Q4 2019 Earnings Call
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Who follow at that time, if anyone should require assistance during the conference. Please press Star then zero on your Touchstone telephone I would like to turn the conference over to your host Dr. John breakup.
Nice precedent of Investor relations and corporate communication off the tolerable your tell TV. Please go ahead.
Thank you operator, good morning, everyone and welcome to a tourist fourth quarter and full year 2019 conference call.
On today's call will provide an update of our clinical operational and strategic progress as well as review our upcoming milestones in key objectives for 2020.
Earlier. This morning, we issued a press release, providing an overview of the company's fourth quarter and full year 2019 financial results. This press release and an updated investor presentation are available in the Investor and media section editorial bio dot com.
Joining me on todays call our Dr. Pepper, Pascal to Sean President and Chief Executive Officer bulk Koby car, Chief Financial Officer, and Joe Newell, Chief Operations Officer, and Dr., AJ Joshi, Chief Medical Officer.
We begin with prepared comments from Pexco and then open the call for your questions.
We'd like to remind listeners that during the call. The company's management will be making forward looking statements actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the company's business. These forward looking statements are qualified in their entirety by the cautionary statements can.
Then in today's press release, and the company's SEC filings.
These statements are made as of today's date and the company undertakes no obligation to update these statements.
Now I'd like to turn the call over too as far as President and Chief Executive Officer Pascal to Sean. Thanks.
Thank you gentlemen, thanks to all of you for joining us this morning.
2019 was a year protegee prioritization and significant advancement of 40 said immunotherapy program.
I would like to highlight that we've made important progress on all four strategic priority.
We have also extended cash position into Q2 2021.
And we continue to leverage subset experience to advance or no lucky over the shelf T cell immunotherapy platform.
Building on these significant progress and momentum let me start by reviewing the recent highlights anticipated Muslim full stop sale.
We are currently conducting a phase two clinical trials, we stop sale.
Patients Weve Epstein Barr virus.
Associated both transplant, the full productivity of diesel PC as the industry, that's effectively setting.
I will talk about remains on track to initiate the tough said via the submission to the FDA in the signal of us on 20.
We currently.
Eight sites in the United States, and Australia actively enrolling patients and preparing to open additional sites in the U.S., Canada and you'll.
Two while the second we submitted clinical trial you application will see a two said well you opened countries in November and December of 2019, which will allow us to oppose clinical side can you help in 2020.
We are excited as we recently received CE approval in the UK, Austria in Spain.
These additional sites are being added to support full enrollment the phase three study or whether they are not necessary to meet the number of patients required for the plan safely into under license.
Indeed as I just mentioned, we continued to be on Twox to initiate a topcell get a submission will patient weve NPV positive PTSD in a single dogs optimism 20.
We plan to all the PBM and meeting with the FDA high yield to be submission.
Which we will discuss the totality of to up sell data, we and our academic collaborators have generated including the phase at city and so the Colts MSK phase two studies and expanded access program.
As a reminder, we most recently presented data from the in December 2019 at Ash annual meeting.
These data complies long term clinical results for 61 patients with diverse NPV associated disease, including efficacy and safety data for 26 patients we've hit ups effectively BV positive because the.
And safety findings for 55 patients with all the TBV associated disease.
The data demonstrate the Topcell was generally well tolerated in all patients participating to be stood.
Importantly in the signal of 22 patients we enter the DPT as.
Would've liked the met disability criteria for the ongoing Topcell phase three study. The overall response rate for the HCT cohort was 55%, we've a two year estimatable survival of 79%.
For the Esselte cobalt overall response rate was 82% and two years to make you to vote survival was 81%.
We also engage in multiple activities designed to expand access to up sell for patients in Europe.
Recently submitted a bid yet peak investigation plan of peak IP to eat in May.
Following EMEA approval of the PSB at our plans to submit the Topcell you marketing authorization applications for patient Weve NPV positive because the in 2021.
The clinical data generated to date, we vote 80 in this view Portlands also support the potential of stop sales as a transformative therapy in several other NPV associated disease.
In the signal as of 2020, we expect to initiate enrollment of a topcell phase to mitigate study, including a two six additional neutropenia NPV positive disease.
In addition.
We are and all the final planned patients the phase one be both from the phase one be two clinical study of Topcell in combination with anti PD, one therapy in patients with in patients with platinum resistant or intolerant NPV associated nasopharyngeal casino NPC.
Prior to starting the phase two portion of the study we will evaluate the initial results of the phase Wendy.
As well as it relates to effectively NPC clinical landscape.
