Q2 2020 ZIOPHARM Oncology Inc Earnings Call
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Greetings and welcome to the ZIOPHARM oncology second quarter Twentytwenty earnings Conference call.
At this time, all participants I know leasing only mode.
Question answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press Star Theater on your telephone keypad.
As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host, Chris Taylor, Vice President of Investor Relations and corporate Communications.
Thank you operator, good afternoon, and welcome to the ZIOPHARM Oncology conference call in the webcast to review results for the second quarter ended June 30 2020.
This afternoon, we filed our 10-Q and issued our second quarter financial news release, both of which are available any investor section of our website ZIOPHARM Dot com.
For informational purposes.
We've also included in our webcast to set a powerpoint slides.
To accompany today's commentary.
These slides can also be found on our website in the Investor section.
During this call the company will make a number of forward looking statements, including statements regarding the potential therapeutic candidates in our development pipeline.
Regulatory status financial information and business trends.
Forward looking statements are subject to numerous risks uncertainties, describing our 10-Q and within other filings that we may make what the FCC from time to time.
Participating on our call today for ZIOPHARM.
Dr. Laurents Cooper, Chief Executive Officer, and South to collect Chief Financial Officer following commentary for our management team will open the call for QNX.
And the interest of time, we kindly request that you ask one question a follow up as needed and then please feel free to return to the queue. Thank you.
To get started I'll turn the call over to Dr. Cooper good afternoon Laura.
Thank you, Chris and good day, everyone. We're pleased to update you on our progress this quarter, a summary of which is provided on slide number three.
Cobot 19 continued to dominate the news cycle and impact everyday like this quarter, we are working within the local and regional guidelines to keep our employees safe we've adapted to the new paradigm and we're executing on all fronts.
I'm mindful that the pandemic is ongoing and made me to further adapt and the future to the changing landscape.
First I will provide a review of our programs specifically at the end C.I.M.D. Anderson.
Starting with our TCR T program, where we continue to advance towards the dosing. The first patient in this phase two trial led by Dr. Stephen Rosenberg at the end <unk>.
All feel an urgency to begin dosing as quickly and safely as possible and the NCR has informed us that laboratory functions are incrementally coming back online.
As mentioned on earlier updates, we undertook engineering runs at our facility in Houston, while the N. C. I was shut down and have now weve laid that information back to Dr. rosenberg's team to help the anti accelerate their enrollment plans as they reopen during the ongoing pandemic.
In addition, they're beginning to proactively scream referrals for patients for Neoantigens and T cell receptors or TCR surrendered then eligible for the trial. This is needed as a result of the pandemic can result in shut down some of the patients who are anticipated to be treated where unfortunately lost due to progression.
That malignant disease.
We appreciate the N C I strong support I look forward to updating you on that progress.
Now turning to our TCR T program that we are running from die from facilities alongside the MD Anderson Cancer Center campus in Houston.
Our staff is establishing the moratorium bio informatics that are commercially oriented to identify neoantigens and TCR <unk> for the personalize TCR tea and library TCR T program.
In addition to identification of TCR, it's from our internal programs, we expect to continue to in license additional TCR us from the anti dust further expanding the number of receptors in our library targeting shared neo antigens in hot spots.
The I didn't receptors are anticipated to improve the chance that a patient identified during the screening process camera Cdeight T cells genetically modified using a TCR from a library.
By enlarging the library throw in licensing or identifying ourselves, we're creating a powerful asset and database, which we will continue to grow over time.
We have a jump start on the company's work in Houston, given the investigational new drug application I N D. At the end Psi and the feedback from the F.D.A. on our pre I N D package.
Our teams are focused on generating the CMC Nonclinical I, India, enabling data for submission of a ZIOPHARM sponsored I indeed.
In the FDA feedback received earlier this year, we obtained the helpful guidance that our planned I NDC submission could initially be utilized for the human application of multiple targets and multiple Tc ours.
This will save us time, and streamline our regulatory submission to target cancers, such as gynecologic colorectal pancreatic non small cell lung cancer and cholangio carcinoma.
This progress means that the company will likely submitted its I. Indeed in early Twentytwenty, one with anticipated enrollment beginning in mid 2021.
Given that terrific momentum building our library, we plan to initially in role to this TCR T. R. Under our ZIOPHARM sponsored I'd and then in role to the personalized TCR T R.
As a way of highlighting the rapid pace of our work we have progressed from licensing the core technology to anticipated dosing of TCR tea and as I fraud sponsored clinical trial and approximately two years.
Moving to our controlled aisle 12 program, we have dose the first patient in our D. I P.G. phase one two study in pediatric brain tumors that Larry cancer Center in Chicago under the Cat, Eric Dr. Stewart Goldman.
