Larimar Therapeutics Reports Second Quarter 2025 Financial Results
Rhea-AI Summary
Larimar Therapeutics (Nasdaq: LRMR) reported Q2 2025 financial results and provided updates on its nomlabofusp development program for Friedreich's ataxia (FA). The company plans to submit a Biologics License Application (BLA) for accelerated approval in Q2 2026, supported by $203.6 million in pro forma cash providing runway into Q4 2026.
Key developments include: FDA's recommendation for safety database requirements, planned initial data from the 50 mg open label study in September 2025, completion of adolescent PK run-in study with 14 participants, and expansion of the open label study to include children. The company reported a Q2 2025 net loss of $26.2 million ($0.41 per share) compared to $21.6 million in Q2 2024.
Larimar strengthened its position through a $65.1 million public offering in July 2025 and published two peer-reviewed articles supporting nomlabofusp's mechanism of action. Global Phase 3 study sites have been identified with patient recruitment expected to begin later in 2025.
Positive
- FDA provided clear guidance on safety database requirements for BLA submission
- Strong cash position of $203.6M providing runway into Q4 2026
- Successfully completed $65.1M public offering in July 2025
- Published two peer-reviewed articles supporting mechanism of action
- Expanded clinical program to include adolescents and children
- FDA openness to using skin frataxin levels as surrogate endpoint for accelerated approval
Negative
- Increased net loss to $26.2M in Q2 2025 from $21.6M in Q2 2024
- Higher R&D expenses of $23.4M vs $19.7M year-over-year
- Initial data from 50 mg dose study still pending
News Market Reaction 52 Alerts
On the day this news was published, LRMR gained 14.52%, reflecting a significant positive market reaction. Argus tracked a peak move of +11.5% during that session. Our momentum scanner triggered 52 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $47M to the company's valuation, bringing the market cap to $370M at that time.
Data tracked by StockTitan Argus on the day of publication.
- Initial data from the 50 mg dose in the open label study and the adolescent PK run-in study planned for program update in September 2025
- Adolescent participants from the PK run-in study and patients with FA who have not participated in prior nomlabofusp clinical studies are currently screening and enrolling in the open label study; planning to enroll children (2 to 11 years of age) directly into the open label study
- FDA recommended that the safety database include at least 30 participants with continuous study drug exposure for 6 months, and a subset of at least 10 participants for 1-year; large majority of safety data should be from participants receiving 50 mg nomlabofusp
- Published two peer-reviewed articles; the nonclinical data included in the publications were part of the data submitted to FDA to support the mechanism of action of nomlabofusp and the potential use of skin FXN concentrations as a reasonably likely surrogate endpoint
- BLA seeking accelerated approval on track to be submitted in the second quarter of 2026
- Global Phase 3 study activities ongoing including qualification of identified sites with patient recruitment expected to initiate later this year
$203.6 million in pro forma* cash, cash equivalents and marketable securities as of June 30, 2025, with projected cash runway into the fourth quarter of 2026
*Pro forma cash, cash equivalents, and marketable securities of
BALA CYNWYD, Pa., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its second quarter 2025 operating and financial results.
“We are pleased with our continued strong execution as we further advance our nomlabofusp program towards potential registration. Importantly, we have written communications in hand from the Food and Drug Administration (FDA) for key elements of our Biologics License Application (BLA) submission including safety database recommendations and a potential accelerated approval pathway based on the use of skin frataxin levels as a novel surrogate endpoint. We also recently published two peer-reviewed papers, including nonclinical data contributing to the FDA’s openness to using skin frataxin (FXN) concentrations as a reasonably likely surrogate endpoint (RLSE),” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “Enrollment in our open label study is ongoing, and new study participants are now receiving the lyophilized formulation of nomlabofusp. We have several important near-term catalysts ahead including initial data from the 50 mg dose of our open label study and data from the adolescent pharmacokinetic (PK) run-in study expected in September 2025. Global sites have been identified for our Phase 3 trial, and we expect to initiate patient recruitment later this year. With our balance sheet strengthened through our recent capital raise, key clinical data approaching, and a clear regulatory path in place, we are well-positioned to submit our BLA for nomlabofusp in the second quarter of 2026 as the first potential disease modifying therapy for Friedreich’s ataxia (FA).”
Highlights
- Initial 50 mg Open Label Study Data Expected in September 2025: The ongoing open label study continues to enroll, and active study participants are currently receiving the 50 mg dose of nomlabofusp. Larimar plans to provide an update on open label data on at least 30 to 40 study participants who received at least one dose of nomlabofusp in September 2025.