I will now turn to 80, 188, or allergenic T cell immunotherapy for the treatment of patients with policies looked at both closes.
Recall that up X teams to present 19, we reported encouraging early data from the phase one a multicenter open label dose escalation study evaluating the safety and efficacy of 80 188 in patients with progressive form of unmet.
Safety results showed that a course of for those goals 80, 188 was well tolerated in patients with policy limits.
We reported at six months Fortiweb in the lowest dose cohort one of six patient with clinical improvement using the criteria. We define our take trips. This improvement was also maintain at 12 months.
In Q2, two out of six patient, which clinical improvement at six months.
We recently selected the core $3 to initiate the randomized double blind placebo controlled phase one be part of this study.
Our decision to initiate a phase one be was based on achieving in court free or predetermine criteria of an acceptable safety profile and three out of six patient achieving clinical improvement at six months for more than one clinical study site.
Looking ahead, we expect to present updated clinical data at appropriate for us, including six months forward for all calls into 2020.
And he has to be in pool by or manufacturing process as well as the yield the possibility to make significant number of doses from one you go back as you know recently, we've announced that we stop sales, which is at the beginning the same type of process, where we harvest sales for.
Settles, we select and activate these sales we are now able to make 400 dosage.
From one newco back to this type of efficiency of our manufacturing process is what we want to see in the manufacturing of a key 30 to 90 and the preclinical stage. We are twice now is indicative that we are on the right back in terms of making not only.
Rapidly, bringing the product to the clinic, but also making manufacturing this product in a very efficient way.
Got it thank you for all that detail very helpful.
That's part of leads into my other question when we think about your car T pipeline long term.
We anticipate using easy Archie platform that you that you mentioned you're building out here and you had a comment about partnering potential is is is this platform that you're thinking about versus say like a partnership with MSK.
For the EPA two to seven.
Thank you for your question, so clearly accrual on pipeline in Carty in terms of strategic priorities.
Yes.
Moving to Allergenic car T based on the BDC sales 80 assisted to 19, let these in preclinical a Indianapolis study and eight years 30 to 71 be mitigated in targeted allergenic Carty, but is also in preclinical I IND, enabling studies. So we saw the truth of the most advance.
We have also activities, we've all collaborators at memorial Sloan Kettering as well as that MOSFET cancer Center in Tampa, where at the earliest stage. We have some exciting type of car TSR being develops and these are developed first by these academy could avoid those are autologous.
Marty and once we are moving into a full development, we going to as usual develop an allusion exertion based on the DVD sales. What we've built is a tool allows any coffee platform based on the CBD T cells and this is another syncope platform that benefit from the work we've done on top.
Well as well as the work we're doing on 81 inch it. So there is a clear correlation between these we have the most advanced allows any T cell immunotherapy, we stop sale Hi. This is not in phase three and we don't know any others that is in phase three at this stage right. Now we have the August manufacturing process, there will be going to leverage that and thats, what we everyday.
Team is doing as within our manufacturing unit leveraging that experience to make.
Oberst and efficient process for aluminum copy based on businesses.
Getting a question on partnering as we say we are very advanced platform for aluminum Carty. So thats why there is strong interest regarding the possibility to partner.
Weve around this platform to be able to vbloc create develop and make allergenic parties and the same time. When also open discussion on buffering other assets of our pipeline.
Got it thanks very much for taking the questions.
I mean im showing no further questions at this time I would now like to turn the conference back to call to Sean.
Thank you very much operator.
So thank you very much for being there today for conference.
Clearly, we're making significant progress. This is an exciting time for all of us at Idaho and Im very pleased to have had the opportunity to review recent accomplishments and discuss our upcoming milestone for 2020.
We are a great deal of momentum coming into 2020, and I look forward to updating you on our continued progress in a months ahead.
We aim at transforming the lives of many patients in need of course values or use disease and this is possible only for the contribution of many individuals to whom we are very thankful, including our shareholders or committed employees or clinical investigators or khatami collaborators.
And of course, all the patients.
Depicting studies, thank you very much.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful. Thank you may all disconnect.
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Good morning, ladies and gentlemen, and welcome to the Apollo why you tell what beauty excuse for full year 2019 financial results Conference call. That's fun all participants are in listen only mode later, well conduct request stripping down first <unk>.
And instructions will follow the time, if anyone should require assistance during the conference. Please press Star then zero on your Touchstone telephone I would like to turn the conference over to your host Dr. John Grey card.
I suppose the desktop Investor relations and corporate communication off the tolerable your torpedo. Please go ahead.
Thank you operator, good morning, everyone and welcome to a tourists fourth quarter and full year 2019 conference call.
