Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 338

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 338
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 rate of future growth of our revenues and expenses. Our prior losses and expected future losses have had, and will continue to have, an adverse effect on our working
capital, our ability to fund the continued commercialization of FYARRO, the development of FYARRO for additional indications and any future product candidates, our ability to achieve and maintain profitability and the performance of our stock price.

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Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery, development and commercialization of FYARRO and other product candidates that we may develop in the future. We have one product approved for commercialization in the United States, FYARRO, for the treatment of advanced malignant PEComa, which was approved by the FDA in November 2021 and launched commercially in the United States in February 2022. Our ability to generate substantial product sales sufficient to achieve profitability depends on our ability, alone or with strategic collaboration partners, to obtain the regulatory and marketing approvals necessary to successfully complete discovery, development and eventual commercialization of additional indications or any future product candidates, and commercialize FYARRO or any other future product candidates, if approved, in foreign jurisdictions. We do not anticipate generating revenue from product sales significant enough to achieve profitability for the foreseeable future. Our ability to generate future revenue and achieve profitability depends significantly on our ability, or any current or future collaborator’s ability, to achieve several objectives, including, but not limited to:

| • |     | demonstrating the safety and efficacy of FYARRO to the satisfaction of the FDA and obtaining regulatory approval                                         
 for FYARRO for other indications and for any other product candidates that we may develop in the future, if any, for which there is a commercial market; |

| • |     | launching and successfully commercializing FYARRO or any other product candidates that we may develop in the                                            
 future following any regulatory approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators; |

| • |     | maintaining a commercially viable supply of, and manufacturing relationships with third parties that can provide                                                                                                  
 adequate, in both amount and quality, products and services to support clinical development and meet the market demand for FYARRO or any other product candidates that we may develop in the future, if approved; |

| • |     | completing development activities successfully and on a timely basis; |

| • |     | obtaining additional regulatory and marketing approvals for FYARRO for additional indications; |

|