ZIOPHARM Oncology, Inc.
Q4 2019 Earnings Call Transcript

Published: 3 Mar 2020

[Operator:]

Ladies and gentlemen, thank you for standing by. And welcome to the Ziopharm Oncology Fourth Quarter and Year-End 2019 Conference Call. At this time, all participants are in a listen only mode [Operator Instructions]. Please be advised that today’s conference is being recorded [Operator Instructions].I would now like to hand the conference over to your speaker today, Mr. Chris Taylor, Vice President of Investor Relations. Thank you. Please go ahead.

[Chris Taylor:]

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 Investor's section of our Web site, ziopharm.com. For informational purposes, we have also included in our webcast a set of PowerPoint slides to accompany today's commentary. These slides can also be found on our Web site in the Investor's 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 SEC from time-to-time.Participating on our call today for Ziopharm will be Dr. Laurence Cooper, Chief Executive Officer; Sath Shukla, CFO; and Dr. David Mauney, President. Following commentary from our management team, we will open the call for Q&A. In the interest of time, we kindly request that you have one question and a follow-up as needed and then please feel free to return to the queue. Thank you.And to get started, I'll turn the call over to Dr. Cooper. Good afternoon, Laurence.

[Laurence Cooper:]

Thanks, Chris and good afternoon everyone. We're pleased to have 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 the patients with solid tumors. We believe Ziopharm stands alone in the vision to be able to treat oral solid tumors. We have advanced multiple innovative technologies that have been widely published based upon convincing preclinical and clinical data. We have Phase 1 and 2 INDs across each of our clinical programs, and have alignment to execute on them with world class partners.Finally, we are addressing the largest possible oncology markets by going after solid tumors. With approximately $177 million in our treasury, Ziopharm is now in its strongest fundamental position to-date 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 has been just 16 months since we forced our corporate independence and could truly focus on solid tumors. We've accomplished a great deal during this time period, and I will highlight a few.In addition to having multiple trials in the R&Ds for all of our programs, we have secured contracts in cooperation with MD Anderson extending into TCR-T, we have licensed 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 2020 and beyond. Based on feedback, anticipated need and competitive analysis, we are accelerating our ability to manufacturer T-cell products. Our path to commercial viability starts and finishes with a requirement to control manufacturing. This is true whether it’d be for our upcoming clinical trials or our longer term plans to offer commercial therapy.Since 2019, we've been investing in talent and infrastructure to produce T-cell products for ourselves, and are accelerating these efforts in Houston, Texas. We have leased facilities from MD Anderson Cancer Center and we’ll open additional laboratory spaces in the next two months. We have already begun to execute on expanding our manufacturing plans for TCR-T, which were include scaling up for GMP manufacturing, and we will share more details about this work this year. At JP Morgan in January, we had multiple ATR meetings with the buy-side, sell-side and large pharma.It is readily apparent that going after solid tumors is the dominant T-cell oncology theme for 2020, and we have five areas of competitive advantage to collectively we believe are unique us. First, we're infusing T-cell to attack and kill cancer cells. As a reminder, the administration of T-cell has a proven ability to eliminate kilograms of tumor. Second, we're using TCRs to target new antigens, which are present in multiple types of solid tumors and are their Achilles' heel.Third, we are genetically modifying T-cells from the peripheral blood, which have the staying power to recycle killing function to eliminate tumor. Fourth, we harness cytokines so engaging and control the immune response. And fifth, we use non-viral manufacturing based on DNA plasmids from the sleeping beauty system to achieve the scale needed to address multitudes of patients with different types of solid tumors.We are 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 updated timelines for each of our core programs; our CFO, Sath Shukla, will then discuss the recent financings, as well as our Q4 2019 financial returns; and then our President, David Mauney, 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 2 IND with Dr. Steve Rosenberg at the NCI is the first of several game-changing trials that come for Ziopharm. We recognize the delays relative to past guidance in dosing the first patients on this trial and therefore, wanted to provide more granular information on the study status and why we remain and the NCI remains excited by this study. That's how 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 NCI process. After an NCI and IND is cleared, there are several steps that the NCI puts in place for any trial before the first patient is enrolled. This includes transfer of production for research group to the manufacturing team. As we near 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 TCR-T.These new learnings benefit not only the study of the NCI, 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 a proven engine of ingenuity. Their efforts have also helped de-risk the TCR-T trial as Ziopharm moves to control our own program at Anderson. I'm happy to report that the NCI is moving towards the final engineering runs, which when completed will ready then to enroll the first patient. In the interim, patients who come to the NCI continue to be evaluated and considered for this study. The most appropriate candidates are going through the TCR procurement process with their tumors resected neo-antigens identified as TCRs made. Based on the very recent input from the NCI, we estimate that Dr. Rosenberg will treat the first patients in the first half of this year. We are confident with the updates to the NCI process and plans for enrollment, and we're eager to share news of the first patient enrolled.I've mentioned in January’s webcast update, we are also implementing plans to bring the TCR-T program under our control. One of last year's important