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Imunon, Inc. (IMNN)

Q1 2018 Earnings Call· Fri, May 11, 2018

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Transcript

Operator

Operator

Good morning. My name is Matt and I will be your conference operator today. At this time, I would like to welcome you to the Celsion’s First Quarter 2018 Financial Results Conference Call. [Operator Instructions] This call is being recorded. 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 first quarter 2018 investor conference call to discuss our first quarter results, which we announced this morning before the market opened. During our call today, Celsion’s Chairman, President and CEO, Michael Tardugno will provide an operational update on our clinical programs and I will summarize our financial results for the first quarter. Today’s call will be archived and a replay will be available beginning tomorrow and will remain available by phone until May 25, 2018 as well as available on Celsion’s website for 90 days. Before we begin the call, we wish to inform participants that we will be making forward-looking statements regarding Celsion’s current expectations and projections about future events. Generally, forward-looking statements can be identified by terminology such as may, should, expect, anticipate and similar expression. These terms are based upon current expectations and assumptions and are subject to a number of risks and uncertainties, including those set forth in the company’s periodic reports filed with the SEC, many of which are difficult to predict. No forward-looking statements can be guaranteed and actual results may differ materially 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 made on this conference call based on new information, future events or otherwise except as required by law. At the end of today’s formal remarks, we will open the call for questions. I would now like to turn the call over to Mr. Michael Tardugno. Mike?

Michael Tardugno

Analyst · Oppenheimer

Thank you, Jeff. Good morning, everyone and thank you for joining today’s call. With me are Dr. Nicholas Borys, Celsion’s Chief Medical Officer and Jeffrey Church, our Chief Financial Officer from whom you have just heard. As always, we are very pleased to have the opportunity to update you on our progress and to answer your questions. Now, let me start this call by reminding you that our 2018 Annual Shareholder Meeting will be held on Tuesday of next week at the Westin Hotel in Princeton, New Jersey, I would like to encourage all shareholders of record to consider joining us for the meeting if you can. If you have pleasure to see you, because as always, it’s great to meet with you in person whenever possible and we are on a great deal. Since we just held our year end call a little over a month ago, today’s conference call will be relatively brief and perhaps redundant in a few closes, but there is much worth repeating. So, let me start this call, where we ended our call in March and to remind you, I made four key points for investors to consider as Celsion entered this year 2018. Number one, we have an operationally tight focus with both conserves cash and more importantly ensures the timely events when of our two very promising clinical trials, the OPTIMA study, our pivotal Phase 3 trial of ThermoDox, a newly diagnosed primary liver cancer reminds you that’s the largest unmet medical need remaining in oncology today in the OVATION II study, a Phase 1/2 trial of our gene mediated immunotherapy GEN-1 in newly diagnosed advanced ovarian cancer patients. And number two, Celsion started the year with a strong balance sheet over 20 months worth of cash and runway sufficient to achieve…

Jeffrey Church

Analyst

Thank you, Mike. During the first quarter of 2018, we continued to execute our important clinical development initiatives with a very tight focus on our two lead product candidates. We ended the quarter with $20.8 million of total cash and investments. During the first quarter, we used approximately $4.7 million in cash in line with our current year projections. Typically, the first quarter of each year is the highest due to one-time payments with respect to respective things as annual insurance premiums for 2017 performance bonuses. Based on our budget projections, our current cash position enables us to cover our projected operating needs into the third quarter of 2019. We are pursuing additional non-dilutive capital doing innovative program offered by the state of New Jersey. This creative economic development program of Forbes companies like Celsion, the opportunity to sell is accumulated net losses to profit generating businesses. We estimate that this program could generate $10 million in additional cash to extend their operating run-rate into the first half of 2020 well beyond several important value inflection points for both ThermoDox and GEN-1 clinical development programs. Celsion’s first quarter 2018 financials were included in the press release which was issued before the market opened this morning. Our Form 10-Q for the quarter ended March 31 was also filed this morning. We continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value. We maintain a very tight focus on our pivotal Phase 3 trial for ThermoDox in primary liver cancer and the follow-on Phase 1/2 clinical trial for GEN-1 in newly diagnosed ovarian cancer patients. Operating expenses were $4.4 million in Q1 2018 compared to $4.9 million in the same period last year. This decrease is in line with our earlier projections and the…

Michael Tardugno

Analyst · Oppenheimer

Thank you, Jeff. I will conclude my prepared remarks by saying that our two drug candidates represent exciting advances in cancer research and have the potential to change the trajectory for patients with pro-prognosis. If either ThermoDox or GEN-1 shows continued positive data we have the opportunity not only to transform patient’s lives and medical practice, but the company as well. Our work is very important. Our aspirations are high and I look forward to reporting our progress this year as we continue our pursuit of effective new medicines for patients with difficult cancers. So now, I would like to ask the operator to open the line for your questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] And our first question will come from Hartaj Singh with Oppenheimer.

Emma Nealon

Analyst · Oppenheimer

Hi, good morning. This is actually Emma on for Hartaj. First, is there any update on the enrollment status for OPTIMA, I think it was about 80% last quarter?

Michael Tardugno

Analyst · Oppenheimer

Yes. So, when we continue to progress according to our schedules, we are over 86%, 87% enrolled. So, actually a little bit of both in our projections out.

Emma Nealon

Analyst · Oppenheimer

Great. And then just on GEN-1 do you plan to present the Phase 1b PFS data from OVATION at medical conference?

Michael Tardugno

Analyst · Oppenheimer

Nick?

Nicholas Borys

Analyst · Oppenheimer

Yes. We are looking at both presenting that data at a conference we are going to be discussing that which one with our investigators and also writing that up as an abstract and submitting it.

