Earnings Transcript for ONCS - Q2 Fiscal Year 2016
Executives:
Richard Slansky - Chief Financial Officer Punit Dhillon - President and Chief Executive Officer Robert Pierce - Chief Scientific Officer Sharron Gargosky - Head, Clinical Development and Operations
Analysts:
Jason McCarthy - Maxim Mark Breidenbach - H. C. Wainwright Kumar Raja - Noble Life Sciences
Operator:
Hello and welcome to today’s conference for OncoSec’s Second Quarter 2016 Financial Results. My name is Chelsea and I will be your web event specialist today. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded today. An archive of this call will be available on OncoSec’s website following the meeting. It is now my pleasure to turn the call over to Mr. Richard Slansky, Chief Financial Officer at OncoSec. Mr. Slansky, the floor is yours.
Richard Slansky:
Thank you, Chelsea. Good afternoon, everyone and welcome to our second quarter financial results conference call. Before we begin, I would like to inform you that today’s call may contain certain forward-looking statements relating to our business, including but not limited to our plans to develop DNA immunotherapies and delivery technologies. Any statements about our goals, expectations, beliefs, plans, designs, objectives, assumptions or future events or performance are forward-looking statements. Please keep in mind that actual events or results may differ from the expectations discussed as a result of different factors, including outcomes of clinical trials and product development programs, evaluation of potential opportunities, the level of cash consumption, the assessment of OncoSec’s Technology by potential corporate partners, capital market conditions, timing of events and other subjects. We believe our statements are based on reasonable assumptions. However, these statements are not guarantees of performance and involve known and unknown risks and uncertainties and may cause the actual results to be materially different from any future results expressed or implied by such statements. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in our filings with the SEC. We disclaim any duty to update forward-looking statements. Now, I am pleased to introduce our President and CEO, Punit Dhillon. Punit will lead us through our call today. Punit?
Punit Dhillon:
Thanks, Richard. Good afternoon, everyone and thank you for joining. I would like to take a moment to review the agenda for our call today. First, I will share an update on key milestones since our last conference call. Then Richard will provide an overview of our second quarter financial results for the 2016 fiscal year. I will then close with a brief overview of how our recent achievements fit into our corporate strategy and upcoming milestones. And afterwards, Dr. Robert Pierce, our Chief Scientific Officer and Dr. Sharron Gargosky, Head of Clinical Development and Operations will join us in opening the floor for a Q&A session. As a brief introduction and as you may have seen, we have recently announced the appointment of Dr. Gargosky as Head of Clinical Development and Operations. Dr. Gargosky has over 20 years of experience in clinical development and operations in the field of pharmaceutical and biologic development. She has managed global programs from early research phase through the FDA approval process and we are thrilled to have her on board. We believe that she will be integral in advancing our clinical programs, prioritizing our product development strategy, and identifying opportunities to leverage ImmunoPulse to address a significant unmet need in oncology. With the addition of Dr. Gargosky as a consultant, we will not be seeking replacement for Dr. Le, our former Chief Medical Officer at this time. We believe that Dr. Gargosky’s expertise added to our existing clinical staff and we have sufficient clinical talent and expertise in-house to drive our clinical strategy forward. Now, on to a discussion of the progress that we have achieved this past quarter. In the second quarter of fiscal year 2016, we have continued to advance our clinical pipeline with OncoSec’s lead program, ImmunoPulse IL-12. As you may know, ImmunoPulse IL-12 employs intratumoral electroporation to enhance the local expression of interleukin-12 or IL-12 as it’s commonly known. ImmunoPulse IL-12 has an excellent safety profile and can generate local immune responses as well as systemic anti-tumor effects. Preclinical and clinical data have laid the groundwork for expansions into combination approaches, new tumor indications and future therapeutic candidates based on its defense mechanism of IL-12. We have seen that ImmunoPulse IL-12 is the rational choice for combination therapies with anti-PD1 agents and may increase the number of patients who will benefit from anti-PD1 therapy. We believe ImmunoPulse IL-12’s ability to promote a systemic, tumor-specific immune response holds the greatest potential to provide meaningful clinical benefits to patients and investment value for OncoSec’s shareholders. First, I would like to provide an update on our clinical operations and current files starting with our lead program in melanoma. In terms of clinical trial updates, we have completed patient enrollment in the Phase 2 extension study of ImmunoPulse IL-12 for the treatment of melanoma. And as you may recall, this trial is an extension of our previous OMS-I100 Phase 2 melanoma trials for which we have previously reported results that included a best overall response rate of 31% and a complete response rate of 14%. 