Enliven Therapeutics(ELVN)

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Enliven Therapeutics(ELVN) - 2020 Q2 - Quarterly Report
2020-08-14 11:29
Clinical Development - The company is focused on developing IMR-687, an oral treatment for sickle cell disease (SCD) and ß-thalassemia, with a multimodal mechanism of action [93]. - A Phase 2a clinical trial of IMR-687 showed a 55% reduction in reported vaso-occlusive crises (VOCs) from 38 to 17 over an 18-month period [98]. - The company initiated a Phase 2b clinical trial for IMR-687 in SCD and ß-thalassemia, with interim data expected in the first half of 2021 [95]. - A patient in the open label extension trial showed a 77% increase in F-cell percentage from 26.1% to 46.3% [101]. - The Phase 2a clinical trial of IMR-687 was reported to be well tolerated, with top-line data expected in Q4 2020 [94]. - The company began preclinical research on IMR-687 for heart failure with preserved ejection fraction (HFpEF) in collaboration with the Necker Institute of Paris [105]. - The company is evaluating the impact of the COVID-19 pandemic on its clinical trial timelines, which may cause delays [95]. - The ongoing COVID-19 pandemic has caused minor disruptions to clinical trial operations, but no significant adverse impact on financial condition has been reported to date [114]. Financial Performance - Operating losses for the three and six months ended June 30, 2020, were $10.3 million and $17.7 million, respectively, with an accumulated deficit of approximately $72.2 million [108]. - The company has not yet generated revenue from product sales and will incur significant expenses related to commercialization if regulatory approval is obtained [109]. - The company has not generated any revenue since inception and does not expect to do so in the near future [117]. - As of June 30, 2020, the company had $106.3 million in cash, cash equivalents, and investments, expected to fund operations into mid-2022 [112]. - Research and development expenses for Q2 2020 were $7.9 million, an increase of approximately $3.5 million from $4.4 million in Q2 2019 [130]. - The increase in research and development expenses was primarily due to a $2.8 million rise in costs related to clinical materials and oversight of clinical trials for IMR-687 [130]. - Total operating expenses for Q2 2020 were $10.3 million, compared to $5.6 million in Q2 2019, reflecting a $4.7 million increase [129]. - The net loss for Q2 2020 was $10.2 million, compared to a net loss of $5.4 million in Q2 2019, representing an increase of $4.8 million [129]. - The company anticipates that general and administrative expenses will increase as the business expands to support ongoing research and development activities [126]. - General and administrative expenses increased by approximately $2.2 million from $1.8 million for the six months ended June 30, 2019 to $4.0 million for the six months ended June 30, 2020 [136]. - Research and development expenses increased by approximately $5.7 million from $7.9 million for the six months ended June 30, 2019 to $13.7 million for the six months ended June 30, 2020 [135]. - Total operating expenses increased by $7.9 million from $9.8 million for the six months ended June 30, 2019 to $17.7 million for the six months ended June 30, 2020 [134]. - Net cash used in operating activities for the six months ended June 30, 2020 was $18.8 million, primarily due to a net loss of $17.4 million [141]. - Net cash provided by financing activities for the six months ended June 30, 2020 was $96.1 million, primarily due to $80.4 million of net proceeds from the IPO [145]. - The company raised $17.1 million in gross proceeds from the issuance of Series B Preferred Stock on February 25, 2020 [139]. - The company anticipates significant increases in expenses related to ongoing research and development activities and operating as a public company [148]. - The company has not yet commercialized IMR-687 and does not expect to generate revenue from it or any future product candidates for several years [139]. Cash and Investments - As of June 30, 2020, the company had $106.3 million in cash, cash equivalents, and investments [140]. - The company expects to fund its operating expenses and capital expenditure requirements into mid-2022 based on current cash resources [149]. Regulatory and Compliance - The company is classified as an "emerging growth company" (EGC) under the JOBS Act, allowing it to delay the adoption of certain accounting standards [156]. - The company will remain an EGC until it reaches total annual gross revenues of $1.07 billion or more [159]. - The company has not experienced material changes to its critical accounting policies during the three and six months ended June 30, 2020 [154]. - The company may present only two years of audited financial statements and related Management's Discussion and Analysis due to its EGC status [158]. - The company has opted for exemptions from certain reporting requirements under the Sarbanes-Oxley Act [158]. Market Risk - The company is not currently exposed to significant market risk related to foreign currency exchange rates, but may contract with foreign vendors in the future [161]. - An immediate 10% change in interest rates would not have a material effect on the fair market value of the company's investment portfolio due to the low risk profile of its investments [160]. - The company holds investments in corporate debt securities and commercial paper, which are affected by U.S. interest rate changes [160].
Enliven Therapeutics(ELVN) - 2020 Q1 - Quarterly Report
2020-05-07 12:12
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, 2020 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 (St ...