Imunon Inc (IMNN) 2009 Q4 法說會逐字稿

Welcome,ladies and gentlemen. At this time I would to welcome everyone to the Celsion Corporation's fourth-quarter and year-end 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. Instructions will be given at that time.

I would now like to turn the conference over to Ms. Marcy Nanus of The Trout Group. Please go ahead, ma'am.

Thank you. Good morning, everyone, and thank you for joining us. Today's call will be archived for replay beginning today at 3 PM and will remain archived until February 24, 2010. The replay can be accessed at 888-203-1112 or 719-457-0820. The conference ID is 956-4955. The call also will be available on the Company's website at www.Celsion.com for 30 days after 3 PM today.

Before we begin we wish to inform participants that forward-looking statements are made pursuant to the Safe Harbor provisions 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, possible actions by customers, suppliers, 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 said, I'd like to turn the call over to Michael Tardugno, President and CEO of Celsion.

Thank you and good morning all and thank you for joining us and for your continued interest in Celsion. As Marcy said, I am Michael Tardugno, Celsion's President and Chief Executive and I'm joined today by Timothy Tumminello, Celsion's Controller and Chief Accounting Officer and Doctor Nick Borys, our Vice President and Chief Medical Officer.

Since our last conference call and as noted by our public announcements, your Company has made much progress. We are delighted to be here with you this morning to provide you with specific additional information and to update our progress and to answer your questions.

For today's call, Tim will provide comments regarding our fourth-quarter and 2009 full-year results including a detailed review of the P&L and balance sheet following which I will cover a number of topics, including the progress of our global Phase III liver cancer trial, an update on our Phase I/II recurrent chest wall/breast cancer study and our joint research agreement with Philips Healthcare.

We will then have time for questions.

Before I pass the call over to Tim, I have a few introductory comments. First, I want to thank Celsion employees for all of their contributions this past year, their efforts as I've noted in the past are consistent with the promise of ThermoDox and our heat-sensitive liposomal technology to provide a significant treatment option for cancer patients.

I take great pride in being part of this team and look forward to working together in the coming year which I predict will be a most significant year in Celsion's history.

Second, I'd like to add some context to the recent announcement that we are holding an R&D day for our shareholders and the investment community in New York City on February 24. The goal of this conference, first, is consistent with our commitment to provide open information as we are able to, to our investors.

And secondly and most importantly is to share the views of three of our highly respected clinical investigators with regard to ThermoDox's potential to treat the largest unaddressed global cancer hepatocellular carcinoma also known as HCC or primary liver cancer.

With over 650,000 incidents and five-year survival less than 10%, HCC is projected to be the world's number one cancer by 2020. It is the focus of our pivotal global HEAT study and the singular subject of our conference, at which we will hear from Professor Richard Finn, M.D., medical oncologist at UCLA Medical Center. Professor Ronnie Poon, Professor of Surgery at Queen Mary Hospital University of Hong Kong. Doctor Poon -- among other things -- will report on our Phase I results and his view of the support that they provide for our Phase III trial. And Professor Ricardo Lencioni, Director of Diagnostic Imaging and Intervention at Pisa University Medical School of Medicine, who will speak on the current and future role of interventional procedures with treating HCC and the expected impact of ThermoDox in combination with radiofrequency ablation.

We will also have the pleasure of hearing from the inventor of our heat-sensitive liposomal platform from a professor named [David Needham], PhD, Professor of Mechanical and Biomedical Engineering and Material Science at Duke University. Doctor Needham plans to give us an overview of the underlying technology and the reasons to believe in our drug platform and in ThermoDox's potential as a potent anticancer chemotherapeutic, in particular.

And for a peek into what has the potential to be the future of chemotherapy, Doctor [Shem Prokop], PhD and head of HIFU high-intensity focused ultrasound research and development at Philips Healthcare, will cover our joint research which has designed and evaluates the clinical potential of HIFU plus ThermoDox. I am sure that he will convince you that Celsion and Philips' partnership is based on a paradigm-changing view that HIFU-mediated drug delivery has its most significant potential when combined with our liposomal technology, uniquely engineered to target tumors in the presence of mild heat.

