ImmunoCellular Therapeutics' CEO Discusses Q4 2012 Results - Earnings Call Transcript

ImmunoCellular Therapeutics Ltd. (NYSEMKT:IMUC)

Q4 2012 Earnings Call

March 5, 2013 5:00 PM ET

Executives

Jane Green – IR

Andrew Gengos – President and CEO

David Fractor – CFO

John Yu – Founder, Chief Scientific Officer and Chairman

Analysts

Jason Kolbert – Maxim Group

Luca Pancratov – Roth Capital Partners

Megan Dow – MLV & Company

Steve Chase – comScore

Rajesh Patel – Red Acre Capital

Bob Fuerst – American Portfolios

Operator

Good afternoon everyone, and welcome to the ImmunoCellular Therapeutics Fourth Quarter and Full-Year 2012 Financial Results 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 be given at that time. (Operator Instructions) Today’s conference is being recorded.

At this time, I would like to turn the call over to Jane Green, ImmunoCellular’s Investor Relations Group. Please go ahead ma’am.

Jane Green

Good afternoon. Welcome to ImmunoCellular Therapeutics conference call to discuss the company’s fourth quarter and full-year 2012 financial results and corporate update. Today’s call is being recorded and is also available via webcast.

Participating in today’s call are Chief Executive Officer, Andrew Gengos; Chief Scientific Officer, Dr. John Yu; and Vice President Finance and Principal Accounting Officer, David Fractor. Following this introduction, Mr. Gengos will discuss the company’s performance and future outlook, Mr. Fractor will review the company’s financial results and then the company will take questions.

If you have not received the copy of the fourth quarter 2012 financial results press release the company issued today, you can obtain one by visiting the company’s website www.imuc.com. ImmunoCellular would like to remind everyone that during the conference call, members of the management team will make certain forward-looking statements. Statements as to matters of events, historical facts as defined in the Private Securities Litigation Reform Act of 1995.

These statements involve risks and uncertainties that could cause actual events or results to differ materially from the events and include statements about our plans, objectives, expectations and intentions with respect to the potential and timing for success of our scientific approach of cancer immunotherapy and our ICT-107, ICT-121 and ICT-140 products, clinical development efforts, operations, financial conditions and other statements that are not historical in nature, particularly those that use the terms such as will, potential, could, can, believe, intend, continue, plans, expects, projects, estimates or similar language.

Important factors known to us that could cause actual events, actual results to differ materially from those expressed in such forward-looking statements include those set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the SEC. Please review these and the company’s other filings.

Now I’d like to turn the call over to ImmunoCellular’s CEO, Andrew Gengos.

Andrew Gengos

Thanks, Jane. And thank you all for joining our call today. This is ImmunoCellular’s first time hosting a quarterly conference call and webcast. Given the company’s progress in the last year, we think it’s an excellent time to begin providing regularly scheduled corporate updates for the financial community.

Over the last few months since I joined ImmunoCellular, I really have enjoyed meeting with our current and perspective institutional investors during financial conferences such as JP Morgan and BIO CEO, as well as talking with some of our shareholders. In the coming weeks at the Ralph and the BioCentury Future Leaders conferences, I hope to meet with many more of you.

I share with John Yu, ImmunoCellular’s founder and CSO, a real genuine interest in building strong relationships with our investors and perspective investors and discussing the issues that are most important to you. We appreciate the depth of your interest in our company and as 2013 moves forward, John and I intend to be as accessible as we can at financial community events, scientific and medical meetings and through direct outreach.

Today, we’re pleased to have the opportunity to discuss with you our 2012 performance and the milestones we intent to achieve in 2013. We will look forward to taking your questions following our prepared remarks.

2012 was a year of significant progress and maturation for ImmunoCellular during which we achieved a number of important objectives. We completed enrollment for the Phase II trial of ICT-107 in patients with newly diagnosed glioblastoma. And that trial continues to progress well. We also published results of the ICT-107 Phase I clinical trial in a prestigious peer-reviewed scientific publication.

