ZIOPHARM Oncology Inc (ZIOP)

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ZIOPhttp://www.nasdaq.com/symbol/ziopHealth Caren/aMedical Specialities

Latest ZIOPHARM Oncology Inc (ZIOP) company news

Should You Have ZIOPHARM Oncology Inc’s (NASDAQ:ZIOP) In Your Portfolio?

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If you own shares in ZIOPHARM Oncology Inc (NASDAQ:ZIOP) then it’s worth thinking about how it contributes to the volatility of your portfolio, overall. In finance, Beta is a measure of volatility. Volatility is considered to be a measure of risk in modern finance theory. Investors may think of volatility as falling into two main categories. The first type is company specific volatility. Investors use diversification across uncorrelated stocks to reduce this kind of price volatility across the portfolio. The second type is the broader market volatility, which you cannot diversify away, since it arises from macroeconomic factors which directly affects all the stocks on the market.

Some stocks see their prices move in concert with the market. Others tend towards stronger, gentler or unrelated price movements. Beta is a widely used metric to measure a stock’s exposure to market risk (volatility). Before we go on, it’s worth noting that Warren Buffett pointed out in his 2014 letter to shareholders that ‘volatility is far from synonymous with risk.’ Having said that, beta can still be rather useful. The first thing to understand about beta is that the beta of the overall market is one. A stock with a beta below one is either less volatile than the market, or more volatile but not corellated with the overall market. In comparison a stock with a beta of over one tends to be move in a similar direction to the market in the long term, but with greater changes in price.

View our latest analysis for ZIOPHARM Oncology

What does ZIOP’s beta value mean to investors?

Looking at the last five years, ZIOPHARM Oncology has a beta of 1.24. The fact that this is well above 1 indicates that its share price movements have shown sensitivity to overall market volatility. If the past is any guide, we would expect that ZIOPHARM Oncology shares will rise quicker than the markets in times of optimism, but fall faster in times of pessimism. Many would argue that beta is useful in position sizing, but fundamental metrics such as revenue and earnings are more important overall. You can see ZIOPHARM Oncology’s revenue and earnings in the image below.

NasdaqCM:ZIOP Income Statement Export September 20th 18

Does ZIOP’s size influence the expected beta?

With a market capitalisation of US$423.5m, ZIOPHARM Oncology is a very small company by global standards. It is quite likely to be unknown to most investors. It has a relatively high beta, suggesting it is fairly actively traded for a company of its size. Because it takes less capital to move the share price of a small company like this, when a stock this size is actively traded it is quite often more sensitive to market volatility than similar large companies.

What this means for you:

Since ZIOPHARM Oncology tends to moves up when the market is going up, and down when it’s going down, potential investors may wish to reflect on the overall market, when considering the stock. This article aims to educate investors about beta values, but it’s well worth looking at important company-specific fundamentals such as ZIOPHARM Oncology’s financial health and performance track record. I urge you to continue your research by taking a look at the following:

  1. Future Outlook: What are well-informed industry analysts predicting for ZIOP’s future growth? Take a look at our free research report of analyst consensus for ZIOP’s outlook.
  2. Past Track Record: Has ZIOP been consistently performing well irrespective of the ups and downs in the market? Go into more detail in the past performance analysis and take a look at the free visual representations of ZIOP’s historicals for more clarity.
  3. Other Interesting Stocks: It’s worth checking to see how ZIOP measures up against other companies on valuation. You could start with this free list of prospective options.

To help readers see past the short term volatility of the financial market, we aim to bring you a long-term focused research analysis purely driven by fundamental data. Note that our analysis does not factor in the latest price-sensitive company announcements.

The author is an independent contributor and at the time of publication had no position in the stocks mentioned. For errors that warrant correction please contact the editor at [email protected].

Is the Options Market Predicting a Spike in ZIOPHARM Oncology (ZIOP) Stock?

As of late, it has definitely been a great time to be an investor in BioLineRx Ltd. (BLRX).

Investors in ZIOPHARM Oncology, Inc. ZIOP need to pay close attention to the stock based on moves in the options market lately. That is because the Sep 21, 2018 $3.00 Call had some of the highest implied volatility of all equity options today.

What is Implied Volatility?

Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell-off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.

What do the Analysts Think?

Clearly, options traders are pricing in a big move for ZIOPHARM Oncology, but what is the fundamental picture for the company? Currently, ZIOPHARM Oncology is a Zacks Rank #2 (Buy) in the Medical – Biomedical and Genetics industry that ranks in the Top 38% of our Zacks Industry Rank. Over the last 60 days, two analysts have increased their earnings estimates for the current quarter, while none have dropped their estimates. The net effect has taken our Zacks Consensus Estimate for the current quarter from a loss of 13 cents per share to a loss of 11 cents in that period.

Given the way analysts feel about ZIOPHARM Oncology right now, this huge implied volatility could mean there’s a trade developing. Oftentimes, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected.

Looking to Trade Options?

