Inovio Pharmaceuticals Inc (INO) 2015 Q1 法說會逐字稿

Greetings and welcome to the Inovio Pharmaceuticals, Inc. first-quarter 2015 financial results conference call. (Operator Instructions). As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Bernie Hertel, VP of Investor Relations and Communications for Inovio Pharmaceuticals. Please go ahead, sir.

Thank you. Good morning, ladies and gentlemen. Today's call may contain certain forward-looking statements relating to our business, including our plans to develop DNA immunotherapies and electroporation-based delivery technologies, as well as our capital resources.

Please keep in mind that actual events or results may differ from the expectations discussed as a result of a number of factors, including uncertainties inherent in preclinical studies, clinical trials and product development programs, including but not limited to the fact that preclinical and clinical results referenced on the call may not be indicative of results achievable in other trials, studies and trials -- may not achieve the results desired and they may not commence or be completed in the time periods anticipated.

There may also be risks related to collaborative arrangements, including the timing and receipt of payments, the availability or potential availability of alternative therapies for the conditions targeted by the Company or its collaborators, issues involving product liability, issues involving patents, the adequacy of our capital resources, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year 2014, our 10-Q for the quarter ended March 31, 2015 and other regulatory filings from time to time.

Finally, there can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products or that any of the forward-looking information provided will be proven accurate.

Now Inovio's President and CEO, Dr. J. Joseph Kim.

Thank you, Bernie. Good morning, everyone. In the first quarter of 2015, Inovio set in motion several key activities that could benefit not only our investors, but human health globally based on Inovio's immunotherapies. Consider these five Inovio initiatives launched just in the past few months. First, Inovio raised $87.4 million primarily to fund our upcoming Phase 3 trial for VGX-3100, our therapy that demonstrated regression of a cervical precancer and elimination of the HPV virus, the cause of the condition that frequently leads to cervical cancer.

Second, in partnership with Roche, we initiated a clinical trial to treat those infected with hepatitis B virus and received a $3 million milestone payment for reaching this important milestone. Third, in a small sample preliminary review, we revealed that our therapy for HPV caused head and neck cancer generated robust cancer-killing T-cell immune responses. Fourth, we received a $16 million government grant to further develop our DNA-based HIV vaccine.

Finally, in the first quarter of this year, Inovio was selected by the US government to lead a $45 million program to produce and test a preventive Ebola vaccine and a DNA-based monoclonal antibody to treat those already infected. This is an impressive yet also seemingly diverse set of accomplishments.

You might ask how do they fit into Inovio's corporate strategy. Let me take a few moments to discuss this. Our vision is to develop and commercialize targeted DNA-based immunotherapies to fight cancers and infectious diseases. The progress we have seen with the advancement of immunotherapies focused on certain immune-modulating mechanisms has been exciting and clearly validates the important role and the potential of activating T-cells.

Despite the successes, many analysts have noted that we have still really to scrape the surface. There is certainly one key shortcoming among all the capabilities that are being advanced. That is the ability to safely activate antigen-specific killer T-cells in vivo, or in the body, in a manner that may function strongly as a monotherapy or in combination with other immune-modulating mechanisms.

To create some context, there are mechanisms that inhibit cancer cells' ability to neutralize the killer T-cells that are hunting them down. There are mechanisms that manufacture vast quantities of T-cells outside the body, but risk inducing significant detrimental inflammatory responses in the body.

To be technical for a brief second, the most natural and powerful killer T-cell immune responses occur by having a significant antigen presence visible through the MHC class I presentation mechanism. Inovio's DNA-based approach using its electroporation delivery method is the only way we know of that uses this mechanism by presenting only the antigens related exclusively to the targeted cancer or infectious disease while other approaches targeting this mechanism have anywhere from an additional 10 to 1000 antigenic proteins associated with the carrier virus or bacteria, known as a vector, which ultimately distracts the immune system and attracts unwanted responses. This precludes or reduces the benefit of boosting, which is fundamentally central to good immune responses.

Think about it, it's like our brain. Repetitive exposure to information is fundamental to learning. It is no different for the immune system. So undoubtedly, Inovio is very excited about its technology positioning and its unique potential role in the spectrum of immune-modulating mechanisms.

