Oncternal Therapeutics, Inc.

Greetings. Welcome to the Oncturnal Therapeutics, Inc. Q3 2021 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. Thank you. You may begin.

Thank you, Alex. Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Brett Meyer, and our CMO, Dr. Celine Yazzie. We welcome all of you. Today's call includes a business update and discussion of our 2021 third quarter financial results and upcoming milestones, which will be followed by Q&A. Today's press release and a replay of today's earnings call will be available on the investor relations section of Oncternal's website for at least the next 30 days. We also filed our 10-Q for the third quarter 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 and future financial and operating performance. 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 10Q for quarter ended September 30, 2021. This conference call contains time sensitive information that is accurate only as of the date of this live broadcast, November 4th, 2021. We undertake no obligation to revise or update any forward looking statements to reflect events or circumstances occurring after the date of this conference 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 Internal, we are committed to developing novel treatments for patients with cancer who have critical unmet medical needs. We're advancing a recently expanded and robust product pipeline with clinical and preclinical product candidates that target several such cancer indications. Our development efforts focus on biological pathways implicated in cancer genesis and progression. I'd like to discuss ROR1 first. We believe we have one of the most advanced and diverse pipelines targeting ROR1 based on our deep expertise and experience with this target. Our lead asset, ROR1-inhibiting antibodies, Sermtuzumab, we're announcing today has a new generic name, and its INN will be Zelovertumab from now on. we will be presented updating results from our ongoing Phase 1B2 clinical trial with zelovertamab plus ibrutinib in patients with mantle cell lymphoma or chronic lymphocytic leukemia at the American Society of Hematology Annual Meeting in Atlanta in December of this year. You may have noticed that interim results in our abstract, which were based on June data, are available as of today on the ASH website, and we look forward to presenting updated data during our ASH poster presentation on December 13th. Our ongoing interactions with the U.S. FDA regarding potential registration pathways for zolivertimab are progressing well, and we expect to agree on a pivotal study design for patients with mantle cell lymphoma, MCL, in the coming months. ROR1 remains an increasingly visible target in the oncology space since it was the subject of M&A activity, including the acquisition of VELUS-Bio by Merck & Company and NBE Therapeutics by Behringer. VLS-101, which is now known as MK2140, is VELUS-Bio's ROR1-targeting antibody drug conjugate, or ADC, and was originally invented and developed at Unternal. This ADC utilizes zolivertumab as the ROAR-1 targeting moiety. We also continue to collaborate on two investigator-sponsored clinical studies of zolivertumab at UC San Diego. First, a Phase 1B clinical trial of zolivertumab in combination with paclitaxel, for the treatment of women with HER2 negative, metastatic, or locally advanced unresectable breast cancer has completed enrollment. Second, a phase two clinical trial of Xelovertimab in combination with the Venetoclax, a BCL2 inhibitor, in patients with relapsed refractory CLL is ongoing and enrolling patients. With respect to our ROAR-1 targeting cell therapy programs, we continue to advance them toward the CLINICUS plan. For our lead autologous CAR-T program, for which we have selected ONC 808 as the lead, we have made tremendous progress in GMP process development with our CDMO collaborators and are completing IMD supporting preclinical studies with leading academic institutions to enable the submission of the first IND in the first half of 2022. We also made progress regarding potential second-generation allogeneic cell therapy programs. We established a partnership with Cellularity to evaluate placental cell-derived therapies targeting ROAR1, and we strengthened our partnership with the Karolinska Institutet in Sweden including recently joining NextGenNK, the institute's competence center for the development of next-generation NK-based cancer immunotherapies. We also recently announced that we have engaged a group of industry-renowned experts in the cell therapy field to serve as our cell therapy scientific advisory board. and to support our efforts to bring safer and effective RoR1 targeting cell therapies to patients faster. We at Oncternal and our newly formed SAB are very excited about the potential of our cell therapy programs targeting RoR1, which may allow for the selective targeting of tumor cells that express RoR1 while relatively sparing healthy tissues. In another program, we also advanced the development of ONCT216, which was formally designated TK216, our investigational targeted small molecule inhibitor of the E26 transformation-specific or ETS family of oncoproteins. We look forward to the oral presentation of an interim clinical data update next week at the Connective Tissue Oncology Society, or CTOS, 2021 virtual annual meeting. The additional phase two expansion cohort is now open and enrolling Ewing sarcoma patients and is evaluating single agent OCT216 using an intensified dosing regimen designed to increase the amount of OCT216 that it has administered over time. Now, I'd like to provide an introduction to the latest addition to our pipeline. We have designated OCT534 as the lead candidate in our preclinical dual-action androgen receptor inhibitor, or DARI, D-A-A-R-I, program. OCT534 was originally developed by the University of Tennessee and was acquired by Oncternal as part of our reverse merger with GTX in 2019. A substantial body of evidence from in vitro and in vivo studies has been developed that strongly suggests that OCT534 is active on both the N-terminus and the ligand binding domains of the androgen receptor in addition to causing degradation of the receptor. The molecule is active in preclinical prostate cancer models that are resistant to current standard of care therapies, such as enzalutamide and abiraterone. We believe ONC534 may have the potential to address the significant unmet need for men with prostate cancer caused by tumor resistance mechanisms, including those involving expression of androgen receptor splice variants such as ARV7. With that, I will now turn the call over to Rich Vincent to review our financial results and upcoming milestones.