Imunon Inc (IMNN) 2010 Q2 法說會逐字稿

Good morning. My name is Jake, and I will be your conference operator today. At this time, I would like to welcome everyone to the Celsion Corporation second-quarter 2010 earnings conference call.

All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions).

I would now like to turn the call over to Ms. Marcy Nanus of the Trout Group. You may now begin.

Thank you. Good morning everyone. Thank you for joining us. Our second-quarter results were released this morning and are available on the SEC's EDGAR system and on the Company's website.

Today's call will be archived. A replay will begin today at 3 p.m. and will remain archived until August 10, 2010. The replay can be accessed at 877-870-5176 or 858-384-5517. The conference ID is 1474955. The call will also be available on the Company's website at www.Celsion.com for 30 days after 3 p.m. today.

Before I begin the call, we wish to inform participants that forward-looking statements are made pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties, including without limitation unforeseen changes in the cost of research and development activities and clinical trials by others; possible acquisitions of other technologies, assets or businesses, and possible (technical difficulty) competitors, regulatory authorities and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.

With that, I'd like to turn the call over to Mr. Michael Tardugno, President and CEO of Celsion Corporation. Michael?

Thank you Marcy. Good morning to all. Thank you for joining us and for your continued interest in Celsion. I'm joined today by Jeffrey Church, our Vice President and Chief Financial Officer, and Timothy Tumminello, Celsion's Controller and Chief Accounting Officer. Dr. Nicholas Borys, our Vice President and Chief Medical Officer, who is usually here with us for these calls, is traveling today. He is en route to Vancouver which, as you may know, is the site of one of our more important trial sites.

We are delighted to be with you this morning to update our progress and answer your questions since our last conference call. As noted in our public announcements, your Company has made much progress.

For today's call, Jeff will provide comments regarding our second-quarter results, including a high-level review of the P&L and balance sheet, following which I will cover a number of topics, including our progress on our global Phase III liver cancer trial and an update on our Phase I/II recurrent chest wall breast cancer study. We'll then have time for questions.

Before getting started, I want to officially introduce Jeff and welcome him to his first conference call. Welcome Jeff.

Thank you Mike.

Jeff joins us from Alba Therapeutics and brings more than 30 years of experience in corporate finance, mergers and acquisitions, investor relations and SEC reporting. He has worked in both private and public clinical stage life science companies. His time with Wall Street and on strategic corporate issues will serve us well as we move forward.

I have a few comments before Jeff reviews the second-quarter financials. First, I want to thank all that attended our annual shareholders meeting either by phone or in person a few weeks ago. I trust that it was worth your time. For us, our board, the management team and me, I have to tell you that meeting you in person is always invigorating. We value the suggestions, questions and input that come from your attendance. Over the last three years, meeting participation has grown, and so has your support for our marvelous technology and therapeutic focus. I would encourage all shareholders to join us at next year's event.

Again, I want to recognize Celsion employees for their commitment and all of their hard work. We continue to make impressive strides in our clinical programs, preparations for regulatory submissions and commercialization of ThermoDox. I commend them for their reference. Every day I am reminded of what a pleasure it is to be part of this team.

On another note, we made an important announcement with regard to our Board composition. I'm pleased to report that Robert Hooper has joined the Board. Bob brings a great deal of experience to Celsion. His time with Abbott as President of Australia/Asia and as President of IMS North America will serve us well as we consider our commercial plans for ThermoDox. I know he will be a worthy steward for our shareholders and good counsel for management.

On another note, after consideration of his personal and professional obligations, Dr. Gary Pace has resigned from our Board of Directors. Gary, as you know, has been a strong advocate (technical difficulty) (inaudible) been instrumental in Celsion's re-emergence as a drug development company. But we are not losing him completely. He has agreed to an advisory role from which I am sure that we will continue to benefit. We thank him for his dedication and service to our extraordinary mission.