There are two additional active INDs for ICT-121 and ICT-140 with plans underway to begin clinical trials later this year. We brought a second manufacturing site online for ICT-107 advancing our ability to meet the needs of further clinical testing and commercial manufacturing. We also listed on the NYSE MKT and considerably strengthened the balance sheet by raising more than $28 million in two public offerings in January and October. Thus expanding our shareholder base and putting us in a position to achieve our near-term milestones.

And we expanded our IP stake [ph] presented at numerous financial conferences and scientific meetings and significantly strengthened our management team and our Board of Directors. We believe that today ImmunoCellular ranks among the most promising companies pioneering new approaches to treat cancer, and that we have the potential to emerge as a leader in the cancer immunotherapy field. We believe that 2013 will be another year of exciting progress for our company, one in which we continue to make significant contributions to advancing the entire field of cancer vaccines.

We believe that our dendritic cell cancer vaccine discovery and development platform has the potential to significantly improve clinical outcomes for cancer patients and to create meaningful value for all of our stakeholders. I’d like to provide some additional color on our development programs and corporate strategies and then I’ll ask David Fractor to review the fourth quarter and full-year financial results.

I’ll begin with a few remarks about ImmunoCellular’s proprietary platform from which we have generated a pipeline of immunotheraupetic product candidates. We believe that our platform has important technological differences and advantages over conventional and other immunotherapeutic approaches to cancer and that it provides a strong foundation for our potential success.

In designing our platform, we’ve learned lessons from historical dendritic cell approaches and improved upon them. In simple terms, we believe that our approach of generating a powerful immune response to both tumor cells and cancer stem cells which are radiation and chemo resistant has the potential to eradicate tumors and prevent their re-growth. Our lead cancer vaccines use multiple antigens not complete tumor life state and not a single antigen.

We think that with this approach we can get broad tumor coverage but also elicit a potent enough immune response to fight the tumor. Our development strategy is to choose indications that have residual disease not large bulky tumors and to focus on disease settings where the patient is still immune competent and can be an immune response. In designing our mid and later stage clinical protocols, we’re using oncology’s gold standard primary endpoint of overall survival.

This is designed to offset any potential ambiguity regarding progression free survival and how to interpret this result, although of course we will attain these data as well. Manufacturing and supply chain efficiency and cost effectiveness are key differentiators that are continuing to be a focus for us. Our approach only requires a single apheresis from the patient to harvest sufficient Peripheral Blood Mononuclear Cells to yield an enough doses for the expected lifetime of the patient.

Our final product is stable, maintains potency and can easily be stored and easily transported. Compared to other historical programs, we have eliminated significant logistical complexity which potentially enables our expected cost to manufacturing to be within the range of an advanced biologic.

Now let’s talk about the progress and prospects for our three lead development programs. Our Phase II randomized placebo-controlled double-blind clinical trial of ICT-107, a six antigen dendritic cell vaccine targeting glioblastoma tumor and cancer stem cell antigens continues to progress well. A total of 278 patients with newly diagnosed brain cancer were enrolled at 25 centers in the U.S., and a 124 patients have been randomized.

The difference between the number of patients enrolled and randomized relates to a host of screening variables, the key one being their HLA-A1 or HLA-A2 status, a screen that selects for about 50% to 75% of patients. This trial utilizes a one-third, two-thirds design. One-third of the patients are treated with placebo which is their own dendritic cells not exposed to antigen and the treatment arm includes two-thirds or about 80 patients who receive the ICT-107 vaccine. The regimen is four induction doses after radiation and chemotherapy and then maintenance doses until the patient relapses.

This approach fits into and does not disrupt standard of care. We marked the last patient in milestone in September of 2012. We have two milestones expected in 2013, both of which are event driven, which means that the timing of these milestones is estimated rather than being precisely predictable. Based on our current estimation, we still anticipate that the process of conducting the interim analysis could begin this quarter and that the first top line results could be available at the end of this year.

As we’re nearing the end of this quarter and the estimated time for the interim analysis, I’d like to provide some additional perspective on the interim analysis process. That analysis is triggered when the 32nd event or patient death has taken place. Thereafter the events are confirmed at all sites and the data are collected, analyzed and provided to the Data Monitoring Committee to interpret.

