Whitehawk Therapeutics, Inc. Q1 FY2023 earnings call

• FYARRO sales reached $5.9 million in Q1 2023, a 12% sequential growth, driven by commercial team efforts to expand region and increase visibility.
• The PRECISION 1 trial for patients with TSC1 or TSC2 inactivating alterations is accruing evenly between the two study arms, with a diverse mix of over 15 tumor histologies enrolled and no single tumor type dominating.
• The Phase 1/2 trial in collaboration with Mirati Therapeutics for KRASG12C mutant solid tumors is expected to begin patient dosing in Q2 2023.
• The company continues to evaluate nab-sirolimus for new clinical indications, either as a single agent or in combination with other targeted therapies.

The company's key product, FYARRO for the treatment of advanced malignant PEComa, generated sales of $5.9 million in the first quarter, representing a 12% sequential increase from the previous quarter. This is the primary segment performance with FYARRO being the focal product.

• Expect continued growth in FYARRO sales as the commercial team expands reach.
• The PRECISION 1 trial is progressing with enrollment on track, targeting full enrollment by spring 2024.
• The Phase 1/2 trial with Mirati Therapeutics is set to initiate patient dosing in Q2 2023.
• The company is evaluating multiple new clinical indications for nab-sirolimus.

Forward-looking statements are subject to various risks and uncertainties, including those detailed in the company's annual and quarterly filings with the SEC, such as clinical trial outcomes, regulatory approvals, and commercial adoption challenges.

Q: Provide additional color on PRECISION trial enrollment beyond histology and TSC1/TSC2 balance?

A: Baseline characteristics of patients are not released in detail, but most patients have advanced disease and are expected to be second and third line. Confident in having 40 patients with sufficient followup for end-of-year data readout.

Q: Thoughts on FYARRO sales growth trajectory?

A: 12% growth in Q1 is strong, with a reorder rate above 90%, projecting continued growth though acknowledging launch curves may flatten over time.

Q: Details on PRECISION 1 data readout and timelines?

A: Enrollment in PRECISION 1 is expected to be fully completed by spring 2024, with interim data on 40 patients available by end of year, ensuring adequate followup for evaluation.

Q: PEComa market size and presentations?

A: Estimated PEComa patient population is 100-300, with ongoing evaluations; the company will present at meetings like ASCO, though specific details of presentations were not precisely detailed.

Q: PRECISION 1 trial indications and future clinical trials?

A: Over 15 tumor histologies are enrolled in PRECISION 1 with no predominant indication; a combination trial with Mirati Therapeutics for KRASG12C mutant solid tumors is planned to proceed later in the year.