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Edited Transcript of ZIOP.OQ earnings conference call or presentation 5-Nov-20 9:30pm GMT

·33 min read

Q3 2020 ZIOPHARM Oncology Inc Earnings Call NEW YORK Nov 7, 2020 (Thomson StreetEvents) -- Edited Transcript of ZIOPHARM Oncology Inc earnings conference call or presentation Thursday, November 5, 2020 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Adam Levy * Christopher Taylor ZIOPHARM Oncology, Inc. - VP of IR & Corporate Communications * Laurence James Neil Cooper ZIOPHARM Oncology, Inc. - CEO & Director * Satyavrat Shukla ZIOPHARM Oncology, Inc. - Executive VP & CFO ================================================================================ Conference Call Participants ================================================================================ * Alethia Rene Young Cantor Fitzgerald & Co., Research Division - Head of Healthcare Research * David Novak Raymond James & Associates, Inc., Research Division - Research Analyst * I-Eh Jen Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst * Thomas Flaten Lake Street Capital Markets, LLC, Research Division - Senior Research Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Thank you for standing by. This is the conference operator. Welcome to Ziopharm Oncology Third Quarter 2020 Earnings Conference Call. (Operator Instructions) And the conference is being recorded. (Operator Instructions) I would now like to turn the conference over to Chris Taylor, Vice President of Investor Relations and Corporate Communications. Please go ahead. -------------------------------------------------------------------------------- Christopher Taylor, ZIOPHARM Oncology, Inc. - VP of IR & Corporate Communications [2] -------------------------------------------------------------------------------- Thank you, operator. Good afternoon, and welcome to the Ziopharm Oncology conference call and webcast to review results for the third quarter ended September 30, 2020. This afternoon, we filed our 10-Q and issued our third quarter financial results release, both of which are available in the Investors section of our website, ziopharm.com. For informational purposes, we have included in our webcast a set of PowerPoint slides to accompany today's commentary. These slides can also be found in the Investors section of our website. During this call, the company will make several 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-Q and within other filings that we may make with the SEC from time to time. Leading our call today for Ziopharm will be Dr. Laurence Cooper, Chief Executive Officer; and Sath Shukla, Chief Financial Officer. Following commentary from our management team, we will open the call to Q&A. (Operator Instructions) Thank you. I'll now turn the call over to Dr. Cooper. Good afternoon, Laurence. -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Chris, and good day, everyone. We hope you are safe and well. We have been making progress in many areas while navigating the impact of the COVID-19 pandemic. This is a challenging environment for everyone. Yet where we have direct control, we are executing and have been making meaningful advancements. First, let me begin with our Sleeping Beauty TCR-T program, where we are making great strides to progress our internal program from our Houston campus alongside MD Anderson. Ziopharm has expeditiously expanded our infrastructure footprint in Houston, leasing facilities from MD Anderson to increase our laboratory presence. We have hired highly-skilled personnel specializing in areas such as the genetic modification and growth of primary T cells, bioinformatics, process development, manufacturing of clinical-grade T cells, correlative studies and ancillary services. Our team is optimizing today's T cell biology and establishing foundational science for next-generational programs intended to overcome challenges posed by the tumor microenvironment and to increase T cell functionality. Also, behind the scenes, our team has been working on assembling data in support of regulatory documents as well as investigating next-generation technologies combining TCRs with cytokine biology. We have built a formidable bioinformatics program in support of neoantigen identification and a group that identifies and characterizes T cell receptors or TCRs. Manufacturing of our TCR-T for human use is an important part of the program. We are building a clinical production unit, or CPU, to provide backup to our outsourced approach to manufacturing. This pilot facility not only helps insulate Ziopharm from uncertainties in the supply chain, but may also facilitate and accelerate the testing of new future ideas in the clinical setting. We are only using a small portion of our existing footprint on the MD Anderson campus for this, and expect it will be ready for manufacturing and compliance with current good manufacturing practices next year in support of our clinical timelines. We continue to be on track to file our IND in the first quarter of next year. And as previously disclosed, Ziopharm has prioritized the TCR-T hotspot trial, for which we anticipate treating patients in mid-2021. Also, as mentioned before, we are preparing for this submission based on the information received from the FDA earlier this year through the pre-IND process. To prepare for this trial, the team has curated and embedded immune receptors from our libraries