Following their review of the data, they will make a recommendation to the company that we either continue the trial or stop the trial based on safety and futility. It is very important to remember that the company will remain fully blinded during the interim analysis and throughout the remainder of the trial. From the time that the 32 events has been reached and verified to when we receive the recommendation from the DMC, is likely to be several weeks.

This process means that we are likely to receive the recommendation from the DMC and be in a position to announce the recommendation in the second quarter. In our view, a positive outcome of the interim analysis would be that we receive a recommendation to continue the trial. In order to maintain the blinding of the study however, no additional information will be made available to us.

By the end of the year, we expect to see overall survival primary endpoint data and numerous data on secondary endpoints from the trial such as progression free survival, OS and PFS at various time intervals, immune response and safety. We will analyze all of this information to determine how we approach the FDA in an end of Phase II meeting and what the feasibility and possible design of a Phase III trial could be.

So this is going to be a very exciting year for this program and quite frankly for our company. Our next program is ICT-140, a seven antigen dendritic cell vaccine targeting ovarian tumor and cancer stem cell antigens. We plan to conduct an open-labeled Phase IIa trial in patients with ovarian cancer at three or four U.S. sites and anticipate that the first patient in this study will be enrolled in the second half of this year.

Our third program is ICT-121. We will be supporting a principal investigator sponsored Phase I trial at Cedars-Sinai in Los Angeles. And 20 patients will be enrolled with recurrent glioblastoma. We anticipate that the first patient in the study will be enrolled in the second quarter. The vaccine targets a single antigen, CD133. Depending on the outcome of this trial, there are various ways in which we could take this program forward.

We could move forward with ICT-121 as a single antigen vaccine in glioblastoma, and/or other solid tumors as CD133 is expressed on many cancer stem cells in many solid tumors. Another alternative is to insert it into other vaccines that we are working on which could represent possible lifecycle extension strategies for ICT-107 and ICT-140. There are many interesting options for this program which makes it an exciting asset for our company.

In terms of our company’s overall strategy, here is what we currently foresee over the next three to five years. Our goal is to build a leading independent cancer immunotherapy company. If we achieve clinical success with ICT-107, we believe that we could commercialize this program ourselves in major markets such as the United States and perhaps Europe.

Glioblastoma is a specialty orphan indication that is primarily treated post surgery by neuro-oncologists. There are a manageable number of neuro-oncology centers in the U.S. So a small company such as ours could potentially address this market. We believe it may well be in the best interest of our shareholders to pursue this independent strategy. We could also consider partnerships for other territories and markets that we could not reach ourselves and we plan to explore this option.

In 2013, we plan to build out our capabilities with the assumption that we will move forward with the strategy for ICT-107 as part of our overall efforts to prepare for success. In terms of our financial resources, as David will discuss in a few minutes, our cash position at the end of the year should enable us to achieve our near-term objectives. We plan to continue to operate as a lean organization with a strong focus on expense management and to invest in growing our capabilities in a focused and prudent manner.

As we look ahead to our prospects for 2013, we believe that we have some important value creating milestones ahead of us. To reiterate, we expect that the interim analysis for the Phase II trial of ICT-107 by the DMC will be available in the second quarter with top line results from the trial anticipated at the end of this year.

As I mentioned both of these milestones are event-driven so the exact timing is unpredictable, but we believe our current assumptions are reasonable. We anticipate initiating the Phase IIa trial of ICT-140 with the first patient enrolled in the second half of the year. ICT-121 is anticipated to begin its Phase I trial with the first patient enrolled in the second quarter. Everyone at ImmunoCellular shares the excitement of the prospect of having three novel clinical programs ongoing by the second half of 2013.

And I’ll end my remarks on a personal note. Here is what I saw when I was considering joining ImmunoCellular late last year. First, there is a great team. Next, we have quite provocative data in the Phase I trial of ICT-107 which I found validating for progressing to Phase II and thought provoking in terms of what we could potentially see from this ongoing trial and where this program could lead with respect to the potential to bring this to market ourselves.

We have an advanced proprietary dendritic cell platform that utilizes cancer antigens and targets cancer stem cells and represents a promising approach to cancer immunotherapy. We have the potential to advance multiple programs from this robust platform which is very exciting. We also have the potential to build a leading cancer immunotherapy company that can be bring benefits to patients, their families, and the medical community. And I also believe that our ability to deliver value shareholders is within our reach.