Each week, our very own Dave Bartosiak gives his top options trades. Check out his recent live analysis and options trade for the NFLX earnings report completely free. See it here: Bartosiak: Trading Netflix's (NFLX) Earnings with Options or check out the embedded video below for more details:


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CORRECTING and REPLACING -- Ziopharm Oncology Announces Scott Braunstein, M.D., Operating Partner at Aisling Capital, Nominated to Board of Directors

BOSTON, Sept. 04, 2018 (GLOBE NEWSWIRE) -- In a release issued earlier today by Ziopharm Oncology, Inc. (ZIOP), please note the Company's upcoming annual meeting of stockholders is being held Sept. 18 rather than Sept. 8 as originally issued. The corrected release follows:

Ziopharm Oncology, Inc. (ZIOP) today announced that its Board of Directors has nominated Scott Braunstein, M.D., an Operating Partner at Aisling Capital, a leading healthcare investment firm, for election to the Board of Directors at the Company’s annual meeting of stockholders on Sept. 18.

In addition to Aisling Capital, Dr. Braunstein has held leadership positions including serving as the Chief Operating Officer at Pacira Pharmaceuticals, Inc., a specialty pharmaceutical company. He also spent more than 12 years in finance as a healthcare analyst and portfolio manager at J.P. Morgan Asset Management. He is the Chairman of the Board of Directors of Artara Therapeutics and a member of the Board of Directors of Esperion Therapeutics.

“We believe Scott will bring a dynamic mix of corporate strategy and finance experience which will help Ziopharm advance our two platform technologies, Controlled IL-12 and Sleeping Beauty,” said Ziopharm’s Lead Director Scott Tarriff, who is Chief Executive Officer of Eagle Pharmaceuticals. “As we evolve our Board with the addition of Scott and others, we are better positioned to support the Ziopharm team in executing its mission of harnessing immunotherapy to fight cancer.”

Dr. Braunstein has been nominated along with two new independent director nominees and three returning director nominees to stand for election to Ziopharm’s Board of Directors. Last month, the Company announced the nominations of two independent director nominees, Paratek Pharmaceuticals’ Chief Financial Officer Doug Pagán and Scholar Rock’s Chief Operating Officer Elan Ezickson to succeed Sir Murray Brennan, M.D., and former U.S. Sen. William Wyche Fowler, both of whom continue to serve as directors and will retire from the Board when their terms expire on Sept 18. The nomination of Dr. Braunstein is in addition to the five director candidates described in Ziopharm’s proxy statement previously furnished to stockholders and filed with the Securities and Exchange Commission (SEC) on Aug. 8. Additional details regarding the new proposal for the election of Dr. Braunstein can be found in a supplement to the proxy statement, which was filed with the SEC on Aug. 31 and is also available on the Company’s website.

About Dr. Braunstein, Independent Director Nominee
Dr. Braunstein is an Operating Partner at Aisling Capital, a leading investment firm. He held leadership roles including Chief Operating Officer, Chief Strategy Officer and Senior Vice President of Strategy at Pacira Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the clinical and commercial development of new products utilized in acute patient care. Earlier in his career, Dr. Braunstein held positions in finance at Everpoint Asset Management and J.P. Morgan Asset Management. He began his career as a practicing physician at the Summit Medical Group and as Assistant Clinical Professor at Albert Einstein College of Medicine and for Columbia University Medical Center after completing his training at the New York Hospital/Cornell Medical Center, his research experience at Rockefeller University, and earning his medical degree from the Albert Einstein College of Medicine.

About Ziopharm Oncology, Inc.

Ziopharm Oncology is a Boston-based biotechnology company focused on the development of next-generation immunotherapies utilizing gene- and cell-based therapies to treat patients with cancer. In partnership with Precigen Inc., a wholly-owned subsidiary of Intrexon Corporation (XON), Ziopharm is focused on the development of two platform technologies designed to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of multiple cancer types: Controlled IL-12 and Sleeping Beauty for genetically modifying T cells. The Company's lead asset, Ad-RTS-hIL-12 plus veledimex, has demonstrated in clinical trials the potential to control interleukin-12, leading to an infiltration of T cells that fight cancer. Ad-RTS-hIL-12 plus veledimex is being evaluated as a monotherapy and in combination with immune checkpoint inhibitors to treat brain cancer and other tumor types. The Company also is advancing therapies using Sleeping Beauty, a non-viral approach to genetically modify chimeric antigen receptor (CAR+) and T-cell receptor (TCR+) T cells, which target specific antigens in blood cancers and neoantigens in solid tumors. Sleeping Beauty is designed using the Company's point-of-care technology, a shortened manufacturing process which potentially can be developed as a decentralized manufacturing process based in hospitals. These programs are being advanced in collaboration with Precigen and with MD Anderson Cancer Center, the National Cancer Institute and Merck KGaA, Darmstadt, Germany. 

Forward-Looking Statements Disclaimer

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the skills, experience and expertise the independent director nominees would bring to the Ziopharm Board of Directors if elected; the retirement of Sir Murray Brennan, M.D., and former U.S. Sen. William Wyche Fowler from the Ziopharm Board of Directors following the 2018 annual meeting of stockholders; and the director nominee slate proposed for election at the 2018 annual meeting of stockholders. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s ability to advance certain activities; whether chimeric antigen receptor T cell (CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, or any other product candidates will advance further in the preclinical research or clinical trial process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether chimeric antigen receptor T cell (CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, and the Company's other therapeutic products it develops will be successfully marketed if approved; the strength and enforceability of the Company's intellectual property rights; competition from other pharmaceutical and biotechnology companies; as well as other risk factors contained in the Company's periodic and interim reports filed from time to time with the Securities and Exchange Commission, including but not limited to, the risks and uncertainties set forth in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and subsequent reports that the Company may file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Contact:
David Connolly
Ziopharm Oncology
617-502-1881
[email protected]

 

Ziopharm Oncology Announces Scott Braunstein, M.D., Operating Partner at Aisling Capital, Nominated to Board of Directors

BOSTON, Sept. 04, 2018 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (ZIOP) today announced that its Board of Directors has nominated Scott Braunstein, M.D., an Operating Partner at Aisling Capital, a leading healthcare investment firm, for election to the Board of Directors at the Company’s annual meeting of stockholders on Sept. 8.

