Q1 2022 Plus Therapeutics Inc Earnings Call
At this time, all participants have been placed in a listen only mode and the floor will be opened for your questions. Following the presentation.
If you would like to ask a question at that time. Please press star on your Star one or you touched on telephone keypad. If at any point. Your question has been answered you may remove yourself from the queue by pressing the pound Keith we ask that you. Please pickup your handset to allow optimal sound quality. If you should require operator assistance. Please press star zero.
Before we begin we want to advise you that over the course of the call and question and answer session forward looking statements will be made regarding events trends business prospects and financial performance, which may affect plus therapeutics future operating results and financial position.
All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the risk factors section included in plus Therapeutics annual reports on Form 10-K , and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time, plus Therapeutics advises you to review these risk factors.
Actors in considering such statements plus therapeutics assumes no responsibility to update or revise any forward looking statements to reflect events trends or circumstances. After the date. They are made it is now my pleasure to turn the floor over to Dr. Marc Hedrick, plus therapeutics, President and Chief Executive Officer, Sir you may begin.
Thank you very much Gretchen good afternoon, everyone.
Thank you once again for taking the time to join US today as we provide an overview of recent business highlights and discuss our 2022 first quarter financial results.
Joining me on the call today is Dr normal of grants, our Chief Medical Officer.
Andrew Sims, our Chief Financial Officer.
Ill begin the call by reviewing our recent corporate and clinical progress before turning the call over to Norman who will provide commentary on our clinical progress for 2022, and then following norm and Andrew will review our financials.
Despite the short interval since we last reported quarterly results I continue to be very pleased with our overall progress.
We work towards several meaningful catalysts and milestones throughout 2022.
During the first quarter, we began enrolling patients in our respect El Limn trial of 186 or <unk> in patients with Leptomeningeal metastases or LLS.
The trial is a multicenter just wanted to a dose escalation study to determine the MTB maximum tolerated dose at MFC.
In safety and efficacy of <unk> 186 and <unk>.
LTM is typically fatal complication associated with advanced cancers that affect a fluid line structures of the central nervous system and lift them in <unk>.
Median survival with current aggressive treatment.
About three to eight and a half months dips.
Pending on which primary tumor Costa LTM.
And the one and two.
Simply.
Survival without treatment is only a few weeks.
LMS diagnosed in approximately 5% of cancers.
Are patients at autopsy.
U S annual incidence is about 110000 patients and growing and the prevalence of neurologic impairment in these patients is about 50%.
Most common tumors, giving rise to LMR breast cancer lung cancer melanoma and gastrointestinal malignancies.
There are no FDA approved therapies and standard treatment that is employed includes external beam radiation therapy to the affected sites.
Followed by chemotherapy, given either orally or intravenously or even directly into the cerebrospinal fluid.
Although we can only draw a limited conclusions from our initial experience were very pleased with the outcome and the first patient receiving a single administration of 186 are Enel spa.
Specifically, we found that the drug circulated rapidly throughout the cerebral spinal fluid space.
We found that radiation was released to the left the <unk> G. CSF for at least one week after treatment.
The patient exhibited no adverse events and 186 RNA will reduce the circulating tumor cell counts by over 98% at two weeks. After treatment. This is really about as good as it gets in a first demand.
First patient in a phase one trial. So we're very excited about this very preliminary results. We now have two.
Six sites being on boarded.
We're on track to have at least the first two cohorts completed by the end of 2022, and hopefully a bit more than that.
As to our outgoing our ongoing clinical development program for 186 <unk> in recurrent glioblastoma, we have a number of updates.
First as a reminder, that trial is a dual phase <unk> multi center.
<unk> cohort open label.
Volume in dose escalation study for recurrent glioblastoma or GBM.
The trial is currently funded to a significant degree.
Many of you may know by the U S National Institutes of health of NCI.
Leo Blastoma effects about 13000 patients annually in the U S and about the same number of patients in the EU and so most common non lethal form of brain cancer and treatment of this devastating disease remains a very significant unmet medical challenge.
Now in terms of the clinical data 23 patients have been treated and 186 arnelle appears to be safe and well tolerated in this data presented most recently back in March can be found in detail on our website.
And that's accessible to anyone.
In summary, no dose limiting toxicities have been observed.
Generally mild to moderate Aes had been seen at <unk> SA is all grade three or lower and most are not deemed to be <unk> related.
In terms of drug delivery, we are now reliably able to deliver over 100 gray.