This trial builds upon our experience with recurrent glioblastoma or RGB yen and extend the asset into another disease type that's building value of controlled aisle 12, as a platform technology.
Additional children are being evaluated and we are targeting enrollment of 12 pediatric patients with the I.P.G. and the initial portion of the trial, which is designed to evaluate the safety and tolerability of a single intra tumoral injection at AD Rts H. high IL 12.
Given along with oral dealt with a lot of mass.
Other referral centers participating in the trial are the Dana Farber Cancer Institute in Boston, and the University of California, San Francisco.
D. I P.G. provides another potential regulatory path. In addition to targeting RGB M for commercial approval of controlled aisle 12, with a timeline and economics that appear favorable for the company.
In our phase two combination study with Regenerons the tile in patients with our GBM, we completed enrollment in Q2 as anticipated with 40 patients. Thanks to the ongoing dedication of our clinicians and trial sites.
This study is designed to evaluate the safety and efficacy of control dial toll in combination with a PD one inhibitor patients received aisle 12 intra tumoral really at the time of surgical resection, plus 20 milligrams of all of a lot of Mexico 14 days.
As designed patients are also receiving intravenous elliptical every three weeks until documentary progression or withdraw from the study.
Our scientific and clinical team, we're pleased to present three posters at this year's American Society of clinical oncology virtual annual meeting and we expect additional data from a monotherapy and combination studies to be presented at one or more scientific conferences later this year.
In our car T program the process for an I.M.D. filing in Taiwan is underway with try on therapeutics coordinating the clinical trial and I in D. activities.
He didn't buy or sell a joint venture between ZIOPHARM and trial has filed a preliminary I indeed package with the center for drug evaluation or C. D E in Taiwan for the assessment of I propose clinical trial with our targets Cdnineteen specific membrane bound car co expressed with membrane bound aisle 15.
Produced using rapid personalized manufacturing or RPM as a reminder, the RPM process enables car T to be infuse the day off the gene transfer.
This assessment by Taiwanese C. D is anticipated to facilitate some potentially expedite the approval at the final I Indy submission expected by the end of this year.
This trial is anticipated to be one at the first car T studies in Taiwan based on their expertise and extensive clinical trial network in greater China. The trial team is actively considering additional clinical sites for autologous Cdnineteen car T program in the future.
Regarding our CD 19 specific car T program at MD Anderson, we have secured approval to commence enrollment in the study with allogeneic donor derived T cells in patients with CD 19, expressing malignancies, who have relapsed after bone marrow transplantation, and we anticipate that dose thing will begin shortly.
This was accomplished at Indiana say emerges from its coal that 19 shutdown and is validation of the importance of this study. We're pleased to have this trial open to enrollment and are excited about the opportunity.
To summarize.
We are not partners that may clinical progress in the past quarter, including.
Sorry, completing enrollment in our phase two controlled I'll 12 combo study.
Second dosing the first pediatric patient Denardi I.P.G. study for control dial 12 third presenting additional data on controlled I'll 12 at this year's ASCO conference.
Fourth undertaking regulatory filings in Taiwan for our autologous phase one CD 19 specific car T. RPM study and lastly, initiating our allogeneic phase one cdnineteen specific car T. RPM study at Indiana.
On the corporate side as we had announced at the beginning of the year, we continue to pursue opportunities to strengthen our board and management.
The board is currently deliberating upon the outcome of our recent annual meeting and the feedback received.
Building on the search process, which had begun earlier this year, our directors are considering potential replacements and or additions to the board to this end. We were pleased to announce recently. The addition of James Wong to our board of directors.
We're also building out our scientific advisory Board, our SMB, beginning with Dr. Carl June as chair.
As we look to other changes we have previously discussed plans to recruit a chief medical officer and the searches ongoing. In addition, we also initiated a search for executives to strengthen the senior team reporting to me. This is an exciting time for ZIOPHARM and the time its right to look for opportunities.
To strengthen our board and build out the senior team.
The time is also right for an R&D day, providing an opportunity for shareholders analysts and other members of the investment community to hear from our team as well as leaders all of our collaborative clinical programs.
Dr. Rosenberg from the anti and others have already agreed to participate for an event, which will be scheduled. This fall. We are looking for it to sharing further details with you as the date approaches.
This is also an appropriate time to showcase our technology and plans as we have accomplished so much sense forging independence about 22 months ago.
We are developing cutting edge science and have rapidly and cost effectively put in place the necessary support system, leading edge technologies and infrastructure to accomplish our goals slide four provides an overview of these events and to summarize briefly here.