So let's review our strategy. The essence of biotech development is generating data. With good data, you move forward. With lesser data, you back up and try other approaches or perhaps you can deprioritize or even kill it. Inovio is absolutely committed to generating data through rigorous studies and analyses. We first wanted to be convinced of the ability of our technology platform to generate immune responses with the right characteristics, which we have done in our HIV and HPV Phase 1 studies.

In our first double-blind Phase 2 study, we have also shown efficacy that is statistically significant and clinically relevant and important. With this evidence in hand, we will proactively progress individual programs through to FDA approval while at the same time broadening our pipeline.

As you know, we have a large and growing pipeline. How are we prioritizing our efforts? First and foremost, Inovio is an immuno-oncology company. Cancer has significant unmet patient needs. It represents significant profit potential as well. We are very motivated to advance and expand our cancer pipeline and we are willing to apply our own capital to do this.

Our DNA immunotherapy technology is just as relevant to the prevention and treatment of infectious diseases. With significant third-party funding, we are pleased to advance these programs. Some, such as hepatitis B, may in fact represent a very large commercial opportunity. Others may fit more into the realm of having stockpiling potential. They can all provide financial benefits to Inovio and these developments all generate new knowledge that can leverage across our platform.

It is clear from our performance of recent years we have the focus and ability to secure resources to help us in our endeavor. We have been very effective in securing grants, collaborations and partnerships. These inputs provide financial and knowledge resources that help to minimize share dilution and also contribute to valuable guidance to our efforts.

Unlike many of our peers, Inovio has a platform that can generate a multitude of products. Indeed, we have built a very rich pipeline of products. We also realize that we will not be able to fully develop all of our products on our own. What we will do is to secure partnerships for some of our products while retaining some through full commercialization.

We can do a partnership at the preclinical stage, like we did with INO-1800 with Roche or even later, even after Phase 2 or even after Phase 3. We appreciate the validation that comes with credible partnership deals and value the resources that can enhance value for the Company and its shareholders.

Finally, where do our technology and products fit within the system of immune-modulating mechanisms and products? Is our antigen-targeting immunotherapy the one unique addition that can by itself help the immune system to mount a more powerful and effective response to diseases? Or will it have to be a part of a combination?

We are happy to function as a monotherapy or as part of a combination. However, what we are not indifferent to is establishing a clear basis of data that allows us to characterize the utility of our technology and ensuring we secure the appropriate value for our approach.

We will emphasize that it is not our class of immune technology that is crowded with multiple competitors. We are sensitive to the importance of time, but we will do the job correctly. It is premature to go into the details now, but I assure you that we are being proactive in advancing our monotherapy trials and establishing the immunogenicity of our products in different disease areas. We are also conducting research to assess our technology alongside complementary technologies. I can only say stay tuned.

So let's place all of our current activities into this framework. I'm going to divide them into the categories of cancers and infectious disease. VGX-3100 is our most advanced program. This HPV cancer immunotherapy targets antigens related to a spectrum of disease from initial viral infection through, for example, cervical dysplasia and cervical cancer, as well as other precancers and cancers. We have repeatedly reiterated in detail the positive results of our randomized placebo-controlled double-blind Phase 2 study. I will not repeat the results here.

Suffice to say that these results are a significant step forward providing women and their physicians a nonsurgical approach to treat precancers, which our market research has shown is a desired solution. After a lengthy exercise to measure and analyze all the T-cell data after we reported the top-line data last July, we do look forward to seeing the full Phase 2 data sets being published in a top peer-reviewed journal this year.

With our next step being a Phase 3 registration study of VGX-3100, we do need to manufacture the biologic agent, the immunotherapy, in the same facility we would use for future commercial production. We do have to scale up device manufacturing as well. We will also be meeting with the FDA to review the Phase 2 data and our proposed Phase 3 plan. We are working proactively on all of these steps in parallel.

We have recently raised $87.4 million in gross proceeds through an equity offering. With these funds in hand, we no longer face uncertainty regarding funding for this planned Phase 3 trial. We have all the components in place and are on track to launch this study in early 2016.

Last month, we released our first ever data related to the use of our DNA therapy for a cancer. The preliminary data show that INO-3112 for treating HPV-caused cancer generated strong CD8+ killer T-cell responses in three of four patients with head and neck cancer associated with HPV types 16 and 18 infection.

