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Celsion Corporation (NASDAQ:CLSN)

Q1 2013 Earnings call

May 9, 2013 11:00 am ET

Executives

Jeffrey W. Church – Senior Vice President, Corporate Business Strategy and Investor Relations

Michael H. Tardugno – President and Chief Executive Officer

Gregory Weaver – Senior Vice President and Chief Financial Officer

Nicholas Borys – Vice President and Chief Medical Officer

Analysts

Keith A. Markey – Griffin Securities, Inc.

Operator

Good morning, my name is Andrea and I will be your conference operator today. At this time, I would like to welcome everyone to the Celsion Corporation first quarter 2013 financial results conference call. (Operator instructions) as a reminder today’s call is being recorded.

I will now like to turn the call over to Jeff Church. Please go ahead.

Jeffrey W. Church

Thank you. Good morning everyone, and thank you for joining us. Our first quarter 2013 financial results were released this morning before the market opened. We also filed the Form 10-Q for the third three months ended March 31 2013 at the same time. The form 10-Q is available on the SEC’s Edgar system, and the company’s earnings release and Form 10-K are both available on our company’s website at www.celsion.com. Today’s call will be archived, the replay beginning today at 2 PM Eastern, and will remain available by phone until Thursday, May 24, 2013, and will be on our website for 30 days.

Before we begin the call, we wish to inform participants that forward-looking statements are made pursuant to the Safe Harbor Provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, the risk of clinical failures, delays or increased costs, unforeseen changes in the cost of our research and development activities and clinical trials by others, possible acquisition of other technologies, assets, or businesses, and possible adverse action by customers, suppliers, competitors, regulatory authorities and other risks detailed from time-to-time in the company’s periodic reports filed with the Securities & Exchange Commission.

Following our formal remarks today, we will open the call for questions. I’d like to turn the call over to Mike Tardugno, President and CEO of Celsion. Mike?

Michael Tardugno

Thanks, Jeff. Good morning and thank you for your interest in and support of Celsion. I’m joined today by Dr. Nick Borys, our Chief Medical Officer; Gregory Weaver, our Chief Financial Officer; and of course Jeff Church, from whom you’ve just heard, our Senior Vice President of Investor Relations and Corporate Strategy.

Today, in addition to discussing our first quarter 2013 financial results, we will cover three important topics, first we will provide an update on the Phase III HEAT Study and primary liver cancer, as we have noted in our press release, our post hoc review identified an important signal, indicating and optimize RFA treatment in combination with ThermoDox. As mentioned by RFA dwell time, may provide a meaningful overall TFS and survival benefit and thereby providing a basis for convincing hypotheses and for next steps.

Second, we will discuss our restructuring initiatives, which targets lower operating costs, align our resources with our current development strategy and provide an operating runway to ensure the long-term goals of the company will continue to be addressed. And third, we will give a brief update on our rationale to engage Cantor Fitzgerald to assist us in evaluating strategic acquisition opportunities.

But first I’d like to talk about the Phase III HEAT Study. As you know, we’ve been conducting an analysis of the data from the Phase III HEAT Study of ThermoDox and hepatocellular carcinoma analysis which we will call post hoc. Following the announcement on January 31 that ThermoDox in combination with radiofrequency ablation did not meet the Study's primary endpoint. The overall results of the HEAT Study indicated virtually no difference between the control arm and the ThermoDox arm. Recall that under our special protocol assessment, the study was powered at 80% that showed 32% improvement in progression free survival or PFS.

The post hoc is being conducted in conjunction with the support from two separate consulting data management entities. One of which has managed the HEAT Study database since the beginning of the clinical trial. The second is an independent data analysis group for use in all proprietary algorithms, this group has consulting with FDA and others, other big pharma and smaller biotech companies to uncover non-obvious data trends.

In addition, we are ensuring the clinical data with and obtain substantial input from many of our HEAT Study clinical investigators as well as other liver cancer and clinical data access. To be clear and in particular with retrospective post hoc analysis, any announcement of the trend of positive data coming from a retrospective look should be viewed with caution. As I pointed out earlier much of what we will discuss is not many threshold for statistical significance.