50% of the patients also had regression in at least one distant untreated lesion. The objective of the extension study is to assess the safety and efficacy of an alternate treatment cycle with ImmunoPulse IL-12 in 21 patients with advanced melanoma. The OMS-I100 Phase 2 study assessed the safety and efficacy of ImmunoPulse IL-12 in a 90-day treatment cycle, while this extension study valued at 6-week or 42-day treatment cycle with ImmunoPulse IL-12. This study provides an opportunity to assess whether a modified treatment schedule can provide additional clinical benefits to patients and the trial will also evaluate additional biomarkers to provide further scientific understanding of ImmunoPulse IL-12. With respect to our combination trial of ImmunoPulse IL-12 with Merck’s approved anti-PD1 agent, KEYTRUDA, in patients with advanced melanoma, the goal of this trial is to demonstrate that ImmunoPulse IL-12 can convert non-inflamed low TIL or low tumor infiltrating lymphocyte tumors into one that have an inflammatory micro environment or a high TIL, which will prime the tumors for therapy with KEYTRUDA. Patient enrollment for this trial is on track and we are on target to complete enrollment by the end of 2016. With leadership from our clinical and regulatory teams, we intend to use the data from our clinical trials to advance our melanoma approval strategy. Data analysis from our melanoma clinical trials is ongoing and we have begun to process new data from our melanoma programs, including the combination trial with KEYTRUDA meeting one of the most important long-term milestones as a company for the year. We look forward to sharing these data with you at key scientific conferences later in 2016. In summary, we continue to execute on our melanoma trials in order to address a great unmet medical need in oncology with the goal of defining a commercialization pathway for our technology in melanoma. Now, in the triple-negative breast cancer study, we are continuing to enroll patients into our pilot biomarker trials and look forward to sharing top line data readouts with you later this year. This study is particularly important in evaluating ImmunoPulse IL-12’s ability to enhance tumor immunogenecity in this patient population leading to increased tumor infiltrating lymphocytes, or TILs. We anticipate ImmunoPulse IL-12 will drive a tumor-specific inflammatory response as we have seen in other indications and increase the number of patients who may benefit from treatment when combined with anti-PD1 therapy. As noted in our previous conference call, we have taken additional measures to control our burn rate and implement immediate cost efficiency. To focus our clinical expenditures and conserve cash, we have prioritized our efforts to focus on melanoma in breast cancer, where we believe we have the greatest market opportunity and can drive the greatest value. To that end, we will put further enrollment in the head and neck cancer trial on hold for the time being. We have stopped enrolling patients in the study, but patients that are already enrolled and undergoing treatment in the study will continue. We are planning to present available data from this study, including supporting preclinical data at the upcoming EUROGIN 2016 Conference in June. This clinical decision allows us to better manage our resources appropriately, while executing our strategy and programs that we believe will maximize value for OncoSec. Now, I will discuss our efforts to grow our pipeline beyond ImmunoPulse IL-12. First, we have stated the intention of announcing a new molecule candidate for our ImmunoPulse platform in the first half of 2016 and we have made significant advancements in establishing a new ImmunoPulse product. To-date, we have demonstrated clinical proof-of-concept of our platform’s feasibility by showing that IL-12 drives tumor-specific CD8s and up scope of responses, meaning distant untreated lesions are regressing, making it a key pillar of any future combination. We firmly believe the field of cancer immunotherapy is moving rapidly towards the use of combination therapies and our intratumoral delivery platform positions us well to participate in this evolution. One of the unique differentiators of our technology is the ability to deliver multiple genes encoding immune molecules in a single treatment. As