Larimar Therapeutics Inc.
03/19/2026 | Press release | Distributed by Public on 03/19/2026 05:04
$244.5 million in pro forma* cash, cash equivalents and marketable securities as of December 31, 2025, with projected cash runway into the second quarter of 2027 (Form 8-K)
$244.5 million in pro forma* cash, cash equivalents and marketable securities as of December 31, 2025, with projected cash runway into the second quarter of 2027
*Pro forma cash, cash equivalents, and marketable securities of $244.5 million reflects $136.9 million of cash, cash equivalents and marketable securities as of December 31, 2025 combined with the $107.6 million in net proceeds from the recently completed February 2026 public offering.
Bala Cynwyd, PA, March 19, 2026 - Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its fourth quarter and full year 2025 operating and financial results.
"This is an exciting and pivotal time for Larimar as we continue advancing nomlabofusp toward registration. Receiving Breakthrough Therapy Designation from the Food and Drug Administration (FDA) highlights both the significant unmet needs in Friedreich's ataxia (FA) and the potential of nomlabofusp to address the underlying frataxin (FXN) deficiency that causes the disabilities experienced by people with FA," said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. "Importantly, our ongoing engagement with the FDA reinforces our registrational path, and we remain on track to submit our Biologics License Application (BLA) seeking accelerated approval in June 2026. In the second quarter of this year, we expect to report topline data from our open label (OL) study, as well as initiate screening in our global confirmatory Phase 3 study. With a strengthened balance sheet following our recent financing and an extended cash runway into the second quarter of 2027, we are strongly positioned to execute on our registrational milestones over the next 12 months. Nomlabofusp has the potential to become the first disease-modifying therapy for FA, and we are committed to delivering it as rapidly as possible to the FA community who continues to face significant unmet medical need."
Highlights
•
Breakthrough Therapy Designation: In February, the FDA granted Breakthrough Therapy Designation to nomlabofusp for the treatment of adults and children with FA. The designation was based on the FDA's review of available clinical data from the Company's ongoing OL study evaluating nomlabofusp in adult and pediatric patients with FA.
•
FDA Meeting Comments Support Planned Submission of BLA in June 2026: In February, following a recent Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot
program meeting with FDA and review of preliminary clinical data for the nomlabofusp program, Larimar announced continued alignment with the FDA on BLA content including:
o
FXN as Novel Surrogate Endpoint: FDA reaffirmed willingness to consider use of FXN as novel surrogate endpoint and confirmed that the preliminary exposure-response data presented exploring the relationship between nomlabofusp exposures and clinical outcome measures is the type that can support the future BLA.
o
Reference Population: FDA confirmed the process proposed for selecting a reference population based on matched subjects from the Friedrich's Ataxia Clinical Outcomes Measure Study (FACOMS) database for the natural history comparisons of clinical endpoints to be used for the BLA submission and offered to provide advance review and comment on the proposed statistical plan.
o
Safety Dataset: FDA stated that the adequacy of the safety dataset will be a matter of review at the time of BLA submission.
o
Global Phase 3 Study: FDA is aligned with plans to have the global confirmatory Phase 3 study underway at the time of BLA submission and confirmed that change from baseline in the Upright Stability Score (USS) (a subscale of mFARS) is a reasonable and clinically relevant primary endpoint for the planned Phase 3 study.
•
Strengthened Balance Sheet: In February, Larimar completed a public offering of common stock with net proceeds of $107.6 million that included new and existing leading healthcare investors, extending its projected cash runway into the second quarter of 2027.
•
Topline OL Study Data in Second Quarter of 2026: Larimar plans to report topline data from the OL study that is intended to support BLA submission in the second quarter of 2026.
•
Global Confirmatory Phase 3 Study: Plan to initiate screening in the second quarter of 2026, with dosing of first patient expected mid-2026.
•
BLA Submission on Track: BLA seeking accelerated approval planned to be submitted in June 2026; U.S. launch targeted for first-half 2027, if approved.
Fourth Quarter and Full Year 2025 Financial Results
As of December 31, 2025, the Company had cash, cash equivalents and marketable securities totaling $136.9 million. Together with net proceeds of approximately $107.6 million from the February 2026 public offering, the Company has projected cash runway into the second quarter of 2027.
The Company reported a net loss for the fourth quarter of 2025 of $62.5 million, or $0.73 per share of common stock, compared to a net loss of $28.8 million, or $0.45 per share of common stock, for the fourth quarter of 2024.
Research and development expenses for the fourth quarter of 2025 were $59.4 million compared to $26.7 million for the fourth quarter of 2024. The rise in research and development expenses was primarily driven by an increase of $30.4 million nomlabofusp manufacturing costs, including process performance qualification and commercialization scale up activities, an increase of $1.5 million in costs associated with ongoing clinical studies, an increase of $0.5 million in professional consulting fees for quality, clinical, and regulatory activities, an increase of $0.3 million in personnel expense primarily due to increased headcount related to nomlabofusp development, and an increase of $0.3 million in non-clinical costs related to assay development and other drug development costs.
General and administrative expenses for both the fourth quarter of 2025 and the fourth quarter of 2024 were $4.6 million due to an increase of $0.4 million in professional consulting fees related to ongoing and
increasing commercial activities and offset by a decrease of $0.4 million in non-cash stock compensation expense.
Other income (expense), net was $1.5 million of income in the three months ended December 31, 2025 compared to $2.5 million of income in the three months ended December 31, 2024. The decrease was primarily driven by lower interest and accretion income due to lower interest yields and lower average investable cash, cash equivalents, and marketable securities balances.
For the full year 2025, the Company reported a net loss of $165.7 million, or $2.27 per share of common stock, compared to a net loss of $80.6 million, or $1.32 per share of common stock, for the same period in 2024.
Research and development expenses for the full year 2025 were $154.2 million compared to $73.3 million for the same period in 2024. The rise in research and development expenses was primarily driven by an increase of $63.3 million in nomlabofusp manufacturing costs, including process performance qualification and commercialization scale up activities, an increase of $6.3 million in costs associated with ongoing clinical studies, an increase of $5.9 million in professional consulting fees for quality, clinical, and regulatory activities, an increase of $4.3 million in personnel expense primarily due to increased headcount, and an increase of $2.1 million in non-clinical costs related to assay development and drug development.
General and administrative expenses for the full year 2025 were $18.3 million compared to $17.6 million for 2024. This increase was primarily attributable to an increase of $1.2 million in personnel expense driven by increased headcount and an increase of $0.9 million in professional consulting fees primarily related to ongoing and increasing pre-commercial activities, partially offset by a decrease in non-cash stock compensation expense.
Other income (expense), net was $6.8 million of income in the twelve months ended December 31, 2025 compared to $10.3 million of income in the twelve months ended December 31, 2024. The decrease was primarily driven by lower interest and accretion income due to lower interest yields and lower average investable cash, cash equivalents, and marketable securities balances.
About Larimar Therapeutics
Larimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Larimar's lead compound, nomlabofusp, is being developed as a potential treatment for Friedreich's ataxia. 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.
Larimar Therapeutics Inc. published this content on March 19, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on March 19, 2026 at 11:05 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]