Jeffrey Church - SVP and CFO Michael Tardugno - Chairman, President and CEO Nicholas Borys - Chief Medical Officer.
Keith Markey - Griffin Securities Barry Rubin - Arsenal Investments.
Good morning. My name is [indiscernible] 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. All lines have now been placed on mute to prevent any background noise. Following the speakers’ remarks there will be a question-and-answer session.
[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 nine months of 2017.
Today’s call will be archived and a replay will be available beginning tomorrow and will remain available by phone until November 28th 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 terminology such as may, should, expects, anticipate, plan, estimate or similar expression.
These statements are based upon current beliefs, expectation and assumptions, and are subject to a number of risk 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 material 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 upon 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’d 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 just heard. As always, we are delighted to have the opportunity to update you on our progress and to answer your question.
For those of you are knew the story, I’d like to give you a quick elevated pitch. Celsion’s oncology focus development stage company with two platform technologies both of which have product candidates and clinical trials.
Our lead technologies are novel heat sensitive liposome that incorporates non-chemotherapeutics, it’s administered IV and one in the presence of tissue that’s been heated to just above body temperature, it’s about 40 degrees Celsius.
The Celsion nanoparticle releases its payload to create a locally high concentration of the drug at target's local regional and solutions. Our first candidate on this platform is ThermoDox, ThermoDox as the name implies as heat sensitive liposomal formulation of doxorubicin.
ThermoDox is being evaluated in combination with radiofrequency ablation, that’s RFA in a global multi-center pivotal Phase 3 study of the largest unmet medical need remaining an oncology and that’s hepatocellular carcinoma also known as HCC primary liver cancer. We call our second and equally important platform TheraPlas.
TheraPlas is short for therapeutic plasmids, as the name implies, this is nanoparticle based cell transfection technology has the ability to return DNA sequences, product for proteins with known anti-cancer properties, interactive 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 actually is the production of the highly effected inflammatory protein of cytokine interleukin 12. IL-12 is well known to actively 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 and newly diagnosed Phase III and Phase IV ovarian cancer patients. And as we announced yesterday evening, based on highly encouraging data, we are now moving forward with randomized Phase I/II study in this very patient population.
So, in summary there’s two platform technologies, two drug candidates, one in Phase III and one non-moving to Phase II rapidly, both showing very promise, and at chemotherapy, representing the legacy of medicine with an innovative means to improve both safety and efficacy and that's the holy grail of oncology folks.
They evaluated in the largest unmet medical need in oncology. And the second investigational product, this one in the future of medicine, immunotherapy, showing some remarkable potential ovarian cancer, malignancy that effects the lives of over 200,000 women annually.
Our goals as we’ve communicated over the past conference calls remain unchanged and that has been successfully completed the development of these novel innovated pharmaceutical elegant solutions to some cancers made difficult challenges, and if we are right, even Gen-1 are successful, the development of one if not two of the most important medicines in a generation.
The Celsion conference call in the August we have announced several important milestones that continue to drive momentum both in and outside of the clinic and I wanted to touch on those. First on the financial side. Our balance sheet is strong. For the past four months we've significantly improved our cash balance.
We announced several equity capital initiatives totaling almost $28 million, then we did some of the most non-diluted fashions available to us. Our cash position now provides an operating long runway going to the second quarter of 2019. That means the company has sufficient capital to achieve the follow.
First, and importantly is the full enrollment of around 550 subjects in the upcoming study here, pivotal Phase 3 study that we just spoke of ThermoDox in primary liver cancer, and we also within this cash runway we expect to provide results from the study, first pre-point in turn efficacy and analysis projected to appearing on the first quarter of 2019.
Additionally, we will initiate a follow-on Phase I/II clinical study of GEN-1 as a [indiscernible] first line therapy for the treatment of newly diagnosed stage 3 and 4 ovarian cancer patients this quarter, fourth quarter of this year. Our target is to enroll approximately 50% of the 90 subjects by year end 2018.
Again, within our current cash balance. And this will be an open label study and we’re also file periodic reporting throughout the conduct of the trial of the safety and clinical results.
Second topic today is our R&D day, I want to remind you, I want to go over quickly, I want to remind you though that at October 12, we have an R&D day in your city, the goal of which is to provide investors and analysts with an update on our clinical programs that we just focused.
If you go to our website, I believe you 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 travel from regions where HCC is a significant health problem including South Korea, Philippines and regions in Europe, to discuss past and current experiences with ThermoDox for the treatment of HCC including and importantly representative case study.
Dr. Borys provided the important data supporting the hypothesis from the study and moderated a panel discussion among these three investigators.
With regards to GEN-1 the lead clinical investigator for the innovation study and then leading immuno-oncology experts from the Roswell Park Cancer Institute focused on the clinical and translational data from our recently completed Phase 1b study.
