Thomas Kim – General Counsel and Corporate Secretary Joseph Kim – President and CEO Maggie Campbell – Finance Director.
Brian Klein – Stifel Jason McCarthy – Maxim Jonathan Aschoff – Brean Capital.
Greetings, and welcome to the Inovio Pharmaceuticals’ Third Quarter 2014 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, Thomas Kim, General Counsel and Corporate Secretary for Inovio. Thank you, sir. You may begin..
Thank you. Today’s call may contain certain forward- looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and 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 we have referenced on the call may not be indicative of results achievable in other trials, studies and trials may not achieve the results desired, and they may not commence or be completed in the time periods anticipated, 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-ended December 31, 2013, our Form 10-Q for the quarter ended September 30, 2014, and other regulatory filings from time-to-time.
Finally, there can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products or that any of the forward-looking information provided will be proven accurate.
Now Inovio’s President and CEO, Dr. J. Joseph Kim..
Thank you, Tom. Good morning, everyone. There’s a new world of oncology coming and Inovio is proud to be a leader in the new way cancer patients will be treated by training a patient’s own immune system to fight cancer.
I ask you to imagine overall where a woman has an alternative to surgery for a condition that often leads to cancer when surgery currently is her only option today. Imagine a world where immunotherapy resolves cervical lesions caused by the HPV virus that goes further and eliminates the virus altogether.
Imagine, the effect this would have on woman and those around her who will hear that their wife, their mother or their friend’s condition will most likely not progress to cancer, to avoid surgery and is [inaudible] from HPV virus that caused cervical lesions in the first place.
Finally, imagine a world where a new immunotherapy treats all cancer caused by the HPV virus, cervical cancer, anal cancer and head and neck cancer which happens to be the fastest growing cancer in men today.
Inovio’s effort is directed towards creating such a world where pre-cancers and cancers are attacked with the novel immunotherapy, fighting disease with your own enhanced immune system rather than with the surgeon’s knife.
Inovio’s took giant step towards this new world of cancer immunotherapy in the third quarter of this year by successfully meeting our Phase 2 endpoints in Inovio’s first efficacy trial with our lead immunotherapy product, VGF-3100.
I’m add to say that represents a technology breakthrough, the first critically meaningful efficacy results from T cells generated exclusively in vivo in the history of this [field]. Let me emphasize some critical points from our successful efficacy trial.
Our Phase 2 data suggests we have the potential to offer women with this emotionally challenging high grade pre-cancer condition a 50% chance of regressing the disease to a low grade condition or a complete clearance. I do want to reemphasize one set of numbers.
40% of the VGF-3100 treated patients experienced not just regression of the dysplasia but also full clearance of HPV in conjunction with dysplasia regression whereas only 14% of the patients in the placebo [inaudible].
Because of these impressive results we have previously announced we will initiate a Phase 3 program for this lead immune therapy targeting cervical dysplasia.
So far, so for a snapshot our HPV clinical plan preparing a paper for publication in a major medical journal, we also expect to have our end of Phase 2 meeting with the FDA next year and we expect we will launch a Phase 3 trial by early 2016, our most conservative estimate.
In the meantime, we are evaluating a comprehensive Phase 2 plans that includes identifying country participants, reviewing clinical sites, recruiting investigators and refining the Phase 3 protocol. And we’re also advancing our marketing development efforts focused on the end game of commercialization.
While our medium term goal is a successful Phase 3 trial leading to a marketing approval for CIN 2/3 and a new treatment paradigm are still with you, our ultimate goal that is to own the HPV therapy space.
This HPV market includes other pre-cancers and cancer caused by the HPV such as vulvar pre-cancer, vaginal pre-cancer and other anal, genital neoplasias as well as the cancers of the cervical, head and neck cancer as I mentioned before, aerodigestive cancer and anal-genital cancer.
We have plans to begin human trials for all these cancers and have initiated or soon will initiate several clinical studies. In fact, in September Inovio initiated a Phase I clinical trial in patients with aerodigestive cancers. Our immunotherapy for this disease targets human papilloma virus which causes most aerodigestive cancers.
