Q3 2022 INmune Bio Inc Earnings Call
[music].
Greetings and welcome to the immune bio third quarter 2022 earnings call.
At this time all participants have been placed on a listen only mode. A question and answer session will follow the formal presentation. If you would like to have an opportunity to ask questions. During today's event. Please press star one on your telephone keypad, if anyone should require operator assistance. Please press star zero on your telephone keypad as a reminder, this conference is.
Being recorded a transcript will follow within 24 hours of this conference call. At this time. It is my pleasure to introduce Mr. David Moss CFO isn't mean bio David. Thank you the floor is now yours.
Thank you Donna and good afternoon, everybody. We thank you for joining us for the call for immune <unk> third quarter 2022 financial result.
With me on the call this doctor RJ tests.
You have immune bile and Doctor are CJ Barnum head of neuroscience, who together will provide a business update on our dominant negative TNF platform for DN TNF for short.
Also on the call is Dr. Mark Lidell, Chief Scientific officer of immune bio who will provide an update on our memory like natural killer cell oncology platform.
Before we begin I remind everyone that except for statements of historical facts. The statements made by management and responses to questions. On this call conference call are forward looking statements under the Safe Harbor provision of the private Securities Litigation Reform Act of 1995. These.
These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements. Please see the forward looking statements disclaimers on our company's earnings press release as well as risk factors in the company's SEC filings, including our most recent quarterly filing with the SEC Theres no assurance of any specific outcome.
Undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made as the facts and circumstances underlying these forward looking statements may change.
Sept as required by law immune bio disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.
With the forward looking statements behind US now I'd like to turn the call over to Doctor RJ Tassie CEO of immune bile RJ.
Yes. Thank you David and today's call has organized a little bit differently, we have both mark with Dell and CJ Barnum on the call and I believe going forward.
You will see this larger cast on the calls because.
We are complicated company with a lot of programs going on and we believe that investors learn the most when they hear directly from the people that are responsible for those programs. So I will begin with X pro with some just topline comments and obviously the most important.
<unk> issue is the clinical hold that we are under the <unk>.
The FDA as we've stated previously the clinical hold was placed on X Pro 15, 95 due to manufacturing issues. These issues are technical in nature and they are related to the fact that manufacturing batches.
We're separated by many years and by geography, I E different manufacturing plants and this has caused some problems related to the manufacturing controls and release testing.
We have been working very closely with the FDA and our manufacturing teams to resolve these problems and we continue to look forward to clearing these hurdles.
Despite this delay we continue to make progress with the a D O two trial in mild Alzheimer's disease patients in Australia, and we are exploring other regulatory venues.
We will hopefully be able to open the trial and continue to enroll patients or begin to enroll patients.
X Pro program is like a coiled spring once the clinical hold is lifted.
We will.
To have both <unk> and mild a D and <unk>, three and mci or mild cognitive impairment enrolling in all regulatory.
Jurisdictions.
Soon after those two programs are enrolling we plan to launch the treatment resistant depression program in the U S.
Importantly, we will update guidance on the timing of top line Readouts in the Alzheimer's trials at the end of the year, obviously, the timing of those readouts depends on.
Our discussions with the FDA.
I will now pass it back to Doug for C. J Barden Barnum the VP of Neurosciences to speak about the Alzheimer phase two programs.
Thank you RJ.
Jay mentioned, we continue to enroll patients in Australia for the <unk> study.
<unk> is a blinded randomized placebo controlled study evaluating cognition in patients treated with EXPAREL for six months.
We are pleased to announce that the first patient has completed their six month phase III study.
Notably this patient has elected to enroll in our open label extension study. This open label extension is a 12 month study where safety and efficacy are evaluated in an unblinded fashion.
All patients that enroll in the open label extension study receive EXPAREL.
The open label extension has three purposes first it as a recruiting tool patients are offered a year of therapy after participation in the trial.
This helps in a product approval strategy.
The FDA and other regulatory authorities focussed on both efficacy and safety.
And label extension provides the expanded and extended safety database required for approval.
Finally, the open label extension provides long term efficacy data.
In the phase one trial MRI Biomarkers showed continuous improvement through 12 months.