We will conclude the conference with a panel discussion at which time the presenting physicians will take questions from the audience.

I trust all of you listening have received invitations. If you have not please contact Marcy Nanus at Trout. You will be admitted in person, only if you RSVP.

For those who cannot make it to New York City we will be webcasting and taking questions by e-mail. We are excited to hold this event and expect it to be a very informative and interactive review of HCC interventional procedures and the potential of our first drug in clinical research, ThermoDox.

And third, before I turn this microphone over to Tim, I'd like to make a few comments as background on our financials.

We finished 2009 with over $14 million in cash, along with our strategic actions to reduce expenses. Our cash balance had the immediate effect of fully funding current operations through 2010. And that concludes our phase III HCC study, our plans and progress in our phase I/II RCW study, our continued [CMC] work and our joint research with Phillips to evaluate HIFU and ThermoDox.

This financial runway is what we promised you following our capital raised last September. Now, as for future financing needs, our strategy and our approach remains unchanged. We will always seek to find the most non-diluted means to raise cash including commercial licenses for ThermoDox, where the terms are attractive and represent a long-term value for the Company.

In that regard, we continue to believe that a second license agreement for ThermoDox will be completed in 2010.

And as always, we will always look for events that have the potential to minimize dilution or that can be accretive in order to enhance shareholder value. In the meantime however, your Company will continue to progress its research programs and will work to make sure that news flow properly reflects our advances in bringing ThermoDox to market through the rigor of well-executed clinical programs and well-defined regulatory pathways which, as you may know, has been established with FDA through our SPA, our special protocol assessment agreement, for our phase 3 trial and with a written agreement for our pivotal RCW study.

Now I'd like to turn it over to Tim who will cover our fourth-quarter and year-end financials. Tim.

I'd like to give a summary of our fourth-quarter and year-end 2009 financial results. For the fourth quarter ended December 31, 2009, our net loss was $2.3 million or $0.19 per diluted share compared to a net loss of $0.9 million or $0.09 per diluted share for the of 2008.

For the full year 2009, our net loss was $15.2 million or $1.43 per diluted share compared to a net loss of $11.8 million or $1.16 per diluted share in 2008.

Our net loss from operations for the fourth quarter 2009 was $3.8 million compared to $1.5 million for the same period in 2008. The difference between the two quarters is that Celsion received a $2.5 million licensing payment from Yakult for Japanese ThermoDox rights that was recorded in 2008 as licensing revenue.

Operating expenses decreased to $3.8 million in the fourth quarter of 2009 compared to $4 million in the same period of 2008. For the full year, 2009 operating expenses were $17 million compared to $14 million in 2008. Comparing quarter to quarter, research and development costs decreased to $0.6 [million] with $3 million incurred in the fourth quarter of 2009 to $3.6 million in 2008.

For the full year R&D costs increased $1.7 million to $13.7 million compared to $12 million in 2008. These cost increases are attributable to clinical trial costs for the primary liver cancer clinical studies as well as drug manufacturing costs to support the trials.

Comparing quarter to quarter, general and administrative expenses increased $0.3 million with $0.8 million incurred in the fourth quarter of 2009 compared to $0.5 million in 2008.

For the full year, G&A expenses increased $1.3 million to $3.3 million compared to $2 million in 2008. These costs are non-cash items and are attributable to the expiration and the (inaudible) reserve the Company recorded prior to 2008 and amortized as a reduction of G&A expenses through mid-2009. The non-cash effect of this reserve was $1.1 million in 2009 compared to $2.1 million in 2008.

The Company ended the year with a total of $14.1 million in cash investments and other receivables in current assets which will provide sufficient cash to fund ThermoDox clinical studies for primary liver cancer and recurrent chest wall/breast cancer through the end of 2010.

As always we continue to manage our spend very carefully and are always finding ways to do more with less and are realizing cost savings at every opportunity.

With that, I now hand it back to Mike.

Thanks Tim. Now I'd like to give you an update on our global phase III primary liver cancer study which is designed to evaluate the efficacy and safety of ThermoDox in combination with radiofrequency ablation when compared to RFA alone which as you know is becoming the global standard procedure for non-resectable disease.

