Oncternal Therapeutics, Inc.

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-Q filed today and our previously filed Form 10-K for the full year ended December 31, 2023. This call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 8, 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. With that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmaier.

Thank you, Rich, and good afternoon, everyone. At OCTURNAL, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs. Oncd534, our novel dual-action androgen receptor inhibitor, or DARI, continues to advance through the dose escalation portion of the Phase I-II study, and we continue to see strong demand from investigators. As a reminder, preclinical studies showed that Oncd534 inhibited prostate cancer cells through both the ligand binding domain and the N-terminal domain of the androgen receptor, and it also induced degradation of the ender receptor. Thanks to this novel mechanism, we believe OCT534 may address key prostate cancer escape mechanisms from currently approved AR pathway inhibitors, such as enzalutamide and abiraterone, which include multiple LBD mutations, as well as splice variants, such as ARV7. The clinical trial is proceeding well. We have not observed any dose-limiting toxicities or other concerning side effects. And we recently announced that the sixth dosing cohort of the study is now fully enrolled. Patients in this cohort are receiving 1,200 milligrams of OX34 administered orally once per day. The decision to move to this dose level was made by the study's safety review committee after reviewing data from the patients treated to date, including the third dose level of 600 milligrams 534 daily. We plan to share an initial clinical data update for ONC534 later in the third quarter. Now switching gears to ONC808, our autologous ROAR-1 targeting CAR-T product. Our Phase 1-2 study in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR-T treatment, is enrolling and treating patients. There have been no dose-limiting toxicities observed in the current dosing cohort. We expect to report updated clinical results, including data from patients treated with the new dosing schedule in the fourth quarter of 2024. With this, I now turn the call back to our CFO, Rich Vinson. Rich? Thank you, Jim.

Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was 0.8 million for the second quarter ended June 30, 2024. Our total operating expenses for the second quarter ended June 30, 2024 were 9.7 million. including 1.4 million in non-cash stock-based compensation expense. Research and development expenses totaled 6.6 million, and general and administrative expenses totaled 3.1 million. Net loss for the second quarter was 8.6 million for a net loss of $2.89 per share, basic and diluted. As of June 30, 2024, we had approximately 3 million shares of common stock outstanding, $21.4 million in cash, cash equivalents, and short-term investments, and no debt. We believe these funds will be sufficient to support our operations into the first quarter of 2025. With respect to upcoming milestones, we are looking forward to the following updates. For ONC 534, our lead DARI product candidate, we expect to present initial clinical data in the third quarter of 2024 with additional data readouts in the fourth quarter of 2024. Bronx 808 or Roar 1 Autologous RT, we expect to report a clinical data update in the fourth quarter of 2024. With that, I will turn things back over to the operator for the Q&A portion of this afternoon's call. Diego?

Thank you. And at this time, we will conduct our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset. Once again, to ask a question, press star 1. We'll pause for a moment while we poll for questions. And our first question comes from Carl Burns with Northland Capital Markets. Please state your question. Thanks for the question and congratulations on the progress.

With respect to the clinical data update for 534 in the third quarter, or late third quarter to be specific, what should we be expecting there? Safety data, which would be inclusive of the 1,200 milligram dose, Would we be also potentially expecting PSA reduction numbers? And if so, would that be through the first five cohorts or all the cohorts? And then I have a follow-up as well. Thanks.

Go ahead, Salim.

Yeah, Carl. So, I mean, with regards to what we would expect, we would expect to present a safety data for sure. and plus some of the PSA parameters probably will be an early one because, you know, based on the follow-up period will be not too long.

Great. And then the additional clinical data in the fourth quarter, what might that consist of? Thanks.

So in the first quarter, the additional clinical data will be probably more of a longer follow-up, more cohorts, I mean, you know, if we have. So I think we'll be more advanced than what we're going to be showing in the third quarter.

And finally, with respect to 808, how many patients, if you could disclose, have been enrolled with the update that you anticipate in the fourth quarter How many subjects might that be cover? Thanks.

Yeah, Carl, we haven't disclosed the enrollment on the CAR-T program yet. But I think as you know, and as we show in our corporate deck, we have, we revised the dosing regimen with the CAR-T, which we found were very active, very active T cells. And we have enrolled patients under the revised and amended dosing scheme, and we're not seeing any dose-limiting toxicity.

Great. Thanks. And, again, congratulations on the progress.

Okay. Thank you.

Our next question comes from Camp Dolliver with Brookline Capital Markets. Please state your question.

Great. Thank you. With regard to 534, and this question is admittedly speculative, but is there any possibility you would move to higher dosing cohorts after you get the data, particularly from the sixth cohort?

So, Kemp, it's a great question. We're collecting a lot of data on these patients. And so we have pharmacokinetic data. We've got some interesting and novel biomarker work that we're doing. And then, of course, the efficacy and the safety. And so decisions about dose levels for any additional cohorts will be made with the scientific review committee based on the totality of available data.

Okay, that's helpful. And then, again, on the same theme, are there any practical limits with regard to administration if you go to higher doses?

So, we have a, we're using a 200 milligram tablet. And so, it is perfectly feasible to give more than six tablets a day. for if the data suggests that we should go higher.

Great. That's all I have for the moment.

Thank you.

Thank you, Ken.

And there are no further questions at this time. I'll hand the floor back to Dr. James Breitmaier for closing remarks.

Thank you, Diego. So as you can tell, we remain encouraged with the Phase I results from our clinical programs and are looking forward to clinical data updates with you in the coming months. So I'd like to thank you for joining us today, and we look forward to updating you throughout this year. Thank you, and good afternoon.

This concludes today's conference. All parties may disconnect. Have a great evening.