Celldex Therapeutics, Inc.

Good day, ladies and gentlemen, and welcome to the Celldex Therapeutics year-end 2018 conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Sarah Cavanaugh, Senior Vice President of Corporate Affairs. Ma'am, you may begin.

Thank you. Good afternoon and thank you 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, and Sam Martin, senior vice president and chief financial officer. 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 CELDEX'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 CELDEX's Annual Report on Form 10-K, Corley reports on Form 10-Q and its current reports on Form 8-K, as well as those described in Selvix'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 Selvix 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 end of the call. I'd now like to turn the call over to Anthony.

Thank you, Sarah. Good afternoon, and thank you for joining us. On today's call, I will provide a review of our business and an update of our clinical programs, specifically the ongoing Celldex-led studies of CBX1140 and CBX3379. As you'll likely read this afternoon's press release, we will have a number of preclinical programs that we will be presenting data on in 2019, and I've asked Tibor to walk you through these efforts and how they fit into the larger clinical development strategy. Sam will then review the financials and we'll close with your questions. As we look at the business overall, our pipeline remains strong and well diversified. We have two programs in the clinic and continue to execute on our development strategy to file a new IND every 12 to 18 months. We've made a series of difficult but necessary decisions over the last year as we focused on extending and directing our financial resources to the advancement of the programs we believe can bring the most value to both patients and shareholders, and we thank you for your continued support. As we look forward to the future, we believe we are all well positioned for potential success and look forward to a productive year. Let me first start with an update of CDX1140. This is a fully human antibody targeted to CD40, a key activator of immune response, which is found on dendritic cells, macrophages, B cells, and several cancer types. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies. However, systemic toxicity associated with broad CD40 activation has limited their dosing. We selected 1140 based on its unique properties relative to other CD40 agonist antibodies. It binds to the CD40 receptor in a manner that results in a linear dose-dependent agonist activity which may allow for higher systemic dosing and better tumor penetration at the optimal agonist levels. 1140 does not require cross-linking through FC receptor interactions for its agonist activity allowing more consistent and controlled immune cell activation. Also, 1140 does not interfere with the natural activation of CD40 by its ligand which may further potentiate local immune response. Finally, 1140 has a remarkably good safety profile while demonstrating potent immune activation in our preclinical studies. The ongoing phase one trial is a multi-dose dose escalation study of CBX1140 in patients with recurrent, locally advanced, or metastatic solid tumors and B-cell incommons. An important goal of the study is to achieve dosing levels that will provide good systemic exposure without dose-limiting toxicity. We believe the relatively low doses of the other potent CD40 agonist antibodies tested in the clinic to date may limit their potential in modifying the tumor microenvironment. We have made great progress so far. Six cohorts have been completed, and we are now enrolling the seventh cohort in which patients are dosed at 1.5 mg per kg of CDX1140, a dose significantly higher than other agonists targeting CD40s. Assuming we successfully complete this cohort, we will enroll the eighth cohort dosing at 3 milligrams per keg of CDX1140. Data to date from these cohorts suggest that 1140 has a desirable safety profile without any dose-limiting toxicities, and based on biomarker data, is demonstrating clear signs of biological activity associated with CD40 activation. The main target cells of 1140 are dendritic cells, which are the key cells for initiating anti-tumor immune responses. However, studies have shown that many patients are lacking in these cells. R-CBX301 is a recombinant dendritic cell growth factor known also as C-Flip3 ligand. It has been clinically shown to greatly increase the number of dendritic cells in patients, leading to more potent immune responses. Therefore, we have included CVX301 in a separate arm of this Phase 1 study as a priming agent to increase the number of dendritic cells available to respond to CVX1140. Study participants receive a fixed dose of 301 and increasing doses of 1140. We are nearing the close of the DLT window for the second of six potential cohorts right now. While this is still very early in the study, preliminary evidence of enhanced immune activation has been observed without additional safety concerns. Our goal in this study is to identify the recommended dose and regimen of 1140 with or without CDX301. The study allows for expansion cohorts and specific tumor types that will help define our regimen for additional combination therapies, such as with barilumab and B-cell lymphomas, which has looked promising in preclinical models. We're excited about the 1140 program and its clinical potential. We presented data from this study at CITSE in late November and look forward to updating that presentation at AACR in early April. Our next program is CVX3379, a monoclonal antibody targeting ERB3, which is also called HER3. ERB3 is found on tumor cells in a variety of cancers, including head and neck, Thyroid, Breast, Lung, and Gastric Cancers, as well as Melanoma. It is implicated in cancer cell growth and survival as well as resistance to targeted therapies. 3379 may play an important role in overcoming this resistance and it specifically targets ERB3 with potent affinity and locks it into a deactivated state, uniquely blocking its interactions with its ligand and also with other oncogenic drivers. In a previously completed phase one study, we saw evidence of anti-tumor activity among the nine patients with head and neck cancer who were treated with 3379 in combination with Erbitox, an EGFR inhibitor, including a durable complete response in a patient who had previously progressed on Erbitox as a model therapy. We recently completed enrollment to the first stage of assignment two stage design phase two study. 3379 is being given in combination with Erbitux in patients with HPV-negative advanced head and neck squamous cell carcinomas whose tumors have previously been treated with an anti-PD-1 checkpoint inhibitor and have become resistant to Erbitux. In accordance to the study design, if at least one of the 13 patients enrolled in the first stage achieves a partial response, enrollment can progress to the second stage. While a durable, confirmed, complete response has been documented, we will conduct a comprehensive review including the full data set before making decisions on future development as patients are still undergoing treatment and are eligible for evaluation. We plan to present updated data from this study at a medical meeting later this year. Beyond our clinical stage programs, we have been actively advancing a portfolio of unique preclinical antibodies and Bispecific Molecules. These candidates are being developed for use in strategic combinations that engage the human immune system to treat specific types of cancer or other diseases. In 2019, you'll see data from a number of these programs, and we thought it would be helpful to highlight a few of them on this call. So I will turn the call over to Tibor. Tibor?