Good afternoon. My name is Lisa, and I will be your conference operator today. At this time, I’d like to welcome everyone to the Celsion’s Third Quarter 2014 Financial Results 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. Jeff Church, Senior Vice President and Chief Financial Officer of Celsion. Please proceed.

Thank you. Good afternoon, everyone, and thank you for joining us today to discuss our third quarter 2014 financial results, which we announced this morning. Today’s call will be archived. The replay will be available beginning tomorrow and will remain available by phone until Wednesday, November 26, 2014. And will also be on Celsion’s 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 research and development activities; possible acquisition of other technology 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 now to Michael Tardugno, President and CEO of Celsion. Mike?

Thank you, Jeff. Good afternoon, thank you for joining us today. With me are Dr. Nick Borys Celsion’s Chief Medical Officer and Senior Vice President and by phone from Huntsville Dr. Khursheed Anwer, our Executive Vice President and Chief Science Officer. Khursheed, if you want us to know that you are there please.

Yes, good afternoon I’m here. Good to be part of the conference.

Thank you. And Jeff Church, from whom you just heard, Celsion’s Senior Vice President and Chief Financial Officer. As always we are excited to have the opportunity to update you on our recent progress. Over the past few months we have worked steadfastly to integrate EGEN, this marvelous nucleic acid focus development company that we acquired last June, to integrate them within the Celsion organization and framework. The complimentary fit as we’ve been saying all along is nothing short of remarkable. Now all at once, Celsion is a fully integrated development stage company with capability from discovery to NDA from the bench to the market and everything in between. The key word here is “Position”. We are well positioned, with platform technologies and chemotherapy, immunotherapy and RNA therapy and programs in all stages of development targeting some of the most globally significant cancers of our life time. Well positioned, Celsion has now has multiple opportunities to create value for our shareholders and represents a development company, I’m sure that you will agree of unique proportion, well positioned to bring each of our programs forward into clinical trials over the next six to 12 months. Well positioned, with a strong balance sheet to make major progress in our important work. For example, our registrational Phase III OPTIMA study is progressing very, very well. We are now recruiting patients in key markets in the Asia Pacific region and will be aggressively adding important clinical sites in Europe, North America and Taiwan in the fourth quarter as planned. Our clinical trial application for China was filed last April. And with very positive face-to-face interactions with the China FDA, we expect CFDA clearance of the OPTIMA study in early 2015, a timeline appearing to be about 10 to 11 months. This is much less…

Thank you, Mike. Starting with cash, we’ve reported total cash and investments at September 30, 2014 of $43.8 million, as compared to $43.1 million at the end of 2013. Our cash position reflects the proceeds from a registered direct common stock offering in January 2014, along with the second draw in June of $5 million under our Hercules loan facility. We have maintain a strong cash position over the first nine months of 2014, while initiating a global Phase III pivotal trial and primary liver cancer the OPTIMA and broadening our product pipeline and technology platform through the June, 2015 acquisition of EGEN. Our current cash position puts us in a strong financial position to advance the development of our expanded product pipeline. Our cash usage over the first three quarters of 2014 has been $1.6 million per month, and is estimated to reach approximately $2 million per month with the full implementation of the OPTIMA study, and the integration and clinical development of the newly acquired assets from EGEN. Our current cash is projected to carry us well into the second half of 2014, well pass the announcement of many key development and partnering activities. Net cash used for operations was $14.8 million in the first nine months of 2014, which I say is above – which is approximately $1.6 million per month. This compares to $6.1 million for the same nine-month period in 2013. This increase is due to higher operating cost related to the initiation of the OPTIMA study, the inclusion of post acquisition operations of EGEN and the one-time acquisition cost associated with the EGEN acquisition. In addition, cash used in operations during 2013 which favorably impacted by a $5 million technology transfer fee which we receive from Hisun, our Chinese manufacturing partner. Research and development…

Great, Jeff. Thank you. I’m marveled how interesting, how you can bring to the life the financial report of a company like ours [indiscernible]. I would like to ask you to make one correct first, you report the statement of 2014 and 2016.

