Q4 2020 Earnings Call

To begin shortly please continue standby. Thank you for your patience.

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Good evening and welcome to times fourth quarter fiscal year 2020, Investor Conference call.

I'd like to remind you that this call is being recorded.

Now, let's turn the call over to Brian Gil Corporate Communications and Investor Relations for time.

Thanks, Daniel and welcome everyone to our fourth quarter in fiscal year 2020, Investor Conference call.

Press release reporting our financial and operating results can be accessed by going to the Investor Relations section.

Times corporate website at Www Dot time, Inc.

Outcome.

Joining me today with prepared remarks, our chairman and Chief Executive Officer, Steve Hoffman.

Our president and Chief Financial Officer, Ben Killer.

Chief operating officer, Michelle orphan.

Medical Officer, Dr. Giuseppe Delpriore.

And our Chief business Officer, Dr., Jonathan Eckard.

As a reminder, during todays call will be making forward looking statements regarding our financial and operational outlook. In addition to regulatory in product development plans.

These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted a description of these risks can be found in our most recent 10-K to be filed with the FCC. These statements speak only as of today's date, and we specifically disclaim any obligation to update or revise them I'd.

Now I'd like to turn the call over to our chairman and Chief Executive Officer, Steve Hoffman.

Thank you, Brian good afternoon, and thanks for joining us today.

In fiscal 2020 or fourth full year as a public company time deliberate extraordinary results, culminating with the launch of our first pivotal trial that will evaluate estimating aid for patients with third line pancreatic cancer.

Our highest corporate priorities for Twentytwenty work to present, our growing body of clinical data at major international medical meetings.

Initiate pivotal studies and second third line pancreatic cancer expand clinical study programs into shortcomings.

Sure capital resources that better position time to carry out its pivotal trial.

And advance planning for clinical trials in metastatic breast prostate and hematological cancers, as well as continue to develop preclinical and mechanism data studies.

We anticipate multiple catalysts and drivers of value when fiscal year 2021.

Including the release of new preclinical as some 88 and time 18 data.

We truly believe that our accomplishments demonstrate our leadership position in this emerging class of cancer metabolism based therapies.

I'd like to take a moment and discuss the effective cobot 19 on time and our ability to continue pursuit of our objectives.

Hi, I'm just developed techniques to allow its executives to maintain uninterrupted pursuit of responsibilities and duties as well is incorporated adaptations to continue group and committee endeavors. We.

We have also inventoried sufficient clinical supplies like drug product to allow us to serve patients in our trials.

It is important to note that our clinical trials have been minimally affected by the CRO V. crisis. This is in part because of the essential nature of treatment and third line pancreatic cancer and sarcoma and because we offer an oral drug there can be taken remotely and doesn't require a hospital or infusion center for application.

Additionally, I assume 88 has shown a historically small amounts of adverse events, making patient management by the treating oncologist potentially easier.

Now I'd like to turn the call over to our leadership team to share with you in more detail their perspectives on fiscal Twentytwenty and key value drivers expected in fiscal Twentytwenty, one, let's turn it over to Michel portion.

Thank you Steve we're truly excited about the launch of our time pivotal trial in pancreatic cancer using SM 88.

The launch of the precision promise study, which also has registration intent.

And importantly, we are excited about the opportunity to bring the potential of estimated to patients with advanced pancreatic cancer, where their therapeutic options are limited.

Before I move onto our regulatory focus I wanted to provide a brief summary on key highlights that we will touch on today covering time, our science clinical development and commercial opportunities.

Fiscal Twentytwenty represented our fourth full year as a public company.

But time, it's been a leader in the field of cancer metabolism for over a decade with experience studying cancer metabolism based therapies or C. M. B T. S is which are protected by strong global patent portfolio of more than 190 patent applications granted an indoor pending our.

Patent portfolio broadly covers composition methods manufacturing and use putins extending beyond 2032.

