ZIOPHARM Oncology, Inc. (ZIOP) Q1 2020 Earnings Conference Call May 7, 2020 4:30 PM ET
Chris Taylor - Vice President, Investor Relations and Corporate Communications
Laurence Cooper - Chief Executive Officer
Satyavrat Shukla - Chief Financial Officer
David Mauney - President
Conference Call Participants
Alethia Young - Cantor Fitzgerald
David Novak - Raymond James
Ramakanth Swayampakula - H.C. Wainwright & Co., LLC
Thomas Flaten - Lake Street Capital Markets, LLC
Yale Jen - Laidlaw & Company
Greetings and welcome to the Ziopharm Oncology First Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host, Chris Taylor, Investor Relations at Ziopharm. Thank you, sir. You may begin.
Thank you, operator. Good afternoon and welcome to the Ziopharm Oncology conference call and webcast to review results for the first quarter ended March 31, 2020. This afternoon we filed our 10-Q and issued our first quarter financial news 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 on our website in the Investors 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-Q 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, Chief Financial Officer; 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 ask one question and a follow-up as needed, and then please feel free to return to the queue.
Please also bear in mind that the management team are physically distancing, so apologies in advance if this disrupts the flow of information during our call today. Thank you.
And to get started, I’ll turn the call over to Dr. Cooper. Good afternoon, Laurence.
Thank you, Chris, and good afternoon, everyone. We are pleased to be here with you today for an update of our progress this quarter. With COVID-19 globally adversely affecting people and businesses, the past weeks have been unlike any we have experienced.
I’m proud of our employees for having executed and adapted to the new working environment. In fact, we were already well prepared for working remotely and thus have remained open for business and are working at full capacity. For those who can, they are working from home, taking meetings virtually and executing seamlessly. For those who need to be in a physical space, such as our laboratory staff, our clinical trials team, our partnered clinicians and manufacturing personnel, we have adapted and modified schedules to ensure safety and productivity.
Based on guidance from federal and state governments, as well as our hospital-based partners, we are continuously revisiting our policies to safely allow freedom of movement. I’m very pleased that we’ve been able to keep operating at a high level, which is a testament to the commitment of our team.
Externally, our clinical partners at the National Cancer Institute or NCI and MD Anderson Cancer Center have implemented work restrictions to protect patients and their employees. And as a result, our clinical studies under IND with these 2 institutions are temporarily paused. This delay impacts not just us, but the industry at large, executing on non-COVID-19 trials.
We are in active communications with the NCI and MD Anderson and adapting in real time. Of course, investors and stakeholders will have questions on when these studies can begin enrolling. While we are ready to start back up with them, once their restrictions lift, the timing of this though is not under our control.
With regards to other hospitals, however, we’ve continued to be able to accrue to our clinical trials. This has enabled us to continue dosing of patients with recurrent glioblastoma or rGBM with Controlled IL-12. Other countries are also able to work with less restrictions under COVID-19 and that is good news for our joint venture, Eden BioCell, which operates within Greater China.
While COVID-19 has created uncertainty, we are fortunate to be well positioned to weather this storm. We completed our financing last quarter ahead of the pandemic and we believe we have sufficient cash to fund us through meaningful milestones and activities into mid-2022. The increased capital also enables us to carefully accelerate certain expansion activities, as we will describe and strategically strengthen our teams internally.
Turning to a more detailed review of our programs, in the NCI-sponsored phase 2 study led by Dr. Steven Rosenberg, as we have previously mentioned, they were in the midst of finishing the final engineering T-cell runs, which will allow for treatment of patients to the non-viral TCR-T trial.
Ziopharm has reacted to the current work restrictions at the NCI and prioritized certain internal activities. Specifically, undertaking these engineering runs within the company, details of which we can then provide to our partners at the NCI, so they are ready to enroll patients with solid tumors to the TCR-T trial.
To this end, we completed the opening of additional laboratory space in Houston, successfully accomplished during the pandemic. We are optimistic data from these runs will help the NCI get back up to speed more quickly, once they open and resume full activities. Building out the TCR-T program with MD Anderson in Houston, affords us several advantages.