such we believe that ImmunoPulse is the optimal platform for the intratumoral delivery of multiple immunomodulatory genes. With the next ImmunoPulse combination product, our solution will be to deliver multiple DNA encoded agents directly into the tumor that targets several facets of tumor immune conversion and therefore mount an orchestrated attack to increase tumor immunity. The new product will also leverage our latest advancements in electroporation and further position OncoSec as a leader in Gene Electro-Transfer technologies in cancer immunotherapy. Our core biological discovery activities are currently focused on exploring new candidate combinations with IL-12 to expand our ImmunoPulse platform technology. We are continuing to evaluate in-vivo activity of these molecules in our pre-clinical experimental models. In the near-term, our plan is to continue to refine our selection of the next development candidate by reviewing pre-clinical data, assessing potential clinical indications and eventually working towards filing of a new ImmunoPulse IND. So to recap, we look forward to telling you more about this first of its kind novel DNA combination molecule delivering multiple immunomodulatory teams in combination which we still intend to announce in the first half of 2016. We will also continue to position ImmunoPulse as an ideal combination partner for checkpoint inhibitors and other immunotherapies. Finally, we stated the intention of announcing a new collaboration in the first half of 2016. OncoSec continues to establish relationships with academic leaders and industry participants to further advance our research. Our leadership in intratumoral immunotherapy and Gene Electro-Transfer make us well positioned to attract collaborators who want to enter and participate in the growing immuno-oncology field. In the near-term we will seek to establish collaborations with industry participants and academic centers similar to the ones we have already done with key biologics Plexxikon, UC Davis and Mass General Hospital. We believe we are making good progress in these discussions and we will update you as we have something more tangible to announce. So in summary, OncoSec’s core strategy is now focused in two specific areas; defining a product registration path to develop ImmunoPulse IL-12 in combination with anti PD-1 in melanoma and pipeline expansion with discovery, research and development of new combination – of a new combination molecule candidate. I will go further – I will go into further details on our corporate strategy and future milestones, but for now I would like to turn the call over to Richard Slansky to provide the financial results for the second quarter of 2016. Richard?
Richard Slansky:
Thanks Punit and good afternoon everyone. We issued our financial results via press release and filed our Form 10-Q before this conference call today. For the second quarter of fiscal 2016, we reported a net loss of $7 million or $0.42 per share based on weighted average shares outstanding of 16.8 million. This is compared to a net loss of $4.6 million or $0.38 per share based on weighted average shares outstanding of 12.3 million for the same three months period last year. For the six months ended January 31, 2016, we reported a net loss of $14.1 million or $0.89 per share based on weighted average shares outstanding of 15.8 million. This is compared to a net loss of $8.7 million or $0.71 per share based on weighted average shares outstanding of 12.3 million for the same six months period last year. The increase in net loss for the three months and six months periods ending January 31, 2016 compared with the same periods in 2015 resulted primarily from an increase in patient treatment costs related to our various clinical trials, an increase related to salaries, inclusive of stock-based compensation and the additional personnel to support business and market development and an increase in other outside services primarily related to consulting services to assist with the development of next generation electroporation device prototypes, novel electroporation technologies and combination studies. There were no revenues for the three months and six months ended January 31, 2016 or January 31, 2015. Research and development expenses were $4.1 million for the second quarter of fiscal ’16 compared to $2.9 million for the same period in 2015. Research and development expenses were $7.8 million for the six months ending January 31, 2016 compared to $5.4 million for the same period in 2015. Our research and development expenses primarily include expenses related to the development of our therapeutic product candidates and electroporation technologies. These expenses also include certain clinical study expenses, intellectual property prosecution and maintenance costs and quality assurance expenses. These expenses primarily consist of salaries, employee benefits, stock-based compensation