Please standby, and good morning. My name is Nick, and I will be your operator today. At this time, I would like to welcome you to the Celsion Corporation's Second Quarter 2021 Financial Results Conference Call. At this time, I would like to turn the call over to Kim Golodetz. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to Celsion's Second Quarter 2021 Financial Results and Business Update Conference Call. As has been Celsion's practice and as noted by the operator, prepared remarks will be followed by a question-and-answer session. During today's 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 is significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic. This means results could change at any time and the contemplated impact of COVID-19 on Celsion's operations, financial results and outlook is the best estimate based on the information for today's discussion. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, August 12, 2021. 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, Chairman, CEO and President. Michael?

Thank you, Kim. Good morning, everyone. Joining me today are Jeffrey Church, our Chief Financial Officer, who will provide a review of Celsion's recent financial results; and Dr. Nicholas Borys, our Chief Medical Officer, who will discuss our OVATION 2 study; Dr. Khursheed Anwer, who is in Huntsville, Alabama, our Chief Science Officer, will be available during the Q&A session to answer your questions regarding our recently announced vaccine initiative. Now if you've read our press release this morning, you know that the first half of 2021 has been very busy and productive for Celsion. I'd like to think that we are well positioned as we continue to make good progress in advancing our programs with supporting interim clinical data and growing recognition of our lead investigational product, GEN-1 and its promise to address advanced ovarian cancer. Moreover, our strong cash position, along with our ability to access additional sources of funds is sufficient to reach key milestones in both our OVATION 2 study with GEN-1 and to establish proof of concept with an IND filing for PLACCINE, our next-generation vaccine platform, assuming, of course, that our preliminary research is positive. During today's call, we will briefly review these programs and provide an update on where things stand. Now briefly, I'd like to cover 2 of our lead technology platforms. I'll start with TheraPlas, which is our lead technology platform. TheraPlas and its adaptations are our proprietary synthetic nonviral carrier engineered to deliver plasma DNA and messenger RNA therapeutics. GEN-1, incorporating the immune stimulating cytokine IL-12 is the first investigational product on this platform and is currently being evaluated in the Phase II OVATION 2 study. I can say unequivocally that the pace of study enrollment has allowed us for a look at some encouraging, albeit early data among advanced…

Thank you very much, Mike. Our OVATION 2 study is an open-label, randomized Phase II study in treatment-naive advanced ovarian cancer patients. This is a subset of patients whose tumor burden is too great for immediate surgical intervention. OVATION 2 combines GEN-1 with standard of care chemotherapy. In our study, half of the chemotherapy and GEN-1 is given before surgery and the other half is given after surgery. The purpose of this approach is to shrink the tumor as much as possible to make the surgeon's job as easy as possible. Usually, in about half of the cases, the surgeon is able to remove all the visible tumor. When GEN-1 is added to the chemotherapy, then the surgeon is able to remove all the tumor in about 80% of the cases. This is good news for our patients. Following the surgery, patients are given the other half of the chemotherapy, plus/minus the GEN-1 in order to address any remaining disease. The study's primary objective is to see if GEN-1 can delay any return of the cancer. This is called progression-free survival. The OVATION 2 study is designed to see if we can delay the return by at least 30%. The statistical language is that the study is designed with an 80% confidence interval for an observed progression-free survival hazard ratio of 0.75, which means an approximately 33% improvement in risk for cancer progression. We are now closing in on 60% of the projected 110 patients have been or are being enrolled in the study. In July, following a preplanned interim safety review of 55 as treated patients, the Data Safety Monitoring Board, or DSMB, unanimously recommended that the study continue treating patients with the dose of 100 milligrams per meter squared. The DSMB further determined that safety is satisfactory with…

Okay. Thank you. Nick, great overview, as usual. I would just like to make a comment about the GOG. The Gynecological Oncology Group represents over 200 of the most important investigational sites for ovarian cancer in the United States and some of the institutions outside of the United States. Their interest in our trial is a quite humbling. And I think very important as we continue our work. So your interaction with them is very important to the company. We thank you for that. Now I'd like to turn to our PLACCINE initiative. Of course, we have a working hypothesis. I'd like to share that with you. It's that the DNA plasmid has the potential to be superior to an mRNA vaccine in a number of very important ways, and I'd like to share those with you. PLACCINE comprised of multiple antigens reduces the possibility that evolving virus variants will escape vaccine dependent immunity. I think COVID-19, the D variant, for example. The DNA-based vaccine allows for a longer, more durable response, longer activity, meaning production of the antigens and accompanying cytokine may potentially improve memory T cell vaccination -- activation. A DNA-based vaccine that co-expresses the cytokine IL-12 may induce a better quality immune response. And last but not least, a formulated DNA-based vaccine will have improved stability and better working temperatures as shown in actual use in our immunotherapy product, GEN-1. While these, we believe, are important advantages. Now on to progress -- important potential advantages. On the progress, our scientists have successfully produced a family of vaccine vectors. They verified their composition and formulated these vectors with our proprietary nonviral delivery systems. In addition, they have demonstrated expression of S1 and antigens and of IL-12 cytokine, by ELISA, PCR and Western blot analysis following transfection and cell…