that already contained 30-plus TCRs that together can treat 19 unique tumor mutation HLA combinations. We have sufficient TCRs to launch our first TCR-T clinical program, and to begin with, will be clinically evaluating a subset that recognize common hotspot mutations in KRAS and TP53 genes for patients with advanced cholangiocarcinoma, gynecologic, colorectal, pancreatic and non-small cell lung cancers. These 2 genes have fundamental importance to the formation and growth of malignancies. For example, KRAS promotes cell differentiation, proliferation and survival. Dominant cancerous mutations of KRAS are typically single amino acid substitutions highly prevalent in tumors. We have seen recent data how small molecules targeting the so-called G12C variant of KRAS can result in anticancer responses, and the vulnerability of tumors to KRAS biology bodes well for our TCR-T library approach. Ziopharm's neoantigen and TCR hunting technologies allow us to identify TCRs that recognize KRAS mutations that include the G12C variant as well as other mutations. Thus, while small molecules can only target G12C, we are building a library that targets other genetic changes to KRAS. In addition to targeting KRAS, Ziopharm is also targeting another driver mutation. TP53 is considered among the most mutated genes in human cancers as it functions as a transcription factor to regulate cell division and stabilize the genome. Our neoantigen and TCR hunting technologies have enabled us to assemble a library of TCRs that target TP53 mutations, which we can draw from in our clinical trials. And this bodes well for our future as this gene is genetically altered in almost every type of cancer. After the IND has cleared, enrollment to the library TCR-T trials will be based on rapid screening of patients for pre-identified neoantigens and matching these mutations with TCRs from the library that recognize the targets with shared HLA. We will be accruing patients from multiple cancer types at one of the nation's top cancer centers with support of multiple physicians. We are, in an essence, conducting a trial treating 5 indications with multiple TCRs under one clinical protocol. Our advantage grows, as we continue to increase the number of TCRs in the library, through licensing on our own in-house discovery team. Indeed, just this past quarter, we expanded the TCRs available for us to use in our library. Simply put, the larger the number of TCRs available to clinical use, the greater the chance of matching the targeted mutations and HLA with a prospective patient's cancer. Our advantage continues further as we bring online the personalized TCR-T trials. This technology targets patients' unique antigens in their cancer rather than shared mutations in neoantigens. This personalized approach is applicable to most epithelial cancers, and we address head-on the need to efficiently target multiple individual cancer mutations that give rise to each patient's unique neoantigen mixture. We will address this opportunity after initiating the library TCR-T trial by launching our personalized TCR-T trial with the capability to administer T cells with more than one specificity for more than one neoantigen. With our plan to rapidly treat patients after screening with TCRs from our library as well as layering in a personalized approach with the potential to treat multiple types of solid tumors in the majority of patients, one can begin to appreciate the breadth and potential of our internal TCR-T program. The build-out of our infrastructure and expertise in support of our TCR-T program requires careful planning and execution that dates to the split with our former partner. This requires a tremendous expertise in the know-how of cell and gene therapy. I'm fortunate to have been working on genetically modified T cells for 20-plus years. In all that time, I've never worked with a group that is so quickly up to speed, competent, resourceful, focused and excited about the work they're doing for patients. We are proud at Ziopharm that we are tracking to a timeline from licensing TCRs to filing a corporate IND in about 2 years, which stacks up well compared to other cell therapy companies. We were able to achieve this rapid progress, thanks to the unwavering support from Dr. Steven Rosenberg at the National Cancer Institute or NCI. He and his team have been helping to guide the creation of Ziopharm's internal program as well as making TCRs available for in-licensing to our library. You will recall that after we separated from our former corporate partner in October 2018, Ziopharm had limited capabilities, and were reliant on the NCI to advance the TCR-T program through a cooperative research and development agreement or CRADA. We have guided the market since early 2019 that we've been building out our own internal capabilities to commercialize the TCR-T program. Thus, while we are grateful to the NCI, we are no longer dependent on them to make progress on the TCR-T program. This is important to note as the NCI hones in on when they will be able to treat the first patient on the Sleeping Beauty personalized TCR-T trial. In my conversations with Dr. Rosenberg, he reiterates the potential of the Sleeping Beauty platform and his excitement about his first nonviral TCR-T trial at the NCI. This program is under the direction and timing of Dr. Rosenberg, and he believes that the dosing of the first patient