Jeffrey Church - Senior Vice President and Chief Financial Officer Michael Tardugno - Chairman, President and Chief Executive Officer Nicholas Borys - Chief Medical Officer.

Emma Nealon - Oppenheimer Edward Sherman - DSW Associates.

Good morning. My name is Matt and I will be your conference operator today. At this time, I would like to welcome you to the Celsion’s First Quarter 2018 Financial Results Conference Call. [Operator Instructions] This call is being recorded. At this time, I would like to turn the call over to Mr.

Jeffrey Church, Celsion’s Senior Vice President and Chief Financial Officer. Please proceed, Mr. Church..

Thank you. Good morning, everyone and welcome to our first quarter 2018 investor conference call to discuss our first quarter results, which we announced this morning before the market opened.

During our call today, Celsion’s Chairman, President and CEO, Michael Tardugno will provide an operational update on our clinical programs and I will summarize our financial results for the first quarter.

Today’s call will be archived and a replay will be available beginning tomorrow and will remain available by phone until May 25, 2018 as well as available on Celsion’s website for 90 days.

Before we begin the call, we wish to inform participants that we will be making forward-looking statements regarding Celsion’s current expectations and projections about future events. Generally, forward-looking statements can be identified by terminology such as may, should, expect, anticipate and similar expression.

These terms are based upon current expectations and assumptions and are subject to a number of risks and uncertainties, including those set forth in the company’s periodic reports filed with the SEC, many of which are difficult to predict. No forward-looking statements can be guaranteed and actual results may differ materially from such statements.

The information on this call is provided only as of the date of this call and Celsion undertakes no obligation to update any forward-looking statements made on this conference call based on new information, future events or otherwise except as required by law. At the end of today’s formal remarks, we will open the call for questions.

I would now like to turn the call over to Mr. Michael Tardugno.

Mike?.

New Horizons and Treatments at an investor event in New York. Dr. Thaker’s presentation highlighted GEN-1 is a novel approach designed to deploy IL-12 without the toxicities associated with the recombinant form of the protein and outline results from the OVATION study.

Our presentation noted immunological changes consistent with the ability of GEN-1 to increase peritoneal levels of IL-12 and its downstream anticancer cytokines with little changes in systemic circulation and no systemic toxicities. If you are interested, presentation can be found on our website.

Now, before turning the call over to our CFO, I would like to say that I expect 2018 to be an important, if not transformational year. I think on our last call, I said this is our year.

One way, our focused development efforts for ThermoDox in Gen-1 will make significant progress achieved with operational excellence and backed by responsible financial and capital management. Now, with that to discuss our financials, I will now turn the call over to Jeff.

Jeff?.

Thank you, Mike. During the first quarter of 2018, we continued to execute our important clinical development initiatives with a very tight focus on our two lead product candidates. We ended the quarter with $20.8 million of total cash and investments.

During the first quarter, we used approximately $4.7 million in cash in line with our current year projections. Typically, the first quarter of each year is the highest due to one-time payments with respect to respective things as annual insurance premiums for 2017 performance bonuses.

Based on our budget projections, our current cash position enables us to cover our projected operating needs into the third quarter of 2019. We are pursuing additional non-dilutive capital doing innovative program offered by the state of New Jersey.

This creative economic development program of Forbes companies like Celsion, the opportunity to sell is accumulated net losses to profit generating businesses.

We estimate that this program could generate $10 million in additional cash to extend their operating run-rate into the first half of 2020 well beyond several important value inflection points for both ThermoDox and GEN-1 clinical development programs.

Celsion’s first quarter 2018 financials were included in the press release which was issued before the market opened this morning. Our Form 10-Q for the quarter ended March 31 was also filed this morning. We continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value.

We maintain a very tight focus on our pivotal Phase 3 trial for ThermoDox in primary liver cancer and the follow-on Phase 1/2 clinical trial for GEN-1 in newly diagnosed ovarian cancer patients. Operating expenses were $4.4 million in Q1 2018 compared to $4.9 million in the same period last year.

This decrease is in line with our earlier projections and the result of our cost reduction efforts implemented during 2017 and prudent cash management. Our projected cash utilization for 2018 the entire year is approximately $16 million or averaging about $4 million per quarter.

