Larimar Therapeutics Reports First Quarter 2021 Operating and Financial Results
- Topline data from placebo-controlled Phase 1 program in Friedreich's ataxia patients to be announced tomorrow,
- Cash and investments of
“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
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
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
About
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
| Investor Contact: jallaire@lifesciadvisors.com (212) 915-2569 |
Company Contact: Chief Financial Officer mcelano@larimartx.com (484) 414-2715 |
Consolidated Balance Sheets
(Unaudited)
| 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 | ||||
| Consolidated Statements of Operations | ||||||||
| (In thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| Quarter Ended |
||||||||
| 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 | ||||||
Source: Larimar Therapeutics