We separated from a foreigner partner in October 2018, and now operate as an independent company.
The FDA has cleared I indeed, a phase two solid tumor trial using the sleeping beauty platform infusing sleeping beauty modified T cells targeting unique neoantigens. This is the first non viral TCR t. technology utilize that the NCR under the direction of Dr., Steve I'm Rosenberg.
We established our internal TCR T program in 2019 with the recruitment of key leadership licensing of TCR hotspot library from anti Fortunately expanded relationship with MD Anderson added new independent space on the MD Anderson campus and received important feedback from the FDA for our first ZIOPHARM.
I'm, sorry, TCR T. clinical trial, we are expeditiously building out the capabilities in Houston to establish a commercial path for our TCR T program. We completed the initial phase of the expansion and the team has already made meaningful contributions such as providing data to the anti the team in Houston is supporting our planned clinical program in Indiana.
So we try to arm.
Library, TCR t. targeting shared neo antigens, and hotspot and second personalize TCR t. targeting unique antigens similar to the trial at the NCR.
Despite the ongoing can't pandemic, we've made significant progress as we prepare for our corporate I'd and early 2021.
Next in the U.S., we recently initiated a new study at MD Anderson aimed at further validating our RPM platform targeting Cdnineteen car T.
We formed our joint venture in greater China called eaten by sell with funding committed by our partner try on Therapeutics. Our partners have made rapid progress building out a fantastic team in first grade facilities and set about aggressively pursuing a clinical path developing RPM technology in Taiwan. The team is on track to file that I end.
D. this year with additional clinical opportunities to follow that we received FDA fast track designation for controlled aisle 12, and have enrolled three clinical trials evaluating both monotherapy and combination for RGB and the team has generated encouraging clinical data, which has been presented at ASCO snow and in.
Published form in science translational medicine.
Most recently, we completed enrollment in our phase two combination study would lead time and those are first the I.P.G. patient did a pediatric study.
Furthermore, we populated most of our board as we forged independent with the additions that does the gone Scott Braunstein I know on Asics than in 2018, followed by two additions last year with Dr., Chris Bowden, and Heidi Hagen as mentioned earlier, we recently added James long to the board also.
We named Dr., Carl June as Chairman R.R.S.A.B. and are adding other key players to join this group.
For new sell side analysts have initiated coverage on ZIOPHARM.
And lastly, we have worked to puts ZIOPHARM in a strong financial position to weather the ongoing cobot 19 pandemic uninsured visibility into key clinical data out but in each of our programs.
This is quite a list of accomplishments, we look forward to providing additional details during our R&D presentations in the fall our anticipated milestones for the remainder of Twentytwenty a detailed on slide number six so now let me turn the call over to fast for a review of our financials.
Thank you Martin and good afternoon everybody.
Let me start for the quick reveal <unk> financial results for departure.
As noted in our news release research and development expenses were 12.1 million for the second quarter of Twentytwenty.
You bet to 10 million for Q2 of 29 team.
The increase reflects increased headcount.
Including the recruitment just keep personnel to expand our capabilities to support the growth so far so to be business.
And an increase in gene therapy trial expenses and contracted support services.
DNA expenses were 6.6 million for the second quarter of Twentytwenty.
Compared to 4.8 million for the second quarter of 29 team.
The majority of this increase reflects increased recoupment of key personnel expanding capabilities to support the growth of our business and to a lesser extent.
That associated costs, such as legal and facilities expenses.
Accumulative basis for the second quarter of Twentytwenty.
Fortunately net loss applicable to common shareholders of 18.6 million.
Or nine cents per basic and diluted share.
Probably in the second quarter of French Cnineteen.
ZIOPHARM recorded net loss applicable to common shareholders, a 14.6 million.
Nine cents partnership basic and diluted.
Cash and marketable securities as of June Coty Twentytwenty.
Was $163.5 million.
In addition, we also had to keep him into balance of approximately 14 million, but look to be conducted by the company at MD Anderson.
Consistent with prior disclosures.
Gosh position is forecasted to be sufficient to provide funding for our programs and infrastructure bid intimate twentytwenty too.
With that I'll turn it back to the operator for questions.
Thank you.
At this time, we will be conducted a question and answer session.
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One moment, please widely poll for questions.
Our first question is from Chris Howerton with Jefferies. Please go ahead.
Great. Thanks for taking the questions and hoped and all you are well on does Oakland too.
So I think Oh for for me. The key question would just be kind of when can we expect.
The next 12 data, particularly in GBM and when can we start to kind of crystallized regulatory paths with the in that indication for that asset.
