Imunon, Inc. (IMNN) Q4 2014 Earnings Report, Transcript and Summary

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.

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?

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 first line can be in treating oncology patients. This is a population that’s generally in that respect often treated with an intent to cure. And who are much more likely to join a clinical trial particularly if the standard of care is also included in the treatment protocol. I’d point out also the ideal candidates for immunotherapy research, the immune systems not having been insulted with prior chemotherapy treatment. The pipeline that we acquired with EGEN has brought us the promising lead to immunotherapy candidate most significantly broadening our comprehensive development strategy. That candidate, we call GEN-1. GEN-1 is an IL-12 DNA plasmid incorporated into our proprietary non-viral vector a synthetic polymer nanoparticle delivery vector. This system, which we call TheraPlas is definitively demonstrated a capability to promote transduction of its plasmid payload into human cells. The cellular machinery [indiscernible] taken over to produce and enable persistent and durable local secretion of the cytokine interleukin-12 or IL-12. The activity lasted for several days or weeks depending on the target. IL-12, we may know as they well known, well characterized anti-cancer agent which recruits multi mechanisms of the human immune system to attack a broad range of cancers, unlike the toxicities, poor tolerability, and poor pharmacokinetics of systemically, intravenously administered recombinant IL-12, that’s factory produced IL-12. GEN-1 inspires secretion of highly-tolerable endogenous or self produced IL-12. Its value as an adjuvant to chemotherapy in combination with chemotherapy in patients with a relatively healthy immune system is the subject of our research. Today, Gen-1 has been evaluated in three clinical trials; first is a monotherapy, second in combination with platinum-based chemotherapy and a third in combination with Doxil which we will speak more about. Each of these proof-of-concept studies is demonstrated safety evidence of potential expected immune system response and solid evidence of potential clinical benefit. In most recent trials at GOG managed study which completed and recently completed enrollment of platinum-resistant patient. The study clearly demonstrated that GEN-1 not only combined safely with Doxil, it also just an impressive clinical response rate on the direction of the GOG is the cooperative group that managed this study. The study ended protocol before which the maximum tolerated dose or MTD. The timing from the study however has been included in a recent abstract submitted to ASCO and shortly we expect to report important translational of data from the tissue samples taken during patient treatment cycles. We expect this to be a confirming high profile announcement. As we saw this past February when Dr. Khursheed Anwer, our CSO presented GEN-1 preclinical studies as well as top line findings from the GOG trial. If you are interested that presentation is available on our website. Together the results of findings provide convincing evidence of associated biological activity with no overlapping toxicities between GEN-1 is combined with Doxil reinforcing our view of GEN-1 as a candidate for combination therapy in newly diagnosed ovarian cancer patients. And with that we announced this past February at first-line neo-adjuvant Phase I dose finding trial which is accepted with our comment by FDA. The goal of the study is to identify an appropriate dose, we suspect a much higher dose for GEN-1 and we saw on the GOG study along with biomarkers for our future Phase II trial. We planned to enroll 830 patients with four to five U.S. sites in a 3+3 dose-escalation study in combination with [indiscernible]. Patients will then undergo surgery and will be followed for recurrence. Technological response rates will be collective. The trial is expected to take approximately 18 months to complete. And with that we are already planning ahead, we are planning for a follow-on study with the timing contingent on the neo-adjuvant study that I just spoke of. We also planned to begin a second ovarian cancer trial late in 2015 in the second half. Now this study will evaluate GEN-1 in combination with Doxil as we just discussed, but this time with the addition of Avastin. Supporting this is our preclinical combination studies which have demonstrated clearly that our GEN-1 plus Avasitin synergistic anti-cancer potential is a great deal of potential in ovarian cancer studies. The mechanism of these two therapies just make a great deal of sets. One important element of IL-12 is that stimulation of the production of interferon gamma, or inf-gamma it’s a body’s natural anti-angiogenic effect against abnormal blood vessel formation needed to support the growth of tumors. A similar proven mechanism with exact - is with Avastin. So we look forward to providing you with additional information on this study as we formalize our plans later this year. Behind the ovarian cancer we’ve been advancing our preclinical efforts with GEN-1 and glioblastoma multi form or brain cancer or more commonly known as brain cancer and other indication with few treatment options. We have multiple compressive preclinical studies underway and we expect to report data from these studies in the second quarter. In addition these studies will be used to support an IND filing later this year. We are very excited about the potential in ovarian cancer, glioblastoma, the glioblastoma program could very well become the main focus our general and development program and potentially the near-term priority for the company. We believe that our