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Ziopharm Oncology Inc (NASDAQ:ZIOP)Q4 2019 Balance CallMar 2, 2020, 4:30 p.m. ET

Operator

Ladies and gentlemen, acknowledge you for continuing by and acceptable to the Ziopharm Oncology Fourth Division and Anniversary 2019 Appointment Call. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to duke the appointment over to your apostle today, Mr. Chris Taylor, Vice President of Investor Relations. Acknowledge you. Amuse go ahead.

Chris Taylor — Vice President, Investor Relations and Accumulated Communications

Thank you, operator. Acceptable afternoon and acceptable to the Ziopharm Oncology appointment alarm and webcast to assay after-effects for the fourth division of 2019. This afternoon we filed our 10-K and issued our 2019 anniversary after-effects release, both of which are accessible in the Investors breadth of our website ziopharm.com. For advisory purposes, we accept additionally included in our webcast a set of PowerPoint slides to accompany today’s commentary. These slides can additionally be activate on our website in the Investors section.

During this call, the Aggregation will accomplish a cardinal of avant-garde statements, including statements apropos the abeyant ameliorative candidates in our development action authoritative status, banking advice and business trends. Avant-garde statements are accountable to abundant risks and uncertainties as declared in our 10-K and aural added filings that we may accomplish with the SEC from time to time.

Participating on our alarm today for Ziopharm will be Dr. Laurence Cooper, Chief Executive Officer; Sath Shukla, CFO; and Dr. David Mauney, President. Afterward annotation from our administering team, we will accessible the alarm for Q&A. In the absorption of time, we attentive appeal that you ask one catechism and a aftereffect as bare and afresh amuse feel chargeless to acknowledgment to the queue. Acknowledge you.

And to get started, I’ll about-face the alarm over to Dr. Cooper. Acceptable afternoon.

Laurence J.N. Cooper — Chief Executive Officer

Thank you, Chris, and acceptable afternoon everyone. We are admiring to accept the befalling to allege with you today and we acceptable those of you who are new to Ziopharm. By way of introduction, we took affecting accomplish avant-garde in 2019 to body aloft our plan to action assay to patients with solid tumors. We accept Ziopharm stands abandoned in the eyes to be able to amusement all solid tumors. We accept avant-garde assorted avant-garde technologies that accept been broadly arise based aloft acceptable preclinical and analytic data. We accept Phase 1 and 2 INDs above anniversary of our analytic programs and accept alignments to assassinate on them with world-class partners. Finally, we are acclamation the better accessible oncology markets by action afterwards solid tumors.

With about $177 actor in our treasury, Ziopharm is now in its arch axiological position to date beneath my tenure. Our antithesis breadth gives us the adeptness to beforehand against the admeasurement and calibration bare to auspiciously assassinate on our vision. It has been aloof 16 months aback we artificial our accumulated adeptness and could absolutely focus on solid tumors. We’ve able a abundant accord during this time aeon and I will highlight a few.

In accession to accepting assorted trials and INDs for all of our programs, we accept anchored affairs and cooperation with MD Anderson accretion into TCRT, we accept a accountant analytical bookish property, and we accept broadcast our business developments in Wall Street outreach. We additionally spent abundant of 2019 alive with acclaimed third parties to accretion a added compassionate of the abiding appraisal hypothesis for anniversary of our amount assets. We are application that advice to beforehand our acclimate for 2020 and beyond. Based on feedback, advancing charge and aggressive analysis, we are accelerating our adeptness to accomplish T-cell products. Our aisle to bartering action starts and finishes with the requirements of controlled manufacturing. This is accurate whether it’d be for our accessible analytic trials or our best appellation affairs to action bartering therapy.

Since 2019, we’ve been beforehand in aptitude and basement to aftermath T-cell articles for ourselves and are accelerating these efforts in Houston, Texas. We accept busy accessories from MD Anderson Blight Center and we’ll accessible added class amplitude aural the abutting two months. We accept already amorphous to assassinate on accretion our accomplishment affairs for TCR-T which will accommodate ascent up for GMP accomplishment and we will allotment added accommodation about this assignment this year.

At JP Morgan in January, we had assorted ATR [Phonetic] affairs with the buy side, advertise ancillary and ample pharma. It is readily credible that action afterwards solid tumors is the ascendant T-cell oncology affair for 2020 and we accept bristles areas of aggressive advantage that collectively we accept is altered to us. First, we are infusing T-cell to beforehand and annihilate blight cells. As a reminder, the administering of T-cells has a accurate adeptness to annihilate kilograms of tumor. Second, we are application TCRs to ambition neoantigens which are present in assorted types of solid tumors and are there Achilles’ heel. Third, we are genetically modifying T-cells from the borderline claret which accept the blockage adeptness to recycle killing action to annihilate tumor. Fourth we accouter cytokines to appoint and ascendancy via allowed response. And fifth, we use non-viral accomplishment based on DNA plasmids from the Sleeping Beauty arrangement to accomplish the calibration bare to abode multitudes of patients with altered types of solid tumors. We are in the adapted abode with the adapted assets and active on our plan with a able banking base. Abnormally as we accretion analytic data, we accept amazing upside abeyant as a accessible aggregation adapted now and throughout the year.

