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Inovio Pharmaceuticals, Inc. (INO)

Q2 2016 Earnings Call· Mon, Aug 8, 2016

$1.13

+0.89%

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Transcript

Operator

Operator

Greetings and welcome to the Inovio Pharmaceuticals Second Quarter 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Bernie Hertel, Vice President of Investor Relations and Communications. Thank you, sir. You may begin.

Bernie Hertel

Analyst

Thank you, Operator. Good morning, ladies and gentlemen. Thank you for joining us today. 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, products and product candidates, as well as our capital resources, all of which involves certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the latest SEC disclosure documents and our recent press release. These statements speak only as of today’s date and we undertake no duty to update or revise them. Presenting today are Dr. J. Dr. J. Joseph Kim, Inovio’s President and CEO; and Peter Kies, our CFO. I will now pass the call over to Joseph.

Dr. J. Joseph Kim

Analyst · Piper Jaffray. Please proceed with your question

Good morning, everyone. Thank you for joining us. Today, I want to review with you the big picture of where Inovio is going. You know we are focused on realizing the potential DNA vaccines and immunotherapies. And we sit in a prominent position with respect to the knowledge capital, IP and financial capital generated and applied to the advancement of this promising technology. So, let me detail our overall vision for the development of our technology. Inovio’s aspiration is to have not just one but three products filed for marketing approval with the FDA, or in Phase 3 by the year 2020. We call this Inovio Vision 2020. The three specific product opportunities we are focused on to achieve this vision are first, VGX-3100 for CIN and VIN or cervical and vulvar pre-cancers as well as chronic HPV infection; second, a cancer product, the first oncology could be our new cancer target INO-5400 or it could be INO-3112 which is partnered with MedImmune; third, an infectious disease product from among Ebola, MERS or Zika vaccines. This does not imply that you won’t see R&D development or clinical development activities in advancements on other diseases and products. Because our products all use common technology, we can create new antigens and even new approaches such our dMAbs which are complementary to each other. All the data we generate provides important learning, applicable across all products. All funding that we get for any disease or product helps advance the overall platform while reducing overall burn rate. But these three focus aspirations form the basis for our vision and where we are committed to directing resources. So, let’s talk about where we are achieving those aspirations, and why this is an important juncture. First, our lead candidate VGX-3100 and Phase 3. In the third…

Peter Kies

Analyst

Thank you, Joseph. Let me first address our announcement last week that Roche terminated our partnership for clinical development of an immunotherapy to treat hepatitis B. This decision by Roche is of course disappointing but it is not uncommon for big pharma and biotechs to make strategic shifts in their technology and disease focus. Based on the progress we have made across our portfolio, we are optimistic that our hepatitis B immunotherapy can make a meaningful difference in this chronic infection, which can lead to liver cancer. If that is achievable, then this product will be a more valuable asset to Inovio whether we retain full economic rights or we partner the program. Not surprisingly, this interim safety data we have seen to-date for this hepatitis B trial fits in our historically favorable safety profile. Immunoanalyses are planned to take place after completion of enrollment. Since Inovio was already leading and managing this Phase 1 trial and Roche funding for this trial will continue through its completion, this study will continue on track without disruption. We expect to complete enrollment in the first half 2017 and report results in the second half of the next year. With respect to the financials, I am sure you’ve all read our press release. So, I won’t repeat the operating numbers published. I will note that in June, we did implement an ATM facility. Through this facility, the Company sold approximately 119,000 shares of common stock at an average price of $11.12 per share for net proceeds of $1.3 million in the second quarter. As of June 30th, we had $134.5 million in cash and short term investments. Joseph, back to you.

