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Xencor, Inc. (XNCR)
Q1 2018 Earnings Conference Call
May 7, 2018 16:30 ET
Josh Rappaport - Stern, IR
Bassil Dahiyat - President & CEO
John Desjarlais - Chief Scientific Officer
John Kuch - VP, Finance
Edward Tenthoff - Piper Jaffray
Arlinda Lee - Canaccord Genuity
David Nierengarten - Wedbush Securities
Previous Statements by XNCR
» Xencor's (XNCR) CEO Bassil Dahiyat on Q4 2017 Results - Earnings Call Transcript
» Xencor's (XNCR) CEO Bassil Dahiyat on Q3 2017 Results - Earnings Call Transcript
» Xencor's (XNCR) CEO Bassil Dahiyat on Q2 2017 Results - Earnings Call Transcript
At this time, I would like to turn the call over to Josh Rappaport of Stern Investor Relations. Please proceed.
Thank you, operator. Good afternoon, this is Josh Rappaport with Stern Investor Relations. Welcome to Xencor's first quarter 2018 financial results conference call.
Earlier this afternoon, we issued a press release which outlines the topics we plan to discuss today. The release is available at www.xencor.com. Today, on our call, Bassil Dahiyat, Ph.D., President and Chief Executive Officer, will discuss the Company's business highlights and provide an update on Xencor's clinical programs; John Desjarlais, Chief Scientific Officer, will discuss preclinical progress; and John Kuch, Vice President of Finance, will review the financial results from the first quarter of 2018. Then, we will open up the call for your questions.
Before we begin, I would like to remind you that during the course of this conference call, Xencor 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 for future operations, the Company's partnering efforts, the Company's capital requirements, the Company's future product offerings, and the Company's research and development programs. These forward-looking statements are not historical facts, but rather are based on Xencor's current expectations and beliefs and are based on information currently available to us. The outcome of the events described in these forward-looking statements is 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 sections of Xencor's 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 Bassil.
Thanks, Josh, and good afternoon, everyone. The core of Xencor's approach to creating antibody therapeutics is our XmAb engineering platform.
By making small changes to an antibody structure, especially it's Fc domain, we can improve it's natural functions and performance. The plug and play nature of this small suite of XmAb Fc domains that we've created allows us to engineer nearly antibody to have improved potency, longer half-life or bispecific structure. This flexibility and portability enables us to shake multiple shots on goal simultaneously to generate proof-of-concept data, helps from which programs we will independently advance, which we will partner and which we would terminate. These accomplishments in the first quarter, both internally and by our partners demonstrate this approach. Since the last quarters call, we announced the addition of our new XmAb IL15 bispecific platform at the American Association for Cancer Research annual meeting which will enable the rapid development of target T-cell activators. Our partners, Alexion and MorphoSys, each reported positive late-stage clinical data validating the safety and clinical utility of our Fc domains. And we raised roughly $245 million to fund our development efforts beyond 2022.
Looking ahead, we expect to announce initial data from two ongoing clinical trials in 2018; our Phase 2 trial of XmAb5871 in Systemic Lupus Erythematosus or SLE; and Phase 1 results from our first bispecific oncology candidate, XmAb14045 while continuing to expand our clinical and research stage pipelines. Specifically before the end of the year we expect to initiate our first Phase 3 trial of XmAb5871 in IgG-4 related disease or IgG4-RD and Phase 1 trial of XmAb20717, our most advanced tumor micro-environment activator. We also plan to file two investigational new drug applications for additional tumor micro-environment activators, XmAb's 22841 and 23104.
With that, I'll transition to discuss our clinical efforts in greater detail beginning with our lead program, XmAb5871. 5871 is a first-in-class monoclonal antibody that targets CD19 with it's variable domain and uses our XmAb immune inhibitor Fc domain to target FcyRIIb, a receptor that inhibits B-cell function. We're currently evaluating 5871 in two indications; IgG4-RD and SLE, both of which have a strong rationale for B-cell inhibition and represent areas of high unmet need. I'll first talk about IgG4-RD. As you've heard, it's described before; it's a newly defined fiber inflammatory autoimmune disease, it typically affects multiple organs, causes tumor-like swellings and a variable degree of fibrosis and potentially irreversible organ damage. It's characterized by a lypmhoplasma-setic [ph] infiltrate the effected organs rich in IgG4 positive plasma cells, hence the name. There are no therapeutic options of proof of the approximately 40,000 affected in the U.S. and corticosteroid are the standard-of-care.
Now based on positive final data from our Phase 2 trial of 5871 and IgG4-RD, majority of all patients who completed the study achieved a primary endpoint of at least a two point reduction in the IgG4-RD responder index and 8 patients received disease remition; we believe we may be able to provide the first therapy of proof specifically through achievement of IgG4-RD. Because there is no regulatory precedence for an approval pathway in IgG4-RD we have engaged with the U.S. Food & Drug Administration and the European Medicines Agency to design the most appropriate Phase 3 program and based on these discussions we plan to initiate a randomized placebo-controlled double-blinded Phase 3 study to evaluate the addition of 5871 to standard-of-care in approximately 200 to 250 patients with IgG4-RD in the second half of this year.