Q4 2023 Oncternal Therapeutics Inc Earnings Call
Participants
Richard Vincent; CFO; Oncternal Therapeutics, Inc.
Jim Breitmeyer; President and CEO; Oncternal Therapeutics, Inc.
Carl Byrnes; Analyst; Northland Capital Markets
Hartaj Singh; Analyst; Oppenheimer & Co., Inc.
Kemp Dolliver; Analyst; Brookline Capital Markets
Presentation
Operator
So Greetings and welcome to Oncternal Therapeutics Fourth Quarter 2023 financial results call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Richard Vincent, Chief Financial Officer. Thank you, Richard, you may begin.
Richard Vincent
Thank you, Alicia. Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Breitmeyer; and our CMO Dr. Salim Yazji. Today's call includes a business update and discussion of our results for the fourth quarter and full year 2023. Our 10-K for the full year 2023 was filed earlier today. Today's press release and a replay of today's call will be available on the Investor Relations section of our terminals website for at least the next 30 days. Please note that certain information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act.
We will be making forward-looking statements during this call about future events such as our business and product development strategies, the timing of our clinical studies, planned interim data updates, regulatory filings and our cash runway. Our actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with our business. These forward-looking statements should be considered in conjunction with and are qualified by the cautionary statements contained in today's press release and our SEC filings, including our Form 10 K for the full year ended December 31st, 2023, as filed today, this call contains time-sensitive information that is accurate only as of the date of this live broadcast, March seventh, 2024.
We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call. Without that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmeyer.
Jim Breitmeyer
Thank you, Rich, and good afternoon, everyone. At Oncternal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical need. We continue to be excited about the potential of Oct. five three four and its novel mechanism of action, which may address a significant unmet need for advanced prostate cancer patients who progressed after currently approved AR. pathway inhibitor therapy and before they move into more aggressive treatment options such as chemotherapy or radioligand therapy.
Earlier this year, we announced that for patients with metastatic castrate resistant prostate cancer had been enrolled into our Phase one two dose escalation dose expansion study of Oncophage three, four, we have been able to dose escalate as planned without unexpected dose-limiting toxicities and the third dosing cohort of 160 milligrams of Oct. five three four is now fully enrolled. We plan to announce an initial clinical data update for this program late next quarter. With respect to RADOARO. one targeting autologous CAR T. We released initial clinical data in December from Phase one two study Oct. eight oh eight one oh one. In patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T therapy.
We saw an encouraging response signal at the initial dose of one times 10 to the six CAR T cells per kilogram with two of the three patients achieving complete metabolic response and the third achieving a partial response as of the December fourth cutoff date. Common adverse events in this dosing cohort included decreased blood counts, pneumonia and Grade one two cytokine release syndrome or CRS. First patient treated at the dose level of three times 10 to the six CAR T cells per kilogram, an 80 year old with bulky disease who had received four probably previous lines of therapy, including CD19 CAR T EXPECT experienced a fatal serious adverse events consistent with CRS and immune effector cell associated neurotoxicity syndrome.
This patient autopsy showed no histological evidence of his lymphoma despite the fact that there were two large tumor masses present prior to treatment with only eight oh eight. As a result, as a result of this unfortunate events and in alignment with the FDA, we decided to implement additional protocol changes that include modified eligibility criteria, additional screening for adult infection and testing lower doses of AMP eight oh eight. We believe these changes will help us further ensure patient safety as we investigate the optimal dose of AMP eight away for patients with advanced B-cell lymphoma, including patients who have relapsed after CD19 CAR T treatments, we expect to report updated clinical results, including from this new dosing schedule for AMP eight oh eight in mid 2024.
Overall, our two clinical programs on five three four and on eight oh eight are advancing, and we are looking forward to potential significant value inflection points for the Company from both programs in the near term. With this, I now turn the call over to our CFO, Rich Vincent.
