Oncternal Therapeutics, Inc.

Greetings. Welcome to the Oncternal Therapeutics, Inc. Second Quarter 2022 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 will now turn the conference over to your host, Rich Vincent, CFO. You may begin.

Thank you, Kyle. 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 2022 second quarter financial results, which will be followed by Q&A. Today's press release and a replay of today's call will be available on the investor relations section of of Oncternal's website for at least the next 30 days. Our 10Q for the second 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 study to support a BLA submission, the timing of planned interim data updates, and the timing of our regulatory filings and submissions, including our IND submission for ONCT 808. 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, August 9, 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 Bradmeier.

Thank you, Rich, and good afternoon, everyone. At Internal, we are advancing a focused and robust product pipeline with clinical and preclinical product candidates that target cancers for patients with unmet medical needs. During the second quarter of 2022, we made significant progress across our entire pipeline, including and encouraging data update at ASCO for my Phase I-II study of zolivertimab plus abrutinib in patients with MCL and CLL, which set... So I was saying that we were especially encouraged by our interim data from patients with P53-mutated CLL that we presented at ASCO. This is a challenging population to treat with current standard-of-care BTK inhibitor monotherapy, and the combination of zolivertimab plus abrutinib showed very robust progression-free survival. Also in support of our upcoming Phase III studies, ZELO301, we entered into a clinical trial collaboration and supply agreement with Pharmacyclics and AbbVie Company for their gracious donation of ibrutinib to support our global registrational program. This is an important milestone which further validates the clinical value of testing ibrutinib with zelovertamab. Next, OCT808, our autologous CAR-T therapy product candidate targeting ROR1, also continued to advance and is on track for an IMD filing this month. We are enjoying strong collaborations with our partners, which include the Dana-Farber Cancer Institute's Cell Manipulation Core Facility, along with Lentigen and Miltenyi Biotech. On the allogeneic or off-the-shelf front, our research collaborations with Cellularity and the Karolinska Institute continue to generate encouraging data for our next-generation ROR1-based cell therapies. Finally, OCT53, our lead candidate for the Dual-Action Androgen Receptor Inhibitor, or DARI, program, continued to advance toward an IND filing, and we expect to have pre-IND interactions with the FDA in the fourth quarter 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 N-terminal and the ligand-binding domains of the androgen receptor, inhibiting its function and inducing its degradation. Preclinical data have shown that OCT534 exerts antitumor activity in clinically relevant treatment-resistant prostate cancer models. including those with AR amplification and zalutamide-resistant or expressing androgen receptor splice variants, such as ARV7, all of which represent significant medical unmet needs for patients with prostate cancer. This broad advancement of our pipeline has occurred against the backdrop of a focused execution, vigilant resource cash management approach. Now let me turn the call over to our internal CMO, Salim Yaji, to discuss our Xelovertimab clinical data and phase three plans in more detail.