Imunon Inc (IMNN) 2017 Q3 法說會逐字稿

Good morning. My name is Alexsis, and I will be your conference operator today. At this time, I would like to welcome you all to the Celsion Third Quarter 2017 Earnings Conference Call. (Operator Instructions) At this time, I would like to turn the call over to Mr. Jeffrey Church, Celsion's Senior Vice President and Chief Financial Officer. Please proceed, Mr. Church.

Thank you. Good morning, everyone, and welcome to our third quarter 2017 investor conference call, which we announced this morning before the market opened. During our call today, Michael Tardugno will provide an operational update on our clinical programs and I will summarize our financial results for the third quarter and first 9 months of 2017.

Today's call will be archived and the replay will be available beginning tomorrow and will remain available by phone until November 28, as well as available on Celsion's website for 90 days.

Before we begin the call, we wish to inform participants that we will be making forward-looking statements regarding Celsion's current expectations and projections about future events. Generally, these forward-looking statements may be identified by terminologies such as may, should, expects, anticipates, plans, estimates or similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, including those set forth in the company's periodic reports filed with the Securities and Exchange Commission, many of which are difficult to predict. No forward-looking statements can be guaranteed and actual results may differ materially from such statements.

The information on this call is provided only as of the date of this call and Celsion undertakes no obligation to update any forward-looking statements contained in this conference call based on new information, future events or otherwise, except as required by law.

At the conclusion of today's formal remarks, we will open the call for questions.

I now like to turn the call over to Mr. Michael Tardugno, Celsion's Chairman, President and CEO. Mike?

Thank you, Jeff. Good morning, everyone, and thanks for joining us for today's call. With me are Dr. Nicholas Borys, Celsion's Chief Medical Officer; and Jeffrey Church, our Chief Financial Officer, from whom you've just heard. As always, we are delighted to have the opportunity to update you on our progress and to answer your questions.

For those of you who are new to the story, I like to give you a quick elevated pitch. Celsion is an oncology-focused development stage company with 2 platform technologies, both of which have product candidates in clinical trials. Our lead technology is a novel heat-sensitive liposome that incorporates known chemotherapeutics. It's administered IV and one in the presence of tissue that's been heated to just above body temperature -- it's above 40 degrees Celsius. The surrogate nanoparticle releases its payload to create a locally high concentration of the drug that targets local regional cancer lesions.

Our first candidate on this platform is ThermoDox. ThermoDox, as the names implies, is a heat-sensitive liposomal formulation of doxorubicin. ThermoDox is being evaluated in combination with radiofrequency ablation, that's RFA, in a global multicenter pivotal Phase III study of the largest unmet medical need remaining in oncology, and that's hepatocellular carcinoma, also known as HCC or primary liver cancer.

We call our second and equally important platform TheraPlas. TheraPlas is short for therapeutic plasmas. As the name implies, this nanoparticle based transfection -- cell transfection technology has the ability to turn DNA sequences coded for proteins with known anticancer properties into active agents for sustained local cellular production of the biologic for which its programmed.

Our first candidate on this platform is an immunotherapy that we call GEN-1. GEN-1 activates the production of the highly effective inflammatory protein or cytokine, interleukin-12. IL-12 is well known to reactively recruit the entirety of the body's immune system to work against deadly cancers.

GEN-1 has been recently evaluated in a Phase I study in new diagnosed Stage III and IV ovarian cancer patients. And as we announced yesterday evening, based on highly encouraging data, we are now moving forward with a randomized Phase I, II study in this very same patient population.

So in summary, that's 2 platform technologies, 2 drug candidates, 1 in Phase III and 1 now moving to Phase 11 rapidly, both showing great promise, a chemotherapy representing the legacy of medicine with an innovative means to improve both safety and efficacy. Now, that's the holy grail of oncology, folks. Being evaluated in the largest unmet medical need in oncology.

And a second investigational product, this one in the future of medicine, immunotherapy, showing some remarkable potential in ovarian cancer malignancy that affects the lives of over 200,000 women annually.

Our goals, as we have communicated over the past conference calls, remain unchanged and that is to successfully complete the development of these novel, innovative pharmaceutically elegant solutions to some of cancer's most difficult challenges. And if we're right, if either GEN-1 or ThermoDox is successful, you will have been party to the development of 1, if not 2, of the most important medicines in a generation.

