Jeffrey Church – SVP and CFO Michael Tardugno - Chairman, President and CEO Dr. Nicholas Borys - Chief Medical Officer.

Jason McCarthy - Maxim Group Keith Markey - Griffin Securities.

Please standby. Good morning. My name is Emily, and I will be your conference operator today. At this time, I would like to welcome you all to Celsion Second 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’d 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 second quarter 2017 investor conference call, which we announced this morning before the market opened.

With me on our call today, Michael Tardugno will provide an operational update on our clinical programs and I will summarize our financial results for the second quarter and first six months of 2017.

Today’s call will be archived and a replay will be available beginning tomorrow and will remain available by phone until August 29, 2017, 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 forward-looking statements can be identified by terminology such as may, should, expects, anticipate, intends, plan, believe, 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 files 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, of course, from whom you just heard, our Chief Financial Officer. As always, we are delighted to have the opportunity to update you on our progress and answer your question.

And for those of you know me you can probably tell from my voice, I am fighting a cold, so please bear with me, we have got a lot to talk about and I'll try to keep the volume up.

I’d like to start by saying once again that our fundamentals are sound, our progress is significant, and our excitement is palpable as the achievement of several important milestones we reported during the second quarter, milestones that continue to drive momentum both in and outside of the clinic.

Our corporate goals remain unchanged and that is to develop novel, innovative, simple therapeutic solutions to address complex unmet medical needs, all the while pursuing long-term value for our shareholders. We do so with a great deal of focus on two primary clinical programs. The first is, the Phase III OPTIMA study.

We’re working to rapidly advance the evaluation of our heat sensitive liposomal formulation of doxorubicin, that’s ThermoDox, for the treatment of newly diagnosed primary liver cancer patients.

With over 850,000 incidents, primary liver cancer or HCC or hepatocellular carcinoma as its known, as you know, is the world's largest unmet medical need remaining in oncology. Our second and equally important work is in ovarian cancer.

Leveraging our clinical development expertise, we've expanded our product pipeline to include the emerging science of immunotherapy. Our novel IL-12, that’s interleukin-12 gene mediated product candidate GEN-1 is now being evaluated exclusively in the OVATION study of newly diagnosed Stage III and Stage IV ovarian cancer patients.

With both these programs treating patients in first line, success with either will establish both the significant advance in medicine and as you can imagine a substantial return to our shareholders.

It’s worth repeating what I said just a moment ago and what I’ve said repeatedly during our prior calls, the fundamentals of our company are sound, without question are sound. Let me give you three reasons to believe.

First, based on the data from 285 patients in the prior HEAT study, a highly de-risked Phase III OPTIMA study of ThermoDox plus optimized RFA, that’s RFA conducted for 45 minutes in newly diagnosed HCC patients is on track and on budget.

The study is being conducted, I might say in a most professional and highly efficient manner with all of the major costs and heavy lifting behind us.

We have active support from some of the most respected researchers and important institutions in the liver cancer world, with over 60 active clinical sites recruiting patients, 14 regulatory authorities from across the globe including Europe, North America, and Asia, and all the 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. We are enrolling patients in line with our budget projections and feel confident that 550-patient enrollment requirement will be met mid next year.

Bottomline, we have less than one year from completing enrollment and approximately five to six quarters for the first look at efficacy data.

We have a proven and highly reliable supply chain with three redundant contract manufacturing organizations, that’s CMOs, 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.

And finally, the study’s independent Data Monitoring Committee just recently completed a preplanned review of the first 275 or 50% of the patients randomized in the trial as of April.

Based on the assessment of safety, data quality, protocol compliance, and trial risk, the DMC unanimously recommended that the study continue without revision, I doubt that the DMC also commended the company for the rate of enrollment in the study with the potential to significantly expand the use of RFA and HCC.

