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spk02: 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.
spk01: 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?
spk05: 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.
spk03: Thank you very much, Mike. Our Ovation 2 study is an open-label, randomized Phase 2 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 to 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 pre-planned 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 no dose-limiting toxicities reported. During this pre-planned review, we also reported interim clinical data from the first 36 patients who had interval debulking surgery. The data showed that 20 patients were treated with Gen 1 at a dose of 100 milligrams per meter squared plus the neoadjuvant chemotherapy with 16 out of 20 patients or 80% having no residual disease or R0. And R0 is good news for the patients and suggests an improved survival outcome. 16 patients were treated with chemotherapy only, with nine out of those 16 patients, or 56%, having no residual disease, a favorable comparison for Gen 1. When we look at these ongoing findings and the published results from our Ovation 1 study, there is consistency in our data, and we show that Gen 1 is working because at higher doses, patients do better in terms of resection rates and chemotherapy response scores. In other words, our patients are doing better than the control group, and our patients at higher doses do better than those at lower doses. Two good indicators of strong treatment activity. As a review, 2021 has definitely been a year of progress for Gen 1 and the Ovation program. In February, the FDA awarded Celsion Fast-Track designation for Gen 1. This designation is a recognition that Gen 1 is a potentially important therapy in patients with ovarian cancer. In March, one of the most important scientific meetings on women's cancer, the annual meeting of the Society of Gynecological Oncology accepted for presentation the Ovation 2 study so that other physicians and researchers can get acquainted with our work. And last week, perhaps our most important scientific milestone this year, was having the findings of our Ovation 1 study published in the prestigious peer-reviewed journal from the American Association for Cancer Research. This publication is open access and can be downloaded by anyone interested in reading it. The current version is in manuscript form, while the nicely typeset form will be available in a few weeks. You can find the link to it on the CELCION website. The key finding of this published study is that GEN1 can be safely administered in combination with chemotherapy in newly diagnosed patients with advanced ovarian cancer. The patients receiving GEN1 at higher doses did better, and we also showed that GEN1 activated the immune system against the cancer. During this time, the lead medical researchers of the gynecological oncology group contacted us to discuss a partnership with CELCION for developing GEN1 in ovarian cancer. Working together, we have developed plans to collect molecular profile of patients enrolled in our Ovation 2 study to help understand who would benefit most from Gen 1. This may result in a future amendment of our study, which would focus our research on the patients with the greatest likelihood of treatment success. Throughout the second quarter of our Ovation 2, investigators continued to work through the pandemic and to recruit patients, collect data, getting us to the point where we now have a robust base of data which we will be using for future designs. We also held two data safety management board meetings to ensure the safety of Gen 1 and to keep a careful watch on the integrity of the study itself. To date, the Ovation 2 study is experiencing good enrollment, and we are seeing consistent efficacy as we did in Ovation 1, with manageable safety at a dose that is clearly impacting ovarian tumors. With that overview, I'll turn it back over to Michael.
spk05: Okay, thank you, Nick. Great overview, as usual. I'd 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 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 Placine Initiative. Of course, we have a working hypothesis I'd like to share there 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. A plasmid comprised of multiple antigens reduces the possibility that evolving virus variants will escape vaccine-dependent immunity. Think COVID-19, the D variant, for example. A 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 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 at better working temperatures as shown in actual use in our immunotherapy product Gen 1. These, we believe, are important advantages. Now on to progress, important potential advantages. On to progress, our scientists have successfully produced a family of vaccine vectors. They verified their composition and formulated these vectors with our proprietary non-viral delivery systems. In addition, they have demonstrated expression of S1 and M antigens and of IL-12 cytokine by ELISA, RTC-PCR, and Western blot analysis, following transfection and cell culture systems. Immunization of mice with one or more of these vectors resulted in the production of immunoglobulin G antibodies and cytotoxic T cells, response specific to the spike antigen of the COVID. of the SARS-CoV-2 virus. Parallel in vivo studies are in progress to optimize vector composition, delivery route, dosing and dosing frequencies, and production of neutralizing antibodies. Hopefully, and I'd say we're quite confident that we'll be able to present some of these data at upcoming scientific conferences later this fall. We look forward to doing that. and sharing that information with you, our investors. So you may be asking yourself, why now? We posed this question