Imunon, Inc. (IMNN) Q3 2014 Earnings Report, Transcript and Summary

Good afternoon. My name is Lisa, and I will be your conference operator today. At this time, I’d like to welcome everyone to the Celsion’s Third 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. Jeff 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 third quarter 2014 financial results, which we announced this morning. Today’s call will be archived. The replay will be available beginning tomorrow and will remain available by phone until Wednesday, November 26, 2014. And will also 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 risks and uncertainties including, without limitation, the risk of clinical failures, delays or increased costs, unforeseen changes in the cost of research and development activities; possible acquisition of other technology 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 for questions. I’d like to turn the call over now to Michael Tardugno, President and CEO of Celsion. Mike?

Thank you, Jeff. Good afternoon, thank you for joining us today. With me are Dr. Nick Borys Celsion’s Chief Medical Officer and Senior Vice President and by phone from Huntsville Dr. Khursheed Anwer, our Executive Vice President and Chief Science Officer. Khursheed, if you want us to know that you are there please.

Yes, good afternoon I’m here. Good to be part of the conference.

Thank you. And Jeff Church, from whom you just heard, Celsion’s Senior Vice President and Chief Financial Officer. As always we are excited to have the opportunity to update you on our recent progress. Over the past few months we have worked steadfastly to integrate EGEN, this marvelous nucleic acid focus development company that we acquired last June, to integrate them within the Celsion organization and framework. The complimentary fit as we’ve been saying all along is nothing short of remarkable. Now all at once, Celsion is a fully integrated development stage company with capability from discovery to NDA from the bench to the market and everything in between. The key word here is “Position”. We are well positioned, with platform technologies and chemotherapy, immunotherapy and RNA therapy and programs in all stages of development targeting some of the most globally significant cancers of our life time. Well positioned, Celsion has now has multiple opportunities to create value for our shareholders and represents a development company, I’m sure that you will agree of unique proportion, well positioned to bring each of our programs forward into clinical trials over the next six to 12 months. Well positioned, with a strong balance sheet to make major progress in our important work. For example, our registrational Phase III OPTIMA study is progressing very, very well. We are now recruiting patients in key markets in the Asia Pacific region and will be aggressively adding important clinical sites in Europe, North America and Taiwan in the fourth quarter as planned. Our clinical trial application for China was filed last April. And with very positive face-to-face interactions with the China FDA, we expect CFDA clearance of the OPTIMA study in early 2015, a timeline appearing to be about 10 to 11 months. This is much less than the recent 18 months review on our [global] process which has become typical for trials of this size and significance. And with approximately 50% of the worlds HCC incidence that’s almost 400,000 new cases in China alone. Study initiation in China is a clear priority for us in parallel with our application Celsion had identified sites with expected high volume patient enrollment for rapid initiation. With these sites, we are pre-negotiating contracts and readying documents for IRB submission. In addition to OPTIMA and as we reported in our press release this morning, we are delighted to announce that we are preparing to advance ThermoDox into a European base study in recurrent chest wall breast cancer. This is a trial that has been inspired by the U.S. DIGNITY program. This program is made up of a series of small trials that have shown impressive findings, but have been extremely difficult to enroll. In this indication, we find a desperate population of post mastectomy, refractory patients who face the end of their life with facilitating complication. We now have a great deal of data to show that we can improve their lives. And now with the support and encouragement from European thought leaders a resolve has been strengthened to continue this work. We will share more details about these plans in a few minutes. We are also preparing to advance our first immunotherapy candidate GEN-1 we formerly referred to as EGEN-001 frankly I find GEN-1 easier to present. We are advancing our first immunotherapy candidate GEN-1 into a study to more fully establish the relationship between the activation of cellular immunity and combined with the standard of care and efficacy in first line ovarian cancer patients. Design and consultation with thought leaders from MD Anderson the University of Alabama at Birmingham, Washington University, Roswell Park Cancer Center and Cancer treatment centers of America when completed this Phase I trial is expected to fully define and OPTIMA dose to enhance population and powering for high potential lower risk registrational program. We now look forward to an agreement with the FDA in the first quarter of next year to initiate the study. Behind the ovarian cancer program we plan to advance GEN-1 into a second indication. While they could very well become the priority for the company and that’s in glioblastoma multi form of GBM or more commonly known as brain cancer. Our plan is to file an IND for Phase I study in this indication in the second quarter of 2015. Support from the medical community for both of these trials is compelling as is our data. We look forward to sharing more with you at upcoming scientific and medical meetings. Now, I’d like to provide a more detailed review of the OPTIMA study. In September, we enrolled our first patient in our Phase III OPTIMA trial in primary liver cancer, also known as HCC or hepatocellular carcinoma. The study is designed to evaluate ThermoDox in combination with standardized radiofrequency ablation we are now calling it sRFA in primary liver cancer. The study will enroll approximately 550 patients globally and up to 100 sites in North America, Europe, China and Asia Pacific. It is a two-arm, double-blinded randomized study comparing ThermoDox in combination with sRFA, standardized to a minimum of 45 minutes across all investigators in the study versus sRFA alone. OPTIMA is designed and powered base in our learnings from the 700 patient HEAT study, which shows clearly that RFA when used within its design limitations has a much better effect in patients with a 3 centimeter lesions or greater. Larger tumors require more time, this we learnt. Our assessment is a minimum of 45 minutes is required for an optimal outcome. The primary endpoint for this study is overall survival. The study is powered to show a 33% improvement in OS, the statistical plan calls for two interim efficacy analyses by an independent data monitoring committee or DMC. The support for OPTIMA is significant and comes from; one, an exhaustive retrospective analysis of the previous Phase III HEAT study; it’s based on convincing post-hoc OS data; and is further reinforced with prospective confirmatory pre-clinical data in animal and computational models. Post-hoc findings and hypothesis supporting OPTIMA do not represent our view alone. I want to repeat that. It’s not our view alone. The data were shared with the HCC research community during major international medical conferences. I can say confidently there is a great deal of optimism for the OPTIMA study among virtually all of the most important names in HCC research worldwide. I’ll remind you of the most recent clinical evidence from our quarterly Overall Survival sweep in the HEAT study. As of June 30, 2014 and a sub group of 285 patients who received sRFA treatment, 285 patients represents approximately 41% of the