Imunon, Inc. (IMNN) Q3 2015 Earnings Report, Transcript and Summary

Good morning. My name is Vicky and I will be your conference operator today. At this time, I would like to welcome everyone to Celsion’s Third Quarter 2015 Earnings Conference Call. This call is being recorded . 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 morning, everyone, and thank you for joining us today to discuss our third quarter 2015 financial results, which we announced this morning before the market opened. Today’s call will be archived. The replay will be available beginning tomorrow and will remain available by phone until November 19, 2015, and it 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 risk and uncertainties including, without limitation, the risk of clinical failures, delays or increased costs, unforeseen changes in the cost for our 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 for questions. I’d like to turn the call over now to Mr. Michael Tardugno, Chairman, President and CEO of Celsion. Mike?

Thank you, Jeff. Good morning. I’d like to start by thanking all of you for taking the time to join us for today’s call. I am here with Dr. Nicholas Borys, Celsion’s Chief Medical Officer and Jeff Church from whom you’ve just heard, our Chief Financial Officer. As always we are delighted to have this opportunity to update you on our progress. We’ve got a lot to cover today, so I'm going to get started quickly here by highlighting two recent and important ones, both of which you will find a link to on our website. The first is a video link to this past September's ILCA conference, in a Symposium sponsored by Celsion. The video includes three discussions by world renowned physicians, specifically addressing the potential of ThermoDox plus confidently administered RFA to treat patients with intermediate stage HCC. The presenters came from Asia, Europe and North America representing all of the medical specialties involved with liver cancer research including medical, interventional and surgical oncology, which -- as well as hepatology. During this session we hear for the first time from Professor Lencioni, from the Pisa University School of Medicine, with ThermoDox, in fact representing treatment with curative intent. From Ghassan Abou-Alfa from Memorial Sloan Kettering, that there is no question that ThermoDox works in HCC. However variability in RFA application maybe an issue. And from Professor Ronnie Poon, that ThermoDox represents an effective alternative to surgery, Professor Poon of course, you may even have heard from us many times before is an Honorary Professor of Surgery at the University of Hong Kong Queen Mary Hospital and a Member of the Governing Board of the International Liver Cancer Association. From a surgeon, an interventionalist and medical oncologist from Asia, Europe and USA all endorsing ThermoDox’s global potential in our Phase III OPTIMA Study. At this level we had the open conference however, but also at ASCO and the ECIO and the WCIO and now the [HDTA], the Asian Conference on Tumor Ablation from which Dr. Borys just returned. Both Professors Tak and Lin from Korea and Taiwan took center stage with plenary and oral presentations to discuss the progress of ThermoDox and its potential for cure. All-in-all, over the past two years, five medical conventions, three of them in consecutive years, two sponsored Symposiums and presenters representing some of the most important names in the HCC research. The message from the medical community could not be clearer, the OPTIMA Study based on convincing timings from the OS subgroup that we’ve been following, has the potential to be the best and perhaps the only new opportunity for HCC patients in the foreseeable future. Now I’d like to turn to our Gene Mediated Immunotherapy and our surplus platform. The second link on our website is to our R&D Day held last week in New York City. For those of you who could not attend either in person or by live webcast, I strongly encourage you to listen to the achieve recording of the event. It was a great meeting covering the underlying science as well as our pre-clinical and clinical experience with our Gene or DNA based therapeutics, primarily focusing on our second investigational product we call GEN-1. GEN-1 as you know is acquired with critical IL-12 to turn on the body's cellular machinery to produce the immune system activating cytokines interleukin-12 . During the session, we heard from Dr. Donald Braun, VP of Transitional Research and key Science Officer for Cancer Treatment Centers of America to discuss, as he calls it the multi-potent anti-tumor effects of IL-12, and in particular, it's variance to ovarian cancer patients in a local format produced in a safe and sustained manner, GEN-1. Dr. Thaker and Dr. Leath, gynecologic oncology surgeons at Washington University in St. Louis and the University of Alabama Medical School, respectively, both PIs in our Phase I OVATION Study, who view their positive experience with GEN-1 along with their high expectations for potential and combined with chemotherapy and soon to be combined with Avastin and Doxil as a second line treatment for platinum-resistant ovarian cancer patients. Dr. Thaker and Dr. Leath went on to discuss the epidemiology and treatment of ovarian cancer patients in a role that GEN-1 could play in the clinical trials if we are successful. Again I encourage you to view and listen to both sessions through the links on our website. We provide these discussions from top researchers in the world. So that you may have a better understanding of our science, our trials, our potential and the important work that Celsion is doing. Please take advantage of this opportunity. Our third quarter proved once again to be productive for Celsion, who was marked by continued progress across our platform technologies in chemotherapy and Gene Mediated Immunotherapy. We have also been quite impressed with