Dr. J. Joseph Kim

Analyst · Piper Jaffray. Please proceed with your question

Thank you, Peter. In summary, Inovio’s expertise and technology in DNA-based immunotherapies that generate robust killer T cells to fight disease, but which can also rapidly generate antibodies to prevent infection, our aim is to establish and clinically validate a disruptive common development platform for products that attack cancer and treat and prevent infection. Our strategy has been to achieve proof of concept with Phase 1 and Phase 2 clinical trial data. We think we’ve developed a great data set showing strong immune response data across multiple diseases and products. And obviously, we have the benefit of correlating those results to efficacy and our completed Phase 2 study. The second part of our strategy is to spread cost and risk with non-dilutive partner funding, R&D grant and sponsor clinical studies. With over $130 million in third-party grants alone since 2009 and not accounting for a significant dollars already spent via partnerships, collaborations and sponsor studies, we have done a great job of extending the value of Inovio’s own research dollars, the dollars that we receive from investors. The third component of our strategy relates to the realization of value from our work. We see ourselves as innovators, guided of course by the intersection of clinical need and commercial opportunity. Ultimately, we prefer to develop our own products on our own to commercialization and in appropriate cases to see late stage development progress in the hands of suitable strategic partners, while aiming to maximize value for each product at each stage that is our overriding goal. We have important milestones before year-end in all three elements of our vision. I look forward to speaking with you over the next quarters as we are able to provide details on our progress. Now, I’m pleased to respond to your questions.

Operator

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Charles Duncan with Piper Jaffray. Please proceed with your question.

Charles Duncan

Analyst · Piper Jaffray. Please proceed with your question

Good morning, Joe and team. Thanks for taking our questions, and thanks for the thorough overview. I just had a couple of questions with regard to cervical dysplasia program. I’m sure you are going to provide more details in the future. But, could you give us a little bit more color on the study design or at least the sizing in terms of approximate patient numbers and timelines?

Dr. J. Joseph Kim

Analyst · Piper Jaffray. Please proceed with your question

Yes, good morning. Thanks Charles. Approximately the total patient numbers will be about 350 patients. And the end points will be very similar to our Phase 2 data. We had a really robust and strong efficacy data that was correlated with our immune responses. And based on those results, the regulators are in agreement that these are very good end points. So, we’ll be able to provide exact details when we launch the study, as I said in the fourth quarter of this year. The overall dosing and the scheme will be much similar to our Phase 2, three injections over the first three months of the accrual; and primary end points and the secondary will be at the month nine or week 36. So, much of the design I expect will be similar to our Phase 2 study that was published in the Lancet last year.

Charles Duncan

Analyst · Piper Jaffray. Please proceed with your question

Okay, excellent. That’s helpful. I t doesn’t seem like the regulators would require a more extended clinical endpoint.

Dr. J. Joseph Kim

Analyst · Piper Jaffray. Please proceed with your question

Yes, correct. And, as I’ve stated in the prepared statement, the product has been manufactured at commercial scale in preparation for the launch activities, post Phase 3; and also our commercial device has been designed and developed and manufactured. And these are all coming together in Phase 3. So, we’re quite pleased on the progress on all fronts.

Charles Duncan

Analyst · Piper Jaffray. Please proceed with your question

Okay, super. So, the second question I had is on the issue that Peter actually mentioned and that was on the announcement last week on Roche. I can certainly understand maybe a change in the strategic direction. That said, HPV seems like very challenged in the potentially commercial opportunity. I guess I’m wondering if you can share any additional color with regard to the feedback from Roche and/or other potential partners. Have you had any other indications of interest program and perhaps post that Phase 2 data, would there be an interest in partnering yet again?

Dr. J. Joseph Kim

Analyst · Piper Jaffray. Please proceed with your question

Yes, we’ve had interest in the program since the announcement of our Roche’s termination. Many of these were same parties who were interested in the program before we struck the deal with Roche in late 2013. As you said, hep B is a huge potential market, perhaps one of the largest if not the largest untapped chronic infection market out there. What’s interesting about this termination is as we said, the big pharmas and biotechs have changes in directions and strategies, and there seems to have been the driver for that from this Roche decision. We feel very strongly about the potential about INO-1800 as hep B therapy. There has been stellar, strong safety profile and interim analysis thus far; and there has been zero immune responses review or analyses done. So, I think this is a very strong product that whether we develop this internally post completion of Phase 1 study that’s as I said, we expect to be funded through Roche; whether we develop this further on our own or we partner this program we think INO-1800 will make a potentially high significant impact in the treatment of hep B going forward.

