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Celldex Therapeutics, Inc. (NASDAQ:CLDX)

Q2 2012 Earnings Call

August 10, 2012, 08:30 am ET

Executives

Anthony Marucci - President & CEO

Chip Catlin - SVP & CFO

Tom Davis - SVP & Chief Medical Officer

Tibor Keler - SVP & Chief Scientific Officer

Analysts

Jonathan Aschoff - Brean Murray

Mara Goldstein - Cantor Fitzgerald

Biren Amin - Jefferies

Joe Pantginis - Roth Capital Partners

Mani Mohindru - ThinkEquity

Steve Brozak - WBB Securities

Operator

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.

In addition, in patients with triple negative breast cancer who are also highly expressed GPNMB, even greater activity was seen and the CDX-011 ARM we reported overall response rate of 36% versus a 0% response rate for Investigator’s Choice. Importantly, while tumor expression of GPNMB correlated with improved response rate for CDX-011 treated patients this was not observed for patients receiving Investigator’s Choice signifying that the on target effect of CDX-011.

Looking forward, a critical question is durability of response and progression free survival overall. PFS is an important indicator of duration of response. While the PFS data from the EMERGE study is not yet mature as treatment continues and there are patients who have not yet crossed over or progressed. The Kaplan-Meier curve shows an improvement in PFS present in triple negative patients overall, but more significant in high GPNMB expressers and most marked in the combined group with a difference between the curves with statistical significance despite the small patient numbers.

These results are particularly encouraging in the heavily pretreated populations such as this where the median number of prior courses of therapy for metastatic disease were six in the CDX-011 cohort and in five in the Investigator’s Choice. While study data continue to mature and patients continue to be followed based on these initial data, we are confident that we have now established a clearly defined and rich patient population for targeted CDX-011 therapy, and that we have a reliable diagnostic assay that identifies the relevant GPNMB expression patterns and levels in breast cancer.

Together, patients with high GPNMB expression levels and patients with triple negative disease account for more than 35% of the total breast cancer patient population, and we believe CDX-011 can play a vital role as a much needed treating option for these patients. Importantly, the Emerge study results have put us in a position to comfortably discuss possible approval paths with the regulators. We look forward to finalizing the data from the study and anticipated updated results in the fourth quarter of 2012 as we’re exploring CDX-011’s potential and other indications that are known to express GPNMB.

As we look to the second half of the year, we have a number of initiatives underway. But in the rindopepimut we will continue to bring on additional centers around the world and screen and enroll patients in the ACT IV study and the ReACT study in glioblastoma and also providing ongoing support to the pontine glioma study sponsored by Stanford University.

The survival data from the Phase II ACT III study continues to mature and we expect to release updated data at an appropriate venue later this year. Likewise as I mentioned a few minutes ago, we expect to present updated results on the EMERGE CDX-011 study in metastatic breast cancer during the fourth quarter of 2012.

We expect to also present mature results from our Phase I study of CDX-1401 in the fourth quarter of 2012. CDX-1401 is a novel antibiotic based targeted cancer vaccine candidate, being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

NY-ESO-1 represents an important target for developing therapeutics against multiple cancers. The antigen which is expressed in a wide variety of cancer cells not as significant loads in most normal tissues has been extensively characterized in preclinical and clinical studies and themselves to be highly immunogenic. We will report data on all 45 patients treated in the Phase I study which start with various doses of CDX-1401 in combination with activators of toll like receptors.

In the second half of the year, we plan to initiate a Phase II pilot study in CDX -1135 in dense deposit disease, an orphan kidney disease in children and young adults. Dense deposit disease is caused by uncontrolled activation of the alternative pathway of complement. Complement activation can lead to progressive kidney damage and failure. CDX-1135 has been shown to inhibit the complement cascade at both the C3 and C5 levels and has shown clear biological activity both for strong renal function and reversing kidney damage in animals of dense deposit disease and blocking complement activity in earlier human clinical trials.