From a mechanism of action perspective time is pursuing a unique approach that exploits. The extensively studied warburg effect by developing first in class compounds that to cancer cells through disrupting their cancer metabolism with multiple mechanisms of action.

Equally excited about the progress, we're making it moving our clinical trials forward with the ongoing enrollment of patients in our pivotal time 88 Pang part two trial for third line pancreatic cancer.

Pecans phase two three precision promise registration intent trial in second line pancreatic cancer and in the hope sarcoma phase two trial for Ewing's anhydrous Sarcom us.

And importantly in today's uncertain environment, we cues emphasize enough the benefits of delivering an oral cancer therapy to the market an oral therapy with a potential advantages of SM 88 can be delivered to the patients home administered with a glass of water and the patient could be potentially monitored by the doctor.

Through existing Tele medicine platforms.

Now, let me turn the call over to Dr., Jonathan Eckard, our Chief business Officer for his preliminary analysis of preclinical data on SM 88, and time 18.

Thank you Michelle.

We recently announced the acceptance of abstracts for us to mediate had another pipeline program timely team for poster presentation at the Ace Yours June virtual meeting.

Well additional results will be presented at meeting the abstracts highlight some interesting information.

Regarding estimate.

So maybe is a proprietary see MPT investigational compound.

Leverages, the altered cancer metabolism to target various cancer functions and tumor processes.

These may include disrupting amino acid transport protein production for survival processes like a tough.

There are also indications estimate it could have broader impacts, including altering the immune dynamics the tumor micro environment.

This abstract focus on cellular effects that single agent has to mediate that's without the MPS components had on in vitro and in vivo cancer models.

One main observation reported was estimated to significantly reduce tumor size in mouse finagraph models compared to controls.

The abstract also reported dose dependent.

Committee increases of cellular reactive auction species in several cancer cell lines as well as alterations in cellular pathology.

As for background Autophagy is the digestion and recycling of a sell own components and is an important mechanism employed by many cancers.

Touchy has had increased focus as a target and cancer therapy and is currently being studied independent clinical trials.

Additionally, the abstract outlines the potential impact estimate it may have on immune alteration, specifically on the tumor associated macrophages portends.

These cells or focus on current immune oncology research and we look forward to presenting additional detail on these and other related immune fundings during the upcoming JCR meeting.

We are deepening our investigation smbs effects and multiple cancer models, both internally and with our academic partners and why you had Mayo clinic, we aim to leverage the learning from these data to inform us on the optimal future developments settings in combination paths with estimating eight.

Moving to time 18.

Time 18 is another cancer metabolism based compounds designed for intra tumoral delivery.

Primatene is distinctly composition, but like us to mediate it aims to leverage susceptibility use of the cancer that are related to its altered metabolism.

Solid tumors have different physiological environments compared to normal tissue. Many of these differences stem from the alteration of the cancer cell metabolism, whether it's the lowered ph from an excess lactic acid, resulting from like offices or other metabolic bride products build up around the tumor.

Timing team has a combination of a proprietary surfactant with a specific steroid acid.

This combination ultra is the permeability of the cancer cell membranes, increasing their susceptibility. So toxic by products. They have produced in the steroid acid is aimed to target metabolism pathways used by cancer cells.

Importantly, a core goal and the creation of time between was to create a product that will be effective in the tumor microenvironment, while minimizing detrimental impacts to normal tissue local tissue or systemic toxicities.

In the HCR abstract we outlined encouraging initial preclinical results. These included in vivo Xenograft mouse models were 11 out of 12 mice treated with timely team has complete responses of the tumors within two weeks and this is compared to all 12 tumors in the control treated mice that continued to grow aggressively.

And importantly, there was no reported local or systemic toxicities and the time heating treated animals.

Well intra tumoral delivery represents a different market them oral listen mediate we believe the opportunity for a safe and effective intra tumoral agent lifetime 18 could be substantial.

Not only in patients with tumors that may not be surgically resectable, but also in patients with tumors, where radio oncology therapy could be considered high risk.

