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Larimar Therapeutics Larimar Therapeutics Reports Third Quarter 2021 Operating and Financial Results November 12 , 2021 BALA CYNWYD , Pa . , Nov. 12 , 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 third quarter and year to date September 30 , 2021 operating and financial results . " We are advancing towards 2022 with a strong balance sheet , the backing of high - quality institutional investors , and compelling Phase 1 data that demonstrate proof - of - concept for CTI - 1601 , " said Carole Ben - Maimon , MD , President and Chief Executive Officer of Larimar . " We continue to collect and analyze data from our 180 - day non - human primate toxicology study so that we can continue moving towards the resolution of CTI - 1601's clinical hold and an expected return to the clinic in the first half of next year . We are working expeditiously towards this goal , as patients with Friedreich's ataxia ( FA ) urgently need disease - modifying therapies . With a differentiated mechanism of action targeting the root cause of FA , we believe CTI - 1601 is uniquely positioned to potentially address this need and look forward to its continued clinical development . " Third Quarter 2021 Highlights • Prior to the third quarter , the United States Food and Drug Administration ( FDA ) placed a clinical hold on the CTI - 1601 clinical program after Larimar notified the agency of mortalities that occurred at the highest dose levels of a 180 - day non - human primate ( NHP ) toxicology study designed to support extended dosing of patients with CTI - 1601 . In the clinical hold letter , the FDA stated that it needs a full study report from the NHP study and that Larimar may not initiate additional clinical trials until the Company has submitted the report and received notification from the agency that additional clinical trials may commence . At the time of the notice , the Company had no interventional clinical trials with patients enrolled or enrolling . In July 2021 , Larimar completed dosing in the 180 - day NHP toxicology study , and it continues to collect and analyze data . While there is no way to predict the FDA's response ( which the Company anticipates will not be received prior to the first quarter of 2022 ) or whether they will require additional data or testing before lifting the clinical hold on CTI - 1601 in full or in part , the Company expects to initiate its Jive open - label extension and pediatric multiple ascending dose trials in the first half of next year . • Under an Equity Distribution Agreement with an investment bank , the Company may sell up to an aggregate of $ 50 million of shares of common stock from time to time in connection with an “ at the market ” program . In July 2021 , the Company sold 2,342,720 shares under the agreement for net proceeds of $ 19.9 million . As of September 30 , 2021 and the date of this announcement , $ 29.2 million of common stock remains available for sale under this program . • In August 2021 , Larimar initiated a non - interventional healthy volunteer study designed to generate data for comparison to patients with FA . Third Quarter 2021 Financial Results As of September 30 , 2021 , the Company had cash , cash equivalents and marketable debt securities totaling $ 78.0 million . The Company reported a net loss for the third quarter of 2021 of $ 16.8 million , or $ 0.92 per share , compared to a net loss of $ 10.3 million , or $ 0.64 per share , for the third quarter of 2020 . Research and development expenses for the third quarter of 2021 were $ 14.0 million compared to $ 6.9 million for the third 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 of $ 6.4 million , higher non - clinical and internal laboratory costs of $ 1.3 million , an increase of $ 0.3 million in personnel related costs due to headcount additions in our research and development functions , and an increase of $ 0.3 million in stock - based compensation expense associated with stock option grants made in the second half of 2020 and thus far in 2021 , partially offset by a decrease of $ 1.4 million in clinical trial costs . General and administrative expenses for the third quarter of 2021 were $ 2.7 million compared to $ 3.4 million for the third quarter of 2020. The decrease in general and administrative expenses as compared to the prior year period was primarily driven by a decrease of $ 1.1 million in professional fees primarily associated with accounting , legal and consulting fees partially offset by an increase of $ 0.8 million in stock - based compensation expense associated with stock option grants made in the second half of 2020 and thus far in 2021. General and administrative expenses for the third quarter of 2020 included costs associated with the Company's May 2020 reverse merger with Zafgen , Inc. ( the Merger ) For the nine - months ended September 30 , 2021 , the Company reported a net loss of $ 41.5 million , or $ 2.48 per share , compared to a net loss of $ 28.3 million , or $ 2.69 per share for the same period in 2020 .