Oncternal Therapeutics, Inc. (NASDAQ:ONCT) Q4 2023 Earnings Call Transcript

Page 2 of 2

Dr. James Breitmeyer: Salim?

Dr. Salim Yazji: Yes. So, I mean, actually, this is what I said earlier, we will evaluate the 0.3×10^6 and 0.6, which is the two new cohorts that we added first before we decide if we want to go again into one or we want to do an intermediate dose above one and between one and three. And that will be decided by the SRC, as I said earlier, because, as you know, the one was well tolerated, and we moved into the next cohort. So, I think, based on what we’re going to see from the 0.3 and 0.6, that will be decided if we’re going to add more patients into one or do an intermediate dose between one and three.

Kemp Dolliver: Okay. And what’s the reason for potentially dosing at one again? Is it because — are the protocol changes significant enough that the data wouldn’t be comparable?

Dr. Salim Yazji: No. And that’s why I said the SRC will meet and will decide. And the only reason probably will be there if we start seeing some toxicity at 0.6, and then we will want to add more patients into one. I mean I think there’s multiple reasons to do that, but I mean, I cannot predict what we’re going to see, but it’s all going to be depending on what the data will tell us from the two new cohorts.

Kemp Dolliver: Okay. That’s fine. And with regard to the approvals that are remaining, are you awaiting IRB approvals or the FDA?

Dr. Salim Yazji: No, we have actually got agreement with the FDA about the protocol changes. And actually, everything was submitted to the IRB and we’re just awaiting some of the logistical things that decide to be done as the last things to be — before we initiate the enrollment again.

Kemp Dolliver: Okay. Got it. And Richard, it sounds like there will be a small amount of expenses for zanubrutinib in ’24, but we’re probably talking about a 6-digit number or less. Is that a fair assumption?

Dr. James Breitmeyer: Rich?

Richard Vincent: That’s close.

Operator: Thank you. There are no further questions at this time. I’d like to turn the floor back over to Dr. James Breitmeyer for closing remarks.

Dr. James Breitmeyer: Thank you, Alicia. We continue to advance our two clinical programs towards significant clinical data inflection points by midyear, while reiterating our cash runway guidance into 2025. We are excited to be advancing the clinical development of novel pathways in areas with very high unmet medical need, specifically patients with metastatic castrate-resistant prostate cancer harboring androgen receptor mutations and splice variants and patients with aggressive B-cell lymphoma who are relapse, refractory or unable to obtain CD19 CAR T therapy. With that, thank you for joining us today, and we look forward to updating you throughout the year. Alicia?

Operator: Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

Follow Oncternal Therapeutics Inc. (NASDAQ:ONCT)

Page 2 of 2