milestones was our announcement on October 28th of an expanded research and development agreement with MD Anderson to encompass our TCR-T program, and which provides the new home for our growing team and interest in Houston.The relationship with MD Anderson it's a significant competitive differentiator as it enables us to execute on two Ziopharm led approaches infusing TCR-T for solid tumors. One uses TCR’s existing in a library to target neo-antigens occurring in hotspots. The other is based on the work of the NCI under IMD to target personalized neo-antigens. Both approaches use the same methodology to produce TCR-T using the sleeping beauty system developed at the NCI. These two packs provide us and patients the best chance to treat many types of solid tumors.At MD Anderson, we can enroll patients with a variety of solid tumors and we anticipate significant patient flow to our TCR-T program. Indeed, our set of licensed TCRs and the NCIs is already enough to begin enrollment to the hotspot trial. The access to patients and tissues will accelerate the expansion of the library of TCRs targeting neo-antigens in hotspots. We continue to work on our regulatory roadmap, and are currently engaged with FDA on our two approaches targeting neo-antigens in solid tumors.We believe that already having an open Phase II IND with the NCI provides us with a head start and 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 on our IL-12 program. In 2019, we made considerable clinical progress in our controlled IL-12 program, and received positive FDA feedback granting us fast track designation and in Europe, we have received an orphan drug designation. We have completed enrollment to our two recurrent glioblastoma or GBM Phase 1 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 levels.Beginning in the third quarter of 2019, we commenced a Phase 2 study for recurrent GBM in combination with Regeneron's Libtayo, and that study should complete enrollments in the first half of 2020. Since our last quarterly call, five additional clinical sites have come online with now seven of 10 sites enrolling patients. In total, more than 95 patients with recurrent GBM have been treated at the desired 20 milligram dosing of veledimex, with over 80 patients enrolled since 2018 alone. More than three quarters of those patients received low dose steriods, which we believe help IL-12 achieved 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 extend the program outside of recurrent GBM. We believe that if IL-12 could meaningfully improve patient outcomes in this cancer then it can be effective in many other indications, either alone or in combination with immune checkpoint inhibitors.Considerable data were published or presented from these studies during 2019, including at ASCO in June and at the Society of Neuro-Oncology or SNO, in November. Results from the Phase 1 monotherapy main trial were also published in the journal Science Translational Medicine last August. Links to these presentations can be found on our Web site. Our team's presentation at SNO a few months ago provided evidence for the first time of regression of glioblastoma based on imaging. We also presented confirmatory data, demonstrating 16 month median overall survival in patients with recurrent unifotal disease receiving low dose steroids.We are pleased to note that the Ziopharm team received the top five award at SNO 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 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 milestone, we announced in October that the FDA had cleared an investigator initiated IND for Phase 1 clinical trial to be conducted at MD Anderson. As we have previously stated, this study will evaluate infusion at donor derived CAR-T created through rapid personalized manufacturing or RPM in patients with CD19 expressing leukemias and lymphomas who have relapsed after allogeneic bone marrow transplantation. Under the RPM process, we can those patients as soon as the day after gene transfer, including verification but the CAR-T needs release criteria.During our last quarterly call, we said our team was working hard with MD Anderson to get the trial started by the end of 2019. As a reminder, MD Anderson is manufacturing the product for the study. And as we rounded out the year, some delays were experienced as the technology transition to their GMP facility. But I'm pleased to tell you things have gone well since. Final qualification batches are underway with the required regulatory step referred to as the site initiation visit or SIV planned in the coming weeks. Indeed the first patient is being identified by our principal investigator for this trial, and initiation of this study is an important near-term milestone for our company. And we look forward to sharing views 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 encoring long-term outcome data after infusion of sleeping beauty modified CAR-T based on a prior generation of this technology. This describe outcomes of patients with relapsed or refractory B-cell lymphoid malignancies, all of whom had received CD19 specific CAR-T infused autologous bone marrow transplantation. Four 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 personalized manufacturing with TCR. These results show that T-cells genetically modified using DNA plasmids from the sleeping beauty system to express TCR with membrane bound IL-15 exhibited anti-tumor effects. These data build on our approach to reduce the cost and complexity of T-cell therapies.Finally, an uptake on our joint venture Eden BioCell. 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 is staffed and equipped and the scientists are currently conducting test runs of the RPM process. They have also commenced discussions with the Taiwanese FDA as we expect the first trial to start at a large hospital in Taipei. Our partners at Eden BioCell advise us the IND for the autologous RPM CD19 CAR-T trial will be filed this year. It is worth noting that the travel restrictions with new corona virus in China have to-date not prevented Eden's ability to work in Taiwan. And while the situation will continue to be monitored, we are not experiencing significant delays.In summary, over the past 16 months, we have assembled the technology, people and funds and made significant progress in all our programs, dispose well for the future; and 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 to Ziopharm. And now, I will hand the call to our CFO, Sath Shukla.

