Jeff Church - Senior Vice President and Chief Financial Officer Mike Tardugno - President and CEO Nicolas Borys - Chief Medical Officer.

Edward Sherman - DSW Associates.

Good morning. My name is Terence and I will be your conference operator today. At this time, I would like to welcome you all to the Celsion Second Quarter 2018 Financial Results 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 go ahead, sir. .

Thank you. Good morning, everyone. And welcome to our investor conference call, to discuss our second quarter 2018 results, which we announced this morning before the market opened. During our call today, Mr.

Mike Tardugno, Celsion’s Chairman, President and CEO will provide an operational update on our clinical programs and I will summarize our financial results for the second quarter ended June 30, 2018.

Today’s conference call will be archived and a replay will be available beginning tomorrow and will remain available by phone until August 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, forward-looking statements can be identified by terminology such as expect, anticipate, believe and other similar expression.

These statements are based upon current 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. No forward-looking statements can be guaranteed and actual results may differ materially from such statements.

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 Mike. .

Thank you, Jeff. Good morning, everyone, and thanks 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 just heard.

As always, we are very pleased that we have the opportunity to update you on our progress and following our prepared remarks to answer your questions.

I want to start this morning by saying we could not be more pleased to report that the company is sound on the fundamentals and with a solid cash position we expect to continue to meet our objectives frankly and with a great deal of confidence. I think it's safe to say that Celsion is well-positioned.

And for those who have been following us, you know that our goals have been consistent and that we have made steady and demonstrable progress towards those ends.

Our plans worth repeating again from last quarterly conference call during which I said that number one, we would maintain an operationally tight focus to ensure efficient cash utilization and timely achievement and development milestones.

Number two we would maintain a strong cash balance sheet with a financing strategy focused on enhancing shareholder value and providing a cash runway to critical inflection points, including data analysis from our phase 3 trial in HCC in our phase 1 portion of our phase 1, two study in ovarian cancer.

And number three that we are committed this company is committed to a steady news flow of key developments. So let me translate for you these objectives into our real life accomplishments. With regards to our second quarter expenses I don’t want you to be misdirected.

We will not enhance the risk on the spending line on the financial section of today's earnings announcement. I want to point out clearly that our cash spending is in line with our budgets and trial enrollment expenses and that GAAP accounting requires us to burden our operating expenses with over $2.5 million of noncash stock option expenses.

Jeff will discuss this more. But I want to say our cash spending is in line with our tight focus, completion of enrollment of the OPTIMA study our global 550 patient Phase 3 study of ThermoDox in newly diagnosed primary liver cancer is in sight and will happen soon, putting Celsion on a glide path to data.

Based on this we expect to see the first interim efficacy analysis it’s a preplanned analysis late in the second quarter of next year. We expect that this analysis will be prognostic and not definitive at the first treatment, important directionally nonetheless, we'll talk about that in some detail later in the script.

Anticipated successor Celsion quotes from consultants to assist with drafting the ThermoDox NDA, it’s not too soon to start. Our experience suggests that this is a 12 to 24 month process door to door from the initiation of the project when we see positive data to the time we submit an application to the FDA.

As we continue to ensure our regulatory pathways is optimized last month we met again in person with the China FDA, the CFDA, we reconfirmed that an NDA for ThermoDox can be filed directly with the China FDA, following positive data. The FDA will grant fast-track and all but guaranteed a six month review and this was a surprise.

They also suggested that response rates would be acceptable as the primary endpoint; this position as I said was surprising that the agency would rather see one, two and three year survival percentages versus overall survival reset the bar for approval in the largest market for ThermoDox on the planet and that’s China.

Quite different from overall survival from what we have seen in the heat study data, three year survival appears to provide a lower threshold for success than overall survival does; potentially further derisking the study.

And we have a lot more work to do with regards to this development and we will keep you posted but it is a very important development that deserves a great deal of our attention.