expenses, outside design and consulting services, laboratory supplies, contract research organization expenses and clinical study supplies. We expensed all research and development costs in the periods in which they are incurred. Now, general and administrative expenses were $2.9 million for the second quarter of fiscal ’16 compared to $1.8 million for the same period in 2015. General and administrative expenses were $6.3 million for the six months ending January 31, 2016 compared with $3.3 million for the same period in 2015. Our general and administrative expenses include expenses related to our executive administrative functions accounting in finance, Board governance, compliance, information technology, legal facilities, human resources and corporate communications activities. These expenses consist primarily of salaries and benefits, stock-based compensation costs, independent auditor costs, legal fees, consultants, travel, insurance and public company expenses such as stock transfer agent fees and listing fees in connection with listing on a national exchange. Now with respect to our balance sheet, at January 31, we had $30 million in current assets, approximately $29 million of which were cash and cash equivalents. This was compared to $33.6 million in current assets in January of 2015 were approximately $32 million were cash and cash equivalents. Our current ratio is very healthy at 7.5 to 1 and we have no debt. Our current cash includes funds that we raised in the second quarter. On November 9, 2015, we closed the registered direct offering. The gross proceeds to us from the November public offering were approximately $7.5 million. After deducting fees or expenses, the net proceeds from the sale of the common stock were approximately $6.9 million. There were warrants associated with the stock issuance and the details of the transactions are outlined in our Form 10-Q. These funds help to facilitate the execution of our upcoming milestones that we believe will support the long-term success of OncoSec. We are keenly aware of the state of the life science and financial markets especially since the September 2015 decline. Many life science and biotechnology companies have been significantly – have seen significantly lower market caps. While we cannot control market conditions, nor the market value of our own stock, we remain confident in the value that we are creating and believe that the market over time will recognize our pre-clinical and clinical value generating activities. As Punit stated earlier, we have been analyzing our burn rate and our spending in an effort to develop strategies and plans to further extend our cash runway. We are making certain changes and adjustments to focus our spending. We expect our burn rate to decline slightly over the next few quarters as we focus our efforts on preclinical programs to select our most promising candidate combination molecule and focus our efforts on clinical and regulatory development for ImmunoPulse IL-12 in combination with other immunotherapies. By focusing our discovery research and clinical efforts, we believe we will maximize our value and we anticipate that our funds will be sufficient to allow us to continue to operate our business for at least the next 12 to 15 months during which time we expect to achieve certain milestones that enhance our market value. Finally, we mentioned in our last conference call that we were preparing to move to a new efficient, fully equipped laboratory facility and combine our lab, clinical discovery research, product development and administrative functions under one roof. We successfully moved all of our laboratory operations into the new facility before the end of calendar 2015. Our scientific and clinical teams and technical teams are excited to be working together in an even more efficient and effective manner. And with that, I will hand the call back over to Punit for a discussion about our corporate strategy and future milestones. Punit?
Punit Dhillon:
I started speaking in, but I was on mute, apologize. So, thanks for that, Richard. Let me just end with my point of view on the broader significance of our recent accomplishments and how they fit into OncoSec’s corporate strategy. So, ImmunoPulse IL-12 has already shown promising clinical data in metastatic melanoma demonstrating that local intratumoral treatment with ImmunoPulse IL-12 successfully induces tumor inflammation and can lead to objective clinical responses. And as we have seen with ImmunoPulse IL-12, it can promote a pro-inflammatory tumor micro environment and generates local TIL infiltration leading to systemic anti-tumor immune responses. It’s a great target for overcoming the tumor’s natural defense mechanisms. And what we have shown is that priming the immune system with ImmunoPulse IL-12 may enhance responses to anti-PD1 bucket. We believe that established – can everybody still hear me?
Richard Slansky:
Yes.
