Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 406

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 406
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 our other product candidates that we may develop in the future may adversely affect our future profit margins and
our ability to commercialize FYARRO or any other product candidates that we may develop in the future that receives regulatory approval on a timely and competitive basis.

We are dependent on a single-source supplier for the drug product FYARRO, and the loss of such supplier could harm our business.

We rely on a single-source supplier, Fresenius Kabi, for our drug product FYARRO. In January 2022, we entered into the Fresenius Agreement, which we most
recently amended effective as July 31, 2024 to, among other things, extend the term of the Fresenius Agreement to September 30, 2024. The term of the Fresenius Agreement has now expired. Although we believe we presently have sufficient
supply of FYARRO for at least the next two years based on our estimated demand and are seeking to enter into a new agreement with Fresenius Kabi for the manufacture of FYARRO, if we are unable to enter into a new agreement on favorable terms or at
all, our business could be materially adversely affected.

We also have supply agreements in place for key raw materials used in the manufacture of FYARRO
such as for the drug substance sirolimus and for human albumin, which are key ingredients in the drug product. Our suppliers could discontinue the manufacturing or supply of FYARRO at any time. Our suppliers may not be able to meet our demand for
their products, either because of acts of nature, the nature of our agreements with those manufacturers or our relative importance to them as a customer, and our manufacturers may decide in the future to discontinue or reduce the level of business
they conduct with us either entirely or for a particular territory. The loss of any of the foregoing would require significant time and effort to locate and qualify an alternative source of supply.

We currently rely on a single company for such manufacturing for FYARRO. Any contractual disputes between us and such manufacturer, the inability to enter
into a new commercial supply agreement with Fresenius Kabi or loss of manufacturing ability by such manufacturer could similarly require significant time, effort and expense to locate and qualify an alternative source of manufacturing, which could
materially harm our business.

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In addition, we might not be able to identify and qualify additional or replacement suppliers for the drug
product FYARRO or for the key raw materials used in the manufacture of FY