Earnings Transcript for ONCS - Q2 Fiscal Year 2017

Executives: Richard Slansky - Chief Financial Officer Punit Dhillon - President and Chief Executive Officer Chris Twitty - Director of Clinical Science

Analysts: Jason McCarthy - Maxim Group Yi Chen - Rodman & Renshaw Tarun Aswani - Noble Capital Markets Roshni Mahadeo - Rodman & Renshaw

Operator: Hello and welcome to today's conference call for OncoSec Medical Incorporated Second Quarter and Year to Date Fiscal 2017 Financial Results. My name is Iola and I will be your operator for today. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. [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, Iola Jonathan. Good afternoon and welcome to our second quarter and year to date fiscal 2017 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 nucleic acid asset based immunotherapy and delivery technologies. Any statements about our goals, expectations, beliefs, plans, designs, objectives, assumptions or future events or performance are forward-looking statements. 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 that may cause the actual results to be materially different from any future results expressed or implied by such statements. Important factors which could cause our actual results to differ materially from those in these forward-looking statements are detailed in our filings with the Securities and Exchange Commission. These include but are not limited to the success and timing of our product development activities and clinical trials, our ability to develop and commercialize our product candidates, our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities, our partners ability to develop, manufacture and commercial our product candidates and to improve the manufacturing process, the size and growth potential of the markets for our product candidates and our ability to service those market, the rate and degree of acceptance of our product candidates, our ability to attract and retain key scientific or management personnel, our ability to meet our milestones, including the timely release of clinical data and commercial launch of ImmunoPulse IL-12, our expectations regarding our ability to obtain and maintain intellectual property protection, the level of our corporate expenditures, our ability to raise capital to fund our operations and the assessment of our technology by potential corporate partners. We disclaim any duty to update forward-looking statements. I'm now 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'd like to take a moment to review the agenda for our call today. First, I will review the rationale and significance of our Phase II combination trial of pembrolizumab with ImmunoPulse IL-12 and discuss our recently granted Fast Track designation and registration-directed clinical study. Then Richard will provide an overview of our second quarter 2017 and year-to-date fiscal financial results. I will conclude with a brief update on the melanoma development strategy moving toward - moving forward on our upcoming milestones. Finally, Dr. Chris Twitty, Director of Clinical Science will be stepping in today for Dr. Sharron Gargosky and he will join us as we open the floor for any Q&A that the callers may have. Now, onto the discussion of the progress we've achieved this past quarter. We are delivering on our mission to address an unmet medical need in melanoma with ImmunoPulse IL-12. As you may know our lead candidate Dr. immuno – sorry, ImmunoPulse IL-12 is an intratumoral gene therapy that expresses interleukin-12 or IL-12 for the treatment of melanoma. We believe ImmunoPulse IL-12's ability to promote a systemic, tumor-specific immune response with a favorable safety profile can provide meaningful clinical benefit to patients, as well as an investment value for OncoSec shareholders. We are pleased with the recent Phase II clinical data from our melanoma trial that are focused on advancing ImmunoPulse IL-12 in combination with anti-PD-1 therapy in a PD-1 non-responding melanoma patient population. Recently, we were granted Fast Track designation for this indication by the Food and Drug Administration. This is a significant milestone for OncoSec and we believe an important third-party validation of our technology and approach. Our primary focus over the coming months is to initiate a melanoma registration direct clinical study referred to PISCES. We believe the data from this trial has the potential for priority review with the FDA, as well as an accelerated approval. Furthermore, we believe that it has the potential to attract a strategic partner that will be instrumental in commercializing our innovative therapy in melanoma. The start up activities related to the registration-directed study are underway and we plan to initiate the study with a drug supply agreement with a collaborative partner for anti-PD-1. Now, I'd like to share with you some additional details on our development program and data related to our pipeline. First, I'd like to briefly outline our development strategy for the combination approach of ImmunoPulse IL-12 with and anti-PD-1 therapy. While patient responses to anti-PD-1 therapies, whether as a monotherapy or as a combination of nivolumab and ipilimumab are effective and durable, the majority of patients 60% to 80% in most solid tumor indications do not respond to these treatments. One of the most pressing questions that exist in oncology today, is how do we make these patients respond better to an anti-PD-1 therapy. In particular, with the current melanoma treatment paradigm what happens when a patient fails to respond to anti-PD-1 therapy? The growing consensus is that the type of – type and level of immune cells present within the tumor microenvironment play a critical role in determining a response to checkpoint inhibitors. Research suggests that tumors with immunologically inflamed microenvironment or hot tumors are likely to respond to therapy. Whereas tumors lacking in immune infiltrate or cold tumors are not likely to respond. Based on previous evidence