Celldex Therapeutics, Inc.

ladies and gentlemen this is the operator today's conference call will begin in two minutes until that time your lines will again be placed on hold thank you for your patience again ladies and gentlemen this is the operator today's conference call will begin in two minutes until that time your lines will again be placed on hold thank you for your patience Thank you. Thank you. Ladies and gentlemen, thank you for standing by and welcome to the Celltex Therapeutics year-end 2021 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. To ask a question during the session, you will need to press star 1 on your telephone. please be advised that today's conference call is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Sarah Cavanaugh. Thank you. Please go ahead.

Good afternoon, and welcome to the Celldex Therapeutics fourth quarter and full year 2021 financial results and corporate update conference call. Just to remind everyone, certain matters discussed in today's conference call and or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties relating to future events and or the financial future performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. The risk factors that may affect results are detailed in Celldex's most recent filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2021, which can be found on our website, celldex.com, or on sec.gov. A question and answer session will follow the formal presentation. As a reminder, the call is being recorded. Our press release and the slides that accompany today's call are posted on our website. I will now turn the call over to Anthony Marucci, CEO of Celtics Therapeutics. Please go ahead, Anthony.

Anthony Marucci Thank you, Sarah. Good afternoon, everyone, and thank you for joining us. On today's conference call, we are excited to provide a recap of our recent progress and discuss our ongoing development plans in more detail. Joining me on the call today are Dr. Tibor Keller, co-founder and chief scientific officer, Dr. Diane Young, senior vice president and chief medical officer, Dr. Margot Hicciosi, senior vice president of regulatory affairs, and Dr. Diego Alvarado, our executive director of research, are also joining us remotely from our New Haven office for Q&A. We had a very strong year in 2021 with promising clinical data across our programs and follow-on offering that further secured our balance sheet, providing us with an expected cash runway through the end of 2025. In July 2021, we reported positive data from our lead candidate, CDX0159, a unique mast cell depleting antibody. The Phase I and chronic-inducible urticaria results were presented during a late-breaking poster discussion session at the IACI Annual Congress and demonstrated that patients experienced a 95% complete response rate and an overall response rate of 100% after only a single dose of 0159. These responses were rapid and durable with a favorable safety profile. Importantly, we validated our serum biomarker, tryptase, by demonstrating correlation with depletion of skin mass cells and with the clinical endpoints. In September of 2021, at the EADV Congress, we further bolstered these results when we reported additional data demonstrating notable improvements in symptom control and quality of life for the patients on study. In total, these data are unprecedented in this patient population and clearly demonstrate that O159 has the potential to become an important new treatment option for patients suffering from chronic inducible urticaria. In the latter part of 2021, we initiated two additional studies for CDXO159. The first, a phase one healthy volunteer study with our subcutaneous formulation And the second was the initiation of CDX0159 and perigo nodularis in a Phase 1b placebo-controlled study. Today we are pleased to report positive results from our Phase 1 subcutaneous formulation of CDX0159 in healthy volunteers. Subcutaneous administration of CDX0159 eliminated the mild infusion reactions observed in some individuals dosed with the IV formulation, and we were very pleased that none of the volunteers had injection site reactions as sometimes observed with subcutaneous formulations. The study also demonstrated favorable pharmacokinetic and pharmacodynamic properties, supporting the use of the subcutaneous formulation in our upcoming Phase II studies in CSU and Sindhu, as well as other indications moving forward. The successful development of the CDXL159 subcutaneous formulation is a key step forward in the development of this program as it offers a convenient administration route for patients and physicians. T-Ball will discuss these data in more detail later during this call. Our strong in-house development capabilities allowed us to rapidly advance this formulation and complete in-house manufacturing activities. In Q1 2022, we initiated the transfer of our current CDX 0159 manufacturing process to a contract manufacturing organization to optimize and scale up current process to support late-stage trials and to prepare for future commercialization. In further support of our Phase II readiness activities for the urcaria studies, we are pleased to report positive interim data after completing the in-life dosing portion of our six-month chronic toxicology study in non-human primates. Results from this study were fully in line with our expectations, and we believe these data strongly support our upcoming phase two trial initiations at CSU and Sindhu next quarter, and continued expansion into future indications. Tibor will also discuss these findings in more detail. In addition to our preparation for our Phase II studies in CSU and Sindhu, we are expecting more data this year from CVX0159 with data from the Phase I Multiple Ascending Dose IV Study in Chronic Spontaneous Urticaria, planned to be submitted for presentation at IACI 2022 in July. On today's call, Diane will provide updates on our pipeline programs and discuss in more detail our expansion into our fourth indication for CVX0159, eosinophilic esophagitis, or EOE. In assessing future indications for expansion, we consider multiple factors including the patient need, scientific rationale, and what other insights these indications may give us into the potential future opportunities for CVX0159. EOE is the most important type of eosinophilic gastrointestinal disease, and recent studies have suggested that mast cells may be an important driver in the disease. Given the lack of effective therapies for EOE and CVX's O159 potential as a mast cell depleting agent, we believe that EOE is an important indication and look forward to initiating this new study in the fourth quarter. At Celldex, our core focus is to mine our deep experience in antibody drug discovery to develop therapeutics for patients with devastating diseases. We seek to design and execute robust, rigorous clinical trials as efficiently as possible and in order to support regulatory approvals and provide the broadest possible access to patients who might benefit from our investigational medicines. We believe the updates to our programs outlined today and the emerging data strongly position us to execute on these future goals. With that, I will turn the call over to Tibor to go through the CDX-0159 subcutaneous formulation data results and discuss the completion of the Phase II readiness activities. Tibor?