In addition to Aisling Capital, Dr. Braunstein has held leadership positions including serving as the Chief Operating Officer at Pacira Pharmaceuticals, Inc., a specialty pharmaceutical company. He also spent more than 12 years in finance as a healthcare analyst and portfolio manager at J.P. Morgan Asset Management. He is the Chairman of the Board of Directors of Artara Therapeutics and a member of the Board of Directors of Esperion Therapeutics.

“We believe Scott will bring a dynamic mix of corporate strategy and finance experience which will help Ziopharm advance our two platform technologies, Controlled IL-12 and Sleeping Beauty,” said Ziopharm’s Lead Director Scott Tarriff, who is Chief Executive Officer of Eagle Pharmaceuticals. “As we evolve our Board with the addition of Scott and others, we are better positioned to support the Ziopharm team in executing its mission of harnessing immunotherapy to fight cancer.”

Dr. Braunstein has been nominated along with two new independent director nominees and three returning director nominees to stand for election to Ziopharm’s Board of Directors. Last month, the Company announced the nominations of two independent director nominees, Paratek Pharmaceuticals’ Chief Financial Officer Doug Pagán and Scholar Rock’s Chief Operating Officer Elan Ezickson to succeed Sir Murray Brennan, M.D., and former U.S. Sen. William Wyche Fowler, both of whom continue to serve as directors and will retire from the Board when their terms expire on Sept 18. The nomination of Dr. Braunstein is in addition to the five director candidates described in Ziopharm’s proxy statement previously furnished to stockholders and filed with the Securities and Exchange Commission (SEC) on Aug. 8. Additional details regarding the new proposal for the election of Dr. Braunstein can be found in a supplement to the proxy statement, which was filed with the SEC on Aug. 31 and is also available on the Company’s website.

About Dr. Braunstein, Independent Director Nominee
Dr. Braunstein is an Operating Partner at Aisling Capital, a leading investment firm. He held leadership roles including Chief Operating Officer, Chief Strategy Officer and Senior Vice President of Strategy at Pacira Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the clinical and commercial development of new products utilized in acute patient care. Earlier in his career, Dr. Braunstein held positions in finance at Everpoint Asset Management and J.P. Morgan Asset Management. He began his career as a practicing physician at the Summit Medical Group and as Assistant Clinical Professor at Albert Einstein College of Medicine and for Columbia University Medical Center after completing his training at the New York Hospital/Cornell Medical Center, his research experience at Rockefeller University, and earning his medical degree from the Albert Einstein College of Medicine.

About Ziopharm Oncology, Inc.

Ziopharm Oncology is a Boston-based biotechnology company focused on the development of next-generation immunotherapies utilizing gene- and cell-based therapies to treat patients with cancer. In partnership with Precigen Inc., a wholly-owned subsidiary of Intrexon Corporation (XON), Ziopharm is focused on the development of two platform technologies designed to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of multiple cancer types: Controlled IL-12 and Sleeping Beauty for genetically modifying T cells. The Company's lead asset, Ad-RTS-hIL-12 plus veledimex, has demonstrated in clinical trials the potential to control interleukin-12, leading to an infiltration of T cells that fight cancer. Ad-RTS-hIL-12 plus veledimex is being evaluated as a monotherapy and in combination with immune checkpoint inhibitors to treat brain cancer and other tumor types. The Company also is advancing therapies using Sleeping Beauty, a non-viral approach to genetically modify chimeric antigen receptor (CAR+) and T-cell receptor (TCR+) T cells, which target specific antigens in blood cancers and neoantigens in solid tumors. Sleeping Beauty is designed using the Company's point-of-care technology, a shortened manufacturing process which potentially can be developed as a decentralized manufacturing process based in hospitals. These programs are being advanced in collaboration with Precigen and with MD Anderson Cancer Center, the National Cancer Institute and Merck KGaA, Darmstadt, Germany. 

Forward-Looking Statements Disclaimer

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the skills, experience and expertise the independent director nominees would bring to the Ziopharm Board of Directors if elected; the retirement of Sir Murray Brennan, M.D., and former U.S. Sen. William Wyche Fowler from the Ziopharm Board of Directors following the 2018 annual meeting of stockholders; and the director nominee slate proposed for election at the 2018 annual meeting of stockholders. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s ability to advance certain activities; whether chimeric antigen receptor T cell (CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, or any other product candidates will advance further in the preclinical research or clinical trial process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether chimeric antigen receptor T cell (CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, and the Company's other therapeutic products it develops will be successfully marketed if approved; the strength and enforceability of the Company's intellectual property rights; competition from other pharmaceutical and biotechnology companies; as well as other risk factors contained in the Company's periodic and interim reports filed from time to time with the Securities and Exchange Commission, including but not limited to, the risks and uncertainties set forth in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and subsequent reports that the Company may file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Contact:
David Connolly
Ziopharm Oncology
617-502-1881
[email protected]

 

Edited Transcript of ZIOP earnings conference call or presentation 8-Aug-18 8:30pm GMT