So, with virtually no operational risk and all the major costs behind us, we now look forward to study completion and data readout, and if you believe the many analyses supporting OPTIMA conducted by the company and by others, including an independent analysis of the OS data conducted by the National Institutes of Health, that’s the NIH, and you have to agree that our chances for success in this very important study are quite good.

Second reason to believe is GEN-1 in the OVATION study has shown clear signs of biological activity and is showing early signs, and that’s early -- that that significant trends of clinical benefit.

The Phase Ib dose escalating study evaluating our innovative gene mediated IL-12, that’s interleukin-12 immunotherapy know as GEN-1 in newly diagnosed ovarian cancer patients has completed enrollment with 15 evaluable patients. Clinical findings from the study will be presented by our lead investigator, Dr.

Premal Thaker, Professor of Medicine at Washington University in St. Louis, at the 2017 ASCO Conference. Recently, translational data from the study was reviewed with leading immuno -oncology experts at the Roswell Park Cancer Institute. The translational data has shown that production of therapeutic IL-12 in this patient population is dose dependent.

There appears to be a clear relationship between dose and activation of key elements of the immune system, particularly the cytokine interferon-gamma, the protein responsible for tumor specific T-cell activation and trafficking.

Importantly, early clinical findings appear to tie this translational data with a margin negative resections that are reported in all of the patients treated at the highest dose cohort. Third reason to believe, while we operate with virtually no mistakes or surprises as you know, our cost structure is lean and our spending is efficient.

We continue to operate with a small staff supplemented with highly professional contract research organizations.

Our future spending on average will be approximately $1.3 million per month, that’s approximately $15 million per year to conduct two major clinical studies, global Phase III study that we just talked about in our advance clinical trials in newly diagnosed ovarian cancer patients. I would say it can’t get much better than that.

So to summarize, Phase III OPTIMA study is on track, OVATION is complete, and showing exciting potential for GEN-1, and we have a cost structure, the envy of our industry.

So I’ll guide you that our fundamentals are not sound, we have got a work that is not of significance, because if we are right looking at the potential for $1 billion market opportunities in both indications. Now I would like to go on a little bit more detail starting with ThermoDox.

And just to repeat, the Phase III OPTIMA study is now over 60% enrolled, on track to completed enrollment of 550 patients during the second quarter of next year. Our target population is newly diagnosed HCC patients. The primary endpoint is overall survival. The study is 80% powered to show a 33% reduction in the risk of death.

If achieved, ThermoDox will be -- will represent the only non-surgical curative option for intermediate HCC patients. That’s a single administration of ThermoDox plus RFA, in many cases performed in an outpatient setting, which potentially could be a curative treatment.

The hypothesis for OPTIMA -- the OPTIMA study is supported with statistically significant but not preplan, I repeat, but not preplan statistically significant subgroup data from our prior HEAT study, 701 patient evaluation of ThermoDox in combination with RFA.

The OPTIMA study designed -- is derived from 285 patients from the HEAT study whose single lesion was treated with RFAs standardized for greater than 45 minutes in this large well-bonded, well-balanced subgroup represented over 40% of the HEAT study patients, a group that we followed for over three years, we see that treatment with a combination of ThermoDox and standardized RFA, that’s RFA for more than 45 minutes, provided an average 54% reduction -- risk improvement in overall survival.

The hazard ratio in this analysis was 0.65 with a p equal to 0.02.

Simply put, this translates into a greater than two-year survival benefit for the ThermoDox over the optimized RFA-only group and after 80 months, the median overall survival for ThermoDox group still had not been reached and this population historically, median time to death in this population is about 36 months and our study was 57 months, like the core compare group -- for comparable group treated with RFA for 45 minutes.

Now these conclusions and observations are not hours long. As I mentioned, the NIH conducted independent analysis of all single lesion patients, more than 60% of the study population and concluded that the longer after heating times when combined with ThermoDox resulted in a statistically significant improvement in overall survival.

