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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 14, 2024

 

 

Larimar Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-36510	20-3857670
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
Three Bala Plaza East
Bala Cynwyd, Pennsylvania				19004
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (844) 511-9056

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		LRMR		Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On March 14, 2024, Larimar Therapeutics, Inc. announced its financial results and operational highlights for the fourth quarter of 2023 and for the year ended December 31, 2023. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information furnished pursuant to this Item 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Below is a list of exhibits included with this Current Report on Form 8-K.

Exhibit No.		Document
99.1		Press Release issued by Larimar Therapeutics, Inc. on March 14, 2024*
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

*Furnished herewith.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			Larimar Therapeutics, Inc.
Date:	March 14, 2024	By:	/s/ Carole S. Ben-Maimon, M.D.
			Name: Carole S. Ben-Maimon, M.D. Title: President and Chief Executive Officer

 

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Larimar Therapeutics Reports Fourth Quarter and Full Year 2023 Operating and Financial Results and Provides Update on Nomlabofusp Development

 

Bala Cynwyd, PA, March 14, 2024 – 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 2023 operating and financial results.

 

“This year we made tremendous progress across key clinical and regulatory milestones for our nomlabofusp program. We were thrilled to recently report positive top-line data and successful completion of our Phase 2 dose exploration study. Nomlabofusp was generally well-tolerated and demonstrated dose-dependent increases in skin and buccal cell frataxin levels. Importantly, skin frataxin levels as a percentage of levels in healthy volunteers more than doubled in all patients after 14 days of daily treatment with 50 mg. The clear dose-response and the magnitude of increase in tissue frataxin levels further reinforces the therapeutic potential of nomlabofusp to address frataxin deficiency, the known root cause of disease in patients with Friedreich’s ataxia (FA),” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “Additionally, the first patient in our OLE study has been dosed. The OLE study will inform on the long-term safety profile and long-term tissue frataxin levels. We remain on track to report interim data from the OLE study in the fourth quarter of 2024.”

 

Dr. Ben-Maimon continued, “On the regulatory front, we are continuing discussions with the FDA on the potential use of frataxin as a novel surrogate endpoint to support accelerated approval. We are also beginning to plan for a global double-blind placebo-controlled confirmatory study expected to be initiated prior to a potential BLA submission. The BLA submission is targeted for the second half of 2025. We believe our clinical datasets supporting nomlabofusp’s differentiated mechanism of action, coupled with our strengthened balance sheet and expected runway into 2026, strongly position us for execution of our upcoming pivotal milestones designed to help address the urgent unmet needs of the FA community.”

 

 

Recent Highlights

 

 

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Fourth Quarter and Full Year 2023 Financial Results

 

As of December 31, 2023, the Company had cash, cash equivalents and marketable securities totaling $86.8 million. As noted above, in February 2024, we raised approximately $161.6 million in net proceeds through a public offering of common stock.

The Company reported a net loss for the fourth quarter of 2023 of $13.0 million, or $0.30 per share, compared to a net loss of $9.4 million, or $0.21 per share, for the fourth quarter of 2022.

Research and development expenses for the fourth quarter of 2023 were $10.6 million compared to $7.2 million for the fourth quarter of 2022. The increase in research and development expenses compared to the prior year period was primarily driven by an increase of $1.1 million in drug manufacturing costs, an increase of $0.8 million in consulting expenditures, an increase of $0.7 million in personnel expense, an increase of $0.4 million in clinical costs related to an increase in the OLE study partially offset by a decrease in clinical costs associated with the Phase 2 nomlabofusp trial discussed above.

General and administrative expenses for the fourth quarter of 2023 were $3.5 million compared to $3.2 million for the fourth quarter of 2022. The increase in general and administrative expense was primarily driven by an increase of $0.2 million in stock-based compensation expense associated with stock option grants made in 2023, an increase of $0.1 million in personnel expense and an increase of $0.1 million in operational costs primarily related to technology, partially offset by a decrease of $0.2 million in legal fees.

For the full year 2023, the Company reported a net loss of $36.9 million, or $0.84 per share, compared to a net loss of $35.4 million, or $1.37 per share for the same period in 2022.

Research and development expenses for the full year 2023 were $27.7 million compared to $24.3 million for the same period in 2022. The increase in research and development expenses compared to the prior year period was primarily driven by an increase of $1.9 million in personnel expense, an increase of $1.3 million in clinical expense, an increase of $1.1 million in consulting expenditures, an increase of $0.5 million in nonclinical development costs, an increase of $0.5 million in internal lab costs, and an increase of $0.3

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million in stock-based compensation expense associated with stock option grants made in 2022 and 2023, partially offset by a decrease of $2.0 million in drug manufacturing costs and a decrease of $0.2 million in royalty fees associated with the milestone achieved in 2022.

General and administrative expenses for the full year 2023 were $14.1 million compared to $12.3 million for the same period in 2022. The increase in general and administrative expense was primarily driven by an increase of $0.7 million in stock-based compensation expense associated with stock option grants made in 2022 and 2023, an increase of $0.5 million in personnel expense, an increase of $0.5 million in operational costs primarily related to technology and an increase of $0.4 million in professional fees primarily related to legal, accounting and consulting services, partially offset by a decrease of $0.3 million in insurance expense.

 

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 (also known as CTI-1601) and other planned product candidates, Larimar’s planned research and development efforts, including the timing of its nomlabofusp clinical trials, interactions with the FDA and overall development plan 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; 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.

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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

 

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Larimar Therapeutics, Inc.
Consolidated Balance Sheet (dollars in thousands except share and per share data)
		December 31,			December 31,
		2023			2022
Assets
Current assets:
Cash and cash equivalents			$ 26,749		$ 26,825
Marketable securities			60,041		91,603
Prepaid expenses and other current assets			3,385		2,311
Total current assets			90,175		120,739
Property and equipment, net			684		831
Operating lease right-of-use assets			3,078		2,858
Restricted cash			1,339		1,339
Other assets			659		638
Total assets			$ 95,935		$ 126,405
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable			$ 1,283		$ 1,686
Accrued expenses			7,386		8,408
Operating lease liabilities, current			837		611
Total current liabilities		9,506			10,705
Operating lease liabilities		4,709			4,797
Total liabilities		14,215			15,502
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, 2023 and December 31, 2022; no shares issued and outstanding as of December 31, 2023 and December 31, 2022		—			—
Common stock, $0.001 par value per share; 115,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 43,909,069 and 43,269,200 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively		43			43
Additional paid-in capital		270,150			262,496
Accumulated deficit		(188,554)			(151,605)

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Accumulated other comprehensive loss		81		(31)
Total stockholders’ equity		81,720		110,903
Total liabilities and stockholders’ equity		$ 95,935		$ 126,405

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Larimar Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share data)
		Three Months Ended December 31,				Year Ended December 31,
		2023		2022		2023		2022
Operating expenses:
Research and development		$ 10,648		$ 7,218		$ 27,670		$ 24,250
General and administrative		3,514		3,221		14,088		12,276
Total operating expenses		14,162		10,439		41,758		36,526
Loss from operations		(14,162)		(10,439)		(41,758)		(36,526)
Other income, net		1,169		1,014		4,809		1,171
Net loss		$ (12,993)		$ (9,425)		$ (36,949)		$ (35,355)
Net loss per share, basic and diluted		$ (0.30)		$ (0.21)		$ (0.84)		$ (1.37)
Weighted average common shares outstanding, basic and diluted		43,905,903		43,897,603		43,901,241		25,761,394

 

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