Company: WHWK
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001628280-25-023932
Chunk: 6

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 3
Chunk 6
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 ADC Therapies or any other product candidates that we may develop in the future, if approved;

•completing development activities successfully and on a timely basis;

•our ability to complete investigational new drug (“IND”) application enabling studies and successfully submit INDs or IND supplements or comparable applications, which become effective without any objections by the FDA or comparable regulatory authorities before commencing a clinical trial for the ADC Therapies and any future product candidates;

•establishing and maintaining relationships with contract research organizations (“CROs”) and clinical sites for the future clinical development of the ADC Therapies and any other future product candidates that we may develop;

•timely receipt of regulatory approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;

•developing or contracting for an efficient and scalable manufacturing process for the ADC Therapies and any future product candidates, including obtaining finished products that are appropriately packaged for sale;

•following regulatory approval, negotiating and maintaining an adequate price for the ADC Therapies or any future product candidates, both in the United States and in foreign countries where our products are commercialized;

•a continued acceptable safety profile following any regulatory approval of product candidates;

•commercial acceptance of product candidates by patients, the medical community and third-party payors;

•obtaining coverage and adequate reimbursement by third-party payors for any product candidates;

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•satisfying any required post-regulatory approval commitments to applicable regulatory authorities; identifying, assessing and developing new product candidates;

•obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

•protecting our rights in our intellectual property portfolio;

•defending against third-party interference or infringement claims, if any;

•entering into and maintaining, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize the ADC Therapies and any future product candidates; and

•addressing any competing therapies and technological and market developments and attracting, hiring and retaining qualified personnel.

We may never be successful in achieving our objectives and, even if we do, may never generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease our value and could impair our ability to maintain or further our research and development efforts, raise additional necessary capital, grow our business or continue our operations