Now it’s not true for the RFA alone, so the RFA without ThermoDox. So quality measure also reviewed by the DMC was compliance with the minimum 45 minute RFA treatment specified in the protocol, rest about this compliance rate, so I am pleased to report you that there has been 99% plus compliance rate with the specific requirement.

In addition to maintaining our focus on quality, execution of the OPTIMA study, we are also highly focused on the commercial opportunity for ThermoDox which is led by our regulatory strategy. 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 study to enroll sufficient number of patients from which raise the country to support registrational filings in U.S., Europe, China, South Korea, Taiwan and Vietnam among others.

The China FDA, that’s the CFDA and from Celsion in a face to face meeting and if the ongoing Phase III OPTIMA study successful the trial could serve as the basis for direct regulatory filing in China without the need for prior approval in the U.S. or Europe, which is typically required.

This will allow, as I have pointed out before, the company to accelerate its plans for regulatory filing in China and if approved provide for significantly earlier launch date in China than it was originally expected. Why is this important? While China represents, perhaps, most significant market opportunity for ThermoDox globally.

As 50% of the 850,000 new cases diagnosed each year originate in China is 425,000 approximately. Moving to HCC and this -- in that country and this mark future largest market for pharmaceuticals in the world, I would say, safe to say that we are well-positioned.

I’d now like to turn the GEN-1 for little bit more detail here also our immuno-oncology candidate developed on our TheraPlas platform. GEN-1 is a gene-mediated immuno-therapeutic which recruits the entirety of the immune system to fight malignancy.

GEN-1 active agent is a DNA plasmid coded for the cytokine interleukin-12, as we mentioned, IL-12 plasmid is incorporated into a non-viral nanoparticle delivery system, that delivery system known as TheraPlas.

When administered locally into a body cavity like the peritoneum of the bladder or even a cavity that's been created by the surgical removal of a tumor mass, nanoparticles invade surrounding cells and take over the metabolic machinery then turning each cells into a mini factories for the sustained local production of IL-12.

Our first indication for GEN-1 is ovarian cancer, for patients newly diagnosed with advance -- with this advanced malignancy there is less than 45% chance of five years survival. One of the major reasons is diagnosis is made in patients are symptomatic at Stages III and IV with the cancer metastasis.

In previous trials this patient population -- in this patient population GEN-1 has been used either as a monotherapy or in combination with chemotherapy with some promising results.

As indicated earlier, Celsion's first trial in this indication, that’s when we sponsored after acquiring the GEN-1 asset, we called the OVATION study, is now fully enrolled, clinical findings and translational data being analyzed with the final review of all the data by scientific and Medical Advisory Committee in September.

OVATION study enrolled 15 valuable newly diagnosed Stage III and Stage IV ovarian cancer patients, all patients presented with heavy disease burden prior to debulking surgery patients were treated with standard platinum and taxane, the goal of which is to improve surgical outcome by shrinking the tumor reducing the accompanied fluid known as ascites.

Through this regimen we added eight weekly cycles of GEN-1. Following treatment with GEN-1 patient's then receive interval of debulking surgery. So I would like to summarize the early, I can’t say, early, but remarkable nonetheless results that we have seen so far and we will continue to update you with this information as it becomes available.

Of the 14 valuable patients treated in the entire trial we saw 100% disease control rate, 86% objective response rate as measured by RECIST criteria, two patients demonstrated a complete response, 10 patients a partial response and two patients demonstrated stable disease of their cancer.

Of the five patients treated in the highest dose cohort there was 100% objective response rate, with one complete response and four partial responses.

All 14 patients had successful resections with tumors with nine patients that 64% having an R0 resection, which indicates -- R0 indicates a microscopically margin-negative resection in which no growth or microscopic tumor remains in the tumor bed.

Of the five patients treated at the highest dose cohort, all five patients 100% experience in R0 surgical resection, seven of the eight patients 87% in the highest two dose cohorts experienced an R0 resection.