Whether it's an infectious disease or precancer or cancer, the immune system uses the same mechanisms to eliminate infected or mutated cells. In immuno-oncology, it's all about the T-cell and we showed in our cancer patients that the CD8 killer T-cell responses we generated were in line with the best-in-class T-cell responses that we generated in our Phase 2 efficacy trials of our cervical precancer study. We look forward to further data from this head and neck cancer study later this year.

It is noteworthy that the incidence of HPV-caused head and neck cancer has been rapidly rising, especially HPV-associated oropharyngeal cancer in men. By 2025, researchers believe that HPV will be the causative factor of 90% of all head and neck cancers. We expect to report additional immune response data from our HPV head and neck and cervical cancer studies, as well as our hTERT study in breast, lung, pancreatic cancer over the next few quarters.

We will also soon launch our prostate cancer study with INO-5150. I will tell you that we have a rigorous ongoing effort to characterize a broad set of cancer indications, the antigens associated with these cancers and our R&D and preclinical priorities to advance further cancer immunotherapies into the clinic. We are also conducting research to assess the impact of immune-modulating mechanisms that may be complementary to our novel DNA-based immunotherapies as well.

On the infectious disease front, we took an important step with our partner Roche by moving from preclinical into a Phase 1 trial for hepatitis B immunotherapy INO-1800. This large, randomized, open label, active-controlled, dose escalation study is evaluating the safety, tolerability and immunogenicity of Inovio's hepatitis B immunotherapy alone or in combination with IL-12-based immune activator. This study will help with the design of a future Phase 2 protocol.

Hepatitis B shares characteristics similar to hepatitis C, which has witnessed several notable successful drug successes. Antiviral treatments used to control hep B usually do not eliminate the virus and there are no cures. With prevalence nearly double that of hepatitis C, there is significant opportunity for a hepatitis B immunotherapy able to actually clear the virus.

Moving to HIV, having completed the development of PENNVAX-GP under a prior $25 million grant, we are on track to soon initiate a Phase 1 trial of this HIV vaccine. In March, Inovio and its team of academic collaborators were awarded a new $16 million grant from the NIAID to expand the coverage of Inovio's PENNVAX HIV vaccine to additional HIV strains and advanced new technologies to further improve vaccination outcomes. We have one of the most dynamic HIV programs in the world.

Finally, Ebola and our DNA-based monoclonal antibody application. In a half a year period, we have secured with our collaborators, including MedImmune, two awards from DARPA, one for $12 million in October of last year, the other for $45 million this quarter. DARPA, which is the Defense Advanced Research Projects Agency, is the arm of our government that places bets to support the advancement of important new technologies with potentially significant benefits to government and society.

Case in point, the Internet we know today began as DARPAnet. Under the $45 million Ebola grant, the Inovio-led consortium is taking a multifaceted approach to develop products to prevent and treat Ebola infection. Inovio is the only pharma company that DARPA has relied on to develop both a preventative vaccine and the treatment for those infected. This project incorporates Inovio's DNA-based vaccine against Ebola with the first patient expected to be dosed this quarter. It also involves a highly potent conventional protein-based therapeutic monoclonal antibody product against Ebola.

What is exciting is that this award also funds the development of a therapeutic DNA-based monoclonal antibody product, or dMAb, against Ebola. This Inovio innovation enables expedient design and manufacture using proven fermentation technology and may provide more rapid therapeutic benefit. DARPA awarded us $12 million last October to develop dMAbs against influenza and antibiotic-resistant bacteria. We believe our dMAb technology has tremendous potential advantages relative to existing conventional monoclonal antibody products, as well as for diseases for which monoclonal antibodies could not be developed currently. This technology could by itself serve as a foundation for a biotech company. We are pleased to have the resources and programs to advance this technology further. Now, our CFO, Peter Kies, will provide our financial highlights. Peter.

Thank you, Joseph. Good morning, everyone. Total revenue was $5.2 million for the three months ended March 31, 2015 compared to $2.4 million for the same period in 2014. Total operating expenses were $13.5 million compared to $12.4 million. The net loss attributed to common shareholders for the quarter ended March 31, 2015 was $10.6 million, or $0.17 per share, compared to $10.8 million, or $0.20 per share for the quarter ended March 31, 2014.

