Core Insights - The article emphasizes a fundamental investment approach focused on identifying mispriced opportunities in the market, particularly in cyclical industries, energy, industrials, and under-followed mid-cap companies [1] Group 1: Investment Strategy - The investment strategy is centered on cash flow durability, balance sheet strength, and understanding the risks associated with different capital structures [1] - The focus is on situations where market sentiment has diverged from the underlying economic realities, allowing for potential investment opportunities [1] - The approach includes seeking asymmetric setups where companies have already faced market punishment while their fundamentals are stabilizing or improving [1] Group 2: Market Dynamics - The article highlights that expectations in certain industries often become detached from reality, creating opportunities for investors [1] - It notes that modest changes in market expectations can lead to substantial changes in stock prices, particularly in the context of cyclical industries [1]

Company Overview - Larimar Therapeutics is focused on developing treatments for Friedreich's ataxia, a rare neurodegenerative disease affecting approximately 5,000 patients in the United States and around 20,000 globally [4][5] - The disease primarily affects pediatric patients, with about 70% of diagnoses occurring before the age of 14, leading to progressive deterioration and early mortality [4] Disease Mechanism - Friedreich's ataxia is caused by a deficiency in frataxin, a protein crucial for mitochondrial function [5] - Patients typically have only 20% to 40% of normal frataxin levels, with severely affected individuals having as low as 5% to 10% [5] - Heterozygous carriers, such as the parents of affected children, do not exhibit symptoms of the disease [5]

Larimar Therapeutics (NasdaqGM:LRMR) FY Conference January 14, 2026 12:00 PM ET Company ParticipantsCarole Ben-Maimon - President and CEOConference Call ParticipantsHenry Jiang - AnalystHenry JiangToday, my name is Henry Jiang. I'm with the banking team here at JPMorgan, and it's my pleasure to introduce Larimar Therapeutics today. Presenting today will be Dr. Carole Ben-Maimon, President and CEO of Larimar. Just a quick note: we'll have time for Q&A after the presentation, so please wait until then for any ...

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Drug Development and Regulatory Plans - Larimar is developing nomlabofusp as the first potential disease-modifying therapy for Friedreich's ataxia (FA), targeting a patient population of approximately 20,000 globally, with around 5,000 in the U.S.[3] - The company plans to submit a Biologics License Application (BLA) for nomlabofusp in Q2 2026, with a U.S. launch targeted for early 2027, following FDA recommendations for accelerated approval based on frataxin levels as a surrogate endpoint[7] - The company has received multiple regulatory designations for nomlabofusp, including Orphan Drug and Fast Track designations in the U.S., and PRIME designation in the EU[7] - The START Pilot Program continues to expedite the clinical and regulatory development of Nomlabofusp, selected as one of 7 novel drug development programs by the FDA[54] - The FDA's new milestone-driven program launched in September 2023 aims to accelerate the development of therapies for rare diseases, providing more frequent and rapid interactions with the FDA[54] - The program is designed to facilitate the development of programs to the pre-BLA meeting stage, ensuring high-quality and reliable data for BLA support[54] Clinical Study Results - Data from a long-term open-label study indicates that 100% of participants at Day 180 had skin frataxin (FXN) levels greater than 50% of healthy volunteers, demonstrating sustained increases over time[11] - The median skin FXN levels increased from 2.70 pg/µg at baseline to 13.44 pg/µg at Day 180, indicating significant improvement in treatment efficacy[12] - Nomlabofusp demonstrated a median improvement of -2.25 in mFARS scores compared to a worsening of 1.00 in the FACOMS reference group after one year of treatment[18] - 10 out of 10 participants in the open-label study achieved skin FXN levels over 50% of median levels in healthy volunteers after 6 months of treatment[20] - The ongoing long-term open-label study has shown consistent directional improvement across four key clinical outcomes after one year of treatment[20] - In a cardiac mouse model, nomlabofusp increased median survival from 98 days (vehicle) to 166 days, demonstrating its potential efficacy[26] Safety and Tolerability - Safety observations from the open-label study showed that the most common adverse events were mild to moderate injection site reactions, with 7 participants experiencing anaphylaxis, all of whom recovered without complications[14] - The dosing regimen for nomlabofusp has been revised to a test dose of 5 mg followed by 25 mg daily for the first 30 days, then increasing to 50 mg daily, aimed at reducing the severity of potential anaphylaxis[15] - Nomlabofusp has shown a long-term safety profile with most adverse events being mild to moderate and not leading to withdrawals[19] - The Phase 2 study was generally well tolerated, with mild to moderate injection site reactions being the most common adverse events[40] Patient Population and Unmet Need - A national survey of clinicians treating FA patients indicated that 98% believe there is a need for treatments targeting frataxin levels directly, highlighting the high unmet medical need in this area[5] - The global Phase 3 study will include 100-150 ambulatory participants aged 2-40 years, focusing on safety and tolerability as well as upright stability and mFARS as primary outcomes[21] - The trial population included a broad representation of adults with Friedreich's Ataxia, with over 50% being non-ambulatory at baseline[48] Intellectual Property and Market Position - Larimar's intellectual property portfolio for nomlabofusp includes patents extending into 2040, providing a strong foundation for market exclusivity upon approval[8] Collaboration and Data Access - Larimar has established a strong relationship with FARA, joining the TRACK-FA Neuroimaging Consortium as an industry partner[57] - FARA provides access to a Global Patient Registry with demographic and clinical information on over 1,000 FA patients, aiding in patient recruitment and education[57] - The TRACK-FA initiative collects natural history data to establish disease-specific neuroimaging biomarkers for potential use in clinical trials[57] - Larimar will have access to all study data from TRACK-FA for regulatory filings as appropriate[57]

