Financial Performance - The net loss for Q3 2024 was $23.2 million, compared to a net loss of $20.8 million in Q3 2023[9] - Enliven's total operating expenses for Q3 2024 were $27.1 million, compared to $24.2 million in Q3 2023[13] - Research and development (R&D) expenses increased to $21.3 million in Q3 2024 from $19.6 million in Q3 2023, while general and administrative (G&A) expenses rose to $5.8 million from $4.6 million in the same period[9] Cash and Assets - The company had cash, cash equivalents, and marketable securities totaling $291.8 million as of September 30, 2024, providing a cash runway into late 2026[9] - The company’s total assets increased to $305.4 million as of September 30, 2024, up from $271.9 million at the end of 2023[14] - Enliven's stockholders' equity rose to $288.4 million as of September 30, 2024, compared to $245.9 million at the end of 2023[14] Clinical Development - 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[5] - Enliven plans to report additional Phase 1 data for ELVN-001 and ELVN-002 in 2025, with an expected enrollment of approximately 60-100 patients across various lines of therapy[6] - The company continues to progress ELVN-002 in combination trials for HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC)[8] Market Opportunities - The company is encouraged by the recent accelerated approval of Scemblix for first-line CML, which may create a significant opportunity for ELVN-001 in second-line treatments[3]

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 ...

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. - ...

Core Insights - Enliven Therapeutics presented updated Phase 1 data for ELVN-001, showing a cumulative major molecular response (MMR) rate of 44.4% (8/18) by 24 weeks in patients with chronic myeloid leukemia (CML) who have failed or are intolerant to existing therapies [1][3][6] - The drug ELVN-001 is a highly selective small molecule kinase inhibitor targeting the BCR-ABL gene fusion, which is the oncogenic driver in CML [2][11] - The trial demonstrated that ELVN-001 is well-tolerated, with no dose reductions and a median treatment duration of 20 weeks, indicating a favorable safety profile [1][8][9] Patient Demographics - As of June 25, 2024, 39 patients were enrolled in the Phase 1 trial across five dose levels, with a median treatment duration of 20 weeks [5] - A significant portion of the patient population was heavily pretreated, with 69.2% having received three or more prior tyrosine kinase inhibitors (TKIs) and 25.6% having received five or more [5] Efficacy Data - Among the 18 evaluable patients, a cumulative MMR rate of 44.4% was observed by 24 weeks, with stable or deepening responses noted between weeks 12 and 24 [6][7] - In TKI-resistant patients, the cumulative MMR rate was 41.7% (5/12), and in post-asciminib patients, it was 40.0% (4/10) [7] Safety Profile - ELVN-001 has shown a favorable safety profile, with no dose reductions or discontinuations due to treatment-emergent adverse events (TEAEs) at doses of 40 mg or higher [8] - There were no Grade 3 or higher non-hematologic treatment-related adverse events reported, indicating a well-tolerated treatment [8] Clinical Implications - The ongoing trial suggests that ELVN-001 may address the limitations of current active-site TKIs, particularly for patients who have failed treatment with allosteric inhibitors [4][9] - The data presented reinforces the potential clinical utility of ELVN-001 across the CML treatment paradigm, especially given the chronic nature of the disease [4][9]

While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy. 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, ...

Core Viewpoint - Enliven Therapeutics, Inc. announced updated Phase 1a data for its small molecule kinase inhibitor ELVN-001, which will be presented at the ESH-iCMLf 26th Annual John Goldman Conference in Prague from September 27-29, 2024 [1]. Group 1: Product Information - ELVN-001 is a potent and highly selective small molecule kinase inhibitor targeting the BCR-ABL gene fusion, which is the oncogenic driver for chronic myeloid leukemia (CML) patients [2]. Group 2: Presentation Details - The oral presentation will cover the preliminary safety and efficacy of ELVN-001, presented by Dr. Fabian Lang from Goethe University Hospital [3]. - The session is scheduled for September 28, 2024, from 3:00 to 4:20 p.m. CEST, with the presentation taking place from 3:35 to 3:50 p.m. CEST [3]. Group 3: Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule inhibitors aimed at improving the lives of cancer patients through precision oncology [4]. - The company aims to address unmet needs in cancer treatment by designing potentially first-in-class or best-in-class therapies based on insights into clinically validated biological targets [4].

Enliven Therapeutics, Inc. (ELVN) closed the last trading session at $22.20, gaining 1.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $35.25 indicates a 58.8% upside potential. The mean estimate comprises four short-term price targets with a standard deviation of $3.77. While the lowest estimate of $32 indicates a 44.1% increase from the current price level, the most optimistic ...

Enliven Therapeutics, Inc. (ELVN) closed the last trading session at $23.77, gaining 5.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $34 indicates a 43% upside potential. The average comprises four short-term price targets ranging from a low of $32 to a high of $38, with a standard deviation of $2.83. While the lowest estimate indicates an increase of 34.6% from the current pr ...

