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Imunon, Inc. (IMNN)

Q2 2018 Earnings Call· Tue, Aug 14, 2018

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Transcript

Operator

Operator

Good morning. My name is Terence and I will be your conference operator today. At this time, I would like to welcome you all to the Celsion Second Quarter 2018 Financial Results 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 go ahead, sir.

Jeff Church

Analyst

Thank you. Good morning, everyone. And welcome to our investor conference call, to discuss our second quarter 2018 results, which we announced this morning before the market opened. During our call today, Mr. Mike Tardugno, Celsion’s Chairman, President and CEO will provide an operational update on our clinical programs and I will summarize our financial results for the second quarter ended June 30, 2018. Today’s conference call will be archived and a replay will be available beginning tomorrow and will remain available by phone until August 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, forward-looking statements can be identified by terminology such as expect, anticipate, believe and other similar expression. These statements are based upon current 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. 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. I’d now like to turn the call over to Mike.

Mike Tardugno

Analyst

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 Chief Financial Officer from whom you just heard. As always, we are very pleased that we have the opportunity to update you on our progress and following our prepared remarks to answer your questions. I want to start this morning by saying we could not be more pleased to report that the company is sound on the fundamentals and with a solid cash position we expect to continue to meet our objectives frankly and with a great deal of confidence. I think it's safe to say that Celsion is well-positioned. And for those who have been following us, you know that our goals have been consistent and that we have made steady and demonstrable progress towards those ends. Our plans worth repeating again from last quarterly conference call during which I said that number one, we would maintain an operationally tight focus to ensure efficient cash utilization and timely achievement and development milestones. Number two we would maintain a strong cash balance sheet with a financing strategy focused on enhancing shareholder value and providing a cash runway to critical inflection points, including data analysis from our phase 3 trial in HCC in our phase 1 portion of our phase 1, two study in ovarian cancer. And number three that we are committed this company is committed to a steady news flow of key developments. So let me translate for you these objectives into our real life accomplishments. With regards to our second quarter expenses I don’t want you to be misdirected. We will not enhance the risk on the spending line on the financial section of today's earnings announcement. I want to point out…

Jeff Church

Analyst

Thank you, Mike. Details regarding Celsion second quarter 2018 financials were included in the press release and Form 10-Q made available this morning. As Mike mentioned we continue to make strong steady progress in advancing our two key clinical program and we continue to be focused on efficient cash management to ensure successful execution. As of June 30, 2018 Celsion’s cash balance was $26.3 million, providing us 6.5 quarters of operating runway, enabling us to continue to focus on clinical and operational execution into the first quarter of 2020. In June we closed on a four year $10 million venture debt agreement with Horizon Technology Finance Corporation, for which the first two years this obligation is interest payment only and net proceeds from this debt financing are included in our June 30th cash balance. This debt agreement provides additional flexibility to finance our development programs and operating needs at an interest rate of less than 10% at a very modest warrant coverage. We are also pursuing other financing initiatives and tools to further bolster our capital position and to finance the company's clinical trials; to that end I am pleased to say that an application to sell our net operating losses based in New Jersey has been expected and on this past Friday, August 10 the Board of the New Jersey Economic Development Association recommended the application for approval. This avenue of nondilutive financing has made available to us under unique economic development program initiatives by the state of New Jersey and should allow us to receive up to $8 million to $10 million in nondilutive capital from the sale of New Jersey-based NOLs for tax years 2011 to 2017. Actual amount that we will receive this year will be determined by the state and will be dependent on how…

Mike Tardugno

Analyst

Thank you, Jeff. As always a very nice overview. Our ThermoDox and GEN-1development programs continue to make significant progress as you can see we remained steadfast in our objective to deliver transformative new medicines for patients with HCC and ovarian cancer, we’ve a number of important milestones ahead in the coming months and I look forward to reporting them to you along with our progress. This concludes our prepared remarks for today so I’d like to ask the operator to open the lines for your questions and please no more than two to give everyone a chance to ask questions. Operator?

Operator

Operator

[Operator Instructions] The first question comes from Hartaj Singh.