I also pointed this out at our last conference call following a meeting in Princeton, New Jersey with our medical advisors. And we first reported on a large subgroup of patients approximately 575 with 3 cm to 5 cm lesion showing a clinically meaningful benefit although not statistically significant. We also noticed two recommendations were made at the meeting by our advisors; first, they strongly recommended that we continue to follow patients to determine if there is an overall survival benefit particularly in the smaller lesion population, which we will do. And second we were encouraged to rationalize the subgroup to better understand what if any variable or variables contributed to the potential for better outcome. This is the post hoc.

With relatively mature emerging findings from our post hoc analysis are quite encouraging, (inaudible) suggests that ThermoDox remarkably can improve overall survival patients with a single lesion, undergoing RFA for minimum of 45 minutes. These findings apply to single HCC lesions regardless of size, which represents about 65% of the HEAT Study population, which you will recall is 700 patients.

These findings reinforce our understanding that profusion and adequate heating of the tumor in the surrounding liver tissue are important factors in ensuring that ThermoDox and HCC is activated at the target tissue from a plasma concentration of ThermoDox measured overtime is an important factor in determining when to HEAT targeted tumors. ThermoDox concentrations found in the targeted liver tissue may be more important. This phenomenon has been noted by David Needham and others in scientific publications and presentations.

These findings along with our analysis showing growth time is an important factor in improving outcome in ThermoDox treated patients. This will be discussed by our two lead clinic investigators, Professor Ronnie Poon, our lead Asia-Pacific investigator and Riccardo Lencioni, our lead European investigator.

At the WCIO we’ll be covering this in more detail. The WCIO will be hold in New York on May 16. The ThermoDox specific materials will be posted on our website, as soon as possible filing their separate presentation. And I'm sure Dr. Borys will have further comments on this.

So what are our next steps? We're refining our clinical models to better understand the influence of RFA dwell time and local tissue concentrations of ThermoDox and longer RFA ablation times and efficacy. We will then validate the model of animal studies, which we would expect to complete over the summer. Assuming our hypothesis is supported, we will then meet with FDA to discuss these filings.

For contact, I think it might be appropriate for you to consider the HEAT Study like Phase II like population, highly robust, well controlled and randomized. At this point, we will propose a regulatory debt forward, which may likely include additional clinical studies based on FDAs predictive enrichment guidance.

And we will continue to follow our patients in a HEAT Study for overall survival endpoint with a great deal of focus of some group of patients with single lesions having HEAT dwell times greater than 45 minutes. Now on planning this work, we took a long hard look at our organization and infrastructure.

As many of you know in the last quarter of 2012 and early 2013, we have begun to build out our confidences for regulatory medical affairs and prepare for the NDA filing. We initiated early sales and marketing plans as well as activities in surgical, commercial manufacturing.

Following our January announcement, we took another look at the resources necessary needed by the company to move forward. In April of this year, we implemented a program to restructure the company to ensure that our resources and current business strategies worldwide.

Doing so, we are eliminating about one-third of our full-time equivalent workforce, which includes permanent contract part-time employees as well as several full-time consultants. Our head count is now at approximately 15 full time equivalents FTEs, another which is consistent with the personal levels we have effectively operated with over the last number of year.

As mentioned previously, we are also differing cost associated with the ABLATE Study and we will do so until such time as we better understand the results from HCC trial. In all these restructuring measures we’ll bring our operating expense to under $1 million per month when fully implemented.

Our restructuring, I would like to note that our restructuring will have no effect on continuing monitoring of patients to overall survival in the HEAT Study followed through on our subgroup by processes and testing and the regulatory plans for the HEAT Study, continuation of the DIGNITY Study, continued sponsor support for various HIFU programs and as a last point, our financial plan going forward will allow for initiation of joint clinical development program with Phillips’ combining Sonalleve with ThermoDox and patients having metastatic lesions to the fall.

