Oncternal Therapeutics, Inc.

Greetings. Welcome to Octernal's first quarter 2024 financial results call. At this time, all participants are in a listen-only mode. A 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. Please note, this conference is being recorded. I'll now turn the conference over to your host, Richard Vincent, Chief Financial Officer. You may begin.

Thank you. It's my pleasure. 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. Salim Yazgi. Today's call includes a business update and discussion of our first quarter-ended March 31, 2024 financial results that were filed earlier today. Today's press release and a replay of today's call will be available on the investor relations section of Alternals 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-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, May 9th, 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. Onc534, our novel dual-action androgen receptor inhibitor, or DARI, is advancing rapidly through the dose escalation portion of the Phase 1-2 study, and we continue to see high demand and engagement from KOLs, investigators, and patients. We believe that by interacting with both the ligand binding domain and the N-terminal domain of the androgen receptor, and by inducing degradation of the AR, Onc534 may address many prostate cancer escape mechanisms to approve AR pathway inhibitors, such as enzalutamide and abiraterone, including many LBD mutations and splice variants, such as ARV7. We have recently opened several top academic centers to join the Phase I-II study, and the investigators are enthusiastic. We are also happy to announce that the fourth dosing cohort of the study is now fully enrolled. Patients in this cohort are receiving 300 milligrams of ARN534 once per day orally. 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 those at the third dose level of 160 milligrams on 534 daily. Based on preclinical analyses, we are optimistic that study participants are receiving doses along 534 that may be within the active dose range for anti-tumor activity. We plan to share an initial clinical data update for this program late in the second quarter of this year. Now switching gears to 808, our ROAR-1 targeting ontologous CAR-T, we are also happy to announce that the Phase 1-2 study in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR treatment, is again open and enrolling patients. We'd like to thank the team and our investigators for the swift implementation of protocol amendments which include modified eligibility criteria, increased monitoring for infection, and evaluating lower doses. As a reminder, we recently shared an encouraging initial response signal at the one times 10 to the sixth CAR T cells per kilogram dose, with two of the three patients achieving complete metabolic response, and the third achieving a partial response. as of the December 4th cutoff date. We expect to report updated clinical results, including data from patients treated with the new dosing schedule in mid-2024. With this, I will now turn the call back to our CFO, Rich Vincent. Rich?