Q4 2019 Earnings Call
Ladies and gentlemen, thank you for standing by welcome to ZIOPHARM oncology fourth quarter and year end 2019 conference call. At this time, all participants are in listen only mode.
The speaker presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone.
Today's conference is being recorded if you require any further assistance. Please press Star then zero.
I like to hand, the conference over to your Speaker today, Mr., Chris Taylor, Vice President Investor Relations. Thank you. Please go ahead.
Thank you operator, good afternoon, and welcome to the ZIOPHARM Oncology conference call and webcast to review results for the fourth quarter of 2019. This afternoon, we filed our 10-K and issued our 2019 year end results release, both of which are available in the investors section of our web site ZIOPHARM Dot com.
For informational purposes. We have also included in our web cast a set of Powerpoint slides to accompany today's commentary. These slides can also be found on our website in the investor section.
During this call the company will make a number of forward looking statements, including statements regarding the potential therapeutic candidates in our development pipeline regulatory status financial information and business trends forward looking statements are subject to numerous risks and uncertainties as described in our 10-K and within other filings that we may make with.
The FCC from time to time.
Participating on our call today for ZIOPHARM will be Dr., Lawrence Cooper, Chief Executive Officer, South shoe close CFO and Dr., David Mooney precedent.
Following commentary from our management team will open the call for QNX and the interest of time, we kindly request that you ask one question and a follow up as needed and then please feel free to return to the queue. Thank you.
And they get started I'll turn the call over to Dr. Cooper good afternoon.
Thank you, Chris and good afternoon, everyone.
Yes, I had the opportunity to speak with you today and we welcome those of you who are new to ZIOPHARM.
By way of introduction.
We took dramatic steps forward in 2019 to build upon our plan to offer treatments to patients with solid tumors. We believe ZIOPHARM stands alone in the vision to be able to treat all solid tumors.
We have advanced multiple innovative technologies that have been widely published based upon convincing preclinical and clinical data.
We have phase one and two I indies across each of our clinical programs and have alignment to execute on them with world class Parkers.
Finally, we are addressing the largest possible oncology markets by going after a solid tumors.
With approximately $177 million in our Treasury ZIOPHARM is now in its strongest fundamental position today under my tenure, our balance sheet gives us the ability to accelerate towards the size and scale needed to successfully execute on our vision.
It's been just 16 month since we forged our corporate independence and could truly focused on solid tumors. We've accomplished a great deal. During this time period, and hi, and I will highlight a few.
In addition to having multiple trials in diabetes for all about programs, we have secured contracts in cooperation with MD Anderson extending into TCR tea, we have a license critical intellectual property and we have expanded our business developments and wall Street outreach.
We also spent much of 2019, working with well known third parties to gain a deeper understanding of the long term valuation proposition for each of our core assets.
We are using that information to develop our blueprint for twentytwenty and beyond based on feedback anticipated need and competitive analysis, we are accelerating our ability to manufacture T cell products.
Okay pop the commercial viability.
Starts and finishes with requirements or control manufacturing. This is true whether it be for our upcoming clinical trial or a longer term plans to offer commercial therapy.
Since 2019, we've been investing in talent in infrastructure to produce T cell products for ourselves and are accelerating these efforts in Houston, Texas.
We have leased facilities from Indiana skin cancer Center, and well open additional laboratory space within the next two month, we've already begun to execute on expanding our manufacturing plans for TCR tea, which will include scaling up for GMP manufacturing and we'll share more details about this work this year.
JP Morgan in January we had multiple eight here meetings with the Buyside sell side and large pharma. It is readily apparent that going up the solid tumors is the dominant T cell oncology theme for 2020, and we have five areas of competitive advantage that collectively we believe a unique to us.
Yes.
First we are infusing T cells to attack and kill cancer cells. As a reminder of the administration of T cells has a proven ability to eliminate kilograms of tumor.
Second we are using TCR is to target Neoantigens, which are our present in multiple types of solid tumors and all of their Achilles heel.
Third we are genetically modified T cells from the peripheral blood, which have to staying power to recycle killing function to eliminate tumor.
Fourth we harness cytokine to engage in control the immune response and fifth.
We use non viral manufacturing based on DNA plasmas from the sleeping beauty system to achieve the scale needing to address multitudes of patients with different types of solid tumors. We're in the right place with the right assets and executing on our plan with a strong financial base.