In summary, with approximately $46 million in cash and investments at the end of the quarter, we have sufficient resources to execute a well measured ThermoDox program and to identifying a quarter additional products and technology to broaden our pipeline which I will talk about next.

As part of the restructuring program, we evaluated our current business strategy. We continue to believe strongly in our LTSL technology our heat-sensitive liposomes technology and in ThermoDox. But as we saw in January, our clinical setback as we experienced with the HEAT Study can have a dramatic impact on the development stage company.

With the strong balance sheet, we believe it is appropriate to explore acquisition of additional complementary products or technologies that will provide the company with growth potential and mitigate some of the risk associated with drug development.

We have a very talented group of professionals who are expert in clinical development, regulatory affairs and planning as well as commercial manufacturing. This was to the engagement of Cantor Fitzgerald to work with Celsion to conduct a comprehensive review of merger and acquisition opportunities with a goal of identifying novel, clinical stage products with near-term value creating potential. The process is not fully active, I will note that this is a target rich environment for M&A particularly when you look specifically at private mid-stage opportunities. Jeff Church will comment more on this shortly. In the end, however any acquisition must be accretive from a valuation standpoint. Our first responsibility is as always to improve shareholder value.

Now with that, I conclude my formal remarks. I’ll turn it over to Greg Weaver to give an overview of our first quarter 2013 financial results. Greg?

Gregory L. Weaver

Thank you Mike. Starting with cash, we reported total cash and investments at March 31 of $45.9 million as compared to $23 million at December 2012, which is an increase of $23 million in the quarter and reflects a doubling of our cash balance. We finished Q1 with a much stronger balance sheet following the execution of our financing strategy, post HEAT Study results, which puts us in a strategic position to develop our liposomal technology platform and explore M&A opportunities.

To highlight our fund raising activity in Q1, first in January, we received an R&D payment of $5 million from Hisun Pharmaceuticals. Next in Q1, we raised $6.8 million met under an ATM with Cantor Fitzgerald. This ATM agreement was subsequently put on hold in accordance with the terms of the preferred stock offering to follow. Then on February 22, we sold 15,000 shares of convertible preferred for net proceeds of $13.8 million. The preferred shares are convertible into 12.1 million shares of common and pay no interest, no dividends, have no rights and no preferences.

And during the first quarter, we received $400,000 from the exercise of warrants and options. As of today, the Company has a total of 51.6 million shares of common stock outstanding. We reported a net loss for Q1 of $651,000 compared to the net loss of $6.2 million in Q1 of last year. The Q1 loss from operations was $4.8 million offset by a non-cash benefit of $4.3 million from quarterly one liability accounting.

And the first quarter income statement includes accounting for one-time non-cash team dividend of $4.6 million from the convertible preferred share issued in February as part of the $15 million offering. The preferred stock has no dividend rights or any other preferences at all. This was entirely driven by the required accounting rules.

Total Q1 operating expenses reflect a drop of 22% to $4.9 million from $6.3 million in Q1 of last year. Cash provided by operations was a positive $1.8 million in Q1 driven mostly by the continued drop in operating expenses. Our lower operating cost is the result of continued downward trend in our drug development expenses consistent with our prior guidance.

R&D costs decreased $3.2 million in the current quarter, for the G&A expenses total of $1.7 million or relatively flat year-over-year.

Regarding our expense control program initiated in the first quarter, we’ve taken the appropriate proactive steps to manage costs in the wake of the downturn in market cap. First, we reduced our compensation related expenses by about a third on an annualized basis. Then we reduced various administrative costs as well as curtailed clinical development costs related to the ABLATE Study.

The combination of these measures reduces our cost significantly and a combination with the downward trending clinical cost, we expect that our going forward run rate would be roughly $1 million a month in operating expenses before debt service. This reflects the drop in overall expenses from prior year levels of about one third. And importantly provides cash sufficient to execute next steps in our ThermoDox development program.

Thank you, I’ll now turn the call over to our Chief Medical Officer, Dr. Nick Borys.

