11/7/2022

speaker
Conference Operator
Operator

Good day, and thank you for standing by. Welcome to the Zencore Q3 2022 conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Charles Lyles. Please go ahead.

speaker
Charles Lyles
Investor Relations

Thank you, and good afternoon. Earlier today, we issued two press releases which outlined the topics we plan to discuss today. The press releases are available at www.zencore.com. With me on the call are Basil Dahia, President and Chief Executive Officer, John Desjardins, Chief Scientific Officer, John Cush, Chief Financial Officer, and Alan Yang, Chief Medical Officer, Ralph Zitnik, Executive Medical Director and Head of Autoimmune, will join us for Q&A. On our agenda, we will first review recent business news and financial results, followed by the presentation of results from the Phase 1 Single Dose Study of XMAP564 in Healthy Volunteers. This slide should be visible on the webcast and are also available for download on the Events and Presentations page of our website. We will then open up the call for your questions after both the prepared remarks and presentation. Before we begin, I would like to remind you that during the course of this conference call, Zencore Management may make forward-looking statements, including statements regarding the company's future financial and operating results, future market conditions, the plans and objectives of management, future operations, the company's partnering efforts, capital requirements, future product offerings, and research and development programs. These forward-looking statements are not historical facts, but rather are based on our current expectations and beliefs and are based on information currently available to us. The outcome of the events described in these forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from the results anticipated by these forward-looking statements. Section of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. With that, I'll pass the call over to Pat.

speaker
Basil Dahia
President & Chief Executive Officer

Thanks, Charles. We'll focus today on our just-released XMAP 564 data and comment briefly on other topics. To frame the discussion, we've used our array of modular protein engineering tools to create a broad internal development portfolio in oncology and autoimmune disease and take multiple simultaneous shots on goal in the clinic. Our intent is to use proof-of-concept data from our early-stage studies to guide which programs we advance, which we terminate, and which we partner so that we use our resources on programs with the greatest potential for success and make room in our portfolio for the next wave of XMAP biospecifics and engineered cytokines. We're excited to share with you an important step along this journey, very promising biomarker data for 564, our second engineered cytokine program. But first, we'll briefly review upcoming data presentations for other programs and some business highlights. First, for Vidalimab, our Phase II PD-1 by CTLA-4 dual checkpoint bispecific antibody. It's enrolling a Phase II study for patients with metastatic castration-resistant prostate cancer after two prior lines of therapy. in combination with chemotherapy or a PARP inhibitor, depending on molecular subtype. It's an indication with a high unmet need and is currently without much checkpoint inhibitor use beyond MSI-high tumors, even though small studies of combination PD-1 and CTLA-4 inhibitions showed promise. Later this week at the Society for Immunotherapy of Cancer meeting, we will present some data from the first few handfuls of patients in the safety running portion of the study with a focus on patients receiving the combination of budalumab, a taxane, and a platinum agent. We're also conducting a second Phase II study with a more convenient every-three-week dosing schedule in patients with clinically defined high-risk metastatic castrate-resistant prostate cancer, which will allow us to study Vidaliband monotherapy in a specific population of aggressive prostate cancer where we saw confirmed partial responses in our Phase I study. We're also enrolling cohorts of patients with advanced gynecologic tumors. Now, for Plimodimab, our CD20 by CD3 bispecific, as you probably saw, an abstract was accepted for presentation at the American Society of Hematology annual meeting in December. We'll present updated clinical results from the expansion cohort in a Phase I study for patients with non-Hodgkin's lymphoma. We've observed that Plimodimab has remained generally well-tolerated with encouraging monotherapy activity. In addition, we've initiated a cohort to study subcutaneous dosing. We also continue to enroll patients in a Phase II combination study with tafacitumab and lenalidomide. Now, with that, I'll turn it over to John Cush to provide a brief financial update. Thank you, Basil.

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