Oncternal Therapeutics, Inc. (NASDAQ:ONCT) Q4 2022 Earnings Call Transcript

Salim Yazji: No, I just want to say it’s just like, probably we are starting our trial in a very good those that could be therapeutic even in an early cohort. We don’t know yet, but we would expect to give at least an early safety and maybe some hints of efficacy by end of 2023. So it all depends, how actually high the dose is and how therapeutic it is, and also how many patients we can enroll by the end of the year. Jim, please go ahead.

James Breitmeyer: No, Salim, that’s exactly what I would have said. And Hartaj, you said you had one other question.

Hartaj Singh: Yes, thank you, Jim. Just P&L, Rich, your spend — OpEx in this quarter was very much in line with what we were expecting. Usually fourth quarters tend to be a little bit heavy. Just any thoughts on I mean, you’ve given us an idea of where your cash run rate goes till, but can you just give us any idea as to how OpEx kind of trends over the next two to four quarters, roughly?

Richard Vincent: So Hartaj, historically we have not provided guidance on a prospective basis. Historically, we’ve burned about $12 million in the third quarter. We’ve burned about $4 million in the fourth quarter ’22. And as stated, we have $63 million in the bank that we believe will get us into the first quarter 2024. So we definitely expect things to ramp-up. We’ve got the ZILO-301 program, ONCT-808 is pulling up real time, and with hopefully, the IND activities on the 534 program, we’ll be nearing the clinic by the end of 2023 there as well. So spend will definitely be ramping up sequentially as we go quarter-by-quarter.

Hartaj Singh: Great. Thank you, Rich, Jim, Salim, thank you all for the questions.

Richard Vincent: Thank you, Hartaj.

Operator: And our next question comes from the line of Carl Byrnes with Northland Capital Markets. Please proceed with your question.

Carl Byrnes: Great, thanks for the question and congratulations on your progress. I was wondering if you might be able to give us a little more commentary on the site activation for ZILO-301 in the U.S. and then what your expectations are in terms of site activation in Europe or outside of the United States for the balance of 2023? Thanks.

Salim Yazji: Sure.

James Breitmeyer: Go ahead, Salim.

Salim Yazji: Yes, I mean I think what we have did, we did actually contact a big number of sites not only in the U.S. but also outside of the U.S. And as you know, I mean due to the post-COVID situation as well as geopolitical situation that’s happening between Ukraine and Russia, we are not seeing, the sites are actually lining up as fast as we would like to, but I think we are going in the right direction there.

Carl Byrnes: Great, thank you. And then just a follow-up question on 808. At the end of the year, if you’re expecting maybe some preliminary efficacy and PK data, what would be a reasonable expectation in terms of progression, all things considered, when you would be able to identify recommended Phase 2 dose for that candidate 808, thanks.

Salim Yazji: So we’re actually — we are having dose escalation study, as I said earlier, it’s going to be three plus three design, and I think we’re having a multiple timepoint to check the efficacy of the CAR program. Once we evaluate this based on efficacy and safety, I think that’s where we need to decide what will be the recommended Phase 2 dose. So I mean it all depends what we see and when we see it. I think it’s very early on now to speculate, but we have a big hope that this can happen fast.