Inovio Pharmaceuticals, Inc. (INO) Q4 2017 Earnings Report, Transcript and Summary

Greetings. And welcome to the Inovio Fourth Quarter 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Benjamin Matone. Please go ahead sir.

Thank you. Good afternoon and thank you for joining us today. Today’s call is also being webcast live at our website, ir.inovio.com and will be available for replay as indicated in our press release. During this call, we will be making forward looking statements relating to our business including our plans to develop SynCon DNA immunotherapies in combination with our proprietary CELLECTRA delivery devices as well as our capital resources all of which involve certain assumptions, risks and uncertainties and could cause actual results to differ materially from these statements. These statements are based on the beliefs and expectations of management as of today. Our actual results may differ materially from our expectations. Investors should read carefully the risks and certainties described in today’s press release as well as the risk factors included in our filings with the SEC. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events or otherwise. With me today are Dr. Joseph Kim, President and CEO; Peter Kies, Chief Financial Officer. I would now like to turn the call over to Inovio’s President and CEO, Dr. Joseph Kim.

Thank you, Ben, and good afternoon, everyone. I’m very excited to discuss our fourth quarter and year-end results for 2017 with you as well as provide a few updates on our recent clinical development. Inovio continues to be well-positioned to bring forth relentless innovation and executional excellence towards advancing DNA immunotherapies to treat both cancer and infectious diseases. We are also continuing to make strong progress on enrolling patients in Phase 3 trial with our lead product candidate VGX-3100 for treating high-grade cervical dysplasia, which I plan to highlight later in the call. In addition to our precancer and cancer-focused therapies, Inovio continues to effectively utilize recent grant and non-dilutive funding for our infectious diseases platform. These collaborations and funding continues to support our versatile technology while providing us with multiple out-licensing opportunities. In 2018, we expect additional external funding to support these efforts. Since coming off our clinical hold, our path for getting VGX-3100 back on track has been a straight line. We commenced our pivotal Phase 3 clinical program to evaluate the efficacy of 3100 in June of 2017, and I’m excited to report that we have already opened nearly 50 U.S. trial sites today and have initiated nearly 10 trial sites internationally to recruit patients. And our overall enrollment is on track. Ultimately we plan to open 100 sites across five continents. We’re also continually adding innovative features to our HPV franchise. You may also recall that in November, we published a post-hoc analysis of data generated from our Phase 2b trial of VGX-3100 in which we identified in treatment biomarker signatures that predicted success of VGX-3100 treatment with 94% accuracy, as early as two weeks after the completion of treatment regimen at week 14. I want to emphasize that this was for 22 weeks prior to the formal efficacy assessment and we continue to believe that these biomarkers can aid doctors in guiding patient care during treatment using VGX-3100 and improve the overall value of the franchise. As mentioned during our last quarter’s earnings call, we plan to initiate a Phase 2 proof of concept study to extend our VGX-3100 program into anal dysplasia, and we expect this to occur within the next two months. This adds to our ongoing Phase 2 trial for vulvar dysplasia caused by the HPV virus that’s [ph] up in recruiting patients. So, for VGX-3100, you can expect the Phase 3 data from the two cervical dysplasia studies to be available in 2020. And we anticipate open label Phase 2 data for both then and in 2019. Lastly, as it pertains to VGX-3100, we entered into an amended license and collaboration agreement with ApolloBio Corporation, which we expect to become effective, as well as received the upfront payment of $23 million before the end of this month. Upon approval by ApolloBio stockholders and receipt of other regulatory approvals. As a refresher for everyone, this partnership grants ApolloBio the exclusive right to develop and commercialize VGX-3100 in greater China, including Hong Kong, Macau and Taiwan, which we believe will offer broader capabilities, resources and market opportunities for treating patients with cervical dysplasia across the globe. Turning to our Phase 1b program, we announced interim Phase 1 results in a press release this morning, which demonstrated the potential of INO-1800 as an immunotherapy for this widespread infection that is a major cause of liver cancer. Key to my optimism about INO-1800 is that it generated HBV specific killer T cell across all cohorts and we see INO-1800 as a key immunotherapy component of an effective anti-HBV combination therapy. These results were very encouraging. And we expect to report additional data from this trial at upcoming scientific conferences and in a publication. As it relates to the next steps for hepatitis B program, our current focus is on selecting and working with a partner who could best advance INO-1800 in a combination therapy. We have had and are continuing to have discussions with several potential partners, and we expect to further