Now, since our last conference call in mid-August, we have announced several important milestones that continue to drive momentum both in and outside of the clinic and I want to touch on those.

First, on the financial side. Our balance sheet is strong. Over the past 4 months, we significantly improved our cash balance. We announced several equity capital initiatives totaling almost $28 million, and we did so in the most non-dilutive of fashions available to us. Our cash position now provides an operating runway well into the second quarter of 2019. That means the company has sufficient capital to achieve the following.

First, and importantly, is the full enrollment of all 550 subjects in the OPTIMA Study, our pivotal Phase III study that we just spoke of, ThermoDox and primary liver cancer. And we also within this cash run rate expect to provide results from the study's first preplanned interim efficacy analysis, projected to occur on the first quarter of 2019.

Additionally, we will initiate a follow-on Phase I, II clinical study of GEN-1 as a neoadjuvant first line of therapy for the treatment of newly diagnosed Stage III and IV ovarian cancer patients this quarter, fourth quarter this year. Our target is to enroll approximately 50% of the 90 subjects by year-end 2018, again within our current cash balance.

And as this will be an open label study, we will offer periodic reporting throughout the conduct and the trial of safety and clinical results.

Second topic today is our R&D Day. And I want to remind you -- I want to go over quickly. I want to remind you, though, that on October 12 we held an R&D Day in New York City, the goal of which was to provide investors and analysts with an update on our 2 lead clinical programs that we just spoke of. If you go to our website, I believe you will find the insights from the discussion to be invaluable as you assess Celsion's long-term potential.

So briefly, the OPTIMA Study was discussed. The OPTIMA Study clinical presenters, representing multiple medical disciplines, including hepatology, interventional radiology and surgery, traveled from regions where HCC is a significant health problem, including South Korea, Philippines and regions in Europe. They discussed past and current experiences with ThermoDox for the treatment of HCC, including and importantly representative case studies.

Dr. Borys provided the important data supporting the hypothesis from the study and moderated a panel discussion among these 3 investigators.

With regards to GEN-1, the lead clinical investigator for the OVATION Study and a leading immuno‑oncology expert from Roswell Park Cancer Institute focused on the clinical and translational data from our recently concluded Phase 1B study. And a copy of this presentation and the audio are on our website under news and investors, financial events. I encourage all of you to take some time to listen and review the material. I think you will find it very insightful and instructive, as I said earlier, as you consider the long-term potential for Celsion and these 2 very important and intriguing products.

Our third topic today is ThermoDox and the Phase III OPTIMA Study. If you got our press release, we're now 70% enrolled. The Phase III OPTIMA Study is on track to complete its 550 patient subject recruitment around the middle of next year. The study's hypothesis is based on substantive learnings from a large subgroup, analysis of the prior HEAT Study, which I will remind you, as you know, failed to meet its PFS endpoint.

Well, the hypothesis is supported with some of the most persuasive and productive prospective and retrospective data that has ever been taken in my experience for a clinical trial. Much of this data analyses were included and accepted by peer-review in our recently published manuscript of the HEAT Study in Clinical Cancer Research, that's a high impact medical journal. The leader author for this publication is Professor Tak, if you're interested in or planning to search for this article.

In the article, the author -- or in the manuscript, the authors conclude that in the intermediate size HCC combining radio frequency ablation, RFA, conducted for a minimum of 45 minutes with ThermoDox has significant potential to dramatically improve overall survival and should be studied.

I want to point out that the conclusions noted in the manuscript are neither ours nor are HEAT Study manuscript authors alone. I'll remind you that the National Institutes of Health conducted a completely independent analysis of the intent to treat population of all 437 single lesion patients in the study and concluded that longer RFA heating times when combined with ThermoDox results in a statistically significant improvement in OS, overall survival.

Now, this is not true of RFA alone. So -- and just looked at 2 cohorts, RFA with ThermoDox and RFA alone and they concluded that when combining RFA -- or ThermoDox with RFA the longer heating times result in a statistically significant improvement in overall survival. This conclusion was presented at the RSNA conference last December to a standing room only crowd.

Now, I'll point out that the NIH strongly supported its thesis in the follow-on OPTIMA Study. And by the way, the analysis that was conducted by NIH is in the same population that's currently being recruited and treated in the OPTIMA Study.

So on -- now, our highly derisk -- and I'll call it highly derisked Phase III OPTIMA Study of ThermoDox plus RFA standardized for 45 minutes in newly diagnosed HCC patients is on track and on budget. I can also report that all of the major costs and heavy lifting for this trial are now behind us.