Q2 2018 ZIOPHARM Oncology Inc Earnings Call

NEW YORK Aug 22, 2018 (Thomson StreetEvents) -- Edited Transcript of ZIOPHARM Oncology Inc earnings conference call or presentation Wednesday, August 8, 2018 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* David Connolly

ZIOPHARM Oncology, Inc. - VP of Corporate Communications & IR

* David M. Mauney

ZIOPHARM Oncology, Inc. - Executive VP, Chief Business Officer & Interim COO

* Laurence James Neil Cooper

ZIOPHARM Oncology, Inc. - CEO

* Scott L. Tarriff

ZIOPHARM Oncology, Inc. - Lead Director

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Conference Call Participants

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* Reni John Benjamin

Raymond James & Associates, Inc., Research Division - Senior Biotechnology Analyst

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to the ZIOPHARM Second Quarter 2018 Earnings Conference Call. (Operator Instructions) As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Mr. David Connolly, Vice President of Corporate Communications and Investor Relations. Sir, you may begin.

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David Connolly, ZIOPHARM Oncology, Inc. - VP of Corporate Communications & IR [2]

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Thank you. Earlier today, we released our financial results for the second quarter 2018 with a press release that is available on our website.

During today's call, representatives of the company will make a number of statements that are forward-looking, including statements regarding the potential of therapeutic candidates in our development pipeline. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described in our SEC filings.

And with that, I'll turn the call over to Laurence Cooper, our CEO.

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [3]

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Thank you, David, and thank you all for joining me today. So we'll begin on Slide 3. Let me first go over the agenda and the speakers for the call.

Initially, I'll provide updates on the CAR-T programs, including the current status of the FDA hold on the third-generation trial targeting CD19; the status of our TCR program with Dr. Rosenberg and his group at the NCI; and then an update on controlled IL-12 studies that are enrolling patients both as monotherapy and in combination with immune checkpoint inhibitors. Then, our Lead Director, and he's been newly appointed, Scott Tarriff, will outline plans from the perspective of our Board. And finally, our Chief Business Officer and Interim COO, David Mauney, will provide an update to our current balance sheet and cash time line and a brief overview of other activities.

Just transition to Slide 4. And with that, and at the beginning, let me start with some reassurance. All of us at ZIOPHARM believe we're on the edge of achieving important value-driving milestones. Our platforms and vision remain intact, and we are executing on a plan for growth. And we expect this trend to continue, even to accelerate. We do acknowledge the downturn in our stock and the anxiety it has caused. But let us keep in mind, however, where we have come from and where we are going.

Over the last approximately 3 years, we have transitioned to a broad immuno-oncology company focused on driving forward 2 major and distinct platform technologies that, when successful, will have overcome the major problems in the field of immuno-oncology that our competitors face, namely how does one target solid tumors and how does one bring down the costs of cell therapy? The field of immuno-oncology will not reach its full potential unless these 2 problems are overcome. And the good news for ZIOPHARM is that we are already implementing the answers with our 2 platform technologies.

One platform is a cell therapy approach based on the Sleeping Beauty system, the most clinically advanced approach to genetically modifying cells without using a virus. And the second platform being a gene therapy technology to control IL-12, IL-12 being a master regulator of immune system. We, at ZIOPHARM, understand the complexities relative to being first movers, and we feel that the market opportunity for our technologies is even stronger today.

So let's review together where these program stand beginning on Slide 5. I'll start with the Sleeping Beauty platform for cell therapy and an update on our IND status regarding our third-generation Phase I trial to evaluate CD19-specific CAR-T, which can be produced in under 2 days, or as we say, using point-of-care technology. We announced in May that the IND had been filed by MD Anderson, the trial sponsor. And in June, we announced that the FDA had requested more information and placed this IND on clinical hold. We now know what the FDA requires to complete the IND process. And ZIOPHARM, Precigen and MD Anderson Cancer Center are all working together in an expedited fashion.

With regards to the questions in the hold letter, the agency has requested additional information related to the chemistry manufacturing and controls. We appreciate the agency's feedback, and we're confident that this time that these questions that the agency has posed can all be addressed.

Our approach to the 2-day very rapid manufacturing of autologous T cells is bold. Our T-cell product is based on cutting-edge science, and we understand our approach will be scrutinized given that we are first-mover for the manufacture of autologous T cells in under 2 days. Our guidance for the beginning of this year was to initiate the trial in the second half of 2018. And thus, we already built in a buffer in case additional time was needed after filing the IND.

ZIOPHARM and our partners at MD Anderson and Precigen are rapidly executing on the plan to bring IND off hold as possible. For example, we already begun preclinical studies to develop additional data to support the IND application. We anticipate these studies, which are expected to take a few months to complete, will provide us with the data we need to answer the agency's questions. Indeed, we are focused on responding to the agency as soon as possible. But the timing of the clinical trial anticipated to be initiated by the end of this year may be impacted. And as we get more clarity from the FDA throughout this process, we'll get a better idea as to the effect on our time lines.

What happens after this IND is effected? Well, we're not waiting to find out, and we're already working closely with MD Anderson to get the trial team up and running. Thus, as soon as we're off hold, we can complete this process to begin recruiting and treating patients. We anticipate enrolling up to 15 patients and look forward to sharing data and updates with you along the way.

