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Larimar Therapeutics Reports Third Quarter 2022 Operating and Financial Results
BALA CYNWYD, Pa., Nov. 10, 2022 (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 2022 operating and financial results. “This is an exciting time for Larimar, as we recently received regulatory clearance for CTI-1601’s return to the clinic under a partial hold and completed a capital raise with a premier life science investor syndicate,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “These important accomplishments allowed us to begin enrolling patients in the first cohort of our Phase 2 trial in Friedreich’s ataxia patients, which continues to make progress. The trial’s results are expected to inform CTI-1601’s long-term dose regimen, thereby building upon the clinical proof-of-concept data generated in our Phase 1 program. We are grateful for the continued support we have received from the Friedreich’s ataxia community and our shareholders over these past months and look forward to CTI-1601’s continued development as a potentially disease-modifying therapy.” Third Quarter and Subsequent Highlights
Third Quarter 2022 Financial Results As of September 30, 2022, the Company had cash and marketable securities totaling $124.7 million which provides projected cash runway into the second half of 2024. The Company reported a net loss for the third quarter of 2022 of $8.3 million, or $0.37 per share, compared to a net loss of $16.8 million, or $0.92 per share, for the third quarter of 2021. Research and development expenses for the third quarter of 2022 were $5.6 million compared to $14.0 million for the third quarter of 2021. The decrease in research and development expenses was primarily driven by a decrease of $6.7 million in drug manufacturing costs, a decrease of $1.0 million in nonclinical development costs, a decrease of $0.5 million in consulting expenditures, a decrease of $0.5 million in clinical expense partially offset by an increase of $0.4 million in personnel expense. General and administrative expenses for the third quarter of 2022 were $2.9 million compared to $2.7 million for the third quarter of 2021. The increase in general and administrative expense was primarily driven by increases in professional fees associated with legal and accounting services and in personnel expense. The Company reported a net loss for the nine months ended September 30, 2022 of $25.9 million, or $1.32 per share, compared to a net loss of $41.5 million, or $2.48 per share, for the nine months ended September 30, 2021. Research and development expenses for the nine months ended September 30, 2022 were $17.0 million compared to $32.1 million for the nine months ended September 30, 2021. The decrease in research and development expenses was primarily driven by a decrease of $9.0 million in drug manufacturing costs, a decrease of $3.5 million in clinical trial expense, and a decrease of $3.3 million in nonclinical development costs. General and administrative expenses for the nine months ended September 30, 2022 were $9.1 million compared to $9.3 million for the nine months ended September 30, 2021. The decrease in general and administrative expense was primarily driven by a decrease of $0.5 million in operational costs primarily related to technology and recruiting services and a decrease of $0.4 million in professional fees primarily associated with legal and consulting expense, partially offset by an increase of $0.5 million in stock-based compensation expense associated with stock option grants made in 2021 and 2022. About Larimar Therapeutics Forward-Looking Statements In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others, Larimar’s ability to successfully engage with the FDA and satisfactorily respond to requests from the FDA for further information and data regarding the CTI-1601 clinical trial including the FDA review of data from cohort one from the Phase 2 dose exploration trial and FDA ‘s agreement to escalate the dosing in cohort two, the timing and outcomes of Larimar’s interactions with the FDA concerning the partial clinical hold, the success, cost and timing of Larimar’s product development activities, nonclinical studies and clinical trials, including CTI-1601 clinical milestones; that preliminary clinical trial results may differ from final clinical trial results, that earlier non-clinical and clinical data and testing of CTI-1601 may not be predictive of the results or success of later clinical trials, and assessments; the ongoing impact of the COVID-19 pandemic on Larimar’s future clinical trials, manufacturing, regulatory, nonclinical study timelines and operations, and general economic conditions; Larimar’s ability and the ability of third-party manufacturers Larimar engages, to optimize and scale CTI-1601’s manufacturing process; Larimar’s ability to obtain regulatory approvals for CTI-1601 and future product candidates; Larimar’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators, and to successfully commercialize any approved product candidates; Larimar’s ability to raise the necessary capital to conduct its product development activities; and other risks described in the filings made by Larimar with the Securities and Exchange Commission (SEC), including but not limited to Larimar’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. These forward-looking statements are based on a combination of facts and factors currently known by Larimar and its projections of the future, about which it cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent Larimar’s management’s views only as of the date hereof. Larimar undertakes no obligation to update any forward-looking statements for any reason, except as required by law. Investor Contact: Company Contact:
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