While the data from the open label extension are not placebo controlled north blinded. They do provide additional information that will inform the clinical development strategy.
We expect to report data from the open label extension in 2023.
Finally, we remain as confident as ever that we have the right drug for the right target too.
Two recent developments reinforced this belief.
The first comes from the literature that continues to provide evidence for targeting TNF yet. Another nationwide study has reported that TNF inhibitors reduce the risk of dementia. There are now five epidemiological studies examining more than 16 million records.
Anti TNF therapies reduce the risk of AED, Android dementia by up to 75%.
The second comes from patients treated in the phase one study we have been extremely encouraged by their desire to remain on therapy. As a result of their persistence. We have opened a special access program in Australia like compassionate use in the United States as a result patients now have another avenue.
You get access to EXPAREL in Australia, and we have another means of collecting long term safety information now.
Now I'd like to pass the call back to RJ.
Thank you C J I'll now move to Inc.
Our natural killer cell priming program.
Mds AML program, a phase one clinical trial program in the U K continues.
To progress the.
The oncology landscape for cell therapies is mainly focused on liquid tumors. This is only 10% of cancers.
We have generated compelling human preclinical data in solid tumors that suggests that <unk> may be an ideal therapy for the treatment of solid tumors that is 90% of cancers or solid tumors.
Historically or even not even historically currently this group of cancers is not well served by cell therapies, We believe refocusing Inc.
<unk> solid tumors meets an unmet medical need with it with great potential.
I'll pass it to Dr. Mark with Dallas, Chief Scientific officer of immune vial to describe this in more detail Mark.
Thank you Jay and thank you everyone for joining today's call.
So a couple of weeks ago, we shared with the investment community.
<unk> positive efficacy data in multiple solid tumor cancer cell lines.
Jay just alluded to and as we highlighted in our recent press release on the topic solid tumors as Jay just said all the majority of human cancers and licensed cell therapies currently only focus on the on the 10% of Kansas, the hematologic cancers or liquid tumors.
The recent data we've obtained build on data we've had for some years.
To provide insights into why the company believes that didn't mean as natural killer cells or NK cells to life, a variety of immunosuppressive nature, and hypoxia and regulatory cells within the active tumor microenvironment or the field, who was the TMA for short.
So the interaction of the TMA with infiltrating immune cells and with the resident cancer cells trying to achieve a progression and it is thought to be the reason why most or many maybe all cell therapies are in.
Effective in that setting at the moment.
So these complex interactions have to be considered when designing cell therapies to treat solid tumors, where the Tam is hostile because one the presence.
Suppressive regulatory cells and to the low levels of oxygen, that's what we call hypoxia.
So we've been doing a lot of our experiments in the hypoxic setting in vitro to see how immune overcomes.
Overcomes that environment so.
Cell therapy has to overcome these.
These impairments to see to treat somebody Cumulus successfully.
So we've shown the immune converts patients normal resting NK cells into what are called memory like NK cells.
And that these targets solid tumors, even in the <unk> and the presence of immunosuppressive immuno regulatory cells and extreme hypoxia.
I've said, we see in the TMA.
And the company's preclinical data with human NK cells targeting cancer cells shows.
The NK cells from patients and from healthy donors designs NK resistance. So they choose from ovarian cancer breast cancer prostate cancer renal cell carcinoma, and most recently nasopharyngeal cancer cells.
So when comparing resting NK cells or NK.
A normal NK cells from healthy donors patients' peripheral blood before treatment.
The Indian prime cells demonstrated enhance ability to kill all of these resistant tumor cell lines.
I was fortunate enough to be invited to present these data at a recent conference the innate killer.
In Europe .
On October 19th and a video of that presentation is available on the company's website under the services therapies tab.
In videos or the company is our Youtube channel.
But in the field of cell and gene therapies. It is becoming increasingly apparent that regulate regulatory agencies such as the FDA require extensive understanding of the mechanism of action that these type of novel drugs before they'll consider licensing them for commercial supply so I'm guessing.
In the field to support a BLA.
Like all companies in the 17th or if you feel the heavily science driven and when a different in this.
Attempt to better understand the mechanism of action.