We continue to conduct additional time 18, preclinical studies with a goal of identifying and I N D. Enabling passed this year.

And in parallel we will work with our medical Advisory Board and external partners to identify the pen potential initial treatment setting.

And at this time, we will assess the most strategic path to advance time 18 program into the clinic.

So we look forward to sharing more detail preclinical data on both us immediately and time 18 at the AC our virtual meeting in late June.

Now I'd like to turn the call back over to Michelle to share with you or regulatory updates.

Well.

Thank you John.

Based on the encouraging clinical data presented at multiple medical meetings in fiscal year, Twentytwenty time launched our own pivotal trial evaluating some 88 as a potential therapy for patients with third line pancreatic cancer. We had received very helpful guidance from our esteemed medical Advisory board and from the FDA.

Prior to initiating the trial.

We had announced in January that the first patient wasn't bolt.

It is important to note that we do not know the extent to which to covert 19 pandemic will continue to spread and impact society. We have worked closely with all of our clinical trial sites and all of our clinical trials are still actively enrolling we are proud we were able to keep our trials active despite the challenging pandemic.

Okay.

We will continue to monitor the situation and evaluate the potential impact to our business.

Patients with third line pancreatic cancer have limited options in a very poor prognosis expected survival for third line patient is only two to two and a half months.

There are over 10000 patients in the U.S. actively seeking third line treatment for pancreatic cancer.

We have a great sense of urgency to advance Esa mediate for patients, who so need a treatment option.

We continue to work closely with the clinical trial sites to address any potential challenges and ensure that clinical supplies and services are available to support the continuity of care of all enrolled patients.

We do anticipate full enrollment of time, Eddie plank part too by the end of calendar year, Twentytwenty or early 2021, and we anticipate data could follow and 2021.

This brings us one step closer to the potential commercialization of our lead CMB T. candidate FM 88.

Members of our team have broad experience and expertise and launching multiple disease altering cancer therapies into the U.S. market, including Abraxane for pancreatic cancer and.

And we're confident that we will be ready to commercialize Esa mediate with successful completion of the trial.

The first part of the time media Pink studies still has patients on study and we expect to present, the final data and publication and or presentation in the second half of Twentytwenty.

In addition, working in close partnership with the pancreatic cancer action network. The precision promise study initiated and has enrolled the first patient.

This trial is also designed with registration intent.

As to mediate is the first experimental therapy in this adaptive design trial and will be studied in second line pancreatic cancer patients as a monotherapy.

For those of you who are not familiar with Pan can I encourage you to learn about this exceptional organization. It is the world's largest advocacy group focused on pancreatic cancer and we're honored that estimate was chosen as the first therapy to be examined in its second line trial.

As you could see on the slide the trial is being conducted at highly regarded institutions around the country.

Circled. The also represents a great unmet medical need and significant opportunity for all stakeholders.

Approximately 12000 patients diagnosed each year without good treatment options Ewing's sarcoma, one of our treatment arms, often afflicts teenagers and young adults.

We are passionate about advancing Esa mediate through our trial partnership with Dr. Chawla and the Joseph Ahmed Foundation.

The trial is also actively enrolling.

The primary endpoint is overall response rate. So we would anticipate data becoming available starting at 20 to 21.

We're very fortunate to have the opportunity to develop a compound such as Esa mediate which has already demonstrated clinical responses in 15 different cancer types across four separate studies, both solid tumors and hematologic malignancies.

As a result, these data will help drive our decisions and expanding into large growing markets that are addressing the needs of patients with advanced cancers, where there are limited and in effective treatment options.

We will continue to make appropriate investments and our C. M B T pipeline, including potentially expanding our clinical trials into prostate breast cancer and door hematology.

We are encouraged by what we have accomplished and are very excited about the opportunities that lie ahead.