Especially as we gain clinical data, we have tremendous upside potential as a public company right now and throughout the year.
Laying out the agenda for this call.
With uptake timelines for each of our core programs. Our CFO statutes I will then discuss the recent financing as well as our Q4 2019 financial return and then our President David Mooney will conclude the prepared remarks before turning the call over to the operator for questions.
With that let me start with an update on our TCR T program.
The phase two I in D., we talk to Steve Rosenberg against the <unk>. It's the first of several game changing trials to come for ZIOPHARM.
We recognize the delays relative to past guidance and dosing the first patients on this trial.
And therefore, one is to provide more granular information on the studies status and why we remain and the N. C. I remain excited by this study that's I'll provide an update on where we stand based on our most recent feedback to relieve concern about this trial starting.
In recent months.
We have learned a great deal about the N C. I process after an anti R. and D. is cleared there are several steps up but that the NCR puts in place.
Any trial before the first patient has enrolled this includes transfer production for research group to the manufacturing team.
As we need a patient enrollment dr. Rosenberg and his group had been working diligently with Dr. drew denninger and our team and have identified improvements to the manufacturing process used to produce sleeping modified T. CRP. These new learnings benefit not only the study at the end Sky.
But also the production of T cells, which will be undertaken in our clinical program at MD Anderson.
I have reviewed these data and they significantly build upon the use of the sleeping beauty system. This is exactly what we want our partner to do as they are approve an engine of ingenuity.
Their efforts have also helped de risk the TCR T trial ZIOPHARM moves to control our own program at Indiana said.
I'm happy to report the DNC I is moving towards a final engineering runs, which when completed well ready then turn roll the first patient in the interim patients who come to the NC I continued to be evaluated considered for this study. The most appropriate candidates are going through the TCR procurement process with their tumors were.
Sector Neoantigens identified TCR has made.
Based on the very recent input from the NCR, we estimate that Dr. Rosenberg what treat the first patient in the first half of this year, we are confident with the updates to the NCR process and plans for enrollment and were eager to share news of the first patient enrolled.
As mentioned in wet in January is webcast update.
We're also implementing plans to bring the TCR T program under our control.
One of last year's important milestones, what's our announcement on October 28 of an expanded research and development agreement with Indiana Sun, So compared to 22 encompass our TCR T program, which provides a new home for our growing team an interest in Houston.
The relationship with Indiana said, it's a significant competitive competitive differentiator as it enables us to execute on who's our problem, let approaches infusing TCR T for solid tumors, one uses TCR as existing a library to target neoantigens occurring at hot spots.
The other is based on the work at the NCR and I N D to target personalized neoantigens. Both approaches use the same methodology to produce TCR T. Using the sleeping beauty system developed at the NCR.
These two paths provide austan patients the best chance to treat many types of solid tumors.
I didn't pianists than we can enroll patients variety of solid tumors, and we anticipate significant patient flow to our TCR T program. Indeed, our set up license TCR Austin. The NCR is already enough to begin enrollment to the hotspot trial.
The access to patients and tissues will accelerate the expansion at the library of TCR is targeting neoantigens in hot spots.
We continue to work on our regulatory roadmap and are currently engaged F. T. A on our two approaches targeting neoantigens in solid tumors.
We believe that already having an open phase two lie and deal with the NCR provides us with a head start on a template for these discussions.
We will provide updates regarding the protocols and timing as those discussions progress.
The TCR T program is a tremendous opportunity for patients in the company with everything we've seen to date, we believe we have a strong chance of success and tremendous value creation.
Next I will touch upon our aisle 12 program.
In 29 team, we made considerable clinical progress in our controlled I'll 12 program and received positive FDA feedback granting as fast track designation and in Europe, where we received an orphan drug designation.
We have completed enrollment to our two recurrent glioblastoma or GBM phase one studies with 36 patients in the monotherapy expansion study and 21 patients in the dose escalation combination study with Opdivo, which included an additional 12 patients treated at the highest dosing level.
Beginning in the third quarter of 2019, we commenced the phase two study for recurrent GBM in combination with Regenerons the tie out and that study should complete enrollment in the first half of 2020.
Since our last quarterly call five additional clinical sites have come on line with now seven to 10 sites enrolling patients in total more than 95 patients with recurrent GBM have been treated the desired 20 milligram dosing of OLED amex with over 80 patients enrolled since 2018 alone.