the interest that RNA development companies have shown in our lung specific RNA delivery platform and the feasibility work that has done -- that has been done to show its potential. Operationally we continue to improve the efficiency and reduce costs. In early September, it was with great pleasure that we were able to announce the completion of the integration of EGEN Incorporated, which we acquired 13 months earlier. With EGEN, which is I'd like to say, marvelous biology based early stage development company, Celsion has entered the gene therapeutics stage confidently and with impressive technologies. And as a fully integrated development stage company with proven effective capabilities and experience from product concept to NDA, as we like to say from the bench to the market and with every confidence in between. The now combined assets of our company are highly complementary, oncology focused, based on nanoparticles technology and all with first line therapeutic potential on combination with the standard of care. Now that the integration is complete, we have consolidated all early stage pre-clinical assets in Huntsville, Alabama, and our clinical development, CMC, business development and administrative functions at our headquarters in Lawrenceville, New Jersey. Doing so we have improved our cost structure and increased our efficiency. Now let's discuss the progress that we've made across our technology platforms and products during the quarter, and we begin with GEN-1. As I alluded to earlier GEN-1 is an IL-12 plasmid incorporated with our non viral vector synthetic polymer nanoparticle delivery system platform that we call TheraPlas. The distinct activities of GEN-1 was highlighted by Dr. Braun, Dr. Leath and Dr. Thaker at the R&D Day, which among other things; number one, provide the safe means for the sustained production of therapeutic levels of IL-12. And two, allows for multiple dosing cycles typically not available to viral vector delivery platforms. We recently provided an update on our clinical strategies for GEN-1 establishing its clinical utility in two indications. GEN-1 has already demonstrated promising clinical activity and tolerability in platinum-resistant and recurring ovarian cancer patients. It has shown improved anti-cancer effects when combined with Avastin and Doxil in preclinical models. The requirements studied impressive pre-clinical activity in glioblastoma multi-form or GBM. Our initial clinical focus however would be on the localized treatment of ovarian cancer. In late September we announced the first patient enrolled into the OVATION Study, a Phase 1b dose escalating clinical trial combining GEN-1 with the standard of care for the treatment of newly-diagnosed ovarian cancer patients. The first patient in the study was enrolled at the University of Alabama in Birmingham. In addition to UAB, Oklahoma University Medical Center, Washington University in St. Louis and the Medical College of Wisconsin are all recruiting patients in the OVATION Study. The OVATION Study will identify a safe, tolerable and therapeutically active dose of GEN-1. The study will enroll three to six patients per dose level. We will evaluate safety and efficacy, while defining the starting dose to our planned follow on study, a Phase 1/2 study beginning our pivotal program combining GEN-1 with Avastin and Doxil. We are hoping that OVATION will also generate important translational data to drive future studies, as well as attempt to define an enhanced population by patients with tumor characteristics. I am pleased to inform that first dosing cohort is enrolling its first three patients. The study will continue to enroll patients into the first half of next year in higher doses of GEN-1 and interim data will be made available after each dosing cohort as patients becoming evaluable. In mid October we announced findings from a well designed preclinical program combining GEN-1 with Avastin and Doxil in mice transplanted with widely disseminated SKOV3 ovarian cancer on cells. In fact the findings from the study demonstrated a significant anti-cancer effect in tumor inhibition as compared to untreated animals as well as a statically significant improvement over the combination of Avastin and Doxil alone. Together with the portfolio's impressive study, the protocols following this is planned for later this year. We like the update and agreed for a Phase 1/2 study -- Phase 1/2 design so that we can efficiently advance GEN-1 in combination with Doxil and Avastin through clinical testing. We’ll keep you updated on our feedback. And just a follow-up comment on GEN-1, I don’t have to tell you this, but the implications of our therapeutic GEN-1 working in combination with Avastin and Doxil, two of the most widely used cancer therapies are something remarkable. Now I would like to shift our focus to ThermoDox, our proprietary heat-activated liposomal encapsulation of doxorubicin, which is being evaluated in combination with optimized RFA and microwave hypothermia, in Phase 3 development for primary liver cancer and Phase 2 development for RCW breast cancer, respectively. We made quite a bit of progress with this program in the third quarter, now first some encouraging data. In August we shared with you an update on the latest overall survival data from the Phase 3 HEAT Study in primary liver cancer, with the data showing that in a large well balanced subgroup of 285 patients representing 41% of the study patients in the trial, the combination of ThermoDox with optimized RFA provided a 58% improvement in OS compared to the optimized RFA group alone. Most importantly, and with this OS suite, the median overall survival for the ThermoDox group has been reached, which translates to a 25.4 month or 2.1 year survival benefit over the optimized RFA group alone. The ThermoDox plus optimized RFA group had immediate survival of 75 months was significant [indiscernible] is a