Good morning. My name is Cathy and I will be your operator today. At this time, I would like to welcome you all to Celsion’s 2020 First Quarter Financial Results Conference Call. All lines have now been placed on mute to prevent any background noise. Following the speakers' remarks, there will be a question-and-answer session. [Operator Instructions]I would like to turn the call over to Kim Golodetz. Please go ahead, ma’am.

Thank you and good morning everyone. Welcome to Celsion Corporation’s conference call to discuss its first quarter 2020 financial results. As has been Celsion’s practice and as noted by the operator, prepared remarks will be followed by a question-and-answer period. Today’s conference call will be archived and the replay will be available beginning later today through May 29, 2020 and the webcast will be available for the next 90 days on Celsion’s website.During this call, management will be making forward-looking statements regarding Celsion’s expectations and projections about future events. Generally, forward-looking statements can be identified by terminologies such as expects, anticipates, believes or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the Company’s periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed and actual results may differ materially from such statements.In particular, there are significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic. This means results could change it anytime and contemplated impact of COVID-19 on Celsion’s operations, financial results and outlook is the best estimate based on the information for today’s discussions. I also caution that content of this conference call is accurate only as of the date of the live broadcast, May 15, 2020. Celsion undertakes no obligation to revise or update comments made during this call, except as required by law.With that said, I’d like to turn the call over to Michael Tardugno, Celsion’s Chairman, CEO and President. Michael?

Thank you, Kim, and good morning everyone. Joining me today is Jeffrey Church, Our Executive Vice President and Chief Financial Officer, who will provide a review of Celsion’s recent financial results in a few minutes. Also on the call for the question-and-answer portion is Dr. Nicholas Borys, our Chief Medical Officer. As always, it's a pleasure to speak with you.But it's hard to believe once again, I'm speaking with many of you who are confined to home is this COVID epidemic continues to impact our daily lives. I hope that all of you have remained safe and healthy and will continue to do so. We've had a great deal of exciting news during the first quarter in recent weeks from both of our lead programs, first and critically important, our ThermoDox Phase III OPTIMA Study for the treatment of newly diagnosed hepatocellular carcinoma or primary liver cancer reached the prescribed number of events in April for our second pre-planned in term efficacy analysis and I will discuss this more in a minute.Equally important however is the wave of ongoing positive news that we reported regarding the development of GEN-1, our immunotherapeutic currently being evaluated in the OVATION 2 study, a Phase I/II to trial in newly diagnosed advanced ovarian cancer patients. In addition to our steady drumbeat of positive clinical research dose, as I've outlined in my letter to shareholders last month, after seeing the extraordinary volatility and signals of economic retrenchment, we have smartly taken steps in the most shareholder-friendly ways to strengthen our financial position.Jeff will talk about this more, but our goal as you know is to further assure that our cash runway extends into the second quarter of 2021, during which we expect to report several key milestone events. I'd also like to report, as I…

Thank you, Mark. Details of Celsion's first quarter 2020financial results were included in the press release we issued this morning and in our Form 10-Q, which we felt today before the market open. As Mark stated, in recent weeks as clinical progress has accelerated as we near the important milestone for the second prepaid interim data review, which is expected to occur in less than two months. In the meantime, we've been smart about raising capital and keeping tight control on all of our corporate expenses. We've also kept a careful eye on cost of goods while making sure we're able to tap into adequate supplies of our lead compound both in the U.S. and abroad.As the march 31 2020, Celsion's cash, short term investment, and interest receivable were $15.7 million. In addition, we had a receivable of $1.8 million from the sale of our New Jersey State net operating losses, which we were able to monetize in April, bringing our cash balances $17.5 million. Our quarter end cash position includes $6 million in net proceeds from the sale of equities during the first quarter, which includes $4.3 million from the registered direct offering of stock and warrants price at the end of February. We have opportunistically strengthened our balance sheet to buffer against the potential for continued erosion of our share price in the face of current public market uncertainty while we complete the OPTIMA Study.Our current cash plus future plan sales of our New Jersey State NOLs will extend their operating runway through the second quarter of 2021. Importantly, this is well beyond the final data readout of the OPTIMA Study, which if needed would occur during the first quarter of 2021. Our cap table includes approximately 29.3 million common shares outstanding and approximately 3.6 million warrants, of…

