Celsion Corporation

My name is Nick, and I will be your operator today. At this time, I would like to welcome you to the Celsius Corporation's second quarter 2021 financial results conference call. All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question and answer session. At that time, you may press star one on your phone to ask a question. Please keep in mind, if you're using a speakerphone, you must release your mute function to allow your signal to reach our equipment. Again, that's star one to ask a question during the Q&A session. At this time, I would like to turn the call over to Kim Golodets. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodets with LHA. Welcome to CELCION's second quarter 2021 financial results and business update conference call. As has been CELCION'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 Celcion'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 CELCION's operations, financial results, and outlook is a 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 12th, 2021. CELCION 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 Torduno, 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 Celcion's recent financial results, and Dr. Nicholas Boris, our chief medical officer, who will discuss our Ovation 2 study. Dr. Krishid Anwar, 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 CELCION. 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, GEN1, 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 Placine, 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 two of our lead technology platforms. I'll start with TheraPlas, which is our lead technology platform. TheraPlas and its adaptations are our proprietary synthetic non-viral carrier engineered to deliver plasmid 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 2 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 ovarian cancer patients. Dr. Boris will be discussing this more in a few minutes. And in a further adaptation of our technology, our unique understanding of plasmid vector construction provides the basis for our next-generation vaccine platform that we call Plascene. Plascene is a proprietary approach to DNA plasmid-based vaccine, and in its current iteration, is designed with multiple viral antigens with an immune modifier, like the cytokine IL-12, all delivered within a single plasmid vector. We believe that this approach to nucleic acid vaccine design holds the promise of clinical and technical advancements over the highly efficacious and very impressive new generation of mRNA vaccines. And we'll talk more about this in a few minutes. Driving our research is an outstanding group of scientists, that have recently been reinforced with individuals with advanced knowledge in molecular biology, immunology, and vaccine development. We continue to build relationships with development partners in vector construction, analytical method development, and supply chain capability. We have improved our capacity to produce high volumes of research quantities of vaccine prototypes for our proof of concept work. In addition, as you know from our press releases, we have assembled a vaccine advisory board comprised of highly recognized researchers, along with new board members whose experience and backgrounds will provide new and enabling perspectives on our work. To date in 2021, we have taken advantage of favorable market conditions to raise more than $60 million in equity capital, with the most recent raise of almost $14 million completed in early April. Our cash position was additionally improved with a sale of $2 million of our New Jersey net operating losses. We further strengthened our balance sheet with a new $10 million loan facility with Silicon Valley Bank, which allowed us to repay $6 million of much higher interest venture debt. Jeff will provide more details regarding this financing during his comments, but bottom line, is that we have smartly strengthened our balance sheet with investor-friendly straight common stock deals and non-dilutive financings, all of which provide a cash runway comfortably through 2024. That assumes, of course, our current spending projection. That's a period of time sufficient to reach a number of important development milestones, including progression-free survival data from the Ovation 2 Phase 2 study and proof of concept from our vaccine initiative. Now, before asking Dr. Borst to give you his perspective on the Ovation 2 study, I want to remind you that the subject of the trial is Gen 1. Gen 1 is our DNA-based immuno-oncology candidate, and as I mentioned, its foundation is TheraPlas. Unlike viral delivery systems that can only be administered once because of the immune response to the delivery system itself, Gen 1 is not the subject of neutralizing activity of an individual's immune system. This ability to dose repeatedly makes GEN1, our unique formulation of IL-12, an ideal candidate for study in oncology. To date, more than 100 ovarian cancer patients have been treated with GEN1 in our clinical trials. The results so far demonstrate excellent safety and recently published clinical data supported by translational data that clearly show activation of a significant dose-dependent innate and adaptive immune response, and remodeling of the immune microenvironment to proimmune. So just let me capture that a little bit the way I like to characterize Gen 1's observed mechanism. It's like taking one foot off the immune system's brake and putting the other foot squarely on the immune system's gas pedal. So with that as kind of a descriptor, I'm going to turn the call over to Nick Borse. for an overview of Gen 1 in our Ovation clinical program. Nick? I'm sorry.