that IL-12 plays a vital role in triggering an inflammatory response investigators at the University of California, San Francisco and OncoSec formed a collaboration to demonstrate that ImmunoPulse IL-12 could convert a cold non-inflamed melanoma lesion into a hot tumor, thereby improving the activity of certain checkpoint inhibitor therapies such as KEYTRUDA. KEYTRUDA is a PD-1 inhibitor marketed by Merck that releases immune suppression resulting from PD-1 activity. We employ multiple tumor and immune response parameters to accurately predict clinical benefit focusing on the anti-PD-1 non-responder patient. Since at the start of our trial neither KEYTRUDA nor OPDIVO were approved in the US. At the time of initiating the ongoing combination study, patients who were progressing on anti-PD-1 therapy did not exist in large enough numbers. Therefore, it was not feasible to initiate a study that enrolled true non-responsive or refractory patients. Our test methods include state-of-the-art immune monitoring and tracking technologies, such as multispectral immunohistochemistry, RNA expression of immune related genes, TCR sequencing, multiparameter flow cytometry, and melanoma specific scoring of PD-L1 expression by 22C3. Based on the broad panel of these assays and their overall correlation, we are confident that the patients enrolled in the study are representative of patients who would not respond to anti-PD-1 therapy alone. The results to date from this investigator – from the Phase II investigator sponsor trial indicates that ImmunoPulse IL-12 can increase the response rates in patients who are not expected to respond to anti-PD-1 therapy alone. So, briefly I am getting into – provide a summary of the recent ASCO and SITC data. With all that background, I'd like to explain the significance of the latest combination data presented by Dr. Alain Algazi at the ASCO-SITC conference on November 23rd, 2017. The study resulted - results showed an objective response of 43%, and best overall response rate of 48% in 22 patients. These data are consistent with and expand upon the clinical data from 15 patients that were presented at SITC conference in November, 2016. To put these new data in perspective, KEYTRUDA monotherapy had an overall response rate of 33% in all cumbers [ph] meaning, not naïve anti-PD-1. So put another way, this data or these data were based on not retreating anti-PD-1 non-responders. The combination therapy also continued to demonstrate a favorable safety profile and was well-tolerated. It is important to note that of the 22 patients enrolled, nine had previous checkpoint inhibitor therapy and 33% of the subset demonstrated an objective response to combination therapy. Moreover, analysis of the biomarker data indicated that the combination of ImmunoPulse IL-12 and KEYTRUDA is able to convert cold tumors to hot tumors in patients who responded to the combination treatment. We believe this affect underscores the potential of OncoSec's approach to resolve a significant unmet need in immunotherapy treatment paradigm across many tumors, even beyond melanoma with our innovative intratumoral delivery. Based on this evidence, we believe that ImmunoPulse IL-12 has the potential to rescue patients that are clinically failing anti-PD-1 treatment by combining it with and anti-PD-1 - with an approved anti-PD-1 inhibitor, like pembrolizumab or nivolumab. We are truly grateful to the investigators and especially the patients for their continued participation in the study. Now I'd like to discuss how we are advancing ImmunoPulse IL-12 in a registration-direct clinical study. On February 27th, we announced that the FDA granted OncoSec Fast Track designation for ImmunoPulse IL-12 to treat patients with metastatic melanoma following disease progression on either pembrolizumab or nivolumab. We believe our clinical development plan, which is focused initially on ImmunoPulse IL-12 in the non-responder population addresses a large underserved patient population in the immunotherapy treatment paradigm. The Fast Track designation serves as an important validation of our plan and the potential to help this population in melanoma patients with a significant unmet medical need. With Fast Track designation, we believe there is potential for accelerated approval in the anti-PD-1 non-responder population by 2019. In addition, we believe there is a possibility to evaluate ImmunoPulse IL-12, plus checkpoint inhibitor therapy and confirmed the clinical benefit in the first line setting in a Phase III confirmatory trial which could be initiated prior to OncoSec's accelerated approval BLA filing. By following this development path and meeting regulatory criteria set by the FDA, we believe that ImmunoPulse IL-12 has the potential to become a first-in-class therapy and an important agent in immunotherapy treatment to improve response rates to checkpoint inhibitor therapies, like pembrolizumab. As a next step in advancing a clinical program, we are introducing our registration-directed trial called PISCES, which stands for anti-PD-1 IL-12 stage III, stage IV combination electoperation study. PISCES is a Phase 2b, open label, multicenter study of ImmunoPulse IL-12 in combination with an anti-PD-1 in patients with stage III or IV melanoma. These patients will be progressing on either pembrolizumab or nivolumab, as a monotherapy or in combination with another approved checkpoint inhibitor. The core objectives of this trial are to assess the efficacy, safety and tolerability in up to 24 weeks of combined treatment. As we plan to initiate the PISCES trial in the first half of this calendar year 2017, we look forward to working closely with the FDA at this important stage of our clinical program. I'll go further into details on the market opportunity and upcoming milestones for the remainder of 2017 fiscal year in the second half of this call. But for now, I'd like to turn the call over to Richard Slansky, our chief financial officer, to provide the financial results for Q2 of 2017. Richard, over to you.

