Celldex Therapeutics' CEO Discusses Q2 2012 Results - Earnings Call Transcript

Celldex Therapeutics, Inc. (CLDX)

Q2 2012 Earnings Call

August 10, 2012, 08:30 am ET


Anthony Marucci - President & CEO

Chip Catlin - SVP & CFO

Tom Davis - SVP & Chief Medical Officer

Tibor Keler - SVP & Chief Scientific Officer


Jonathan Aschoff - Brean Murray

Mara Goldstein - Cantor Fitzgerald

Biren Amin - Jefferies

Joe Pantginis - Roth Capital Partners

Mani Mohindru - ThinkEquity

Steve Brozak - WBB Securities



Good morning and welcome to Celldex Therapeutics second quarter and 2012 update conference call. My name is Chanel and I will be your operator on today's call.

Before we begin our discussion, I have been asked to caution listeners that today's speakers will be making forward-looking statements. Such statements reflect 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 Celldex’s actual results to differ materially from those in the forward-looking statements include those set forth under the heading Risk Factors and management’s discussion and analysis of financial condition and results of operations and Celldex’s annual report on Form 10-K quarterly reports on Form 10-Q and its current report on Form 8-K as well as those described in Celldex’s press release and filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in the entirety by this cautionary notice. You should carefully review all these factors and be aware that there maybe other factors that could cause these differences. These forward-looking statements are based on information, plans and estimates as of this call and Celldex does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other things.

Please be advised that the question-and-answer period will be held at the close of the call. I would now like to turn the call over to Mr. Anthony Marucci, President and CEO of Celldex Therapeutics. You may proceed.

Anthony Marucci

Good morning and thank you for joining us. I am Anthony Marucci, President and CEO of Celldex. Joining me on the call today, are Chip Catlin, our Senior Vice President and Chief Financial Officer; Dr. Tom Davis, our Senior Vice President and Chief Medical Officer and Dr. Tibor Keler, our Senior Vice President and Chief Scientific Officer.

The second quarter was an extremely productive quarter for Celldex. We had a number of key accomplishments which I want to take a few moments to review this morning before asking Chip to walk through the financial results. We will then open the call for your questions.

During the second quarter of 2012, Celldex continued to progress well with our two ongoing rindopepimut clinical trials. A pivotal ACT IV study in patients with newly diagnosed EGFRvIII-positive glioblastoma and the Phase II ReACT study in patients with recurring EGFRvIII-positive glioblastoma.

As we have discussed in the past, the ACT IV study will be conducted worldwide and approximately 19 countries around the globe at almost half the sites located outside the United States. This has been a major undertaking for our clinical team and they are doing a great job. In total, there are now more than 150 clinical sites around the world that have been selected to participate in the Phase III ACT IV study and our last count 78 of these sites were actively screening patients. The Phase II ReACT study is also well positioned with 25 study sites selected to participate and 17 actively screening.

In May, we also reported exciting preliminary results for our late second stage candidates in our pipeline CDX-011 in metastatic breast cancer. As most of you know, CDX-011 is a first-in-class next-generation antibody drug conjugate that targets a Celldex proprietary target Glycoprotein NMB or GPNMB.

GPNMB is an internalized glycoprotein that has been identified in multiple malignancies and has been reported to be presented specifically in 40% to 75% of all breast cancers. In breast cancer there has been a marked correlation with high expression and poor outcomes including metastases and death. This is particularly true in the triple negative breast cancer population.

The Phase IIb study of randomized EMERGE study was designed by Celldex to help us understand the role of CDX-011 could play in treating patients with GPNMB expressing breast cancer. Earlier work in both breast cancer and melanoma clearly signal that CDX-011 could play an important role in GPNMB expressing cancers. A further study was needed to identify the most responsive patient populations and their corresponding GPNMB expression pattern.

While CDX-011 demonstrated a consistent response profile in comparison to our prior studies in breast cancer, we now have new insight in for the drug’s ability to elicit more pronounce response rates in the predicted patient substance.

Preliminary results from the EMERGE study suggests that CDX-011 induces impressive response rates compared to the commonly available therapies in patients with advanced refractory breast cancer and with high GPNMB expression defining as expression equal to greater than 25% of tumor cells and in patients with triple negative.

In the high GPNMB expressing patient population, treatment with CDX-011 resulted in a 32% overall response rate which includes both confirmed and unconfirmed responses, whereas treatment in the Investigator’s Choice single-agent chemotherapy ARM resulted in the 13% response rate. CDX-011 also demonstrated strong response rate in patients with the extremely difficult to treat diagnosis of triple negative breast cancer across all levels of GPNMB expression with a CDX-011 overall response rate of 21% compared to a 0% response rate for Investigator’s Choice.

Read the rest of this transcript for free on seekingalpha.com

If you liked this article you might like

Melinta Up After Deal for Medicines' Infectious Disease Unit -- Biotech Movers

Melinta Up After Deal for Medicines' Infectious Disease Unit -- Biotech Movers

What Adam Feuerstein Got Right and Wrong About Biotech Stocks in 2016

What Adam Feuerstein Got Right and Wrong About Biotech Stocks in 2016

2016 Was a Terrible Year for Biotech but the Tweets Were on Point

2016 Was a Terrible Year for Biotech but the Tweets Were on Point

Corbus Pharma Bear Thesis Is Alive and Well on Sclerosis Drug Data Skewed Positive

Corbus Pharma Bear Thesis Is Alive and Well on Sclerosis Drug Data Skewed Positive

Celldex Therapeutics (CLDX) Stock Up on Q2 Results

Celldex Therapeutics (CLDX) Stock Up on Q2 Results