All patients experienced a dramatically clinically significant decrease that was over 90% in the cancer antigen 125 protein that’s CA-125 protein levels as of the most recent follow-up and with the average decline for all patients treated at 97%, remarkable 97%. CA-125 used to monitor certain cancers during and after treatment.

CA-125 is present in greater concentrations in ovarian cancer cells and other cells. Now what clinically significant here is a 50% reduction charges compared to we had over 97% average decline in CA-125 50% reduction is considered clinically meaningful.

Of the seven patients who received GEN-1 treatment over one year ago and are being followed, only one patient's cancer has progressed after almost 12 months, it’s 11.7 months. This compares favorably to the historical median progression free survival of 12 months for newly diagnosed patients with Stage III and IV ovarian cancer.

Of the remaining six patients who have been on this study for over year, their PFS is over 16 months with the longest progression free patient at 22.4 months. So we also just reported the latest translational data for 12 to 15 patients, which indicated convincing evidence of IL-12 for gene transfer and immune system activity.

Data from the remaining three patients will be incorporated in September and reviewed by our Scientific Advisory Committee. A few weeks ago, we reported that translational data was -- this translational data was reviewed with leading immune-oncology experts in Roswell Park Cancer Institute and I will summarize as follows.

The treatment-related changes in immune system activating cytokines like interferon-gamma and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little or no changes observed in the patients' systemic circulation.

We saw pronounced decreases in the density of immunosuppressive T-cell signals like the T-Reg cell like the FoxP3 in PDL-1 and increases in CD8 cells in the tumor microenvironment. The ratio of CD8 cells to immunosuppressive cells was increased by approximately 75%.

It was increased in approximately 75% of patients, suggesting an overall shift in the immune tumor environment from immunosuppressive to pro-immune stimulatory, an increase in the rate of CD8 to immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved overall survival.

These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and promotes a pro-immune T-cell population dynamic in the tumor microenvironment.

More importantly, these distinct immunological changes in the local disease environment appear to translate into clinical benefit and warrant the continued development of GEN-1 as we will do.

Now to summarize GEN-1 and ovarian cancer patients is biologically active, appears to have an immuno-stimulatory effect in the peritoneal fluid in a dose-dependent manner and promotes a pro-immune T-cell activity in the tumor tissue itself.

So our next step in our clinical strategy our following review by our Scientific Advisory Board will be to outline on our Phase II program for GEN-1, which could likely continue in the current population of newly diagnosed patients, although what considering the alternative in platinum resistant patients, but we will make a decision following the review by our scientific advisory group.

Following that, we of course, will submit our protocol for Phase II program with the NDA hopefully before the end of the fourth quarter. So with that, those are my prepared remarks. I will now turn the call over to Jeff to review our financial results.

Jeff?.

Thank you, Mike. During the second quarter we continued to efficiently utilize our cash as we effectively execute our clinical development initiatives. We ended the second quarter with $3.6 million of total cash and investment that included the exercise of outstanding warrants during the second quarter totaling over $5 million.

Subsequent to the end of the quarter, this was in early July we announced the completion of the $5 million registered direct equity offering with several institutional investors.

This capital infusion should cover operating needs for the balance of 2017 at which time we will be less than six months from completing patient enrollment in our pivotal Phase III study in primary liver cancer and about four quarters from the first planned interim efficacy analysis.

This significant very inflection for the company is now coming into view. Celsion's 2017 second 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 June 30, 2017 was filed on Monday, August 14th, after the market close.

We continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value. Our clinical development focus is squarely on the enrollment of our pivotal Phase III trial for ThermoDox in primary liver cancer and the earlier phase studies for GEN-1 in ovarian cancer.

Operating expenses were $9.6 million in the first half of 2017, compared to $10.2 million in the same period of 2016. Cash used for operation in the second quarter ended June 30, 2017 was $4.2 million, compared to $4.3 million in the prior year.