Laying out the calendar for this call, I will amend the timelines for anniversary of our amount programs, our CFO, Sath Shukla, will afresh altercate the contempo financing, as able-bodied as our Q4 2019 banking allotment and then, our President, David Mauney will accomplish the able remarks, afore axis the alarm over to the abettor for questions.

With that, let me alpha with an amend on our TCR-T program. The Phase 2 IND with Dr. Steve Rosenberg at the NCI is the aboriginal of several game-changing trials to arise for Ziopharm. We admit the delays about to accomplished advice in dosing the aboriginal patients on this balloon and accordingly basal to accommodate added diminutive advice on the abstraction cachet that why we abide and the NCI charcoal aflame by this study. Thus, I’ll accommodate an amend on breadth we angle based on our best contempo acknowledgment to abate affair about this balloon starting.

In contempo months, we accept abstruse a abundant accord about the NCI process. Afterwards an NCI IND is cleared, there are several accomplish that puts — that the NCI puts in abode for any balloon afore the aboriginal accommodating is enrolled. This includes alteration of assembly from analysis accumulation to the accomplishment team. As we abreast accommodating enrollment, Dr. Rosenberg and his accumulation accept been alive agilely with Dr. Drew Denninger and our aggregation and accept articular improvements to the accomplishment process, acclimated to aftermath Sleeping Beauty adapted TCR-T. These new learnings account not abandoned the abstraction at the NCI but additionally the assembly of T-cells, which will be undertaken in our analytic affairs at MD Anderson. I accept advised these abstracts and they decidedly body aloft the use of the Sleeping Beauty system. This is absolutely what we appetite our ally to do as they are a accurate agent of ingenuity. Their efforts accept additionally helped derisk the TCR-T balloon as Ziopharm lose the ascendancy of our own affairs at MD Anderson. I’m blessed to address that the NCI is affective against the final engineering runs which aback completed will accessible them to accept the aboriginal patient.

In the interim, patients who arise to the NCI abide to be evaluated and advised for this study. The best adapted candidates are action through the TCR accretion action with their tumors resected, neoantigens articular and TCRs made. Based on the actual contempo ascribe from the NCI, we appraisal that Dr. Rosenberg will amusement the aboriginal accommodating in the aboriginal bisected of this year. We are assured with the updates to the NCI action and affairs for acceptance and we’re acquisitive to allotment account as the aboriginal accommodating enrolled.

As mentioned in January’s webcast update, we are additionally implementing affairs to accompany the TCR-T affairs beneath our control. One of aftermost year’s important milestones was our advertisement on October 28 of an broadcast analysis and development acceding with MD Anderson to beset our TCR-T affairs and which provides a new home for our growing aggregation and absorption in Houston.

The accord with MD Anderson is a cogent aggressive differentiator as it enables us to assassinate on two Ziopharm led approaches infusing TCR-T for solid tumors. One users TCR’s absolute in a library to ambition neoantigens occurring in hotspots. The added is based on the assignment at the NCI and the IND to ambition abandoned neoantigens. Both approaches use the aforementioned alignment to aftermath TCR-T application the Sleeping Beauty arrangement developed at the NCI. These two paths accommodate us and patients the best adventitious to amusement abounding types of solid tumors.

At MD Anderson, we can accept patients with a array of solid tumors and we ahead cogent accommodating breeze to our TCR-T program. Indeed our set of accountant TCRs and the NCI is already abundant to activate acceptance to the hotspot trial. The admission to patients and tissues will beforehand the amplification of the library of TCRs targeting neoantigens in hotspots. We abide to assignment on our authoritative roadmap and are currently agreeable FDA on our two approaches targeting neoantigens in solid tumors. We accept that already accepting an accessible Phase 2 IND with the NCI provides us with a arch alpha and a arrangement for these discussions. We will accommodate updates. Apropos the protocols and timing as those discussions progress. The TCR-T affairs is a amazing befalling for patients and the Company. With aggregate we’ve apparent to date, we accept we accept a able adventitious to success and amazing amount creation.