Earlier this year we initiated clinical trials in HPV caused cervical cancers and head and neck cancers targeting HPV type 16 and 18. We are moving rapidly because the unmet need for patients suffering from these forms of cancer is significant. Turning to our financial review, Peter Kies, our CFO is travelling today.
So Maggie Campbell, our Finance Director will provide our third quarter financial update.
Maggie?.
Thank you, Joseph. I will ask our listeners to refer the news release we issued this morning and our 10-Q filed on Friday for specific financial figures. And at this time I will just note some key highlights from our third quarter financial results.
We are receiving significant ongoing revenue through payments from Roche under our ongoing collaborative research and development arrangements.
We did recognize a decrease in revenue for the comparable three and nine-month periods in 2014 and 2013, primarily because of lower payments from this partnership in those recent quarter compared to the large upfront payment associated with this partnership agreement concluded with Roche in the third quarter of 2013.
Increased R&D expenses for the three and nine months period was primarily related to work conducted under our Roche partnership and expenses relating to preparations for future clinical trials. As Inovio progress and grows we are hiring more staff which also contributed to the overall increase in our operating expenses.
The $23.7 million and $21.9 million decrease in net loss attributable to common stock holders for the three and nine months ended September 30, 2014 compared with the same period in 2013 resulted primarily from a higher non-cash accounting expense in 2013.
And as of September 30, 2014 our cash and cash equivalents and short-term investments were $100.9 million compared with $52.7 million as of December 31, 2013. This increase was primarily due to the net proceeds from our March 2014 financing and warrants and options exercised during the period.
As of September 30, 2014 the company had 60.5 million shares outstanding and 66.6 million fully diluted. Based on management’s projections and analysis we believe that our cash, cash equivalents and short-term investments are sufficient to meet our planned working capital requirements through the end of 2017.
In addition we planned to raise additional cash as necessary, this time for the phase III of VGX-3100. More detailed information can be found in our press release issued this morning and on our website in the IR section under SEC filings. Joseph back to you..
Thank you, Maggie. Let me touch for a moment on Inovio response to the recent Ebola outbreak. Our lead products are obviously focused on oncology and that’s where Inovio’s primary efforts are based.
But as we felt more responsibility to direct our flexible vaccine and immunotherapy platform against the virus for which we already have impressive preclinical published results.
In published testing of our Ebola vaccine last year 100% of vaccinated guinea pigs and mice were protected from death after being exposed to a lethal dose of the Ebola virus.
Our research has also found significant increases in neutralizing raising antibiotic [inaudible] and strong and broad levels of vaccine induced T-cell including [killers] T-cells sales suggesting that this product does provide both preventive and treatment benefits.
Based on these results we are moving our DNA vaccine against Ebola into human trials early next year and as in all of disease areas we are targeting we are proactive in seeking collaboration and funding them may provide effective support for our development opportunity.
In October, we also announced that Inovio was part of an alliance with the University of Pennsylvania and Medimmune, which received a DARPA award of $4.2 million to develop Inovio’s DNA-based Monoclonal antibodies against influenza and antibiotic resistance bacteria.
Monoclonal antibody technology has already achieved multiple market-proven product successes including over $50 billion in sales today. We believe Inovio’s DNA-based Monoclonal technology could significantly extend the medical benefits and efficiency of this concept. We’re pleased to be awarded this money from the U.S.
defense, events, research, projects, agency or DARPA which is a leading supporter of promising intellectual technology and to collaborate with Medimmune, which is a leader in vaccine development and Monoclonal antibody product.
I would like to emphasize for our investor some important elements of this emerging initiative in DNA-based Monoclonal antibody. First, this is not a departure from our core technology.
We’re leveraging our core proprietary optimized DNA plasmid and electroporation delivery technology platform we have already used to create dozens of product candidates. We’re simply plugging in different genetic codes to produce yet another useful immune component.