The pilot study will be conducted in small number of patients to define an appropriate dosing regimen preferred to clinical development. Since we expect to see disease control in these patients the endpoints of complement control and the early reversal of kidney damage can trigger a modestly sized registration strategy. We have already discussed these plans with FDA in a pre IND meeting and have their agreement with this approach.

We are also on-track to complete the Phase I trial of CDX-1127 in solid tumors during the second half of 2012 and hematological cancers in the first half of 2013. We will also complete approval of Phase I study of CDX-301 in healthy volunteers which will provide important safety data and dosage information to inform the next steps for this program, which we believe will involve the achievement of cancer patients requiring hemopoietic stem cell transplantation. So as you can see the second half of the year will be just as busy as the first with data readouts across three programs and initiation of new clinical study.

With that I will turn the call over to Chip to review the second quarter financial results and then we will open the call to your questions. Chip?

Chip Catlin

Thank you, Anthony. For the second quarter of 2012, Celldex reported a net loss of $13.8 million or $0.23 per share compared to a net loss of $10.2 million or $0.27 per share for the second quarter of 2011. The increase in net loss of $3.5 million between the three months periods is primarily due to higher R&D expenses in 2012 versus 2011 including increased clinical trials costs incurred in ramping up enrollment in the rindopepimut ACT IV and ReACT studies.

For the six months ended June 30, 2012; Celldex reported a net loss of $27.3 million or $0.50 per share compared to a net loss of $20.3 million or $0.58 per share for the six months ended June 30, 2011.

Again the increased loss resulted in higher R&D expenses primarily for clinical trails costs partially offset by lower amortization expenses in the first six months of 2012. At June 30, 2012; Celldex reported cash, cash equivalents and marketable securities of $78.7 million. The decrease in cash, cash equivalents and marketable securities of $13.5 million from March 31, 2012 is primarily due to planned increased operational expenses during the quarter related to ongoing studies of rindopepimut including the pivotal ACT IV study and the Phase II ReACT study.

During the six months ended June 30, 2012; we raised net proceeds of $8.5 million through the sale of 2.5 million shares of common stock under our control equity financing facility with Cantor Fitzgerald and issued a 12.1 million shares of our common stock in an unwritten public offering that resulted in net proceeds to $43.4 million, together providing a financial runway in 2014.

As of June 30, 2012; Celldex had 58.8 million shares outstanding.

I'll now turn the call over to Anthony for closing comments. Anthony?

Anthony Marucci

Thank you ,Jeff. On a final note, I am very pleased to announce today that Celldex has added two important positions to its management team. First Dr. Rick Wright has joined Celldex as our Vice President of Commercial Development. Rick has over 20 years of diverse experience in the bio-pharmaceutical industry including leadership positions in R&D, new product commercialization and marketing and sales at Bristol Myers and Novartis.

Secondly, Sarah Cavanaugh has joined Celldex team as our new Vice President of Investor Relations and Corporate Communications. Sarah is a proven IR professional with over 15 years experience in life sciences and healthcare industry. I look forward to working closely with both Rick and Sarah as Celldex continues the development its product pipeline.

This concludes our prepared remarks and we’re now ready for your questions. Operator.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Jonathan Aschoff, Brean Murray.

Jonathan Aschoff - Brean Murray

I have three questions. I was wondering if you could better pin down when results from each of the Phase II recurrent brain cancer trials will be available and I guess far more importantly than that net are you still comfortable describing at least one of them as being able to support or being able to be the primary data set in support to some sort of accelerated approval prior to any Phase III conclusion?

Tom Davis

Hi, Jonathan. So the most important studies that you are describing is the ReACT study which is focusing on patients with recurrent glioblastoma. We know these populations still expresses VIII and based on some anecdotal experience we have had in compassionate use, we believe that we can actually have a very profound impact even patients with significant disease.

We still are on track to complete the approval of this study by the end of this year perhaps early next year. So things are going well at this point. It’s a good size Phase II study and if we do see significant results, it certainly could form the basis for our discussion with the FDA around approval but we have not yet had that discussion. So a lot will depend on the data if the data really do look like this clear activity and there is a potential for that trial to use for registration.

