Q2 2022 INmune Bio Inc Earnings Call
[music].
Greetings and welcome to the immune bio second quarter 2022 earnings call.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. 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's my pleasure to introduce Mr. David Moss co founder and Chief Financial Officer of immune bio David the floor is yours.
Thank you Doug and good afternoon, everybody. We thank you for joining us for the call for immune <unk> second quarter 2022 financial results with me on the call is Dr. <unk> <unk> CEO and co founder of IMMU buyout, who will provide a business update on our DN TNF platform <unk>.
And Dr. Mark <unk>, Chief Scientific Officer, and co founder who will provide.
Provide an update on our NK cell priming 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 conference call are forward looking statements under the Safe Harbor provisions of the private Securities Securities Litigation Reform Act of $19 95.
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 disclaimer on the company's earnings press release as well as the risk factors in the Companys SEC filings, including our most recent quarterly filing with the SEC.
There is no assurance of any specific.
Undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made at the facts and circumstances underlying these forward looking statements may change.
Except as required by law in new bio disclaims any obligation to update we'll update these forward looking statements to reflect future information events or circumstances.
Now I'd like to turn the call over to Dr. RJ <unk> co founder and CEO of EMEA.
Ed.
Thank you David Thank you everyone for joining the call.
As usual I'll arrange my remarks to highlight the key takeaways for the first quarter and subsequent period and provide updates on our platform programs.
Ill review development of development of the next Pro then hand, the call to Mark Labelle. Meanwhile.
CSO, who will speak about recent developments at <unk> before David discusses financial results upcoming milestones and we move to Q&A.
You are all aware that we received a clinical hold letter from the FDA.
Clinical hold relates to manufacturing issues, the new Expo was manufactured by <unk> at their Boulder facility.
A different manufacturing sites than the previous ex pro batches.
Triple Challenge of the New company manufacturing, our first in class therapy at a new manufacturing site all contribute to the Fda's caution.
We are working with the FDA to answer there CMC questions.
Youre not willing yet to give a timeline to resolving this hold at this point, we have not changed our timelines for reporting top line results on Mci and mildly <unk> trials.
This decision is being continuously evaluated.
The whole purpose, if the whole persist for longer than anticipated it will affect the timing of the topline data readout.
X pro for the treatment of <unk>.
<unk> is our flagship program phase.
A phase II program in patients with mild Adi is enrolling patients in Australia.
I remind you that Adi is capital a capital B small lie.
Is 80, Alzheimer's disease caused by neuro inflammation.
<unk> targets neuro inflammation inflammation, we use enrichment criteria to enroll patients who have neuro inflammation driving their dementia. We believe this is one of the reasons that we learned so much from our phase one trial.
I have confidence in the outcome of our phase II trial.
This simple strategy allows us to design smaller shorter trials.
And we believe in the U S. This still allows us to have a market target.
40% of patients with mild Alzheimer's disease, there may be more but we believe at least 40% Amit our enrollment criteria.
We will initiate the phase III Mci trial once we resolve the clinical hold.
To our knowledge, we are the only company that is separated the development of therapies development.
Our strategies for the treatment of mild Alzheimer's disease and Mci.
Most trials treat.
Something they called early.
Which is an artificial construct or combination of mild Alzheimer's disease, plus Mci. We believe two trials was more informative and less risky.
While on the topic of how immune vials 80 programs differ from others.
I'll remind you we're using <unk> as the primary cognitive endpoints.
Mac early Alzheimer's disease, Mci cognitive composite has a validated scale designed to detect cognitive CIT and changes in patients with mild <unk>.
Our Mci the sensitive instrument is purpose built for these patients.
We are doing this call from San Diego, while attending AIC.
Congress Association International Conference, which is the largest Alzheimer's disease conference in the World.
The world of AED drug development is changing rapidly and <unk> is leading the change of innovation and Alzheimer's disease. At this meeting we are witnessing a drift away from targeting amyloid and tau towards other therapeutic strategies and I am happy to say that neuro inflammation and <unk>.
<unk> are frequent topic.
The use of Biomarkers, such as those used in our phase one trial and deployed in our innovative phase two programs are gaining acceptance and seeing broader use.
There is no question that the use of Biomarkers will improve our ability both at immune vial by the field that large to bring novel therapies to patients with Alzheimer's disease faster and with less risk.