- Adolescent PK Run-In Data in September 2025: Larimar completed dosing of 14 adolescents (12-17 years of age) in a PK run-in study for pediatric patients with FA in March 2025. Adolescents received a weight-based dose expected to match the PK of adults receiving the 50 mg dose or placebo. The safety and PK data from this study are expected during the nomlabofusp program update in September 2025.
- Recent Expansion of Open Label Study Participants: Adolescent participants from the PK
run-in study are currently being screened and enrolled in the open label study. Also, patients with FA who have not participated in prior nomlabofusp clinical studies are being screened and enrolled into the open label study. In addition, Larimar plans to enroll children (2 to 11 years of age) directly into the open label study. - Announced FDA Safety Database Recommendations: In June 2025, Larimar announced that the FDA recommended evaluating safety in at least 30 participants with continuous study drug exposure for 6-months, with a subset of at least 10 of those participants on continuous study drug exposure for 1-year. The FDA also recommended that the large majority of safety data should be from participants receiving the 50 mg dose.
- Published Nonclinical Data on Nomlabofusp in Two Peer-Reviewed Articles: In July 2025, Larimar announced the publication of nonclinical data evaluating the mechanism of action, pharmacodynamics, and pharmacology of nomlabofusp as a novel FXN protein replacement therapy designed to address the underlying cause of FA in two peer-reviewed articles. These data were included in the briefing package reviewed by the FDA in support of using skin FXN concentrations as a RLSE for Larimar’s registrational program seeking accelerated approval for nomlabofusp.
- BLA Submission on Track: In the second quarter of 2026, Larimar plans to submit a BLA seeking accelerated approval.
- Identified Global Phase 3 Sites: Following feedback from FDA and European Medicines Agency (EMA) on the study protocol, global Phase 3 study sites in the U.S., E.U., U.K., Canada, and Australia were identified and are currently being qualified and initiated. Larimar expects to begin patient recruitment later this year.
- Initiated Transition to Lyophilized Form of Nomlabofusp: In May 2025, Larimar began to introduce the lyophilized product formulation intended for commercialization into the open label study.
- Strengthened Balance Sheet With
$65.1 Million Public Offering: In July 2025, Larimar announced a public offering of common stock with net proceeds of$65.1 million supported by existing and new leading healthcare investors that extends its projected cash runway into the fourth quarter of 2026.
Second Quarter 2025 Financial Results
As of June 30, 2025, the Company had cash, cash equivalents and marketable securities totaling
Second quarter of 2025 compared to the second quarter of 2024
The Company reported a net loss for the second quarter of 2025 of
Research and development expenses for the second quarter of 2025 were
General and administrative expenses were
Six months ended June 30, 2025, compared to the six months ended June 30, 2024
The Company reported a net loss for the first six months of 2025 of
Research and development expenses for the six months ended June 30, 2025, were
General and administrative expenses were
About Larimar Therapeutics
Larimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Larimar’s lead compound, nomlabofusp, is being developed as a potential treatment for Friedreich's ataxia. Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds. For more information, please visit: https://larimartx.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on Larimar’s management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including but not limited to statements regarding Larimar’s ability to develop and commercialize nomlabofusp and any other planned product candidates, Larimar’s planned research and development efforts, including the timing of its nomlabofusp clinical trials, interactions and filings with the FDA, expectations regarding potential for accelerated approval or accelerated access and time to market and overall development plans and other matters regarding Larimar’s business strategies, ability to raise capital, use of capital, results of operations and financial position, and plans and objectives for future operations.
In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others, the success, cost and timing of Larimar’s product development activities, nonclinical studies and clinical trials, including nomlabofusp clinical milestones and continued interactions with the FDA; that preliminary clinical trial results may differ from final clinical trial results, that earlier non-clinical and clinical data and testing of nomlabofusp may not be predictive of the results or success of later clinical trials, and assessments; that the FDA may not ultimately agree with Larimar’s nomlabofusp development strategy; the potential impact of public health crises on Larimar’s future clinical trials, manufacturing, regulatory, nonclinical study timelines and operations, and general economic conditions; Larimar’s ability and the ability of third-party manufacturers Larimar engages, to optimize and scale nomlabofusp’s manufacturing process; Larimar’s ability to obtain regulatory approvals for nomlabofusp and future product candidates; Larimar’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators, and to successfully commercialize any approved product candidates; Larimar’s ability to raise the necessary capital to conduct its product development activities; and other risks described in the filings made by Larimar with the Securities and Exchange Commission (SEC), including but not limited to Larimar’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. These forward-looking statements are based on a combination of facts and factors currently known by Larimar and its projections of the future, about which it cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent Larimar’s management’s views only as of the date hereof. Larimar undertakes no obligation to update any forward-looking statements for any reason, except as required by law.
