Earnings Labs

Inovio Pharmaceuticals, Inc. (INO)

Q1 2015 Earnings Call· Mon, May 11, 2015

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Transcript

Operator

Operator

Greetings and welcome to the Inovio Pharmaceuticals Inc. First Quarter 2015 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Bernie Hertel, Vice President of Investor Relations and Communications for Inovio Pharmaceuticals. Please go ahead, sir. Bernie Hertel - Vice President-Investor Relations & Communications: Thank you. Good morning, ladies and gentlemen. Today's call may contain certain forward-looking statements relating to our business, including our plans to develop DNA immunotherapies and electroporation-based delivery technologies, as well as our capital resources. Please keep in mind that actual events or results may differ from the expectations discussed as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, and product development programs, including but not limited to the fact that pre-clinical and clinical results referenced on the call may not be indicative of results achievable in other trials and studies, and trials may not achieve the results desired, and they may not commence or be completed in the time periods anticipated. There may also be risks related to collaborative arrangements, including the timing and receipt of payments, the availability or potential availability of alternative therapies for the conditions targeted by the company or its collaborators, issues involving product liability, issues involving patents, the adequacy of our capital resources, the impact of government healthcare proposals, and other factors set forth in our Annual report on Form 10-K for the year 2014, our 10-Q for the quarter ended March 31, 2015, and other regulatory filings from time to time. Finally, there can be no assurance that any product in Inovio's pipeline will be successfully developed or…

Peter D. Kies - Chief Financial Officer

Management

Thank you, Joseph. Good morning, everyone. Total revenue was $5.2 million for the (21:24) three months ended March 31, 2015, compared to $2.4 million for the same period in 2014. Total operating expenses were $13.5 million compared to $12.4 million. The net loss attributed to common shareholders for the quarter ended March 31, 2015, was $10.6 million or (21:55) $0.17 per share compared to $10.8 million or $0.20 per share for the quarter ended March 31, 2014. The increase in revenue was primarily due to payments received from Roche under our partnership agreement established in September 2013. Research and development expenses for the quarter ended March 31, 2015 were $9.4 (22:26) million compared to $8.2 million for the quarter ended March 31, 2014. The increase in research and development expenses was primarily or generally related to the increase in investment in all of our product development programs. General and administrative expenses remained consistent quarter-over-quarter at $4.1 million for both periods. As of March 31, 2015, cash, cash equivalents, and short-term investments were $81 million compared to $93.6 million as of December 31, 2014. At quarter-end, the company had 60.7 million shares outstanding and 67.8 million shares on a fully diluted basis. Subsequent to the quarter, we triggered a milestone payment of $3 million from Roche for the initiation of our hepatitis-B Phase I program. On March 5, 2015, as discussed earlier, the company closed an unwritten public offering of 10.925 million shares of the company's common stock, including 1.425 million shares of the company's common stock that was issued pursuant to the underwriter's exercise (24:03-24:05) were approximately $82.1 million. We were pleased that many knowledgeable institutional biotech investors participated in this round of financing. We intend to use the net proceeds we received from this offering for general corporate purposes,…

Operator

Operator

Thank you. At this time, we'll be conducting a question-and-answer session. We invite analysts to ask questions at this time. Our first question comes from the line of Charles Duncan with Piper Jaffray. Please proceed with your question. Charles C. Duncan - Piper Jaffray & Co (Broker): Hey. Good morning, guys. And first of all, congrats on a good quarter of progress and thanks for taking the questions. Joe, my first question is regarding the VX-3100 (sic) [VGX-3100] (29:03) cervical dysplasia trial design, and perhaps timing and costs. I guess, when can you tell us more about the design, roughly the number of patients, and what you anticipate the timing and cost to be for that trial? J. Joseph Kim - President, Chief Executive Officer & Director: Yes. Absolutely. All of these details will be finalized probably by early fall or late summer when we actually have the end of Phase II meeting with the FDA to formally discuss all these conditions, but we expect the size of our Phase III trials to be approximately 350 patients. There'll be one-to-one randomization, and there will be multiple endpoints to be looked at similar to our Phase II studies, the regression of CIN2/3 down to normal, full complete clearance, as well as the elimination of HPV virus from the cervical area, as well as perhaps even the rest of the body cavities as well where HPV virus can lurk. So, we expect to launch the study in early 2016. We are fully on track for that. And we expect the total study length to be about two and a half years. And it's – we're very excited to get this first Phase III trial for Inovio immunotherapy going as soon as possible. Charles C. Duncan - Piper Jaffray & Co (Broker): And,…