remarkable finding. Patient survival of more than five years is considered cure. In our well bounding, well tested subgroup patients receiving ThermoDox plus optimized RFA are living over 6.5 years and I would venture to say that some of those who are dying are not dying with their cancer. As I mentioned earlier, the cure of potential for ThermoDox plus optimized RFA has become more fully appreciated, as we have presented these results at leading liver cancer and oncology meetings worldwide. As the earlier mentioned, ILCA Symposium experts on the panel entitled, Intermediate HCC - Cure versus Palliation, expressed unanimous support for the hypothesis that ThermoDox plus optimized RFA significantly extend survival which is the basis for our ongoing OPTIMA study. Phase 3 OPTIMA Study is involving ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes for treating lesions three to seven centimeters versus standardized RFA-alone treating lesions three to seven centimeters. We view the OPTIMA study as a highly U.S. pivotal trial with strong supportive data from the HEAT Study further supported by multi-variate analyses and with the prospect of revealing preclinical data, while our competing trials can [add a deviant] to our primary liver cancer at this time. In the current treatment option, Nexavar provides a modest survival benefit of less than three months. To be sure, primary liver cancer historically is the most prevalent cancer in the world remains the largest unmet medical need less than oncology. And by 2020, HCC is expected to be the number one cancer worldwide surpassing lung cancer. The OPTIMA Study is expected to enroll up to 550 patients globally in clinical sites in the United States, Europe, China and Asia-Pacific. We have over 50 sites activated and enrolling patients. And China’s 21 sites are expected come on very soon. In parallel with CFD's review of our clinical trial implication we’ve been working with the Chinese clinical sites to ensure a rapid start-up in China, where some 50% of incidents of HCC occur. We’ve also made progress with our efforts in recurrent chest wall breast cancer. We announced a positive interim data from our Phase 2 U.S. DIGNITY trial. Of the 17 patients we recall enrolled and treated in the study, 13 were eligible for a evaluation of efficacy. And based on interim data each and every patient -- each and every evaluable patient experienced clinical benefit over a highly refractory disease with a local response seen with complete response or a partial response of 69% observed in per clinic evaluable patients, notably five complete responses and four partial responses. I’d also mention that four patients were noted with stable disease. These data are consistent with previously reported Phase 1 data for ThermoDox plus hypothermia and RCW breast cancer including combined data from our Phase 1 DIGNITY Study and a Duke University sponsored Phase 1 trial of ThermoDox. We have positioned U.S. DIGNITY Study for breakthrough therapeutic status and our applications filed in October 2015 with hopes that we can announce a positive review by the FDA some time before the end of the year. One of our leading investigators in the DIGNITY Study, Dr. Hope Rugo will be presenting final Phase II data at the San Antonio Breast Cancer Conference on December 12, 2015. The remarkable results from the U.S. DIGNITY trial have driven investigator interest for our upcoming Euro-DIGNITY Study, which will evaluate completing partial response up to six types of the ThermoDox plus hypothermia and radiation treatment. Euro-DIGNITY will be conducted in five countries with assistance from MedLogics, the hypothermia device company based in Italy. The open label study, which will enroll of total 70 patients and the potential to support a registration filing in Europe. We anticipate enrollment at the beginning in the first half of 2016 with a ramping up sometime in 2017. Now to the EAP and while it has taken some time for filing and posting discussions, during the third quarter, we reported that the ThermoDox early access program or EAP with myTomorrows, the Dutch company that we have partnered who makes a business in EAP. We announced that EAP will include patients with primary liver cancer and with liver cancer metastasis as well as recurrent chest wall breast cancer patients. The program spans all 22 countries in the EU as well as Switzerland, Turkey and Israel. Celsion is highly committed to providing patients who need viable treatment options with access to ThermoDox. It stands now with 500 patients having received treatment. The safety profile is well recognized and is highly acceptable to the oncology community. The physicians that will be allowed access to ThermoDox in EAP will be well trained. To that end, we announced earlier this week, the addition of Dr. Edwin De Wit to the Celsion management team. Dr. De Wit will oversee our working interest for the OPTIMA enrolled DIGNITY studies as well as partnering with myTomorrows to provide leadership and oversight from the EAP. Edwin has experience in this area having previously spearheaded a similar program for European Oncology therapeutics. Now I’d like to briefly touch on our TheraSilence RNAi delivery platform. As you will recall, and as mainly announced in ProGene preclinical findings confirming that the TheraSilence technology platform can be safely and effectively, deliver RNA directly to the lungs with a high level specificity. By partnering with RNA therapeutic companies, we believe that TheraSilence represents a very low cost, lower resource requirement development opportunity. Two such collaborations are in progress, evaluating fairly on a lung-directed product candidates. We hope to announce progress on both programs in the coming quarters, with data mergers from early collaborative efforts. So that concludes my remarks. I’ll turn the call now over to Jeff, who will review our financials. Jeff?