Now we are very lucky because the immune by the work of immune is based upon data getting back to the early two thousands and we've been focused on the mechanism of action since first publications in 2006 in our latest data from proteomics genomics and metabolic mix clearly explain how it works and they delineate that.
Differences between ink being primed NK cells, and NK cells Prime with cytokines used by our competitors. The recent video presentation explains some of these very complex data and I encourage you if youre interested to Kevin to go and watch them.
In parallel with increasing our knowledge about the mechanism of action, we continue to treat patients to expand our clinical trial activity.
<unk> patients have received the complete three dose regimen to stifle with complete safety and obviously the phase one trial setting.
Driving a.
Indeed, the most recent patient was treated on an outpatient basis, which is in our plan treatment scenario and then of course, it's a world away from the days of hospitalization associated with current adult T cell therapies.
As I said all patients treated so far have shown evidence of NK cell activation in vivo and we were analyzing the biomarker data to find those which best predict clinical outcome.
The first Mds patient treatment remains well 15 months post treatment and is enjoying much improved quality of life with only occasional hospital visits.
The second patient was a young lady with acute myeloid leukemia, which are transformed from Mds, obviously, the targeted disease, that's a trial.
And with bone marrow failure, it's actually received a third three allogeneic stem cell transplants and.
And that was eleonore failure.
Having been hospitalized for over six months due to her neutropenia offering community stabilized her blood counts and had neutrophil recovery such that she was allowed to discharge from hospital and get a months after after we treat it.
She experienced reduced pain, which is an indication of reduction in cumulative.
And we are scheduled for fourth allogeneic stem cell transplant, but suddenly she relapsed unexpectedly and died quickly.
This summer seven months after treatment with <unk>.
The third patient treated has chemo refractory.
M. L. After two failed stem cell transplants like a second patient. This is a very very severe unwell tasting tasting.
In his disease stabilized for four months before relapsing with a new leukemic claim.
I think the acute myeloid leukemia.
However, he says easiest currently control with low dose chemotherapy and he too is awaiting a transplant at the moment.
Our most recent patient is a young 17 year old Mds patient another one who relapsed with acute myeloid leukemia back in 2020 after an unrelated transplant and again she relapsed after second unrelated transplants in 2022.
Content besides enough how severe these patients cells.
To some extent the chemotherapy she achieved remission and was treated compassionately with immune as consolidation therapy in July this year.
She showed evidence of improved NK cell function and she remains well.
With very low level of detectable disease and have any merit.
And waiting.
The treatment.
So it was very early in the development of <unk>.
Restricted to using the lowest dose of the drug. So what are these patients have received the lowest dose tend to eight cells the chief.
<unk> Chief investigator, who looks after the trial and is treated all four patients said recently.
All enjoying improvement in general fitness with resolution of fetus stabilized or even improved blood counts and we were able to give breaks from the low dose chemotherapy they've been receiving.
Definitely improvement in subjective parameters of wellbeing mood appetite and indeed clinical performance status.
So that encourages us greatly and Furthermore, the trial has now been selected for presentation at the American Society of Hematology Annual conference.
New Orleans in a few weeks' time in December .
Finally, we've received approval to widen the trial inclusion criteria to allow patients like the three compassionate cases to be enrolled in the trial in the future.
Moreover, the second UK trial site is scheduled for initiation on the ninth of November after an 18 months today.
Third UK trial site is in discussion at present and I'm doing a presentation that this Friday.
The company has also submitted an application to the Greek medicines agency to open the trial with colleagues of mine Athens to speed up recruitment for them.
Okay.
In preparation for the increased recruitment into the lower trial in Mds and the ongoing trials in solid tumor indication opening new trials in solid tumor indications the company's invested enough scaling the manufacturing process and the validation of that new process to cgmp is now complete and we're ready for the next manufacturing runs before the end of the year.
The combination of the basic research into the mechanism of action the manufacturing improvements in the clinical trial operations, but the company in an excellent position for capitalization.
New products in 2023.
I'll now pass the call back to okay.
Yeah.
Thank you Mark.
As we passed as we enter the last couple of months of the year. The company's events calendars turns towards oncology. Many forget that we actually have an oncology program with X pro with the DN TNF program and in fact, our first phase one clinical trial.
