Clene Inc. Files 8-K for Material Definitive Agreement

TL;DR

Clene Inc. signed a big deal, filing an 8-K on Jan 28, 2025.

AI Summary

Clene Inc. announced on January 28, 2025, that it entered into a Material Definitive Agreement. The filing also includes financial statements and exhibits related to this agreement. The company, formerly known as Chelsea Worldwide Inc., is incorporated in Delaware and headquartered in Salt Lake City, Utah.

Why It Matters

This filing indicates a significant new agreement for Clene Inc., which could impact its business operations and financial standing.

Risk Assessment

Risk Level: medium — Material Definitive Agreements can introduce new risks or opportunities, the specifics of which are not detailed in this summary.

Key Numbers

• 001-39834 — SEC File Number (Identifies the company's filing with the SEC)
• 85-2828339 — IRS Employer Identification No. (Company's tax identification number)

Key Players & Entities

• Clene Inc. (company) — Registrant
• January 28, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• Salt Lake City, Utah (location) — Principal executive offices
• Chelsea Worldwide Inc. (company) — Former company name

FAQ

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value CLNN The Nasdaq Capital M
• $230.00 — rtieth of one share of Common Stock for $230.00 per share CLNNW The Nasdaq Capital
• $45.1 million — , the "Company") announced a four-year, $45.1 million grant ("the NIH Grant") from the Nation
• $8.0 million — year of the ACT-EAP in an amount up to $8.0 million during the period from September 1, 202

Filing Documents

• clnn20241218_8k.htm (8-K) — 30KB
• ex_759091.htm (EX-10.1) — 18KB
• 0001437749-25-002265.txt ( ) — 202KB
• clnn-20250128.xsd (EX-101.SCH) — 4KB
• clnn-20250128_def.xml (EX-101.DEF) — 14KB
• clnn-20250128_lab.xml (EX-101.LAB) — 18KB
• clnn-20250128_pre.xml (EX-101.PRE) — 14KB
• clnn20241218_8k_htm.xml (XML) — 5KB

01 Entry into a Material Definitive Agreement

Item 1.01 Entry into a Material Definitive Agreement. Previously, on October 5, 2023, Clene Inc. and its wholly owned subsidiary, Clene Nanomedicine, Inc. (together with Clene Inc. and its other subsidiaries, the "Company") announced a four-year, $45.1 million grant ("the NIH Grant") from the National Institute of Health ("NIH") to the Company, in collaboration with Columbia University ("Columbia"), the prime awardee, and Synapticure, a neurology specialty health clinic. On April 3, 2024, the Company entered into a grant subaward agreement with Columbia (the "Subaward") for the first year of the NIH Grant. The NIH Grant supports an Expanded Access Program (the "ACT-EAP") for CNM-Au8 treatment of amyotrophic lateral sclerosis ("ALS"), and was awarded under the Accelerating Access to Critical Therapies for ALS Act. On January 28, 2025, the Company entered into a grant subaward amendment ("Subaward Amendment 1") with Columbia, which provides for reimbursement of Company expenses for the second year of the ACT-EAP in an amount up to $8.0 million during the period from September 1, 2024 to August 31, 2025. The other terms of the Subaward as disclosed in a Current Report on Form 8-K filed with the Securities and Exchange Commission on April 9, 2024, remain in full force an effect. The foregoing description of Subaward Amendment 1 does not purport to be complete and is qualified in its entirety by reference to the text of Subaward Amendment 1, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Exhibit Description 10.1* FDP Subaward Amendment, dated January 28, 2025, by and between Clene Nanomedicine, Inc. and the Trustees of Columbia University in the City of New York. 104 Cover Page Interactive Data File (formatted as Inline XBRL). * Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. We agree to furnish supplementally a copy of such omitted materials to the SEC upon request. 1

SIGNATURES

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. CLENE INC. Date: January 30, 2025 By: /s/ Robert Etherington Robert Etherington President and Chief Executive Officer 2

View Full Filing

View this 8-K filing on SEC EDGAR