Punit Dhillon:
Okay. We believe that establishing clinical response data supporting the combination rationale of ImmunoPulse IL-12 with anti-PD1 in melanoma offers the greatest opportunity to generate value in the near-term. The positive data we have seen thus far and ongoing data from our current studies will help inform the next steps in clinical development and support a potential registration pathway. Similarly, from an R&D perspective, we believe that the future of immunooncology is the combination of multiple agents that targets several facets of tumor immune conversion. Therefore, we are leveraging the unique capabilities of our ImmunoPulse platform to deliver potentially synergistic immune molecules to combat multiple facets of immune suppression and increase tumor immunity. We believe that this is a revolutionary approach compared to conventional therapies that have been using systemic approaches. By continuing to validate our technology both pre-clinically and clinically, we expect to be in a stronger position to advance our product development towards commercialization and generate value for our shareholders. So, before closing, I would like to reemphasize OncoSec’s upcoming milestones. For our near-term milestones, we plan to announce the new key academic or industry collaboration in the first half of this year and announce a new lead candidate for our ImmunoPulse platform. By the end of the year, we plan to have preliminary clinical and biomarker data from our Phase 2 clinical trials. These data will be presented at key scientific conferences. We also expect to provide updates on our preclinical programs, including studies with our existing industry collaborators as well as the continued expansion of our R&D pipeline. We will also continue to evaluate clinical and regulatory pathways for our melanoma program and we are encouraged by positive enrollment rates and are generating clinical data that we believe will continue to support our combination approach and rationale. And finally, we have made and continued to make significant progress that will allow us to execute on our strategy to develop and commercialize DNA-based intratumoral cancer immunotherapies. So, at this time, we would be happy to address some of your questions.
Operator:
[Operator Instructions] And our first question comes from the line of Jason Kolbert with Maxim. Your line is now open.
Jason McCarthy:
Hi, guys. It’s Jason McCarthy for Jason Kolbert. Just in terms of the histology work and the biomarker work that you are doing, I know you are driving TILs into tumors, particularly in melanoma which are highly immunogenic. Are there a lot of – are you seeing a lot of presence of Tregs or are you specifically augmenting or down-regulating PD1 on the T-cells that are coming in? And if you are seeing a bunch of Tregs in there, are you considering aside from a PD1, an anti-PD1 or PDL-1, potentially a CTLA4, which might address that Treg population in the tumor?
Robert Pierce:
Yes, that’s a really good question. This is Dr. Pierce. I can speak to what we have already gotten public with and that’s mainly based on some of our preclinical mouse models. I mean, like Tom Gajewski has shown, when you drive inflammation, you kind of drive multiple arms of it simultaneously and you do in fact see together with an influx of activated CD8s that are TH1 in nature, they kind of bring along with them a Treg population as well, right. So, the idea that you would simultaneously want to add a molecule that would deactivate the Treg arm, I think is a very good one and certainly a path that we have gotten down conceptually, but I can’t really go into anymore details on that.
Jason McCarthy:
Right, great. Thank you. Yes. And also I know there is a lot of debate, not debate, but evidence in the literature that there are multiple ways that checkpoints work, checkpoint inhibitors and it’s not just really binding or altering the expression of some of these receptors with something like IL-12, IL-6 has been shown to impact some of these receptors as well. That’s something – are you looking at the expression if you are actually changing the expression of PD1 inside of tumors at all? I don’t know if you addressed that on the last question.
Robert Pierce:
So, that too is a really interesting point. And I would reflect upon something that I have always found curious which is ImmunoPulse IL-12 has this definite CR rate associated with it in the patients that we have treated in melanoma. And you would predict from first principles that even if you are driving an effective anti-tumor CD8 response that they should get hung up on the PD1 checkpoint, because we know they go into the tumor, make interferon-gamma and PDL1 gets up-regulated. So, it’s always been a mystery to me and something that we are actively trying to understand is why in some of these patients is IL-12 alone as a monotherapy sufficient to kind of blow right through that checkpoint. And I think you point out an area of interesting sort of inquiry, which is IL-12 itself affecting the intrinsic regulation of those checkpoint pathways in those cells. And that’s certainly something that we have been keeping our eye on and investigating.