The increase in revenue was primarily due to payments received from Roche under our partnership agreement established in September 2013. Research and development expenses for the quarter ended March 31, 2015 were $9.4 million compared to $8.2 million for the quarter ended March 31, 2014. The increase in research and development expenses was primarily generally related to the increase in investment in all of our product development programs.

General and administrative expenses remained consistent quarter over quarter at $4.1 million for both periods. As of March 31, 2015, cash, cash equivalents and short-term investments were $81 million compared to $93.6 million as of December 31, 2014. At quarter-end, the Company had 60.7 million shares outstanding and 67.8 million on a fully diluted basis.

Subsequent to the quarter, we triggered a milestone payment of $3 million from Roche for the initiation of our hepatitis B Phase 1 program. On March 5, 2015, as discussed earlier, the Company closed an unwritten public offering of 10.925 million shares of the Company's common stock, including 1.425 million shares of the Company's common stock that was issued pursuant to the underwriter's exercise of its options. This was at a public offering price of $8 per share.

The gross proceeds from this offering were $87.4 million. Net proceeds to the Company after deducting underwriters discounts and commissions were approximately $82.1 million. We were pleased that many knowledgeable institutional biotech investors participated in this round of financing. We intend to use the net proceeds received from this offering for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses, manufacturing expenses and potential acquisition of companies and technologies that might complement our business.

Overall, based on management's projections and analysis, the Company believes that cash, cash equivalents and short-term investments are sufficient to meet its planned working capital requirements, including the cost of its planned Phase 3 clinical trial of VGX-3100 through the end of 2018. More details can be found in our press release issued this morning and on our website in the Investor Relations section under the SEC filings. Joseph, now back to you.

Thank you, Peter. Let me end with my point of view on the broader significance of our recent steps. First, we are pleased to have been able to share the first cancer data from our DNA-based immunotherapy technology. We believe we have a vital role to play in securing the unrealized potential to treat cancers better.

Second, we are moving proactively, along with creating new antigen-targeting immunotherapies, we are constantly seeking additional application and refinement of our core DNA plasmid and electroporation delivery platform. Our new DNA-based monoclonal antibodies are one example. We have notable disease targets and other immune-modulating mechanisms that we are pursuing with this application and we look forward to reporting our progress in the future.

Third, we've secured over $130 million in government awards to support Inovio programs in the past six years alone. These monies are very helpful in minimizing dilution and advancing our core technology and products. Fourth, we have clearly shown our capability to secure an advance valuable collaborations and partnerships. Roche entrusted Inovio to secure the FDA approval of our IND and conduct the hepatitis B Phase 1 study. We now look forward to enrolling patients in this study rapidly, this important disease and huge commercial opportunity.

These types of relationships do bring validation and valuable resources. We are fully committed to securing additional grants, collaborations and partnerships and look forward to further steps forward on this front. Finally, we have all the necessary resources to advance the VGX-3100 into Phase 3 and are on track to move this lead program into the clinic early next year.

To close today, we have completed a solid first quarter for Inovio to kick off what I expect will be another year of successful execution on our strategy to commercialize DNA-based immunotherapies to treat cancers and challenging infectious diseases. Now, thank you very much and I am now ready for questions that you may have.

(Operator Instructions). Charles Duncan, Piper Jaffray.

Good morning, guys and first of all, congrats on a good quarter of progress and thanks for taking the questions. Joe, my first question is regarding the VGX-3100 cervical dysplasia trial design and perhaps timing and costs. I guess when can you tell us more about the design, roughly the number of patients and what you anticipate the timing and cost to be for that trial?

Yes, absolutely. All of these details will be finalized probably by early fall or late summer when we actually have the end of Phase 2 meeting with the FDA to formally discuss all of these conditions. But we expect the size of our Phase 3 trial to be approximately 350 patients. There will be one-to-one randomization and there will be multiple endpoints to be looked at similar to our Phase 2 studies.

The regression of CIN2/3 down to normal, full complete clearance, as well as the elimination of HPV virus from the cervical area, as well as perhaps even the rest of the body cavities as well where HPV virus can lurk. So we expect to launch this study in early 2016. We are fully on track for that and we expect the total study length to be about 2.5 years. We are very excited to get this first Phase 3 trial for Inovio immunotherapy going as soon as possible.