Additionally, on August 7th, the OPTIMA Study's independent Data Monitoring Committee completed a preplanned interim review of the first 275 or 50% of the patients randomized in the trial as of April 2017.

Based on their assessment of safety, data quality, protocol compliance and trial risk, the DMC unanimously recommended that the study continue according to protocol to its final readout without revision. And by the away, I'll also note that the data presented to DMC indicated that there has been 99% plus compliance with a minimum of 45 minutes RFA heating time as required in the protocol.

I'll also note that the 14 regulatory authorities from across the globe, including Europe, North America and Asia in all major HCC markets have reviewed and approved the OPTIMA Study protocol. We have engaged internationally recognized world-class CROs and data management teams to ensure good clinical practice, ICH compliance, protocol adherence and high quality data analytics. And we have a proven and highly reliable supply chain with not 1, not 2, but 3 redundant contract manufacturing organizations, that's CMO, who are registered and capable of producing ThermoDox for all regions of the world, providing a cost structure that all but guarantees high gross margins regardless of the country or the local economy.

I would also submit that with little, if any operational risk, and all of the major cost behind us, the OPTIMA Study as we now see it is -- we're now beginning to look forward to study completion and data readout.

If you believe the many analyses supporting the OPTIMA Study, some of which I just talked about, including an independent analysis of overall survival conducted by the NIH, then you'll have to agree that our chances of success here are very good.

In addition to maintaining our focus on high quality execution of the study, we've also paid attention to the enormous commercial opportunity for ThermoDox, which is led by our regulatory strategy as follows. ThermoDox has received FDA Fast Track designation, which provides for, among other things, priority review.

ThermoDox has been granted orphan drug designation for primary liver cancer both in the U.S. and Europe, which extends market exclusively for 7 and 10 years respectively in these major revenue markets.

Based on prior discussions and subject to successful trial, we have designated the OPTIMA Study -- we have designed, I'm sorry, designed the OPTIMA Study to enroll a sufficient number of patients from each ethnicity or country to support registration of filings in the U.S., Europe, China, South Korea, Taiwan and Vietnam.

Additionally, the CFDA, that's the China FDA, informed Celsion that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or Europe, as which is currently required for foreign company applications.

This would allow Celsion to accelerate its plans for regulatory filing in China, and if approved, provide for a significantly earlier launch date in China than originally expected.

China, as you know, represents -- or is perhaps the most significant market opportunity for ThermoDox globally as approximately 50% of the over 850,000 new cases diagnosed each year originate in China, in this market, the largest future market for pharmaceuticals in the world. I believe it's safe to say that we are well positioned.

Our fourth topic this morning is GEN-1, our marvelous entry into immunotherapy. GEN-1, our immuno-oncology candidate developed on our TheraPlas technology platform, as I discussed, is a GEN-1 -- is a gene-mediated immunotherapy which recruits the body's entire immune system to fight malignancies.

GEN-1's active agent is a DNA plasma and coded for the cytokine IL-12, as we discussed. The IL-12 plasma is incorporated into our proprietary nonviral nanoparticle delivery system. When administered locally into a body cavity like the peritoneum or bladder or even a cavity created by surgical removal of a tumor mass, the nanoparticles invade surrounding cells and take over the metabolic machinery, turning each cell into a mini factory for local sustained production of the IL-12 protein.

The first indication we're studying for GEN-1 is ovarian cancer. For patients newly diagnosed with this cancer there's less than a 45% chance of surviving 5 years. One major reason is diagnosis is made when patients have advanced disease at Stages III and IV when the cancer has spread.

In previous clinical trials in this patient population, GEN-1 has been used either as a monotherapy or in combination with chemotherapy and has shown promising results. Most importantly, GEN-1 has shown clear signs of biological activity and early signs of clinical benefit in our recently completed Phase 1b dose escalation trial that we call the OVATION Study.

The OVATION Study evaluated GEN-1 plus neoadjuvant chemotherapy followed by de-bulking surgery in newly diagnosed Stage III and IV ovarian cancer patients. Prior to de-bulking, patients were treated with up to 3 cycles of platinum and taxane, the goal of which was to improve surgical outcome by shrinking the tumor mass. To this regimen, we added 8 weekly cycles of GEN-1.

