly as the company hires additional personnel and incurs costs associated with being a public company [146]. - Research and development expenses increased to $21.3 million for the three months ended September 30, 2024, compared to $19.6 million for the same period in 2023, representing an increase of 8.6% [150]. - General and administrative expenses rose to $5.8 million for the three months ended September 30, 2024, up from $4.6 million in 2023, an increase of 26.1% [151]. - Total operating expenses for the nine months ended September 30, 2024, were $77.7 million, compared to $60.8 million for the same period in 2023, an increase of 28% [154]. - Non-cash charges for stock-based compensation increased to $14.8 million in 2024 from $9.9 million in 2023, reflecting a rise of 49.5% [169][170]. Losses - Net loss for the three months ended September 30, 2024, was $23.2 million, compared to a net loss of $20.8 million for the same period in 2023, reflecting a 11.5% increase in losses [149]. - The company reported a net loss of $65.8 million for the nine months ended September 30, 2024, compared to a net loss of $52.2 million in 2023, indicating a worsening of 25.9% [169][170]. Financing Activities - 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, reflecting an increase of 15.0% [169][170]. - Net cash used in investing activities decreased significantly to $36.7 million in 2024 from $187.1 million in 2023, a reduction of 80.4% [171][172]. - Net cash provided by financing activities was $93.2 million for the nine months ended September 30, 2024, down from $234.2 million in 2023, a decrease of 60.2% [174][175]. Product Development - The company is advancing two lead product candidates, ELVN-001 and ELVN-002, with milestones expected in 2025 for Phase 1 safety/efficacy studies [124]. - The company anticipates significant increases in expenses related to advancing clinical development programs and expanding its pipeline of product candidates [162]. External Factors - The company is monitoring macroeconomic and geopolitical developments that could impact its operations and research timelines [134][135]. - The company does not currently engage in any hedging activity to reduce potential exposure to currency fluctuations, although it may consider this in the future [184]. Lease Obligations - The company has entered into a non-cancellable operating lease for approximately 20,011 rentable square feet of office and laboratory space from January 1, 2025, through December 31, 2026 [177].

Financial Performance - The net loss for Q3 2024 was $23.2 million, compared to a net loss of $20.8 million in Q3 2023[7]. - Enliven's total operating expenses for Q3 2024 were $27.1 million, up from $24.2 million in Q3 2023[7]. - Research and development (R&D) expenses for Q3 2024 were $21.3 million, an increase from $19.6 million in Q3 2023[7]. - General and administrative (G&A) expenses for Q3 2024 were $5.8 million, compared to $4.6 million in Q3 2023[7]. - The weighted-average shares outstanding for Q3 2024 were 48.3 million, compared to 41.0 million in Q3 2023[7]. Cash Position - The company has a strong cash position with $291.8 million in cash, cash equivalents, and marketable securities, expected to provide a cash runway into late 2026[7]. - Enliven's total assets as of September 30, 2024, were $305.4 million, an increase from $271.9 million as of December 31, 2023[7]. Clinical Trials and Research - Enliven Therapeutics reported a cumulative major molecular response (MMR) rate of 44.4% (8/18) for ELVN-001 in a Phase 1 clinical trial for chronic myeloid leukemia (CML) by 24 weeks[3]. - Enliven plans to report additional Phase 1 data for ELVN-001 in 2025, including approximately 60-100 patients across various lines of therapy[7]. - The company is progressing with ELVN-002, focusing on combination clinical trials for HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC)[3].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) For the transition period from _________ to _________ Commission File Number: 001-39247 ENLIVEN THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Delaware 81-1523849 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2 ...

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 March 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) (State or other juris ...

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, 2023 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 ...

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 September 30, 2023 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) (State or other j ...

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, 2023 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) (State or other jurisd ...

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 March 31, 2023 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) (State or other juris ...

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, 2022 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 IMARA INC. (Exact name of Registrant as specified in its charter) Delaware 81-1523849 (State or other jurisdiction of incorpora ...