These factors and others added up to a compelling personal investment thesis for me and I believe that they can translate into the same for our existing and future investors. Now I’d like to ask David Fractor to review our financial results for the fourth quarter and full-year 2012 and then we’ll open up the call for your questions. David?

David Fractor

Thank you, Andrew. For the year ended December 31, 2012, the company incurred a net loss of $14.5 million, or $0.35 per share basic and diluted, compared to a net loss of $5.7 million for the year ended December 31, 2011, or $0.21 per basic and diluted share. The increase in the loss between the years reflects the continued expansion of company’s research and development program and increases in general and administrative expenses. The loss for 2012 also includes a charge of $2.3 million related to the revaluation of the company’s warrant derivatives and $496,000 in stock-based compensation. The valuation of our warrant derivatives is heavily influenced by the price of our common stock as of the valuation date.

As of December 31, 2012, the price of our common stock was $1.92 per share compared to a $1.30 – excuse me, $1.36 per share at December 31, 2011 which represents an increase of $0.56 per share or 41%. The net loss for 2011 includes a credit of $2.9 million related to the revaluation of the warrant derivatives and a charge of $1.2 million for stock-based compensation.

For the quarter ended December 31, 2012, the company reported net income of $484,000, or $0.01 per share basic and diluted share, compared to a net loss of $1.5 million, or $0.05 per basic and diluted share. The net income for the quarter ended December 31, 2012, reflects a credit of $2.7 million related to the revaluation of the company’s warrant derivatives. The net loss for the quarter ended December 31, 2011 reflects a credit of $1.4 million related to the revaluation of the company’s warrant derivatives.

The company reported that its cash used in operations during 2012 was $12.4 million compared to $6.4 million in 2011. The increase reflects the continued ramp-up of the company’s Phase II clinical trial of ICT-107, as well as research and development activities for ICT-121 and ICT-140.

Additionally, the company’s general and administrative expenses increased in 2012 in order to develop and support its additional infrastructure as we incurred additional expenses for investor relations, travel, personnel, board and professional fees.

For the quarter ended December 31, 2012, the company used $3.2 million cash for operations compared to $1.8 million in the same period of 2011. The increase in the quarter reflects the expansion of the company’s research and development and general and administrative expenses.

During 2012, the company completed two equity financings in January and October which provided $28.6 million, net of expenses, and the company also received $3.2 million from the exercise of warrants. As of December 31, 2012 the company had $26.2 million in cash.

Andrew Gengos

Thank you, David. Operator, would you please now open up the call for questions?

Question-and-Answer Session

Operator

(Operator Instructions) The first question comes from Jacob Kolbert from Maxim Group.

Jason Kolbert – Maxim Group

Thank you, Jason Kolbert. Hi Andrew congratulations. Boy, what a fantastic and great run down you just gave. I want to ask you to talk about two things. How we get to the number of 32 events with 278 patients enrolled in the trial, hold on, and a 124 patients actually randomized to the trial going for 32 events and assuming an average survival in the control group of 17 months, drives you to a point that you assume you need – if you had a 100% efficacy and active and if the control follows 17 months, then it’s just a question of when the first 32 patients were to hit 17 months. And obviously it won’t be like that, but can you give us some example in terms of how the enrollment progress from the time the trial was started, so that gives you comfort in the year-end guidance for hitting the 32 events?

Andrew Gengos

Hi Jason, thanks for that question. I think John probably is in a better position to answer that, so I’ll let him address it.

John Yu

So thanks Jason, for your question. With regard to the number of patients randomized, the number increased overtime in a linear fashion. The number – the anticipation of the 32 events came from a program where the outcome of patients was modeled with 80% power to show a nine-month survival benefit in the experimental group versus the treatment group.

So there were various scenarios that were modeled and we – and thereby gave the expectation of the 32 events to occur in the first quarter. So we’re waiting for those events to come out, and for the DMC to review those events and to let us know once that’s occurred. So I think that’s as much color as I can give you with regard to that scenario, Jason.

