Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 333

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 333
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 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 a company capable of supporting commercial activities.

We have incurred significant net losses since our inception, and we expect to continue to incur significant net losses for the foreseeable future.

We have incurred significant net losses since our inception, have only been generating revenue from product sales since February 2022, and have
financed our operations principally through private placements and public offerings of our securities, federal grants and proceeds from licenses. Our net losses were $12.5 million and $16.3 million for the three months ended
September 30, 2024 and 2023, respectively. We had an accumulated deficit of $314.4 million as of September 30, 2024, and $269.0 million as of December 31, 2023. These losses have resulted primarily from costs incurred in
connection with research and development activities, costs incurred in connection with commercializing FYARRO and general and administrative costs associated with our operations. We have only one product approved for commercial sale which generated
net product sales of $7.2 million and $18.7 million for the three and nine months ended September 30, 2024, respectively. Although we have commenced winding down the PRECISION1 trial and have suspended enrollment in the Phase 2 trials
for EEC and NETs, we continue to incur significant selling, general and administrative expenses as well as research and development expenses related to our ongoing operations, including operating expenses related to the cost of commercializing
FYARRO, research