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Imunon, Inc. (IMNN)

Q4 2014 Earnings Call· Thu, Mar 12, 2015

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Transcript

Operator

Operator

Good morning. My name is Katherine, and I will be your operator for today. At this time, I’d like to welcome everyone to Celsion’s Fourth Quarter 2014 Financial Results 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 proceed.

Jeffrey W. Church

Analyst · Griffin Securities

Thank you. Good afternoon, everyone, and thank you for joining us today to discuss our fourth quarter 2014 financial results, which we announced this morning. Today’s call will be archived. The replay will be available after 2 P.M today until Thursday, March 26, 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 pursuing to the Safe Harbor Provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, the risk of clinical failures, delays or increased costs, unforeseen changes in the cost for research and development activities; possible acquisition of other technologies, assets or businesses; and possible adverse action by 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 up for questions. I’d like to turn the call over to Michael Tardugno, Chairman, President and CEO of Celsion. Mike?

Michael H. Tardugno

Analyst · Griffin Securities

Thank you, Jeff. Good morning, everyone, thank you for joining us today. 2014 certainly has been an exciting and transformational year for the company. And I am pleased to have the opportunity to update you on our recent progress. So I’ve a lot to cover this morning as we made a great deal of progress and so I’d ask you just to bear with me. Of our many important accomplishments this past year foremost among them is the successful acquisition of EGEN, They call EGEN this marvelous biology based early stage development company in Huntsville, Alabama. Our acquisition strategy targeted to partner with a strong R&D platform that was also a great synergistic and strategic fit for Celsion. In just a few months the acquisition is more than moved up to our expectations for presenting us with a range of new business opportunities moving forward. With the acquisition Celsion enters 2015 all at once as I like to say all at once, as a fully integrated development stage company with proven capabilities and experience from feasibility to NDA, from the bench to the market and everything in between. More importantly, we are now extremely well positioned to make significant progress related to our platform technologies and chemotherapy, immunotherapy and RNA therapy with programs and virtually every stage of development targeting some of the most globally important forms of cancers of our life time. Our position now means that we have multiple opportunities to create value for our shareholders, as we bring each of our programs forward into important clinical research over the next 12 months. We have a portfolio of highly complementary assets, oncology focused based on nanoparticle technology all with first line therapy potential and combination with the standard of care. And as we all know how valuable the…

Jeffrey W. Church

Analyst · Griffin Securities

Thank you, Mike. Starting with cash, we’ve reported total cash and investments at December 31, 2014 of $37.1 million, as compared to $43.1 million at the end of 2013. Our cash position reflects the proceeds from an equity offerings in January 2014, along with the second draw in June 2014 of $5 million under our Hercules loan facility. We have maintained a strong cash position since the beginning of 2014 even with the initiation of the global OPTIMA Phase III pivotal trial and broadening our product pipeline through the June, 2014 acquisition of EGEN. Our current cash balance puts us in a strong financial position to advance the development of our expanded product pipeline. We have strong financial controls in place driven by annual budget process and monthly financial reporting systems to ensure each programs contributes to the achievement of our corporate objectives, product development initiatives and business strategies. Net cash used for operations was $21.4 million in 2014 which is approximately $1.8 million per month, this compares to $9.5 million for 2013. This increase is due to higher operating cost related to the initiation of the OPTIMA study, the inclusion of post acquisition operations of EGEN and the one time acquisition cost associated with this acquisition. In addition, cash used in operations during 2013 was favorably impacted by a $5 million technology transfer fee which we receive from Hisun, our Chinese manufacturing partner. Our cash uses is estimated to reach approximately $2 million per month with the full implementation of the OPTIMA study and the integration and clinical development of the newly acquired assets from EGEN. Our current cash is projected to support operating activities for the next to years, well pass the announcement of many key development milestones and anticipated partnering activities which Mike spoke about earlier. Research…