On today's call will provide an update of our clinical operational and strategic progress as well as review our upcoming milestones and key objectives for 2020.
Earlier. This morning, we issued a press release, providing an overview of the company's fourth quarter and full year 2019 financial results. This press release and an updated investor presentation are available in the Investor and media section at a tar bio dot com.
Joining me on todays call our Dr. Pepper Pascal to shown President and Chief Executive Officer, who Paul could be car, Chief Financial Officer, and Joe Newell, Chief Operations Officer, and Dr., Ajay Joshi, Chief Medical Officer.
We begin with prepared comments from Pascal and then open the call for your questions.
We'd like to remind listeners that during the call. The company's management will be making forward looking statements actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the company's business. These forward looking statements are qualified in their entirety by the cautionary statements can.
Then in today's press release, and the company's SEC filings.
These statements are made as of today's date and the company undertakes no obligation to update these statements.
Now I'd like to turn the call over too as far as President and Chief Executive Officer Pascal to Sean.
Thank you gentlemen, thanks to all of you for joining us this morning.
To put the 19, while the year cottage, Jake prioritization significant advancement.
He said immunotherapy program.
I would like to highlight that we've made important progress on all four strategic priorities.
We have also extended of cash position into Q2, 2021, and we continue to leverage stops that experience to advance or no about the of the shelf T cell immunotherapy platform.
Building on these significant progress and momentum let me start by reviewing the recent highlights and anticipated milestones for Topcell.
We are currently conducting a phase clinical trial, we stop sale.
Patients Weve Epstein Barr virus.
Okay. That's located both cost from the full productivity is easily be C.L.D. in the relapse could fluctuate setting.
Uh-huh remains on track.
At the top Sebelius submission to the FDA in a single.
The first on 20.
We don't see 58 sites in the United States, and Australia activity and the all in patients and now preparing to open additional sites in the U.S., Canada and you'll.
Well be send we submitted clinical trial, you application or C.G.. A two said all you opened countries in November and December of 2019, which will allow us to offend clinical sites in Europe into for than 20.
We are excited as we recently received CE approval in the UK, Austria and Spain.
These additional sites are being added to support for all month. The phase three study whether they are not necessary to meet the number of patients required for the planned phase into under license.
Indeed as I just mentioned, we continued to be on Twox to initiate the topcell give this submission for patient Weve NPV positive PTSD in a cigarette butts off 2020.
We plan to all the previously meeting with the FDA, Hi, you ought to be submission.
Which we'll discuss the totality of Topcell data, we and our academic collaborators have generated.
That being the phase three at city and so the goals MSK phase two studies and expanded access program.
As a reminder, we most recently presented data from the in December 2019 at Ash annual meeting.
These data compiled long term clinical results for six to one patients with diverse you'd be associated diseases, including efficacy and safety data for 26 patients. We that's effectively be positive security and safety findings for 55 patients with all the executed.
Yeah.
The data demonstrate that up sale was generally well tolerated in all patients participating to be stood.
Importantly in this segment of 22 patients with NPV positive BT as.
Where does like the med distributed criteria for the ongoing upstairs basically study. The overall response rate for the FCC colt what 55%, we've a two years to make use of all survival of 79%.
For the Esselte gold overall response rate was 82% and to make it evolves survival was 81%.
Also engage in multiple activities designed to expand access to topcell for patients in Europe.
Recently submitted a bid gets sick investigation plan of IP to in May.
You may approval of the PSB I thought our plans to submit the Topcell you marketing authorization applications for patients with NPV positive speakeasy in 2021.
The clinical data generated to date, we've all even if you programs also support the potential of stuff. So as a transformative therapy said all the NPV associated disease.
So don't focus on 20, we expect to initiate enrollment over topcell face to mitigate study.
Including up to six additional neutropenia NPV positive busy.
In addition, we are an all the final plan patients the phase one be both from the phase one two clinical study of stop sale in combination with anti PD one therapy in patients we in patients with platinum resistant ovarian bbsixty nadeau foreigners only casino MPC.
Prior to starting the phase two portion of the study we will evaluate the initial results, albeit phase one be.
Well as it relates the fact that we NPC clinical landscape.
I will now turn to 80 188 or lose any you said immuno therapy for the treatment of patients with progressive looked at both because it will these.
We called that up it seems to present, a 19, we bolted on coaching early data.
The phase one a multicenter open label, both escalation study evaluating the safety and efficacy of 80, 188, inpatient weve progressive form of unmet.
Safety results showed that the cost of full those goals when 88 was well sort of aged in patients with policy limits.