And finally we’ve begun the process of re-validating the commercial potential of ThermoDox in the U.S., Europe and China; our early work suggests a blockbuster opportunity by any standard or measure.

Now on the Gen-1, our gene-mediated IL-12 immunotherapy, we’ve initiated two of the four phase 1 clinical sites for the OVATION II study; our 130 subject randomized open label phase 1, 2 study of Gen-1 in newly diagnosed advanced ovarian cancer patients.

We expect to announce the first patient anytime now and our initial goal remains unchanged that as we complete phase 1 enrollment for the therapeutic arm before the end of the year. So you can see achievement of development milestones is in line with our tight focus.

We are committed to maintaining a strong balance sheet and in the most non-dilutive ways possible. In June we added two quarters to our operating run rate at very low cost with a recently announced venture loan with Horizon the $10 million four year note is interest only for the first two years and is a good deal for shareholders.

Also in June we applied for the sale of our New Jersey net operating losses which if fully approved will add another three quarters worth of operating runway taking the company well into the fourth quarter of 2020, a point of which the results from our phase 3 Optima study and our phase 1, 2 OVATION 2 study should be well behind us.

I hope you can see and it's clear that our strong balance sheet strategy focused on shareholders’ value, is being implemented.

And last I also trust that you can see the proprietary ThermoDox in general one programs have big meaningful advances, and we continue to expect to announce steady news flow for each of these programs over the balance of 2018 and 2019.

So particularly for those who maybe new to the story I would like to talk now about Celsion's unique value proposition. Celsion has two platform technologies in a clinical stage, one chemo therapy the legacy of ontology and one an immuno therapy the future of oncology.

Both are nanoparticle based, both are being evaluated in newly diagnosed treatment naïve cancer patients and indications of high unmet need populations what we believe the chance for clinically meaningful outcomes not small change but meaningful outcome so the best chance to be achieved.

Both platforms are designed to work in combination with the standard of care, and if we are successful, this approach will provide us with an extraordinary amount of pricing power and the potential for rapid adoption and market penetration.

Our first platform is a proprietary heat sensitive liposomal vessel that can be loaded with a range of chemotherapeutics.

We call the technology ESL lysolipid thermally sensitive liposomes, invented at Duke University we hold the exclusive license to all medical applications of the technology in its current form it's engineered to be administered intravenously.

When it meets with tissue that's been heated just above body temperature, that's above 40°C all the liposome rapidly releases its payload in high local concentration.

That our technology works is in incontrovertible, publications and manuscripts are replete with the evidence and I would encourage you to refer to them if you need information in that regard please check with our investor relations.

Our first drug and applied form is called ThermoDox a name is being conditionally approved by virtually every regulatory agency worldwide. ThermoDox as the name implies is the heat sensitive liposomal formulation of doxorubicin, a broad-spectrum antibiotic that has shown activity in both breast and liver cancers among others.

Our lead indication for ThermoDox is HCC or hepatic cellular carcinoma it's also known as primary liver cancer. And some what I’ll say will be repetitive from earlier conference call but again I think it bears repeating.

ThermoDox is being evaluated in combination rate with radiofrequency ablation, administered for a minimum 45 minutes in the phase 3 optima study this is a global trial being conducted in 14 countries and 17 time zones and in all major markets where hepatocellular carcinoma is a significant problem.

That the final readout of 550 patient studies Optima study powered to detect a 33% reduction in the risk for death.

The evidence supporting the thesis for the Optima study is overwhelming and is based on our understanding of the application of RFA for 3 centimeter and larger lesions and the survival impact when RFA used correctly that is for 45 minutes heating and combined with ThermoDox.

In 285 patient subgroup that was 42% of the entire population from a prior heat study a group that was followed every quarter for 2.5 years many time death in the treatment arm was never reached after 80 months.

