Alaunos Therapeutics, Inc. Q3 FY2020 Earnings Call

Thank you for standing by. This is the conference operator. Welcome to the ZIOPHARM Oncology Third Quarter 2020 Earnings Conference Call. As a reminder, all participants are in a listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. I would now like to turn the conference over to Chris Taylor, Vice President of Investor Relations and Corporate Communications. Please go ahead.

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 also included in our webcast a set of PowerPoint slides to accompany today's commentary. These slides can also be found in the Investor 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 for Q&A. In 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. I'll turn the call over to Dr. Cooper. Good afternoon, Laurence.

Thank you, Chris, and good day, everyone. We hope you're safe and well. We've been making progress in many areas while navigating the impact of the COVID-19 pandemic. This is a challenging environment for everyone. Yes, 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, and 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-generation 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 TCR with cytokine biology. We have built a formidable bioinformatics program in supportive neoantigen identification and a group that identifies and characterizes T-cell receptors or TCR. 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 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 abetted immune receptors from our library that already contains over 30 TCRs that together can treat 19 unique human mutation HLA combinations. We have sufficient TCRs to launch our first TCR-T clinical program. And to begin with, we'll be clinically evaluating a subset that recognized common hotspot mutations in KRAS and TP53 genes for patients with advanced cholangiocarcinoma, gynecologic, colorectal, pancreatic, and non-small cell lung cancers. These two 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 that are highly prevalent in tumors. We have seen recent data on how small molecule targeting the so-called G12C variant of KRAS can result in anti-cancer responses, and the vulnerability of tumors to KRAS biology bodes well for our TCR-T library approach. ZIOPHARM neoantigen and TCR hunting technologies allow us to identify TCR that recognized 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 genomes. 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 trial, 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 trial 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 occurring patients from multiple cancer types at one of the nation's top cancer centers with support from multiple positions. We are essentially conducting a trial treating five 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 for clinical use, the greater the chance of matching the targeted mutations and HLA with prospective patients' cancers. 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 and neoantigens. This personalized approach is applicable to most epithelial cancers. We will address the need to efficiently target multiple individual cancer mutations to 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 the T-cell with more than one specificity, for more than one neoantigen. With our plan to rapidly treat patients off the screening with TCR from a 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. To build out our infrastructure and expertise in support of our TRCT-T program requires careful planning and execution that dates to the split with our former partner. This requires tremendous expertise in the know-how of cell and gene therapy. I'm fortunate to have been working on genetically modified T-cells for over 20 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 are doing for patients. We are proud of ZIOPHARM that we are tracking to a timeline from licensing TCRs to filing a corporate IND in about two 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 internal programs as well as the TCRs available for licensing to our library. You will recall that after we separated from our former corporate partner in October 2018, ZIOPHARM had limited capabilities and was 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 non-viral 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 diaphragms engineering runs back to the NCI to generate Sleeping Beauty modified T-cells and they have authenticated this methodology already 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 Institutes 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 autologous CAR-Ts that are produced using rapid personalized manufacturing or RPM technology. RPM enables T cells to be infused as soon as the day after gene transfer. This is based on the Sleeping Beauty System’s ability to safely 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-Ts. Given the promise of the RPM technology, Eden BioCell and partners have been approached to treat patients with multiple relapsed CD19 positive malignancies on 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 cells weeks after 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 modified 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 1 trial. The study will enroll patients that have relapsed after bone marrow transplantation to 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 1/2 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 three clinical sites, the Reiki 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 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 cytokines. 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 the initial patients. You will see us at the upcoming virtual Society for Neuro-Oncology or SNO conference later this month, where we have three 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 two study of controlled IL-12 with the PD-1 inhibitor Libtayo in Recurrent Glioblastoma and an update on the combination study without 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 Wong 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. The ZIOPHARM board now consists of eight individuals, including seven non-employee directors, who have extensive experience in finance, business development operations, and healthcare among other areas of expertise. The board is highly focused on what is best for shareholders and the long-term success of the company. 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 two highly qualified directors in recent months, the board will continue to utilize the services of an independent national executive search firm to facilitate additional refreshment, and we look forward to sharing more as the process continues. During the quarter, we also named four additional new members to our Scientific Advisory Board led by Dr. Carl June, welcoming Dr. 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 of 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 and 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?

Thanks, Laurence. I'm very excited to join you and the ZIOPHARM team. I've tracked the company's innovation in the cell therapy space, as well as the promising platforms and programs for some time. In my due diligence, it was clear that ZIOPHARM is well positioned to attain a number of value-enhancing milestones across all three 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.

Thanks, Adam and welcome aboard. We are so pleased that you've 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 that 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 on 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 about 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.

