Full Press Release Details
Larimar Therapeutics Reports Fourth Quarter and Full Year 2021 Operating and Financial Results
Bala Cynwyd, PA, March 25, 2022 Larimar Therapeutics, Inc. ( Larimar ) (Nasdaq: LRMR), a clinical-stage biotechnology company
focused on developing treatments for complex rare diseases, today reported its full year 2021 operating and financial results.
was highlighted by our first clinical data readouts, which demonstrated the potential of CTI-1601 to address the root cause of Friedreich s ataxia by increasing frataxin levels in patients, said
Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. With these important proof-of-concept data in hand, we continue to work expeditiously to
identify the best path forward through the resolution of CTI-1601 s clinical hold. Our commitment to furthering CTI-1601 s development remains steadfast, and
the urgent unmet needs of patients with Friedreich s ataxia continue to inspire us. We look forward to our continued progress and would like to thank all those who played a role in the advancement of our Phase 1 program over the past year
including our clinical trial participants, their families, and members of the Friedreich s Ataxia Research Alliance.
Fourth Quarter and Full Year 2021 Financial Results
As of December 31, 2021, the Company had cash and cash equivalents totaling $70.1 million.
The Company reported a net loss for the fourth quarter of 2021 of $9.1 million, or $0.50 per share, compared to a net loss of $14.2 million, or
$0.89 per share, for the fourth quarter of 2020.
Research and development expenses for the fourth quarter of 2021 were $6.3 million compared to
$10.6 million for the fourth quarter of 2020. The decrease in research and development expenses compared to the prior year period was primarily driven by lower clinical supply manufacturing costs of $4.1 million and a decrease of
$1.5 million in clinical trial costs, partially offset by higher non-clinical and internal laboratory costs of $0.4 million, an increase of $0.3 million in personnel related costs due to
headcount additions in our research and development functions, an increase of $0.3 million in professional fees primarily related to consulting services and an increase of $0.2 million in stock-based compensation expense associated with
stock option grants made in 2021.
General and administrative expenses for the fourth quarter of 2021 were $2.8 million compared to $3.8 million
for the fourth quarter of 2020. The decrease in general and administrative expenses as compared to the prior year period was primarily driven by a decrease of $0.7 million in professional fees primarily associated with accounting, legal,
communication and consulting fees and a decrease of $0.3 million in facility costs, partially offset by an increase of $0.2 million in stock-based compensation expense associated with stock option grants made in 2021.
For the full year 2021, the Company reported a net loss of $50.6 million, or $2.95 per share, compared to a net loss of $42.5 million, or $3.57 per
share for the same period in 2020.
Research and development expenses for the full year 2021 were $38.4 million compared to $31.4 million for
the same period in 2020. The increase in research and development expenses compared to the prior year period was primarily driven by higher non-clinical and internal laboratory costs of $3.2 million, an
increase of $2.0 million in personnel related costs due to increased headcount in our research and development functions, an increase of $1.3 million in stock-based compensation expense associated with stock option grants made in the
second half of 2020 and in 2021, higher clinical supply manufacturing costs of $0.4 million, an increase of $0.4 million in professional fees primarily related to consulting services, partly offset by a decrease of $0.6 million in
clinical trial costs.
General and administrative expenses for the full year 2021 were $12.1 million compared to $11.4 million for the same
period in 2020. The increase in general and administrative expenses as compared to the prior year period was primarily driven by an increase of $2.0 million in stock-based compensation expense associated with stock option grants made in the
second half of 2020 and in 2021, an increase of $1.1 million in other operating expenses including insurance, recruiting and IT costs required to function as a public company, an increase of $0.3 million in personnel related costs due to
increased headcount, partially offset by a decrease of $2.1 million in professional fees primarily associated with accounting, legal, communication and consulting fees and a decrease of $0.6 million in facility costs associated with the
sublease agreement entered in late 2020.
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 statements regarding Larimar s expectations regarding its ability to resolve the 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 CTI-1601, the timing and outcome of Larimar s planned interactions with the
FDA concerning the clinical hold on CTI-1601, the success, cost and timing of Larimar s product development activities, nonclinical studies and clinical trials, including
CTI-1601 clinical milestones; that 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 clinical trials, and assessments; the ongoing impact of the COVID-19 pandemic on Larimar s future clinical
trials, manufacturing, regulatory and nonclinical study timelines, the ongoing impact of the COVID-19 pandemic and the potential impact of the Russian invasion of Ukraine on Larimar s ability to raise
additional capital 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 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 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: | Company Contact: | |
| Joyce Allaire | Michael Celano | |
| LifeSci Advisors | Chief Financial Officer | |
| jallaire@lifesciadvisors.com | mcelano@larimartx.com | |
| (212) 915-2569 | (484) 414-2715 |
Larimar Therapeutics, Inc.
Consolidated Balance Sheet
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 70,097 | $ | 68,148 | ||||
| Marketable debt securities | 24,490 | |||||||
| Prepaid expenses and other current assets | 2,107 | 5,314 | ||||||
| Total current assets | 72,204 | 97,952 | ||||||
| Property and equipment, net | 1,049 | 1,040 | ||||||
| Operating lease right-of-use assets | 3,406 | 3,936 | ||||||
| Restricted cash | 1,339 | 1,339 | ||||||
| Other assets | 669 | 419 | ||||||
| Total assets | $ | 78,667 | $ | 104,686 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,660 | $ | 2,634 | ||||
| Accrued expenses | 6,592 | 5,843 | ||||||
| Operating lease liabilities, current | 594 | 515 | ||||||
| Total current liabilities | 8,846 | 8,992 | ||||||
| Operating lease liabilities | 5,408 | 6,002 | ||||||
| Total liabilities | 14,254 | 14,994 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock; $0.001 par value per share; 5,000,000 shares authorized as of December 31, 2021 and December 31, 2020; no shares issued and outstanding as of December 31, 2021 and December 31, 2020 | ||||||||
| Common stock, $0.001 par value per share; 115,000,000 shares authorized as of December 31, 2021 and December 31, 2020; 17,710,450 and 15,367,730 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively | 18 | 15 | ||||||
| Additional paid-in capital | 180,645 | 155,290 | ||||||
| Accumulated deficit | (116,250 | ) | (65,614 | ) | ||||
| Accumulated other comprehensive loss | 1 | |||||||
| Total stockholders equity | 64,413 | 89,692 | ||||||
| Total liabilities and stockholders equity | $ | 78,667 | $ | 104,686 |
Larimar Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,292 | $ | 10,563 | $ | 38,396 | $ | 31,407 | ||||||||
| General and administrative | 2,794 | 3,832 | 12,069 | 11,397 | ||||||||||||
| Total operating expenses | 9,086 | 14,395 | 50,465 | 42,804 | ||||||||||||
| Loss from operations | (9,086 | ) | (14,395 | ) | (50,465 | ) | (42,804 | ) | ||||||||
| Other income (loss), net | (48 | ) | 192 | (171 | ) | 322 | ||||||||||
| Net loss | $ | (9,134 | ) | $ | (14,203 | ) | $ | (50,636 | ) | $ | (42,482 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.50 | ) | $ | (0.89 | ) | $ | (2.95 | ) | $ | (3.57 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 18,338,853 | 15,985,199 | 17,164,284 | 11,883,106 |