Richard Slansky: Thanks, Punit. We issued our financial results via press release today and filed our Form 10-Q after market closed. For the second quarter of fiscal 2017, OncoSec reported a net loss of $5.4 million or $0.27 per share, compared to a net loss of $7 million or $0.42 per share for the same period last year. The decrease of $1.6 million in net loss for the second quarter compared with the same period in 2016, resulted primarily from, first, a decrease in research and development expenses, $1.2 million of which related to clinical trial costs that were lower due to lower number of patient enrollments in a smaller number of actively enrolling trials, as well as lower trial management costs. And second, a decrease of $400,000 related to lower salary and non-cash stock compensation. The decrease in clinical trial costs is partly related to our strategic decision to focus our clinical efforts and resources on our IST and registration-directed combination trial in melanoma and move toward database lock on some of our other trials. For the six months ended January 31, 2017, OncoSec reported a net loss of $11 million or $0.57 per share, compared to a net loss of $14.1 million or $0.89 per share for the same period last year. The decrease of $3.1 million in net loss for the six months ended January 31, 2017, compared with the same period in 2016, also resulted primarily from, first, a decrease in research and development expenses mainly $1.8 million related to clinical trial costs and outside services cost that were lower due to a lower number of patient enrollments in a smaller number of clinical trials, as well as lower trial management costs. Second, a decrease of $1.1 million related to lower salary and non-cash stock compensation costs, and third, a decrease of $200,000 related to lower accounting fees. As you can see, we have focused our clinical effort on reducing our discovery research and administrative efforts to drive toward a potentially marketable product. We believe that we could have a marketable product in melanoma in 2019. There were no revenues for the three and six months ended January 31, 2017 or January 31, 2016. Our research and development expenses were $2.9 million for the second quarter of fiscal '17, compared to $4.1 million for the same period in 2016, a reduction of $1.2 million. General and administrative expenses were $2.5 million for the second quarter of fiscal '17, compared to $2.9 million for the same period in '16, a reduction in $400,000. Research and development expenses were $6 million for the six months ended January 31, 2017, compared to $7.8 million for the same period in 2016, a reduction of $1.8 million. And general and administrative expenses were 5 million for the six months ended January 31 2017, compared to $6.3 million for the same period in 2016, a reduction of $1.3 million. Once again, a reduction in spending was primarily driven by our decision to focus our efforts on bringing one clinical candidate to market and thereby extending our cash runway, which we have now done. At January 31, 2017, we had $20.5 million in cash and cash equivalents, as compared to $28.7 million of cash and cash equivalents at July 31, 2016. We expect these funds to be sufficient to allow us to continue to operate our business for at least the next 12 months. Last quarter, we announced the creation of our wholly-owned subsidiary OncoSec Medical Australia Pty, Ltd or OncoSec Australia. We expect to enroll and conduct a significant portion of our clinical trial in Australia where there is a high rate of melanoma cases. Although we have incurred only small expenses to establish the subsidiary and engage a clinical research organization, you will notice that we have begun reporting on a consolidated basis and we have added a statement of comprehensive loss to our filing, as required under Generally Accepted Accounting Principles. We maintain our subsidiary in Australian dollars and convert US dollars for consolidation with an adjustment for foreign currency translation. We believe our clinical trials in Australia will generate a very cost-effective clinical trial data for our registration-directed study. We are committed to continue our efforts to utilize our cash in a best way possible to maximize value to our loyal and dedicated shareholder base. Now with that, I'll turn the call back over to Punit to review our melanoma development strategy and some of our upcoming milestones. Punit?

