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Imunon, Inc. (IMNN)

Q2 2013 Earnings Call· Thu, Aug 8, 2013

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Transcript

Operator

Operator

Please standby. Good morning. My name is Priscilla, and I will be your conference coordinator today. At this time, I would like to welcome everyone to the Celsion Corporation Second Quarter 2013 Financial Results 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 Jeff Church. Please proceed.

Jeffrey Church

Management

Thank you. Good morning, everyone, and thank you for joining us. Our second quarter 2013 financial results were released this morning before the market opened. We also filed our Form 10-Q for the quarter ending June 30, 2013 at the same time. The Form 10-Q is available on the SEC’s Edgar system, and the Company’s earnings release and Form 10-Q are both available on our website at www.celsion.com. Today’s call will be archived, the replay beginning at 2 PM Eastern, and will remain available by phone until Thursday August 22, 2013, and will on our website for 30 days. Before we 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, the risk of clinical failures, delays or increased costs; unforeseen changes in the cost of our research and development activities, possible acquisition of other technologies, assets, or businesses; and possible adverse action 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. Following our formal remarks today, we will open the call for questions. I’d like to turn the call over to Mr. Michael Tardugno, President and CEO of Celsion. Mike?

Michael H. Tardugno

Management

Thanks, Jeff. Good morning and thank you for your interest in and support for Celsion. I’m joined today by Dr. Nick Borys, our Chief Medical Officer and by Jeff Church, from whom you’ve just heard, our Senior Vice President and CFO. Today in addition to discussing our second quarter 2013 financial results by providing an update on three important topics, they are these. First, an update on the Phase III HEAT study and primary liver cancer. As we noted in previous press releases, our post hoc review of the HEAT study data has identified an important signal suggesting that an optimized RFA treatment in combination with ThermoDox as measured by RFA 12 time or heating time may provide a meaningful overall PFS and survival benefit. This insight is consistent with the mechanism of our HEAT-activated liposomal technology. Longer heating sign activates more drug release in the margins and tissue surrounding the tumor target. We’re following this development with all appropriate scientific rigor and belief as to our medical advisors at this group deserves our attention and continued exploration. Our second topic, our restructuring initiatives announced in April 2013 has been fully implemented. Cost reduction and corporate realignment steps were taken and I might add with care and vision to adjust spending levels, reducing pressure on our cash resources, while maintaining the necessary capability and the competencies important to Celsion’s current business plans and strategy. Our balance sheet was further strengthened during the quarter to a timely and I might add smart equity offering. Our recent financing not only reflects the investment community’s confidence in Celsion, but importantly, ensures the company’s ability to advance our ThermoDox program among other clients. Third topic our rigorous comprehensive strategic acquisition project designed to identify new technologies and products for our development pipeline is progressing. The competency of our management team, cash reserves and our vibrancy as a public entity provides us with a strong position as the company exposed M&A options to expand our research interests and to reduce our exposure to a single development program. Now, before I jump into each of these topics, I’d like to comment on the 2013 Annual Meeting, which was held on July 19 in New York City. First of all I’ll report that all five proposals were approved by shareholders by a substantial margin. I want to thank you for your support. I also want to thank those who were able to attend in spite of the high record temperatures and we can all access to that. New York City proved itself to be a venue with easy access for many and a location that I might add it was quite affordable. So we look forward to future Annual meetings in the Big Apple which I hope will be well attended. And this time we will try to make sure that we will there in the Yankees or in the town.

Jeffrey W. Church

Management

Now, I would like to review some history and recent developments with our Phase III HEAT study. If you’ve been following our press releases, it’s clear that we are well positioned in oncology and then we have significant support to fully evaluate the HEAT study data. As you know, we have completed a comprehensive retrospective post hoc analysis from which we have determined the following. Those patients with relatively smaller lesions did better when given ThermoDox as compared to the control group. Our experts found us to be important and urged this to continue our analysis so, we can understand why. When we looked at those patients in particular, we saw that longer RFA treatment time appears to be another key factor. When we look at all the patients with the single lesion, we saw that longer RFA procedures correlate very well with improved outcomes in all tumor sizes. This was particularly enhanced in the ThermoDox group. These findings reinforces our understanding that profusion further enhance fatigue together with adequate heating of the tumor and the surrounding liver tissue are important factors in ensuring that doxorubicin is highly concentrated in the targeted tissue. The plasma concentration of ThermoDox is an important factor in determining when to heat targeted tumors ThermoDox concentrations found in the targeted liver tissue appear to be more important. This data from a large cell group greater than 40% of the study, or approximately 300 patients continue to mature when it comes to overall survival. And we are, of course, following off patients in the HEAT Study to the secondary OS endpoint to determine benefit if any. As promised we’ve been collecting data on a quarterly basis. Our latest overall survival analysis was recently completed for patient data collected as of June 30. Now we would like…

