Good morning. My name is Roxy, and I will be your conference operator today. At this time, I would like to welcome everyone to the Celsion Corporation First Quarter 2014 Financial Results Conference Call. [Operator Instructions] I would now like to turn the call over to Mr. Jeffrey Church. Please proceed.

Thank you. Good morning everyone, and thank you for joining us. Our first 2014 financial results were released this morning before the market opened. We also filed our Form 10-Q for the quarter ended March 31, 2014 at the same time. The Form 10-Q is available on the SEC's EDGAR system and the company's earnings release and Form 10-K are both available on our website at www.celsion.com. Today's call will be archived. The replay will be available beginning today at 2 P.M. Eastern and will remain available by phone until Thursday, May 22, 2014, and will also be via 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 of our research and development activities; possible acquisition of other technologies, assets or businesses; and the 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 up for questions. I'd like to turn the call over to Mr. Michael Tardugno, President and CEO of Celsion. Mike?

Thanks, Jeff. Good morning. Thank you for joining us and for your interest in and support for Celsion. I'm joined today by Dr. Nick Borys, our Chief Medical Officer; and by Jeff Church, from whom you've just heard, our Senior Vice President and Chief Financial Officer. Let me start by saying it's good to be with this morning to outline our goals for 2014, a year that is set to be transformative for Celsion, and to review the progress against our 4 key objectives that provide for the underlying foundation of our research programs and our future value proposition. First, as we've announced, Celsion is moving forward with our pivotal Phase III OPTIMA study of ThermoDox, in combination with optimized radiofrequency ablation or RFA, for hepatocellular carcinoma, which will -- we will refer to as HCC or primary liver cancer throughout our call this morning. This study design is based on compelling data from post-hoc analysis of our HEAT study, and is the result of more than a year of disciplined and methodical analysis of the data from this 700-patient clinical trial, continuing consultation with leading liver cancer experts and our PIs and with discussions and input from key regulatory agencies, the U.S. FDA chief among them. The OPTIMA study reflects our strong commitment to and belief in our ThermoDox program for primary liver cancer, which has established a high potential pathway for approval for this formidable and deadly cancer. Second, we continue to leverage the potential of ThermoDox in additional indications. The data we are seeing from our other ThermoDox programs, including RCW, that's recurrent chest wall breast cancer, preclinical work with HIFU, an intensity-focused ultrasound, underscore ThermoDox's broad potential in a wide variety of cancers. And in combination with other heat delivery devices, it's abundantly clear that our…

Thank you, Mike. Starting with cash, we reported total cash and investments at March 31, 2014 of $52.2 million as compared to $43.8 million at the end of 2013. At the current projected spending levels, this represents over 3 years of operating runway. The increase in our cash position reflects the completion of a $15 million registered direct common stock offering in January. This financing was priced at the market with minimal warrant coverage. We also have another $15 million available to us under our loan facility with Hercules Technology Growth Capital. Our financing Strategy puts us in a strong strategic position to continue the development of our heat-sensitive liposome technology platform, as well as to explore the acquisition of other promising clinical stage products. As Mike mentioned earlier, a very important component of our strategic plan is a strong balance sheet and the ability to raise additional capital at the appropriate time, and on attractive terms, to efficiently advance our clinical development programs and execute our product acquisition initiative. Our January 2014 financing was completed on terms that were very attractive. At the market, as I've stated, with 50% warrant coverage, it should be noted that half of the warrants issued have a 1-year term, not the traditional 5-year term, we see in other financing. This creative financing structure is the envy of our industry. At the end of the first quarter, the company's working capital was approximately $48 million. We have a very strong internal control and budgetary system over spending. Our culture has been and will continue to focus on the smart use of cash with our commitment to efficient clinical research and product development and growing shareholder value. Our internal operating expenses for the first quarter of 2014 were $5.2 million compared to $4.8 million last…

Well, thank you, Jeff. As you can see, Celsion is focused on its future. We're executing against our objectives for the year and moving forward with our pivotal OPTIMA study, backed by compelling data and with the support of key opinion leaders worldwide. We believe in ThermoDox, its value proposition and continue to explore its potential in additional applications. We have a strong balance sheet and the flexibility to consider a number of strategic options that could complement or provide synergies with our efforts. We hope to create value for our shareholders and, most importantly, make a significant difference in the lives of cancer patients and their families. As always, we greatly appreciate your interest in the company, and we look forward to updating you on our continued progress. Now with that, we'll go to questions. [Operator Instructions] So operator, if you would open the line for questions, please?

[Operator Instructions] We'll take our first question from Keith Markey with Griffin Securities.

I do have just one. I was just wondering, considering what you've said about ThermoDox and its applications that you're investigating, how do you see ThermoDox being used either with RFA or other heating modalities as -- possibly in conjunction with immunotherapeutics?

In conjunction with what?

Immunotherapeutics.

Immunotherapeutics.

Fine. And I think that's an interesting question. I think for the most part, we are focused on populations where RFA is a standard of care, Keith. I'm going to turn this over to our Medical Officer in a minute here because I'm not the doc. But RFA or a surgical procedure, typically, I think the paradigm is if you can remove a cancer lesion you do. The value of ThermoDox with RFA, yet to be demonstrated, but the data is quite compelling, suggests that when we add ThermoDox to this procedure, it improves the outcome, and my view is if immunotherapies become available for patients who are initially treated with radiofrequency ablation, it would be a program or a therapeutic that would be complementary too a treatment with RFA. And Nick?

