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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 positive initial data from its ongoing open label extension (OLE) study of nomlabofusp for Friedreich's Ataxia. The study, involving 14 participants treated with 25mg daily subcutaneous injections for up to 260 days, showed promising results in increasing frataxin (FXN) levels. Tissue FXN levels increased from 15% to 30% in buccal cells and from 16% to 72% in skin cells at Day 90, with early trends showing clinical improvements.
The company has initiated dose escalation to 50mg in 6 participants and plans to expand to adolescents in early 2025. With $203.7 million cash on hand as of September 2024, providing runway into Q2 2026, Larimar aims to submit a Biologics License Application in 2H 2025 for potential accelerated approval.
Larimar Therapeutics presented data from Phase 1 and Phase 2 dose exploration studies of nomlabofusp for Friedreich's ataxia (FA) at ICAR 2024. The studies, involving 61 adults with FA, showed that daily 50mg nomlabofusp administration could achieve frataxin (FXN) levels similar to asymptomatic carriers. Treatment modified gene expression and lipid profiles, trending towards healthy control values. The company plans to expand studies to include children and adolescents, with a program update expected mid-December 2024. A Biologics License Application (BLA) submission is targeted for second half of 2025.
Larimar Therapeutics (LRMR) reported Q3 2024 financial results with a net loss of $15.5 million ($0.24 per share). The company maintains a strong balance sheet with $203.7 million in cash and equivalents, projecting runway into 2026. Their lead program, nomlabofusp for Friedreich's ataxia, continues advancement with key upcoming milestones including: a program update in mid-December 2024, initiation of PK run-in study in adolescents by year-end, planned global confirmatory study mid-2025, and targeted BLA submission in 2H 2025. The company recently received ILAP designation from MHRA to accelerate market access in the UK.
Larimar Therapeutics (Nasdaq: LRMR) announced three poster presentations at the upcoming International Congress for Ataxia Research (ICAR) in London, U.K., from November 12-15, 2024. The presentations will showcase data from the company's nomlabofusp Phase 1 studies and Phase 2 dose exploration study for Friedreich's ataxia treatment.
Nomlabofusp is a novel protein replacement therapy designed to deliver frataxin to mitochondria, addressing the root cause of Friedreich's ataxia. The presentations will cover:
- Effects of nomlabofusp on tissue frataxin levels, plasma lipid profiles, and gene expression
- Disease characteristics and tissue frataxin concentrations in adult patients
- Prediction of tissue frataxin levels with long-term nomlabofusp administration
Dr. Russell Clayton, Chief Medical Officer of Larimar, will give an oral presentation on November 14, 2024.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotech company specializing in treatments for complex rare diseases, has announced its participation in two upcoming investor conferences. The company's management team will engage in one-on-one meetings with investors at:
- The Wells Fargo Healthcare Conference in Boston, MA (September 4-6, 2024)
- The H.C. Wainwright 26th Annual Global Investment Conference in New York, NY (September 9-11, 2024)
These conferences provide Larimar with opportunities to connect with potential investors and showcase their progress in developing innovative treatments for rare diseases.
Larimar Therapeutics (Nasdaq: LRMR) reported Q2 2024 financial results and operational updates for its nomlabofusp program. Key highlights include:
- All 7 sites activated for open label extension (OLE) study; interim data expected in Q4 2024
- Selected for FDA's START pilot program to accelerate rare disease therapeutics
- Joined TRACK-FA Neuroimaging Consortium as industry partner
- Planning PK run-in study in adolescents by year-end 2024
- Global confirmatory study planned for mid-2025
- BLA filing targeted for 2H 2025 for accelerated approval
- $226.1M cash runway into 2026
Q2 2024 financials: Net loss of $21.6M ($0.34/share) vs $8.4M ($0.19/share) in Q2 2023. R&D expenses increased to $19.7M from $5.9M, mainly due to higher manufacturing and clinical trial costs.
Larimar Therapeutics announced that the FDA has selected its therapy, nomlabofusp, for the START pilot program. This program aims to accelerate the development of treatments for rare diseases. Nomlabofusp is a novel protein replacement therapy targeting the root cause of Friedreich’s ataxia (FA) by delivering frataxin to mitochondria.
The selection was based on the therapy's potential for clinical benefit and its development readiness. The START program facilitates enhanced communication with the FDA, which can speed up pivotal study initiation and the path to a Biologics License Application (BLA), currently targeted for the second half of 2025. Interim data from an ongoing open-label extension study is expected in Q4 2024.
Larimar's participation in START could improve development efficiency through more frequent interactions with the FDA, ensuring high-quality, reliable data to support future applications.
Larimar Therapeutics (Nasdaq: LRMR) announced that the FDA has removed the partial clinical hold on their nomlabofusp (CTI-1601) program, aimed at treating Friedreich’s Ataxia (FA). This decision followed the review of data from a recently completed Phase 2 dose exploration study, which included 25 mg and 50 mg cohorts. The study showed that nomlabofusp was well-tolerated and demonstrated dose-dependent increases in frataxin levels. Larimar plans to escalate the dose to 50 mg in the ongoing open-label extension (OLE) study. Interim data from this study is expected in Q4 2024, with a Biologics License Application (BLA) submission targeted for the second half of 2025.
Larimar Therapeutics reported positive Phase 2 data for nomlabofusp in treating Friedreich's ataxia, with dose-dependent increases in frataxin levels. BLA submission expected in 2025, with FDA discussions ongoing. A financing round raised $161.8 million, extending cash runway to 2026. First patient dosed in OLE study with interim data due in Q4 2024.
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