Earnings Call Transcript - IMNN Q2 2021

Operator, Operator

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.

Kim Golodetz, Conference Call Host

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?

Michael Tardugno, Chairman, CEO and President

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, 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 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 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 to look at some encouraging, albeit early data among advanced ovarian cancer patients. Dr. Borys will be discussing this more in a few minutes. Then a further adaptation of our technology is our unique understanding of plasmid vector construction, which provides the basis for our next-generation vaccine platform that we call PLACCINE. PLACCINE 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 cytokine IL-12, all delivered within a single plasma 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 the 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 II study and proof-of-concept from our vaccine initiative. Now before asking Dr. Borys 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 GEN-1, 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 GEN-1 in our clinical trials. The results so far demonstrate excellent safety, and recently published clinical data supported by translational data clearly show activation of a significant dose-dependent innate and adaptive immune response and remodeling of the immune microenvironment to pro-immune. So just let me 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 a descriptor, I'm going to turn the call over to Nick Borys for an overview of GEN-1 in our OVATION clinical program. Nick?

Nicholas Borys, Chief Medical Officer

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, 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, known as 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 of cancer progression. We are now nearing 60% of the projected 110 patients who have been or are being enrolled in the study. In July, following a preplanned interim safety review of 55 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 preplanned 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 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 9 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 concerning 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, which are 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 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 accepted the OVATION 2 study for presentation so that other physicians and researchers can get acquainted with our work. 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 a link to it on the Celsion website. The key finding of this published study is that GEN-1 can be safely administered in combination with chemotherapy in newly diagnosed patients with advanced ovarian cancer. The patients receiving GEN-1 at higher doses did better, and we also show that GEN-1 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 Celsion for developing GEN-1 in ovarian cancer. Working together, we have developed plans to collect the 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 patients with the greatest likelihood of treatment success. Throughout the second quarter of our OVATION 2 investigators continued to work through the pandemic to recruit patients and collect data, getting us to the point where we now have a robust base of data that 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.

Michael Tardugno, Chairman, CEO and President

Thank you, Nick, for the great overview. I want to comment on the Gynecological Oncology Group, which includes over 200 crucial investigational sites for ovarian cancer in the U.S. and some international institutions. Their engagement with our trial is essential as we move forward, and we appreciate your efforts with them. Now, I'd like to discuss our PLACCINE initiative. We have a working hypothesis that the DNA plasmid could outperform an mRNA vaccine in several significant ways. PLACCINE, which includes multiple antigens, aims to minimize the chances of vaccine-resistant virus variants, like the Delta variant of COVID-19. The DNA-based vaccine has the advantage of offering a longer-lasting immune response, with extended activity leading to better memory T cell activation. Additionally, a DNA vaccine that includes the cytokine IL-12 may generate a more robust immune response. Furthermore, a formulated DNA vaccine will demonstrate better stability and operational temperatures, as evidenced by our immunotherapy product, GEN-1. While we believe these are notable potential benefits, let’s go over our advancements. Our scientists have successfully created a series of vaccine vectors, confirming their composition and formulating them with our proprietary non-viral delivery systems. They have also shown the expression of S1 and IL-12 cytokine through various analyses after transfection and cell culture. Immunizing mice with some of these factors led to the production of specific immunoglobulin G antibodies and cytotoxic T-cell responses targeting the spike antigen of SARS-CoV-2. We are actively conducting parallel in vivo studies to refine vector composition, delivery methods, dosing, and frequencies, as well as enhance neutralizing antibody production. We are optimistic that we will be able to present some of this data at upcoming scientific conferences this fall and are eager to share this information with our investors. You may be wondering why we are pursuing this now, especially since current mRNA vaccines are very effective. Another question is about our likelihood of achieving commercial success. These fundamental inquiries can be addressed with three key points. First, our immediate objective is to validate our vector and delivery technology in preclinical studies, using current mRNA vaccines for comparison. Once our hypothesis is validated, and if commercial opportunities arise, we will seek partners for COVID-19 clinical trials. Second, and even more critical to our strategy, once we confirm our hypothesis, we will begin developing vaccines to combat a wider array of infectious viral agents. Third, we may be on the brink of a significant breakthrough. The combination of antigens with IL-12 could lead to both preventative and therapeutic solutions. The creation of genuinely therapeutic vaccine technology could transform our approach to infectious diseases. We are genuinely enthusiastic about the prospects of the PLACCINE platform and look forward to advancing our research and sharing our updates with you. Before I hand the call over to Jeff, I want to address an important issue that has gained urgency this proxy season: many shareholders are not voting their shares. This is a significant concern. I’m not just referring to voting for or against management proposals; I mean simply casting a vote. We had to adjourn our Annual Shareholder Meeting to allow time for our proxy solicitors, along with Jeff, Tim Tumminello, and me, to gather enough votes for a quorum. We are not the only company facing this challenge; a quick search shows that many others have also had to reschedule their meetings to obtain quorum. This year’s difficulty securing a quorum is new for us and stems from several factors. Data indicates that only about 32% of retail shareholders usually vote in shareholder meetings, which is even lower for small-cap companies like Celsion. Moreover, under stock exchange regulations, banks and brokers who aggregate shares under street name often have the authority to vote on routine matters in the absence of beneficial owners' instructions. Historically, they have exercised this authority. However, this year, many online brokers, including Charles Schwab and TD Ameritrade, have chosen not to vote on these routine items, citing a federal rule, Rule 2251, as restrictive—a rule that actually allows brokers to vote on routine matters without shareholder instructions. After acquiring TD Ameritrade, Ascensia Brokerage House has concentrated retail investors, adding to this issue. Worse, Robinhood has also stopped voting shares on discretionary items. This creates a significant hurdle for companies with substantial retail holdings like Celsion in achieving the 50% share voting needed for a quorum. So, what are we doing about it? Our company aims to highlight this issue and advocate for a solution, starting with ensuring that brokers interpret Rule 2251 correctly. We are developing a strategy to urge brokerages to return to their previous practices. We also want to strengthen our engagement with individual investors. We need to identify who can clarify the language of these rules and help cut through the confusion among various parties involved. Navigating the complexities of stock exchange governance is challenging, but we are committed to finding a solution. Additionally, we’re working on grassroots support for a proper interpretation of the rules, as there are various stakeholders affected by this situation, including investment banks, law firms, auditors, and proxy solicitors. We are connecting with a lobbyist associated with the National Investor Relations Institute and the Society for Corporate Governance, which includes Corporate Secretaries. Additionally, we are exploring options for direct retail investor engagement through new services like mobile apps and considering lowering the quorum threshold, which would require investor approval. While I wish we didn't have to spend our time on this, the reality is that companies like Celsion are dedicating too much time and resources to proxy solicitation. The lack of voting participation is disheartening. One share, one vote is a fundamental principle of corporate governance, and it’s essential to remember what investors are voting on. Proxy proposals often play a critical role in a company's future success. Celsion is deeply committed to this initiative, and we urge our investors to recognize that their lack of engagement could impact human health as we strive to advance life-saving therapies. Now, I’ll turn the call over to Jeff. Jeff?