Nicholas Borys

Thank you, Greg. Immediately after the unblinded data from the HEAT Study was released, the company initiated a comprehensive and systematic review of the data in order to learn and build on the outcome of the study. We conducted a detailed review of various study sub-groups and invited our lead investigators and liver cancer experts to a comprehensive HEAT Study review meetings here in New Jersey within weeks of the data release from the DMC.

We have determined early on that patients with relatively small lesions did better when given ThermoDox compared to the control group. Our experts found this data to be important and urged us to continue the analysis, so that we could understand why. When we looked at those particular patients, we saw that longer RFA dwell times was a key factor.

RFA dwell times as you may know was not prescribed in the HEAT Study due to many important factors such as liver health, local cooling effect of circulation, immediacy of critical organs such as the gallbladder et cetera. Then when we looked at all patients with single lesions, we saw that RFA dwell times improved outcomes in all tumor sizes. This was particularly enhanced in the ThermoDox group. This effect has not been to hold in patients with multiple tumors and I believe this is because each tumor needs to be treated individually when it comes to ThermoDox and RFA.

This early data, although not statistically significant and not quite mature when it comes to OS is nevertheless indicating a marked improvement in PFS and survival in ThermoDox treated patients.

The overwhelming majority of our liver experts and PIs are impressed with these data and have endorsed that we continue our work on ThermoDox and HCC. Our experts and investigators are in fact anxious to review the findings with their peers at the scientific community at upcoming scientific meetings such as the WCIO in New York. As Mike mentioned earlier, we will make public the presentations.

We conclude that the dwell time data although not perfect is impressive enough to continue our ThermoDox program and we have developed the plans to validate these findings and to initiate discussions with regulatory authorities.

What we have clearly learned from our HEAT Study is that, there is a major sub-group of patients that appear to have a marked benefit from ThermoDox due to dwell times.

We’ll confirm our findings through collaborations with research teams such as the NIH and through preclinical studies as Mike mentioned earlier. I hope that all of you can understand that conducting a post hoc analysis, the HEAT Study was not only important towards the understanding of ThermoDox, but also towards the understanding of treating HCC in general.

I gratefully uncover this data that looking-forward to having all of the review at upcoming medical meetings. The HEAT Study although not successful today, they very well be serving as a foundation for our future successful study of ThermoDox and HCC.

With that, I’d like to return the call to Mike.

Michael H. Tardugno

Thanks Nick, I would like to ask Jeff to give us an update on our M&A project with Cantor, Jeff.

Jeffrey W. Church

In April, we engaged Cantor Fitzgerald to conduct a comprehensive and systematic review of merger and acquisition opportunities with the goal of identifying novel products of companies with near-term value creation potential for Celsion to acquire. We’ve worked with Cantor in developing in appropriate filter or screen of fine tune this search effort, and have established a process to quickly and efficiently evaluate potential new opportunities. The type of products or companies we’re targeting much be accretive and potentially synergistic with our product development focus and internal resources and expertise.

We have reviewed the landscape of potential targets which consistent mostly of private biotech and life science companies. Their strong balance sheet public company status and established clinical development expertise and infrastructure are important assets to Celsion. We’ve already identified about 10 targets and will critically evaluate them over the coming weeks.

As Mike stated earlier the goal of this important initiative is to identify additional complementary products with technologies that will help the Company grow, mitigate risk associated with the singe product with technology platform and create greater value for our stake holders.

With that I will turn the call back to Mike for his closing remarks. Mike?

Michael H. Tardugno

Thank you Jeff. As I hope our remarks made it clear that the company is moving forward and focused on its future. We will complete our analysis of the HEAT Study, we with our collaborators and partners as well as regulatory agencies to discuss our latest findings and prudently determine our next steps.

We have strong balance sheet and now have the flexibility to engage in a number of strategic options. Our partnerships continue and we expect them to remain strong. We’ll continue to focus on our critically important work and look forward to reporting our progress, as we head throughout this year. Doing so we hope to create value for our shareholders and most importantly we’ll make a difference in the lives of patients and their families. As always we greatly appreciate your interest in the Company, we look forward to updating you on our continued progress.

