Earnings Transcript for ONCS - Q3 Fiscal Year 2017

Executives: Punit Dhillon - CEO Richard Slansky - CFO Chris Twitty - Head of Clinical Science Sharron Gargosky - Head of Clinical Development & Operations

Analysts: Jason McCarthy - Maxim Group Yi Chen - H.C. Wainwright Kumar Raja - Noble Capital Markets Michael - National Securities

Operator: Hello and welcome to OncoSec Medical Incorporated Fiscal Third Quarter and Year to Date 2017 Financial Results Conference Call. My name is Carman and I will be your web event specialist today. At this time, all participants are in a listen-only mode. Please be aware that today's conference call is being recorded. Later we'll conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] I would now like to turn the conference over to Mr. Richard Slansky, Chief Financial Officer at OncoSec. Mr. Slansky, please go ahead.

Richard Slansky: Thank you, Carman and good afternoon. After the market closed today, OncoSec issued a press release that provides a corporate update and financial results for the quarter and nine months ending April 30, 2017. The press release is available on our website at www.oncosec.com. We remind listeners that today's call is being webcast on our website and will be available for replay. During today's call, we will be making certain forward-looking statements. These many include statements regarding the success and timing of our ongoing and planned clinical trials, regulatory filings, review and approval, future research and development, drug substance and device manufacturing, commercial development objectives including licensing opportunities, forecast for commercialization, our cash burn and other 2017 financial guidance among other things relating to our business including, but not limited to, our plans to develop nucleic acid asset-based immunotherapy and delivery technologies. These forward-looking statements are based on current information, assumptions and expectations that are subject to chance and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in our forward-looking statements. These and other risk factors are described in our periodic filings made with the securities and exchange commission, including our Form 10-Q for the period ended April 30, 2017. You are cautioned not to place undue reliance on these forward-looking statements and the company disclaims any obligation to update such statements. With that, I'll turn the call over to Mr. Punit Dhillon, President and Chief Executive Officer of OncoSec Medical, Punit?

Punit Dhillon: Thanks Richard. Good afternoon, everyone, and thank you for joining us today. Joining me on the call today in addition to our CFO, Richard Slansky, who you just heard from, will be Dr. Sharron Gargosky, OncoSec's Chief Regulatory and Clinical Officer; and Dr. Chris Twitty our Head of Clinical Science. I'll take a moment to review the agenda for today's call. First, I'll recap our recent clinical data. I'll then turn the call over to Dr. Chris Twitty to discuss the mechanism and combination rationale for ImmunoPulse IL-12. Then Dr. Sharron Gargosky will provide us with some clinical updates and discuss the clinical collaboration with Merck, our regulatory pathway for ImmunoPulse IL-12, and some details regarding PISCES our registration directed study in melanoma. After that, Richard will provide an overview of our third quarter 2017 and nine month financial results. Finally, we'll open the floor for a Q&A session. All right. So, over the last several years, we've been building a company that has culminated in multiple significant achievements in the first four months of 2017. In February, we presented interim data demonstrating that the combination of ImmunoPulse IL-12 and KEYTRUDA led to a 48% best overall response rate at 24 weeks in patients predicted to not respond to an anti-PD1 checkpoint therapy. This was soon followed by the FDA granting fast-track designation for treatment of melanoma patients who have previously failed OPDIVO or KEYTRUDA therapy with a combination of IL-12 and KEYTRUDA. And lastly, we just recently announced our clinical collaboration and supply agreement with Merck through which we are securing a drug supply for our soon to be initiated registration-directed clinical trial, PISCES. As a CEO and founder of OncoSec, I'm proud to say that we are a pioneer in intratumoral immunotherapies and now one of the leading immunotherapy companies with a significant lead over others that are now following. Initiating our pivotal study is an exciting phase in our growth and development as of our technology company and this includes the less visible behind-the-scenes work regarding the regulatory submissions, working with our CROs, site startup, and other initiation activities including negotiation of the many different agreements and contracts related to the PISCES study. We remain focused on taking the necessary steps to succeed in the registration-directed PISCES trial as we continue to deliver on our mission of addressing an unmet medical need in melanoma with ImmunoPulse IL-12. Now just wanted to take a moment to recap the clinical development path. As I mentioned on May 10, 2017, we announced our collaboration and supply agreement with Merck to evaluate the combination of ImmunoPulse IL-12 and their best-in-class therapy KEYTRUDA in the PISCES clinical trial. This signifies the completion of one of our major development milestones for 2017. This is the first registration-directed study to evaluate the safety and efficacy of this combination in patients with metastatic melanoma following disease progression on an anti-PD1 therapy. On our last conference call, we provided a summary of the Phase II combination data, which we presented at ASCO-SITC demonstrating an objective response of 43% and a best overall response rate of 48% in 22 patients after 24 weeks of combination treatment. Of the 22 patients enrolled who are predicted to not respond to anti-PD1 therapy, nine had previously been treated with at least one checkpoint inhibitor. Of this subset, we noted 33% demonstrated an objective response in combination of IL-12 or ImmunoPulse IL-12 and KEYTRUDA. We believe these are encouraging and note that several companies have now followed the lead of OncoSec by exploring the anti-PD1 refractory population in melanoma. Moreover, we believe that OncoSec to date has provided some of the most comprehensive biomarker analysis in this nonresponder patient population, and this underscores the potential for ImmunoPulse IL-12 to generate both a local and systemic immune response that potentially results in improved response rates when combined with KEYTRUDA. With that said, I'll ask Dr. Chris Twitty to join us today to provide a brief review of the immune monitoring data presented at ASCO-SITC and provide his perspective on the importance of this data in the context of other combination immunotherapies in the anti-PD1 nonresponder population.