Thanks Jeff. Well done. Before we open the call to questions, I want to remind you all of the memorandum of understanding that we signed last year with officials from the Hangzhou Yuhang Economic Development area to establish a subsidiary in the Yuhang District of Hangzhou. The MoU, I'll remind you, provide the Company with significant financial incentives.The area for the subsidiary is located in one of China's biotech hubs, where the Chinese government has made development of advanced medical technologies that address unmet patient needs a high priority. The primary purpose of this subsidiary is to commercialize innovative cancer therapy starting with ThermoDox. In addition, China, the subsidiary will focus on all nearby developing markets including the Philippines, Malaysia, Thailand, and Vietnam.Hisun, our local manufacturing partner for ThermoDox is expected to provide an economically viable cost structure by establishing a low cost and has established a low cost of production for these geographies. Registration of the subsidiary has been completed. These subsidies name in English, if you see it, is Celsion Hangzhou Pharmaceutical Limited.Best point, we've begun drafting, as I said the NDA and NAA for Europe for ThermoDox and HCC. Our goal is to have both sufficiently prepared to complete a filing within six months for the unbinding of the OPTIMA Study. For example, if we announced positive data from the second interim analysis in July, we would hope to have a filing made around the beginning, the very beginning of 2021. We remain active with investors, albeit by telephone during this time. We will continue to re remain so as we have so many exciting milestones ahead of us this year.And with that, we'll open the call to your questions. Operator?

Thank you. At this time we will open the floor for questions. [Operator Instructions]First questioner, your line is live.

It's Hartaj Singh from Oppenheimer. I apologize. I did not know what that was supposed to be me. Thanks Mike. Thanks Jeff. Just a quick question. A couple of questions on ThermoDox and then on GEN-1, and by the way, congratulations for all the good work that you're doing, following through on all of the expectations that you had set and we do understand the delay COVID-19 I think that's almost every company that we know is having some kind of impact. So, on ThermoDox can you talk a little bit, you've been updating investors with the OPTIMA blinded PFS, over the last couple of years. Can you talk a little bit about how that has changed since the last interim, when you did the first interim, the blinded PFS that you've been monitoring for the OPTIMA Study? And then also could you specifically talk about while you be working, dropping the NDA and the MAA, MAA assuming OPTIMA successful. What are the specific rate limiting steps? What are the things that take those six months to get you to that early 2021 filing, assuming this interim is successful? And I just got a couple of quick follow-up on GEN-1. Thank you.

Yes, sure. Great question. Thank you very much. So, with regards to the blinded PFS data, the most recent information comes from the first interim analysis. So, we don't do the comparison except, otherwise it may not be accurate, except for presentation to the DMC. In that analysis, we saw that, when we pulled the two arms from the HEAT Study subgroup, that 285 patient prospective subgroup, median time to progression for the two arms together is 16.8 months. When we pull the 2 arms of the 556 patients, in the current OPTIMA Study, median time to progression is 17.2 months.So, they're virtually on top of each other. So, the basis for the study was the Kaplan-Meier that we generated from these 285 patients showing two-year improvement in overall survival. We as a marker now are falling PFS from that group, as compared to the OPTIMA Study, and we see that they're falling almost exactly. We recall that the threshold for success for the OPTIMA Study is lower than the hazard ratio, and it has a higher P-value but a lower threshold, than what we saw in HEAT Study subgroup. So we're encouraged, we're really encouraged by that.The second and I think, I believe it was one of the rate limiting steps for filing the NDA. So, much of the rate limiting activity has to do with engaging with the FDA, Hartaj. So tomorrow we were to have a positive result from the DMC, we would immediately place a call to the FDA. We would let the FDA know that, we have a positive outcome and would like to have a pre-NDA meeting with them. We give them some idea of the top-line then we have to submit a formal letter to the FDA requesting this meeting.And we're drafting that letter as we speak. It takes a little bit of time to make sure we're asking the right questions. So, this meeting is pre-NDA meeting, usually accompanies a series of questions along with the top line data from the trial. Scheduling that meeting takes about 60 days and in some cases 90 days, almost half of the time to prepare the NDA. Once, we have the FDA's understanding of what they're looking for then we can finalize the NDA, which is probably another two to three months.

Great, Mike. And then just on that, specifically in terms of just the I know, an NDA or an MMA would have three sections, right, the preclinical CMC and clinical. So, I assume your preclinical and CMC section should be good to go, I mean, the OPTIMA trials are going for a while. It's really the clinical section and the results from the OPTIMA second interim that you'll need to discuss with the regulators, correct?