BALA CYNWYD, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that members of the company’s management team will present and participate in 1x1 investor meetings at the 44th Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, CA from January 12 – 15, 2026. Details on the presentation can be found below. Date: Wednesday, January 14, ...

Core Insights - The health care sector is experiencing a trend of oversold stocks, presenting potential buying opportunities for undervalued companies [1][2] Group 1: Oversold Stocks - Larimar Therapeutics Inc (NASDAQ:LRMR) has an RSI of 29.9, with shares falling 12.1% to close at $3.12. The company reported a wider-than-expected quarterly loss but highlighted positive long-term data from a clinical study [3][8] - Perrigo Company PLC (NYSE:PRGO) also has an RSI of 29.9, with shares declining 1.7% to close at $13.61. The company reported mixed third-quarter results and lowered its FY25 adjusted EPS guidance, despite gaining market share in several categories [4][8] - ORIC Pharmaceuticals Inc (NASDAQ:ORIC) has an RSI of 29.6, with shares falling 4.5% to close at $10.65. The company has seen a 16% decline in stock price over the past month [5][8]

Core Insights - The health care sector is experiencing a trend of oversold stocks, presenting potential buying opportunities for undervalued companies [1][2] Group 1: Oversold Stocks - Larimar Therapeutics Inc (NASDAQ:LRMR) has an RSI of 29.9, with shares falling 12.1% to close at $3.12. The company reported a wider-than-expected quarterly loss but highlighted positive long-term data from a clinical study [3][8] - Perrigo Company PLC (NYSE:PRGO) also has an RSI of 29.9, with shares declining 1.7% to close at $13.61. The company reported mixed third-quarter results and lowered its FY25 adjusted EPS guidance, despite gaining market share in several categories [4][8] - ORIC Pharmaceuticals Inc (NASDAQ:ORIC) has an RSI of 29.6, with shares dropping 4.5% to close at $10.65. The company has seen a 16% decline in stock price over the past month [5][8]

Drug Development - The company is focused on developing nomlabofusp, a recombinant fusion protein aimed at increasing tissue frataxin (FXN) levels in patients with Friedreich's ataxia (FA), a rare disease with no current treatment options [131]. - As of September 2025, 65 participants have received at least one dose of nomlabofusp across various studies, with 39 participants in the ongoing open label study [138]. - In December 2024, the company reported positive initial data from the open label study, including safety and FXN levels, and increased the dose to 50 mg daily for enrolled participants [138]. - The FDA has granted Orphan Drug Designation and Fast Track Designation for nomlabofusp, and the company is participating in the START pilot program to expedite drug development for rare diseases [137]. - The ongoing open label study has shown consistent improvements in clinical outcomes and skin FXN levels, suggesting a potential treatment effect [144]. - The FDA has recommended focusing on skin FXN concentrations as a surrogate endpoint for accelerated approval, acknowledging a relationship between increased FXN levels and relevant tissues [138]. - The company plans to submit a Biologics License Application (BLA) seeking accelerated approval for nomlabofusp in the second quarter of 2026 [144]. - The company aims to advance the development of nomlabofusp through additional clinical trials and related manufacturing costs [180]. - Plans include seeking regulatory approvals for nomlabofusp and other potential product candidates [180]. Financial Performance - Revenue from product sales remains at $0, with no expectations of generating revenue in the foreseeable future [152]. - Research and development expenses for Q3 2025 increased by $31.0 million to $44.9 million compared to Q3 2024 [160]. - Total operating expenses for Q3 2025 were $49.5 million, up from $18.3 million in Q3 2024, reflecting a $31.2 million increase [159]. - Net loss for Q3 2025 was $47.7 million, compared to a net loss of $15.5 million in Q3 2024, representing a $32.2 million increase [159]. - Research and development expenses for the nine months ended September 30, 2025 increased by $48.3 million to $94.9 million compared to the same period in 2024 [164]. - Total operating expenses for the nine months ended September 30, 2025 were $108.5 million, up from $59.6 million in 2024, indicating a $48.9 million increase [163]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $74.7 million, compared to $48.9 million in 2024 [169]. - As of September 30, 2025, the accumulated deficit was $372.3 million, with cash, cash equivalents, and marketable securities totaling $175.4 million [176]. - The company anticipates that current cash resources will fund operations into Q4 2026, with plans to seek additional funding if necessary [177]. Capital and Funding Challenges - The company may face significant challenges in raising additional capital, which could adversely affect its business objectives and financial condition [178]. - Insufficient funding could lead to the curtailment or discontinuation of research and development programs, impacting business prospects [179]. - General and administrative expenses for Q3 2025 increased by $0.2 million to $4.6 million compared to Q3 2024 [161]. Strategic Plans - The company intends to identify, acquire, or in-license additional product candidates and technologies to expand its portfolio [180]. - There are no off-balance sheet arrangements that could impact the financial statements [182]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures [185].