Chris Twitty: Thanks, Punit. As you know, checkpoint blockade therapies have transformed oncology. Unfortunately for most indications, a significant portion of patients will not respond to therapy allowing their cancers to continue to grow. A key question that immuno-oncologists have come to focus on is, why do some patients fail anti-PD-1 checkpoint blockade therapies. While there is likely not a simple answer to this question, recent findings finance have shown that both the number of CD8 positive T cells and levels of PDL1 in the patient’s tumor microenvironment are important predictors of an effective anti-PD-1 driven response. Current efforts to understand the mechanism underlying these observations point to immunogenicity of this tumor as a critical factor, which may have tied not only to tumor mediated suppression, but also to genetic or epigenetic pathway and even a composition of the patient's microbiome. Before discussing the rationale for its combination with anti-PD-1 checkpoint blockade, I would like to take a moment to highlight immunobiology underlying OncoSec's ImmunoPulse IL-12. ImmunoPulse IL-12 is a gene base that is DNA therapeutic delivered intratumorally by electroporation that allows tumors to produce IL-12, a proinflammatory cytokine capable of coordinating innate and adaptive immune responses. Specifically, ImmunoPulse IL-12 initiates the release of tumor-associated antigens while activating dendritic cells to promote enhanced antigen presentation. This in turn promotes an effective priming and polarization of CD4 positive and CD8 positive T cell towards Th1 and Tc1 responses respectively. In addition to dendritic cells, IL-12 also augments innate community by increasing natural killer cells. Thus, ImmunoPulse IL-12 dependent intratumoral immune modulation effectively transforms a patient's treated lesion into an in-situ vaccine that primes not only a local but also a systemic immune response, increasing the number of CD8 positive tumor-infiltrating lymphocytes or TIL. OncoSec's therapy can release and effectively present tumor antigens inflaming both treated and distal that is non-treated cold tumors with NK cells and Th1 or Tc1 polarized cells. However, the tumor may increase levels of PDL1 to apply an immunological break turned adaptive resistance, which can diminish the magnitude of an antitumor response. Thus, the synergy of combining ImmunoPulse IL-12 with KEYTRUDA that is anti-PD-1 is evident as it allows each therapeutic to work optimally. KEYTRUDA works by blocking the PD-1 PD-L1 access, blunting the effects of adaptive resistance, allowing for more robust antitumor immune response. And ImmunoPulse IL-12 works by altering the immunogenicity of the tumor, driving the frequency of tumor-infiltrating lymphocytes at its transformation of a cold to hot tumor. These tumors often lead to increased PDL1 expression on the tumor, providing the substrate to maximize the utility of this antibody. Data to support these mechanisms comes not only from the literature, but also from our own immune monitoring and biomarker program fortified with some key collaborations with notable academic and industry leaders. I would like to briefly highlight some of the data that is being presented in early 2016 at the AACR and SITC annual meetings as well as recently in 2017 at the ASCO-SITC annual meeting. Working closely with our clinical oncologists to obtain longitudinal bio-samples allowing for the interrogation of tumor DNA by TCR sequencing demonstrates the significant increase in a fraction of productive T cells and T cell commonality in responding patients. Further nanostring analysis of tumoral gene expression revealed a significant increase in gene sets related to adaptive and innate immune responses in responding patients. Using multispectral immunochemistry allowed us to visualize the transformation of cold pretreatment lesions into a hot tumor, evidenced by a brisk immune infiltrate with the requisite ratio of CD8 positive T cell to PD-1 expressing tumors or monocytes. This powerful observation occurred at both treated and untreated distill lesions. Relatedly evaluation of the peripheral blood mononuclear cells by ELISA and flow cytometry provide additional evidence of a productive systemic immune response. Collectively data from our immune monitoring program has closely aligned with published literature. It is worth noting that while each of these immunological endpoints address different components of tumor or immunobiology, the results are overwhelmingly aligned in supporting the previously described mechanisms. While these data are coupled with outstanding clinical responses that Sharron will speak to next, we're increasingly confident that this combinatorial approach will make a huge impact in patients who are currently unable to benefit from anti-PD-1 therapies. I would like to turn it over now to Sharron Gargosky.

