Whitehawk Therapeutics, Inc. Q2 FY2023 earnings call

• FYARRO sales for Q2 2023 were $6.2 million, with 6% sequential growth and 80% year-over-year growth. Sales to date total over $27 million in 16 months on the market.
• PRECISION 1 trial is progressing well, with steady accrual between TSC1 and TSC2 study arms, broad representation of over 15 tumor types. Expected to provide interim analysis of 40 patients with follow-up by end of 2023.
• Expanded FYARRO pipeline to investigate mTOR pathway inhibition in endometrial cancer and neuroendocrine tumors (NETs) with promising preclinical data.
• Initiated Phase II trial of nab-sirolimus with letrozole for advanced/recurrent endometrioid-type endometrial cancer (EEC), and Phase II multicenter trial for NETs. Phase I/II trial of nab-sirolimus and adagrasib in KRAS G12C mutations started with first patient dosing completed.
• FYARRO has strong commercial access with over 90% of commercial lives covered, over 165 unique ordering accounts, and 85% reorder rate in Q2.

FYARRO sales for the second quarter were $6.2 million, showing a 6% sequential increase over the previous quarter and 80% growth over the prior year quarter. FYARRO sales to date have reached more than $27 million in just 16 months on the market. At the end of the second quarter, there were more than 165 unique ordering accounts, up 13% from the first quarter, and the reorder rate was approximately 85% in the quarter.

• Expect to provide interim analysis of PRECISION 1 trial on 40 patients with follow-up by end of 2023.
• Aim to complete enrollment in PRECISION 1 trial by spring 2024 and report final results as data matures.
• Anticipate early data from ECC and NETs studies in next year.

Q: Can you just remind us whether that data cut is triggered once these 40 patients have reached a minimum follow-up period? And if so, what's the minimum required follow-up there? And I think I heard you, Loretta, but I just wanted to confirm that these interim data will be reported on just investigator-based assessment and there will not be a central review at this point in the study.

A: Yes, these will be investigator responses and they will not be subjected to IDMC review. The minimum follow-up is attempting to provide six months of follow-up on most patients, with the shortest possibly about 4.5 months.

Q: For the NETs study, it sounds like the strategy there is to generate a data set that maybe potentially points to superiority over everolimus, and then you could maybe look to get that published and then included in guidelines. I guess, am I correct there? And if so, what's the scope of a potential data set you think you would need to generate to pursue that route?

A: We don't need huge numbers. We are planning to do a relatively small Simon Two-stage study. We will look to see if response rate is improved because the oral rapalogs are associated with a very low response rate and we believe our superior pharmacology will show markedly superior response rate. If we see a signal in the first small subset of patients, we will be prepared to expand the study to a larger number.

Q: Given that you expect enrollment to complete in the spring 2024, what would it mean for the top line data analysis? Are we still on track for first half of next year for data readout? And what should we expect for that top line data readouts?

A: We anticipate completing enrollment by end of first quarter. And then as the data mature, we will report out final results as quickly as we can. We probably anticipate having something to report out by end of year, early next year.

Q: For FYARRO market penetration, is there anything you could communicate with us, Scott? And how much growth should we expect for the subsequent quarters?

A: We haven't shared market penetration information. We continue to be pleased with FYARRO's performance in PEComa. We had 6% growth in this quarter, with a strong April and May followed by a softer June. Not able to guide on back half growth but positive on launch progress.

Q: Can you comment on what you're actually seeing in terms of duration of therapy and how it compares to what you saw in the clinical development program?

A: We haven't shared duration data yet. We still want a little more time out there. As we move more into first line, which we've seen happen in the first half of this year, that should bode well for duration, and we'll have a better read in coming quarters.

Q: Boris Peaker asked about PRECISION 1 having 15 indications enrolled. Curious, are there any predominant indication that you're observing, maybe endometrial or something else?

A: We are seeing the most patients from the most common tumors. GYN tumors as a group (ovarian, endometrial, etc.), bladder (with high TSC1 mutations), a smattering of sarcomas, GI tumors (pancreas, gall bladder, hepatocellular), and lung is starting to be a more common type.

Q: For the expansion strategy, any specific mutation or genetic mutation beyond the TSC1 and 2 may be suitable for FYARRO? And any other biomarker strategy you will potentially to implement even in those traditional histology-based trial, maybe more better for FYARRO?

A: We will take direction from data. We will look at co-mutations from PRECISION 1 data. At this moment, not taking on additional studies but always looking at other combinations.

Q: For the ECC and the NETs study, would you be able to guide a little bit about the initial data we can start to see?

A: Both studies are anticipated to begin enrolling in this calendar year. Anticipate some early data, probably some time next year.