Financial Performance - The net loss for the third quarter of 2025 was $47.7 million, or $0.61 per share, compared to a net loss of $15.5 million, or $0.24 per share, for the same period in 2024[7]. - The net loss for the first nine months of 2025 was $103.2 million, or $1.50 per share, compared to a net loss of $51.8 million, or $0.86 per share, for the same period in 2024[10]. - The net loss for the three months ended September 30, 2025, was $47,712 thousand, compared to a net loss of $15,499 thousand for the same period in 2024, indicating a year-over-year increase in losses of approximately 208%[20]. - The net loss per share, basic and diluted, for the three months ended September 30, 2025, was $0.61, compared to $0.24 for the same period in 2024, representing an increase of approximately 154%[20]. - The total comprehensive loss for the three months ended September 30, 2025, was $47,637 thousand, compared to $14,991 thousand for the same period in 2024, indicating an increase of approximately 217%[20]. Research and Development - Research and development expenses for the third quarter of 2025 were $44.9 million, up from $13.9 million in the third quarter of 2024, primarily due to a $25.8 million increase in nomlabofusp manufacturing costs[8]. - Research and development expenses for the three months ended September 30, 2025, were $44,931 thousand, significantly up from $13,919 thousand in the same period of 2024, representing an increase of about 222%[20]. - A median improvement of 2.25 in the modified Friedreich Ataxia Rating Scale (mFARS) score was observed after 1 year, compared to a worsening of 1.00 in a FACOMS reference population[5]. - In the open label study, 100% of participants (n=10) achieved skin FXN levels similar to asymptomatic carriers after 6 months of daily nomlabofusp administration[5]. - Seven out of 39 participants in the open label study experienced anaphylaxis in the first 6 weeks of dosing, but returned to their usual state of health after standard treatment[4]. - The company is implementing a modified starting dose regimen to mitigate the risk of anaphylactic reactions, which includes a 5 mg test dose followed by a 25 mg dose[5]. - The company plans to submit a Biologics License Application (BLA) seeking accelerated approval for nomlabofusp in the second quarter of 2026[4]. Assets and Liabilities - As of September 30, 2025, Larimar Therapeutics had cash, cash equivalents, and marketable securities totaling $175.4 million, with a projected cash runway into the fourth quarter of 2026[6]. - Total current assets decreased from $195,304 thousand as of December 31, 2024, to $183,223 thousand as of September 30, 2025, a decline of approximately 6%[18]. - Total liabilities increased from $28,413 thousand as of December 31, 2024, to $48,312 thousand as of September 30, 2025, reflecting a rise of about 70%[18]. - The total stockholders' equity decreased from $171,812 thousand as of December 31, 2024, to $139,038 thousand as of September 30, 2025, a decline of about 19%[18]. Operating Expenses - General and administrative expenses for the third quarter of 2025 were $4.6 million, compared to $4.3 million in the third quarter of 2024[9]. - Total operating expenses for the nine months ended September 30, 2025, were $108,479 thousand, compared to $59,597 thousand for the same period in 2024, an increase of about 82%[20]. - Other comprehensive loss for the three months ended September 30, 2025, included an unrealized gain on marketable securities of $75 thousand, compared to a gain of $508 thousand in the same period of 2024[20]. Shareholder Information - The weighted average common shares outstanding for the three months ended September 30, 2025, were 78,324,767, up from 63,806,158 in the same period of 2024, an increase of approximately 22%[20].