Item 5. Other Information
ITEM 5. OTHER INFORMATION
Securities Trading Plans of Directors and Executive Officers
No officers or directors, as defined in Rule 16a-1(f), adopted and/or terminated of a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as defined in Regulation S-K Item 408, during the second quarter ended June 30, 2024.
Entry into a Material Definitive Agreement
On July 26, 2024, Denali and Biogen MA, Inc. and Biogen International GMBH (collectively, “Biogen”) executed a Side Letter to the Right of First Negotiation, Option and License Agreement (the “ROFN and Option Agreement”), entered into on October 6, 2020 and amended on August 17, 2023. Pursuant to the Side Letter, Biogen terminated its license to the ATV:Abeta program enabled by Denali’s TfR-targeting technology against amyloid beta for the potential treatment of Alzheimer's disease, effective as of the date of the Side Letter, and granted Denali rights to data generated during the collaboration. As a result of the termination, all rights to develop, manufacture, perform medical affairs activities, and commercialize new TfR-targeting ATV:Abeta therapeutics reverted to Denali.
The foregoing description of the Side Letter does not purport to be complete and is qualified in its entirety by reference to the full text of the Side Letter, which is filed as an exhibit hereto.
106
Table of Contents
ITEM 6. EXHIBITS
EXHIBIT INDEX
Incorporated by Reference
Exhibit
Number
Description Form File No. Number Filing Date
10.1#
Denali - Biogen Side Letter.
— — — Filed herewith
31.1 Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act.
— — — Filed herewith
31.2 Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act.
— — — Filed herewith
32.1* Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act.
— — — Furnished herewith
32.2* Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act.
— — — Furnished herewith
101.INS XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Incline XBRL document — — — Furnished herewith
101.SCH Inline XBRL Taxonomy Extension Schema Document. — — — Furnished herewith
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document. — — — Furnished herewith
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document. — — — Furnished herewith
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document. — — — Furnished herewith
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document. — — — Furnished herewith
104 The cover page from the Company's Quarterly Report on Form 10-Q for the three months ended June 30, 2024, formatted in Inline XBRL (contained in Exhibit 101)
— — — Furnished herewith
* The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Denali Therapeutics Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.
# Portions of this exhibit have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC.
107
Table of Contents
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 thereunto duly authorized.
DENALI THERAPEUTICS INC.
Date: August 1, 2024 By: /s/ Ryan J. Watts
Ryan J. Watts, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)
Date: August 1, 2024 By: /s/ Alexander O. Schuth
Alexander O. Schuth, M.D.
Chief Operating and Financial Officer
(Principal Financial and Accounting Officer)
108
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.