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Edited Transcript of CLSN earnings conference call or presentation 11-May-18 3:00pm GMT

Q1 2018 Celsion Corp Earnings Call

COLUMBIA May 16, 2018 (Thomson StreetEvents) -- Edited Transcript of Celsion Corp earnings conference call or presentation Friday, May 11, 2018 at 3:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jeffrey W. Church

Celsion Corporation - CFO, Senior VP of Corporate Strategy & IR and Corporate Secretary

* Michael H. Tardugno

Celsion Corporation - Executive Chairman, President & CEO

* Nicholas Borys

Celsion Corporation - Senior VP & Chief Medical Officer

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Conference Call Participants

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* Edward Sherman

* Emma Kathleen Nealon

Oppenheimer & Co. Inc., Research Division - Associate

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Presentation

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Operator [1]

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Good morning. My name is Matt, and I'll be your conference operator today. At this time, I would like to welcome you to the Celsion's First Quarter 2018 Financial Results Conference Call. (Operator Instructions) This call is being recorded. At this time, I'd like to turn the call over to Mr. Jeffrey Church, Celsion's Senior Vice President and Chief Financial Officer. Please proceed, Mr. Church.

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Jeffrey W. Church, Celsion Corporation - CFO, Senior VP of Corporate Strategy & IR and Corporate Secretary [2]

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Thank you. Good morning, everyone, and welcome to our first quarter 2018 investor conference call to discuss our first quarter results, which we announced this morning before the market opened.

During our call today, Celsion's Chairman, President and CEO, Michael Tardugno, will provide an operational update on our clinical programs, and I will summarize our financial results for the first quarter. Today's call will be archived and the replay will be available beginning tomorrow and will remain available by phone until May 25, 2018, 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 expectation and projections about future events. Generally, forward-looking statements can be identified by terminologies such as may, should, expect, anticipate and similar expressions. These terms 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 SEC, many of which are difficult to predict.

Those 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 made on this conference call based on new information, future events or otherwise, except as required by law.

At the end 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. Mike?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [3]

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Thank you, Jeff. Good morning, everyone, and thank you for joining 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 very pleased to have the opportunity to update you on our progress and to answer your questions.

Now let me start this call by reminding you that our 2018 Annual Shareholder Meeting will be held on Tuesday of next week at the Westin Hotel in Princeton, New Jersey. I would like to encourage all shareholders of record to consider joining us for the meeting if you can. It'd be our pleasure to see you because as always, it's great to meet with you in person whenever possible. We learn a great deal.

Since we just filed our year-end column a little over a month ago, today's conference call will be relatively brief, and perhaps we've done this in a few places but there is much worth repeating. So let me start now this call where we ended our call in March and to remind you, I made 4 key points for investors to consider as Celsion entered this year, 2018: number one, we have an operationally tight focus which both conserves cash and more importantly, ensures the timely advancement of our 2 very promising clinical trials, the OPTIMA Study, our pivotal Phase III trial of ThermoDox on newly-diagnosed primary liver cancer. Remind you that's the largest unmet medical need remaining in oncology today; and the OVATION II study, a Phase I/II trial of our gene-mediated immunotherapy, GEN-1 within newly-diagnosed ovarian cancer patients.

Number two, when Celsion started the year with a strong balance sheet with 20 months' worth of cash and runway sufficient to achieve a number of very important development objectives, including full enrollment and a read of the data from the first interim analysis of the OPTIMA Study and the initiation of OVATION II and top line results from the first cohort of up to 12 patients in -- that therapy's 6 in the treatment arm and 6 in the control arm in the study by the end of the year.

The third point to consider, as you're thinking about Celsion, is our trials continue to advance. Investors should have expectation of a steady news flow of key developments over the course of 2018 and then into 2019.

And now before, we'll be pursuing non-dilutive means to add to our financial resources, including the sale of net operating losses or NOLs, which could add 2 to 3 quarters' worth of operating runway, taking the company well into 2020, a point at which the results of our -- from our Phase III OPTIMA Study should be well behind us, and Jeff will speak to this in more detail later in the call.

Let me repeat, 2018, an operationally tight focus ensuring timely achievement of clinical development goals; an efficient cash utilization; a strong balance sheet providing runway to critical inflection points, including full enrollment of a Phase III study and the first interim efficacy analyses; a commitment to a steady news flow of key developments and a financing strategy that focuses on shareholder value. That's our plan.

