Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2022 Earnings Call Transcript

Alan and I will have a very quick conversation on that, and we will adjust as necessary. But right now, we feel like we’re managing the amount of accessible accounts and physicians either live or virtually, fairly effectively and efficiently. As I mentioned, we’ve seen calls — overall calls increased quarter-over-quarter about 10% and actually year-over-year about 10%, looking at the fourth quarter. So we’re happy with the current progress. And again, oncology specialty is restrictive. So we’re also increasing our nonpersonal promotion to try to generate engagement with those clinicians that we cannot access. So hopefully, that helps a little bit.

Unidentified Analyst: Very helpful. Thank you so much.

Jeff Ludwig: Appreciate it.

Operator: Thank you. Your next question comes from Sahil Kazmi with B. Riley Securities. Please state your question.

Sahil Kazmi: Hi Alan, thanks for taking our questions here. Just a couple from us. First of all, can you talk about how you’re thinking about the opportunity in head and neck squamous cell cancer. Any color you can provide there as well as the small lung cancer discussions you’re planning to have with the FDA in the first half of the year?

Alan Auerbach: Yes, absolutely. Thanks for the question. In head to neck cancer, so this is a study that’s being done — as an investigator-sponsored study, this was ongoing at the time that we purchased the drug from Takeda of using alisertib in combination with pembrolizumab in patients with RB deficient head and neck cancer. I think we’re going to have to see the data before we can really comment on the opportunity. It’s obviously a smaller tumor type. I think trial is just kind of getting going on enrollment. So we’ll expect to — I would expect we’ll probably have data if I to just ballpark it, probably Q3-ish of this year is probably when we start to see data, hopefully find a conference to present it some in the Q3, Q4 time frame.

So I think once we get the data on that, we’ll be more happy to comment on the opportunity. In terms of small cell lung cancer, you’ll remember that there is a published study in the Journal of Thoracic Oncology of paclitaxel plus alisertib versus paclitaxel alone. Alisertib is an Aurora kinase inhibitor. So in a lot of the pathways, which are present in a pretty good percentage of the small cell lung cancer patients, which includes these things like RB1 deficiencies and RB1 mutations, c-Myc elevations and things like that. That’s where the best efficacy was seen and that includes both a PFS benefit and an OS benefit in that trial. So I think what we’d like to have the discussion with the FDA on is kind of that biomarker-directed approach with the drug because our feeling is that’s really going to be our opportunity to show the best risk benefit, the best possibility of showing the most maximum benefit, but also something that just differentiates alisertib from the other drugs in small cell lung cancer.

Small cell lung cancer has been a tumor that has largely just consisted of various cytotoxic drugs. And other than the IO drug, you haven’t really seen a biomarker-directed approach in small cell lung cancer the way you have in non-small cell lung cancer. Certainly, in non-small cell lung cancer, you have the EGFR mutations, the APP mutation, the last ones and things like that. You haven’t really seen the same type of biomarker-directed approach in small cell lung cancer and that’s really the approach we’re looking to take. So that’s where the discussion with the FDA is going to focus on.