I’m sorry. Yes, I’d mentioned that occurring cash is projected to take us well into the second half of 2016

I just summarize by saying we are clearly well positioned for the strong balance sheet and a number of value creating opportunities across multiple programs, perhaps most importantly our programs are addressing some of the most critical needs on oncology today. Primarily liver cancer, ovarian cancer, recurrent chest wall breast cancer and of course glioblastoma multiform. We are addressing first line settings and evaluating solutions for indications or treatment options are limited. We’re advancing our Phase III OPTIMA trial for ThermoDox, targeting registration in significant markets around the world, and building momentum with our pipeline. We look forward to advancing our ThermoDox DIGNITY program and GEN-1 through keep data readouts and into additional studies over the next six to 12 months. We have a strong balance sheet with resources and capabilities to advance our key development programs. We believe that we have the right mix of programs and technology in our pipeline to assure value for our shareholders. And most importantly, to make a significant difference in a lives of cancer patients and their families. So with that I just – I want to conclude with my remarks with a recognition. Some of a great and generous man, a person who committed his life to the pharma industry. And more recently the small biotech like Celsion passed away. That person was Max Link. I had the great honor to know Max as a mentor and a colleague and as a friend. He will be missed and while he will be missed by all of us who knew him, and certainly by me. We can take comfort in knowing that his legacy will advance you to people that he touched and inspired. A world was made better by Max Link. As always, we really appreciate your interest in the company and we look forward to updating you on our progress as we continue to look forward on these very important clinical programs. We’ll now go to questions. So I’d like to ask the audience to limit them to no more than two so that everyone can have an opportunity to get answers. So operator, if you will the open the line please, I’d appreciate it.

(Operator Instructions) And we’ll take our first from Keith Markey with Griffin Securities.

Hi, guys. Congratulations on a good quarter. Two question, okay, well I was wondering Mike if you could elaborate a little bit about the DIGNITY study in Europe that you are planning to do. What kind of technology you are going to be using and perhaps a little bit more about the patients if you could?

I’ll talk a little bit about the technology which are very, very, very excited about. I’d like to ask Dr. Borys to about the patients. It is the patients have a little bit of different complexion of the patients and we have been recruiting in United States. And I think it makes it all the more interesting and actually provides an even more impressive opportunity for us to provide a better outcome. But then Nick can speak to that, we won’t be able to get into the details of the study design at this point Keith. We presented this study -- we’re presenting this study to the Ethics committee at the IRCCS center in Candiolo, outside of Turin. Once we have Ethics committee agreement then I think it would probably be more appropriate for us to get into details of the protocol. Let me say this, we had a number of investigator including Dr. Borys who was one of the authors are published recently the results of our two Phase I studies, the full data was impressive to say it at least. Following that, we received a letter of interest from one the foremost radiation oncologist in Europe, asking if we would be interested in discussing with him an opportunity of/for a clinical program in Europe. We had to a great degree we had discounted Europe as a site for rolling patients because the devices in Europe that are becoming the standard of care or are not approved for use in the United States. The device that we believe is probably the most advanced and the most sophisticated with some. And I’m hardly to one to describe it adequately but with some feedback in planning capability we can only dreamed frankly when we had first planed our DIGNITY program in…

Thanks Mike. The type of patients that our European colleagues are looking at is a little bit more earlier in disease that what we’ve been seeing in the U.S. What caught the eye of the investigators in Europe is that the U.S. data, here we have patients that have failed after a mastectomy after they’ve had two rounds of chemotherapy and even after radiation. And the most interesting aspect of it is, when patients even have a previous doxorubicin, they still responded to ThermoDox. So in Europe where hyperthermia is for our mainstream, they are now looking at applying what a very cutting edge approach which is called trimodal therapy in these patients. So when these patients present for the first time with recurring chest wall cancer we’re now at giving them simultaneously chemotherapy through ThermoDox localized and then sensitizing that with hypothermia treatment and then giving radiation. And that’s a trimodal approach where the cancer will be hit from three different sides. So we’re very excited about this and as well as the investigators out there and we look forward to reporting to you on that in the near future.

Okay. Thank you very much. And for my second question I was wondering if you could tell us a little bit or try to characterize perhaps what you meant by an impressive overall survival benefit that you’ve seen in China and Hong Kong, I don’t expect statistical data, but just try to put it into or compare it perhaps with the overall HEAT study results?