In the meantime, our second-generation trial infusing CD19-specific CAR-T manufactured with the Sleeping Beauty System continues to enroll and treat patients at MD Anderson. This study helps us advance our understanding of T-cell dosing, CAR design, approaches to reduce the time to manufacture the T cells and understandings around the release criteria. This effort will continue until we commence the third-generation trial, at which point we'll stop enrolling on the second-generation trial. Importantly, we highlight that some patients in the second-generation trial have achieved complete responses 6 months post infusion, which together with the data which we published from our first-generation trial, indicates that the Sleeping Beauty system can exert meaningful anti-tumor responses. Thus, our learnings and these clinical data bode well for our groundbreaking third-generation study, which we also call point-of-care.

Just transition to Slide 6 and my update on the CD33 CAR-T program. We are treating patients at MD Anderson with refractory AML using a lentivirus to genetically modify T cells. These patients can be difficult to enroll and treat as they are so medically fragile, but we are learning a great deal. And just as a reminder, this trial was designed to evaluate CD33 as a target, and we expect to decide on whether to transition this to the Sleeping Beauty platform and its very rapid nonviral manufacturing and to do this by the end of the year.

On Slide 7, I'll provide a brief update regarding Merck KGaA as they have selected 2 targets to pursue using ZIOPHARM's Sleeping Beauty platform technology. The initial proof-of-concept preclinical studies have been successfully completed with Precigen, and Merck KGaA is currently evaluating next steps for these targets. And we look forward to providing you updates on Merck KGaA's progress in the future.

Slide 8. Now let me turn to the TCR programs. As you know, we are currently working with the NCI and Dr. Rosenberg under our CRADA, leveraging the Sleeping Beauty platform to generate T cells that express personalized T-cell receptors, or TCRs, to target neoantigens buried within solid tumors. We believe we stand alone in this area as the Sleeping Beauty platform provides a practical, nonviral approach to manufacturing tumor-specific, and thus, patient-specific autologous T cells to go after their neoantigens. We do not believe the viral-based genetic modification processes are going to be scalable to undertake commercial endeavors for T cells targeting neoantigens.

I'm delighted to report that we've made tremendous strides to the NCI on our CRADA. They have developed a process using our Sleeping Beauty system to enable these neoantigen-specific TCRs to be expressed on patient's T cells. It's critical to note that this approach to manufacturing had to be individualized, or said differently, personalized, as each TCR for each patient is different. And this contrasts with the work we and others are undertaking with CARs, where one CAR design can serve the needs of many patients sharing a cancer type. Thus, the Sleeping Beauty system is ideally suited to this new manufacturing as the nonviral DNA plasmid can be readily adapted to express unique TCRs and the genetically modified T cells can be manufactured based on technologies the team at the NCI has already successfully tested in humans. The path to the clinic and the map for the IND filing is in place, and we remain on track to submit the investigator-initiated IND in the fourth quarter this year.

As anticipated, targeting neoantigens within solid tumors has become a hot area. Indeed, a very hot area. The ability to apply therapies that recognize neoantigens using TCR-modified T cells offers real possibilities of targeting solid tumors, which will likely dwarf the market for CAR-T, which are largely confined to the therapy for hematologic malignancies or blood cancers. As such, we've accelerated our global TCR outreach and we're discussing with other parties about ways to expand on this program. We believe the field of TCR therapy for solid tumors is wide open and filled with opportunities, and we have an exciting opportunity therein.

Slide 9. Let me go on and address our controlled IL-12 program, or platform for gene therapy. At ASCO this year, we updated the survival data from our Phase I trial delivering IL-12 as a single agent in patients with recurrent glioblastoma or rGBM. As of May 2018, we showed an encouraging median overall survival of 12.7 months, and that had been sustained for patients treated with a single injection of adenovirus, or as we say, Ad-RTS-hIL-12, plus 20 milligrams daily dosing of veledimex. And that was sustained to a mean follow-up time of 12.9 months.

This median overall survival compares very favorably to the 5 to 8 months median overall survival established in the historical controls with patients with recurrent GBM, which is a key reason why this platform garners continued interest. To build upon these clinical data, we're enrolling patients at multiple sites in United States in an expansion trial of this Phase I study and plan to add up to 25 patients in the cohort receiving 20 milligrams daily dosing of veledimex.

The patient population is further refined based on our past learnings, in that enrollees will not have received bevacizumab for their disease and are not receiving steroids for the 4 weeks prior to therapy initiation. And I'll remind everyone, in the past, we've shown data that patients with recurrent GBM receiving low-dose corticosteroid had 100% overall survival after receiving our controlled IL-12 platform.

Early this year, we embarked on efforts to broaden the clinical reach for the technology based on interest and feedback from potential partners. First, we are combining our IL-12 therapy with immune checkpoint inhibitors. And this past quarter, we dosed the first patient in our Phase I clinical trial to evaluate the controlled IL-12 platform in combination with Opdivo, a checkpoint inhibitor, in adult patients with recurrent GBM. We're pleased to report this patient is doing well, and we are now actively enrolling additional patients on our way up to 18 enrollees with recurrent GBM in this single-arm multi-institution study, which will evaluate the safety and tolerability of this combination regimen, establish the optimal dosing and measure overall patient survival.