Cash used for operations in the six months ended June 30, 2017 was $7.3 million and that compared to $9 million in the prior year. 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 mentioned above, and prudent cash management.

Also during the second quarter, we paid off our venture debt facility with Hercules. The company currently has no debt on its balance sheet. We continue to operate with a lean organizational structure, which now has less than 20 full-time equivalent employees. Our spending is directed to research and development activities.

We expect our current quarterly cash used for operation to be under $4 million per quarter for the balance of 2017 and 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 product programs.

For the second quarter ended June 30, 2017, we reported a net loss of $4.9 million, compared to a net loss of $4.5 million in the same prior year period. For the six months ended June 30, 2017, our net loss was $10.1 million, compared to a net loss of $10.2 million for the same six month period in 2016.

We continue to evaluate organizational structure and have aligned our resources and clinical programs with our near-term development objectives. R&D costs were $3 million in the second quarter, compared to $3.3 million in the same period last year. R&D costs for the first six months of 2017 were $6.5 million, compared to $6.8 million last year.

Our research and development expenditures in the current year are focused on continuing the enrollment and treatment of patients in the Phase III OPTIMA study and completion of enrollment and follow-up of the patients in the Phase I OVATION study using GEN-1 to treat ovarian cancer.

General and administrative expenses for the second quarter were relatively constant when compared to the prior year by $1.6 million this year compared to $1.5 million last year. G&A expenses were down $300,000 in the first half of 2017 when compared to the same period in 2016.

This 10% decrease was primarily the result of lower personnel and operating costs resulting from the reorganization and staff reductions announced in 2016, lower insurance premiums and professional services costs and a tighter clinical focus on these programs that will drive shareholder value in the near-term through the readout of our pivotal Phase III OPTIMA study.

Other non-operating expenses increased by $530,000 in the second quarter and $330,000 in the six-month period ended June 30, 2017, primarily as a result of a non-cash, I want to emphasize, non-cash adjustments to our earn-out milestone liability. This was offset by lower interest expense on our venture debt facility with Hercules.

As I mentioned earlier, this loan facility was fully paid off in June 2017. The second quarter of 2017 also included a deemed dividend charge related to the re-pricing of certain outstanding warrants during the month of June.

As I mentioned earlier, the company received over $5 million in gross proceeds from the exercise of warrants during the quarter, included in this total are approximately $1.3 million warrants which were re-priced and then immediately exercised which yielded over $3 million in gross proceeds to the company.

These warrants were previously registered and were included in our fully diluted capitalization. I will now turn the call back to Mike. What the hell happened here..

Sorry, I was -- we were on mute..

Thank you..

Yeah..

Okay. Thanks..

Okay. So I'll just repeat, just the concluding remarks. Phase III OPTIMA study is on track. OVATION is complete and showing exciting potential for GEN-1. As Jeff points out, our cost structure well-managed and the NVA, I would say, the NVA of our industry, we are looking forward now to continue our work.

So, with that, I'd like to open the lines for questions. Operator, if you would and I would ask those on the line if you limit your questions to no more than two, so that we can provide everyone an opportunity to participate in the Q&A.

Operator?.

Thank you. [Operator Instructions] And we will go first to Hartaj Singh with Oppenheimer. Please go ahead..

Good morning, Hartaj..

Hi. Good morning. This is Emma [ph] on for Hartaj, actually..

Hi, Emma..

With regard to GEN-1, I think, in the past there was some interest in evaluating its potential in a post surgery setting to delay or prevent the tumor recurrence occurrence.

Could you just give us any update or color on the latest thinking there and how that might fit into the clinical development plan?.

I am sorry.

I just missed the first part of your question, could you just repeat that, please?.

Sure.

So on GEN-1, you had mentioned in the past that there was interest in evaluating a potential in a post surgery setting to delay or prevent tumor recurrence, could you just update on the color or latest thinking there on how that might fit into the clinical development plan?.