Next, I will blow on our IL-12 program. In 2019, we fabricated ample analytic beforehand in our Controlled IL-12 affairs and accustomed absolute FDA acknowledgment acceding us fast clue appellation and in Europe, breadth we accustomed an drop biologic designation. We accept completed acceptance to our two alternate glioblastoma or GBM Phase 1 studies with 36 patients in the monotherapy amplification abstraction and 21 patients in the dosage accretion aggregate abstraction with OPDIVO which included an added 12 patients advised at the accomplished dosing level. Alpha in the third division of 2019, we commenced the Phase 2 abstraction for alternate GBM in aggregate with Regeneron’s Libtayo and that abstraction should complete acceptance in the aboriginal bisected of 2020. Aback our aftermost annual call, bristles added analytic sites accept arise online with now seven of 10 sites enrolling patients.

In total, added than 95 patients with alternate GBM accept been advised at the adapted 20 milligram dosing of veledimex with over 80 patients enrolled aback 2018 alone. Added than three-quarters of those patients accustomed low dosage steroids, which we accept helps IL-12 accomplish an immune-mediated anti-tumor effect. The auspicious after-effects we accept apparent to date and the accepted abstracts from these added patients will advice acquaint our accommodation on afterwards date analytic studies in alternate GBM and potentially aggrandize the affairs alfresco of alternate GBM. We accept that if IL-12 can advisedly beforehand accommodating outcomes in this blight afresh it can be able in abounding added break either abandoned or in aggregate with allowed checkpoint inhibitors. Ample abstracts were arise and presented from these studies during 2019 including at ASCO in June and at the Society for Neuro-Oncology or SNO in November. After-effects from the Phase 1 monotherapy basal balloon were additionally arise in the account Science Translational Medicine aftermost August. Links to these presentations can be activate on our website.

Our team’s presentation at SNO a few months ago provided affirmation for the aboriginal time of corruption of glioblastoma based on imaging. We additionally presented acknowledging abstracts demonstrating 16 months average all-embracing adaptation in patients with alternate unifocal ache accepting low dosage steroids. We are admiring to agenda that the Ziopharm aggregation accustomed the Top 5 accolade at SNO based on these abstracts and we are encouraged by the accretion action amid the beforehand association and abeyant ally in this program. This absorption is additionally constant with our affairs at JP Morgan. We abide to adviser the patients enrolled in these studies and ahead accouterment added updates with the abeyant for acquiescence of assorted abstracts at above medical affairs in the aboriginal bisected of this year.

I will accomplish with an amend on our CAR-T program. In accession important 2019 milestone, we arise in October that the FDA had austere an investigator-initiated IND for a Phase 1 analytic balloon to be conducted at MD Anderson. As we accept ahead stated, this abstraction will appraise beverage of donor acquired CAR-T created through accelerated abandoned accomplishment or RPM in patients with CD19 cogent leukemias and lymphomas who accept relapsed afterwards allogeneic cartilage bottom transplantation. Beneath the RPM action we can dosage patients as anon as the day afterwards gene alteration including analysis that the CAR-T meets absolution criteria.

During our aftermost annual call, we said our aggregation was alive adamantine with MD Anderson to get the balloon started by the end of 2019. As a reminder, MD Anderson is accomplishment the artefact for this study. And as we angled out the year some delays were accomplished as the technology transitioned to their GMP facility. But I’m admiring to acquaint you things accept gone able-bodied since. Final accomplishment batches are beneath way with the appropriate authoritative accomplish referred to as the armpit admission appointment or SIV planned in the advancing weeks. Indeed, the aboriginal accommodating is actuality articular by our arch investigator for this balloon and admission of this abstraction is an important near-term anniversary for our Aggregation and we attending avant-garde to administration account with you in the aboriginal bisected of this year.

There are two added contempo items to acknowledgment apropos our use of the Sleeping Beauty arrangement to reprogram T-cells. Aftermost month, we arise in the account Claret auspicious abiding aftereffect abstracts afterwards beverage of Sleeping Beauty adapted CAR-T based on a above-mentioned bearing of this technology. This declared outcomes of patients with relapsed or adverse B-cell lymphoid malignancies, all of whom had accustomed CD19 specific CAR-T alloyed afterwards autologous cartilage bottom transplantation. Four patients approved abiding chain of CAR-T abounding years afterwards infusion. Bristles year progression-free adaptation and all-embracing adaptation was 71% and 86% respectively.

Last December, our aggregation presented at the 2019 ASH Annual Meeting new preclinical abstracts acceptance accelerated abandoned accomplishment with TCR. These after-effects appearance that T-cells genetically adapted application DNA plasmids from the Sleeping Beauty arrangement to accurate TCR with film apprenticed IL-15 apparent anti-tumor effects. These abstracts body on our access to abate the amount and complication of T-cell therapies.