ability to demonstrate it clinically meaningful improvement and overall survival with limited side effects in this patient population can be achieved with a relatively small Phase I or Phase I/II clinical study. Our current experiment with study of GEN-1 in combination with ThermoDox is the current standard of care, but also note that Avastin has been approved for GBM so we are currently also planning a preclinical program to evaluate the potential of GEN-1 Avastin combination in this setting. So now I’ll just close my GEN-1 comments by noting that in some observations, in personal observations that I had in dealing with opinion leaders and thought leaders in the medical community I would say to you that support is from the medical community is strong as I have seen it as of the date and our experience with this immunotherapy. We look forward to sharing more information with you at upcoming Scientific and Medical meetings. Now I would like to discuss the second platform that was obtained through the acquisition. That’s still a silence proprietary delivered platform for virtually every variety of therapeutic RNA in development. As you know the two components in respective RNA therapy strategy, the therapeutic RNA sequence itself in the delivery system. Based on our collective research thus far we appear to have a RNA delivery platform that is distinctive. I’d say to you this is a technology with significant potential. For most companies in the RNA space were focused on non-lung specific indications typically the liver. Our TheraSilence technology is designed to enable delivery of RNA to the lung. This is unique, it’s a unique property. We have demonstrated lung-specific delivery of mRNA, siRNA, RNAi, microRNAs and using our proprietary technology platforms. The results from various preclinical models and recent non-human primate studies primary critical. TheraSilence safely delivers RNA to the lung virtually at the exclusion of other organs. This unique characteristic will significantly block the feel of RNA therapy and as you might imagine we are working to leverage the value of this platform. We have been collaborating with multiple collaborations with a number of RNA companies, RNA development companies we believe given the data, then an arrangement on a license there in 2015 is not out of the question assuming we can get that done the extensive data generated in some earlier work EGEN’s previous collaboration with Roche. We believe that will serve as a basis for our interest in an internal RNA product development program. So all of this to us is very exciting and the conformation that we recently developed strong RNA expression specific to the lung in a non-human primate model is the basis for our excitement. So its only been about eight months but as you can see we have now fully integrated EGEN with Celsion and are already beginning to realize value and targeting a substantially new commercial opportunities from their programs. Together, with our progress for ThermoDox in both primary liver cancer, or HCC and in the current chest wall breast cancer or RCW. We have a high value portfolio of first line oncology programs and we are moving forward in a thoughtful and in efficient way. Now let me talk about a chemotherapy platform the first level of which is ThermoDox. The latest OS data sweep from the HEAT Study, while the HEAT Study was completed and results were announced two years ago. We have been following this group now for two years. The latest data sweep was announced in February and its clear, the result again support our hypothesis and radiofrequency ablation or RFA when it used within its design limitation has the potential to be highly effective in treating patients with intermediate stage HCC. Respect and significantly more so, when the HEAT treatment is administered in combination with our lysolipid thermally sensitive liposome formulation of doxorubicin ThermoDox. These findings represent a seventh consecutive dataset collected over two years each demonstrating an impressive OS benefit each with an improving p-value or confidence level. The consistency and ever improving strength of the data reinforces our confidence in the protocol for ongoing pivotal Phase III study the OPTIMA Study. Now, let me just go back to the clinical evidence that we just spoke off from the January 2015 quarterly OS sweep this is a subgroup of 285 patients representing 41% of the HEAT Study is a patients who received RFA for greater than 45 minutes, we are now calling sRFA or standardized RFA greater than 45 minutes. While we note a 40 - I mean 59% improvement in overall survival in the ThermoDox plus sRFA arm versus sRFA arm alone. That’s standardized RFA 45 minutes plus, minus ThermoDox and the arm that has ThermoDox we see an impressive 59% improvement. This has been established repeatedly over eight quarter consistently with high confidence, the most recent p-value being 0.023. And the recent conversion I had with Professor Riccardo Lencioni, MD, Ph.D. at University of Pisa, an expert in radio frequency ablation he said to me that he is now referring the potential to standardized RFA plus ThermoDox not as an intent to treat procedure, but as an intent to cure. By the way I’ve referenced the 59% improvement versus sRFA alone translates to a greater than two-year improvement in survival, which is extremely meaningful in this deadly cancer, where median survival outside of the HEAT study has historically been a relatively short 30 months. And well there should be some caution since this is a retrospective analysis, our findings are striking and that they are not diminished in any way by an extensive multivariate Regression Analyses that was conducted by Dr. Borys, with the direction of the Professor Joseph Llovet. Joseph Llovet is an MD, Ph.D. well