total 700 patient studies. In that cohort we noted a 57% risk improvement in overall survival in the ThermoDox plus standardized RFA arm versus standardized RFA alone, and improved and established repeatedly and consistently over the past seven quarters, consistently with high confidence and most recently with the p-value of 0.037. A 57% risk improvement versus sRFA alone is an extremely meaningful outcome in this historically deadly cancer, where median survival outside of the HEAT study was a relatively short 30 months. I will note however, that median survival data has improved some with their approval of Nexavar or sorafenib. But it hasn’t been by much. And well, there should be some caution since this is a retrospective analysis and as we said multiple times. Our findings are striking and that they are not diminished in any way on an extensive multivariate Cox Regression Analyses, which analyzed if any of a multitude of key factors or patients characteristics may have bias or hypothesis. We are activity recruiting patient at some 15 sites now. We recently received the MAA approval via the Virtual Harmonization Process or VHP to begin the trial in Europe and plan to bring sites onboard in German, France, Italy and Spain in the near term. We also have submitted an application for clinical trial approval as I said to the China FDA, the CFDA is reviewing the OPTIMA study design rationale, as well as the sub-group of patient treating in China and the overall safety data from the HEAT study and have committed to work with us to complete their review of our application as quickly as possible. Now supporting their interest this data from over – from 29 patients enrolled in the China and Hong Kong sections of the HEAT study, which we haven’t discussed until now, and this is really the first time we reported this. And so, this is new news, of the 154 Chinese patients with a single lesion over 71% of them were treated with optimized RFA procedure. It’s a procedure of standardized RFA procedure. That’s a treatment of – with RFA greater than 45 minutes. The clinical findings for the entire cohort of Chinese patients with a single tumor regardless of size show an impressive OS benefit. And I hope and our convince may led to additional opportunities for registrational discussions with the CFDA in the relatively in near future. I note that maturity of the Chinese data still developing, it is impressive nonetheless. All-in-all, we are pleased, I’d say, very pleased with the progress that we’ve made and look forward to ramping up the enrollment as more sites come on the line globally. Now I’d like to turn to the DIGNITY study, our ongoing Phase II study of ThermoDox plus hyperthermia in recurrent chest wall breast cancer. Supported by published full data from both an independent study at Duke University and a conformational Celsion’s sponsored study, we continue to report remarkable findings in this difficult to treat refractory population. These are patients who are post-hysterectomy, who have failed at least two lines of chemotherapy and have failed radiation before entering our trial. They are out of treatment options. In June, we’ve reported update interim findings from the ongoing Phase II DIGNITY study demonstrating that a local clinical response rate of greater than 50% has been observed in the first 12 patients with this refractory occurrence, notably with three complete responses. These results are consistent with the clinical responses that we’ve seen in the poll data accounting for some 29 patients. So in summary, we’re totaling up of 41 refractory patients with greater than 50% clinical response rate and with five complete responses, impressive data. The trial is progressing and we are hopeful to complete enrollment over the next few quarters and look forward to reporting update interim findings as soon as they are available. The strength of data in this indication incurred several investigators in Europe to approach us for European based study. I say that again, we were approached by thought leaders in Europe who practice radiation oncology, hypothermia to treat these patients approach us. This past week, Nick Borys and I met with these thought leaders and investigators in Europe and presented our data for the ThermoDox studies in RCW breast cancer. We’re pleased to report today that we are moving forward with the Europe DIGNITY Study. The European study of ThermoDox plus hypothermia and RCW breast cancer, and up to six major cancer centers including two national cancer reference centers in Italy, here to Turin and Genoa, one center each in Prague, Amsterdam, Warsaw and Tel-Aviv. We’re conducting this trial in partnership with MedLogics, the leading providing of advance state-of-the-art hypothermia devices and we’re part of the studies architecture, the trial design is a spontaneous investigators sponsored study with centralized DSMB, Medical monitoring, data management, quality control and independent monitoring, and may enroll up to 100 patients. Costs for this design are significantly lower than the U.S. DIGNITY study by an order of magnitude, Studies we know that positive disease control and all this rates in the population. And we have completed enrollment in the Phase Ib study in platinum-resistant ovarian cancer patients, under the direction of the ClinicalLogic Oncology Group of GOG. Tissue samples from these patients are enroute to analytical laboratories as we speak. We expect to have a dose dependent translational data read out by year end. In early next year we should be able to assess and report on any evidence of an OS signal. The data today however supports our rationale for advancing Gen-1 into additional combination trials with the goal of targeting first line therapy plus the standard of care. Activation in the immune response is particularly more effective for individuals whose immune system is healthier and far or less compromise by previous chemotherapy. We’re on track to meet with the FDA regarding our clinical development plans for Gen-1 in ovarian cancer as I described the plans earlier with the goal of reaching consensus regarding the trial design in the first quarter of next year and having trial underway and enrolling patient in the second quarter. In parallel with our ovarian cancer program we are advancing development of Gen-1 in glioblastoma multiform or brain cancer. Preclinical studies have demonstrated that the administration of GEN-1 in the brain can lead to IL-12 expression and recruitment of the immune system that lasts for approximately one month. We look forward to sharing additional preclinical data as soon as it’s available perhaps as soon as at the end of the year for some or all of the preclinical data. I want you to know, this program represents a high priority for Celsion as this indication offers the potential to advance GEN-1 to the market with a small well design study. Our goal is to be in a position to launch clinical studies in this syndication in the first half of 2015. And finally, an update on GEN-2, our RNA therapeutic based in our TheraSilence platform, GEN-2’s potential has been demonstrated in numerous preclinical studies show a unique capability for payload delivery with lung specificity. IN lung cancer we note a two prong approach in addition of tumor growth by anti-angiogenesis and promotion of direct killing of the tumor with MicroRNA. Dr. Anwer recently presented data demonstrating evidence of siRNA delivery, mRNA delivery and gene silencing into lung. Although early, we are excited about the potential of the TheraSilence platform and look forward to providing updates on our efforts as we progress through critical preclinical studies. Taking a step back now and looking at our pipeline as a whole, we have a very active clinical development effort underway. We are moving forward with a strategic, efficient and in order to maximize return on investment manner in these programs and drive them into the market as rapidly as possible. Now with that, I’ll turn the call over to Jeff for review of our financials. Jeff.

