Celldex Therapeutics, Inc.

Hello. Welcome to CELF-DEX conference call and webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to turn the conference over to Sarah Kavanagh. You may begin. Thank you.

Good evening, and thank you all for joining us to discuss the latest results from our Phase 2 Barzavolumab Program in Chronic Spontaneous Cuticaria, or CSU, which are being presented tomorrow morning in a late-breaking oral presentation at the European Academy of Allergy and Clinical Immunology Congress in Glasgow, Scotland. The embargo on the study listed at the start of the call, and this evening we will be discussing the data set in full. Joining me on the call today are Anthony Marucci, Co-Founder, President, and Chief Executive Officer, Dr. Tibor Keller, Co-Founder, Executive Vice President, and Chief Scientific Officer, Dr. Diane Young, Senior Vice President and Chief Medical Officer, and Dr. Margot Hicciozzi, Senior Vice President of Regulatory Affairs. We are also very pleased to be joined by Dr. Martin Metz, Professor, Department of Dermatology and Allergy, Head of Translational Research, and Deputy Head of Clinical Trials at Charité University in Berlin. and the lead investigator for this study. Doctors Yang and Metz are joining us quite late from separate locations in Europe, and I really appreciate that. Please note the slides for tonight's call are available on the Investor Relations section of our website. Tomorrow at 4.12 a.m., when the oral presentation begins, the slides for the presentation will post on our website in the Science section under Publications. Again, the content we are discussing this evening covers the IYAKI presentation in its entirety. Before we begin our discussion, I'd like to direct your attention to slide two with respect to important information regarding the forward-looking statements that today's speakers will be making. Please be advised that a question and answer period will be held later in this call. I'd now like to turn the call over to Anthony.

Thank you, Sarah, and good evening, everyone. Thank you for joining us. In 2020, at the European Academy of Allergy and Clinical Immunology, we presented our first data from the Varzolomab program where we demonstrated that a single dose of Barzol is well tolerated and could profoundly and verbally reduce plasma triptanase, consistent with systemic mast cell suppression. In just five years, we have made remarkable progress. Barzol is now in phase three studies in CSU, enrolling patients around the world, and we are in phase two development in four other indications, chronic inducible urticaria, eosinophilic esophagitis, Virago modularis and atopic dermatitis. This year at IACI, the team will present data from our now completed phase two study in CSU that we believe clearly shows that Barzal is best in disease and can be broadly used for all patients suffering from moderate to severe CSU as shown on slide four. If CSU is a disease of misery and more effective treatment options are needed to help patients regain control of their lives. In this 76-week large randomized phase two study, Barzal consistently demonstrated the highest reported complete response rate in the field at every point in time. Patients experienced rapid complete responses as early as two weeks after the first dose. Response rates continue to deepen over 52 weeks of active treatment, and today we will show you that seven months after completing Barzol treatment, up to 41% of the patients continue to have a complete response. This is important because we know that having a complete response, which means no highs, no itch, is directly correlated with improved patient quality of life. Importantly, we are seeing this benefit across all patients on study, including patients with disease that hasn't responded to omalizumab. We believe this function of addressing the root cause of disease, the mast cell, which is exactly what we set out to do when we began development of Barzal. Barzal's unique profile and data is resonating with the medical community who need new treatment options for this terrible disease. In February of this year, we commissioned an outside research firm to conduct a survey across 205 allergists, dermatologists, nurse practitioners, and physician assistants in the United States who treat patients struggling with CSU. We learned, as you can see on slide five, that these providers largely ranked characteristics tied to efficacy and quality of life as the most important when choosing treatments for CSU. Healthcare provides for them the same survey indicated that approximately two-thirds of their patients with CSU have what they consider to be moderate to severe disease. As we go through the data tonight, I want to keep us in track and bring us back to the patients and the importance of quality of life because it is so often overlooked. As outlined on slide six, 92% of patients report their CSU impacts all aspects of their daily lives, and in a recent publication reported that patients with CSU also suffer from anxiety and depression and are at an increased risk for suicide compared to the general population. Current clinical guidelines recommend that achieving a complete response is the goal of treatment, and patients report that their disease has no impact on their quality of life when they have a complete response. Therefore, this is the goal for patients, for physicians, and for Celldex. To set the stage on slide seven before Diane walks us through the 76-week results, I want to remind you of how this trial data has progressed. First, an incredible 93% of patients on this study experienced a clinically meaningful reduction in disease burden and had either a complete response or milder disease symptoms during the active treatment period. As you can see over the timeline of this Phase II, we initially presented our 12-week data where we met all our primary and secondary endpoints for the study and showed complete response rates up to 51% compared to just 6% placebo. Later in 2024, we presented our 52-week data, and once again, we showed a remarkable complete response rate of up to 71%, which is the highest seen in a well-controlled global study. Tonight, we present our 76-week data set, and we couldn't be more excited about these data and what it means to patients and physicians. We believe we have developed a medicine of choice for all patients with moderate to severe CSU, And we look forward to confirming our data in Phase III studies now being conducted around the world. So, with this as a backdrop, let me ask Diane to walk you through the data in detail. Diane?