Now I'd like to review our technology and our clinical studies, beginning with our lead investigational drug, ThermoDox. ThermoDox, as you know, as the name implies, is a heat-sensitive liposomal formulation of doxorubicin. It's being evaluated in combination with radiofrequency ablation, administered for a minimum of 45 minutes in a patient population with tumors greater than 3 centimeters, less than 7 centimeters in a study -- Phase III study called the OPTIMA Study.

So this is a global trial being conducted in 14 countries across 17 time zones in all markets where hepatocellular carcinoma or primary liver cancer or HCC, as we will call it, is a significant problem. The 550-patient study is powered to detect a 33% improvement in overall survival.

The thesis for our protocol is based on our understanding of the application of RFA for 3-centimeter and greater lesions and the survival impact when RFA is used correctly, that's a minimum of 45 minutes, and combined with ThermoDox.

In a 285-patient subgroup, that represents 42% of the entire intent-to-treat population from the prior HEAT Study, the group that was followed for over 2.5 years. Median time to death in the treatment arm is never reached after 80 months. That's more than 6.5 years median survival and over 2 years better than the control group.

Our investigators, excited about the results that concluded that a single dose of ThermoDox with properly administered RFA has the potential to be cured. We have been presenting this narrative at multiple medical conferences over the last number of years.

In addition to our survival observation, the thesis for combining ThermoDox with RFA standardized for a minimum of 45 minutes has been tested in preclinical and computational models. Our conclusion that combining ThermoDox with properly administered RFA has the potential for greater than a 2-year survival benefit is not Celsion's alone. It has been validated by the medical research community in multiple publications and journals.

Manuscripts supporting the basis for the OPTIMA Study cover virtually every aspect of our analyses and have been published in peer-reviewed journals, including Clinical Cancer Research in 2017, PLoS ONE in 2015 and the Journal of Hyperthermia in 2010. These analyses support the premise that the longer the heat -- the target lesion in surrounding tissue is heated, the greater the doxorubicin concentration, leading to, we hypothesize, a more effective tumor treatment and the potential for significant improvement in overall survival.

In April -- this past April, the independent Data Monitoring Committee, or DMC, met for a scheduled unblinded review of the data from the study. This review, among other things, includes ensuring each site's compliance with the specified minimum RFA heating time. The DMC unanimously recommended that the OPTIMA Study continue according to its protocol to its data readout, a recommendation that was based on their assessment of safety and data integrity of the first 75% of patients randomized in the trial through early February.

In addition, and very importantly, we learned that the blinded progression-free survival in the intent-to-treat population for the study is so far consistent with the PFS in the subgroup population that showed benefit in the HEAT Study. Let me say that again. We learned that the blinded progression-free survival in the intent-to-treat population in the OPTIMA Study is so far consistent with the PFS in the subgroup patient population that showed benefit in the HEAT Study.

Now I want to emphasize the study is blinded and remains blinded, and no definitive conclusion can be drawn to point at ThermoDox's performance specifically. We nevertheless view this finding as encouraging and continue to believe that ThermoDox with properly administered RFA will be found to be effective in treating HCC.

Now I want to repeat some comments from the last call, last March call, for those who are new to Celsion. In 2016, at the request of the Director of Interventional Oncology, we provided the National Institutes of Health with 3 terabytes of HEAT Study data, from which they conducted an independent analysis of the intent-to-treat population of 437 single-lesion patients from the HEAT Study.

Now this is a different population than I just discussed, where we saw an improvement in overall survival in the treatment arm equal to greater than 80 months -- median time to death greater than 80 months. So this population, single-lesion patients, all patients with single lesion in the study were evaluated, where the study looked at 2 virtually identical -- where the evaluation studied 2 virtually identical cohorts. It's RFA with ThermoDox and RFA alone.

What the NIH concluded was that when combined with ThermoDox, longer RFA heating times resulted in a statistically significant improvement in overall survival. This was not true of RFA alone. These findings were presented at the RSNA conference in December 2016, that's the Radiological Society of North America conference, one of the largest medical conferences conducted annually in the world.

More recently in February 2018, an abstract discussing the company's Phase III HEAT Study evaluating ThermoDox in combination with RFA was 1 of 6 selected for presentation -- where the HEAT Study manuscript by lead author Dr. Wong Youn Tak as part of the lecture of the presidential selection of the Korean Liver Cancer Association's 12th Annual Scientific Meeting in Seoul, South Korea.