We continue to make much in significant progress and we are pleased to report the following. We have enrolled nearly 50% of the study population with 274 patients treated. And as reported this morning 14 patients with signed consents and eligible to be treated within the next week or so.

We have opened new sites in China, Thailand, Philippines, Malaysia and additional sites in Taiwan and Korea. And we now have 10 trial sites now open in Japan and have treated nine patients in that country. All in all, by the end of this month we expect to have 70 sites enrolling patients, including three new sites in Italy.

And after some very successful investigator meetings in Thailand and Korea and China, which we saw investigators from virtually all of the Asian countries, we have every reason to believe that our confidence in our new sites and countries is not misplaced.

Lastly, we reported -- as we reported recently, our DMC has reviewed unblinded data from approximately 120 patients. It has found no safety issues and has recommended study continuation. While this is a significant milestone safety, as you know, is not assured with any drug, particularly chemotherapeutic.

So we are now in 11 countries with 62 sites enrolling patients. We expect the following. We expect to fully enroll in the study at 600 patients over the next five to six months. It's a little bit later than we talked about on the last conference call, but it's our very best estimate based on what we believe the enrollment trends are.

Some of the latest that we've seen in country approvals like China and getting these new sites up and running has taken a little bit more time than we anticipated. That said, however, it's not a significant delay as I believe we reported last time, we expected to complete enrollment by June of this year.

Assuming the historical data is reasonably predictive, completing enrollment as planned will result in enough progression to [remove] our endpoint for the celebrated review as progression-free survival or PFS. So it will result in a number of -- enough progressions to be able to determine ThermoDox's efficacy as an adjuvant to our phase within 12 to 18 months following the last patient in, depending upon when we see average progression in the control arm.

We also expect to receive qualitative report from the DMC's interim analysis once the study has reached 190 events. Again, those events are progressions.

While the review will be blinded to Celsion, so we won't have hard data but we will have a recommendation coming in one of three ways which I will repeat for you. I mentioned this last time we spoke.

The recommendation could be that the study should continue as is, and we expect this will be the most likely outcome. They can also suggest that the data supports the discussion with the FDA for an early NDA application. That would be a terrific outcome.

Or that the study suggests that ThermoDox will not meet our endpoint objective, which we believe is a very, very remote probability.

So that is the update on HCC.

Now I want to turn to our our RCW program. A pivotal phase I/II RCW study is enrolling patients at five sites. Last time we spoke I said six but recently Duke has asked to join the study at the Phase II, once we dose escalate and move to Phase II.

So we currently have five sites. NYU, Saint Barnabas, and New Jersey, Rhode Island for -- Rhode Island Hospital, Florida Cancer Institute and Virginia Commonwealth University along with the Cancer Treatment Center of America, in Oklahoma, and Duke -- which will be joining the study at the Phase II. We have initiated seven sites and we recorded this, I believe, again at the last share or last shareholder conference call.

Now as background you will recall that we initiated the RCW trial based largely on the FDA's written support that our Phase I/II study may be considered pivotal, pending a robust objective complete response rate which was our primary endpoint. Also note that the data from Duke's Phase I trial, which is fully enrolled through the 40 mg cohort show that ThermoDox, in combination with hypothermia, has the potential to be an effective treatment option to locally control this disease.

We have now treated -- Celsion, our study -- we have now treated the 40 mg cohort and scheduled the dose escalation and safety review with our DSMB in early March. Assuming the DSMB agree, we will be treating patients at 50 mg -- at the 50 mg cohort in March, dose escalating to 50 mg in March -- which we will call the MTD if supported by continued safety data.

Our experience so far suggests that recruiting patients will not be easy. It has not been easy. But we also don't believe it's impossible. We have a number of very aggressive actions and activities in place to encourage physicians to consider this trial for patients they are treating with this disease.

You may have noted our recent new website. I believe it's the DignityStudy.com. If you haven't we offer that you take a look. While that part and parcel is -- that's part and parcel of our effort to reach out to the oncology community and these patients to make them aware of our study.

