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Larimar Therapeutics, Inc. (Nasdaq: LRMR) is a clinical-stage biotechnology company dedicated to developing innovative treatments for complex rare diseases. The company's lead compound, CTI-1601, is currently undergoing Phase 1 clinical trials as a potential treatment for Friedreich’s ataxia, a progressive genetic disorder. Using its proprietary cell-penetrating peptide technology platform, Larimar aims to design fusion proteins that address deficiencies in intracellular bioactive compounds.
CTI-1601, a subcutaneously administered, recombinant fusion protein, is engineered to deliver human frataxin (FXN) directly to the mitochondria in patients with Friedreich’s ataxia. This approach is intended to mitigate the symptoms of this debilitating disease, offering hope to patients and their families.
Larimar Therapeutics reported a net loss of $9.1 million in Q3 2023, with research and development expenses totaling $6.6 million. The increase in expenses is attributed to ongoing clinical trials, personnel costs, and professional fees. The company had $95.6 million in cash, cash equivalents, and marketable securities as of September 30, 2023, ensuring sufficient liquidity into Q1 2025.
Recent activities include initiating an underwritten public offering of common stock and pre-funded warrants to raise funds for further research and development, particularly for the continued progression of CTI-1601.
Partnerships with financial entities such as Leerink Partners, Citigroup, and Guggenheim Securities have bolstered Larimar's market presence, demonstrating strong investor confidence and commitment to its mission.
For more information, visit Larimar Therapeutics, Inc.
Larimar Therapeutics (LRMR) announced a Type C FDA meeting scheduled for early Q3 2022 to address the ongoing clinical hold on its CTI-1601 program. This meeting aims to resolve issues related to previous mortalities in a non-human primate study, which led to the hold. As of March 31, 2022, Larimar reported $62.6 million in cash, indicating a runway into Q3 2023. The company recorded a net loss of $8.9 million for Q1 2022, an improvement from $12.1 million in Q1 2021, while R&D expenses decreased from $9.0 million to $5.8 million.
Larimar Therapeutics (Nasdaq: LRMR) reported its full-year 2021 financial results, highlighting clinical progress in developing CTI-1601 for Friedreich’s ataxia. Positive Phase 1 trial data indicated dose-dependent increases in frataxin levels, showing that CTI-1601 is generally well tolerated. Despite these advancements, the FDA's clinical hold remains in effect, necessitating more data. For 2021, the company recorded a net loss of $50.6 million, or $2.95 per share, with R&D expenses rising to $38.4 million. Cash reserves stood at $70.1 million as of year-end 2021.
Larimar Therapeutics (Nasdaq: LRMR) announced that the FDA is maintaining its clinical hold on the CTI-1601 program, requiring additional data for resolution. The company is reassessing its study plans and aims to engage the FDA for guidance. Despite this setback, Larimar believes there is a path forward based on existing data from Phase 1 trials, which showed CTI-1601 was generally well tolerated. The company emphasizes its commitment to CTI-1601 and has a strong cash position to support operations through at least 2023 while managing burn rates under a cost reduction plan.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotechnology company, announced management participation in virtual 1x1 investor meetings at the Piper Sandler 33rd Annual Healthcare Conference from November 29 to December 2, 2021. The company is focused on developing treatments for complex rare diseases, particularly its lead compound CTI-1601, which is undergoing a Phase 1 clinical program for Friedreich's ataxia. Larimar aims to leverage its intracellular delivery platform to create new fusion proteins for additional rare diseases.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotechnology company, announced its participation in 1x1 investor meetings at the Guggenheim Virtual Neuro/Immunology Conference on November 15-16, 2021. The company focuses on developing treatments for complex rare diseases, with its lead compound CTI-1601 currently in a Phase 1 clinical program targeting Friedreich's ataxia. Larimar aims to utilize its intracellular delivery platform for other fusion proteins aimed at rare diseases characterized by deficiencies in intracellular bioactive compounds.
Larimar Therapeutics, Inc. (Nasdaq: LRMR) reported its third quarter and year-to-date results as of September 30, 2021. The company has a strong balance sheet with $78 million in cash and marketable securities. Despite a clinical hold on its CTI-1601 program by the FDA due to safety concerns, they have compelling Phase 1 data and are focused on addressing Friedreich’s ataxia. The net loss for Q3 2021 was $16.8 million ($0.92 per share), increasing from $10.3 million in Q3 2020. R&D expenses rose to $14 million from $6.9 million in Q3 2020, driven by higher clinical supply costs.
LARIMAR Therapeutics, Inc. (Nasdaq: LRMR) announced participation in 1x1 investor meetings at the SVB Leerink CybeRx Series event focused on neuromuscular and rare diseases, scheduled for September 22-23, 2021. Larimar is a clinical-stage biotech company dedicated to developing treatments for complex rare diseases, with its lead compound, CTI-1601, undergoing Phase 1 clinical trials as a potential treatment for Friedreich's ataxia. The company aims to leverage its innovative intracellular delivery platform for future therapies targeting additional rare diseases.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotechnology company, announced that Carole Ben-Maimon, MD, will present at the Morgan Stanley 19th Annual Global Healthcare Conference from September 9-15, 2021. The event features 1x1 investor meetings and will include a fireside chat on September 9 at 5:00 PM ET. Larimar is focused on developing treatments for complex rare diseases, notably its lead compound CTI-1601 for Friedreich's ataxia, currently in Phase 1 clinical trials in the U.S.
BALA CYNWYD, Pa., Aug. 19, 2021 – Larimar Therapeutics, Inc. (Nasdaq: LRMR) announced that Dr. David Bettoun will present at the World Orphan Drug Congress USA 2021 on August 27. His presentation, titled 'Expanding Therapeutic Possibilities for Rare Diseases,' will showcase preclinical in vitro data on Larimar's proprietary protein replacement therapy platform. Larimar is focused on developing treatments for rare diseases, with its lead compound, CTI-1601, currently in Phase 1 trials for Friedreich's ataxia.
Larimar Therapeutics (LRMR) reported positive Phase 1 results for CTI-1601, demonstrating proof-of-concept in Friedreich’s ataxia patients. Subcutaneous doses (50 mg and 100 mg) achieved frataxin levels comparable to normal heterozygous carriers. Safety data revealed no serious adverse events. As of June 30, 2021, the company had $70.6 million in cash. A $20 million equity financing was closed on July 2, 2021. However, the FDA placed a clinical hold on the CTI-1601 program due to mortalities in a toxicology study, requiring further data for trial resumption.
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