Earnings Labs

Imunon, Inc. (IMNN)

Q4 2017 Earnings Call· Tue, Mar 27, 2018

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Transcript

Operator

Operator

Good morning. My name is Evan, and I will be the conference operator today. At this time, I would like to welcome you to the Celsion Fourth Quarter 2017 Earnings Conference Call [Operator Instructions]. Following the speakers’ remarks we will have a question-and-answer session [Operator Instructions]. At this time, I would like to turn our conference 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 year end investor conference call to discuss our 2017 results, 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 fourth quarter and the full year ended December 31, 2017. Today’s call will be archived and a replay will be available beginning tomorrow and will remain available by phone till April 10, 2018, as well as available on Celsion’s Web site 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 expect, anticipate, believe and other similar expression. These statements are based on current expectations 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. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. At the end of today’s formal remarks, we will open the call for questions. Now, I’d like to turn the call over to Mr. Michael Tardugno, Celsion’s Chairman, President and CEO. Mike?

Michael Tardugno

Analyst · Oppenheimer. Please go ahead

Thank you, Jeff. Good morning, everyone, and thanks for joining today’s call. With me are Dr. Nicholas Borys, Celsion’s Chief Medical Officer and Jeffrey Church, our CFO from whom you’ve just heard. As always, we are delighted to have the opportunity to update you on our progress and to answer your questions. I’d like to start this morning by saying as we noted in our press release; Celsion had an exceedingly productive 2017 substantially strengthening our balance sheet, while making meaningful progress with our ongoing clinical programs in primary liver cancer and ovarian cancer; entering 2018 with over $25 million in cash and investments; expecting to complete enrollment in our pivotal Phase III trial of ThermoDox and the largest unmet medical need in oncology; and moving aggressively to confirm our very impressive early clinical data with a randomized study of our gene mediated immunotherapy GEN-1 in newly diagnosed advanced ovarian cancer patients. We are well positioned. Positive data from either of these programs will be transformative for the medical community, for patients, and most certainly for Celsion’s shareholders. I’ve every confidence that 2018 will prove to be the milestone year for the Company, this may be our year. For those of you who are new to Celsion, I’d like to start by providing a high level overview. Celsion is an oncology focused development stage company with two platform technologies, both of which have product candidates in clinical trials. The most advanced technologies are novel heat sensitive liposome that incorporates well known approved chemotherapeutics. It is administered intravenously, circulating the liposomes through the blood vessels. When they come in contact with the target tissue that’s been heated just above body temperature, that’s above 40 degree centigrade, the nanoparticles released their payload to create a locally high concentration of the drug that…

Jeffrey Church

Analyst

Thanks Mike. During the fourth quarter 2017, we continued to efficiently deploy our cash as we execute our important clinical development initiatives. We ended the year with $24.2 million of total cash and investments. We further strengthened our balance sheet with the modest $1.3 million equity raise of our ATM facility with Cantor Fitzgerald in January 2018. During the fourth quarter, we raised $17 million through the exercise of previously issued and outstanding warrants at their original struck prices completed an underwritten equity offering of shares of common stock and warrants totaling $6.6 million and selectively sold another $3.9 million of our common stock of the ATM facility in November 2017. As Mike mentioned, based on our current budget projection, this significant capital infusion enables us to cover our projected operating needs into the third quarter of 2019. Celsion’s 2017 financials were included in the press release, which was issued before the market opened this morning. Our Form 10-K for the year ended December 31, 2017 with audited financial statements we’ve 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 tight development focus on our pivotal Phase III trial for ThermoDox in primary liver cancer and the following Phase I/II clinical trial for GEN-1 in newly diagnosed ovarian cancer patients. Net cash used in operations for the year ended December 31, 2017 was $16.6 million. This compares to $18.4 million in the prior year. Also during the year, we paid off our venture debt facility with Hercules. Currently, we have no debt on our balance sheet. Operating expenses were $19 million in 2017 compared to $21.2 million in the same prior year period. This decrease is in line with our earlier projections and…

Michael Tardugno

Analyst · Oppenheimer. Please go ahead

Thank you, Jeff. Before I make my concluding remark, operator, would you -- I just want to do a telephone check, I got a notice here that our Internet went down. Can you hear us?

Operator

Operator

Yes, I can.

Michael Tardugno

Analyst · Oppenheimer. Please go ahead

Yes, thank you. So Jeff, thanks for that summary, terrific as usual. I’d like to conclude my prepared remarks by reminding you that our fundamentals are sound, our work is of major consequence. If successful, we’re looking at a large potential market opportunity in both primary liver cancer and ovarian cancer. With both of our clinical programs designed to treat first line patients, success with either program will establish both a significant events for patients and position the company for success. Now, that’s the closing of our prepared comments. So I’d like to ask the operator to open the lines for your questions. And please limit them to no more than two, so that we give everybody the chance to ask a question. Operator?

Operator

Operator

[Operator Instructions] Our first question comes from Hartaj Singh from Oppenheimer. Please go ahead.

Unidentified Analyst

Analyst · Oppenheimer. Please go ahead

On GEN-1, could you just walk us through the FDA’s comments on the OVATION II protocol, and then what specific changes you’ve made to the study design?

Michael Tardugno

Analyst · Oppenheimer. Please go ahead

Nick, you want to do that. Let me just make -- there weren’t a lot, I want to just make sure we capture the major ones.

Nicholas Borys

Analyst · Oppenheimer. Please go ahead

The FDA basically asked us to make the study a bit more robust. And specifically, they were asking us to collect the overall survival data. And our primary endpoint in that study is progression free survival, and FDA said please add the overall survival data to this, so we complied with them.

Unidentified Analyst

Analyst · Oppenheimer. Please go ahead

And then just one follow-up. Do you plan to continue to provide updates on PFS for the patients in OVATION I, particularly those in that highest dose cohort?

Nicholas Borys

Analyst · Oppenheimer. Please go ahead

Yes, Emma, so we’re following on all the patients obviously have been treated. We’ve been following them for survival -- I mean for progression. We’ll continue to do so till the last patient is progressed, if in fact they do progress. So we will be reporting on these patients throughout the coming year.

Operator

Operator

[Operator Instructions] There appears to be no other questions at this time.

Michael Tardugno

Analyst · Oppenheimer. Please go ahead

So I’ll just the close by saying, we remain a very optimistic, both of our clinical programs showing on significant promise. We remain very excited for the potential of ThermoDox to show a positive result in the early part of 2019. Now we look forward to providing you with updates in the future and as we advance our development pipeline, look forward to our press releases and our next conference call. Again, thank you for joining us for today's call.

Operator

Operator

This does conclude today’s conference. Thank you for your participation. You may disconnect.