As it appears now, enrollment will extend well into 2011 and given this situation, we have a contingency, I want you to know that. If we do not see enrollment traction in the reasonably near future, we are prepared among other options to open the trial to other superficial cancers, such as melanoma and sarcoma. And as Doctor Borys suggested that some time ago and we have made some plans and preparations, I believe -- the protocol draft is completed.

So should we decide that we are not going to make the progress on a timely basis that we had anticipated when previously planning the study, and that was suggested by some very rigorous market research. Should we find that to be the case, then we may choose to open the study up which will have the impact, however, of having a further discussions with FDA as to the status of this Phase II study as a potential pivotal trial.

So I want to also note that this study will provide current confirmatory endpoint data on a patient-by-patient basis. So we will be in a position to assess our endpoints as the study progresses. And we will report accordingly as we enroll patients, as they are evaluated as long as we have agreement to do so with our investigators and the DMC.

\I'd like to make a few comments about ThermoDox manufacturing. On the last conference call we noted that the FDA indicated support for our commercial scale manufacturing plants. Their view is based on our experience in producing some 15 GMP batches and the stability data that we have shown that support ThermoDox in its final packaging form.

The agency has also agreed to our plans to add a second manufacturing partner. I am pleased to report on the direction of Bob Reed, we have produced a commercial skill batch [set] -- the second manufacturing site under GMP. We are scheduling, in fact, a second GMP batch at the site as we speak.

Our goal is to generate clinical supplies for our Phase III trials from the site, include them in the Phase III study and, therefore, mitigating -- hopefully mitigating the need for an independent review of this manufacturing site post-approval of our product by the agency. So this is a significant milestone for us. As our manufacturing strategy is designed to reduce risk associated with reliance on a single source, there's a potential to provide best pricing and as I said eliminates the needs for additional large-scale additional studies to support our large-scale commercial production.

I want to move on to our HIFU program, our strategic initiative to study the potential of ThermoDox with this novel approach to hyperthermia and ablation. It is progressing well. Recall that to accomplish this work we sign a joint research agreement with Philips Healthcare, the premier manufacturer of high-intensity focused ultrasound systems.

The agreement that provides funding for these studies will be principally formed by Philips and it has been under their existing R&D program. In return, we've amended our existing [credo] with the NCI to incorporate experiments that are of particular interest to Celsion in this joint research program, with Philips in particular.

Our immediate objective is to have our preclinical work completed, sufficient to support an IND filing with the FDA. We expect to complete this research in a timeframe to submit this filing by midyear and we may choose further to file a CTA with the NEA should we decide to conduct portions of the trial in Europe.

Based on our initial work and if agreed by the agency, our clinical program will focus on two very important indications. In this order we have announced this previously, first is (technical difficulty) metastasis to the bone where we believe that HIFU plus ThermoDox has the potential both to treat the lesion and to provide pain relief incidents [to bone mass], is in excess of 300,000 globally.

And the second is pancreatic cancer, an indication with very high mortality rates, incidents almost equal is mortality in the US alone with some 37,000 plus individuals being diagnosed with this very devastating cancer.

Now with regards to our research, we -- not surprisingly we have learned a lot. We also have accomplished very -- quite a bit. I'm going to share some of that with you at the risk of providing some information here that our R&D people would probably consider to be a little bit confidential.

I just want to say this. We are really on the cusp here of a breakthrough. I believe we have established that HIFU plus ThermoDox works in theoretical models. We have shown theoretical models to be very predictive in tandem studies where we have shown HIFU can release doxorubicin from ThermoDox in these phantom models.

We've demonstrated HIFU and ThermoDox have significant improvement in efficacy, treating tumors in mice. We've demonstrated HIFU can hold hyperthermic temperatures for extended periods of time in soft and bony tissue. This is a very important development.

HIFU is not designed to be a hyperthermia device. It has been designed by all the manufacturers as an ablative device.

Being able to locally hold temperatures at hyperthermia in a hyperthermia range goes to the heart of how our drug is activated and really is an important breakthrough. And in fact, it is critical to the protocol that Doctor [Borys] has designed for our clinical program.

We have shown that HIFU delivers very high concentrations of docs in comparing heated muscles in rabbits versus non-heated muscle, non-heated tissue, similar tissue in the same rabbit. We have established safety in near and far fields tissue, a very important element of our program.