Now, I have a few comments on the financials and financing. Our second-quarter spending is somewhat higher than planned, most of which is associated with timing of ThermoDox manufacturing and actions taken to accelerate enrollment in both of our clinical trials and a few other one-time expenses. That said, we believe our cash balance has the immediate effect of funding current operations through 2010. That includes our Phase III HCC study and our Phase I/II recurrent chest wall breast cancer study. We'll continue to be judicious and cautious with expenses, as we have always been.

As for our future financing needs, our strategy and approach remain unchanged. We will only seek to find the most non-dilutive means to raise capital, including commercial licenses for ThermoDox where the terms are attractive and represent long-term value for the Company and our shareholders. In that regard, we continue to believe that a second license agreement for ThermoDox will be completed in 2010. We will always look for [events] that have the potential to minimize dilution or that can be accretive in order to enhance shareholder value.

When and if we do need or decide to raise capital, our recently announced $15 million equity financing facility set a basis for terms. As Celsion elects or if Celsion elects to use the facility, the number and price of shares sold in each draw is at a pre-negotiated attractive discount, as we reported, between 5% and 6% depending on our market cap. The cost of the transaction is exceedingly low. A placement agent receives a fee of 1% to 0.5%, depending upon the amount of cash that we draw, as opposed to the 5% to 6% typical fees for bankers and legal costs. All in all, this equity line provides us with a financing option at a very competitive cost of capital with no warrants, I might add, and should strengthen our position in licensing and future financing activities.

Financially, we are well positioned with a promising, potentially one of the most significant new drugs, arguably for the largest unaddressed cancer in the world. In the meantime, however, your company will continue to progress its research programs and will work to make sure that [news] (inaudible) properly reflects our accomplishments and advances in bringing ThermoDox to market through the rigor of well-executed clinical programs in a well-defined regulatory pathway which, as you may know, has been established with FDA through an SPA for our Phase III trial and with written agreement for a pivotal study for our recurrent chest wall breast cancer study.

Now, I'd like to turn it over to Jeff for the second-quarter financials. Jeff?

Thank you Mike.

Our second-quarter results reflect the significant progress in the development activities for ThermoDox, both in the clinic, with our Phase III HCC pivotal trial now over two-thirds enrolled, as well as on the manufacturing front with the qualification of a second manufacturing site to support our future regulatory submissions.

Celsion reported a net loss of $2.6 million for the second quarter of 2010, compared to a $4.6 million loss for the comparable period in 2009. This decrease is primarily due to a $1.8 million change in the fair value of the common stock warrants issued in connection with the registered direct stock offering in September 2009. Excluding this non-cash item, the Company's operating loss for the quarter was consistent with the prior year, as costs associated with the 600 patient Phase III HCC trial was slightly higher than last year, offset by lower costs for the RCW trial due to the utilization of internal resources during the current year versus an outside CRO last year.

Celsion reported a net loss of $8.8 million for the six-month period ended June 30, 2010, compared to an $8.2 million loss for the comparable prior-year period. This increase is, again, due to higher costs associated with the HCC trial as new clinical sites and new countries were added to the clinical development program.

Cash used in operations totaled $6.8 million during the first half of 2010, or approximately $1.1 million per month, resulting from numerous activities undertaken to enhance enrollment in our HCC trial. We believe that the additional sites added to the trial during the first half of the year, coupled with other outreach efforts to our clinical sites and principal investigators, will help ensure the completion of enrollment by the end of the year. These one-time expenditures are expected to pay dividends in the second half of 2010. We expect our monthly use of cash to approximate $1 million per month over the remainder of 2010.

The Company ended the quarter with $5.7 million in cash and investments, which should be sufficient to fund operations to the end of 2010. The Company has a $50 million shelf registration statement in place that allows us to issue any combination of equity securities to fund future development costs.

As Mike discussed earlier, in June 2010, the Company entered into a committed equity financing facility, or CEFF, with small-cap biotech value fund to sell up to $15 million of common stock over a 24-month period at a predetermined discount of between 5% and 6%. The CEFF adds another important leg to the Company's financing strategy moving forward. It provides an important backstop to enhance our other options for raising additional capital, that is through a strategic collaboration or licensing transaction with a third party or through the sale of stock.