More than three quarters of those patients.
Received low dose steroids, which we believe helped aisle 12 achieve an immune mediated anti tumor effect.
The encouraging results, we have seen to date and the expected data from these additional patients will help inform our decision on later stage clinical studies in recurrent GBM and potentially expand the program outside of recurrent GBM.
We believe that if all 12 can meaningfully improve patient outcomes. In this cancer then it can be effective and many other indications either alone or in combination with immune checkpoint inhibitors.
Considerable data what published or presented from these studies during 2019, including at ASCO in June and at the society of neuro oncology or so in November.
Results from the Phase one monotherapy main trial. We're also published in the Journal Science Translational Medicine last August links to these presentations can be found on our website.
Our teams presentation at Sno, a few months ago provided evidence for the first time of regression of Glioblastoma based on imaging.
We also presented a confirmatory data demonstrating 16 months median overall survival in patients with recurrent unit focal disease, receiving low dose steroids.
We're pleased to know the ZIOPHARM team received the top five awarded snow based on these data and we are encouraged by the increasing enthusiasm among the investment community and potential partners in this program.
This interest is also consistent with our meetings at JP Morgan.
We continue we continue to monitor the patients enrolled in these studies and anticipate providing additional updates with the potential for submission of multiple abstracts at major medical meetings in the first half of this year.
I will conclude with an update on our car T program.
In another important 2019 milestones, we announced in October that the FDA cleared and investigator initiated I.D. for a phase one clinical trial to be conducted at Indiana. So.
As we've previously stated this study will evaluate infusion of donor derived car T created through rapid personalized manufacturing or RPM in patients with CD 19, expressing leukemias and lymphomas relapse opt to allogeneic bone marrow transplantation.
Did the RPM process, we can dose patients as soon as the day after gene transfer including verification.
That's a car T meets release criteria.
During our last quarterly call. We set our team was working hard with MD Anderson to get the trial started by the end up 2019 as a reminder, Indiana fund is manufacturing the product for the study as we rounded out the year. Some delays were experience as a technology transition to their GMP facility, but I'm pleased to tell you think.
As of Barnwell sense final qualification batches are underway with the required regulatory steps referred to as the site initiation visit arrests Ivy planned in the coming weeks. Indeed, the first patient is being identified by our principal investigator for this trial initiation of this study is an important near term milestone for our company.
We look forward to sharing news with you in the first half of this year.
There are two additional recent items to mention regarding our use of the sleeping beauty system to reprogram T cells.
Last month, we published in the journal blood encouraging long term outcome data after infusion of sleeping beauty modify car T based on a prior generation of this technology. This described outcomes of patients with relapsed or refractory b cell lymphoma malignancies, all of whom had received CD 19 specific car T.
Infused softer autologous bone marrow transplantation for patients demonstrated sustained persistence of car T. Many years after infusion.
Five year progression free survival and overall survival was 71 and 86% respectively.
Last December our team presented at the 2019 Ash annual meeting new preclinical data validating rapid personalize manufacturing with TCR. These results show that T cells genetically modified using DNA plazas from the sleeping beauty system to express TCR with membrane bout aisle 50.
Exhibited antitumor effects. These data build on our approach to reduce the cost and complexity of T cell therapies.
Finally, an update on our joint venture eat in bio sell.
Things continue to progress well with our colleagues in greater China. The tech transfer for the RPM technology is largely complete the GMP manufacturing facility, a staff and equipped and the scientists that currently conducting test runs of the RPM process.
They have also commenced discussions with the Taiwanese F.D.A. as we expect the first trials to start at a large hospital in Taipei.
Our partners at Eton Bustelo advise us the R&D for the autologous RPM Cdnineteen car trial will be filed this year. It is worth noting that the travel restrictions with new Corona virus in China I have to date not prevented edens ability to work in Taiwan, and while the situation will continue to be monitored we're not experience.
Seeing significant delays.
In summary.
Over the past 16 months, we've assembled a technology people and funds and made significant progress in all our programs. This bodes well for the future as throughout the year, we expect to have data on TCR T deeper clinical insight into controlled IL 12, and RPM for car T.
These programs provide significant value, creating opportunities and this breadth of upside potential appears unique desire farm.
Now I will hand, the call to our CFO Saf schuessler.
Thanks, Lauren and good afternoon, everyone. Let me begin by saying give few words about our recent financing efforts.
