Good morning. My name is Kevin, and I will be your conference operator today. At this time, I would like to welcome everyone to Celsion’s Second Quarter 2015 Financial Results Conference Call. Today’s conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session [Operator instructions]. I would now like to turn the call over to Mr. Jeffrey Church, Senior Vice President and Chief Financial Officer of Celsion. Please proceed.

Thank you. Good morning, everyone, and thank you for joining us today to discuss our second quarter 2015 financial results, which we announced this morning before the market open. Today’s call will be archived. The replay will be available beginning tomorrow and will remain available by phone until August 24, 2015, and it will also be on Celsion’s Web site 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 risk and uncertainties including, without limitation, the risk of clinical failures, delays or increased costs, unforeseen changes in the cost for our research and development activities; 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 and Exchange Commission. Following our formal remarks today, we will open the call for questions. I’d like to turn the call over to Mr. Michael Tardugno, Chairman, President and CEO of Celsion. Mike?

Thank you, Jeff. Good morning. I’d like to start by thanking all of you for taking the time to join us for today’s call. I am here with Dr. Nicholas Borys, Celsion's Chief Medical Officer and Jeffrey Church from whom you’ve just heard, our Chief Financial Officer. As always we are delighted to have this opportunity to update you on our progress and to take your questions. I have lot to cover this morning so I’ll go right to it. For those who have been following us you know that Celsion’s strength lies both in the breadth of our research as well as our focus and we’ve leveraged both as promised as we have been promising you since the acquisition of EGEN to generate some -- what we believe are impressive results for the first six months of 2015. As we record our announcements it’s clear that we have set the stage with for what is becoming very productive year for our company for clinical partners and for our shareholders. I’d like to make a few comments regarding our breadth. With the acquisition of EGEN this marvelous biology based early staged development company at Huntsville, Alabama. We have become all of once a fully integrated company with proven capabilities from feasibility in preclinical programs, through sophisticated clinical studies and commercialization and with this acquisition all at once, as we get them say, all at once. We have three oncology focused platform technologies in chemotherapy, immunotherapy and RNA therapy. With regard to focus I’d like to make four points. The combined assets of our company are highly complementary. Second they are based in nano-particle technology all. Third, they are being employed in oncology research almost exclusively and fourth are all in the potential for short line therapy in combination with the…

Thank you, Mike. Starting with cash, we reported total cash and investments at June 30, 2015 of $30.8 million, this compares to 37.1 million at the end of 2014. We [strike] that our balance sheet in the second quarter with an $8 million at the market registered direct equity offering with two institutional healthcare investors. Cash used for operations in the second quarter of 2015 was $5.7 million compared to 4.2 million in the same period of last year. Cash used for operations in the first six months of this year were 11.6 million this compared to 9 million in the same prior year period. Our cash used during the first half of 2015 was higher than the projected one rate that we expect in the second of this year and this was due to one-time manufacturing cost for clinical supply needs and for both ThermoDox and GEN-1 programs. We now have sufficient inventories of clinical supplies for our global Phase III OPTIMA Study as well as the Phase I study; we have plans for GEN-1 immunotherapy in 2015, 2016. We do not expect to repeat this level of cash usage in the coming quarters due to the one-time nature of these manufacturing costs for clinical materials. Each year we evaluate our annual spending projections as it compares to our current year operating budget. As part of this important process we had implemented several cost reduction initiatives to reduce operating costs by 15% to 20%. We have evaluated our current organizational structure and have aligned our resources both personnel and clinical programs with our near-term development builds. We expect to reduce our operating cost by approximately $3 million to $4 million on an annualized basis. We estimated our average cash usage for the operating activities of the company to be…