Now I will turn the call over $2 to Dr. Giuseppe dealt priori, who will share his perspective on the clinical data. He is presented at multiple medical meetings this year and opportunities in fiscal year 2021 to continue to expand on our growing body of clinical data and the field of cancer metabolism based therapies.

Thank you Michelle.

We have shared promising clinical data on our lead clinical candidate Ndtv also known as rates been tyrosine with key opinion leaders across multiple international venues, including Ascom ESMO ASG ESMO Gi Gvhd, our bankers I will now review with you a key highlights a tiny D pain and our process.

Cancer trials that have garnered you'd be doozy asthma, beating oncologist the world though.

I will also share with you and you look at our previous clinical data in metastatic breast cancer.

Starting with our pain Christine.

It's important to emphasize and nearly unprecedented poor prognosis patients entering at the start part one of the type media pain trial.

This is evidenced by that permission enrollment criteria that allowed actively progressing disease with no restrictions on tumor size number metastasis or tumor locations and E com performance sensitive.

Despite this we were able to leverage the specificity predicted by the mechanism of action into a tolerable regimen, even for these frail heavily pretreated patients.

I'm just slide we recall last year, when we had to good fortune to share overall survival results for estimating our lead cancer metabolism based comp.

In the Evaluable patient population from part one of our time 80 trial.

Overall survival compared favorably to other analysis by manic set out of Mighty prospective pancreas cancer trial, where the purported survival was only two to two enhancements in a similar patient population.

The results led to our ongoing SD eight guided third line pivotal trial and continues to drive interest even now despite the added challenges.

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This slide demonstrates important circulating tumor cell results in part one time EDI pain patients, who had decent 80% reduction in the circulating tumor cells trended towards greater somebody with a 60% reduction in the risk of death.

Overall about half of patients cheap at least that 80% reduction in their circulating tumor cells bird.

This is important since time is playing a significant role in advancing the development of circulating tumor cells as a potential surg for overall survival in pancreatic and prostate cancer.

Last year in the time mediate paint part one study we learned that our clinical benefit rate was 44% evaluable patients, including stable disease and partial response.

Furthermore, these patients also demonstrated a 92% reduction in the risk of debt.

One results matter because responses are rare or not observed that all in advance and Christian.

Our goal is to develop and deliver better safer medicines to cancer patients with advanced disease.

Is extremely important to deliver therapy with tolerable safety profile when working with frail extremely poor prognosis groups typically are not able to receive any additional therapy.

Remarkably we continue to dessert and report impressive safety data for SSD across a variety.

In a tiny the pain part one study estimated he was well tolerated only 4% of patients or to a 49 reporting serious adverse events, Steve at least potentially related Baird.

In aggregate East SGT has demonstrated encouraging safety profile at March 15 different tumor types, including solid tumors and hematologic malignancies in four separate studies, representing approximately 100 patients.

Pointing to note at the time EDI paying say part one is still ongoing, albeit now is part to IDE pivotal randomized controlled trial.

We continue to follow up part one patients and look forward to presenting in publishing the final data near the end of 20 Twond.

I'm just slide we move onto prosecutes.

In the signing of advanced prostate cancer time, catching the attention key thought leaders major institutions. When we shared our final phase two data on patients being treated with SMB for recurrent prospects at six months, 100% of patients were free of metastatic progression and 87% of patients.

Remain free of any radiographic progression.

These data are important because it's an 88 demonstrated meaningful clinical results without typical hormone related side effects. If confirmed in a randomized study SMB could postpone the need for hormone therapy and change occurring treatment paradigm for patients with Biochemically recurrent prestage.

As we discussed or time is playing a leadership roles clinical development circulating tumor cells.

Phase two prostate study improvement in circulating tumor cells number was document based on these findings we are working with a leading institution and investigators in prostate cancer, including Memorial Sloan Kettering University of California, San Francisco and the Albert Einstein College of Medicine.

We continue to pursue opportunities for prospective trials to confirm estimate results leveraging outside.