We reported at six months photo at in the lowest dose cohort one of six patient with clinical improvement using the criteria, we define egg trips.
This improvement was also maintain a 12 months.
Cool to two out of six patient, which can you got improvement at six months.
We recently selected the called $3 to initiate the randomized double blind placebo controlled phase one be part of this study.
All decision to initiate a phase one be was based on achieving Gottfried.
Predetermined criteria of an acceptable safety profile and three out of six patient achieving can it go to important month.
Six months for more than one can you go to study site.
Looking ahead, we expect to present updated clinical data at appropriate falls, including six months wallet for alcohol in Q2 2020 at 12 months would fall into sit on top of 2020.
Additionally, we recently re treated the first patients in the open label extension portion of the phase when they study which is designed to a low patients will compete one year in a dose escalation portion of the study to be retreated annuity using the call $3 for up to four years.
We also on Fox to initiate enrollment of undermines placebo controlled phase one.
Study in a second or third quarter of 2020.
Site activation for this study is in office and we are expecting an increased number of leading mm centers to participate in the us and Australia.
In addition, I thought leading expense recently published a review article in trends in moniker dollars medicine regarding the mechanistic connection between infection and mess.
Now, let's discuss always busy coffee platforms.
2020 transportation and fitted out throughout the meeting last week and academic team presented a clinical study in patients with relapsed refractory b cell malignancies tweeted, we have an off the shelf allusion need Cdnineteen car T made from primary though not all partially it should be much third party donor ABVD.
Sales in.
In this first in human study, we be NPV Cdnineteen car T cells investigators observed durable complete responses for five out of six patients will receive partially it should be much NPV Cdnineteen company sales not affected from third party donors.
No thats going to really syndromes or neurotoxicity, both great too and no dose limiting toxicities were observed booked in food.
We have multiple NPV cdnineteen car T doses.
Also mill confirmed Gvhd was observed in patients who receive third party to know NPV Cdnineteen car T cells.
Importantly, investigators also observe durable complete response CR Weve median follow up of 26.9 months for five out of six patients will receive partially it should be much NPV cdnineteen coffee sales manufactured from third party to others, including four out of.
Our responses in patients with NHL.
One out of one response in patients with CLL and ended the person's survival with NHL and CLL.
Findings from this study provide initial clinical proof of principle that an NPV T cell platform has the potential to generate off the shelf I look at any cost immunotherapy with and durable responses low risk of toxicity and the hot did deteriorate to patients.
We continue to make progress in advancing of multi protocol T to uptick candidate.
We expect that our collaborators at MSK with some meat and high end due to the FDA. In this segment first quarter of 2024, 22, 71, an autologous middle that in targeted carty in patients with advanced middle to drama.
These programs and cooperates next generation technologies, including a novel Costimulatory domain, one X X that may offer greater Pitt systems, and more physiologic T cell signaling.
As well as a btwob domain and they got the receptor that is designed to provide intrinsic checkpoint inhibition and look the solid tumor microenvironment.
Furthermore, we have started clique unico I IND, enabling studies for eight years 30 to 71 and other shelf allergenic TBV resulted in targeted carty with the same next Gen. Carted technologies are 80 22 71.
In addition, we have started preclinical I Indy, enabling studies for eight years 30 to 90 anybody cdnineteen targeted carty that incorporates one X X.
We believe at our house of the shelf Allergan HBV Kathy platform is differentiated and has tremendous potential as an engine for continued innovation leveraging social mobile LTV piece sale safety expansion trafficking and persistence characteristics.
Our dedicated facility in southern docs as the flexibility to produce multiple T cell and kept immunotherapy and integrates preclinical and for Thats not research process science quality control and regulatory CMC capabilities and they're wonderful.
Such close integration enables rapid development and Scott as of August manufacturing processes to support our potential current and future clinical and commercial demand.
The efficiency of manufacturing platform capabilities as recently been demonstrated with significant improvement in our manufacturing yield we stop sale.
Commercial stage process is no enabling us to make over 400, though this from a single donor Newcastle today.
Overtime, we believe our commercial manufacturing process.
With a low for cost of goods profile similar to those of biologics.
In addition, we will lead program already in phase three and T cell manufacturing commercial validation activities progressing well, we're taking a significant competitive advantage for us.
In other shelves allergenic T cell immunotherapy.
Not surprisingly, we are seeing us Tom level of interest from potential partners to access off the shelf T cell platform and we also see opportunities for potential partnership with the current product portfolio.
On the operational hold earlier. This month, we are pleased to welcome Christine you have enough as a new chief commercial officer.