Radiation dose to tumors, which is our empirically determined and minimal dose threshold of adequate absorb radiation and we can get well over 80% and.
And we think 90% is achievable in terms of reliable dose delivery of 100, great fine.
Finally, we have observed both the median and mean overall survival signal that exceeds the best published published rate for monotherapy.
Yep.
Based on this data I'd like to just explain our big picture plan.
We plan to bifurcate the current GBM clinical development plan based on tumor size.
So for tumors, approximately 15 to 20, Ccs and volume, which represents about one half to about two thirds of all recurrent glioblastoma.
We plan to use the cohort six dose of $22 three militaries and eight eight Ccs of volume as a recommended.
<unk> phase II Registrational dose.
For tumors of larger size potentially requiring greater radiation radiation dosages and treatment volumes.
We intend to continue our phase <unk> dose escalation trial to establish the upper limits of dose and potential for DLT or dose limiting toxicities.
In 2022 for GBM, we have two key regulatory milestones we have already in 2022 submitted and ask for the first of two FDA meetings, specifically a type C. CMC meeting to determine the sufficiency of our CMC package for <unk>.
<unk> 186, now to support a registrational trial.
And then relatedly to the CMC development our team.
Tenuous to make excellent progress in our drug scale up and manufacturing activities.
Specifically the company is finalized.
<unk> drug development and characterization activities for GMP manufacturing to support our planned phase II Registrational trial and commercially commercialization activities thereafter.
The company remains on track to deliver GNP personnel by mid 2022.
The FDA meeting is a clinically focused meeting.
<unk> for Q2, Q3 to solicit FDA feedback on our planned phase III Registrational trial, using a recommended phase two dose as mentioned 'twenty, two three militaries and a little a little less than nine Ccs of volume.
Also during Q1, we completed another key milestones specifically, we successfully completed the preliminary evaluation phase and entered into a broad partnership with meta data to use it.
Troll arm platform and real world data as the competitors for Glioblastoma trials.
The primary goal of this partnership is to develop an FDA compliant control group of patients identical to the patients thus far treated in our phase <unk> trial and in the planned phase III Registrational trial.
That data will be used to support our planned end of phase meeting with the FDA and proposed phase II illustration of trial.
More generally.
Is that a control arm or FCA platform facilitates the use of historical clinical trial data in a manner that has been favorably received by the FDA.
Is that <unk> reduced the time and costs associated with complex clinical trials in rare diseases, such as Glioblastoma.
Power for fewer patients to be exposed to placebos or existing standard of care treatments that might not be effective for them.
It offers them greater access to potentially life changing therapies and although a recent advancement. The FDA has already agreed to recognize a phase III clinical design, incorporating an SCA and a registrational randomized control arm for recurrent glioblastoma.
Besides initiating our phase II Registrational trial with <unk> in recurrent GBM as I mentioned above we also continued enrollment in our phase <unk> dose escalation GBM trial and that will continue.
Finally, this quarter, we intend to open a phase II multi dosing extension trial of <unk> in recurrent glioblastoma.
As you know if you follow the company Glioblastoma is notoriously difficult to cure and with current disease is the norm.
This extension trial will give us important information about the utility of multiple potential doses of 186 are now in the overall treatment paradigm for these patients.
If all of the trials to determine that.
50, feasibility and potential efficacy of using additional doses of R&D.
In patients following the initial single administration of <unk> now as we have done previously in the phase <unk> trial.
It's really important to our big Dream, one day, it's not carrying GBM turning it into a chronic disease in which we help patients with brain cancer.
Finally in Q1, we announced our license of a novel radio Embolic micro particle technology from the University of Texas.
As we've said many times, we believe the future cancer therapy as precise targeting of tumors with the most potent cancer, killing agents, while minimizing damage to normal tissues.
This transaction builds upon our existing millennium nano liposome technology and with this new technology, we can with a resorbable biomaterials embolic technology, coupled with a highly potent radiotherapeutic isotope.
Almost any solid organ tumor in the body using the standard intervention radiological needs and leverage the breadth of the human vascular system.
Rhenium 188, <unk> hundred 86, but rhenium 188, nanos pursuant biodegradable alginate microspheres.
188, Arnelle Bam or just banned for short is a next generation fully resorbable technology that solves many of the existing problems with current radio embolic technology, that's been out there for many decades.
The band Technology incorporates rhenium 188 isotope for use as the Radiotherapeutic source.
Okay.