Thank you, Mike. Starting with cash, we’ve reported total cash and investments at September 30, 2014 of $43.8 million, as compared to $43.1 million at the end of 2013. Our cash position reflects the proceeds from a registered direct common stock offering in January 2014, along with the second draw in June of $5 million under our Hercules loan facility. We have maintain a strong cash position over the first nine months of 2014, while initiating a global Phase III pivotal trial and primary liver cancer the OPTIMA and broadening our product pipeline and technology platform through the June, 2015 acquisition of EGEN. Our current cash position puts us in a strong financial position to advance the development of our expanded product pipeline. Our cash usage over the first three quarters of 2014 has been $1.6 million per month, and 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 carry us well into the second half of 2014, well pass the announcement of many key development and partnering activities. Net cash used for operations was $14.8 million in the first nine months of 2014, which I say is above – which is approximately $1.6 million per month. This compares to $6.1 million for the same nine-month period in 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 the EGEN acquisition. In addition, cash used in operations during 2013 which favorably impacted by a $5 million technology transfer fee which we receive from Hisun, our Chinese manufacturing partner. Research and development costs were $10.7 million in the first nine months of 2014 versus $7.5 million for the same period in 2013. Again, this is reflecting increase cost associated with the launch of the OPTIMA study. This includes the initiation of clinical site as well as the manufacturing cost related to the clinical supply needed to run that program. As Mike mentioned earlier, we will be initiating up to 100 clinical sites and have expanded development footprint into Europe. G&A expenses were $6.8 million in the first nine months of 2014 compared to $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-compensation expense. Our 2014 expenses as I mentioned earlier included one-time costs of $1.2 million for legal and banking fees and due diligence expenses associated with EGEN acquisition. For the first nine months of 2014, we reported a net loss of $19 million, compared to a net loss of $4.3 million for the same period in 2013. Let me just point out, last year’s net loss was positively impacted by two non-cash non-operating items, the first, a non-cash benefit of $8.1 million from the change in valuation in common stock warrant liability associated with two equity financings in September 2009 and June 2013. The second item was a non-cash dividend from the beneficial conversion feature of $4.6 million related to the preferred stock equity financing which we announced in February 2013. If you look at the comparable periods in 2014 and 2013 without these non-cash items, and the one-time EGEN acquisition cost, loss for third quarter of 2014 was $2.7 million higher than the comparable period last year, and $5.4 million higher in the first nine months of this year when compared to the first nine months of last year. Our corporate focus has always been and will continue to be aligned with advancing a product pipeline through value creating clinical trials and outside collaborations. I will now turn the call back to Mike.