Michael H. Tardugno

Analyst · Griffin Securities

Thanks Jeff. As Jeff mentioned our cash position is strong it will take us through some meaningful milestones and business developments over the next few years. Over the past year we have been focused on identifying and advancing the most promising opportunities for the company. Once that will not only create significant value for our shareholders and leverage our development capabilities but also offer and importantly offer meaningful treatment advances for patients, that’s what we are here for. We are now committed to executing our clinical and business guarantees around each of these opportunities in over the next few months we will begin to see these initiatives and goals come to fruition. We expect to report progress with our efforts in Europe for RCW breast cancer and receive expected approval from the CFDA to launch the OPTIMA study in China. In addition, we defined our path forward for GEN-1 in both ovarian and glioblastoma cancer indications. And we look forward to sharing more data from these programs in connection with scientific presentations, well also advancing these programs into important clinical trials. We are well-positioned, positioned to execute our strategy with the strong balance sheet, improving development capabilities to bring forward the diverse set of first line therapies that address some of the most underserved cancer indications world-wide. Primary liver cancer, recurrent chest wall breast cancer, ovarian cancer, glioblastoma multiforme among them. As always, we greatly appreciate your interest in the company and look forward to updating you on our progress as we continue to move forward with these very important clinical programs. Now I’d like to go to questions operator, so I’d ask you to the audience to limit them to no more than two so that everyone can have an opportunity to get answers to their questions. So operator, I would like you – ask you to openthe line please.

Operator

Operator

Yes, sir. [Operator Instructions] Our first question comes from Keith Markey with Griffin Securities.

Keith A. Markey

Analyst · Griffin Securities

Good morning Mike and Jeff.

Michael H. Tardugno

Analyst · Griffin Securities

Good morning Keith.

Jeffrey W. Church

Analyst · Griffin Securities

Good morning.

Keith A. Markey

Analyst · Griffin Securities

You had a very busy 2014. I was just wondering if you could - if you are going to continue your analysis of the HEAT Study population to give us further updates or just more or less the end of that post study analysis.

Michael H. Tardugno

Analyst · Griffin Securities

So our inclination is to continue the analysis Keith. The subgroup that we are following has not reached the median unbelievably. Nick, do you want to add anything on that. Nick Borys is here with us.

Nicholas Borys

Analyst · Griffin Securities

Hi, Keith.

Keith A. Markey

Analyst · Griffin Securities

Hi, Nick.

Nicholas Borys

Analyst · Griffin Securities

Yes, we are going to continue the OS sweeps until we cross the median, this will be very helpful not only to reestablish the importance of the HEAT data, but also help us predict the outcome of the OPTIMA Study as well.

Keith A. Markey

Analyst · Griffin Securities

Yes, I had a feeling that it might have an effect on your estimated time for the OPTIMA Study. Also there is been some speculation that Chinese FDA might grant some sort of an approval based upon the HEAT Study population. I was just wondering in light of that 59% survival benefit you recently reported, you see some movement on their side toward some kind of an approval for you?

Nicholas Borys

Analyst · Griffin Securities

Well, there is precedent for that Keith. I don’t know that we can speak specifically to a strategy in that regard, but we’ve seen recently that drug-eluting beads, doxorubicin-eluting beads were approved with some very limited data, data that would probably not be easily accepted by the regulatory community in other countries. And the rationale behind that I suspect is that in China there are over 400,000 new cases of HCC every year. And so a regulatory authority like the CFDA has a responsibility not only to ensure that the drug products are both safe and effective, but also responsibility to where they see an opportunity to advance the state-of-the-art in medical treatment. We’ve also seen a second example where the - if I can say this, this may not be the appropriate way to think about it, but for the relative [indiscernible] approval has been lowered. FOLFOX was recently approved to treat HCC patients and I believe it was a subgroup analysis or a follow-on analysis following a failure to meet a primary end point in its original study. And I do not believe if I recall the data that the clinical benefit for us is overwhelming, but there was clinical benefit. So there is precedent and I think that precedent is not because the CFDA is loose or in its standard for approving drugs and in fact we know that they’re following U.S. FDA policy almost perfectly. But there is an exception here, they have got an exceptional situation obviously at that way with an epidemic of primary liver cancer and it’s only going to get worse. So would there be an opportunity for us to discuss the potential based on the subgroup analysis and assuming that we will conducting a conformational study using a cohort of Chinese sites and I don’t want to speculate with you, but certainly is an intriguing opportunity.