Finally, an amend on our collective adventure Eden BioCell. Things abide to beforehand able-bodied with our colleagues in Greater China. The tech alteration for the RPM technology is abundantly complete, the GMP accomplishment adeptness is staffed and able and the scientists are currently administering analysis runs of the RPM process. They accept additionally commenced discussions with the Taiwanese FDA as we apprehend the aboriginal trials to alpha at a ample hospital in Taipei.

Our ally at Eden BioCell admonish us the IND for the autologous RPM CD19 CAR-T balloon will be filed this year. It is account acquainted that the biking restrictions with new coronavirus in China accept to date not prevented Eaton’s adeptness to assignment in Taiwan and while the bearings will abide to be monitored, we are not experiencing cogent delays.

In summary, over the accomplished 16 months we accept accumulated the technology, bodies and funds and fabricated cogent beforehand in all our programs. This bodes able-bodied for the approaching as throughout the year, we apprehend to accept abstracts on TCR-T added analytic acumen into controlled IL-12 and RPM for CAR-T. These programs accommodate cogent value-creating opportunities and this beyond of upside abeyant appears altered to Ziopharm.

And now I will duke the alarm to our CFO, Sath Shukla.

Satyavrat (Sath) Shukla — Executive Vice President, Chief Banking Officer

Thanks, Laurence and acceptable afternoon everyone. Let me activate by adage a few words about our contempo costs efforts. To accomplish our eyes to beforehand treatments for all patients with solid tumors it is basal that we accumulate the Aggregation able-bodied capitalized in allegory to competitors in the corpuscle and gene analysis space. As we arise at the end of the third division of 2019, our banknote balances at that time provided a aerodrome into the aboriginal bisected of 2021 which meant that to abstain a growing affair analysis assessment we would charge to accession basal in the aboriginal several months of 2020. We anxiously evaluated this timing and advised it to be risky. We do accept bazaar catalysts accepted this year but we came to the cessation that acquisitive and cat-and-mouse for the exact adapted time while advertisement the Aggregation to basal markets and political risks was imprudent.

Furthermore, accustomed that abounding of the biotechs were anchored basal in backward 2019 and aboriginal 2020 abeyant accord fatigue and bound accessible allotment could affectation abundant added risks if we waited too connected to defended financing. We accordingly began active on animating our antithesis breadth starting in December aboriginal agreeable in some ATM costs for about $16 million. However, afterward a acknowledged GBM accident breadth aggregate the Company’s affairs with assorted top bank biotech investors, administering angry off the ATM and affianced in a acceptable financing. This costs was accomplished quickly, derisked our antithesis breadth and will now accredit us to beforehand and accomplish abounding important goals for the abutting two cardinal years for the Company. The gain in accession to accepted bazaar prices and altitude additionally avert the alarm of application the ATM anytime in the abreast future. The new basal serves abounding analytical purposes and to assignment bottomward a bit added accurately accompanying to the use of these proceeds, we can; first, beforehand the body out of our new Houston adeptness on the campus of MD Anderson, which will serve as the foundation for the bartering aisle for our TCR program; second, beforehand the amplification of our TCR library to abutment our TCR hotspot trial; next, beforehand the application of specialist cadre for our TCR affairs and additionally to abutment abeyant adorning analytic initiators for our controlled Il12 affairs as we beforehand against later-stage studies and potentially added break and we can now booty ascendancy of accomplishment with both cadre and basement which has acutely been a attached agency for us compared to our peers, abounding of whom ascendancy manufacturing. We see about circadian account of abundant gene and corpuscle analysis accomplishment beforehand and we ahead this new breadth abandoned will accommodate abundant amount for Ziopharm in the average and connected term.

Turning to the specific banking after-effects for Ziopharm’s fourth division of 2019. As acclaimed in our account release, analysis and development costs were $10.2 actor for Q4 of 2019 compared to $8.2 actor for Q4 of 2018. This access reflects amplification of the Company’s analytic programs, including the admission of the Phase II aggregate balloon of controlled IL-12 with Libtayo as able-bodied as attending for both TCR and CAR-T programs.

G&A costs were $5.8 actor for the fourth division of 2019, compared to $4.6 actor for the fourth division of 2018. This access reflects our added headcount, application of key cadre and broadcast capabilities.

On a accumulative base for the fourth division of 2019, we arise a net accident applicative to accepted shareholders of $15.7 million, or $0.09 per basal and adulterated share. Comparably in the fourth division of 2018, Ziopharm recorded net assets applicative to the accepted shareholders of $194.5 actor or $1.29 per allotment basal and diluted. The added assets attributable to accepted shareholders in 2018 resulted primarily from the damage and acknowledgment of all the Company’s Series 1 adopted banal captivated by its above accomplice and the abandonment of Ziopharm’s obligations beneath a pharma acceding accounting for about $207 million.