Great, Jeff. Thank you. I’m marveled how interesting, how you can bring to the life the financial report of a company like ours [indiscernible]. I would like to ask you to make one correct first, you report the statement of 2014 and 2016.

I’m sorry. Yes, I’d mentioned that occurring cash is projected to take us well into the second half of 2016

I just summarize by saying we are clearly well positioned for the strong balance sheet and a number of value creating opportunities across multiple programs, perhaps most importantly our programs are addressing some of the most critical needs on oncology today. Primarily liver cancer, ovarian cancer, recurrent chest wall breast cancer and of course glioblastoma multiform. We are addressing first line settings and evaluating solutions for indications or treatment options are limited. We’re advancing our Phase III OPTIMA trial for ThermoDox, targeting registration in significant markets around the world, and building momentum with our pipeline. We look forward to advancing our ThermoDox DIGNITY program and GEN-1 through keep data readouts and into additional studies over the next six to 12 months. We have a strong balance sheet with resources and capabilities to advance our key development programs. We believe that we have the right mix of programs and technology in our pipeline to assure value for our shareholders. And most importantly, to make a significant difference in a lives of cancer patients and their families. So with that I just – I want to conclude with my remarks with a recognition. Some of a great and generous man, a person who committed his life to the pharma industry. And more recently the small biotech like Celsion passed away. That person was Max Link. I had the great honor to know Max as a mentor and a colleague and as a friend. He will be missed and while he will be missed by all of us who knew him, and certainly by me. We can take comfort in knowing that his legacy will advance you to people that he touched and inspired. A world was made better by Max Link. As always, we really appreciate your interest in the company and we look forward to updating you on our progress as we continue to look forward on these very important clinical programs. We’ll now go to questions. So I’d like to ask the audience to limit them to no more than two so that everyone can have an opportunity to get answers. So operator, if you will the open the line please, I’d appreciate it.