We are collaborating with multiple principal investigators and drawing from a large pool of patients with solid tumors, which is expected to help with trial enrollment. These collaborators have deep clinical experience in a variety of tumor types, which will be helpful as we develop T-cell products targeting neoantigens.
In our laboratory nested within the MD Anderson campus, we are continuing to develop our personalized and [live re] [ph] TCR-T programs targeting solid tumors. As a reminder, we already have sufficient TCRs targeting public neoantigens in hotspots to begin the TCR-T arm at MD Anderson.
We have already made progress undertaking a pre-IND meeting with the FDA, which included non-clinical information, as well as CMC and clinical sections. We are evaluating their feedback and factoring in the impact of COVID-19 and expect to provide an update on the status and the timing of the trial at the next quarterly call.
We are gratified to have both NCI and MD Anderson as partners in our Sleeping Beauty program, targeting neoantigens in solid tumors with T-cell receptors. Being aligned with 2 of the world’s thought leaders in immuno-oncology, we have optionality and the ability to move forward in a position of strength. And we look forward to continuing our work with them.
Moving to our Controlled IL-12 program. During the pandemic, our teams have been able to execute. And we continue to actively enroll patients with rGBM in our phase 2 combination trial with Regeneron’s Libtayo.
In fact, we anticipate completing enrollment in the first-half of this year, as we’ve previously guided. Patients and physicians remain highly motivated to receive this potentially lifesaving treatment. We currently have adequate drug supply for our current studies. And while our vendors have had some minor delays, we remain on track as previously guided.
In our phase 1 combination IL-12 study with OPDIVO, we completed enrollment in the fourth quarter of 2019, and are on track to disclose data from that trial throughout this year. Additionally, we anticipate results from our monotherapy study through the course of the year, which completed enrollment in the first quarter of 2019.
Our scientific and clinical teams are looking forward to presenting clinical data at ASCO this year with its new virtual format. As follow up matures, we continue to emphasize Median Overall Survival, or MOS, as the endpoint, as this metric is used by the FDA to approve oncology products for rGBM. We believe that based on recently published data, MOS for patients with rGBM beyond 12 months is encouraging.
In our phase 1 CAR-T program, the pandemic has created delays with the site initiation visit or SIV with MD Anderson for the trial to administer CD19-specific CAR-T. As previously guided, this was the last step needed to open the trial. This study infuses CAR-T as soon as the day after gene transfer using our technology referred to as Rapid Personalized Manufacturing or RPM. The delay is due to MD Anderson’s policies regarding the pandemic. And we, like others, wait on their input on when this meeting will take place.
Once the SIV occurs, MD Anderson can enroll and infuse our first patient. To reiterate, from ZIOPHARM side all is in place to begin the trial, including clearance of the IND from the FDA, approval from IRB and verification runs reassure that we can meet 70% viability of engineered T-cells.
As a reminder, this trial infuses donor-derived or allogeneic T-cells in patients that have relapsed after bone marrow transplantation with CD19 expressing malignancies. We are also pursuing the infusion of patient-derived or autologous CD19-specific CAR-T and RPM. To update you on these efforts, we have aligned with our partner Eden BioCell to undertake this work in Greater China.
Developing our autologous RPM process with our team in Asia takes advantage of their recent success with multiple manufacturing runs, and their ability to navigate the challenges of the pandemic. This change also reduces the burden on Ziopharm’s financials and prioritizes our activities with MD Anderson.
Eden BioCell has been making tremendous progress on implementing the autologous RPM process in Greater China, and specifically is on track to file their first IND this year for a clinical trial in Taiwan. This supports our strategic plan for this program, which is to continue to engage with potential partners for this asset, leveraging clinical data from both CD19 specific allergenic and autologous RPM CAR-T trial.
I want to thank our employees, partners, providers and patients for their dedication and trust during this difficult time. It is challenging, but we are making progress and will emerge in a strong position when the pandemic lifts.