That’s more than 7.5 years median survival more than two years better than the control group, again single dose of ThermoDox with properly used RFA in intermediate sized tumors has the potential to be curative now that’s not my word that’s the word our investigators are using when they present this data to their colleagues.

With over 850,000 new cases annually this is the largest unmet medical need in oncology period.

Median time of death for this population has historically been reported in multiple journals as 36 months, although refinement in RFA techniques many of them driven by our prior study with this refinement overall survival is improving globally; in addition to our survival observations the study’s thesis has been tested in prospective preclinical and computational models, manuscripts supporting the basis for the OPTIMA study cover virtually every aspect of our analyses that we’ve published in peer-reviewed journals including Clinical Cancer Research Plus 1 and the Journal of Hypothermia.

Based on this research and our data analysis with the OPTIMA study we believe that we arrived at the best design and protocol to fully evaluate ThermoDox and in fact treating primary liver cancer, HCC and its potential for cure of this very difficult form of cancer. I talked about RFA timing.

So compliance is extremely important and compliance is an important aspect of our quality review of the study, last April for example, the Independent Data Monitoring Committee met to review, among other things, each site compliance with the minimum RFA heating time.

The DMC reported that over 99% of sight declared to the RFA protocol in addition, very importantly, we had some interesting news I presented at the last quarterly call, we learned that the blinded progression free survival from the intent to treat population for the OPTIMA study is so far consistent it’s not slightly better than the PFS that we saw in the subgroup that we see in subgroup population that showed benefit in the HEAT study.

We want to emphasize that the study is blinded and no definitive conclusion can be drawn to point to ThermoDox's performance specifically, we nonetheless view this finding as encouraging and continue to believe that ThermoDox with longer duration RF ablation, can be found to be effective, very effective in treating HCC.

I also want to remind you once again at the request of the Director of Intervention Oncology we provided at the National Institutes of Health with 3 terabytes that’s 3 millions millions of HEAT study data from which they conducted an independent analysis of the intent to treat population a 437 single lesion patients from the HEAT study, the subgroup analysis that I just talked about previously 285 patients, this slice of the data conducted by the NIH independently looked at 437 single lesion patients in that same study.

The NIH concluded that when combined with ThermoDox longer RFA heating trends results in a statistically significant improvement in overall survival. The same is not true for RFA alone. We have ThermoDox longer procedure a statistically significant improvement in overall survival.

These findings were presented at standing room only crowd at the RSNA, that’s the Radiological Society of North America Conference in December of 2016. And there’s more.

Adding to the body’s evidence supporting the importance of sufficient heating time to the delivery of ThermoDox are results from phase 1 trial of ThermoDox that were just published last month in a peer-reviewed journal The Lancet Oncology.

This phase 1 trial was conducted by a multidisciplinary team of five medical engineers, oncologists, radiologists and anesthesiologists at the University of Oxford in the United Kingdom.

The phase I trial evaluated safety and efficacy of ThermoDox along with another heating method some of you may notice focused ultrasound also known as Hyfuels to noninvasive means to use acoustic energy to heat tissues, so ThermoDox combined with focused ultrasound for the treatment of liver cancers.

The study successfully show that ThermoDox, the Oxford team is focused ultrasound technique increased doxorubicin delivery to tumors up to tenfold in many of the patients in this 10 patient trial think the evidence is clear.

On the regulatory front I note that the 14 regulatory agencies from across the globe in all major HCC markets, including Europe, North America and Asia have reviewed and approved the Optima study protocol.

I will remind you that our regulatory strategy is based on these interactions we designed the Optima study to enroll a sufficient number of patients from each country to support registrational filings and market launch in the US, Canada, Europe, China, South Korea, Taiwan and the Philippines, Thailand, Malaysia and Vietnam and the US ThermoDox has received fast-track designation and provides for among other things priority review.

ThermoDox has also been granted orphan designation for primary liver cancer in both the US and Europe, which extends market exclusivity for seven and 10 years respectively in these major markets.

