Inovio Pharmaceuticals Inc (INO) 2017 Q4 法說會逐字稿

Greetings, and welcome to the Inovio Fourth Quarter 2017 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, 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 on 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 uncertainties 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; and 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 developments. Inovio continues to be well positioned to bring forth relentless innovation and execution of excellence towards advancing DNA immunotherapies to treat both cancer and infectious diseases.

We're also continuing to make strong progress on enrolling patients in Phase III 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 pre-cancer and cancer-focused therapies, Inovio continues to effectively utilize recent grant and non-dilutive funding for infectious diseases platform. These collaborations and funding continues to support our versatile technologies, while providing us with multiple out-licensing opportunities. In 2018, we expect additional external funding to support these efforts.

Since coming off of our clinical home, our path for getting VGX-3100 back on track has been a straight line. We commenced our pivotal Phase III 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 5 continents.

We are also continually adding innovative features to our HPV franchise. You may also recall that in November, we published a post-op analysis of data generated from our Phase IIb 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 2 weeks after the completion of treatment regimen at Week 14.

I want to emphasize that this was full 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 II proof-of-concept study to expand our VGX-3100 program into anal dysplasia, and we expect this to occur within the next 2 months. This adds to our ongoing Phase II trial for vulvar dysplasia caused by the HPV virus that's up in recruiting patients. So for VGX-3100, you can expect the Phase III data from the 2 cervical dysplasia studies to be available in 2020, and we anticipate open label Phase II data for both VIN and AIN 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 receive the upfront payment of $23 million before the end of this month, upon approval by ApolloBio's 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 I program. We announced interim Phase I 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 cost of liver cancer.

Kin to my optimism about INO-1800 is that it generated HPV-specific killer T cells 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 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 payments from MedImmune, which was triggered by MEDI0457, formerly known as INO-3112, in combination with their durvalumab, their PD-L1 checkpoint inhibitor, completing the Phase I safety review portion of the study and advancing to the Phase II efficacy stage of the trial.

MedImmune is testing the combination of potent patients with recurring metastatic HPV-associated head and neck squamous cancer in a Phase II clinical trial with an estimated total enrollment of 50 patients. We expect other regulatory milestones ahead from our MEDI partnership in 2018.

In conjunction with MEDI's development of MEDI0457, our progress associated with VGX-3100 for cervical, vulvar and anal pre-cancers fully positions Inovio as a leading immunotherapy provider for HPV-caused or HPV-related diseases across the landscape of HPV infection from pre-cancer to cancer in both men and women.

Now let's take a look at our INO-5401 program. INO-5401 encodes for 3 of our top cancer antigens -- 3 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 2 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 2 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 I/II IO trial for bladder cancer evaluating Roche's Genentech PD-L1 checkpoint inhibitor in combination with INO-5401 and INO-9012, and immune activator encoding IL-12. This trial is designed to evaluate the safety immune response and efficacy in approximately 80 patients in a vast 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-L1 checkpoint 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 IO program, we also initiated a Phase I/II immuno-oncology trial, evaluating 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 2 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 the 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 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 IO 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 2 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 & 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 vaccines, improving its novel and versatile ASPIRE platform.

Specifically, these grants provide Inovio with both the resources and opportunities towards the discovery of delivering optimized synthetic antigenic genes into cells, which speaks for our 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 1.1 -- negative $0.011 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 noncash 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 in 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 3 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, VIN and AIN, with VGX-3100 and cancers caused by HPV, 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 cancer. 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 safety and immunogenicity data that additionally develop novel commercially attractive vaccine franchises.

These 3 goals show where we're going and how we're going to get there. Now to your questions. Operator?

(Operator Instructions) Our first question comes from Charles Duncan with Piper.

I had a couple of questions. So first one, I just want to dismiss quickly. And that is, recently a minor share competitor had a clinical hold placed on a cervical cancer trial. And I'm just kind of wondering if you could compare and contrast your technology to that minor share competitor? And whether or not you think your efforts are at risk?