Operator

Operator

Thank you. Our next question comes from the line of Brian Klein with Stifel. Please proceed with your question. Brian J. Klein - Stifel, Nicolaus & Co., Inc.: Great. Thank you very much. Just wondered if you could elaborate a little bit more on your efforts of combining your various vaccines with some of the checkpoint inhibitors, including ones that are now on the market and commercialized? J. Joseph Kim - President, Chief Executive Officer & Director: Yeah. Thank you, Brian. We have ongoing pre-clinical evaluation of these programs. And I don't want to scoop our own publication that we're planning, but a combination of our DNA immunotherapies with checkpoint inhibitors that's on the market were similar versions of that for pre-clinical studies. We're able to adequately (36:13) generate much higher immune responses and anti-tumor responses in these animal studies. So, these are various combination potentials that we are seriously evaluating, as I've said in my prepared statements. So, these are some of the directions that we are looking at. And there are many potential combinations that we can have. Remember, I'm not going to say the checkpoint inhibitors are commoditized but there are multiple – there's already three approved, and there's probably another half a dozen in the next couple of years that will get approved. So, there will be many potential partners or combination opportunities that will be out there. Our goal – our primary preference is not to do these fly-by-night drug combo (37:16) deals. Our preference will be to do marriages, having license deals where Inovio gets immediate and long-term financial benefits of our – presence of our DNA-based immunotherapy. So, our preference is to do marriages. There could be multiple marriages, but not to do this one-night-stand type of combining couple of different drugs with no financial commitments to either side. So, there will be a lot more on this later. So, I would say as before, please stay tuned. Brian J. Klein - Stifel, Nicolaus & Co., Inc.: Great. Thanks. And just one final question on the prostate cancer study you're planning on. Can you talk about the patient population you're planning to go after and what concomitant therapies the patients will be on? J. Joseph Kim - President, Chief Executive Officer & Director: So, we haven't really talked about this in greater length, but it'll be healthier patients in biochemical relapse. They will have – they would have had received surgery or chemoradiation prior to this. They would have rising PSA levels and we'll be able to track that as a biomarker, as well as to generate the safety and T-cell immune responses in these patients overall rapidly. And our goal will be to go into a later-stage patients in the follow-up trial, where we will certainly measure the survival and overall benefits, anti-cancer effects. Brian J. Klein - Stifel, Nicolaus & Co., Inc.: Great. Thanks so much. J. Joseph Kim - President, Chief Executive Officer & Director: Thank you, Brian.

Operator

Operator

Thank you. Our next question comes from the line of Jonathan Aschoff with Brean Capital. Please proceed with your question.

