Larimar Therapeutics Reports Third Quarter 2022 Operating and Financial Results
Larimar Therapeutics (LRMR) reported its Q3 2022 results, showcasing a net loss of $8.3 million, or $0.37 per share, compared to $16.8 million, or $0.92 per share in Q3 2021. The company raised approximately $75.2 million through equity offerings and had $124.7 million in cash as of September 30, 2022, projecting a cash runway into H2 2024. The first cohort of its Phase 2 trial for CTI-1601 in Friedreich's ataxia patients is underway, with updates expected in Q2 2023 and top-line data anticipated in H2 2023.
- Phase 2 trial for CTI-1601 is progressing as planned.
- Cash and marketable securities of $124.7 million provide financial stability into 2024.
- Decrease in net loss from $16.8 million in Q3 2021 to $8.3 million in Q3 2022.
- Net loss of $8.3 million indicates ongoing financial challenges.
- R&D expenses remain significant at $5.6 million despite reductions from previous year.
- First cohort of Larimar’s Phase 2 dose exploration trial of CTI-1601 in Friedreich’s ataxia patients is ongoing and proceeding in line with the Company’s planned timeline
- Larimar expects to provide an update on the Phase 2 trial in Q2 2023 and anticipates reporting top-line data from both cohorts in 2H 2023
- Cash of
$124.7 million at September 30, 2022 provides projected cash runway into 2H 2024
BALA CYNWYD, Pa., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its third quarter 2022 operating and financial results.
“This is an exciting time for Larimar, as we recently received regulatory clearance for CTI-1601’s return to the clinic under a partial hold and completed a capital raise with a premier life science investor syndicate,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “These important accomplishments allowed us to begin enrolling patients in the first cohort of our Phase 2 trial in Friedreich’s ataxia patients, which continues to make progress. The trial’s results are expected to inform CTI-1601’s long-term dose regimen, thereby building upon the clinical proof-of-concept data generated in our Phase 1 program. We are grateful for the continued support we have received from the Friedreich’s ataxia community and our shareholders over these past months and look forward to CTI-1601’s continued development as a potentially disease-modifying therapy.”
Third Quarter and Subsequent Highlights
- In September 2022, the U.S. Food and Drug Administration (FDA) lifted the full clinical hold previously placed on the CTI-1601 program and imposed a partial hold, thereby clearing the initiation of the 25 mg cohort of a Phase 2, four-week, placebo-controlled, dose exploration trial in Friedreich’s ataxia (FA) patients. The study’s 25 mg cohort is currently ongoing and proceeding in line with the Company’s planned timeline. Additional cohorts and/or other clinical trials are contingent on a review of the study’s 25 mg cohort data by the FDA and the data monitoring committee. Larimar expects to provide an update on the trial in Q2 2023 and anticipates reporting top-line data in 2H 2023.
- In September 2022, Larimar raised net proceeds of approximately
$75.2 million through an underwritten offering of common stock. Deerfield Management and other notable life science investors participated in the offering. - In October 2022, Larimar announced the issuance of U.S. Patent No. 11,459,363, which provides composition of matter protection for CTI-1601 into at least July 2040.