Jason McCarthy:
Right. And just one quick follow-up, when you are recruiting for these studies and you are focusing on it, we are discussing this yesterday about PD1 non-responders. How are you selecting the PD1 non-responders other than extensive medical review, you have some data suggesting that there is variable expression or over-expression of PDL1 or PD receptor in these patients that maybe precludes them for being sensitive to KEYTRUDA or another PD1s?
Robert Pierce:
So, there are multiple ways to skin this CAT. Really, the purest way is to take patients who are clinically refractory to a PD1 agent. And some of those patients have been enrolled into our ongoing combination study with IL-12 and pembrolizumab, because they are not excluded. So, sometimes we get those patients. But the basic study design though allowing for those clinical refractory patients was really a low TIL selection assay. And as you know, I have been in this that sort of what I have been doing for the last number of years when I was at Merck prior to coming to OncoSec was really defining that PD1 non-responder population. So, we are pretty confident that we know how to select it and working with the folks at UCSF who have developed their own flow-based assay that’s how those patients are currently being selected and the test characteristics of that screening assay we are pretty comfortable with.
Jason McCarthy:
Great. Thanks, guys. Looking forward to more progress as you get more data.
Robert Pierce:
Great, thank you.
Operator:
Thank you. And our next question comes from the line of Mark Breidenbach with H. C. Wainwright.
Mark Breidenbach:
Hi, guys. Thanks for taking the questions. I was a little bit surprised to hear that the enrolment in head and neck trial has been discontinued, maybe I missed it during the prepared remarks, but did you say how many patients have actually been enrolled in this trial so far?
Punit Dhillon:
Hey guys, I will take this call – this question. So Mark no we haven’t said the enrollment number. And as we have indicated in the call today, we really took a hard look at where we are having our clinical expenditures and wanted to make sure that we are kind of drive the most value as we prioritize our efforts. We are focusing our efforts on melanoma and breast cancer. We believe that we have the greatest market opportunities to – and greatest opportunity to drive value in those two different programs in the near-term. So we decided that we are going to kind of optimize and focus on those particular programs as we focus our resources. And there is going to be data that’s going to come out of that program, I can let Rob answer that as he is going to be presenting preclinical and clinical data later in the year.
Mark Breidenbach:
Okay. And the – I have got to say it’s been looking pretty good for Opdivo in that indication, I think in January we saw one of Bristol-Myers Phase 3 trials and early because the study met its primary overall survival endpoint and I am just wondering down the road thinking we see an Opdivo approval, are you thinking that revisiting in a combination with ImmunoPulse as well?
Punit Dhillon:
Yes, absolutely. So all of these current programs beyond the current melanoma combination that were already undergoing is to continue to support the rationale of IL-12 timing and immune response for better response with and anti-PD-1 or anti-PDL-1. So that’s the full intention of the other programs. But at the same time, we have limited bandwidth and we have to kind of focus our energy and interest on things that we believe are going to drive the best near-term value for everyone involved in these programs. Rob do you want to elaborate?
Robert Pierce:
Yes. I can amplify on that Mark. We did not enroll enough patients to have the pause in enrollment based on clinical responses or biomarker data. So just to put away that concern, it was purely based on a desire to conserve resources, it wasn’t based on say no or lack of signal from the study. That’s just the fact. You are absolutely right that given the response rates of PD-1s both pembrolizumab and Opdivo in head and neck cancer that this is an area that we are continued to be interested in, it fits the same biology that we are seeing across multiple solid tumor types and we just want to be opportunistic about where we put our resources right now.