Jonathan M. Aschoff - Brean Capital LLC

Management

Thanks. Hi Joe, I was looking for some clarity surrounding what'll be the most important topics at the end of Phase II meeting for VGX-3100. How much of it is nine-month efficacy? How much of it is 21-month efficacy? Because it's really hard to imagine that the safety differential from 9 months to 21 months matters, given that no patient received VGX-3100 for months before even a 9-month assessment. And water and naked DNA that encodes open reading frames for antigens already heavily present in the patient, it doesn't exactly strike me as a safety concern ever. So, what exactly is going to go on at that meeting? J. Joseph Kim - President, Chief Executive Officer & Director: Yeah. So, thank you, Jonathan. The 21 months, that's the set of (40:12) framework is, the patients receive three injections in Phase II and also projected two injections too, in Phase III in the first 3 months into the arm. And there's a 6 months' wait after the last injection. And primary efficacy readout was and is planned to be in Phase III, month 9 readout, whether their CIN2/3 pre-cancers have been regressed and/or the virus in the cervix has eliminated – has been eliminated. So – and then, we built then a 12-month follow-up primarily for safety because women who didn't clear at month 9 received a surgery to remove their lesions. So, month 21 readout really is based on safety. And really, this is a overabundance of caution as to – as a – one of the first, if not the first, DNA immunotherapy delivered with electroporation to go into human patients. We wanted to have this much safety read-outs early as possible. So, we don't expect any surprises. We don't have all of the data compiled for 21 months safety and immunogenicity and so on. But, reading into Phase II and the Phase II meetings, clearly, the biggest objective for us is to nail down the endpoints, agree on, and then giving their concurrence on the endpoints because they're the final arbiter, as well as the overall framework of our protocol. And we feel very confident that we will be able to achieve our objectives. But obviously, it's not done until it's done, and we look forward to doing this in the third quarter.

Jonathan M. Aschoff - Brean Capital LLC

Management

Okay. Joe, what is known about the spontaneous remission rates for these patients? Is it either early on or never, or is it kind of constant, more or less, over time? J. Joseph Kim - President, Chief Executive Officer & Director: I think it's more dynamic. So – and also, it's also a question of spontaneously, their base immune system can clear. That's why even clearance to normal in our placebo group was approximately 17% compared to over 40% for our treated group. So, what we're doing is we're improving upon the natural immune system's ability to clear in some of these women. We want to apply it to about half or even larger population by providing a non-surgical option. What's also complex is, in this placebo group or overall in nature, you're not just infected possibly one time. This is a sexually transmitted disease, and there could be repeat viral infections. We certainly have to prove it in the clinic. But once we can clear the virus, I believe we have generated a long-term memory T-cell responses that can clear the virus over longer time. I mean, this is not going to be a clinical claim until we prove that in the trial. But knowing what we know in T-cell immunology, we hold this to be true, not necessarily true in the spontaneous regression column. So, you know, there are multiple reasons why VGX-3100 as a first non-surgical alternative for women with these high-grade cervical pre-cancers is going to be very attractive for the patients and the physicians who are treating them. In fact, we've done a market research of almost 500 physicians across U.S. and top five countries in Europe, as well as almost 200 patients who have just recently experienced the CIN2/3 diagnosis and treatment. And, overall, (44:43), there's a – what they told us, both from the physicians and the patients from this quantitative market research, is that there's a strong demand for a non-surgical treatment alternative for these women who wants to be treated non-surgically. So, we feel very good about the positioning of VGX-3100 once we finish our Phase III studies. So, we can't wait till we get to – we get this study started.

Jonathan M. Aschoff - Brean Capital LLC

Management

Okay. Lastly, what has been done on the manufacturing front since you've generated the Phase II data? J. Joseph Kim - President, Chief Executive Officer & Director: Yeah. So, as I've stated before, in biological products, where you make your Phase III products has to be where you're going to eventually make your commercial products. So, all of our Phase I and Phase II products are made in our manufacturing affiliates' facility in Houston and VGXI facility. So, we had to search out and find the best contract manufacturer who can manufacture our products consistently commercially. And we have done so. And in the past several months, we have transferred the VGXI process over to this new manufacturing company. And that work is going as planned, and that's where we are making the Phase III critical products as well as to our planned commercial products once this product hits the market. Similarly, Jonathan, just I have to touch on this as well, all of our Phase I and Phase II studies are done with our pilot-scale prototype delivery devices. Since our Phase II preliminary data or top-line data was released last summer, we have designed and constructed a commercial-scale delivery device which looks nice but very easily used and very robust and can be mass-produced. And that work is going now. And we expect to have these units available for Phase III in time to launch the study in very early part of 2016.

Jonathan M. Aschoff - Brean Capital LLC

Management

All right. Thank you very much. J. Joseph Kim - President, Chief Executive Officer & Director: Thanks, Jonathan.