Punit Dhillon: All right. Thanks, Richard. Before closing, I'd like to outline OncoSec's melanoma development strategy and the upcoming development milestones. As I mentioned earlier, we are planning to initiate a registration-directed trial which we call PISCES designed to fill a great unmet medical need in oncology. OncoSec is in a favorable position to secure the first approval in the setting with the melanoma product for a second line therapy following anti-PD-1 failure. Instead of focusing on a traditional clinical growth, we are pursuing an accelerated pathway with our Phase II registration-directed clinical trial. With the Fast Track designation in hand now, this allows for potential priority review, as well as accelerated market approval in the anti-PD-1 failing population by 2019 based on surrogate endpoint. At the time of the BLA filing, we plan to initiate a confirmatory Phase III study in the PD-1 illegible melanoma patient in the front line setting. Beyond the melanoma market, we believe there is a potential to expand ImmunoPulse IL-12 in the non-responder population to other cancer indications as well. Indications for this combination approach may include squamous cell carcinoma of the head and neck, among others. We continue to demonstrate that ImmunoPulse IL-12 is differentiated from our other immunotherapy competitors through a favorable safety profile, anti-tumor activity in multicenter studies across multiple indications, data that for the first time demonstrate improved response rate in predicted anti-PD-1 non-responder patients, a focused development plan on a near-term commercialization opportunity, low development and production costs for an affordable therapy and flexible platform using DNA and electroporations with a broad applicability. With that said, I'd now like to reemphasize OncoSec development milestones. First, we plan to finalize the drug supply agreement for PISCES or anti-PD1 to ensure the initiation of the study in the first half of this year. This is included into our forecast - into our guidance that we've given in our 12 month cash runway. In terms of pipeline expansion, we are working on a new investigational new drug application for first in human studies for next clinical candidate which we believe to be filed in 2018. Through our technology access program, we plan to expand the use of our delivery technology, including our trace enabled electroporation devices, which stands for tissue-based, real-time, adaptive control electroporation. We will continue to expand our research collaborations with industry and academic key opinion leaders in the field using our technology access program. And lastly, we're continuing to try – we'll continue to try and secure a licensing or commercial partnership and that is the primary objective of the ImmunoPulse IL-12 program in melanoma and looking to commercialize that program, with the help of a pharma partner. Our primary motive to enhance value for our shareholders is to continue to focus on the clinical development strategy for ImmunoPulse IL-12 and to seek a strategic commercial partnership. In an effort to help us achieve these objectives, we intend to be opportunistic about bringing in non-dilutive capital, as well as Wall Street validation by attracting healthcare institutional funds. In conclusion, we have made and are continuing to make significant progress that will allow us to execute on our strategy to develop and commercialize DNA based intratumoral cancer immunotherapies. And with that, I will turn the call over to Iola for the question-and-answer session and I invite Richard and Chris to join us for the call.

Operator: [Operator Instructions] Our first question comes from Jason McCarthy with Maxim Group. Your line is now open.

Jason McCarthy: Hey, guys. How are you? In the PISCES study, can you give us a sense, I don’t know if you've disclosed yet, you know, how many patients you'd expect to enroll for registration study and given that its open label, are there any thoughts as to you know, an interim analysis when you get to x number of patients that we can get a sense of if the therapy is working?

Punit Dhillon: Yes. Thanks for that question Jason. So, initially the clinical trial is expected to be a 48 patient clinical trial, with the primary endpoint of overall response based on the regulatory framework that we've laid out. So we are expecting - we are expecting the primary endpoint there to be - overall response to 24 weeks and our stats are based on 30% response rate. It's a two stage study where we have – sorry, a 7 [ph] two stage design, where we're looking for response rate in the first stage before continuing on in the second Phase II development.

Jason McCarthy: Okay. And with the multicenter approach, how long do you think it would take to enroll 48 patient and when do you think we could – what's the target timelines for data? Thanks for taking the question.

