Oncternal Therapeutics, Inc.

Greetings, and welcome to the Unkternal Therapeutics first quarter 2023 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Richard Vincent, Chief Financial Officer.

Thank you, Joe. 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, 2023 financial results that were filed earlier today, 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 Longternal's 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 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 are 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, May 4th, 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.

Thank you, Rich, and good afternoon, everyone. At Oncternal, we are advancing a focused and robust product pipeline with clinical and preclinical product candidates that target cancers for patients with unmet medical needs. We recently announced a strategic reprioritization to focus on advancing our ROR1 targeting cell therapy, Onct808, and our novel dual-acting AR inhibitor, ONC534, towards significant clinical catalysts within the next 12 to 18 months. At the same time, on April 3rd, we decided to close with our Phase I, II, and Phase III studies of zolivertimab in combination with ibrutinib due to major shifts in the ibrutinib's tyrosine kinase inhibitor landscape. which was followed by an announcement by our partner of their plans to withdraw Ibrutinib's FDA accelerated approval in mantle cell lymphoma. This decision allowed us to extend our expected cash runway into 2025 and reinforces our mission to address important unmet needs for patients with hematologic malignancies and prostate cancer. Looking to the future, we are very excited about the clinical potential of our ROR1-targeting autologous CAR-T, ANKD808, which is being investigated in a recently-initiated Phase I-II clinical trial. ANKD808 leverages our extensive clinical experience with zolverinab, which was found to be safe in several Phase I and II studies. Specificity for tumor cells is also suggested by data from clinical testing of xelovertamab vedotin, an antibody drug conjugate, using the same targeting antibody, which has shown that RoR1 can be targeted without unwanted off-tumor, on-target activity. Our preclinical models show robust and specific cytotoxic activity of ONKT808 against RoR1-expressing cells from multiple tumor types. Our manufacturing process is reproducible, scalable, and only eight days in duration. As previously guided, we expect our initial clinical data readout in late 2023 with additional clinical data readouts in 2024. Our ONC 808-101 Phase 1-2 study will enroll patients with relapsed or refractory aggressive B-cell lymphoma including those who have failed previous CD19 CAR T therapy. In phase one, increasing doses of Onc808 CAR T cells will be evaluated to help us determine the recommended phase two dose using a standard three plus three dose escalation design. The starting dose will be one times 10 to the sixth CAR expressing T cells per kilogram, and this dose has potential to exert anti-tumor effects considering that other CAR-T products can be effective at similar doses. Phase two of the study will investigate the recommended phase two dose using assignment two stage design, which will help us to further evaluate the safety and efficacy of OncDataway. As a reminder, patients who have failed CD19 treatment have extreme unmet medical need with little likelihood of responding to the next treatment and median progression-free survival of only three months and overall survival of only five months. We are also very enthusiastic about our novel and first-in-class dual-action androgen receptor inhibitor, OCT534, which both inhibits AR activity and induces its degradation. We have now concluded IND-enabling studies and we are assembling the IND and are on track for submitting it in mid 2023. Preclinical models suggest activity directed to both the N-terminal and ligand binding domains of the AR. ONC 534 is active against preclinical models of the most common forms of resistance to current standard of care AR-directed therapies, including AR amplification, LBD mutations, and AR splice variants that are constitutively active even though lacking the LBD. A Phase I-II clinical trial in patients with metastatic castration-resistant prostate cancer who are resistant to AR inhibitor treatment is expected to open shortly after the IND is cleared. We expect to present initial clinical results in mid-2024. Let me now turn the call back to Internal CFO, Rich Vincent.