We reported that GEN-1 plus neoadjuvant chemotherapy produced positive clinical results with no dose limiting toxicities and promising dose dependent and efficacy signals. In the first 14 patients treated in the study, there has been a 100% disease control rate, 86% objective response rate, 2 complete responses and 100% overall response rate according to RECIST criteria at the highest dose.

Then of the 14 surgical -- surgically resected patients, 12 patients had successful resection of their tumors; 1 patient demonstrated complete pathological response, that's a pCR; 64% of patients had a R0, that's a margin negative resection; and 100% R0 resections were observed at the highest dose. Additionally, the third protocol treatment group is exceeding expectations, with greater than 13 months PFS and going strong.

We also reported the following translational research findings from the available patients in the OVATION Study. All 15 patients in the study showed a greater than 90% drop in their CA-125 levels. I remind you that a 50% drop is considered to be clinically significant. And the ratio of CD8 cells to immunosuppressive cells was increased in approximately 75% of patients, suggesting an overall shift in the tumor microenvironment from suppressive to pro immune stimulatory.

The data has shown that production of therapeutic IL-12, interferon gamma and VEGF levels in this patient population are thus related and more predominantly in the peritoneal fluid with little or no changes in patient's blood samples.

Mostly importantly, these distinct immunological changes in the local disease environment appear to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential combination in both first and second line of ovarian cancer.

These data, along with dose and safety analysis, were presented to medical experts, KOLs and our Medical Advisory Board on September 27 of this year. Last Friday, as you all know, in our press release we filed for a 90 patient open label randomized Phase I, II protocol to evaluate GEN-1 in this same newly diagnosed ovarian cancer patient population.

The treatment protocol is almost exactly the same as the prior Phase 1b OVATION Study with 1 major addition. And that is, following de-bulking surgery, patients will continue to receive interperitoneal doses of GEN-1 for 2 months. My hypothesis is that continuous stimulation of the immune system after surgery may further provide a beneficial effect of attacking cancer progression.

Phase I, II study will begin with a Phase I dose escalating run in to ascertain whether a higher dose of GEN-1 is both safe and active. As we reported earlier, we have not seen any dose limiting toxicities in our prior Phase 1b OVATION Study. However, we also observed some of the most promising efficacy signals were at the highest dose. So it's clear to us that a next higher dose should be evaluated prior to moving on to the Phase II portion of the study.

So after the Phase I portion of the study is completed, we will initial an open label study of approximately 90 newly diagnosed Stage III and IV ovarian cancer patients, which will allow for periodic reporting of results throughout the clinical trial. We expect to have several important clinical announcements from this study during 2018 and 2019.

So now I'm going to move on to our fifth and final point before I turn the call over to Jeff, and that's our financial strength and our lean cost structure. Let me just start by saying our organization structure is lean. Our spending is highly efficient and very predictable. We continue to operate with a very small staff of less than 20 employees, supplemented, however, with highly professional contract research organizations.

Our future spending on average will be approximately $1.3 million per month. That's approximately $15 million to $16 million per year to conduct 2 major clinical trials, a global Phase III pivotal trial on primary liver cancer and advanced clinical trials on newly diagnosed ovarian cancer.

With the recent capital raised in October, we are in an extraordinarily strong financial position. Our cash runway will carry us well into the second quarter of 2019.

And so with that, I will now turn the call over to Jeff for review of our recent financing activities in 2017 and our third quarter financial results. Jeff?

Thank you, Mike. During the third quarter 2017, we continued to efficiently utilize our cash as we effectively execute our clinical development initiatives. We ended the third quarter with $2.7 million of total cash in investments that included the completion of a $5 million registered direct equity offering of shares of common stock and warrants with several institutional healthcare investors in July 2017.

Subsequent to the end of the third quarter, this was in October, we raised $70 million through the exercise of previously issued and outstanding warrants and also completed an underwritten equity offering of shares of common stock and warrants with Oppenheim & Company which totaled $6.6 million. This significant capital infusion will cover our projected operating needs well into the second quarter of 2019.

Celsion's 2017 third quarter financials were included in the press release which we issued before the market opened this morning. Our Form 10-Q for the quarter ended September 30th also was filed this morning.

We continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value. Our clinical focus remains squarely on the enrollment of our pivotal Phase III trial for ThermoDox in primary liver cancer and now the new Phase I, II clinical trial toward GEN-1 in ovarian cancer.

