Q2 2021 ZIOPHARM Oncology Inc Earnings Call
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Greetings and welcome to the Xylophone of Oncology, Inc. Second quarter 2021 corporate update at this time all participants are in a listen only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.
Please note. This conference is being recorded I will now turn the conference over to your host Adam Levy Executive Vice President of corporate development and Investor Relations. Thank you you may begin.
Thank you operator, good afternoon, and welcome to the XIAFLEX from Oncology conference call and webcast to review our updates for the second quarter ended June 30 of 2021.
This afternoon, we issued our press release, which is available and the investors section of our website <unk> Dot com.
Additionally, we posted a powerpoint presentation to accompany today's commentary, which can also be found and the investors section of our website.
Larry Let me remind everyone that during the call the company will make a number of forward looking statements.
The statements regarding the potential therapeutic candidates and our development pipeline.
<unk> status and financial information and business trends.
And we're looking statements are subject to numerous risks and uncertainties as described in our most recent 10-K and 10-Q filing.
And within other filings that we may make with the SEC from time to time.
On our call today, we have Heidi Hagen and interim Chief Executive Officer, who will present, a brief corporate summary.
He will be joined by Dr. Rafael a buffer chief Medical officer, who will present, an update on our clinical programs.
In addition, we are joined by led the group, our EVP and GM of cell therapy.
And James Huang, our executive Chairman, who will be available during the Q&A portion after our prepared remarks.
And to get things started I'll turn the call over to Heidi Hagen.
Heidi. Please go ahead.
Thank you Adam and welcome everyone. Let me start up of Shay and I'm excited by the progress we have made across multiple fronts since our last call and made it.
Indeed, the ending of the year, we have truly transformed the company and you can see the progress reflected on slide 4 of the deck. We posted this is a different company.
Turning now to the details of our progress which are summarized on slide 6 of the materials.
Since our last quarterly update we achieved several key milestones for our TCR T program.
We successfully completed the commissioning of the cgmp clinical production and completed H epic process validation and the facility in Houston. These.
And these critical steps of the naval the facility to use for a phase 1.2 G C. Archie library trial in.
In addition, the team is complete and process qualification with healthy donor cells, which will support the use of the facility to manufacture of TCR T cells or the clinical trial.
We remain on track to dose patients in our phase 1.2 G. C. R. T Library trial and the second half of 2021 and we are anticipating doing so in the fourth quarter.
We have and emphasizing our strategy on our TCR program and all of the company's efforts are being directed towards this program.
We've never been more enthusiastic or optimistic well I'll say the L. A will shell share more on this and a few moments.
Moving now to the balance sheet.
We ended the first half of 2021 with approximately $76.7 million and today, we announced and we have successfully executed a venture debt facility with Silicon Valley Bank for $50 million.
And immediate draw down of initial $25 million tranche, which is not included in our end of second quarter cash balance.
The $25 million initial tranche and extends the company's cash runway each of the fourth quarter of 2020.2.
Well beyond the time required to generate and assess the initial clinical data from our phase 1 true TCR T Library trial.
I want to make it clear that the company had and continues to have a multitude of options for financing and balance sheet fortification.
The board and management team are deliberate kit on the best path forward and took into account, both where the science is and where our cash runway brought us.
The guiding principle of course with shareholder impact.
We've done this and a smart way with minimal dilution.
As we said previously we have no intention of selling shares at the current stock price, which we believe significantly undervalues the company.
And regarding our current market valuation, we understand the concerns of shareholders have expressed we believe continuing to execute is the right way to demonstrate to the market and we are a leading oncology focused TCR company. We firmly believe we are on the right track.
The company is now operating from a position of strength with meaningful progress and our groundbreaking TCR T library trial, enabling activities.
And in our efforts to strengthen the balance sheet.
And we're doing exactly what we said we would do earlier this year and we have growing momentum that is exciting to see.
We are now and a position where the company will succeed or fail based on the science and the clinical data rather than operational considerations and the challenges.
Before I turn the call over to Raphael Ali, Let me say a word on the search for a permanent CEO and.
As we mentioned in our press release the board is very close to a decision and we would expect and announcement and the very near future and.
Number of well qualified candidates were considered and we are looking forward to making announcement.
Let me turn the call over raw family.
Thank you Rajeev, let me start by saying a few awards of the Guy and think of what progress you know, we're probably going to you're going to get the library program.
The main trunk, we achieved another major milestone and for our TCR T Library program.
And the commissioning of the cgmp nickel production and unit or CPU.
We're allowed the safety profit 40 days journey for the newly constructed of TCR and manufacturing and parts of Houston.