Of course execution is extremely important and on the execution side I’m pleased to report that we have engaged internationally recognized world class contract research organizations and data management teams. The goal is to ensure good clinical practice, ICH compliance, protocol adherence and high quality data analytics.

We also have a proven and reliable supply chain with three redundant contract manufacturing organizations. All are registered and capable of producing ThermoDox in all regions of the world. And I would say a blended price basis providing us with very high respectable gross margins once we are commercial form.

So now as I referred earlier to the interim analyses I would like to give you some guidance. So if you have it pull out your pencil, we expect to complete enrollment shortly as I said, after which the Optima study will be on a glide path to data. The study as you know, and we have said has been designed with two preplanned interim efficacy analyses.

The first will occur at 118 deaths, the second at 158 deaths and if needed the final analysis at 197 deaths.

So I want to put this in perspective for you, the basis for all the stent plan for the Optima study has been the heat study subgroup, that group demonstrated a hazard ratio of 0.65 with the PE equal to .02 but most of us are not statisticians so I'm going to translate that for you, our hazard ratio 0.665 represents a 54% reduction in the risk for death in the therapeutic arm, that's the basis.

Now the first interim analysis to the Optima study will begin successful if it demonstrates a hazard ratio of 0.61, that converts to a 64% reduction in risk for death, now that’s a high bar. Results at this point from this analysis are likely to be prognostic and not definitive.

In other words, we will most probably know than we are on track for success at the next preplanning interim analysis or final efficacy analysis at that point. The second interim efficacy analysis will be deemed successful if it demonstrates a hazard ratio of 0.7 which translates to 42% reduction in the risk for death.

When compared to the HEAT study subgroup it appears that we have a much better chance for success at this point. And if needed the final analysis will be deemed successful with the hazard ratio of 0.7 or 33% reduction in risk for death.

0.75 -- I am sorry or 33% reduction, a much lower bar for success by almost 40% and the 54% improvement on which the plan was based. The final analysis, if needed, will likely be in late 2020 at point of which we’ve been talking about all of our NOLs are approved for sale, at point which we should have sufficient cash to cover that analysis.

So, I think positioned -- well positioned was the where I started this conversation, I think you can see, the company is making a great deal of progress and is well-positioned for the coming next two years. So I want to conclude our discussion of ThermoDox and HCC with commercial opportunity.

We’ve talked about this before with over 850,000 incidents that's new cases of HCC each year worldwide, the addressable market opportunity for ThermoDox is conservatively over 200,000 patients annually with intermediate stage HCC on a global basis the incidence of HCC is growing at 5% annually and recent reports from the CDC, The Center for Disease Control indicated that in the United States the rates of new liver cancer cases grossed 38% over the period 2003 to 2012 and that the death rate from liver cancers increased 56% since 2012.

This is a problem and ladies and gentlemen if we’re right ThermoDox is successful in the OPTIMA study it will be one of the most important new drugs in oncology and the generation if not our lifetime I believe that sincerely.

Now shifting gears to Gen-1 our proprietary gene therapy and in development for localized treatment of advanced ovarian cancer. As I discussed in the last call Gen-1 developed on our TheraPlas technology platform that's a novel immunotherapy, which recruits the immune system to fight malignancies.

Our Gen-1’s active agent is a DNA plasmid coded for a potent anticancer cytokine, that’s an inflammatory protein interlukin-12 or IL-12, IL-12 plasmid is incorporated that DNA’s strand is incorporated into our proprietary synthetic nanoparticle delivery vector, when administered locally into a body cavity like the peritoneum -- the peritoneum cavity, or the bladder or even a cavity created by surgical removal of a tumor mass, these nanoparticles invade surrounding cells and take over the cell’s metabolic machinery, turning each into a little biopharmacy for the sustained up to seven days production of the IL-12 protein.

The first indication we are studying for GEN-1 is in ovarian cancer. For newly diagnosed patients this cancer -- with this cancer there’s less than a 45% chance of surviving five years.