I will note that the Company has successfully completed an important licensing transaction for ThermoDox in the Japanese territory with Yakult in 2008. The Yakult transaction provided an upfront payment, reimbursement or sharing of development costs and commercial-based payments in the form of milestones and royalty payments, and demonstrated our ability to execute on this important business strategy. We will continue to balance our need for capital against the timing of events discussed above with the goal of enhancing shareholder value.

At this time, I will turn the call back to Mike.

Thanks Jeff. Before I get into progress on our clinical studies, I want to report a very recent event. Late yesterday in an ASCO special article published in the JCO HEAT study was named as a priority trial by the NCI clinical trials planning committee. As such, we join the ranks of Merck, ImClone, Bayer, and other large pharma companies. The NCI -- the implications of this are the NCI/NIH will not fund the competing studies in our area of interest. We will have more on this later today in a press release, if it's not already gone out. I suspect that we timed the release to try to coincide with this conference call. So you may be able to view it right now.

Now, I'd like to update you on the HEAT study, our global Phase III primary lower cancer study which is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation, when compared to radiofrequency ablation alone. Radiofrequency ablation, as we reported, as you may know, is becoming the global standard procedure for non-resectable disease. I think that is pointed out also in the JCO manuscript.

We continue to make much progress. Enrollment is over 67% now as of this reporting. Over the last quarter, we enrolled approximately 0.8 patient per day. The recent trend is slightly better as approaching now one patient per day. I can report to you that we have a healthy backlog in patients that passed screening and are [eligible] to be treated. That typically happens within a week after being identified. Our target to complete the enrollment in the study is between 35 and 36 patients a month, so we have a little bit more work to do. Continuing improving enrollment is a singular focus for the Company and a commitment that's made by every member of the management team.

I am pleased to report the following. The HEAT study has been expanded to include 75 investigational sites, now in 11 countries worldwide. We hope to have one more additional site in Italy by month's end; that will take us to 76 investigator sites. That will conclude our expansion of the Phase III trial program.

I just want to remind you and as you may recall, when we initiated this Phase III trial, we had planned on 42 sites, recognizing very early on that, in order to efficiently enroll the study and within a reasonable timeframe, your management team quickly repositioned the trial. We changed CROs and expanded our footprint into three additional Southeast Asian countries, the goal of which is of course is to make sure that we are bringing the trial to investigator sites where primary liver cancer or hepatocellular carcinoma is a disease that of significance and, in doing so, make sure that we complete this trial on a timely basis. Achieving and managing this number of sites, as I've mentioned to you in the past, is no small feat.

I want to also remind you that our CROs are financially aligned with the enrollment progress. In some cases, our CROs are penalized for failure of meeting enrollment targets. We believe this is a fair, albeit unique arrangement with the CROs, so we have the intention of the entire management team and our primary CRO to assist us in assuring that we are using every means at our disposal to bring patients into our trial as quickly as possible.

Another point on the trial is, in addition to the US, the HEAT study is designed with a concentration of sites in countries where hepatocellular carcinoma is a serious problem, including China, Japan, Taiwan and Korea. As I've said in the past, our goal is to enroll a study cohort in each of these countries sufficient to support registration, avoiding the need for a separate local study that's typically required for foreign country drug approval. The strategy, I'll remind you, provides Celsion with the fastest path to approval in markets where ThermoDox may provide a life-saving treatment option and certainly provides, if we are successful, early access to significant market opportunity.

So August will be a very important month for us. We have a full court press, if I can give you that kind of metaphor in China. Our clinical team plans to meet with virtually every investigator as possible in that country.

Our goal is to encourage enrollment as a primary objective, and also to assure that data quality is nothing less than perfect. In that regard, to ensure there are no surprises with data or with protocol compliance, we've completed a rigorous audit, as I promised you we would at our highest enrolling sites. Again, assuring data entry and accuracy is a very important part of making sure that our trial (inaudible) is not only completed in a timely basis, but that the data that comes from the trial is in a condition that it's immediately useful and submittable to the various regulatory agencies.