X Pro has uses beyond the treatment of <unk>.
We'll start a phase II trial in patients with the treatment with treatment resistant depression soon after the eight mile.
<unk> and Mci trials are underway in the U S.
We're performing IND, enabling preclinical studies in ALS.
All of our CNS programs have received support in the form of non dilutive funding from the Alzheimer's Association the National Institute of mental health.
ALS Foundation, respectively.
Common denominator of the CNS indications as destructive neuro inflammation caused by immune dysfunction.
In our opinion neuroma formation drives the core pathology of synaptic dysfunction and <unk>.
<unk> cell death that is a requirement of cognitive loss.
Our successful phase one program showed that X pro safely decreases neuro inflammation improve synaptic function decreases nerve cell death and promotes remodel nation.
And the patients with mildly.
We saw a positive clinical response.
Immune viral believes that the synaptic connections can be stored degenerating axons can be made healthy and re myelinated when a patient when the brain's immune system is normal normalized and controlled by X problem.
The phase III studies are designed to answer these questions.
Okay.
The clinical hold.
We will delay the initiation is initiation of the phase II trial in X growth for treatment resistant depression.
The NIMH gave us a $2 9 million grant and the <unk>.
Trial design is consistent with our CNS drug development philosophy, we will enroll patients with peripheral biomarkers of inflammation, including elevated CRP dysfunctional MRI neuroimaging biomarker to evaluate the activity of a pathway in the brain towed to both tied to both depression and inflammation. This is.
Six week double blind.
<unk> controlled study it is unique to <unk>.
Primary outcome measures are functional activity measured by MRI.
But we will also be measuring other biomarkers and clinical outcomes.
Yes.
Finally on the preclinical front with X pro during the second quarter as a percentage of preclinical data demonstrating that <unk> promotes re myelination at the junction of the white and gray matter in animals with multiple sclerosis. This work was presented at the third European conference in neuro inflammation and provides mechanism.
Kenneth stick insight into the re myelination, we saw in patients in.
Adi trial.
Finally as we.
We consider intermune, our proprietary NK, killing cell priming platform, a novel suite of time of buying.
To NK cells induces many of the same effects in NK cells.
Others achieved with a complex cocktail of cytokines based on new data. These statement understates the power of income into alter NK cell function.
Patients with cancer.
Transforms resting NK cells into cancer, killing memory like NK cells in the patient to make these cancer, killing and memory like NK cells with cytokines, you need a complex cytokine triplet of IL 12, 15, and 18. These cytokines complicate both manufacturing and the care.
<unk> of <unk>.
Answer patients because of cost.
<unk> target side effects common to many cytokine treatments.
In contrast, cytokine prime to NK cells.
And can only activates NK cells as well tolerated without any kind of medication and in fact can be given as an outpatient.
The ml memory like NK cells present in <unk>.
The improvement may be better at killing cancer cells and the TMA.
The tumor microenvironment of solid tumors, the increase fitness to link noon pronged NK cells is due to an upregulation of mitochondrial proteins I'll.
I'll remind you that mitochondria are the engines of the sell in are essential for NK survival and we believe this increased fitness may be the cause of the extended therapeutic persistence.
Inc of memory like NK cells and treated patients.
Mark with Dell will provide more details on the patients in a moment, but to our knowledge and commune priming is the only in Q.
NK therapy reporting improved functional mitochondrial function and therapeutic persistent for Alaska lasting more than 100 days.
These observation combined with the data presented on the ability of them.
I mean, the primary NK cells.
That thrive and the conditions of the tumor microenvironment, including hypoxia has driven our strategy to pivot our development program towards solid tumors.
I've said enough for now I'm going to turn it over to Mark with Dell, Chief Scientific Officer, and Kim in Mark.
Thank you Ajay can everyone hear me.
For me lately.
Yes, you're fine Mark.
Thank you well thank you all for joining the call.
As RJ said I'm going to update the current status.
The development program.
You need a refresher our initial in human trial.
In place of a single center in the UK.
It's enrolling patients with literally a bone marrow disease called Myelodysplastic syndrome MTS.
More recently with the.
The most severe disease called acute myelogenous leukemia or AML.
And at this point as of today, we've treated four patients each patients received three doses of including in fact, taking full.
<unk> received.
With me today.
And we are monitoring their response and ask the question.
Patients are actually very different from their disease perspectives. The first patient is an mds patient.
