Aurinia Pharmaceuticals Inc

Good morning, and welcome to ARINIA's ARIT Intercept Phase 1 Study Results Conference Call. Please be advised that a Q&A session will follow ARINIA's prepared remarks. You may be placed at the question queue at any time by pressing star 1 on your telephone keypad, and we ask you please limit yourselves to one question and one follow-up. I will now turn the call over to Peter Greenleaf, Chief Executive Officer of ARINIA. Please go ahead, sir.

Good morning. Thank you all for joining us to discuss the results from our ARIT Intercept Phase 1 Single Ascending Dose Study. ARIT Intercept has been previously referred to as AUR 200. Joining me on the call today are Dr. Greg Keenan, our Chief Medical Officer, and Joe Miller, our Chief Financial Officer. Before beginning our discussion, I'd like to direct your attention to slide two, which contains important information regarding forward-looking statements. With that introduction, let me now turn the call over to Dr. Greg Keenan to walk you through the R-Tintercept Phase 1 study results. Greg?

Thank you, Peter. It's a pleasure speaking with you today about R-Tintercept and the results of our Phase 1 single ascending dose study. R-Tintercept is a dual BAP April inhibitor. It contains a BCMA-engineered extracellular binding domain optimized for for superior affinity to BAF and APRIL. Other dual BAF and APRIL inhibitors use TASI-engineered extracellular binding domains. DCMA has a stronger natural affinity for APRIL than TASI. RX-intercept also contains an IgG4-FC domain with no appreciable effector function. Other dual BAF-APRIL inhibitors use IgG1-FC domains IgG4 is considered the least inflammatory across the IgG subclasses, in part because it poorly activates the complement system. Before we talk about our RRT intercept results, just a few words on the important roles of BAF and APRIL in the immune system and why modulating these cytokines may be a good treatment approach for a wide range of autoimmune diseases. Both of these cytokines regulate B-cell survival and differentiation, with BAF more targeted at differentiating and mature B-cells, and APRIL more targeted at plasma cells. Thus, targeting both BAF and APRIL depletes a broader set of B-cells, including plasma cells, than targeting a single cytokine. ART Intercept may prevent the activation of autoreactive B-cells and reduce their numbers and associated immune globulins in the body, thereby reducing important drivers of B-cell-mediated autoimmune diseases. Aritintercept has high binding affinity for both BAF and APRIL. As you can see in this slide, when compared in in vitro studies to atacicept and telatacicept, two BAF APRIL inhibitors from other sponsors, aritintercept has three to eight-fold higher binding affinity. Additionally, as you can see in this slide, R-Atenercept potently inhibits both BAF and APRIL-mediated B-cell proliferation as compared to the competitor dual BAF-APRIL inhibitors. Compared to Atacicept and Telatacicept, R-Atenercept is six to 53-fold more potent at inhibiting BAF and APAL-mediated B-cell proliferation. On this side, you can see our results in non-human primates. R-Atenercept reduced the immunoglobulins IgA, IgM, and IgG by up to 76, 67, and 43% respectively. R-Atenercept was well-tolerated with no adverse findings in any of the doses tested. Moving to our phase one results, we enrolled 61 healthy subjects in a standard single ascending dose study design. Subjects were treated with placebo for one of six subcutaneous doses of our tintercept, 5, 25, 75, 150, 225, and 300 milligrams. You can see our safety results on this slide. R-intercept was well-tolerated, all dose levels tested. There are no treatment-related grade 3 or higher adverse events. There were no treatment-related serious adverse events, and there were no discontinuations due to treatment-related adverse events. There was one SAE, a concussion, due to a motor vehicle accident reported as not treatment-related. Adverse events that occurred in more than one subject were Injection site reactions, which occurred in 24% of subjects who received ART intercept versus 13% of subjects who received placebo. All injection site reactions were grade one. Headaches, which occurred in 11% of subjects who received ART intercept versus 7% of subjects who received placebo. Upper respiratory tract infection, which occurred in 7% of subjects who received ART intercept versus 0% of subjects who received placebo. and back pain, which occurred in 4% of subjects who received RRT intercept versus 0% of subjects who received placebo. This slide depicts the pharmacokinetic curves of subcutaneous RRT intercept, a half-life of six to eight days after a single dose in the target dose range was observed. On this slide, you can see the pharmacodynamic effects of ART intercept treatment. Single doses of ART intercept led to robust and long-lasting reductions in immunoglobulins. Specifically, mean reductions from baseline to day 28 of up to 48, 55, and 20% were observed for IgA, IgM, and IgG, respectively. Importantly, we believe these long-lasting pharmacodynamic effects support once-monthly dosing. On the next three slides, we provide some comparative results to provide context. Please note that these are cross-trial comparisons and therefore should be interpreted with caution. On this slide, you can see that our tintercepts effect on IgA compares favorably to that for BAF april inhibitors from Vertex, Vera, and Remigen as well as Otsuka's anti-APRIL. On this slide, you can see the same comparison for IgM. Again, R-T-intercept compares favorably. And finally, on this slide, you can see the same comparison for IgG, with R-T-intercept again comparing favorably. With this, I will turn the presentation back over to Peter.