Jason Kolbert – Maxim Group

Thank you, John, and great to hear your voice as well, but help me understand just a little bit more color, I mean the Phase I trial, those patients had pretty dramatic efficacy. So it seems like the powering assumptions that you are using for the Phase II trial are very conservative in comparison to what the Phase I results are. Am I correct in walking away with that assumption?

John Yu

Well so the assumption was for nine-month survival benefit based on the fact that when you have a small Phase I trial which is expanded to a larger Phase II trial, which is blinded and randomized, the expectation of the delta in survival is generally becomes tighter. And so in order to account for that we used a nine-month survival benefit. So the number of events that we’re waiting for, for the interim results is essentially the 50% of the expected events which is 64 by the end of trial.

Jason Kolbert – Maxim Group

Got it. All right, perfect, thank you. And one last question, it’s about manufacturing, I’m really excited to hear that you have second source of manufacturing. Can you tell me a little bit about what that means and what it means in terms of let’s say you have a dramatically good result at the end of the year, what kind of position will you be in then to scale up? Should you need to either for a larger pivotal trial or in the best case scenario for an expedited approval?

Andrew Gengos

Jason, I’ll take that question. The second manufacturer that we’re referring to there is PCT. And we have been working with them as a supplier for both the Phase I trial and the Phase II trial, and planning for the Phase III trial. So to be clear they provided some of the treatment involved in the Phase II trial. We are also having discussions with other potential manufacturers to create more options for any additional clinical work and commercial availability, should we have a registration in this product in the future.

Jason Kolbert – Maxim Group

Okay, terrific. Thank you guys and thanks for the update. I appreciate it.

Andrew Gengos

Thanks.

Operator

The next question comes from Luca Pancratov from Roth Capital Partners.

Luca Pancratov – Roth Capital Partners

Hi guys and thank you so much here for providing the update. We’re definitely looking forward to the interim analysis. So on that, I would just have a question. Will the DMC be looking in a blinded or un-blinded fashion at immune responses in that two arms just to get more of a sense of what is the immunocompetence level as the base line or if concurrent treatment with Temozolomide affects in the end-responses?

John Yu

Thank you Luca, this is John. That’s a very good question. The DMC will not be looking at immune analysis at that time. They will be merely looking at safety events of the death events and they will un-blinded. The trial will remain blinded to the company and they will let us know whether they have recommended for us to continue the trial based on their futility and safety analysis. So they will not be looking at immune parameters at that point because that data will not be available to them at that time.

Luca Pancratov – Roth Capital Partners

Perfect, thank you very much. And then thank you very much for the updates on the plans of potential commercialization or going it alone in GBM. So I was wondering, Andrew, can you give us a little bit more sense of what are the background activities that you’re undertaking, and the event that you would have good clinical results to go forward. So it is good to hear if you’re manufacturing in the first place?

Andrew Gengos

Sure, Luca and thanks for the question. I would characterize what we are doing as planning at this stage. Obviously we don’t have the Phase II results of ICT-107, and we don’t expect them until the end of the year. And so what we’re doing is what I would call a commercialization readiness assessment where we’re going to look at key functions. We’ve talked about manufacturing already and we’re going to identify what are the gaps that we have between our position today and what we would need to fill in order to both conduct a Phase III trial as well as commercialize ICT-107, should FDA give us registration.

If we find that some of those gaps can be addressed in 2013 prior to the availability of the Phase II data, we will go ahead and do that. We will also be prudent about how much we will invest prior to the Phase II data to address any potential gaps.

Luca Pancratov – Roth Capital Partners

Yes, that’s absolutely fair. Thank you very much for the update. And again looking forward (inaudible).

Andrew Gengos

Thank you.

Operator

The next question comes from Megan Dow from MLV & Company.

Megan Dow – MLV & Company

Hi everybody, congratulations on your first call. It’s nice to hear. I wanted to follow-up a little bit on Luca’s question regarding your plan moving forward. Is University of Pennsylvania going to be phased out in the manufacturing process and PCT really going to be taking over, so you can validate your manufacturing process? And working in terms with the other vaccines, should we be expecting manufacturing validation for both 140 and 121, as you move forward you discuss combining a particularly 121 without their vaccines? And then I have a follow-up question.