With that, I would now like to 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 unusually, research and development expenses were $12.7 million for the first quarter of 2020, compared to $9.5 million for Q1 of 2019. The increase reflects the progress of our clinical programs, including costs associated with our licensing of IP from the NCI, assist in the expansion of our TCR program.
Manufacturing once designed to further our CD19 allo CAR-T study with MD Anderson Cancer Center and personnel expenses to expand our research and manufacturing capabilities for cell therapy on gene therapy, increased cost reflected continued enrollment of the phase 2 combination trial of Controlled IL-12 with Libtayo.
G&A expenses were $6 million for the first quarter of 2020 compared to $4.1 million for the first quarter of 2019. The majority of this increase reflects our increased headcount, including the recruitment of key personnel, expanding our capabilities to support the growth of our business, and to a lesser extent, other related costs such as those associated with expanding our patent portfolio, and facilities expenses.
On a cumulative basis for the first quarter of 2020, we reported a net loss applicable to common shareholders of $18.3 million or $0.09 per basic and diluted share. Comparably in the first quarter of 2019, Ziopharm recorded net loss applicable to the common shareholders of $13.4 million or $0.08 per share basic and diluted.
Cash and marketable securities, as of March 31, 2020, was $171 million, including proceeds from our recent financing. In addition, we also had a prepayment balance of approximately $18 million for work to be conducted by the company at MD Anderson. Our cash position is sufficient to provide funding for all our programs, and infrastructure build in to mid-2022. And will allow us to add the TCR trial in Houston enrolling to the personalized and hotspots arms.
Proceeds with the continued build out of our new system facility on the campus of MD Anderson, which will serve as the foundation for the commercial path for our TCR-T program, continued expansion of our proprietary TCR library to support the TCR-T hotspot arm, advanced the recruitment of specialist personnel for our TCR-T program, and also to support potential broadening clinical initiatives for a Controlled IL-12 program. As you progress towards later state studies and potentially other indications.
And finally, to take control of TCR-T manufacturing with both personnel and infrastructure. With that, I will turn the call over to David for final comments.
Thank you, Sath. As Laurence mentioned earlier, we are very proud to be operating at full capacity in the midst of the global impact from the COVID-19 pandemic. We have been very mindful of protecting the health and well-being of our employees. And we will continue to operate in a safe and prudent manner as we execute on our strategic plans. We have made tremendous progress recently. We completed the first phase of the buildout an expansion to our laboratory in Houston, which we believe will be a key asset in our commercialization strategy down the road.
We are working to complete engineering runs in Ziopharm’s operational facilities, to support the timeline for patient dosing at the NCI, when they reopen. We have also received instructive feedback from the FDA during the pandemic with regards to our TCR-T trials in Houston. We are all set for our CAR, RPM, allo trial, and are moving along expeditiously, awaiting the SIV at MD Anderson to begin enrollment.
Our tech transfer with Eden BioCell is complete and our buildout an IND progress are going very well. Our IL-12 remains on track, driven by the tremendous support of our clinicians and patients in great execution by our own teams. We continue to anticipate meaningful milestones in our programs throughout this year. We have worked extremely hard and have made tremendous progress over the last 9 to 12 months especially to strategically build a company primarily targeting solid tumors with multiple platform approaches.
We enable these efforts by building a strong foundation for a scalable cost effective next generation immunotherapy with the potential to treat all patients with solid tumors. We currently have full commercial rights to our therapies, which have the potential to address multibillion dollar markets. Like others in our space, we have experienced delays during this pandemic. However, we continue to engage in dialogues with strategic partners, who appear enthusiastic to see our clinical data. And with our strengthened cash position, we have expanded these discussions to include both in-licensing and out-licensing potential.
Our internal BD process is already supported with new headcount, and with counsel from outside advisors to review and advise on valuation and longer term plans for each of our core assets. With human data anticipated over the course of this year, our options continue expanding and provide flexibility to ultimately enhance shareholder value.
Over the past year, we have significantly and carefully expanded our team from 49 employees in December 2018 to just over 80 employees today, many of whom are located in Houston and focused on our TCR-T program. We expect targeted growth to continue in 2020. Given that each of our core solid tumor programs are in or entering phase 2, we also think it’s important that we continue to strengthen our senior team and capabilities.