advance this product through a collaboration or partnership. Shifting now to our immuno-oncology focused programs, I’ll start with our head and neck cancer patient trial. As HPV caused head and neck cancer remains the fastest rising cancer among men in the United States, we are pleased to see this program moving forward with our partner MedImmune for treating HPV-related cancers. Just this past December, we received a $7 million milestone payment from MedImmune, which was triggered by MEDI0457, formerly known as INO-3112, in combination with the durvalumab, the PD-L1 checkpoint inhibitor completing the Phase 1 safety review portion of the study and advancing to the Phase 2 efficacy stage of the trial. MedImmune is testing the combination approach in patients with recurrent metastatic HPV-associated head and neck squamous cancer in a Phase 2 clinical trial within estimated total enrollment of 50 patients. We expect other regulatory milestones ahead from our MEDI partnership in 2018. In conjunction with MEDI’s development o MEDI0457, our progress associated with VGX-3100 for cervical, vulvar and anal precancers fully positions Inovio as a leading immunotherapy provider for HPV-caused or HPV-related diseases across the landscape of HPV infection from precancer to cancer in both men and women. Now, let’s take a look at our INO-5401 program. INO-5401 encodes for three of our top cancer antigens -- three of the top cancer antigens including human telomerase reverse transcriptase or hTERT, WT1 and PSMA. Indeed, 2017 was a pivotal year for Inovio as we initiated two combination immuno-oncology trials in bladder cancer and glioblastoma. Bladder cancer is considered one of the more immune-responsive cancers while glioblastoma is one of the most difficult to treat cancers. With these two shots on goal, Inovio has targeted both ends of the immune-responsive cancer spectrum allowing us to see INO-5401’s broad potential. Just last quarter, we initiated a Phase 1/2 I-O trial for bladder cancer evaluating Roche/Genentech PD-L1 checkpoint inhibitor in combination with INO-5401 and INO-9012, an immune activator encoding IL-12. This trial is designed to evaluate the safety, immune response and efficacy in approximately 80 patients, in advanced bladder cancer, specifically advanced unresectable metastatic urothelial carcinoma. As a reminder, the majority of the patients to be enrolled in this trial will be checkpoint inhibitor refractory patients or patients who have previously received and failed to demonstrate meaningful response to an anti-PD-1 or PD-L1checkpoint inhibitor alone. We anticipate having interim immune response and safety data as well as potentially early signals of efficacy in 2019. And as for our third shot on goal within our I-O program, we also initiated a Phase 1/2 immuno-oncology trial to evaluate Regeneron’s PD-1 checkpoint inhibitor, cemiplimab or REGN2810 in combination with INO-5401 and INO-9012. This open label trial is designed to evaluate the safety, immune response and clinical efficacy in approximately 50 patients with newly diagnosed glioblastoma multiforme or GBM, which is an aggressive brain cancer. Enrollment for our GBM program remains on track to begin within the next two months. And we anticipate having interim immune response and safety data in 2019. I also want to highlight our January announcement involving our clinical collaboration with the Parker Institute for Cancer Immunotherapy, as I think this is something many investors underappreciated. Our ability to continue to develop and progress our innovative DNA immunotherapies to be used as a next-generation treatment for cancer remains a core component for our strategic goals. Our initial trial that is under consideration would address muscle invasive bladder cancer with INO-5401 in combination with checkpoint inhibitors and immune modulators where Parker will have the responsibility for clinical study execution as well as to provide funding for the initial set of trials. Through the Parker Institute’s unique model, we will be able to work with university research pioneers and combination oncology therapy partners while leveraging the Parker Institute’s capabilities and expertise to ultimately lead to better cancer patient responses to immunotherapy, all of which aligns with our goal to address cancer with our ASPIRE in immunotherapies. So, looking at our key and fundamental catalysts over the next 6 to 12 months, 2019 will provide us with significant discoveries from our I-O programs, while we can expect 2018 to provide us with more resources and executing capabilities from our infectious disease platform. Just this past January, we announced the collaboration with the Wistar Institute, to advance two novel SynCon vaccine programs against tuberculosis and malaria, which are both fully funded by more than $4.6 million in total grants from the Bill and Melinda Gates foundation and the NIH. These grants from the Gates Foundation and from the NIH will provide -- will continue to support Inovio’s efforts to develop, new DNA vaccine, employing its novel and versatile ASPIRE platform. Specifically, these grants provide Inovio both the resources and opportunities towards the discovery of delivering optimized synthetic antigenic genes into cells, which speaks for broader capabilities and initiatives to generate robust targeted T cells and antibody responses. Now, I’d like to introduce our CFO, Peter Kies, who will discuss our fourth quarter and end of year financials. Peter?