Jeffrey Church, Chief Financial Officer

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 three years, we have raised nearly $15 million from the sale of these NOLs, equivalent to nearly a full year's operating expenses without any dilution to our investors. We have an additional $5 million of unused New Jersey NOLs available 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 of 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 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 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 PLACCINE 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 $0.5 million due to lower regulatory and manufacturing costs related to the ThermoDox program. General and administrative expenses were $2.6 million for the second quarter of this year compared with $1.9 million for the second quarter of last year. This $700,000 increase is primarily attributable to higher noncash stock compensation expense of $100,000, an increase in professional fees of $400,000, and an increase in premiums on our director and officers' 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. Celsion 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% when the previous venture debt with Horizon was established. 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, 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.

Michael Tardugno, Chairman, CEO and President

Thanks, Jeff. Good 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 personal technology platforms, more than one versatile technology platform, and an 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 the United States and outside the United States is exemplary. 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 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 written 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 is a good question, and we've addressed it 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 strong encouragement from the 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 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 and had a very likely conversation with the agency, with a strong endorsement of our work in ovarian cancer, but they were 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 that we apply for our Fast Track Designation, having many of the same advantages as breakthrough designation, albeit not quite 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 Fast Track status, which was approved in short order, and we announced that once we had the approval not too long ago. In the meantime, it's our intention, as the FDA suggested, once we have some additional data—and we’re getting close—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.

Operator, Operator

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

Kumar Raja, Analyst

And also congratulations on all the progress. 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?

Michael Tardugno, Chairman, CEO and President

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.

Nicholas Borys, Chief Medical Officer

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, I believe we have over 22 sites recruiting patients at the moment in both the 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 timelines for getting the patients in.

Kumar Raja, Analyst

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

Nicholas Borys, Chief Medical Officer

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 providing 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.

Michael Tardugno, Chairman, CEO and President

I would like to elaborate on that, if you don't mind, Kumar. Celsion has decided to concentrate the majority of its efforts on immuno-oncology, immunology, and vaccines. We recently announced the establishment of a subsidiary in Zug, Switzerland, where we are placing all of our intellectual property assets for ThermoDox. We have appointed physician Andreas Fass, who is one of our Board members, as our Managing Director. He is working directly with these initiatives to ensure the Celsion team remains focused on our immuno-oncology and immunology vaccine programs. Management of these relationships and support for the clinical trials will come through Zug and our Managing Director, Andreas. Additionally, we have allocated a small budget to support these activities and will proceed unless there is a significant reason not to do so, which we are currently seeing. We do not anticipate that our support for ThermoDox activities will significantly affect our cash position.

Kumar Raja, Analyst

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.

Michael Tardugno, Chairman, CEO and President

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

Khursheed Anwer, Chief Science Officer

So Kumar, thank you for that question. We are still in the process of building our composition of different vaccines. We have seen immune response to multiple antigens. We haven't gotten to a point of protective utilization assays. With respect to what's been known, there are ways where people are using in some cases of plasmid irises, which lowers the expression of the second antigen and maybe some subunit vaccines. In the case of 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 a benefit.

Operator, Operator

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

Michael Tardugno, Chairman, CEO and President

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 enjoy speaking with our investors, and we look forward to your participation. We encourage you to ask other shareholders to join us in these conference calls. We're going to find a way to reach out to investors to increase participation. And 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. This is exemplified by our work and our talented scientists, clinicians, and technical staff. We look forward to keeping you appraised of our progress throughout the year. We will bring you up to speed on any important events outside of the regular quarterly meetings, and you can count on us to ensure 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.

Operator, Operator

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