Daily subcutaneous injections of 25 mg nomlabofusp in 14 participants were generally well tolerated for up to 260 days in the ongoing open label extension (OLE) studyTissue frataxin (FXN) levels showed mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90Tissue FXN levels increased and were maintained over time, with mean levels increasing from 15% of healthy volunteers (HV) at baseline to 30% in buccal cells and from 16% to 72% in skin cells at Day 90Early trends to ...

Core Insights - Larimar Therapeutics announced positive initial data from the ongoing open label extension (OLE) study of nomlabofusp, indicating it is generally well tolerated and shows potential clinical benefits for patients with Friedreich's ataxia (FA) [1][2] Group 1: Study Results - Daily subcutaneous injections of 25 mg nomlabofusp were well tolerated for up to 260 days in 14 participants [1] - Tissue frataxin (FXN) levels increased significantly, with buccal cells rising from 15% to 30% and skin cells from 16% to 72% at Day 90 [1][2] - Early trends towards improvement in clinical outcomes were observed at Day 90, suggesting potential clinical benefits across a broad spectrum of FA patients [1][4] Group 2: Pharmacokinetics and Safety - Pharmacokinetic data indicated that nomlabofusp levels in plasma reached a steady state by Day 30, with no further accumulation noted [1][4] - The most common adverse events were mild injection site reactions, with serious adverse events occurring in two participants that resolved within 24 hours [3][2] Group 3: Development Plans - The dose of nomlabofusp has been escalated to 50 mg daily for six participants, with plans to increase the dose for all current participants [5][2] - Screening for adolescents in a pediatric pharmacokinetic study is ongoing, with dosing expected to start in early 2025 [1][5] - A global confirmatory/registration study is planned to initiate in mid-2025, with a Biologics License Application (BLA) submission targeted for the second half of 2025 [1][6] Group 4: Financial Position - As of September 30, 2024, the company reported a strong balance sheet with $203.7 million in cash and investments, providing a runway into the second quarter of 2026 [1]

Core Viewpoint - Larimar (LRMR) shares have increased by 16.4% in the past four weeks, closing at $7.74, with a potential upside indicated by Wall Street analysts' price targets suggesting a mean estimate of $22.67, representing a 192.9% upside [1] Price Targets and Estimates - The mean estimate consists of nine short-term price targets with a standard deviation of $6.93, where the lowest estimate of $14 indicates an 80.9% increase, and the highest estimate suggests a 365.1% surge to $36 [2] - A low standard deviation among price targets indicates a high degree of agreement among analysts regarding the stock's price movement direction [7] Earnings Estimates and Analyst Sentiment - Analysts are optimistic about LRMR's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which has shown a strong correlation with near-term stock price movements [9] - The Zacks Consensus Estimate for the current year has risen by 14.4% over the past month, with three estimates increasing and no negative revisions [10] - LRMR holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for upside [11]

Product Development - The company is focused on developing nomlabofusp, a treatment for Friedreich's ataxia, which aims to increase frataxin levels in patients [68]. - The Phase 2 trial of nomlabofusp showed dose-dependent increases in FXN levels in all evaluated tissues after 14 days of daily dosing [70]. - The FDA lifted the partial clinical hold on nomlabofusp in May 2024, allowing further clinical development [70]. - The ongoing open label extension study for nomlabofusp is evaluating safety, pharmacokinetics, and frataxin levels in patients [70]. - The company plans to initiate a global confirmatory study by mid-2025, targeting a Biologics License Application filing in the second half of 2025 [70]. - The company has received multiple designations for nomlabofusp, including orphan drug designations in the U.S. and EU, and participation in the FDA's START pilot program [70]. Financial Performance - The company has not generated any revenue from product sales to date and does not expect to in the foreseeable future [78]. - Net loss for the three months ended September 30, 2024, was $15.5 million, an increase of $6.4 million from a net loss of $9.1 million in the same period of 2023 [82]. - Research and development expenses for the three months ended September 30, 2024, increased by $7.3 million to $13.9 million compared to $6.6 million in the same period of 2023 [82]. - General and administrative expenses for the three months ended September 30, 2024, rose by $0.6 million to $4.3 million compared to $3.8 million in the same period of 2023 [85]. - Research and development expenses for the nine months ended September 30, 2024, increased by $29.5 million to $46.5 million compared to $17.0 million in the same period of 2023 [87]. - General and administrative expenses for the nine months ended September 30, 2024, increased by $2.5 million to $13.1 million compared to $10.6 million in the same period of 2023 [88]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $48.9 million, compared to $24.1 million in the same period of 2023 [92]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $161.8 million, primarily from a common stock offering [94]. - As of September 30, 2024, the company had an accumulated deficit of $240.3 million and cash, cash equivalents, and marketable securities of $203.7 million [96]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it continues to advance the development of its product candidates [96]. Capital Raising - In February 2024, the company completed a public offering, issuing 19,736,842 shares at $8.74 per share, raising approximately $161.8 million [72]. - The company completed a public offering in February 2024, issuing 19,736,842 shares and receiving net proceeds of approximately $161.8 million [96]. Risks and Compliance - The company is subject to risks common to pre-commercial biotechnology firms, including regulatory approval and funding challenges [71]. - The company qualifies as a "smaller reporting company" and is not required to provide certain market risk disclosures [102]. - No recent accounting pronouncements applicable to the company were mentioned in the financial statements [100].