Many have tried and many have failed to control IL-12. However, we are the company that has successfully learned to harness this important cytokine. The reason so many have attempted to work with this powerful cytokine, IL-12, and the reason our data stand out is that IL-12 is a master regulator of the immune system, capable of kick-starting a cascaded immune activity and remodeling the tumor microenvironment to achieve powerful anticancer effects. We know this forces the tumor cells to begin defending themselves against the invading army of T cells, and they do this with immune checkpoints. This gives us a clear indication that combining our IL-12 platform with immune checkpoint inhibitor, such as blockading PD-1 or anti-PD-1, has the potential to further impact solid tumors. Simply put, immune checkpoint inhibitors, such as those walking PD-1 and PD-L1, will be compromised and rendered ineffective if insufficient T cells are not in the tumor. Our ability to control IL-12 enables us to put T cells in the tumor.

In other words, IL-12 can turn cold tumors hot. These clinical data and plans establish a strong future for our controlled IL-12 platform. It has become clear to us that potential partners wish to see antitumor activity of the drug as a single agent, and that, that drug can indeed drive T cells deep into the tumor and do so with a sustained effect. Our data already suggests we can do both, which bodes well for the future of this platform. We look forward to announcing our collaboration validating the potential for controlled IL-12, and we plan to move forward with one or more additional tumor types to explore the potential of this powerful cytokine in combination with immune checkpoint inhibitors.

We're pushing the pedal in all areas. We are growing our company, strengthening our board and advancing each of our 2 core platform technologies based on a vision that remains very much intact. We believe the hold on the third-generation trial targeting CD19 is solvable. The TCR program is nearing the clinic and producing many new opportunities, and the IL-12 platform is well positioned to drive strong collaborations and partnerships.

Slide 10, please. I just want to take a little time out and offer, really, my gratitude and my thanks to Sir Murray Brennan, a world leader in oncology, for his commitment to, and leadership of ZIOPHARM as our formal Lead Director; as well as the distinguished Senator Wyche Fowler, who has faithfully worked with ZIOPHARM for many years.

And I'm now delighted to turn the call over to our newly appointed Lead Director, Scott Tarriff, to discuss some of the steps the company is undertaking, most notably, the changes to our board announced just this week. Scott has been a valuable member of our board for about 3 years and is a dynamic and experienced leader with a well-documented history of success, including his current role as CEO of Eagle Pharmaceuticals. Scott?

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Scott L. Tarriff, ZIOPHARM Oncology, Inc. - Lead Director [4]

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Well, thank you. Thank you, Laurence. First, let me say that I'm proud to have been asked to take over as Lead Director for ZIOPHARM Oncology. I'm excited about what's in store for this company and the potentially transformative technologies we are advancing. Our focus is on driving forward these core technologies, Sleeping Beauty and controlled IL-12, as they are on the precipice of making a meaningful impact on cancer and driving shareholder value. Our first task in hand is rebuilding and strengthening our Board of Directors by broadening the experience and expertise of our members. We have started this process with this week's nomination of 2 new directors: Elan Ezickson, the Chief Operating Officer and Head of Corporate Development at Scholar Rock; and Doug Pagan, the CFO at Paratek Pharmaceuticals.

The nominations of Doug and Elan mark the beginning of real changes to the Board as we expect to add more directors in the coming weeks and months. We have 7 authorized seats on the Board, and 2 remain vacant. We have several excellent and interested candidates in various stages of the recruitment process, and I am confident we will build a new board that will be very well suited to support our exciting plans.

Lastly, as we remain focused on advancing our platform technologies, our company needs to grow in terms of people, adding talent to match our future expectations. As a result, we expect to recruit the talent needed to complement Laurence and his team in order to efficiently execute on our plans.

I'm excited about my role, thrilled about the additions to the Board, and I look forward to working with Laurence and his team to help build the best possible ZIOPHARM. When these efforts prove successful, all key constituents, partners, investors and patients will see tremendous benefit and value.

With that, I look forward to welcoming Elan and Doug to the team and thank the continued support of Laurence and the rest of the ZIOPHARM team. And I'll call -- the call back to Laurence.

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [5]

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Thank you, Scott. And we'll go to Slide 12. I appreciate your confidence in me and the team. And I look forward to working with you and the new board.

I would now like to turn the call over to our Chief Business Officer and Interim Chief Operating Officer, David Mauney, who will provide a brief on our finances and other activities. David?

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David M. Mauney, ZIOPHARM Oncology, Inc. - Executive VP, Chief Business Officer & Interim COO [6]

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Yes. Thank you, Laurence, and thank you, Scott, for the remarks. And thank you to everyone on this call. We're now on Slide 13. And to start, I would actually go directly to our balance sheet status.

As we detailed on our press release this afternoon, we have approximately $40.4 million in cash at ZIOPHARM as of the end of the second quarter, June 30, 2018. This $40.4 million is a primary source of cash for our controlled IL-12 program, the work we do at the NCI as well as our G&A. So we believe we have time to drive real value for these 2 programs and cover our costs over the coming months with our existing cash and potential for collaboration. In addition, there's $31.7 million at MD Anderson, prepaid to cover our clinical and preclinical development work done there. These resources cover all of our existing CD19 and CD33 CAR work at MD Anderson as well other important initiatives we are exploring and investigating in partnership with them. Most importantly to remember, these funds available at MD Anderson will cover all of these activities just mentioned well beyond 2019.

I want to reiterate, as a result, that we are not currently pressed or feeling rushed towards a heavily dilutive financing, particularly given our current stock price. We are working very hard in this area and will continue to update you as we move towards a longer-term balance sheet security plan.