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 the third quarter of 2019. The difference reflects increased clinical trial activity and increased headcount in our R&D team. G&A expenses were $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 and legal costs associated with an expanded fashion 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 requested a $60.8 million or $0.36 per share non-cash charge for an inducement port. 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 prior disclosures, our cash position is forecasted to be sufficient to provide funding for all our programs and infrastructure built into mid-2022. With that, I will turn it back over to Laurence.

Thank you, Sath. Before I open the call for Q&A, I want to mention again our plans 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 advisors, and KOL. And with that, operator, we're pleased to move to Q&A.

Thank you. And our first question is from the line of Roger Tung with Jefferies. Please go ahead.

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 TP53 and potential, the targeted tumor types. Maybe Lauren, can you just comment a little bit about the potential addressable market among those targeted cancer types considering the new antigen you're targeting and the HLA matching kind of a library.

Yes, absolutely, Roger. This is a crucial aspect of our program, and I appreciate your question. There are several factors involved in selecting these cancers. First, we consider the representation of the antigens for KRAS and TP53. Second, we look at the composition of patients at MD Anderson, focusing on those who have the appropriate HLA background. Lastly, we assess the market potential. Currently, my perspective is to establish proof-of-concept in these significant tumor types. We can attract patients from MD Anderson, where they are well represented, and they carry the right mutations for screening. Moreover, there are substantial opportunities with the types of tumors we are targeting. For instance, the potential market for colorectal cancers is enormous on its own, as is the non-small cell lung cancer market. All three elements of our strategy are coming into alignment. We are focusing on the appropriate tumors, utilizing the right biological approaches, and we are addressing formidable market opportunities.

All right, great. Yeah, that's helpful. And 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 on what's left to prepare for the IND? And yeah, so that's that.

Yeah, Roger, that's an important part, too. I mean, just to kind of frame this, again, we've gone from soup to nuts in two years. Two years, I just got to emphasize that that's a remarkable amount of progress. That's establishing the team, building our lab, 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 of 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.

Great. Thank you. Yeah, that's all from me. Thank you. Thank you, guys.

And our next question is from the line of Yale Jen with Laidlaw & Company. Please go ahead.

Good afternoon, and thank you for the questions. I have two. The first one is to clarify that the TCR-T trial will most likely be treating patients at MD Anderson next year, and there may or may not be a trial conducted at the NCI. Is that correct?

No. So, Yale. Thank you. I just want to 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 are quite right, right. That's the 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. ZIOPHARM will also have a personalized TCR-T trial, but we're managing that important workstream to start after the library trial has commenced.

Okay, great. That's very helpful. And also just two quick ones. The first one is that you guys going to have a presentation at SNOW. So what should investors expect from those presentations at this moment?

Sure. So obviously, you know, 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 three presentations. One of them will address the early data in DIPG. And in particular, looking at how this particular patient survived the end and tolerated the technology. This is incredibly important, you know, at this early stage. The second is around the two combinations study. So one is a Phase 2 trial with Libtayo and the other one is a Phase 1 trial in combination with OPDIVO. So we'll have some maturing data without OPDIVO and we'll have the initial set of data with Libtayo.

Okay, thanks, Laurence. That's very helpful. The last question is about some recent chatter regarding a minor shareholder who sent out a public letter. Do you have any comments on that?

Yeah, no, I think as we've said, publicly, we value input from all of our shareholders and take their feedback seriously.

Okay, great. Thanks a lot. Thanks for taking the question.

Thank you.

Our next question is from the line of Alethia Young with Cantor. Please go ahead.

Hi, guys. Thanks for taking my questions. I guess, you know, on the SNOW data sets, I mean, do you have a perception that the combos yield a greater synergy than monotherapy? And I mean, I guess, doesn’t really matter, either way. And then, you know, next question is on TCR-T trial at MD Anderson. I mean, just to break it down a bit more, is it really related to like, kind of the capacity and kind of dynamics related to COVID or are there other factors that are lingering to kind of get everything up and running appropriately there? Thanks.

In terms of the combination trial, we see significant potential. As you may know, we presented data at ASCO this year showing that patients with recurrent GBM who received IL-12 had a median overall survival of around 16 months, which is now backed by mature long-term follow-up data. This result stands out not only among our competitors but also when compared to historical data where patients in similar settings typically survived about 12 months. This finding is quite encouraging on its own. As you've mentioned, we are now looking at the possibility of combining IL-12 with PD-1 inhibitors to see if that enhances outcomes. Regardless, ZIOPHARM has a clear path toward advanced clinical trials, both for monotherapy and potentially for the combination as well. Regarding the TCR-T trial, I believe you referred to MD Anderson, but you're actually referencing the NCI. Our partnership with the NCI is crucial. Steve has significantly contributed to ZIOPHARM over the years, particularly with the IMB process. The message has been consistent since 2019: ZIOPHARM is increasingly taking charge of its own future. In the beginning, after parting ways with our partner, we lacked the resources and infrastructure to drive the program forward. However, we have since secured funding and hired the necessary personnel, enabling us to establish a team that can carry out our program independently. This does not undermine the valuable work that Dr. Rosenberg is conducting, and we are eager to see his patients participating in trials. However, ZIOPHARM is now in a position to operate on its own timeline. Overall, progress is going well.