And last year, we were completing large animal tumor and non-tumor study. With all this done or near done, it appears now that we are on track to file our IND mid this year. So I am very excited about this and you're going to hear more about it if you take the opportunity to join either by web or in person our R&D date.

Now I'd like to outline what we see as milestones ahead for the balance of 2010. We expect to fully enroll our Phase III HCC trial. We expect to complete Phase I portion of our RCW trial and begin enrollment in Phase II and where we report on medical efficacy as we have data and have agreement to do so. Because it's very important.

And lastly, we will continue -- we continue to believe that a second license agreement for ThermoDox will be negotiated with the execution of the deal in 2010.

Now in closing, I'd like to say that our strategy is clear and our execution is showing results on all fronts. Your Company is stable and focused.

We have sufficiently funded our ThermoDox program. Two major pivotal events and certainly through this year. Thanks to our dedicated staff, the fourth quarter and 2009 was extremely productive for Celsion. We are well-positioned to deliver results that will make what I'm going to predict 2010 Celsion's year.

And lastly before I go to questions we look -- I want to just re-iterate we look forward to your participation in the upcoming R&D event by web or by in person next week.

And now we are going to go to questions, but I got two questions this morning by e-mail that were so insistent that I respond that I am going to answer those in this conference call. I'm going to answer those questions now before we open up the line.

First question I got is why does our new Dignity website provide for only two investigator sites when we have been saying that there have been more than that in five most recently? The answer to this is we can only post those investigator websites on or those investigator contacts on our website once we have IRB approval from each of the sites.

So we are pursuing approval or -- through the IRB review process. As soon as the IRB gives their 'okay', we will be adding the additional sites to the website.

Second question I got -- and it was very insistent that I answer it publicly is -- why are we not updating the CEO letter on a more frequent basis. I will commit to you on this phone.

First I will agree to that. This past quarter we did not update the CEO letter. Although I will say that we have been pretty diligent in that regard in the past. So I commit to you on this phone call that the letter will be updated on a more frequent basis.

So with that, Operator, if you would open the call to questioners, I would appreciate it.

(Operator Instructions). Griffin Securities, [Keith Markey.]

Could you give us a little bit additional information about the effect of adding new indications to your RCW trials? If you did that in terms? And what that would mean to both the conduct of the trial and the expected or potential termination date?

By opening the trial to more superficial indications, we believe that that will have the effect of allowing us to enroll the study more quickly and that is a primary objective. The goal would be to establish the MTD for ThermoDox in a -- a more of an all-comers phase 1 approach. We could then decide whether or not to continue all-comers as a Phase II study in which case this probably would not then be a pivotal trial.

Or we could choose them based on data and any expectation that this data could generate more interest in the study from the oncology community to refocus our efforts on the RCW indication as we reviewed it with FDA for the Phase II portion alone.

So I don't think we have done enough homework yet to be able to provide for you what we think the -- our new enrollment projection would be, but I can tell you this contingency has taken a lot of time from Doctor Borys. He has reviewed it in some detail with -- this isn't -- as you know, this is not a -- just a 'flip a switch' and make this kind of a change. We -- there's been consultation with a number of medical advisors in the oncology community as well as the radiology community and with our DSMB. And of course, then, there's all the protocol design work.

Nick, do you want to comment?

Sure. Yes I would like to add my comments to Mike and basically say that, as a scientist, you want to try to keep your population as homogenous as possible which is why we would like to complete the study with RCW.

But as some of you are aware, there's been some really nice data coming from the hypothermia community in other superficial cancers, mainly soft tissue sarcoma. And also we believe that there could be some usefulness with this technology in other cancers, namely melanomas.

So we are looking to balance that, depending on our cool rate, and depending on the opportunity.

And so I think we -- follow us into the future. And we should be -- have more things to say about that.

Thank you. I do appreciate the amount of work that would go into redesigning the trial. It is unfortunate that more patients aren't stepping forward. I think this would be of benefit to them and also, obviously, to you to be able to enroll them.

Thank you for taking my question.

