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].

Core Insights - Larimar Therapeutics reported positive long-term data from its open label study of nomlabofusp, indicating potential to alter the disease course of Friedreich's ataxia (FA) [2][3][4] - The company plans to submit a Biologics License Application (BLA) seeking accelerated approval in the second quarter of 2026 [2][4][10] Clinical Development - In the open label study, 100% of participants achieved skin frataxin (FXN) levels over 50% of median levels in healthy volunteers after 6 months [3][4] - 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 the FACOMS reference population [3][4] - The company is implementing a modified starting dose regimen to mitigate the risk of anaphylactic reactions, which will also be incorporated into the Phase 3 protocol [4][10] Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $175.4 million, with a projected cash runway into the fourth quarter of 2026 [5][10] - 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 [6][19] - Research and development expenses for the third quarter of 2025 were $44.9 million, significantly higher than $13.9 million for the same period in 2024, primarily due to increased manufacturing costs for nomlabofusp [7][11] Future Plans - Larimar plans to provide an update on the nomlabofusp development program, including regulatory discussions and the open label study status, in the first quarter of 2026 [10][11] - The company is focused on advancing its global Phase 3 study and preparing for patient enrollment [10][11]

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Larimar Therapeutics, Inc. due to allegations of materially misleading business information issued by the company [1]. Summary by Relevant Sections - **Company Investigation**: The investigation focuses on Larimar Therapeutics, Inc. (NASDAQ: LRMR) and the potential impact of misleading information on its shareholders [1]. - **Shareholder Rights**: Shareholders who purchased Larimar Therapeutics securities may be entitled to compensation without incurring out-of-pocket fees or costs [1].

Core Viewpoint - DJS Law Group is investigating Larimar Therapeutics, Inc. for potential violations of securities laws related to misleading statements and undisclosed information regarding a clinical study [1][2]. Investigation Details - The investigation centers on Larimar's September 29, 2025 announcement of an open-label study involving daily subcutaneous injections of Nomlabofusp for Friedreich's Ataxia, which was presented as having positive results despite severe allergic reactions experienced by multiple participants [2]. - Following the release of this information, Larimar's shares experienced a significant decline of 33.66% [2]. Legal Representation - DJS Law Group specializes in securities class actions and corporate governance litigation, representing large hedge funds and alternative asset managers [4].

Core Viewpoint - Larimar Therapeutics, Inc. is currently under investigation for potential securities fraud violations, which may impact its market reputation and investor confidence [1] Group 1 - The investigation is being conducted by the DJS Law Group, indicating potential legal implications for the company [1] - The announcement suggests that investors may have rights to discuss their concerns regarding the situation [1]

Core Viewpoint - The Schall Law Firm is investigating potential securities law violations by Larimar Therapeutics, Inc. following the announcement of adverse reactions in a clinical study, which led to a significant drop in the company's stock price [1][2]. Summary by Sections Investigation Details - The investigation centers on whether Larimar Therapeutics made false or misleading statements or failed to disclose critical information to investors [2]. - On September 29, 2025, Larimar reported data from an ongoing study of Nomlabofusp for Friedreich's Ataxia, claiming positive results while also revealing that seven participants experienced severe allergic reactions or anaphylaxis [2]. Market Reaction - Following the announcement of the study results and the adverse reactions, Larimar's shares fell by over 33.6% on the same day [2].