(Operator Instructions) And we’ll take our first from Keith Markey with Griffin Securities.

Hi, guys. Congratulations on a good quarter. Two question, okay, well I was wondering Mike if you could elaborate a little bit about the DIGNITY study in Europe that you are planning to do. What kind of technology you are going to be using and perhaps a little bit more about the patients if you could?

I’ll talk a little bit about the technology which are very, very, very excited about. I’d like to ask Dr. Borys to about the patients. It is the patients have a little bit of different complexion of the patients and we have been recruiting in United States. And I think it makes it all the more interesting and actually provides an even more impressive opportunity for us to provide a better outcome. But then Nick can speak to that, we won’t be able to get into the details of the study design at this point Keith. We presented this study -- we’re presenting this study to the Ethics committee at the IRCCS center in Candiolo, outside of Turin. Once we have Ethics committee agreement then I think it would probably be more appropriate for us to get into details of the protocol. Let me say this, we had a number of investigator including Dr. Borys who was one of the authors are published recently the results of our two Phase I studies, the full data was impressive to say it at least. Following that, we received a letter of interest from one the foremost radiation oncologist in Europe, asking if we would be interested in discussing with him an opportunity of/for a clinical program in Europe. We had to a great degree we had discounted Europe as a site for rolling patients because the devices in Europe that are becoming the standard of care or are not approved for use in the United States. The device that we believe is probably the most advanced and the most sophisticated with some. And I’m hardly to one to describe it adequately but with some feedback in planning capability we can only dreamed frankly when we had first planed our DIGNITY program in the United States. State of the art equipment manufactured by the company call Medlogics and they have a device as known as [alpha] device. That will be the standard for use in treating these patients. The goal is evaluate ThermoDox plus and plus ThermoDox or hypothermia provide by the seller device, in combination with the standard of care for these patients. It’s really exciting opportunity. We had a conference that was convened in a matter of weeks following our expression of interest in our first meeting with Dr. Professor [Gabrielle] that meeting was attended [indiscernible] key opinion leaders from some of major institutions in Europe, and as just as well as in Tel Aviv. They came prepared to work. We spend two days working with them. Outlining a clinical protocol which in many ways follows the protocol that we’ve been using in the United States with some of important differences. At the very end, we went around the table, there was absolute commitment from each of the investigators to quickly initiate a study and frankly to in kind, not with cash, but in kind absorbs some of the cost of the program. We could not have asked for better outcome. But my sense is that the way the study is constructed and we’ll talk about in more following an Ethics committee agreement. The way they started constructed. We may have an opportunity to talk to the European agencies the EMA, with respect to the -- maybe an opportunity to consider the registrational aspect of this study or study of this similar design. And maybe Nike will talk about the patients.

Thanks Mike. The type of patients that our European colleagues are looking at is a little bit more earlier in disease that what we’ve been seeing in the U.S. What caught the eye of the investigators in Europe is that the U.S. data, here we have patients that have failed after a mastectomy after they’ve had two rounds of chemotherapy and even after radiation. And the most interesting aspect of it is, when patients even have a previous doxorubicin, they still responded to ThermoDox. So in Europe where hyperthermia is for our mainstream, they are now looking at applying what a very cutting edge approach which is called trimodal therapy in these patients. So when these patients present for the first time with recurring chest wall cancer we’re now at giving them simultaneously chemotherapy through ThermoDox localized and then sensitizing that with hypothermia treatment and then giving radiation. And that’s a trimodal approach where the cancer will be hit from three different sides. So we’re very excited about this and as well as the investigators out there and we look forward to reporting to you on that in the near future.

Okay. Thank you very much. And for my second question I was wondering if you could tell us a little bit or try to characterize perhaps what you meant by an impressive overall survival benefit that you’ve seen in China and Hong Kong, I don’t expect statistical data, but just try to put it into or compare it perhaps with the overall HEAT study results?