Different admission criteria and characteristics than 186 in the mid to high energy beta particle, but with a half life of only about 17 hours per longer path lengths of over three millimeters. It also produces gammage gamma energy.
Again on energy that we can use for high quality real time imaging of the Bam construct in the Oregon.
The company will initially focus on developing the <unk> technology is the next generation radio embolization therapy for liver cancer, and which blocks the hepatic artery segments that supply blood to the board.
Tumor, while also providing radiotherapy by directly irradiating the tumor.
Liver cancer is a rare disease with an increasing annual incidents and a five year overall survival rate of only about 20%.
The global opportunity for localized embolization, chemo embolization radio amortization for primary and secondary cancer.
In the liver is about 1 billion three opportunity globally.
We have three objectives in 2022 for our band program.
The technology cancer phase, which has been completed.
And we are on track to complete key CMC feasibility studies.
Enabling preclinical studies and an FDA pre IMD meeting this year.
With that ill turn the call over to Dr. La France Norman. Thank you Mark following on Mark's comments, and 2022, and our GBM clinical development plan.
Extend the existing respect GBM.
Trial.
And program and two pronged development plan first and most importantly is the respect GBM phase III Registrational trial, using the cohort six recommended phase II dose that Mark mentioned earlier, the company and its key advisers believe the safety profile and the clinical efficacy efficacy signal.
Of a potential doubling of overall survival in patients with the absorb radiation doses greater than 100 Gray has the potential to be an approvable.
NDA for recurrent GBM.
Pending the outcome of our plans.
FDA meetings, our two planned FDA meetings, we will initiate the first sites for that Registrational trial by year end in the interim we will be executing executing our clinical operations plan.
To be ready to achieve this milestone.
It's a continuation of the phase II dose escalation trial supported by NCI for larger tumors and third is a phase two multi dose extension trial for patients previously treated in patients that will be treated in the two trials just mentioned.
In terms of GBM data presentations for <unk> 2022, we plan to provide key GB.
<unk> clinical updates at the following medical meetings the society of nuclear Medicine meeting.
It's Julian Vancouver, Snow as co sponsored clinical trials in brain Mets meeting in Toronto in August .
And as Martin.
Vienna in Paris, respectively. Both in September .
And potentially the A&M in Barcelona in October and a snow annual meeting in Tampa in November .
Additionally, I'll be participating at the metadata synthetic control arm focused industry Roundtable next week on April 26th.
Mark mentioned, our clinical team and investigators were very pleased with the first patient outcome and respect the Lf trial.
The first patient of any new condition with an investigational drug is always an exciting.
But with many unknowns a few comments.
Back from one of the very experienced investigators from the trial was that they had never seen such a clinical response and the first patient in the phase one first in man trial. The delivery of Iron eldest trial is very simple straightforward five minute outpatient procedures to an existing Omega reservoir.
Our substantial existing biomarkers, such as tumor cell count, which we are measuring CSF, which is simple to obtain and these patients are also a number of additional exploratory biomarkers, we are looking at as well.
Italy, plus will perform several several preclinical studies to evaluate additional.
Treatment paradigms with Arnelle.
With 186, Arnelle, specifically multi dose administrations in combination treatment with immunotherapy, such as PARP and checkpoint inhibitors, both known to be synergistic with radiation.
<unk> impressive initial results at the first dose with a single Arnelle monotherapy plus believes optimal patient benefit can be amplified with multiple.
Doses <unk> combination therapies for <unk>.
Current trial Im optimistic enrollment will proceed rapidly based on the significant unmet medical need very well tolerated and easy dose administration and the enthusiastic responses received from investigators and clinical sites along with other ill just wants to hear of our trial.
Developing preliminary clinical data and medical meeting presentations planned for <unk> in 2022 were presented a few minutes ago and finally.
<unk> is being developed for pediatric brain cancer, a key goal here is to obtain FDA approval.
On Chartwell in Chicago and are on track to hit. This milestone later this year next I will turn the floor to our CFO , Andrew Sanders, who will review financials over to you Andrew Thank you gentlemen, and good afternoon everyone.
Please refer to our press release issued earlier today for a summary of our financial results for the 2022 first quarter ended March 31 2022.
As of March 31, 2022, cash and cash equivalents were $21 2 million compared to $18 4 million as of December 31, 2021.
Represents 18% to 24 months of cash on hand.
Cash used in operations for the three months ended March 31, 2022 was $3 9 million compared to $2 million in the first quarter of 2021. The main changes between 2021 and 2022 as follows.