recognized as a lead researcher and lead expert in the field of primary liver cancer. The OPTIMA Study as we recall will enroll approximately 550 patients with tumors ranging from three to seven centimeters. The two arm double blinded randomized study compares ThermoDox in combination with standardized RFA that’s greater than 45 minutes versus the standardized RFA alone greater than 45 minutes. The primary endpoint is the overall survival, the study is 80% power, it show at 33% improvement in OS. By comparison let’s go back to the subgroup, the comparison group to subgroup has shown us 60% improvement in OS with 98% confidence. So the hurdle for success in the OPTIMA study, 33% results that we have seen so far, the convincing results that we have seen so far in our retrospective analysis with similar subgroup that’s being evaluated in the OPTIMA study shows a 60% improvement with a high degree of confidence. Our first preplanned interim look at the results in the study is expected to occur in 2017, mid-to-late 2017 if necessary a second interim look would be approximately 10 months thereafter. Trial sites for the study have been selected to support registration in multiple key markets was up to 100 sites although we may not need that many as the study team has pointed out to me. Collectively those sites are in North America, Europe, China and Asia-Pacific. We are now actively enrolling patients at some 40 sites and we have identified 14 sites for initiation some of which are currently active in Germany, Italy and Spain expanding our footprint in Europe is something that we absolutely wanted to accomplish with the OPTIMA study and we can see the interest from investigators based on the results from the HEAT study that we published to date. Now to China, our application for study approval for the China FDA and the CFDA is nearing final review. This review is taken longer than we anticipated, but we have been in the queue with every other Phase III study that’s been submitted. We understand now with the study is currently being reviewed, we expect approval in the very near-term, CFDA officials have committed to us through Dr. Borys and me personally that they have committed to working with us to initiate the OPTIMA study as quickly as possible. Supporting their interest we talked about this last call is some very interesting data from over 200 patients who are enrolled in the HEAT study from 200 patients from China and Hong Kong. Of the 150 for our Chinese patient cohort with a single lesion and that’s what we are focused on. Over 70% of these patients receive the treatment from standardized RFA that’s over 45 minutes or greater, 70% are Chinese patients. This compares to less than half of the patients in the balance of the study receiving a 45 minute procedure. It’s not surprising that the clinical timing for the entire cohort of Chinese patients for a single tumor regardless of tumor size who an impressive benefits. I hesitate to give you the numbers, because it’s a small group and we cannot calculate a P value, but the trend here is nothing short of remarkable. Now I want to give you a quick update with regards to our manufacturing partner in China, its key element of our strategy, our approval strategy and our manufacturing strategy, partners Hisun Pharmaceuticals, one of the largest domestic pharmaceutical companies in china, under the guidance of our Chief Technology Officer Dr. Robert Reed, our tech transfer of the ThermoDox manufacturing process to Hisun has been completed. And I'm delighted to say that our transferring technology from the U.S. to China is a [Yeoman] task and this was done - the commitment and great efforts of the small team that Bob directs. Hisun is successfully manufactured three registration batch of the ThermoDox for the China territory, three batches of ThermoDox produced in Hisun’s state of the art manufacturing facility meeting all of our high quality standards at a cost that will ensure 90% plus gross margins regardless of the market or the country in which ThermoDox is sold. We’re in the processing of conducting stability and appropriate Pharmacokinetic studies to demonstrate comparability of the product to our U.S. manufactured ThermoDox which is currently manufactured at two CMO’s in the United States. Once done we will include the Hisun manufactured product - Hisun manufactured ThermoDox I should say in the OPTIMA study in the EU DIGNITY programs which I want to talk about next. All-in-all we’re pleased with the progress that we have made with the HCC program, I hope you agree, we look forward to reporting our global accomplishments in the coming months. Now lets turn to U.S. DIGNITY. This is an indication that we I would say under Dr. Borys’ leadership we breath life into you know this group of patients, we’ve had a diagnosis of breast cancer, and following a mastectomy the recurrence occurs on the chest wall when the recurrence occurs, its usually very aggressive and very difficult to treat these refractory patients who are enrolling in our study and patients who have failed at least two lines of chemotherapy, typically a fail of radiation. And that the program has produced some incredible results and those results were recently published a full data from both an independent study that was conducted at Duke University and a conformational study that was sponsored by Celsion. So I am pleased to report that we are near at the end of patient enrollment of the U.S. study with the final two patients now scheduled for treatment. It appears that we could be winding up U.S. study in the third quarter with results potentially available for presentation at a major conference like the San Antonio Breast Cancer Conference in December. Findings to date however have been striking, we have previously reported