Thanks, Joseph. Total revenue was $8.8 million and $42.2 million for the quarter and year ended December 31, 2017, compared to $8.5 million and $35.4 million for the same periods in 2016. Operating expenses were $31.7 million for the last quarter and $125.9 million for the year ended, compared to $30.9 million and $111 .6 million for the same periods in 2016. Net loss attributed to common shareholders for the quarter and year ended December 31, 2017 was $21 .5 million or $0.24 per share and $88.2 million or $1.08 per share, as compared to a net loss attributed to common stockholders of $26.2 million or $0.35 per share and $73.7 million or negative $1.01 per share for the same period in 2016. Research and development expenses for the quarter and year ended December 31, 2017 were $24.6 million and $98 .6 million as compared to $23.9 million and $88.7 million for the same periods in 2016. The year-over-year increase in R&D expenses was primarily due to -- was actually related to an increase in employee headcount to support our R&D and clinical trial activities. General and administrative expenses for the quarter and year ended December 31, 2017 were $8 million and $28.3 million, compared to $7 million and $23.9 million for the same periods in 2016. The increase in G&A expenses for the year was primarily related to an increase in employee headcount and non-cash stock-based compensation. Finally, our financial position remains very solid with total cash and cash equivalents and short-term investments of $127.4 million compared to $104.8 million as of the year-end December last year. At quarter end, the Company had 90.4 million shares outstanding and 99.6 million shares outstanding on a fully diluted basis. Back to you, Joseph.

Thanks, Peter. Before we get to your questions, please remember the three top goals that Inovio will deliver on becoming. Number one, the go-to immunotherapy solution provider for all diseases caused by HPV, including for precancerous diseases like CIN, [ph] VIN and VaIN with VGX-3100 and cancers is caused by HTV, along with MEDI in utilizing MEDI0457. Number two, to become a leader in T cell generating immunotherapy in combination with PD-1 and PD-L1 checkpoint inhibitors for multiple cancers, MEDI0457 with MEDI as well as INO- 5401 with both Regeneron and Genentech. Number three, to become a leader in a new vaccine development for rapidly combating emerging infectious diseases, utilizing full external funding and to leverage platform’s safety and immunogenicity data to additionally, develop novel commercially attractive vaccine franchises. These three goals show where we’re going and how we’re going to get there. Now for your questions. Operator?

[Operator Instructions] Our first question Charles Duncan with Piper. Please go ahead.

Thanks for taking the questions, Joe, and thanks for the overview. I had a couple of questions. So, first one, I just wanted to dismiss quickly, and that is recently in mind share competitor had a cohort [ph] placed on cervical cancer trial. And I’m just wondering if you could compare and contrast your technology to that mind share competitor and whether or not you think your efforts are at risk.

First of all, I don’t think our efforts are at risk at all. Obviously, I can’t directly speak to the competitor’s clinical hold. But our ASPIRE platform and our product candidates have demonstrated safety, favorable safety profile in over 1,500 patients dosed over 5,000 times across multiple trials and multiple indications. And it’s not surprising that we have a very strong safety profile as our products are elegantly designed, engineer, pure DNA sequences delivered with transient electrical energy. So, we don’t use any chemicals. We don’t use any adjuvant, we don’t use any viruses or bacteria to deliver our products. So, I think ASPIRE platform and product candidates are superior in its design. And so far, the clinical data has borne out.

