Ladies and gentlemen, good morning. My name is David, and I will be your operator today. At this time, I would like to welcome you all to Celsion’s 2020 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 . At this time, I would now like to turn the conference over to Kim Golodetz. Please go ahead, ma'am.

Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to Celsion Corporation’s 2020 financial results and business update conference call. Attach has been Celsion’s practice and as noted by the operator, prepared remarks will be followed by a question-and-answer period. 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.

Thank you, Kim, good morning, everyone. Joining me today are Jeff Church, our Chief Financial Officer, who will provide an overview of Celsion’s recent financial results. Dr. Khursheed Anwer, our Chief Science Officer, who will address questions regarding our recently announced vaccine initiative, and Dr. Nicholas Borys, who will join us for Q&A. Dr. Borys is our Chief Medical Officer. I'd like to start by saying that we kicked off 2020 with great hope and anticipation, never expecting to face a global pandemic or complete refocus of our company 2020 turned out to be a year of enormous challenge. I trusted to recognize that in many ways we rose to the occasion. Today the company is financially strong and focused on a pipeline of product candidates that have every potential to deliver significant value. I'm proud of our staff and our ability to navigate the events of 2020, the work has positioned us for the opportunities that we have outlined in our recent press releases and that I will be addressing on the call this morning. Importantly, we have been diligent in our capital formation responsibilities. Using a broad range of facilities and incentives we have provided in the most shareholder friendly ways, a cash runway that will see us through multiple anticipated value creating milestones. Jeff Church will discuss these in more detail. But it's safe to say that our optimism, that our gene based immune immunology will benefit patients and shareholders alike, is supported with a strong balance sheet. I have to say that we’ve grown more confident in our future virtually each and every day. We're advancing two immunology platforms starting with TheraPlas, our novel synthetic nonviral delivery platform, a platform organically developed in our Huntsville, Alabama laboratories under the direction of Dr. Anwer. This has been his life's work and underlies the basis for our platform's first drug candidate, GEN-1, our DNA mediated IL-12 immunotherapy, now showing evidence of promise in later stage clinical oncology trials. An adaptation of the TheraPlas technology forms our second product initiative. This time, leveraging our delivery IP to unlock the potential of our novel multi systronic or multiple gene plasma technology, which has the potential for significant advancement over existing nucleic acid vaccine approaches.

Thank you, Michael. Details of Celsion's 2020 financial results were included in the press release we issued this morning and in our Form 10-K, which we filed today before the market opened. As Mike indicated, the company's balance sheet is as strong as it's been in many years, and we ended the year 2020 with $17.2 million in cash and cash equivalents. This compares to $14.

Thank you, Jeff. I want to close our prepared remarks by underscoring that Celsion has great potential to create value for our shareholders and future patients, and a highly capable staff committed to bringing life-saving medicines to market. We have versatile platform technologies in the exciting area of nucleic acid therapy. Our competency, span the scope of what is required to rigorously evaluate our drug candidates. Our relationship with regulatory authorities, both in and outside the United States are exemplary. And as Jeff pointed out, we have cash sufficient and with smart spending and prudent cash management, we expect to deliver on our promises over the next three years. During the months, when we were working hard to refocus of the company, we're relatively quiet, as you know, particularly with respect to our activities and with the investment community. I'm pleased to note that we did recently participate in the 33 Annual Roth Conference, held virtually this week, including one-on-one meetings. We expect to be participating in additional conferences as the year unfolds, we will keep you posted. We also plan to conduct virtual non-deal road shows and ultimately, hopefully, back to live events before the end of the year. So with that as an overview of our business and our financials, we'd now like to open the call to your questions. Operator?

Our first question comes from with Brookline.

I'm on behalf of Kumar from Brookline. Appreciate the business update. I had a question with regards to the vaccine program. Now assuming the preclinical data for the COVID vaccine study turns out to be promising. Now in terms of enrollment of patients later for the clinical trials downstream, do you anticipate challenges especially for older patients now that we already have a few vaccines out there?

Nick, do you want to try to address that, please?

And as you know, the way we're dealing with the COVID is an evolving issue. The US FDA has published guidance documents on and for consideration and when doing clinical trials with the next-generation of agents. So part of this might not require the same type of very large patient populations that you've seen with the previous virus development plans. So we'd be working closely with the FDA to find the most efficient patient population. And depending on the aim of our vaccine, will work with the FDA accordingly. But I think you'll see in the future, there will be different types of clinical trials, probably not as large as what we've been seeing in the past.

I'd like to add to that also. And maybe more broadly, more strategically this is a very crowded field, as I pointed out in my prepared remarks. And as you know, I mean, we're very new to this vaccine, vaccinology technology. And our immediate goal here is to establish proof-of-concept and to petition and receive approval for an IND from the FDA. I think at this point, the company will obviously outline a clinical pathway, trial pathway going forward, as Dr. Borys pointed out. But truly, I think, given the advantages that we anticipate from a DNA vaccine approach, particularly using a single plasmid multi cistronic, or multi gene as we talked about it. We will be looking for development partners at that point, particularly among those players who already have a foothold in the market. And so the company is very realistic, very, very realistic about the potential for challenges with a clinical program for COVID-19. I think more importantly, however, more broadly, however, once we've established proof-of-concept in a SARS-like environment, we intend, as I said earlier, we intend to leverage that to begin addressing a number of unaddressed vaccine or vaccine opportunities. And I think before we get off the call, since there's not been a lot of questions in the queue. Maybe Dr. Anwer. Khursheed, could you talk about some of the other vaccine opportunities that this DNA, single plasmid, multi gene approach could address?

