Whitehawk Therapeutics (WHWK) Q2 2024 earnings summary

Executive summary

• FYARRO net product sales reached $6.2 million in Q2 2024, up 15% sequentially and stable year-over-year, with $51.1M in cumulative sales since 2022.

• PRECISION1, a tumor-agnostic trial for TSC1/TSC2-altered solid tumors, is fully enrolled with 120 patients; two-thirds interim analysis is expected in Q3 2024, and final results are anticipated in early 2025.

• Additional Phase 2 trials in endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NET) are enrolling rapidly, with initial data expected by year-end 2024.

• Termination of the Mirati collaboration in May 2024 to prioritize other clinical programs.

• Demand increased across new and existing accounts, with 80% of accounts ordering multiple times in 2024.

Financial highlights

• Cash, cash equivalents, and short-term investments totaled $78.6 million as of June 30, 2024, expected to fund operations into Q4 2025.

• Net loss for Q2 2024 was $14.6 million, improved from $18.0 million in Q2 2023.

• Operating expenses for Q2 2024 were $21.8 million, down from $25.7 million in Q2 2023.

• Research and development expenses were $13.1M in Q2 2024; SG&A expenses were $7.9M, both down from the prior year quarter.

• Gross margin remains high, with cost of goods sold at $1.4 million for the first half of 2024 on $11.5 million in net sales.

Outlook and guidance

• Cash runway is expected to fund operations into Q4 2025 based on current plans.

• PRECISION1 interim analysis is expected in Q3 2024, with full results in early 2025 to support a potential FDA filing.

• Initial data from EEC and NET trials anticipated by year-end 2024.

• Awaiting arbitration decision in the EOC dispute in the second half of 2024, which could impact future SG&A expenses.

• Anticipated $5.8 million payment to BMS due by August 26, 2024, under the license agreement.