[Marc Robins] with [Towers Financial Resources].

Thank you. It sounds like a lot of work is getting done.

Thank you, Marc. It's been a long time. Good to hear from you.

First of all, I haven't seen an updated presentation package so before I get off if you could please take a note. Send me one of your updated presentations. I would appreciate it in preparation for next week.

And then, secondly, you went through your objectives for 2010 awfully quickly. Could you repeat those for me?

Yes, I'll do that. Of course, these aren't our only objectives, but these are the ones that I think are important, immediately important for the investor community.

Objective number one is to complete enrollment in our Phase III trial. That's 600 patients, including enrollment.

Second objective was to complete our Phase I portion of our recurrent chest wall/breast cancer trial and begin enrollment in our Phase II portion of that trial. And as a side to that -- as an aside to that, we will report on clinical efficacy as we have data and have agreement to do so from our investigators since this is an open label trial, Marc.

When we can read results, as patients are evaluated, we may be in a position to report clinical activity and clinical results as the patients are evaluated.

And the last, I think, very important milestone for this year, is to conclude a second license agreement for ThermoDox in calendar 2010. And that is fully completed, negotiated and execution of the deal.

Thank you.

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

Thank you. Good morning and thank you for reviewing your progress. Speaking of progress, when I think about the potential of ThermoDox, I think about the opportunity on how big the market size, how big is localized HCC? And then I think about the appropriateness of therapy of RFA in combination with ThermoDox and the penetration.

Can you talk about any new information you might have on the incidents and prevalence of the disease as well as any guidelines that have -- that may potentially affect or potentiate or maybe even negatively affect the opportunity for RFA and ThermoDox?

Are you talking about global incidents? Or are you --?

I was thinking of -- both. I know there's been a lot of attention saying the HCC may become the number one cancer in 2020. I don't know if those are still updated. So I would take either national or global.

So incidents globally, as reported -- most recently reported and extrapolated by us based on the growth in incidents -- projected growth in incidents. So we would say that global incidents is 650,000 cases globally.

In the US, it's reported at 20,000. Of those cases we believe that RFA is indicated for about 25% of the patients. That's a fairly large population with the potential to be treated with ThermoDox and radiofrequency ablation.

So what was the second part of your question?

Second part is any new guidelines or consensus statements that have come out advocating the use of RFA in patients with localized HCC?

You've got the -- there was a recent publication as a matter of fact that a group of the experts that are involved in the MCC in criteria for establishing how cancers treated are now evaluating the use of RFA as a standard for a certain patient group in cancer.

Over the last five to six years, RFA has evolved from a treatment that was experimental in the early days. Then it got FDA approval and now it is being considered for MCC and guidelines as a standard of care for these group of patients with small to medium tumors that have HCC.

So this bodes very well for us in working with RFA as an adjunct and also to respond to your earlier question about the incidents, you will note from recent publications from the American Cancer Society, there's only three cancers out there at this point that are growing in incidents.

And one of them is, in fact, HCC. So this is a growing problem in the US and it is a growing problem worldwide that we hope to be in a position to address very effectively with ThermoDox.

That was helpful. And speaking of gross, one of the areas -- you've talked about a number of opportunities for ThermoDox and for the technology there, but I know that one area of clinical concern is metastases that actually don't -- that originate in other organs and then end up in the liver. Do you have an update on any programs you are considering there? And what -- how would you rank that in the hierarchy that you set up for the potential for your technology?

So, I mean, your question is one that we've given a lot of thought to. So we are not prepared to fully announce it yet, but we believe metastases to the liver are -- and some of it is supported by our Phase I data -- is a very important next research project for the Company. So I am not sure I want to give you any more than that at this point.

We are -- we may be making an announcement in that regard over the next month or so.

Okay. We will stay tuned. Thanks for the update.

Private investor, [Phillip Wellman].

Hello, Michael. A lot of my interests I'm interested in a lot of things, but one of them is the licensing deals for three reasons.

It shows interest and credibility in our technology, provides funding through milestone payments and upfront, and then obviously if we get a product approved we have a sales force that is up and ready to go.