on this trial will occur next year. We have completed the technology transfer of Ziopharm's engineering runs back to the NCI to generate Sleeping Beauty modified T cells, and they have authenticated this methodology and are in the process of repeating the runs in their GMP facility. However, the treatment of the first patient is dependent on regulatory review changes at the National Institute of Health and significantly, the availability of patients. While Dr. Rosenberg's team is working to replenish the queue of potential patients that was sadly depleted due to the shutdown, the pace of identifying prospective recipients of TCR-T is slower than before COVID-19. There are a few patients with solid tumors in the wings that could be eligible for treatment, but the ongoing pandemic is unfortunately taking a toll, which we believe will impact the NCI's ability to enroll patients to any TCR trial. Moving now to our CAR-T program, where we have active programs, both here in the United States at MD Anderson and in Greater China with Eden BioCell, our joint venture, which we own 50-50 with TriArm Therapeutics. Ziopharm is delighted by the progress reported by Eden BioCell and its partners. In Taiwan, Eden BioCell has begun the process of filing an IND to be completed by the end of the year for a clinical trial to assess patient-derived or autologous CAR-T that are produced using rapid personalized manufacturing or RPM technology. RPM enables T cells to be very quickly infused as soon as the day after gene transfer. This is based on the Sleeping Beauty system's ability to stably insert multiple genes into T cells and without the need to propagate T cells outside the body. After gene transfer, also known as electroporation, the T cells are genetically modified to express the CD19-specific chimeric antigen receptor, or CAR, and membrane-bound IL-15 or interleukin-15. The very next day, the T cells meet release criteria and are infused. This state-of-the-art technology helps address the worldwide urgent need to reduce costs and simplify production of CD19-specific CAR-T. Given the promise of the RPM technology, Eden BioCell and partners have been approached to treat patients with multiply relapsed CD19 positive malignancies under compassionate use. They are pleased to report the dosing of several patients with autologous CD19 specific CAR-T manufactured using the RPM process. Initial data confirmed the presence of infused T cell week softer infusion in peripheral blood and bone marrow, and that RPM CAR-T can be infused without unexpected toxicities. These data appears to support the benefit of genetically modifying T cells with membrane-bound IL-15. Additional follow-up is underway in Asia. At MD Anderson in Houston, our CD19 specific CAR-T study with donor-derived or allogeneic T cells prepared under RPM is open. And the team is already screening and evaluating patients for enrollment in the Phase I trial. The study will enroll patients that have relapsed after bone marrow transplantation with CD19 expressing malignancies. We will be highlighting the progress in our T-cell program at our planned R&D Day, which is scheduled for Q1 next year to allow us and our aforementioned guest speakers' time to provide a comprehensive overview of our program. Now to our controlled IL-12 program, specifically, our Phase I/II study in pediatric brain tumors. We may treat up to a total of 12 patients in the initial portion of the trial. And I'm pleased to say that all 3 clinical sites, Lurie Cancer Center, Dana-Farber and UCSF, are active. The trial is designed to evaluate the safety and tolerability of our viral vector engineered to produce IL-12 or interleukin-12 under the regulation of oral dosing of veledimex. During the past quarter, we received a rare pediatric disease designation for controlled IL-12 in the investigational treatment of diffuse intrinsic pontine glioma or DIPG. At this early point in the trial, we are focused on the safety of the first patients. Ziopharm's clinical partners are instrumenting the brainstem of children, which is obviously critical and sensitive anatomy, in order to inject the virus to conditionally deliver our powerful IL-12 cytokine. We are treating children with literally no options for survival as their DIPG relentlessly invades the brainstem. We will be closely monitoring the tolerability and safety of these initial patients. You will see us at the upcoming virtual Society for Neuro-Oncology or SNO conference later this month, where we have 3 abstracts accepted for presentation. We will present new data on controlled IL-12, including a first look at the DIPG indication, initial data from the Phase II study of controlled IL-12 with the PD-1 inhibitor, Libtayo, in recurrent glioblastoma, and an update on the combination study with Opdivo in recurrent glioblastoma. We plan to announce additional details as we get closer to the conference. On the corporate side, during the quarter, we expanded our Board of Directors with the additions of biotech entrepreneur James Huang, following shareholder feedback; and industry veteran, Kevin Buchi, after a national search. The appointments complement last year's additions of Dr. Christopher Bowden and Heidi Hagen. Ziopharm's Board now consists of 8 individuals, including 7 nonemployee directors, who have extensive experience in finance, business development, operations and health care, among other areas