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company reported a net loss of $19.95 million for Q2 2024 and $42.69 million for H1 2024, with total assets of $327.0 million and cash of $312.4 million [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2024, total assets increased to $327.0 million from $271.9 million, driven by marketable securities, while total liabilities slightly decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $96,871 | $100,141 | | Marketable securities | $215,519 | $153,007 | | Total current assets | $318,127 | $266,151 | | **Total assets** | **$327,043** | **$271,867** | | **Liabilities & Equity** | | | | Total current liabilities | $22,105 | $25,894 | | **Total liabilities** | **$22,111** | **$25,961** | | **Total stockholders' equity** | **$304,932** | **$245,906** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to $19.95 million in Q2 2024 and $42.69 million for H1 2024, primarily due to higher operating expenses, especially Research and Development Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $18,826 | $15,183 | $38,796 | $27,063 | | General and administrative | $5,777 | $4,951 | $11,794 | $9,489 | | Loss from operations | $(24,603) | $(20,134) | $(50,590) | $(36,552) | | Net loss | $(19,950) | $(16,721) | $(42,688) | $(31,445) | | Net loss per share | $(0.41) | $(0.41) | $(0.95) | $(1.05) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $43.8 million for H1 2024, with a net decrease in cash of $3.3 million, ending with $96.9 million in cash - Financing activities in H1 2024 were driven by **$89.7 million** in net proceeds from a Private Placement, while H1 2023 financing was driven by **$161.4 million** from the Financing Transaction and **$73.1 million** in net cash acquired from the reverse recapitalization[15](index=15&type=chunk) Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(43,796) | $(32,893) | | Net cash used in investing activities | $(51,550) | $(151,549) | | Net cash provided by financing activities | $92,076 | $234,621 | | **Net (decrease) increase in cash** | **$(3,270)** | **$50,179** | | **Cash at end of period** | **$96,925** | **$125,769** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a clinical-stage biopharmaceutical firm, its February 2023 merger, March 2024 private placement, and sufficient cash to fund operations for at least 12 months - The company is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule inhibitors for cancer[17](index=17&type=chunk) - As of June 30, 2024, the company's cash, cash equivalents, and marketable securities of **$312.4 million** are expected to be sufficient to fund operations for at least the next 12 months[28](index=28&type=chunk) - In March 2024, the company raised **$90.0 million** in gross proceeds from a private placement of common stock and pre-funded warrants[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on lead product candidates, increased R&D and G&A expenses, and sufficient cash to fund operations for at least 12 months [Overview](index=30&type=section&id=Overview) Enliven Therapeutics is a clinical-stage biopharmaceutical company developing small molecule inhibitors for cancer, with two lead candidates and sufficient capital to fund operations for at least 12 months - The company is advancing two parallel lead product candidates, **ELVN-001** (BCR-ABL inhibitor) and **ELVN-002** (HER2 inhibitor)[109](index=109&type=chunk)[110](index=110&type=chunk) - The company relies on third parties for manufacturing and does not own or operate manufacturing facilities[111](index=111&type=chunk) - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities of **$312.4 million**, which is expected to fund operations for at least the next 12 months[113](index=113&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) For H1 2024, R&D expenses rose to $38.8 million and G&A expenses to $11.8 million, driven by clinical trials, manufacturing, and stock-based compensation Operating Expenses Comparison for the Six Months Ended June 30 (in millions) | Expense Category | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $38.8 | $27.1 | +$11.7 | | General & Administrative | $11.8 | $9.5 | +$2.3 | - The increase in R&D expenses for H1 2024 was primarily driven by a **$5.5 million** increase in clinical trial expenses and a **$2.6 million** increase in contract manufacturing expenses[138](index=138&type=chunk) - The increase in G&A expenses for H1 2024 was mainly due to a **$2.4 million** increase in stock-based compensation related to higher valuations on equity grants[139](index=139&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) The company has historically funded operations through equity financing, including a $90.0 million private placement in March 2024, with $312.4 million in cash and marketable securities - The company secured **$90.0 million** in gross proceeds from a Private Placement in March 2024[141](index=141&type=chunk) - The company has an effective shelf registration statement for up to **$400.0 million** and an at-the-market (ATM) sales agreement for up to **$200.0 million**, with no sales made under the agreement as of June 30, 2024[142](index=142&type=chunk) - Future capital requirements are substantial and will be used to advance the BCR-ABL and HER2 programs through clinical development, expand the pipeline, and support operations as a public company[144](index=144&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and marketable securities, with limited exposure to foreign currency exchange risk - The company's primary market risk is interest rate sensitivity on its cash and marketable securities, but due to their short-term nature, the impact of a **100 basis point** change is considered immaterial[160](index=160&type=chunk) - Foreign currency exchange risk is limited to a small number of vendor contracts and is not currently hedged[161](index=161&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2024[162](index=162&type=chunk) - No material changes to the internal control over financial reporting occurred during the quarter