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Imunon, Inc. (IMNN)

Q3 2017 Earnings Call· Tue, Nov 14, 2017

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Transcript

Operator

Operator

Good morning. My name is [indiscernible] and I will be your conference operator today. At this time, I would like to welcome you all to the Celsion Third Quarter 2017 Earnings Conference Call. All lines have now been placed on mute to prevent any background noise. Following the speakers’ remarks there will be a question-and-answer session. [Operator Instructions] At this time, I would like to turn the call over to Mr. Jeffrey Church, Celsion’s Senior Vice President and Chief Financial Officer. Please proceed, Mr. Church.

Jeffrey Church

Analyst

Thank you. Good morning, everyone. And welcome to our third quarter 2017 investor conference call, which we announced this morning before the market opened. During our call today, Michael Tardugno will provide an operational update on our clinical programs and I will summarize our financial results for the third quarter and first nine months of 2017. Today’s call will be archived and a replay will be available beginning tomorrow and will remain available by phone until November 28th as well as available on Celsion’s website for 90 days. Before we begin the call, we wish to inform participants that we will be making forward-looking statements regarding Celsion’s current expectations and projections about future events. Generally, these forward-looking statements may be identified by terminology such as may, should, expects, anticipate, plan, estimate or similar expression. These statements are based upon current beliefs, expectation and assumptions, and are subject to a number of risk and uncertainties, including those set forth in the company’s periodic reports filed with the Securities and Exchange Commission, many of which are difficult to predict. No forward-looking statements can be guaranteed and actual results may differ material from such statements. The information on this call is provided only as of the date of this call and Celsion undertakes no obligation to update any forward-looking statements contained in this conference call, based upon new information, future events or otherwise, except as required by law. At the conclusion of today’s formal remarks, we will open the call for questions. I’d now like to turn the call over to Mr. Michael Tardugno, Celsion’s Chairman, President and CEO. Mike?

Michael Tardugno

Analyst

Thank you, Jeff. Good morning, everyone, and thanks for joining us for today’s call. With me are Dr. Nicholas Borys, Celsion’s Chief Medical Officer; and Jeffrey Church, our Chief Financial Officer from whom you just heard. As always, we are delighted to have the opportunity to update you on our progress and to answer your question. For those of you are knew the story, I’d like to give you a quick elevated pitch. Celsion’s oncology focus development stage company with two platform technologies both of which have product candidates and clinical trials. Our lead technologies are novel heat sensitive liposome that incorporates non-chemotherapeutics, it’s administered IV and one in the presence of tissue that’s been heated to just above body temperature, it’s about 40 degrees Celsius. The Celsion nanoparticle releases its payload to create a locally high concentration of the drug at target's local regional and solutions. Our first candidate on this platform is ThermoDox, ThermoDox as the name implies as heat sensitive liposomal formulation of doxorubicin. ThermoDox is being evaluated in combination with radiofrequency ablation, that’s RFA in a global multi-center pivotal Phase 3 study of the largest unmet medical need remaining an oncology and that’s hepatocellular carcinoma also known as HCC primary liver cancer. We call our second and equally important platform TheraPlas. TheraPlas is short for therapeutic plasmids, as the name implies, this is nanoparticle based cell transfection technology has the ability to return DNA sequences, product for proteins with known anti-cancer properties, interactive agents for sustained local cellular production of the biologic for which its programmed. Our first candidate on this platform is an immunotherapy that we call GEN-1. GEN-1 actually is the production of the highly effected inflammatory protein of cytokine interleukin 12. IL-12 is well known to actively recruit the entirety of the body's…

Jeffrey Church

Analyst

Thank you, Mike. During the third quarter of 2017, we continue to efficiently utilize our cash as we effectively execute our clinical development initiatives. We ended the third quarter with $2.7 million of total cash and investments that included the completion of the $5 million registered direct equity offering of shares of common stock and warrants to the several institutional healthcare investors in July 2017. Subsequent to the end of the third quarter, this was in October we raised $17 million to the exercise that previously issued in outstanding warrants and also completed an underwritten equity offering of shares of common stock and warrants with Oppenheimer & Company, which totaled $6.6 million. This significant capital infusion will cover our projected operating needs well into the second quarter of 2019. Celsion's 2017 third quarter financials were included in the press release which we issued before the market opened this morning. Our Form 10-Q for the quarter ended September 30, also was filed this morning, we continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value. Our clinical focus remains squarely on the enrollment of our pivotal Phase III trial for ThermoDox in primary liver cancer and now the new Phase I/II clinical trial for GEN-1 in ovarian cancer. Operating expenses were $13.8 million in the first nine months of 2017, compared to $15.5 million in the same period of 2016. Cash used for operations in the third quarter ended September 30, 2017 was $5.1 million, compared to $4.7 million in the prior year. Cash used for operations in the nine months ended September 30 was $12.4 million compared to $13.7 million in the prior year 2016. These results are in line with our earlier projections and are the result of our cost reduction…

Michael Tardugno

Analyst

Thank you, Jeff. So, I will just conclude and remind you that our fundamentals are sound and our work is of major consequence. Because if we are right, we're looking at the potential for a $1 billion market for $1 billion market opportunities both in ovarian cancer primary liver cancer. Assuming we're right, we also look forward to a significant increase in our market capitalization. With both of our clinical programs designed to treat patients in the first line successful with either program will establish both a significant advance in medicine and a substantial return to our investors. With that being the conclusion of our prepared comments, I'd like to ask the operator to open the lines for your questions. And ask you limit the number of questions to more than two so that we can provide everyone with an opportunity to participate in the Q&A session. Operator?

Operator

Operator

[Operator Instructions] And we’ll take our first question Keith Markey. Please go ahead. Your line is open.