of expertise. The Board is highly focused on what is best for shareholders and the long-term success of the company, and a process has been underway since July following our Annual Meeting to refresh the Board with complementary skill sets optimal for a clinical-stage company in our space. Building on the appointment of 2 highly-qualified directors in recent months, the Board will continue to utilize the services of an independent national executive search firm to facilitate additional refreshments, and we look forward to sharing more as the process continues. During the quarter, we also named 4 additional new members to our Scientific Advisory Board led by Dr. Carl June, welcoming Drs. Adi Barzel, Gavin Dunn, Matt Porteus and Kole Roybal. We continue our plans to recruit a Chief Medical Officer and potentially other senior executives. In our news release this afternoon, we announced the addition of Adam Levy, who joined us this week as Executive Vice President, Investor Relations and Corporate Communications. Adam was most recently Executive Director and Head Corporate Strategy and Investor Relations for Gilead sciences. Previously, he was VP, Corporate Strategy for Alexion and Executive Director, Corporate Strategy for Bristol-Myers Squibb. He also had prior leadership positions with Novartis and McKinsey & Company. He earned a PhD in Molecular Biology from the University of Illinois and an MBA in Finance and Strategy from Northwestern University, Kellogg School of Management. Adam will be working with Chris, Sath and the rest of the Ziopharm team, directing our IR and communications efforts as we move forward. We are glad to have him aboard, and offer you the chance to hear from him directly. Adam? -------------------------------------------------------------------------------- Adam Levy, [4] -------------------------------------------------------------------------------- Thanks, Laurence. I'm very excited to join you and the Ziopharm team. I've certainly tracked the company's innovation in the cell therapy space as well as the promising platforms and programs for some time. In my diligence, it was clear that Ziopharm is well-positioned to attain a number of value-enhancing milestones across all 3 platforms. I fully recognize that we have more work to do, and I'm eager to get started. In particular, I look forward to working closely with our shareholders and analysts, several of whom I know very well from my time at Gilead. Thanks again for the opportunity, Laurence. -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [5] -------------------------------------------------------------------------------- Thanks, Adam, and welcome aboard. We are so pleased that you have joined us. In closing, I will return to this year's priorities that we have previously communicated. We have been focused on building out our internal T cell program as a value driver for the future, executing on the controlled IL-12 program and bringing our RPM technology to the clinic with CD19-specific CAR-T, all while being careful stewards of capital. While no one could have anticipated the gravity of the ongoing pandemic, we were able to put in place the financing and our own infrastructure beginning in the first quarter of this year to help us weather uncertainties. We have been working diligently through the challenges of COVID-19 and the resulting delays from some of our external partners. However, I do not want these challenges to overshadow the fact that we have made important progress, and are excited by the culmination of all of that good work. With that, let me now turn the call over to Sath for a review of our financials. -------------------------------------------------------------------------------- Satyavrat Shukla, ZIOPHARM Oncology, Inc. - Executive VP & CFO [6] -------------------------------------------------------------------------------- Thank you, Laurence, and good afternoon, everyone. Let me start with a quick review of our financial results for the quarter. As noted in our news release, research and development expenses were $14 million for the third quarter 2020, compared to $8.6 million for Q3 of 2019. The difference reflects increased clinical trial activity and increased headcount in our R&D team. G&A expenses was $6.4 million for the third quarter of 2020, compared to $4.8 million for the third quarter of 2019. The increase is primarily due to higher headcount, legal costs associated with an expanded patent portfolio and facility costs. On a cumulative basis for the third quarter of 2020, we reported a net loss applicable to common shareholders of $20.3 million or $0.10 per basic and diluted share compared to a net loss of $74 million or $0.43 per share for the third quarter of 2019, which had reflected a $60.8 million or $0.36 per share noncash charge for an inducement warrant. Cash and marketable securities, as of September 30, 2020, was $135.5 million. In addition, we also had a prepayment balance of approximately $11.4 million for work to be conducted by the company at MD Anderson. Consistent with our prior disclosures, our cash position is forecasted to be sufficient to provide funding for all our programs and infrastructure build until mid-2022. With that, I will turn it back over to Laurence. -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [7] -------------------------------------------------------------------------------- Thank you, Sath. Before I open the call for Q&A, I want to mention again our plan to conduct an R&D Day. We're excited to showcase our progress and provide an opportunity for the investment community to hear from our very distinguished faculty of clinical partners, scientific advisers and KOLs. And with that, operator, we're pleased to move to Q&A. