Oncternal Therapeutics, Inc.

Greetings and welcome to Ongtanal Therapeutics Inc Q4 2021 Financial Results Conference 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, CFO of Ontanil Therapeutics, Inc. Please go ahead, sir.

Thank you, Peter. 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. Selim Yazgi. Today's call includes a business update and discussion of our 2021 fourth quarter and full year 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 Ontario's website for at least the next 30 days. We filed our 10-K for the full year 2021 earlier 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 VLA 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 after the date of this live broadcast, March 10, 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's my pleasure to hand the call over to our CEO, Dr. Jim Breitmaier.

Thank you, Rich, and good afternoon, everyone. At Uncturnal, we are advancing a diversified and robust product pipeline with clinical and preclinical product candidates that target cancers with unmet medical need. During the fourth quarter of 2021, we made significant progress in the development of our entire pipeline, including Zolivertimab, our investigational potentially first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1, otherwise known as receptor tyrosine kinase-like orphan receptor 1. We reached consensus with the FDA on the design and key elements of our planned global phase 3 study, ZELO301, designed to treat patients with relapsed or refractory mantle cell lymphoma with Xelovertimab in combination with Abrutinib. And we also received positive feedback from the agency on the key elements of our Xelovertimab development program. We expect to initiate the phase three study in the second quarter of 2022. Our commitment to this study and the positive developments on the regulatory front were all supported by clinical data from our ongoing phase one, two clinical trial of zolivertamab plus ibrutinib for patients with MCL or CLL, with efficacy and safety data that are encouraging compared to historical results with ibrutinib alone. Our CMO, Celine Yazzie, will summarize these exciting clinical results in a moment. We also made progress in our cell therapy program. We selected OCK808, an autologous CAR-T targeting ROR1, as our lead candidate. the lentivirus manufacturing campaign is progressing to plan at Lentigen, and we have very encouraging results for the number of expanded T cells, the CAR expression, and the T cell phenotype for the potential GMP CAR-T cell generation process development program. We had a very productive pre-IND meeting with the FDA, and IND enabling preclinical work is on track for a mid-2022 IND submission. Salim will also discuss the plan clinical development plan for our lead candidate. Research collaborations with Cellularity and with the Karolinska Institute continue to generate supportive data for our next generation off-the-shelf ROR1-based cell therapies. We are also very excited about OCT534. our lead candidate androgen receptor or AR inhibitor. At our R&D day in January, we presented detail about OCT534's novel mechanism of action as a dual action androgen receptor inhibitor or DARI, D-A-A-R-I, which also induces degradation of the androgen receptor. Our DARIs appear to be highly differentiated as we believe they interact with both the N-terminal domain, or NTD, and the ligand binding domain, or LBD, of the AR, inducing AR inhibition and degradation. Preclinical data presented at the AACR NCI EORTC Virtual International Conference on Molecular Targets showed that OCT534 exerts anti-tumor activity in clinically relevant prostate cancer models, including those with AR amplification, enzalutamide resistant, or that express androgen receptor splice variants, such as ARV7. These data suggest that OCT534 could play an important role in addressing unmet needs for prostate cancer patients with advanced treatment-resistant disease. Finally, We presented interim clinical data from the ongoing Phase 1-2 study of OCT216, our investigational targeted small molecule inhibitor of the E26 transformation-specific, or ETS, family of oncoproteins, at the CTOS 2021 virtual annual meeting. Two patients with relapsed refractory Ewing sarcoma continue to enjoy durable complete responses. including one patient who had a CR for 24 months on treatment and continues to have no evidence of disease off treatment after several months. We continue to explore optimizing the ONC216 treatment regimen for patients with Ewing sarcoma and are currently enrolling a new cohort of patients being treated with single-agent ONC216 using an intensified dosing schedule. Let me now turn over to our internal CMO, Dr. Saleem Yashi.