Moreover, we understand that scientific and clinical data are the heartbeat of any biotech as such we intend to share the final data from our phase Twob at current prostate cancer study in a peer reviewed publication in the second half of discount.

So on this slide we see a summary of our previously presented experience with estimated in breast cancer. She was a first human trial and our compassionate use experience we have gathered sample of approximately 25 patients metastatic breast.

These patients experienced the clinical benefit with a favorable safety profile. The overall response rate was 44% Theres no indication of resistance based on hormone receptor status prior treatment for metastatic site.

And now unanticipated ward drug related adverse events.

These clinical results are encouraging for patients with metastatic breast cancer and their health care providers, who are looking for new approach and potentially a better option.

Based on these findings and strong support from key opinion leaders and their institutions. We are exploring opportunities for the development of less than 88 as a potential treatment for patients with advanced metastatic breast cancer.

Now, let me turn the call over to Bend Taylor for his comments on our financial and operating results.

Thank you just let me.

As of the fourth quarter ended March 31st 2020, we had approximately 26.7 million in cash and equivalents compared.

Compared to 11.5 million in the third quarter.

Our fourth quarter cash balance includes 20 million from that January strategic investment by Eagle Pharmaceuticals at $2 per share.

Our operational cash burn rate for the fourth quarter fiscal year 2020.

5.9 million compared to 4.9 million to the previous quarter and 4.2 million for the quarter.

Fourth quarter fiscal 2019.

The increase over the prior quarters, primarily attributable to timing of payments rather than difference in operational activities.

Operational cash flow into the full fiscal year 2020 was 19.6 million compared to 20.1 million in prior year.

The burn rate for both the most recent quarter end the year was generally consistent with their previous guidance and predominantly reflected costs associated with our ongoing clinical trials for Anthony mediate.

Based primarily on our active clinical trials preparation for a potential SMB 88, new drug application with the FDA and our preclinical activities time anticipates that its quarterly operational cash burn is expected to average approximately 70 million per quarter for fiscal year 2021.

As has generally been shown in previous quarters, we expect the actual net quarterly cash burn to be lower than the operational cash burn based on anticipated opportunities for cash inflows across multiple channels, including private public and strategic market to support our long term goals and objectives.

We believe that our cash equivalent that March 31st 2020, together with anticipated access to additional capital is adequate to carry our the pivotal trials in pancreatic cancer.

Troughing sarcoma advance potential programs in breast in Hematological cancers, as well as continue our preclinical mechanistic studies.

It is important to now that turned significantly increased its inventory of estimating and MPS components. During the fourth quarter fiscal 2020 to ensure supply chain continuity for our ongoing clinical studies during any uncertainty caused by the Colgate pandemic.

The company remains confident in its ability to continue to supply estimate the eight for existing and potential future trials.

Today, We also announced the conversion of all 8 million of our outstanding 2019 works.

Further all the warrant holders have agreed to a leak out agreement that restricts potential sales of shares associated with warrants for six months and bands initiating any short sales during that period.

The majority of the warrants are converting to common shares at a ratio of.

I will 0.41 to five to one in other words 5.8 million warrants to 2.4 million common shares.

The remaining 2.2 million warrants are being exchanged for new warrants with $1.80 strike price in removes the price protection anti dilution and governance provisions from the previous won't.

For a more detailed review of the revised worn agreements. Please see the 8-K that was filed today after market close.

At this time I'll turn the call back over to Steve Hoffman for closing comments.

Thank you Ben.

Im can proudly say that we have met or exceeded all corporate goals for twentytwenty and our outstanding team plans to continue that performance go through 2021 and beyond.

For fiscal 2021, we have no higher priority tend to successfully execute our time 18 Pang pivotal trial that is evaluating our lead cancer metabolism base candidates oral assume 88 as a potential treatment for patients with third line pancreatic cancer.

So those 10000 patients with pancreatic cancer actively seeking third line treatment. There are currently no FCTA approved therapies and no oncology guideline recommendations for active therapy.

