Q3 2020 ZIOPHARM Oncology Inc Earnings Call

See we are building a library that targets other genetic changes to K Ras.

In addition to targeting KRS ZIOPHARM is also targeting another driver mutation.

T. P 53 is considered among the most mutated gene 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 TCR as the target TP Pfifty three 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 I., Andy 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 a delay we.

We will be accruing patients from multiple cancer types at one of the nation's top cancer centers with support of multiple positions.

We are in an essence conducting a trial treating five indications with multiple TCR under one clinical protocol.

Our advantage grows as we continue to increase the number of TCR is in the library through licensing on our own in house discovery team. Indeed, just this past quarter, we expanded the TCR is available for us to use in our library.

Simply put the larger the number of TCR is available for clinical use the greater the chance of matching the targeted mutations NHL play with a prospective patients cancer.

Our advantage continues further as we bring online the personalized TCR T trial. This technology targets patients unique antigens in their cancer rather than shared mutations in neoantigens.

This personalized approach is applicable to most epithelial cancers, and we addressed head on the need to efficiently target multiple individual cancer mutations that gave rise to each patients unique neoantigen mixture.

We will address this opportunity after initiating the library TCR T trial by launching our personalized TCR T trial with the capability to administer T cells with more than one specificity for more than one neoantigens.

With our plan to rapidly treat patients off the screening with TCR us 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.

The build out of our infrastructure and expertise in support of our TCR T program requires careful planning and execution that date to the split with our former partner.

This requires a tremendous expertise in the know how of cell and gene therapy.

I'm fortunate to have been working on genetically modified T cell for 20, plus years and all that time I've never worked with a group that is so quickly up to speed competent resourceful focused and excited about the work they're doing for patients.

We are proud of ZIOPHARM that we are tracking to a timeline from licensing tcrs to filing a corporate I'd 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 anti.

He and his team have been helping to guide the creation of ZIOPHARM internal programs as well as making TCR is available for in licensing to our library.

You will recall that after we separated from our former corporate partner in October 2018, ZIOPHARM has limited capabilities and we are reliant on the anti to advance the TCR T program through a cooperative research and development agreement or crater.

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 anti we're no longer dependent on them to make progress on the TCR T program.

This is important to note as the Npis hone 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 key reiterates the potential of the sleeping beauty platform and his excitement about it first non viral TCR T trial at the anti 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 ZIOPHARM is engineering runs back to the anti to generate sleeping beauty modified T cells and they have offensive stated this methodology aren't and are in the process of repeating the runs in their GMP facility.

However, the treatment of the first patient is dependent on a regulatory review changes at the National institutes of health and significantly the availability of patients.

While Dr. Rosenberg 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 Ti is slower than before COVID-19.

There are a few patients with solid tumors in the wings the could be eligible for treatment, but the ongoing pandemic has unfortunately, taking a toll which we believe will impact the npis 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 Eaton bias sell our joint venture, which we own 50 50 with try on therapeutics.

ZIOPHARM is delighted by the progress reported by Eaton biodiesel and its partners in Taiwan in Viatel has begun the process of filing an i. Andy to be completed by the end of the year for a clinical trial to assess patient derived autologous.

Car T that are produced using rapid personalized manufacturing or RPM technology.

RPM enables T cells to be very quickly and views as soon as the day. After gene transfer. This is based on the sleeping beauty system ability to stay Billy insert multiple genes into T cells and without the need to profit propagate T cells outside the body.

After gene transfer also known as electroporation. The T cells are genetically modified to express a cdnineteen specific kamerick antigen receptor or car and membrane bound aisle 15 or interleukin 15.

The very next day the T cell meet release criteria and are infused this.

Patrick brain tumors.

We made 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 Leery cancer Center Harbor and UCSF are accurate.

The trial is designed to evaluate the safety and Tolerability of our viral vector engineered to produce aisle 12 are interleukin 12 under the regulation of oral dosing of <unk>.

During the past quarter, we received a rare pediatric disease designation for controlled I'll 12 in the investigational treatment of diffuse the intrinsic ponting glioma or D. IPG.

At this early point in the trial, we are focused on the safety of the first patients.

<unk> clinical partners are instruments in the brain stem of children, which is obviously critical insensitive and add any in order to inject a virus to conditionally deliver powerful I'll 12 cytokine.

We are treating children with literally no options for survival as that D. IPG 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 Snow Conference. Later this month, where we have three abstracts accepted for presentation.

We will present, new data on controlled I'll 12, including a first look at the D. IPG indication initial data from the phase two study of controlled I'll 12, with the PD one inhibitor lip tile and we're currently have us stoma and an update on the combination study with Opdivo and 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 long following shareholder feedback an industry veteran Kevin Bucci after a national search.

The appointments complement last year's edition of Dr. Christof about it and Heidi Hagen.

Xylophone Board now consists of eight individuals, including seven non employee directors, who have extensive experience in finance business development operations and help get among other areas of expertise. The board is highly focused on what is best for shareholders in the long term success of the company and a process has been.

Underway since July following our annual meeting to refresh the board with complimentary skill sets optimal for a clinical stage company in our space.

Building on the appointment of too 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 for additional new members to our scientific Advisory Board led by a Doctor call June welcoming doctors Addy bars al Gavin done, Matt, Matt Party and Cole Royal.

We are so pleased that you joined us.

In closing I will return to this year's priorities that we had previously communicated we have been focused on building out our internal T. Several program as a value driver for the future executing on the control IL 12 program and bringing our RPM technology to the clinic with CD 19 specific car.

All while being careful stewards of capital.