Yes, Michael, clearly, using DNA based vaccines, we have advantage over some of the traditional way of vaccinating against pathogen. So as Michael said, once we have proof of concept, we could really expand technology into other pathogens. And clearly, that's something is under consideration in-house and we could really consider two different directions, go after pathogens such as CMV, RSV and factions that there is no vaccine, and so that could be certainly those type of pathogens and seasonal flu also where still where a traditional type of vaccines are used. So those are some of the areas under consideration now, but that's sort of a dynamic area, and we are sort of constantly looking into what could be the potential market based on the potential partner also. So yes, CMV, RSV, seasonal flu those are some of the, what I could say, what type of pathogens we could go after.

I just had a quick question with regards to the approval of GEN-1. Now from a regulatory standpoint, I believe you'll have the ORR and PFS data by the end of the year, so would that be sufficient for the expedited approval plan?

We're conducting a randomized Phase II study. We are likely not, in the current construct, likely not to have enough patients for a definitive result. But Dr. Borys is exploring an adaptation or an adaptive approach, maybe you want to talk a little bit about that, Nick?

As you mentioned, the data that we have immediately right now is to see the extent that the surgeons could remove the tumor at interval debulking. So our 0 rates are very good. And the primary endpoint of the study is progression-free survival. So that takes place many months after the patients complete their chemotherapy. So we are exploring other avenues where we could use an accelerated process with the FDA on getting an approval type design for a study. There's much to be explored there, maybe using combination endpoints and seeing if we could accelerate that. So I think we'll be talking much more about that in the near future.

Our next question comes from stockholder, .

So you spoke of ThermoDox in that you guys are not planning to give up on that technology, and I applaud that. Can you talk a little bit more about some of the other use cases, you are a little bit more in-depth about other directions you think that you may be taking that? You briefly touched on that, but I was hoping you might elaborate a little bit more.

And as I said earlier in my prepared remarks, an equivocal study does not mean a failed drug, and we know ThermoDox quite well and feel that its mechanism has some potential value in medicine. Unfortunately, we did not demonstrate efficacy in primary liver cancer, and we can all speculate about the reason behind that. So our role here going forward will be limited. We have a number of, I call, premier investigators who've expressed an interest in continuing their research in both preclinical and clinical situations or trials. We have promised them and we'll continue to support these trials with our institutional knowledge. And with product, we have a solid supply chain and can continue to support these activities. But I mean, we've talked about some work that's being done in Utrecht, some work that's being done in Oxford more recently, a very strong interest almost and let's call it a demand, frankly, and I say that kind of tongue and cheek from the NIH. And maybe, Nick, you can talk a little bit about the Oxford and the Utrecht studies, if you don't mind.

As you know, Oxford University has probably the most experience in terms of the clinical experience with ThermoDox. They published in the Lancet two years ago on their work in liver cancer, and now they'd like to apply that work into pancreatic cancer using this new cutting-edge technology called HiFU or high-intensity focused ultrasound. This is a new way of heating deep structures into the body. They're very excited about that. I think you'll be hearing more about that again this year. We also have work that's being initiated in Utrecht, and this is what Mike was alluding to in terms of breast cancer. And the idea would be that ThermoDox can play an important role in patients that are interested in having lumpectomies instead of radical surgery. So this is where, again, HiFU is being applied, ThermoDox is being applied and it might be a great alternative for patients that are good candidates for lumpectomy. So we continue to be excited about the future for ThermoDox and so are many of our investigators, as Mike said.

So I just close this out with -- we probably won't be hearing much from us with regards to ThermoDox going forward. The company's focus really would be in this area of immunology and vaccinology. Unless, of course, there are some breakthroughs that are important for medicine, frankly, from these investigator-sponsored studies.

At this time, we have no other questioners in the queue. So I'll turn it back to our speakers for closing comments.

Well, I want to thank all of you who participated in the call this morning. I want you to know that we are very committed to our work, we’re driven by this commitment to bring new medicines to patients in need. And by the work of the talented clinicians and scientists and the technical staff that participate in our trials and our preclinical work, we think we have something very, very important in terms of platform technologies that can add immeasurably to the exciting new generation of vaccines that are currently addressing COVID-19. If we're right, the advance that we make can provide substantial improvements in durability, range of treatments, in capability to address the mutational capability of pathogens. So we'll continue our work there, along with our very important working on important to the investigators and the patients with this newly diagnosed, very difficult-to-treat indication. We will look forward to keeping you appraised of our progress. And as always, we are available to you for questions. We'll speak again shortly after the first quarter, I will present to you our 2021 first quarter results. We trust you'll have a nice afternoon. Thank you very much.

Ladies and gentlemen, that concludes this morning's presentation. Thank you for your participation. You may now disconnect.