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For the abounding year 2019, R&D costs came in at about $38.3 actor compared to $34.1 actor in 2018 while G&A came in at $19.5 actor hardly beneath the $19.9 actor in 2018. The access in R&D absorb while advancement conduct on the G&A absorb reflects the Company’s connected charge to optimal basal allocation to focus on advanced the science. We are committed to growing our business and putting Ziopharm in the best accessible position to capitalize on our acute technologies.

In accession to the $80 actor in banknote at year-end, we additionally had a accommodation antithesis of about $20.3 actor for assignment to be conducted by the Aggregation at MD Anderson beneath the new agreement. Incorporating our contempo costs activity, our banknote position now enables us to accommodate allotment for all our programs and basement body into mid 2022.

And now I will about-face the alarm over to David for final comments.

David Mauney — President

Thanks, Sath. Afore I accommodate some comments on our business, I’ll allotment a abrupt chat on new coronavirus or COVID-19. Our thoughts go out to all of those afflicted by this difficult illness. We are currently assessing the appulse a broader advance of the affliction may accept on our business and accept amorphous anecdotic acknowledgment affairs as needed. As Laurence noted, our colleagues at Eden and TriArm accept accepted that they abide authoritative beforehand and they do not currently apprehend cogent business disruption in our CD19 affairs in Greater China.

Further acceptance in our IL-12 analytic trials, all of which are in the US, are either complete or advancing achievement and we accept biologic accessible to complete our advancing studies. Our planned TCR-T analytic trials arise artless by the outbreak. We apprehend to altercate the accessible appulse of the new coronavirus with our added partners, including the NCI and MD Anderson as the bearings in the US evolves. And of advance we will be evaluating the appulse this may accept on our employees’ day to day activities. Fortunately, we already accept the IT systems in abode that acquiesce best of our advisers to assignment accidentally if needed.

We accept acutely accomplished abounding things in the aftermost 16 months and attending avant-garde to a affluent future. I would like to acerb reinforce our vision, which is to accommodate abutting bearing ameliorative options to amusement any accommodating with a solid tumor. And if we accomplish that ambition cogent rewards can be seen. We accept formed adamantine and fast to actualize altered attributes of Ziopharm which Laurence has covered today and the bazaar befalling for us is amazing as Ziopharm has bartering rights to assorted billion dollar markets.

We are of advance affianced in assorted connected dialogs with abeyant ally and, as Laurence mentioned, we accept accretion abstracts on the timing and amount propositions for anniversary of our assets. With the contempo financings, we can move above our outlicensing discussions to now additionally accept added efforts breadth we are because in-licensing technology and IP to body aloft our basal assets. We accept broadcast our business development accommodation internally and we accept affianced third parties to assay and admonish on appraisal and longer-term affairs for anniversary of these assets. We apprehend to accept animal abstracts in duke above our three programs over the advance of this year. This will put us in an enviable position, accouterment us cogent adaptability for both in-licensing added technologies and advancing collaborative affairs for our absolute therapies.

A few comments on the alignment we are building. We assassin over 30 bodies aftermost year and apprehend alike added this year, including in the C-suite. And with the resumes already in hand, we apprehend to abide the trend of landing top bank bodies with accomplished capabilities. We are architecture up and accretion on our Investor Relations efforts and accept activated affairs to accept appointed account beat calls and we will access our contiguous affairs with our above shareholders abnormally action forward. We accept affianced a West Coast close and are in the action for a abounding accumulated rebranding. Abnormally as we get all of our trials rolling, we are a absolutely altered aggregation than we were on October of 2018 and that should accommodate a new attending and feel, a new name and a new banal ticker. We apprehend this rebranding accomplishment to cycle out in the added bisected of this year and attending avant-garde to afterlight the bazaar on added specific timing and action as we get closer.

It hasn’t consistently been easy. The Laurence’s eyes abounding years ago was to accommodate a rational, scalable, cost-effective immunotherapy that could accept an appulse on not aloof some markets of blight patients, but all of them. If there is one affair I can say with certainty, Laurence’s training gives him an astonishing adroitness for seeing the cine comedy out afore the calligraphy is alike accounting and we accept the fortitude, charge and now the abetment to see his predictions arise accurate for all of us.

Thank you for your connected abutment and with that I about-face the alarm over to the abettor for questions.

Operator

Thank you. [Operator Instructions] Our aboriginal catechism comes from Yale Jen with Laidlaw & Company. Your band is now open.

Yale Jen — Laidlaw & Aggregation — Analyst

Good afternoon. And acknowledgment for demography the questions and congrats on the beforehand that’s absolutely arresting altogether. Maybe two quick questions here. The aboriginal one is for the MD Anderson in agreement of TCR-T development. Are you guys action to delay for the NCI complete their agreement and alpha to accept accommodating afore the assignment over in MD Anderson so you accept added homogenized the protocol, analytic abstraction protocols, or you will accept added array of modification or acclimation on that?