Enrolled in the trial and responded very well remains alive and well more than 14 months from the date of this first treatments last year.
No side effects to any of the three doses that he received trading.
<unk> increased NK cell activation from generation of Jay described memory like NK cells. After both the first second and third doses.
Memory like NK cells for maintenance peripheral blood for over 100 days after his last infusion.
We found out about it.
Alcohol and very encouraging.
He is a 78 roadmap at the time that the treatment and he had severe mds in other words, all three lineages all of his blood.
Production, we're in pad he had low neutrophils red.
Red cells, and you have low platelets.
Platelets.
Yes.
And a very poor quality of life regular hospital admissions to receive blood transfusions to cope with this.
So a lot of questions and keeping Clayton installations.
Most after completing statement as disease burden is reduced somewhat but more importantly, it's quality of life has improved dramatically. Thanks return to playing badminton with his friends in a longer needs frequent transfusions doesn't.
It doesn't require a platelet transfusions at all.
Clinical stages as reflected in a decrease in what we call the <unk> status.
Which is severely impaired theory, which is what you and I.
What's cool.
A second patient actually he was he got Lady <unk> with relapsed acute myeloid leukemia, okay relapsed after allogeneic transplant from non related so Cyrus yellow.
Hey, Mara was complete dysfunctional and had been hospitalized for six months due to inadequate blood neutrophils, which are the sales.
Bacterial sepsis.
You had a single dose of $300 million.
Followed by two doses.
12 days of $100 million.
Last week, the first patient she immediately show the presence of memory like NK cells for each infusion and east assisted with over 60% of the NK cells in her bone marrow at 140 days being activated memory like NK cells.
Within one month of completing a treatment.
One day treatment of course within one month of neutrophil counts improved significantly and sufficient neighborhood to be discharged home for the first time in seven months.
You've spoken with James since you went through mixed starting to climb Arizona to fulfilling the Congress.
But put that in simpler terms donor stem cell graft initially did not fully established itself.
After the immune therapy.
Got it.
I.
Think solvable with routine chemotherapy and seven months after completing treatment. He remained alive and with confirmed disease and was awaiting Singapore getting there for a second transplant.
That would be a few weeks ago I had some recognition that her disease relapse rapidly since he died.
Longer response responsive to chemotherapy, but.
What we were delighted to hear from her treating physician wasn't quite can be definitely improved posting menus. This game for a good quality of life. That's an outpatient something we did not achieve with chemotherapy.
And I think that really does point the aim of this trial program.
Quality of life to get people home.
Ultimately to that disease.
Third patients followed very shortly after the second cycle as a young man who was 1980 is now also hubs.
Relapsed leukemia, but he's actually had to failed stem cell transplants. So it was even higher risk than they already had a very high level of disease, including pain.
Plain old town.
And then it's unresponsive to chemotherapy.
As seen with the two previous patients who showed no side effects were sponsoring and treatment and we saw significant observation his blood NK cells after each infusion.
However, these never develop the memory like phenotype that we'd seen in the other two patients and Thats. One therefore much predicted he didn't show any evidence of clinical improvement.
We're seeing that and it came for the.
Chemotherapy remains alive with control disease.
I think two weeks ago, we treat that fourth patients. Another really see originally laid out I think this is.
The story that you will be aware of with other.
Early stage drug development capital you end up treating really extremely ill patients until you Franklin the efficacy of your drug.
So this is again another young lady with refractory acute myeloid leukemia.
She's more received all three doses.
The third one was today in fact today she received outpatient.
I think <unk> convinced that.
The infusions are safe and once again showing no side effects.
We are waiting the lab test results to see if she has responded.
But she is again another patient with a high level of disease.
We don't expect to see character yourselves the week, we hope to see an improvement.
During the quarter, we received muscle registration by the United Kingdom National Institute for Medical Research.
<unk> Mds trial and.
That means that it's promoted in the UK to rational hematologic oncologists at all UK hospitals and allows them to submit patients to be enrolled in the trial at the single trial Central interesting University Hospital in South Hampton.
Additionally, we are pleased to report that the company will be expanding <unk> Mds AML trial into the U S. The.
The European Union with submission underway for two trial the trial into hospitals.
With whom we're working very closely.
The company will provide an update along with data levels patients' response to remain in the future.
<unk>.
And then future corporate.