Thanks Jeff. As Jeff mentioned we ended the quarter in a strong financial position. We’re focusing our cash as he pointed out on research as oppose to overhead. And we believe we have sufficient funds to take us through many of the exciting upcoming milestones that we presented on today’s call. So I'd like to conclude with this before we go to your questions. With the trials in Phase 3, Phase 2 and Phase 1 as I like to say in some of cancers globally most important forms. Celsion is extremely well positioned for success. They’re making great progress with our platform technologies in chemotherapy, immunotherapy and soon some exciting announcements I hope will be coming from our RNA therapy. Our strategy to advance clinical development in first line and the combination with the standard of care and only applies to ThermoDox it also expands to all of our immunotherapy and RNA delivery platforms. Our [wages] in GEN therapy specifically focusing on having both drug and delivery mechanism along with our ability to target lung disease in combination, the combination that we believe no other company can match and tend to exploit this advantage with strategic partnerships, collaborations and to our own independent clinical research. Our global approach is unique and requires patients. In the end however, we not only serve the interest of the patients and physicians we’re establishing a template with the potential for an extraordinarily oncology success focused research and development initiative. Celsion has leadership, the technology and the experience in place to maximize our opportunities and to shape our strongest commercial potential. We believe the month and years ahead will continue to be transformative and exciting for you, for us and for cancer patients around the world. So we greatly appreciate your interest in the company and we look forward to updating you on our progress as we continue to move forward with these very important clinical programs. With that now I’d like to welcome the call to questions. Please limit them to two to give everybody a chance to speak. Operator if you will please open up the lines

Thank you. [Operator Instructions] We’ll take our first question from Daniel Brims. Your line is now open.

First question is on the HEAT study, the data you put out last week I noticed it was trending in the Chinese population but wasn’t reaching statistical significance of that. What was the reason behind that?

I’m going to ask Dr. Borys to comment on that one. Would you mind Nick?

Yes, there is two factors to take into consideration with the [Apex] of groups or countries of sub groups study. Number one that you might know that the HEAT study Chinese cohort started at least one year after the main cohort started because of we know the long time it takes to get through the Chinese regulatory hurdles. So just now is the data starting to mature in China, so you're seeing that and we're very pleased to see that the data is just basically following the same trends that we saw the main body of the study population. So with that we always felt that whether we use ThermoDox in the U.S., Europe, Asia or China we're getting very similar results and the Chinese population is beginning to verify that.

And my second question, the U.S. DIGNITY study as you said is fully enrolled, when do you and you're going to be presenting some data at St. Antonio Breast, is that going to be the final data when do you expect us to see the final data for that study?

Just a quick answer to your question, the final data will be presented at the St. Antonio Breast Cancer Conference. I think for the most part however Dan we’ve been keeping you and the investment community largely aware of the efficacy results as they have developed. We call this an open level trial, so we've been providing interim information on an ongoing basis, but the final data presentation will be first heard at the St. Antonio Breast Cancer Conference.

We will take our next question from Keith Markey. Your line is now open.

I was just wondering, is type responsible for bringing the HEAT study data through the CFDA and do you have a sense of how the Chinese regulatory agency may view these median overall survival data that you reported?

I mean the second part of your question might be a little speculative on our part. So what I can say about our interactions with the CFDA, I mean generally quite positive, we have not met the agencies a number of times over the course of initial submission of the study and then again throughout the course of the study just to keep the regulatory officials aware of what we're doing. Recently over the past maybe seven or eight months, we have met with the agency, I think I can say with our questions that we're encouraged with the results like any agency however they have some views about a retrospective analysis, and they gave us some thoughts on what might be appropriate next steps for the Chinese population separately from the rest of the world. We think we're in a good position to evaluate those recommendations with the partner like Hisun and I think once we've completed our evaluation and we have Hisun's input we're likely to make an announcement moving forward Keith, but it'll be premature at this point to make any generalized statements in the panel like.

We will take our next question from Jason Kolbert. Your line is now open.

This is really financial, I know you've run through the numbers Jeff, they were pretty correct where you've talked two years worth of one way. Can we go through what the R&D projection would be for 2015 and what it would be for next year 2016? And same question for G&A because that was too fast I didn't quite get it and based on my assumptions the numbers didn't add up?