Unidentified Analyst

Analyst

Hi, this is Anna on for Hartaj. Just on the OpEx side from the non-cash spending that you decided this quarter can you just help us thinking about the R&D spend and whether this is now a reasonable runway going forward into the second half of the year and into next year as well?

Jeff Church

Analyst

Excluding the non-cash charges, we believe that our R&D expenditures remain on track and in line with our previous guidance somewhere in the neighborhood of 4 million a quarter. We tend to spend a little bit more in the first half of the year and with the completion of enrollment to the OPTIMA study, we still expect to see our annual spend in the 16 million pretty much in line with the split between R&D and G&A expenditures.

Operator

Operator

Our next question comes from Edward Sherman.

Edward Sherman

Analyst

On the PFS data from the OVATION Ib study are we awaiting the data from the patients who are in the highest dose cohort?

Mike Tardugno

Analyst

I think more than just on highest dose cohorts are common.

Jeff Church

Analyst

Yes that’s probably the majority of the patients, that we’re waiting for and that we’re still keeping track of in that last dose but there’s I think there’s a handful more in the middle doses as well.

Edward Sherman

Analyst

Okay, thank you. Does that -- I would think that bodes well for the subsequent trial given the increase in dose?

Mike Tardugno

Analyst

Yes I am with you.

Edward Sherman

Analyst

Mike you had mentioned back in March that we would be awaiting a publication from the NIH regarding their post hoc analysis any idea when that might come?

Mike Tardugno

Analyst

I don’t -- we talked to the NIH just not too long ago Dr. Borys and I and they told us that would be submitting the manuscript here shortly. They did not identify the journal for us so we just rely on their testimony here that they’re submitting their manuscript for publication. I suspect that they will be done, if nothing else, researchers, particularly those in the academic setting are very focused on getting public attention.

Edward Sherman

Analyst

Just one last question, I had a hard time believing that you can still be on schedule given your -- you had stated back in the last conference call that you expected the initiation of the trial within a couple of weeks which most people took to mean the beginning of June we’re now in the middle of August, a patient has not been randomized, almost three months delay how can you expect to be on track?

Mike Tardugno

Analyst

So what I said, we would be on track for initiating the phase II portion later next year and I also mentioned in the prepared comments that in order to be able to do that we had planned to conduct the phase 1 portion with four sites, now we’re adding two more sites, so we would be adding a total of six sites to complete the phase 1 portion.

Edward Sherman

Analyst

And you think that will make up for three-month delay.

Mike Tardugno

Analyst

We have more patients being evaluated for inclusion in the study with an increase in number sites so on order to move to the phase two portion we have treated total of six patients in the therapeutic arm and will be accompanied by probably six patients but it could be fewer, in order to complete the phase 1 portion. And so with six sites, we expect to be able to able to get that done. I don't have a crystal ball. I can tell you what our operating plans are and what that history has been.

Edward Sherman

Analyst

Okay all right look forward to it, thanks.

Jeff Church

Analyst

And you should take comfort in the fact that management is recognized at we just, we should manage our cash in combination with the execution and were going to take steps, proactive steps to attempt to catch up if not exceed our plans and study.

Edward Sherman

Analyst

No and I appreciate that I just think you need to appreciate the fact that people take your word literally and when you under promise or overpromise and under deliver in a company that has some credibility concerns, you know you can see what happens to your stock. So maybe next time.

Mike Tardugno

Analyst

Maybe next time what?

Edward Sherman

Analyst

Maybe next time don’t overpromise, don't say two weeks is going to be the initiation when three months pass and nobody knows what’s going on.

Mike Tardugno

Analyst

I’m not going to debate it with you, study was initiated in two weeks, we did have sites up and running in June.

Edward Sherman

Analyst

I’m not trying to be combative, I’m just saying. Okay thank you.

Operator

Operator

[Operator Instructions] There are no further questions in the queue, I would like to turn the call back over to you speakers.

Mike Tardugno

Analyst

So again I want to thank you everyone for joining us on today's call and for your interest in Celsion. As I started this call I want to conclude with the same comments that we continue to make significant progress, we have a strong balance sheet and Celsion as you can see is positioned for success. Thank you again. We look forward to talking with you on our next conference call.

Operator

Operator

Thank you ladies and gentleman this concludes today’s conference. You may now disconnect.