So when you look at all of this, the NIH's interest, our investigators' and the HEAT Study's interest in bringing the HEAT Study data and the results showing an improvement in overall survival to their colleagues in multiple medical conferences, Dr. Tak's presentation, you look at all of this, you can't help but conclude, as I said before, this is one rare time where clearly, the medical community gets it before Wall Street does.

I'll also note that the 14 regulatory authorities from across the globe and all major HCC markets, including Europe, North America and Asia, that reviewed and the approved the OPTIMA Study protocol. The regulatory strategy is based on these interactions. We've designed the OPTIMA Study to enroll a sufficient number of patients from each country to support registrational filings and market launch in the U.S., Canada, Europe, China, South Korea, Taiwan, the Philippines, Thailand, Malaysia, Vietnam.

In U.S., ThermaDox has received Fast Track Designation and provides for, among other things, priority review. ThermoDox has also been granted orphan drug designation for primary liver cancer both in the United States and Europe, which extends market exclusivity for 7 and 10 years, respectively, in these major revenue markets.

Additionally, the CFDA, that's the China Food and Drug Administration, informed Celsion, that's Dr. Borys and me, that if the ongoing Phase III OPTIMA Study is successful, trial could serve as a basis -- data from the trial could serve as a basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or Europe, which is currently required for many foreign company applications.

While this departure from convention would allow Celsion to accelerate its potential regulatory filing in China, and if approved, will provide for a significantly earlier launch in China than originally anticipated. China represents, of course, perhaps the most significant market opportunity for ThermoDox globally is approximately 50% of the over 850,000 newly diagnosed HCC cases originate in China each year.

So with regard to the trial itself on the execution side, we have engaged internationally recognized world-class contract research organizations and data management teams to ensure Good Clinical Practice, ICH compliance, protocol adherence and high-quality data analytics. We also have a proven and highly reliable supply chain with 3 redundant contract manufacturing organizations who are registered and capable of producing ThermoDox in all regions of the world, supporting high gross margins regardless of the market.

Now I want to turn to GEN-1. As I discussed last month, GEN-1, developed on our TheraPlas technology platform, is a gene-mediated immunotherapy, which recruits the body's immune system to fight malignancy. GEN-1's active agent is a DNA plasmid coded for the potent anti-cancer cytokine, IL-12 or interleukin 12.

The IL-12 plasmid is incorporated into our proprietary synthetic nanoparticle delivery system called TheraPlas. When administered locally into a body cavity like the bladder or the peritoneum or even a cavity created by surgical removal of a tumor mass, these nanoparticles invade or transvect the surrounding cells and take over the metabolic machinery, turning each cell into a little biopharmacy for the local sustained production of interleukin 12.

The first indication we're studying for GEN-1 is, as you know, is a ovarian cancer. For patients newly diagnosed with this cancer, there's less than a 45% chance of surviving 5 years. One of the major reasons for this is that the diagnosis is made when the patients have advanced disease, typically in stages III and IV when their cancer has spread throughout the pelvic region.

In previous clinical trials in patient populations with recurrent disease, GEN-1 has been used both as a monotherapy and in combination with standard chemotherapy that has shown promising results. Most importantly, however, GEN-1 demonstrated clear signs of activity and clinical benefit in newly diagnosed ovarian cancer patients in our Phase Ib dose escalation trial, the OVATION I study.

The OVATION I study evaluated GEN-1 plus neoadjuvant chemotherapy, followed by interval debulking surgery in newly diagnosed advanced ovarian cancer patients. The goal of neoadjuvant chemotherapy is to improve surgical outcome by shrinking the tumor mass and drying up the accompanying fluids known as ascites.

In the study, we added 8-weekly cycles of GEN-1 to this chemotherapy regimen then followed by surgery. Our findings from the study include the following, and I would say in this population, include very impressive findings: first, the GEN-1 plus neoadjuvant chemotherapy demonstrated no dose-limiting toxicities. It is safe up to the highest dose tested at 79 milligrams per meter square.

The investigators in the Oversight Committee, that's the DSMB, did not find any significant toxicities associated with GEN-1. There are clear dose-dependent bioactivity in efficacy findings among the patients treated in the protocol. The clinical findings included a partial or complete response in 86% of patients. The surgeons were able to completely remove all visible tumor, an outcome known as an R0 resection in 100% of patients treated with the highest dose.

Distinct immunological changes in the tumor microenvironment appear to be pro-immune in 75% of patients. PFS, importantly following this clinical result, PFS is projected to be over 21 months. Historically, PFS and its patient population is approximately 12 months.