Achieve our vision to develop treatments for all patients to solid tumors.
It is essential that we keep the company well capitalized in comparison to competitors and B cell and gene therapy space.
As we disclosed at the end up you could quarter essentially 19.
Our cash balances at that time for why dated runway into the first half of 2021.
Which meant that to avoid a going concern audit opinion, we would need to raise capital in the for several months of Twentytwenty.
We carefully evaluated this timing and considered to be risky.
We do have markets calculus expected this year, but we came to the conclusion that hoping and reaching for the exact right time, while exposing the complete to capital markets and political risks.
Was imprudent.
Furthermore, given that many of the biotechs, where security capital in late 2019, an early twentytwenty.
Potentially do factor.
And limited available funding goodwill substantial additional risks if we waited too long to secure financing.
We therefore began executing unfortunately, our balance sheet starting in December.
Most engaging and some ATM financing or approximately $16 million.
However, following a successful JPM event, maybe shared the company's prospects that much but talk to your biotech investors.
Management turned off the ATM and engaged in a traditional financing.
This financing was achieved quickly de risks our balance sheet and bill now enable us to accelerate and achieve many important call for the next two similar to yours for the company.
The proceeds in addition to go to ask marketplaces and conditions.
Oh preclude the necessity or using the ATM anytime in the near future.
The new capital. So many critical purposes entered drifted down a bit more concretely related to the use of these proceeds.
We again.
Good.
Accelerate the build out for a new Houston facility on the campus of MD Anderson.
Which will serve as some dilution for the commercial passport our TCR programs.
Second accelerate the expansion of our TCR library to support our TCR hardcore trial.
Next advanced the recruitment of specialist or so now what our Tcf program.
And also to support potential broadening clinical initiatives for our controlled IR truck program as we advance toward later stage studies and potentially other indications.
And we can now take control of manufacturing the book personnel and infrastructure, which clearly being a limiting factor for us compared to appears many of whom control manufacturing.
We see almost daily news of substantial gene and cell therapy manufacturing investment and we think this new area alone the pro white, great value for ZIOPHARM in the medium and long term.
Turning to these financial results for ZIOPHARM fourth quarter of Frente 19.
As noted on a news release research and development expenses were $10.2 million for Q4 of 2019.
Compared to $8.2 million, but Q4 of trying to your team.
This increase reflects expansion of the company's clinical programs, including the initiation of the phase two combination trial.
Unfold I as well the live trial.
As well as work for both DCR and car T program.
DNA expenses were 5.8 million for the fourth quarter of 2019 compared to four point Sixmillion for the fourth quarter of 2018.
This increase reflects our increased headcount recruitment of key personnel and expanded capabilities.
On the accumulated basis for the fourth quarter of Fenty 19, we reported a net loss applicable to common shareholders of $15.7 million.
Nine cents per basic and diluted share.
Comparatively in the fourth quarter of 2018, ZIOPHARM recorded net income applicable to the common shareholders of $194.5 million.
Oh 1.2, $9 per share basic and diluted.
The increased income attributable to common shareholders and 2018 resulted primarily from the from the for future and return of all the companies.
Cities, one preferred stock hedge biased pharma partner.
Andy Relinquishment ZIOPHARM obligations under a pharma agreement.
Commenting for approximately $207 million.
For the full year 2019.
R&D expenses came in at approximately $38.3 million compared to $34.1 million and 20 a team.
Well again, a came in at $19.5 million slightly below the $19.9 million in 20 a team.
The ramp in R&D spend while maintaining discipline on DNA spend reflects the company's continued commitment to optimal capital allocation to focus on progressing the sign.
We are dedicated to growing our business and pushing ZIOPHARM and the best possible position to capitalize on our compelling technology.
In addition to the 18 million in cash adherent. We also had a repayment balance of approximately $20.3 million.
Well look to be conducted by the company at MD Anderson under the new agreement incorporating our recent financing activity our cash position now enables us to provide funding for all our programs and infrastructure built into mid trends if you too.
And now I'll turn the call over to David for final comments.
Thanks.
Before I provide some comments on our business I'll share a brief word on new Corona virus or co bid 19.
Our thoughts go out to all of those affected by this difficult illness. We're currently assessing the impact a broader spread of the illness may have on our business and have begun identifying mitigation plans as needed.