On to Slide 14. And as Laurence highlighted, we are also growing as an organization. In fact, I am pleased to announce that, since our last call, we have added to our team, including key hires and program management in Investor Relations. First, and in June, Dr. Catherine Venturini joined the company as vice President and Program Lead for the controlled IL-12 gene therapy program. Previously, Dr. Venturini spent 10 years in discovery and then development at Bristol-Myers Squibb, managing early and late-stage programs, including Abilify, SPRYCEL, EMPLICITI and Yervoy. Most recently, she worked at Biogen, and later, its spin-off company, Bioverativ, where she led clinical development and clinical operations teams.

Also, I'm very pleased to report that just this week, Mike Moyer joined us as Vice President of Portfolio Strategy, a newly created position in Investor Relations. Mr. Moyer joined ZIOPHARM from Stifel, where he was the firm's first health care sector desk specialist. Prior to that, he was in institutional sales at Summer Street Research. Mike will work closely with me, with David Connolly and the team at Trout Group as we seek to strengthen our current and future institutional relationships.

Now let me speak briefly on some business development activities. Again, we have said this in the past and it continues today, we have multiple advanced-stage business development opportunities in front of us. And this is both in the U.S. and abroad. And we realize the need to close these potential deals sooner than later. But as I said before, we're not going to do a deal just to do a deal or get it done, as we believe our platforms represent tremendous value and we have patience. More specifically, and as Laurence mentioned, we are working diligently and with urgency on closing clinical collaborations around our IL-12 platform, which we will believe -- which we believe will validate our approach. Our clinical work is still early. The promise of our Sleeping Beauty nonviral manufacturing to target TCRs and neoantigens as well as its flexibility to accommodate different CAR targets is gaining traction worldwide.

Diving a bit deeper on our IL-12 platform, we pivoted earlier this year to add to shots on goal in the form of combination therapy, first with immune checkpoint inhibitors as well to target multiple tumor types. Many, if actually not all, of our conversations with would-be strategic partners sent us in this direction. There are 2 lines of evidence that fuel these discussions. As Laurence mentioned, first activity as a monotherapy; and second, kick-starting the immune system to make checkpoint inhibitors work better. I believe we are one of the very few companies that can do that, and that belief has spread.

Lastly, we are also focused on improvements at the operational level throughout ZIOPHARM as we grow. As you have heard, we have begun to rebuild our board. As Scott highlighted, we are accelerating efforts to expand our team at ZIOPHARM in anticipation of our immediate and future plans. And we've also been fortunate to enjoy globally recognized partners in the corporate, government and academic arena. And we have a renewed focus on optimizing each and every one of these relationships.

In sum, I want to thank all of our shareholders for supporting us during these turbulent times and want you to know that inside the walls of ZIOPHARM, a high level of optimism and enthusiasm is building.

And with that, I'll turn the call back over to Laurence.

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [7]

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Thank you, David. Slide 15. In conclusion, I believe that today is an opportune time to be a shareholder and a supporter of ZIOPHARM. Together with our Board, we are becoming stronger as an organization, and we're completely dedicated to our goals.

I end this call as I started. ZIOPHARM has 2 potential solutions to solve the problem facing companies who are serious about treating cancer using immuno-oncology. Our 2 platforms address the critical issues of how to target solid tumors and how to bring the costs of immuno-oncology under control. All of us at ZIOPHARM have the passion and expertise to see these efforts bear fruit, realizing of course that these are cutting-edge technologies and they take time to generate data and achieve consensus. We're not here -- I'm not here to iterate on the mundane, but rather to strive to resolve the major challenges facing the immuno-oncology world. This is hard work, but we are up for the challenge. And as we pass this test, the investors and, most importantly, the patients, will be rewarded for many years to come.

So thank you. So now let me turn it over to the operator for questions and answers.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from Ren Benjamin with Raymond James.

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Reni John Benjamin, Raymond James & Associates, Inc., Research Division - Senior Biotechnology Analyst [2]

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Laurence, can we talk or dig into a little bit more regarding the second-generation product and the ongoing study? When might we see some updated results? And usually, when we're -- at least when I think about it, when we're transitioning from second generation to third generation, and it is kind of like a quantum leap, this switch, transaction efficiencies as well as comparable efficacies to what might already be in the marketplace, I think, would be a very important comparison to do. And can you just talk a little bit about what you're seeing in that second-generation trial and how confident you feel that it could be translated into the third generation?

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [3]