Have you had any recent discussions with the agency around it, perhaps as a result of this recent news or do you feel like it’s not necessary?

No, we haven’t had any concerns or discussions about that.

And if I could just ask a question regarding VGX-3100 cervical dysplasia. You mentioned that the site initiation was going well, I think you have about 60 out of 100 that you started up. When you start a site, that doesn’t necessarily mean that you’ve enrolled patients at that site. I think, you mentioned enrollment was on track, but could you provide a little bit more color on either numbers or the kind of patient characteristics that you are seeing enroll in that trial.

Well, I can tell you that enrollment currently is on track as we planned. As we discussed before, we don’t plan to give a play by play numbers like the ESPN Sports Center. But, once we complete and enroll the first trial, we will report that. But what I can tell you in terms of the context of our site openings, you are correct. Just because the site is opened for recruiting, doesn’t mean we have utilized that site to already recruit -- dosing the patients. But typically, you’ve got to first open it and then enroll the patient. So, we are pretty optimistic and very happy with how we are progressing now.

And interest in the trial seems to be -- either from patients or investigators thus far seem to be -- how would you characterize the interest thus far?

It’s very high. March 4th was the first international HPV day that was celebrated or memorized throughout the world. As you know, there has been more and more recognition of what kind of diseases that HPV infection causes including cervical dysplasia and cancerous as well the head and neck cancer in men. And it’s finally being recognized as a number one, sexually transmitted disease. And you and I have known this for a long time, but I think the world in general is starting to recognize it more, and the physicians and patients, there’s huge interest in having a immune therapy based treatment that doesn’t involve surgery, which has lots of side effects and complications. So, I think the overall sentiment and excitement is on Inovio’s favor in our VGX-3100’s favor.

And then, last question, I appreciate you’ve taken them all, is that the biomarker information that you mentioned was pretty intriguing from the previous study. And I guess I’m wondering in the ongoing Phase 3, are you still collecting that biomarker signature information and could that prove to be call it a validation set or study, and may you perhaps pursue a companion like diagnostic type thing or I guess it would be a prognostic thing, or is this just a background research?

I think you hit the head -- nail on the head with the earlier part of your question. So, the published data that we mentioned is actually from a post-hoc analysis of our 167-patient data from our Phase 2 studies. And having found that we actually prospectively built that into our Phase 3 evaluation as secondary endpoint. So, those information are getting gathered, and we will be able to in a double-blinded fashion be able to test our hypothesis that we can predict as early as week 14, how well all the patients are responding at week 36. And that in itself, as you said, can be served as a separate diagnostics or companion treatment aid that will definitely help in managing the disease with VGX-3100, and I think in an overall health economic way, will improve the commercial value of our franchise.

Our next question comes from Joel Beatty of Citi. Please go ahead.

This is Sean [ph] calling in for Joe. I’d like to thank you for taking my question. For my first question, can you talk briefly on the market opportunity for your HPV franchise, specifically, what message will differentiate your vaccine from the current surgical intervention, and also what role emerging diagnosis could play in that setting?

Yes, absolutely. So, HPV-caused precancers currently are treated mostly with surgical procedures. And especially for cervical dysplasia, surgery can cause -- have lots of surgery-related side effects. But perhaps most importantly, the cervix, which is a critical component of women’s reproductive capability is damaged. So, the post lead [ph] patients have twice the rate in future birth, twice the rate of miscarriages and preterm birth. And because the surgeons cannot see the virus in the top layer of the cervix, often they miss and the virus is still there. So, approximately a quarter of the patients, even right after the surgery still we can detect the presence of HPV. So, there are recurrences. And up to 16% of the women after the surgical procedure CIN 2/3 experience recurrence, so having to go through this procedure again. When you look into vulvar and anal dysplasia, the recurrence rates bounce up to 50 to 60%. So, that’s a major disadvantage of the surgical procedure. Market opportunity is about 400,000 women are newly diagnosed for CIN 2/3 just in the U.S and Western Europe alone and that 10 to 20 times when you include the rest of the world. So, we’re talking about a huge potential market and for vulvar and anal dysplasia, this is much smaller, but it also gives us an opportunity for utilizing those indications as orphan disease indication. So, we are positioning VGX-3100 as the first in class, first nonsurgical and first immunotherapy solution for these diseases.