Punit Dhillon: Yes. Thanks again. So Jason, so the expectation there is that we would – we're expecting to start first patient in by Q2 of 2017 and then we – this calendar 2017, its going to be a study conducted in the US and Australia for starters and then we'll add European sites as well, roughly 10 to 20 centers across those three geographies, which would give us estimation of finishing enrollment by Q2 of 2018. So we're looking for very concise quick enrollment within a year on this particular population of anti-PD-1 failures and then we would have data along the way. It is an open label study. So we would have the initial data based on a strong cohort of patients and a six month follow-up. So it could be as early as Q4 calendar year 2017 and then final data by Q1 of 2019.

Jason McCarthy: Great. Thanks for taking the questions.

Operator: Our next question comes from Yi Chen with Rodman & Renshaw. Your line is now open.

Yi Chen: Hi. Thank you for taking the question. So in the investigator sponsored Phase II trial, out of these - out of those nine patients who had previously received the anti-PD-1 therapies, overall response rate was 30%, 33% - 33% and the for the total 22 patients the overall response rate was 43%. So for your upcoming trial, obviously you are enrolling patients who have failed previous anti-PD-1 therapies. So, do you think the 33% number is more representative than the 43% number or you know, in terms of trying to understand or project what the number of outcome could be for the upcoming trial?

Punit Dhillon: Yes. Thanks, Yi. That’s a great question and it’s interesting how everyone – we'll continue to parse out the data on and try to come up to the - come to the conclusions based on this initial data set. We're very excited about this initial signal that we've seen in the 22 patients and it was nice to see that 33% response rate in the 9 patient that had previous checkpoint therapy. But the data - the numbers are still really small there in order to really predict the significance of that. That the registration-directed study is based on statistics to have response rate of at least 30%, and that if you recall, that's how the current study is been powered as well. But I will pass the call on to Dr. Twitty, who can probably answer more from a scientific perspective of the similarities between the two patient groups.

Chris Twitty: Thanks, Punit. Yes, I think it’s a relevant question, it’s difficult to answer accurately. There is a few things, I think in our favor in terms of achieving that 30% response for the PISCES trial relative to our trial. One of those beings sorts of a purposeful enrollment of patients without going into the specifics. But such things as intervening therapy stage disease is sort of a cohort that is little bit more controlled and as Punit said powered. So we feel strongly that we're going to build –achieve this endpoint, but you know, of course, the science and the data will inform us of that as we enroll.

Punit Dhillon: Yes. Just putting in perspective in terms of what that expectation was, is now currently when those patients are failing in the current setting and based on our discussions with key opinion leaders that response rate is roughly 10% when they are being retreated with checkpoint inhibitor drug. So we're looking at – we've taken a conservative estimate or now hypothesis of 15% and added another 15% delta on that for showing a response of 30% or above in the two study. So we hope that continues based on the number of patients we're going to be enrolling.

Yi Chen: Okay. Thank you. Second question, do you expect a more technology access program agreements to be signed during the rest of 2017?

Punit Dhillon: Yes. So first, we just signed our first agreement with Inhibrx - those press release earlier this week. As I stated earlier in the year, the technology - the point of the technology access programs is about continuing to be innovative in our business model, to look at how we can continue to extract value from our preclinical platform and pipeline, as we focus more and more resources on and our focus internally as a company on a clinical program in the melanoma program. So we were still interested in it and advancing our platform and proliferating the technology with the help of additional outside collaborators and frankly there is just too many different applications of the technology for us to pursue every single opportunity internally at OncoSec. So we do expect other collaborations to be signed, but they are – they are not large licensing deals by any means that as I've stated before, these are cash flow positive or cash flow neutral opportunities where we can proliferate the technology, allow other collaborators to utilize the technology and publish on the use of the trace enabled approach that we take and then from there we hope that they can lead to the next phase of a potential licensing opportunity with a commercial application. So although we do expect to sign more agreement, they are not material, relative to what we would expect on a commercial licensing opportunities for IL-12 program, which is the main focus of our clinical program.

Yi Chen: Okay. Thank you.

Operator: Our next question comes from Kumar Raja with Noble Capital Markets. Your line is now open.