Third Quarter 2022 Financial Results
As of September 30, 2022, the Company had cash and marketable securities totaling
The Company reported a net loss for the third quarter of 2022 of
Research and development expenses for the third quarter of 2022 were
General and administrative expenses for the third quarter of 2022 were
The Company reported a net loss for the nine months ended September 30, 2022 of
Research and development expenses for the nine months ended September 30, 2022 were
General and administrative expenses for the nine months ended September 30, 2022 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, CTI-1601, 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 Larimar’s expectations regarding its ability to resolve the partial clinical hold imposed by the FDA related to CTI-1601, Larimar’s ability to develop and commercialize CTI-1601 and other planned product candidates, Larimar’s planned research and development efforts, including the timing of its CTI-1601 clinical development plan and other matters regarding Larimar’s business strategies, 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, Larimar’s ability to successfully engage with the FDA and satisfactorily respond to requests from the FDA for further information and data regarding the CTI-1601 clinical trial including the FDA review of data from cohort one from the Phase 2 dose exploration trial and FDA ‘s agreement to escalate the dosing in cohort two, the timing and outcomes of Larimar’s interactions with the FDA concerning the partial clinical hold, the success, cost and timing of Larimar’s product development activities, nonclinical studies and clinical trials, including CTI-1601 clinical milestones; that preliminary clinical trial results may differ from final clinical trial results, that earlier non-clinical and clinical data and testing of CTI-1601 may not be predictive of the results or success of later clinical trials, and assessments; the ongoing impact of the COVID-19 pandemic 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 CTI-1601’s manufacturing process; Larimar’s ability to obtain regulatory approvals for CTI-1601 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 | ||||||||
| (Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 86,047 | $ | 70,097 | ||||
| Marketable securities | 38,652 | — | ||||||
| Prepaid expenses and other current assets | 2,428 | 2,107 | ||||||
| Total current assets | 127,127 | 72,204 | ||||||
| Property and equipment, net | 909 | 1,049 | ||||||
| Operating lease right-of-use assets | 2,997 | 3,406 | ||||||
| Restricted cash | 1,339 | 1,339 | ||||||
| Other assets | 643 | 669 | ||||||
| Total assets | $ | 133,015 | $ | 78,667 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 849 | $ | 1,660 | ||||
| Accrued expenses | 7,939 | 6,592 | ||||||
| Operating lease liabilities, current | 632 | 594 | ||||||
| Total current liabilities | 9,420 | 8,846 | ||||||
| Operating lease liabilities | 4,933 | 5,408 | ||||||
| Total liabilities | 14,353 | 14,254 | ||||||
| Commitments and contingencies (See Note 8) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock; | — | — | ||||||
| Common stock, authorized as of September 30, 2022 and December 31, 2021; 43,269,200 shares and 17,710,450 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 43 | 18 | ||||||
| Additional paid-in capital | 260,839 | 180,645 | ||||||
| Accumulated deficit | (142,180 | ) | (116,250 | ) | ||||
| Accumulated other comprehensive loss | (40 | ) | — | |||||
| Total stockholders’ equity | 118,662 | 64,413 | ||||||
| Total liabilities and stockholders’ equity | $ | 133,015 | $ | 78,667 | ||||
Larimar Therapeutics, Inc. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,582 | $ | 14,028 | $ | 17,032 | $ | 32,104 | ||||||||
| General and administrative | 2,931 | 2,702 | 9,055 | 9,275 | ||||||||||||
| Total operating expenses | 8,513 | 16,730 | 26,087 | 41,379 | ||||||||||||
| Loss from operations | (8,513 | ) | (16,730 | ) | (26,087 | ) | (41,379 | ) | ||||||||
| Other income (expense), net | 193 | (75 | ) | 157 | (123 | ) | ||||||||||
| Net loss | $ | (8,320 | ) | $ | (16,805 | ) | $ | (25,930 | ) | $ | (41,502 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.92 | ) | $ | (1.32 | ) | $ | (2.48 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 22,228,228 | 18,287,924 | 19,649,558 | 16,768,458 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (8,320 | ) | $ | (16,805 | ) | $ | (25,930 | ) | $ | (41,502 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain/(loss) on marketable debt securities | 17 | (1 | ) | (40 | ) | (1 | ) | |||||||||
| Total other comprehensive income (loss) | 17 | (1 | ) | (40 | ) | (1 | ) | |||||||||
| Total comprehensive loss | $ | (8,303 | ) | $ | (16,806 | ) | $ | (25,970 | ) | $ | (41,503 | ) | ||||
FAQ
What were Larimar Therapeutics' earnings results for Q3 2022?
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