Q4 2021 Plus Therapeutics Inc Earnings Call
Commentary on our clinical expectations for the remainder of 2022.
Following Norman Andrew will review our financials.
2021 in early 2022 has been marked by significant progress as we work toward our mission to become a global leader in developing precision targeted radio therapeutics for cancer.
In 2021, we continued to advance our lead investigational targeted radiotherapeutic drug <unk> nano Microsome are our enel and our U S respect GBM trial.
As a reminder, the trial is the dual phase one two multicenter sequential cohort open label volume in dose escalation study.
The trial is currently funded to a significant degree by the U S NCI National Cancer Institute.
Our initial indication for our Enel is recurrent glioblastoma, which affects approximately approximately 13000 patients annually in the U S and about the same number of patients in Europe .
Most common and lethal form of brain cancer in the treatment of this saving disease remains a significant unmet challenge.
Recall also that our Enel is proprietary life of Soma encapsulated radionuclide that has delivered local regionally via targeted three dimensional convection enhanced delivery.
It is administered directly to the tumor types.
Bypassing the blood brain barrier.
The active agent is <unk> 186, isotopes, which is a dual energy emitter, releasing both cancer, killing beta particles, which are high energy electrons as well as gamma particles, which are useful for imaging localization and dosimetry.
We provided positive interim data from the phase one to respect GBM trial in patients with recurrent GBM.
At the society for Neuro oncology annual meeting an education day last November 2021, and then we updated the data set at the Bios CEO Conference in New York This month.
Both of those presentations can be found now on our website.
According to the most recently presented interim clinical data set 186, Arnelle delivered via convection enhanced delivery is feasible to at least $31 two military radiation and $12 three milliliters of volume.
No delivery failures were observed in the average absorbed dose of 276 gray of radiation plus delivered to the tumors over the course of the trial thus far.
Average absorbed radiation to the tumor increased and correlated with dose escalation.
In fact, we've shown that we can successfully deliver up to 740 gray.
Or 20 times the amount of radiation dose one can deliver with traditional external beam radiation in the recurrent setting.
As an aside about radiation therapy published studies indicate that <unk> external beam radiation provides the best incremental improvement in survival of all therapies currently available for Glioblastoma.
Which is about five months and.
And improve survival and it remains to stay in a central component of multimodal therapy for GBM in many other cancers. So there's no question radiation works in GBM.
Furthermore, and.
With respect trial key drug delivery parameters, such as flow rate Catherine et cetera were increased during the course of the trial.
And that increase correlated with better drug delivery outcomes and improved overall survival.
186, Arnelle is also thus far well tolerated without dose limiting toxicities.
As an acceptable safety profile.
There were no adverse events, thus far in the trial with the outcome of deaths or discontinuation due to adverse events.
And placement of up to four catheters and a patient.
Thus far been safe.
As to efficacy.
And its interestingly similar the efficacy results, thus far to our preclinical results.
And absorb radiation dose of greater than 100, gray and patients.
It's with increased overall survival.
Although the phase one trial is neither designed nor powered for efficacy we are observing promising signals of both biological effect and increased overall survival.
And the latter cohorts of the trial, specifically cohorts five through eight.
Receiving greater drug volumes in radiation doses.
Frankly, more optimized delivery parameters.
Nine of the 12 patients or 82% of those patients towards five to eight.
We received a therapeutic dose of 100 gray or better.
And we believe it's entirely possible to achieve a 90% or greater.
Coverage of 100, greater better going forward.
Thus far in 'twenty three total subjects treated in respect with recurrent GBM.
The median excuse me the mean and median overall survival for the entire group is currently at 38 weeks to 50 weeks, respectively with seven patients remaining alive.
It's interesting to note that in this current trial, which was initiated by the academic physicians back in 2015.
It's very unusual.
Sure.
Have such long term overall survival data, which we do in this trial.
Therefore, when we take the logical step in and take advantage of what's been done by the the academics that started the trial and assess a subset of patients who received at least a minimum therapeutic dose of radiation as I've mentioned thats greater than 100 grave radiation.
There were treated in the initial five cohorts, which range from a start date of March 2015 through to July 2020, which is the longest survival data we have in the trial. Thus far the median and mean overall survival stands at 80 to 88 weeks, respectively with two patients still alive.
