OncoSec's (ONCS) CEO Punit Dhillon on Q3 2016 Results - Earnings Call Transcript

| About: OncoSec Medical (ONCS)
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OncoSec Medical Incorporated (NASDAQ:ONCS) Q3 2016 Earnings Conference Call June 9, 2016 4:15 PM ET


Punit Dhillon - CEO

Richard Slansky - CFO

Robert Pierce - Chief Scientific Officer

Sharron Gargosky - Head of Clinical Development & Operations


Kumar Raja - Noble Life Sciences Partners

Jason McCarthy - Maxim Group

Yu Chen - H.C. Wainwright


Hello and welcome to today's conference for OncoSec’s Third Quarter 2016 Financial Results. My name is Kaley and I will be your conference coordinator 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, Kaley good afternoon everyone. And welcome to our third quarter financial results conference call. Before we begin, I'd 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, which include outcomes of our 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 that may cause the actual results to differ materially 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'm 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 share an update on corporate achievements since our last conference call, then Richard will provide an overview of our third quarter and year to date financial results for the 2016 fiscal year. I will then close with a brief overview of our corporate strategy and upcoming milestones and afterwards Dr. Robert Pierce our Chief Scientific Officer and Dr. Sharron Gargosky, Head of Clinical Development & Operations will join us in opening the floor for a Q&A session.

Now onto a discussion of the progress we have achieved this past quarter. In the third quarter of our fiscal year 2016 we continue to advance our clinical pipeline with OncoSec's lead program ImmunoPulse IL-12 as well as our pre-clinical program and 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 a very favorable safety profile and has shown to generate both local immune responses and systemic antitumor effects and pre-clinical and clinical data have laid the groundwork for expansion into combination approaches, new tumor indications and future therapeutic candidates. We've seen that ImmunoPulse IL-12 is a rational choice for the combination therapy with anti-PD-1 agent and may increase the number of patients who may benefit from anti-PD-1 therapy, and we believe ImmunoPulse IL-12’s ability to promote a systemic tumor specific immune response, can provide meaningful clinical benefits to patients and investment value to OncoSec shareholders.

First I'd like to provide an update on the clinical and pre-clinical studies that we presented at the American Association for Cancer Research annual meeting in April. We presented pre-clinical data from our collaborations with Heat Biologics in a poster entitled invivo intratumoral electroporation of 2P 96 IGFC OX 40L -- OX 40 Ligand stimulating CD8 positive T-cells across timing to tumor-specific newer antigens. It's a mouthful in terms of a poster. This research focused on evaluating the combination of Heat and OncoSec's immunotherapy platform meeting one of our important milestones for the year.

In brief, the data showed that combining Heat’s compact vaccines with our intratumoral DNA electroporation delivery platform simulated an expansion of new antigen-specific CD8 positive T-cells leading to a regression in both treated and untreated cancer tumors in two different mouse models. We're excited by these findings and look forward to further exploring synergies between Heat and OncoSec's platforms.

In a separate oral presentation Dr. Alain Algazi from the melanoma center at UCSF Helen Diller Family Comprehensive Cancer discussed follow-up data of patients who were treated with the ImmunoPulse IL-12 and then later went on to receive an anti-PD-1 or PD-L1 therapy. These new data were generated from a single site retrospective analysis of the Company's phase 2 mono-therapy clinical study of ImmunoPulse IL-12 in patients with a dense melanoma and after coming off of ImmunoPulse IL-12 therapy, monotherapy a subset of patients subsequently received an anti-PD-1/PD-L1 therapy either as their next line of treatment or later line of treatment and 14 patients who were treated with ImmunoPulse IL-12 and then went on to receive anti-PD-1 or PD-L1 therapy were valuable for subsequent response to PD-1 blockade.

The PD-1/PD-L1 associated overall response based on 14 patients was 64%. Furthermore 8 of these 14 patients received anti-PD-1/PD-L1 with no intervening therapy after treatment with ImmunoPulse IL-12 and of these 8 patients, an overall response rate of 75% was observed. Although this is a small subset of patients and a retrospective analysis, these observed response rates are much higher in these patients than the expected 30% to 40% seen with anti-PD-1 monotherapy.