The remainder of them talk to those patients and the phase 1 through those finally, starting in the third 1 off work and when you when you want.
And I anticipate the dockworkers and during the fourth quarter.
The trial is the mutual you're targeting 6 individuals forward and to work and indicators from the core lines of carcinoma, pancreatic and ovarian endometrial and correlate and.
A lot of cancer.
And we're selected due to the frequency of chaos and the board keeps you can see and you guys.
These are just the initial 2 more sites as we plan to expand the introducing already indication of the future.
We continue to qualify additional TCR T and our library and plan to of man.
And the second half would be easier to include the CCR.
These are the function, we'd increase the potential U T V.
The good both banks and in population and address the bulk of metro market for the library.
The addition of all chaos and or the PPP mutations or other genetic cause of parts of associate the ease for the tumors such as Egfr we.
We plan to provide updates from the library and neither of these yet.
We know that there is an interest in our manufacturing strategy and capabilities. So let me say you're worried about this.
Revenue growth today more detail because the guys in their contract manufacturer. The report of our TCR T cell product.
During the 20th Duane we successfully transferred the manufacturing process and give you our bayou.
And for them and.
And a contract manufacturing organization with cgmp soak that up your manufacturing of car T D D and the woodlands and fixed.
Each of the batch the that generated that both <unk> and I want all of the laboratory, where the basis of our busy and people are sharing of our R&D and be filing area of easier.
And I walked into compute the process, where you could get extraordinary except the process validation to facilitate the music or manufacturing of dish.
Sure.
You mentioned previously we have been implementing the strategy now to teach you and you've got production capacity outside of work with ease of use of them.
You have done and be used to provide greater fixed the bleed flexibility and control of these important aspects of clinical development and rapidly moving forward with that'd be sure of what our manufacturing capabilities. The.
The commissioning and grow our community of our product production and doing the adult CPU Rollouts of 50 person as part of your day sure were completed this past quarter the.
And it is complete and protest where do you think the ocean, which will support the opening with the proximity to manufacture of TCR T cells for the clinical trial.
And the ability to use both of our work for CBD and give the EIS for manufacturing and provided US is strong as the view of risk mitigation and greater capacity as we scale up of clinical trial activity.
I want to remind everyone. Why we are so confident in our TCR program.
As you May recall, we shared exciting vehicles, a day about area of GCI.
The ACR annual meeting, where we presented the multiple TCR could be stably expressed using sleeping beauty transportation to redirect that he cut out blocks block T cells or tumor.
The arts, our unique specificity and started getting recurring if you could give me a good D C and chaos substitution infrequent.
And I provide.
We plan on providing additional preclinical data further demonstrating the strong volume beyond.
And the program and neither of these the August MTV confidence.
Based on ongoing dialogue and we didn't get together and you're very optimistic that we will.
The content of consistently and find the types of what type of mutation and that's really matches with our library within the target patient population.
These along with the companion and body of preclinical data and <unk>.
Progress on manufacturing.
The strong because of your confidence of the program.
We expect the door patients and decide the being in the fourth quarter. We didn't show it reads out the during the first half of 'twenty 2.
The previously those reads out mediocre I couldn't see the consequences, but we will provide updates as soon that would be out of meaningful data from share.
Let me also provide the brief update on our interest to get from a feed and 19, the RPM of car T cell therapy program being conducted and day, 1 but you can buy yourself, our joint venture we try it out and therapeutics.
We have included more detail both in our press release, and our 10-Q, which were up 5 and yet today.
Good day.
Excuse me the trials and in addition, and March 2 patients have been dosed and evaluate the north serious adverse events were reported and neither of these patient.
Laboratory of your talks with the nuclear support of free we previously published the known by the opening and do the gene transferred the effective and genetically modifying or total with T cells.
Patients were infused and days off the June Castor, that's shortening the turnaround time and providing a clear advantage over the buyout of methods.
Based on the old laboratory data for the surprise to patients the eat and by your sales team along with the lead investigator the order would be the 2 ports of from 15 of Biopharma and concluded that further process development work required to optimize the REIT.
<unk> the manufacturing process in order to more consultants, Inc. We manufactured products into the side of their clinical dose range of C. B study there.
And the terms of the joint venture agreement and they try the arm and he didn't buy your sales team will attempt to make the necessary process development improvements before the accusing that addition of a patient.
And then go find could do is unknown and made it quite of up to 20 months.
And I'm going to COVID-19 outbreak and you can tell you 1 presents added onto the.
Uncertainty to the time line.
Operational activity and the manufacturing facility are currently at the low due to the employees of the street shortly the do they run banning the use of the fixture and not impacting the clinical trials and broadly and day 1.