One of the major reasons for this is that the diagnosis is made when most patients have advanced disease it's stages three and four when the cancer spreads throughout the pelvis region.

In previous clinical trials in this patient population GEN 1 has been used either as a monotherapy or in combination with chemotherapy and has shown promising results, most importantly, however, GEN 1 clearly demonstrated scientific activity in clinical benefit in our phase Ib dose escalation study, the ovation one study recently completed.

I want to go over some of the data from the trial with you. Ovation Study evaluated GEN 1 plus neoadjuvant chemotherapy followed by interval debulking surgery in newly diagnosed but treatment naïve stage three and four patients.

The goal of the neoadjuvant chemotherapy I will remind you is to improve surgical outcome by shrinking the tumor masses and drying up the accompanied fluids known as cytis. In this study to the neoadjuvant chemotherapy we added eight weekly cycles of GEN 1. Now the finding and these are small number folks, but the findings are impressive nonetheless.

As I go over a few bullet points with you. Gen1 plus neoadjuvant chemotherapy demonstrated no dose limiting toxicities and is safe up to 80 milligrams per meter squared. Investigators in the oversight committee, that's DSMB did not find any significant toxicities associated with Gen one.

There is clear evidence and compelling evidence of dose dependent bioactivity and efficacy signals. The clinical findings included a partial complete response in 86% of patients in small numbers, but directionally are impressive. The surgeons and all of our PIs in this study are surgeons OB/GYN surgeons.

We’re able to completely remove all visible tumor which is called an R0 resection in 100% of patients treated at the highest dose this is an important outcome because it's clear from the R0 equates to improve our overall survival.

This can be a logical changes in the local disease in the tumor micro environment appear to be pro immune in three quarters of 75% of subjects, and PFS a reported surrogate for survival. PFS is now projected to be over 24 months in the treated per protocol patients. And we still haven't reached a definitive meeting.

Historically, PFS in this patient population is about 12 months. Based on these findings in November 17, we talked about since we announced the submission of the phase 1, 2 clinical trial protocol to the FDA for GEN 1 and for the localized treatment of ovarian cancer.

This is an open label randomized study called the ovation two study will treat the first six patients in the GEN 1 arm at a dose higher than we concluded the prior study at 100 milligram per meter square, followed by continuation at the selected dose either at 100 or 80 mg per meter square in the phase 2 and up to 130 subjects.

The entry criteria and treatment protocol are the same as the prior phase 1B ovation one study with one major addition. And this is important.

So you know that patients are treated with neoadjuvant chemotherapy plus Gen 1 followed by surgery in the therapeutic arm patients will continue to receive up to nine additional intraperitoneal doses of GEN-1, following surgery to be a maintenance treatment.

Our hypothesis is that continuous stimulation of the immune system after surgery may provide a further benefit by delaying progression which again we know is a surrogate for improved survival.

Now I want to give you an update on that study; we have had a few delays most administratively, non-technically and frankly most related to costs, how religious we are about controlling our costs and we negotiate hard, all those negotiations are now behind us; we expected to have three functioning clinical sites in August; and now have two we expect to have all four of the originally planned phase 1 sites by September, we’ll add two more as a catch up for total of six in effort to make up for lost timing, we remain optimistic that we will be on track to initiate the Phase 2 randomized portion of the ovation 2 study in the second quarter of 2019.

Now importantly and I know everyone is focused on data as are we. This will be an open label study we will report data periodically throughout 2019.

Going back to the OVATION I study we continue to follow patients and we currently expect final PFS data from the OVATION I study within the second half of this year, assuming the PFS for the treated per protocol remains strong, we plan to discuss options for accelerating our program with FDA, including a review of our breakthrough designation, on that later.

But the more I look at the data more optimistic I become. So we’re very excited by Gen-1’s prospects and we’re looking forward to both the OVATION I one final PFS readouts in the initial -- in the initiation OVATION II in early -- I am sorry the initial OVATION II data in the coming months.