Additional mechanist support was observed with multiple biomarker analysis demonstrating that ImmunoPulse IL-12 promoted the development of an inflamed tumor microenvironment including the increase of CD8 positive tumor infiltrating lymphocytes or TILs. And as you may recall from our previous conference calls, the presence of exhausted PD-L1 positive and CD8 positive TILs appears to represent a prerequisite for an effective anti-PD-1/PD-L1 monotherapy response.

So we're very encouraged by this data from this retrospective analysis and that has provided promising evidence that ImmunoPulse IL-12 can prime the immune system thereby enhancing the response to anti-PD-1 therapies and potentially addressing a great unmet need in immuno-oncology namely non-response to the PD-1 blockade.

Now, I would like to take a moment to discuss how this retrospective data fits into our overall melanoma developments strategy. For a dense melanoma patients, we have been building a strong portfolio of supportive clinical file that shows a favorable safety and tolerability profile and anti-tumor activity with ImmunoPulse IL-12, and as you may recall, we previously reported positive data or results from the OMS-I100 Phase 2 melanoma trials that included best overall response rate of 31% based on modified RECIST and 48% of those patients experienced clinical bind at either partial, complete or disease stabilization.

If you recall 50% of those patients also had regression in at least one descent untreated lesion, suggesting a systemic anti-tumor immune response triggered by local tumor treatment or also known as abscopal responses. In addition a second cohort was added to the OMS-I100 melanoma trial to evaluate and alternative dose frequency and to assess additional biomarkers furthering the scientific understanding of ImmunoPulse IL-12.

We recently announced that we’ve completed patient enrollment in this trial, enabling us to complete data capture and to start a final analysis of the trial data. And finally we have an ongoing phase 2 investigate response of trial or IST combining ImmunoPulse IL-12 with Merck's approved anti-PD-1 blockade antibody pembrolizumab in patients with advanced melanoma. Now hypothesis is predicated on the findings that patients with low tumor infiltrating lymphocytes are generally nonresponsive to anti-PD-1 therapy. And if you recall in the IST, we're actually screening or prescreening patients based on a TIL-based assay and over the weekend, data at ASCO was presented with our bio-collaborators using this assay confirming the predictive capabilities of the assay to show non-responders using monotherapy anti-PD-1.

It thereby confirmed that ImmunoPulse IL-12 can help this patient population we're addressing in this clinical trial because they're unlikely to respond anti-PD-1 alone. As observed in the retrospective analysis that pretreatment of priming with ImmunoPulse IL-12 may alter the immune environment enabling the tumor to become responsive to anti-PD-1 blockade and this prospective trial will allows us to test this entire hypothesis.

As a new update we recently opened an additional site for this trial at the Huntsman Cancer Institute, University of Utah Healthcare and investigators are actively recruiting patients for this clinical trial. We are thrilled for the Huntsman Cancer Institute to join UCSF as a second site for this phase 2 clinical trials and look forward to working with Dr. Andtbacka who is a leader in the field of instrumental immunotherapy and his team to advance our ongoing trial. Patient enrollment for this trial is on track and we are on target to share interim data later this year at an upcoming scientific conference.

Alright, so, based on this very encouraging data in melanoma and under the leadership of our clinical and regulatory teams we are working diligently to advance our melanoma development program and registrations strategy for ImmunoPulse IL-12 in combination with anti-PD-1 in patients with advanced melanoma. We believe based on our current clinical data and clinical development path that ImmunoPulse IL-12 will be well positioned for consideration of a fast track designation by the FDA and we are currently working on a fast track application to file with the FDA in a very near term.

The fast track designation is designed to facilitate the development and expedite the review of therapies that can treat serious conditions and fulfill a significant unmet medical need, namely those patients who currently do not respond to anti-PD-1 therapies alone. And we are planning a multi-center clinical trial of ImmunoPulse IL-12 in combination with an approved anti-PD-1 agents in patients with phase 3 and 4 melanoma who have failed pembrolizumab and/or nivolumab treatment.

We are planning to meet with the FDA in the second half of calendar 2016 to seek input on this registration directed file design and I want to add, we believe that the market opportunity for ImmunoPulse IL-12 and melanoma and anti-PD-1 treatment landscapes holds an immense value. The melanoma -- more increased incidence in melanoma as well as the uptick of new anti-PD-1 drug such as pembrolizumab and nivolumab.