But again not brings extensive and metallurgy oncology neuroscience and auto immune disease commercialization experience throughout the AR, which are very valuable as a company advances commercialization activities what upset.
We also created a chief operations officer, all to continue to drive operational excellence across the company program and platform and appointed junior well, that's our Q on chief technical operational FISA through this new or.
Turning to our financial positions, we extended of cash runway into the second quarter of 2021.
We ended 2019, weve cash cash equivalents and short term investments totaling 259.1 million.
Compared to 282.9 million as of September 3200, 19.
Of note pro forma cash and investments as of December 31, 2019, including ATM and option exercise proceeds from January 2020 was 282.7 million.
In closing the progress we made into the 19 has positioned us well for commanders success Ccs.
Delivering on key milestone for ourselves or lead pipeline candidate and further advancing other promising programs globally, how the work of all at the as Andres.
I'd now turn the call back to the operator to begin accruing a portion of the code operator.
Ladies and gentlemen, if you have a question at this time. Please press the star doubled the number one key on your Touchstone Palace. Alan If your question has been answered you wish to remove years fall from the Q. Please breast parrot key your first question comes from the line has.
Ill deal with Cowen and company. Please ask your question.
Good morning, Thanks for taking my questions and congrats on the progress.
Just a couple on on tap so first since you're guiding to having a pre BLA meeting.
And the second half for this year and starting the filing later in the second half this year it seemed that youve sufficiently enrolled.
Patients for the interim analysis present et cetera.
Thank you failed for your question, we're not making any comment on the enrollment at this stage.
And we are confirming our guidance that we plan to initiate filing of the DNA in a symbol for 2020 following.
PBM meeting with the FDA, where will present the totality of data.
And what's your most recent picking on when you.
Publicly release the.
The data from interim analysis is that likely to happen with the filing for reported be sometime later.
As we said we plan to cause present these data on the study at an appropriate Congress, but we do not intend to do that before the fighting.
And we want to preserve the integrity of what is an open clinical study, where we will start to initiate the filing with an interim analyses of the data. So we would certainly discuss with the FDA. During a period meeting what is the best way to be able to covenant.
These data in due time, but at some time the initiation of the via the filing by itself is a material event will will indeed communicate publicly that we initiated the DNA fighting.
Great and last question for me is on the.
Requirements for completing the filing and starting with particular time clock do you think you'll be in a position to clarify what those requirements are at the time of the BLA filing at the time of the initiation of filing or.
We'll even more in subsequent discussions happen with the FDA. Once initial filings made as to exactly what will be necessary to run to get to produce for time clock started.
Well, we will communicate about the initiation of there'll be a filing we will be hopefully be able to give more details on that optical BLE fighting and hence about what is the anticipated time of competition.
Got it perfect. Thanks for taking my questions.
Your next question comes from the lines have on human with Canaccord. Please ask your question.
Hi, good morning, Thanks for taking my question.
Just curious it sounds like you have been adding additional trial sites for tax now just wondering if you have a target number in mind. The total number of sites that you would like to have open and actively enrolling patients.
Thank you are jumping a question agent you ought to think that long short so I think.
First off we have as you know we have 38 sites open in the U.S. today and it's important to note that those 38 sites are the number that's necessary to achieve that interim analysis time point. So that we can have the initiation of the late in the second half 2020.
In terms of Europe, Canada, and other sites I can give me a general sensor in Europe, we wouldnt have enrolled probably up to about 24 sites.
Okay great.
And then in terms of.
The data that are coming this year for 18, one eight Ana.
How should we be thinking about.
Kind of the key points from that data I noticed you have.
Sort of a different way of looking at the efficacy based on a positive.
Just curious as to how we should be thinking about.
The efficacy when you give us data.
12 month follow up there.
Sure so in in the first half of 2020.
We should expect six months data on all four cohorts and then also 12 months data on the first three cohorts. The we've talked about the types of analyses that we do in the initial the way. We described the initial data was really meant as for signal seeking and making decisions about the drop and as you know weve achieved.
Gold and the Phase one study, which is safety and that and the decision to move forward with a cohort three.
We do expect at present some additional.
Composite disability measures.
In that first half 2020 timeframe as was the second half.
Okay, great. Thank you.
Your next question comes from the line as Matt said with William Blair You May ask a question.
Good morning here. Thanks for taking my question first I guess follow up on Phil's question. So really the next kind of material disclosure, we get on top. So then would be the from the initiation of a rolling submission is that correct or could there be.
Immaterial update ahead of that.
So our current plan is I say to communicate what we believe will be in material today I the initiation of the BLE fighting instead on Basel 2020.