Sharron Gargosky: Thanks Chris. Thanks for that wonderful clinical science backup update there. So as Puneet mentioned our collaboration and supply agreement with Merck will support our clinical trial PISCES in evaluating this combination of the ImmunoPulse IL-12 and their best-in-class KEYTRUDA. Our teams have been working really closely with the Merck clinical team to ensure that our PISCES protocol meets the standards of both organizations and I'm really happy to report that we on track to initiate the trial. Furthermore, this collaboration provides OncoSec with pharma validation and millions of dollars in savings for the drug supply that we need for our registration-directed trial. So, to give you a little update on how the PISCES program and the clinical trial is actually progressing right now, PISCES is the name we've given our Phase II open label multicenter study of IL-12 in combination with KEYTRUDA in the stage III-IV melanoma patients. PISCES stands for anti-PD1 IL-12 stage III-IV combination electroporation study. So, you can see why PISCES is a better way for us to refer to it. In the trial, a total of 48 eligible patients will be enrolled into this study in the Simon 2-stage design with the primary endpoint of best overall response rate by an independent central review group based on our research division 1.1. These eligible patients who will be those with stage III or IV metastatic melanoma who -- they will have been progressing or have progressed on either KEYTRUDA or OPDIVO as either a monotherapy or as a combination of those approved therapies. Currently we're working with several prominent research centers in the U.S. and in Australia and we're going through the rigorous clinical site evaluation and selection process. We still do you plan to be open to patient enrollment at the latter part of this month June and although this is a somewhat aggressive timeline as such, our team has been working very hard and very closely with all of our collaborators, our vendors, with Merck, our CROs and as you would expect the drug and device manufacturers. So, we're confidence that we can meet these expectations and in doing so, ensure that OncoSec maintains its competitive edge. All the details of the trial are of course on clinicaltrials.gov. So where are we with our regulatory pathway, with our fast track designation in hand and this amazing immune monitoring data that's really showing those differences between responder and non-responders, we have our drug available and device and the clinical outcome data to date, we really believe that there is a strong potential for an accelerated approval in this nonresponder patient population, of course based on the clinical trials outcome. So now, I would like to hand it back over to Punit who will go into further details about our melanoma development strategy. Thanks, Punit.