To that end, we have engaged in a search for a Chief Medical Officer, and we’ll also add additional senior drug developers, as well as executives who can further drive our business development activities across our programs. We are also further expanding our investor relations capabilities and will increase engagement with our shareholders in order to better reflect the growing needs of our organization. Also, as our shareholders know, we have been able to expand and refresh our board over the last 18 months, with the addition of 6 new directors, all of whom we believe bring important contributions to evaluating and developing our business strategy.
As we enter this next phase of execution, we anticipate one addition to our board, so that we are well suited to move into our next phase with a full complement of trusted leaders guiding us in our drug development, financing and business development activities.
I want to express my sincere thanks to our team, our board and our partners. We have been able to move forward during these unprecedented times with each of our programs and still anticipate achieving meaningful milestones this year across the board, including teeth TCR-T, Controlled IL-12 and RPM for CAR-T. We also look forward to presenting data at the upcoming ASCO conference and will participate in a variety of industry events throughout the year.
In closing, we are in the right space with the right assets, and executing on our plan with a strong financial base. While the world has paused for a moment, we continue to push to move forward on the exciting path ahead. We acknowledge the stress that is placed on all. And we appreciate and especially now thank you for your continued support, as we execute and continue progressing as a company.
And now, I will turn the call over to the operator to open it up for any questions.
Thank you. We will now be conducting our question-and-answer session. [Operator Instructions] Our first question comes from Alethia Young with Cantor. Please proceed with your question.
Hey, guys. Thanks for taking my questions and congrats on the progress throughout the quarter and navigating tough times. One, I’m not sure how much you can offer or forgive on this. I’m just kind of curious about, what are the puts and takes that kind of getting like the NCI and the MD Anderson studies back in queue, like what are their metrics for evaluating kind of how to get studies back up and running, which I’m sure they want to?
And then, with IL-12 and PD-1 combination with Libtayo, can you just talk about how you think about next steps once you get the data, and then what kind of results, kind of what gave you the confidence moving forward with that program? Thank you.
Yeah. Thanks, Alethia. And also, welcome to you in the Ziopharm story. So in terms of the NCI and MD Anderson, I think it’s obviously important trials for us and for them. But also maybe just a framing statement, back at JP Morgan we put out guidance that in the first half of 2020 we had 3 major milestones that would be hit. For instance, our phase 2 enrollment would be complete for our combination data. With Libtayo, we would be – data readout for Opdivo, we would have data readout on IL-12 with monotherapy.
And in addition, we hoped to be placing patients at the NCI on a clinical trial with the TCR, and enrolling patients on the Sleeping Beauty allo RPM trial at Anderson. So if you just kind of look at those 5 major milestones, 3 of those 5 we’ve hit. And we’re giving strong guidance that they will be there.
Now, regarding the NCI and the MD Anderson, the way Ziopharm thinks about it is that back in March, when the pandemic impacted the United States, these hospitals appropriately reacted like a light switch. They turned off partnerships not just with us, but across the oncology spectrum, really as they factored in the COVID-19 patients and so forth.
That is beginning now to loosen. And indeed, MD Anderson and the NCI are gingerly heading towards reopening. But that’s a process Alethia. I’m sure others are saying the same thing. So what Ziopharm has done with both of those institutions is to communicate frequently and regularly.
For instance, just this week, I talked to Steve Rosenberg at the NCI, and I also talked to leadership at MD Anderson, to essentially hear from them in their own words that our trials are a priority for these 2 institutions. And that’s important, because as they phase in essentially their opening, the NCI and MD Anderson will be selecting trials that will go forward faster than others.
And we have every reason to believe that we are part of that first and exciting wave. So in addition to all of that, we have worked with them essentially to minimize the pain they have when they reopen. For instance, we have a JSC with MD Anderson. We’re actively working through problems as they come back online with their senior leadership team. And the same can be said with the NCI.
It’s not just Dr. Steven Rosenberg, we’re talking to. We’re talking to the entire representatives, from the entire leadership team, whether it’s the GMP facility, whether it’s purchasing, or whether it’s the scientists. All of that, essentially, puts us in great shape to be among the first wave to open the trial, when that happens.