This projection should remain consistent into 2019 as we complete full enrollment of 550 patient Phase 3 OPTIMA study in the third quarter of this year and increase our clinical development focus on GEN-1 in the second half of this year through 2019.

We continue to operate with a lean organizational structure with approximately 21 full-time equivalent employees. Most of our spending is directed to research and development activities.

As we look forward, we believe that maintaining the strong balance sheet is important to continue the strong development momentum we have built around our lead program. For the quarter ended March 31, 2018, we reported a net loss of $4.5 million which compares to a net loss of $5.2 million in the same prior year period.

R&D costs for Q1 2018 were $2.7 million compared to $3.5 million in 2017. Our research and development expenditures were lower due to tighter clinical development focus on those programs that we believe to help drive shareholder value in the near-term through the readout of our pivotal Phase 3 OPTIMA study.

General and administrative expenses for the first quarter of 2018 were $1.7 million compared to $1.5 million in 2017. This increase in G&A costs were due to higher non-cash stock compensation expense, coupled with higher professional fees largely related to recruiting and consulting services for business development and commercialization initiatives.

As a result of paying all of our venture debt loan with Hercules in June 2017 the company had no interest expense in 2018. That compares to $150,000 of interest expense in the first quarter of last year. I would like to conclude by stating that our balance sheet and business fundamentals are strong.

We are well positioned to deliver important milestones around each of our product development programs. We have the financial tools and support to properly capitalize the company for future success. I will now turn the call back to Mike..

Thank you, Jeff. I will conclude my prepared remarks by saying that our two drug candidates represent exciting advances in cancer research and have the potential to change the trajectory for patients with pro-prognosis.

If either ThermoDox or GEN-1 shows continued positive data we have the opportunity not only to transform patient’s lives and medical practice, but the company as well. Our work is very important.

Our aspirations are high and I look forward to reporting our progress this year as we continue our pursuit of effective new medicines for patients with difficult cancers. So now, I would like to ask the operator to open the line for your questions.

Operator?.

Thank you. [Operator Instructions] And our first question will come from Hartaj Singh with Oppenheimer..

Hi, good morning. This is actually Emma on for Hartaj.

First, is there any update on the enrollment status for OPTIMA, I think it was about 80% last quarter?.

Yes. So, when we continue to progress according to our schedules, we are over 86%, 87% enrolled. So, actually a little bit of both in our projections out..

Great.

And then just on GEN-1 do you plan to present the Phase 1b PFS data from OVATION at medical conference?.

Nick?.

Yes. We are looking at both presenting that data at a conference we are going to be discussing that which one with our investigators and also writing that up as an abstract and submitting it..

Great.

Should we expect initial announcement to come in the form of a press release or is that still kind of TBD?.

Could you repeat that please, Emma?.

Sure.

When the PFS data is available around midyear, should we expect that to first come as a top line press release or is that still to be determined?.

Well, that would be a top line press release..

Great. Thank you, both..

Thank you..

[Operator Instructions] We will now go to Edward Sherman with DSW Associates..

Hi guys.

I think you are doing a fantastic job given the resources that you have, it’s not easy to conduct two trials, but I have a question regarding the milestone payment for GEN-1 when would that be due?.

Yes. So, the milestone payment with some referred to as contingent value rights, milestone payment that they are likely talking about is tied to achieving progress in the Phase 2 portion of the GEN-1 study in ovarian cancer. That’s not likely to happen on our current estimate. That’s not likely to happen until later in 2019..

Great. And let me ask you this, you seek that….

Edward just so while running on topic, the milestone at the company’s election can be paid in either cash or stock from a combination thereof..

Sure, right. I saw that actually. So, you say that this is one of the rare occasions where the medical community gets it before the investment community.

Why do you think that is and if it’s true and I don’t mean to be critical, but what does it say about the efforts the company is making in getting the word out?.

Yes. So, I mean – and I am not going to apologize for the efforts we spend a good deal of time in conferences and meeting with investors individually and in small groups. Getting the word out is a top priority for the company.

I will have to say we are – the major portion of the investment of the company has been focused on ThermoDox over the last number of years. It’s not usual for a company to continue to develop a product particularly in the same indication following a sale of trial. So, we are not used to putting good money after that.

And I can promise you the majority of us here, maybe one or two, they are qualified, but majority of us here are not candidates, but we are pretty darn good at what we do.