Second, this technology is complementary to our existing DNA-based immunotherapy, potentially inducing unique immune response characteristics to help fight cancers or infectious diseases.
For example, this technology has the potential to very rapidly induce preventive or therapeutic immune responses adding to the exceptional magnitude and durability of immune responses in consumption with excellent safety profile to-date that we have observed with DNA immunotherapy.
Furthermore any of our DNA immunotherapies or DNA Monoclonal antibodies may potentially be used alone or in combination. Finally this project represents a step forward into another new disease area, antibiotic resistance bacteria a very concerning problem in the modern healthcare world. The bottom line is something our many followers already know.
Inovio is not a one trick pony. We’re expanding our portfolio with a potentially very valuable new tool applicable to a broad array of diseases. This dramatically extends the potential clinical utility and up-market opportunity for our technology. Inovio is clearly not still and we have many milestones to look forward to over the next quarter.
We do expect the Phase I study of our fully funded HIV immunotherapy trials to start by the end of the first quarter next year. We expect initial data from our hepatitis C, cervical cancer and head and neck cancer studies in 2015. We also look forward to the initiation of our hepatitis C trial with Roche. This will trigger a milestone payment.
More importantly Hep C is an unresolved disease and a substantial market opportunity. While I earlier emphasized our HPV cancer franchise, we are broadly developing momentum with our overall cancer portfolio. We have an equally strong product candidate with our hTERT cancer immunotherapy INO-1400.
hTERT or human telomerase reverse transcriptase is found is 85% of human cancers. So the big picture is that INO-1400 holds potential as a broad spectrum cancer immunotherapy.
By the end of the year we expect to initiate our first human trial for INO-1400 either alone or in combination with Inovio’s IL-12 immune activator in adults with breast, lung and pancreatic cancers. We also look forward to starting with Roche our prostate cancer program in 2015 as well. Let me end with our goal in cancer.
Our aim is to have the best and most expensive pipeline of active cancer immunotherapies with the potential to safely seek out and destroy cancer cells, creating a world in which more doctors will tell their patients our tests show you are cancer free. Thank you this morning and now I’m ready for your questions..
Thank you. We will now be conducting a question-and-answer session. (Operator Instructions). Thank you. Our first question comes from the line of Charles Duncan with Piper Jaffray. Please proceed with your question..
Hi guys it’s Roy, for Charles. Thanks for taking the questions. I wondered if you could remind us if you disclosed then the magnitude of milestones from Roche for the study for [inaudible] if you’re going to amortize them or recognize them once..
So we have not disclosed how much it will be but it will be in mid-single digit payments, mid-single digit millions for each Hep C and prostate cancer. In terms of accounting, I think Maggie can help answer that..
I believe that the first is something that we will be able to recognize once all the objectives have been completed, regarding the milestones..
Okay. [inaudible] for use of cash.
You think we will see data both of those in 2015?.
The data control will be made by Roche. So they’re paying for it and they control the data. And they have publicly stated that no data will be presented before Phase II efficacy has been demonstrated.
Where we will be able to make these payments recognizable to signal to the market where these programs are will be based on the 8-Ks filed by furthering these milestone payments..
Great. And then to me – I certainly [called] dysplasia Phase III in early ‘16.
When do you think we might keep data from that?.
So I will vary this question. Obviously it will be a registrational license study. So we expect perhaps in two to three years after the study initiation, will be when the Phase III study will be un-blinded and reported..
Okay. Thank you and then another question on that, back on Ebola, I guess I think now that you’re in non-human primate studies and is that going to be necessary for an animal [rule] approval or it’s part of the Phase I and the other animal data for this. Thanks..
Yeah, well. We’re quite excited. In the published, previously published study from last year we’re able to protect 100% of the animals, in these cases with this one injection from both death and illness from the challenge with exposure to a weak Ebola dose.
