Good morning. My name is Laurie, and I will be your conference operator today. At this time, I’d like to welcome everyone to Celsion’s First 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 sir.

Thank you. Good morning, everyone, and thank you for joining us today to discuss our first quarter 2015 financial results, which were announced yesterday after the market closed. Today’s call will be archived. The replay will be available beginning tomorrow and will remain available by phone until May 26, 2015, it will also 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 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 want to start by thanking all of you for taking the time to join us for today's call. I am here with Dr. Nick Borys, Celsion's Chief Medical Officer and Jeff 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. 2015 has gotten off to a great start setting the stage for what we believe will be a very productive and very successful year for our company and for our shareholders. Celsion's announced acquisition on EGEN this marvelous biology based early stage Development Company in Huntsville, Alabama. With that announcement our company entered 2015 all at once as a fully integrated development stage company with proven, effective capabilities and experience from product concept to NDA,from the bench to the market and everything in between. The combined assets of our new company are highly complementary, oncology focusedand based on nano-particle technology and all by the way with first line therapy potential in combination with the standard of care. Our press releases over the last quarter have chronicled continued progress with our now three platform technologies in chemotherapy, DNA therapy and RNA therapy, with programs in virtually every stage of development Phases III, II and I, targeting some of the most globally important cancers of our lifetime. We are well positioned with multiple opportunities to create value for our shareholders and new medicines for the medical community. And this year only through April so far, I'd like to summarize what we have announced and remind you that this is just in the last three months. First is great momentum in our breast cancer research program, with interim data showing continued remarkable results and refractory recurrent chest wall patients over two-thirds…

Thank you, Mike. Starting with the cash, we reported total cash and investments at March 31, 2015 of $30.1 million, this compares to $37.1 million at the end of 2014. Cash used for operations in the first quarter of 2015 was $5.9 million compared to $4.8 million in the same period of 2014. We estimate our average cash use to be approximately $1.5 million per month over the next three years, with the full implementation of the OPTIMA study and the integration and clinical development of our newly acquired assets from EGEN. We continue to monitor our cash expenditures to ensure the most efficient use of cash to generate shareholder value. Our first quarter cash usage was higher than our projected run rate, due in large part to one time manufacturing costs for clinical supply needed for both the ThermoDox and GEN-1 development program. We now have sufficient inventories of clinical supplies for our global Phase III OPTIMA Study, as well as the numerous Phase I and Phase II studies, we have planned for the GEN-1 immunotherapy program in 2015 and 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. We continue to maintain a strong cash position and we remain in a strong financial position to ensure the development of our pipeline including the expansion of GEN-1, a very exciting development for our company. Our current cash is projected to support operating activities will past the announcement of many of the key development milestones Mike discussed earlier. R&D costs were $4.5 million in the first quarter of 2015 compared to $2.9 million a year ago. The increase mares the higher cost associated with our expanded pipeline, following our EGEN acquisition, including our GEN-1 TheraSilence program as well as the ramp-up of the OPTIMA study and the cost associated with the manufacturing of clinical supply needed for these development programs over the next two year, which I discussed earlier. G&A expenses were $2 million in the first quarter of 2015. This was down 400,000 or about 17% from a year ago. This was due primarily to lower insurance premiums. I will now turn the call back to Mike.

Thank you, Jeff. As Jeff mentioned, we ended the quarter in a strong financial position, and believe we have sufficient funds to take us through many of the exciting upcoming milestones I discussed on today’s call. With our strong balance sheet and proven development capabilities, we remain committed to our efforts of bringing forward a portfolio of therapies to address some of the most underserved cancer indications worldwide, in liver cancer, RCW breast cancer, ovarian cancer and GBM brain cancer, which I’ve said in the past coming upon the outcome of these pre-clinical studies could become the focus of the Company in the relative near-term. We’re moving quickly and thoughtfully as we advance GEN-1 and we look forward to exploring its potential in both frontline ovarian cancer, as well as, and importantly, with combination with Avastin. As I mentioned earlier, if the synergies we have seen with Avastin in pre-clinical studies have gone out in the clinic, we will have a tremendous opportunity with GEN-1 to combine with one of the most widely used cancer treatments and hopefully in multiple indications. In the near-term, though we’re focused on expanding the GBM and we are on track with an IND filing in that indication for later this year. For ThermoDox, we are successfully executing our OPTIMA trial very much on target. And at the same time we are leveraging the positive data in the RCW breast cancer study to accelerate the development of ThermoDox in this indication in Europe. The third-party support from investigators from our European partners underscores the significant, near opportunity for ThermoDox in this indication. So, I hope, I’ve given you a good snapshot of what we’ve been doing over the past few months, and the opportunities that our work in ThermoDox and with GEN-1 and with other opportunities, platform opportunities, that provided us with the consolidation with the merger with EGEN. They’ll be a good opportunity -- good overview of what the company plans for and the opportunities that exists for you, our shareholders, as well as the medical and the patients that we serve. As always, 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, we are happy now to take your questions. So please keep them to two to give everybody a chance to speak. Operator, if you would please open the lines.