Now based on these findings in November 2017, we announced the submission of the Phase I/II clinical trial protocol to the FDA for the localized treatment of ovarian cancer. It's an open label randomized study we called the OVATION II study. We plan to treat the first 6 patients in the GEN-1 arm at 100 milligrams per meter squared, that's 30% -- approximately 30% greater than the previous dose. The last dose that was treated -- the last cohort that was treated with the highest dose in the last study. So it will be a study -- we'll start with 100 milligrams per meter square followed by a continuation of the selected dose in the Phase II portion in up to 130 patients.

The entry criteria and treatment protocol are virtually the same as the prior OVATION I study with one major addition. Following debulking surgery, patients will continue to receive up to 9 additional intraperitoneal doses of GEN-1. This would be a maintenance therapy. Our hypothesis is that continuous stimulation of the immune system after surgery may provide a further beneficial effect by delaying progression.

We fully expect to initiate enrollment in the Phase I portion by June, just a few weeks away, and anticipate initiating Phase II -- the Phase II portion of the study in the first quarter of 2019. As this will be an open label study, we expect to report data periodically throughout 2019.

We're excited with GEN-1's potential as are our PIs. As an example, in March 2018, Dr. Permal Thaker, the lead principal investigator to our GEN-1 development program, presented -- made a presentation entitled, Ovarian Cancer: New Horizons and Treatments, at an investor event in New York. Dr. Thaker's presentation highlighted GEN-1 as a novel approach designed to deploy IL-12 without the toxicities associated with the recombinant form of the protein and outlined results from the OVATION Study.

Her presentation noted immunological changes consistent with the ability of GEN-1 to increase peritoneal levels of IL-12 and its downstream anti-cancer cytokines with little changes in systemic circulation and no systemic toxicities. If you're interested, her presentation can be found on our website.

Now before turning the call over to our CFO, I'd like to say that I expect 2018 to be an important, if not, transformational year. I think on our last call, I said this is our year, one where our focused development efforts for ThermoDox and GEN-1 will make significant progress, achieved with operational excellence and backed by responsible financial and capital management.

I'll pass -- to discuss our financials, I'll now turn the call over to Jeff. Jeff?

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Jeffrey W. Church, Celsion Corporation - CFO, Senior VP of Corporate Strategy & IR and Corporate Secretary [4]

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Thank you, Mike. During the first quarter of 2018, we continued to execute our important clinical development initiatives with a very tight focus on our 2 lead product candidates. We ended the quarter with $20.8 million of total cash and investments. During the first quarter, we used approximately $4.7 million in cash in line with our current year projections.

Typically, the first quarter of each year is the highest due to onetime payments for such things as annual insurance premiums, the 2017 performance bonuses. Based on our budget projections, our current cash position enables us to cover our projected operating needs into the third quarter of 2019.

We are pursuing additional non-dilutive capital doing innovative program offered by the state of New Jersey. This creative economic development program affords companies like Celsion the opportunity to sell its accumulated net losses to profit-generating businesses. We estimate that this program could generate $10 million in additional cash to extend our operating runway into the first half of 2020, well beyond several important value inflection points for both ThermoDox and GEN-1 clinical development programs.

Celsion's first quarter 2018 financials were included in the press release, which was issued before the market opened this morning. Our Form 10-Q for the quarter ended March 31 was also filed this morning. We continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value. We maintain a very tight focus on our pivotal Phase III trial for ThermoDox in primary liver cancer and the follow-on Phase I acute clinical trial for GEN-1 in newly diagnosed ovarian cancer patients.

Operating expenses were $4.4 million in Q1 2018 compared to $4.9 million in the same period last year. This decrease is in line with our earlier projections and are the result of our cost reduction efforts implemented during 2017 and prudent cash management. Our projected cash utilization for 2018, the entire year, is approximately $16 million or averaging about $4 million per quarter. This projection should remain consistent into 2019 as we complete full enrollment of the 550-patient Phase III OPTIMA Study in the third quarter of this year and increase our clinical development focus on GEN-1 in the second half of this year through 2019. We continue to operate with a lean organizational structure with approximately 21 full-time equivalent employees. Most of our spending is directed to research and development activities.

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

For the quarter ended March 31, 2018, we recorded a net loss of $4.5 million, which compares to a net loss of $5.2 million in the same prior year period. R&D costs for Q1 2018 were $2.7 million compared to $3.5 million in 2017. Our research and development expenditures were lower due to tighter clinical development focus on those programs that we believe to help drive shareholder value in the near term through the readout of our pivotal Phase III OPTIMA Study.