What we are planning to do as we are in parallel doing both non-human and human primate studies both in monkeys as well as in Phase I clinical studies, we do feel that because we have the opportunity to challenge the monkeys with a lethal exposure to Ebola virus we think that’s an important step in getting license for this product.
Obviously the human data trumps all and we look forward to getting the immunogenicity and safety study from the currently planned Ebola vaccine study which is quoted as a INO-4200 going forward for treating, preventing and treating Ebola impression..
Okay, and if we should expect that data next year sometime right, is that…?.
Yeah, we expect this to be a rapid study, so we’re working very hard to get that started as soon as possible and we expect to see data in 2015..
Okay, very good. Thank you..
Thanks..
Our next question comes from the line of Brian Klein with Stifel. Please proceed with your question..
Hi, good morning. Thanks for taking my question. Hi Joseph.
First one, 3100 can you tell us if you’re still tracking the patients that were involved in that trial, if you’ve seen any additional responses in either the vaccine treated or the placebo-treated group and conversely if you’d seen any relapses in patients?.
So thank you Brian. So we do have a week 88, so follow-up safety and Immunogenic setting as well as efficacy, [viral] presence, read outs and we do have a week 88 data point all of the initial top-line efficacy, immunogenicity and safety data as you know were based on the week 36 time point.
So yes we will have additional data and we expect those to be part of the reports that will come out in the future and for the week 36 data points obviously we’re looking forward to having a major publication come out as well..
Great.
When you think about the Phase 3, do you anticipate that you’ll be able to utilize the same endpoints as the Phase 2 or do you think the FDA is looking for something different?.
So we expect something similar to the endpoints that we have used. Obviously it’s not definitive until we meet with the FDA, for end of Phase 2 meeting which will be in 2015. There is a final arbiter of that and I feel very strong that we’ll get a pretty good consensus with the FDA in terms of our Phase 3 endpoints..
Great, and then lastly in 3100 as you head into the Phase 3 program are you still considering partnering that asset outside of the U.S.?.
Yeah. So I am glad you asked that. Obviously we’re working extremely hard to get on with the preparations and including getting the products and the commercial level of [inaudible] designs then made so it’s an incredibly large endeavor for our team. But we’ve been undertaking that with great confidence and expertise.
So we’ve always said and we are in discussions with multiple potential partners all of the prep work and the Phase 3 design will go on and we’ll continue to monitor who maybe our best partner going forward. All of the options are on this table including outright out-licensing of the program if the economic conditions are right.
There are other options as you mentioned. We can out-license certain territories or as we discussed earlier we may take on the Phase 3 studies and getting the registration approval of the products on our own and then we may just do a marketing partnership with large pharma channels. But all of those things are on the play.
We always fully disclose these potential options to the market but we are currently in discussions with potential partners but there is always a strong chance that we have the capabilities and the financial and economic incentives to carry on the most of the – and retain the most of the economic rights to this potentially paradigm changing product going forward..
Great, excellent. And just one last question. You mentioned here that you’re planning on initiating that Phase 3 program in 2016, any chance you can move that into a 2015 timeframe? Thank you..
Thank you Brian. Yes it really depends on the end the Phase 2 meeting timeline with the FDA and I certainly would like it in later 2015 versus early 2016. So we’re going to leave no stones unturned but we’re in a highly regulated environment.
So we are at the mercy at some of these regulations and paths that we take but obviously I am just as anxious to get this study started and executed as the next guy..
Thanks for taking my questions..
Thank you..
Our next question comes from the line of Jason Kolbert with Maxim. Please proceed with your question..
Hi, this is Jason McCarthy for Jason Kolbert. I was interested in the prostate cancer vaccine and how you are measuring the efficacy, if you are measuring prostate volume in these animals and also some sense and you might have said this before, the timing of the Phase 1a-1b trial. Thank you..
Yes, thank you Jason. So in pre-clinical phase which we have published multiple locations on there aren’t really suitable and meaningful efficacy animal models. So what we have based on are the immune responses, especially the killer T cells responses to PSA and PSMA target antigens for our prostate cancer program 5150.
