Denali Therapeutics Inc
For the period ended Dec 31, 2024. Filed Feb 27, 2025.
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FY2024 · Filed Feb 27, 2025
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Item 15. Exhibits and Financial Statement Schedules
(a) The following documents are filed as part of this report:
- Financial Statements
See Index to Financial Statements in Part II Item 8 of this Annual Report on Form 10-K.
- Financial Statement Schedules
All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto.
- Exhibits
The documents listed in the Exhibit Index are incorporated by reference or are filed with this report, in each case as indicated therein (numbered in accordance with Item 601 of Regulation S-K).
| EXHIBIT INDEX | |||||
|---|---|---|---|---|---|
| Incorporated by Reference | |||||
| ExhibitNumber | Description | Form | File No. | Number | Filing Date |
| 3.1 | Amended and Restated Certificate of Incorporation of the Registrant. | 8-K | 001-38311 | 3.1 | 12/12/2017 |
| 3.2 | Amended and Restated Bylaws of the Registrant. | 8-K | 001-38311 | 3.1 | 11/18/2024 |
| 4.1 | Specimen Common Stock Certificate of the Registrant. | S-1/A | 333-221522 | 4.2 | 11/27/2017 |
| 4.3# | Form of Pre-Funded Warrant (Amended) | 10-Q | 001-38311 | 4.1 | 5/7/2024 |
| 4.4 | Description of the Registrant’s Common Stock. | — | — | — | Filed herewith |
| 10.1+ | Form of Indemnification Agreement between the Registrant and each of its directors and executive officers. | S-1/A | 333-221522 | 10.1 | 11/27/2017 |
| 10.2+ | 2015 Stock Incentive Plan, as amended, and forms of agreement thereunder. | S-1 | 333-221522 | 10.2 | 11/13/2017 |
| 10.3+ | 2017 Equity Incentive Plan and forms of agreements thereunder. | S-1/A | 333-221522 | 10.3 | 11/27/2017 |
| 10.4+ | 2017 Employee Stock Purchase Plan and form of agreement thereunder. | S-1/A | 333-221522 | 10.4 | 12/7/2017 |
| 10.5+ | Offer Letter between the Registrant and Ryan J. Watts, Ph.D., dated November 10, 2017. | S-1 | 333-221522 | 10.5 | 11/13/2017 |
| 10.6+ | Offer Letter between the Registrant and Alexander O. Schuth, M.D., dated November 10, 2017. | S-1 | 333-221522 | 10.6 | 11/13/2017 |
| 10.8+ | Offer Letter between the Registrant and Carole Ho, M.D., dated November 10, 2017. | S-1 | 333-221522 | 10.8 | 11/13/2017 |
| 10.9 | Lease Agreement between the Registrant and HCP Oyster Point III LLC, dated September 24, 2015. | S-1 | 333-221522 | 10.9 | 11/13/2017 |
| 10.10Ü | Exclusive License Agreement between the Registrant and Genentech, Inc., dated June 17, 2016. | S-1 | 333-221522 | 10.10 | 11/13/2017 |
| 10.11Ü | License and Collaboration Agreement between the Registrant, F-star Gamma Limited, F-star Biotechnologische Forschungs-und Entwicklungsges m.b.H. and F-star Biotechnology Limited, dated August 24, 2016. | S-1 | 333-221522 | 10.11 | 11/13/2017 |
| 10.12Ü | Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated September 6, 2017. | S-1 | 333-221522 | 10.12 | 11/13/2017 |
| 10.12.1# | Amendment No. 2 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated January 18, 2018. | 10-K | 001-38311 | 10.12.1 | 3/19/2018 |
| 10.12.2# | Amendment No. 3 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated July 2, 2018. | 10-Q | 001-38311 | 10.1 | 11/8/2018 |
| 10.12.3# | Amendment No. 4 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated August 30, 2018. | 10-Q | 001-38311 | 10.2 | 11/8/2018 |
| 10.12.4# | Amendment No. 5 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated August 6, 2019. | 10-K | 001-38311 | 10.12.4 | 2/26/2021 |
| 10.12.5# | Amendment No. 3 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated September 11, 2020. | 10-K | 001-38311 | 10.12.5 | 2/26/2021 |
| 10.12.6# | Amendment No. 6 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated December 8, 2020. | 10-K | 001-38311 | 10.12.6 | 2/26/2021 |
| 10.12.7 | Amendment No. 7 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated March 29, 2021. | 10-K | 001-38311 | 10.12.7 | 2/27/2023 |
| 10.12.8# | Amendment No. 8 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated September 8, 2022. | 10-K | 001-38311 | 10.12.8 | 2/27/2023 |
| 10.12.9 | Amendment No. 9 to Development and Manufacturing Services Agreement between the Registrant and Lonza Sales AG, dated December 7, 2022. | 10-K | 001-38311 | 10.12.9 | 2/27/2023 |
| 10.13+ | Amended and Restated Key Executive Change in Control and Severance Plan. | 10-Q | 001-38311 | 10.6 | 11/5/2020 |
| 10.14+ | Executive Incentive Compensation Plan. | S-1 | 333-221522 | 10.14 | 11/13/2017 |
| 10.15+ | Amended and Restated Outside Director Compensation Policy. | 10-K | 001-38311 | 10.15 | 2/28/2022 |