Was in patients with advanced solid tumors.
We will have presentations at three oncology meetings in the next two months city, which is the site society for immunotherapy of cancer.
As American Society of Hematology, and the San Antonio breast cancer Symposium all occur in the last five weeks of the year.
Mark has already mentioned the ash presentation, the subsea in San Antonio breast cancer Symposium presentations on the use of DN TNF to reduce resistance of immunotherapy and mark for expressing tumors.
Particularly the San Antonio breast cancer Symposium data will include combination therapy with an ADC in her two positive breast cancer.
Her two positive breast cancer has been in the news a lot. It is a large market that has doubled in size recently, but still more than half of the patients develop resistant disease, even after therapy with the very best medicines available today.
More details on each of these presentations will be provided as we get closer to each event. We will also as you might expect b ascending attending <unk>, which is a clinical trials in Alzheimer's disease.
At the end of the month.
At this point I'd like to turn the call over to David Moss, Our CFO to review certain financial items David.
Thank you RJ I'll provide a brief overview of our financial results and upcoming milestones before we head to our Q&A session.
Net loss attributable to common stockholders for the quarter ended September 32022 was approximately $7 7 million compared with approximately $9 5 million for the comparable period in 2021.
Research and development expense totaled approximately $5 2 million for the quarter ended September 32022, compared with approximately $6 5 million for the comparable period in 'twenty one.
General and admin expense general and administrative expense was approximately $2 4 million for the quarter ended September 30th 22, compared to $2 5 million for the comparable period in 'twenty one.
As of September 32022, the company had cash and cash equivalents of approximately $57 4 million.
Based on our current operating plan, we believe we have cash sufficient to fund our operations through 2023.
As of November <unk> 2022.
The company had approximately $17 9 million shares of common stock outstanding the same number we've had the last two quarters.
I'd like to further point out that because our burn has been less than budgeted because of the delays and starting the trials in the U S. Further because of the increased activity in Australia and the rise of the U S dollar or Alternatively, the fall of the Australian dollar. This has helped lowered our anticipated budgeted cost of the trial.
Overall.
Further we've as we've been doing in the past we're eligible for rebates in Australia, which return cash that we reinvest into our clinical programs together. These developments help us manage our runway more efficiently.
Now I'd like to move on enlist our upcoming milestones.
Although our phase II <unk> trial for treatment of neuro inflammation has it caused all timers disease is currently on hold pending the FDA manufacturing review, we expect to continue enrolling patients over the coming months with attention to Australia in order to reach the enrollment target of 201.
Topline results for the six month program remains tentatively expected in late 'twenty three but if the whole continues much longer the state will slip into 'twenty four we will provide an update on timelines at the end of the year.
Upon pending resolution of the FDA inquiry, we remain on path to initiate the three months 90 patient phase III program for mild cognitive impairment.
Any unexpected delays, we anticipate having top right results late 'twenty three and again if the FDA hold continues this will slip into 'twenty four.
Additionally, it remains our plan to initiate phase II trials of <unk> in patients with treatment resistant depression, that's partially funded by a $2 9 million NIH grant upon resolution of the FDA manufacturing review.
Additional open label Phase one data of <unk> in high risk Mds AML in the first in the first half of 'twenty three along with the initiation of more sites in the U K and potentially Greece as Mark Lidell had mentioned earlier.
Finally, we plan to launch a second <unk> study in a solid tumor indication, which we announce upon approval with the FDA we.
We expect this to occur occur in the first half of 2023.
At this point I'd like to thank you for your time and attention I'd like to turn it back to the operator to poll for questions Donna.
Thank you ladies and gentlemen, the floor is now open for questions. If you would like to register a question. Please press star one on your telephone keypad at this time.
Formation tone will indicate your line is in the question queue. You May Press Star two if people think sure whats your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
Again that is star one to register a question at this time one moment, please while we poll for questions.
Thank you. Our first question today is going to be coming from Tom Shrader of <unk>. Please go ahead.
Good afternoon.
Be frustrating the hold.
I just have a.
Question at some point do you have to worry you have too many patients from Australia could you and presumably you want some fraction of U S patients any.
Any risk of having to stop enrolling in Australia.
Yes, Thanks, I'll take the C J.