Richard Vincent
Yes, Brett, thank you, Jim. Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $0.3 million for the fourth quarter ended December 31st, 2023 and $0.8 million for the full year 2023. Our total operating expenses for the fourth quarter were $9.9 million, which included $2.2 million in non-cash stock based compensation expense. Full operating expenses for the full year were $42.5 million, which included $7.5 million and non-cash stock-based compensation expense. In the fourth quarter, research and development expenses totaled $6.7 million and general and administrative expenses totaled $3.2 million for the full year.
Research and development expenses totaled $29.8 million, and general and administrative expenses totaled $12.7 million. Net loss for the fourth quarter was $9.2 million for a loss of $3 and $0.11 per share basic and diluted. For the full year, our net loss was $39.5 million for a loss of 13.4 or three per share, basic and diluted. As of December 31st, 2023, we had 2.9 million shares common stock outstanding with $34.3 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into the first quarter of 2025.
With respect to upcoming milestones, we remain on track from five 34 our lead dairy product candidate. We expect to present initial clinical data late in the second quarter of 2024 with additional data readouts in the fourth quarter of 2020 from A. to ATRO. one autologous CAR T. We expect to report a clinical data update mid 2024 with additional data readouts in the fourth quarter of 2020. For now, I will turn the call back over to Jim.
Jim Breitmeyer
Yes. Thanks, Rich. So with that, I think we are ready to take questions. Alicia, if you could see ask open up the floor for questions.
Question and Answer Session
Operator
(Operator Instructions) Carl Byrnes, Northland Capital Markets.
Carl Byrnes
Thanks for the question and congratulations on your progress. I was just wondering if when you have the update in the late second quarter on program five 34 is that going to be data through the one 60 milligram dose? And then when would you expect to begin dosing the 300 milligram cohort? And then I have a follow-up as well, please?
Jim Breitmeyer
Sure, Karl. Thank you for the question. So as you know, of course, progress of clinical trials is difficult to predict with accuracy, but we are we are hopeful that we'll be able to be speaking about both the 160 milligram dose and the 300 milligram dose at the by the end of the second quarter.
Carl Byrnes
Oh, great. That's very helpful. And then moving over to A2A. In terms of the specifics of eligibility criteria, you mentioned screening for infection and then also the new dosing schedule. Have you have you provided an update on what that new dosing schedule is? Obviously it's going to be priced somewhere significantly below one to the power of 10 to six. Is that like are starting at like 0.25 and then escalating from there.
Jim Breitmeyer
Thanks. Thank you, Carl. And that's that's exactly right. And the gasoline, do you want to you want to discuss a new dosing schedule? Sure. So called the dosing schedule, we'll start with 0.3 times 10 to the six, and then the next dose level will be 0.6 times 10 to the six and then will be one. And then based on the results, the SRC can decide if they want to do anything between one and three and because we haven't SRC's, it's actually making. So so dosing decision. And the SRC is the PI.'s who are enrolling in the study as well as an independent academic physician who was treating patients was CAR-T and company physicians.
Carl Byrnes
Great. Perfect. Thank you. That's very helpful.
Sure.
Operator
Hartaj Singh, Oppenheimer.
Hartaj Singh
Great. Thank you. Thank you for the questions. I have got a couple of one is maybe to just dig in a little bit to the questions earlier about long term five, three, four in some calls, we've done with key opinion leaders. They have indicated that there's a high unmet need for such a mechanism of action in the area of metastatic castrate resistant prostate cancer arm. You, Richard, if you can just kind of give us an idea of what that market size looks like, you know, and what would be the TAM potentially even you know, in terms of pricing because there is an genericization in the market? Just any thoughts there? And I got a couple of quick follow-ups.
Jim Breitmeyer
Sure, Hartaj, thanks. Thank you for the question. So so there's there's two we've been penciling in two different market sizing options. The first would be if we if it is a drug that is used in patients who are who have failed, who have metastatic disease and have failed and available one or more available androgen receptor pathway inhibitors. And and we do believe that there is a potential for a sales potential of $1 billion or near near 1 billion.
But as you know, unlike some other drugs that are in development and are focused on mutations of the androgen receptor on five three four is also very active against cancers expressing the native androgen receptor. So that means that it has the potential to move into earlier lines of therapy such as hormone-sensitive prostate cancer. And so as you can imagine with that kind of indication, the and there's an multibillion dollar potential.