We project that our therapy will be a more conservative pricing estimate compared to the other approved treatments currently in the market and it's expected to come in around $60,000 as the average cost per patient. Based on the projected average cost per patient and the patient population we aim to address the adjusted sales for ImmunoPulse IL-12 has the potential to reach 300 million by 2024. In conclusion we believe there's a clear pathway for ImmunoPulse IL-12 in the current market and we will continue to advance our melanoma trails in order to address a great unmet medical need in oncology.

Now I will discuss our efforts to grow our pipeline beyond ImmunoPulse IL-12 and our advancements in Gene Electro-Transfer technologies. We firmly believe that the field of cancer immunotherapy is moving rapidly towards the used combination therapies and/or intratumoral delivery platform, sorry our intratumoral delivery platform positions us very well to participate in this next evolution. As such we believe that ImmunoPulse is the optimal platform for intratumoral delivery of multiple immunomodulatory genes.

And then as has been mentioned previously in our presentations we intend to develop a new ImmunoPulse combination product, which will deliver multiple DNA encoded Immuno modulatory [ph] agents directly into the tumor targeting multiple facets of tumor immune subversion and therefore mount an orchestrated attack to increase tumor immunity.

We have made significant advances in establishing a new ImmunoPulse product and have been advancing several pre-clinical multitude of positive candidates. All pre-clinical positive candidates includes encoding for IL-12 as their backbone and encode -- and we've been able to show encoding of up to 16 including known potent co-symmetry [ph] molecules. As an update on timing, we intend to nominate one of these pre-clinical candidates by Q4 of fiscal 2016.

In the third quarter of our fiscal -- sorry. Our rapid pre-clinical development platform can validate new target at a fraction of the cost and time required for other approaches to get from bench to first in human studies. Our new ImmunoPulse product will also leverage our latest advancements and [indiscernible] and further position OncoSec as a leader in Gene Electro-Transfer technologies in cancer immunotherapy.

And on this note, we're thrilled to announce that we've made significant progress in the field of Gene Electro-Transfer, in fact members from our discovery research team will present new study results in two poster presentations at AACR's special conference on engineering and physical sciences in oncology taking place later this month. We believe these findings represent an unprecedented advancement to the practice of Gene Electro-Transfer in immunoonoclogy and are very much looking forward to sharing our advancements with you in the next few weeks.

I'll go further into the details on our upcoming milestones for the rest of the year, but for now I'd like to turn the call over to Richard Slansky to provide financial updates and results for fiscal Q3 of 2016. Richard, over to you.

Richard Slansky

Thanks Punit, and good afternoon everyone. We issued our financial results via press release and we filed our Form 10-Q before this conference call today. For the third quarter of fiscal 2016 we reported net loss of 6.3 million or $0.37 per share based on weighted average shares outstanding of 17 million. This is compared to a net loss of 6 million or a $0.48 per share based on weighted average shares of 12.3 million for the same three months period last year.

Our loss was also lower than last quarter by about $700,000. As Punit stated in our last quarterly conference call, we have been analyzing our burn rate and our spending in an effort to develop strategies and plans to further expand our cash runway. Although this is an ongoing effort for us we are seeing some of those results.

Now for the nine months ending April 30th 2016, we reported a net loss of 20.3 million or a $1.27 per share. And this is based on weighted average shares outstanding of 16 million. This is compared to a net loss of 14.7 million or a $1.19 per share based on weighted average shares outstanding of 12.3 million for the same nine month period last year. The increase in net loss for the three and nine month period ending April 30th 2016 compared to the same period in 2015 resulted primarily from increased, an increase in patient treatment cost related to our various clinical trials and increase related to salary inclusive of stock based compensation and the additional personnel support business and product development and an increase in other outside services primarily related to consulting services to assist with the development of our next generation electoperation device prototypes. Novel electroperation technologies and our combination study. As we continue to be in the pre-revenue phase of our company there were no revenue for the three and nine months ending April 30th, 2016 and April 30th, 2015.