That’s very helpful. And then my second question is…

And then, I think you were asking about the diagnostics, and I think I covered that a little bit earlier with Charles’s question. But, I think having a diagnostics -- or tools that can help to manage the disease during treatment, will be highly valuable additional sources of revenue and also great tool for the patients and the doctors.

That makes sense. Thank you. And my second question is, could you provide any enrollment update on your study I-O checkpoint study? And then, as a quick follow-up to that, will your studies be evaluating from a from mutational [ph] burden?

The last question first. We will be evaluating those information in each of those studies. What I can tell you about our INO-5401 study is that we had our IND approved late last year, we are working to open the sites and have the first patients dosed, both for our bladder and GBM studies in the next few weeks. And we have 20 plus sites in each study, ready to know. For MEDI0457 study, MedImmune has full control of the information. But what I can share with you publicly is we have gone from the Phase 1 leading portion to Phase 2 which triggered the milestone payments that I mentioned in my earlier statement. So, the head and neck study is little bit ahead compared to our own 5401 studies. But we would like to see healthy competition along our sibling I-O programs.

And then, my final question is can you provide any additional color on the Parker Institute collaboration, specifically what will be the focus of the studies and which products will be enrolled?

Which products is, initially, it’s INO-5401. And the Parker Institute agreement or the master agreement really covers a broad collaboration between Inovio and the Parker Institute. Our initial studies that we are contemplating together is in muscle invasive bladder indication where we will be utilizing INO-5401 in combination with other checkpoint or immune modulators that the Parker has access from other organizations. So, which is distinct from our currently open study for treating metastatic PD-1, PD-L1 refractory bladder cancer patients with Genentech’s PD-L1 inhibitor. So, our goal is to really expand into bladder cancer where Inovio has a significant presence and expertise and dominance in terms of the checkpoint combination and treatment paradigm for such an important cancer.

Our next question comes from Gregory Renza with RBC. Please go ahead.

Just a few quick ones, if I may. Just returning to 3100 and the enrollment. So, could you just please remind us or perhaps provide additional color on the potential mix with U.S. versus international and what you are potentially doing to account for any potential durability there or ensure consistency of study once it certainly set up?

In our Phase 2 study, we knew -- we had a aspiration of having VGX-3100 as a global product that can reach multiple regions including our home region of U.S. and also primary markets of Western Europe and elsewhere. So, we had a breakdown of about 70% U.S. sites and 30% global, even in our Phase 2 studies. Now, Phase 3, in efforts to expand our enrollment capabilities and also accessing other market opportunity regions, we will have approximately more than half of our enrollment ex-U.S. So, I mean, those we have certain goals. But, I think we’re not going to have any portions that are preselected, meaning we’re going to enroll -- we’re going to open these sites and let them enroll as rapidly as possible. So, there’s no quota for any of the regions and so on. What we saw in our Phase 2 studies was that whether it was in the U.S. or ex-U.S., we didn’t really see any statistical significant differences among the responses from these patients and their demographic makeup didn’t really make any difference.

Got it. Thank you. With respect to the timing and the coordination of the Phase 3s and REVEAL 1 and 2, what’s the latest on REVEAL 2 as far as getting that up and running, how should we think about that timing?