And I’ll just add one more piece there, Alethia, and that is that we haven’t been sitting still either. The team has worked very hard to expand our laboratory footprints in Houston. You heard Sath and David talk about the capital as well as the human additions. These efforts are paying off, because for instance, we are already taking some of the burden off the NCI as they work to recover.
And we’re launching into essentially what we call engineering runs, so that we can essentially tick that box so that patients can be accrued when they open. So it’s a longwinded answer to your first one. But I’m sure many, many questions will be around this. So I just wanted to give a fulsome set of comments there.
The second is the PD-1 study with Libtayo and the next steps. So this is a phase 2 trial done with Regeneron. And it really builds off the phase 1 trial with the Opdivo. That phase 1 trial really sets the stage for understanding the first time that IL-12 can be partnered with a checkpoint inhibitor for the treatment of brain tumors.
And that has essentially been done. We’ve finished accrual and we will be reporting out some data at ASCO as we indicated. The PD-1 with Libtayo is a phase 2 trial. Sizeable number of patients are going to be on that trial. We, as we’ve guided, we will be finishing accrual in the – really shortly, first-half of this year. And then the data will incubate. We’ve said on earnings call. And we’ve said repeatedly that the way forward for these patients – excuse me – for these data are going to be measured by median overall survival.
And we need essentially time therefore to understand the median overall survival. Now, having said that, there are really some interesting, I think, additional data that have bubbled up not only in the monotherapy and in the Opdivo study, but also – we hope also in the Libtayo study, which really demonstrates that IL-12 is a therapeutic agent for brain tumors.
For instance, we’ve been reporting out now MRI imaging, where patients, not just 1 patient, but multiple patients are having a diminution in their lesions. And we are doing important and quite elegant biopsy studies to again show the mechanism of action based on immunohistochemistry.
So, Alethia, does that give you perhaps more than you wanted, but I wanted to make sure I gave you the full sense of where we are and the enthusiasm, we have for the GBM program.
Yeah. That was very helpful. Thank you.
Thank you. Our next question comes from David Novak with Raymond James. Please proceed with your question.
Good afternoon. Thanks for taking my questions. I guess 2 quick ones for me today on timing. The first one being, with respect to the allo CD19 trial, we were really looking forward to some data here in order to garner some validation around the rapid [manufactured third-gen SP enabled] [ph] CARs. And back in October, I think there was some hope in the market that we would have the first patient dose in Q1, which would have been prior to COVID-19 impact. So I was just hoping that you might be able to discuss or clarify some of the challenges, technical or otherwise, that might have come into play here beyond COVID-19 as any?
Sure, David. Thank you. And well, let’s keep you on the line, because I think I heard the second question. So in terms of the allo RPM trial, the guidance we put out at J.P. Morgan was that we would enroll patient in that trial at MD Anderson in the first half of 2020. That guidance actually stood really until the pandemic hit, and indeed, we still reacting and really quite frankly following MD Anderson’s lead as they react to the COVID situation.
In my prepared remarks today, we went to some effort to really show that MD Anderson has really done everything it needs to open that trial. And I highlighted like we have the IND, we have the IRB, we’ve repeatedly demonstrated the manufacturing is robust to achieve this 70% viability. So we are ready. And the last kind of box to be texted – ticked, is the site initiation visit at MD Anderson. And literally in our last earnings call, we said that box will be ticked. But soon after COVID hit and our partner MD Anderson, I think, appropriately slowed down all of the work with their partners, not just us, but others as they essentially responded to COVID.
What you’re hearing from me today on top of that, I think this is loosening. And so from the Ziopharm side, we’re ready to go. And we really expect MD Anderson to prioritize our trial from their side as they get going. But obviously, it’s a fluid situation, so I can’t give you an exact time. But I can certainly tell you that we’re pressing really hard on this.
Great. Thanks, Laurence. And just secondly, switching gears, the NCI TCR-T trial, and once restrictions have been lifted. Could you give us a bit more detail around estimated timeline, for example, how quickly you think that first patient could actually be enrolled post-easing of restrictions, and what that interval might look like between enrollment and first dose?