Our research and development expenses were 3.4 million for the third quarter of fiscal 2016 compared to 3.9 million for the same in 2015. Research and development expenses were 11.1 million for the nine months ending April 30th 2016 compared to 9.3 million for the same period in 2015. Our research and development expenses primarily include expenses related to the development of our therapeutic product candidate and electro operation technology. These expenses also include certain clinical study expenses, intellectual property costs and quality assurance expense. These expenses primarily consist of salaries, employee benefits, stock based compensation costs, outside design and consulting services, laboratory supplies, contract research organization expenses and clinical study supply. And we expensed all research and development cost in the periods which they incurred.

General and administrative expenses were 2.9 million for the third quarter of fiscal 2016 compared to 2.1 million for the same period in 2015. General and administrative expenses were 9.2 million for the nine month period ending April 30th compared to 5.4 million for the same period in 2015. Our general and administrative expenses include expenses related to our executive and administrative function, accounting and finance, board governance, compliance, information technology, legal, facilities, human resources and corporate communications activities. And these expenses consist primarily of again salaries, benefits, stock based compensation cost, independent other cost, legal fees, consultants travel, insurance and public company expenses for stock transfer agencies and listing fees in connection with our listing on a national exchange.

Now with respect to our balance sheet, at April 30th we had $24 million in cash and cash equivalent as compared to $32 million in cash and cash equivalent in April 2015. However with the net proceeds from our May 26th aftermarket register direct offering which we disclosed last month and which I will discuss a bit more in a moment. Our cash and cash equivalent would have been about $1.1 million higher than last year's balance or approximately 33.1 million at April 30th. Our current ratio was a healthy 6.8:1 before the financing and 9:1 after the financing.

We also have no debt other than normal payables and facility costs. As we mentioned last quarter 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're making certain changes and adjustments to focus our spending. We expect our burn rate to continue to decline for the rest of this fiscal year particularly as we focus our efforts on pre-clinical programs to select our most promising candidate combination molecule and focus our efforts on clinical and regulatory pathway from ImmunoPulse IL-12.

We currently are finalizing our fiscal year 2017 budget and our plans related to them and we will align our financial plan to the strategic plan for next year. We intend to provide more and further insight into these plans and the potential impact on our burn rate, if any during our next regularly scheduled conference call. In the meantime we believe that by focusing our discovery research and clinical efforts we will maximize our value to our shareholders and we anticipate that our funds will be sufficient to allow us to continue to operate our business for at least the next 15 months to 18 months during which time we expect to achieve certain significant clinical and operational milestones.

Now I'd like to provide a short summary of our important financing from this past quarter. We closed the $10 million at the market registry direct financing with the healthcare dedicated fund on May 26, 2016. We are very pleased with the support from this institutional fund and with the terms of the deal which was executed at a premium to market. We executed this transaction when our stock price was at a $1.68 and we priced the financing at a $1.815. We believe this additional funding will allow us to continue to fund our development and extend our runway and at least into Q1 of fiscal ’18.

We believe that this strategic financing will provide us with the extra capital we need to accelerate our development plans for our preclinical and clinical programs including our clinical melanoma strategy. With these funds in-hand we intend to use our melanoma clinical data including the data presented at AACR and the respective combination trial to advance our melanoma approval strategy and help pave a regulatory pathway to ImmunoPulse IL-12 in combination with anti-PD-1 in advanced melanoma as Punit had mentioned. These funds will also help advanced our next ImmunoPulse combination product as we work towards stock filing and new ImmunoPulse IMv [ph] in the future. We believe these milestones will take us to the next inflexion point and support the long-term success for OncoSec so it is crucial we provide the appropriate runway and focus the necessary resources to achieve them.

Now with that, I'll hand the call back over to Punit for a discussion about our upcoming milestones. Punit?

Punit Dhillon

Thanks Richard. So before closing I'd like to reemphasize OncoSec’s upcoming development milestones.

We plan to complete enrollment in the phase 2 melanoma combination study and present interim clinical data, we're working in parallel to meet clinical and regulatory objectives to initiative a melanoma combination registration study, we're focusing on announcing a malleable [ph] multi-gene combination of our ImmunoPulse candidate as well as provide updates on novel advancements in our gene Electro-Transfer platform, we're also focusing on meeting our clinical and regulatory objectives to initiate a phase 1 combination study of the new combination candidate. And finally, we're going to continue to enroll patients in the triple negative biomarkers study as a proof of concept in breast cancer.

