Larimar (LRMR) Reports Positive 25 mg and 50 mg nomlabofusp Data

Rhea-AI Filing Summary

Larimar Therapeutics, Inc. (LRMR) filed an 8-K to report a material event: a press release and conference presentation dated September 29, 2025 announcing positive clinical data from its ongoing long‑term open‑label study of nomlabofusp in participants with Friedreich's ataxia. The filing cites positive results at the 25 mg and 50 mg daily subcutaneous dose levels given either by self‑administration or by a caregiver. The press release and presentation are attached as Exhibit 99.1. The filing text is brief and does not disclose detailed efficacy endpoints, participant counts, statistical results, safety findings, or next regulatory steps.

Positive

• Positive clinical data reported at both 25 mg and 50 mg daily doses of nomlabofusp
• Study allows self‑administration or caregiver administration, suggesting practical dosing flexibility
• Press release and conference presentation attached as Exhibit 99.1, enabling investor review

Negative

• Filing does not disclose participant counts, specific efficacy endpoints, or statistical results
• No safety or adverse event data are provided in the 8‑K text
• No information on regulatory next steps, timelines, or commercialization plans is included

Insights

Clinical Development Analyst

Early positive dose signals at 25 mg and 50 mg.

The company reports positive data from an ongoing long‑term open‑label study of nomlabofusp in Friedreich's ataxia, specifically at daily 25 mg and 50 mg subcutaneous doses. This suggests tolerability and preliminary activity at two dose levels.

However, the filing omits participant numbers, specific clinical endpoints, safety details, and statistical significance, so the clinical meaningfulness and durability of the reported "positive" findings cannot be assessed from this document alone.

Investor Relations / Material Events Specialist

Material event disclosed with limited detail; attachments referenced.

The 8‑K properly attaches a press release and a conference presentation as Exhibit 99.1 dated September 29, 2025, meeting disclosure requirements for a material event. This provides investors the primary sources to review.

Because the filing itself is concise and lacks quantitative results, investors must consult the attached press release and presentation for substance; the 8‑K alone is insufficient to evaluate investment impact.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Larimar Therapeutics (LRMR) announce in the 8‑K?

The 8‑K states Larimar announced positive data from an ongoing long‑term open‑label study of nomlabofusp in Friedreich's ataxia at 25 mg and 50 mg daily subcutaneous doses.

When were the results announced?

The press release and conference presentation attached to the filing are dated September 29, 2025.

Does the 8‑K include detailed efficacy or safety data?

No. The 8‑K references "positive" data but does not include participant numbers, endpoints, statistical measures, or safety details in the filing text.

Where can I find the full details of the announcement?

The filing attaches the press release and conference call presentation as Exhibit 99.1; those documents should contain the full disclosed details.

Was the dosing self‑administered or given by caregivers?

The filing states the daily subcutaneous injections were either self‑administered or administered by a caregiver.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 09/29/2025 - 07:00 AM Learn about SEC filing dates

false 0001374690 0001374690 2025-09-29 2025-09-29

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): September 29, 2025

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)		(I.R.S. Employer Identification No.)

Three Bala Plaza East, Suite 506
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 8.01 Other Events.

Press Release

On September 29, 2025, Larimar Therapeutics, Inc. (the “Company”) issued a press release announcing positive 25 mg and 50 mg data from the Company’s ongoing long-term open label study evaluating daily subcutaneous injections of nomlabofusp self-administered or administered by a caregiver in participants with Friedreich’s ataxia. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Investor Presentation

On September 29, 2025, the Company will host a conference call to discuss a regulatory update and use a slide presentation in conjunction with the call. A copy of the presentation is filed herewith as Exhibit 99.2, and incorporated herein by reference.

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 September 29, 2025*
99.2		Larimar Therapeutics, Inc. Conference Call Presentation, dated September 29, 2025*
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Filed 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.
By:		/s/ Carole S. Ben-Maimon, M.D.
Name:		Carole S. Ben-Maimon, M.D.
Title:		President and Chief Executive Officer

Date: September 29, 2025