Charles Duncan

Analyst · Piper Jaffray. Please proceed with your question

And then, last question is on Vision 2020 for Inovio. I am not sure if I caught this, I had trouble with the dial in. But in addition to Zika potentially being something that could emerge to the commercial stage by 2020, what about oncology; what do you see as the indication that you think could emerge by 2020 to the commercial stage?

Dr. J. Joseph Kim

Analyst · Piper Jaffray. Please proceed with your question

Yes. So, Inovio Vision 2020 is a catch phrase but we think it’s three areas that we think we bring a product to the market or very close in advancing in Phase 3 by year 2020. That’s a high aspirational goal. One has HPV products, VGX-3100 and second is oncology. Right now, there we have multiple horses in this race internally. Obviously INO-3112 is further along because we have strong immune responses in Phase 1 and we’ve licensed that product to MedImmune and they are planning to do multiple studies combining their immune molecules with INO-3112 to bring about the best one-two punch combination in head & neck and cervical and other HPV driven cancer indications, as we stated. We think that’s probably the favorite horse in oncology, but I like the chances of INO-5400. I know we have not unveiled every detail on this program, but we’re working very diligently to bring the best combination of antigens anchored by our hTERT antigen but with two additional high profile antigens along with the checkpoint combination to treat a very lethal cancer. So, we look forward to perhaps seeing this product leapfrog in a more accelerated fashion. And then I also want to throw in the hat for INO-5150, which is our prostate cancer therapy. As stated, we’ve completed the enrollment of 60 patients for this study just recently, and we look forward to having some data by end of this year. So, we like multiple shots on goal. And I think at the end, our shareholders will be the winner. And as you know, the cancer is an area that can have rapid development based on successful data in the clinic. And the third area is from the emerging infectious diseases. So, it could be Zika, it could be Ebola, it could be MERS. But based on the data from the clinic, I think that one of those three could be on its way to becoming our first product, based on the medical needs from the market.

Operator

Operator

Our next question comes from the line of Thomas Shrader with Stifel. Please proceed with your question.

Thomas Shrader

Analyst · Thomas Shrader with Stifel. Please proceed with your question

I don’t have a lot of questions but I am a little interested in the HPV program. Now that you have full control, do you anticipate this will remain only a therapeutic vaccine? I mean, there are prophylactic HPV vaccines and they work incredibly poorly in large population. So, do you think you will stay only in the therapeutic realm or is this a chance to rethink where this vaccine might fit?

Dr. J. Joseph Kim

Analyst · Thomas Shrader with Stifel. Please proceed with your question

Well, Tom, thanks for the question. In the long run, we can look at all different additional opportunities, but right now we’re focusing on 1,800 as immunotherapy for chronically infected hep B patients. Our current trial with about 90 plus patients is designed to both, look at safety and immunogenicity but also get a sense of a signal of efficacy, meaning we’re looking at S antigen and E antigen, seroconversion in these patients as well. So, that’s where we think has the best unmet medical need, and also have the potential highest commercial value for us. And we’re quite excited about this. A quarter billion chronically infected hep B patients are pretty much poorly treated at this point. And it’s a major disease that can lead to liver cancer and other liver problems, as you know. So, we are -- I can’t say I’m happy to have a major partnership terminate, but I’m very happy to get our baby back because we see the potential in this. And we’ll quickly move to clinical data; having full control of this will allow us to move more rapidly into the next steps.

Operator

Operator

Our next question comes from the line of Yi Chen with H.C. Wainwright. Please proceed with your questions.

Yi Chen

Analyst · Yi Chen with H.C. Wainwright. Please proceed with your questions

Hi, thank you for taking my question. I wonder if you could give us some additional color on 5400. Is there any possibility that it can be used by itself as a monotherapy; and also, when it’s used in combination with checkpoint inhibitor, whether the indication needs to be an approved indication for any checkpoint inhibitors on the market? Thank you.