Platform updates.
In our previous call, we announced we were about the submission applications to U K Mexican regulator.
Charlie to open a second thought I think.
Berrien cancer.
This was submitted.
And was approved what was not been acted on by the hospital due to the moratorium on new phase one trials in cancer in the U K because of the backlog of cancer treatment post Covid lockdown.
We're fully committed to expanding the program into solid tumors.
While in discussion with relevant key opinion leaders, we will provide more guidance on the solid tumor escape once we've completed discussions with the FDA.
I will now pass the call back to Roger Thank you very much.
Thank you Mark.
Press release earlier this week regarding upcoming events.
We'll be attending the <unk> conference and participating in a panel to discuss the role of <unk>.
Targeting neuro inflammation.
Precursor to Alzheimer's disease as an aside I have to say that members of the company.
Involved in the Alzheimer's program are increasingly being queried by both the.
The business press in the lay press about.
The importance of.
This strategy for treating Alzheimer's disease, so not only is it.
Gaining traction at the.
Antefix and medical level, what's gaining traction at the business and public level were all quite pleased about that.
The <unk> meeting in New York is open to shareholders and if any of our existing or prospective shareholders are able to attend the event.
Certainly plan to meet with you there.
At this point I'll turn it over to David Martin our CFO on the calendar 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 into our Q&A session.
Net loss attributable to common stockholders for the quarter ended June 32022 was approximately $6 8 million compared to approximately $6 7 million for the.
For the period ended in 2021.
Research and development expenses totaled $4 2 million for the quarter ended June 32022, compared to approximately $4 5 million for the comparable period in 2021.
General and administrative expenses was approximately $2 2 million for the quarter ended June 32022, compared to $2 1 million for the comparable period in 2021.
Other expenses were approximately <unk> 5 million.
<unk> 5 million for the quarter ended June 32022, compared to 0.1 million for the comparable period in 2021.
At June 32022, the company had cash and cash equivalents of approximately $61 2 million.
Based on our current operating plan, we believe our cash is sufficient to fund operations through 2023.
As of August three 2022, the company had approximately $17 9 million shares of common stock outstanding.
Now I'd like to move on enlist our upcoming milestones.
Although our phase III <unk> trial for treatment of neuro inflammation is a cause of Alzheimers disease is currently on hold pending the FDA manufacturer view.
Which we are working towards a resolution as quickly as possible, we expect to continue enroll patients over the coming months.
With attention to Australia in order to reach our enrollment target of 201 top line results for the six months programming candidly expected in late 2023 I'll.
I'll remind investors the more we do in Australia.
Currently cheaper due to the strength of the US dollar and the R&D rebate program available on Australia.
Upon resolution of the FDA inquiry, we remain on the path to initiate a three months 60 patient phase II program for mild cognitive impairment bar.
Barring any additional unexpected delays, we anticipate having top line results mid to second half of 2023.
Additionally, it remains our plan to initiate phase II trial of <unk> in patients with treatment resistant depression that is partially funded by the $2 9 million NIH Grant later in the calendar year again upon resolution of the FDA manufacturing review.
Additional open label Phase one data in high risk Mds and AML later this year and next as market indicators and finally, we plan to launch a second <unk> study in a solid tumor.
Phase one program with a target sometime early 2023.
So although we have encountered we believe minor impediments to advance your expert.
While we are building momentum with our trials in Australia, and we're pleased to progress during the quarter. We're pleased with our progress during the second quarter as we continue to advance our pipeline towards evaluating crazy milestones.
We thank our loyal shareholders as always and we reiterate we're always available to speak with you should you have questions. Please don't hesitate to reach out at.
At this point I'd like to thank you for your time and attention and I'd like to turn it back to Doug to poll for questions Doug.
Thank you ladies and gentlemen at this time, we will be conducting a question and answer session.
If you'd like to ask a question you May press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.
Our first question comes from the line of Tom Shrader with <unk>. Please proceed with your question.
Hello, Good afternoon, Thanks for taking my questions as we head into this trial.
And maybe C. J F. These on what do we know about the Adi group has anyone ever done a post hoc analysis from a big trial, either either beta a beta antibody, where sito cholinesterase are they going to progress faster. They gotta progressed slower do we know what the placebo group will look like I'm curious what information you have going in.
Yes, Thank you Tom.
C J, it's not on the call, but I will.