Punit Dhillon: Thank you, Sharron. That's a great update. So, I would like to outline OncoSec's melanoma development strategy and why we believe we have an advantage over many of our competitors. To start, OncoSec was the first and to the best of our knowledge, only company to clearly outline a regulatory plan for treating melanoma patients who have previously failed OPDIVO or KEYTRUDA. This was validated by the FDA granting OncoSec clinical trial approval and fast track designation in February of this year. It's been reviewed and incorporated feedback by multiple regulatory experts and the FDA. This coupled with the strong data we presented at ASCO and SITC and the pending start of our PISCES trial, this really places OncoSec in a position where we could be the first company to have a therapy approved in the anti-PD1 refractory setting in melanoma. Second important point here is that a significant benefit of -- the significant benefit that we provide comparably to other companies is the intratumoral therapy is safety. The clinical data to date for ImmunoPulse IL-12 as a single agent or in combination with KEYTRUDA has consistently demonstrated a well-tolerated and remarkable safety profile. So, in other words, the clinical benefit of ImmunoPulse IL-12 is not compromised by the toxicity you may see in other drugs or other combinations and this is very important because less toxicity and fewer safety issues related to the treatment themselves potentially means less burden on the patients and the hospital systems. As we continue to take the necessary steps to prepare ImmunoPulse IL-12 for commercialization, we expect to begin discussing our plans for commercial manufacturing of our product. We believe and are confident that the commercial opportunity for ImmunoPulse IL-12 to be truly significant. Anti-PD-1 refractory melanoma is a major unmet medical need. There are currently no available treatment options for patients with metastatic melanoma who have failed anti-PD-1 therapy and OncoSec is in a position to be the first available treatment to this population. Furthermore, as our focus is on bringing the ImmunoPulse IL-12 to the market, we'll continue to actively pursue and expand the pipeline with checkpoint combination in multiple indications. So, we're looking to increase the value of our IL-12 franchise by doing additional combination. Lastly, OncoSec believes that the tumor targeted approach of delivering the right genes to appropriately modified tumor microenvironment and create an immune most suitable for combinations with checkpoint therapies is the best and safest approach for the future of immunotherapy combination. The data that we presented to date has demonstrated that delivering IL-12 locally with electroporation is both safe and effective and OncoSec's mission is to continue to lead the field in tumor-targeted delivery of gene so that we can build on the success of the ImmunoPulse IL-12 franchise by making available safe and effective technologies that can deliver genes to deeper and more difficult to reach tumors. So, before I conclude, I just want to make a couple other remarks. We firmly believe that we have a compelling value proposition for investors and with the successful execution of the PISCES trial and potential accelerated approval and the commercialization of ImmunoPulse IL-12, we believe that significant value still remains to be realized relative to our current market valuation. As such, we continue our efforts to communicate our development strategy to current and potential investors, including dedicated healthcare institutional funds and we expect that these efforts will result in a broader shareholder base and market Cap appreciation. So, at this point, I would like to turn the call over to Richard for a financial update.

