BOULDER, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (NASDAQ:ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced the appointment of Lori Kunkel, MD, to its Board of Directors. Dr. Kunkel brings more than twenty-five years of experience in oncology and immunology drug development and commercialization to the Board. "Lori has served as scientific adviso ...

Financing includes participation from new and existing investors Net proceeds, along with existing cash, cash equivalents and marketable securities, are expected to extend cash runway into late 2026 and through multiple key clinical milestones for ELVN-001 and ELVN-002 Company to host an event with KOLs on April 11, 2024, to discuss initial proof of concept data from a Phase 1a trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) BOULDER, Colo., March 19, 2024 (GLOBE NEWSWIRE) -- Enliven ...

Enliven Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update Initial proof of concept data from Phase 1a trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) is expected in the second quarter of 2024 IND application to evaluate ELVN-002 in combination with trastuzumab in patients with HER2+ metastatic breast cancer and colorectal cancer received U.S. FDA clearance Strong balance sheet, closing the year with $253 million in cash, cash equi ...

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 ...

BOULDER, Colo., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven) (Nasdaq: ELVN), a clinical-stage precision oncology focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced that management will participate in a panel discussion at TD Cowen’s 44th Annual Health Care Conference in Boston, MA, on Tuesday, March 5, 2024, at 12:50 p.m. ET. The panel will be webcast live and can be accessed by visiting the investor relations section of th ...