I'll put on my C. J had I mean, one of the things that CJ has worked very hard with with his statistical team.
Is evaluating this very question and he and his group took data from the AD neat group, which is a well characterized group from U S C.
And basically extracted the patients that had the equivalent of our Biomarkers remember we have peripheral blood biomarkers for the most part we knew the ones that.
Elevated CRP or April four.
And determined how they progressed compared to patients that didn't have those biomarkers and there were really three important findings. The first is that they do progress more rapidly so patients with neuro inflammation have more rapidly progressive.
Cognitive decline in patients without neuro inflammation secondly is.
That rapid progression occurs in a way that has less variance and what I mean by variances mean, theres less statistical noise around that decline.
And that is what gives us the third advantage it provides us with an ability to model.
The response compared to the treatment group in a way that allowed us to do both.
Shorter trials and the smaller trials as you know for the mild a deep patients. It's a six month trial based on 200 patients.
In a two to one randomization now by the standards of Phase II trials in Alzheimer's disease, that's quite small, but it's because of the advantage you identified that.
Adi agreed the Hot group the neuron flame group is unique and that it is a rapid progressive.
With low variance and we believe that we will very quickly see a difference that allows us to demonstrate the cognitive benefits.
So that is.
We didnt pick that rabbit out of a hat that was based on hard work by CJ and statistical consultants.
And then a second question.
Yes.
<unk> end point, there, we're starting to they're starting to be an enormous amount of work on these endpoints that will change faster.
Earlier, they tend to stress things like episodic memory.
The question is are they all very close as emad quite close and the question is is there any fear that youll all be sort of uncovering new endpoints. It it'll be hard to compare or is there a sense that they're close enough that an active drug really should hit all of them.
Dressing the same things just whatever is note I'd be curious because there's there's starting to be a lot of these end points well, yes, thats a little beyond my.
Casual conversation.
Judy Judy Yeager, who is our.
Consultant on this topic is really one of the world's leading experts in neuro cognitive evaluation and I remind you that the way <unk> was built it took data from three large datasets.
Three were in the U S. One in Europe combine them and evaluated them in a way to find out which of the elements from for all practical purposes, either Adas cog 13 or CVR.
We're most sensitive and predictive in patients with mild to moderate mild.
<unk> D and Mci remember the problem with <unk> and Adas Cog is theyre really designed we're built for patients with mild.
With moderate to severe disease and the way I like to describe it is that.
If youre going to make sushi you don't do it with an axe you don't do with a blunt instrument you do with the Super Sharp Japanese nice and in fact, the blunt instrument of Adas Cogs and CVR is not well designed for mild.
Mci so it is a purpose built.
Story the advantage is right now that is validated.
And although no one has gotten a drug approved at the FDA is well aware of it and other groups are using it so.
The field will.
Move away from Adas, Cogs and CVR, whether they decide on one end.
End point, which is we think <unk> is the best one or others will take some time.
<unk> is a well designed well validated tool ideally suited for the purpose, we're putting it to use and we're confident that we and other companies. When we go to the FBI. They will have a very good conversation with them.
Great. Thanks for the answers.
Our next question comes from the line of Mike mentality with B Riley. Please proceed with your question.
Hi, This is where you moved on from China today, Congratulations again.
Really nice quarter there.
Just a couple of questions unless I'm.
I'm just trying to think about.
The clinical hold and.
Anything positive that we may be able to tease out of this.
Just thinking about.
Is there a way or can you front run.
Enrollment or site openings within the U S or are you able to shift capital.
More towards Australia, insights et cetera, or anything along those lines.
Might not be on hold during the hold I guess so yes. Good question. Yes. So remember this is this whole business is a little spotty. It's U S space, we continue to have.
Have patients enrolling in Australia, we have announced that we when we think of this trial, it's in North America, and Australia thoughts trials. So that includes Canada and as you can imagine we are exploring other places where we might be able to open sites. So bye all.
Means we are exploring and spending a significant amount of both human of human capital.
I'm trying to shall we say find the solution to this problem that is independent of.
The timing associated with the FDA.
I will say that we did have an investigator meeting in the.
I see here and I can tell you that the enthusiasm of the clinical teams for this trial are quite high for a lot of the reasons, we always talk about when we.
Now showcase the trial it is unique in design they like the idea that it's a separate trial for Mci and mild <unk>.