Thank you, Mike. Starting with cash, we ended the third quarter of 2015 with over $24 million in total cash and investments. For the quarter ended September 30, 2015, we reported a net loss of $4.3 million or $0.19 per share compared to a net loss of $6.9 million or $0.40 per share in the same period of last year. Cash used for operations in the third quarter of this year was $5.3 million, compared to $5.8 million in the same period last year. Cash used for operations in the first nine months of this year were $16.9 million, compared to $14.8 million in the same period last year. In September, we reported that we implemented a reorganization following the full integration of our EGEN operations. We evaluated our current organizational structure and have aligned our resources both personnel and clinical development programs with our near-term development objectives. As a result of this action, we expect to realize a 15% to 20% reduction in personnel and related annual operational costs going forward into the fourth quarter and into the subsequent years 2016 and 2017. We estimate that our average cash usage for operating activities will be approximately $1.4 million per month and that reflects the full implementation of the OPTIMA Study and our plans for the GEN-1 and TheraSilence programs. Our projections include modest revenues in the EAP program as well as lower personnel and operating costs resulting from the full integration of the EGEN acquisition and realignment of functions as discussed above and in Mike’s earlier comments. We continue to monitor our cash expenditures to ensure the most efficient use of cash to create shareholder value and project that our cash flow support operations into early 2017 passed many of the milestones outlined earlier. R&D costs were $2.8 million in the third quarter of 2015 compared to $4.6 million in the same period last year. R&D costs were $11 million in the nine months ended September 30, 2015, compare to a similar number of $10.7 million in the comparable nine months period last year. The increase in R&D costs in 2015, is primarily due to expenses associated with the operations of EGEN, costs associated with starting up and initiating the Phase III OPTIMA Study as well as production of clinical supply this year for the anticipated GEN-1 Phase I clinical studies. General and administrative expenses were $1.5 million in the third quarter of this year compared to $2 million in the same period in 2014. And they were $5.3 million in the nine months ended September 30, 2015 compared to $6.8 million in 2014. These 20% to 22% decreases in G&A expenses were primarily the result of lower personnel and operating costs, as well as lower insurance premiums and these lower operating costs were the result of reorganization and staff reductions announced in September. I’ll now turn the call back over to Mike.