And a copy of this presentation and the audio are on our website under News and Investors financial desk. 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 long-term potential of associates and these two very important intriguing products. Our third topic today is ThermoDox in the Phase III OPTIMA Study.
If you read our press release, we’re now 70% enrolled the Phase III OPTIMA Study is on track to complete its 550-patient subject recruitment. We’re on the middle of the next year.
The study’s hypothesis is based on our substantive learning from a large sub group analysis of the prior week study, which I will remind you as you know minutes of PFS endpoint. While the hypothesis is supported with some of most persuasive and productive perspective and retrospective data that has ever been taken in my experience for clinical trial.
Much of this data analysis ere included and accepted by peer review and recently published manuscript of the HEAT study in clinical cancer research. It’s a high impact medical journal. The lead author for this publication is Professor Tak, if you are interested in or planning to search for this article.
In the article -- in the manuscript the authors conclude in the intermediate sized HCC combining Radiofrequency Ablation, RFA, conducted for a minimum of 45 minutes with ThermoDox is significant potential to dramatically improve overall survival it should be studied.
I want to point out that the conclusions noted in the manuscript on either Arsenal or HEAT study manuscript authors alone.
I will remind you that the National Institutes of Health conducted a completely independent analysis of the intent to treat population of all 447 single legions patients in the study and concluded that longer RFA heating times when combined more ThermoDox resulted in a statistically improvement in overall survival. Now this is not true of RFA alone.
So, they looked at two cohorts RFA with ThermoDox and RFA alone and they concluded that when combining RFA or ThermoDox with RFA, the longer heating times resulted in a statically significant improvement in overall survival. This conclusion was presented at the RFA conference last December to a standing room only crowd.
And I turn off with the NIH’s strongly supported this thesis in the follow-on OPTIMA study. And by the way the while analysis was conducted by NIH’s in the same population that’s currently being recruited and treated in the OPTIMA study.
So now our highly de-risked, risked Phase III OPTIMA study of ThermoDox plus RFP standardized for 45 minutes in newly diagnosed HCC patients is on track and on budget. The guys report that all of the major costs and heavy lifting for this trial are now behind us.
Additionally, on August 7, the OPTIMA study’s independent Data Monitoring Committee completed a pre-planned 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.
By the way also note that the data presented at the DMC indicated that there has been 99% plus compliance with minimum 45 minutes RFP heating time as required in the protocol.
Also note that the 14 regulatory authorities 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 one, not two, but three redundant contract manufacturing organizations, that’s CMO, who are registered and capable of producing ThermoDox in all regions of the world, providing a cost structure that ALBA guarantees high gross margins, regardless of the country or the local economy.
I would also summit that with little, if any operational risk and all the major costs behind us via 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 which I just talked about, including an independent analysis of overall survival conducted by the NIH, then you 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 have 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 among other things priority review.
ThermoDox has been granted orphan drug designation for primary liver cancer in both the U.S. and Europe, which extents market exclusivity for seven years and 10 years, respectively, in these major revenue markets.
Based on prior discussions and subject to a successful trial, we have designed the OPTIMA study to enroll sufficient number of patients from each ethnicity or country to support registrational filings in the U.S., Europe, China, South Korea, Taiwan and Vietnam.
Additionally, the CFDA, that’s China FDA informed Celsion that if the ongoing Phase III OPTIMA study successful the trial could serve as the basis for direct regulatory filing in China without the need to file for prior approval in the U.S. or Europe, which is currently required to foreign company applications.
This would allow Celsion to accelerate this plans for regulatory filing in China and if approved, provide a significant lead earlier launch date in China than originally expected.
China as you know represents or as perhaps the most significant market opportunity for ThermoDox globally and is approximately 50% of the over 850,000 new cases diagnosed each year originated in China. In this market the largest future market for pharmaceuticals in the world I believe it safe to say that we are well positioned.
Our fourth topic this morning is GEN-1 our marvelous entry into immunotherapy. GEN-1 our immune-oncology candidate developed in our fair [indiscernible] technology platform as I discussed is a gene mediated immunotherapeutic which recruits the body entire immune system to fight malignancies.
GEN-1's active agent is a DNA plasmid coded for the cytokine interleukin IL-12, as we discussed the IL-12 plasma is incorporated into our proprietary non-viral nanoparticle delivery system. When administered locally into a body cavity like the peritoneum in bladder, or even a cavity created by surgical removal of tumor mass.
The nonoparticles invade surrounding cells and takeover the metabolic machinery turning each cell into mini factory for local sustained production of the IL-12 protein. The first indication of when we're studying for GEN-1 is ovarian cancer. The patients newly diagnosed with this cancer there is less than 45% chance of surviving 5 years.
