Larimar Therapeutics Reports First Quarter 2021 Operating and Financial Results
Larimar Therapeutics (Nasdaq: LRMR) reported its Q1 2021 results, highlighting significant progress in its Phase 1 trial for Friedreich's ataxia (FA). The company has cash and investments amounting to $81.4 million as of March 31, 2021, with a net loss of $12.1 million or $0.76 per share. The increase in R&D expenses to $9.0 million reflects higher clinical costs and personnel hiring. Management announced that topline data from the Phase 1 study will be revealed on May 11, 2021, which will include crucial pharmacodynamic data.
- Topline data from Phase 1 FA trial to be announced, providing important insights for future development.
- Cash and investments of $81.4 million as of March 31, 2021.
- Q1 2021 net loss increased to $12.1 million from $6.7 million in Q1 2020.
- Research and development expenses rose significantly to $9.0 million from $5.0 million in Q1 2020, indicating increased costs.
- Topline data from placebo-controlled Phase 1 program in Friedreich's ataxia patients to be announced tomorrow, May 11, 2021- Management to discuss during webcast and conference call at 8 a.m. ET
- Cash and investments of
BALA CYNWYD, Pa., May 10, 2021 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its first quarter 2021 operating and financial results.
“Our Phase 1 program in Friedreich's ataxia (FA) made strong progress over the past few months and we will be announcing topline data from the program tomorrow,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “In addition to safety and tolerability findings, the upcoming announcement will include pharmacodynamic data assessing frataxin levels in buccal cells, skin, and platelets. These data provide important insights that we expect will inform CTI-1601’s further development, as FA is caused by patients’ inability to produce sufficient amounts of frataxin and CTI-1601 is the only drug candidate that we are aware of in clinical development that is designed to address the root cause of the disease by delivering this crucial protein to patients.”
First Quarter 2021 Highlights
- Completed dosing in its double-blind, placebo controlled, multiple ascending dose (MAD) clinical trial evaluating CTI-1601 in Friedreich's ataxia (FA) patients.
Upcoming and Anticipated 2021 Milestones
- Announce topline data from placebo-controlled, Phase 1 program in FA patients on May 11, 2021
- Initiate Jive open-label extension clinical trial: expected in 2H 2021
- Initiate Multiple Ascending Dose (MAD) trial in patients under 18 years of age: expected in 2H 2021
First Quarter 2021 Financial Results
As of March 31, 2021, the Company had cash, cash equivalents, and marketable debt securities totaling
The Company reported a net loss for the first quarter of 2021 of
Research and development expenses for the first quarter of 2021 were
General and administrative expenses for the first quarter of 2021 were
Conference Call and Webcast
Larimar will host a conference call and webcast tomorrow, May 11, 2021 at 8:00 a.m. ET to discuss topline data from its placebo-controlled Phase 1 program in FA patients. To access the webcast, please visit this link to the event. To participate by phone please dial 855-327-6837 (domestic) or 631-891-4304 (international) and refer to conference ID 10014696. Following the live event, the archived webcast will be available for 90 days.
About Larimar Therapeutics
Larimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. The company’s lead compound, CTI-1601, is currently being evaluated in a Phase 1 clinical program in the U.S. as a potential treatment for FA. 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 CTI-1601 and other planned product candidates, Larimar’s planned research and development efforts, 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, the success, cost and timing of Larimar’s product development activities, studies and clinical trials, including CTI-1601 clinical milestones; the impact of the COVID-19 pandemic on Larimar’s clinical trial, manufacturing, regulatory and nonclinical study timelines, ability to raise additional capital and general economic conditions; Larimar’s ability to optimize and scale CTI-1601’s manufacturing process; Larimar’s ability to obtain regulatory approval 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 the Company 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 views 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
(Unaudited)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 62,193 | $ | 68,148 | ||||
| Marketable debt securities | 19,245 | 24,490 | ||||||
| Prepaid expenses and other current assets | 4,689 | 5,314 | ||||||
| Total current assets | 86,127 | 97,952 | ||||||
| Property and equipment, net | 998 | 1,040 | ||||||
| Operating lease right-of-use assets | 3,805 | 3,936 | ||||||
| Restricted cash | 1,339 | 1,339 | ||||||
| Other assets | 750 | 419 | ||||||
| Total assets | $ | 93,019 | $ | 104,686 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,230 | $ | 2,634 | ||||
| Accrued expenses | 4,611 | 5,843 | ||||||
| Operating lease liabilities, current | 534 | 515 | ||||||
| Total current liabilities | 8,375 | 8,992 | ||||||
| Operating lease liabilities | 5,860 | 6,002 | ||||||
| Total liabilities | 14,235 | 14,994 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock; | — | — | ||||||
| Common stock, | 15 | 15 | ||||||
| Additional paid-in capital | 156,470 | 155,290 | ||||||
| Accumulated deficit | (77,702 | ) | (65,614 | ) | ||||
| Accumulated other comprehensive loss | 1 | 1 | ||||||
| Total stockholders’ equity | 78,784 | 89,692 | ||||||
| Total liabilities and stockholders’ equity | $ | 93,019 | $ | 104,686 | ||||
| Larimar Therapeutics, Inc. | ||||||||
| Consolidated Statements of Operations | ||||||||
| (In thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| Quarter Ended March 31 | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 8,974 | $ | 5,007 | ||||
| General and administrative | 3,132 | 1,667 | ||||||
| Total operating expenses | 12,106 | 6,674 | ||||||
| Loss from operations | (12,106 | ) | (6,674 | ) | ||||
| Other income, net | 18 | - | ||||||
| Net loss | $ | (12,088 | ) | $ | (6,674 | ) | ||
| Net loss per share, basic and diluted | $ | (0.76 | ) | $ | (1.10 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 15,996,133 | 6,091,250 | ||||||
FAQ
What were Larimar's Q1 2021 financial results?
When will Larimar announce topline data from its FA trial?
What is the status of Larimar's Phase 1 clinical trial?
How much cash does Larimar have as of March 31, 2021?