Exhibit 99.1 Larimar Therapeutics Reports Third Quarter 2024 Operating and Financial Results • Nomlabofusp program update expected mid-December to include available safety, pharmacokinetic (PK) and frataxin data, as well as available clinical outcomes observations from patients with Friedreich's ataxia (FA) receiving 25 mg of nomlabofusp daily for 30-180 days in ongoing open label extension (OLE) study • Initiation of PK run-in study in adolescents on track by year-end 2024 • Initiation of global confirmato ...

Nomlabofusp program update expected mid-December to include available safety, pharmacokinetic (PK) and frataxin data, as well as available clinical outcomes observations from patients with Friedreich's ataxia (FA) receiving 25 mg of nomlabofusp daily for 30-180 days in ongoing open label extension (OLE) study Initiation of PK run-in study in adolescents on track by year-end 2024 Initiation of global confirmatory/registration study planned mid-2025 Biologics License Application (BLA) submission for nomlabofu ...

Oppenheimer has initiated coverage on Larimar Therapeutics LRMR, a clinical-stage biotechnology company focused on developing treatments for rare diseases. The analysts view the company's lead program, Nomlabofusp, as a differentiated, disease-modifying therapy that targets the key pathogenic mechanism of frataxin (FXN) deficiency in Friedreich's ataxia (FA). Lower FXN levels predict early onset, disease severity, and faster progression. Friedreich's ataxia is a rare neurodegenerative disease affecting ~20, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ____ Commission File Number: 001-36510 LARIMAR THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 20-3857670 (State or o ...

Financial Performance - The net loss for the second quarter of 2024 was $21.6 million, or $0.34 per share, compared to a net loss of $8.4 million, or $0.19 per share, for the same period in 2023[6]. - The company reported a net loss of $36.3 million, or $0.62 per share, for the first six months of 2024, compared to a net loss of $14.9 million, or $0.34 per share, for the same period in 2023[7]. - Net loss for Q2 2024 was $21,627,000, compared to a net loss of $8,366,000 in Q2 2023, representing an increase of 158%[14]. - Net loss per share for Q2 2024 was $0.34, compared to $0.19 in Q2 2023[14]. - Comprehensive loss for Q2 2024 was $21,752,000, compared to $8,354,000 in Q2 2023[14]. - Net loss for the six months ended June 30, 2024, was $36,281,000, compared to $14,892,000 for the same period in 2023[14]. Research and Development Expenses - Research and development expenses for the second quarter of 2024 were $19.7 million, an increase of $13.8 million from $5.9 million in the second quarter of 2023, primarily due to increased manufacturing costs for nomlabofusp[6]. - Research and development expenses for the first six months of 2024 were $32.6 million, up from $10.4 million in the same period of 2023, reflecting increased costs associated with nomlabofusp[7]. - Research and development expenses for Q2 2024 were $19,682,000, a significant increase of 234% compared to $5,875,000 in Q2 2023[14]. - Research and development expenses for the six months ended June 30, 2024, totaled $32,621,000, up from $10,437,000 in the same period of 2023[14]. Operating Expenses - General and administrative expenses for the second quarter of 2024 were $4.9 million, compared to $3.7 million in the second quarter of 2023, an increase of $1.2 million[6]. - Total operating expenses for Q2 2024 reached $24,599,000, up 156% from $9,620,000 in Q2 2023[14]. - Total operating expenses for the six months ended June 30, 2024, were $41,333,000, compared to $17,257,000 in the prior year[14]. Cash Position - As of June 30, 2024, Larimar Therapeutics reported cash, cash equivalents, and marketable securities totaling $226.1 million, providing a projected cash runway into 2026[5]. Clinical Development - The company plans to initiate a pharmacokinetic (PK) run-in study in adolescents by year-end 2024, with an initial enrollment of 12-15 patients[3]. - All 7 sites for the open label extension (OLE) study have been activated, with interim data expected in Q4 2024[4]. - Larimar has been selected by the FDA to participate in the START pilot program for nomlabofusp, which may aid in achieving the timeline for the Biologics License Application (BLA) submission targeted for the second half of 2025[2]. - Larimar plans to initiate a global confirmatory study by mid-2025, with potential sites in the U.S., Europe, U.K., Canada, and Australia[1]. Shareholder Information - Weighted average common shares outstanding increased to 63,801,792 in Q2 2024 from 43,897,603 in Q2 2023[14]. - Other income (expense), net for Q2 2024 was $2,972,000, compared to $1,254,000 in Q2 2023[14].

START is a new milestone-driven program designed to accelerate development of novel therapies intended to address an unmet medical need for rare diseases Nomlabofusp was selected based on potential for clinical benefit in a rare neurodegenerative disease and demonstrated development program readiness START pilot program is intended to improve development efficiency through enhanced communication with the FDA Nomlabofusp is expected to be one of three CDER programs and one of six total programs selected by t ...