Now with that we’ll go to questions and I’d like to ask you to limit them to no more than two to give everyone a chance to get answers.

So operator, if you would please open the lines for questions.

Question-and-Answer Session

Operator

(Operator Instructions) We’ll go first to Keith Markey of Griffin Securities.

Michael H. Tardugno

Good morning, Keith.

Keith A. Markey – Griffin Securities, Inc.

Good morning, thank you for taking my call. A couple of questions, I was just wondering is it possible that the longer dwell times with the probe are also essential really for optimizing RFA and it would seem like that would be one of the outcome from the HEAT Study that would just simply be beneficial to everybody in the community.

Michael H. Tardugno

You want to answer that Nick.

Nicholas Borys

Hi, Keith. This is Nick. I think you are essentially correct, when we spoke about this with our experts. There was a sense that the abiotic community may have been under treating their patients, and our data clearly points the direction that more heat is better. But adding to that, we think that ThermoDox even compounds that even further improving upon that. But yes, it seems to be clear to us that more heat to these patients isn’t the better.

Keith A. Markey – Griffin Securities, Inc.

If I could ask Peter, extend upon that is it necessarily a higher temperature or just that would be also beneficial or is that maintaining a particular temperature for a longer period of time that would be equally beneficial to the patients than for a ThermoDox?

Michael H. Tardugno

So that’s a great question Keith. And is the one that we will be addressing to a modelling, we’ve talked out updating our empirical model following which we will validate the model with some our non-clinical studies.

Jeffrey W. Church

We expect to complete that work over the next few months?

Keith A. Markey – Griffin Securities, Inc.

Great. And then my second question really was just simply, when do you expect you might be able to come to a decision about how to proceed with ThermoDox?

Michael H. Tardugno

Fortunately that is the question isn’t it? So we have a pretty good internal plan to follow through on the evaluation of our hypothesis very critically and very carefully. Nick Borys has organized our medical advisors to evaluate our hypothesis as expeditiously as possible. We continue to look carefully at the data as it’s coming to us in further cuts and slices. So I guess with all that I don’t want you to be impatient, And certainly not as impatient as I am. So our hope would be that sometime, if well before the end of the year that we would be able to present our hypothesis and our plan forward to the FDA.

Keith A. Markey – Griffin Securities, Inc.

Great. Thank you very much.

Operator

And we’ll go next to Mitch Landgraf (inaudible).

Unidentified Analyst

Hi, good morning gentlemen.

Michael H. Tardugno

Good to hear your voice Mitch.

Unidentified Analyst

My question follows up with aftermarket in regard to like plan going forward. In regard to non-U.S. markets that you possibly China, any other Asian markets that were your studies going on. Is there any possibility that with the data that we have that there is any possibility of a path that goes right through registration or registrational with the follow-up study, without having to do another study before submitting that data for possible registration approval in any other territories.

Michael H. Tardugno

Another very good question. Now, I think we certainly are looking for opportunities to present the data as soon as possible to any regulatory agency particularly those were HCC is a major problem. You know that we have a strategic relationship with Hisun, I plan to meet them later this month to discuss the data and engage their view of a regulatory strategy going forward. But, I have to say this, I think for the most part, all the major regulatory agencies around the world are harmonized on this subject.

The data from the trial from the, announced in January by indicated that there was not a benefit as this study was designed, while this sub-group analysis will take more work, validation, the hypothesis have to be confirmed, following which we will make a decision on that plan going forward in which regulatory agencies to discuss the regulatory strategy with.

Unidentified Analyst

And secondly, it is in regard to from a layman’s point of view, it seems like what we have discovered with the benefits of the longer RFA and the expect the synergies to come back that has with ThermoDox, which is surprising within our understanding of the activity of ThermoDox in the way the LTSL works from the very beginning. But then in that regard, a layman could make the conclusion that it speaks really strongly to using Philips’ Sonalleve or HIFU machines that it can accomplish volumetric heating in a probable fashion. Some real excitement of that would be quite the perfect mix. Is that too simplistic of maybe an assumption to make or can you speak to how, what we’ve learned with does trials speak to how much HIFU and ThermoDox or our LTSL would work well together?