Jonathan Aschoff - Brean Murray

Okay, regarding any BD surroundings CDX-011 is the data that you already having in hand essentially all you need to bring to the table or is the December's upcoming data something potential partners would really rather see first?

Anthony Marucci

We are having discussions on the program with the data we have already Jonathon. So the number of discussions ongoing now.

Jonathan Aschoff - Brean Murray

Okay, and lastly regardless of the patient set triple negative status would any future trial with 011 enroll only patients that at least also express GPNMB on 25 plus percent of the sales?

Anthony Marucci

Well the two key questions in this program are accelerated approval based on limited size study versus a large randomized trial and in order to obtain (inaudible) approval, it makes sense to target the highest responding population and as you saw from the study the triple negatives you also express high levels at GPNMB would appear to have the greatest benefit.

Jonathan Aschoff - Brean Murray

At least you would always put so in there was that 25 plus percent, the triple negative is fine but they would definitely also at least always 25 plus percent?

Anthony Marucci

Right now that reflects the population to go after but the discussion with the FDA will revolve around whether they would accept that population with a very high response rate would prefer a randomized study and in which case we might consider a larger patient population that could ultimately lead to a large market. The variable is there but the key message from the 11 from the emerged study reeling with the facts that targeting makes difference and that the drugs clearly works better in population with highest expression.

Operator

Our next question comes from the line of Mara Goldstein with Cantor Fitzgerald

Mara Goldstein - Cantor Fitzgerald

I have two questions and the first is just follow-up on CDXO 11 and I believe that you said you expected (inaudible) Phase to meeting with FDA in the fourth quarter. I am just curious about the supply quantities of product for doing a phase III so as I recall if you have the permissions of contract manufacture on mind I am wondering how that stands at this point in time and then secondarily on the R&D spending on CDX 1135 and in your filing it appears that the amount of money that you are spending on that program is quite high relative to the stage of development compared to other products at the similar stage and I am wondering if you can speak to the activities associated with this work and why it appears so much higher than other compounds?

Tibor Keler

With regards to your first question regarding product supply we believe we are in good position that the product supply is not going to be the limiting factors for initiating our next trial with CDX-011 and which is likely to happen in the second to middle of next year.

Mara Goldstein - Cantor Fitzgerald

Okay. And but you have the supply that can be used currently, correct?

Tibor Keler

Yes.

Mara Goldstein - Cantor Fitzgerald

And then on CDX-1135?

Tibor Keler

Could you repeat the question?

Mara Goldstein - Cantor Fitzgerald

Its just the R&D spending, if you look at your filings, what you are spending on that relative to other compounds at similar stage of development, is it pretty big number and I am just wondering if you could give us an idea of what are the activities associated with the work and why they appear so high relative to other things?

Tibor Keler

So for CDX-1135 it was really a matter of us producing the clinical grade material for initiating this study and so really all of our efforts in spending have been internally around the manufacturer of the product.

Mara Goldstein - Cantor Fitzgerald

And if I could just sneak one more question if you don't mind and its actually from news I saw yesterday about Avastin and a front line trial and GBM reaching its statistical significance and I'm just curious if you've seen any of this yet and if you think it will have any impact on enrollment in ReACT or even in the main rindopepimut trial?

Tom Davis

We are still working through the results there and of course we see significantly more data to really understand what this means for patients as well as folks who are consultants. However all along we've made it fairly clear that Avastin is an active drug in this phase but it's not necessarily competitor. We have reason to believe that Avastin and rindopepimut can work very well together and certainly our expectations would be to get the combination rather than try to compete with Avastin.

Operator

Our next question comes from Biren Amin of Jefferies.

Biren Amin - Jefferies

Just a question on emerge have all locations progressed in the CDX-011 arm and when we will have mature PFS data at San Antonio breast. Thanks.

Tom Davis

I can tell you at this point that no, the patients has not all progressed 11 arm. There are patients still being treated.