While major reason of diagnosis is made the patients have advanced disease have stages 3 and 4. When the cancer is spread, the previous clinical trials in this patient population GEN-1 has been used either as a monotherapy or a 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 called the OVATION study.
The OVATION study evaluated GEN-1 plus [indiscernible] and chemotherapy followed by debulking surgery in newly diagnosed stage 3 and 4 ovarian cancer patients. Prior to debulking, our patients were treated with what the three cycles of platinum and taxane the goal of which was to improve surgical outcome by shrinking the tumor mass.
To this regimen we added eight weekly cycles of GEN-1. We reported that GEN-1 plus new regimen chemotherapy produced positive clinical results with no dose limiting toxicities and promising dose -- and efficacy signals.
In the first 14 patients treated in this study there has been 100% disease control rate, 86% objective response rate, 2 complete responses and 100% overall response rate according to resist criteria at the highest dose.
Then of the 14 surgically receipted outpatients, 5 patients had successful reception of their tumors, one patient demonstrated complete cytological response at some PCR, 64% of patients had an entire zero that's a margin negative reception and 100% or zero receptions were observed at the highest dose.
Additionally, the per protocol treatment group's exceeding expectations with greater than 13 months PFS and going strong. We also reported the following translation of research findings from the available patients in the OVATION study.
All 15 patients in this study showed greater than 90% drop in the CA125 levels, I'll remind that a 50% drop is considered to be clinically significant.
And the ratio of CD8 cells to immunosuppressive cells has increased in approximately 75% of patients suggesting an overall shift in the tumor microenvironment from suppressive to pro-immune stimulatory.
The data shown that production of therapeutic IL-12 interferon-gamma and VEGF levels in those patient population are dose related and more predominantly [indiscernible] flow are no changes in patient’s blood samples.
Most importantly these distinct immunological changes in the local disease environment appear translate into clinical benefit and want to continue development of our GEN-1 IL-12 immunotherapy is a potential combination in both first and second line of ovarian cancer.
These data along with dose and safety analyses 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 90 patient open label randomized Phase I/II protocol to evaluate GEN-1 in this say newly diagnosed ovarian cancer patient population.
The treatment protocol is almost exactly the same as the prior Phase Ib OVATION study with one major addition. And that is following debulking surgery, patients will continue to receive interferon doses of GEN-1 for two months.
Our hypothesis is that continuous stimulation of the immune system after surgery that further provide a beneficial effect attacking cancer progression. Phase 1/II study will begin with a Phase I dose escalating run to as attain whether higher dose of GEN-1 is both safe and active.
As we reported earlier we are not saying any dose limiting toxicities in our prior Phase 1b OVATION study, however we also drove most promising efficacy signals were at the highest dose. So, it’s clear that next higher dose should be evaluated prior to moving on to the Phase II portion of the study.
So, after the Phase 1 portion of the study is completed, we’ll issue an open label study of approximately 90 newly diagnosed Stage 3 and 4 ovarian cancer patients, which will allow for periodic reporting of results throughout the clinical trial. We expect there are several clinical announcements from this study during 2018 and 2019.
And now I’m going to move on to our fifth and the 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 offering with the very small staff of less than 20 employees supplemented our 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 two major clinical trials of global Phase III pivotal trial in primary liver cancer and advance clinical trials in newly diagnosed ovarian cancer.
In recent camp raised in October, we are in an extraordinarily strong financial position, our cash run rate will curious long for the second quarter of 2019. So, with that, I will turn now to the call over to Jeff for a review of our recent financing activities in 2017 and our third quarter financial results.
Jeff?.
Thank you, Mike. During the third quarter of 2017, we continue 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 and investments that included the completion of the $5 million registered direct equity offering of shares of common stock and warrants to the several institutional healthcare investors in July 2017.
Subsequent to the end of the third quarter, this was in October we raised $17 million to the exercise that previously issued in outstanding warrants and also completed an underwritten equity offering of shares of common stock and warrants with Oppenheimer & 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 30, 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 for GEN-1 in ovarian cancer. Operating expenses were $13.8 million in the first nine 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 $5.1 million, compared to $4.7 million in the prior year. Cash used for operations in the nine months ended September 30 was $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 that 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, which now less than 20 full-time employees. Our spending is directed to research and development activities. We expect our cash used 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 prior year. For the nine months ended September 30, 2017, our net loss was $16.1 million, compared to a net loss of $16.7 million for the same nine-month period in 2016.
R&D costs were $3.3 million in the third quarter of 2017, compared to $4.2 million in 2016. R&D costs for the first nine 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 analyze of the data in the Phase 1 OVATION study and the initiation of a follow-on Phase 1/2 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 in the third quarter of 2017 was due to lower non-cash 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 and -- productions 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 their pivotal Phase 3 OPTIMA study.
During the third quarter ended September 30, other expenses included a non-cash charge of $2.5 million related to the impairment of certain in process research and development assets related to the development of our glioblastoma multiform or GBM cancer product candidate.