Jeffrey W. Church

Management

Thank you, Mike. Starting with cash, we reported total cash and investments at June 30, 2013, of $48.9 million as compared to $23 million at the end of 2012, an increase of $26 million in the first six months of 2013. We finished the quarter with a much stronger balance sheet, following the execution of our financial strategy after the announcement of the Phase III HEAT Study results earlier this year, which puts us in a strong strategic position to continue the development of our LTSL technology platform, as well as to explore the acquisition of other promising clinical stage product opportunities. I would like to highlight our fundraising activities in the first six months of 2013. In the first quarter, Celsion raised net proceeds to $21 million from two financing transactions, which we discussed on our last conference call. In June, we completed a registered direct offering of common stock generating gross proceeds of $9.8 million. This financing was executed at the market. Therefore there was no discount and more importantly no warrants were issued as part of that financing. Our financing was executed very efficiently with healthcare investors familiar with Celsion and its development program. And as Mike stated earlier, the financing terms for this transaction were very attractive and provides the company with strong cash reserves to execute its business strategy. As of today, we have a total of 61.2 million shares of common stock outstanding. We have no outstanding preferred shares as all the previously issued preferred stock has been fully converted to common shares. Total operating expenses for the second quarter 2013 reflected drop of 30% from the $5.7 million in the second quarter last year to $3.8 million in the current quarter. Total operating expenses for the first half of 2013 reflected similar decrease,…

Michael H. Tardugno

Operator

Thanks, Jeff, and nice overview. As I hope our remarks made clear the company is moving forward and focused on its future under Dr. Borys’ direction. We completed our analysis of the HEAT Study, meet with our collaborators and partners as well as regulatory agencies to discuss our latest findings and prudently determine our next steps. We have a strong balance sheet, and now have the flexibility to engage a number of strategic options. Our partnerships continue and we expect them to remain strong. We continue to focus on our critically important work and look forward to reporting our progress as we have throughout the year. Doing so, we hope to create a value for our shareholders and most importantly, we’ll make a significant difference in the lives of patients and their family. Now with that operator we will go to questions. And we’ll ask the listening audience to limit your questions to no more than two, to give all a chance to get answers to their questions. So operator, please open the line. Certainly. (Operator Instructions)

Jeffrey W. Church

Management

Operator, can we start with the first question please?

Operator

Operator

We’ll take our first question from Keith Markey with Griffin Securities. Your line is open.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

Good morning, Michael. Good morning, Jeff, Nick. I was wondering, based up on the overall survival trends you’ve seen lately, when do you think that the median will be reached in the HEAT Study, in terms of overall survival?

Michael H. Tardugno

Operator

So, I’m going to give you an answer with some caution, because you know, it’s difficult to predict the – currently for survival end point. The debt rate unfortunately the debt rate is something that we’ve looked at for a reasonably carefully. I would say it’s going to be at least two quarters maybe three.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

Okay.

Michael H. Tardugno

Operator

Let me just reserve, but I’ll make a point here is that that we could be updating that in the next conference call with the longer or shorter timeline. That is just a reasonable projection based on the rates that we’ve seen so far.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

Right. Yeah that’s all I could expect. And then I was just wondering is it statistically possible that you would get a significant benefit in overall survival within the subgroup that you’ve identified or is it just simply too smaller group to be able to come to a significant result?

Unidentified Company Representative

Analyst

Well, the answer to that is yes. I mean do you want to expand on that at all?

Nicholas Borys

Analyst

Yeah, I think as we’ve been reporting all along that as we look at the data particularly in the patients to optimize heating times, the data certainly gives us more, more confidence that we’ve found how best to treat these patients. And based on that and based on the numbers, I think it is very well possible that we could see statistical significance.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

That would great.

Nicholas Borys

Analyst

You are becoming more confident of the significance of the subgroup with each reading of the data so far.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

That would be great, because wouldn’t it help to potentially shorten the overall development of ThermoDox if you should chose to go forward?

Michael H. Tardugno

Operator

Absolutely.

Jeffrey W. Church

Management

Yes.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

Okay. And then I was just wondering, could you, I know that things are to a certain extent in state the of flux, but could you sort of outline the milestones that you are aware of at least for 2013 and 2014 at this point?