Laurence J.N. Cooper — Chief Executive Officer

Yeah, Thanks, Yale. I’ll booty that catechism first. So the analytic trials at MD Anderson, you can ahead those to alpha alongside the NCI. The NCI to us is a affairs that has abundant value, not abandoned today but action forward. You could I ahead apprehend connected abundance by Dr. Rosenberg and his accumulation and those learnings beneath our CRADA will augment aback into MD Anderson and appropriately our analytic trials. So to put it all together, we adore the accord with Steve and his accumulation as about the foundry. But we’re a bartering arch company. We appetite to beforehand drugs for solid tumors. And so we will assassinate on that eyes at MD Anderson and you accept — we’ll accept added to say about that action forward.

Yale Jen — Laidlaw & Aggregation — Analyst

And afresh maybe to chase up a little bit on that from a acquirement — amount perspective, should we ahead that already you alpha the MD Anderson assignment on TCR-T, the R&D amount could access added substantially, I guess, than contrarily we were modeled?

Laurence J.N. Cooper — Chief Executive Officer

Yeah, so, we’ll assay the archetypal one added time and get aback to you on that, Yale. But, yes, there will be a access in the R&D amount acutely for sure, because we are an R&D company. And if you attending at how abundant we absolutely put in opex this year and our runways on cash, afresh we acknowledge that adapted now we are anticipating a banknote demography us into average of 2022, we can array of aback into some of access expected, acutely this year, additionally abutting year and afresh action into 2022. So absolutely the apprehension is that we will assassinate added and accordingly we will absorb more.

Yale Jen — Laidlaw & Aggregation — Analyst

Okay. Great. I’ll go aback to chain and maybe accept some aftereffect later.

Laurence J.N. Cooper — Chief Executive Officer

Okay. Acknowledge you.

Operator

Thank you. Our abutting catechism comes from Thomas Flaten with Lake Street Capital. Your band is now open.

Thomas Flaten — Lake Street Basal — Analyst

Great. Acknowledgment for demography my question. To chase up on the beforehand catechism with account to the MD Anderson TCR abstraction active alongside NCI, accustomed that you’re still in discussions with FDA about protocols and things like that, could you accommodate some added granularity on those specific discussions, IND submissions clearances etc., aloof so we accept how those things will run alongside one another?

Laurence J.N. Cooper — Chief Executive Officer

Yeah. Thanks, Thomas. So the — I ahead the way I ahead about it is, the playbook in agreement of the IND has been accustomed by Steve Rosenberg. We booty that playbook now and acclimate it to our own bartering adverse needs at MD Anderson. Those discussions are beneath way with the regulators. They will arise to blow soon. And afresh we will amend you and the bazaar on our affairs in fuller detail.

Thomas Flaten — Lake Street Basal — Analyst

And then, I guess, affectionate of angry into that and afresh I’ll jump aback in the queue, with account to accepting abstracts for above all three programs in 2020, could you animadversion a little bit aloft what types of abstracts we ability apprehend to see? I’m accepting agitation seeing the timelines arise calm with affectionate of the ample aboriginal half, added bisected guidance.

Laurence J.N. Cooper — Chief Executive Officer

Sure. We’ve got a accelerate absolutely that we — that’s on the deck. So the way we we’re accession the Aggregation is absolutely aloof a book end this in the aboriginal bisected of 2020 at the moment. So as you attending at those programs, we’ll accept the dosing at the NCI trial, that’s the Phase 2, we’ll accept acceptance to our Phase 1 balloon for the accelerated abandoned architect of CAR-T, we’ll accept advertisement about the achievement of acceptance and the antecedent abstracts readout for our controlled IL-12 in aggregate with Libtayo, we’ll accept Phase 1 abstracts readout with controlled IL-12 in aggregate with Opdivo, and we’ll accept Phase 1 abstracts readout from controlled IL-12 as a monotherapy in that broadcast cohort.

So those bristles activities will be in the aboriginal bisected of this year. And afresh as we get into about the abutting division or so, we’ll afresh move that timeline so that you can attending added into the Aggregation for the added bisected of this year. But that’s a appealing cogent amalgamation for aloof this aboriginal half.

Thomas Flaten — Lake Street Basal — Analyst

Just a follow-up, sorry.

Laurence J.N. Cooper — Chief Executive Officer

Sure.

Thomas Flaten — Lake Street Basal — Analyst

So if you’re action to see dosing in the aboriginal bisected at NCI, do you accept a faculty from Rosenberg with account to cardinal of patients, accent of acceptance so that you can absolutely get abstracts out in 2020?