Yeah, thanks, David. Again, a critical question really building on the uncertainties around the COVID-19 situation. So from our perspective, as we guided the market, last earnings call there was a box to be checked. There wasn’t unanticipated, but it was going essentially under the auspices of the NCI and that was these engineering runs so sort of transition from the world that have a bench research and academia to a more robust GMP environment. Those engineering runs were essentially underway, or about to be scaled to achieve the necessary numbers, when COVID hit the NCI.
So we entered into sort of a hurry up offense and put in place additional laboratory assets in and around MD Anderson in our Houston campus. Those assets are online, and they are essentially undertaking those engineering runs. So that, David, I think, it will be a big help to the NCI when they come back online. Prior to COVID, our guidance was first patient dosing for this phase 2 trial in the first half of 2020. Obviously, COVID has put some uncertainty around that and we’re still factoring that in. I’m sure, you’re hearing this for many of your companies that you’re following. But I think again, you should rest assure that I’m talking to Steve Rosenberg, he’s communicating this as a priority. And we’re going to essentially move as fast as possible when they open.
Excellent. Well, thank you very much and looking forward to that data at ASCO, and I’ll hop back in the queue.
Thank you, David.
Thank you. Our next question comes from the line of RK with H.C. Wainwright. Please proceed with your question.
Thank you. Can you hear me, okay, Laurence?
Yes. Thank you, RK.
So some of the questions have been answered. So just trying to understand, what would be the next steps from the Libtayo trial, and also another question for Sath. Just to saying through expenses with others. So they are – in terms of your R&D numbers and other operational expenses.
Got it. RK, just because the line is faint. I will repeat your question for transcription purposes. So the first is to me and the second is to Sath around expenses and operation. So your question on Libtayo really builds off what Alethia was saying, and that is where – what the next step? So we’re going to complete enrollment to the phase 2 trial in the first half of this year. We’re on track to do so. It really demonstrates I think the enthusiasm patients and providers have for this asset. That data then will essentially be reported out at upcoming meetings. Obviously, the top-line data is around the median overall survival.
So as these patients essentially mature through their survival, we will be reporting that out. In addition, we will have for investors, the potential for other interesting observations like MRI datasets where we have shown in the past that the tumor is actually shrunk as a result of IL-12 therapy. And also, we are working hard on our biopsy data to again show the mechanism of action. So that IL-12 turning, if you would, cold tumors to hot.
The program with PD-1 inhibitors can therefore be compared to the monotherapy arm itself. And obviously, we started monotherapy earlier, we put out I think some very encouraging data in the past, the survival looks quite robust in this subgroup of patients, who have low dose steroids. And so we’ll be going forward looking at how the monotherapy data package compares to the combination data package because, obviously, that would help them with next steps and more advanced trial designs. And then if I could, RK, I will transition to Sath for an update from the financial part.
Thank you. Thank you, Laurence.
Yeah, sure. So thanks, Laurence. How are you, RK?
Doing good. Surviving.
Great. All right. So just to answer your question, as I understood it, for R&D, you saw that our spend for this quarter went up by about $2-million-and-change compared to the last quarter. R&D is our priority. So COVID notwithstanding, we would expect sort of a similar ramp to take place by the middle of the year. And then after that, some trial costs will wind down, but we will have more people than we had compared to last year. So I starting in the middle of the year, for the rest of the year, you can probably expect R&D to be flattish, so to sum up near-term a bump, I – and then after that some of ins and outs for a flattish R&D for the rest of this year before ramping up next year.
On the G&A, I – we did disclose as you saw that we will be bringing in some more senior personnel, so we’ll probably end up seeing somewhere by the end of the year, let’s say, by four quarter a 10% and change increase on G&A. But that’ll be a ramp. It’s partly dependent on when some of the expertise we want to bring in on the G&A side actually comes in. So the ramp will be slower than the R&D ramp, which as you know is really the route that we want to go for the company, R&D spend always take precedence, because frankly, that’s with a site. Did that answer your question?
