Celldex Therapeutics, Inc.

Welcome to the Celldex Therapeutics Mid-Year 2020 Conference Call. My name is James, and I'll be your operator for today's call. All participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the Q&A session, if you have a question, please press star 1 on your phone. And then I'd like to turn the call over to Sarah Cavanaugh. Teri, you may begin.

Thank you very much. Good afternoon, and thank you all for joining us. With me on the call today are Anthony Marucci, co-founder, president, and CEO of Celldex, Dr. Tibor Keler, co-founder, executive vice president, and chief scientific officer, Dr. Diane Young, senior vice president and chief medical officer, Sam Martin, senior vice president and chief financial officer, Dr. Margo Heath-Chiozzi, senior vice president of regulatory, and Dr. Diego Alvarado, senior director of research. Before we begin our discussion, I'd like to mention that today's speakers will be making forward-looking statements. Such statements reflect on current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Certain of the factors that might cause CELDX's actual results to differ materially from those in the forward-looking statements include those set forth under the headings Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations in CELDX's Annual Report on Form 10-K, quarterly reports on Form 10-Q and its current reports on Form 8-K as well as those described in CELDEC's other filings with the SEC and its press releases. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should carefully review all of these factors and be aware that there may be other factors that could cause these differences. These forward-looking statements are based on information, plans, and estimates as of this call and CELDEC does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors New information, future events, or other changes. Please be advised that the question and answer period will be held at the close of the call. I'd also like to mention that because of the current COVID-19 situation and also two of our offices are located in the areas of the hurricane, we do have folks dialing in from a number of different remote locations. And I ask that you bear with us if phone lines are a little scratchy because we're dealing with multiple issues on that end. So with that, I'd like to turn the call over to Anthony. Anthony?

Thank you, Sarah. Good afternoon everyone and thank you for joining us. We hope you are all safe and healthy and appreciate your taking the time to connect with us today. We are looking forward to updating all of you on our progress and providing more detail on our plans for the future. I want to take a few minutes to review the recent events and then I will ask Diane to update you on our clinical programs and Sam to review the financials. We will close the call with your questions. As you may likely know, in early June of this year, Dr. Marcus Maurer, a leading medical expert in urticaria whose research focuses on mast cells, presented data from our KIT inhibitor, CVX0159, in a late-breaking session at the EAA-CI Annual Congress. These data provided important proof of concept for the program and suggested significant potential to dramatically impact mast cell-driven disorders. These data also help support a $150 million public offering driven by high-quality healthcare investors. Importantly, these proceeds will fund the company through 2023 and a number of very important milestones. We are on track to initiate two studies of CDX-0159 and chronic urticaria this fall and have completed considerable work that Diane will discuss to support expanded development and 2021 and beyond. As we have always done, we believe it is important to focus our resources, both people and financial, on the programs that hold the most promise for patients and shareholders. Based on the current data we have in-house, we have prioritized the development of our kit inhibitor, CVX0159, our CVX40 agonist, CVX1140, and the first candidate for our bispecific program, CDX527, which combines our proprietary CD27 agonist with PD1 blockade. In turn, we have made the decision not to advance our ERB3 inhibitor, CDX3379, which has been in an exploratory study with cetuximab to assess the utility of biomarkers for patient selection in cetuximab-resistant head and neck cancer. Despite prophylactic treatment, which Diane will discuss in more detail, patients continue to have difficulty tolerating the therapy, and we believe our resources are best utilized to expand the development of CVX0159 and our other pipeline programs. For our CVX0159 program, we intend to start two urticaria studies, one in inducible urticaria and the other in spontaneous urticaria, this fall. and to initiate both the phase one study of CVX527 and refractory advanced cancers as well as a combination cohort of CVX1140 with chemotherapy and treatment of naive metastatic pancreatic cancer later this year. These programs will support multiple data readouts later this year and next year including results from the CVX0159 study and inducible uricaria in the first quarter of 2021, and the results from the study in spontaneous urticaria in the second half of next year. We are also in the midst of a thorough assessment of additional opportunities for CVX0159, and as we narrow this list, we plan to initiate a third study in another mast cell-driven disease next summer. With this introduction, I would like to ask Diane to cover these activities in more detail. Diane?