| Investor Contact: Joyce Allaire LifeSci Advisors jallaire@lifesciadvisors.com (212) 915-2569 | Company Contact: Michael Celano Chief Financial Officer mcelano@larimartx.com (484) 414-2715 |
| Larimar Therapeutics, Inc. | ||||||||
| Consolidated Balance Sheet | ||||||||
| (In thousands except share data) | ||||||||
| (unaudited) | ||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 20,587 | $ | 33,218 | ||||
| Short-term marketable securities | 117,937 | 150,236 | ||||||
| Prepaid expenses and other current assets | 7,032 | 11,850 | ||||||
| Total current assets | 145,556 | 195,304 | ||||||
| Property and equipment, net | 797 | 881 | ||||||
| Operating lease right-of-use assets | 2,468 | 2,838 | ||||||
| Restricted cash | 606 | 606 | ||||||
| Other assets | 561 | 596 | ||||||
| Total assets | $ | 149,988 | $ | 200,225 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,169 | $ | 2,424 | ||||
| Accrued expenses | 21,351 | 20,872 | ||||||
| Operating lease liabilities, current | 1,129 | 1,060 | ||||||
| Total current liabilities | 26,649 | 24,356 | ||||||
| Operating lease liabilities | 3,485 | 4,057 | ||||||
| Total liabilities | 30,134 | 28,413 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock; | — | — | ||||||
| Common stock, | 64 | 64 | ||||||
| Additional paid-in capital | 444,420 | 440,758 | ||||||
| Accumulated deficit | (324,621 | ) | (269,158 | ) | ||||
| Accumulated other comprehensive gain (loss) | (9 | ) | 148 | |||||
| Total stockholders’ equity | 119,854 | 171,812 | ||||||
| Total liabilities and stockholders’ equity | $ | 149,988 | $ | 200,225 | ||||
| Larimar Therapeutics, Inc. | ||||||||||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||||||||||
| (unaudited) | ||||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||
| Research and development | $ | 23,368 | $ | 19,682 | $ | 49,919 | $ | 32,621 | ||||||||||||||||
| General and administrative | 4,424 | 4,917 | 9,060 | 8,712 | ||||||||||||||||||||
| Total operating expenses | 27,792 | 24,599 | 58,979 | 41,333 | ||||||||||||||||||||
| Loss from operations | (27,792 | ) | (24,599 | ) | (58,979 | ) | (41,333 | ) | ||||||||||||||||
| Other income, net | 1,610 | 2,972 | 3,516 | 5,052 | ||||||||||||||||||||
| Net loss | $ | (26,182 | ) | $ | (21,627 | ) | $ | (55,463 | ) | $ | (36,281 | ) | ||||||||||||
| Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (0.34 | ) | $ | (0.87 | ) | $ | (0.62 | ) | ||||||||||||
| Weighted average common shares outstanding, basic and diluted | 64,027,892 | 63,801,792 | 63,996,126 | 58,677,749 | ||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||
| Net loss | $ | (26,182 | ) | $ | (21,627 | ) | $ | (55,463 | ) | $ | (36,281 | ) | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Unrealized loss on marketable securities | (63 | ) | (125 | ) | (157 | ) | (231 | ) | ||||||||||||||||
| Total other comprehensive loss | (63 | ) | (125 | ) | (157 | ) | (231 | ) | ||||||||||||||||
| Total comprehensive loss | $ | (26,245 | ) | $ | (21,752 | ) | $ | (55,620 | ) | $ | (36,512 | ) | ||||||||||||
FAQ
What are the key financial results for Larimar Therapeutics (LRMR) in Q2 2025?
When will Larimar Therapeutics (LRMR) submit its BLA for nomlabofusp?
What are the FDA's safety database requirements for LRMR's nomlabofusp?
What upcoming catalysts does Larimar Therapeutics (LRMR) have in 2025?
How much did Larimar (LRMR) raise in its July 2025 public offering?