Yeah. Thanks, Chris So for the I'll 12 data our practice has been for the last several years to present, both at ASCO, which we did earlier this year and then also had snow which is later in the year. Those two conference as offer an opportunity really to showcase our technology and I'll take both.
I will keep to that rhythm, we do have other opportunities in between that at investor conferences to provide other insights into the program.
The a regulatory path is important to of course to us and the monotherapy data that we were pointed out at ASCO really represents both from the main study as we call it and the expansion study and no more patients are being added to that dataset that data reported in at ASCO.
So quite favorably with about 16 also months about survival.
That data therefore, we expect to continue to mature or through the year and continue to look good through the year.
The combo data with Opdivo, that's the sort of phase one trial and then the phase two trial with live tyo, those data or less mature because they started after I'm done monotherapy data we reported initial snapshot at ASCO with the Opdivo data that actually looked.
Again quite favorable with the median overall survival not being reached we continue to track those patients Kras and then more part out how those patients so doing through the air as I mentioned, a major conference being snow at the end of the year.
Once the company has that data sat and.
Therapy, which is basically there and the combo data set which is really now added value to the company because that monotherapy look so good. The company can then look at where the next steps are and we'll have potentially two shots for regulatory approval. The first is the monotherapy data.
Yeah.
And the second there's the combination dataset and I want to look out with my colleagues and with the board how the monotherapy stacks up versus the combination therapy, but again just to emphasize you know the company's feeling pretty good at this point because we already have that monotherapy data basically in hand in the combo. You know you know it looks to us only.
On an upside if you would.
Yeah Okay.
Okay.
That makes sense yeah on the maybe if I may just one more question with the start to kind of you know what what in your if you could describe the differences between what the NC I India's in what's yours, I hope or am I, Andy will eventually look like and what kind of.
Key differences in gating factors to kind of get that is.
Sure. So the I, Andy wed see Rosenberg isn't I. Indeed, it sponsored by the end T I M and as an academic I'd and builds on Steve's work.
With us as a partner our I N D is our own essentially corporate sponsored hi, Andy and that I, Andy as I guided it just on the call today has some significant benefits for us and that.
We can initially use that I, Andy from multiple targets a multiple TCR. Therefore, the CMC package that we're putting into that I, Andy will cover both trials in other words, the library trial, where we are targeting shared neoantigens with a if you would have sat or a library of TCR as well as the a personal.
Wise, a trial in which patients receiving one or more TCR for going after one or more.
At their own private mutations so that that that guidance here for the street its actually a big advantage for us and it's something that we can take advantage now within our corporate structure as we roll out. These two trial not ones, probably two trials and under our banner initially beginning.
With enrollment at MD Anderson.
Okay, all right well very good and again. Thank you so lunch for taking the questions and really really great to see or the continued progress. Despite the covance stuff that we're all doing yeah. Thank you so much crests yeah.
Our next question is from Thomas Flatten with Lake Street Capital markets. Please go ahead.
Good afternoon, guys. Thanks for taking the question just two or just a follow up on the question about the I all told regulatory strategy.
What's the what's the recent Steve your conversations with Sta round that have they given you any any guidance for hint says to what they would feel would be or appropriate or they also waiting for the datasets and so this is a no kind of mid 2021 activity for my from an F. day discussion perspective.
Yeah. Thanks, Thomas So we've had initial conversations with the FDA on the phase three pivotal trial and that initial conversation was based on us pushing our drug candidate or candidates as I've mentioned against a Iran. In a randomized trial again.
So essentially best practices as you know I'm you know the treatment in it for recurrent GBM.
It has basically very few therapeutic options and we have looked at that data in other words, what are sort of the best available treatment to patients can get and it ranges, but it ranges from somewhere between six to 12 months, depending on the study and the and the people reporting.
The data our current monotherapy.
Beats all of that.
60 months of overall, a median overall survival. So as we look to the pivotal trial. If we are going to do a randomized trial, we feel pretty good about it because we now have a sizable number of patients in both the monotherapy as rather than the combination therapy and certainly from the monotherapy data with the day.
And now really maturing quite nicely it looks good compared to quote what would be a randomized control. So therefore, our initial thought about how we move forward. It is with that preliminary conversation with the FDA I would say, though that the date as mature it a lot since that conversation you know we have them or I scans.
Increasingly a larger pool of patients and I think there are opportunities to go back to the FDA and share with them some of our data and get essentially refinements about what that pivotal trial will look like.
Do you think though if we look across it and I know, it's a different disease states and different drugs, but if you looked at the checkpoint inhibitors, you particular gave them getting away with a very well single arm open label studies in the small number of patients given unmet needs do you think theres not right you needed there to leverage some of the learnings from from us.
