Company: DNLI
Filing Date: 2025-12-09
Form Type: 424B5
Source: 0001628280-25-056085
Chunk: 4

Company: Denali Therapeutics Inc.
Filing Date: 2025-12-09
Form: 424B5
Chunk 4
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 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, changes in currency exchanges rates and currency controls, and increased labor market competition;

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

• our financial performance; and

• the intended use of proceeds from this offering.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate, and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of the document containing the applicable statement and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this prospectus supplement and the accompanying prospectus. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this prospectus supplement to conform these statements to actual results or to changes in expectations.

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In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus supplement or the accompanying prospectus, as the case may be