Operator

Operator

Thank you. Our next question comes from the line of Yi Chen with H.C. Wainwright. Please proceed with your question. Yi Chen - H. C. Wainwright & Co., Inc.: Hi. Thank you for taking my question. Joseph, can you give us any rough idea on when can we expect to see some initial results from the hTERT DNA immunotherapy in breast, lung, and pancreatic cancer? And also, when we see those results, is that going to be on those – all three types of cancer or just one type of those cancers? Thank you. J. Joseph Kim - President, Chief Executive Officer & Director: Thank you, Yi. So hTERT INO-1400 study is enrolling now. We launched that late last year, early this year. And it's actually three studies in one. It's the same product, same procedure, but we're enrolling roughly equally 18 patients total in breast, 18 patients total in lung, and 18 patients in pancreatic cancer. So, we don't have a quota, but we're enrolling them as fastly as – as fast as the patients become eligible. And it's an open-label study. Our primarily – our primary objective is obviously safety. But also, we want to know, a same question as what we asked for the head and neck cancer patients, can we indeed generate the similar levels of high CD8-positive killer T-cell responses against, in this case, hTERT as the engine in these cancer patients? And it's an open-label study and we should begin to have some early data by the fourth quarter or by year-end this year. But the full set of data probably will be available by mid-2016. There are other measurements and other biomarkers for the following, but really, the bottom line is can we extend the excellent safety signals to these hTERT drugs? And so far, so good. And the second primary objective is can we generate the powerful killer T-cells against this new antigen, non-HPV antigen similarly to what we've seen in our cervical pre-cancer and head and neck cancer patients? And we'll all have to stay tuned for that. But I think our chances are good. Yi Chen - H. C. Wainwright & Co., Inc.: Thank you. J. Joseph Kim - President, Chief Executive Officer & Director: Thanks.

Operator

Operator

Thank you. Our next question comes from the line of Jason Kolbert with Maxim. Please proceed with your question.

Jason Wesly McCarthy - Maxim Group LLC

Management

Hi, Joseph. It's Jason McCarthy. Thanks for taking the question. Sounds like everything is going really well. And I wanted to go back to the oncology program and you were talking about checkpoints. But when you're talking beyond safety of activating T-cells and the (50:30) is also running into this problem. You run into the issue of adaptive resistance in multiple solid tumors. And it's likely not driven by a single checkpoint but more than one checkpoint. So my question is, if you adopt your vaccines to use your DNA-based monoclonals or your DNA-based immunotherapies to mitigate having to partner with somebody for a single-checkpoint inhibitor that might be out there? J. Joseph Kim - President, Chief Executive Officer & Director: Boy, Jason, I think you have bugged our rooms or you're extremely perceptive. And certainly, we can go about this in multiple ways. Number one, our goal was to answer it, yes, but let me go into more detail. Number one, we have our own active DNA vaccines or DNA immunotherapy against specific antigens of cancer. And we've shown that in head and neck cancer, we look forward to show that in hTERT and prostate and so on. So, that was our primary goal number one. Number two, we're also doing combination studies in animals, and we have good assurance that combining with checkpoint inhibitors, whether they're on the market now or soon to be in the next few quarters, could be a additive effect. It's the same brake-and – removing-the-brake-and-pressing-down-the-accelerator model. And number three – so, that's number two. That's an approach that we can follow. Again, we don't want to give away the cow (52:16) for free. We want to make sure we get the right economics for that. And number three, as you alluded to, because…

Jason Wesly McCarthy - Maxim Group LLC

Management

Great. Thank you very much. J. Joseph Kim - President, Chief Executive Officer & Director: Thank you.

Operator

Operator

Thank you. (54:41) searching, there are no further questions at this time. I'd like to turn the floor back to you for any final remarks. J. Joseph Kim - President, Chief Executive Officer & Director: So, thank you all for who have listened today on time or read the transcripts. I'd like to express our true appreciation for all of our shareholders and supporters. Thank you very much.

Operator

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.