Well, I’d say, we get to still it’s a small number and we always hesitate to give out data on the small number not statistically significant given the size of the population but all the improvement in overall survival, I believe could be reasonably comparable and maybe slightly better than what we’ve seen in the cohort that we’ve been following Keith. Now that said, if the data is not – if you recall the Chinese portion of the study came on one year later than the rest of the study. So the data is not as mature as or the information that we’ve been evaluating in the 285 patient cohort. We’ve received radio frequency ablation for minimum of 45 minutes. So we could move slightly what frankly it’s been stable, that’s been stable over the course of evaluation and I would say that – we were looking forward to one more read out for survival. We delayed this quarterly readout for -- I think probably for financial reasons that’s relatively expensive proposition to gather this data. So we essentially instead of picking up on the quarter, we are delaying it four or five weeks in order to ensure that his next data readout gets us cash for median. Now we can see with confidence to view in the investor community that the data represents information that would be accepted from in a rigorous statistical environment. So give us a little bit more time, I think maybe I answered your question. So give us little bit more time perhaps maybe the next time we get together on a quarterly call we can give you more definitive information.

Well, actually the answer that you gave me was very good. Thank you.

And we’ll now go to Reni Benjamin with H.C. Wainwright

Hey, good afternoon, guys. Doctor how are you? Thank you for taking the questions. My two questions, I guess the first one is, you started the OPTIMA study, congratulations on that. Can you give us a sense of what will trigger the interim analysis and when do you think those interim analysis may occur?

Yes, so the trigger that’s an event driven trial – the first point I want to make sure I get the number exactly right. The first interim analysis occurs after – the first interim analysis is after 118 OS events. And we have – we’re looking at stopping the study for efficacy, if we see a hazard ratio with confidence of 0.61. If we use the HEAT study as a basis to project when we would reach 180 events it would be approximately 36 months after the first patient was enrolled. The second interim analysis would be at 158 OS events. We’ll be looking for Hazard ratio of 0.70. And I believe for –if we use the HEAT study as a yardstick this would be around 42 to 44 [wants]. And then the final read out if we have to got that far remember the data that we are looking at currently suggest that we should cross the threshold for clinical benefit after we got 118 events. So it will be very close, if we can reproduce the data we reproduce the findings that we saw in the HEAT study. But if we have to go all the way to a 33 % improvement on our Hazard ratio of 0.75 there would be 197 events and our expectation for that is about 52 months something in that range from the time first patient is enrolled.

Got it. Thank you for that. And then just in regards to the Euro-DIGNITY study, in your prepared remarks you mentioned that it was an extremely difficult trial to enroll here in the U.S. and a 100 patients seems, it would just seem to be even more difficult to enroll. How long do you anticipate this trial to take? And what is it about Europe that makes you think that enrollment could go quicker?

Even Dr. Borys had been swapping notes. When I first came back from Italy, I met a professor [Gabriel] this IRCCS and forgive me if I can’t tell you what that acronym is, it’s an Italian acronym for a national cancer reference center. When I first met Gabriel I asked him about his patients and recruitment. In Europe, at the stage that we are considering enrolling patients, his center sees about 10 new candidates a month, which in as we discussed with the other investigators in our conference this past week end, it’s not a typical. After we apply the inclusion, exclusion criteria we have [woodled] that down to maybe 20% of that population or so. So that’s what we are looking at. Nick is also an unbeliever. I’m going to be the optimist in the crowd. But when we listen to the physicians talk to us and I think with a great deal of confidence. And by the way they have some money on the line on this too. They are participating in kind, with many of the required procedures being either funded directly by the hospital or being reimbursed through the normal insurance payment system in Europe. When we talk Turkey with this group of physicians they believe well discounted some I suppose but they believe they can enroll a study within a 24 month period, perhaps sooner. We are planning on 36 months. But that’s kind of how we are being guided by, it’s always says the Borys rule of thumb is whatever they tell you discount it by 50%. So that’s kind of how we are looking at. I can’t tell you how excited this group, but they do treat these patients currently they treat them with radiation and hypothermia. In their centers they are seeing a good number of patients and they all think they counted them for us and in pretty exact in terms, so they came prepared to talk about enrollment rates. But we are providing for them as an opportunity for some of these patients to include in this standard of care, so it’s not like it’s a last ditch effort, including the standard of care pretreatment with ThermoDox plus hyperthermia. So how realistic are the enrollment rates? Probably better in this trial than we seen in others. How are we going to count on the enrollment rates to project the conclusion of the study as presented by the investigators? Probably not, so, the way we are budgeting this study and we’ll be talking about with the investment community. It’s going to be about 36 month study that as we see it.