So I want to conclude by saying we’re looking forward to delivering on our clinical development plans and achieving multiple important milestones over the remainder of the year we are well-positioned with financial resources backed by prudent financial and operational management to achieve our goals.

And now to discuss the financials I’d like to turn the call over to Jeffrey Church.

Jeff?.

Thank you, Mike. Details regarding Celsion second quarter 2018 financials were included in the press release and Form 10-Q made available this morning. As Mike mentioned we continue to make strong steady progress in advancing our two key clinical program and we continue to be focused on efficient cash management to ensure successful execution.

As of June 30, 2018 Celsion’s cash balance was $26.3 million, providing us 6.5 quarters of operating runway, enabling us to continue to focus on clinical and operational execution into the first quarter of 2020.

In June we closed on a four year $10 million venture debt agreement with Horizon Technology Finance Corporation, for which the first two years this obligation is interest payment only and net proceeds from this debt financing are included in our June 30th cash balance.

This debt agreement provides additional flexibility to finance our development programs and operating needs at an interest rate of less than 10% at a very modest warrant coverage.

We are also pursuing other financing initiatives and tools to further bolster our capital position and to finance the company's clinical trials; to that end I am pleased to say that an application to sell our net operating losses based in New Jersey has been expected and on this past Friday, August 10 the Board of the New Jersey Economic Development Association recommended the application for approval.

This avenue of nondilutive financing has made available to us under unique economic development program initiatives by the state of New Jersey and should allow us to receive up to $8 million to $10 million in nondilutive capital from the sale of New Jersey-based NOLs for tax years 2011 to 2017.

Actual amount that we will receive this year will be determined by the state and will be dependent on how the annual report allocated among companies applying, any amounts not used this year can be carried forward. There is the $15 million cap for any one company, so our plan is to continue to use this program until we reach the maximum allowed.

In addition to this, we have a cost-effective warrant free after market facility with Cantor Fitzgerald.

This allows us to be opportunistic with respect to any need for future capital raises, this $25 million ATM facility has been in place for 2012, and there is approximately $11.7 million still available to us, so you can see we’ve not use the ATM to finance the company over the last five to six years, but rather to use it opportunistically to raise between $2 million to $3 million annually.

For the second quarter ended June 30, we reported a net loss of $8.2 million compared to a net loss of 5.2 million in the same period in 2017. For the six months ended June 30, 2018 net loss was 12.7 million compared to a net loss of 10.4 million for the same six-month period last year.

This increase was due to higher patient enrollment in our phase 3 Optima study as we push to complete enrollment in this pivotal trial, also contributing to this increase were higher non-cash stock option expenses as required by GAAP accounting and higher professional fees and personnel costs related to NDA and commercialization preparation and business development initiatives.

Operating expenses were $12.5 million in the first half of 2018 compared to 9.4 million in the same period of 2017. Important thing here is cash, actual cash used for operations in the first six months ended June 30, 2018 was 8.8 million compared to 7.3 million in the prior year these results are in line with our earlier projections.

We expect that cash utilization to decrease in the second half of the year with the completion of enrollment in the phase 3 Optima study and the continuation of a prudent cash management program.

We continue to operate with a lean organizational structure with 25 full-time equivalent employees our spending will continue to be directed to research and development activities.

We expect our quarterly cash usage for operations to be approximately $4 million per quarter about the 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. Our balance sheet and business fundamentals remain strong.

We are committed to executing our financial and operating plans and we have the financial levers to properly capitalize the company for success and drive value for our shareholders. I'd now like to turn the call back to Mike. .

Thank you, Jeff. As always a very nice overview.

Our ThermoDox and GEN-1development programs continue to make significant progress as you can see we remained steadfast in our objective to deliver transformative new medicines for patients with HCC and ovarian cancer, we’ve a number of important milestones ahead in the coming months and I look forward to reporting them to you along with our progress.