Richard Slansky: All right. Thanks, Punit and good afternoon, again everyone. We issued our financial results via a press release today and we filed our form 10-Q after the market closed. For the third quarter of fiscal 2017, OncoSec reported a net loss of $4.6 million or $0.22 per share, compared to a net loss of $6.3 million or $0.37 per share for the same period last year. The decrease of $1.7 million in net loss for the third quarter ended April 30, 2017, compared to the same period in 2016 resulted primarily from a decrease of $700,000 related to our clinical trial costs that were lower due to a lower number of patient enrollments in a smaller number of actively enrolling trials as well as lower trial management costs and a decrease of $200,000 related to lower R&D salary costs. This was offset by $200,000 increase in cost related to initial clinical site startup costs in Australia and also a decrease of $900,000 in stock compensation expenses, mainly related to a reduction in the value of equity compensation awards, the independent members of our Board of Directors and a decrease of $100,000 in G&A salary costs. Now for the nine months ended April 30, 2017, OncoSec reported a net loss of $15.6 million or $0.79 per share. This is compared to a net loss of $20.3 million or $1.27 per share for the same period last year. The decrease in net loss for the nine-month period ended April 30, 2017, compared with the same period in fiscal '16 resulted primarily from a $2.5 million decrease in research and development expenses, primarily related to the result and a decrease of $2.1 million of clinical trial costs that similar to the quarterly results were due to a lower number of patient enrollments in a smaller number of actively enrolling trials. A decrease of $700,000 related to lower R&D salary costs and a decrease in travel costs of $200,000, which was offset by an increase of $200,000 related to stock compensation expenses as a result of our tender offer to exchange stock options and an increase of $300,000 related to initial clinical startup costs to establish our clinical presence in Australia. A $2.3 million decrease in general and administrative expenses was primarily the result of a decrease of $1.5 million in stock compensation expense, a decrease of $300,000 in G&A salaries and a decrease of $200,000 in accounting fees and a decrease of office supplies of about $100,000 offset by an increase in other income of about $200,000. There were no revenues for the quarter ended April 30, 2017, or April 30, 2016. At April 30, 2017, OncoSec had $16.1 million in cash and cash equivalents as compared to $28.7 million of cash and cash equivalents at July 31, 2016. Our team continues to seek cost-effective ways to achieve our goals while maximizing efficiency and prudent spending of our cash resources. As you will note in our filings, we believe our cash -- our current cash funds to be sufficient to allow us to continue to operate our business for at least the next nine months under our current business plan. We are actively pursuing various activities that would allow us to fund operations through the completion of our registration-directed study PISCES and beyond. Now with that, I'd like to pass it over to Carmen, our operator, will open up the conference call to question. Carmen?

Operator: Thank you. [Operator instructions] And one first question is from the line of Jason McCarthy with Maxim Group. Your line is now open.

Jason McCarthy: Hi guys. Thanks for taking the questions. Just a couple. For the PISCES study, depending on the 16 patients of data that you're expecting towards the end of the year that you could potentially use to convert to a registration study, what overall response rate would you consider to be significant enough to approach the FDA to see if you can go through a registration.

Sharron Gargosky: Can I speak to that Punit?

Punit Dhillon: Yes please.

Sharron Gargosky: Okay. So, hi. This is Sharron. So, I think the first thing is that, that number of 16 isn't any particular magic number there with what we might do to convert and look at this. It really being an open label trial that we're able to look at, at real time, of course we're going to be evaluating and looking at our subjects as they come in. So, we'll just go with as they enroll, as the patients come in and what our datasets look like honestly. So, there is no magic around that particular number, but with regards to what we would like to see with regards to like a response rate, the agency tends to like to see a 15% to 20% I would say my personal judgment, a shift in the change of above baseline of what you're seeing in a patient. And when we designed this trial, doing it -- looking at patients who have progressed based on the research criteria, you have some level of false positive in there that the literature is well aware of and it's been documented. So, we took a very conservative approach and set that at 15% of potential false-positive as our baseline and looked at a 15% shift above that and so we're looking for at least a 30% response rate in our study. If we get more than that as we've seen in the current study that we've been presenting since 2016, that would be terrific right, but that's what we're actually looking for in our PISCES trial.

Jason McCarthy: Okay. Great. And then Punit you had mentioned in the past some new products in the pipeline that have potentially multi-antigen, DNA-based multiple antigens, can you give us an update on pipeline progress and when we can expect or anticipate an announcement of the next product that could move into the clinic?

Punit Dhillon: Yes, so I'll just talk at a high-level and then Sharron or Chris feel free to chime in terms of actual developments. We have been advancing our ImmunoPulse IL-12 at a much faster clip than we've been doing on the preclinical pipeline. However, we have made a significant investment in IP on the multigene constructs and the new next-generation electroporation. So there, the strategy that we've implored is to continue to look at other co-development strategies and most notably our technology access program where we're doing several different collaborations, where we continue to advance the IP and advance the potential preclinical targets to go into an IND enabling setting. So, we've recently got to a place where we have selected several candidates that are ready for IND enabling studies, but our current resources are really squarely focused on showing value from our clinical program and we'll look to advance the new multigene constructs and the next-generation electroporation with other co-development opportunities while we're limited in terms of our bandwidth and resources.