REVEAL 1, just to jog our memory is in study portion as a study for REVEAL 1 and 2 identical dosing at month zero, one and three, and efficacy and safety evaluation at month nine or week 36. REVEAL 1, just like our Phase 2 study had, the FDA asked for a one year safety follow-up. So, it’s full 88-week study. So, 36 weeks actively monitor and then there’s a safety monitoring of another year, so it’s 88-week study completely. REVEAL 2 is through week 36 is identical as REVEAL 1, but we have a one month follow-up or four weeks follow-up. So, the total study period for that is 40-week study. So, each studies will enroll 198 patients. And as you could imagine, we want to land at the same time. So, we started REVEAL 1 first last year and then REVEAL 2 we expect to start when we are about to finish REVEAL 1. The reason for that is there’s no need to start REVEAL 2 before the REVEAL 1 is completely doses, because you’re really the last person in for REVEAL 1, which has the longer follow-up. So, as you can imagine, our team is looking very extensively in how best to manage that. My current projection is REVEAL 2 will start by end of this year or early part of next year.

Great. Thank you. And just one more on the 1800 just curious when you’d expect to share that forward data. And then, also it sounds like partnership, certainly the goal, just curious to get a sense of tiny expectations on the partnership certainly, most importantly when you expect to share that data…

So, partnership first, as I said that finding a right partner that can most effectively move the program forward in combination with other drug to have the most effective, anti-HPV regimen is our primary goal. So, we have had meetings and discussions with several top potential partners, and we will share additional -- these new data with them privately and under confidentiality. I think, that’s our primary goal, because that’s the best value driver for us. In terms of presenting to the field, we are evaluating several liver or viral conferences this year, and we are also drafting a manuscript going forward. So, all of these things are forthcoming. And as they happen, we will certainly share those with you and others. In terms of our focus, I just want to add to this, we are looking at a partner for INO-1800 because really our true focus where our hearts and mind, and where we’re spending our money really is our HPV program and our I-O combination programs. Everything else, we want to leverage and bring value to our Company, but through our partners with companies and funders and so on. So, we see infectious disease as ways to add value but where we drive value is really in the where our focus is which is our HPV and I-O combination therapies.

Our next question comes from Alex Schwartz with Stifel. Please go ahead.

I had two question. First off, can you give us an update on the next steps with your HIV program, maybe what trials are you looking to conduct next? As well as, when I look at your milestones, I see additional data report publications of HIV for this year. What can we expect to see next with HIV, both in results and maybe a next study?

You can expect to see two things. One is our HVTN 098 data that where the topline data was presented last year. The full data sets are getting prepared and we are working with HVTN and our collaborators to submit a manuscript later in 2018. So, you would expect to see a full Phase 1 data through a publication and additional presentations in conferences in ‘18. In terms of why we were so excited about that data is the vaccine that has the potential to protect against multiple different subtypes and clades, and the level of T cell immune responses generated in that study as well as antibodies. And just to remind us, these are all funded with an NIH grant and conducted by the HVTN which is a NIH funded clinical trials group. They conducted all the trials and they conducted all the assays. And they have the wherewithal to compare platform-wise with all the other HIV vaccines that they have tested in the last 25 years. And guess what, we had the best T cell responses from any other vaccine platforms that were tested. And so, we share their optimism and excitement in there. Where that studies is going to go with that program for PENNVAX-GPs going to go, once these are clarified, then we can share with the public. But, we expect there to be additional studies with PENNVAX-GP in a preventive HIV vaccine setting. Now, the second part of our HIV program is also fully funded by the NIH. We have received with our clinical collaborator at UCSF Dr. Steven Deeks who is the PI for a new study that’s being prepared, where we’re using PENNVAX-GP as a immune therapy and it will be used in combination with antiviral drugs initially. And what’s so cool about this is the second part of these clinical studies will bring in a PD-1 checkpoint inhibitor with the goal of seeing if an immunotherapy combined with PD-1 can -- along with antiviral HIV drugs can help to clear the virus in the patients where the virus is hiding away in different reservoirs or different sites in the body, but perhaps using these different drug combinations again flush out the virus and may I say to bring about a functional cure of HIV infection. Now, this is a very high risk, high potential benefit type of a trial. Precisely what you want to use, external funding from the NIH to do. So, more information on the study when it starts and when they progress, we will share with the public.

