Good morning. My name is Angel and I will be your conference operator today. At this time, I would like to welcome everyone to the Celsion’s Fourth Quarter 2015 Earnings Conference Call. 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 go ahead.

Thank you. Good morning, everyone, and thank you for joining us today to discuss our fourth quarter and full-year 2015 financial results, which we announced this morning before the market opened. Today’s call will be archived and the replay will be available beginning tomorrow and will remain available by phone until April 30, 2016. Today's call 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’d like to start by thanking all of you for taking the time to join us today. I'm here with Dr. Nicholas Borys, Celsion’s Chief Medical Officer and with Jeffrey Church from whom you’ve just heard, our Chief Financial Officer. As always we are pleased to have this opportunity to update you on the progress that Celsion is making and in particular with the two clinical investigational stage products in primary liver cancer, recurrent chest wall breast cancer, ovarian cancer, and our upcoming program in glioblastoma or brain cancer. As you can tell from our press release, this morning Celsion has had a very productive fourth quarter, and if you look back even further, you will see that the company has posted an impressive record of accomplishment throughout this past year of 2015. I'd like to highlight a few of them. Completing the integration of EGEN this marvelous gene focused development stage company in Huntsville, Alabama was accomplished. Doing so, we rationalized a clinical strategy for the EGEN and Celsion Technologies and launched OVATION study in first line ovarian cancer patients. The study is supported with translational data demonstrating exciting immunotherapeutic potential of our first product from EGEN GEN-1. We established early stage feasibility programs with development partners in one of the most exciting new fields of medicine, microRNA to determine if our lung directed delivery platform TheraSilence combined with certain mIRs, microRNAs, and anti-mIRs developed by these companies can have a positive effect on the course of the disease in preclinical models. We will know the outcome of this research and whether it will lead to a partnership soon. We obtained approval in China for the OPTIMA Study, one of the few companies to do so and a few non-China companies to do so…

Thank you, Mike. Starting with cash, we ended the year with over $20 million of total cash and investments. For the year ended December 31, 2015 we reported a net loss of $22.5 million or $1.03 per share and that compares to a net loss of $25.5 million or $1.38 per share in 2014. Cash used for operations in 2015 was $20.8 million compared to $21.4 million in the same period of last year. We reported in our last call that we implemented a reorganization following the full integration of our EGEN operations. We evaluated our current organizational structure and have aligned our resources and clinical programs with our near term development objectives. As Mike discussed earlier, we have tightened our development focus on OPTIMA and EURO-DIGNITY for ThermoDox and are advancing GEN-1 in ovarian cancer. As a result of this action we expect to realize a 15% to 20% reduction in personnel and related annual operational cost going forward into 2016. We estimate that our average 2016 cash usage for operating activities will be approximately $4 million per quarter and that reflects the full implementation of the OPTIMA Study and our clinical development plans for the GEN-1 program. We continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value and projected our cash will support operations through 2016 pass many of the milestones outlined earlier. R&D costs were $14.7 million in 2015 compared to $15 million last year. Our R&D expenditures in 2015 were focused on the startup and clinical site initiation for the Phase III OPTIMA Study as well as the first of two clinical studies using GEN-1 to treat ovarian cancer and also the production of the clinical supplies needed to support these clinical initiatives. General and administrative expenses were $6.7 million in 2015 compared to $8.9 million last year. This 25% decrease was primarily the result of lower personnel and operating costs resulting from the reorganization and staff reductions announced in the third quarter of 2015, lower insurance premiums and tighter clinical development focus on those programs that we believe will drive shareholder value in the near term through the readout of the pivotal Phase III OPTIMA Study anticipated in 2018. I will now turn the call back over to Mike.

Thanks, Jeff. I hope that it is clear that we are advancing clinical programs that are based on leading edge technology platforms and that ThermoDox and GEN-1 our two clinical stage investigational products are addressing significant markets and have the potential to provide patients with safer more effective treatments and we remain fully committed to bringing forth this portfolio of therapies to address the unmet treatment needs of patients with cancer worldwide. Our balance sheet remains strong which we believe will allow us to execute on many of the upcoming milestones that we’ve discussed this morning. The progress we've made over the last several months have set the stage and positions us for what we believe will be a very successful 2016. 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. We’ll now open the call to questions. Operator and for those interested in asking questions we would ask you keep them to no more than two.

Thank you, sir. [Operator Instructions] We’ll go ahead with our first question from Jason McCarthy of Maxim. Please go ahead.

Hi Michael, hi Jeff. It sounds like things are going well for you guys. I know we’re waiting for OPTIMA, enrollments are going well. It’s a next year event to complete enrollment and we're really focused on GEN-1 in the immuno-oncology space. And can you talk to me a little bit about the open label nature of the neoadjuvant study and you know if you are dosing patients, three to six patients per cohort do you plan to release data as you get data periodically over the next quarter to two quarters? In our opinion, we could see a little bit of immuno-oncology data really going a long way for our company.