Got it thanks, and then just two other questions on the pipeline I guess, you mentioned the final patients enrolled and the.
These are franjo carcinoma study.
Possibly see results later this year that solving for early 21.
And I realize this is an investigator sponsored study, but do you anticipate MSK, providing an update on the first gen mezzanine on car at some point this year I know they've been enrolling patients beyond mesothelioma as well.
So just curious if you've had in discussions with them on on their plans there.
Okay. Thank you My first question Asia sure So Matt regarding the NPC studying the we've enrolled.
As you indicated we enrolled the final patient in the phase one be portion of the study.
And our anticipation is we're going to evaluate the results enacted the entire NPC landscape because as you know that whole treatment landscape has been evolving so as the results mature and we assess the landscape will then make decisions as to the appropriate for him to to present those assessments.
And second question regarding the first generation missiles that in Carty as you said this is an investigator initiated study.
What we understand the Dod investigator is continuing to Fortiweb. These patients and also including additional patient study. It is we understand the incentive the invigorate investigator at the appropriate stage to communicate further reserves that study.
In Congress, we cannot comment that the state on which while the when exactly that will occur, but that's certainly the plan of the investigator.
Thanks for taking my questions.
Hi, Graham, ladies and gentlemen.
If you had a question at this time. Please press the star tend to number one key on your Capstone Salah found if your question has been answered or events to remove yourself from the Q. Please press the pound key. Your next question comes from the line up selling Ziad with Mrs. We Securities you May ask your question.
Hey, guys. Thanks, so much for taking my questions. Thanks for all of the color as usual.
It's a few for me on the multiple sclerosis program. If you did I hear you correctly in saying that we're going to be getting 12 month data.
All right Hey, Andrew yen.
For the cohort three.
So in terms of 12 month data in the first half of 2020, absolutely we would be getting.
In 2000 data through courts, one through three okay for all six patients in cohort.
Yes.
Okay.
So when were when we're thinking about 18 wanting Dx I know this was.
Something that came up at ACTRIMS last year are you guys still thinking here.
Right.
You know that the.
We're going to need 12 month data for investors to really diligence FY 18 wanted to.
Because the profile or most six month data.
The enough.
One when we're going into and yen.
Wherever you presented data will that be enough of a time duration to diligence this data set.
Yes, I think when you when you take a look at certainly in all and that studies you'd like to see some duration of response, so like anything else 12 months is better than six months.
When we talk about the ultimate proof of concept that certainly is going to come at the one year endpoint in the phase one be randomize portion, but certainly the 12 month data offer. This portion of the study would provide good additional support ethic.
Okay, and lastly from me on the read dosing for multiple sclerosis are you guys expecting.
Upon read those re dosing that though the one year time point and the two year time point further improvement in disability or some sort of plateauing.
Yeah, Hey, we don't really have.
Data to suggest one way or the other obviously, we'd love. It if we have further improvement, but I think the most important thing is whatever improvement we achieved if you're able to maintain that that is already a major win and progressive M.S.. So that should be our baseline that we work off.
Okay excellent. Thanks, so much.
Your next question comes from the line as Ben Bernanke with Stifel. You May ask your question.
Oh, hi, Thanks for taking my question. So this is a question regarding car T.
So how has the memorial Sloan Kettering, Saudi impacted your thinking on Lymphodepletion, and whether or not this needs to be done and wet and to what extent you think this could be done an outpatient setting.
Thank you for your questions.
I think as you know these study that was presented last week is an academic study in.
10 patients.
And that study as going for some time with different type of 24 depleting regimen using these patients. So we do not think we can draw a conclusion right now on what will be well seabold if any need for the patient regimen for 80 832 19. This is something that we plan to stuff.
In all.
First in human study or whatever what we going to do is.
With MSK on the spot skill sets of data that the and more particularly on sampled study.
Block now and load to be able to better understand the expansion assistance of the NPV Carty Cdnineteen T cells in these patients and see whether there is any relationship whatsoever with the NIM for the pink regimen that they've got so that will be informative for us as we design.
The protocol for first in human study with eight years 32 19.
Okay, perfect Almond and just one more question on 18 22 71.
What's getting further mesothelioma I and de submission and are there any plans to develop this in addition.
In solid tumors outside of mesothelioma.
So thank you there's no particular dating is just a ton needs to put together all the data things up onsite progressing well and of course, there will be the time then to submit that I, Andy as we said it will be done by our collaborators at MSK in the second or third quarter 2020.