We believe we can feel that unmet need for pancreatic patients with a new approach that applies the latest advances in the field of cancer metabolism.

Right targeting the mechanisms of pancreatic cancer edit scores, we hope to deliver significantly improved outcomes for patients.

We're excited about the potential of estimated as a first in class therapy, and we're looking forward to the results of this promising new approach for patients in our pivotal study.

As time at time, we aspire to play a leading role in advancing the field of cancer metabolism.

Where we can serve as a valuable resource for health care providers their patients in advocates well hope for in deserve better safer medicines.

We are prepared and ready to execute our strategy in fiscal year, Twentytwenty, one and to maximize our value proposition for all of our stakeholders.

Thank you for your interest in time that concludes my prepared remarks, I would now like to turn the call over to the operator for question and answer session.

Ladies and gentlemen to ask a question you will need a press star one on your telephone to.

To withdraw your question press the pound key.

Please standby, what we compile the Q and a roster.

And our first question comes from Sean Lee with H.C. Wainwright. Your line is now.

Oh, good afternoon, guys and thanks for taking my questions.

My first question is on the ongoing impact from the cold in 19 pandemic.

During the prepared remarks, you mentioned that the so far the clinical studies have been minimally affected I was wondering does that refer to the pink 88 study or for the precision promise study as well and how much visibility do have into that study.

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Hi, Sean as Michelle Corp, and thank you so much for joining us and thank you for the question. So in regard to covert 19 art prepared remarks were intended for all of the essence 88 ongoing clinical trials in terms of pancreatic cancer and sarcoma I'll talk specifically about.

Hi, at 88 bank, which as our pivotal third line study I'm you know as Steve indicated in his prepared remarks, and I I reiterated we've we fortunately have seen minimal impact you know this is such a challenging pandemic, but I will say for time, we had our 88 study up and running in most sites.

For the pandemic hit we've seen minimal impact since the pandemic hit yeah. This is a situation where it vance pancreatic cancer is such a great unmet need our trial has stayed active throughout the pandemic will set the benefit of an oral therapy, you know in a sense that the patient does not need to go to the treatment center for a minute.

Straighten and where were you know we're excited to continue to partner with our clinical trial sites and if any future challenges do arise to continue to work with them to address the challenges.

Good so I take it that a patient enrollment is also.

Going along as expected and you haven't seen any slowdown to that.

Yes. So thank you Sean we you know we had previously guided that we anticipated full enrollment by the end. The 2020 I. We did give the flight update today in terms of saying, we anticipate full enrollment either by the end to 2020 or the beginning of 2021, but as Stephen I said in our prepared remarks to date the impact has been minimal.

In terms of the impact on enrollment.

Great Thats good to hear and thank you for the additional color.

My second question is on the.

Prostate cancer program, so with the final data from the phase two though to be published later this year.

As a company plan to advance the.

Estimate into a pivotal study in.

Lastly cancer as well.

Yeah. So so excellent question, let me start and then I'll X. I'll ask Giuseppe if he would like to to add anything on so in terms of prostate that the key next milestone for us in prostate will be a publication of the manuscript from the phase two study the phase two data had been presented by Giuseppe at ESMO and if you will note on the poster from.

No really some very well recognize thought leaders in prostate participated with Giuseppe on that final analysis. So we have continued to engage with thought leaders in terms of what the future potential might be for us immediate and prostate we've not to date initiated the registration study or discussed one but yeah as we indicated.

During our prepared remarks that is an area that we may look to for further expansion.

So let me turn now to Dr. dot prairie for any additional comments on prostate.

Hi, Michelle was right on the answers and.

On the emphasize enthusiasm that is reflected in our previous presentation posters and collaborators on this trial. So we look forward to the future.

Great that was helpful. Well My last question is on the time 18, so with the.

Im sorry. They see are also have a first look at how that biological forms I was wondering what will be the potential timeline for density and into the clinic.

Thanks again for taking my questions.