Michael Tardugno

You’re right. You’re spot on. We do have a lot of excitement, continuing excitement, lot of potential for HIFU to work in combination with ThermoDox to treat a range of cancers. I mean, our vision, very consistent with Philips being a non-invasively treating term a locally high concentration of doxorubicin can be a very safe and very effective therapy. I don’t want to get ahead of myself with that. We are excited about the potential, there’s no doubt, as is Philips. I can say this to you is that we’ll be reviewing the results to-date with Philips team and we will be planning a strategy going forward. My hope is to be able to discuss that by the next conference call.

Unidentified Analyst

That’s great. Especially encouraging to see Philips just standing strong there, going nowhere. So, thank you very much for the time. That answers the question.

Michael Tardugno

Thank you.

Operator

(Operator Instructions). We’ll go next to [Alex Robert], a private investor.

Unidentified Analyst

Yes. Good morning.

Michael Tardugno

Good morning, Alex.

Unidentified Analyst

My question is a detailed one, which touches on both the other gentlemen have just talked about, but what dictated the dwell times during the study? I get the impression as that the dwell times were not the same, if, for all the patients. So who decided how long the dwell time was going to be for all these patients scattered all over the world?

Michael Tardugno

Yeah, that is an important question. And we did not prescribe the duration of the dwell time with the HEAT Study, because each patient needs to be individualized and the tumors in the livers could be placed, for example, near a major vessel whether there could be a cooling effect, which would demand a longer dwell time or could be placed in the part of the liver that’s very easily heated or is very fragile.

So, to come up with a comprehensive minimal dwell time at that time when we designed the Study, didn’t seem to fall in with our preclinical data at that time. Now that we have the chance to review data from 700 [and what] patients, we are getting a much stronger signal on the importance of dwell time. So this dwell time is, I think, very important not only for ThermoDox but for the entire RFA community to understand better.

Unidentified Analyst

Thank you. Yes, that clarifies the question I had on my mind for quite a while. And my second follow-up question is, of course you’ve been comparing this all the time with RFA alone. What are you going to be able to do in the future to show the effects of RFA alone versus the RFA plus your chemical treatment?

Michael Tardugno

I don’t think, I don’t believe our strategy. Unless there is a new therapy coming to market during our development period, I don’t believe our clinical strategy for evaluating ThermoDox will change and that needs to be seen, that is combining ThermoDox with RFA, comparing it to RFA alone appears to be the appropriate accepted standard for evaluation not only by the FDA, but virtually all the regulatory agencies that we have spoken with.

Michael Tardugno

Perhaps I didn’t have stated my questions correctly. When you’ve done this follow-on study the one you’re doing now, is there any indication that, have you got any comparison between the longer dwell times with the chemical and an equipment longer dwell time without the chemical?

Michael Tardugno

Perhaps I misspoke or maybe you misunderstood me. We have not initiated any follow-up studies. We are currently analyzing the data from the Phase III trial.

Unidentified Analyst

If I understand that, in the data was there any data where you can make a comparison between the two?

Michael Tardugno

Yeah. That’s exactly how we’ve been coming to developing our hypothesis. We have been comparing dwell times between a ThermoDox group and the control group. So that’s exactly the exercise we took. And so, I think that answers your question. So moving into the future, we have to think about doing prospective studies. At no studies now that we have this data to support this idea then we begin thinking about prescribing 12 times.

Unidentified Analyst

Sorry for the confusion here.

Unidentified Company Representative

No. It’s okay.

Unidentified Company Representative

Appreciate your question.

Unidentified Analyst

Thank you very much. Thank you. My questions are both very clearly answered. Thank you.

Operator

And we will go next to [John Colman], private investor.

Unidentified Analyst

Hi, good morning.

Michael Tardugno

Good morning, John.

Unidentified Analyst

A quick question, just if you could give a brief follow-up on the other studies that haven’t been addressed. You’ve been talking about the HEAT Study. So if you can, just provide maybe a brief update and I’ll leave you with that. Thank you.