Laurence J.N. Cooper — Chief Executive Officer

Yeah, we — so that timeline and with account to the accessible is absolute by Dr. Rosenberg, and that’s absolutely a lot of the catalyst for us to be affective the technology beneath our own INDs bottomward to Houston with MD Anderson. But accepting said that, Steve’s been an accomplished abettor of our technology and absolutely bluntly the acreage and consistently put out important updates, and I apprehend them to do the aforementioned with acceleration about our program.

Thomas Flaten — Lake Street Basal — Analyst

Okay. I’ll get aback in the queue. Thanks.

Operator

Thank you. Our abutting catechism comes from RK of H.C. Wainwright. Your band is now open.

Swayampakula Ramakanth — H.C. Wainwright — Analyst

Thank you. Acceptable afternoon, Laurence.

Laurence J.N. Cooper — Chief Executive Officer

Hi.

Swayampakula Ramakanth — H.C. Wainwright — Analyst

Just on the NCI program, as you’re acquirements added about the action itself, so afterwards NCI runs these acknowledged accomplishment runs for the analytic actual to get started, is there annihilation abroad that they charge to do afore they get the abstraction going?

Laurence J.N. Cooper — Chief Executive Officer

Yeah, that’s an accomplished point. So the manufacturing, obviously, is an important allotment that’s absolute beneath the IND. You’ve heard my comments about how afresh acquirements was added on top of the IND. And afresh already Steve is accessible to go, the patients afresh about that are in the chain can afresh be treated. So there’s action to be, I think, an important allotment of the adventure breadth not abandoned the accomplishment solutions, I ahead aback he’s arrested that box, but the patients afresh about accept that analytic charge that they charge to about accept that TCR therapies and Steve governs that alteration about as patients arise off chain into about the analytic trial.

Swayampakula Ramakanth — H.C. Wainwright — Analyst

Okay. Acknowledge you. And on the controlled IL-12 program, alfresco of GBM, what added tumors would you be — would you ahead are acceptable targets and if costs is no issue, which ones would you be action after?

Laurence J.N. Cooper — Chief Executive Officer

Yeah. That’s a abundant question. So for us, we are — our analytic abstracts absolutely teaches us that IL-12 can about-face accomplished bump hot, and we ahead that’s important, abnormally for tumors that accept bootless allowed checkpoint inhibitors. So we are attractive carefully at those types of tumors. In added words, immunological deserts, ones in which they can be afflicted from an arrival of T-cells, and there’s a set of those tumors out there, RK, and generally those tumors bout up actually, absolutely frankly, to the ones that don’t account from allowed checkpoint inhibitors.

Swayampakula Ramakanth — H.C. Wainwright — Analyst

Okay. Acknowledge you. And afresh the aftermost catechism is apropos the abstracts accepted during the aboriginal half, is that appealing abundant delay till the end of the aboriginal bisected into ASCO or it could be any other…

Laurence J.N. Cooper — Chief Executive Officer

It could be anytime. It could be anytime. We see a connected accession of abstracts throughout this aboriginal half.

Swayampakula Ramakanth — H.C. Wainwright — Analyst

Perfect. Acknowledge you actual much, Laurence, for demography my questions.

Operator

Thank you. Our abutting catechism comes from Jim Birchenough with Wells Fargo. Your band is now open.

Nick Abbott — Wells Fargo — Analyst

Good afternoon. It’s Nick on for Jim this afternoon and, yes, congratulations on aloof seems like this is action to be a abundant year for the Company. So I’m abiding you’re actual aflame about all the progress. Aloof in agreement of the hotspot trial, so the new antigen trials, it seems like the cogwheel — aberration actuality amid the NCI access and your access will be in agreement of the algorithms and technologies acclimated to analyze the hotspots. Alfresco of that the two trials will be actual similar. Is that the case?

Laurence J.N. Cooper — Chief Executive Officer

Yeah, I ahead that’s a acceptable starting point, Nick. Both the NCI and Ziopharm will be advancing the abandoned TCR-T therapy. That’s a actual ample band-aid absolutely for best patients, absolutely absolutely bluntly with solid tumors. In addition, though, Ziopharm with its accomplice at MD Anderson will be developing the hotspot trial. And as you apperceive that’s the way to amusement a subset of patients but to do so abundant faster, because you’re screening the patients for the mutated antigen.

Nick Abbott — Wells Fargo — Analyst

Right, right. And on that trail, Laurence, will you be in a position to about — I ahead you fabricated a animadversion that you already accept abundant TCRs from the library to assassinate a trial. Will it be an all-comer balloon or will you initially will say, well, let’s attending at assertive subset KRAS, for example?

Laurence J.N. Cooper — Chief Executive Officer

Yeah. No, that’s absolutely the adapted question, Nick. We’re in chat about that. There’s basically those kinds of balloon designs. And we appetite acknowledgment from the FDA on that blazon of balloon architecture and afresh we’ll get aback to you.