Okay. Thank you. And then, a second question, more of a modeling question. In addition to the potential $23 million upfront by ApolloBio, what other revenue milestones are you anticipating this year? And do you have a sense of where your year-end cash balance may be?

So, $23 million this quarter from ApolloBio is a major non-dilutive license fee expect. We could project additional partnerships can generate more non-dilutive cash into the Company. We’re not comfortable in sharing that exact number at this point. But, as we see -- as these things become more solidified, we can do that in the future. In terms of ending cash balance, we expect the overall net burn for next -- 2018 and ‘19 to be approximately $70 million. So, with our current cash plus what’s coming in from Apollo, we expect about two years of cash runway right now, which I think is a solid financial position at Inovio’s. And obviously, we will look to bring in additional non-dilutive partner and grant funding going forward as well.

Our next question comes from Yi Chen with H.C. Wainwright and Company. Please go ahead.

My first question is, can you update us on the current status of the ZIKA trial in Puerto Rico? When can we expect to see results and what are the likely steps after the data readout?

Yes. So, ZIKA trial, we had enrolled all 160 people prior to -- last year prior to the hurricane problems that the island had. So, we expect very little disruption from the problem that they have been having in the island. 80 people have received our vaccine, 80 have received the placebo and they are participating through frequent follow-up visits. We expect to have the final visit later this year and the results we be tabulated and we expect to be reported. Our first trial in the U.S. and Canada, the results were published in the New England Journal of Medicine, where we had 100% antibody response rates in all participants. So, we’re looking forward to similar level of results from our Puerto Rico trial. What’s really cool about the design of this trial is a placebo controlled nature. We could have a early look of signal of efficacy. We are hoping to see a difference between the vaccinated group versus the non. Obviously really it’s driven by the infection rates in the island with ZIKA. And based on both sets of study data, we are working -- we are discussing with various potential funders for the next steps in advancing our ZIKA vaccine to Phase 2 evaluation and beyond. So, this is a program that we will utilize external funding to advance.

And my second question is do you expect to have the universal flu vaccine enter the clinic sometime this year?

So, that’s really the question. Flu vaccine is a key R&D area for us, for our research group. And we published really forceful paper in vaccine earlier this year, or late last year, showing that we can protect against multiple different streams of H1N1. We also have similar results for H3N2, which is a second component and then type B as well. We are -- similar to my response to ZIKA, we are evaluating the potential funders for advancing the flu program. Obviously with the recent flu season we have encountered, there is a strong push for better seasonal vaccines, which Inovio’s candidates can serve. And as you approach better seasonal vaccines, I think we can eventually get to where these vaccines can be universal or highly broadly protective. And our clinical progress, which we will share as they happen, and the timelines will be predicated upon the external funding, but we have very active discussions going right now.

Our next question from Jason McCarthy with Maxim Group. Please go ahead.

Hi. This is Michael Okunewitch on behalf of Jason McCarthy. So, I was just wondering if you could give us an update on some of the other trials, such as Ebola and MERS.

Yes. Both studies are completing, meaning, there are some safety follow-ups and so on. The top line data have been presented at conferences where we expect to have clinical publications for both Ebola and MERS Phase 1 studies this year in 2018.

Thank you. My others questions are already answered. So, thanks for taking my question.

Great. Thank you very much.

Thank you. There are no further questions at this time. I would like to turn the floor over to Joseph Kim for closing comments.

Thank you everyone for your questions and joining us this afternoon. We have a lot to look forward to here at Inovio over the next 6 to 12 months. And I know we are all very eager to see additional clinical results during this time. I want to just remind everyone on what makes Inovio so special and what I think -- what I think places of in the best position to execute over the next 12 months. Utilizing our ASPIRE technology platform, we have been able to establish our T cell activating immunotherapy as a foundational component for treating HPV as well as in combination strategies to improve patient responses to checkpoint inhibitors for treating cancer, all while having a favorable safety profile. So, again, we look forward to providing more updates from posters, publications and from various presentations over the coming months. Thank you again everybody for joining us tonight, and have a great evening.

This concludes today’s teleconference. You make disconnect your lines at this time. And thank you for your participation.