John Yu

Thank you, Megan. This is John Yu. So with regard to the UPENN and PTC being our manufacturing sites, you are correct that UPENN has been phased out and the manufacturing has in the later faucets of the trial than solely performed at PCT. It was a smooth transition to transition the manufacturing from UPENN which is a completely academic facility to a more potentially commercializable facility of PCT. And so the manufacturing process was validated through the process of transition.

As we initiate the clinical trials for ICT-121 as well as for ICT-140, the manufacturing of the dendritic cells will remain largely unchanged. We have been working diligently over the past quarter in streamlining our manufacturing process and increasing efficiencies where we can. And so we feel we are moving toward a scalable process that can then lead towards commercialization.

Megan Dow – MLV & Company

Fantastic. That’s great to hear. In regards to 121, it’s pretty exciting to hear, you are thinking in the future about where else the vaccines since it is targeting the cancer stem cells can be applied. Can you talk a little bit more about what you are envisioning for that product?

John Yu

So thank you for your enthusiasm for the idea of targeting this cancer stem cell antigen. It has been something that we’ve been working on in the lab and in the company for the last six years. And as you know, we recently received a patent in that up until targeting CD133. As Andrew alluded to, I think it’s exciting that we are targeting a ubiquitous cancer stem cell antigen that’s expressed in a host of different cancers that we can certainly apply to different cancers including non-small cell lung cancers, melanoma, colon cancer and a host of other cancers.

And also potentially include in our vaccine products that are targeting multiple antigens. So those two avenues are what we plan to pursue and address over the next year.

Megan Dow – MLV & Company

Fantastic, thank you. Good luck for 2013.

John Yu

Thank you.

Andrew Gengos

Thanks, Megan.

Operator

The next question comes from Steve Chase [ph] from comScore [ph].

Steve Chase – comScore

Yes, hi congratulations on a great quarter. I just was wondering if you could give some color on your burn rates given the fact that you are going forward with ICT-140 and 121. Essentially I am asking how do you think your burn rate of 3.2 will change with these in the mix now?

David Fractor

This is David. I’ll answer the question. We anticipate that in the foreseeable future that our burn rate will not significantly change based on the ramp-up of ICT-121, 140 compared to where we have been in 2012.

Steve Chase – comScore

Okay, great. Thank you very much.

David Fractor

Thank you. You’re welcome.

Operator

The next question comes from Rajesh Patel from Red Acre Capital.

Rajesh Patel - Red Acre Capital

Hi guys, thanks for taking my question. I just wanted to understand a little bit some of the factors besides the HLA-A1/A2 that might cause somebody to not be randomized from the 278 that were screened?

John Yu

Hi Rajesh, this is John Yu. Thanks for your question. So besides HLA which is the main factor that screens patients during the enrollment process, if they are plan to be randomized and are HLA-A1 or A2, there are a couple of other reasons that they may not choose to pursue. The trial one maybe personal reasons to not engage in a randomized clinical trial. Another maybe that there is – that they may have clinical parameters that no longer allow them to engage in the trial whether it be lab parameters or other clinical parameters that may arise.

These are relatively infrequent events but certainly can arise and lead to patients not being randomized.

Rajesh Patel - Red Acre Capital

Okay, so I guess and not put a cart before the horse but in sort of in real practice the HLA factor is really the main factor that would determine sort of your addressable patient population. Is that the right way to think about it?

John Yu

Sure. In this particular trial, other things that affected whether patients were randomized after being screened were adverse affects that may have origin from surgery, and also scheduling travel to large cities if the patients happen to be in more rural areas. And they are not being to make that type of travel. So those are other factors that may have prevented them from becoming randomized or treated in the final analysis.

Rajesh Patel - Red Acre Capital

Okay, that’s helpful, and then one last question. Have you folks had any discussions with FDA about sort of what level of overall survival benefit would sort of be reasonable to think about an accelerated approval versus doing a Phase III before filing for an NDA?

John Yu

This is John Yu. In response to your question, no, we have not had those discussions with the FDA.

Rajesh Patel - Red Acre Capital

Okay, great. Thanks so much for taking my questions.