Thanks, Jeff. A few concluding remarks. We remain fully committed to our investigation and product development programs and to the therapies that address unmet needs of patients with cancers worldwide. Our [biology] remains strong. We believe will allow us to execute on many of the upcoming milestones that I just spoke of including the initiation of two clinical trials in the next year with our GEN-1 and our ThermoDox programs both of which we believe are some of the most exciting programs in product development today. As you can see the products we've made over the last 12 months, deciding the stage for what we believe will be a strong ending to 2015 and will position us for what should be a very successful 2016. Now with that, it's always an great opportunity for us to answer your questions. So operator we would like to open the line to questioners and we would ask the questioners to limit them to two in order for everyone to have a chance to ask us a question. Operator?

Thank you. [Operator Instructions] We will go to our first question from Keith Markey with Griffin Securities.

Good morning Mike and Jeff. Thanks for taking my questions. Two questions; one, I was wondering if you might be planning to establish an office in Europe possibly to at least help in the training of doctors involved with the trials over there and the use of the your drug with the EAP program?

Keith exactly that's -- the answer to your question that's exactly what we are doing. We are establishing our office in Switzerland, potentially that is central to what we believe are the major countries for the EAP and it's a country where Edwin resides. From that office, I mean actually we have our subsidiary, call it our Celsion GmbH. From our office in Switzerland what we plan to do is provide technical and clinical support to the myTomorrows team to assist the physicians who we believe are qualified, the six physicians with understanding our product and positioning it's application and ensuring the proper training before any product is made available to those physicians.

Great, thank you. And then I was wondering, based upon with these progressions that you started in the overall HEAT Study how soon might the Chinese cohort of the HEAT Study saw a significant benefit?

Nic can you answer that. So the question is of the Chinese cohort what percentage of significant benefit.

Yes. How soon would we see it?

How soon we see benefit from the Chinese cohort.

Yes.

That's an interesting question Keith and I'm very pleased to say that the Chinese cohort was very consistent with the overall population. So patients that are treated with ThermoDox, whether they are Asian or Caucasian, we believe will have very similar responses. And I think your question is coming from the fact that the Chinese cohort were the last ones to be enrolled into the HEAT study and their data was the last one that we were able to review of a wide suite and we saw results that are very consistent with the overall population. So for us that was very good news.

Will go next to Mark Breidenbach with H C. Wainwright.

Hey, guys thanks for taking the questions. We saw some very nice proof-of-concept data for the TheraSilence platform presented at your R&D Day in preclinical model of pulmonary arterial hypertension. Should we be viewing this as sort of foreshadowing for each of your clinical program or should we really be expecting the first clinical application of the technology to be more closely linked to Celsion's core focus in oncology?

Yes, it's a very good question. So we don't want to confuse any investors or anyone interested in the company. Our focus is on oncology. What the PAH model demonstrates first is the utility of this platform, we are delivering therapeutic RNA with one specificity to treat lung specific disease. So we have an interest however in making sure that if this technology has potential then it is developed. And so if it's of interest to a partner or collaborator to continue development beyond the initial feasibility we will make sure that the -- this therapeutic is available to that. Now we’ve been looking, we’ve been discussing with various potential partners the potential for our continued development by another [party].

