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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): August 10, 2023

 

 

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 August 10, 2023, Larimar Therapeutics, Inc. announced its financial results and operational highlights for the second quarter ended June 30, 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 August 10, 2023*
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:	August 10, 2023	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 Second Quarter 2023 Operating and Financial Results

 

Bala Cynwyd, PA, August 10, 2023 – Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its second quarter operating and financial results.

 

“Advancing our 50 mg cohort in our Phase 2 study and initiating our OLE study following FDA review of unblinded Phase 2 data from our 25 mg cohort are major advances in the development of CTI-1601 as potentially the first therapy designed to increase frataxin levels and address the underlying deficiency driving FA’s devastating clinical course,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “We are pleased to see that 25 mg was generally well tolerated and increased frataxin levels when dosed daily for 14 days. We are also very excited to now be able to initiate long-term dosing in the OLE trial in patients who participated in our Phase 1 or Phase 2 studies. The ability to follow patients in a long-term study that will assess increases in frataxin over months is very important to moving the development program forward.”

 

Dr. Ben-Maimon continued, “As we look ahead, we are focused on initiating our 50 mg cohort shortly, and plan to initiate our OLE trial in the first quarter of 2024. We expect to report top-line safety, pharmacokinetic, and frataxin data from the 50 mg cohort of our Phase 2 trial in the first half of 2024, and interim data from the OLE trial in the fourth quarter of 2024. Importantly, these trials will inform our future dose and dose regimen selection, as well as help to explore the long-term safety and pharmacokinetic and pharmacodynamic profiles of CTI-1601. With these key milestones ahead of us, coupled with our robust clinical dataset, we believe we are well-positioned to further advance the development of CTI-1601, with its unique mechanism of action and potential to be disease modifying for patients with FA.”

 

Second Quarter and Subsequent Highlights

 

 

 

 

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Second Quarter 2023 Financial Results

 

As of June 30, 2023, the Company had cash, cash equivalents and marketable securities totaling $104.2 million, which provides projected cash runway into the fourth quarter of 2024.

The Company reported a net loss for the second quarter of 2023 of $8.4 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.47 per share, for the second quarter of 2022.

Research and development expenses for the second quarter of 2023 were $5.9 million compared to $5.6 million for the second quarter of 2022. The increase in research and development expenses was primarily driven by an increase of $0.5 million in test method development and optimization, an increase of $0.4 million in personnel related costs, an increase of $0.2 million in stock-based compensation expense associated with stock option grants made in 2022 and 2023, partially offset by a decrease of $1.1 million in clinical supply manufacturing costs.

General and administrative expenses for the second quarter of 2023 were $3.7 million compared to $3.0 million for the second quarter of 2022. This increase was primarily driven by an increase of $0.3 million of professional fees primarily related to increased legal expense, an increase of $0.2 million in stock-based compensation expense associated with stock option grants made in 2022 and 2023 and an increase of $0.2 million in personnel related costs.

The Company reported a net loss for the first half of 2023 of $14.9 million, or $0.34 per share, compared to a net loss of $17.6 million, or $0.96 per share, for the first half of 2022.

Research and development expenses for the first half of 2023 were $10.4 million compared to $11.5 million for the first half of 2022. The decrease in research and development expenses was primarily driven by a decrease of $1.5 million in clinical supply manufacturing costs, a decrease in assay development costs of $0.2 million partially offset by an increase of $0.5 million in personnel related costs, an increase of $0.3 million in stock-based compensation expense associated with stock option grants made in 2022 and 2023.

General and administrative expenses for the first half of 2023 were $6.8 million compared to $6.1 million for the first half of 2022. The increase in general and administrative expense was primarily driven by an increase of $0.3 million in stock-based compensation expense associated with stock option grants made in 2022 and 2023, an increase of $0.3 million of professional fees primarily related to legal expense, and an increase of $0.2 million in personnel related costs.

 

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

 

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limited to 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 trials 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 CTI-1601 clinical milestones and continued interactions with the FDA regarding the partial clinical hold; 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 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 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

 

 

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Larimar Therapeutics, Inc.
Condensed Consolidated Balance Sheet
(unaudited)
		June 30,		December 31,
		2023		2022
Assets
Current assets:
Cash and cash equivalents		$ 94,321		$ 26,825
Marketable securities		9,879		91,603
Prepaid expenses and other current assets		2,278		2,311
Total current assets		106,478		120,739
Property and equipment, net		677		831
Operating lease right-of-use assets		2,578		2,858
Restricted cash		1,339		1,339
Other assets		644		638
Total assets		$ 111,716		$ 126,405
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$ 2,344		$ 1,686
Accrued expenses		4,365		8,408
Operating lease liabilities, current		566		611
Total current liabilities		7,275		10,705
Operating lease liabilities		4,511		4,797
Total liabilities		11,786		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 June 30, 2023 and December 31, 2022; no shares issued and outstanding as of June 30, 2023 and December 31, 2022		—		—
Common stock, $0.001 par value per share; 115,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 43,269,200 shares issued and outstanding as of June 30, 2023 and December 31, 2022		43		43
Additional paid-in capital		266,372		262,496
Accumulated deficit		(166,497)		(151,605)
Accumulated other comprehensive loss		12		(31)
Total stockholders’ equity		99,930		110,903
Total liabilities and stockholders’ equity		$ 111,716		$ 126,405

 

 

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Larimar Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(unaudited)
		Three Months Ended June 30,				Six Months Ended June 30,
		2023		2022		2023		2022
Operating expenses:
Research and development		$ 5,875		$ 5,644		$ 10,437		$ 11,450
General and administrative		3,745		3,043		6,820		6,124
Total operating expenses		9,620		8,687		17,257		17,574
Loss from operations		(9,620)		(8,687)		(17,257)		(17,574)
Other income (expense), net		1,254		20		2,365		(36)
Net loss		$ (8,366)		$ (8,667)		$ (14,892)		$ (17,610)
Net loss per share, basic and diluted		$ (0.19)		$ (0.47)		$ (0.34)		$ (0.96)
Weighted average common shares outstanding, basic and diluted		43,897,603		18,338,853		43,897,603		18,338,853
Comprehensive loss:
Net loss		$ (8,366)		$ (8,667)		$ (14,892)		$ (17,610)
Other comprehensive gain (loss):
Unrealized gain (loss) on marketable securities		12		(57)		43		(57)
Total other comprehensive gain (loss)		12		(57)		43		(57)
Total comprehensive loss		$ (8,354)		$ (8,724)		$ (14,849)		$ (17,667)

 

 

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