Larimar Therapeutics Inc SEC Filings

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.

Opaleye entities and individual James Silverman report a passive Schedule 13G showing shared beneficial ownership of 4,110,000 shares of Larimar Therapeutics common stock, representing 4.80% of the class. The filing states the shares are held by Opaleye, L.P., with Opaleye Management, Inc. acting as adviser and Mr. Silverman exercising control over the adviser. Voting and dispositive power are reported as shared for all 4,110,000 shares and no sole voting or dispositive power is claimed. The filing is voluntary and certifies the stake is not intended to influence control of the issuer.

Larimar Therapeutics (LRMR) is advancing nomlabofusp through clinical development with multiple recent regulatory and clinical milestones. The company increased open-label dosing to 50 mg daily and has active participants receiving that dose. In March 2025 the Safety Monitoring Team deemed anaphylaxis a likely adverse drug reaction and the protocol was amended to add antihistamine premedication for the first month. Adolescent PK run-in dosing (ages 12–17) completed dosing of 14 participants in March 2025 and some adolescents are transitioning into the open-label study.

Regulatory interactions include FDA acceptance of a lyophilized formulation for clinical use and FDA feedback under the START pilot that it is open to considering skin FXN concentration as a reasonably likely surrogate endpoint, subject to review in a future marketing application. FDA recommended safety database targets for an accelerated BLA: at least 30 participants with six months continuous exposure and a subset of at least 10 with one year. Larimar plans a BLA submission in Q2 2026. A July 2025 publication reported supporting nonclinical data. The company raised net proceeds of approximately $65.1 million in July 2025, which management expects to fund operations into Q4 2026.

Janus Henderson Group plc filed Amendment No. 5 to a Schedule 13G reporting its position in Larimar Therapeutics, Inc. (CUSIP 517125100). The filing states that Janus Henderson and certain indirect subsidiaries beneficially own 0 shares of Larimar common stock, representing 0.0% of the class. The report lists Janus Henderson as Type IA, HC with a principal address at 201 Bishopsgate, EC2M 3AE, United Kingdom, and shows 0 sole and shared voting and dispositive powers. The filing names JHIUS, JHIUKL and JHIAIFML as indirect subsidiaries providing investment advice to Managed Portfolios and includes a power of attorney dated December 9, 2022. The statement is signed by Kristin Mariani on 08/14/2025.

Larimar Therapeutics, Inc. announced its financial results and operational highlights for the second quarter ended June 30, 2025, via a press release furnished on August 14, 2025. The Current Report does not include the numerical results in-line but references that the press release is provided as Exhibit 99.1.

The company also posted an updated corporate slide presentation on its website, furnished as Exhibit 99.2, which company representatives will use in investor and analyst meetings. The filing states the furnished materials are intended to be "furnished" and not "filed" under the Exchange Act.

Form 4 filed 8 Aug 2025 shows that Deerfield-affiliated funds led by managing partner James E. Flynn increased their ownership in Larimar Therapeutics (LRMR).

• Date of trade: 31 Jul 2025
• Type: Open-market purchases (Code “P”)
• Shares bought: 9,375,000 common shares in aggregate:
• Deerfield Private Design Fund III: 3,387,529 sh @ $3.20
• Deerfield Private Design Fund IV: 3,387,539 sh @ $3.20
• Deerfield Healthcare Innovations Fund: 2,599,932 sh @ $3.20
• Cash outlay: ≈ $30.0 million
• Post-trade holdings (indirect): Fund III 9.54 m, Fund IV 9.54 m, HIF 7.32 m, Deerfield Partners 4.21 m shares
• Flynn, Deerfield Mgmt entities and the funds remain directors by deputization and >10 % beneficial owners.

The filing consolidates positions across multiple Deerfield vehicles; each filer disclaims beneficial ownership beyond its economic interest. No derivative transactions were reported.