Short and that it is.
That we actually provide patients with an additional 12 months of drug.
Whether they are in the active or placebo arm. So the clinical teams like it they're excited they too are frustrated by the those in the U S by the clinical hold but we are not standing still wringing, our hands waiting for the FDA.
Being as innovative as we as as you can imagine we would be but by the same token we.
We have learned not to make predictions until we have our bird in hand.
You can be assured we are working hard and as things loosen up or move forward. We will let you know.
Okay extra color.
Core <unk>.
Was curious if we might be able to expect.
Say, maybe an interim data readout I know you were discussing before.
More patients during today's call.
Maybe getting a little bit further after that.
Third dose really has allowed us to take.
Take effect.
Or did those were more like in terms of what you saw what you presented with the first dose.
A much more robust data readout ahead of the full data readout.
Mark.
Thank you yes.
It's.
Somewhat difficult to answer that.
In a straightforward way.
The pace will slow patients treated and one of them is being featured on the clinical trial the Airbus three because of the severity of their disease.
Inclusion criteria for the trial.
The increase in compression okay.
Lower in the UK about possible use.
The investigation or clause means that we get to.
Sample those patients in a formal.
Sampling program. So we don't have we won't have the full of sites.
So 119 days follow up.
Against a program of.
If something dates.
<unk> said that we have endeavored to get when the patients are being treated routinely.
But to get additional blood samples, but we call it required them because they are not part of a formal protocol.
Definitely the data we've got the data on the.
Two.
Perhaps that use cases, and we're gathering data on the most recent compassionate use case, who because of her age.
With eye disease, we expect to be able to monitor lux real closely because you'll be having more routine blood tests. So we will report those data as they as they come through.
We are expecting to see the same.
The effects that we've seen in the other three patients that we will see activation of NK cells or changing.
And hopefully we will see the generation of memory like NK cells.
As I said those assays will be dealt with.
That's helpful color.
I appreciate that and just sort of follow up or expand on that.
You might have covered this I know I know you mentioned the.
You've now have registration throughout the EU.
And our site opening up I believe you said it was in Greece.
You have plans to bring <unk> to the U S, which may also expedite trial enrollment.
To reach that benign patients.
So we have no plans to bring the.
The Mds trial to the U S.
Because of the competition for that patient population in terms of other trials that are ongoing but we do have plans to bring it to the U S for a different indication the data.
Weather.
So I'll leave that to RJ to decide how far we can get in terms of importance.
Lisa.
The shareholder base, but yes, we have.
Ongoing discussion Mr bring visibility to the U S.
Yes, just to reinforce what Mark says I mean, we've been touting for I think since is the NK killer summit, which I believe was in February of the remarkable data that Mark has shown about the advantage of <unk>.
Prime cells in the tumor microenvironment of solid tumors. So we because of the combination of frustration and competition quite honestly of cell therapy programs and hematologic malignancies.
One <unk> is ideally suited for.
Solid tumors too, we're going to pivot to program the solid tumors and our plan is.
Pending discussions with the FDA to actually run those trials in the U S. Because we believe the U S is just a little less.
Congested with the aftermath of COVID-19.
That has been a problem in the U K. So our hope is that we will have more news. After we've kind of had our discussions with the FDA are exactly what the tumor is how we're going to treat it and when those trials will begin in the U S.
Understood I really appreciate that and congratulations again look forward to hearing your talk tomorrow at AIC.
Great. Thank you.
Our next question comes from the line of Daniel Carlson with Tw Research Group. Please proceed.
Hey, guys. Thanks for taking my questions.
I know you're excited about the trial in the U S in terms of the.
The nation's excited about enrollment so can you talk anything about the momentum you're seeing in Australia. They are seeing.
Enrollment faster than than you would expect over there.
So we're not going to give numbers, we're pleased with the way things are going.
I will say that because of what's going on in the U S. We are also expanding the sites that we had initially planned to open in the U S who is going to be a trial driven I think we've said this before driven primarily by the U S with an assist from Canada, and Australia, and obviously as I said earlier were.
Although we ultimately think most of the patients are going to come from the U S. I'm not we're not resting on our hands, we're moving to expand activities in these other regulatory venues.
And so we're pushing we're pushing hard and.
So far we're pleased.
Okay.
Great.
And then in terms of <unk> I was wondering if you could just.
