Avenue Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits
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Securities registered pursuant to Section 12(b) of the Act: None
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| Title of Class | Trading Symbol(s) |
| Common Stock | ATXI (OTC Markets Group, Inc.) |
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| Item 1.01. | Entry into Material Definitive Agreement. |
On February 18, 2026, Avenue Therapeutics, Inc. (the “Company”) entered into a license agreement (the “License Agreement”) with Duke University (“Duke”), whereby the Company obtained from Duke an exclusive, worldwide license to certain patents and know-how for the development and commercialization of products, including ATX-04 (clenbuterol), for the treatment of lysosomal storage diseases, subject to customary retained rights for Duke and other non-profit or governmental institutions to use the licensed technology for non-commercial research and educational purposes. Under the License Agreement, the Company agreed to make an upfront payment and reimburse certain patent expenses to Duke, and to make development, regulatory, and commercial milestone payments upon the achievement of certain milestones. In addition, the Company is obligated to pay a tiered low single-digit royalty on future net sales of licensed products. The Company intends to advance ATX-04 through a late-stage clinical development program leveraging existing human safety and efficacy data, with an initial focus on treating Pompe disease as an adjunct to enzyme replacement therapy (“ERT”).
The License Agreement includes customary development and commercialization diligence obligations for the Company, as well as customary termination provisions, including for uncured material breach, certain insolvency-related events and specified patent challenges, and otherwise continues on a product-by-product and country-by-country basis for so long as royalties are payable.
The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, which the Company expects to file as an exhibit to a subsequent filing with the Securities and Exchange Commission.
| Item 8.01 | Other Events. |
The Company issued a press release on February 23, 2026 announcing its entry into the License Agreement, a copy of which is attached as Exhibit 99.1 hereto.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibits are furnished herewith:
| Exhibit Number |
Description | |
| 99.1 | Press Release, dated February 23, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AVENUE THERAPEUTICS, INC. | ||
| (Registrant) | ||
| Date: February 23, 2026 | ||
| By: | /S/ DAVID JIN | |
| David Jin | ||
| Interim Principal Financial Officer and Chief Operating Officer | ||