Clene Inc. Files 8-K for Material Definitive Agreement

TL;DR

Clene Inc. signed a big deal on 4/3. Details to follow.

AI Summary

Clene Inc. entered into a material definitive agreement on April 3, 2024. The company, previously known as Chelsea Worldwide Inc., is a pharmaceutical preparations company based 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 future financial performance.

Risk Assessment

Risk Level: medium — Material definitive agreements can introduce new risks or opportunities, and the specifics of this agreement are not detailed in the provided text.

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
• Chelsea Worldwide Inc. (company) — Former company name
• April 3, 2024 (date) — Date of earliest event reported
• 6550 South Millrock Drive, Suite G50 (location) — Principal executive offices address
• Salt Lake City, Utah (location) — Principal executive offices city and state

FAQ

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value CLNN The Nasdaq Capital M
• $11.50 — e-half of one share of Common Stock for $11.50 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
• $7.3 million — nses for the NIH EAP in an amount up to $7.3 million during the period from September 25, 20
• $30.9 million — any under the NIH Grant may total up to $30.9 million in aggregate, inclusive of the Subaward

Filing Documents

• clnn20240409_8k.htm (8-K) — 31KB
• ex_651360.htm (EX-10.1) — 46KB
• 0001437749-24-011545.txt ( ) — 233KB
• clnn-20240403.xsd (EX-101.SCH) — 4KB
• clnn-20240403_def.xml (EX-101.DEF) — 13KB
• clnn-20240403_lab.xml (EX-101.LAB) — 17KB
• clnn-20240403_pre.xml (EX-101.PRE) — 13KB
• clnn20240409_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 Colombia University ("Colombia"), the prime awardee, and Synapticure, a neurology specialty health clinic. The NIH Grant will support an Expanded Access Program (the "NIH EAP") for CNM-Au8 treatment of amyotrophic lateral sclerosis ("ALS"), and was awarded under the Accelerating Access to Critical Therapies for ALS Act. On April 3, 2024, the Company entered into a grant subaward agreement (the "Subaward") with Colombia pursuant to the NIH Grant. The Subaward includes reimbursement of Company expenses for the NIH EAP in an amount up to $7.3 million during the period from September 25, 2023 to August 31, 2024. Disbursement of funds for the NIH EAP will be paid to the Company based on the Company's submission of invoices to Colombia for reimbursement on a monthly or quarterly basis. Of the $45.1 million total award, subawards to the Company under the NIH Grant may total up to $30.9 million in aggregate, inclusive of the Subaward, and may extend to August 31, 2027 and will be governed by future agreements or addendums. Either Colombia or the Company may terminate the Subaward with 30 days written notice. Notwithstanding, if NIH terminates the NIH Grant, Colombia will terminate the Subaward in accordance with the NIH requirements. In the performance of the Subaward, the Company may use background intellectual property, which it developed at private expense prior to the Subaward, including certain inventions and related technical data (the "Background IP"). However, the Company (i) does not and will not grant any licenses to Colombia or the U.S. Government in the Background IP, either express or implied;

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Exhibit Description 10.1 FDP Cost Reimbursement Subaward, dated April 3, 2024, by and between Clene Nanomedicine, Inc. and the Trustees of Colombia University in the City of New York. 104 Cover Page Interactive Data File (formatted as Inline XBRL). 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: April 9, 2024 By: /s/ Robert Etherington Robert Etherington President and Chief Executive Officer 2

View Full Filing

View this 8-K filing on SEC EDGAR