As Lawrence noted our colleagues at Eton and try arm have confirmed that they continue making progress and they do not currently expect significant business disruption and our Cdnineteen program in greater China.
Further enrollment in our I, all 12 clinical trials all of which are in the us are either complete or nearing completion, and we have drug available to complete our ongoing studies.
Our planned TCR key clinical trials appear unaffected by the outbreak.
We expect to discuss the possible impact of the new Corona virus with our other partners, including the NCR and MD Anderson as a situation in the U.S. evolves and of course, we will be evaluating the impact. This may have on our employees day to day activities.
Fortunately, we already have the IP systems in place that allow me for employees from work remotely if needed.
We have obviously achieved many things in the last 16 months and look forward to a prosperous future.
I would like to strongly reinforce our vision, which is to provide next generation therapeutic options to treat any patient with a solid tumor and if we achieved that goal significant rewards can be seen.
We have worked hard and fast to create unique attributes of ZIOPHARM, which lawrence's cover today and the market opportunity for US is tremendous ZIOPHARM has commercial rights to multiple billion dollars markets.
We are of a course of course engaged in multiple continued dialogues with potential partners and as Lawrence mentioned, we have increasing data on the timing and value propositions for each of our assets.
With the recent financings, we can move beyond our out licensing discussions to now also have additional efforts, where we are considering in licensing technology and IP to build upon our foundational assets.
We've expanded our business development capacity internally and we have engaged third parties to review and advise on valuation and longer term plans for each of these assets.
We expect to have human data in hand across our three programs over the course of this year. This will put us in an enviable position, providing a significant flexibility for both in licensing additional technologies and pursuing collaborative transactions for our existing therapies.
A few comments on the organization. We are building we hired over 30 people last year and expect even more this year, including in the C suite.
And with the resumes already in hand, we expect continued the trend of lending top tier people with excellent capability.
We are building up in expanding on our Investor relations efforts and have activated plans to have scheduled monthly outreach calls and we will increase our face to face meetings with our major shareholders, especially going forward.
We have engaged to west coast firm and are in the process for a full corporate rebranding.
Especially as we get all of our trials Rolling we are a completely different company than we were in October of 2018 and that should include a new look and feel a new name and a new stock ticker.
We expect this rebranding effort to rollout in the second half of this year and look forward to updating the market on more specific timing and process as we get closer.
It hasn't always been easy the largest vision many years ago was to provide a rational scalable cost effective immunotherapy that could have an impact on not just some markets of cancer patients, but all of them.
If there is one thing I can say with certainty Lawrence's training gives them an uncanny knack for seeing the movie play off before the script as even written.
And we have the fortitude commitment and now the backing to see us predictions come through for all of us.
Thank you for your continued support and with that I turn the call over to the operator for questions.
Thank you.
As a reminder to ask a question you will need to press Star then one on your telephone to withdraw your question press the pound key.
Please standby will we compile the culinary roster.
Our first question comes from Yale Jen with Laidlaw <unk> Company. Your line is now open.
Good afternoon, and thanks for taking the questions and congrats on the progress that's quite a remarkable altogether, maybe two quick questions here. The first one is for the MD Anderson internal self DCR Pete.
Development.
Are you guys going to wait for the NCR completely there.
Protocol and softer enrolled patients before the work over in MTN essentially you have a mall homogenized. The protocol clinical study protocols or you will have additional is sort of modification all adjustment on your own data.
Yeah. Thanks, a yellow I'll take that question first so the.
Clinical trials at Indiana Sun.
You can anticipate those to start alongside the NCR.
The anti to US is a program that has great value not only today, but going forward.
I think expect continued iteration by Dr. Rosenberg.
And his group and those learnings under our credo will be back into MD Anderson and thus our clinical trials.
So to put it all together we enjoyed the relationship with Steve and his group as essentially the foundry, but we're a commercial leading company we want to develop drugs for solid tumors and so we will execute on that vision at Indiana, and you'll have we'll have more to say about that going forward.
And then maybe just talk a little bit on data.
From a revenue out cost perspective should we anticipate that once you start MD Anderson work on TCR Pete.
R&D expenditure.
Increase more substantially I guess a than otherwise we'll open.
[music].
Yes, So I will review the model one more time and get back to you on that shale, but yes, there will be a ramp in the in the R&D expenditure, obviously for sure because we had an oddity company and if you look at how much how much we actually I, which an opex this year.