Total operating expenses for the first quarter 2020 to $3 9 million compared to total operating expenses of $2 5 million for the first quarter of 2021.
Approximately <unk> 7 million of this increase is due to research and development expenses and <unk> 6 million is due to legal intellectual property and professional fees in 2022.
Interest expense decreased from 247000 in the first quarter 2021 to 198000 in the first quarter of 2022. This decrease cost reflects the principal pay pay down the commenced in November 2021 on the Oxford debt.
Net loss for the first quarter of 2002 was $4 1 million.
<unk> 19 per share compared to a net loss of $2 seven or <unk> 33 per share for the first quarter of 2021.
And now I'll turn it back to Mark.
Great.
Thank you Andrew.
Before we move on to Q&A, Let me just summarize key milestones anticipated for 2022.
First with respect to the.
186, Arnelle GBM trial.
We're planning for a clinically focused FDA meeting mid year 2022 to propose a phase II Registrational clinical trial and trial design using the cohort 688, slash $22 three military dose as detailed earlier.
We expect to initiate the phase two.
At the end of the year.
We anticipate the CMC focused FDA meeting in the second quarter of 2022, perhaps the beginning of the third quarter.
And to clarify that's to resolve any open C&C CMC issues that may exist at that time.
Regarding drug availability very important that we have GMP drug availability to proceed with the trial, we are on track, but CMC activities for RTL.
We plan to complete those and have that GMP phase three ready drug supply available by mid 2022.
Also in 2022, we will report phase two data and enrollment.
Updates in an ongoing manner as Norman mentioned for the respect <unk> trial and our goal is to complete enrollment and at least initial two cohorts this year.
Regarding the pediatric brain tumor trial, we plan to get our IND submitted relatively soon this year and be able to initiate that trial towards the end of the year.
Regarding our recently acquired rights to the 188, Arnelle Bam real embolization therapy technology, we plan to complete key CMC and FDA IND, enabling studies and a pre R&D meeting also this year.
So at that point, I think we'll move to Q&A and I'll turn the call over to Gretchen stretching back to you.
Okay.
At this time, if you'd like to ask a question. Please pass the star and one on you touched on keypad. If at any point. Your question is answered you may remove yourself from the queue by pressing the pound key again, we do ask that you pose your question. Please pick up your headset handset to provide optimal sound quality.
Thank you. Our first question is coming from Ed Woo.
Your line is open.
Yeah. Thanks for taking my question I was wondering if you have a couple of meetings planned with the FDA. This year do you know if the timing has reverted back to normal post COVID-19 or do you see that there is still possible delays at this possibly.
Running a little bit longer than you expect.
Northern Virginia.
That's a great question.
We won't know until FDA gets back to us, but I'm anticipating that will probably follow their published guidance for these meetings meetings.
Horizon, the answer usually within three or four weeks and the meeting date by 75 days.
As you know they have the right to actually move those meeting dates up sooner than that.
Guidance is require them.
I am not anticipating those to be pushed out.
Further than than usual as they were.
Were occurring earlier in the pandemic.
Great. Thank you and then my last question is Youre correct Youre correct.
GBM trial is funded by the NIH do you anticipate trying to get additional funding for some of these other indications that you are working on.
Ed.
So.
One of the reasons we.
We're based in Texas, because they are opportunities too.
Texas specific.
LNG related grants as I know Youre aware.
That's called Secrets.
Yeah.
We've.
We've been very interested in obtaining funding for our various programs.
Unfortunately for the GBM program. They typically don't fund phase three trials, but they will fund.
Phase one to phase II, so that's definitely something that's of interest.
Where we are up at the plate with secret.
And continue will continue to be there to funding cycles a year.
And so we spend a lot of time trying to.
<unk> non dilutive ways.
Pain funding like secret. So we will continue to do that but our.
As per our previous plan, we won't talk about specific grant, we commend, but once we.
Once we.
And if we get something approved and funded we'll certainly talk about that once were notified.
Great well, thank you and I wish you guys. Good luck. Thank you.
Thank you.
And once again, if you do have a question you May press star one on your telephone keypad at this time.
We will take our next question from Sean Lee at H C <unk>.
<unk>.
This is Sean Lee from H C Wainwright.
Thanks for taking my questions.
My first one is on the <unk> study, it's great to hear that.
The first patient is doing well.
But.
Traditionally with chemotherapy.
Physical chemotherapy to treat.