Operating expenses were $13.8 million in the first 9 months of 2017 compared to $15.5 million in the same period of 2016. Cash used for operations in the third quarter ended September 30, 2017 was $1 -- I'm sorry, $5.1 million compared to $4.7 million in the prior year. Cash used for operations in the 9 months ended September 30th was $16 -- I'm sorry, $12.4 million compared to $13.7 million in the prior year 2016.

These results are in line with our earlier projections and are the result of our cost reduction efforts implemented during 2016, a tighter product development focus, as Mike mentioned earlier, and prudent cash management.

During the first half of the year, we paid off our venture debt facility with Hercules. The company has no debt on its balance sheet. We continue to operate with a lean organizational structure with now less than 20 full time employees.

Our spending is directed to research and development activities. We expect our cash use for operations to be approximately $4 million or less per quarter for the balance of 2017 and 2018. We expect this number to decline in 2019 with the full enrollment of the OPTIMA Study projected to be completed by mid-2018.

As we look forward, we believe that maintaining a strong balance sheet is important to continue the strong development momentum we have built around our lead clinical development programs.

For the third quarter ended September 30, 2017, we reported a net loss of $5.7 million compared to a net loss of $6.4 million in the same period in the prior year. For the 9 months ended September 30, 2017, our net loss was $16.1 million compared to a net loss of $16.7 million for the same 9 month period in 2016.

R&D costs were $3.3 million in the third quarter of '17 compared to $4.2 million in 2016. R&D cost for the first 9 months of 2017 were $9.9 million compared to $11 million last year. Our R&D expenditures in the current year are focused on the continuing enrollment and treatment of patients in the Phase III OPTIMA Study and the completion of enrollment and analysis of the data in the Phase I OVATION Study and the initiation of a follow-on Phase I, II clinical trial using GEN-1 to treat ovarian cancer.

General and administrative expenses for the third quarter were $1.2 million compared to $1.5 million in the same period last year. This 22% decrease during the third quarter of 2017 was due to lower noncash stock compensation expense, lower personnel cost and reduced professional fees. G&A expenses were down $600,000 in the first 9 months of 2017 when compared to the same period in 2016; that was $4.3 million this year versus $4.9 million in 2016.

This 12% decrease was primarily the result of lower personnel and operating cost resulting from the reorganization of staff reductions announced in 2016, lower insurance premiums and professional service cost and a tighter clinical focus on those programs that will help drive shareholder value in the near-term through the readout of our pivotal Phase III OPTIMA Study.

During the third quarter ended September 30th, other expenses included a noncash charge of $2.5 million related to the impairment of certain in process research and development assets related to the development of our glioblastoma multiforme or GBM cancer product candidate. This impairment represents a delay in the GBM program largely due to competitive IL-12 products being evaluated in the same indication. This impairment charge was offset by a $1.2 million reduction in the earn-out liability related to potential milestone payments for the GMB product candidate.

Interest expense decreased by $0.5 million in 2017 due to lower principal balances outstanding under our debt facility with Hercules. As I mentioned earlier, this loan facility was paid off in full on June 1, 2017.

I like to conclude by stating that our balance sheet is strong and we are well positioned to execute our business initiatives. The financing climate for Celsion and many other small cap biotech companies over the past 2-plus years has been extremely challenging. We are now well positioned to deliver important news around our product development programs and have the financial tools and investment banking analyst support to properly capitalize the company for future success.

I'll now turn the call back to Mike.

Thank you, Jeff. It's a good overview. So I'll just conclude with reminding you that our fundamentals are sound and our work is of major consequence, because, if we're right, we're looking at the potential for $1 billion market opportunities both in ovarian cancer, primary liver cancer. Assuming we're right, we also look forward to a significant increase in our market capitalization.

With both of our clinical programs designed to treat patients in first line, successful with either program will establish both a significant advance in medicine and a substantial return to our investors.

With that being the conclusion of our prepared comments, I would like to ask the operator to open the lines for your questions.

(Operator Instructions) And we'll take our first question from Keith Markey.

I was wondering in the press release you issued this morning -- or I guess it was yesterday, you mentioned that you would like to enroll relatively healthy -- patients with relatively healthy immune systems in the upcoming GEN-1 Study. I was wondering what criteria will you use to identify them.

So I think what we're trying to communicate there is these are first line patients for the most part are treatment naive, Keith, getting treatment naive with the anticancer agents or chemotherapies, of which, as we all know, do have a detrimental effect on the immune system. I mean our point there was that these patients for the most part are first line and newly treated. And maybe Nick can expand on that please.

