Company: DNLI
Filing Date: 2025-02-27
Form Type: S-3ASR
Source: 0001628280-25-008647
Chunk: 19

Company: Denali Therapeutics Inc.
Filing Date: 2025-02-27
Form: S-3ASR
Chunk 19
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 explore a robust pharmacodynamic range of these candidates in humans;

• the expected potential benefits and potential revenue resulting from strategic collaborations with third parties and our ability to attract collaborators with development, regulatory, and commercialization expertise;

• the timing or likelihood of regulatory filings and approvals;

• our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations, and/or warnings in the label of any approved product candidate;

• the extent to which any dosing limitations that we have been subject to and/or may be subject to in the future, may affect the success of our product candidates;

• the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

• the terms and conditions of licenses granted to us and our ability to license and/or acquire additional intellectual property relating to our product candidates and TransportVehicle;

• our ability to obtain funding for our operations, including funding necessary to develop and commercialize our current and potential future product candidates;

• future agreements with third parties in connection with the commercialization of our product candidates;

• the size and growth potential of the markets for our product candidates, if approved for commercial use, and our ability to serve those markets;

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• the rate and degree of market acceptance of our product candidates;

• existing regulations and regulatory developments in the United States and foreign countries;

• potential claims relating to our intellectual property and third-party intellectual property;

• our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

• our plans and ability to develop our own manufacturing facilities;

• the pricing and reimbursement of our product candidates, if approved and commercialized;

• the success of competing products or platform technologies that are or may become available;

• our ability to attract and retain key managerial, scientific and medical personnel;

• the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;

• our ability to enhance operational, financial, and information management systems;

• the impact of adverse economic conditions such as instability in the financial services sector, rising interest rates, rising inflation, and increased labor market competition;

• the impact of increased geopolitical uncertainty, the global pandemic, and related global economic disruptions and social conditions on our business;

• expectations regarding the intended use of proceeds from our Private Investment in Public Equity ("PIPE") financing that was announced on February 27, 2024; and

• our financial performance.

We have based these forward-looking statements largely on our current expectations