false000137469000013746902023-08-102023-08-10

 

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.

 

 


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


 

 


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

 


img46574298_0.jpg 

Larimar Therapeutics Reports Second Quarter 2023 Operating and Financial Results

Initiation cleared for 50 mg cohort in Phase 2 Friedreich's ataxia (FA) dose exploration trial following FDA review of unblinded 25 mg cohort Phase 2 data
Initiation cleared for open-label extension (OLE) trial following FDA review of unblinded 25 mg cohort Phase 2 data
Top-line safety, pharmacokinetic, and frataxin data from the Phase 2 trial’s 50 mg cohort expected in 1H 2024
Initiation of OLE trial with 25 mg daily dosing expected in Q1 2024; interim data expected in Q4 2024
Cash, cash equivalents and marketable securities of $104.2 million as of June 30, 2023, provides projected cash runway into Q4 2024

 

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

 

In July 2023, following FDA review of unblinded safety, pharmacokinetic, and frataxin data from the Phase 2 trial’s 25 mg cohort, Larimar received FDA clearance to initiate both a 50 mg cohort in the Phase 2 dose exploration trial evaluating CTI-1601 for FA and an OLE trial. Initiation of additional U.S. clinical trials are contingent on FDA review of Phase 2 data from the 50 mg cohort and any available data from the OLE due to the partial clinical hold.

 

In May 2023, Larimar announced top-line data from the 25 mg cohort of its ongoing Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 for the treatment of FA. Data from the 25 mg cohort demonstrated that daily subcutaneous injections of 25 mg CTI-1601 for 14 days were generally well-tolerated and led to increases in frataxin levels from baseline compared to placebo in all evaluated tissues (skin and buccal cells).

 

In July 2023, Larimar strengthened its executive clinical leadership with the appointment of Russell “Rusty” Clayton, DO, as Chief Medical Officer. As one of Larimar’s closest advisors for the last 5 years, Dr. Clayton has attended every meeting between Larimar and the FDA and has been chair

 


 

of Larimar’s Scientific Advisory Board since inception. Dr. Clayton succeeds former CMO Nancy M. Ruiz, MD following her retirement.

 

In June 2023, Larimar joined the broad-market Russell 3000 Index with inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index and appropriate growth and value style indexes.

 

 

 

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

 


 

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

 

 


 

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

 

 


img46574298_0.jpg 

 

 

 

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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Document And Entity Information
Aug. 10, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 10, 2023
Entity Registrant Name Larimar Therapeutics, Inc.
Entity Central Index Key 0001374690
Entity Emerging Growth Company false
Securities Act File Number 001-36510
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 20-3857670
Entity Address, Address Line One Three Bala Plaza East
Entity Address, City or Town Bala Cynwyd
Entity Address, State or Province PA
Entity Address, Postal Zip Code 19004
City Area Code (844)
Local Phone Number 511-9056
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Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol lrmr
Security Exchange Name NASDAQ

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