Unfortunately, I don't have the details in front me. We do anticipate -- what I indicate in the first half of 2015 R&D, we had at 8.2 million and G&A for the first six months was 3.8 million and we anticipate the R&D to be coming down largely due to some high manufacturing cost for clinical supply and also some other areas where we've looked at the clinical programs et cetera. And we've sort of indicated here with our guys that we've come down in the neighborhood of 15% to 20% over these numbers in the first half of the year. And I would say a similar sort of 15% reduction also the G&A due in large part to some organizational structural changes that we'll be implementing in the second half of the year.

But still, I mean, if I -- even if I use 15% reductions I end up showing our burn rate of call it 20 million in 2016 plus the second half of 2015. So I am trying to understand how you can say that you have cash for the next two years worth of operations even with the 20% reduction I am closer to six quarters?

Here again based on also what our projection is on a monthly basis moving forward of 1.3 to 1.4 but easing those projections it’s around 22 to 24 month. I’ll take a look and we can talk why but these are the current projections…

I won’t understand because in the second quarter of '15 I guess on a quarterly basis you came in at 5.3 and maybe we could just chat offline. And looks -- switch gear and talk a little bit about this partnership that you announced this morning, can you talk a little bit about how that came about and how that might change the trial timeline, so I'd be very appreciative to better understand that.

Jason, are you talking about the early access program?

Yes.

So the early access program operates independently from our clinical trials and we’ve expanded it from RCW patients exclusively to include now patients who are treated with liver disease and that includes metastasis to the liver as well as primary liver cancer patients who are indicated for Radio Frequency Ablation. The implications for clinical trial are for the most part de minimus we will not -- in study centers where the clinical trials are ongoing we will not make the early access problem available in centers outside, in institutions including community hospitals who are using Radio Frequency Ablation to treat these patients and our objective will be to provide them with sufficient awareness so they understand the potential value all the data in not in but understand the potential value of combining ThermoDox with Radio Frequency Ablation assuming that Radio Frequency Ablation is controlled properly every flex fee, amount of fee required to probably ablate the tumor of significant size. So we don’t see any either the synergy or conflict with the --

So that's what I’m trying to understand the risk versus benefit here because you have a drug that’s currently in a pivotal trial and you’re going to be treating patients with the drug outside the trial. So it seems like on the one hand you’re using this as kind of awareness marketing prelaunch but on the other hand isn’t they’re regulatory risk, you have to track these patients. So I’m trying understanding that’s very unusual situation where you have a pivotal right but you’ve been actually treating patients with the drug outside the pivotal trial. So that’s why I don’t quite understand this. So it maybe unusual for the moment but I think you’re going to find this approach appeals to quite a number of companies who have convinced they have a drug they can produce to GMP standards who have a history of using the investigational product in sufficient number of patients to be confident in the safety profile and who are working with the company like myTomorrows who insist on protocol compliance as well as follow very carefully the outcomes of patients. So we have treated in the EAP. We’ve looked at the risk, reward potential here. We believe properly executed that the EAP represents an opportunity that does not expose us to a great deal of risk.

We’ll take our next question from Hartaj Singh. Your line is now open.

Just one quick one on the EAP will you have to go through the regular negotiations country-by-country, get reimbursement and then start signing on patients meaning that I would imagine about a 12 month process. And then just remind with that is that would you have to go through the reimbursement negotiations separately for each label meaning the each indication like chest-wall you have one set of negations for liver -- and anther one or will they be sort of joined together as you go through Germany, France, UK et cetera?

So pricing is not negotiated, let me start there Hartaj. So we have a statistic price which depending upon the market and maybe even the institution we're prepared to make some allowances depending upon the individual circumstance. So EAP afford this quite a bit of flexibility in that regard. What the bottom line is that we take this value inherent in this investigational product at this point so it’s not a give away by any means. The process for establishing payment is opposed to reimbursement. So, since we’re operating outside of what's considered to be the approved drug. So, unregistered medical products UMPs in Europe have a status by law. They are not -- the pricing is not established through the normal negotiation means of the regulatory authorities in each of the countries, they're in many cases the pricing is established with local institutions who have budgets for these kinds of procedures and some cases the national health authorities have small budgets set aside relatively small budgets set aside for payments for these kind of procedures. These countries are little bit different and that's why the expertise of a company like myTomorrows is important to making sure that we're getting appropriate awareness in that patients and physicians and institutions are aware of the costs. But the last point I try to make and I'd like to make is that in some cases prior to arriving at an agreement with an institution or local authority patient made very well pay for this therapeutic on their own, so it could be private pay.

