Larimar Therapeutics(LRMR) - 2025 Q1 - Quarterly Report

PART I - FINANCIAL INFORMATION Financial Statements This section presents the unaudited condensed consolidated financial statements for Larimar Therapeutics as of March 31, 2025 Condensed Consolidated Balance Sheets The balance sheet as of March 31, 2025, shows a decrease in total assets to $170.2 million and in total stockholders' equity to $144.3 million Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total current assets | $165,485 | $195,304 | | Total assets | $170,175 | $200,225 | | Total current liabilities | $22,134 | $24,356 | | Total liabilities | $25,904 | $28,413 | | Total stockholders' equity | $144,271 | $171,812 | Condensed Consolidated Statements of Operations and Comprehensive Loss For Q1 2025, the company reported a net loss of $29.3 million, a significant increase from the $14.7 million loss in Q1 2024 Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $26,552 | $12,939 | | General and administrative | $4,636 | $3,795 | | Total operating expenses | $31,188 | $16,734 | | Loss from operations | ($31,188) | ($16,734) | | Other income, net | $1,907 | $2,080 | | Net loss | ($29,281) | ($14,654) | | Net loss per share, basic and diluted | ($0.46) | ($0.27) | Condensed Consolidated Statements of Changes in Stockholders' Equity Stockholders' equity decreased from $171.8 million to $144.3 million in Q1 2025, primarily due to the quarterly net loss - Total stockholders' equity decreased by $27.5 million during Q1 2025, from $171.8 million to $144.3 million, mainly due to the net loss[20] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $26.5 million in Q1 2025, reflecting higher R&D spending Q1 2025 vs Q1 2024 Cash Flows (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($26,540) | ($10,411) | | Net cash provided by (used in) investing activities | $14,448 | ($68,364) | | Net cash provided by financing activities | $— | $162,151 | Notes to Condensed Consolidated Financial Statements The notes detail the development of nomlabofusp for Friedreich's ataxia, positive regulatory interactions, and the company's liquidity position - The company's lead product candidate, nomlabofusp, is a recombinant fusion protein intended to deliver human frataxin (FXN) to the mitochondria of patients with Friedreich's ataxia (FA)[26] - The FDA selected nomlabofusp for its START Pilot Program and is open to considering FXN concentration as a reasonably likely surrogate endpoint (RLSE), with a BLA submission targeted for the end of 2025[33][39] - As of March 31, 2025, the company had $157.5 million in cash, cash equivalents, and marketable securities, sufficient to fund operations into the second quarter of 2026[48][50] - In February 2024, the company completed an underwritten public offering, raising net proceeds of approximately $161.8 million[91][92] Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) Management discusses the clinical progress of nomlabofusp, the significant increase in R&D expenses, and the company's liquidity and capital resources Overview and Program Update Larimar is a clinical-stage biotech company advancing nomlabofusp for Friedreich's ataxia with positive trial data and favorable regulatory feedback - The FDA is open to considering FXN concentration as a reasonably likely surrogate endpoint (RLSE) to support a future marketing application for nomlabofusp[149] - A global Phase 3 study is on track to be initiated by mid-2025[150] - An update on OLE trial data, including participants dosed for over a year, is planned for September 2025[145] - In March 2025, the OLE protocol was amended to include premedication for the first month of dosing to reduce the risk of allergic reactions, including anaphylaxis[145] Results of Operations The net loss for Q1 2025 increased to $29.3 million, driven by a $13.6 million rise in R&D expenses for the nomlabofusp program Comparison of Operations for Q1 2025 and Q1 2024 (in thousands) | | 2025 | 2024 | Increase (Decrease) | | :--- | :--- | :--- | :--- | | Research and development | $26,552 | $12,939 | $13,613 | | General and administrative | $4,636 | $3,795 | $841 | | Total operating expenses | $31,188 | $16,734 | $14,454 | | Net loss | ($29,281) | ($14,654) | ($14,627) | - The $13.6 million increase in R&D expenses was primarily driven by a $7.1 million increase in nomlabofusp manufacturing costs and a $2.8 million increase in clinical costs[171] Liquidity and Capital Resources The company held $157.5 million in cash and equivalents as of March 31, 2025, which is expected to fund operations into Q2 2026 - As of March 31, 2025, the company had an accumulated deficit of $298.4 million and cash, cash equivalents, and marketable securities of $157.5 million[182] - Current cash, cash equivalents, and marketable securities are anticipated to fund operations into the second quarter of 2026[184] - Net cash used in operating activities increased to $26.5 million in Q1 2025 from $10.4 million in Q1 2024, reflecting increased R&D activity[175][176] Quantitative and Qualitative Disclosures About Market Risk As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk - As a "smaller reporting company," Larimar is not required to provide information regarding market risk[190] Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025 - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures are effective as of March 31, 2025[193] - No material changes in internal control over financial reporting occurred during the quarter[195] PART II - OTHER INFORMATION Legal Proceedings The company is not currently involved in any legal proceedings that would have a material adverse effect on its business - As of the report date, there are no threatened or pending legal actions that could reasonably be expected to have a material adverse effect on the company[196] Risk Factors This section directs investors to the risk factors discussion in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - Investors are advised to carefully consider the risk factors described in the company's 2024 Annual Report on Form 10-K[197] Other Required Disclosures (Items 2-6) The company reports no unregistered sales of equity, no defaults on senior securities, and no new officer trading plans during the quarter - There were no unregistered sales of equity securities or use of proceeds during the quarter[198] - No defaults upon senior securities were reported[199] - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter ended March 31, 2025[201]