Mark Breidenbach:
Okay, that’s completely understood. Thanks for clarifying. And one follow-up with regards to one of Jason’s questions, I think I heard that you are enrolling some patients who have actually come off of PD-1 therapy and have actually proven to be refractory to P1 antibodies in the ongoing combination trail, but that’s still enrolling, will these patients be the first sort of experience in that post-PD-1 failure setting that we have been able to evaluate or maybe in the Phase 2 extension are we seeing any patients that came off of PD-1 therapy and then received ImmunoPulse IL-12 monotherapy?
Punit Dhillon:
And Sharron you may want to weigh in here, but to the best of my knowledge and it was really a timing in the evolution of the anti-PD-1 field, I don’t believe any PD-1 refractory patients were treated in our Phase 2 melanoma studies either the main or the extension. I believe that’s true. So this will be really our first experience of taking a bonafied clinically refractory to PD-1 patient and then giving them the combination therapy. Interestingly are the current trial – is this low TIL selection requirement and of course those patients are proving to be low TILs as one would predict. So I think all the biology is panning out as we have said over the last couple of years. We are very confident in these biomarkers and what they mean. And so I think we have a very good study design and we will see some very interesting results which we hope to present in the course of this year.
Mark Breidenbach:
Okay, fantastic. Thanks for taking the questions and good luck.
Punit Dhillon:
Thank you.
Operator:
Thank you. And our next question comes from the line of Kumar Raja with Noble Life Sciences. Your line is now open.
Kumar Raja:
Hi, this is Kumar Raja in for Rahul. So I wanted to ask about strategy for identifying the multi-win combinations, so here I started looking at validated or novel targets and what is the expectation in terms of the number of multi-genes you want to target there?
Punit Dhillon:
So that’s a good question, we haven’t – again, we haven’t gone public with any of our – the details about our polycistronic constructs. Let’s just say that we feel the truly differentiating feature of DNA electroporation over and against our closest competitors which would be oncolytic viruses is the fact that we could stack multiple genes. And pre-clinically we are already putting in five or six genes. The question as to how do you vest select for ones that you think are then going to have additive or synergistic effects in the clinic is a very, very important one and we do have some I think very solid immunologic screening paradigms that we are applying. But that’s really kind of proprietary and we can’t go into it. But if you have any ideas send them to us and we will add them.
Kumar Raja:
Yes. And in terms of clinical and biomarker data that is expected what kind of markers can we see there, are you looking at any antigens or what kind of data can we expect there?
Punit Dhillon:
You mean for the future combination, new ImmunoPulse product?
Kumar Raja:
No for the preliminary data you are expecting from the melanoma trial like what kind of biomarker data can we expect there?
Punit Dhillon:
Well, I think it’s clear that what we have already discussed in terms of our kind of standard tool box that we have developed which is the multi-parametric immunohistochemical assays that we have worked with Paul Tumeh at UCLA on to show that we are driving TILs and in fact that they are the right kind of TILs. They are high PD-1 immediately adjacent and in fact inducing PDL-1 within the tumor, NanoString of course is something that I was – we were early adopters when I worked at Merck in terms of developing the NanoString gene profiles that are predictive of response to pembrolizumab, so these two are – were sort of some of the basic tools that we are using. We are also exploring as many people in the field are the TCR repertoire analysis which we showed in the nature paper also correlates with being able to predict response to PD-1. So all of these are now I think kind of the basic things that sophisticated investors and potential partners want to see.
Kumar Raja:
Okay, great. Thank you so much for taking my questions.
Punit Dhillon:
You are welcome.
Operator:
Thank you. And if there are no additional questions, we will turn the call back over to Mr. Dhillon for his closing comments. Mr. Dhillon?
Punit Dhillon:
Great. Thank you again for participating in our second quarter conference call. On behalf of our Board of Directors and dedicated team, we truly appreciate our ongoing support and confidence in OncoSec as we continue to advance our immunooncology pipeline. If you have any further inquiries or need clarification on the topics we discussed today, please don’t hesitate to contact us at investors@oncosec.com. And we look forward to providing additional updates on our next conference call. Thank you for your time and attention this afternoon.
Operator:
This concludes our teleconference. You may now disconnect. Have a good day.