Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 60

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 60
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 “The PIPE Financing—Interests of Aadi’s Directors and Executive Officers in the PIPE Financing” beginning on page [●].

Risks Related to the License Agreement and the ADC Programs

Following the Divestment, we will not have any approved products and our pipeline will comprise solely of preclinical assets. The ADC Programs are early in development. Going forward, our business will depend on our ability to advance our current and future product candidates through preclinical studies and clinical trials and obtain regulatory approval of our product candidates, which may fail in development or suffer delays that adversely affect their commercial viability.

Following the Divestment, we will not have any
approved products and our pipeline will comprise solely of preclinical assets. Going forward, our business and future operating results will be dependent on our ability to successfully advance, develop and obtain regulatory approval for and/or
commercialize our current and future product candidates and discover or in-license additional preclinical or clinical assets. Our ability to generate product or other revenue, which we do not expect will occur for many years, if ever, will depend
heavily on the successful development and eventual commercialization of our product candidates, which may never occur.

Prior to initiating clinical
trials of our product candidates, we will need to initiate or complete IND-enabling studies for each of our ADC Programs and we will need to file an IND or similar application to the FDA or regulatory authorities in other jurisdictions. We expect to
submit an IND with respect to our lead product candidate PTK7-CPT113 in the second half of 2025 but we may not be able to file the INDs for our product candidates on the timelines we expect. For example, we may experience manufacturing delays or
other delays with IND-enabling studies. Moreover, we cannot be sure that submission of an IND will result in the FDA allowing further clinical trials to begin, or that, once begun, issues will not arise that result in the suspension or termination
of clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements in the
future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs or to a new IND. Any failure to file INDs on the timelines we expect or to obtain regulatory clearance for our trials may prevent us from
developing product candidates on a timely basis, if at all. A product candidate can unexpectedly fail at any stage of pre