Well, I’d say, we get to still it’s a small number and we always hesitate to give out data on the small number not statistically significant given the size of the population but all the improvement in overall survival, I believe could be reasonably comparable and maybe slightly better than what we’ve seen in the cohort that we’ve been following Keith. Now that said, if the data is not – if you recall the Chinese portion of the study came on one year later than the rest of the study. So the data is not as mature as or the information that we’ve been evaluating in the 285 patient cohort. We’ve received radio frequency ablation for minimum of 45 minutes. So we could move slightly what frankly it’s been stable, that’s been stable over the course of evaluation and I would say that – we were looking forward to one more read out for survival. We delayed this quarterly readout for -- I think probably for financial reasons that’s relatively expensive proposition to gather this data. So we essentially instead of picking up on the quarter, we are delaying it four or five weeks in order to ensure that his next data readout gets us cash for median. Now we can see with confidence to view in the investor community that the data represents information that would be accepted from in a rigorous statistical environment. So give us a little bit more time, I think maybe I answered your question. So give us little bit more time perhaps maybe the next time we get together on a quarterly call we can give you more definitive information.

Well, actually the answer that you gave me was very good. Thank you.

And we’ll now go to Reni Benjamin with H.C. Wainwright

Hey, good afternoon, guys. Doctor how are you? Thank you for taking the questions. My two questions, I guess the first one is, you started the OPTIMA study, congratulations on that. Can you give us a sense of what will trigger the interim analysis and when do you think those interim analysis may occur?

Yes, so the trigger that’s an event driven trial – the first point I want to make sure I get the number exactly right. The first interim analysis occurs after – the first interim analysis is after 118 OS events. And we have – we’re looking at stopping the study for efficacy, if we see a hazard ratio with confidence of 0.61. If we use the HEAT study as a basis to project when we would reach 180 events it would be approximately 36 months after the first patient was enrolled. The second interim analysis would be at 158 OS events. We’ll be looking for Hazard ratio of 0.70. And I believe for –if we use the HEAT study as a yardstick this would be around 42 to 44 [wants]. And then the final read out if we have to got that far remember the data that we are looking at currently suggest that we should cross the threshold for clinical benefit after we got 118 events. So it will be very close, if we can reproduce the data we reproduce the findings that we saw in the HEAT study. But if we have to go all the way to a 33 % improvement on our Hazard ratio of 0.75 there would be 197 events and our expectation for that is about 52 months something in that range from the time first patient is enrolled.

Got it. Thank you for that. And then just in regards to the Euro-DIGNITY study, in your prepared remarks you mentioned that it was an extremely difficult trial to enroll here in the U.S. and a 100 patients seems, it would just seem to be even more difficult to enroll. How long do you anticipate this trial to take? And what is it about Europe that makes you think that enrollment could go quicker?

Even Dr. Borys had been swapping notes. When I first came back from Italy, I met a professor [Gabriel] this IRCCS and forgive me if I can’t tell you what that acronym is, it’s an Italian acronym for a national cancer reference center. When I first met Gabriel I asked him about his patients and recruitment. In Europe, at the stage that we are considering enrolling patients, his center sees about 10 new candidates a month, which in as we discussed with the other investigators in our conference this past week end, it’s not a typical. After we apply the inclusion, exclusion criteria we have [woodled] that down to maybe 20% of that population or so. So that’s what we are looking at. Nick is also an unbeliever. I’m going to be the optimist in the crowd. But when we listen to the physicians talk to us and I think with a great deal of confidence. And by the way they have some money on the line on this too. They are participating in kind, with many of the required procedures being either funded directly by the hospital or being reimbursed through the normal insurance payment system in Europe. When we talk Turkey with this group of physicians they believe well discounted some I suppose but they believe they can enroll a study within a 24 month period, perhaps sooner. We are planning on 36 months. But that’s kind of how we are being guided by, it’s always says the Borys rule of thumb is whatever they tell you discount it by 50%. So that’s kind of how we are looking at. I can’t tell you how excited this group, but they do treat these patients currently they treat them with radiation and hypothermia. In their centers they are seeing a good number of patients and they all think they counted them for us and in pretty exact in terms, so they came prepared to talk about enrollment rates. But we are providing for them as an opportunity for some of these patients to include in this standard of care, so it’s not like it’s a last ditch effort, including the standard of care pretreatment with ThermoDox plus hyperthermia. So how realistic are the enrollment rates? Probably better in this trial than we seen in others. How are we going to count on the enrollment rates to project the conclusion of the study as presented by the investigators? Probably not, so, the way we are budgeting this study and we’ll be talking about with the investment community. It’s going to be about 36 month study that as we see it.