No I do not believe that will be a risk for really two reasons.
The first is that.
We anticipate having other other venues in place.
Bob.
In the near future, but more importantly, remember this is a phase two trial.
I do not although.
Remember after Biogen got added Cana Mab.
Approved I actually speculated that we might be able to get approval after a phase two.
No longer believe that after all of the brouhaha over the anti amyloid drugs, we will have to do a phase III trial, hopefully, we only have to do one.
It will be an international trial that include both Europe , and the United States and undoubtedly Japan. So that's.
Reasonable question, but I do not worry at all I think just as an aside one of the things that the FDA is focused on.
Increasing the diversity and clinical trials and that's an issue that we are focused on and obviously the best place to get diversity as in the United States not in Australia.
And then I have a question kind of what are the surprises I thought in the <unk> readout is how good the CVR sum of boxes did after so many people have talked about alternate endpoints does that change your thinking at all you're one of the company's most focused on better endpoints, but it.
Do you think CVR summer box, there should be a co primary or because it seems to have worked very well and the only trial that has really worked very well.
C J, yes.
Yes, I can take this thanks.
Thanks, Tom.
So you may recall, the CVR is a secondary endpoint and we actually powered the study to see an effect on the CVR. So.
So to your point, we were not going to try to reinvent the wheel. We don't have to we think there are better cognitive endpoints for this group, but the combination of cognitive and functional <unk> still.
Performs fairly well and it has performed fairly well. So I think the jury is still out the phase II study as Archie mentioned is not not a registration study and.
And we have enough patients again, it's powered towards that to know exactly how to do the phase III study. So I think we're in a really good position.
Okay. Thanks.
Thank you. The next question is coming from my uncle <unk> of B Riley Securities. Please go ahead.
Hey, Deane.
Thanks for taking our question.
Just on the Australia, all phase III study cohort did you say how many patients do you have any data in.
And then.
These <unk> data set.
Okay.
Advanced like what what component of the data I know youre looking at a number of biomarker data and safety data.
As you get into the open label its action.
Do you get unblinded due I'm just curious if you can give.
Yes.
Yes, So let me let me clarify a couple of things remember the phase II portion of the trial.
Is blinded randomized right. So there is no read out before all patients get six months and what we've been promising as topline data by the end of 2023 that may slip if the FDA hold continues much longer.
The open label extension that CJ mentioned, what happens is patients who were on when.
When they get unblinded our on.
X Pro continue if they want to for up to 18 months and patients who were on placebo.
Actually I guess, the technical term might be get crossed over to X pro if they want to for up to 12 months of therapy and in those patients. That's the open label portion so.
But it's a totally different clinical trial, even has different study remember study number C. J I'll, let you comment on what kind of.
Information will be available for the patients who are in the open label extension that we'll be talking about.
Thanks, RJ, so Mike I think.
To point out is that the endpoints are similar in terms of the clinical and the Biomarkers will be doing MRI collecting blood and that sort of thing.
Okay.
It'll be how are we going to look at the data I think the.
The most important thing as it relates to clinical data I am not a big fan of.
Open label trial.
Cognitive data.
It doesn't really tell me anything if patients know they're on the drug we absolutely know that.
There is a placebo effect. So that's of limited value in my opinion, but the biomarker data will be interesting we know what it looks like in the phase one study.
Part of what we'll want to see assuming that the open label extension data is available before close of the.
The phase II blinded study is that the Biomarkers are performing the same way are we continuing to see an improvement in the metrics that are important to us and white matter in particular and some of these other things that we're looking at we've got a nice Mark we've got a more homogenous group here and I think thats really going to help us in the expectations that we will see a difference I think we are.
It is going to get interesting is in the patients that come into the study from being an ex pro versus those that come in from not being an ex pro to see if there is a difference in their trajectory I don't know what the answer is and of course, we're not going to know by the time, the enrollment study whether or not they have been.
Active drug or placebo, but that data will be of value as I mentioned as it relates to clinical development and how we think about it moving forward in terms of duration and number of patients that will all get put into the bucket.
So.
Primarily it's not I'm talking about efficacy, but it really is about safety.
And to build off that database of safety and long term safety that we will absolutely need to or we can get approval does that answer your question.