That’s helpful. And second question really I guess is directed at Jeff, are we still expecting to see first revenues from the ThermoDox Early Access Program start-up during the fourth quarter? And then can you offer any guidance on what to expect from those revenues?

As Mike indicated, this is a process that we’re very much involved in. We haven’t given any guidance. We do as I mentioned in my notes, just the modest revenue moving forward which is a bit new in some of our projections. We do anticipate first in the fourth quarter and with headwinds, expertise and experience in these type of programs and with presence in Europe, we’re hopeful that this will move forward in a way that we had anticipated when we first signed up myTomorrows.

Yes, I think I’d like to add to that also, as I don’t want to mislead anyone. The EAP is not going to be a major revenue generator by any means. If it is, then we will be delighted but surprised. The revenue that will be generated from the EAP is secondary to our interest. Our initial interest is making sure that a drug that we know can be administered safely. It has shown great potential to treat two indications successfully and in the proper hands can be -- and with proper training can be used to treat patients in Europe before the drug is approved, that’s our major interest. On revenue, secondary and every little bit of revenue always helps, but more importantly the experience that we gain in clinical practice, the improved outcomes in treating patients that we expect, the endorsement from the medical community you have experienced outside of our clinical programs is our major objective.

We’ll go next to Jason Kolbert with Maxim Group.

It's actually two analysts here, you have Jason Kolbert and Dr. Jason McCarthy, so we have four questions. My question really has to do with the velocity of enrollment, given the fact that you have 50 sites open now and another 20 coming in China in OPTIMA. It sounds like you're going to hit that 75 target really quick. So can you give us some idea based on how the enrollment numbers are looking now, when we might hit the 550? And that’s part one. Part two has to do with, once the trial is completely enrolled, what do you think the timing might look like given the assumptions around standard of care for the overall survival endpoint? Thanks and then I’ll hand it off to McCarthy.

So good question, I think I believe we’ve always been reasonably precise with our [indiscernible], like our understanding what enrollment rates should look like in [pre-clinical] like we have a great deal of experience obviously enrolling patients in our earlier Phase 3 trial. With the difference being that the patients they we are enrolling in the OPTIMA Study in a single lesion as opposed to patients in the HEAT Study had [mock populations]. So, I am pleased to tell you that for the study types that we have open, the enrollment rate and actually it's exceeding our expectations. Over the last four months we have been pleasantly surprised with enrollment rates. And I think it's not only a function of the availability of our clinical trial in some areas where if you see a problem. But also confidence we’re seeing among physicians with regards to the value of putting patients into the study. Dr. Borys just came back, we’ve had -- actually we’ve been meeting with physicians around the world. Dr. Borys just came back from the ACTA Conference he may want to comment about on some of the insights and support that he saw from interventionalists in Japan. But also we had a kind of congress for PIs in Bangkok not too long ago with an extraordinary level of support to them there. So I am not answering with precision your question. so let me just take it little bit further. So at current enrollment rates we could -- viewing without China, we could see a study enroll, within the projections that we gave you and I think when we first mentioned over a year ago that we expected to enroll between 30 and 36 months, China will be a nice positive to that. So subsequently -- so the longer people live the better, but the long people live, the longer it takes us to evaluate of what we have will be successful. So patient survival is always kind of double edge sword. We want patients to live longer but we also like to know the results of the study too obviously. But again we have projections on that based on our understanding from the OS suites that we’ve taken from each study and it seems to us in this case, it would be with less precision because the standard of care is improving. That subsequent to enrollment six to eight months, maybe nine months after the study us fully enrolled we may be able to evaluate patients at the first pre-clin interim analyses. Because we’ve mentioned to everyone and it's in our presentation deck on our website, first interim analysis I believe is at 116 events -- 118 events on 18 decks. So I hope that answered your question. Once China comes on and we get our studies heads up and rolling above the -- may be by the end of the first quarter or through the second quarter. We can be a little bit more precise with our new enrollment rates at the study conclusion on that.

Thank you Mike, that’s really helpful. Let me turn over to Dr. McCarthy, who had a couple of questions, I know he was excited by some of the things he learned at the R&D Day.