[Sath Shukla:]

Thanks Laurence, and good afternoon, everyone. Let me begin by saying a few words about our recent financing efforts to achieve our vision to develop treatment for all patients with solid tumors. It is essential that we keep the company well capitalized in comparison to competitors in the cell and gene therapy space.As we disclosed at the end of the third quarter of 2019, our cash balances at that time provided a 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 first several months of 2020. We carefully evaluated this timing and considered it to be risky. We do have market catalyst expected this year, but we came to the conclusion that hoping and reaching for the exact right time while exposing the company to capital markets and political risk was imprudent.Furthermore, given that many of the biotechs were securing capital in late 2019 and early 2020, potential deal fatigue and limited available funding could post substantial additional risk if we waited too long to secure financing. We therefore began executing on fortifying our balance sheet starting in December, first, engaging in some ATM financing for approximately $16 million. However, following a successful JPM event where we shared the company's prospects at multiple top tier biotech investors, management turned off the ATM and engaged in a traditional financing. This financing was achieved quickly, de-risked our balance sheet, and will now enable us to accelerate and achieve many important goals for the next tow pivotal years for the company. The proceeds in addition to current market prices and conditions also preclude the necessity of using the ATM anytime in the near future.The new capital serves many fiscal personal purposes and to drill down a bit more concretely related to the use of these proceeds, we can; first, accelerate the build out of our new Houston facility on the campus of MD Anderson, which will serve as foundation for the commercial path for our TCR program; second, accelerate the expansion of our TCR library to support our TCR hotspot trial; next, advance the recruitment of specialists personnel for our TCR program and also to support potential broadening clinical initiatives for our controlled IL-12 program as we advance toward later state studies and potentially other indications; and, we can now take control of manufacturing with both personnel and infrastructure, which have been a limiting factor compared to our peers, 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 will provide great value for Ziopharm in the medium and long-term.Turning to the specific financial results for Ziopharm fourth quarter of 2019. As noted in our news release, research and development expenses were $10.2 million for Q4 of 2019 compared to $8.2 million for Q4 of 2018. This increase reflects expansion of the company’s clinical programs, including the initiation of the Phase 2 combination trial of controlled IL-12 Libtayo, as well as look for both TCR and CAR-T programs.G&A expenses were $5.8 million for the fourth quarter of 2019 compared to $4.6 million for the fourth quarter of 2018. This increase reflects our increased headcount, recruitment of key personnel and expanded capabilities.On a cumulative basis for the fourth quarter of 2019, we reported a net loss applicable to common shareholders of $15.7 million or $0.09 per basic and diluted share. Comparably in the fourth quarter of 2018, Ziopharm recorded net income applicable to the common shareholders of $194.5 million or $1.29 per share basic and diluted. The increased income attributable to common shareholders in 2018 resulted primarily from the forfeiture and return of all the company’s Series 1 preferred stock held by its pharma partner and the relinquishment of Ziopharm obligations under a pharma agreement, accounting for approximately $207 million.For the full year 2019, R&D expenses came in at approximately $38.3 million compared to $34.1 million in 2018, while G&A came in at $19.5 million, slightly below the $19.9 million in 2018. The ramp in R&D spend, while maintaining discipline on the G&A spend, reflects the company's continued commitment to optimal capital allocation to focus on progressing the science. We are dedicated to growing our business and putting Ziopharm in the best possible position to capitalize on our compelling technologies.In addition to the $80 million in cash at year end, we also had a payment balance of approximately $20.3 million for work 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 build into mid-2022. And now, I will turn the call over to David for final comments.