Our run rate on cash I've been be disclosed that right. Now we are anticipating a cash taking us into middle of 2022, we go sort of back into some of the ramp expected. Obviously this year well. So we get on next year, and then going into Twentytwenty too. So a lot. So certainly the expectation is that we will execute more than that.
Well vivo spend more.
Okay, Great go back to the Q, Dan or maybe have some follow up little.
Okay. Thank you.
Thank you. Our next question comes from Thomas Flatten with Lake Street Capital. Your line is now open.
Great. Thanks for taking my question to follow up on the <unk> earlier question with respect to the MD Anderson TCR study running alongside NCR, given that you're still in discussions with FDA around protocols and things like that could you provide some more granularity on on those specific discussions I, Andy submissions or clearances et cetera. So we understand how those things will run alongside one.
Yeah. Thanks, Thomas So the I think you know the way I think about it is the playbook in terms of the island. The has been established spicy Rosenberg, we take that playbook now and adapted to our own commercial facing needs at MD Anderson.
Those discussions.
Our underway with the regulators and they will come to rest soon and then we will update you in that and the market on our plans in full of detail.
And then just kind of tied into that and then I'll jump back into queue with respect to having data for across all three programs in 2020 could you comment a little bit of on what types of data with respect to see I'm, having trouble seeing the timelines come together with the kind of the broad first half second half guidance.
We've got a slight actually.
The we that's on the deck.
So the way we're positioning the company is really just the you know bookend. This in the first half of 2020 at the moment.
So if you look at those programs will have the dosing at the anti trial. That's a phase two will have enrollment to our phase one trial for the rapid personalize manufacture a party we'll have a announcement around the completion of enrollment and the initial data read out for our control.
Ill 12 in combination with that tile.
We'll have phase one data read out with controlled I'll 12 in combination with Opdivo.
And we'll have phase one data readout from controlled all 12 as a monotherapy in that expanded cohort. So those five activities will be in the first half of this year and then as we get into essentially the you know that the next quarter or so we'll then move that timeline. So that you can look deeper into the company for the second half.
This year, but that's a that's a pretty significant package for just this first half.
Just a follow up sorry, so if you're going to see dosing in the first half and then.
Do you have a sense from from Rosenberg with respect to number of patients cadence of enrollment. So that you can actually get data out in 2020.
Yeah, we so.
That timeline and with respect to the public is governed by Dr. Rosenberg.
It's really a lot of the impetus for us to be moving the technology under our own I NDS.
Downtown Houston with MD, Anderson, but having said that Steve has been an excellent steward of our technology and quite frankly, the field and regularly put out important updates and I expect tend to do the same with rapidity around our program.
Okay, I'll get back into queue. Thanks.
Thank you. Our next question comes from RK of H.C. Wainwright. Your line is now open.
Thank you.
Good afternoon Lawrence.
I just on the on the NCR program.
We are learning more about the process itself. So after incidences successful manufacturing runs for the clinical material to get so is there anything else that they need to do before they get this study going.
Yeah, that's an excellent point so as the the manufacturing obviously is an important part that's governed under the indeed, you've heard my comments around how then learning was added on top of the Andy.
And then once Steve is ready to go the patient then essentially that are in the Q.
And then be treated.
So there's going to be a I think a an important part of the story, where not only are the manufacturing solution. I think please check that box, but the patients then essentially have that clinical needs that they need to essentially.
Received that TCR therapies, and Steve given that transition essentially as patients come off the Q into essentially the clinical trial.
Okay. Thank you and then on the control the Io 12 program.
You know outside of GBM.
Bordeaux tumors would you be.
Where do you think are likely targets.
Our next cost us noise issue, which ones would be going after yeah. That's a great question. So for US. We're you know our clinical data really teaches us that I, all 12 concern cold tumors Hot and we think thats important, especially for tumors that have failed.
The and checkpoint inhibitors. So we are looking closely at those types of tumors in other words immunological desert ones in which then can benefit from up you know an influx of T cells and there's a set those tumors out there RK and often those tumors match up actually quite frankly to the ones that don't benefit from immune checkpoint inhibitors.
Okay. Thank you and then the last listeners.
Turning to India.
Expected during the first half.
Is that pretty much.
Wait till the end of the I know the first half into ask or could be it could be.