And if you will from entering the press release and consistent with our strategic focus and PCR and the companies seeking and consider the and broker partnership to enable a part of the development of the investigation of what you'd be 19 of RPM cut piece of debt.
Several parties have expressed interest in such a partnership including and try it out and therapeutics. The company. We've carefully consider all options regarding the future of of the joint venture the technology and the global the roaming pathway in order to maximize shareholder value.
It is important to note the the TCR and kept the processes are intrinsically different.
And a fall of separate process development pathways.
While both involved with it and do the gene transfer the contract manufacturing processes and.
And the target indication and I'd be saying.
Additionally, the tissue of your clinical program is investigating the treatment of OLED range of solid tumors.
What is the car T program has been focused on hematologic malignancy.
We do not believe that they're finding from car T. The read through to the TCR T program you can find the at least 1 I'll get the that's 1 of our pipeline and milestones and the materials, we shared earlier today.
And then let me conclude by reiterating what makes the day pardon me of unique and.
And why we are sort of excited light 5 and the material is the greater presentation of what's driving the body of put off the.
The rights of the right target and the right platform with that we'll now turn the call of of your Barry The who will help us beginning of the QA ocado.
Thank you at this time, we will be conducting a question and answer session.
The ask a question. Please press star 1 on your telephone keypad. The confirmation tone will indicate your line is and the question Kim you.
And you May press star 2 and he would like to remove your question from the queue.
Participants using speaker equipment and may be necessary to pick up your handset before pressing effect.
1 moment, please while we poll for questions.
My apologies.
And quite technical difficulty.
Okay. Thank you for your patience of our first question comes from Alethia Young of Cantor Fitzgerald. Please state your question.
Hi, This is neena on for Alethia, and thanks for taking our questions.
So for the Taiwan, a child can you. Please just discuss what.
And what's the current manufacturing and process was exactly and and who runs it.
And the second 1.
Is there anything you can leverage from your own experience with them and you're factoring of TCR T to help with the <unk>.
And then the <unk> program. Thanks.
Thanks, Nina let me.
And maybe ask Ellie of Raffaele to comment on the manufacturing process and Taiwan.
Sure.
I'll start.
So the manufacturing process in Taiwan, and the needle utilizes the rapid personalized manufacturing process, our RPM process. So I'm.
Essentially it's very simple process were sleeping beauty is use chi the genetic transfer and T cell.
Sales are released shortly thereafter, and and fused immediately so within 2 days of the gene transfer and this is quite different than the TCR process, which actually utilizes and ex vivo propagation so of mark kind of traditional type of.
The propagation process that allows the cells to grow to larger numbers.
So are you asking about Q1 from manufacturing process distance are performed by the E try on the team. So the time team and Taiwan does the manufacturing at a cgmp facility on site at the National Taiwanese of University.
And.
Certainly there are yeah.
Just in terms of the processes that are have been developed and are continuing to.
We continue to perform process research and processed.
Process development to always improve the processes. There are obviously things that 1 learns.
The improvements that can be made across the board. So I think just you know as the field and general progress says.
And there are learnings that can be made that will help us to improve the processes for the.
And the foreseeable future.
But the.
And they are appropriate.
Yeah, if I can add debt is also.
The structure of difference between the car and the TCR, they're competing and default.
So that is the size of the sequence and without.
And going through the details there are 2 different construct right 1 of the sleeping beauty of the gene transfer it works very well we bought a.
6 of them keep that in mind and you've got 2 different.
No.
You know.
Got it.
I would also add this is Heidi and I would also add you asked the question about the TCR process and its reflection on.
And the car T process and yes, the TCR process is.
Is it market share process.
And a couple of more years, and our hands and that and the laboratory and in facilities and so there are opportunities to yeah further and trade of the process and their insights that we have gained and we know of that our colleagues at it and he didn't have also gained.
And some insights to along those lines, so and just to answer. Your second question is that there is experience and and understanding of does reflect on the opportunities with that particular process and product.
Okay that makes sense. Thank you.
Nina and anything else, we can help you with.
Oh no. Thank you.
Hi, Thank you.
As a reminder, if you would like to ask a question. Please press star 1 on your telephone keypad and confirmation tone will indicate your line is and the question queue for participants using speaker equipment and it may be necessary to pick up your handset before pressing the star.
1 moment, please while we poll for additional questions.
It appears there are no more questions at this time.
And I'd like to now turn the call back to the Heidi Hagen for closing remarks.
So our 10-Q will be filed and the next several days and I would like to thank everyone for joining us today and have a great rest of your day and it's been a pleasure talking with you.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.
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