Emma Nealon

Analyst · Oppenheimer

Great. Should we expect initial announcement to come in the form of a press release or is that still kind of TBD?

Michael Tardugno

Analyst · Oppenheimer

Could you repeat that please, Emma?

Emma Nealon

Analyst · Oppenheimer

Sure. When the PFS data is available around midyear, should we expect that to first come as a top line press release or is that still to be determined?

Michael Tardugno

Analyst · Oppenheimer

Well, that would be a top line press release.

Emma Nealon

Analyst · Oppenheimer

Great. Thank you, both.

Michael Tardugno

Analyst · Oppenheimer

Thank you.

Operator

Operator

[Operator Instructions] We will now go to Edward Sherman with DSW Associates.

Edward Sherman

Analyst

Hi guys. I think you are doing a fantastic job given the resources that you have, it’s not easy to conduct two trials, but I have a question regarding the milestone payment for GEN-1 when would that be due?

Michael Tardugno

Analyst · Oppenheimer

Yes. So, the milestone payment with some referred to as contingent value rights, milestone payment that they are likely talking about is tied to achieving progress in the Phase 2 portion of the GEN-1 study in ovarian cancer. That’s not likely to happen on our current estimate. That’s not likely to happen until later in 2019.

Edward Sherman

Analyst

Great. And let me ask you this, you seek that…

Michael Tardugno

Analyst · Oppenheimer

Edward just so while running on topic, the milestone at the company’s election can be paid in either cash or stock from a combination thereof.

Edward Sherman

Analyst

Sure, right. I saw that actually. So, you say that this is one of the rare occasions where the medical community gets it before the investment community. Why do you think that is and if it’s true and I don’t mean to be critical, but what does it say about the efforts the company is making in getting the word out?

Michael Tardugno

Analyst · Oppenheimer

Yes. So, I mean – and I am not going to apologize for the efforts we spend a good deal of time in conferences and meeting with investors individually and in small groups. Getting the word out is a top priority for the company. I will have to say we are – the major portion of the investment of the company has been focused on ThermoDox over the last number of years. It’s not usual for a company to continue to develop a product particularly in the same indication following a sale of trial. So, we are not used to putting good money after that. And I can promise you the majority of us here, maybe one or two, they are qualified, but majority of us here are not candidates, but we are pretty darn good at what we do. So, just to give you a little bit more history so far on this the failure of the case study, to me this primary endpoint TFS, we took a very intense look at the data as we headed at the time with some of the most notable names in the hepatocellular carcinoma research. It appeared to us that there was a relationship between heating dwell time and an improvement in outcome in patients. So, when we pursue that and not only relied on the data from the study but also as I pointed out in my prepared remarks, we evaluated these hypotheses in computational models and in prospective preclinical models, notably in a pig model. All of that took time to be honest with you. In the meantime, on the company’s confidence in this notion that’s radiofrequency ablation was conducted with an extreme amount of variability that was not obvious to anyone when the study was – the HEAT study…

Edward Sherman

Analyst

Okay. If I may ask just one last question, there was I believe something intimated by Adam Forstein about a chart after the HEAT study that showed that after 45 minutes, the uptake of ThermoDox basically fell off the mat, so that there is no reason to believe that it would be more effective after 45 minutes?

Michael Tardugno

Analyst · Oppenheimer

Well, I am not familiar with that. And I think our research would suggest quite a bit otherwise. I would refer you to the HEAT study manuscript publication in CCR and also to our publication on [indiscernible] demonstrating the accumulation of doxorubicin, there is a function of heating dwell time in healthy livers of pigs. I think that point that you just made would be immediately dismissed.

Edward Sherman

Analyst

I am glad to hear that actually. I am glad to hear that, but if that were the case though, why if given that it’s a HEAT-sensitive liposome, why isn’t there something that you thought about prior to the HEAT study if it seemed sort of obvious?

Michael Tardugno

Analyst · Oppenheimer

Yes. So, well, maybe we should take some of this offline, but it was not – the variability in the use of radiofrequency ablation was not obvious. There was a point of discussion among our investigators and during the prosecution of the negotiation of the SPA with the FTA, we have spent a considerable amount of time on the standard of care in the application of radiofrequency ablation in newly diagnosed patients with tumors greater than 3 centimeters. It was the opinion of this group that radiofrequency ablation administered according to academic procedures was reasonably consistent throughout medical practice. And in fact, it turned out not to be. So, there was a point of discussion, it wasn’t a major oversight on the company’s part – what twice the major oversight was our lack of knowledge and I think the medical communities knowledge of how RFA was being applied. In fact, I think there maybe some embarrassment when we look back at HEAT study data, because we now know, Edward, this company, your company, if you have an investment in our stock.

Edward Sherman

Analyst

And I do.

Michael Tardugno

Analyst · Oppenheimer

Now knows more about the use of radiofrequency ablation in primary liver cancer than any other company on the planet and that was not true just when we initiated the HEAT study.

Edward Sherman

Analyst

Okay. I just want to say you guys are doing a great job. Keep it up the good work.

Michael Tardugno

Analyst · Oppenheimer

Thank you.

Operator

Operator

[Operator Instructions]

Michael Tardugno

Analyst · Oppenheimer

So operator, there appears to be no more questions. So, I am going to close the meeting and thank all of you for listening, for your attention and your interest in the company. We encourage your questions like Edward’s and for those of you on the line, the next time we get a chance to speak with you by conference call, please feel free to ask questions, particularly those that are maybe knowing actually and reading you to accept some information that may not be correct with regards to the company. So with that again, I want to thank you. We remain very excited about our prospects for 2018. You can count on this management team to keep you updated as we advance our development pipeline and we look forward to successful results. Thank you again.

Operator

Operator

And once again, this does conclude our call for today. Thank you for your participation. You may now disconnect.