And then you will -- just the different like chest wall, liver mets will those be negotiated separated I guess with local institutions or government or they'll just -- if you just get approval for one you should start getting reimburse with the others also?

Yes, I can't answer that with confidence because each I think -- as I pointed out, each one of the countries and by institutions is a separate discussion, has opposed the negotiation.

And then other just the housekeeping matter is that, I saw you share comps at 19.96 million for this year but with the registered direct that you did, it seems your share stayed stable between first and second quarters, so is that I am just missing something because that was in the second quarter right, so shouldn't your share count have gone up?

It should have, so I think it's 23 million at this point, right.

Got it, so that's the fully diluted.

We will take our next question from Mark Breidenbach. Your line is now open.

I was wondering first if you could just speak to the underlying reasons behind the delay and opening Chinese sites for OPTIMA?

Let me start by saying that while we're waiting for the clinical trial application the work is way through the approval process. We have been negotiating contracts with each of the sites. We have the IRP or F6 committee's submission ready to go. We are not unique so that being said we're not unique in this long review and approval process. The Chinese government has a great deal of transparency associated with clinical trial applications. If you are conversant you can read Chinese, you are welcome to look, but the CFDA allows sponsors and the public to track the progress of their review online. So there is a Web site devoted to this information. And what we know this is we're not unique and taking a long time for this clinical trial application review, it was reported in one of the local newspapers that the backlog of clinical trial applications that the CFDA is considering is about 18,000 applications and that information is about six months old. So there is an enormous amount of interest in clinical studies in China and the backlog is beginning to reflect in more applications, I'd say that's number one. And now I'll speculate with you a little bit too as the Chinese authorities are looking also for us to make sure that our clinical trial applications in the acceptance of those applications are up to world standards, global standards because we've seen over the course of our experience with the CFDA a very aggressive move towards modernization adopting practices and principles that we would consider to be consistent with those in of USFDA and of the EMEA. So implementation also as we see as we talk to the sensible to CFDA, and we do quite often implementation of those practices and programs requires training and additional resources. So I guess the bottom line this is -- there is -- we're in a queue and there is nothing that it's apparent to us and obviously we would know, but there is no hesitation from a quality of the study standpoint.

Then let's switch gears quickly to GEN-1, I think I heard that the results of the neo-adjuvant planned study are going to be used to inform the follow-on study in combination with Avastin. Does that mean that the follow-on study with Avastin would not initiate until late 2016?

I think we can say that depends, so if I mean those things are -- so our plan is to initiate the Avastin plus Doxil plus GEN-1 study in the first of 2016 and I think more on track for that. Initiating the neo-adjuvant study which we expect to be relatively soon. Getting patients onboard -- the dose that we left off in the prior study in Phase 1b study, completing that cohort and moving to the next level, so we move to the next dosing level safely could likely inform the starting point for the Avastin study. So if we complete the evaluation of higher doses in the neo-adjuvant study obviously that would be basis for the starting point for the GEN-1 plus Avastin program. However if we are to hire those and still not have completed the neo-adjuvant study we would likely start at the higher dose but not the final dose that would be enlightened in the neo-adjuvant, is that make sense?

Yes, what about the GBM study, what are you thinking in terms of timing for that one?

I don’t -- I think we can definitely give you a timeline. So we’re just kind of curious with where we are at. We’ve completed a range of studies combining GEN-1 with temodar, temozolomide is an alternative standard of care therapy for these patients following our section and the standard of care indicated in the MCC and guideline appears to us to the BCNU clear their way for us following surgery. So we have a great deal of safety data and efficacy data in a preclinical model for combining GEN-1 with BCNU, I don’t know that's very good, very promising. With temodar be a treatment also -- by the way treatment at temodar also includes radiation following surgery. So the radiation component we have yet to complete, so we complete that successfully. We are currently in discussion with key opinion leaders, surgeons, neurosurgeons, neuro oncologist who treat these patients. We could have a clinical protocol design completed based on the final safety study is covered our radiations. In time for a submission at the very end of this year the first quarter next year for an IND submission, so that’s the status.