In terms of clinical studies we expect that to start in sometime in 2015. We are working very closely with Roche. We announced the last quarter that we were retooling to target the uses and testing of this immunotherapy in castrate-resistant prostate cancer patients who are really the sicker, more advanced patients.
And we also disclosed the likely [inaudible] include an arm that we will look along with check point inhibitor molecules – and that these have been publically discussed previously.
So we are working with our Roche partner to work out all of these and I think we are very close and look forward to announcing the start of that trial by letting the market now that the milestone payment has been received.
The end points for those studies really be multi-faceted, obviously the greatest interest is the survival benefit and so on but those things are going to stay longer to look.
What we want to see is can we – just as we have seen with VGX-3100 and pre-cancer, cervical pre cancer patients combined is the strong antigen specific killer T cell immune responses in the later stage prostate cancer patients, both in the periphery as well as in the prostate tissues and can we also see the benefit measurements to the tissue as well as the overall and progression-free survival of these patients.
So it will be multi-faceted, along with safety obviously as you look forward in all of our trials, our safety profile overall across different trial have been extremely favorable as we had expected. Just remember our product is pure DNA formulated and pretty much a pure water. So its design could be safe and so far all indications provide that it is.
So we are quite excited to start INO-5150 prostate cancer therapy with Roche. I am just as excited to start our INO-1800 product for treating hepatitis C, hep-C, as many folks in the market have said. In fact the hep C market was four times as many people chronically infected with very little drug treatment options available today.
So we and Roche as well as our key opinion leaders that we have talked feel that our immunotherapy 1800 has a strong potential to pay an important role in this, what will be the increasingly huge market to treat patients who have the chronic Hep C infection and we are still very excited and happy with partnership that we have with Roche going forward..
Great. Thank you very much..
Thank you Jason..
(Operator Instructions). Our next question comes from the line of Jonathan Aschoff with Brean Capital. Please proceed with your question..
Thank you good morning Joe..
Hi Jonathan, how are you, sir?.
I’m all right. So I was wondering between now and starting a 3100 Phase III you have the 36 week data in hand, this 88-week data is coming and so does this 88 week data trump the 36 week data.
Is there some truth to that and that’s kind of a large component of [inaudible] about a 1.5 year between Phase II and in Phase III potential start or is that off base..
Well that’s not off base but 36 week data is probably the primary important data. 88 week was put in essentially a week, one year after the primary endpoint for – to monitoring the safety. This was the first in man or first in woman study. So we wanted to make sure that we have long term follow up data.
We also want to make sure that the strong T-cell, the killer T-cell immune responses that have been seen are consistent and durable through that long period. I don’t think we’re going to see any real differences in the efficacy readout as well as the [bar] clearance read out. So we’re gone look and those things will come up in early next year.
Now the importance of our conservative timeline is that the week 88 data may be required to have the whole set down in the Phase II meeting with the FDA. And it’s less of a factor then obviously we will have the end of Phase II meeting with the FDA earlier in the year and move forward even faster.
So at this point we like to set off human response [inaudible] and deliver more that’s in the model of our company. But we feel good about the week 36 data which shows for the first time an active immunotherapy, deliverance and beyond can generate such a powerful immune responses that leads to clinical clearance of a disease.
And that’s [a fact] that actual cause of the disease in the first place which is HPD virus.
So we’re running full speed ahead close and getting to the 3100 study phase III study started as well as to take advantage of this unique opportunity to become the full service therapy provider, therapeutic solution provider to all diseases caused by the HPV infection which is tremendous.
Many percentage of our general population is infected with HPV virus and especially the types that cause problems like at [16-18 6] for instance and we’re looking to a time that Inovio can provide products to treat and clear many of these infections and those diseases.
So we’re at the cusp of this and we’re the leading company in this regard and we look forward to maintaining and expanding our leadership in this field going forward..