I see. So as a maintenance therapy, I mean, following surgery continually to treat patients.

Yes, Nick, do you want to?.

Well, as you know, there’s plenty of roles for immuno-therapeutic therapies and we are looking for the ideal fit for GEN-1, so in this last set of clinical studies that we've done, we are now looking at -- in this new adjuvant setting where we have the tumor at the time of enrollment of the patient, we get the biopsy of the tumor, and then we get follow-up on the patients once the tumor has been removed in that interim surgical setting.

So I think at the end of this, we are going to have a pretty good idea where it is going to be the strong points for GEN-1, and the effect it directly has on the tumor. So, I think, again the message here is watch the space and I think there might be an interesting world there..

Yeah. I think, if I just could add something, in reading in the recent JCL, some -- an article regarding some of the stem cells like the pre-cancer, like cancer related stem cells that go untreated like chemotherapy and they seem to find a way to continue to evade the immune system from the source of metastasis.

There is some suggestion here that immunotherapy and maybe GEN-1, maybe one of those therapeutics that has the potential to address those cancer-related stem cells that go untreated when the primary disease is then addressed. So that will be a part of our discussion with the Scientific Advisory Committee in September..

Okay. Great. Thanks, Nick and Mike..

Thank you..

[Operator Instructions] And we will go next to Jason McCarthy from Maxim Group. Please go ahead..

Hi, guys. Thanks for taking the question.

Two questions, one, first off, Mike, you are saying, you are about 60% enrolled of the 550 patients now and you are on target for second quarter ‘18 to complete enrollment, could you just review with me the timing for completion of enrollment and after that when would you expect the first interim look at the data?.

Yeah. Good question. Thank you. So over 60% enrollment, 60% of 550, you could do with your counsel as 530 patients, more than 530 patients quite a few more actually. Our enrollment rate target has been exceeded actually in the last three months.

We have been planning about 18 patients a month to over 20 patients a month, and you can kind of do the math yourselves. If that continues, Jason, we should be in the middle of the second quarter next year completing enrollment on the study and it could even get better. Nick Borys has been very anxious. Dr.

Borys has been very anxious to initiate few more new sites, we have commissioned our CRO in Vietnam to add two more sites and we are working with the Chinese CRO, who is attached to our global CRO to add five more sites in China. So there is every reason for us to believe that the enrollment rate can pick up.

So we are actually quite pleased with where we are at, after actually experiencing an over one year delay in getting study approval in China, of course, we weren’t the only one, the entire world waited for China to reorganize the CFDA to accept new protocol applications.

So the death rate is really what -- and that's a horrible way to think about it, I guess, but the event rate is key to the first interim data look, first interim look will be at 118 events, Jason. We are looking for about a -- hazard ratio of about 0.62, I believe, p equal to 0.052 to unblind the study.

The data that supports that, of course, comes from the HEAT study in this very similar population, not as well-controlled as we're controlling in, I would say, in the OPTIMA study or the -- this patient population treated with more than 45 minutes saw hazard ratio of 0.65 p equal to 0.02.

There is an all time chance here that at 118 events, we would be quoting success. If not, we have -- as you know we have a second interim analysis followed by the final analysis. So the question was when will we get that first look. Obviously, the DMC meeting was just recently completed.

We know the number of events, I am not going to share them in this call, the numbers of events are valuated based on the enrollment rate, our statistician gives us the prediction of when that 118 number will be hit in.

So our thinking here, our best thinking here is about two quarters following full enrollment of the study, that could change, but we will give you an update in the next quarter based on, we will have actually, I think, a former handle on the number of events in the next quarter, so that's our best thinking at this point, Jason..

Okay. Great. Thank you.

And just the split between China and the rest of the site, how many patients were Chinese based patients, the need for China FDA to allow you to file there?.