Well, thanks for the question Jason, so we have already in the first two patients in the neoadjuvant study we've released some information regarding their response to the treatment following the debulking surgery. It would be our intention certainly with the agreement of our investigators to continue to report results as we are confident in the outcomes. So yes, it’s an open label study, I think it’s important for us as we see the benefit of more and more or otherwise to the benefit of our therapy. We will be reporting it to the investment community, probably not on a patient by patient basis, but more in groups of patients. What I do want to point out though something that may not be clear also associated with this trial is the collection of translational data. So we are collecting with each patient tissue samples that should give us an indication of the value of the immuno-stimulating capability of IL-12 with various markers and proteins and the like both systemically and locally. So our plan is to collect enough translational data from tissue samples from the first two cohorts. We believe that we could draw a line between two points, begin to draw a line -- maybe begin to see a trend from the first two cohorts and we will be reporting the results of that translational analyses. That could likely come later in the – or earlier in the third quarter of this year.

Okay, great and just a brief question on ThermoDox and the DIGNITY Study, I know you’re planning to do a study in a slightly different population in Europe, do you have plans to advance ThermoDox in recurrent chest wall here in the U.S.?

Yes, so we have studied that very carefully. Part of our strategy I think was the as we have talked about a little bit of a disappointment that we had with breakthrough. I mean there is no doubt that the, in this refractory population the results that we have seen are nothing short of remarkable. The fact that the N is so small, it has been a challenge for us. We are hopeful that with the breakthrough designation, there would be the support, implicit support from the FDA to assist us with by advancing recruitment in the United States. Without that, however, it is difficult frankly for us to consider a separate U.S. trial. So what Nick has been talking about is including at least one U.S. site in the EURO-DIGNITY study. It is a little bit of a challenge, but he has reached out to a few investigators who have indicated their strong interest in thermal therapy plus ThermoDox for these patients. The challenge for us is this, we have standardized the EURO-DIGNITY study on a device that is not sold in the United States and it’s an advanced device. We think it represents next generation superficial hyperthermia technology. So while we’ve essentially standardized the European study on this non-U.S. – device, so what our challenge is not only finding an investigator site that will recruit patients in the U.S. I think we may have done that, but it is also now to convince FDA to combine an IDE with an IND. So we’re working on it. We'd like to have some representation from at least one U.S. site in the EURO-DIGNITY study to give us a voice if nothing else with FDA as we consider registrational programs.

Thank you very much guys.

Thank you.

And your next question will come from the line of Keith Markey of Griffin Securities. Please go ahead.

Good morning, Mike, Jeff and Nick. Couple of questions, first I was just wondering, can you tell us how many actual sites in China are enrolling patients at this point and when do you think this will complement will be up and running?

Yes Nick will take that.

Hi this is Nick. We just initiated our first site just about two weeks ago now. We just had our investigator meeting just a few weeks before that. So we’re looking at a pretty rapid startup. We don’t have a magic number of sites that we want have up and running in China, but you could expect around well over 20 maybe 25 sites. So China is very important to us. We have great enthusiasm and I think we’re going to have good enrollment.

Great, thank you and then I will...

Keith I would like to just add to this, so I attended the investigator meeting, the kick off meeting for the Chinese contingent. We had all of the most important thought leaders in China along with I think a very motivational review of the HEAT study data and its potential by Professor Poon whom we all know is a globally recognized as a thought leader in primary liver cancer. Without a question – without question the enthusiasm for this study, I think largely driven by the incidents. I mean it is overwhelming. HCC is overwhelming the healthcare systems in China. But it’s very clear to us that among interventional oncologists they believe that there is an opportunity here to substantially improve outcomes and provide a health economic solution that is far superior to what they are currently – what they are currently experiencing.

Great, thank you. And then I was just wondering as far as the R&D and G&A expenditures go through this year, should we look for them to be comparable to what you posted for 2015?

Actually we, Keith this is Jeff. We actually anticipate a lower level in 2016 to the tune of around 10% to 15% largely due to the full year effect of the reorganization that we implemented last year. And then as we discussed during the call, tighter focus around the ThermoDox programs in primary liver cancer and recurrent chest wall breast cancer and then the ovarian focus for GEN-1. So we anticipate that our operating expenses, R&D, and G&A will be up approximately $4 million a quarter for next year.

Okay. Great, thank you.

Okay. Thanks.

Your next question will come from the line of Mark Breidenbach of H.C. Wainwright. Please go ahead.

Hi guys, just a couple of questions for you this morning. First I was hoping you could help us frame the serum biomarker results we saw from the first two patients innovation, we see that the first couple of patients had substantial drops in [indiscernible] levels. Can you remind us if just the biomarker was monitored in the Phase 1B GOG study and if so can we draw any conclusions about GEN-1 working better or worse when deployed in the earlier neoadjuvant setting?