Hi guys. What I’ve been finding really interesting and I think is not talked about so large is that, there has been a lot of push backs on the CAR T stage that vaccines and TIL therapies are not going to work. And what we’re finding out is that ovarian cancers and lung cancers and melanoma cancers seem to be the most highly immunogenic cancers that are out there. So a lot of that it seems to be tied to IL-12 and IL-12 delivering was particularly attractive to GEN-1 at the R&D Day, because things like you figured out how to get it into an ovarian tumor at least into the area, which could have significant upside in ovarian cancer treatments particularly with vaccine or some type of TIL therapy. And my question is have you been talking to partners and people in the vaccine stages or the T-cell stage, we’ve already seen Inovio partner with MedImmune on core cervical cancers, which are also highly immunogenic?

So in this regards to this -- first thank you very much for those comments. We’re quite excited with this approach that we have invested for the most part by our colleagues in Huntsville very, very exciting proposition not only provides this -- being a stimulating agent on the first dosing. But the ability to continue to dose patients to recruit the immune system to work in combination with chemotherapy was very exciting to us. And now with Avastin some preclinical data we’ve seen in the early models is nothing short of astounding. So with regards to business development, I can tell you that we have a very active business development and outreach program to a variety of companies. Those involved with biologics, who are in this space and those who are involved with earlier stage development programs in other therapeutic areas as we have. That’s about as much as I can say at this point.

Okay. I also think it’s really interesting, the combination with chemotherapy which is some people think that chemotherapy is just going to go away, it’s not and we’re seeing some of the CAR T people like [indiscernible] using chemotherapy to influence their T-cells. And I’m excited to see where GEN-1 with chemotherapy have potentially with the vaccine and where that's heading in the next year. Thank you, guys.

Yes. So already we have moved the check point inhibitors to the cell.

Thanks guys. I appreciate the update.

Thank you. Next please.

We’ll go next to [Barry Rubin] with [indiscernible].

Good morning, [Barry].

Thank you, good morning and thank you for the great progress as always. I just had a quick question on glioblastoma. You answered my question on the last conference call about the difference on your product versus others. But are you planning to -- [indiscernible] I don’t know. Are you planning to do this alone or with a partner?

So our three initial programs are beyond in the first stage in the clinic won't be done alone. That’s our current plan.

Okay. And when do we get the first results on any treatment. Is that a year or so away or what timeline I wasn’t sure?

You’re talking about glioblastoma specifically.

Yes, that’s correct.

So I think we gave a pretty comprehensive update. Just let me tick back a little bit and maybe the rest of the listeners can better understand where it is coming from. So GBM we have shown in preclinical models that GEN-1 works very, very synergistically with one strategy in post surgical patients and that's using a technology that delivers a BCNU therapeutic called Gliadel. We are seeing that again in animal models. Now we have seen an improved outcome overall survival in tumor inhibition. .We've also evaluated our GEN-1 with an emerging standard of care, maybe the standard of care for many surgeons treating these patients and that's with temozolomide. We admit the data we've seen is incontrovertible. Tumor inhibition in these animals when we combine our GEN-1 with temozolomide is pretty astounding and we are able to discuss this data with quite a bit of confidence and some of it is included in our vaccine. Now with regards to our clinical program, Dr. Borys and Khursheed Anwer, our Chief Science Officer have been meeting with both surgeons and neuro surgeons around the world literally, mostly in the United States but some European physicians also and surgeons also. They discussed methods of administration. We probably have a one last step here, Barry, lastly to ensure that the method of administration that we are contemplating as it meets all of the expectations of surgeons who treat these patients. And we expect to, all in the next three to four months complete our work in that regard. Subsequently we believe we would have enough mechanism on this method of administration information along with the safety and efficacy data from preclinical models to file an IND. An IND in this indication obviously will require a discussion with FDA. So I would say the earliest that we would be treating patients could be in the second half of next year, will be the very earliest. Because these patients unfortunately have a very aggressive disease and subsequently a short life span, the data from treating patients, this is one I think that's interesting to us. Data from treating a small number of patients can tell us with some confidence whether or not we are on the right track in a relatively short period of time. So as we said in the past, assuming that we have the answer through this method of administration in the relative near term, it's about a matter of reference, just a matter of when. So the answer to this method of administration our GBM could become the priority for the company.