Correct. Yes, I should have mentioned that. So for the most part, the preclinical and CMC sections are complete. So, in the narrative for the critical section, we haven't draft. It's just a matter of populating it.

Okay. And then on GEN-1, I was noticing that you have those good hazard ratios against the synthetic control study, which is really interesting. I think the future of clinical trials will see more of those. But one question I had was, why did you see such a big dispersion? When you look at the hazard ratios and it's reflected in the P-values being 0.1 and above 0.1. The hazard ratios were dispersed from like a little as 0.15 or 0.16, all the way up to 1.7. Why was that happening? Is it just small numbers or what was the reason for that?

Yes, so I'm not sure I understand the question completely. The hazard ratio that we just discussed was 0.53, 0.53. The P-value is…

The confidence intervals around that are pretty wide, right. So, that's how I'm asking, where's that coming from?

I think it's largely due to small numbers. I'm Dr. Borys Nick, do you have any insight?

Yes, that's correct, Mike. When I discussed that with the statisticians, statisticians from the Aspen group, I'm sorry. People said it's relatively due to this -- ND in this type of analysis what they told me that that the P-value really shouldn't be the focus the hazard ratio. So, we think that hazard ratio [technical difficulty]…

Unfortunately, Nick, you're breaking up a little bit.

I'm sorry. We talked both with the, our in-house statisticians and the statistician from Medidata, and they agreed that the P-value was due to a small number.

Great. And then just for future purposes because I know that relation to is designed with a hazard ratio 0.75. Is there any kind of -- from this synthetic control arm study, will you be able to show why some of the patients that were showing a poor hazard ratio? Why they were performing as such? Because, again, my only concern is that you've got a really good hazard ratio, but if the dispersion is pretty wide, you'd be kind of interesting to see why the patients that had a suboptimal hazard ratio, why they had it if possible?

Nick, do you want to fill that?

Yes, I think that's why it's important to work closely with the FDA. And currently, our next phase study is a 130 patients study which will address, all the variability that we see in a biological system, such as a cancer. And that's where I think you'll start seeing tighter P-values at a stronger HR.

Great, all right. Thank you. And I understand that. My last question is. I appreciate all the questions. It's just the delay, which is completely understandable. Michael, we've seen it with a lot of other companies, in fact, most of our companies. But one question I want to have is your manufacturing lots. Can you just talk about how many lots you need for the Phase II? Where are you with that manufacturing campaign? And then why specifically do you want to have the formulation scientists on site? I mean, will this be an ongoing issue, meaning, if OVATION 2 successful, maybe you get quick therapy. I mean, will you always need to have formation scientists at the manufacturing site in order to be able to produce these lots? And thank you for the question.

Yes, sure. So, we manufactured the clinical supplies in relatively small batches and sufficient size to be able to scale within the FDA limitation. So, we're able to scale 10 times the clinical batch size, assuming that that clinical batch size has been properly engineered, that then it's validatable and it has the established its quality through registration studies. The infrequency of manufacturing clinical supplies is the issue.That is if we were a regular, regularly produced product by CMO, I would have no hesitation of producing commercial product without having a person in the facility. But clinical supplies are produced infrequently. And in many cases, there are minor adjustments made to the batch records. When, during the course of manufacturing, particularly at Phase I and Phase II.So, we think it's important, not all companies do this. This is a maybe an obsession on my part. But we think it's important to have an individual in the plan during these infrequently manufactured products because manufacturing people are -- they're exposed to multiple, many, many, many kinds of manufacturing, and they lose some of their knowledge as a function of time, whether the time is six months or nine months or 12 months.So having our experts on site, make sure that assures us that we are not losing product due to this infrequency of manufacturing, that's simply yet. And for GEN-1, this is a particularly important issue. It takes about a year. Historically, it's taken about a year, not for us, but for every manufacturer or sponsor whose product includes a plasmid or some gene therapy, takes it almost a year to schedule a batch.So if we were to consume some of our plasmid in the finished product manufacturing, that did not meet our requirements, and we had to dispose of it. We had a show away. We would be waiting a long time at a very high cost for a subsequent batch to fill out the requirements for the clinical trial. And we just don't -- we think that's a risk. Even if it's a small risk, it's a risk that we can take.

Yes, no, Mike, that makes a lot of sense. And I actually lodged you for it. I think that's a very smart on your part. I'm very prudent. I'm agreeing. Thanks for all the questions we're looking forward to July. Take care.

