BALA CYNWYD, Pa., March 24, 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 fourth quarter and full year 2024 operating and financial results.
“The strong clinical and regulatory progress across our nomlabofusp program reinforces the timing of our planned Biologics License Application (BLA) submission expected by the end of 2025 to seek accelerated approval. Importantly, we are enthusiastic about the recent FDA interactions and their openness to consider skin frataxin (FXN) concentrations as a potential novel surrogate endpoint reasonably likely to predict clinical benefit in patients with Friedreich’s ataxia (FA). Acceptability of FXN as a novel surrogate endpoint will be based on review of the data by the Food and Drug Administration (FDA) in the future BLA. As we previously disclosed, we have been collecting skin FXN concentration data throughout the development program,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “Overall, FDA’s recommendations are in line with our current approach, and we appreciate the frequent dialogue via our participation in the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program as we further refine our registrational plan.”
Dr. Ben-Maimon continued, “Our open label extension (OLE) study continues to advance, with some participants on daily treatment for up to one year. We continue to actively enroll study participants, and all participants are currently receiving the 50 mg dose. The 25 mg initial data we presented in December showed increased and sustained FXN levels over time and early trends in improved clinical outcomes in patients with FA. Our pediatric pharmacokinetic (PK) run-in study continues to progress, and we expect to complete the dosing of the adolescent cohort by the end of this month and report available data in September 2025. We also plan to enroll children 2-11 years of age in the clinical program. We have received feedback from both FDA and European Medicines Agency (EMA) on the protocol for our global Phase 3 trial and are on track to initiate this trial mid-2025. We believe our near-term data package strongly positions us to bring the first potential disease modifying therapy to patients with FA.”
Recent Highlights
Fourth Quarter and Full Year 2024 Financial Results
As of December 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $183.5 million.
The Company reported a net loss for the fourth quarter of 2024 of $28.8 million, or $0.45 per share, compared to a net loss of $13.0 million, or $0.30 per share, for the fourth quarter of 2023.
Research and development expenses for the fourth quarter of 2024 were $26.7 million compared to $10.6 million for the fourth quarter of 2023. The increase in research and development expenses was primarily driven by an increase of $15.0 million in nomlabofusp manufacturing costs including lyophilization development, production scaling costs and manufacturing costs related to producing doses to be used in ongoing and planned clinical trials, an increase of $1.3 million in personnel expense due to increased headcount, an increase of $1.0 million of professional fees related to consulting costs, and an increase of $0.5 million in stock compensation costs associated with 2024 grants, partially offset by a decrease of $1.7 million in clinical trial costs primarily associated with decreased activity in the dose exploration study in 2024.
General and administrative expenses for the fourth quarter of 2024 were $4.6 million compared to $3.5 million for the fourth quarter of 2023. The increase in general and administrative expenses was primarily driven by an increase of $0.6 million in professional fees primarily related to consulting costs related to commercial activity and other public company related expenses, and an increase of $0.4 million in personnel expense due to increased headcount.
Other income (expense), net was $2.5 million of income in the three months ended December 31, 2024 compared to $1.2 million of income in the three months ended December 31, 2023. The increase primarily relates to interest income on a higher investment base and higher investment yields on that base during the current period.
For the full year 2024, the Company reported a net loss of $80.6 million, or $1.32 per share, compared to a net loss of $36.9 million, or $0.84 per share, for the same period in 2023.
Research and development expenses for the full year 2024 were $73.3 million compared to $27.7 million for the same period in 2023. The increase in research and development expenses was primarily driven by an increase of $36.1 million in nomlabofusp manufacturing costs including lyophilization development, production scaling costs and manufacturing costs related to producing doses to be used in ongoing and planned clinical trials, an increase of $4.5 million in personnel expense due to increased headcount, an increase of $1.3 million of professional fees related to consulting costs, an increase of $1.2 million in clinical costs primarily associated with the ongoing OLE study which began dosing participants in the first quarter of 2024, an increase of $1.0 million in stock compensation costs associated with 2024 equity compensation grants, an increase of $0.9 million related to the Friedreich’s Ataxia Research Alliance (FARA) Track-FA program, an increase of $0.3 million in internal lab costs and an increase of $0.2 million in facility costs associated with the new lab space.
General and administrative expenses for the full year 2024 were $17.6 million compared to $14.1 million for 2023. The increase in general and administrative expenses was primarily driven by an increase of $1.5 million in professional fees primarily related to consulting costs related to commercial activity and other public company related expenses, an increase of $1.4 million in personnel expense due to increased headcount, an increase of $0.4 million of other expense related to computer software, information technology services and recruiting and an increase of $0.2 million in stock compensation costs associated with 2024 equity compensation grants.
Other income (expense), net was $10.3 million of income in the twelve months ended December 31, 2024 compared to $4.8 million of income in the twelve months ended December 31, 2023. The increase primarily relates to increased interest income on a higher investment base and higher investment yields on that base during 2024.
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; delays in patient recruitment, including as a result of changes in clinical protocols and adverse events; 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 Sheets | ||||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,218 | $ | 26,749 | ||||
| Marketable securities | 150,236 | 60,041 | ||||||
| Prepaid expenses and other current assets | 11,850 | 3,385 | ||||||
| Total current assets | 195,304 | 90,175 | ||||||
| Property and equipment, net | 881 | 684 | ||||||
| Operating lease right-of-use assets | 2,838 | 3,078 | ||||||
| Restricted cash | 606 | 1,339 | ||||||
| Other assets | 596 | 659 | ||||||
| Total assets | $ | 200,225 | $ | 95,935 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,424 | $ | 1,283 | ||||
| Accrued expenses | 20,872 | 7,386 | ||||||
| Operating lease liabilities, current | 1,060 | 837 | ||||||
| Total current liabilities | 24,356 | 9,506 | ||||||
| Operating lease liabilities | 4,057 | 4,709 | ||||||
| Total liabilities | 28,413 | 14,215 | ||||||
| Commitments and contingencies (See Note 8) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock; $0.001 par value per share; 5,000,000 shares authorized as of December 31, 2024 and December 31, 2023; no shares issued and outstanding as of December 31, 2024 and December 31, 2023 | — | — | ||||||
| Common stock, $0.001 par value per share; 115,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 63,815,065 and 43,909,069 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively | 64 | 43 | ||||||
| Additional paid-in capital | 440,758 | 270,150 | ||||||
| Accumulated deficit | (269,158 | ) | (188,554 | ) | ||||
| Accumulated other comprehensive gain (loss) | 148 | 81 | ||||||
| Total stockholders’ equity | 171,812 | 81,720 | ||||||
| Total liabilities and stockholders’ equity | $ | 200,225 | $ | 95,935 |
| Larimar Therapeutics, Inc. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended December 31, | Three Months Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 26,738 | $ | 10,648 | $ | 73,278 | $ | 27,670 | ||||||||
| General and administrative | 4,555 | 3,514 | 17,612 | 14,088 | ||||||||||||
| Total operating expenses | 31,293 | 14,162 | 90,890 | 41,758 | ||||||||||||
| Loss from operations | (31,293 | ) | (14,162 | ) | (90,890 | ) | (41,758 | ) | ||||||||
| Other income, net | 2,469 | 1,169 | 10,286 | 4,809 | ||||||||||||
| Net loss | $ | (28,824 | ) | $ | (12,993 | ) | $ | (80,604 | ) | $ | (36,949 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.45 | ) | $ | (0.30 | ) | $ | (1.32 | ) | $ | (0.84 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 63,810,823 | 43,906,281 | 61,256,084 | 43,901,241 |