Then there is other additional thing like we're continuing to support new academic and industrial collaborations. So we're looking forward to sharing these updates with you over the next few months and in conclusion we have made and continued to make significant progress to allow us to execute on our strategy to develop and commercialize DNA based intratumoral cancer immunotherapy and we look forward to continuing that discussion as we get more definition around our melanoma registration study and these advancements.

So at this time, we would be happy to address some of your questions and I am going to turn it over to the operator.

Question-and-Answer Session


Thank you. At this time, we would like to any questions you might have for us today. [Operator Instructions] Our first question comes from the line of Kumar Raja with Noble Life Sciences Partners. Your line is open.

Kumar Raja

So I had a question regarding this T-cell exhaustion marker, so here how you used a bit like the samples from the earlier trials. So are you following these samples in the responding patients to see what is happening, especially with regard to the data you presented at AACR where the patients were treated with IL-12 and then went onto PD-1 inhibitor? So do you have any plans to use these, assign those patients to see what is happening in those patients? And in terms of this assay, what needs to be done to be used as a companion diagnostic?

Robert Pierce

Sure this is Dr. Pierce, I'll address those questions and I'll pass it onto Sharron Gargosky, if she has some additional points to make. First let me be clear that right now in our ongoing investigator sponsored trial at UCSF in the Huntsman Cancer Research or the cancer institute, we’re selecting patients based on the flow cytometric assay which was presented at ASCO.

In brief how this assay works as we biopsy a tumor and dissociate it and stain for variety of markets, but the most salient being CD8, PD-1 and CTLA4. We've discovered that the percentage of [audio gap] high CTLA4 double positive CD8 is strongly predictive of response to PD-1 therapies both nivo and TemRO [ph] as a monotherapy and this was presented at ASCO and we're expecting the manuscript to be accepted for publication in the near future.

So that's how we're selecting patients in the current trial, those samples also are Those samples are also are available, the pre-treatment samples are available for the standard IHC that we've published before and developed in collaboration with [indiscernible] the multi-parametric IHC and then we're getting post-treatment biopsies. So the plan here is to be able to show not just that the combination leads to responses far in excess of what would be predicted based on their TIL status, but that it corresponds with an increased number of activated CD8s in the tumors.

Kumar Raja

So, and the diagnostic question?

Robert Pierce

And the diagnostic so, moving forward, although I've been involved in the development of Merck's IHC assays as a companion diagnostic, I would say from a company perspective if you can move into a patient population where you don't need a companion diagnostic, it can make the process cheaper certainly and potentially by focusing on PD-1's failures which is where we are concentrating our thinking for this registration trial you could open up the possibility of an accelerated approval pathway, so that's where we’re going. If that pans out and that remains to be seen pending discussions with the FDA, then we wouldn't require a companion diagnostic although we're very interested in using it as an analytic tool.

Kumar Raja

I just had one more question on the combination sheet biological [ph] compact you presented some data at the AACR. So, what needs to be done next for those trials to move forward, like what needs to be done before you can move into human trials for those combinations?

Robert Pierce

Let me first address the scientific foundation there and then I’ll let Punit talk about potential business ramifications of it. We were very pleased to see that our basic concept of using electroporation to deliver Heat's gp-96-Ig into the tumor actually did what we thought, which was to export neoantigens into the immune system and generate neoantigens specific CD8 responses. So, that was -- what we are -- our hypothesis was, we tested it and we found that that was the case in these mouse models. So, I think we have a strong case to try to move forward in that sort of approach, but that remains in sort of in the business development arena.

Punit Dhillon

And to add to that, that's exactly where we’re at in terms of evaluating, in terms of portfolio management with some of the other opportunities that both companies are considering and we're looking forward to seeing additional data before making that next decision point.


Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.

Jason McCarthy

Dr. Pierce, this is a question I think for you. Merck is doing a phase 3 study with Kimbrough and chemotherapy and lung cancer, and I think they're going to start a second one soon, if they haven't starting that already. And my question is, when you're thinking about your registration study and since you're treating patients that are non-responders that are in stage 3, stage 4 or later, I would imagine that some of these patients maybe if not all are on some type of chemotherapy and I guess the thinking is that chemotherapy could also influence in changing a non-responder to a responder, to a checkpoint. Is that something that you're considering in your phase -- in what would be a registration trial and are you kind of keeping an eye on something like that in the ongoing study now?