Thank you so much, Hartaj.

Our next question comes from Matthew Cross of JonesTrading.

First off, I guess, I'll start with OPTIMA given that it sounds like the next time we may be talking about this program that you may have a positive result here hopefully. And so just wanted to get kind of a reiteration of your plans regarding commercialization, I know you've previously spoken to wanting to handle things in the U.S., internally, and partner out in places like Europe and China. Just wanted to get kind of the latest on that positioning given, taking into account COVID and this kind of ever changing landscape? And then second was one GEN-1. Was hoping you could kind of remind us of any plans that you might have to look at longer term follow-up from the phase one portion of OVATION 2, maybe to confirm some of the benefits of maintenance dosing and potential read through to the phase two portion, I guess, particularly because maintenance dosing is the more novel exploratory parts to speak OVATION 2 to relative to OVATION-1?

Good questions. Thank you. So, let me just start with the commercialization of ThermoDox. I don't see you in any circumstance the COVID situation affecting our commercial plants. As you consider the timelines from a positive readout of the study to launching a product, it could be 12 to 14 months from the timing of a fast track, even for the biggest of companies, 12 to 14 months before you're prepared to launch. And that's assuming that the FDA or other regulatory agency gives you a fast track priority review. So, hopefully, this COVID situation will be better understood by the medical community and better managed, and not if it's persisting and other year and a half out here, we've got more provinces for than just ThermoDox.This ThermoDox addresses the largest unmet medical need remaining in oncology. By the time this drug is approved, there will be close to a million incidents worldwide. Highly concentrated in the most strategic market focus right now for big pharma and that's China. So you can imagine China being the potential for the largest pharmaceutical market on the planet with 50% of the global incidents of the largest unmet medical need with literally no therapeutic options for newly diagnosed patients. They have treatment options, but no drug options for newly diagnosed patients. So there's a great deal of interest for this drug to a particular population. And when you look at it globally, I mean, our business models are very conservative, as Jeff pointed out, blockbuster, a billion dollar plus market.So I don't think we're going to have any difficulties with finding suitable partners. I mean, we'll have our choice really, I'm sure that I'll have with partners who we believe have the best capability to launch this product at the optimum prices given…

Yes, I agree. It's a very interesting opportunity for GEN-1. We're already proving that the drug has a very nice safety profile, both in patients that have bulky disease pre-surgery, and now we're proving post-surgery that the drug has a nice safety profile. So, it is very well-positioned for looking at as a maintenance therapy. So, if the data that we're establishing through seeing our synthetic control the data from the first phase one, if all that keeps on lining up the way we're seeing it right now, there are further opportunities as you suggest.

And I'd just add to Nick's point. Nick has been instrumental in developing a kind of a home health care approach. We've been working with a third-party who pre-prepares ID type demonstrations for home administration. So, just thinking about it more broadly, that this strategy really fits nicely into a commercial potential where patients would be required to administer this GEN-1 add up, some frequency throughout the course of the rest of the life perhaps.

Our next question comes from Raj Kumar of Brookline Capital Markets.

Hi, thanks for taking my questions. So first, regarding the following the 158 patient tests, what are you seeing in terms of further follow up? Are you seeing events as expected? And if you need to stop the trial for efficacy, how long will this patient continue to be followed up and are there any changes expected because of the COVID-19 situation?

Yes, I think you're asking if the trial is successful. Will we stopped the study and stopped following patients? Is that the question?

Yes, kind of sense of whether you stop following the patient or if you follow how long you will be following? And whether there will be any changes because of this COVID-19 situation.

Yes, I don't see COVID impacting this or our OVATION studies at all, frankly. But that's a question that we'll ask the FDA, I think our point of view is that we will continue to follow patients for survival, and I think that only strengthens our hand. But Nick, do you want to weigh in on that?

Yes, this is Nick Boris. And I agree that, we're going to take the counsel from FDA. And also remember, as Mike mentioned earlier in the presentation, we are also looking to submit in China and Europe. And the Chinese authorities may want to see continuation of some of their patients or other regions as well. So, we're going to leave that option open to whatever the best sciences and whatever the regulatory authorities are indicating to us.

And with regard to GEN-1, once you start manufacturing, at what time point do you think we'll be comfortable to reinitiate, the Phase II?