Keith A. Markey

Analyst · Griffin Securities

Certainly it sounds like one that they would benefit from. Thank you very much.

Michael H. Tardugno

Analyst · Griffin Securities

Thank you.

Operator

Operator

Thank you. I will continue on with Daniel Brims with Cantor.

Daniel Brims

Analyst

Hi, thanks for taking the question. When you are doing the ovarian study, why did they stop the study before reaching in MTD and from preclinical date do you expect to reach pretty much a plato in the IL-12 levels at the level that you stop dosing it?

Michael H. Tardugno

Analyst · Griffin Securities

Yes, that’s a great question I think I want to answer the first half of it and I’ll ask Dr. Borys to answer the second half if we haven’t answered. So when we close down the acquisition this study has not get completed its full cohort for treating patients? We petition the GOG to continue this study and doses that they ended up with 36 milligram per meter square in comparison nearly delivered GEN-1. It reached the label claim for Doxil I think it was 40 milligrams per meter square maybe 50, but that was the protocol, that’s the protocol we allowed for those dosing levels. We have petition to continue the study beyond that and even offer to pay, full pay the cost to do so. The administrative machinery at GOG just the administrative machinery at GOG because indeed we have the support of the treating physicians. Concluded that we have reach the protocol, we ended the protocol that was in. I can’t give you a better answer was kind of frustrating to us. In fact the Phase I study that were contemplating, the neo-adjuvant study that were contemplating likely would be a designed quite a bit differently and we have hired those to start with.

Daniel Brims

Analyst

All right.

Michael H. Tardugno

Analyst · Griffin Securities

Yes the second part of your question, what was it?

Daniel Brims

Analyst

No that kind of answers the question, and the second question was with the studies that you are planning that are along with or doing basically having an anti-angiogenic component to them, can you elaborate on those more?

Michael H. Tardugno

Analyst · Griffin Securities

And you are talking about Avastin.

Daniel Brims

Analyst

Yes.

Michael H. Tardugno

Analyst · Griffin Securities

Yes, so we have some preclinical data that demonstrates that GEN-1 or IL-12 formulation of therapies are in combination with Avastin in a murine model has a remarkable effect in tumor inhibition studies, remarkable. And I think that - you know the logic there is pretty obvious to me, the mechanisms being potentially very synergistic in limiting the angiogenesis in tumor latent tissue. I think Nick would you have anything more to add to that?

Nicholas Borys

Analyst · Griffin Securities

Yes, I think that’s basically big, so we saw very promising date in the preclinical models, we know that GEN-1 works better in combination particularly with other anti-angiogenesis drug such as [predicament] and we are moving forward on that program and to go back to your last question as well, we are looking at immune markers in the patients from the GOG study and we should have that data as well in the near future. So we’re anticipating we’ll some sort of dose response effect with the immune markers.

Daniel Brims

Analyst

All right. Thank you.

Michael H. Tardugno

Analyst · Griffin Securities

Thank you, Dan.

Operator

Operator

Thank you. [Operator Instructions] and with no additional questions, I would like to turn the floor back over to our speakers for any additional or closing remarks. I beg your pardon. We do have an additional question. Mr. Benjamin with H.C. Wainwright. Please go ahead.

Reni J. Benjamin

Analyst

Hi good afternoon.

Michael H. Tardugno

Analyst · Griffin Securities

Good morning.

Reni J. Benjamin

Analyst

Good morning guys and thanks for thanks for taking the questions. Just very quickly, could you give us a sense of some sort of an enrollment update on OPTIMA and just how many sites you think could be on, you know could come on over the quarters or this year?