[Operator Instructions] We’ll go first to Daniel Brims with Cantor.

Can you give us some idea of what the, I guess, scientific underpinning is for synergy that you might see with Avastin in those ovarian cancer studies?

Nick, do you want to take this?

Sure. As you know, Avastin is an axon VEGF in order to start the cancers of their blood supply. And with the GEN-1 product, it also when you release IL-12 it also is a VEGF inhibitor. So, we prove that concept, as Mike mentioned before, in our animal studies and we aim to show that as well in HEMO study. So, I think the science there as a very powerful VEGF inhibitor in the ovarian cancer and other models as well is there. So pretty excited about getting that started.

And I guess the immunosuppressive effects of Doxil, you are not too worried about in those studies?

Yes, that’s a very good question. We know that from this mechanism of action, there will be -- there isn’t much an inhibitory effect on the VEGF activities on the side of that. But whether we’ll have any affects from Doxil is doubtful from our animal studies and also when you look at previous IL-12 study, you don’t see it that much. I mean something we keep an eye on and I think it’s a very good question.

Our next question is from Keith Markey with Griffin Securities.

I was wondering in your conference -- in your earnings release, you talk about a strategic options being pursued for ThermoDox in China. And I was wondering if you could elaborate on that.

We can’t give you much more information than we have included in our press release Keith we see the opportunity for ThermoDox in China to be enormous. Frankly, you know that primary liver cancer is, I mean, over-used term, but ubiquitous. So I mean there's over 400,000 new cases diagnosed every year in China. I think we see a great deal of support, Dr. Borys and I had met numerous times with the CFDA with the CDE section signed for drug evaluation section of the CFDA. They’ve encouraged us in a number of ways to consider the Chinese population, in addition to our work in the OPTIMA Study. We are considering those options and we are considering them in -- I'm going to be careful with this, but considering them in conjunction with our work with HISUN. Beyond that I can't say too much more. But it's obvious to us that China remains a very strategic opportunity, not only for the Company, our Company, but for the universe of multinational pharmaceutical companies. We’ll see ThermoDox not only as an entry into the, a branded product entrée into the largest future pharmaceutical market on the planet, but also the largest syndication, in oncology indication, in the largest pharmaceutical market on the planet. So, exploring all of those options, I am, and I don't want to get ahead of myself or over my skis, on this one. But we think the work that we're doing is very much appreciated by the regulatory community as well as our partner and importantly with the medical advisors and investigators who have been working with us diligently on this development program.

But the Chinese regulatory agency hasn't allowed you to start the OPTIMA study locally yet, have they?

No, I think there's -- and we're little disappointed with the timing. But I can give you some background on that too. We saw recent publication. Of course we follow or clinical -- it's all online. It's very transparent and absolutely transparent where the status of the review of our clinical trial application is. We started out with a filing at the same time, I think 18,000 other filings were made -- potentially the backlog -- maybe I'm saying that incorrectly. The backlog at CFDA I understand to be 18,000 filings for clinical trial agreements and similar kinds of requests. So, they took a great deal of time to get to a point where they had reviewed our application. We have recently gotten two or three, what I consider to be more informational side questions, regarding CMC which is interesting, mostly on methods. How do you do this? How do you do that? Nothing that goes to the heart of -- no nothing, no serious questions that go to the heart of the protocol. We've submitted our responses to -- we're in the processes related to our prior responses to those questions. And I would expect the CFDA to act pretty quickly on now with the responses in hand. That's the best I can give you. I don’t think there's any difference. And we may be even getting a little bit of benefit, I don't know, I don't think there's any difference in the time it's taken, CFDA, to review our application than it has for the 18,000 other applications they've seen over the last year.

Okay thanks, if I could ask one more….

It's really just in 18,000….

That is size of the market, so it’s pretty amazing.

And an enormous number, if I could just ask you one other thing. I was just wondering if you could tell us a little bit about your pricing strategy in the Early Access program, and what the starting price is, or would be for the average patients in that program?

That's going to vary little bit from country-to-country. And I'm somewhat reluctant to give you the exact numbers. But I can share with you this is -- but what we’ve decided to do, we think so there is already this price intension between what we see is this enormous clinical benefit in the HCC development program, if we’re right, if we were right. And we see two or three years improvement, and no less, when you add ThermoDox to standardized RFA, if we’re right. The value of this treatment is just spectacular. I can’t even put, at this point, I wouldn't put a number on it. We know that Sorafenib, for example, for 12-week survival benefit, cost the patient, or cost the healthcare system somewhere between $60,000 and $70,000 for 11-weeks. So, we want to be very conscious to the value of ThermoDox, single-treatment of ThermoDox, single treat to treat HCC, on the one hand. On the other hand, we have an non-approved medical product that it will be prescribed, is in the process of being prescribed, to treat patients who have serious lesions on the chest-wall who will be treated multiple times, maybe as many as six or up to the lifetime maximum exposure to anthocyanins. So six cycles, and these things come in vials, so it's about 18 vials to treat a patient with RCW versus three to four vials to treat a patient with HCC. So, we got a little bit of price intension here. So, what we've decided for the Early Access program is not to price on a per vial basis, at this point in time. I mean we’ll eventually get there, but we're not ready to do that, so we decided to price on a per patient basis, not on a per vial basis. So, if a patient has six-cycles, five-cycles and four-cycles of ThermoDox, they're probably going to pay the same amount of money for this treatment regimen. Now we may negotiate that a little bit. Depending upon the market and the reimbursement conditions for -- depending on the country and the reimbursement conditions for the particular hospital or physician, it varies a little bit by hospital, actually some of the countries in Europe. So, I tried to give you a sense and the value of our drug is comparison to an approved drug. And what we're trying to deal is this tension of non-approved medical product being used to treat patients pretty much on a fairly sub-setting versus the real value of ThermoDox and providing an overall survival benefit to primary liver cancer patients. It didn't answer your question. But I hope I gave you the outline of what we're dealing with.