Last, as we reported earlier in a press release, our DMC, our independent DMC, has reviewed unblinded data from approximately 300 patients. It has found no safety issues, as we suspected it would -- would not -- and has recommended study continuation. I can also report to you that progressions, the events that are associated with our accelerated end point, progressions are tracking well against our model, our modeled expectations for progressions to occur at this stage in the trial.

The DMC has also recommended continuation of the Japanese cohort after a specific focus on a safety review of the 12 patients that were presented to the DMC. The safety review is a specific requirement of the Japanese TMDA and we are delighted to have that recommendation from the DMC as it allowed us to restart enrollment in the Japanese investigator sites following the DMC meeting.

Looking forward, we can expect the following. Assuming the historical data is reasonably predicted, once enrollment is completed in our Phase III trial, we should enough progressions at 380 events to be able to determine ThermoDox's efficacy as an adjuvant RFA within 12 to 16 months following the last patient entered.

On another note, the DMC will conduct an interim analysis once the study has enrolled 60 patients and has -- 600 patients, I'm sorry -- and has reached 190 events. These two events could happen in nearly the same timeframe.

The review blinded to Celsion will include a safety efficacy and futility analysis. We will report on the results of that in general terms, I'm sure as we have in the past, following DMC meetings when that information is available.

Now, I'd like to turn to our recurrent chest wall breast cancer program. Our pivotal DIGNITY study is now enrolling patients at seven sites, NYU, Saint Barnabas in New Jersey, Rhode Island Hospital, Florida Cancer Institute, Virginia Commonwealth University, University of California San Francisco, and Washington University.

Now, on the good news front, we've seen a pickup in enrollment. By no means have we completely cracked the enrollment code. As it appears now, we will continue to project that enrollment will extend well into 2011. We are now treating at the 50 milligram cohort and expect to complete the Phase I portion of this trial this quarter. Assuming no dose limiting toxicities, 50 milligrams per meter squared will be declared the maximum tolerated dose for the remainder of the study.

I would also like to remind you -- and we issued a press release on this -- that the study data will be presented by [Bridget O'Connor], our investigator at the Rhode Island Hospital at the ASTRO conference in November.

As I said on our last call, we have made contingencies related to slow enrollment. Due to the challenges of patient recruitment, we are looking at other options to open the trial to other superficial disease such as melanoma and sarcoma, should we not gain traction in enrollment. We'll have more on this after we review the data from our Phase I trial and assess enrollment opportunities later at the end of this year.

Moving on to our HIFU program, HIFU plus ThermoDox, evaluating the combination treatment to treat other difficult diseases. Our initiative has shown some encouraging data from preclinical studies are sufficient to support an IND amendment which we hope to file later this summer. The first indication that we are interested in evaluating this very innovative and important combination of therapy is in metastatic bone cancer. We will be announcing the acceptance of the IND amendment as soon as we are comfortable the agency has reviewed the documentation and once we have concluded the final financing discussions with our partner in this enterprise, Philips Healthcare.

Now, I'd like to outline what we see as milestones ahead for the balance of 2010. Our target is to enroll 600 patients in our Phase III HCC trial. We expect to complete the Phase I portion of our RCW trial and then consider the best way forward for a Phase II in evaluating ThermoDox, either in continuing in RCW patients or in evaluating ThermoDox in superficial cancers. We expect to initiate a Phase II colorectal liver meds trial as a follow-on to our Phase III HCC trial. Lastly, we continue to believe that a second license agreement for ThermoDox will be negotiated with the execution of the deal in 2010.

The last thing, I want to note that we are presenting at the Collins Stewart Healthcare Conference in New York next week and at Rodman & Renshaw in September. I extend an invitation to all of you who are in attendance to meet with us. We do look forward to meeting you at these events.