General and administrative expenses for the first quarter of 2018 were $1.7 million compared to $1.5 million in 2017. This increase in G&A costs were due to higher noncash stock compensation expense, coupled with higher professional fees, largely related to recruiting and consulting services for business development and commercialization initiatives. As a result of paying all of our venture debt loan with Hercules in June 2017, the company had no interest expense in 2018. That compares to $150,000 of interest expense in the first quarter of last year.

I'd like to conclude by stating that our balance sheet and business fundamentals are strong. We are well positioned to deliver important milestones around each of our product development programs. We have the financial tools and support to properly capitalize the company for future success.

I'll now turn the call back to Mike.

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [5]

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Thank you, Jeff. I'll conclude my prepared remarks by saying that our 2 drug candidates represent exciting advances in cancer research, that it depends on the changes -- the trajectory for patients with poor prognosis.

If either ThermoDox or GEN-1 shows continued positive data, we have the opportunity not only to transform patients' lives and medical practice but the company as well. Our work is very important. Our aspirations are high. And I look forward to reporting our progress this year, as we continue to our pursuit of effective new medicines for patients with difficult cancers.

So now I'd like to ask the operator to open the lines for your questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question will come from Hartaj Singh with Oppenheimer.

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Emma Kathleen Nealon, Oppenheimer & Co. Inc., Research Division - Associate [2]

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This is actually Emma on for Hartaj. First, is there any update on the enrollment status for OPTIMA? I think it was about 80% last quarter?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [3]

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Yes. So when we continue to progress according to our schedules, we're over 86%, 87% enrolled, so actually a little bit better than our projections now.

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Emma Kathleen Nealon, Oppenheimer & Co. Inc., Research Division - Associate [4]

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Great. And then just on GEN-1, do you plan to present the Phase Ib PFS data from OVATION at a medical conference?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [5]

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Nick?

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Nicholas Borys, Celsion Corporation - Senior VP & Chief Medical Officer [6]

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Yes. We're looking at both presenting that data at a conference. We're going to be discussing that, which one with our investigators and also writing that up as an abstract and submitting it.

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Emma Kathleen Nealon, Oppenheimer & Co. Inc., Research Division - Associate [7]

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Great. So should we expect that initial announcement to come in the form of a press release or is that still kind of TBD?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [8]

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Would you repeat that please, Emma?

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Emma Kathleen Nealon, Oppenheimer & Co. Inc., Research Division - Associate [9]

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Sure. When the PFS data is available around midyear, should we expect that to first come as just top line press release or is that still to be determined?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [10]

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Well, that would be a top line press release.

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Operator [11]

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(Operator Instructions) We will now go to Edward Sherman with DSW Associates.

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Edward Sherman, [12]

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Listen, I think you're doing a fantastic job, given the resources that you have. It's not easy to conduct 2 trials. But I have a question regarding the milestone payment for GEN-1. When would that be due?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [13]

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Yes. So the milestone payment, these are -- some refer to them as contingent value rights, milestone payment that they're likely talking about is tied to achieving progress in the Phase II portion of the GEN-1 study in ovarian cancer. That's not likely to happen on our current estimate. That's not likely to happen until late in 2019.

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Edward Sherman, [14]

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Great. And let me ask you this. You see...

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [15]

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Edward, just so -- while we're on that topic. The milestone, at the company's election, can be paid in either cash or stock or a combination thereof.

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Edward Sherman, [16]

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Sure, right. I saw that actually. So you say that this is one of the rare occasions where the medical community gets it before the investment community. Why do you think that is? And if it's true, and I don't mean to be critical, but what does it say about the efforts the company is making getting the word out?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [17]