This impairment represents a delay in the GBM program, largely due to competitive IL-12 products been evaluated in the same indication. This impairment charge was offset by a $1.2 million reduction in the earn out liability related to the pension milestone payments for the GBM product candidates.
Interest expense decreased by $0.5 million in 2017 due to lower principle balances outstanding under our debt facility with Hercules. As I mentioned earlier this loan facility was paid off in full on the 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 client 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. So, I will just conclude and remind you that our fundamentals are sound and our work is of major consequence. Because if we are right, we're looking at the potential for a $1 billion market 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 the 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'd like to ask the operator to open the lines for your questions. And ask you limit the number of questions to more than two so that we can provide everyone with an opportunity to participate in the Q&A session.
Operator?.
[Operator Instructions] And we’ll take our first question Keith Markey. Please go ahead. Your line is open..
Good morning, and thank you for taking my questions, Mike, Jeff, appreciate it. 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 that relatively healthy immune systems in the upcoming GEN-1 study.
I was wondering what criteria will you use to identify them?.
Yes, I think what we’re trying to communicate there is these are first line patients who are, for the most part is treatment naïve, with anti-cancer agents or chemotherapies as we all know do have a detrimental effect of the immune system.
So, our point there was that these patients for the most part are first line and newly treated maybe Nick, can expand on that please..
Yes, so for true what we’ll be looking at is that they’re going to have to have a good performance status. So definitely based on performance status one. So, you might be familiar with that.
So, these are relatively healthy individuals and as said Mike, this is the first line of therapy, so their immune systems haven’t been exposed any previous chemotherapy drugs that could affect or alter give you immune systems status..
Okay. Thank you. 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 have any of the patients in the OVATION study treated with 75 milligrams per meter square dose had any disease progression or past delays since the trial began?.
At 79 milligrams per meter square? Do you know?.
As far as I know those patients are the latest that we’ve enrolled. And they all did very well as you know, surgically they all had zero resections that means that after the treatment of GEN-1 and their new chemo therapy they went into 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..
I would also add that, Keith, just quickly if you ask about that, none of the patients on the study have died..
That’s even better. Thank you..
[Operator Instructions] And we’ll take our next question from Barry Rubin. Please go ahead. Your line is open..
Thank you.
What is your current share count?.
Our share count is approximately 16 million shares..
And is there going to be any future dilutions from any one?.
We’re not anticipating any immediately, but as far as ones that could be money.
But Jeff, do you want to talk about that?.
Yes. In addition to the 16 million shares which are outstanding we have approximately 3 million of warrants at various strike prices ranging from about $3 to about $6 and change. So, on a fully diluted basis, our shared outstanding warrants, it’s about $19 million. So, it’s $120 million on a fully diluted basis.
To address the second point, I mean, 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 into the first preplanned interim outlook.
We never said we are not going to raise additional capital, but we believe that it can certainly be done at a very attractive cost of capital, but right now $19 million on a fully diluted basis..
May I ask the second question?.
I would also point out this, I think it’s an important you know, our ThermoDox now was in Phase III, the study is virtually at precipice of concluding enrollment, just a little over a year away from the first interim rate.
So, we’ll be -- in GEN-1, it’s showing, it continues to show the kind of clinical results that we saw in the first trial, I'm sure will be very interesting. So, I guess we'll be looking for non-diluted that means also to improve our cash balance..
May I ask one scientific question?.
Sure..
Okay.
If I'm correct [indiscernible] just had a product approved for liver cancer, I may be wrong but that’s what I had seen in the press is, if I’m correct what’s the difference between their product and yours?.
I’m trying to recall the product that they got approved. I have to look into it, I mean, this is something that 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 two products..
Let me explain on that a little bit, I believe [indiscernible] was talking about as indicated for patients who [indiscernible] multi-kinase inhibitor and as Dr. Borys pointed out, we’re evaluating ThermoDox in first-line in combination with the first-line treatment.
And we are asked often about competition for drugs that are currently in development and we know none actually at Phase III and none that are showing the kind of the promise what ThermoDox is.
The point of this is that and I take it [indiscernible] an oncology that we’ll continue on for a long time and that this is, as you can cut it off, if you will, or if you can effectively, you have the same effect by burning a tumor with radio frequency ablation, you will.
And what we know is this, that our phase being adopted on in many countries around the world and many medical societies around the world is an alternative to surgery.
In a similar way for phase predominant first-line treatment, ThermoDox will be adopted very quickly, and there is some magic bullet that can eliminate and eradicate the tumors effectively as surgery or heat. ThermoDox would be 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 want to thank all of you again for your interesting Celsion for joining us. We remain very excited about potential of our chemotherapy and immunotherapy programs. And we 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 innovation 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..