Perfect. Thank you very much. Thank you both of you, guys.
Thank you, RK.
Thank you. Our next question comes from the line of Thomas Flaten with Lake Street Capital Markets. Please proceed with your question.
Thank you. And thanks for taking the questions. I had some trouble with the call earlier. And I was curious if you guys had given some more description around the instructive feedback that you received from the FDA with respect to the MD Anderson TCR study. And if you didn’t, I was wondering if you could help me understand what that means.
Yeah, Thomas, actually, you caught it, actually, with the word instructive. So we dialogue with the FDA through a pre-IND process. That was fulsome. It was preclinical data. It was CMC data, touched on manufacturing. And despite the stress they’re under from COVID, they were responsive and provided us with guidance move forward, that’s going to be very, very helpful, because as you know, we’re really tracking this to Ziopharm’s sponsored IND.
And that covers not only the personalized T-cell receptor therapy, and perhaps for others on the call, I’ll just amplify that to say personalized T-cell receptor therapy is therapy that’s targeting individual neoantigens, antigens that are unique to the patient. And so we have a process that we’re talking with the FDA about that looks very similar to the phase 2 IND at the branch with Steve Rosenberg, whereby we will be generating those T-cell receptors against the neoantigens in real time. So that’s one part of the FDA dialogue. The second part of the FDA dialogue was around the allogeneic T-cell receptors. Those are kind of science words I use, but what that really means are T cell receptors that are in a library against shared antigens or shared neoantigens that are in hotspots.
So we’ve received feedback on both of those as we plot essentially going forward. That’s been really, really helpful. They were helpful comments, I think, for the investors, you should know that, that we have a path forward. Nothing was too surprising on these – on the FDA feedback. It really was reassuring and gave me, and the team has sent how – what the expectations are from the FDA for a company sponsored IND? We indicated in our prepared remarks that we would have more for the investors that the next earnings call as we factor in and COVID-19 into the feedback from the FDA.
Great. And then…
Company. Yeah, please.
No, no, no. That’s very helpful. Thank you. And then with respect to Eden BioCell, one, I was wondering if you could narrow down the timing of that IND submission a little bit and then what – beyond the IND submission, how should we think about timing to first patient enrollment?
Yeah, thank you. And so for the work with Eden BioCell, they are headquartered in Shanghai, but they have reached across Greater China. The first part of their work will be in Taiwan with a major hospital there. And this will be significant, because Taiwan at the moment does not have a strong party presence. So Eden BioCell could be among the first in this CD19 space.
And the rapid manufacturing that we have tech-transferred to Eden BioCell is very, very appealing for the patient population and the infrastructure in the Taiwan system, and quite frankly, in Mainland China as well. There – that group Eden BioCell group informs us that they will be ready to submit the IND this year. I’d like to sit with that, Thomas, as a sort of a general statement, hopefully be able to provide you more detail and clarity. I do think from the investor side, as a reminder, we owned 50-50 with Eden BioCell. So this there is an upside, quite a lot of upside actually for the investor with the group out there. And they are moving very, very rapidly. I mean, they have achieved scale, infrastructure, I think that is very heartwarming and really justifies our trust and investment with them.
Great. Thanks so much for taking the questions. Much appreciate it.
Thank you. Our next question comes from Yale Jen with Laidlaw & Company. Please proceed with your question.
Thanks for taking the questions, and glad the movement, the forward progress at this point. I have two questions here. The first one is wanted to clarify that in the ASCO meeting you were also presenting data of MRI as well as biopsy of two groups of treatments. Is that correct, the combo as well as the mono?
Yeah, yes. So we will have at ASCO, the phase 1 readout of the Controlled IL-12 program in combination with Opdivo, as well as phase 1 data-readout of the Controlled IL-12 program as monotherapy along with sort of the main study and the expansion cohort, yes.
Okay. And the second one is follow-up on the previous one, which is that what might be the gating factors at this point for Eden to – before they can file an IND in Taiwan?