John Yu

Thank you.

Operator

(Operator Instructions) The next question comes from Bob Fuerst [ph] from American Portfolios.

Bob Fuerst – American Portfolios

Congratulations Andrew, John, David. It was a great quarter, and just a couple of quick questions. As far the median survival of the control group, I see a lot of chatter online of some people say they used 14 months, 17 months. What is the number that you guys are using for that?

Andrew Gengos

So the number – we use two numbers. And the reason we use two numbers is we are trying to bracket our expectation of the control group. And these numbers come from a very large trial that was run in the mid 2000s.

Bob Fuerst – American Portfolios

Right.

Andrew Gengos

That we’ve talked about before, but that trial looked at 287 patients that received the surgery, chemotherapy and radiation therapy that is what you would think of as standard of care today. In that large group 287 patients, the median survival was 14.6 months.

Bob Fuerst – American Portfolios

Okay.

Andrew Gengos

However because our Phase I and Phase II trial is more skewed towards complete resection or almost complete resection. There is another number that we look at from that same study which is a smaller group. It’s a 113 patients that had that same standard of care surgery, radiation therapy and chemotherapy, but were deemed completely resected and that number is 18.8 months. So it’s subjective which number you’d like to use but we consider both of them.

Bob Fuerst – American Portfolios

So tell me if I misheard you, but I thought you said that we’re expecting the interim results till the second quarter, is that right or am I hearing things?

John Yu

We are expecting that we will learn of the interim analysis result from the DMC, the Data Monitoring Committee in the second quarter.

Bob Fuerst – American Portfolios

Okay. So when this trial was designed – when you came up with that number, is it based on 17 – was it 17.8 months or is it based on the 14.6 months?

John Yu

It was based on the 18.8 months in the control group and the additional nine-months in the experimental group with the two-to-one ratio of experimental to control patients.

Bob Fuerst – American Portfolios

Okay. So it was based on – the control group was based on 18.8 months?

John Yu

Yes.

Bob Fuerst – American Portfolios

Okay. And one last question John, I appreciate it. if I know, you know by talking with you guys, you don’t want to put too much weight on when the interim results – when the 32 events take place, but would there be I mean if it was really prolong say a few months, would a person read too much into that, I mean how far along would it have to go without the 32 events before we view it as the major positive?

John Yu

Bob, I think the best answer is that we’ll have to address that if we get there. In other words I think it’s just speculation at this point. Our expectation is unchanged on the timing of this result because with the process of collecting, analyzing, providing the data to the DMC and receiving their communication takes several weeks. We think we will hear the result in the second quarter. I think you are hypothetical question is probably best dealt with if we find ourselves there.

Bob Fuerst – American Portfolios

Okay. And one last question, can we assume that the 32 events have taken place if you are saying that you are expecting these results in the second quarter?

John Yu

It’s a yes-no question so I’ll give you a yes-no answer, no. But let me explain. We are blinded to the trial. We won’t know the information about when the 32 events occur. What we will know is once the DMC has met, we will have their answer. So I don’t expect to know until the trial is fully finished and the data un-blinded when exactly we hit the 32 events.

Bob Fuerst – American Portfolios

All right. So you’re saying you are unaware if that’s already occurred, is that what you’re saying?

John Yu

I have no idea.

Bob Fuerst – American Portfolios

Okay. That’s fine. All right, so I don’t want to put you on the spot but just curious. All right, thanks a lot guys, great quarter.

John Yu

Thank you, Bob.

Andrew Gengos

Thank you, Bob.

Operator

At this time, I show no further questions. I would now like to turn the call back over to Andrew Gengos.

Andrew Gengos

Well thank you, Jamie. I want to thank everybody again for participating in today’s call and webcast. We plan to be active in meeting with investors across the country in the coming weeks and months and we look forward to providing you with additional updates on our progress during the course of 2013. Thanks everybody. We’ll end the call now.

Operator

Ladies and gentlemen, that does conclude the conference for today. Again thank you for your participation. You may all disconnect. Have a good day.

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ImmunoCellular Therapeutics (IMUC): Q4 EPS of -$0.01 beats by $0.07. (PR)