And Joe, I realize that you still need to get that FDA or that feedback from the agency in the third quarter before you start the study. But is it your plan for this to not only be necessary, but sufficient to support registration or filing an NDA with the FDA for approval? And then secondarily, what are you assuming in terms of that timeline that you laid out with regard to patient enrollment? It would seem to me that with the full publication of the earlier data that enrollment may go faster than in the previous study?

Yes, second question first. I agree with you. With the efficacy data in hand, the enrollment will be much more accelerated than what we had experienced for Phase 2 where we went in without any efficacy data. So obviously we want to get it done as soon as possible. We like to project less and deliver more.

As far as the FDA, we are going by the assumption that this will be the sufficient registrational study, but obviously the final arbiter is the FDA and we have not yet had the formal communication from them regarding the endpoints, as well as the design. But based on our meetings with the advisory board and so on, we feel very good about our design and moving forward.

That's helpful, Joe. Last question from me, sticking with HPV, I'm wondering if you could guide to additional data out of the head and neck study that's ongoing. When would you anticipate that to move into later perhaps registrational trials as well for head and neck?

Yes, absolutely. So head and neck -- so we have pilot studies for head and neck and cervical cancer. Last month, we were able to analyze the first four patients, their immune response data and we were very pleased to see that three out of four first patients from this study generated CD8 T-cell responses against HPV 67 antigen similar -- to the level that were similar and robust as what we have seen in our 150 patient Phase 2 cervical pre-cancer study. So that what this hints at is we can translate our data from the pre-cancer patients to cancer patients, so we are quite excited about this. We are still enrolling these patients and we look forward to presenting a larger set of immune response data.

Safety data, thus far, have been excellent. So we continue to show a strong safety signal from our programs and up till now we have treated over 550 patients across different trials that we have ran and we haven't seen any concerning safety signals. So knock on wood, we are very excited about that as well.

How we are going to roll into a larger 2B or Phase 3 study for head and neck is to evaluate what are the T-cell levels that we can generate and then we will go into more survival-based trials after learning what we can from this 20-patient pilot study. So we are just on track as to where we had wanted to be. We are exactly where we would like to be. So are very excited about our head and neck INO-3112 program.

Similarly with cervical cancer. So we have multiple shots on goal in cancer that we will be able to present to the market in the next several quarters.

Thanks for the added color, Joe.

Brian Klein, Stifel.

Just wondering if you could elaborate a little bit more on your efforts of combining your various vaccines with some of the checkpoint inhibitors, including ones that are now on the market and commercialized.

We have ongoing preclinical evaluation of these programs and I don't want to scoop our own publication that we're planning, but combination of our DNA immunotherapies with checkpoint inhibitors that are on the market or similar versions of that for preclinical studies. We are able to actively generate much higher immune responses and antitumor responses in these animal studies.

So these are various combination potentials that we are seriously evaluating, as I said in my prepared statement. So these are some of the directions that we are looking at and there are many potential combinations that we can have. Remember, I'm not going to say that checkpoint inhibitors are commoditized, but there are multiple -- there's already three approved and there's probably another half a dozen in the next couple years that will get approved. So there will be many potential partners or combination opportunities that will be out there.

Our primary preference is not to do these fly-by-night drug combo deals. Our preference would be to do marriages, having licensed deals where Inovio gets immediate and long-term financial benefit of our presence of our DNA-based immunotherapy. So our preference is to do marriages. There could be multiple marriages, but not to do this one night stand type of combining a couple different drugs with no financial commitments to either side. There will be a lot more on this later, so I would say as before please stay tuned.

Great, thanks. And just one final question on the prostate cancer study you are planning on. Can you talk about the patient population you are planning to go after and what concomitant therapies the patients will be on?

So we haven't really talked about this in greater length, but it'll be healthier patients in biochemical relapse. They will have received surgery or chemoradiation prior to this. They will have rising PSA levels and we will be able to track that as a biomarker, as well as to generate the safety and T-cell immune responses in these patients overall rapidly. And our goal will be to go into later stage patients in the follow-up trial where we will certainly measure the survival and overall benefits, anti-cancer affects.