Or other drug classes and other disease states just to kind of advanced the program quick more quickly.
Yeah, I think I think ZIOPHARM has two opportunities to advance the program all quickly. The first just as you're guiding Thomas and that is continued conversation with the regulators and the second is our campaign for Ponting Glioma DPG and there is a you know <unk>. Unfortunately.
Opportunity because you know these children die so rapidly and with so little available to them. There really is no opportunity to randomize in that setting you can't randomize again, nothing kind of thing.
So there are opportunities in both camps, both by extending the program from a draw epicentral drug for GBM into a platform and then to essentially a evaluate it there with the regulators how the drug might be a on a faster track or for that recurrent GBM setting.
That's super helpful. Thanks, so much.
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Our next question is from Yale Jen with Laidlaw ankle. Please go ahead.
Oh, good afternoon, and thanks for taking the questions.
Just follow up.
The previous why into <unk>.
E G. Given the pediatric indications there is there are differences in term of treating the patient for instance, the there're use or other factors.
Ill take into the study done.
Yeah. Thanks, Yeah. That's good question. So we learnt a lot from treating and the I don't patients with recurrent GBM, particularly the role of steroids.
And in the dosing of the aisle 12, and there's a lot of Max that learning has been applied to the pediatricians taking care of these children with that the I did you. So they now have a essentially all of that data available to them and.
We can work with the physicians to do just what you're suggesting and that is limit the amount of steroid use for these kids. So they can get the maximum potential benefit from mild 12.
Okay, Great that's helpful and maybe just one more question here.
Is that in MD Anderson, you do have a library you suggested that could be a quicker way to start the Yankees study and that could you describe a little bit more interim up the scope.
And potentially size up this library at this point I undertake the so growing situations.
Still that.
At this moment.
Yeah, Yeah, I'm glad you mentioned at the library.
It's essentially a collection of TCR is that are against mutations in P 53, K Rasen EG fr.
That library was then license from the NCR and we already have it in our Arsenal and in fact, it's a sufficient size to already begin enrollment.
The the because that library essentially has been gotta, so quickly and now our team in Houston can essentially kick the tires on not library and make sure an offensive Kate It does what we think it's gonna do we can accelerate our program to put patients into the trial to benefit from that library.
TCR.
We recognize of course that the larger the library the better the chance of getting paid given patient with for instance, the P 53 mutation or as a kid reputation could benefit. So we're not only gonna proceed continue to in license TCR as for the anti but also we have a hole.
Program built out in Houston now to essentially expand the library under our own auspices and that's an important part for the company on a away essentially to track progress for our company is the size of that library no. Today, obviously for competitive advantage, we can't revealed a number of Tc ours.
And so forth, but I can give reassurance that it's a sizable number and indeed, it's sufficient to begin the trial and I can further go on and say that were quite strategic about the way. We are building. This library. We know for instance, some mutations are more representative and other than than others. We know.
Certain h. delay a more popular than others and we can essentially use our resources carefully to build a library. So we at the maximum chance of enrolling in particular patient to this trial.
Okay, Great and again congrats on the progress.
Difficult time.
Thank you.
Our next question is from Arthur here with H.C. Wainwright. Please go ahead.
Thank you for taking my question. These Oscar for RK, just regarding the TC Archie trial, both at the end see I and the M.D. Anderson could you guys remind us as these are also use their oh RPM technology or its.
Tony applied to sleeping beauty.
That's great offer thank you for a namely to clarify so the RPM technology, the rapid personalized manufacturer.
Enables T cells to be genetically modified on one day, and then simply infuse the next day.
That technology is built off two pivotal pieces the sleeping beauty system.
And a molecule called membrane bound I'll 15.
We have tested both sleeping beauty and membrane Vonage 15 in the car and in the TCR space and we can show in both essentially gene types. If you would the technology works.
We are initially testing, but RPM technology in the car T space in clinical trial. So in other words were doing and our phase one trial, both in the United States and in Taiwan, using the car T. RPM that learnings can then come back and inform on whether we're going to use the.
P M in the TCR space, but again I would emphasize that we've done a lot of the preliminary work and it the value of I'll 15 for TCR looks pretty good as we showed at ash in publication last December.
Thank you for that and that congratulations on the progress.
Ladies and gentlemen, thank you for joining I would like like to turn the conference back over to Dr. Cooper for closing remarks.
Thank you operator, and thank you everyone for joining US today, we certainly hope you're safe and well look forward to updating you through burchill investor conferences over the next couple of months during our fall R&D event and on our next quarterly call. Good day everyone.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant Dave.
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