Maybe just one follow up. Sorry about that. Regarding the academic institutions and the CAR-T study, are there any expectations that we might see some data on that program in 2021 since you're just getting started? How important do you think it is to obtain some proof of concept with the CAR-T?

That's a great question. As you know, we can both buy and sell under compassionate use, as well as through the IND that's progressing in the Taiwanese process. We're quite optimistic about that. Next year, there will likely be one or two lines of communication back to investors from Asia regarding the proof of concept for rapid manufacturing. My comments today indicate that the technology, at least in its early stages as communicated to us, looks encouraging, so we're cautiously optimistic. We will also validate this in Houston with our partner, MD Anderson, as we have a Phase 1 trial enrolling patients there, and we will report those data. You're right about the timing, and as this data matures, we will be able to provide more information in the New Year. Essentially, investors should know that there is some initial good news.

Awesome. Great. Thank you for the follow-up question.

Next question is from the line of David Novak with Raymond James. Please go ahead.

Good afternoon, folks. Thanks for taking my questions. I guess, just one in 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, which is unlikely to lighten in the near-term? What's the risk here of further delay post Q1 2021?

Yeah, so thank you, David. So, I think the 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 timelines 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, act sense 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 Institutes 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’s working under, that's not a big burden, but he 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. As I guided in my remarks a few minutes ago, this affects not all program and we believe it affects other programs at the NCI.

Got it, great. Thanks, Lawrence. 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, advisors, 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?

Hey, David, yeah, it's hard to say right now, we disclosed G&A estimate for this number, that right now might be 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’s a state funding? We couldn't tell you at this moment in time.

Perfect. Thanks very much.

Sorry. I'm just going to give you another flavor, you know, in terms of MCI, ZIOPHARM seat, we value the shareholders input. But we're also focused on executing. You heard me again go through the type of work down in Houston, the type of work we're doing up in Charlestown in the 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.

Okay, perfect. Well, thank you very much, guys. I'll hop back in the queue.

Thank you.

Our next question is from the line of Thomas Flaten with Lake Street Capital Partners. Please go ahead.

Thank you. And thanks for taking the questions. I apologize, if these are repeats at some challenges with my connection? Did you disclose how many patients have been enrolled in the DIPG study?

No, we haven't yet. We can enroll up to 12. I think you know, Thomas, this is a good example of where you need a great expertise to be able to treat a patient, a child with DIPG. The team that we have assembled at ZIOPHARM to be able to do this, our partners that these three hospitals have all of that, these children with intratumoral they desperately need therapy. And it's a program that really, I think, speaks to 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. We benefit essentially from a great team and a great board to be able to do that.

Great. And then, maybe one for Sath, there was about $2.5 million worth of the pre-payment 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 $11.4 million bucks to last? And when we have to start supplementing that in order to continue things forward?

No, that's correct. If you look at our exposure drawdown, we had a pre-payment of 2.5 million, and our cash decreased by about $18 million. From a run rate perspective, the prepaid balance of approximately 11 million is expected to last for a couple more quarters. After that, it will start to impact the cash balance. The net drawdown I estimate is around 21 million, with about 18 million affecting the cash and 2.5 million coming from completed rates from the NBN. This is what will begin to increase moving forward. Our projections show that the mid-2022 cash reduction aligns with what we've observed in these quarters. While some quarters may see higher seasonal fluctuations, generally, if you extrapolate the cash reduction from this quarter and draw down on that balance, it would align closely with our reported cash reduction.

Got it. And then one final one and I apologize also, this is a repeat, with respect to the allogeneic CAR-T study. How close is screening and evaluating is great, but how close do you think they are to actually identify?

Yeah, yeah, we're working with probably the nation's largest cancer center and it's where I actually had the privilege of working. When I lead the pediatric program, they are constantly transplanting patients. So I think investors can take part 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.

Great, I appreciate it. Thank you for taking the questions.

And there are no further questions on the line at this time. I'll turn the call back to Dr. Cooper for final comments.

Yeah. Thank you so much operator. And thank you everybody, who listened in and participated. Be safe and be well. And we look forward to talking with you next time. Bye-bye now.

That does conclude the conference call for today. We thank you for your participation. And ask that you please disconnect your lines.