[David Mauney:]

Thanks. Before I provide some comments on our business, I'll share a brief word on new corona virus or Covid-19. Our thoughts go out to all of those affected by this difficult illness. We are currently assessing the impact a broader spread of the illness may have on our business, and have begun identifying mitigation plans as needed. As Laurence noted, our colleagues at Eden and TriArm have confirmed that they continue making progress and they do not currently expect significant business disruption in our CD19 program in Greater China.Further enrollments in our IL-12 clinical trials, all of which are in the U. S., are either complete or nearing completion and we have drug available to complete our ongoing studies. Our planned TCR-T 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 NCI and MD Anderson as the situation in the U. S. of all. And of course, we will be evaluating the impact this may have on our employees’ day to day activities.Fortunately, we already have the IT systems in place that allow most of our 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 the solid tumor. And if we achieve that goal, significant rewards can be seen. We have worked hard and fast to create unique attributes for Ziopharm, which Laurence has covered today and the market opportunity for us is tremendous as Ziopharm has commercial rights to multiple billion dollar markets.We're of course engaged in multiple continued dialogues with potential partners and as Laurence 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 outlook in discussions to now also have additional efforts where we are considering in licensing technology and IP to build upon our foundational assets.We have expanded our business development capacity internally and we have engaged third parties to review and advice 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 us 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 to continue the trend at landing top tier people with excellent capabilities. We are building up and 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've engaged a West Coast firm and are in the process for 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 roll out 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 can 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, Laurence's training gives them an uncanny knack for seeing the movie play out before the script is even written. And we have the fortitude, commitment and now the backing, to see his predictions come true for all of us. Thank you for your continued support. And with that, I turn the call over to the operator for questions.

[Operator:]

[Operator Instructions] First question comes from the line of I-Eh Jen with Laidlaw and Company. Your line is now open.

[I-Eh Jen:]

Good afternoon. And thanks for taking the questions and congrats on the progress that’s quite an remarkable altogether. Maybe two quick questions here, the first one is for the MD Anderson in terms of TCR-T development. Are you guys going to wait for the NCI complete their protocol and start to enroll patient before the work over in MD Anderson so you have a more homogenized the protocol, clinical study protocols, or you will have additional sort of modification adjustment on that?

[Laurence Cooper:]

So the clinical trials with MD Anderson, you can anticipate those to start alongside the NCI. The NCI to us is a program that has great value, not only today but going forward. You could I think expect continued iteration by Dr. Rosenberg and his group and those learnings under our CRADA will see back into MD Anderson and our clinical trials. So to put it all together, we enjoy 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 MD Anderson and then we'll have to have more to say about that going forward.

[I-Eh Jen:]

And then maybe to follow-up a little bit on that from revenue cost perspective, we anticipate that once you start the MD Anderson work on TCR-T, the R&D expenditure could increase more substantially I guess than otherwise we will model?