Now the first in human we'd be very innovative construct of carty is going to be in advance and we look at your mouth, but we are already discussing weve investigators about the possibility to use these costs, but this new carty in other type of solid tumors that are overexpressing resulted in an.
Okay. Good already so, although I am cancer and pancreatic cancer.
Okay perfect.
My question. Thank you.
Your next question comes from the line if any palm Rama with JP Morgan you May ask your question.
Hi, Good morning, welcome tough on the call Paul.
Thank you for taking my question Gary.
I can ask about your most upticking thoughts on the market size.
He became positive relapse refractory PD out the invitation only you after my movie Apple to apples, allowing can geography.
How are you thinking about the size and scope of cloud infrastructure to sort of a drafting the patients globally. Thanks, so much.
Thank you very much for your question. So as we already indicated we believe that into your with the setting all four study that could lead to a potential indication in relapsed effectively.
As the.
That is.
Around as a noteworthy which means that we believe that several hundreds patients in the us that could benefit potentially from thats sale.
We believe also that's assuming our number exit in Europe and also assuming all type of number exist in the rest of the world beyond the United States and Youre.
So this is an air trauma indication. This is our first indication for up sale that we hope will be followed by several other indications as we confirm today, we going to start so gondola often doesn't 20 and the holding the mill TECOS study with up to six.
The type of Petrobras D that could lead to seek additional indications there that are going to increase the size. We believe by please affect all four of the population that could be treated efficiently by stop sale.
In terms of the commercial organization that these indeed.
We are being an ultra rare disease and having no other treatment hopes to pay for that the D.. We believed that the commercial organization that wouldnt be need to make sure that patient can access stop sale ease of limited size. It. So we'll be typical often their trial rare disease type of.
Commercial organization.
Okay, great. Thank you so much for taking my question.
Your next question comes from the line as an Maury Raycroft led Jaffray. You May ask your question.
Hi, Good morning, this is facing on from Murray.
With that MSK data and look quite promising specially on.
So what else I may onest mix at how confident are you led and non standard conditioning lymphodepletion contributed to the same amendments and if.
So again this study is we believe.
Clinical proof of principle that the.
He BV based Cdnineteen car T I lose any of the shelves as the six patients where sales were coming from third party donors are demonstrating is.
First of all is safe and effective.
No. They are a limited number of patients we recognize that as well as different type of disease, but altogether the compulsive Nat Geo these data.
Key clinical proof of principle that allergenic, all the shelf Cdnineteen DVD copy, our again safe and effective and we are particularly encouraged by the long term durability of the response, if you think about five out of six.
Patient, we see all and VCR being doable wave in fact survival. Following the photo of 26.9 months survival of 100% innovation with NHL and CLL. These are very encouraging data about the effect of these.
Allergenic off the shelf BBB Cdnineteen car T.
Okay. Thank you and have you considered like what conditioning rates remained in the variables you haven't due to in your current study.
And with strategic focus on.
First of all what we're going to bring to the clinic is a different product.
This is 80 832 19, which is also based on MVP sales, but using I thought on process and especially using a new costimulatory domain, one X X, which is there to bring.
Net increase potentially increased assistance of the sales and less exhaustion of the T cells. So that's a different product but of course will be in fall in office and human study protocol and follow it by the experience that this academic team obtain ways. These contract, which is again a different product.
From a TSMC to 19, but that's why we say that this is a clinical proof of principle, but atheists 30 to 90 is really the product. We are supporting the development of we have started as we say preclinical R&D, enabling studies for that product to bring it to the unique as soon as possible and to be able to.
Two.
Cool the concept of IDB T cell copy platform and the ability to treat patients safely effectively we have another shelf treatment that could be available within days to patients.
Thank you.
Your next question comes from the line as Tony Butler with Roth capital.
Question.
Hey, Good morning. This is tosh doubt mean for Tony here.
And then.
Just quick question on 30 to 19.
Continuation of saw Glenns comment.
Based on the learnings from the TCT Congress data.
Do you have any specific plan as to what kind of population, but you will be targeting lets say CLL initial versus some hello.
We are not communicating at this stage what will be the protocol and the type of patients will address first in human but we do so.
The appropriate time, clearly we believe that there is a medical need today thats still exist in the population of NHL patients CLL patient Ll patients, we will have ourselves to decide at the time, we enter the clinic, where we want to focus, but we believe that eightyfifty to 19 as.
The potential to bring significant benefit to patients.
Thank you that helps.
Your next question comes from the line.
Our common.
Cities you May ask your question.
Hi, this math on for your call. Thanks for taking my question.
I wanted to sort of build on prior question.
The CBD car T study presented at TCT can you talk about any other differences outside of the onex back in military domain.