Nick Abbott — Wells Fargo — Analyst

Okay. And afresh aftermost one for me and I’ll hop aback in the queue. And you referred to IL-12, so now you accept banknote through the average of ’22. You’re action to accept analytical abstracts by midyear for this program. What are you bold in agreement of added trials alpha through the average of ’22 because I ahead at one point in the past, I accept to anamnesis that your adopted way avant-garde with IL-12 was with a partnership.

Laurence J.N. Cooper — Chief Executive Officer

Yeah. No, I ahead as the abstracts arise in, abnormally through the amplification abstraction and the Phase 1 balloon abstraction with Opdivo, we’ve apparent absolutely abating data, Nick. I mean, we’ve got appealing cogent abiding survival, 16 or so months now. We’ve got bright affirmation of anti-tumor aftereffect based on MRI scan. We accept serially biopsied these patients and apparent arrival of T-cells. So these abstracts are — agency that the Aggregation has done a lot of assignment aback about those comments were put out there. At the time that was actual that there was a attending for a abeyant partner. But now I ahead there are abounding options for Ziopharm and we’re action to absolutely about attending at these abstracts advancing in through the year and see what makes the best faculty for the Company.

Nick Abbott — Wells Fargo — Analyst

So — Laurence, so aloof to clarify, do you accept money afresh assigned for added — starting added trials in ’21, ’22?

Laurence J.N. Cooper — Chief Executive Officer

Sure. I’ll about-face it over to Sath here.

Satyavrat (Sath) Shukla — Executive Vice President, Chief Banking Officer

Sure, Nick. So I ahead what I can say is that our banknote aerodrome conservatively does not accept any affiliation and advance at this point. So whatever we appetite to do with the affairs and beforehand it in our GBM and potentially added indications, we accept affected that the allotment for that today comes from the Aggregation for planning purposes and we lay out of the banknote to runway. Obviously, aback abstracts rollout and we adjudge whether and which partnerships to analyze that cardinal could change. But conservatively, we accept not congenital in any affiliation allotment in any of our analyses.

Nick Abbott — Wells Fargo — Analyst

Perfect. Acknowledge you for the clarity.

Operator

Thank you. Our final catechism is a aftereffect from Yale Jen. Your band is now open.

Yale Jen — Laidlaw & Aggregation — Analyst

Thanks for demography up the aftereffect questions. Are you guys action to advertise aback you saw the face on [Phonetic] the TCR-T abstraction at the MD Anderson in the columnist absolution or some added array of methods?

Laurence J.N. Cooper — Chief Executive Officer

Yeah. Thanks, Yale. So aloof to clarify, we will advertise aback the TCR-T balloon starts enrolls at the NCI. We will additionally adviser the bazaar on our plan for our own bartering activities at MD Anderson.

Yale Jen — Laidlaw & Aggregation — Analyst

Okay. And maybe aloof one added catechism here, which is that in agreement of admixture study, Opdivo abstracts you intend to address this bisected of this year, should we ahead annihilation accompanying to the time or the continuance of the abstraction that the endpoint such as so progression chargeless survival, others, or artlessly we should mainly focus on the acknowledgment amount and added accordant dataset?

Laurence J.N. Cooper — Chief Executive Officer

Yeah, I — what I try and do with — what the Aggregation tries to do is appearance survival, because that is the benchmark, that’s by which the EMER [Phonetic] as able-bodied as the FDA will acquiesce abeyant articles to move forward. But in addition, because we assignment with bookish centers, we’re generally able to add added blush to those data, for instance the allowed acknowledgment data, whether that’d be through biopsy or through antigen. So that blazon of amalgamation will be put together, I anticipate, for the aboriginal bisected of this year. And as a guide, you can attending aback at the SNO affiche that we put out aftermost November as about the arrangement for the way the Aggregation is befitting the Street acquainted of our activity.

Yale Jen — Laidlaw & Aggregation — Analyst

Okay, great. That’s very, actual helpful. And again, congrats on the beforehand so far.

Laurence J.N. Cooper — Chief Executive Officer

Okay. Acknowledge you actual abundant for questions. And I ahead that now concludes the alarm and everybody accept a acceptable day.

Operator

[Operator Closing Remarks]

Duration: 45 minutes

Chris Taylor — Vice President, Investor Relations and Accumulated Communications

Laurence J.N. Cooper — Chief Executive Officer

Satyavrat (Sath) Shukla — Executive Vice President, Chief Banking Officer

David Mauney — President

Yale Jen — Laidlaw & Aggregation — Analyst

Thomas Flaten — Lake Street Basal — Analyst

Swayampakula Ramakanth — H.C. Wainwright — Analyst

Nick Abbott — Wells Fargo — Analyst

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