Excellent. Thank you very much and good luck.

Sure. And by the way it’s an open label study similar to the DIGNITY study. So we see overwhelming evidence of similar to what we are seeing in the U.S. DIGNITY study, but we maybe in a position that we’ll be able to talk about results on an ongoing basis. I know that’s an aftermath for some of our investigators but I think it’s important. It’s important for us to communicate how we are doing with this trial to the investment community.

And just one last comment and I hope you can just indulge me. The cost of this study is a fraction, a small fraction of the cost the DIGNITY study on a per patient basis. We are very comfortable that within the guidance, the financial guidance that Jeff just gave you we are able to incorporate this study.

Excellent. Thank you very much and good luck.

Thank you.

(Operator Instructions) We’ll now go to Daniel Brims with Cantor

Hi, thanks for taking my question. My first question is over the DIGNI study I guess. So the protocols in the U.S. and the E are going to be different patient populations. Have you gotten any input from either of the two regulatory agencies as to whether or not you can use both studies to support regulatory approval in the each geography? And I’ll have a follow-up after that.

Yes. It would be our hope that in this population that’s generally refractory to chemotherapy that in the single arm study where we know this disease progresses at a very high rates. It will be our hope to be able to convince regulatory agency with some high percentage of patients with a complete or partial tumor response that the drug is sufficient in the combination therapy is sufficiently valuable to warrant consideration for approval. We’re not there yet, Dan. So I think one of the things Nick has been [indiscernible] or what’s he’s been thinking about is, how do we position this study with the scientific price working console of the EMA, how do we position this study. And let’s gets their advice. I mean, I think everyone knows this is a population of women who die in a very, very, very difficult, with a very difficult complication. If we can provide a quality of life endpoint point, a reasonable quality of life endpoint, my sense is FDA told us by the way, but when we talk to them about the patients that where the population we’re recruiting for the U.S. study they told us that the [QOL] would be a, well actually Dan it was a – overall response rates, but overall complete response here we’re looking for. But which translates in the quality of life. They told us they would accept them as a registrational endpoint. Now, combining the two studies I don’t know that we are in a – I mean now let me turn it over.

Yes, Dan, I think we already have a framework as Mike just mentioned from the regulatory authorities. They are – they already stated and we will be collecting durable complete local response on these patients and we’ll be following these patients as well for survival. So, we do have the ingredients of what they will be looking for and we have to take one step at a time. We now have a study protocol design. We’re going to be studying that, finalizing that and then we’re going to decide how to approach our regulatory strategy. So now we have clinical support. We have a patient population identified and hopefully in the near future we’ll be reporting few more details on a regulatory front.

Okay. Thanks. And my second question is about the OPTIMA study in China. What percentage or how many patients will you need to have in the study that are Chinese in order to basically support regulatory approval there?

One hundred pairs, Dan.

What was that again?

One hundred pairs of patients are required for registration in China. 100 or 200 patients or 100 pairs actually is that is the way the large – or the guidance is written, 100 pairs of patients.

Okay and that’s of – so 200 of the 550 patients?

That’s right. And now we are in a position to manage the trial in a way that we will recruit 200 patients. We think that’s extremely important.

Okay. Thank you.

Thank you.

And we have no other questions in our queue. I’ll now turn the call back to Michael Tardugno for closing remarks.

So I’ll help you with that next time. I just want to thank everybody for taking the time to join us on the call. As you can see the management team here has been working diligently to put some points on the board and for some very important indications using or leveraging some technology which we think can be the future of therapy and some pretty sophisticated and difficult indications. We look forward to speaking with you again at our next quarterly conference call. And that’s in the mean time if you have any questions, please don’t hesitate to contact us. Thank you again and just let me close with one last point. Today’s is Veterans Day, please take a minute if a Veteran and thank him for his or her for their service. Thank you.

And ladies and gentlemen, that does conclude today’s conference. We thank you for your participation.