Great. Thank you for taking the time. I appreciate it.

We will go next to Hartaj Singh with BTIG.

Hi, guys. How are you doing? Thanks for letting me take this question. I will just ask a question, which I generally tend to ask management teams when they've got lots of stuff going on. As we get into this year, into next year and we are thinking already about next year. What are your sort of priorities from a strategic, operational and financial perspective? And just help us order this vast range of activities that you are going -- have going on and how you think about it in terms of just the prioritization kind of framework? Thanks.

Yes. So our lead development program is optimal, there is no question about that. And priority one is to ensure that soon as we have clinical trial agreements with the Chinese, is to take advantage of all the pre work that has been done in China to initiate the Chinese sites of which there are 20 plus. So there is a lot of water behind the dam in that regard, clinical trial application and then we expect the application to be reviewed for the final time in the relative near term. So priority one is initiating those clinical trials sites, which as I said earlier, Hartaj, could add to what appears to be an enrollment rate that is -- that at least for the last number of months over a quarter have exceeded our expectations. Our priority two is, to change the enrollment in our Phase 1 program for ovarian cancer. We know quite a bit about the value of GEN-1 is earlier Phase 1 studies that were conducted by the GOG. Confirming that information in a company sponsored study as well as establishing the starting dose and maybe having some understanding of what an enhanced population looks like and establishing the starting dose for the Avastin plus Doxil plus GEN-1 study in the second half of next year would be priority two. So priority three then, is our work in recurrent chest wall breast cancer and while this is not a big market opportunity and certainly presents for us one of the more compelling applications of our chemotherapy technology to a group of patients who deserve better. Nic and I and particularly Nic, have taken this indication in these people as a personal challenge. We've been working with we believe some of the best and most motivated investigators in the world and you can expect that once we have our European study up and running which we expect shortly to begin enrolling patients. A rapid enrollment and hopefully the data centric 70 patients in about 24 months, it could be very compelling to a regulatory agency. So those are top three clinical priorities. In the pre-clinic, just the four priorities, the four things we’re working on. And the fourth one being as I mentioned earlier, very resource -- a low resource requirement for development program. We think we have something that's quite unique in this lung delivery platform and we’re seeing some very impressive data in pulmonary hypertension. We know then in a non-human primate model that we can deliver [reported] therapeutics directly to the lung with very little accumulation in other organs. It seems to us that some of the collaborative work -- feasibility work that’s going on in our laboratory in Huntsville, Alabama could be -- kind of has the potential to be some of the most breakthrough kind of work that the companies value. A low resource, lowest portion of the priorities, but has the potential to be the biggest impact. And then number five would be GBM at this point. Although as I said earlier I want to stop confusing here, we have a little bit of work here to do on method administration. But assuming we solve that problem GBM could take a higher priority pretty quickly. I will just conclude with all these programs they have been evaluated from a cost standpoint and in our cost estimates and spending plans going forward we’ve a target for the resources and the dollars associated with each.

Thanks Mike that really helps a lot. Now actually just with all the ASH abstracts out today and some of the new fangled gene therapeutic approaches taking a little bit, let's say in a sense just not a great reaction, I think maybe folks might circle back and start looking at companies with drugs that actually have a benefit. Thank you, I appreciate the color.

We have no more questions at this time. so I will turn the call back over to our speakers for any additional or closing remarks.

So again on behalf of the company, I want to thank everybody who has joined us on the call. We are as always very appreciative of your interest and your support. The work that we do could not be done without the support that we get from the investment community and our shareholders. So we greatly appreciate your interest and we look forward to updating you on our progress as we continue to move forward with what we believe are some of the most important clinical programs. Thank you very much.

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