Michael Tardugno

I believe that one we’re prepared to talk about is the DIGNITY Study. That’s combining ThermoDox in combination with microwave heat to treat recurrent chest wall breast cancer. That study is active now at four investigator sites. We’re looking to increase that by at least two more over the next coming months. The goal of the study is to enroll a minimum of 20 patients not only to evaluate efficacy of the treatment is an open-label study but also to establish with confidence comparability between ThermoDox manufacturer at one manufacturing site as compared to another. So that trial is enrolling and as we have information from the trial we’ll be happy to provide an update on an ongoing basis.

Unidentified Analyst

Okay. And then, as far as the other studies go?

Michael Tardugno

While the ABLATE Study we addressed in our formal comments, we have made a decision to differ expenses in ABLATE Study unless and until such time we have a path forward on the HCC trial. As you may know, the ABLATE Study combines ThermoDox with radiofrequency ablation to treat cancer metastasis to the liver. So we thought it prudent and wise to conserve cash, defer and essentially halt the ABLATE Study until we have convincing evidence and our hypothesis for using our RFA in combination with ThermoDox to treat liver lesions is confirmed.

Unidentified Analyst

Okay. All right. I appreciate that.

Michael Tardugno

Thank you.

Operator

And we’ll go net to [Bob Green], a private investor.

Unidentified Analyst

Good morning.

Michael Tardugno

Good morning, Bob

Unidentified Analyst

I’m little late getting in. So you might have already answered a question or two. I’m looking specifically at the HEAT Study cohort 5 to 7. In the PR you said you’re seeing results equal in that study as in the smaller cohort and seems those are larger ones. They probably had the longest duration of HEAT. Are we seeing a good improvement in that group?

Unidentified Company Representative

Well, I think, yes, we’re seeing an impressive improvement based on the data we’re looking at and I would urge you to review the results that will be presented at the meetings where we’ll go through the details.

Unidentified Company Representative

So there will be a more detailed presentation of the findings to-date at the WCIO on May 16 in two scientific sessions separately. Professor Poon and Professor Lencioni will be presenting to scientific audience the early findings from the trial. We will post that information on our website as soon as possible. You can dig a little bit deeper into some of the specifics of the question you asked.

Unidentified Company Representative

The reason I am looking at that particular cohort because there is a very little chance for treatment, other treatments. Six months or they don’t have much…

Unidentified Company Representative

That’s true. Right. That’s true, I mean, that’s true for all the cohorts in the study.

Unidentified Company Representative

And there is a possibility in the larger cohort, larger group that there can be several treatments because of the safety factor. Really that sounds like a no-brainer. If they can treat something multiple times, almost turn it into a chronic disease and there is [bug in anyway] why that doesn’t jump out at everyone.

Unidentified Analyst

Well, we share your view. Thank you very much for your time.

Unidentified Company Representative

Thanks for your time.

Unidentified Analyst

Thank you.

Operator

And we’ll go next to [Justin Porter], private investor.

Unidentified Analyst

Good morning. In the last conference call there was a reference to the possibility of ThermoDox activity in ablation margins confounding accurate CT readings on tumor recurrence. And I was wondering, if there was any more information on that since the last call.

Michael Tardugno

We can’t. What I can tell you is though that project and it’s being headed up by one of our Lead Principal Investigators. He’s currently active. That said, it will take some time, but the information, all of the CT scans have been complied and provided for independent review. Since we have some information from that analysis, we’ll be happy to share that with you.

Unidentified Analyst

Thank you.

Michael Tardugno

You’re welcome.

Operator

And that does conclude the question-and-answer session. I’ll turn the conference back over to management for any closing remarks.

Michael Tardugno

Well, as you can see the company is focused. We remain with a strong balance sheet. We’re focused on the future. We will continue to evaluate the data coming from the HEAT Study or with the potential that we have a hypothesis here that works for the development. We look forward to your continued interest and support of the company, and we thank you for your time. Have a nice day.

Operator

And that does conclude today’s conference. Again, thank you for your participation.

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