Carl Byrnes
Yes, Jim, that's very, very helpful. And then the other question is just going back to eight oh eight. I know that the last time we had talked on our health care conference actually just a few weeks ago. The Oppenheimer Healthcare Conference, you had indicated that you're getting the amendments to IRBs of. When could we start seeing patients being included into the NOVA trial? I know you've already set the time lines for the next data updates, but just any thoughts there?
Jim Breitmeyer
Absolutely. So we are we're very encouraged that our Triage, our treating physicians, our principal investigators are very eager to get patients into the study. And in fact, several patients have been identified with that that the investigators want to get on the study. And so they are doing everything that they can at their sites to expedite the approval of the amended study so that their patients can be treated. So we're optimistic that it's not going to take two.
Carl Byrnes
Great. Thank you, Jim. And then last question is just looking at your OpEx burn, you Richard came in a pretty decent bit, 10% below what we were expecting in the fourth quarter generally tends to be a little on the heavy side, and you've already given your guidance for your cash runway into next year. But just what are the reasons that your R&D was, you know, it seems to be almost $1 million less than what we were expecting. Then, is that the way to think about it sort of going forward.
Jim Breitmeyer
Also, we believe that the primary reason that the fourth quarter came in under it is because we were wrapping up the Zillow three oh one program and we actually did that very efficiently earlier than planned. And we brought a lot of the work in-house kind of in the Q3 timeframe, and we were able to keep those costs down very significantly compared to what the original forecasts look like. So I think the majority of the delivery of one costs are clearly behind us, and that's really holds true for a good chunk of the Zila program costs, even for the Phase one two study, we're really winding that down and treating the last patients there earlier this year started originally with the 9 to 10 million cash burn per quarter be realistic basically through the next few quarters. So keep in mind that the nine to $10 million included roughly two plus million of non cash stock-based compensation expense. So it's closer to the 7.5 to kind of $99 million range as enrollment picks up.
Carl Byrnes
Yes. Great. Thank you, Jim, and thank you, Rich. Thanks for all the questions.
Jim Breitmeyer
Thank you, Hartaj.
Operator
Kemp Dolliver, Brookline Capital Markets.
Kemp Dolliver
Yes, great. Thank you. A couple of questions regarding oh eight. So just to be clear on how the program will proceed. So you've dosed three patients at the one times 10 to the six dose, you're going to go down to the first dose cohort and then move up the stack. And it sounds like you will dose the initial dose a second time such that if you do three patients each, will you potentially at a minimum would have 12, 12 patients before deciding whether you should go up to a higher dose?
Richard Vincent
Yes, so I mean, actually, this is why I said earlier, we will evaluate the 0.3 times 10 to the six from 0.6, which is the two new cohort that we added first before we decide if we want if we want to go again into one or we want to do 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 can see from 0.3 and 0.6, that will be decided if we get to add more patients into one or two and intermediate dose between one and three.
Okay. And what's the reason for potentially dosing at the one one at one again, is it because the protocol changes significant enough that the data wouldn't be comparable No. And that's why I said the SRC will meet and will decide. And the only reason probably would be there if we start seeing some toxicity at 0.6 and then we will may want to add more patients into one. I mean, I think there's multiple reason to do that. But I mean, I cannot predict what we're going to see but it's always 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 or you're waiting, have IRB approvals or are there or FDA?
Richard Vincent
No, we have actually get agreement with the FDA about the protocol changes and actually everything's was submitted to the IRB and we just we think some of the logistical things that decide to be done a lot to last seems to be a while before 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 resolver at I-Mab in 24, but we're probably talking about a six digit number or less is that a fair assumption? Rich, that's close.
Great. Thank you. Thank you, Kemp.
Jim Breitmeyer
Thank you.
Operator
Since you there are no further questions at this time, I'd like to turn the floor back over to Dr. Jim Breitmeyer for closing remarks.
Jim Breitmeyer
Thank you, Alicia. And we continue to advance our two clinical programs towards significant clinical data inflection points by midyear. While we are 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.