Jason McCarthy: Okay. Great. Thank you for taking the questions.

Sharron Gargosky: No worries.

Operator: Thank you. And our next question comes the line of Yi Chen with H.C. Wainwright. Your line is now open.

Yi Chen: Thanks for taking my questions. Seems you end the quarter with roughly $60 million and you anticipated to provide cash runway through the first quarter 2018. So, does that mean we should expect a cash burn of over $5 million a quarter once you start the PISCES trial?

Richard Slansky: So, as you can tell, we're currently burning at about $4.5 million a quarter, and so you'll see that number rise as we get further into the PISCES trial, but we do believe that the cash runway will take us into Q1 of 2018 as we indicated. So yes, it will increase slightly as we move forward, but it will compensate for us under $5 million now.

Yi Chen: Okay. And the lowered amount of stock-based compensation in the reported quarter will maintain in the coming quarters too.

Richard Slansky: Yes, that's correct, and the particular compensation had to do with a one year vesting and that was a one-time event.

Yi Chen: Okay. Got it. Thank you.

Operator: Thank you. And our next question is from the line of Kumar Raja with Noble Capital. Your line is now open.

Kumar Raja: Thank you for taking my questions. I had a couple of questions. One on the clinical sites, so how many sites do you plan to have and what else remains to be done before you can open the site for enrolling the patients. And out of these sites, how many have already experience with the IL-12 ImmunoPulse?

Sharron Gargosky: Okay. So, the number of sites we planned in the protocol Kumar, I put out two study sites. I'm looking at initially having 20 up and running and ready. What's required is kind of the classic pathway, right, of clinical you have to get your ethics approval which I can say we have at a couple of central IRVs. You have to get through contracts and budgets, which we're in good discussions with right now and then with that you can start the trial and do the site initiation visits. So, we're in a good place there with as I said central approval already of the trail by a couple of different ethics major boards. Sites all with contracts and budgets and those dialogues going underway. So what do we have to do to get them started, get the contract signed basically and go out and initiate them? Of those sites who has experience with our existing technology, yes, we have some sites that we have worked with before involved in this trial as I can update clinicaltrials.gov I'll put more on there once their contracts are signed. So, we're going back to some of our familiar groups who have extensive experience with electroporation. Some new centers that have experience with electroporation but perhaps from a different framework like chemo electroporation and that's why I feel pretty confident that we will have sites open and be ready this month.

Kumar Raja: And how many of these sites already have experience with IL-2 and also may be a little bit of color on the collaboration with Merck? How much involvement will Merck have in the following of the clinical trials as well as the progress of the clinical trials?

Sharron Gargosky: Yeah. So, who have experience with IL-12 of the handful we've got right now, I would say that 20% of them have experience with the therapies and all of the electroporation combination space there like that. And where Merck's involvement is, well Merck was incredibly involved in our early dialogues around the clinical protocol in the science of what we were doing. With our immune monitoring, they did a rigorous assessment of what we were doing and how we were doing and we had a lot of conversations with Chris and the teams. With our clinical protocol, we went through extensive review with Merck recognizing that this could be an accelerated approval pathway with commercialization. It went through extensive reviews internally there, but what they expect on the backend once the study actually is running is just a general update. So, I have personally a weekly call with my liaison there just to tell them how things are progressing and that when meeting our own internal deadlines and then once every quarter, we provide a certain amount of update, which is very similar to what we will be doing with our DSMB Board that we have involved to look at safety and general update on the trial. So, their oversite is nothing particularly arduous. It's very much what you might expect of a sponsor just wanting to know how the study is progressing and are there any safety issues with the trial.

Kumar Raja: Okay. Great. Thanks for taking my questions.

Sharron Gargosky: No worries.

Operator: Thank you. And our next question is from the line of Michael [Brunswick] with National Securities. Your line is now open.