Great. Thanks so much.

Jonathan Aschoff, Brean Capital.

Thanks. I was looking for some clarity surrounding what will be the most important topics at the end of Phase 2 meeting for 3100. How much of it's nine-month efficacy? How much of it's 21-month efficacy? Because it's really hard to imagine that the safety differential from 9 to 21 months matters given that no patient received 3100 for months before even a nine-month assessment. And water and naked DNA that encodes open reading frames for antigens already heavily present in the patient -- it doesn't exactly strike me as a safety concern ever. So what exactly is going to go on at that meeting?

The 21 months, just to set the framework, is the patients receive three injections in Phase 2 and also project to end Phase 3 in the first three months into the arm. And there's a six-month wait after the last injection. And primary efficacy readout was and is planned to be in Phase 3, month nine readout, whether their CIN2/3 pre-cancers have been regressed and/or the virus in the cervix has been eliminated.

And then we built in a 12-month follow-up primarily for safety because women who didn't clear at month nine received the surgery to remove their lesions. So month 21 readout really is based on safety and really this is an overabundance of caution as one of the first, if not the first, DNA immunotherapies delivered with electroporation to go into human patients, we wanted to have as much safety readout early as possible.

So we don't expect any surprises. We don't have all of the data compiled for 21-month safety and immunogenicity and so on. But leading into Phase2, end of Phase 2 meeting, really the biggest objective for us is to nail down the endpoints, agree on and then getting their concurrence on the endpoints because they are the final arbiter, as well as the overall framework of our protocol. We feel very confident that we will be able to achieve our objectives, but obviously it's not done until it's done and we look forward to doing this in the third quarter.

Okay. Joe, what is known about the spontaneous remission rates for these patients? Is it either early on or never, or is it kind of constant, more or less, over time?

I think it's more dynamic and it's also a question of spontaneously their base immune system can clear. That's why even clearance to normal in our placebo group was approximately 17% compared to over 40% for our treated group. So what we're doing is we are improving upon the natural immune system's ability to clear in some of these women. We want to apply it to about half or even larger populations by providing a nonsurgical option.

What's also complex is, in this placebo group, or overall in nature, you're not just infected possibly one time. This is a sexually-transmitted disease and there could be repeat viral infections. We certainly have to prove it in the clinic, but once we can clear the virus, I believe we have generated long-term memory T-cell responses that can clear the virus over longer time. I mean this is not going to be a clinical claim until we prove that in the trial, but knowing what we know in T-cell immunology, we hold this to be true, not necessarily true in the spontaneous regression column.

So there are multiple reasons why VGX-3100 as a first nonsurgical alternative for women with these high-grade cervical pre-cancers is going to be very attractive for the patients and the physicians who are treating them. In fact, we've done a market research of almost 500 physicians across the US and top five countries in Europe, as well as almost 200 patients who have just recently experienced CIN2/3 diagnosis and treatment. And overall [some of our leads are], what they've told us, both from the physicians and the patients, from this quantitative market research is that there is a strong demand for a nonsurgical treatment alternative for these women who want to be treated nonsurgically.

So we feel very good about the positioning of VGX-3100, once we finish our Phase 3 studies, so we can't wait till we get this study started.

Okay. Lastly, what has been done on the manufacturing front since you've generated the Phase 2 data?

Yes, as I stated before, in biological products, where you make your Phase 3 products has to be where you're going to eventually make your commercial products. So all of our Phase 1 and Phase 2 products are made in our manufacturing affiliate's facility in Houston, in VGXI's facility. So we have to search out and find the best contract manufacturer who can manufacture our products consistently, commercially and we have done so. And in the past several months, we have transferred the VGXI process over to this new manufacturing company and that work is going as planned. And that's where we are making the Phase 3 clinical products, as well as to our planned commercial products once this product hit the market.

Similarly, Jonathan, just to touch on this as well, all of our Phase 1 and Phase 2 studies are done with our pilot scale prototype delivery devices. Since our Phase 2 preliminary data, where top-line data was released last summer, we have designed and constructed a commercial scale delivery device, which looks nice, but is very easy to use and very robust and can be mass-produced. And that work is going now. We expect to have these units available for Phase 3 in time to launch the study in very early part of 2016.