Dr. J. Joseph Kim

Analyst · Yi Chen with H.C. Wainwright. Please proceed with your questions

The second question first. It really depends. We think the combination with checkpoint inhibitor with our T cell generating cancer vaccine will be the most appropriate combination or most optimal combination out there. And that’s probably one of the reasons why maybe [ph] was to 3112. But for 5400, we think there could be a multiple combination possibilities with 5400, whether they are PD-1 or PD-L1 checkpoint inhibitors. It’s a combination of three antigens that can be applied to multiple solid and liquid tumors. We’re going to go after some of the top targets first with the first indication, which will be unveiled later this year, once all of the details and design and the partnership is left down. But, this will be a step by step process for us to maximally achieve the beneficial effects of our cancer vaccine. Now, as to monotherapy, we think definitely as we’ve seen with VGX-3100, there will be a potential as a monotherapy. But, we believe in terms of time and to commercialization and to the most benefit to the patients, combining with a checkpoint inhibitor to lower the reverse immune checkpoint will be a great combination for our T cell generating product. So, we want to get to -- as part of the Vision 2020, we want to make sure we can bring our best product forward in terms of immune oncology to the market as rapidly as possible. So, we’re going to -- our strategy is to combine with the checkpoint inhibitor from a partner from the get-go. So, we think that’s the fasted and optimal path forward for us.

Operator

Operator

Our next question comes from the line of Jason McCarthy with Maxim. Please proceed with your questions.

Jason McCarthy

Analyst · Jason McCarthy with Maxim. Please proceed with your questions

I just wanted to walk back to infectious disease. You talked about one of your three prongs for 2020. For Ebola or Zika, given the size of the population that would need to be vaccinated, can you give us an insight into what a Phase 2 could look like; how big; how much it could cost? Because we’ve seen groups like J&J and Bavarian Nordic picked their Ebola vaccine; J&J put 200 million into Bavarian Nordic, and they have a 1,200-patient trial ongoing now? So, could you just walk us through what the next steps for Zika and Ebola could look like, in your mind?

Dr. J. Joseph Kim

Analyst · Jason McCarthy with Maxim. Please proceed with your questions

Thank you. Ebola first; it’s not likely [ph] because lack of expansive infection today that we’ll be doing a Phase 2 study for Ebola, rather the FDA has put in place a path forward for animal rule, which in effect as you’re able to do your Phase 2 efficacy readouts in animal species where you can challenge those animals. And we have several non-human primate protection studies ongoing in which we have some data in the past as well with very protection rates, up to 100% in protection. So, based on our immune responses that we generate from safety and immune response studies in healthy volunteers and healthy subjects, combined with efficacy readout from the non-human primates, we think we’ll be a in a great position to talk about how big a safety study might be with the FDA as early as 2017. So, what we’re doing now is to find the right dosing regimen in human subjects. From our 75-subject study that was reported earlier this year, we found that our intradermal delivered vaccine of 4212 was the best generator of immune response -- vaccine immune responses, especially the antibody responses. So, we’re very encouraged by that. And we’re planning to do additional studies to find the best dosing scheme using that delivery method. And consequently, we’re also using the same intradermal delivery for our Zika vaccine that’s currently in Phase 1 study with 40 healthy volunteers. And the next study for the Zika vaccine will be a more of an efficacy signal study in more endemic areas where Zika infection is more prevalent. In Zika, we could do larger Phase 2 studies. And we have commitments to go into those efficacy readout studies in those prevalent Zika infection areas. And that could start by the year end. And we look forward to really testing this vaccine against Zika infection. Going forward, as I said, we’re looking to have additional funders and partners that can work with us, with Inovio and GeneOne, and our collaborators to more rapidly advance our Zika vaccine program forward. And we have lots of different discussions ongoing in that regard currently.

Operator

Operator

It appears we have no further questions at this time. I would now like to turn the floor back over to management.

Dr. J. Joseph Kim

Analyst · Piper Jaffray. Please proceed with your question

So, I’d like to thank you all for listening. What we laid out today is our Inovio Vision 2020, which is not only are we looking to do in the next five plus years to get the first product approved for VGX-3100 for CIN and VIN but also we’re looking to advance two other programs within our oncology and infectious disease components of our platform. And I look forward to providing more details on this vision and discussing how we execute these programs as next several quarters come forward. So, I’m very excited about the progress we’re making. And thank you very much for listening to our presentation.

Operator

Operator

Ladies and gentlemen, this does conclude today’s teleconference. You may disconnect your lines at this time.