Michael: Hi. I have -- apologies I had to jump on an off, so I missed a couple of things, but on this quarter compared to the quarter last year, this is one of the reasons why the cost were down is because of slower enrollments I think, is that right?

Sharron Gargosky: Yeah.

Michael: And do you expect the enrollments to pick up and then is that going to increase the cost?

Punit Dhillon: Michael, you should put that in content in terms of what the current development objectives are and versus the prior trials. So, Sharron can outline that for you.

Sharron Gargosky: Yeah, so hi Michael. So, the things that we -- the reasons why we have these reduced cost is that we've been very proactively cleaning up and closing up trials internally that we're running at within OncoSec. Monotherapy studies have closed, our medical cell studies have closed, out head and neck study is closed. So, a number of trials that we were running, we had now closed them and gone through database lock and getting those clinical study reports done. So, you can imagine that huge cost burn of just having that infrastructure of that trials running is now gone and not part of our budget lines and we were able to accomplish that in a very timely way. So, I think that was great. And then similarly with a number of our vendors honestly just working with them and renegotiating or adjusting contracts appropriately can make a huge difference with a little fiscal responsibility there. And then I guess the third and the final part was with one of the studies, the triple negative breast cancer study, it has been a slower enrolling trial with just a single site and one of the PIs being alpha for a bit. So, we've had a little bit of slow enrollment there again that we intended to accrue and haven't been able to as proactively. So, I think that culmination of events has really led to these inferred savings and decrease in our clinical trials cost and spends that we had thought.

Punit Dhillon: Yes, and if I could just add Michael, one thing I would add to that is that this has been very deliberate and strategic about where did we see the IL-12 program can have the most value with all the data that was accumulated last year. So, we had over 100 patients between multiple different clinical trials in monotherapy setting. So, what we wanted to really set is if there is a development path and let's focus in all of our resources on the development path that can really get us approval and we've identified that melanoma would be the best route relative to our other indications. That doesn’t mean that we're not interested in combination opportunities in those other indications now that we have a larger data set, but for us melanoma definitely stands up because there is a clear unmet need. We had dialogue with the agency and this fast track designation that lays out. There is this population of patients that don't have any available treatment options and there we're also in the lead. So, it's a very clear opportunity for us to focus on and focus our resources on.

Michael: Okay. Thank you. Finally, on this collaboration with Merck, they're going to supply the product. Do they supply it to big discount for free? What's the deal or is it not public?

Sharron Gargosky: It's a classic type of material transfer agreement. So, we're getting the product per se for free. It comes to us as naked vials that we label appropriately for our clinical trial and kit and distribute. So, the product itself is free. The labeling, kitting and distribution becomes our cost center and responsibility.

Michael: Got it. Thanks.

Sharron Gargosky: No worries/

Operator: Thank you. And our question is a follow-up from Yi Chen with H.C. Wainwright. Your line is open.

Yi Chen: Hi. Thank you. Just a quick follow-up. So, regarding the long-term follow-up data from the first cohort patient for an investigator sponsored trial, what long term timeframe we will be looking at and can that data potentially be reported before the primary data readout from the PISCES trial?

Sharron Gargosky: Yeah. Do you want me to tackle that one as well Punit?

Punit Dhillon: Yes, that will be great.

Sharron Gargosky: All right. Hey, yeah, a good question. Yes, the long-term follow-up on the patients we have in the IST study does need to be extracted, monitored and evaluated. I haven't done it today. We had patients currently at two years plus in the trial, a number of patients still in remission and on holiday and you're exactly right with that I need to get that data out and look at it when we get the majority of these patients to 24 months, which will be before the PISCES readout at this stage, has not been done, should be done, will be done.

Yi Chen: Thank you very much.

Sharron Gargosky: No worries/

Operator: Thank you. And this concludes our Q&A session for today. I'll turn the call back to management for any final comments.

Punit Dhillon: Well, thank you all for participating in our third quarter conference call. We look forward to the months ahead and continue to work toward the important milestones on our horizon.

Operator: Ladies and gentlemen, this concludes our teleconference. You may now disconnect. Have a good day.