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Larimar Therapeutics(LRMR) - 2024 Q3 - Quarterly Report
LRMRLarimar Therapeutics(LRMR)2024-10-30 21:03

Product Development - The company is focused on developing nomlabofusp, a treatment for Friedreich's ataxia, which aims to increase frataxin levels in patients [68]. - The Phase 2 trial of nomlabofusp showed dose-dependent increases in FXN levels in all evaluated tissues after 14 days of daily dosing [70]. - The FDA lifted the partial clinical hold on nomlabofusp in May 2024, allowing further clinical development [70]. - The ongoing open label extension study for nomlabofusp is evaluating safety, pharmacokinetics, and frataxin levels in patients [70]. - The company plans to initiate a global confirmatory study by mid-2025, targeting a Biologics License Application filing in the second half of 2025 [70]. - The company has received multiple designations for nomlabofusp, including orphan drug designations in the U.S. and EU, and participation in the FDA's START pilot program [70]. Financial Performance - The company has not generated any revenue from product sales to date and does not expect to in the foreseeable future [78]. - Net loss for the three months ended September 30, 2024, was 15.5million,anincreaseof15.5 million, an increase of 6.4 million from a net loss of 9.1millioninthesameperiodof2023[82].−ResearchanddevelopmentexpensesforthethreemonthsendedSeptember30,2024,increasedby9.1 million in the same period of 2023 [82]. - Research and development expenses for the three months ended September 30, 2024, increased by 7.3 million to 13.9millioncomparedto13.9 million compared to 6.6 million in the same period of 2023 [82]. - General and administrative expenses for the three months ended September 30, 2024, rose by 0.6millionto0.6 million to 4.3 million compared to 3.8millioninthesameperiodof2023[85].−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,increasedby3.8 million in the same period of 2023 [85]. - Research and development expenses for the nine months ended September 30, 2024, increased by 29.5 million to 46.5millioncomparedto46.5 million compared to 17.0 million in the same period of 2023 [87]. - General and administrative expenses for the nine months ended September 30, 2024, increased by 2.5millionto2.5 million to 13.1 million compared to 10.6millioninthesameperiodof2023[88].−NetcashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024,was10.6 million in the same period of 2023 [88]. - Net cash used in operating activities for the nine months ended September 30, 2024, was 48.9 million, compared to 24.1millioninthesameperiodof2023[92].−NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2024,was24.1 million in the same period of 2023 [92]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was 161.8 million, primarily from a common stock offering [94]. - As of September 30, 2024, the company had an accumulated deficit of 240.3millionandcash,cashequivalents,andmarketablesecuritiesof240.3 million and cash, cash equivalents, and marketable securities of 203.7 million [96]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it continues to advance the development of its product candidates [96]. Capital Raising - In February 2024, the company completed a public offering, issuing 19,736,842 shares at 8.74pershare,raisingapproximately8.74 per share, raising approximately 161.8 million [72]. - The company completed a public offering in February 2024, issuing 19,736,842 shares and receiving net proceeds of approximately $161.8 million [96]. Risks and Compliance - The company is subject to risks common to pre-commercial biotechnology firms, including regulatory approval and funding challenges [71]. - The company qualifies as a "smaller reporting company" and is not required to provide certain market risk disclosures [102]. - No recent accounting pronouncements applicable to the company were mentioned in the financial statements [100].