ended June 30, 2024[163](index=163&type=chunk) [PART II. OTHER INFORMATION](index=44&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and does not expect any current matters to have a material adverse effect - As of the report date, the company is not a party to any material litigation or legal proceedings[165](index=165&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company identifies numerous risks related to its early stage, dependence on lead product candidates, history of losses, and need for substantial additional funding - The company is substantially dependent on the success of its two lead product candidates, **ELVN-001** and **ELVN-002**, and failure to advance them would materially harm the business[167](index=167&type=chunk)[177](index=177&type=chunk) - The company has a history of significant net losses (**$197.1 million** accumulated deficit as of June 30, 2024) and expects to incur losses for the foreseeable future[167](index=167&type=chunk)[172](index=172&type=chunk) - Substantial additional funding will be required to complete the development of product candidates, and failure to obtain it could force the company to delay or reduce its programs[167](index=167&type=chunk)[414](index=414&type=chunk) [Risks Related to Financial Position and Need for Capital](index=46&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Need%20for%20Capital) The company is an early-stage biopharmaceutical firm with a limited operating history, no revenue, and significant net losses, making future viability uncertain - The company is an early-stage biopharmaceutical company with a limited operating history, having commenced operations in June 2019, and has never generated any revenue[168](index=168&type=chunk)[169](index=169&type=chunk) - The company has incurred significant net losses, with a net loss of **$42.7 million** for the six months ended June 30, 2024, and an accumulated deficit of **$197.1 million**[172](index=172&type=chunk) [Risks Related to Product Development and Commercialization](index=48&type=section&id=Risks%20Related%20to%20Product%20Development%20and%20Commercialization) The company's success relies heavily on its lead candidates, facing risks from clinical trial outcomes, intense competition, and reliance on third-party manufacturers - The company is substantially dependent on its two lead product candidates, **ELVN-001** and **ELVN-002**, and its business will be materially harmed if they cannot be successfully developed and commercialized[177](index=177&type=chunk) - The company faces substantial competition from large pharmaceutical companies with greater resources, including six FDA-approved BCR-ABL TKIs for CML and several approved and investigational therapies for HER2-altered cancers[219](index=219&type=chunk)[222](index=222&type=chunk)[224](index=224&type=chunk) - Difficulties in enrolling patients in clinical trials, due to factors like small patient populations and competition from other trials and approved drugs, could cause significant delays and increase development costs[215](index=215&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=65&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Legal%20Compliance) The company faces extensive regulatory hurdles, including lengthy approval processes, potential need for companion diagnostics, and compliance with healthcare and data privacy laws - The regulatory approval process is lengthy, time-consuming, and unpredictable, and the FDA or other authorities may not approve the company's product candidates[197](index=197&type=chunk) - The company may be required to obtain approval for a companion diagnostic test, and failure or delay in doing so could prevent commercialization of the therapeutic product[203](index=203&type=chunk) - Business activities are subject to numerous healthcare laws (Anti-Kickback, False Claims Act) and data privacy laws (GDPR, CCPA), and violations could lead to significant penalties and reputational harm[285](index=285&type=chunk)[286](index=286&type=chunk)[290](index=290&type=chunk) [Risks Related to Our Common Stock](index=115&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The market price of the company's common stock is subject to high volatility, future equity financings will cause dilution, and a large percentage of voting stock is concentrated - The market price of the company's common stock is likely to be volatile due to clinical trial outcomes, competitor actions, and market conditions[410](index=410&type=chunk)[411](index=411&type=chunk) - The company will need substantial additional funding, and future equity financings will dilute the interests of existing securityholders[414](index=414&type%3Dchunk)[422](index=422&type=chunk) - As of June 30, 2024, executive officers, directors, and **5%+** stockholders beneficially owned approximately **74.0%** of the company's voting stock, enabling them to control or significantly influence stockholder matters[437](index=437&type=chunk) [Item 5. Other Information](index=123&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the last fiscal quarter - No officers or directors adopted or terminated a Rule 10b5-1 trading arrangement during the last fiscal quarter[444](index=444&type=chunk) [Item 6. Exhibits](index=124&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the company's Restated Certificate of Incorporation and certifications by the Principal Executive and Financial Officers - Key exhibits filed include the Restated Certificate of Incorporation, the Amended and Restated 2020 Equity Incentive Plan, and CEO/CFO certifications[445](index=445&type=chunk)

Exhibit 99.1 Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update Dosed the first patient in the Phase 1b arm of the clinical trial evaluating ELVN-001 in patients with CML that is relapsed, refractory or intolerant to available TKIs Dosed the first patient in the Phase 1a clinical trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in HER2+ MBC and CRC Strong balance sheet with $312 million in cash, cash equivalents and marketable se ...