[Laurence Cooper:]

Yes, so we'll review the model and we’ll try and get back to you on that, I-Eh. But yes, there will be a ramp in the R&D expenditure obviously for sure, because we are an R&D company. And if you look at how much we actually put in OpEx this year and our runways on cash, and we just closed that right now we are anticipating a cash taking us in the middle of 2022, we can sort of back into sort of ramp expected, obviously, this year also next year and then going into 2022. So certainly, the expectation is that we will execute more and therefore we will spend more.

[Operator:]

Our next question comes from Thomas Flaten from Lake Street Capital.

[Thomas Flaten:]

To follow-up on the earlier question with respect to the MD Anderson TCR study running alongside NCI, given that you're still in discussions with FDA around protocols and things like that. Could you provide some more granularity on those specific discussions, IND submissions clearances et cetera, just so we understand how those things will run alongside one another?

[Laurence Cooper:]

I think the way I think about it is, the playbook in terms of the IND, has been established by Steve Rosenberg. We take that playbook now and adapted to our own commercial facing needs at MD Anderson. Those discussions are underway with the regulators, and they will come to rest soon. And then we will update you and the market on our plans in fuller detail.

[Thomas Flaten:]

And then just kind of tied into that, and then I'll jump back in the queue, with respect to having data for across all three programs in 2020. Could you comment a little bit on what types of data we might expect to see? I'm having trouble seeing the timeline come together with kind of the broad for second half guidance?

[Laurence Cooper:]

We've got a slide actually that's on the deck. So the way we we’re positioning the company is really just a book end this in the first half of 2020 at the moment, so as you look at those programs we’ll have a dosing at the NCI trial that’s a Phase 2. We'll have enrollment to our Phase 1 trial for the rapid personalized manufacturer of CAR-T. We'll have announcement around the completion of enrollment and the initial data readout for our controlled IL-12 in combination with Libtayo. We'll have Phase 1 data readout with controlled IL-12 in combination with Opdivo. And we'll have Phase 1 data readout from controlled IL-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 next quarter or so, we’ll then move that timeline so that you can look deeper into the company for the second half of this year. So that's a pretty significant package for jus this first half.

[Thomas Flaten:]

Just a follow-up, so if you're going to be dosing in the first half at NCI. Do you have a sense from Rosenberg with respect to number of patients, cadence of enrollment so that you can actually get data out in 2020?

[Laurence Cooper:]

So that timeline and with respect to the public is governed by Dr. Rosenberg, and that's really a lot of the impetus for us to be moving the technology under our own INDs down to Houston with MD Anderson. But having said that, Steve's been an excellent steward of our technology and quite frankly the field and regularly put out important updates, and I expect them to do the same with rapidity around our program.

[Operator:]

Our next question comes from RK of H.C. Wainwright.

[Swayampakula Ramakanth:]

Just on the on the NCI program, as you’re learning more about the process itself. So after NCI runs these successful manufacturing runs for clinical material to get started. Is there anything else that they need to do before they get the study going?

[Laurence Cooper:]

So the manufacturing, obviously, is a important part that's governed under the IND, you’ve heard my comments around how then learning was added on top of the IND. And then once Steve is ready to go, the patients then essentially that are in the queue can then be treated. So there's going to be, I think, an important part of the story where not only the manufacturing solutions, I think when he’s checked that box, but the patients then essentially have that clinical need that they need to essentially receive that TCR therapies and Steve governs that transition essentially as patients come off queue into essentially the clinical trial.

[Swayampakula Ramakanth:]

And on the controlled IL-12 program. Outside of GBM, what are the tumors would you think are likely target and if costs is no issue, which ones would you be going after?

[Laurence Cooper:]

So for us, our clinical data really teaches us that IL-12 can turn whole tumor hot, and we think that's important, especially for tumors that have failed in the checkpoint inhibitors. So we are looking closely at those types of tumors. In other words, immunological deserts, once in which they can be affected from an influx of T-cells, and there's a set of 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.

[Swayampakula Ramakanth:]

And then the last question is regarding the date expected during the first half. Is that pretty much wait till the end of the first half into ASCO, or it could be any other…

[Laurence Cooper:]

It could be anytime. We see a continued divergence of data throughout this first half.