And the issues that they face is that there is insufficient.
Insufficient penetration of drug into.
Larger solid tumors. So I was wondering is that something that you guys could potentially face with our now as well.
Hey, Hey, Sean Great question, so with Leptomeningeal disease.
One is what is linear and the other is modular the nodular tumors can be.
Few millimeters.
In Socal.
Whereas you have sort of more linear disease, which can be very soon but it is just on the aligning of the left them in <unk>.
So with that with that sort of as a background.
One of the things we're excited about with with our now is it does have some penetration characteristics is delivered within the CSS. It has a pathway.
And average pass link of about.
Two millimeters, but it can have passed links up to closer to four <unk>.
Millimeters. So you can actually get some penetration from nodular disease as well as hitting the linear disease.
So we think that this could have a better.
<unk> and chemotherapy because of some of the limitations of chemotherapy and some of the benefits of that.
Our radio therapeutic.
Yes.
Maybe solicit doctoral of France to see he is an expert in the CFC. If he has anything to add.
It's a great question and one of the unique characteristics of.
<unk>.
The study design and unfortunately.
Tragic disease complication of these patients is the.
Leptomeningeal metastases really spread along the leptomeningeal membrane throughout the subarachnoid space.
And Youre, absolutely right, whether you are a chemotherapy and even CSF administered chemotherapy systemically administered has the challenge of getting there. So you have youre spot on that observation.
And when administered interest equally.
It usually doesn't escapes the CSF very rapidly as you may know that turnover volume in the CSF.
Which has a volume of about 125 ml is five times a day. So you have something in there, but very quickly.
Exits out with that kind of circulation.
Think of it as the CSF physiology circulation physiology Dr.
Enel Liposome design.
It's administered very easily through the Armani is Sean.
Patient is not even aware of it we use a 27 gauge pediatric butterfly needle.
And a five minute administration time period.
They get a little band aid over which they don't really even need but a mandate over the administration side on your.
It's been over the EMEA.
And Thats, an outpatient procedure and we have seen as we predicted.
Not only is their excellent distribution that you heard mark describe the.
The duration of time that Mark also alluded to in his comments.
At the beginning of the call. We have objective evidence imaging evidence because of simultaneous gamma ray disintegration with the rhenium 186.
RTL product staying in the <unk> space for over a week, so given our half life basically the product stays there during its effective.
Energy.
The particle decay period.
And you get full benefit by three or four <unk>, the whole time, and you'll get to kind of the.
Full benefit of that product administration in hindsight Thats, probably why we saw this result and are at this very early at this first dose which is a very small dose six militaries and they get this kind of response.
I think as I mentioned, one of our experienced investigators.
He has never seen this before and that's where we were pleasantly surprised so thank you.
Thanks, Mark and thanks, Dr. Franz.
Very helpful.
My second question is that because youre using a slightly different.
Those deliveries will that place a limit on what kind of radiation dose you're able to deliver compared to their tdm studying.
Oh.
I appreciate that question because that's absolutely.
The benefit of the delivery and LLM makes it so easy.
So instead of having.
The amount that we will deliver is going to be part of our dose escalation trial and we'll find that out.
But I.
I guess, the Geely quicker to your question.
We will go next cohort double the dose we're doing the administered dose in the next quarter after that double that again, so by we hope by year end, we will have experienced at four times. The dose we're using now given the response, we saw on the first patient and given us some preclinical work, we're going to start on nation therapies.
Or multiple.
Multiple dosing therapies.
I don't think the amount of administered dose delivery will be an issue. So.
Youre absolutely right.
You're absolutely correct that we are delivering it differently that actually turned this into an outpatient therapeutic process as opposed to the required inpatient, albeit only a few days for the for.
For the <unk> delivery.
That's great to hear and certainly looking forward to the results later this year.
My final question is on the upcoming phase two GBM study so other than the CMC part.
You are waiting for the FDA meeting.
As well so what else does the company need to prepare before youre able to initiate that study.
So as we go.
Yes.
I know what youre actually surfaced.
So a big part of what we need to do Sean is the is.
As our work with metadata in terms of developing the synthetic control arm.
That's going to be an important part of the trial not only in <unk>.
<unk> enrollment.
The randomization scheme, making a more patient friendly, but also decreasing the cost so thats, we've already done the feasibility assessment with them.
We are we have a strong sense that it's feasible.
That will be developed here relatively soon and then a lot of that will go into.
Into the trial.
I think thats, what you mean other than that.