Okay. Thank you for that. So, Yale, there is a TFDA, a Taiwanese, if you would, FDA, that to my understanding, this will be one of the first CAR-T programs they’re seeing. So you can imagine the team in – under and with Eden BioCell has been working really hard with regulators and principal investigators in Taiwan to prepare the stage, education of the hospitals and the investigators, as well as dialogue with their TFDA regulators.
That is all good news, because now the package when it goes in, will be received essentially, I think with open ears. That package, we’ve not given specific guidance on the date it will go in, except to say will be this year. I couldn’t say that if there wasn’t a significant essentially preparation that have already been done. And that, of course, means that there’s been a tech transfer process, from us here in the United States, to the group in Shanghai and then in Taiwan.
Okay, great. And can I sneak in one more question here?
Please, Yale, of course.
Which is that you – which you have mentioned in the script text that you might – I mean, there’s always the BD opportunities that you need to contemplate. So I’m just curious, among the 3 or 4 assets you currently have for the United States, as well as the rest of the world except China, can you – Is there any priority or any sort of a metrics we’ll go through to determine what will be the one to potentially could be partner out and what will be the one that you most likely want to keep in house to potentially have the full value of your asset?
Sure. Sure. That is asking – you’re asking which one of my children do I like best.
And they all get different…
So, look, they all have – they all are solutions to problems. We think about – and that’s how I’m built and that’s how the company operates. We recognize there hasn’t been a new drug for recurrent GBM in an age. Many of us, have family members and friends who suffer from this disease. We are using our talents to solve that problem.
As that data that comes out, and we hope you’ll see some data you like at ASCO, that will guide essentially around the drug development for IL-12 for GBM. And potentially more, we can do them more and turn IL-12 into more of a platform, since intertumoral delivery of IL-12 is such a useful weapon, turning cold to hot.
That data will bubble up really around the median overall survival. And that could entice partners around that or it could be something that with the Board that we want to prosecute ourselves and build out our own program to essentially develop our [IL-12 asset] [ph]. For the TCR program, that’s probably the largest value driver in the abstract. I mean, we’re talking about, Yale, as you know, platform technology that has the ability to perhaps address all cancers, goes off to the fundamental heartbeat of cancer, that is the genetic insult, the genetic mutation that causes cancer.
We know that therapies that target neoantigens have had major effects already in solid tumors. And we’re in the business now to scale that up and commercialize it. So, as that data comes in, we really would like to, obviously, push that as hard as possible, but it could result in BD activity. And we’re aware of that and indeed, as you heard David say in his prepared remarks, we already talked to groups around that.
And then, for the CAR-T, you can see us already partnering with Eden BioCell and developing a whole new avenue for the investors in Greater China, and really taking advantage of the landscape, being sensitive to our own spend and then taking advantage of the good work that Eden BioCell is doing in Asia. So I think you’re hearing that we’re ready to do partnerships as needed. But at the end of the day, it has to be worth it to the team and to the Board and to the investors. And we’re in great shape going forward.
Hey, Yale. This is David. I’ll just add to this. Obviously, clinical data drives a lot of these discussions. We have done I think a pretty good job, a very good job actually of keeping these dialogues ongoing during a time of worry, during the pandemic. Obviously, IL-12 has an increasing level of data with our TCR-T and CD19 assets to fall sooner behind them.
When we think about Ziopharm as a company though, we think about it as a solid tumor focused company. And so, as Lawrence highlighted just to add an exclamation point, we are working very hard with Eden BioCell, along with our own allo efforts in the U.S. to get as much data as we can as quickly as possible, believing that that data will ultimately drive partnership discussions for that asset, so just wanted to highlight that final point there for you.
Okay, great. Thanks a lot and keep safe, everybody.
Thanks, you too.
Thank you. This concludes our question-and-answer session. So I’d like to turn the floor back over to management for any additional closing comments.
Yeah, thank you, operator, and thank you, everyone, for joining us today. The most important part is be safe and well. We look forward to updating you such as that virtual investor conferences over the coming months and on our next earnings call in August. Good day, everyone.
Ladies and gentlemen, this does conclude today’s teleconference. We thank you for your participation and you may disconnect your lines at this time.