Okay, yeah Joe would the second quarter call next year be a reasonable timeframe for us to hear that 88-week data or does the extra time just make these patients gather around hard to find longer to get the data..
So. Yeah we will – we don’t like to keep data or disclosures longer than we need to the public. So we’ll be able to – we certainly have done that in the past with our July data from the top line was fresh off the unblinding event. So we have the custom and culture of disclosing fully and being transparent.
So we’ll get it out to the public as soon as practicable and possible..
Okay. And then lastly do you have Roche antigen, clearly you wish to go after a different population of prostate cancer but the antigens that you will use, those are still non-disclosed. Just to remind me..
So, no, we disclosed what 5150 is. 5150 is a – our [inaudible] PSA and [inaudible] PSMA antigen. These are myriad DNA sequences combining different monkey and human DNA sequences for those prostate antigens. We have previously said that Roche is funding us directly to investigate, discover and develop additional backup new prostate antigens.
Those are being – that exciting study is getting done right now in pre-clinical models. So we’re – we don’t like to be a one trick pony overall but we certainly are not a one trick pony even when we come to our partnership with our big pharma partners. So we could have additional products coming forward from these programs in collaboration.
So we have, as you and I discussed previously we worked very hard over the last several years to put a platform of technology that recently has demonstrated efficacy and we have multiple, almost a dozen products both in the clinic as well as being worked on, that uses the same patent protection with over 500 patents globally and same mechanism of action to bring about these impressive clinical and immunogenic responses in people.
So just if I can reiterate, we’re to going to [own] post HPV infection immunotherapies market to treat all of the pre-cancers and cancers caused by the HPV infection but expanded that to prostate cancer with prostate specific antigen, with Roche and we’re starting our trial for hTERT, which is currently un-partnered but there’s been a huge interest for it in the field, and our 54 patients, pancreatic lung and breast cancer patient studies, 18 in each group with INO-1400 will start before the year end.
So we currently have a lot of oncology-based milestones and catalysts that will come out in the next several quarters. And all of these cancer studies except for our Phase III are open label study. So all of the Inovio studies head and neck, cervical, pancreas, lung, breast those data can be compiled and reviewed and perhaps reported pretty quickly.
So stay tuned. We have a lot of game changing data that we expect to have from all of these oncology targets. I don’t want to underscore our infection program such as HIV, which will start early next year as well as Ebola. That sort of a hurry up mode and there has been some urgency.
And we think our Ebola vaccine candidate has good as chance if not better than our competitors out there.
So we feel having this DNA based vaccine for preventing or even treating Ebola or other challenging infectious diseases maybe the way to go and the speed in which we can develop, and in which we can manufacture and our availability to repeat those compared to the viral vector vaccine and our product’s stability and so on, there are numerous advantages that our platform has.
So we look forward to continually demonstrating the superiority of our platform and our patent protected product technology that are going forward in 2015..
Okay, thank you Joe..
Dr. Kim it appears we have no further questions at this time. I would now like to turn the floor back over to you for closing comments..
Yes, thank you very much and I would like to thank everyone listening to this conference call and certainly I’d like to thank all of the analysts from various banks who have attentively and asked really interesting question. I would like to leave with just reiterating where Inovio is today.
Inovio is where most company when they start dream about being. This is a place where we have already demonstrated clinical efficacy of our lead product and we have multiple coordinated pipeline of products coming through line and some of those are already in the clinic and many more will enter in the next several quarters.
We have a validating and anchoring partnership with Roche. We have additional potential partners that are closely discussing and engaged with us. We have a strong test position.
We have an increasing human resource position, and we have many studies as well as many catalysts that will be potentially a [inaudible] events in the next several quarters and I certainly look forward to how we will end 2014 as well as the next year which poses many activities and promises to be fulfilled that all of us, our team at Inovio have been working extremely hard to achieve.
So I like to thank you all for listening and just watch us execute. Thank you very much..
Ladies and gentlemen this does conclude today’s teleconference. You may disconnect your lines at this time. Thanks for your participation and have a wonderful day..