Oncternal Therapeutics, Inc.

Greetings and welcome to the oncternal second 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. And it is now my pleasure to introduce to you Richard Vincent, CFO. Thank you, Richard. You may begin.

Thank you, John. 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. Saleem Yazgi. Today's call includes a business update and discussion of our second quarter ended June 30, 2023 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 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 initiation of our preclinical and clinical studies, the timing of planned interim data updates, the timing of our 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, 2022. This call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 10th, 2023. 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. Mute, Jim.

Thank you, Rich, and good afternoon, everyone. At OCTURNL, we are now advancing two clinical stage programs targeting cancers for patients with significant unmet medical needs. Last week, OCTURNL announced that we received a study may proceed letter from the US FDA for the Phase 1-2 dose escalation study of OCT534 for patients with advanced prostate cancer. FDA's review of the IND application was completed before the standard 30-day review period, and our study startup activities are tracking ahead of schedule. With that, we expect to initiate our study in the third quarter and expect our initial clinical data readout in the first half of 2024. We are very excited to bring on 534 to patients suffering from advanced prostate cancer soon. As a reminder, our preclinical study results suggest that Onc534 is active against the most common androgen receptor aberrations that drive tumor resistance to currently approved AR signaling inhibitors, such as Xtandi or Zytiga. Our CMO, Celine Yazdi, will provide more details about the study design and ramp-up plans in a moment. With respect to our ROAR-1 targeting autologous CAR-T, Onc808, We are very pleased to report that the first patients have now been dosed and that enrollment is meeting or surpassing our expectations. We believe OCT808 may be a best-in-class ROR1 targeting CAR-T as it builds on our extensive clinical experience with zolivertimab, which was found to be safe in several Phase I and II studies. Preclinical models show robust and specific cytotoxic activity of OCT808 against ROR1-expressing cells from multiple tumor types. Clinical manufacturing runs completed to date continue to support our thesis that our manufacturing process is robust, reproducible, scalable, and shorter than several approved CAR T therapies. We continue to expect to announce some initial clinical data in late 2023 with additional clinical data readouts in 2024. Let me now turn the call over to Unkternel's CMO, Salim Yazgi, to expand on our clinical plans for ONC 534 and our progress with ONC 808. Celine?