Well, as soon as we start manufacturing, I don't see any real potential of manufacturing failure. It's just a matter of having a person in the facility to provide the guidance, the institutional knowledge, to assure that the setup is correct at the times. There's some time dependencies and temperature dependencies that we don't want to be overlooked. So as soon as we are ready to manufacture. So we can put a person in a facility, it could be as early as September. We will initiate the Phase II program.

And you also talked about continuing the screening the patient. And so what do you expect in terms of bolus of patients at that time point once think of resuming the Phase II?

Yes, so we have a model that we developed now we have a little bit of experience with recruiting patients. The model suggests that we can expect to recruit approximately one patient per month per site. We currently have activated 19. I believe the number is 19. Don't hold me to it. 19 sites are very close to 19. Our expectation is to enroll up to 25 sites in the U.S. and two more in Canada. We're just to -- kind of on a slow walk here, given this COVID situation in initiating those, the balance of those sites.But that could happen very quickly once we -- once the Phase II is initiated again, so we would expect all of the study sites that have been initiated to begin recruiting patients immediately. And as I said, our model shows about one patient per month per site.In the meantime, however, we don't want to lose any momentum and enthusiasm among our investigators. And that's a big that can be a big problem for us. So this company is taking the position that they know there's a modest delay, but it could have an effect. So Nick and as clinical operations people have organized an investigator meeting that will be on the cusp of Initial initiating Phase II.The goal was just to remind everybody what the requirements are, to quickly go through the protocol one more time. So we haven't lost any knowledge of how that the program should be, one of these physicians, see patients who have a limited life span. I mean, when they very, very few patients have any expectation of losing more than three years from diagnosis.So, I mean, it's grim. It's really, it's grim. And when they get together, we've seen this. When we get together in our investigator meetings, the enthusiasm that they generate among each other for our product and these similar kinds of trust is extraordinary. And so our goal here is to continue to motivate our investigators. We have a good number of sites that are ready to go.We'll be adding a few more sites, once manufacturing has been initiated. And we'll kick this thing off as quickly as we can. I think there is one outlier that we don't know. But part of our discussion with FDA is that if they agree with us, and we'd like to substitute some of the control arm patients, organically recruited control arm patients with synthetic control arm patients, not all of them.But if we could replace 25% of the control arm patients, it would immediately reduce the number of patients that we have to recruit into the study and that would accelerate its completion. If we could get the 20 or 25 control arm patients from the synthetic group, that would be a big boost to getting the trial in a little while more quickly. So that's part of the focus.

Okay. Our next question comes from Mitch Landgraf [ph], a Private Investor.

Thanks for taking calls from individual investors. I'll try to be brief. One question, Mike, in regard to the few extra weeks that were wisely taken when you're getting making sure that all the information was correct for the submission for the OPTIMA trial. Just curious, was data already locked? Or is there a chance that those few extra weeks actually provided a little bit more time of separation of the two arms which I think would be good in our case?

Yes. That is yes. A few extra weeks allow the more maturity and a few more patients into the evaluation. The patients -- a few more patients have died. Yes, so the number that the DMC will be reviewing as I think in my prepared remarks, I said was 60 patients.

Yes, that's actually bodes well for even slightly increased likelihood of success at this interim, coming interim which would be awesome. Finally, not a complaint, just some feedback, I'm not sure if there's a technical issue on the website. I can just share from my own direct experience and also that of other individual private retail investors. There seems to be a difficulty with getting any kind of response to non-material just every day, individual investor, retail investor questions that are being submitted through the web portal or phone calls to Mr. Church. And again, that's not meant to be a personal or anything that it's feedbacks that company that somehow that communication channel isn't working. I do appreciate that you take individual investor questions on these calls. In the past investor friendly thing you used to do is to limit questions even from financial advisors than that to two to afford the opportunity for everyone to get in. That also would be appreciated. So didn’t know if you want to address that or just as a quick feedback to the Company, that's something and somewhere in that communication change, there's the breakdown.

Well, I was not aware of any particular problem. We'll look into it much. Thanks for pointing it out.

I thank you as well, best to all.

And at this time, we have no further questions in the queue. I'd like to turn it back over to today's speakers.

Okay, well thank you all very much for your time and your interest in the Company. This morning, we could not be more excited while our prospects and the work that we're doing to make such a huge difference in the lives of cancer patients. And I hope before long, what positive results that we will be seeing some of you face-to-face. But that we again wish you health call during this COVID pandemic.Stay safe. Thank you.

Thank you. Ladies and gentlemen, this concludes today's teleconference. You may now disconnect.