Hi Mark, this is Nick. That is a very good question and the original GOG study first of all you have to keep in mind that was a different patient population. In this current study these are newly diagnosed patients. So they had multi disease on presentation and so here it is not a perfect marker but it is an encouraging marker as Mike was mentioning in his talk. So that particular marker in an advanced setting you are looking for that to really rise and we were reporting that in the GOG study. So I am not sure if we could make the comparison. But you could take this data and go with the literature and take a look to see what this drop really means in other neoadjuvant studies.

Got it. Okay and then did I hear correctly that the third cohort will be the last cohort for OVATION and that was about 61 per meter squared dose or did I miss hear that?

I think perhaps, I said perhaps the third and final if there is an indication that we have not reached the later [ph] the upper level of activity of the immune system we reserve the right to on to the fourth cohort, but I think after fourth cohort that would likely be the end of the trial. So third cohort is - optimistically we are looking at the third cohort to conclude the study, but there is always a chance we may continue to dose escalate into cohort number four.

Understood and if I can just tack on a really quick follow up, is there particular side of efficacy criteria you are looking for before making a go, I know but decision with continued development in the neoadjuvant setting given that the next planned trial is moving back into a platinum-resistant setting?

No, well the number one issue is the safety issue. We want to see that we could come up with a maximal safe dose so that is number one. So, things could happen at this cohort or in the next cohort and then we are carefully monitoring a whole host of immunological markers to see if we could as Mike was saying if we're looking for some sort of a plateau or indicator that we’ve gotten there. As you probably know in many immunological drugs under investigation right now, they haven’t been able to reach toxic doses or high doses or MTDs and so we're trying to balance what we’ve learned from the markers and what we are learning from the toxicity. So, there isn’t any one thing that we will able to point to accept for safety that will dictate a stop to the trial.

And I will just point out also that we may not reach the maximum therapeutic dose in the neoadjuvant study which would give us a basis to for the Phase I/II study combining with Avastin and Doxil to give us a basis to start at a higher dose, start simply at a higher dose and continue to dose escalate in the Phase 1 portion of the Phase I/II study.

Okay, understood alright, thanks for taking the questions and we’re looking forward to seeing the GEN-1 presentation at AACR. Thank you.

Thank you.

Our next question will come from the line of Hartaj Singh of BTIG. Please go ahead.

Good morning, Hartaj.

Hey, good morning Mike, Jeff, just a quick question, two actually I’m sorry, very, very quickly, one is just any update on Europe and just, the programs you’ve got there any kind of the commercialization in the discussions you are having with authorities there on the right chest wall breast cancer program? And then secondly, just can you walk me through over the next six to 12 months what are the important sort of data and just, clinical trial/ readouts because you’re actually got a lot going on and it would be nice to hear what specifically you are expecting over the next six to 12 months? Thanks Mike, Jeff.

Okay, Hartaj. So let me start with Europe and so on the - with regard to the EURO-DIGNITY study about six months ago we decided that it would be, the study would be better managed, we believe it will be better managed not as a spontaneous study, but as a study that is industry sponsored. So we changed the leadership. In doing so we are filing separately with the regulatory agencies and for the various countries, that necessary documentation to initiate this study. That documentation is being submitted as we speak. I suspect as I said at my prepared comments that our first investigator site will be up and up and enrolling patients in April, our goal is to have the balance of the investigator sites in the Czech Republic, Poland, Italy, Israel and potentially one in the United States that to, the U.S. one would come a little bit later to have them all up and running by the third quarter of this year. The goal is to complete enrollment by the end of 2017. With regards to the early access program, as you know we have announced the hiring of an executive who resides in Europe to provide leadership not only for early access program, but also to oversee some of our clinical trial interests and our relationships with key thought leaders in Europe. With regards to the EAP our progress has been slow not because of the lack of interest but the registrational requirements we are finding out to be little bit more challenging than we originally anticipated. I say, and I continue to believe that we will have a successful program. It is just taking us a little bit more time to file the appropriate documentation and get the regulatory support necessary for physicians to be able to prescribe ThermoDox to patients who have exhausted their treatment options. With regards to milestones, upcoming milestones over the next six to twelve months, there is a lot going on. We expect to be able to on a cohort as I mentioned earlier on a cohort by cohort basis provide results from the dose escalation neoadjuvant study in OVATION we will be presenting data from the first to cohorts the translational data from the tissue analysis from the patients enrolled in the first two cohorts. We expect to provide final data from this neoadjuvant study by the end of the year. We expect to submit and initiate the Avastin combination study in quarter four, 2016 and initiate the Euro-DIGNITY study, again with data is an open label study being presented throughout the year and completion of that study in 2017. And of course if things continue to be on track by the end of 2017 announce the completion of enrollment in the OPTIMA study.

Great, thanks Mike, I appreciate that.

Thank you.

[Operator Instructions] And there are no further questions at this time. You may continue.

Okay, again I want to thank all of you for attending today's conference call. As always we are excited to communicate with our investors and shareholders of the investment community generally. We appreciate your interest and look forward to providing you with updates as milestones are achieved over the course of the coming year. Thank you again very much.

This concludes today's call. Thank you for your participation. You may now disconnect.