at our last conference. Why now, since the current mRNA vaccines are so highly effective? Another question might be, what are our chances for commercial success? These two fundamental questions have three answers I'd like to share with you. First, our immediate goal is to validate our vector and delivery technology in preclinical studies using the current mRNA vaccines as comparators. Once we have demonstrated our hypothesis and that our hypothesis has proven, should there be a commercial possibility, we will seek development partners for COVID-19 clinical trials. Second, and even more importantly to our strategy, once our hypothesis has been demonstrated, once it's been proven, we'll begin development of vaccines to address a broad range of other infectious viral agents. And third, as I have said before, we may be on the verge of a potential breakthrough. Combining antigens with IL-12 has the potential to be both prophylactic and therapeutic. The development of a vaccine technology that has the potential to be truly therapeutic, a therapeutic vaccine, if you will, could revolutionize our approach to infectious disease. Needless to say, we are very excited about the Placine platform and its prospects, and look forward to continuing our research and reporting our developments to you. Now, before turning the call over to Jeff, I want to raise an important issue that has intensified during this year's proxy season with respect to many, many shareholders not voting their shares. And this is an important issue, and that's why I want to share it with you during this call. I'm not talking about voting for or against a management proposal. I'm talking about simply voting. As you know, we had to adjourn and reschedule our annual shareholder meeting to a later date to allow our proxy solicitors, along with Jeff, Tim Tuminello, and me, to bring in enough votes to obtain a quorum. And we're not the only company to have to adjourn its annual meeting. A quick Google search finds that many companies resetting their annual meeting dates have in order to muster a quorum. This challenge of securing a quorum was a first for us this year, and is largely due to a confluence of circumstances. Data show that on average, only 32% of retail shareholders cast their ballots for shareholder meetings, and this percentage is even lower for small cap firms like Celsius. However, under stock exchange rules, banks, brokers, and other holders of record who can aggregate client shares in street name typically have discretionarily, have the discretionary authority to vote those shares on routine proposals in the absence of voting instructions from beneficial owners. And they have done so for as long as I recall in the past. However, this year, many online brokers such as Charles Schwab and its affiliate TD Ameritrade have declined to exercise its discretionary option Interpreting a FINRA rule, rule 2251, is prohibitive of this practice, when in fact the rule states that a broker may exercise its discretionary vote for routine matters in the absence of shareholder proxy instructions. Charles Schwab, which had a policy of voting for discretionary items in the same proportion as customer proxies that were actually submitted, acquired TD Ameritrade earlier this year, concentrating retail investors at essentially one brokerage house. Compounding the problem, Robinhood also declines to vote shares held by customers on discretionary items. Needless to say, for companies with large retail holdings like Celcion, it's difficult to get 50% of shares voted in order to reach a quorum. So where do we go from here? Your company has decided, Celsius has decided to bring attention to this problem and push for a solution. Perhaps starting with making sure that brokers are interpreting rule 2251 properly. We're in the process of moving forward with a plan that will hopefully return brokerages to their past practices. But also, we'd like to improve our engagement with individual investors. As a part of our strategy, first, we need to identify who has the authority to clarify the rules, language, and cut through the finger-pointing between the various organizations. In the administrative bureaucracy of stock exchange governance, this, I can tell you, is a challenge. Finding who will step up to the plate for interpretation is not easy. But we'll look. We'll find the means to do so. In parallel, we're working to create grassroots supports for the correct interpretation because there are many parties that may be adversely impacted aside from the issuers, including investment banks, law firms, auditors, and proxy solicitors. We're in contact with a lobbyist who is engaged by the National Investor Relations Institute and the Society for Corporate Governance, which is comprised of corporate secretaries. We're also investigating ways to improve direct retail engagement via new service offerings such as phone apps, as well as to lower the threshold for what constitutes a quorum, which would have to be affirmatively voted on by investors. I'd like to say we certainly should not be doing this. It's an extraordinary use of our time, but bottom line is that companies, including Celcian, spending way too much time and money on proxy solicitation have been forced into doing this. The lack of participation from investors in voting is discouraging. As you know, one share, one vote is central tenet of corporate governance. And let's not lose sight of what investors are voting on, as oftentimes proxy proposals are necessary to facilitate companies' future success. Celsian is passionate about this initiative. We value our investors and impress upon them that their disinterest may impact human health as we work to advance the development of life-saving therapeutics. So with that now, I'd like to turn the call over to Jeff.
