Whitehawk Therapeutics, Inc. Q3 FY2023 earnings call

Introduction

• Marcy Graham starts the call, introducing the team. Scott Giacobello introduces Dave Lennon as the new President and CEO. Dave Lennon discusses nab-Sirolimus, PRECISION 1 trial progress, FYARRO sales ($6M in Q3, 40% growth Y/Y, $80M cumulative in first 9 months of 2023), and ongoing Phase 2 studies (endometrial cancer and neuroendocrine tumors). Loretta Itri details the PRECISION 1 trial, including rapid enrollment, site expansion (over 150 sites), and interim analysis plans. Scott Giacobello provides financial updates: cash position ($119.3M in Q3), R&D expenses ($11.9M in Q3 vs $8.8M prior year), SG&A expenses ($11.2M in Q3 vs $9.9M prior year), and net loss ($16.3M in Q3 vs $14.4M prior year).

FYARRO sales were $6 million in the third quarter, representing a 40% growth over the prior year, and cumulative sales in the first nine months of 2023 reached $80 million. In absolute terms, FYARRO contributed $6M to Q3 2023 sales with a 40% year-over-year growth, and $80M cumulatively in the first nine months.

Forward-looking Statements

• Expect to present early interim data from PRECISION 1 by mid-December 2023.
• Plan to have a two-thirds interim analysis in Q3 2024.
• Anticipate full enrollment in the PRECISION 1 trial by spring 2024 and complete the study by the end of 2024, with full data expected in early 2025.

Risks

• Forward-looking statements may differ materially due to various risks, uncertainties, and factors outlined in the Securities and Exchange Commission filings, including those in the Risk Factors section of annual and quarterly filings.

Q: First, on that second interim analysis which you estimate in 3Q of next year, what efficacy do you need to stop early? And second, in the PEComa market for FYARRO, do you have any sense of kind of what the duration of therapy is turning out to be?

A: Boris, thanks very much for the questions. In terms of the second interim, I wouldn’t comment at this point about what efficacy needs to be. Obviously, we have two arms running within this study and the context of response rate and duration in that combination needs to be considered when we think about potential for stopping a study early. But, of course, we do have that option at that point in time. On the PEComa side in terms of duration, I think what we can see is that duration is consistent with what we’ve been seeing in the clinical trial, and that’s what I would comment at this point.

Q: For the initial interim expected by year-end, with the minimum follow-up of four and a half months, can you just let us know what minimum amount of post-baseline scans that’s insured? And then, for the second interim analysis, I think this is the first we’re hearing of this. So, was this always the plan? And if not, what drove the decision to take another look? And then sort of along these lines, Loretta, if I heard you right, the second interim analysis will allow you to modify the study. Just wanted to understand that a little bit better given it sounds like the study will be fully enrolled by that time, what modifications maybe you could potentially employ then?

A: Hi, Joe. Thanks for your questions. So, let me reply. So the – I’m sorry, I kind of have the order of your questions a little bit confused. Do you think you could repeat the first one, please? Yeah, yeah. Sure, I’ll be quick here. So, the minimum amount of post-baseline scans that’s insured with four and a half months of follow-up. And then the second interim analysis, was this always in the plans? Or is this something new? And what drove the decision? And then, what modifications you could potentially take post the second interim analysis, given that the trial would have been fully enrolled by that point? Okay, great. So, the four and a half month guarantees at least two post-baseline scans. So everyone will have at least the ability to have that kind of follow-up. The interim analysis, the second interim analysis at two-thirds that you were asking a question about, has always been in the statistical analysis plan. It is an adaptive design. This is very common when approximately two-thirds of patients are on study to have a look and to assess whether or not the sample size is sufficient to file early or whether or not you might want to consider resizing. So those are both options that we would have when that interim occurs. But this analysis was always planned. And we will have six months of follow-up. This analysis will look at the independent review of radiologic scans and will be performed by an independent data monitoring committee. So, even though we will have completed enrollment in the study, presumably by that time, we will still be requiring additional follow-up on the entire cohort. I hope that addresses your questions.

Q: In terms of the second interim analysis which you estimate in 3Q of next year, what efficacy do you need to stop early? And second, in the PEComa market for FYARRO, do you have any sense of kind of what the duration of therapy is turning out to be? And then, on that second interim analysis which you estimate in 3Q of next year, what efficacy do you need to stop early? And second, in the PEComa market for FYARRO, do you have any sense of kind of what the duration of therapy is turning out to be [technical difficulty]? And then, on the second interim analysis which you estimate in 3Q of next year, what efficacy do you need to stop early? And second, in the PEComa market for FYARRO, do you have any sense of kind of what the duration of therapy is turning out to be?

A: Boris, thanks very much for the questions. In terms of the second interim, I wouldn’t comment at this point about what efficacy needs to be. Obviously, we have two arms running within this study and the context of response rate and duration in that combination needs to be considered when we think about potential for stopping a study early. But, of course, we do have that option at that point in time. On the PEComa side in terms of duration, I think what we can see is that duration is consistent with what we’ve been seeing in the clinical trial, and that’s what I would comment at this point.

Q: Regarding the Triple Meeting Presentation. It looks like p53 is the most frequently observed comorbidity. Curious how that might impact deep comorbidity, how they might impact the trial activity? And during the interim analysis, will you disclose the other mutations in the patients? Or is it going to be more high level? And then, on the endometrial program. Now the trial is enrolling, how many sites are open? And when do you expect to see initial data from Stage 1 portion of the study?

A: Yeah. So, I’ll take a first crack and Loretta back me up on this. TP53 is the most common co-mutation that you see in that analysis for patients across 440,000 cancers that we looked at. And our internal calculations when we look at those distributions indicate there’s potentially 16,000 new cancer patients each year with either TSC1 or TSC2 mutations. About 50% of those, if I recall, the data correctly, had co-mutations in p53 and although that while high overall is very consistent with what you see across all tumor types and all types of cancers. TP53 is the most common co-mutation in general for different types of tumors. And so, it’s not different from what you might expect overall. And given that we’ve seen responses to patients with TSC1 and TSC2 altered cancers in the past in the retrospective analysis that became the basis for PRECISION 1 and PRECISION 2. We wouldn’t expect it to necessarily negatively impact the trial in any way, and we believe it would work within that context. And Loretta, I don’t know if you would add anything to that? No, I think that’s entirely correct. I would have answered it the same way. Yeah. And then in the interim, we won’t be presenting co-mutation status at this point in time. The numbers, while significant in terms of an initial indicative nature of how the trial is going, we don’t believe would be sufficient to really do a detailed analysis of co-mutation status that would be robust enough to make any determinations on at this point. So, we won’t be sharing that data. So we’ve just started that study. I wouldn’t comment on the number of sites we have, but the community is very excited about engaging in this study and we hope to have an update on the study sometime in 2024.