Earnings Labs

Imunon, Inc. (IMNN)

Q1 2016 Earnings Call· Mon, May 16, 2016

$2.70

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Transcript

Operator

Operator

Good morning. My name is Dana and I will be your conference operator today. At this time, I would like to welcome everyone to the Celsion’s First Quarter 2016 Earnings 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 Mr. Jeffrey Church, Senior Vice President and Chief Financial Officer of Celsion. Please go ahead.

Jeffrey Church

Analyst

Thank you. Good morning, everyone, and thank you for joining us today to discuss our first quarter 2016 financial results, which we announced this morning before the market opened. Today's call will be archived. The replay will be available beginning tomorrow and will remain available by phone until May 30, 2016 and will be on Celsion’s 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 risk 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 and possible adverse action 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, Chairman, President and CEO of Celsion. Mike?

Michael Tardugno

Analyst · Maxim Group

Thank you, Jeff. Good morning. Thank all for taking the time to join us for today’s call. It’s a pleasure to be with you, particularly today as we are in Huntsville, Alabama proud to be meeting with the scientists and technicians who are responsible for the development of GEN-1, our immuno-oncology therapeutic now showing early, but nonetheless remarkable results in the Phase I trial of newly diagnosed stage 3 and 4 ovarian cancer patients. We call this study, the OVATION study. Today with me are Dr. Khursheed Anwer, Ph.D., Celsion’s Chief Science Officer, and Jeffrey Church, from whom you’ve just heard, our Chief Financial Officer, Dr. Borys - Dr. Nick Borys, just back from meeting with our OPTIMA Study TIs in South Korea, is on the line in Lawrenceville and will be available to take questions. I’d like to start by saying that we could not be more pleased with our product portfolio and progress we are making and investments that we have made in GEN-1, our gene-based therapeutic. For those of you who have been following Celsion, you know that we are an oncology-focused development stage company with two of our three technology platforms in the clinic, one in chemotherapy, and one in gene-mediated immunotherapy. For today’s call, we will focus on the two very important, and I’d say highly promising clinical trials for the product candidates that have been developed from these platforms. The first is our neoadjuvant study in first-line ovarian cancer that I just spoke of, the OVATION study combining GEN-1 with standard of care therapy followed by interval debulking surgery. The second is the primary liver cancer OPTIMA Study of first-line Phase III global study of ThermoDox in combination with radiofrequency ablation that has been standardized to a minimum of 45 minutes of time interval…

Jeffrey Church

Analyst

Thank you, Mike. Our balance sheet is well capitalized. We continue to operate in an efficient manner. We ended the first quarter with over $14.3 million in total cash and investments compared to $20 million in cash at the end of 2015. For the first quarter ended March 31, 2016, we reported a loss of $5.7 million or $0.24 per share, compared to a net loss of $7 million or $0.35 per share in the same first quarter of 2015. Cash used for operations in the first quarter of 2016 was $4.7 million. This compares to $5.9 million in the same period last year. This $1.2 million decrease was the result of cost reduction efforts implemented last year, a tighter product development focus and prudent cash management. We operate with a lean organizational structure with only 27 FTEs or full-time equivalent employees. Over 80% of our spending is directed to research and development activities and I would say the majority is more development than research. Historically, our cash usage in the first quarter of each year is the highest due to certain one-time payments. We expect moving forward that our quarterly cash used for operations will be between $3.5 million and $4 million for the balance of the year. As we look forward, we believe that a strong balance sheet is not only in the interest of our shareholders, but it’s vitally important to the continued strong development momentum we have built. We reported in our last call that we implemented a reorganization following the full integration of our EGEN operations. We evaluated our current organizational structure and have aligned our resources and clinical programs with our near-term development objectives. We have tightened our development focus on OPTIMA and Euro-DIGNITY for ThermoDox and advancing GEN-1 in ovarian cancer. As a…

Michael Tardugno

Analyst · Maxim Group

Thanks, Jeff. Thank you very much. Excellent, Jeff, that’s a good summary. I hope people on the line will appreciate the length that the company goes to make sure that the cash resources we have are being devoted in most effective ways to advance our development programs. In particular now that we are in the clinic in the research and development particularly, development that never takes a straight-line, takes sometimes a little surprise left or right. And I hope you can tell that we have – for the most part, passed those hurdles. Now with the pivotal trial, well informed, well understood in Phase III and one of the most promising, immunooncology agents being currently evaluated in the clinic, we could not be happier. And I hope – I mean, we couldn’t be happier to be with you to present the status of the company and it’s truly delightful. So we enjoy the – and value the support of our shareholders. We look forward to providing you with updates in the coming months for both ThermoDox and GEN-1 programs and significant events as they develop. We anticipate for the remainder of the year – the remainder of the year will be productive, specifically for ThermoDox, we expect to see additional OS data from the each study we are going to conduct in another overall survival suite. Perhaps, this will be the last one, we are going to focus on the China cohort which some of you may recall, the China cohort came into the HEAT study at the very end. We are looking to see the median early data from this cohort is promising indeed. We are hopeful that that will continue – I’d tell you, I look forward to presenting the results from that suite as soon as we…

Operator

Operator

[Operator Instructions] We will take our first question from Jason McCarthy with Maxim Group.

Michael Tardugno

Analyst · Maxim Group

Good morning, Jason.

Jason McCarthy

Analyst · Maxim Group

Hi, guys. Hi, how are you? Congratulations on all the progress. We are big supporters of GEN-1, we think it’s really an innovative approach and I just wanted to touch on something that wasn’t talked about as much, TheraSilence, so maybe you can give us an update on the plans in lung cancer and some other indications, I think, particularly in the lung, [indiscernible] to the lung and we think you have a good product there. So you can give us an update that would be great. Thanks.

Michael Tardugno

Analyst · Maxim Group

Sure, happy to do so. We didn’t spend a lot of time on it. So, TheraSilence is based on a technology platform that was developed here in Huntsville. But the beauty of it is, it has a specificity it can deliver on a therapeutic RNA with specificity for the lung. Not perfect in that sense, but the vast majority of the therapeutic RNA ends up in the lung and we see that through multiple pre-clinical studies including we have some very impressive data in the non-human primary. So, we do not own the therapeutic piece of this therapy. It’s being developed by companies who have a focus in RNA therapeutics. We are most interested in working with two companies – we have been working, frankly with two companies who have anti-miRs, one of which or one company which has a – actually a cocktail of three anti-miRs that appear to affect the proteins that support the growth and metastases of cancer cells. Early pre-clinical data, we are not prepared to share with you yet, but only I can say this is from our perspective, very encouraging, it’s safe, and very encouraging in tumor inhibition studies. We are presenting and reviewing this data with our development partner assuming we have concurrence on the value of this program so far. It would not be out of the question for us to be announcing publicly a formal development program funded jointly by our two companies.

Jason McCarthy

Analyst · Maxim Group

Thank you very much.

Michael Tardugno

Analyst · Maxim Group

Thank you.

Operator

Operator

[Operator Instructions]

Michael Tardugno

Analyst · Maxim Group

Come on you guys, I don’t want to stop that easy. Is there anybody? Okay, well, operator, if there are no more questions, I’ll just conclude. I want to thank everyone once again for joining us for today's call as Celsion continues to make great progress in its mission to bring ThermoDox and GEN-1 through the rigors of well managed clinical programs globally. Ultimately, our goal is to bring these two products to market to physicians and more importantly to patients and their families globally to treat some of the most difficult cancers of our lifetime. Again, thank you very much. We look forward to speaking with you on our next conference call.

Operator

Operator

That does conclude today’s presentation. We thank you for your participation.