Enliven Therapeutics(ELVN)

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Enliven Therapeutics(ELVN) - 2020 Q4 - Annual Report
2021-03-04 16:00
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, 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 (State or other jurisdiction of incorpora ...
Enliven Therapeutics(ELVN) - 2020 Q3 - Earnings Call Transcript
2020-11-07 15:36
IMARA Inc. (IMRA) Q3 2020 Results Earnings Conference Call November 5, 2020 8:30 AM ET Company Participants Rahul Ballal - Chief Executive Officer Michael Gray - Chief Financial and Chief Operating Officer Conference Call Participants Joseph Schwartz - SVB Leerink Yigal Nochomovitz - Citigroup Operator Good morning and welcome to the IMARA Inc. Q3 Earnings Conference Call and Webcast. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-an ...
Enliven Therapeutics(ELVN) - 2020 Q3 - Quarterly Report
2020-11-05 12:23
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, 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) | --- | --- | --- | ...
Enliven Therapeutics(ELVN) - 2020 Q2 - Earnings Call Transcript
2020-08-14 16:14
IMARA Inc. (IMRA) Q2 2020 Results Earnings Conference Call August 14, 2020 8:30 AM ET Company Participants Rahul Ballal - Chief Executive Officer Michael Gray - Chief Financial and Chief Operating Officer Conference Call Participants Yigal Nochomovitz - Citi Group Joseph Schwartz - SVB Leerink Operator Ladies and gentlemen, thank you for standing by and welcome to the IMARA Inc. Q2 earnings conference call and webcast. At this time all participant lines are in a listen-only mode. After the speakers' present ...
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 ...