So what we will be looking at is that they are going to have a good performance status. So that's going to be based on the ECOG performance status of 1. So you might be familiar with that. So these are relatively healthy individuals. And as Mike said, this is their first time in therapy, so their immune systems haven't been exposed to any previous chemotherapy drugs that could affect or alter the immune system's status.

I wasn't sure if there was something very specific that you were going to look at possibly. And then I was also wondering if you could tell us how many of the patients in the OVATION Study treated with the 75 milligrams per meter squared dose had any disease progression or passed away since the trial began?

That's 79 milligrams per meter squared. Do you know that exactly?

Now, as far as I know, those patients are -- so those are the latest that we've enrolled and they all did very well, as you know, surgically. They all had R0 resections, which means that after the treatment with GEN-1 and their neoadjuvant chemotherapy, they went in for surgery and the surgeon was able to remove all the tumor possible. So that was good news for those patients. We continue to follow them and we haven't seen progression yet.

And I could also report, Keith, just quickly -- I mean you asked about death. None of the patients on the study have died.

(Operator Instructions) And we'll take our next question from Barry Rubin.

What is your current share count?

Current share count is approximately 16 million shares.

And is there going to be any future dilution from any warrants?

We are not anticipating any immediately. But as far as warrants that could be in money -- Jeff, you want to talk about that?

In addition to the 16 million shares which are outstanding, we have approximately 3 million warrants at various strike prices ranging from about $3 to about $6 in change. So on a fully diluted basis of shares outstanding and warrants, it's about 19 million. So it's under 20 million on a fully diluted basis. To address the second point, we're always going to be opportunistic. But as we indicated, we have a cash run rate that takes us well into the second quarter of 2019 beyond the enrollment of the OPTIMA Study and to the first preplanned interim outlook. We'll never say we'll -- we're not going to raise additional capital, but we believe that it can certainly be done at a very attractive cost to capital. But right now, 19 million on a fully diluted basis.

May I ask a second question?

Barry, I'd also point out this -- I think it's important. ThermoDox now is in Phase III. The study is virtually on the precipice of completing enrollment or just a little over a year away from the first interim read. We -- so we'll be -- and GEN-1 is showing -- if it continues to show the kind of clinical results that we saw in the first trial, I'm sure would be very interesting. So I guess my point with all of that is we'll be looking for non-dilutive means also to improve our cash balance.

May I ask one scientific question?

Sure.

If I'm correct, Exelixis has just had a product approved for liver cancer. I may be wrong, but I thought that's what I had seen in the press. If I am correct, what's the difference between their products and yours?

I'm trying to recall the product that they got approved. I'd have to look into it. I mean this is something I haven't studied lately. But I believe that the product that they got approved is an advanced HCC. We're looking at patients that are newly diagnosed HCC patients and -- which is by far the largest population. So it's a different patient population that we're targeting between the 2 products.

Let me expand on that a little bit, Barry. I believe the drug you are talking about is indicated for patients who failed sorafenib and it's another multikinase inhibitor. And as Dr. Borys pointed out, we're evaluating ThermoDox in first line in combination with the first line treatment. And so we get asked often about competition for drugs that are currently in development and we know of none actually that are at Phase III and none that are showing the kind of promise that ThermoDox has. But the point is this, is that -- and I think there was a truism in oncology that will continue on for a long time and that is: If you can cut it out, you will. Or, if you can effectively have the same effect by burning a tumor with radiofrequency ablation, you will. And what we know is this, is that our Phase being adopted in many countries around the world and in many medical societies around the world is an alternative to surgery, and assuming we're right, our phase predominant first line treatment ThermoDox will be adopted very quickly. Unless there's some magic bullet that can eliminate and eradicate the tumors effectively as surgery or HEAT, ThermoDox will be a treatment without competition in our view for a very, very long time.

(Operator Instructions) And it appears we have no further questions at this time.

So I thank all of you again for your interest in Celsion and for joining us. We remain very excited about the potential of our chemotherapy and immunotherapy programs and look forward to providing future updates as we advance the development of our pipeline.

We value your continued support for our common goal of delivering innovative oncology -- oncologic therapeutics to address some of the most prevalent cancers with the highest unmet need. Thanks again for joining our call.

With that, we'll close our session.

This does conclude today's program. Thank you for your participation. You may disconnect at any time.