interim findings demonstrating that a local response rate of greater than 50% has been observed in the first 12 patients in this Phase II study, these are patients again with refractory recurrence. Notably in this group we’ve seen three complete responses. These results are I want you to know arecompletely consistent with the objective responses that we have seen in the full data from the prior two trials, the published data; the publication is available to you if you are interested in our website. In total now we add some 40 refractory RCW cancer patients over 50% of whom have had a partial or complete response and 70% responders if we include stabilization of this highly aggressive cancer. And we know local controlling this population is a clinically meaningful outcome that is not our view alone that’s also the view of FDA. The strength of this data I wanted to know the recent publication incurred several investigators in Europe to approach us, to approach Celsion and Dr. Borys, myself or European based study. Today I am pleased to report that we have been aggressively moving forward with the Euro-DIGNITY, our European DIGNITY, our European study of ThermoDox plus hypothermia in RCW patients and up to six major centers including two IRCTS, our national reference centers in Italy and Turin, Bologna One each in Prague, Amsterdam, Warsaw and a new development that we have two institutions very high profile institutions in Israel, one in Tel-Aviv and other in HAIFA. We are conducting this trial and partnership with MedLogics the leading provider of advanced state-of-the-art hypothermia devices, we are proud of the study architecture, the trial design is spontaneous, which means something scientifically mean something to the European Medial Community. While Celsion will provide a centralized DSMB, medical monitoring, data management, quality control and independent monitoring, so we can ensure a quality dataset, we intent to enroll up to 100 patients in this study. As we reported on our last call the costs for this study are something else to talk about. We have designed the cost for the Euro-DIGNITY study will be as much as one tenth the study of the U.S. program. With the financial support cash and time being shared among Celsion, MedLogics and the investigators sites. While we now project they have a first patient by June and then completing enrollment 100 patients or 24-months thereafter. I can’t tell you how excited we are with the opportunity, which will allow us to accelerate our efforts in this important indication in the European Community where hyperthermia is routinely used and it’s well recognized and routinely used in combination with other therapies for RCW patients. Our commitment to breast cancer patients is now matched with the support of an engaged and committed group of leading investigators in Europe. I want to talk about the Early Access Program or EAP that we announced recently. Given the European interest for ThermoDox and recurrent chest wall breast cancer, we also began exploring options for this Early Access Program. In January, we announced an EAP partnership with myTomorrows. myTomorrows is the Dutch company with extensive experience and mix of business in EAP. As many of you know Early Access Programs are designed to provide patients with access to investigational drugs or UMPs on approved medical product as they refer to a neuro to address unmet medical needs. I want you know this is not a U.S. equivalent of compassionate use or name patient IND, it’s different in many ways. Most importantly, the Early Access Program is driven by the interest of treating physicians. Also EAP is the European exclusive initiative in the sense that is - it’s a business. EAP products now represent some $6 billion in sales in the European community. Requirements for an EAP program are stringent, but I would share some of them with you, this is not all of them, but some of them. But again they rely heavily on the treating physicians judgment, some of the requirements. Investigational product ThermoDox must be in at least Phase II or better. There must be clear evidence of efficacy and active registration enabling program must be underway, product must be manufactured in compliance with EU manufacturing guidance at an approved manufacturing site no marketing or selling is allowed however physician training and patient awareness campaigns are allowed and are use to educate the medical and patient community. And last point product pricing is determined by the sponsor in this case Celsion. We are providing specific guidance I will note that we expect to charge a commercial price for ThermoDox unless for revenue and guidance I have been asked this question we are not providing guidance at this point, but I will note that the incidence of RCW is approximately 25,000 patients in the big five countries of Europe. But also note that there is somewhere between 35 and 40 centers now that tricky patients using you’ll know these devices to [BSP 500] [indiscernible] device and the one I just spoke of the ALBA hyperthermia device. And if there maybe more centers if we qualify other devices and I hope to be able to report you that we have qualified additional devices in our next conference call. But my goal with all these facts was to give you a clear sense of the potential revenue landscape for ThermoDox specifically for RCW. Well, I’ll track to launch the program in the second quarter; we will provide updates this important effort and revenue is a part of our quarterly findings if not sooner to some break through information. We would like to – I’ll make you aware to our press release. So I hope you are still with us because I think the important part is next, so I am going to turn the call over to Jeff who will review our financials. Jeff?

