Xencor, Inc.

Good afternoon, ladies and gentlemen, and thank you for standing by. And welcome to the second quarter 2021 Zencore 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 over to your speaker for today, Charles Lyles, head of corporate communications and investor relations.

Thank you, and good afternoon. Earlier today, we issued a press release which outlines the topics we plan to discuss today. It's available at www.zencor.com. Today on our call, Basil Dahiat, President and Chief Executive Officer, will review recent business news and pipeline updates. John Desjardins, Chief Scientific Officer, will discuss our cytokine and CD28 programs, and John Cush, Chief Financial Officer, will review financial results. And then we'll open up the call for your questions, and Alan Yang, Chief Medical Officer, will join us then. Before we begin, I would like to remind you that during the course of this conference call, Zincor 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, including but not limited to those factors contained in the risk factors section of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. With that, let me pass the call over to Basil.

Thanks, Charles, and good afternoon, everyone. Zincor's approach to creating antibody and cytokine therapeutics uses our extensive protein engineering tools, centered on our plug-and-play XMAP FC domains to create novel molecular structures, improve natural protein and antibody functions, and create new mechanisms of therapeutic action. This approach enables us to rapidly explore different targets in biology so we can select the most promising programs to take forward. We've been focusing our work on the expansion and use of our XMAP bispecific platform to create antibodies that bind two or more different antigens simultaneously, and also to engineer cytokines with structures and binding affinities optimized for therapeutic use. These plug-and-play tools are highlighted in our partnerships. Currently, we have 16 ongoing partnerships for XMAP technology, which have resulted now in three marketed products, the most recent being Veer and Glasgow SmithKline's anti-SARS-CoV-2 antibody citrovimab. which recently received emergency use authorization for patients with mild to moderate COVID-19. Our Xtend FC technology was integrated into the antibody for the purpose of reducing the dose administered and potentially enhancing its lung tissue bioavailability. This partnership exemplifies our commitment to enabling the broad use of Xmeb FC technologies outside our core focus of oncology and autoimmune disease and demonstrates its applicability in vastly underserved areas like serious infectious diseases. In May, we also entered a similar licensing transaction with Bristol-Myers Squibb to incorporate extended anti-COVID antibodies that's currently in Phase II testing. Now, switching back to our internal programs, we're running nine Phase I or Phase II studies evaluating our own XMAP bispecific antibodies and cytokines. This way, we're taking multiple simultaneous shots on goal in the clinic. And the proof-of-concept data we're generating is guiding which programs we independently advance, which we partner, and which we will terminate. Further, we're continually feeding new molecules that we believe are differentiated into the clinic to keep our pipeline robust. So now I'll touch on the programs with recent updates. Very recently, we initiated a phase two study for XMAB717, our PD1 by CTLA4 dual checkpoint bispecific antibody. It's in patients with metastatic castration-resistant prostate cancer that we classify by molecular subtype. As a monotherapy or in combination, depending on the subtype, Now, we expect to present mature data from the ongoing Phase 1 studies expansion cohorts later this year, specifically in prostate cancer, renal cell carcinoma, and in a basket cohort of tumors without approved checkpoint therapies. We believe that metastatic prostate cancer is an indication with high unmet need and that currently is without much checkpoint inhibitor use. And we think it could benefit from a checkpoint inhibitor, particularly one with XMAP717's dual targeting of PD-1 and CTLA-4 and potentially differentiated tolerability profile. We're also planning new studies of XMAV717 and additional tumor types that we'll guide on later. Now, shifting to plimodimab, our CD20 by CD3 bispecific antibody, under our strategic clinical collaboration with Morphosis and Insight, we'll be investigating the chemotherapy-free triple combination of plimodimab with tafacetamab and lenalidomide in patients with certain lymphomas. Plumonumab's T-cell redirection to tumors and taphacitumab's enhanced ADCC tumor killing combine distinct immune pathways for anti-tumor effect, and we think the combination is a differentiated approach for treating patients with lymphoma. Now, we plan to initiate the first of these studies in patients with relapsed or refractory diffuse large B-cell lymphoma, an aggressive type of NHL, in late 21 or early 2022, once we finalize our recommended dose in our ongoing Phase I study and complete operational preparation for the multinational trial. We plan to present updated data from the ongoing Phase I study later this year. Now, for Tidutimab, our CD3 biospecific antibody that targets SSTR2, we've initiated a Phase II clinical study in patients with Merkel cell carcinoma and small cell lung cancer, which are SSTR2-expressing tumor types known to be responsive to immunotherapies. Later this year, the company plans to present updated data from the Phase I expansion cohort in patients with neuroendocrine tumors, including longer clinical follow-up and updated biomarker data. Last, I'll touch on XMAP819. Later this year, we anticipate submitting an IND for 819, our ENPP3 by CD3 bispecific for renal cell cancer, and we're planning on initiating a phase one study in early 2022. XMAP819 is engineered with reduced potency CD3 binding, as well as a multivalent 2 plus 1 bispecific antibody format, which has two antigen binding domains to the tumor target, providing for more selective binding to the high ENPP3 density expression on tumor cells compared to the lower density on normal cells. This binding selectivity of the XMAP 2 plus 1 format extends the range of targets amenable to CD3 bispecifics, especially solid tumor targets. Recall our partner Amgen's AMG509 program targeting STEEP1 and prostate cancer also uses this format. Now I'll turn it over to John Desjarlais, our CSO, to discuss our rapidly expanding cytokine drug portfolio and CD28 programs.