Yes, 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, engineered, pure DNA sequences, deliver with transient electrical energy. So we don't use any chemicals. We don't use any adjuvants. We don't use any viruses or bacteria to deliver our products. So I think the 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 that, 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 them.

Okay, good. 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're seeing enrolling 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 SportsCenter. But once we complete and enroll the first trial, we will report them. What I can tell you in terms of the context of our site openings, you are correct, just because the sites open for recruiting, doesn't mean we have utilized that site to already recruit -- dosing the patients. But typically, you got to first open it and then enroll the patients. So we're pretty optimistic and very happy with how we're 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 4 was the first International HPV Day that was celebrated or memorized throughout the world. There's -- as you know, there's been more and more recognition of what kind of diseases that HPV infection causes, including cervical dysplasia and cancer as well as the head and neck cancer in men. And it's finally being recognized as the #1 sexually transmitted disease. And even I have known this for a long time. But I think, the world in general is starting to recognize that more. And the physicians and patients, there's huge interest in having an immunotherapy-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 and our VGX-3100's favor.

Okay. And then last question, I appreciate you taking 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 III, could you -- 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 could be a prognostic thing? Or is this just background research?

No. I think you hit the head -- nail in the head with the earlier part of the question. So the published data that we mentioned is actually from a post-op analysis of our 167-patient data from our Phase II study. And having found that, we actually perspectively built that into our Phase III evaluation as a 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 the patients are responding at Week 36. And that in itself, as you said, can be served as the separate diagnostics or companion treatment aid that will definitely help in managing the disease with VGX-3100, and I think, in overall health economic way, will improve the commercial value of our franchise.

Our next question comes from Joel Beatty with Citi.

This is Shawn calling in for Joel. For my first question, can you talk you to us briefly on the market opportunity for your HPV franchise? Specifically, what message will differentiate your vaccine from current surgical interventions? And also, what role emerging diagnostics could play in that study?

Yes, absolutely. So HPV-caused precancerous currently are treated mostly with surgical procedures. 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-nate patients have twice the rate in future birth, twice the rate of miscarriages and preterm births. 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 1/4 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 for CIN 2, 3 experience recurrence, so having to go through this procedure again. And when you look into vulvar and anal dysplasia, the recurrence rates are bounced up to 50% to 60%. So that's a major disadvantage of the cervical procedure. Market opportunity is about 400,000 women are newly diagnosed CIN 2, 3 just in the U.S. and Western Europe alone. And that's 10 to 20x 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're positioning VGX-3100 as the first-in-class, first nonsurgical and first immunotherapy solution for these diseases. And then -- I think you were asking about the diagnostics, and I think I covered that a little bit earlier with Charles' question. But I think having a diagnostics or tools that can help to manage the disease during treatment would be a highly valuable additional sources of revenue and also a great tool for the patients and doctors.

That makes sense. And my second question is, can you provide any enrollment update on your IO checkpoint study? And then as a quick follow-up to that, will your studies be evaluating tumor mutation 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're working to open the sites and have the first patients both for our bladder and GBM studies in the next few weeks. So -- and we have 20-plus sites in each studies ready to enroll. 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 I read-in portion to Phase 2, which triggered the milestone payments that I mentioned in my earlier statement. So the head and neck study is a little bit ahead compared to our own 5401 studies. But I like to have -- we like to see healthy competition among our sibling IO programs.

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

So which products, 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're 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 to from other organization, 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 -- and our goal is to really expand into bladder cancer as -- where Inovio has a significant presence and expertise and dominance in terms of the checkpoint combination and treatment paradigm for such an important cancer.

Your next question comes from Gregory Renza with RBC.

Just a few quick ones, if I may. In just returning to 3100 and the enrollments of the site, could you just please remind us of -- or provide additional color on the potential mix with the U.S. versus international? And that you're potentially doing to account for any potential variability there or what's your consistency of a study once it's certainly set up?

Yes, Greg. So in our Phase II studies, we knew -- we have an aspiration of having VGX-3100 as a global product that can reach multiple regions, including our home region of U.S. and also the primary markets of Western Europe and elsewhere. So we had a breakdown of about 70% U.S sites and 30% global even on our Phase II studies. Now Phase III, 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 proportions 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 other regions and so on. What we saw in our Phase II 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 that really make any difference.

