Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 336

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 336
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 have
devoted substantially all of our resources to research and development activities, business planning, establishing and maintaining our intellectual property portfolio, the commercialization of FYARRO, hiring personnel, raising capital and providing
general and administrative support for these operations.

We are not currently enrolling patients in clinical trials with respect to FYARRO. In August
2024, we halted our Phase 2 study of FYARRO in malignant solid tumors harboring Tuberous Sclerosis Complex 1 (“TSC1”) and Tuberous Sclerosis Complex 2 (“TSC2”) inactivating alterations (“PRECISION1 trial”)
based on interim data and the related analysis by the Independent Data Monitoring Committee, which determined that the study was unlikely to exceed an efficacy threshold necessary to support an accelerated approval, the key goal of the study. We are
completing the wind-down of the PRECISION1 trial and all patients who were still receiving benefit at the time the study was halted were transitioned to an expanded access protocol. In addition, we paused new enrollment, but continue dosing
previously enrolled patients, in our (i) Phase 2 open-label, multi-institutional study to evaluate the efficacy and safety of the combination of FYARRO with letrozole for the treatment of advanced or recurrent endometrioid-type endometrial
cancer (“EEC”) and (ii) Phase 2 multicenter, open-label, single-arm trial to evaluate adult patients with functional or non-functional,
well-differentiated, locally advanced unresectable or metastatic neuroendocrine tumors (“NETs”) of the GI tract, lung, or pancreas who have received ≤2 prior lines of therapy excluding somatostatin analogs (SSTa). Both studies have
enrolled sufficient patients (n=24 and n=12 for EEC and NETs, respectively) to assess initial efficacy signals, with results expected to be reported at a later date.

We have limited experience managing the manufacture of commercial-scale product through a third party and conducting the sales and marketing activities
necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a longer operating history.

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In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and
unknown factors and risks frequently experienced by early commercial-stage biopharmaceutical companies in rapidly evolving fields. We also are transitioning to