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) And our first question is from the line of Robert Song with Jefferies. -------------------------------------------------------------------------------- Unidentified Analyst, [2] -------------------------------------------------------------------------------- Great. Thank you for the update and congrats on the progress. Maybe just a few quick ones from me. So first of all, I see you have kind of disclosed the potential targeted new antigen KRAS and the TP53 and potential, the targeted tumor types. Maybe, Laurence, can you just comment a little bit about the potential addressable market among those targeted cancer types, considering the new entity you are targeting and the HLA matching kind of a library? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [3] -------------------------------------------------------------------------------- Yes. Sure, Roger. It's an important part of our program, and thank you. So there's a number of pieces that go into choosing these cancers. The first is the representation of the antigens of KRAS and TP53. The second is the mixture of patients that make up the MD Anderson, essentially patient portfolio, who's coming to Anderson, who has the right HLA background. And then third is the -- as you're getting into sort of what is the market capability. So the way I think about it right now is establishing a proof-of-concept in these very important tumor types. We will be able to get patients from MD Anderson. They are well represented in the -- among the people come to MD Anderson. And the second is that they have the right mutations that we can screen for. They also, though, are significant, significant opportunities in terms of the types of tumors we're going after. I mean if you just look at the list that we put out, colorectal cancers, I mean that's massive all by itself. Non-small cell lung cancer is massive by itself. So there is -- all 3 pieces of the puzzle now really coming into focus. We're out in the right tumors. We're using the right kind of biology, and we'll be addressing formidable market opportunities. -------------------------------------------------------------------------------- Unidentified Analyst, [4] -------------------------------------------------------------------------------- All right. Great. Yes, that's helpful. And then maybe just stick with the TCR. And since you are on track to file the IND early next year first quarter. Just maybe any additional color you want to comment? What's left to prepare for the IND? And so that's that. -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [5] -------------------------------------------------------------------------------- Yes, Roger, that's an important part, too. I mean just to kind of frame this again, we've gone from soups to nuts in 2 years. In 2 years, I just got to emphasize that. That's a remarkable amount of progress. That's establishing the team, building out the labs, identifying the receptors, working with our colleagues at MD Anderson, putting together the CMC package, putting together the production systems, identifying the manufacturing, finalizing the bioinformatics and all the correlative studies and all of the clinical team. It is full on 24/7 for Ziopharm to be able to do this. And I'm just thrilled to be able to tell investors about all the progress we've made in this. -------------------------------------------------------------------------------- Operator [6] -------------------------------------------------------------------------------- (Operator Instructions) And our next question is from the line of Yale Jen with Laidlaw & Company. -------------------------------------------------------------------------------- I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [7] -------------------------------------------------------------------------------- Just 2 from me. The first one is on -- I just want to clarify that the TCR-T trial most likely we're getting patients and to be treated at MD Anderson next year, and it may or may not actually have a trial being done in the NCI. Is that correct or is that not the case? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [8] -------------------------------------------------------------------------------- No. So Yale, thank you. I just make sure I heard the question correctly. It's a little bit faint on my end. So we have the trial queued up under our own IND at Anderson, you're quite right. That's a library trial. That IND, as we've said, is due to be submitted Q1 next year and then the patients to follow. Then we also have the NCI trial under the direction of Steve Rosenberg for the personalized TCR-T trial. We, Ziopharm, will also have a personalized TCR-T trial, but we're managing that important work stream to start after the library trial has commenced. -------------------------------------------------------------------------------- I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [9] -------------------------------------------------------------------------------- Okay. Great. That's very helpful. And also just 2 quick ones. The first one is that you guys are going to have a presentation at SNO. So what should investors to expect from those presentations at this moment? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [10] -------------------------------------------------------------------------------- Sure. So obviously, the actual meat of it is embargoed, so we'll have more to say as we get closer to that. But I can tell you, we have 3 presentations. One of them will address the early data in DIPG and in particular, looking at how this particular patient survived the -- and tolerated the technology. This is incredibly important. The other one is a Phase I trial in combination with Opdivo. So we'll have some maturing data with Opdivo, and we'll have the initial set of data with Libtayo. -------------------------------------------------------------------------------- I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [11] -------------------------------------------------------------------------------- Okay. Maybe the last -- that's very helpful. And maybe the last question here. It's, just recently, there are some chatter in terms of one minor shareholder of you guys and have some a letter sent out publicly. And would you have any comments on any of those? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [12] -------------------------------------------------------------------------------- Yes. No. I think as we've said publicly, we value input from all of our shareholders and take their feedback seriously. -------------------------------------------------------------------------------- Operator [13] -------------------------------------------------------------------------------- Our next question is from the line of Alethia Young with Cantor. -------------------------------------------------------------------------------- Alethia Rene Young, Cantor Fitzgerald & Co., Research Division - Head of Healthcare Research [14] -------------------------------------------------------------------------------- I guess, one, on the SNO data sets, I mean, do you have a perception that the combo should yield a greater synergy than monotherapy? And I mean, I guess, it doesn't really matter either way. And then next question is on the TCR-T trial with MD Anderson. I mean, just to break it down a little bit more. Is it really related to like kind of the capacity and kind of the dynamics related to COVID? Or are there other factors that kind of are lingering to kind of get everything up and running appropriately there? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [15] -------------------------------------------------------------------------------- Sure. So in terms of the combination trial, we're looking at this as real upside. As you might be aware, we reported at ASCO this year, in patients with recurrent GBM, who are -- who received just the IL-12, had a median overall survival of about 16 months with now a pretty mature long-term follow-up. That by itself really stands apart from really our competitors and quite frankly, from the historical data, where the best of the patients lived about 12 months in the recurrent setting. So that looks really encouraging all by itself. And I think as you said, it's really now option value to see if the combo with IL-12 -- excuse me, the combo of IL-12 with PD-1 inhibitors improves upon that. But either way, Ziopharm has a line of sight now to advance clinical trials, at least with the monotherapy, if not with the combination. So then in terms of the trial, the TCR-T trial, I think you said MD Anderson, but I think you're referring to the NCI there. So what -- Ziopharm's partnership with the NCI is very important. Steve has really leaned in and helped Ziopharm over the years, especially with the IND process. But what you're hearing is the consistent message, really dating back to 2019, that Ziopharm is increasingly taking over, essentially, its own future. At the beginning, when we separated from our partner, we didn't have the resources, infrastructure and so forth to really accelerate that program. However, now we do. Undertaking the fundraising, we've hired the people, we have support. And so we are able now to put in place the teams to execute on our own program. This doesn't diminish the work that Dr. Rosenberg is doing, and we're excited for him to be putting patients on trial. But it really allows Ziopharm to operate now independently Rosenberg under our own time lines. And as we said, this is actually going swimmingly well. -------------------------------------------------------------------------------- Alethia Rene Young, Cantor Fitzgerald & Co., Research Division - Head of Healthcare Research [16] -------------------------------------------------------------------------------- Maybe one follow-up. Yes, sorry, wrong Nazi academic institution. Just on the Eden Cell (sic) [Eden BioCell] CAR-T study, I mean, are there expectations that we could potentially see a little bit of data on that program in 2021 since you're sort of starting? And I mean, how important do you kind of think about getting even just some proof-of-concept there with the CAR-T program? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [17] -------------------------------------------------------------------------------- Yes. That's a great question. So as you know, Eden BioCell has both its work under the compassionate use as well as the IND that's making its way through the Taiwanese process, and we're actually quite optimistic about that. So next year, you're quite right. There'll be 2 -- there will be 1, if not 2, lines of communication back to investors from Asia on these -- on the proof-of-concepts around the rapid manufacturing. My remarks today really gave an indication that the technology, at least in these early, early stages as being communicated to us, actually looks encouraging. So we're cautiously optimistic there. We'll also be able to validate that here in Houston with our partner, MD Anderson, because we also have a Phase I trial that's enrolling patients there. And those data will report out. So I think you're right in the timing in that as these data mature, as we are able to follow-up, we'll be able to say more in the new year. But essentially, what investors need to know is that there's some initial good news. -------------------------------------------------------------------------------- Operator [18] -------------------------------------------------------------------------------- Our next question is from the line of David Novak with Raymond James. -------------------------------------------------------------------------------- David Novak, Raymond James & Associates, Inc., Research Division - Research Analyst [19] -------------------------------------------------------------------------------- I guess just one and one quick follow-up. First, with respect to the NCI TCR trial, could you guys elaborate a little bit on the regulatory requirements being implemented? And understanding that the agency is currently under significant burden, a burden, which is unlikely to lighten in the near term, what's the risk here of further delay post Q1 '21? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [20] -------------------------------------------------------------------------------- Yes. So thank you, David. So I think as shareholders have heard me over the months really work with them on the NCI timelines. And it's been difficult for me to match the NCI time lines and investors' expectations. So increasingly, and this is, I think strategically, you can see us doing this, is that we're building out our own program because we can manage that and execute on that independently. And that really accents and I think emphasizes how important Ziopharm is because it has its own TCR-T program. Steve's work, he's just a genius. And we should just reflect on how amazing this man is for the history of cancer therapy and immunotherapy. He's embraced the Sleeping Beauty system. He wants to see this in the clinic. But just as you point out, David, he has a complex system to manage. And indeed, there is oversight on his program from the National Institute of Health. So obviously, that's the umbrella under which the NCI sits. They have their own regulatory processes in place that Steve and everybody at the NCI has to work under. And those are new systems since the IND essentially was cleared. So that's one set of logistics, if you would, or one set of governance structures that Steve is working under. That's not a big burden, but it takes time to work through that. And then, of course, he has to manage his patient queue, which, as everybody knows, in this time of pandemic is quite difficult. And that involves him hunting for the TCRs and so forth and patients essentially being in the wings waiting to relapse. And as I guided in my remarks a few minutes ago, this affects not only our program, and we believe it affects other programs at the NCI. -------------------------------------------------------------------------------- David Novak, Raymond James & Associates, Inc., Research Division - Research Analyst [21] -------------------------------------------------------------------------------- Got it. Great. And just as a quick follow-up, and again, just quickly touching on the current proxy battle with a dissident shareholder here. These things tend to be quite costly with lawyers, advisers and not to mention, fairly disruptive to operations. So just from that perspective and for modeling purposes on my end, maybe Sath, could you provide us with an estimate on how much you think this might actually cost the company when all is through and done? -------------------------------------------------------------------------------- Satyavrat Shukla, ZIOPHARM Oncology, Inc. - Executive VP & CFO [22] -------------------------------------------------------------------------------- David, yes, it's hard to say right now. We disclosed in our G&A estimate for this number that right now might be in roughly $1 million or around that range, but it's very difficult to say because, frankly, that number depends on how circumstances come in and how the current situation evolves. So would that be something that we anticipate spending? We couldn't tell you at this moment in time. -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [23] -------------------------------------------------------------------------------- Sorry. I'm just going to give you another flavor that in terms of my seat, Ziopharm's seat, we value the shareholders' input. But we're also focused on executing. You heard me, again, go through the type of work done in Houston, the type of work we're doing up in Charleston, in Boston area. The company is executing. And I think that's an important part to remind the investor community is that this company is fully working to better shareholder value and better the lives of these patients. -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- Our next question is from the line of Thomas Flaten with Lake Street Capital Partners. -------------------------------------------------------------------------------- Thomas Flaten, Lake Street Capital Markets, LLC, Research Division - Senior Research Analyst [25] -------------------------------------------------------------------------------- I apologize if these are repeats. I had some challenges with my connection. Did you disclose how many patients have been enrolled in the DIPG study? