Company: WHWK
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001628280-25-015269
Chunk: 55

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 55
---
 negative consequences, including:

•adverse inspection findings;

•additional warnings or otherwise restrict the product’s indicated use, label, or marketing;

•restrictions on a product, distribution, manufacturers or manufacturing processes;

•issuance of warning letters, safety alerts, dear-healthcare-provider letters, press releases or other communications containing warnings regarding the product that would result in adverse publicity;

•voluntary or mandatory product recalls and publicity requirements or withdrawal of a product from the market;

•suspension or withdrawal of marketing or regulatory approvals or other permits or voluntary;

•product seizures, detentions or import bans;

•total or partial suspension of production;

•imposition of restrictions on operations, including costly new manufacturing requirements;

•requirement to establish or modify a REMS;

•requirement to conduct post-marketing studies or surveillance;

•restrictions on drug distribution or use;

•requirements to conduct post-marketing studies or clinical trials;

58

•refusal to approve pending applications or supplements to approved applications that we submit and other delays;

•delays in or the rejection of approvals of additional indications for a product;

•restrictions on our ability to conduct clinical trials, including full or partial clinical holds on, or the suspension or termination of, future trials;

•fines, restitution or disgorgement of profits or revenue;

•reputational harm;

•refusal of government contracts or future orders under existing contracts, exclusion from participation in federal health care programs; or

•injunctions or the imposition of civil or criminal penalties, including False Claims Act liability.

The holder of an approved NDA or comparable regulatory approval must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling, or manufacturing process and the FDA or comparable foreign regulatory authority may refuse to approve pending applications or supplements to approved applications filed by us.

The occurrence of any event or penalty described above may inhibit our ability to commercialize any product candidates that we may develop, if approved, and generate revenue. If regulatory sanctions are applied or if regulatory approval is withdrawn, our value and operating results will be adversely affected.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If we are found to have improperly promoted off-label uses of FYARRO prior to its divestiture or any product candidate that we may develop in the future including the ADC Therapies, if approved, we may become subject to significant liability. The FDA and other regulatory agencies, including the U.S. Department of Justice