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 ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Unaudited financial statements reflect significant asset growth and positive equity by June 30, 2023, driven by a February 2023 merger and financing, despite increased net loss and operating cash usage [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's financial position significantly improved due to increased assets and a shift to positive equity from a deficit | | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total current assets** | $283,175 | $77,753 | | **Total assets** | $288,501 | $83,298 | | **Total current liabilities** | $9,147 | $9,715 | | **Total liabilities** | $9,507 | $10,374 | | **Total stockholders' equity (deficit)** | $278,994 | $(76,825) | *All figures in thousands* - The company's financial position strengthened significantly, with cash, cash equivalents, and marketable securities increasing to **$277.9 million** as of June 30, 2023, from **$75.5 million** at the end of 2022[15](index=15&type=chunk) - Stockholders' equity improved from a **deficit of $76.8 million** to a **positive equity of $279.0 million**, primarily due to the conversion of preferred stock and issuance of common stock related to the February 2023 merger and financing transaction[15](index=15&type=chunk)[20](index=20&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported increased operating expenses and a higher net loss for the six months ended June 30, 2023, driven by R&D and G&A costs | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | **Research and development** | $15,183 | $7,937 | $27,063 | $14,996 | | **General and administrative** | $4,951 | $1,079 | $9,489 | $2,698 | | **Loss from operations** | $(20,134) | $(9,016) | $(36,552) | $(17,694) | | **Net loss** | $(16,721) | $(8,889) | $(31,445) | $(17,558) | | **Net loss per share, basic and diluted** | $(0.41) | $(2.86) | $(1.05) | $(5.87) | *All figures in thousands, except per share amounts* - Operating expenses for the six months ended June 30, 2023, **more than doubled** to **$36.6 million** from **$17.7 million** in the prior-year period, primarily due to increased research and development activities and higher general and administrative costs[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows reflect increased operating cash usage, significant investing in marketable securities, and substantial cash inflow from financing activities | | Six Months Ended June 30, | | :--- | :--- | | | **2023** | **2022** | | **Net cash used in operating activities** | $(32,893) | $(17,485) | | **Net cash used in investing activities** | $(151,549) | $(497) | | **Net cash provided by financing activities** | $234,621 | $414 | | **Net increase (decrease) in cash** | $50,179 | $(17,568) | | **Cash at end of period** | $125,769 | $92,510 | *All figures in thousands* - Financing activities provided **$234.6 million** in cash during the first six months of 2023, primarily from a **$161.4 million** financing transaction and **$81.8 million** in cash acquired from the reverse recapitalization, net of transaction costs[23](index=23&type=chunk) - Investing activities used **$151.5 million**, mainly for the purchase of marketable securities, a **significant change** from the prior year which had minimal investing activities[23](index=23&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the February 2023 reverse recapitalization and financing, which significantly improved liquidity and increased stock-based compensation - On February 23, 2023, the company completed a merger with Former Enliven, which was accounted for as a reverse recapitalization[27](index=27&type=chunk)[28](index=28&type=chunk) - Concurrently with the merger, a financing transaction raised an aggregate of **$164.5 million** through the sale of common stock[31](index=31&type=chunk) - The company expects its cash, cash equivalents, and marketable securities of **$277.9 million** as of June 30, 2023, to be sufficient to fund operations for at least the next 12 months[35](index=35&type=chunk) - Stock-based compensation expense **increased significantly** to **$6.5 million** for the six months ended June 30, 2023, from **$1.4 million** in the same period of 2022[118](index=118&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's biopharmaceutical development, increased expenses, and improved liquidity from the February 2023 merger, ensuring a 12-month cash runway [Overview](index=25&type=section&id=Overview) Enliven Therapeutics is a clinical-stage biopharmaceutical company developing small molecule inhibitors for cancer - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule inhibitors for cancer, aiming to improve both survival and patient well-being[123](index=123&type=chunk) | Program | Target | Disease | Next Milestone | Milestone Expected | | :--- | :--- | :--- | :--- | :--- | | ELVN-001 | BCR-ABL | CML | Phase 1a Safety/Efficacy | 2024 | | ELVN-002 | HER2 & mutants | NSCLC, other solid tumors | Phase 1a Safety/Efficacy | 2024 | - As of June 30, 2023, the company had cash, cash equivalents, and marketable securities of **$277.9 million**, which is expected to fund operations for at least the next 12 months[126](index=126&type=chunk) - The company has incurred **significant losses** since inception, with an accumulated deficit of **$114.3 million** as of June 30, 2023, and expects operating losses to continue[127](index=127&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Results of operations highlight significant increases in R&D and G&A expenses, leading to a higher net loss | Expense Category | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $27.1 million | $15.0 million | +$12.1 million | | General and administrative | $9.5 million | $2.7 million | +$6.8 million | - The **$12.1 million increase** in R&D expenses for the first half of 2023 was primarily driven by a **$5.5 million increase** in clinical trial expenses, along with higher contract manufacturing, preclinical, and personnel-related costs[151](index=151&type=chunk) - The **$6.8 million increase** in G&A expenses for the first half of 2023 was mainly due to higher professional services costs (**$2.1M**), stock-based compensation (**$1.9M**), and accelerated stock option vesting from the merger (**$1.3M**)[152](index=152&type=chunk) - Interest income **rose to $5.1 million** for the six months ended June 30, 2023, from **$136,000** in the prior-year period, due to higher interest rates and larger investment balances[153](index=153&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity and capital resources detail the company's cash position, primary funding sources, and future capital requirements - The company's primary sources of liquidity have been private placements of convertible preferred stock (**$140.5M**) and a common stock sale in a Financing Transaction (**$164.5M**) in February 2023[154](index=154&type=chunk) - On June 23, 2023, the company entered into an "at-the-market" (ATM) sales agreement allowing it to sell up to **$200.0 million** of its common stock[155](index=155&type=chunk) - Net cash used in operating activities **increased to $32.9 million** for the first six months of 2023, compared to **$17.5 million** for the same period in 2022, reflecting higher net loss and changes in operating assets and liabilities[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on short-term investments, with limited foreign currency exposure - The company's main market risk is interest rate sensitivity on its cash, cash equivalents, and marketable securities, primarily U.S. Treasury instruments[181](index=181&type=chunk) - Due to the short-term maturities of its investments, a hypothetical **100 basis point** change in interest rates is not expected to materially impact financial results[181](index=181&type=chunk) - The company has limited exposure to foreign currency exchange risk and does not currently engage in hedging activities[183](index=183&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period, June 30, 2023[184](index=184&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the quarter ended June 30, 2023[185](index=185&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, with a prior merger-related shareholder complaint dismissed - The company is not currently a party to any material litigation[188](index=188&type=chunk) - A shareholder complaint related to the merger was **voluntarily dismissed** by the plaintiff in January 2023 after supplemental disclosures were filed[89](index=89&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section details substantial risks including limited operating history, net losses, and dependence on lead product candidates - The company has a **limited operating history**, has incurred **significant net losses**, and its success is substantially dependent on its two lead product candidates, ELVN-001 and ELVN-002[191](index=191&type=chunk) - Clinical development is **highly uncertain**, and positive results from early trials may not be predictive of success in later trials, which could prevent or delay regulatory approval[191](index=191&type=chunk)[206](index=206&type=chunk) - The company will need **substantial additional funding** to complete the development of its product candidates and may be forced to delay or cut programs if unable to raise capital[191](index=191&type=chunk)[449](index=449&type=chunk) - The company's success depends on its ability to obtain and maintain **intellectual property protection** for its technologies and product candidates[191](index=191&type=chunk)[368](index=368&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=97&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the reported period[479](index=479&type=chunk) [Other Information](index=97&type=section&id=Item%205.%20Other%20Information) CEO Sam Kintz and other executives adopted Rule 10b5-1 trading plans in Q2 2023 for orderly stock sales - CEO Sam Kintz adopted a Rule 10b5-1 trading plan on June 26, 2023, to sell up to **421,665 shares** over two years for asset diversification[483](index=483&type=chunk) - Other directors and executive officers also adopted Rule 10b5-1 plans during the second quarter of 2023[484](index=484&type=chunk)

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 ...