Keith Markey

Analyst

Good morning, and thank you for taking my questions, Mike, Jeff, appreciate it. I was wondering in the press release you issued this morning or I guess it was yesterday, you mentioned that you would like to enroll relatively healthy -- patients that relatively healthy immune systems in the upcoming GEN-1 study. I was wondering what criteria will you use to identify them?

Michael Tardugno

Analyst

Yes, I think what we’re trying to communicate there is these are first line patients who are, for the most part is treatment naïve, with anti-cancer agents or chemotherapies as we all know do have a detrimental effect of the immune system. So, our point there was that these patients for the most part are first line and newly treated maybe Nick, can expand on that please.

Nicholas Borys

Analyst

Yes, so for true what we’ll be looking at is that they’re going to have to have a good performance status. So definitely based on performance status one. So, you might be familiar with that. So, these are relatively healthy individuals and as said Mike, this is the first line of therapy, so their immune systems haven’t been exposed any previous chemotherapy drugs that could affect or alter give you immune systems status.

Keith Markey

Analyst

Okay. Thank you. I wasn’t sure if there was something very specific that you were going to look at possibly. And then I was also wondering if you could tell us have any of the patients in the OVATION study treated with 75 milligrams per meter square dose had any disease progression or past delays since the trial began?

Michael Tardugno

Analyst

At 79 milligrams per meter square? Do you know?

Nicholas Borys

Analyst

As far as I know those patients are the latest that we’ve enrolled. And they all did very well as you know, surgically they all had zero resections that means that after the treatment of GEN-1 and their new chemo therapy they went into surgery and the surgeon was able to remove all the tumor possible. So that was good news for those patients. We continue to follow them and we haven’t seen progression yet.

Michael Tardugno

Analyst

I would also add that, Keith, just quickly if you ask about that, none of the patients on the study have died.

Keith Markey

Analyst

That’s even better. Thank you.

Operator

Operator

[Operator Instructions] And we’ll take our next question from Barry Rubin. Please go ahead. Your line is open.

Barry Rubin

Analyst

Thank you. What is your current share count?

Michael Tardugno

Analyst

Our share count is approximately 16 million shares.

Barry Rubin

Analyst

And is there going to be any future dilutions from any one?

Michael Tardugno

Analyst

We’re not anticipating any immediately, but as far as ones that could be money. But Jeff, do you want to talk about that?

Jeffrey Church

Analyst

Yes. In addition to the 16 million shares which are outstanding we have approximately 3 million of warrants at various strike prices ranging from about $3 to about $6 and change. So, on a fully diluted basis, our shared outstanding warrants, it’s about $19 million. So, it’s $120 million on a fully diluted basis. To address the second point, I mean, we’re always going to be opportunistic, but as we indicated we have a cash run rate that takes us well into the second quarter of 2019 beyond the enrollment of the OPTIMA study and into the first preplanned interim outlook. We never said we are not going to raise additional capital, but we believe that it can certainly be done at a very attractive cost of capital, but right now $19 million on a fully diluted basis.

Barry Rubin

Analyst

May I ask the second question?

Michael Tardugno

Analyst

I would also point out this, I think it’s an important you know, our ThermoDox now was in Phase III, the study is virtually at precipice of concluding enrollment, just a little over a year away from the first interim rate. So, we’ll be -- in GEN-1, it’s showing, it continues to show the kind of clinical results that we saw in the first trial, I'm sure will be very interesting. So, I guess we'll be looking for non-diluted that means also to improve our cash balance.

Barry Rubin

Analyst

May I ask one scientific question?

Michael Tardugno

Analyst

Sure.

Barry Rubin

Analyst

Okay. If I'm correct [indiscernible] just had a product approved for liver cancer, I may be wrong but that’s what I had seen in the press is, if I’m correct what’s the difference between their product and yours?

Nicholas Borys

Analyst

I’m trying to recall the product that they got approved. I have to look into it, I mean, this is something that I haven't studied lately, but I believe that the product that they got approved is an advanced HCC. We’re looking at patients that are newly diagnosed HCC patients and which is by far the largest population. So, it's a different patient population that we’re targeting between two products.

Michael Tardugno

Analyst

Let me explain on that a little bit, I believe [indiscernible] was talking about as indicated for patients who [indiscernible] multi-kinase inhibitor and as Dr. Borys pointed out, we’re evaluating ThermoDox in first-line in combination with the first-line treatment. And we are asked often about competition for drugs that are currently in development and we know none actually at Phase III and none that are showing the kind of the promise what ThermoDox is. The point of this is that and I take it [indiscernible] an oncology that we’ll continue on for a long time and that this is, as you can cut it off, if you will, or if you can effectively, you have the same effect by burning a tumor with radio frequency ablation, you will. And what we know is this, that our phase being adopted on in many countries around the world and many medical societies around the world is an alternative to surgery. In a similar way for phase predominant first-line treatment, ThermoDox will be adopted very quickly, and there is some magic bullet that can eliminate and eradicate the tumors effectively as surgery or heat. ThermoDox would be treatment without competition in our view for a very very long time.

Operator

Operator

[Operator Instructions] And it appears we have no further questions at this time.

Michael Tardugno

Analyst

So, I want to thank all of you again for your interesting Celsion for joining us. We remain very excited about potential of our chemotherapy and immunotherapy programs. And we look forward to providing future updates as we advance the development of our pipeline. We value your continued support for our common goal of delivering innovation oncologic therapeutics to address some of the most prevalent cancers with the highest unmet need. Thanks again for joining our call. With that, we'll close our session.

Operator

Operator

This does conclude today's program. Thank you for your participation. You may disconnect at any time.