Michael H. Tardugno

Analyst · Griffin Securities

Yes I'm happy to do that. So we’re very much on tract with our original plans, I mean the goal is to lead this year at a run rate that allows us to complete study within 24 months of the end of this year. We’ve been saying all along it would be - now about 36 months from the time we gain some traction. So we are very much on track with that - we’ve identified now 72 sites that we believe not only have the capability, but have shown patient population and the skill. I mean you got to use our name correctly. About two-thirds of those sites have been initiated they are up and running. The majority of the balance of those sites are associated with China, so the key issue here is getting China up. The Chinese CFDA is very transparent, they have a website that allows companies like ours or anyone to public to follow the progress of the submissions for various regulatory review and approval. Disappointingly it’s taken us about four, five months longer to get approval in China. Now withstanding that we still remain on track with our enrollment rights, but the study now is in the hands of the reviewer, we’ve seen that on the website, and we expect about a two-month turnaround or two-week turnaround on the review then a formal response within 30 days there after. So that would put us in the May timeframe and based on our latest projections it’s a little bit better than what we expect - well, our updated projection is a little better than we expected. We would like to finish this year, let me just tell you this, so our goal is to get to a run rate of somewhere between 17 and 20 patients per month based on our current run rate and what we expect from China that certainly should be achievable in the September, October timeframe. So we’re still good, now these things are completely predictable as you know, but we probably have a better sense that most because we’ve been down this path before in a particular - the majority of the sites been - are enrolled in the study are those that we’re very familiar with.

Reni J. Benjamin

Analyst

Got it. Just switching gears to the TheraSilence platform, can you talk a little bit or provide a little bit of color regarding kind of the ongoing I don’t know if you want call it collaborations or discussions or just some color regarding the ongoing work with potential partners as they evaluate the platform. I mean are these material transfer agreements or how should we be thinking about it?

Michael H. Tardugno

Analyst · Griffin Securities

I think you should think about them is research agreement or MTAs, Material Transfer Agreements. The most recent series of experiments were conducted with a - and we no we are under certain confidentiality, we are conducted with a company we assume you would be quite familiar. We share the costs of approximately 50/50, that data was conducted in non-human primates or the study is conducted in non-human primates, the date is disproprietary, but we own it jointly we are not able to speak to it directly with all. But all I can say is that we were at this point that I can say is that we were delight with not only the evidence of lung specificity, but also in this limited number of animals the safety component. Now where does that go? So that’s just one and there is another that we refreshed actually to be honest with you and multiple collaborations that were conducted before we join these two companies together. There are 200 companies that we are refreshing our research programs with and both of them have seen some in the earlier research collaborations it seem some very positive. I think the word I use was clinical results that this technology in fact does concentrate RNA is the lung almost with the exclusion of every other organ. And I think we are seeing it of the top anyways CEO or a great deal of interest and rekindling the development programs maybe some reconfirmation is necessary I am not sure, but certainly there is enough interest in the mechanism here. It’s not only the location, but it’s the mechanism. We will probably talk more about that and we are planning at an upcoming R&D Day. That creates an interest that we do have a very potentially a very productive platform for delivering RNA to treat a variety of lung disease so.

Reni J. Benjamin

Analyst

Terrific. Thank you very much and good luck.

Michael H. Tardugno

Analyst · Griffin Securities

Thank you. End of Q&A

Operator

Operator

Thank you. And again with no additional questions. I’ll go ahead and turn things back over to our speakers for any additional or closing remarks.

Michael H. Tardugno

Analyst · Griffin Securities

Well I want to thank everyone for taking the time to join us and for your patience and hopefully your interest in listening to the conversation that we’ve had with you this morning. As you can see this company has been very focused on multiple opportunities, we are building a great deal of momentum. I would like to say to the team here putting a great deal of water behind the dam. As we look forward to 2015, I think you can expect from us a great deal of dialogue and press announcements as we achieved various milestones going forward. We are well positioned to execute our strategy, our balance sheet is strong and with your support we continue to believe that we can make a difference in treating cancer patients. Thank you very much, we look forward to our next conference call.

Operator

Operator

Thank you. And again ladies and gentlemen that does conclude today’s conference. Thank you all again for your participation.