Michael H. Tardugno

Operator

Well, yeah. I think where we are looking at the remainder of the year, Keith is that, we expect to propose a meeting with FDA in the fourth quarter early in the fourth quarter. The meeting would largely be designed to review a proposal for a confirmatory protocol, taking advantage of this enhanced population of – spoke in my prepared remarks. That would be I think a very important milestone to report to the Investment community.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

Okay.

Michael H. Tardugno

Operator

In addition to that we have been spending a great deal of time and effort evaluating our potential M&A candidates. We are hopeful that before the end of year, that we can be announcing to our shareholders a proposal for an M&A transaction, which we believe would be consummated in the first half of 2014. Assuming we have a goal with the FDA and other regulatory agencies, our expectation would be in the first quarter of 2014 to begin enrollment of the confirmatory trial in HCC. By the middle of next year 2014, we would expect to begin reporting case histories from patients who are participating in the recurrent chest wall breast cancer trial.

Unidentified Company Representative

Analyst

I think to name a few. I think the important milestones at this point.

Keith A. Markey

Analyst · Griffin Securities. Your line is open

Very good. Thank you so much. I’ll get into the queue again.

Operator

Operator

Thank you. (Operator Instructions) We’ll take our next question from Sal Marorso, a Private Investor. Your line is open.

Michael H. Tardugno

Operator

Good morning, Sal.

Unidentified Analyst

Analyst

Good morning. How are you?

Michael H. Tardugno

Operator

Great, thank you.

Unidentified Analyst

Analyst

My question was the Phase II that you’re currently in. When do you think we will hear results on that?

Michael H. Tardugno

Operator

Yeah, as I just mentioned it’s an open label trial. We are going to roll approximately 25 to 30 patients. My expectation since it is open label is that, we’ll be able to begin reporting individual case histories in the late and the first half of next year or early or second half of next year.

Unidentified Analyst

Analyst

Okay. And one other question regarding your ponder in China and when do you expect to actually file that or what’s the next step in China?

Michael H. Tardugno

Operator

So what we are considering a confirmatory trial as we did with the HEAT Study. We are considering enrolling patients on a global basis particularly in those countries where HCC is a particularly high incidence. China would be a very important market. So following our discussions with FDA, assuming they are positive and we have every reason to believe they will be. Our next stop would be for, it’s known as the CFDA.

Unidentified Analyst

Analyst

Okay.

Michael H. Tardugno

Operator

The Chinese Food and Drug Administration to review our protocol plans and our overall intentions for marketing assuming a positive outcome while an overall intentions for commercializing ThermoDox in greater territories of China.

Unidentified Analyst

Analyst

Okay. One last question if I may?

Michael H. Tardugno

Operator

Yes.

Unidentified Analyst

Analyst

Okay, regarding is it possible to, I’ve seen it before where the FDA would basically approve make the company to do a Phase IIIb and offer it out for compassionate use as guide something to speak with FDA about regarding ThermoDox here in U.S.?

Unidentified Company Representative

Analyst

Compassionate use is a subject that we have considered. During the course of the HEAT Study, it’s an approach that does not provide the level of control that our disciplined Phase III protocol does. So there is some level of risk frankly.

Unidentified Analyst

Analyst

Okay.

Michael H. Tardugno

Operator

In reporting EUs and AEs and protocol compliance. That said, we’re mindful of our responsibilities and obligations, although now compassionate use is essentially a new protocol for each and every patient.

Unidentified Analyst

Analyst

Okay.

Michael H. Tardugno

Operator

So it’s quite labor intensive, but there maybe an exception.

Unidentified Analyst

Analyst

Okay.

Michael H. Tardugno

Operator

We’ll leave it up to Dr. Borys’ judgment where we would consider offering compassionate of the use. Although, I don’t know that we’ve had a request for that. That clearly makes sense to us.

Unidentified Analyst

Analyst

Okay. All right. Thank you very much.

Michael H. Tardugno

Operator

Thank you.

Operator

Operator

(Operator Instructions) And it appears we have no further questions. At this time I’ll turn the call back to Mr. Tardugno and Mr. Church for closing remarks.

Michael H. Tardugno

Operator

Thank you, operator. Thank you to all that have joined us today and as I hope our remarks may clear the companies moving forward. We continue to focus on our critically important work. And look forward to reporting our progress as we have throughout the year as always. We greatly appreciate your interest in Celsion and your continued support. Thank you and have a nice day.

Operator

Operator

This does conclude today’s program. You may disconnect at any time. Thank you and have a great day.