Yes. Thank you for all that detail did you say how many are about in the.
Bobby.
Bob.
So we have said that we are going to update enrollment numbers at the halfway mark and.
And we will we're still planning to do that so stay tuned.
Got it and then just quickly dropping question on manufacturing.
What sort of growth.
Regulation, but it looks small on those would be the agency responding to Amazon.
Loan volumes mob idea information useful.
Yeah.
Okay.
And how do these discussion.
You may begin.
And also overall, yeah, and if you're able to comment on the shelf label.
The volume of those.
Yeah, yellow getting warmed up for the program.
Yes, so two things first of all these these are the communication is very inefficient. It is it goes on somewhere about a 60 day 45 to 60 day turnaround and Thats just the nature of the Beast.
We have been campaigning very hard to get a face to face or a video conference with them because we believe that will be a more efficient process. We think we.
We're almost there I hope.
The.
There is no concern about.
Running out of drug or drug going out of date not only has the current drug.
Still well within date, but we have we actually manufactured a subsequent batch.
As part of the original campaign that has additional dating so.
There is no concern that we're going to run out of drug.
There is just this continued frustration over a couple of these assays that are.
It didn't exist the first go round with the when the drug was manufactured in the past then is now causing us some conversations with the FDA as David always says we will get through the through this this is not a <unk>.
Safety issue. This is a manufacturing technical issue. It's just an inefficient process that the FDA has in place and we're <unk>.
Trapped by it.
Understood and I am sure you were.
We'll get to them.
And then just quickly for a doctor today.
On the.
Open label or high risk Mds and AML.
Update that you'll look to.
Duane I need three.
And I think the.
What I heard from you was about three patients.
Data you presented a slide what I guess.
You want to want to see in <unk> to sort of make make that determination.
The right patient population you want to be helpful. And can you can you just give color on what we may learn.
And that was maybe.
I'm going to read out.
Yes, I think we have to remember this is a phase one trial in cancer, where from a regulatory perspective, we expected to.
So to design a trial to show safety or to test safety notes test efficacy. So this is one of the big balancing acts that all biotech companies have how do you choose your patient population. So as we've always said and we continue to believe we will use this trial.
The Mds trial to get safety data and to build on our biomarker data to try to identify which changes we see in patients are associated with any clinical benefit we find and thats going to pay out rollout throughout the trial recruitment and as I said, we're putting in place ways to speed up the trial recruitment but.
What we have.
In parallel focusing on it.
Very very constructive dialog with the FDA over I'll move towards solid tumor and.
That's allowing us to put together the IMD for the solid tumor work.
So we will have the R&D submitted to the FDA.
In January on the data we've obtained already from our full of patients treated lateral trial make that possible. So we could never have gone to the FDA for a trial in.
Sorry, Cuba without those data so that they have already paid off in just for patients. Obviously, we intend to get more out of it with time, but time schedule for the solid tumor pivot is to have the IND filed as soon as January .
We would have to be ready for Christmas, but we'll delay it because people are dropping on the fda's desk in the Christmas in my past experience.
Isn't good news so we will.
I'll turn round 90 submission and really quite record time with.
The aim to enroll our first patient in the solid tumor trial in the U S and have our first.
In the U S by the end of Q2 will vary.
In Q3 next year and that's what.
Excites me enormously at the moment.
But as.
As you've either client we will be following up the mds patients as we enroll them and increasingly using those data I have to say.
Yes.
Trial is perspective, and a drug development perspective, I'm very disappointed that we haven't enrolled more patients in the Mds trial on the plus side had the patients will be enrolled in the trial, we wouldn't have been able to present at the American Society hematology, because youre not allowed to present in trial data.
That conference. So the fact, we've got.
Compassionate use patients to present does give us the opportunity to share those data.
With hematologists around the world in December So I hope that answered your question.
Yes on the quality and yield could be announced in the coming weeks. Okay. Thanks for taking my question.
Thank you once again Thats star one to register any questions. At this time. The next question is coming from Daniel Carlson of tailwind Research. Please go ahead.
Hey, guys. Thanks for taking my question.
Yeah.
C J just regarding the special access scheme it sounds like.
