Oncternal Therapeutics, Inc.

Greetings and welcome to the internal Therapeutics Inc. Q3 2022 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, Mr. Richard Vincent, Chief Financial Officer. Please go ahead, sir.

Thank you very much, Ryan. 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. Selene Yazchi. Today's call includes a business update, and discussion of our results for the third quarter ended September 30, 2022, which will be followed by Q&A. Today's press release and the replay of today's call will be available on the investor relations section of Moncturnal's website for at least the next 30 days. Our 10Q for the third quarter 2022 is also available today. 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 potential for our Zillow 301 Phase III study to support a BLA submission, the timing of planned interim updates, the timing of our regulatory filings and submissions, and expected pre-IND feedback. 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, 2021. This call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 3rd, 2022. 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 Acturnal, we are advancing a focused and robust product pipeline with clinical and preclinical product candidates that target cancers for patients with unmet medical needs. The third quarter of 2022 was a pivotal one for Acturnal. First, we announced that we initiated the Xela-301 study, our Phase III clinical trial of Xelavertimab, aduabrutinib in patients with mantle cell lymphoma. As a reminder, Xela-301 is the first registrational study for a therapeutic targeting the important RoR1 pathway, which we believe can play a key role in addressing unmet needs in multiple hematologic and solid tumor indications. Second, we announced the receipt of a study may proceed letter from FDA just 30 days after submitting our IND application for a phase one, two dose escalation study of OCT808, our lead autologous CAR-T product candidate targeting RoR1. This study will be conducted in the U.S. in patients with aggressive B-cell lymphoma, including those who have failed previous CD19 CAR treatment, which represents a significant medical unmet need. Also this morning, we announced that results from our ongoing Phase I-II clinical trial with zolivertimab plus ibrutinib in patients with mantle cell lymphoma or chronic lymphocytic leukemia were accepted as an oral presentation at the American Society of Hematology annual meeting in New Orleans in December of this year. We are very honored by this selection, and we look forward to presenting updated study results, including extending the encouraging progression-free survival data for patients with CLL and p53 alterations receiving Xelabertamab and Abrutinib that we first presented at ASCO 2022. Finally, OCT534, our lead candidate for the Dual Action Androgen Receptor Inhibitor, or DARI program, continues to advance towards an IND filing, and we expect to have pre-IND feedback from the FDA in December of this year. We are optimistic that OCT534 may be a differentiated and novel treatment alternative for patients with advanced prostate cancer, as we believe it interacts with both the end-terminal domain and the ligand binding domain of the androgen receptor, inhibiting its function and inducing its degradation. Preclinical data has shown that OCT534 exerts anti-tumor activity in clinically relevant treatment-resistant prostate cancer models, including those with AR amplification and zalutamide resistance or androgen receptor splice variants, such as ARV7. each of which represents a significant unmet medical need for patients with prostate cancer. On the corporate front, we continue our focus on execution as we remain vigilant on our cash and resource usage, and we estimate we can fund our operations into the first half of 2024 with funds currently available. Let me now turn the call over to Uncterno's CMO, Salim Yazgi, to discuss the status of our Phase III study, ZELO-301, and the plans for the first inpatient study of our autologous CAR-T ANCT-808. Salim?