spk04: Jeff? Thank you, Michael. Details of Celsian'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 three 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 annual wells 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, Celcion 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 Optimus study decreased to $200,000 compared to $600,000 in the prior year quarter. R&D costs associated with the development of Gen 1 to support the Ovation 2 study, as well as the Placine DNA vaccine technology platform, increased to $1.4 million from $900,000 in the prior year quarter. Other costs related to the company's clinical development programs decreased by about half a million dollars due to lower regulatory and manufacturing costs related to the Thermadox program. General administrative expenses were $2.6 million for the second quarter this year, compared with $1.9 million for the second quarter last year. This $700,000 increase is primarily attributable to higher non-cash stock compensation expense of $100,000 and increase in professional fees of $400,000 and an increase in premiums on our director and officer's insurance of $100,000. In June 2021, the company entered into a new $10 million loan facility with Silicon Valley Bank and used $6 million of the facility to retire all outstanding indebtedness with Horizon Technology Finance Corporation. We recognized a $200,000 loss for the debt extinguishment. Celcian incurred interest expense of $200,000 during the second quarter of this year, largely in line with the $300,000 in the comparable prior year period, both related to Horizon interest. This new loan facility provides five months of operating runway at a very low cost of capital. The new loan carries an interest rate of 3%, which compares to an interest rate close to 10% on the previous venture debt with Horizon. On a year-to-date basis, net cash used for operating activities was $7.3 million, which compares to $7.9 million in the first half of 2020. This is in line with our projected cash utilization for 2021 of approximately $17 million, or an average of $4.25 million per quarter. Cash provided by financing activities was close to $55 million during the first six months of 2021. resulting from equity offerings in January and April and proceeds from the Silicon Valley Bank Loan Facility and the sale of our New Jersey NOLs. I'd now like to turn the call back over to Mike. Thanks, Jeff.
spk05: Good view, good overview. I want to close our prepared remarks today by underscoring that we believe that Celsius 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 CELCION. We have a versatile technology platform, more than one versatile technology platform in 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 timelines and support our promises. Before we open the call to your questions, I want to mention that we will be presenting at the HC Wainwright Global Investment Conference being held virtually this year between September 13th and 15th. 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 up front. The question is, where do we stand with our breakthrough status application for Gen 1 in ovarian cancer? That's a good question. We've addressed it, I believe, before, but I think we probably have some more detail to share with you. 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 and newly diagnosed ovarian cancer patients. They were very complimentary 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 for breakthrough designation. We then took the additional step to compare the single arm data to a synthetic control arm. We thought matching our patients treated in the phase one study with patients in control arms who would have otherwise qualified for our study, matching them to the treatment patients in our phase one study might provide the FDA with enough assurances that what we were seeing was not random. We did submit a breakthrough therapy application on that basis. Again, in a very lengthy 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 work. proposal for breakthrough consideration. They did encourage us to come back when we had more data from the phase two study, which you know includes randomized patients. In the meantime, they suggested to us that we apply for a 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 2 study, we will consolidate that with the Phase 1 data and reapply for breakthrough status. So with that, operator, I think we can go on to questions from the attendees, meeting attendees.
spk02: Thank you. And if you would like to ask a question, please signal by pressing star 1 on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star one to ask a question, and we'll pause for just a moment to allow everyone an opportunity to signal. And our first question comes from Kumar Raja with Brookline Capital Markets. Please go ahead.
spk06: Thanks for, good morning. Thanks for taking my questions, and also congratulations on all the progress. So with regard to the genuine ovarian trial, you know, with the pandemic resurfacing 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?
spk05: Yeah, so I think Nick is probably the best person to answer this question. I'd just like to proceed with, you know, 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.
spk03: Yeah, thank you very much for your question. You know, 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 to be maybe 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, recruiting patients at the moment in both in both U.S. and Canada. Our most recent site opening was in Albuquerque, New Mexico, and they're 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 timelines for getting the patients in.
spk06: Okay. And with regard to the pancreatic investigator-sponsored trials, how much involvement does Celsius have there?
spk03: 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.
spk05: I'd like to add a little bit more to that, if you don't mind, Kumar. So Celcion has decided to focus the majority of its energy on immuno-oncology, immunology, and vaccines. We've recently announced that we've established a subsidiary in Zug, Switzerland, and they're placing all of our intellectual property assets for Thermadocs in Zoog. Along with the, we have a managing director, one of our board members, a physician, Andreas Voss, has been named our managing director. He is working directly, so as not to distract the CELCION 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 Zoog and through our managing director, Andreas Voss. I'll just say one more thing. We do have a small budget to support these activities. We want to be sure that 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 Thermadox activities to have any significant impact on our cash position.
spk06: 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 antigen, 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.
spk05: So, Krishit, are you in a position to answer that question, please?
spk07: So, Kumar, thank you for that question. 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 antigens 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.
spk06: Okay, great. Thank you so much.
spk02: Thank you. Thank you. We have no additional questions at this time. I'll turn the call back over to Mr. Tardino for closing remarks.
spk05: Well, thank you very much, and thank you all for your time this morning. We certainly do appreciate your interest in Celsius. I want you to know we enjoy speaking with our investors, and we look forward to your participation. We encourage you, if you have any questions, 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 Celsium, 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 reason to participate in the upcoming HC 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.
spk02: And this concludes today's call. Thank you all for your participation. You may now disconnect.
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