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Sure, sure. So thank you, yes. So we'll have data to report at a major medical meeting, so stay tuned there. The trial was set up to help the company understand the transition from going -- from an academic trial, which was really the first-generation technology, to the new technology, which is what we call the third generation. And I realize that the leap, essentially, to go from what was 28 days of manufacturing, and this is now revisiting some history here, but the first-generation trial took 4 weeks to produce the T cells. Because, of course, this is the first time in human history a transposon system has been used. And so we worked very closely with the agency to establish the release criteria and so forth, and that resulted in a 28-day process. That process, as we published in JCI a couple of years ago now, resulted in meaningful outcomes. And indeed, if I remember correctly, at a recent ASH, we were able to update the survival curves and showed, for instance, in patients who had autologous T cells for non-Hodgkin's lymphoma, they had an 80-or-so percent survival after the stem cell transplantation. And we could see the T cells in some of these patients for up to 4 years. These are really important benchmarking studies to show that the Sleeping Beauty system worked. But the bridge to go from 28 days to less than 2 days is a big jump. And you can already see that the agency is working very hard with us to understand that jump. And so we've derisked -- significantly derisked the program by undertaking this second-generation trial. And it answers questions that is central essentially to starting the point-of-care trial, the less-than-2-day manufacturing. In other words, we reconfigured the CAR design. We have shortened the manufacturing time. We're understanding T-cell dosing. And importantly, we're understanding the release criteria. Because as you can anticipate, if you're doing less-than-2-day manufacturing, that also encompasses not just the production of cells but the release of cells. That all has to be done in under 2 days. So the first part, the production of the T cells, that is engineering around the membrane-bound IL-15. It's engineering around the Sleeping Beauty system. And it's engineering around the switch. That essentially is its own package, but a second campaign has to be undertaken to understand essentially can we get the release testing done under the same -- essentially the same time constraints. And the answer to that is, yes. Because as we go through the second-generation trial, we're pressure-testing all of those ideas. So let me just kind of summarize. It was a long answer, and I apologize to the listeners. The bottom line is the second-generation trial is the transition trial. And we've got many moving parts. Despite many moving parts, we are seeing complete responses in patients that last meaningful amounts of time. And that, together with the first-generation trial, really, I think, underscores our excitement about moving to this less-than-2-day manufacturing.

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Reni John Benjamin, Raymond James & Associates, Inc., Research Division - Senior Biotechnology Analyst [4]

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Great. And just to -- I know you mentioned a major medical conference. The next major one that I can think of is ASH. Would that be a fair assumption. Are we assuming this year as far as an update goes? Or could it be next year?

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [5]

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Yes, I think just stay tuned on that. There's a lot of data coming in on that trial, and we want to provide an update. And of course, we want to provide an update as we transition to the third-generation trial.

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Reni John Benjamin, Raymond James & Associates, Inc., Research Division - Senior Biotechnology Analyst [6]

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Okay. And just switching gears to the TCR programs. At least from a 20,000, kind of, foot view, can you talk a little bit about maybe the learnings from others that have kind of pioneered programs in the TCR space? And any sort of learnings regarding the hemology of these newly identified proteins to self proteins and how you plan on kind of getting...

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [7]

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Right, right. So this -- I mean I could go on for an hour, and I'm sure the audience doesn't want that, so let me kind of just hit the high points here. So the hallmark of cancer -- one of the hallmarks of cancer is genetic instability. But what does that mean? That means that a cancer cell emerges because of a set of genetic insults that essentially has reprogrammed that cell to become autonomous. Those genetic insults can now be sequenced and identified. So they are the, essentially, the Achilles' heel of that tumor. Other lesions, other genetic events occur in cancer cells, but they're not part and parcel of the driver mutations that give rise essentially to the cancer cell, or as we would say, oncogenesis. And examples of those ancillary mutations and overexpressed antigens are, for instance, from the MAGE family, the cancer/testis family. Those mutations, those -- excuse me, changes, those changes are not necessarily critical to the cancer cell biology. So we distinguish ourselves from our competitors because we're going after the fundamental changes, the genetic aberrations that give rise to cancer. Others are going after what I would consider a bystander event. What it means for ZIOPHARM is that we can, therefore, target the heartbeat of the cancer and are not restricted to a subset of cancers that have these overexpressed, for instance, cancer/testis antigens, which, I would add by parentheses, are the minority of cancers. So we stand out because we know, like Dr. Rosenberg knows and like many know, that really you have to go after the neoantigens. That's the key. The problem has been, is the field has lacked a therapy. So many companies have embraced vaccines, and we can talk about that as a compare and contrast another day. But we have said that if you're going to realistically eradicate metastatic solid tumors in a patient, you have to put T cells in that patient. And you have to put T cells in that patient that have neoantigens, and we're the only company that can do that.

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Reni John Benjamin, Raymond James & Associates, Inc., Research Division - Senior Biotechnology Analyst [8]

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Got it, okay. And then just one final one for me. I know we've talked about partnerships before and you can't go into any sort of details, but maybe can you give us a sense of what's the ideal deal that I think you guys would be either happy with or you'd be looking for? Are you happy with a worldwide rights being given to somebody else and taking a royalty? Would you prefer 50-50? I mean, how should we be thinking about these discussions?

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [9]

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Sure. So there's several opportunities to partner with ZIOPHARM. One of them is, for instance, in our cell therapy program around our technologies for point-of-care. We see that as an early opportunity, and we see additional work in that area will drive value. Similarly with the TCR program because we see that if we take on the responsibilities to get a really exciting data, so the chances of partnership -- a meaningful partnership go up. So that really now come to the IL-12 program. That data set, with the 2 founding principles, in other words, that we see single-agent activity and we can see cold tumors turning hot, generates a lot of enthusiasm and a lot of interest from partners. And as David said in his remarks, we're essentially looking carefully at those opportunities and looking for, essentially, that value proposition that the shareholders and the stakeholders around ZIOPHARM can participate in. And so we're -- basically, I can't go much farther because obviously we would tip our hand. I think David said it, and I embrace it, these conversations are pretty advanced. And so we're looking forward to driving those to conclusion.

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Operator [10]

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Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Laurence Cooper for any closing remarks.

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Laurence James Neil Cooper, ZIOPHARM Oncology, Inc. - CEO [11]

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Okay. So thank you all for your attention, and we really appreciate you joining us this afternoon. Thank you so much, operator, and everyone.

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Operator [12]

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Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program, and you may all disconnect. Everyone, have a great day.

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