Now, in closing, I'd like to say that our strategy is clear, our execution is showing results on all fronts, and we are working hard to deliver milestones against our extraordinarily aggressive targets. (inaudible) stable and focused, we have sufficiently funded the ThermoDox program through major pivotal events and through the end of the year.

Now, with that, I will go on to questions. I would like to ask that you limit them to no more than two. So operator, if you would please, let's open the line for questions.

(Operator Instructions). Mark Monane, Needham & Co.

Good morning. Thank you for taking my question, and congratulations on the acquisition of Jeff Church and the new board members.

Thank you so much.

A couple of questions please, as allotted by the powers that be. One has to do with the timing of the interim analysis. While it's been challenging we know to finish the completion of enrollment, the patients most likely who are enrolled will continue to progress. The question is, does that set the stage of the interim analysis maybe even coming before the end of enrollment, or extremely proximal to that event? Does that makes sense, can you go over [price]?

It does. You outline a scenario, Mark, that has some potential, that being that we have 190 events before enrollment is completed. Our SPA, however, requires that both enrollment be completed and 190 events be achieved before the interim analysis is conducted.

That's a helpful clarification, we look forward to that. Then the follow-up -- it's a cloudy and murky day here in New York City. Such is the unfortunate prognosis for many of these patients with primary liver cancer. The trial was started a while ago with a given standard of care. Do you feel that the standard of care has changed at all in liver cancer since the beginning of the trial?

Well, the standard of care for the population defined in our study are just broadly, Mark.

In the study specifically, I guess the question being how -- you start off with a great premise on the unmet need in the area. Do you believe that premise is still valid? What do we know about the target population treatment options?

Yes, well, we believe not much has changed for the population defined in our trial. We do know that [Sarafinid] was approved or about the time we initiated our trial. Of course, that's for advanced stage disease. But I think -- I will refer you to this ASCO publication in the JCO. As a matter of fact, I believe I can forward it to you. I think my comments are supported by this manuscript that nothing has changed in the standard of care.

I would suggest other than that RFA as a procedure has grown in importance in treating non-resectable disease, which bodes well for us. Its adoption in the developed countries is well-documented. Through my last look at it, which was about a year ago, the growth in popularity of this procedure, that's a way to say it, was double digits, in some countries as much as 30% increase in utilization for these intermediate stage patients. We are seeing an adoption in China and other Asian countries at a rate that appears to be similar to what the rate was a few years ago in the developed world.

So all in all, I would say, if anything has changed, it's the increasing use of radiofrequency ablation as opposed to some of the other procedures that were used for these intermediate patients, for example taste and PEI, for seeing radiofrequency ablation as being supplanting those procedures on a numerical basis.

(inaudible) information and we'll look forward to the upcoming events.

Thank you so much, Mark, and thanks for your support.

Keith Markey, Griffin Securities.

Good morning Mike. Thank you for taking my questions. I had just a couple. I was wondering if you could tell us if there are any major markets in which your trial is not being conducted, and if you could run through the scenario as in terms of the estimated time that your trial will be completed, and when you might actually be able to file in the major markets that you're targeting. Thank you.

A good question. So when we originally conceived the study timelines, we were very aggressive. Our assumptions would've suggested that, by the end of 2011, that we would be in a position to submit our NDA. That slipped some. So for the NDA submission in the US, our expectation now is that early 2012 completed NDA. Assuming that we obtain fast-track agreement with FDA, which we have every reason to believe we will, our expectation is to begin a rolling submission, including the preclinical and CMC modules.

So just to give you a little bit more color there and I think related to your questions, assuming we complete enrollment by the end of this year, the historical data would predict events, the 380 events that's required for an analysis of the data, anywhere from 12 to 16 months following the last patient, so that would bring us into early 2012 for data -- for the complete data set and the read on an accelerated end point.

Now, with regards to the first part of your question, are there any major markets that we are not in -- I can -- there are in fact. We are not in India, for example. That's a major market. There are some limitations in India with the use of radiofrequency ablation, (inaudible) reimbursement and with -- my sense is with -- at least as we understood it two years ago, with conducting a trial to the standards for the required by ICH and GCP. So, we elected not to conduct the study in India as a result. Does that answer your questions?