It sounds like things are being well received in Australia in terms of the patients there and I'm wondering what you see.
Get out of this in terms of data.
No.
Can you give us any feeling.
Feedback on how the patients have done since being off drug and we would expect to go with this.
Thanks, Dan I think you cut out a little bit, but I think I got the gist of it.
So I think the reason we bring it up is theres two reasons one is.
It really does reinforce what we believe the drug is going to do to have the.
The few patients that really we're in the phase one study that received what we consider an efficacious dose.
For all intents and purposes demand continued access to the drug I think speaks very well.
As it relates to what we can get out of it.
Not much we can without putting together a full clinical protocol and going through all the regulatory hurdles and.
And that's and that's quite a that's.
Pretty big expense for sort of anecdotal data.
What we what we can get as we can we do get information from the clinician as it relates to safety and we do get a commentary here and theyre now whether or not that.
We can we can share those we haven't really discussed that in detail.
But I would say the longer the patients remain on the drug.
Sure.
The.
I think it's safe to assume that they are seeing some benefit from it and again we get.
Ability to to build our safety database.
And provide access to patients that maybe don't fit in one of our current trials. So these are things that we're looking at and I think I'll point to the same thing which is that we're on the right track here RJ.
Yes, I'd just like to add Thats, an interesting question, Dan and remember with my clinical background I kind of look at this from two sides here, but what I find intriguing that I haven't seen in like oncology or even transplant trials is the clinical teams are very adamant that the patients not be taken off drug.
They're kind of position is look if the patient is doing well I don't care that it's the end of your clinical trial I don't want to have to take the patient off the drug. So you figure out how to make this happen and we're fine with that at the end of the day, it's all about treating patients and if the patients in the clinical teams think they're getting a benefit where.
Thrilled and CJ has put in.
All of the mechanisms or is in the process of putting in the mechanisms so patients aren't removed.
From the product.
If they seem to be having a benefit.
Got you.
And then also just with regard to the FDA I'm curious with the trial running in Australia, and you having patients on drug for over six months now does that factor into their thinking where it's easy for them to say no, but not if it's working elsewhere in terms of the safety right.
Well as you can imagine we've told them about these patients and I think they.
They listen.
I think it will take.
Sure how to do that uhm without causing a big problem with the trial is R. J said I think we're we've got other avenues to take that can deal with the issue.
Yeah that makes sense and then one last question I'm just wondering if the tumor what what is the target cancer, it's going to be for this.
I'd like to be able to tell you that they're going to save that until we <unk>.
It's a tumor that that's a big issue globally uncertainty has a very large unmet needs in the United States, which is why we've got such a large number of clinicians in the states who want to to run the <unk> want want to walk on the trial with this thing uhm once it's another reasonable I'm I'm so excited because it's.
First off <unk> in a large patient population with a very significant unmet need.
Yeah, I'm not trying to be a <unk>, we're not trying to be evasive here, Dan It's just that.
We are sensitive to making sure that when we give them make promises they are very accurate.
So you know, we're being a little more cautious than we have in the past about providing news and I'd rather in some ways to provide stale news then you know progressiveness so to speak.
Yeah. That's that's fine that's good to hear that your partners are excited about it and hopefully enrollment will be will be a lot faster than the U S. Thank you guys for taking my questions I appreciate the good work.
Thank you at this time I'd like to turn the floor back over to Doctor tested for closing comment.
So I think this new format, where we have [laughter] you know you've literally got a third of the company here speaking on the phone, but what we've brought to the quarterly call was really the real expertise in the company within each individual therapeutics.
<unk> and function I've thought it went well please let US know if you think it did not go well or is not appropriate but I think this is going to be more of our standard for the future.
So anyway I really appreciate your your your participation immune bio's of complicated company, we have many promising programs. They are both biologically.
<unk> an interesting despite the frustration.
Frustration with the F. D. A we are making progress in both C. N S in oncology and I can promise you that we will continue to move forward and we will will.
And are making a difference in patients lives so with that <unk>.
Thank you very much and have a nice evening.
Ladies and gentlemen, thank you for your participation. This concludes today's event you may disconnect your lines or block off the webcast at this time and enjoy the rest of your day.
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