Any other it could be anytime it could be anytime we see continued we see a continued you know a double agents a data throughout the first half.
Thank you very much on for taking my question.
Thank you. Our next question comes from Jim Birchenough with Wells Fargo. Your line is now.
Yes.
Good afternoon, they come to Jim softening.
Yes, congratulations onto it seems like this is going to be the yield for the company. So I'm sure you're very excited about all the person.
Just in terms of the.
Hotspot try all sort of the Neoantigen trials.
It seems like the.
No the differential difference here between need NCR, I approach and youre prone to be in terms of.
The algorithms and technologies used to identify the hospital.
Outside of that the two trials will be very similar is that the Ken.
Yeah, I think that's a good starting point Nick.
Yes, both the anti and ZIOPHARM.
We will be pursuing the personalized TCR t. therapy, that's a very broad solution really from most patients actually quite frankly with solid tumors. In addition, though.
ZIOPHARM with its partner at Indiana Center will be developing the hotspot trial energy as you know that's a way to treat a subset of patients but to do so much faster because your screening the patients for the for the mutated.
Antigen.
Right right.
On that trial loans as.
We will you be in a position too.
Essentially I think you made the comment that you already have enough TCOS isn't library to to execute a trial will it be put all come a trial will initially Anthony well, let's look ahead.
Subset of Kt rest for example, yeah, Yeah now that that's exactly the right question neck wheel. We're in dialogue about that then there is basically those kinds of trial designs and we want feedback from the FDA on that type of trial design and then we'll get back yet.
Okay.
And then and then also ran I'll hop back into queue.
<unk> resource aisle 12, and so now you have cash through the middle of 22.
You're going to have critical data by mid year for this program. What are you assuming in terms of additional trials beginning through the middle of 22, big because like I think a 1.2, the pause I seem to recall that Youre preferred way forward. We filed on 12 was with a partnership.
Mhm, Yes, no I think you know as the data have come in you know, especially through the expansion study in the phase one trial study with Opdivo. We've seen you know really reassuring data Nick I mean, we've got pretty significant long term survival 16, or so a month now we've got clear evidence of anti.
My tumor effect, so based on Emrys scan weve, they're really biopsy these patients.
And show an influx of T cells. So these data are you know means that the companies on a lot of work since essentially those comments, we'll put out there at the time that was correct that there was a walk for potential partner, but now I think there are many options ZIOPHARM and we're going to really a essentially look at these data coming in.
Through the year and and see what makes the best sense of the company.
Sorry launch so just to clarify do you have money that assigned for additional starting additional trials.
It is 21 22.
Sure I'll turn it over to South America next so I think what I can say is that our cash runway conservatively does not assume any partnership and push at this point. So whatever you want to do that program and progress in our GBM and potentially other indications.
We have assumed that the that the funding for that today comes from the company for for planning purposes and be layout of the cash runway, obviously when data rollout NV, we decide at the end, which partnerships to explore that number could change, but conservatively we have not been.
In any partnership funding in any of our analyses.
Terrific. Thank you for the clarity.
Thank you are far final question, it's a follow up from your Yale Jen Your line is now open.
Oh, thanks for taking up the follow up question. So Oh, you guys going to announce.
When you start to face on the TCR study at MD Anderson or in the press release or some other sort of matters.
Yeah. Thanks, Yale So just like just to clarify we will announce when the TCR T trial.
Starts are enrolled at the anti we will also guide the market our plans for our own commercial activities at MD Anderson.
Okay, and maybe just one more question, which is that in terms the combo study of T mobile data.
You intend to report just hop up to this year.
Do show, we anticipate anything related to the time or did the duration of the study that written at the endpoints that shows so progression free survival, others or simply which was mainly focus on the response rate and other relevant data.
Yeah, I, you know what I try and do what that but the company tries to do is show survival because that is the benchtop, that's by which you know the EMA or close the FDA will allow potential products move board, but in addition, because we work with academic centers were often able to add additional.
Hello to those data for instance, the immune response data whether that be through biopsy or through a imaging. So that type of package will be put together I anticipate for the first half of this year and is a guide you can look back at the snow poster that we put out yeah last november's essentially as a template for the way the company.
Is keeping the street apprised of our activities.
Okay, Great that's very very helpful and again congrats on the progress so far.
Okay. Thank you very much for questions and I think I'll conclude the call that everybody have a good day.
Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your programming you may now disconnect.
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