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Yes, so I mean -- so I'm not going to apologize for the efforts, we spend a good deal of time on -- in conferences and meeting with investors individually and in small groups. Getting the word out is a top priority for the company. I have to say, we -- the major portion of the investment of the company has been focused on ThermoDox over the last number of years. It's not usual for a company to continue to develop a product particularly in the same indication following a failed trial. So the -- we're not used to putting good money after bad, and I can promise you that a majority of us here, there may be 1 or 2 that qualify, but the majority of us here are not Mensa candidates, although we are pretty darn good at what we do. So just to give you a little bit more history, so following this -- the failure of the case study, to me, its primary endpoint PFS, we took a very intense look at the data, as we had it at the time, with some of the most notable names in hepatocellular carcinoma research. It appeared to us that there was a relationship between heating dwell time and an improvement in outcome in patients. So what we pursued then not only relied on the data from the study but also, as I pointed out in my prepared remarks, we evaluated this hypotheses and computational models and then a prospect of preclinical models, notably in a pig model. All that took time, to be honest with you. In the meantime, with the company's confidence in this notion that radiofrequency ablation was conducted with an extreme amount of variability. That was not obvious to anyone when the study was -- the HEAT Study was originally conceived. The point I'm trying to get to is that following a failed study, there is an appropriate and a reasonable amount of skepticism around any kind of a subgroup analysis. I think the company has done an incredible job of determining that the potential for ThermoDox to be successful in standardized radiofrequency ablation. They've done an incredible job of supporting that with all the appropriate analysis, scientific investigation, input from the medical community and research community and most recently, with an independent analysis by the NIH. Now getting to your point, so putting all of that together and not getting it published, I think that's probably a major milestone in the company that does not get a lot of credit. But the publication of the HEAT study, if you've read it, focuses a great deal of the narrative on the subgroup analysis and why it's valid and why it's important for the medical community to further evaluate ThermoDox in combination with radiofrequency ablation in the Phase III trial. The publication of our prospective preclinical trials, the publication of the computational analyses. Now after this time, I believe we have earned the right to present information that as I have said, the medical community and the research community get it because they've been a part of all of the work that has been done to assure, this management team and our investors, that the work that we're doing in a Phase III study in primary liver cancer is based on very sound and substantial science. So now -- going forward, I think we've earned the right. We now have not only the results of our research but peer-reviewed journals that have critically evaluated the work that has been done. And now with this information in hand, I believe it's just a matter of time now that the investment community will get it.

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Edward Sherman, [18]

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Okay. If I may ask just one last question. There was, I believe, something intimated by Adam Feuerstein about a chart after the HEAT Study that showed that after 45 minutes, the uptake of ThermoDox basically fell off the map. So that there's no reason to believe that it would be more effective after 45 minutes?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [19]

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Well, I'm not familiar with that and I think our research would suggest quite a bit otherwise. I would refer you to the HEAT Study manuscript publication in CCR and also refer you to our publication on PLoS ONE, Swanson, et al., demonstrating the accumulation of doxorubicin as a function of heating dwell time in healthy livers of pigs. I think that point that you just made would be immediately dismissed.

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Edward Sherman, [20]

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I'm glad to hear that actually. I'm glad to hear that. But if that were the case though, why -- doesn't this -- given that it's a heat-sensitive liposome, why isn't there something that you thought about prior to the HEAT Study, which seemed sort of obvious?

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [21]

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Yes. So well, maybe we should take some of this off-line but it was not obvious. The variability in the use of radiofrequency ablation was not obvious. It was a point of discussion among our investigators and during the prosecution of the negotiation of the SPA with the FDA, we've spent a considerable amount of time on the standard of care and the application of radiofrequency ablation. In newly diagnosed patients with tumors greater than 3 centimeters, it was the opinion of this group that radiofrequency ablation administered according to academic procedures is reasonably consistent throughout the medical practice. And in fact, it turned out not to be. So there was a point of discussion. It wasn't a major oversight on the company's part. What was the major oversight was our lack of knowledge and I think the medical community's knowledge of how RFA was being applied. In fact, I think there may be some embarrassment with the -- when we look back at the HEAT Study data. Because we now know, Edward -- we -- this company, your company, if you ever invested in our stock...

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Edward Sherman, [22]

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And I do.

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [23]

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Now knows more use about the use of radiofrequency ablation in primary liver cancer than any other company on the planet. And that was not true with the -- just when we initiated the HEAT Study.

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Operator [24]

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(Operator Instructions)

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Michael H. Tardugno, Celsion Corporation - Executive Chairman, President & CEO [25]

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So operator, there appears to be no more questions. So I'm going to close the meeting, thank all of you for listening, for your attention and your interest in the company. We encourage questions like Edward's. And for those of you on the line, the next time we get a chance to speak with you via conference call, please feel free to ask questions, particularly those that may be gnawing at you and leading you to accept some information that may not be correct with regards to the company. So with that, again, I want to thank you. We remain very excited on our prospects for 2018. You can count on this management team to keep you updated as we advance our development pipeline and look forward to successful results. Thank you again.

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Operator [26]

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And once again, this does conclude our call for today. Thank you for participation. You may now disconnect.