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [26] -------------------------------------------------------------------------------- No, we haven't yet. We can enroll up to 12. I think, Thomas, this is a good example of where you need great expertise to be able to treat a patient, a child with DIPG. And the team that we have assembled at Ziopharm to be able to do this, our partners at these 3 hospitals have all of that. These children are extremists. They desperately need therapy. And it's a program that really, I think, speaks the kind of company that I like to work for, a company that is leaning in that is doing really important work for vulnerable populations. And we benefit essentially from a great team and a great Board to be able to do that. -------------------------------------------------------------------------------- Thomas Flaten, Lake Street Capital Markets, LLC, Research Division - Senior Research Analyst [27] -------------------------------------------------------------------------------- Great. And then maybe one for Sath. The -- there was about $2.5 million worth of the prepayment in MD Anderson that was spent in the third quarter. Once there's patient enrollment and things start really moving down there, how long do you expect that $11.5 million to last? And when will you have to start supplementing that in order to move things forward? -------------------------------------------------------------------------------- Satyavrat Shukla, ZIOPHARM Oncology, Inc. - Executive VP & CFO [28] -------------------------------------------------------------------------------- Yes, so -- no, exactly right. So if you look at our total drawdown, as you say, we came -- we had a drawdown of about $2.5 million there, and our cash number went down a little bit to by about $18 million. So if you think about that from a run rate perspective, that's $11 million and change prepaid balance will be expected to last a couple more quarters, 2 to 3 more quarters. And after that, that will start coming out of the cash balance. So if you think about the net drawdown, it was about 20 -- $21 million. About $18 million of that was on the cash, $2.5 million and change, I believe, from the MD Anderson prepaid. So that will start ramping up going forward. I think if you look at our project ships, let me just close a mid-2022 cash run rate, that's pretty consistent with a total spend that is similar to what we are seeing in this quarter. There will be some quarters that will be higher just seasonality-wise. But in general terms, if you just extrapolate from the cash reduction in this quarter and you draw down on that balance, you would end up right in the ballpark of our disclosed cash from this. -------------------------------------------------------------------------------- Thomas Flaten, Lake Street Capital Markets, LLC, Research Division - Senior Research Analyst [29] -------------------------------------------------------------------------------- Got it. And then one final one, and I apologize also if this is a repeat. With respect to the allogeneic CAR-T study, how close -- screening and evaluating is great, but how close do you think they are to actually identifying the patients? -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [30] -------------------------------------------------------------------------------- Yes. We're working with probably the nation's largest cancer center. That's where I actually had the privilege of working when I led the pediatric program. They are constantly transplanting patients. So I think investors can take heart there that there are patients going through the system all the time. And therefore, we have lots of opportunity to look for patients who would benefit from our technology. -------------------------------------------------------------------------------- Operator [31] -------------------------------------------------------------------------------- And there are no further questions on the line at this time. I'll turn the call back to Dr. Cooper for final comments. -------------------------------------------------------------------------------- Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO & Director [32] -------------------------------------------------------------------------------- Yes. Thank you so much, operator, and thank you, everybody, who listened in and participating. Be safe and be well, and we look forward to talking with you next time. Bye-bye now. -------------------------------------------------------------------------------- Operator [33] -------------------------------------------------------------------------------- That does conclude the conference call for today. We thank you for your participation, and ask that you please disconnect your lines.