In addition to the second licensing deal, has anyone else shown an interest in our technology? Is anyone doing due diligence? Or are you negotiating with any other parties?

Yes. You know, most of this -- these partnering discussions are done under confidentiality. Last year, we had hoped to conclude a license deal with a multinational pharma company. Unfortunately in the very end, that company was acquired by another multinational pharma company. So we are starting at the beginning, frankly, with that group.

In the meantime, however, we have seen interest from multiple potential partners. Some of which are conducting early Phase II diligence. Some of which have asked us for our thoughts on the value of our technology in various markets and how that would translate into a potential deal. So that's about as much as I can (multiple speakers).

No, that's fine. That is very clear. My second question is regarding the ligand peptide that we have talked about in the past and have you decided to exercise your option or not?

Yes. That is a good question and maybe I should've dealt with that upfront.

We did quite a bit of feasibility research on the peptide ligand. We were very encouraged by some early work. We did some experiments to show -- to try to demonstrate that this was a -- this proprietary sequence in fact did show an advantage over other sequences of amino acids and what we concluded was that it did not.

So we didn't think it was anything sufficiently distinctive in this particular peptide that would cause us to want to take a license.

Okay. Thank you very much. Keep up the good work.

Follow-up question from Mark.

Thank you. Couple of sessions ago you've chatted about using the -- I'm going to call it the taxicab molecule to carry other molecules other than the doxorubicin. And we didn't discuss any of that, I don't believe, in this conference call. Has that been back burnered for a while?

Yes. Thank you for asking that question. We've incorporated now, three compounds in addition to doxorubicin in our HEAT sensitive liposomal technology platform, two of which we have discussed with the investment world. One is docetaxel, and the second is carboplatin.

We said our strategy with both of those compounds was to show feasibility, to demonstrate the platform capability of our technology, and provide a future pipeline. We also said beyond feasability we would not invest a lot more money until such time as we have seen ThermoDox through the clinical program.

So we completed quite a bit of feasibility. We are very -- I would say quite happy with the results to date. We will decide whether or not to continue development, either as a function of our financial ability to do so or the interest of the development partner to assist in financing that work.

The third compound we have not identified is we do have one in development that is being funded by another pharma company. And when we get to a point where we believe there may be something worthwhile to talk about, we will share that.

(Operator Instructions). [Bob Greene], who is a private investor.

A couple questions on the HCC. You are going to have a conference I think next week and then one later on in South America and it sounded like we are going to get results of Phase I. Would those be from what was it -- NIH that did that?

Yes. You are talking -- there's a liver cancer conference called the IHPBA. And that's held in various venues around the world. The last one -- I believe -- was in Mumbai, India.

One of our researchers or Phase I researchers and is currently enrolling patients in our Phase III trial is Doctor Robby Kumar. Doctor Robby Kumar completed the Phase I study for us and submitted his data presentation at the IHPBA and he will be doing that. So that -- and they have been reporting on the results of that Phase I work.

So both of them this is the first time really that we got final results from Phase I. So that will be something to hear about.

Yes, well, yes it will be. It will be. Although we have had reports at conferences like these from our investigators on the Phase I results.

These will be the final, final results and that's what we've been waiting for. Another thing on the HCC I think you said there has to be 190 events and then they are going to do a looksee and a progression-free survival.

Assuming that this trial is balanced, that means there's an equal number in the control arm. Is that -- we should probably have to have 400 patients before we could see anything from that?

No. It's 190 events could even -- if it is randomized perfectly, it would be half of those would be in the control arm and half of those would be in the active arm.

And we need to see 190 events you said?

Yes.

That's all I needed. Thank you much.

And gentlemen, there are no further questions at this time. I will turn the conference that covers you for any additional or closing comments.

Well thank you. Could you just check one more time to make sure there are no more questions?

(Operator Instructions).

Okay then. Well, we appreciate your attendance at this conference call this morning. We thank you very much for your support and continued interest in Celsion, and on behalf of the management team here, we value your interest and your ownership in our stock and we intend to continue to address our ThermoDox clinical program in a way that will drive value for your investment. Thank you very much.

Ladies and gentlemen, that does conclude today's conference. We thank you for your participation. You may now disconnect.