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 and development costs were $15 million for 2014 versus $9.4 million in the prior year. Again, this is reflective of the increase cost associated with the launch of the OPTIMA study. This includes which includes initiation of clinical site around the world as well as the manufacturing cost related to drug supplies needed to run despite 150 patient clinical trials. G&A expenses were $8.9 million in 2014 compared to $6.5 million last year. These increases were primarily the result of higher insurance premiums and personnel costs, including $700,000 increase in non-cash stock-based compensation expense. Our 2014 expenses also included one-time costs of $1.2 million for legal and banking fees and due diligence expenses associated with our EGEN acquisition. For 2014, we reported a net loss of $25.5 million or $1.38 per share, compared to a net loss of $12.9 million or $0.95 per share in 2013. As I pointed out last quarter, last year’s net loss was positively impacted by two rather larger non-cash non-operating items, the first of which was a non-cash benefit of $8.1 million from a change in valuation in common stock warrant liability associated with two equity financings in 2009 and 2013. The second item again relating some equity financing was a non-cash dividend from the beneficial conversion feature of $4.6 million related to a preferred stock equity financing which we completed in February of 2013. If you look at the comparable period of 2014 and 2013 without these non-cash items, and we exclude the one-time EGEN acquisition cost, expenses for 2014 were $3.1 million higher than the comparable period last year. Our corporate focus has always been and we continue to be aligned with advancing a diversified product pipeline through value creating clinical trials and outside collaborations. I would now turn the call back to Mike.

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.

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

Good morning Mike and Jeff.

Good morning Keith.

Good morning.

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.

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.

Hi, Keith.

Hi, Nick.

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.

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?

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.

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

Thank you.

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

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?

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.

All right.

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

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?

And you are talking about Avastin.

Yes.

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?

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.

All right. Thank you.

Thank you, Dan.

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.

Hi good afternoon.

Good morning.

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?

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.

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?

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.

Terrific. Thank you very much and good luck.

Thank you. End of Q&A

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.

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.

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