Xencor, Inc.

Good afternoon. Thank you for standing by and welcome to Zencore's fourth quarter and year-end 2022 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that this call is being recorded at the company's request. Now, I would like to turn the call to your speaker today, Charles Lyles, Head of Corporate Communications and Investor Relations. Sir, please go ahead.

Thank you, and good afternoon. Earlier today, we issued a press release which outlines topics we plan to discuss today. The press release is available at www.zencore.com. With me on the call are Basil Zahief, President and Chief Executive Officer, Alan Yang, Chief Medical Officer, John Deserlais, Chief Scientific Officer, and John Cush, Chief Financial Officer. After we make a few comments, we will then open up the call for your questions. 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. 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, including but not limited to those factors contained in the risk factor 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 Basil.

Thanks, Charles, and good afternoon, everyone. We've used our array of modular protein engineering tools to create our internal development portfolio in oncology and autoimmune disease and we use the breadth of this portfolio to 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 can use our resources on programs with the greatest potential for success and make room in our portfolio for the next wave of XMAP bispecifics and engineered cytokines. In addition, we use revenues from our partnership portfolio to support our development. Here's a few pipeline highlights from 2022. For Vudalamab, we continued our Phase II study in metastatic castration-resistant prostate cancer in combination with standard chemotherapy or PARP inhibitor, and we initiated a monotherapy Phase II in MCRPC and in gynecologic tumors, which are just some of the tumor types where PD-1 and CCLA-4 bispecifics have potential. And in November, we reported encouraging single ascending dose data for XNAB564, a regulatory T-cell-targeted IL-2 for autoimmune disease, particularly the strong durability of Treg expansion. As a consequence, we've started the multiple ascending dose study in atopic dermatitis and psoriasis patients to explore extended dosing regimens. We hope to have the psoriasis arms of the study finished by early 2024. And we started phase one studies for two novel T-cell engaging bispecifics. The first was XMAB819, which targets CD3 and ENPP3, an antigen and renal cell carcinoma that was built with our And we built the molecule with our 2 plus 1 format for improved tumor selectivity. We believe 819 offers a new mechanism against a barely explored target with a high unmet need in second and later line RCC. The second T cell engager to start clinical studies was XMAB 808, our first CD28 targeting bispecifics. It co-stimulates T cells when it's bound to its tumor target, B7H3, a widely expressed solid tumor antigen. Exciting early data for CD28 bispecifics has increased our already high enthusiasm to develop this new class of immunotherapies. And we're continually building the next wave of drug candidates with our engineering tools and try to tackle new or hard-to-address biology with them. Two such programs are advancing this year, led by the expected Phase I initiation for our third reduced-potency cytokine, XNAV662, an engineered IL-12, and followed by IND filing for XNAV541, a 2 plus 1 CD3 bispecific targeting Clouden 6 for ovarian cancer. With the well-balanced portfolio of late and early stage programs in development that we can potentially advance to approval and ultimately the market if the data supports it. Our development pipeline gets strong support from our broad alliance portfolio, not just from the revenues it generates, but also from the resources of our co-development partners, those programs that we have partnered. Now, the last of my remarks is that we are in the midst of completing our laboratory and office relocation to Pasadena, where our new facility can accommodate our expanded R&D efforts and will help keep us at the cutting edge of protein engineering. With that, I'll turn the call over to Alan Yang, our Chief Medical Officer, who will review recent updates from a few of our ongoing clinical studies for wholly owned programs.