Oncternal Therapeutics, Inc.

Greetings and welcome to internal therapeutics and third 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 a 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. You may begin.

Thank you, Doug. Good afternoon, everyone, and thank you for joining us today as we cover our first quarter 2022 earnings. 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 first 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 Oncturnal's website for at least the next 30 days. We filed our 10Q for the first quarter of 2022 earlier today as well. 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. 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, May 5th, 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 Uncternal, we are advancing a focused and robust product pipeline with clinical and preclinical product candidates that target cancers for patients with unmet medical need. During the first quarter of 2022, we further sharpened our focus on the achievement of key pipeline catalysts in hematologic malignancies in prostate cancer as we navigated an unprecedented, challenging macroenvironment, which is obviously continuing in the second quarter, including today's stock market events. We made significant progress toward the initiation of our global phase three registrational study, ZELO301, for zelovertamab in patients with mantle cell lymphoma, which is planned to be initiated in the third quarter of 2022. Zelovertamab is our investigational, potentially first-in-class humanized monoclonal antibody that inhibits receptor tyrosine kinase like Orphan Receptor 1 or ROR1, function by binding with high affinity to a biologically important epitope on the receptor. We continue to evaluate additional countries and study sites for the Phase III study to ensure robust enrollment as we mitigate disruptions caused by the situation in Ukraine. As a reminder, we reached consensus with the FDA on the design and major details of the ZILO 301 study plan, which is supported by encouraging data from our ongoing Phase I-II clinical trial of zolivertimab in combination with ibrutinib, the SURL study. We look forward to providing a data update on that study at this year's American Society of Clinical Oncology meeting in Chicago in June 2022. Our autologous CAR T-cell program targeting ROR1, ONCT808, also continues to advance and is on track for an IND filing in mid-2022. In our initial Phase I study, we plan to enroll patients with relapsed or refractory hematologic malignancies, including those who have failed CD19 CAR T-cell therapy. We established a clinical manufacturing agreement with the Dana-Farber Cancer Institute to conduct collaborative CGMP process development and manufacturing activities for use in our upcoming first in human studies. Our partners at the Dana-Farber have some of the best cell manufacturing facilities in the world and proved to be a perfect fit with the cell processing technology we selected for our ROR1 CAR-T program. Research collaborations with Cellularity and with the Karolinska Institute continue to generate encouraging data for our other next-generation off-the-shelf RoR1-based cell therapy program. Next, ONCT534, the lead candidate of our dual-action androgen receptor inhibitor, or DARI program, continues to advance toward IND-enabling studies. ONCT534 may be a highly 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 anti-tumor activity in clinically relevant prostate cancer models, including those with AR amplification and zalutamide resistance, or tumors expressing androgen receptor splice variants, such as ARV7, all of which represent significant unmet medical needs for patients with prostate cancer. Finally, we announced the deprioritization of development of our E26 transformation-specific, or ETS, inhibitor, OCTU16, along with the discontinuation of enrollment in the Phase I-II study evaluating ONC-216 in patients with relapsed or refractory Ewing sarcoma. This resource reallocation will allow us to further focus on hematologic malignancies and prostate cancer, while deploying our capital toward meaningful catalysts, especially those related to our lead asset, Z-loverdomast. Let me now turn the call back to our internal CFO, Rich Vincent.