Yes. Keith, that's interesting question. It's a topic that was discussed at the recent ECIO meeting that Mike mentioned in his presentation. You may have heard -- I guess, maybe that's prompted your question, you may have heard that RFA could cause an immune response in the liver from its activity. And that puts us in a very interesting position of positioning ourselves for future immunotherapies with RFA, with ThermoDox. So I think much research is -- needs to be done there and more exploration. So if -- it's an interesting question, but we need much more answers before we could be definitive.

I think I can say, our view is that immunotherapies hold a great deal of promise as we've seen with Yervoy, but high -- at least at this point, we cannot envision an immunotherapy obsoleting a procedure like RFA that can be used to treat the disease locally, at least at this point.

Yes. Actually, it makes sense, because what I've read is that in some cases anyway, the larger the tumor, the greater the risk that there could be some severe side effects from some of those immunotherapies. And so I guess that if you treat with RFA plus ThermoDox, you basically debulk that tumor and then maybe the immunotherapy would have a better chance of working without the side effects that I've read about.

We will take our next question from Alec Roberts, private investor.

I've had this stock for so long, I can't remember when I first bought it. I buy it as frequently as I can, and I certainly bought it after the 31st of January last year, because I told my wife, when I came downstairs after that, that shock everybody had. And I said, "This doesn't make sense. This doesn't make sense." And you have proved that very well over the last 1.5 years. I just have a simple question, because I've been on every one of these quarterly calls for so long now, but you keep on saying -- I mean, this is a simple question, I'm sorry. You keep on saying, after you give all those great results, that you haven't yet reached the 50% stage of the OS, Overall Survival, and I don't understand what the significance of that statement is. Could you please tell me?

Well, I guess, I referenced the 50% -- reaching 50% of the events in the study has the effect for statisticians of presenting a stable database. So prior to the -- reaching the 50% of the median, there is some uncertainty whether or not the data that's being analyzed is -- you can draw a firm and complete conclusions. So the more patients that you have, the more subjects that you have to evaluate, the more confident you are in the data.

The longer you spin this out, I mean, the longer the people live, the more confident we have with our data, is that what it really means?

Yes. The more -- the greater the number of patients who have experienced an event, in this case, unfortunately, it's death, the higher the confidence we have in the conclusions drawn from the data set.

Okay. So once you hit the 50% OS, what sort of statement -- qualifying statements happen after that?

I think at that point, we would consider the study concluded and would start following this patient subgroup on a quarterly basis.

[Operator Instructions] We'll take our next question from John Conlin [ph], private investor.

Just 2 quick questions. Regarding the OPTIMA study, you mentioned a bunch of countries and regions that are included. I don't think I heard Japan, and I was wondering if Yakult is still involved, to what extent or are they still reviewing the initial patients that were in the HEAT study? And #2, the Lencioni presentation that was made last month, is that going to be up on your website?

Well, let me take the second question first. Do we have an update on when the study -- when the presentation will be available?

It's -- we're working with the ECIO. They typically post that to their site. We're working out the arrangements so that we can get access and rights to post that on our site. So we're hopeful that, that will occur pretty shortly.

With regards to Japan and Yakult, I'd like you to know that Yakult continues to be very strongly interested in ThermoDox, and, even more importantly, in ThermoDox for primary liver cancer. You know that liver cancer -- primary liver cancer in Japan is a problem, it's a very large problem, very high incident rate. They are fully committed to a partnership with Celsion based on the data. While the regulatory and clinical strategy in Japan differs from that in other parts of the world, for the most part, historically, the Japanese rely on a positive outcome from a Phase III trial from other major countries and an approval of that product prior to initiating any bridging studies, that would allow for registration or regulatory approval in Japan. It's just the way they do business. When we initiated the HEAT study, we took a little bit of a risk. I'm not sure if you recall that or are referring to our earlier study, where there were some Japanese investigator sites involved. We took some risk with that because essentially, what we conceded to do was to embed a -- essentially a Phase I study within a Phase III study. And it just was very difficult to compare the Japanese population that was being treated with the rest of the world. And so, on the recommendation of our DMC, we discontinued enrolling patients in the HEAT study, in the prior study. Nick Borys and I have met recently with the Yakult team. We gave them an update. They are -- I can report to you, they are actively looking for ways, assuming that we are successful, and I think we have every reason to believe that we will be. They are actively looking for ways to be able to shorten this period of time for which ThermoDox would be evaluated in Japan for registration. It's an active activity. I wanted you to know that as soon as we have something to report, and I suspect we will over the coming months, as soon as we have something to report that represents meaningful news from this partnership with Yakult, we will do so. But I would say this to you, we are very proud of our relationship with Yakult. They have been supportive from the beginning and even through this disappointment that we had a year ago they continue to follow us very closely and has been a more than just a license partner, they've been a collaborator in many elements of our clinical program.

At this time, there are no additional questions.

So I think we will then close the meeting. And as we close this quarter's conference call, I want to thank all of you, again, for your interest. I can say, on behalf of the entire company, we do look forward to these conference calls, and I think even more importantly, we're looking for an exciting 2014 and of course, we do so with the expectation of your continued support. Thank you very much, and have a good day.

That does conclude today's conference. Thank you for participation.