Our next question comes from Barry Rubin. Your line is now open.

I have a one question if you would be so kind, on the GBM it’s rather difficult thing to resolve as you know medically is there any way that you can tell us what would make our drug different in a more efficacious manner than other items that are out there now?

Jeff you want to take that?

My first reaction to your question would be what makes GEN-1 unique to everybody else is that we are a regional therapy IL-12 as you know was a very powerful modulator at the immune system and previous studies when you gave IL-12 systemically was limited by toxicity very much like traditional chemotherapies and now with our technology we are going to be applying the drug locally where it acts locally on the tumor. So we could apply it during the time of surgery when the tumor is being excised from the brain and the idea would be to apply it that time and as Mike said with the BCNU wafers. No other technology can do that so that’s what I think makes us unique.

Our next question comes from Leo Gibney. Your line is now open.

I wanted to follow up or comments or question earlier about the China you gave us the data for the update on the HEAT trial and the crave out for China. The results were similar but it wasn’t statistically significant. I’m wondering does China require that a crave out for their country or any other countries acquire as you know you lose statistical power if you have to start carving out the data of these regulatory authorities require it. And so I was wondering if you could speak to that? And then also the 15% enrollment in the OPTIMA. Are you on track with that it seems that would be quite a while before enrollment is completed in that too? Those are my questions.

Let me just answer the last question first. So it takes a great deal of time to initiate study sites literally around the world it's not unique to us. So from the time we’ve got we received regulatory approval for trial in the U.S. we then have to submit our trial to regulatory authorities in 12 other countries but you just have to take some time. Subsequent to the regulatory approval then we have identified, usually pre-identified number of investigator sites. In our case we’ve identified 75, 20 of which are in China. We've pre-identified the sites, we've begun negotiating clinical trial agreements which can take 3, 4, 5 or sometimes 6 months. We have a study site in Italy in Ferrara. I think we've been negotiating the clinical trial agreement with that site now for almost 12 months believe it or not and it's just assuming quite a bit exacerbating and we use I think a CRO as good as any with legal resources better than most, and this has -- certainly has our attention. So the point I try to make -- and then following clinical trial agreement, we have an Ethics Committee review or an IRB review maybe the term you're more used to, so it's in the IRB it takes 4 or 5 sometimes 6 weeks to complete their review and make a formal announcement then we initiate the study. One at a times we open up the study sites, so that the picture I am trying to paint for year there is a waterfall of activity that requires to go from zero to 100 and that usually takes about a year, so what you're seeing as we open trial sites then we begin to enroll patients. So you're seeing now that now we have I…

It wasn't so much the maturity of the data, but just the fact that they might, do they require that kind of carve out because you might let's say 60% improving overall survival which is great, but if you carve out just in its sub-segment you're going to lower your statistical power, you might not reach significant, I think Nick may know what I am talking about.

We completely understand, and I don't think anybody should underestimate the discipline in the scientific [regulatory] that CFDA requires of the new drug applications, so although we have -- where we have great deal of confidence in the, now having follow these patients for 2.5 years in the overall survival data it's still in fact retrospect. So the questions remain and we have discussed this with CFDA we are not prepared to make any public announcement this point but on that basis now we have what we think is the reasonable recommendation for us to consider from CFDA.

And it appears we have no further questions at this time. I'll turn the call back to our speakers for any additional or closing remarks.

Well, again as we open up this call, I want to thank all of you for taking the time to join our teleconference, we're excited with the progress of the Company, we hope you are too. We look forward to continuing our dialogue with you as we progress our clinical programs across the Board. Thank you very much for your time and attention this morning. We look forward for your participation on the next call.

This does conclude today’s teleconference. You may now disconnect. Thank you and have a great day.