Got it. And then with respect to the timing and the coordination of the Phase IIIs 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?

Yes. REVEAL 1, just to jog our memories here, is in-study portion of the study for REVEAL 1 and 2 are identical, dosing at month 0, 1 and 3, and efficacy and safety evaluation at month 9 or week 36. REVEAL 1, just like our Phase II study has, the FDA asked for a 1-year safety follow-up. So it's a full 88-week study. So 36 weeks actively monitor and then there's a safety monitoring of another year. So it's an 88-week study completely. REVEAL 2 is through weeks 36, identical as REVEAL 1, but we have 1 month follow-up or 4 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've started REVEAL 1 first last year, and then REVEAL 2, we expect to start when we're about to finish REVEAL 1. The reason for that is, there's no need to start REVEAL 2 before the REVEAL 1 has completely dosed because you're really at the last person in for REVEAL 1, which has a 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. And just one more on 1800. Just curious what venue you'd expect to share that forward data? And then also, it sounds like your partnership, certainly the goal there, I'm just curious if you have a sense of timing expectation on the partnership? But also certainly most importantly, when you expect to share that fuller data and which venue?

Yes. The partnership first, as I said, that the finding a right partner that can most effectively move the program forward in combination with other drugs, 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, this new data with them privately and it's 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're 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're not -- we're looking at a partner for INO1800 because, really, our true focus, where our hearts and mind and where we're spending our money really is HPV programs and our IO 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 it, infectious disease as ways to add value, but where we drive value is really is in the -- where our focus is, which is HPV and IO combination therapies.

Our next question comes from Alex Schwartz with Stifel.

I had 2 questions. First off, can you give us an update on the next steps of 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. Kind of what can we expect to see next with HIV, both in results and maybe next study?

Yes, Alex. You can expect to see 2 things: one is our HVTN 098 data, where the top line data was presented last year. Those full data sets are getting prepared, and we're working with HVTN and our collaborators to submit a manuscript later in 2018. So you would expect to see a full Phase I data through a publication and additional presentations in conferences in '18. In terms of why we were so excited about that data is, it's a 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 assay. And they have the wherewithal to compare, platform wise, with all of 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 platform that were tested. So we share their optimism and excitement in that. Where that study is going to go, where that program for PENNVAX-GP is going to go, once these are clarified and we can share with the public, but we expect there to be additional studies with PENNVAX-GP in a preventive HIV vaccine study. 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, was a PI for a new study that's being prepared, where we're using PENNVAX-GP as an immune therapy, and it will be used in combination with antiviral drugs initially. And then what's so cool about this is the second part of this clinical studies will bring in a PD-1 checkpoint inhibitor with the goal of seeing an immunotherapy combined with PD-1 can -- along with antiviral HIV drug 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 can 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'll share with the public.

Okay, excellent. 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 you're in cash balance maybe?

So $23 million this quarter from ApolloBio is a major non-dilutive license we expect. We could project that 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 -- 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 2 years of cash runaway right now, which I think is a solid financial position that Inovio's in. 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 & Co.

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 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 power problems that they've been having in the island. 80 people have received their vaccine, 80 have received the placebo and they're participating through frequent follow-up visits. We expect to have the final visit later this year, and the results will 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 have 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 control nature, we could have a early look of signal of efficacy. We're 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 -- we're discussing with various potential funders for the next steps in advancing our Zika vaccine to Phase II evaluation and beyond. So this is a program that we will utilize external funding to advance.

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

So that's a really good 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 strains 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're evaluating the potential funders for advancing the flu program. Obviously, with the recent flu season we have encountered, there's 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 the -- 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 comes from Jason McCarthy with Maxim Group.

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. The conferences where we expect to have clinical publications for both Ebola and MERS Phase I studies this year and 2018.

My other questions are already answered.

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're 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 places us 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 immunotherapies 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 may disconnect your lines at this time, and thank you for your participation.