Clinical Trials and Development - The company announced the discontinuation of the Ardent and Forte Phase 2b clinical trials for tovinontrine, impacting its development in sickle cell disease and ß-thalassemia [106]. - Research and development expenses decreased significantly to $0.2 million for the three months ended September 30, 2022, from $10.4 million for the same period in 2021, primarily due to the discontinuation of tovinontrine development [140]. - Research and development expenses decreased by approximately $8.8 million from $27.6 million in 2021 to $18.8 million in 2022, primarily due to a $7.9 million decrease in clinical materials and research costs [145]. Mergers and Acquisitions - An Asset Purchase Agreement was entered into with Cardurion Pharmaceuticals for the sale of tovinontrine, with an upfront cash payment of $34.75 million and potential future payments totaling up to $60 million based on clinical and regulatory milestones [110]. - The company is pursuing a merger with Enliven Therapeutics, where pre-merger stockholders are expected to own approximately 16% of the combined company, while Enliven stockholders will own about 84% [111]. - The merger is contingent upon the completion of the Asset Sale and requires stockholder approvals, with net cash requirements set between $75 million and $95 million [113]. - A contingent value rights agreement will be established for pre-merger stockholders, allowing potential payments based on future events related to the Asset Sale [111]. - The company has entered into a Merger Agreement with Enliven, subject to stockholder approval and customary closing conditions [171]. Financial Performance - The company incurred operating losses of $4.8 million and $31.0 million for the three and nine months ended September 30, 2022, respectively, compared to $13.7 million and $37.1 million for the same periods in 2021 [118]. - As of September 30, 2022, the company had an accumulated deficit of approximately $178.2 million [118]. - The company has not generated any revenue since inception and does not expect to do so in the near future [127]. - The company expects to continue incurring operating losses for the foreseeable future, with potential fluctuations based on strategic decisions [118]. - Net loss for the nine months ended September 30, 2022, was $30.7 million, an improvement from a net loss of $37.1 million in 2021 [144]. - Total operating expenses decreased from $37.1 million in 2021 to $31.0 million in 2022, resulting in a loss from operations of $31.0 million [144]. Cash and Funding - The company has raised $46.8 million from a public offering of 8,333,333 shares at a price of $6.00 per share in July 2021 [117]. - As of September 30, 2022, the company had $56.3 million in cash, cash equivalents, and investments as of September 30, 2022, which is expected to fund operations for at least twelve months [121]. - Net cash used in operating activities was $33.7 million for the nine months ended September 30, 2022, compared to $34.3 million in 2021 [153][155]. - Net cash provided by investing activities increased significantly to $34.7 million in 2022 from $12.9 million in 2021, primarily due to proceeds from maturities of short-term investments [156][157]. - The company anticipates needing substantial additional funding to support ongoing operations and develop a growth strategy [120]. Strategic Alternatives - The company has focused on strategic alternatives, including potential dissolution and liquidation if the Asset Sale or Merger does not close [107]. - If the Asset Sale or Merger does not close, the company may pursue dissolution and liquidation as a strategic alternative [119]. - The company expects operating expenses to decrease significantly following the decision to discontinue the development of tovinontrine and implement workforce reductions [160]. - Future capital requirements will depend on the results of ongoing strategic evaluations, including potential asset sales or mergers [162]. Regulatory and Compliance - The company is classified as an "emerging growth company" (EGC) under the JOBS Act, allowing for delayed adoption of certain accounting standards [175]. - The company can present only two years of audited financial statements and related Management's Discussion and Analysis in registration statements [176]. - The company will remain an EGC until the earliest of December 31, 2025, or until total annual gross revenues exceed $1.07 billion [177]. - Interest income is sensitive to changes in interest rates, but a 10% change would not materially affect the fair market value of the investment portfolio due to short-term maturities [179]. - The company is not currently exposed to significant market risk from foreign currency exchange rates, but may contract with foreign vendors in the future [180].