Yes, thank you very much.

(Operator Instructions). At this time, there are no additional questions in the queue. I will turn the call back over to our speakers for closing remarks.

I'm just going to pause one more minute just to see if there's any last questions that show up.

(Operator Instructions). [Vincent Dempsey], private investor.

How are you doing? I've got a question in terms of the possible partnership or however you want to phrase it. Can you flush it out a little bit because I don't quite see what is involved there.

Flush it out from what -- there's just so much we can talk about with regards to these kinds of activities. Most discussions related to and interest in the license are conducted under confidentiality agreements. But the process for establishing a license, particularly if it involves multiple countries, is one that involves quite a bit of due diligence, market analysis, understanding of our clinical program, regulatory pathway, and the like. There's usually a very deep dive into the underlying science, the manufacturing and CMC related information, as well as the intellectual property. So it takes time; it takes time for a partner to conclude that all of the elements that are necessary for them to go forward are properly understood and acceptable.

That said is, once that's completed, then typically what happens is firms like ours will enter into a financial discussion, usually proceeds -- starts with a memorandum of understanding that proceeds to a negotiations to our term sheet, and then it finally is concluded. If everything turns out to be acceptable to both parties, turns into a fairly lengthy development of something known as a definitive agreement. That's the process.

Got you. So at this point in time, you're fairly satisfied with how it is preceding?

We are, yes.

[Philip Loeman], private investor.

You had talked a couple of conference calls ago about a product number 4 that we were going to try and develop. At what point could you put some color on that?

Yes, so it's a good question. We've demonstrated the platform capability of our technology. We have announced (technical difficulty) the progress that we made with two additional chemotherapeutics, docetaxel and carboplatin. I believe we have reported and actually reported at a conference some of the very impressive results we've seen in tumor inhibition studies, particularly for docetaxel. So we are very encouraged by both of those. I will remind you that our objective with those two compounds was to evaluate and determine the potential for our heat-sensitive liposome to improve or enhance the value of additional compounds. Only to the point through feasibility, that's been done. I mentioned that on conference calls, that we were evaluating another compound being funded by another pharmaceutical company. I think I mentioned, at the time, when and if we are prepared to discuss it further, it would have to be with the agreement of the funding partner. We haven't reached that stage yet.

[Mitch Langrass], private investor.

Good morning. I did -- I wanted to let you know that the press release in regard to the PRIORITY clinic trial did come out just seconds before the conference call. It is a resounding endorsement and recognition of the promise of our technology, and I think it's quite a feather in the cap of Celsion and the Celsion employees. My question is in regard to Japan and Yakult. Perhaps I didn't do enough research myself, but is there anything in our agreement with Yakult in regard to rights of first refusal or marketing rights for areas of Asia outside of Japan?

No. The answer to that question is no.

That's what I needed. Thank you so much. Carry on your wonderful work.

If there are no other questioners on the line --

Chrystyna Bedrij, Griffin Securities.

My question -- actually most of my questions were answered already. I just had a quick follow-up question. Can you just maybe give a current update on what your commercial strategy might be in the US at this point, or just your thoughts on that?

Good question, thank you for asking it. I want to talk more broadly, though. Our plans for commercializing ThermoDox is to license ThermoDox to qualify, and by qualify we mean pharmaceutical companies that are oncology-focused and demonstrate their capability to develop a strong sales and marketing effort around primary liver cancer. So our strategy is to license to those kinds of partners outside the United States.

In the US, we think we have the potential to be the very best steward for ThermoDox. So our intention is, at the moment, is to commercialize ThermoDox in the US ourselves. We believe we have the bandwidth, the insight, the expertise and the understanding of this market to be able to do so and do so effectively. Now, that said, we will always entertain license discussions for the US market if in fact we believe that licensing ThermoDox in the US represents a significant enhancement in value for our shareholders.

Thank you, Michael. Congratulations.

[David Spata], private investor.