Hi, everyone nine will have versus the artesia not steady and.
With these differences between the two products, which should we think about the read through in terms of the data that was presented there and the difference if you think might show up in your clinical program.
So a few things first of all what we're doing with 80 830 to 98 to diesel.
Product food Hopper manufacturing process and development phase. So this will not be an academic.
Hi, Paul study it will be I will tell us to developing that particular product.
And the deficiencies that we anticipate at this time is mainly the defensive costing that we domain as well as in manufacturing process too.
Products not not only allows us to pull in a clinique potentially safety efficacy and persistence and do ability there. But also this is helping to build our platform of low coffee as you know if 32 19 is just one of the illusion unique.
Ebays copy that we are developing and advancing that pool.
Okay.
Hi, Andy enabling studies I in the first in human is going to help us to continue to progress. We are platform. We've made significant progress about it and we going to leverage that public. So two key differences will be onex sex and the manufacturing process.
And we believe that in particular when access is going to bring some significant potential advantage in preclinical studies. These particular costimulatory domain as shown that is indeed.
Using less exemption of the T cells and more persistence. So thats something that is certainly going to bring some potential benefit and other centime.
The fact that we built oberst manufacturing process, allowing us not only to make allergenic Cdnineteen car T. Based on the BDC says that oversight of I heard any coffee based on DVD sales will be something very important debt.
And there was some pop secret of.
Details in the presentation of the epidemic in last week just to give you. An example, the level of coffee says conviction that 20.5% is something that we believe can and easy to be improved by or manufacturing process as well the yield the possibility.
To make significant number of both is from one you go back as you know recently, we've announced that we stop sale, which is at the beginning the same type of process, where we.
Other sales from LCD Aligners, we select and activate these sales we are now able to make 400 doses from one nickel back to this type of efficiency of our manufacturing process.
Is what we want to see in the manufacturing of Heath 30 to 90 and the preclinical stage. We are twice now is indicative that we are on the right talk in terms of making not only.
Rapidly, bringing the product to the clinic, but also making manufacturing this product in a very efficient way.
Got it thank you for all that detail very helpful.
That's sort of leads into my other question. When we think about your car T pipeline long time should we anticipate using easy car T affirmed that you that you mentioned you're building out here and you had a comment about partnering potential is is is this platform that you're thinking about first is they like it partnership with Chi.
For the EPA two to seven one.
Thank you for your question. So clearly all current pipeline in car T in terms of strategic priorities.
Yes.
Moving to Allergenic car T based on the BDC sales Ats 32, 19 that these in preclinical Andy enabling studies and 80 830 to 71 be muted in targeted Allergan in Carty, but is also in preclinical I in the enabling studies. So we saw the through lots are the most advance.
We have also activities, we have our collaborators at memorial Sloan Kettering as well as that Moffitt cancer Center in Tampa, where at the earliest stage. We have some exciting type of car TSR being develops and these are the of low first by these academy could avoid those as autologous.
Our team and once we are moving into four development, we going to as usual develop an allusion exertion based on ABVD sales. What we've built is a tool I lose any coffee platform based on the CBD T cells and this is another syncope platform that benefit from the work we've done on top.
As well as a work we're doing on 81 eight so there is a clear correlation between these we are the most advanced I was any T cell immunotherapy, we stop sale as it is not in phase three and we don't know any others that is in phase three at this stage right. Now we are the August manufacturing process, there will be going to leverage that and that's what we mean every day.
He is doing everything on manufacturing unit leveraging that experience to make over.
Holbert and efficient process for allows any capacity based on the businesses.
Getting your question on partnering as we say we are very advanced platform for lose any carty. So thats why there is strong interest regarding the possibility to partner.
Weve around this platform to be able to develop create develop and make I lose any copies and the same time. We also opened the discussion on partnering other assets offshore pipeline.
Got it thanks very much for taking the questions.
Okay.
Hi.
Im showing no further questions at this time I would now like to turn the conference back to call to Sean.
Thank you very much operator.
So thank you very much for being there today for conference.
Clearly we are making significant progress. This is an exciting time for all of us at Idaho and Im very pleased to have had the opportunity to review recent accomplishments and discuss our upcoming milestone for 2020.
We are a great deal of momentum coming into 2020, and I look forward to updating you on our continued progress in a months ahead.
We aim at transforming the lives of many patients in need of course value. So use disease and this is possible only for the contribution of many individuals to whom we are very thankful, including our shareholders have commented on plays or clinical investigators or khatami collaborators.
And of course, all the patients participating in our studies. Thank you very much.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.