Excellent. Thank you very much and good luck.

Sure. And by the way it’s an open label study similar to the DIGNITY study. So we see overwhelming evidence of similar to what we are seeing in the U.S. DIGNITY study, but we maybe in a position that we’ll be able to talk about results on an ongoing basis. I know that’s an aftermath for some of our investigators but I think it’s important. It’s important for us to communicate how we are doing with this trial to the investment community.

And just one last comment and I hope you can just indulge me. The cost of this study is a fraction, a small fraction of the cost the DIGNITY study on a per patient basis. We are very comfortable that within the guidance, the financial guidance that Jeff just gave you we are able to incorporate this study.

Excellent. Thank you very much and good luck.

Thank you.

(Operator Instructions) We’ll now go to Daniel Brims with Cantor

Hi, thanks for taking my question. My first question is over the DIGNI study I guess. So the protocols in the U.S. and the E are going to be different patient populations. Have you gotten any input from either of the two regulatory agencies as to whether or not you can use both studies to support regulatory approval in the each geography? And I’ll have a follow-up after that.

Yes. It would be our hope that in this population that’s generally refractory to chemotherapy that in the single arm study where we know this disease progresses at a very high rates. It will be our hope to be able to convince regulatory agency with some high percentage of patients with a complete or partial tumor response that the drug is sufficient in the combination therapy is sufficiently valuable to warrant consideration for approval. We’re not there yet, Dan. So I think one of the things Nick has been [indiscernible] or what’s he’s been thinking about is, how do we position this study with the scientific price working console of the EMA, how do we position this study. And let’s gets their advice. I mean, I think everyone knows this is a population of women who die in a very, very, very difficult, with a very difficult complication. If we can provide a quality of life endpoint point, a reasonable quality of life endpoint, my sense is FDA told us by the way, but when we talk to them about the patients that where the population we’re recruiting for the U.S. study they told us that the [QOL] would be a, well actually Dan it was a – overall response rates, but overall complete response here we’re looking for. But which translates in the quality of life. They told us they would accept them as a registrational endpoint. Now, combining the two studies I don’t know that we are in a – I mean now let me turn it over.

Yes, Dan, I think we already have a framework as Mike just mentioned from the regulatory authorities. They are – they already stated and we will be collecting durable complete local response on these patients and we’ll be following these patients as well for survival. So, we do have the ingredients of what they will be looking for and we have to take one step at a time. We now have a study protocol design. We’re going to be studying that, finalizing that and then we’re going to decide how to approach our regulatory strategy. So now we have clinical support. We have a patient population identified and hopefully in the near future we’ll be reporting few more details on a regulatory front.

Okay. Thanks. And my second question is about the OPTIMA study in China. What percentage or how many patients will you need to have in the study that are Chinese in order to basically support regulatory approval there?

One hundred pairs, Dan.

What was that again?

One hundred pairs of patients are required for registration in China. 100 or 200 patients or 100 pairs actually is that is the way the large – or the guidance is written, 100 pairs of patients.

Okay and that’s of – so 200 of the 550 patients?

That’s right. And now we are in a position to manage the trial in a way that we will recruit 200 patients. We think that’s extremely important.

Okay. Thank you.

Thank you.

And we have no other questions in our queue. I’ll now turn the call back to Michael Tardugno for closing remarks.

So I’ll help you with that next time. I just want to thank everybody for taking the time to join us on the call. As you can see the management team here has been working diligently to put some points on the board and for some very important indications using or leveraging some technology which we think can be the future of therapy and some pretty sophisticated and difficult indications. We look forward to speaking with you again at our next quarterly conference call. And that’s in the mean time if you have any questions, please don’t hesitate to contact us. Thank you again and just let me close with one last point. Today’s is Veterans Day, please take a minute if a Veteran and thank him for his or her for their service. Thank you.

And ladies and gentlemen, that does conclude today’s conference. We thank you for your participation.