I had a little more detail about what youre doing in terms of solid tumors, especially you mentioned the preclinical data coming.
Okay.
Mark why don't you review some of that preclinical data.
So we've got a paper.
Like just just comes back.
So the registering with his review of all because as you go without a data lake.
Liquid Cumulus in solid tumors.
Right and.
We know that in point NK cells as RJ said up regulate that is certainly different.
Real membrane transport credit teams, which for those of you on the Cove at all by chemist.
Myself as Lumpiness.
Those are the proteins, where it stays.
Engines at the cell required to bring unique skills and we know that unlike almost all of the flip side, we've looked at it.
Alone up regulate stays nutrient receptor so that means that he'd like to country Outfitter. We just got these day trough in the last few months showing that.
<unk> increased NK cells have these highly state mitochondria, which should mean that they perform better in the tumor micro environment. So the data we have built to support that as we've now put these cells into a model of ovarian cancer, where we do the experiments.
In hypoxia the conditions that the tumor microenvironment sits and where there is so much lower levels of oxygen.
Immune cells are in pad and what we find is that NK cells from patients. If we isolate boost from the in such a fluid of stage patients with ovarian cancer say problem that youre microenvironment, they perform better offerings being probably more than even the NK cells from healthy donors.
The ability to enhance the.
Survival of an NK cell.
The focus here is on TV.
We just don't see it with any of the Sunshine cocktails that we've used so we do believe well, it's very likely that we can fund NK cells in the tumor microenvironment will have therapeutic benefit.
Adoptive NK cell immunotherapies like we decided to delay the slight declines.
Those are really hot off the press day to the they are in the paper that was published.
Back to science translational medicine very soon we are also in that paper, we're looking at at the molecular phenotype of these cells and demonstrating that our unique edge too.
Two such kind of stimulate itself. So yes. There's also a lot of preclinical work that we're doing.
To support the program loss ratios.
Patient enrollment to increase.
Thanks, Mike.
Exciting stuff. Thank you.
Segue to talk to my last question here when you talk about the tumor micro environment.
I'm just wondering if you can talk a little bit about <unk> three you had some good data there.
And I'm just wondering if if that data is being recognized by potential partners because the.
Thank your intention is to use it in conjunction with the stepped in at some point.
So good question.
I think that yes, we are quite excited about the data we have with <unk>.
Or are the ability of <unk> decreased decreased <unk> four expression and much of that work has been focused on her two positive breast cancer.
And.
Uh huh.
As you know that world has been turned on its head in the last two months with the approval of <unk>.
Of Trastuzumab director, Tim which is.
And her too.
That area is rapidly evolving and so we are doing two things Roxana Schillaci, who is the primary scientists behind that work is working with.
What is it.
Diana is actually testing.
You see that in her two is affected by.
<unk> four.
Expression as you know mark and hurt too.
As an ADC and it has.
Took our summary inhibitors.
Intuit as the as the payload they are quite powerful and we need to confirm that in fact that with this powerful targeted chemotherapy in her two positive breast cancer. The story is confirmed now as always we have a.
Plan B you have heard us talk about it and not seen a lot of data yet that the combination of <unk>.
<unk> with Teekay is dramatically prevents resistance improved improves response and and mud for expressing tumors. So many Gi malignancies express much for our PKI targeted tumors. So we have a plan.
Alternative plans and Gi upper Gi malignancies and we're.
Working towards that the bottom line.
Although we're working with the I actually I wouldn't consider it any kind of partnering discussion at this point, it's just a collaboration.
But the fact is the.
The tumor space is interesting.
And we believe this.
Resistance to.
Two targeted therapy strategy.
Yield benefits.
But I want to emphasize that our lead program is expo for Adi.
Pretty excited about that.
And.
We think that at the end of the day, that's going to at least near term drive the value of of immune file.
Okay.
Thank you for that answer.
Cited about that too.
Chris.
Pushed forward. So thanks for taking my questions guys.
Thank you Dan.
There are no further questions I'd like to hand, the call back to RJ chassis for closing remarks.
So this concludes the call we appreciate your participation.
We are continue to move forward, we are quite excited about both the quality of our science and the interest in our programs, while both the clinical and the Investor community and we.
You guys know how to get all of US don't hesitate to call and we look forward to speaking and seeing you soon thank you.
Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation you may disconnect. Your lines at this time and have a wonderful day.