[Operator Instructions] We’ll go next Ren Benjamin with H.C. Wainwright.

I guess, just a couple of quick ones. The first, Mike, can you tell us exactly what studies are ongoing right now? And by the end of the year, I know we'll have the GDM study ongoing, and the Avastin, and Doxil. Can you just tell us when those studies -- you anticipate those studies beginning? And I know OPTIMA, is going on now. I get that. But, for example DIGNITY, are we still following patients, do we still expect to see updates or is everything being shifted to Euro-DIGNITY, just a sense of that would be great?

Yes, so as long as we take more time, of course you’ve got OPTIMA, we’re enrolling patients that's kind of the all-in that’s the best case of 3.5 year study. RCW in the U.S., the U.S. Dignity study, now is -- we didn't talk about this on the call but we petition, we asked the FDA, they agreed with us that we have met our primary endpoints in this study with above 50% of the patients that expected to enroll. The data is so convincing. The bio-comparability data, and efficacy data, the safety data, is so convincing, FDA has agreed with us that we can reduce the population. But I think it was written and projected to be 40-patients, and we're going to complete enrollment in this study. I think we have one more patient -- well we've actually hit the target, but we're going to enroll one more patient and certainly on a compassionate-of-used basis kind of compassionate-of-use. And so that will be 17 patients which is at the fraction of our original target to give some sense of that confidence we have in the data and the FDA has agreed with us. Of course, it's a matter of reviews. They haven't reviewed it completely. So, that study, if we enroll our last final patient in the next month with five-cycles 21-days in each cycle, study would be completed before the end of the year. That's why we're reasonably confident that the data can be presentable, presented at the San Antonio Breast Cancer Conference in December. The Euro-DIGNITY study, the protocol has been Nick and Professor Grabelli in-turn have finalized the protocol absolutely finalized, and we have all the investigator sites, six investigator sites lined-up clinical trial agreements are signed and ready to go. The last step, we're hoping…

So, I just wanted to confirm the neo-adjuvant study will likely start enrolling in July, the combination study with Avastin in ovarian cancer could begin by early next year, did I hear that right?

That is exactly right.

And then the glioblastoma study, the preclinical studies are likely getting finished. But by the third quarter of this year, you could have filed an IND?

Yes, that's our objective. The kind of -- we originally had planned this GBM program to combine GEN-1 with temodar, temozolomide. And then the synergies with Avastin have just been comparable, I mean that's just the -- so we're very excited about that and what we don't want to do is initiate a trial with temodar only to find out later on that we should have crossed the few Ts and few Is an evaluated GEN-1 in combination with Avastin in that setting. So, we’re little bit behind. We originally maybe drift almost behind where we originally projected, and it’s only because of this evolving standard of care in GBM.

And just one final question regarding the OPTIMA enrollment rate, how is everything going, how many sites are on-board and how many are left to be activated?

So, we have 40 sites on-board, 45 hopefully within by the end of the month. I think that's our latest projection. We’re going to get to 72 that we’ve done it. We originally, if you recall, we originally targeted to have 100, but after reviewing points of feasibility and meeting with a number of investigators and sites, we've concluded that 72 sites have the capability and quality, and standardization of the use of RFA consistent with our objectives in the clinical protocol. So, we’ve identified all those sites. Where we are little bit, I mean where we’re behind is in the approval from China. We talked about that a little bit earlier. So the balance of those sites after this 45, probably 47 outside of China, the balance have been identified in as Chinese sites. They will come on over the balance of the year. And as far as enrollment goes, as I said in my comments, we’re approaching about 10% of the study. That's not too far off from where our projections were, even without China.

That will conclude the question-and-answer session. I'd like to turn the conference back over to Mr. Tardugno, for any additional or closing remarks.

Well, again, I want to thank everyone for joining us on the conference call. I hope you can see that not only are we committed to the work that we’re doing and the opportunity that these multiple platforms provide us, we’re also making great progress across the board. So, we’re delighted to talk to you about it. And as always, we appreciate your interest. And we will make sure that as developments work, press releases come out, so you are aware what's going on in the company. And we look forward to again to your participation in our future conference calls. Thank you very much for your time. And have a great week.

That does conclude today’s conference. Thank you all for your participation.