While no one could have anticipated the gravity of the ongoing pandemic, we were able to put in place the financing and our own infrastructure beginning in the first quarter of this year to help us whether uncertainties. We have been working diligently through the challenges of COVID-19, and the resulting delays from some of our.

Our external partners. However, I do not want these challenges to overshadow. The fact that we have made important progress and are excited by the culmination of all of that could work.

With that let me now turn the call over to sat for a review of our financials.

Thank you and good afternoon, everyone.

Let me start with a quick review of a financial results for the closet.

As low churches, unusually research and development expenses $14 million for the towards quarter of 2020.

286 million four Q3 of 2019.

The difference reflects increased clinical trials to itchy and increased head down and a R. D T.

G and a expenses was $6 4 million for the third quarter of 2020.

Compared to four 8 million so he could quarter of 2019.

The inquiries, it's primarily due to Ohio head down.

Legal costs associated with an expanded passion flips for Ya.

And facilities costs.

When it accumulates a basis for the third quarter of 2020, we reported in Nicoloff applicable to common chivalry goes of 23 million.

Or <unk> or basic and diluted shifts compared to a net loss of 74 million or 43 for sure but.

He could quarter of 2019, which had reflected days 68 million or 36 cents for sure.

Non cash charge, but an inducement work.

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One moment please for the first question.

And our first question is from the line of Robert song with Jefferies. Please go ahead.

Great. Thank you for the update and congrats on the progress maybe just a few quick ones from me [laughter]. So first of all I see you have for.

I'm kind of just close the the potential targeted at a new antigen care Reits in the T. P 53, and a potential upside to the targeted a tumor types or maybe the artist can you just a comment a little bit about the the potential addressable market among those targeted cancer care.

So types considering the.

The the new engine, you are targeting and the at the H.L.A. matching a kind of a library.

Yeah sure Roger it's a it's an important part of our program and thank you. So there was a number of pieces that go into choosing a these cancers.

The first is the representation of the antigens K Ras and T. P 53.

Second is the mixture of patients that make up the MD Anderson essentially a patient portfolio who's coming to Anderson, who has the right actually background and then third is the as you're getting into sort of what does the market capability.

So the way I think about it right now is establishing a proof of concept in these very important tumor types. We.

We will be able to get patients from the innocence. The they are well represented in the <unk> among the.

You know the people come to MD Anderson and the second is that you know they have the right mutations that we can scream for they also though are significant significant opportunities in terms of the types of tumors were going after I mean, if you just look at look at the list that we put out colorectal cancers. I mean, that's a massive all by itself non small cell lung cancer massive all by itself.

You know so there is you know all three pieces of the puzzle now really coming into focus we're out in the REIT tumors, we're using the right kind of biology, and and will be a addressing formidable market opportunities.

All right great Yeah, that's helpful.

And then maybe just stick with the the TCR and since you are on track to file the iden D or early next year EPS worst quarter.

Just maybe add any additional color you want or comment what's left to prepare for the I'd and Ah yes. So that's that.

Yeah, Roger that's an important part two I mean, just to kind of frame. That's again, we've gone from soup to nuts in two years.

HM two years I just go to emphasize that that's a remarkable amount of progress that's establishing the team building out the labs identifying the receptor is working with our colleagues at Indiana Sun.

Putting together the CMC package, putting together the production system identifying the manufacturing finalized into bioinformatics and all the correlative studies and all of the clinical team. It is.

Full on 24, seven resolve problems to be able to do this and I'm just thrilled to be able to tell investors about all the progress we have made in this.

Great. Thank you yeah. That's all from me. Thank you figured art Cobots can sure. Thank you.

At this moment.

Sure. So obviously you know the 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 DPG and in particular.

Yielded greater synergy than monotherapy and I mean, I guess does it really matter either way and then yeah. Next question isn't one TCR T trial at MD Anderson I mean I'm.

Just to break it down with it more is it really related to like kind of the capacity and kind of dynamics relate cobot or are there. Other factors that kind of like you know are lingering to kind of get you know everything up and running appropriately there. Thanks.

The consistent message really dating back to 2019, the ZIOPHARM is increasingly taking over essentially its own future at the beginning when we separated from our partner, we didnt have the resources infrastructure and so forth to really accelerate that program. However.

However, now we do.

Undertaken the fund raising we've hired the people we have support and so we were able now to put in place the teams to execute on our home program. This doesn't diminish the work to Dr. Rosenberg is doing and we're excited for him to be putting patients on trial, but it really allows our freedom to operate now independently of sea Rosenberg under our own timelines and as we are.

I said this is actually going swimmingly well.

Raymond James Please go ahead.

Good afternoon folks thanks for taking my questions and I guess just one in one quick follow up first with respect to the Npis TCR trial and could you guys elaborate a little bit on the regulatory requirements being implemented and you know understanding that the agency is currently under significant burden that burden.

It's not a that's not a big burden, but it takes time to work through that and then of course, he has to manage pace in Q, which as everybody knows in this you know.

Time of pandemic is quite difficult and that involves hunting for the Tc ours, and so forth and patients essentially being in the wings waiting to relapse and as I guided in my remarks, a few minutes ago. This affects you know.

Our program and we believe it affects other programs at the anti.

Got it great. Thanks, Lawrence and just as a quick follow up.

And I think Thats, an important part for it 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 Flatten with Lake Street Capital Partners.

Please go ahead.

Thank you and thanks for taking the questions I apologize. If these are repeat that some challenges with my connection did you disclose how many patients have been enrolled into the PG study.

Yeah.