It's really just preparing the meeting package.
In the.
The protocol synopsis.
And the statistical analysis plan, and so forth and those all of those are in progress.
We have the benefit of the ongoing trial.
Sorry go ahead.
No that's good to hear and just wondering.
Follow up.
<unk>.
<unk> get a special protocol assessment with the FDA for the study.
It's possible I don't know that we need one honestly normal do you have any thoughts about that.
That's a great question and people always look through the SBA.
Given our synthetic control arm approach this.
This being a rare orphan disease, we already have fast track.
The potential for breakthrough therapy, certainly is there.
Hitting.
Special Protocol assessment.
Usually you have to go to the FDA and that could actually would probably add time.
So we're in very good shape to proceed.
About as rapidly as possible in drug development, given what we have given the preliminary efficacy signal given a very solid control arm that has already had precedent at FDA for being accepted in GBM in particular.
And SBA.
I think would be.
Kind of redundant and would require additional FDA meetings, and some interactions and negotiations we.
We believe by summer, we will have an agreement.
Third quarter and be able to have sites initiated by the year end Youre very correct that we have to interact with FDA first but we're doing it the fastest way possible.
I see thanks for that and that's all the questions about that.
Thanks, Sean.
Once again, if you do have a question you May press star one on your telephone keypad at this time.
Okay.
Okay.
And it appears we have no further questions at this time I will now turn the floor back over to Andrew.
Thanks Christian.
A question was email then on the GBM trial.
So the question is it sounds like Youre working towards a phase III Registrational trial in GBM towards the end of 2022, while details can you provide about the trial design, including patient numbers.
So.
The answer is.
Can't tell you anything definitively because we haven't talked to the FDA, but I can give you.
Give you some guidance as to how we're thinking about it and I think we've got a pretty reasonable level of confidence at this point that where we're pretty close everything is dependent of course on what the FDA says.
So in terms of number of patients as we've said before we think it's possible to.
We have a successful registrational trial with 100 patients I think we're going to be between 100 200 patients.
No more after we've talked to the FDA.
Primary endpoint will be overall survival I think thats thats clear and that is typical in GBM trials.
On randomization scheme.
Typically for rare disease, you might see a two to one randomization scheme Mark more typically a one to one randomization one of the benefits of the synthetic control arm.
Is that.
Randomization scheme, where it's like a three to two to one perhaps which has been done before were three patients get treated.
And two patients in the control group come from your synthetic control arm and then you actually randomized one patient too.
Youre likely your control arm. So three out of four patients end up getting treated which is very good for enrollment and good ethically for these patients.
So that would certainly.
That would certainly help cost and timing and so forth. So we're kind of hoping it's something more like that which is something that synthetic control arm can provide.
Got it under control perspective.
I think it's very likely we will go to comparison against <unk> preference, which is essentially a kitchen sink approach. That's what these patients because there's really no standard of care for those patients are an extreme situation.
And there aren't there aren't good options.
So from a budget perspective.
With a synthetic control arm and a lower trial size. We think this trial to be closer to $10 million, we've kind of been.
Previously guiding to maybe closer to $2000.
I would say $15 million is probably a pretty good number.
<unk>.
<unk>.
What else I think in terms of sites I think probably 10 sites.
It makes more sense, particularly on the lower end of that 100 or so patients that are in the trial.
And those really respond with what we know are.
World Class sites in terms of convection enhanced delivery, which is a key part of the.
The therapeutic design.
Finally.
In terms of timing.
Closer to 100 patients I think this trial could enroll with 10 sites maybe in 12 months, if we get a good running start.
Typically can take 18 months 12 months to 18 is reasonable depending on the outcome.
What the clinical benefit is so I think we're looking at kind of a 12 to 18 months follow up period. So we're looking at trials that last 24 months to 36 months hopefully closer to 24 months. So all that to say this is what we're what we're thinking of kind of giving you ranges, it's going to be dependent on what the FDA says.
Gretchen are there any other questions.
No further questions over the phone.
Thanks.
Thank you Gretchen and Andrew So just to close I want to say, thank you to everybody that joined us on the call and for those that are listening on the recorded version.
And on behalf of the board I'd, just like to thank once again, our employees and the other members of our team our consultants and so forth.
Physicians that we work with and of course, the patients that they trust us. Thank you very much for your participation and have a good evening.
Thank you. This does conclude today's conference call. Please disconnect. Your line at this time and have a wonderful day.
Okay.
Okay.