Earnings release
Page 1
Larimar Therapeutics Larimar Therapeutics Reports First Quarter 2021 Operating and Financial Results May 10 , 2021 - · Topline data from placebo - controlled Phase 1 program in Friedreich's ataxia patients to be announced tomorrow , May 11 , 2021- Management to discuss during webcast and conference call at 8 a.m. ET - Cash and investments of $ 81.4 million as of March 31 , 2021 BALA CYNWYD , Pa . , May 10 , 2021 ( GLOBE NEWSWIRE ) -- Larimar Therapeutics , Inc. ( " Larimar " ) ( Nasdaq : LRMR ) , a clinical - stage biotechnology company focused on developing treatments for complex rare diseases , today reported its first quarter 2021 operating and financial results . " Our Phase 1 program in Friedreich's ataxia ( FA ) made strong progress over the past few months and we will be announcing topline data from the program tomorrow , " said Carole Ben - Maimon , MD , President and Chief Executive Officer of Larimar . “ In addition to safety and tolerability findings , the upcoming announcement will include pharmacodynamic data assessing frataxin levels in buccal cells , skin , and platelets . These data provide important insights that we expect will inform CTI - 1601's further development , as FA is caused by patients ' inability to produce sufficient amounts of frataxin and CTI - 1601 is the only drug candidate that we are aware of in clinical development that is designed to address the root cause of the disease by delivering this crucial protein to patients . " First Quarter 2021 Highlights • Completed dosing in its double - blind , placebo controlled , multiple ascending dose ( MAD ) clinical trial evaluating CTI - 1601 in Friedreich's ataxia ( FA ) patients . Upcoming and Anticipated 2021 Milestones • Announce topline data from placebo - controlled , Phase 1 program in FA patients on May 11 , 2021 • Initiate Jive open - label extension clinical trial : expected in 2H 2021 • Initiate Multiple Ascending Dose ( MAD ) trial in patients under 18 years of age : expected in 2H 2021 First Quarter 2021 Financial Results As of March 31 , 2021 , the Company had cash , cash equivalents , and marketable debt securities totaling $ 81.4 million . The Company reported a net loss for the first quarter of 2021 of $ 12.1 million , or $ 0.76 per share , compared to a net loss of $ 6.7 million , or $ 1.10 per share , for the first quarter of 2020 . Research and development expenses for the first quarter of 2021 were $ 9.0 million compared to $ 5.0 million for the first quarter of 2020. The increase in research and development expenses compared to the prior year period was primarily driven by higher clinical supply manufacturing costs , an increase in clinical trial costs , an increase in personnel related costs due to headcount additions in our research and development functions , an increase in stock compensation expense associated with stock option grants made in 2020 and Q1 2021 and increases in non - clinical study costs . General and administrative expenses for the first quarter of 2021 were $ 3.1 million , compared to $ 1.7 million for the first quarter of 2020. The increase in general and administrative expenses as compared to the prior year period was primarily driven by an increase in personnel related costs due to increased headcount , and an increase in stock - based compensation associated with stock option grants made in 2020 and in the first quarter of 2021 , an increase in professional fees primarily associated with insurance costs , recruiting services , legal and consulting fees as a result of operating as a public company , partially offset by a decrease in accounting and audit costs related to additional years under audit in the first quarter 2020 . Conference Call and Webcast Larimar will host a conference call and webcast tomorrow , May 11 , 2021 at 8:00 a.m. ET to discuss topline data from its placebo - controlled Phase 1 program in FA patients . To access the webcast , please visit this link to the event . To participate by phone please dial 855-327-6837 ( domestic ) or 631-891-4304 ( international ) and refer to conference ID 10014696. Following the live event , the archived webcast will be available for 90 days . About Larimar Therapeutics Larimar Therapeutics , Inc. ( Nasdaq : LRMR ) , is a clinical - stage biotechnology company focused on developing treatments for complex rare diseases . The company's lead compound , CTI - 1601 , is currently being evaluated in a Phase 1 clinical program in the U.S. as a potential treatment for FA . Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds . For more information , please visit : https://larimartx.com . Forward - Looking Statements This press release contains forward - looking statements that are based on Larimar's management's beliefs and assumptions and on information currently available to management . All statements contained in this release other than statements of historical fact are forward - looking statements , including but not limited to statements regarding Larimar's ability to develop and commercialize CTI - 1601 and other planned product candidates ,