Certainly the data that we would present at the end of the year will be more mature but will not necessarily be final because of course final data relies on all the patients having completed treatment.

Operator

Our next question comes from Joe Pantginis, Roth Capital Partners

Joe Pantginis - Roth Capital Partners

Just a quick question then, a couple quick questions obviously. First on (inaudible), you already address the weekly of your study. So thank you for that. The second part of the question is can you disclose any data so far with the 78 sites that are actively screening with regard to say success rates, with regard to patients that are screened back can then be enrolled?

Tom Davis

Not a good time Joe. Our focus right now is getting [both] the sites and we will give more updates later on in the year and in next year.

Joe Pantginis - Roth Capital Partners

Okay, that’s fair, and then just maybe couple additional color comments on 1135, I know you talked about you know, looking to have a potential discussion with the FDA about registrational path. Is there anything you can add color why since this orphan indication about how this further color like you said can be much smaller study and how we can get to the market in a relative quick fashion because of its orphan status?

Tom Davis

Joe, we already had the discussion with the FDA around the possibility and they are certainly very open to rapid approval for a drug that clearly shows activity. And for us this current pilot study will be critical if we see the kind of activity that’s been seen with other complement inhibitors and other diseases and I think it’s pretty clear that a very modesty size study will be adequate to support approval.

Joe Pantginis - Roth Capital Partners

How would you define moderately sized?

Tom Davis

Well it really all depends on how active the drug is. So a trial size is very dependent on the effect you are looking for. That study could be as small as 30 to 40 patients. It could be larger than that, it really depends on the results of the first patients we treat.

Joe Pantginis - Roth Capital Partners

Sure, no but the magnitude is certainly understand it.

Operator

Our next question comes from Mani Mohindru, ThinkEquity.

Mani Mohindru - ThinkEquity

But a couple questions I have. I just wanted to get a little more sense into what assumptions went into your cash use guidance or cash on (inaudible) to 2014 like for example like what are you assuming for CDX-011 and in terms of the next steps in doing the trial either on your own or looking for a partner before you start a trial as well as for Rindo's ex-US partnership, so what's sort of inbuilt into your guidance there?

Anthony Marucci

Yeah, so as far as partnerships for Rindo we are not building anything into the assumptions. The assumption for CDX-011 is that we would manufacture a little bit more product and start the Phase III trial if we did it on our own sometime in 2013 which again that allows us to have a runaway into 2014. Some of the earlier programs like 1401 and 301, we are talking to the NCI and CTEP doing future studies and then we are going to look for the results for 1127 Phase I before making any decision on the Phase II study going forward. So that’s how we get to that point.

Mani Mohindru - ThinkEquity

Okay and if I may have a follow up question that (inaudible) had on the contract manufacturer. So my assumption was that their facility was in clinical hold and that you were allowed to use whatever product you had, but would that be enough for the next study or are you going to look for another clinical research CRO?

Tibor Keler

As we had described we had negotiations with the FDA around being able to use the material that we have on hand with the reprocessing of the particular batch. So we are still going through that process with the agency and we believe that we will be successful.

Anthony Marucci

And having said Mani, to get a commercial product you have to do several more consistency runs. So additional manufacturing will be required, but certainly what we have on hands is enough to start the trial and get along.

Mani Mohindru - ThinkEquity

Okay and if I may again follow up on one of the questions (inaudible) brought forward. In terms of the Avastin frontline topline data released yesterday, do you think that you have the possibility of an amendment down the road. It probably obviously depends on how you enroll and what the status could be for Avastin in frontline. But have you started thinking along those lines if at all you would have to amend anything in your ACT IV study if actually Avastin gets into frontline?

Anthony Marucci

Well we said we have been aware that these data were coming for quite some time and all along have been planning to work along side of Avastin as I mentioned earlier if necessary. It's a larger issue because the data are important in some sections of the world, but our global study would not necessarily be able to access Avastin in every country. So we will need to see what the data are, we will need to see how rapidly we think it's going to become standard of care. And then we will need to figure out exactly what the FDA would consider here. But there's plenty of time before the standards are going to change.

