Oncternal Therapeutics, Inc.

Greetings and welcome to OncTernal's 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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.

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 Breitmaier, and our CMO, Dr. Celine Yazchi. 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 Monterno's 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 31, 2023 as filed today. This call contains time sensitive information that is accurate only as of the date of this live broadcast, March 7, 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 Oncternal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs. We continue to be excited about the potential of Onct 534 and its novel mechanism of action which may address a significant unmet need for advanced prostate cancer patients who progress 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 four patients with metastatic castrate-resistant prostate cancer had been enrolled into our Phase I-II dose escalation, dose expansion study of OCT534. We have been able to dose escalate as planned without unexpected dose limiting toxicities, and the third dosing cohort of 160 milligrams of OCT534 is now fully enrolled. We plan to announce an initial clinical data update for this program late next quarter. With respect to OCT808, our ROR1 targeting autologous CAR-T We released initial clinical data in December from Phase 1-2 study, OCT808101, in patients with relapsed to 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 1 times 10 to the 6th 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 4th cutoff date. Common adverse events in this dosing cohort included decreased blood counts, pneumonia, and grade 1-2 cytokine release syndrome, or CRS. The first patient treated at the dose level of three times 10 to the sixth CAR T cells per kilogram, an 80-year-old with bulky disease who had received four previous lines of therapy, including CD19 CAR T, experienced a fatal serious adverse event consistent with CRS and immune effector cell associated neurotoxicity syndrome. This patient's autopsy showed no histological evidence of his lymphoma, despite the fact that there were two large tumor masses present prior to treatment with Onc808. As a result of this unfortunate event, 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 OCT808. We believe these changes will help us further ensure patient safety as we investigate the optimal dose of OCT808 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 Onc 808 in mid 2024. Overall, our two clinical programs, Onc 534 and Onc 808 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.