Robert Pierce

This is actually a very complex question, let me take it apart in various ways. Firstly, you're absolutely right that there's emerging data that certain chemotherapeutic agents seem to function to drive immunogenicity through immunogenic cell death, that is largely the work of [indiscernible], who have pioneered this idea and many companies are now exploring it in clinical trials and I think some of the data is looking quite positive.

In melanoma however, immunotherapies are proving to be so active as well as targeted agents like BRAF and MEK inhibitors that I think I haven't heard a peep about anyone thinking of combining chemotherapy with -- in the strict sense with immunotherapeutic agents currently although it's not a bad idea to consider it. Clearly, chemotherapy comes with a certain side effects that you may want to mitigate, however if you re-appropriate chemotherapeutic agents and the right sorts of ones as driving immunogenicity, it may make some sense.

Certainly for our future registration trial I think we have just a clear path forward based on our combination IST and the rationale that we've generated a lot of supportive data for that really IL-12 is itself driving immunogenicity and driving tumor specific kills which then are liberated by an anti-PD-1. So I don't think we need to consider a triple combination at this juncture for a registration path. And Dr. Gargosky if you want to add?

Jason McCarthy

I think I was not -- I didn’t want to -- I wasn't a triple combination, I think I was suggesting like are these patients washed out of chemo? You know I guess, your results with IL-12 could be skewed because you might have set some, you could set some placebos that are on chemo already or have [Multiple Speakers].

Robert Pierce

That's certainly an issue in other tumor types but for melanoma at this point immunotherapies are really first line and even though you know certain labels indicate that you know targeted agents should be first line the NCCN guidelines actually allow for immunotherapies like PD-1 to be first line, so I don't think we'll run into patients that are post chemo, they'll probably all be chemo naïve in this current day.

Jason McCarthy

Okay great, no that's a perfect answer, thank you a lot.

Robert Pierce

You're welcome.


Thank you, our next question comes from the line of Yu Chen with H.C. Wainwright, your line is open.

Yu Chen

Alright, thank you for taking my question. My first question is, what is the anticipated date for the final data readout for the Phase 2 melanoma combination trial and also second question is, based on your current knowledge what's your expectation regarding a pivotal trial size and cost.

Punit Dhillon

Sharron you want to take that.

Sharron Gargosky

Yes, happily. So the first question about when do we expect our readout on the current IST file. Assuming our enrollments stays as it is right now, we anticipate completing enrollment by the end of this year and there after the patients will have the multiplicity of cycles until such time as they progress, so the readout will come after that some time in next year, at least top line data.

With regard to our registration cost program that we're currently looking at, we're looking at a couple of different cohorts and doing this as potentially an adapted design type of staging and it really is predicated on conversations you know with the agency on what they need to see because even if you're seeing powers of 65% to 75% you know response rate, they're still going to want larger cohorts based on safety data, so we've put numbers aside of around 80 patients per group, but that is still as I said to be discussed and clarified with the agency I believe before we can really confirm those final numbers.

Robert Pierce

If I could amplify a little bit, this is Dr. Pierce, obviously as Sharron was saying the final data readout of the IST depends on a lot of inputs, however we're planning on submitting the interim data from that ongoing study very shortly for abstract deadlines that are coming up soon. And are moving on to a registration trial won't be gated on the final data from that study, but from that interim look when we have confidence in our path forward.

Yu Chen

Okay, thank you.


Thank you, I will now like to turn the call back to Mr. Dhillon for closing remarks.

Punit Dhillon

Well, thanks for the clarifications there Dr. Pierce and Dr. Gargosky. So thank you again for participating in our third quarter conference call, on behalf of our board of directors and our dedicated team we truly appreciate your ongoing support and confidence in OncoSec as we continue to advance our immuno-oncology 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@oncasec.com and we look forward to providing additional updates on our next conference call, thank you for your time and attention this afternoon.


This concludes our teleconference, you may now disconnect. Everyone have a great day.

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