So, just to give you a little bit more history so far on this the failure of the case study, to me this primary endpoint TFS, we took a very intense look at the data as we headed at the time with some of the most notable names in the hepatocellular carcinoma research.

It appeared to us that there was a relationship between heating dwell time and an improvement in outcome in patients.

So, when we pursue that and not only relied on the data from the study but also as I pointed out in my prepared remarks, we evaluated these hypotheses in computational models and in prospective preclinical models, notably in a pig model. All of that took time to be honest with you.

In the meantime, on the company’s confidence in this notion that’s radiofrequency ablation was conducted with an extreme amount of variability that was not obvious to anyone when the study was – the HEAT study was originally conceived.

But what I am trying to get to is that following a failed study, there is an inappropriate and a reasonable amount of skepticism around any kind of subgroup analysis.

I think the company has done an incredible job of determining that the potential for ThermoDox to be successful through standardized radiofrequency ablation has done an incredible job of supporting that with the appropriate analysis scientific investigation inputs on the medical community and research community and most recently with an independent analysis by the NIH.

Now, we are getting to your point, so putting all of that together and now getting it published, I think that’s probably a major milestone in the company that does not get a lot of credit, but the publication of the HEAT study, if you read it, focuses on a great deal of the narrative on the subgroup analysis and why it’s valid and why it’s important for the medical community to further evaluate ThermoDox in combination with radiofrequency ablation in a Phase 3 trial publication of our prospective preclinical trials, the publication of the computational analysis.

Now, after this time, I believe we have earned the right to present the information that as I have said the medical community and the research community get it.

So they have been apart of all of the work that has been done to assure this management team and our investors that the work they were doing in Phase 3 study in primary liver cancer is based on very sound and substantial science. So going forward, I think we have earned the right.

We now have not only the results of our research, but peer-reviewed journals have critically evaluated the work that has been done. And now with this information in hand, I believe it’s just the matter of time now that the investment community will get it..

Okay.

If I may ask just one last question, there was I believe something intimated by Adam Forstein about a chart after the HEAT study that showed that after 45 minutes, the uptake of ThermoDox basically fell off the mat, so that there is no reason to believe that it would be more effective after 45 minutes?.

Well, I am not familiar with that. And I think our research would suggest quite a bit otherwise. I would refer you to the HEAT study manuscript publication in CCR and also to our publication on [indiscernible] demonstrating the accumulation of doxorubicin, there is a function of heating dwell time in healthy livers of pigs.

I think that point that you just made would be immediately dismissed..

I am glad to hear that actually.

I am glad to hear that, but if that were the case though, why if given that it’s a HEAT-sensitive liposome, why isn’t there something that you thought about prior to the HEAT study if it seemed sort of obvious?.

Yes. So, well, maybe we should take some of this offline, but it was not – the variability in the use of radiofrequency ablation was not obvious.

There was a point of discussion among our investigators and during the prosecution of the negotiation of the SPA with the FTA, we have spent a considerable amount of time on the standard of care in the application of radiofrequency ablation in newly diagnosed patients with tumors greater than 3 centimeters.

It was the opinion of this group that radiofrequency ablation administered according to academic procedures was reasonably consistent throughout medical practice. And in fact, it turned out not to be.

So, there was a point of discussion, it wasn’t a major oversight on the company’s part – what twice the major oversight was our lack of knowledge and I think the medical communities knowledge of how RFA was being applied.

In fact, I think there maybe some embarrassment when we look back at HEAT study data, because we now know, Edward, this company, your company, if you have an investment in our stock..

And I do..

Now knows more about the use of radiofrequency ablation in primary liver cancer than any other company on the planet and that was not true just when we initiated the HEAT study..

Okay. I just want to say you guys are doing a great job. Keep it up the good work..

Thank you..

[Operator Instructions].

So operator, there appears to be no more questions. So, I am going to close the meeting and thank all of you for listening, for your attention and your interest in the company.

We encourage your questions like Edward’s and for those of you on the line, the next time we get a chance to speak with you by conference call, please feel free to ask questions, particularly those that are maybe knowing actually and reading you to accept some information that may not be correct with regards to the company.

So with that again, I want to thank you. We remain very excited about our prospects for 2018. You can count on this management team to keep you updated as we advance our development pipeline and we look forward to successful results. Thank you again..

And once again, this does conclude our call for today. Thank you for your participation. You may now disconnect..