Thank you, Michael. Details of Celsion's second quarter 2021 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed today before the market opened. The company ended the second quarter of 2021 with $64.5 million in cash and investment securities, restricted cash and accrued interest receivable. Included in this amount is $1.85 million in net cash proceeds received in May from the sale of approximately $2 million of our unused New Jersey net operating losses. Over the past 3 years, we have raised nearly $15 million from the sale of these NOLs, which is equivalent to nearly a full year's operating expenses without any dilution to our investors. And we have an additional $5 million of unused New Jersey NOLs available to the company for sale between 2022 and 2024. At current spending levels, we have sufficient cash to fund operations through 2024. And as Michael said, these funds provide a runway to see us through several important value-creating milestones. Let me now turn to a review of the second quarter and the first half 2021 financial results. For the quarter ended June 30, 2021, Celsion reported a net loss of $5.4 million or $0.06 per share. This compares with a net loss of $5.3 million or $0.18 per share for the quarter ended June 30, 2020. Operating expenses were $5.2 million for the current quarter, which is up $300,000 or 6% from operating expenses of $4.9 million for the second quarter of last year. Breaking this down by line item. Research and development expenses, they were $2.6 million for the second quarter of 2021, and this compares to $3 million a year ago, a decrease of 16%. Clinical trial costs for the Phase III OPTIMA Study decreased to $200,000…

Thanks, Jeff. Good view. Good over overview. I want to close our prepared remarks today by underscoring that we believe that Celsion holds great potential to benefit patients in need and to create value for our shareholders. We have a highly capable team of researchers and clinicians who are committed to bringing life-saving medicines to market. When we look ahead to our anticipated accomplishments, it's helpful to remind you of all of the assets that reside within Celsion. We have a personal technology platform, more than one versatile technology platforms and the exciting area of nucleic acid medicine. Our competencies span the scope of what is required to rigorously evaluate drug candidates. Our relationship with regulatory authorities in both in the United States and outside the United States are exemplary. And with smart spending, great science and prudent cash management, we have sufficient capital to deliver on our time lines and support our promises. Before we open the call to your questions, I want to mention that we will be presenting at the H.C. Wainwright Global Investment Conference being held virtually this year between September 13 and 15. We plan to present and hold one-on-one meetings at the investment conference. We look forward to your participation and meeting you virtually. So now with that overview of our business and financials, we'd like to open the call to questions. Before I turn it over to the operator, we do have a writing question that I think I'll address upfront.

The question is where do we stand with our breakthrough status application for GEN-1 in ovarian cancer? This a good question, and we've addressed it, I believe, before, but I think we probably have some more detail to share with you. While we submitted a briefing document to the FDA outlining our intention to submit for breakthrough status in a preliminary meeting to a screening group. The result of that meeting was a very strong encouragement from FDA to continue our clinical research, our clinical review, evaluation of GEN-1 in newly diagnosed ovarian cancer patients. They were very complementary of the primary endpoints in our trial design. But they indicated to us that we may not have enough data for a proper review for breakthrough -- designation. We then took the additional step to compare the single-arm data to a synthetic control arm. We thought the -- matching our patients treated in the Phase I study with patients in control arms who would have otherwise qualified for our study. Matching them to the treatment patients in our Phase I study might provide the FDA with enough assurances that what we were seeing was not random. They -- we did submit a breakthrough therapy application on that basis, again, and a very likely conversation with the agency, a very strong endorsement of our work in ovarian cancer, but they're concerned that a synthetic control arm, not yet validated, might not be the best way to evaluate our proposal for breakthrough consideration. They did encourage us to come back when we had more data from the Phase II study, which you know includes randomized patients. In the meantime, they suggested to us that we applied for our Fast Track Designation, having many of the same advantages as breakthrough designation, not quite as, I guess, as impactful with the investment community. But from a practical standpoint, breakthrough status gives -- I mean, Fast Track status gives us quite a few advantages with the agency. We submitted an application for a Fast Track status. It was approved in short time. We announced that once we had the approval not too long ago. In the meantime, it's our intention, as FDA suggested once we have some additional data and we're getting close. But additional data from the Phase II study, we will consolidate that with the Phase I data and reapply for breakthrough status. So with that, operator, I think we can go on to questions from the attendees, meeting attendees.