Mani Mohindru - ThinkEquity

And has the FDA given you some kind of guidance around the number of patients that have to be enrolled within the US for the pivotal trial?

Anthony Marucci

We've had detailed discussions with the regulators and they do not specify a specific numbers of US patients that are needed.

Operator

Our next question comes from Steve Brozak, WBB Securities.

Steve Brozak - WBB Securities

There is one question I've got that's general and I will go along and I would like to see what your general answer is. Celldex has an understanding of everything involved with the manufacturing, the clinical development, not just clinical in the US, clinical global on the regulatory side and the business development. Yet there was one thing that caught my eye that you've got a small SBIR grant collaboration with Rockefeller.

Can you describe the differentiation that you have, the ability to go out there and do something that the major pharmas, the major biotechs are doing and you are still able to go out there and be as nimble as doing something like that.

Can you describe what differentiates Celldex from other companies without mentioning those companies by name of course but how you guys can do business and how you guys are able to do everything just like the big boys "according to market cap" you are different.

Tibor Keler

I will start with that question and I think it is a very important part of our culture that we do keep a very strong scientific base, ability to work with both academia and government institutions to help really develop our technology to its best and without expending all the resources from Celldex.

So certainly we prioritize our later-stage programs from a resource point of view, but have been able to leverage our relationship with the NTI, NIH and academic institutions such Rockefeller University for really extended research programs and that really speaks a little bit to the kind of technologies that we have because there is great interest in the academic and scientific community to work with Celldex.

And it's really based on the technologies we have and their great interest in developing them. So I think that we will continue to be part of the way we will develop our pipeline and bring new programs forward.

Steve Brozak - WBB Securities

Great so that you know I guess Wall Street and the investing community looks at you as probably one of the strongest, if not the strongest freestanding monoclonal antibody technology companies on the street. Would you say that’s a good assessment without patting yourselves on the back too much and I'll hop off the line after that answer.

Anthony Marucci

Sure I think that's a great assessment, Steve.

Operator

We have a question coming from the line of Matthew (inaudible) of Oppenheimer.

Unidentified Analyst

Earlier you mentioned that the CDX-011, the next study might kick off in mid 2013. I was wondering if there was anything more you could tell us about the structure of that study and if there is any more color you could add.

Tom Davis

Well obviously it’s a very high priority for us right now to get to that next stage as quickly as we can but again the key question whether or not a modestly sized Phase II will be adequate for accelerated approval or whether we need to go right into the large randomized III. For us the discussion with the FDA and EMA is most critical if it does appear to be fairly fast path forward we would hope to start the study sooner.

If it’s going to require a greater effort to put together a randomized III, it will take a little bit longer, but still we very much believe early to mid 2013 to start that study is a reasonable timeframe.

Unidentified Analyst

Okay and given what you are seeing in the result you have now for a merge I guess with regard to GPNMB expression do you have any thoughts about the size or the cut off there that you might look for.

Tom Davis

So the data we are currently seeing in triple negatives with high GPNMB expression, our response rate in the 30% range would be a very exciting data in the larger population of patients. And I think the FDA has made it very clear that they can and have approved drugs based on that kind of response rate from a single arm Phase II study of a 150 patients.

So I think that would be a best scenario. If we need to be more cautious and look at PFS and overall survival as well, that would need to be a larger randomized study and those typically run 400 to 500 patients. But again there are a lot of variables and lot of discussions we still need to have.

Operator

And now there are no further questions. I would like to turn the call back over to Mr. Anthony Marucci.

Anthony Marucci

Thank you, operator and thanks everyone for joining us this morning

Anthony Marucci

Thank you, operator and thanks everyone for joining us this morning. We look forward to a very productive second half of the year and while we will have multiple opportunities to update you on our progress over the coming months as always, we welcome your questions at any time. With that have a great summer and we look talking to you in the future. Thank you.

Operator

Ladies and gentlemen that concludes the presentation. Thank you for your participation. You may now disconnect.

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