Tarun Aswani: Hi, this is actually Tarun Aswani calling in for Kumar. Thank you for taking my question and congrats on the progress so far this year. Just briefly, at the KOL event, there was mentioned an increased interest in a big pharma partnership, specifically in melanoma, something that would be mutually beneficial to you and give you a upper handing future out-licensing and negotiations, I was just curious on any update on that or any collaboration discussions in the pipeline? Thank you.

Punit Dhillon: Yes. Thanks for participating in the call today and stepping in for Kumar. The – just to answer your question, so we – the guidance that we've given at the moment is that we are focusing on starting a registration-directed trial. We've taken the approach where our – we're conserving our cash runway and one of the ways to achieve that is to secure a drug supply arrangement with the logical melanoma commercial partner, that would put you know, would allow us – sorry, when we bought [ph] down out two potential melanoma partners. So the goal here is to have a drug supply arrangement before we initiate that registration-directed study. We believe that initiating the study and generating the data is what's going to ultimately lead to a larger opportunity from a commercial licensing standpoint for the IL-12 melanoma program. So the expectation for us there is more – is closer to having data in hand on these - on this particular clinical trial, and the endpoint we're trying to meet - we believe it is a significant opportunity when you look at that from a patient - the number of patients that are addressable and that opportunities has roughly 10,000 plus patients that are failing the first-line treatment of the anti-PD-1. So if we look at that specific opportunity and we take the stance that ImmunoPulse IL-12 is potentially the next drug approved in melanoma. This could be an enabling product for allowing BMS and Merck to retreat their patients with anti-PD-1. So that is where we believe that this is the largest opportunity for us from a commercial standpoint and we're focusing our energy on commercializing or getting through the regulatory steps and then ultimately to commercialize with the help of the - of a melanoma entrenched partner. So I would say that the guidance that we can give there is that, first step is to get the drug supply arrangement in place, second step is to get the study enrolling and then as the data is collected from this trial, we would - we are in a stronger place to negotiate a commercial deal.

Tarun Aswani: Okay. Thank you very much. And I appreciate you taking my call, I mean, my questions.

Punit Dhillon: No problem.

Operator: Our next question comes from Roshni Mahadeo with Rodman & Renshaw. Your line is now open.

Roshni Mahadeo: Hi. Thank you for taking my question. What is the estimated cost of the PISCES trial and how does it affect the operating expenses for the second half of the fiscal year 2017?

Punit Dhillon: Richard, would you like to answer that question?

Richard Slansky: Well, let's start with the second part of the question, because we're just starting to ramp up the PISCES trial, so there will not be a significant impact on our operating cost in the second half of fiscal 2017. As we get into the second half of calendar '17, we would expect to see some additional clinical costs, particularly related to our activities in Australia. However, as I mentioned in previous call, one of the great benefits of doing some of our trials in Australia is that we will be getting a economic benefit back, and so approximately 45% of every dollar that we spend in Australia will be reinvested through an economic development activity that’s going on to promote clean business there. And so, on every year clinical dollars that we spend we will get $0.45 back from the Australian government in order to reinvest into our trial. As far as the cost of the entire trial, we have not yet finished all of our calculations on that and we've not made that number public yet. But we will continue to work on that in the future.

Roshni Mahadeo: Okay. Is there any difference in trial design between the two cohorts of the PISCES study?

Punit Dhillon: No, there is no difference in the two different cohorts, its just – its Simon 2-stage design. So we look to have a response rate in Simon 1 before we move on to Simon 2.

Roshni Mahadeo: Okay. And my last question is, now that you have Fast Track, are you applying for orphan drug designation for IL-12?

Punit Dhillon: Yes. So we are working through a pretty - several different components of a regulatory framework here that does include orphan drug designation and breakthrough designation, an accelerated approval framework.

Roshni Mahadeo: Okay, thank you.

Operator: And I am showing no further questions. I would now like to turn the call back over to Mr. Dhillon for his closing remarks. Mr. Dhillon?

Punit Dhillon: All right. Thank you again for participating in our first quarter conference call – sorry, second quarter conference call. On behalf of our Board of Directors, dedicated team and patients, we truly appreciate your ongoing support and confidence in OncoSec as we continue to advance our immuno-oncology pipeline. And if you have any further inquiries or need clarification on the topics we discussed today, please don't hesitate to contact us. We look forward to providing additional updates at our next conference call, which we anticipate will be in early June. And thank you for your time and attention this afternoon.

Operator: This concludes our teleconference. You may now disconnect. Have a good day.