Proposal and this is John occurred so you know our goal right now is to.

It would be more preclinical work identify precisely what would be needed.

To get to the call. Thanks.

But before making.

Hey, Joe official decision on moving to the clinic.

Assess with both our internal and external partners and advisors.

Exactly how to ultimately develop so to drugs were to ultimately develop based on all the preclinical findings and then of course strategically try to figure out the best way to finance to hold to support to move that truck forward into the clinic. So.

As a sudden my prepared remarks that over the course of a year, we will be certainly identifying all those although steps.

That's a great tied once we have some more clarity we should be able to makes more.

Announcements about what the next steps would be in advancing it.

Towards the clinic.

I see no. Thanks.

Thank you.

As a reminder, ladies and gentlemen that Star then one time so question.

And our next question.

Brian.

Custom Kevin together with Oppenheimer. Your line is now open.

Hey, Thanks for the call and and John Thanks for the update with regard to.

The interesting work has been doing on mechanism of action could could you just maybe try to pull some of that work back full circle too.

Pancreatic patients and.

You have was better understand and how that serve informs your thought process on.

Ill see activity in that patient population, which we've seen now empirically and I think Robin I'm curious is better understand the mechanism.

Hi, Thank you very much too.

So.

You know theres so.

Those could be more data coming out.

If you're obviously than the than where it was on the abstract submitted in December.

But one of the things that you know was highlighted in the prepared remarks was the effect of Autophagy, which is a very important process in pancreatic cancer.

Not only to survival, but to a whole bunch of other aspects of how that cancer performs in servers.

In the in the patient and so.

I think that each of the aspect service mediator and we've said it several times and those calls wells that.

It seems to be multiple mechanisms of it which our summit it appears to be working.

So we look forward to not only explaining what we found so far but also taking deeper in.

And I guess like this this information will not only help us an understanding more about specific pancreas, but also other diseases, where those biological processes are known to be important. So I guess the best answer would be please stay tuned to a CR, there's going to be a lot of interesting information just to show.

Are there.

Certainly people are probably picking deeper to your question after that time.

Got it and maybe just as a follow up and yeah. This this may need to wait until after a CR, but if one looks at.

Yes, some of the other prior studies have compounds that part Teva direct impact on a top countries such as the hydroxy Clark when study that sort of read out mixed results in metastatic pancreatic in India.

Not to have any thought processes on you know some of those prior datasets in terms of.

Perhaps for the compounds on sort of optimal too.

You know test the hypothesis here, that's consistent with the mechanism or other things that you think might might help kind of informed by some of those prior experiences yeah shouldn't necessarily be applicable to what we've seen did very promising activity with us on 88.

Jim do only thing ill say is that.

There are several aspects of a tougher GM.

Sounds like hydrochloric written and core Quinn.

Impact it in certain ways and so there are probably.

Better ways or worse ways to impact to profitably.

So those were drugs that were found to have them to do that and.

And so hence the been studied for it.

But there are other drugs c., but for the alternatives in different ways such as the Mek inhibitors for example, so.

I think that additional clarity about not only what the impacts of the tougher GR, but how they come to pass them how they differ similar to other approaches could be important. So again like I said, it's still early days for the study autophagy. So it still remains a focus.

Of people because it's certainly known to be an important process for for many different cancer. So again more than we learned about not only ours, but other approaches and talking to talk to you.

That's super helpful context. Thanks, so much for the information I look forward to buy the additional data out later in June. Thank you.

Thank you. Thank you.

Once again, ladies and gentlemen, if you'd like to ask a question at this time. Please press Star then one now.

I'm not showing any further questions at this time I would now like turn the call back or Brian Gil for any closing remarks.

Thank you Daniel our leadership team will be available after the call if they're already opportunities for bulk discussions.

And I just wanted to let everybody know that fiscal 2021 promises to be another exciting year with multiple callous milestones. We'll certainly keep you current on all of our developments and we thank you again for your interest and support in time.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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