This concludes our prepared remarks for today so I’d like to ask the operator to open the lines for your questions and please no more than two to give everyone a chance to ask questions.

Operator?.

[Operator Instructions] The first question comes from Hartaj Singh..

Hi, this is Anna on for Hartaj.

Just on the OpEx side from the non-cash spending that you decided this quarter can you just help us thinking about the R&D spend and whether this is now a reasonable runway going forward into the second half of the year and into next year as well?.

Excluding the non-cash charges, we believe that our R&D expenditures remain on track and in line with our previous guidance somewhere in the neighborhood of 4 million a quarter.

We tend to spend a little bit more in the first half of the year and with the completion of enrollment to the OPTIMA study, we still expect to see our annual spend in the 16 million pretty much in line with the split between R&D and G&A expenditures..

Our next question comes from Edward Sherman..

On the PFS data from the OVATION Ib study are we awaiting the data from the patients who are in the highest dose cohort?.

I think more than just on highest dose cohorts are common..

Yes that’s probably the majority of the patients, that we’re waiting for and that we’re still keeping track of in that last dose but there’s I think there’s a handful more in the middle doses as well..

Okay, thank you.

Does that -- I would think that bodes well for the subsequent trial given the increase in dose?.

Yes I am with you..

Mike you had mentioned back in March that we would be awaiting a publication from the NIH regarding their post hoc analysis any idea when that might come?.

I don’t -- we talked to the NIH just not too long ago Dr. Borys and I and they told us that would be submitting the manuscript here shortly. They did not identify the journal for us so we just rely on their testimony here that they’re submitting their manuscript for publication.

I suspect that they will be done, if nothing else, researchers, particularly those in the academic setting are very focused on getting public attention..

Just one last question, I had a hard time believing that you can still be on schedule given your -- you had stated back in the last conference call that you expected the initiation of the trial within a couple of weeks which most people took to mean the beginning of June we’re now in the middle of August, a patient has not been randomized, almost three months delay how can you expect to be on track?.

So what I said, we would be on track for initiating the phase II portion later next year and I also mentioned in the prepared comments that in order to be able to do that we had planned to conduct the phase 1 portion with four sites, now we’re adding two more sites, so we would be adding a total of six sites to complete the phase 1 portion..

And you think that will make up for three-month delay. .

We have more patients being evaluated for inclusion in the study with an increase in number sites so on order to move to the phase two portion we have treated total of six patients in the therapeutic arm and will be accompanied by probably six patients but it could be fewer, in order to complete the phase 1 portion.

And so with six sites, we expect to be able to able to get that done. I don't have a crystal ball. I can tell you what our operating plans are and what that history has been. .

Okay all right look forward to it, thanks. .

And you should take comfort in the fact that management is recognized at we just, we should manage our cash in combination with the execution and were going to take steps, proactive steps to attempt to catch up if not exceed our plans and study..

No and I appreciate that I just think you need to appreciate the fact that people take your word literally and when you under promise or overpromise and under deliver in a company that has some credibility concerns, you know you can see what happens to your stock. So maybe next time..

Maybe next time what?.

Maybe next time don’t overpromise, don't say two weeks is going to be the initiation when three months pass and nobody knows what’s going on. .

I’m not going to debate it with you, study was initiated in two weeks, we did have sites up and running in June. .

I’m not trying to be combative, I’m just saying. Okay thank you. .

[Operator Instructions] There are no further questions in the queue, I would like to turn the call back over to you speakers. .

So again I want to thank you everyone for joining us on today's call and for your interest in Celsion. As I started this call I want to conclude with the same comments that we continue to make significant progress, we have a strong balance sheet and Celsion as you can see is positioned for success. Thank you again.

We look forward to talking with you on our next conference call..

Thank you ladies and gentleman this concludes today’s conference. You may now disconnect..