All right. Thank you very much.

Yi Chen, HC Wainwright.

Joseph, can you give us a rough idea on when we can we expect to see some initial results from the hTERT DNA immunotherapy in breast, lung and pancreatic cancer? And also, when we see those results, is that going to be on all three types of cancer or just one type of those cancers? Thank you.

So hTERT INO-1400 study is enrolling now. We launched that late last year, early this year and it's actually three studies in one. It's the same product, same procedure, but we are enrolling roughly equally 18 patients total in breast, 18 patients total in lung and 18 patients in pancreatic cancer. So we don't have a quota, but we are enrolling them as fast as the patients become eligible and it's an open-label study.

Our primary objective is obviously safety. But also we want to know the same question we asked for the head and neck cancer patients. Can we indeed generate the similar levels of high CD8+ killer T-cell responses against, in this case, hTERT as the antigen in these cancer patients? And it's an open-label study and we should begin to have some early data by the fourth quarter or by year-end this year. But the full set of data probably will be available by mid-2016.

There are other measurements and other biomarkers we are following, but really the bottom line is can we extend the excellent safety signals to these hTERT drugs? And so far, so good. And the second primary objective is can we generate the powerful killer T-cells against this new antigen, non-HPV antigen, similar to what we've seen in our cervical precancer and head and neck cancer patients? And we will have to stay tuned for that, but I think our chances are good.

Thank you.

(Operator Instructions). Jason McCarthy, Maxim.

Hi, Joseph, it's Jason McCarthy. Thanks for taking the questions. Sounds like everything is going really well and I wanted to go back to the oncology program and you were talking about checkpoints. But when you are talking about beyond safety of activating T-cells, and the CART space is also running into this problem, you run into the issue of adaptive resistance in multiple solid tumors and it's likely not driven by a single checkpoint but more than one checkpoint.

So my question is could you adopt your vaccines to use your DNA-based monoclonals or your DNA-based immunotherapies to mitigate having to partner with somebody for a single checkpoint inhibitor that might be out there?

Boy, Jason, I think you have bugged our rooms or you are extremely perceptive and certainly we can go about this in multiple ways. Number one, our goal was to -- the answer is yes, but let me go into more detail. Number one, we have our own active DNA vaccines or DNA immunotherapy against specific antigens of cancer and we've shown that in head and neck cancer. We look forward to show that in hTERT and prostate and so on. So that was our primary goal, number one.

Number two, we are also doing combination studies in animals and we have good assurance that combining with checkpoint inhibitors, whether they're on the market now or soon to be in the next few quarters, could be an additive effect. It's the same brake -- removing the break and pressing down the accelerator model.

And number three -- So that's number two. That's an approach that we can follow. Again, we don't want to give away the cow for free. We want to make sure we get the right economics for that. And number three, as you alluded to, because of our capabilities of generating our own monoclonal antibodies and 99% of all the checkpoint inhibitors thus far have been monoclonal antibody-based. So one of our goals is to not only partner with other companies, but make our own checkpoint inhibitors using our own DNA-based monoclonal antibody approach and we're able to leverage our DARPA funding not only to develop those dMAbs against Ebola targets or flu targets or MERSA, these are all important targets and could be valuable products, but we can overall advance the core technologies, the potency, the dosing and all of these things can be tested on other people's funding and support.

So that's really the shock and all we hope to have in the next several quarters that not only can we partner with big companies and bring economic benefits to Inovio, but also I can foresee a future where we will have our own checkpoint inhibitors based on our own technologies that we own, based on over 600 patents that's been issued and pending globally where we can compete with the big boys with our own checkpoint inhibitors and perhaps even have more advantages than what they have. Because these are all DNA-based; we know we can express them. We know they are functionally folded and there's a lot of advantages that we can bring to the table.

And that's really the next -- as I mentioned, the dMAbs are just -- it's only just the beginning, but that has the potential to provide the next booster for the rocket known as Inovio. So we look forward to all these developments in all three fronts going forward.

Great, thank you very much.

Thank you. Dr. Kim, there are no further questions at this time. I'd like to turn the floor back to you for any final remarks.

So thank you all who have listened today on time or read the transcripts. I'd like to express our true appreciation for all of our shareholders and supporters. Thank you very much.