And our first question comes from Kumar Raja with Brookline Capital.

And also congratulations on all the . So with regard to the GEN-1 ovarian trial with the pandemic we are facing again, what are your thoughts on the future enrollment? And in terms of the number of sites on board, where do we stand with regard to that?

Yes. So I think Nick is probably the best person to answer this question. I'd just like to proceed with -- we've been in the business of running clinical trials now together as a team here for some 10,11 years. And I would just characterize the enthusiasm among our investigators as good as it gets. That being said, Nick, the trial sites and what our expectations are.

Yes. Thank you very much for your question. It's clear that the pandemic has impacted everyone, including cancer research and cancer patients. We saw an increase in our patient enrollment. For example, in June, and I think it was a result of the pandemic easing and patients going back for their checkups and follow-ups. It looks like we may be tightening again. But we hold regular conference calls with all our PIs. As a matter of fact, I had one yesterday to review the current situation, and we're all doing our best to continue enrollment. Luckily, we don't have too much competition from other studies. So a lot of focus is on the OVATION 2 study. In terms of our sites, we have over 22 sites, I believe, are recruiting patients at the moment in both U.S. and Canada. Our most recent site opening was in Albuquerque, New Mexico, and they are currently screening a number of patients there. So we're going to continue working hard through the pandemic and hopefully, we'll meet all our objectives and time lines for getting the patients in.

Okay. And with regard to the pancreatic investigator-sponsored trial, how much involvement does Celsion have there?

Yes. So this is in terms of the study that we're working with Oxford University in England. We've worked very closely with the study team. We were involved in the study protocol design. We're obviously supplying the product and we're supplying consulting on any issues of safety. So I'm not sure if they've enrolled their first patient yet, but they're certainly open for enrollment at the moment.

I'd like to add a little bit more to that, if you don't mind, Kumar. So Celsion has decided to focus the majority of its energy on immuno-oncology, immunology and vaccines. We've recently announced that we've established the subsidiary in Zug, Switzerland and are placing all of our intellectual property assets for ThermoDox in Zug, along with -- we have a managing director, one of our Board members of physician Andreas Fass, has been named our Managing Director. He is working directly. So it's not to distract the Celsion team from our immuno-oncology and our immunology vaccine programs. The management of these relationships and support for the clinical trials will be coming through Zug and through our Managing Director, Andrea . I'll just say one more thing. So we do have a small budget to support these activities. We want to be sure that it is -- unless there is a reason to do so, and we're seeing a significant reason to do so. We don't expect our support for the ThermoDox activities to have any significant impact on our cash position.

Okay. Great. With regard to the vaccines, you mentioned about multiple antigens using multiple antigens. So with some other companies, what we have seen is that with multiple antigens, they are seeing comparatively lower neutralizing antibodies compared to using a single antigen. What has been your experience in the preclinical models? And maybe you can provide us some thoughts on what you guys are expecting.

So Khursheed, are you in a position to answer that question, please?

So Kumar, thank you for that question. We have -- we are still in the process of building our composition of different vaccines. And we have seen immune response to multiple antigens. You haven't gotten to a point of protection utilization assays. With respect to what's been known, there are ways where people are using some -- in case of plasmid iris bridge that lowers the expression of second antigen and maybe some subunit vaccines. So I think with a DNA-based approach at least in HIV, people have shown multiple HIV antigen-expressing well. So we haven't gotten to that point yet, but we're hopeful and confident that we should be able to demonstrate benefit.

We have no additional questions at this time. I'll turn the call back over to Mr. Tardugno for closing remarks.

Well, thank you very much, and thank you all for your time this morning. We certainly do appreciate your interest in Celsion. I want you to know we are -- we enjoy speaking with our investors, and we look forward to your participation. And we encourage you if you have any -- other shareholders that you communicate with, we encourage you to ask them to join us in these conference calls. We're going to find a way to reach out to the investors to increase participation. And so with that, I'd like to say that at Celsion, we continue to be driven by our commitment to bring new medicines to patients in need. And this is exemplified by our work and our talented scientists and clinicians and technical staff. We look forward to keeping you appraised of our progress and throughout the year. We will be bringing you up to speed. If any events that are important outside of the regular quarterly meetings, you can count on us to make sure that you have the information. So with that, we hope you have a reason to participate in the upcoming H.C. Wainwright Virtual Conference. And if not, we'll be speaking to you again when we report on our 2021 third quarter financial results in November. Have a great rest of your day. Thank you again.

And this concludes today's call. Thank you all for your participation. You may now disconnect.