| 10.16# | Option and Collaboration Agreement between the Registrant and Takeda Pharmaceutical Company Limited, dated January 3, 2018. | 10-K/A | 001-38311 | 10.16 | 7/13/2018 |
| 10.17 | Common Stock Purchase Agreement between the Registrant and Takeda Pharmaceutical Company Limited, dated January 3, 2018. | 10-K | 001-38311 | 10.17 | 3/19/2018 |
| 10.18 | Standstill and Stock Restriction Agreement between the Registrant and Takeda Pharmaceutical Company Limited, dated February 23, 2018. | 10-K | 001-38311 | 10.18 | 3/19/2018 |
| 10.19 | First Amendment to Lease Agreement between the Registrant and HCP Oyster Point III LLC, dated May 2, 2018. | 10-Q | 001-38311 | 10.1 | 8/9/2018 |
| 10.20Ü | Amended and Restated Gamma IP License Agreement between the Registrant and F-star Gamma Limited, dated August 24, 2016. | 10-Q/A | 001-38311 | 10.2 | 12/6/2018 |
| 10.21Ü | Side Letter between the Registrant and F-star Gamma Limited, dated May 21, 2018. | 10-Q | 001-38311 | 10.3 | 8/9/2018 |
| 10.22Ü | Share Purchase Agreement between the Registrant and F-star Gamma Limited, dated May 30, 2018. | 10-Q/A | 001-38311 | 10.4 | 12/6/2018 |
| 10.23# | Collaboration and License Agreement between registrant and Genzyme Corporation ("Sanofi"), dated October 29, 2018. | 10-K | 001-38311 | 10.25 | 3/12/2019 |
| 10.24 | Common Stock Purchase Agreement between the Registrant and Biogen Inc., dated August 5, 2020. | 10-Q | 001-38311 | 10.1 | 11/5/2020 |
| 10.25# | Provisional LRRK2 Collaboration and License Agreement between the Registrant and Biogen Inc., dated August 5, 2020. | 10-Q | 001-38311 | 10.2 | 11/5/2020 |
| 10.26 | Standstill and Stock Restriction Agreement between the Registrant and Biogen Inc., dated September 22, 2020. | 10-Q | 001-38311 | 10.3 | 11/5/2020 |
| 10.27# | Definitive LRRK2 Collaboration and License Agreement between the Registrant and Biogen Inc., dated October 4, 2020. | 10-Q | 001-38311 | 10.4 | 11/5/2020 |
| 10.28# | Definitive Right of First Negotiation, Option and License Agreement between the Registrant and Biogen Inc., dated October 6, 2020. | 10-Q | 001-38311 | 10.5 | 11/5/2020 |
| 10.29# | Side Letter between the Registrant and F-star Gamma Limited, dated June 30, 2021. | 10-Q | 001-38311 | 10.1 | 8/4/2021 |
| 10.30# | Amendment to Definitive LRRK2 Agreement and Waiver of and Amendment to Right of First Negotiation, Option, and License Agreement. | 10-Q | 001-38311 | 10.1 | 11/7/2023 |
| 10.31 | Securities Purchase Agreement, dated February 27, 2024, by and among the Company and the Purchasers named therein | 8-K | 001-38311 | 10.1 | 2/27/2024 |
| 10.32 | Nominating Agreement by and among the Company and Investor | 8-K | 001-38311 | 10.2 | 2/27/2024 |
| 10.33 | Compensation Recovery Policy (“Clawback Policy”) | 10-K | 001-38311 | 10.34 | 2/28/2024 |
| 10.34# | Denali - Biogen Side Letter | 10-Q | 001-38311 | 10.10 | 8/1/2024 |
| 19.1 | Denali Insider Trading Policy and Guidelines with Respect to Certain Transactions in Securities as amended through March 31, 2023. | 10-K | 001-38311 | 10.35 | 2/28/2024 |
| 21.1 | Subsidiaries of the Registrant. | — | — | — | Filed herewith |
| 23.1 | Consent of Independent Registered Public Accounting Firm. | — | — | — | Filed herewith |
| 24.1 | Powers of Attorney (incorporated by reference to the signature page hereto) | ||||
| 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 | The following materials from the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, formatted in Inline XBRL: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations and Comprehensive Loss, (iii) Consolidated Statements of Cash Flows (iv) Consolidated Statements of Stockholders’ Equity and (v) Notes to Consolidated Financial Statements. | — | — | — | Filed herewith |
| 104 | The cover page from the Company's Annual Report on Form 10-K for the year ended December 31, 2024, formatted in Inline XBRL (contained in Exhibit 101) | — | — | — | Filed herewith |
| * | The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant 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 Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing. |
|---|---|
| Ü | Portions of the exhibit have been omitted pursuant to an order granted by the Securities and Exchange Commission for confidential treatment. |
| # | Certain confidential information contained in this exhibit has been omitted because it is both (i) not material and (ii) is the type that the Registrant treats as private or confidential. |
| + | Indicates management contract or compensatory plan. |
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