Yeah. So the official line on that is 200 patients, 100 pairs of Chinese patients. And we are recruiting patients in Hong Kong, Mainland China and in Taiwan. Although, Taiwan has been the subject of some political discussion, apparently Taiwanese Chinese are not China -- Chinese in some halls of the CFDA.

That being said, we had a very productive conversation with the Deputy Director of CDE of the CFDA interoffice, Dr. Borys and I. Nick gave an overview of the study.

We were trying to achieve in those and actually focused on the China population -- Chinese population from the HEAT study and their comments to us were I think very not only surprising, very supportive.

She indicated that our -- since this is such a health emergency in China that we will not have to wait for a, if the study successful, if we hit our endpoints, we will not have to wait for the CPP from either the U.S.

or Europe, which is typically required before filing an NDA we could file immediately, that was I think a blockbuster comment from here. She also indicated that the 200-patient requirement was under review and so we'll no more, I think, here in the next month or so.

We intent to, Nick and I, along with some others will be in China in September to meet with our investigators as we do annually and we want to take some time to try to sort this out a little bit more.

But 200 patients is the official line we understand that’s evolving and it may -- we may be allowed to include Chinese patients in from other countries like Taiwan, certainly from Hong Kong..

Okay. Great. Thank you, Mike, for taking the questions..

Thank you..

And we will go next to Keith Markey from Griffin Securities. Please go ahead..

Good morning..

Hi, Keith..

Hi..

Okay..

Two questions..

Sure..

One, I was wondering, if you have -- if any of the GEN-1 patients that had R0 resection had progressed with their disease or are those patients still disease stable, I guess, are free?.

The answer is….

As far as we know all the R0 patients are still have no evidence of disease. So we’re following them very carefully on that..

Keith and progression in this population is really interesting.

When we discussed PFS with our study investigators, they suggest to us that we should expect the normal distribution like a [inaudible] (41:27) and that would mean, for example, some patients will progressive after two months, some patients will progress after six months, some patients nine months, some patients 12 months, 15 months, 18 months, 20 months, then you get the median is 12.

In our -- we have not seen any progressions at the -- at any early March. The only progression we have is that just about 12 months and rest of the patients not treated over 12 months, as I pointed out. This whole thing is skewing to a positive PFS result. Now that -- certainly that could change and I don't want to get ahead of myself here.

But and if it does, of course, we will be a very fairly open about it. But PFS leading indicator of overall survival is very encouraging at this point..

Okay. Good. Thank you.

And then, I was wondering, if there might be any news from the NIH about the HIFU study they're doing?.

Will end at the Children's Hospital..

Yes..

Yes. Yeah. I think, I reported on that one and this has just been a pep project for Dr. Borys. We have been very excited about it and for frankly, I -- it’s unfortunate that I have to report to you that we have -- we are not aware of any patients we have enrolled in this study..

Okay. Thank you..

Thank you..

[Operator Instructions].

Okay. Well, I want to thank everybody for your time this morning. I apologize again for the quality of my voice, hopefully in get over this cold pretty quickly.

And just again to conclude, we remain excited, not remain, we are very excited about the potential for both these programs in chemotherapy, this legacy of oncology with our innovative product ThermoDox.

Finally, are excited -- we are excited about the NIH our investigator, so world is looking for to the results of this ThermoDox study in primary liver cancer.

And in immunotherapy, where we are seeing some early and trends, we do not overstated, but early -- nonetheless, remarkable clinical findings so far in our Phase I program moving quickly to Phase II once our Scientific Advisory and Medical Advisory group meeting in September.

And all of that, we value your continued support and we thank you very much for joining us on the call. Our promise to you is that we will keep you updated and I'll promise also is to continue to work to deliver innovative oncology therapeutics to address some of the most important prevalent cancers at the highest unmet need.

Thank you again for joining us on today's call. And with that, adjourn the telephone call. Thank you..

Ladies and gentlemen, that does conclude our conference for today. Thank you so much for your participating. You may now disconnect..