[Operator:]

Thank you. Our next question comes from Jim Birchenough with Wells Fargo. Your line is now open.

[Unidentified Analyst:]

It’s Nick on for Jim this afternoon, congratulations on -- this seems like this is going to be great year for the company. So I'm sure you're very excited about all the progress. Just in terms of the hotspot trial, also the new antigen trials. It seems like the differential, difference here between the NCI approach and your approach will be in terms of the algorithms and technologies used to identify the hotspots outside of the two trials will be very similar. Is that the case?

[Laurence Cooper:]

Yes, I think that's a good starting point, Nick. Both the NCI and Ziopharm will be pursuing the personalized TCR-T therapy. That's a very broad solution really for most patients, actually quite frankly with solid tumors. In addition, though, Ziopharm with its partner at MD Anderson will be developing the hotspot trial. And as you know that’s the way to treat a subset of patients but to do a much faster, because you're screening the patients for the mutated antigen.

[Unidentified Analyst:]

And on that trail, will you be in a position to essentially -- I think you made a comment that you already have enough TCR from the library to execute a trial. Will it be an all-comer trial or will you initially be, well, let's look at certain subset KRAS, for example?

[Laurence Cooper:]

No, that's exactly the right question, Nick. We're in dialog about that, there's 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 to you.

[Unidentified Analyst:]

And then last one form me and I'll back in the queue, and you referred to IL-12, so now you have cash through the middle of ‘22. You're going to have critical data by midyear for this program. What are you assuming in terms of additional trials beginning through the middle of '22? Because I think at one point in the past, I think to recall that your preferred way forward IL-12 was with a partnership.

[Laurence Cooper:]

No, I think as the data come in, especially through the expansion study and the Phase 1 trial study with Opdivo, we've seen really reassuring data, Nick. I mean, we've got pretty significant long-term survival, 16 or so month now. We've got clear evidence of anti-tumor effects are based on MRI scan. We have serially biopsied these patients and shown influx of T-cells. So these data are means that the company's done a lot of work since I think essentially those comments were put out there, at the time that was correct. There was a look for a potential partner. But now I think there are many options for Ziopharm and we're going to really essentially look at these data coming in through the year and see what makes the best sense for the company.

[Unidentified Analyst:]

So just to clarify, do you have money that assigns for additional -- starting additional trials in '21, '22?

[Laurence Cooper:]

Sure, I'll turn it over to Sath here.

[Sath Shukla:]

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 with the program and progress in our GBM and potentially other indications, we have assumed that the funding for that today comes from the company for planning purposes and we layout of the cash to runway. Obviously, when data rollout and we decide whether and which partnerships to explore that number could change. But conservatively, we not built in any partnership funding in any of our analyses.

[Operator:]

Thank you. Our final question is a follow up from I-Eh Jen. Your line is now open.

[I-Eh Jen:]

Are you guys going to announce when you saw the pace on the TCR-T study at the MD Anderson in the press release or some other sort of methods?

[Laurence Cooper:]

So just to clarify, we will announce when the TCR-T trial starts, enrolls at the NCI. We will also guide the market on our plan for our own commercial activities at MD Anderson.

[I-Eh Jen:]

And maybe just one more question here, which is that in terms of combo study, Opdivo data you intend to record this half of this year? Should we anticipate anything related to the time or just the duration of the study that the endpoint such as, so progression free survival others, or simply which is mainly focused on the response rate and other relevant datasets?

[Laurence Cooper:]

What I try and do -- what the company tries to do is show survival, because that is the benchmark, that's by which they -- as well as the FDA, will allow potential products to move forward. But in addition, because we work with academic centers, we’re often able to add additional color to those data, for instance the immune response data, whether that’d be through biopsy or through antigen. So that type of package will be put together I anticipate for the first half of this year. And as a guide, you can look back at the SNO poster that we put out last November is essentially the template for the way the company is keeping this tree apprise of our activity.

[I-Eh Jen:]

Okay, great. That’s very, very helpful. And again, congrats on the progress so far.

[Laurence Cooper:]

Okay. Thank you very much for questions. And I think that concludes the call and everybody have a good day.

[Operator:]

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program and you may now disconnect.