Good morning Michael. I've been a long-term shareholder of Celsion and am very supportive of the science. My question is the range of an upfront payment that would be a requirement of a partnering that you suggested would probably take place by year-end.

We always get these kinds of questions. They are not inappropriate; it's an important question for -- on the minds of many shareholders. I don't think I can talk to you too much about what we consider currently.

Let me say this. The upfront payment largely could be a function of the size of the territory and the sales expectation from that territory for which ThermoDox is licensed. Typically, milestone payments represent some percentage of peak-year sales, so for example, if we look at some comparative fields that have been done recently, and we -- I think we do a pretty good job of surveying the markets so that we understand what the acceptable deal terms look like. The range of an upfront payment -- I mean upfront, immediate, in cash -- could be anywhere from 15% to 25% of peak-year sales for territories outside of the United States.

So what would be the range?

So if it's a $100 million territory, it could be 15% to 25% of $100 million.

So that's your goal, to --

Our goal is to get the very best deals possible.

I know, there's always a balance, though, of what you're giving up long-term versus survival in the short term. Being a shareholder, we are all kind of sensitive to dilution and I think it's difficult to balance the two.

Sure. To be clear, that 15% to 25% represents a payment not only just the upfront payment, but payment is sometimes as the trial or the development program is derisked by hitting various milestones. Like, for example, achieving enrollment, or submitting an NDA, or getting an NDA approved, all of which reduces the risk of -- for the drug not to be approved. So, I wish I could give you more information than that, but I don't think it's appropriate.

Certainly, it would go a long way in supporting some strength of the sales price of the stock, because it's kind of suffered here, and it's just difficult for us to try to stay in the game long-term, especially the long-term shareholders who would have gotten diluted over the years. We are the guys that brought you to this point, and we'd like to see that nice pop of cash coming in where we don't have to be issuing a lot more shares and then give the time for you guys to complete the study and thereby create market value to the science. So that's the balance that we are all hoping to get by hopefully year-end or within the near future. But we are sticking with you, so I am -- I've certainly been with you for a lot of years, so I am looking for the reward. All right, thanks for your time.

We appreciate your support. I can promise you that, in any of these negotiations and as we consider the cash required to support our research, we are very mindful of the responsibility we have to our shareholders.

[Martin Walsh], private investor.

I came in a little after the start of the call, so you may have already mentioned this. But the talk of the second license agreement, I'm just curious whether you can give us anything to anticipate beyond that. Is there anything already in the pipeline on third, fourth, fifth deals? Anything you can add to that?

I really don't think I should. I can just say we've said in the past, is we [set] interest from multiple potential licensing partners, and that due diligence is being conducted, has been conducted, is being conducted by more than one party.

Okay, that's my only question. Thank you.

[Philip Wellman], private investor.

I didn't get a chance to say goodbye last time.

I had a couple of questions but I was a little slow. As we are shooting for 600 enrollment, we also have individual goals at different countries. Would we slow the enrollment globally to push through Japan and China, or would we get our 600 and then overshoot by continuing the trial on a country-by-country basis?

It's a little bit different [for you]. So, we would overshoot for all countries with potentially the exception of Japan. We need to understand with specificity the requirement of the Japanese regulatory authorities before I can give you an answer on that. But if, for example, we reach 600 patients and our target is 150 in China to support a registrational application, and we are only at 125, we would continue enrolling in China until we arrived at the target population -- that said, as we take our 600 patients that were completed as a part of the original scope of the trial, and we begin to review that data.

I thank you and all your coworkers for all your hard work. I am a happy shareholder and hope we can help a lot of people with cancer in the years to come.

That was the last question in our queue.

Again, I want to thank you all very much for your support and continued interest in Celsion. From us to you, we continue to be very, very committed to our very important clinical trials, and we will work very hard to ensure that the milestones that we communicate to you are the most aggressive and achievable that we think are appropriate to create shareholder value. Thank you again.

That will conclude Celsion Corporation's second-quarter 2010 earnings conference call. Thank you for your participation.