That compares very favorably with the 32 weeks overall survival published in a recent meta analysis covering nearly 700 patients with recurrent GBM treated with Bevacizumab monotherapy in the recurrent setting.
And that reference can be found on our website in our corporate presentations.
Furthermore, our team continues to make excellent progress in our drug scale up and manufacturing activities, specifically during 2021, and thus far in 2022, the company entered into multiple collaboration agreements to support its process development and analytical chemistry activities as well as to strengthen our <unk>.
Supply chain and compliance with GMP practices for planned late stage clinical trials the.
The company remains on track to deliver GMP.
Six arnelle in mid 2022.
Before I turn the call over to Norman and he will update you on the path forward for 186, Arnelle I'd like to highlight the agreement that we announced right.
Right at the beginning of January consummated at the end of December is substantially expands our oncology portfolio.
As we've stated before.
We fundamentally believe in the future of cancer therapy is going to be in the precise targeting of tumors with the most potent cancer, killing agents, while minimizing damage to normal tissues.
And we entered into an agreement with the University of Texas for a worldwide exclusive license to develop and commercialize novel Interventional therapeutics for cancer.
The licensed patents, including composition of matter patents for biodegradable Gradable, alginate, microspheres, which we call Bam.
Containing the annualized <unk> loaded with imaging and our therapeutic payloads.
Therapeutic payloads may include radio therapeutics, chemotherapy, Dick's or thermal therapeutics.
The <unk> technology is delivered into the vascular system via standard interventional vascular technology that replaced precisely in the vessels feeding blood to the tumors.
Injected and both blocks all blood flow to the tumors and simultaneously delivers very high doses of cytotoxic compounds for an extended period of time.
Many days later following full radiation K band Resorbs Ah.
Physiologically metabolized and excrete it from the body.
With this technology, we can target almost any solid organ tumor in the body using standard interventional radiological methods to leverage the breadth of the human vascular system.
And deliver a resorbable biomaterial embolic technology, coupled with our highly potent radio isotopes.
The company will initially focus on developing one eight.
<unk> Bam as a next generation radio embolization therapy for liver cancer.
<unk> blocks, the attic artery segments that supply blood to the malignant tumor while also providing one NDA darnell radiotherapy and directly irradiating the tumor.
Next steps in this program, our technology transfer from academia, and completing key enabling CMC and preclinical work.
And with that I'll turn the call over to Norman.
Thank you Mark.
Joining plus therapeutics and to be joining you here today for this call.
A therapeutics focused on radio therapeutics position is firmly for long term growth.
I'm excited to lead the development or expansion.
Of this promising pipeline.
Mark's comments on the respect GBM trial in patients with recurrent glioblastoma and.
In 2022, we expect to materially advanced the investigational drug 86, arnelle for recurrent GBM in other indications.
First we plan to meet with FDA midyear proposed taking our eight eight liter.
And 'twenty two three military as our.
Recommended phase II dose.
We believe this dose is appropriate for 50% to 75% of patients with recurrent glioblastoma based on tumor size and morphology.
Publicly announced earlier this week, we are currently exploring potential phase III.
Pivotal trial designs.
Corporate the use of real World data also known as synthetic control arm.
<unk> trial costs to facilitate enrollment.
In addition, as we have yet to reach dose limiting toxicity with respect GBM trial, and we anticipate to be able to treat larger tumors with 186 are now our goal is to keep the phase one dose escalation trial open and report data both on the previously treated patients and on future <unk>.
Central cohorts we.
We may also consider exploring improve drug dosing parameters.
Recently, we have filed a new clinical protocol with the FDA to allow us to treat patients with recurrent glioblastoma previously treated once with Arnelle.
Benefits from additional Arnelle dose.
GBM is a notoriously difficult to eradicate from the brain and we believe a subset of patients a benefit in terms of greater safety and efficacy following two or more administration.
186 Arnelle.
Furthermore, in 2022, the company will review other GBM disease subtypes to potentially expand the use of 186 are now.
Regarding additional indications.
600, <unk> is also being developed for Russell Meningeal metastases in pediatric brain cancer.
Meningeal metastases as an increasingly common secondary cancer affecting over 100000 patients per year in the U S and patients can present with a broad range of signs and symptoms due to simultaneous involve multiple areas of the cranial spinal access.
With respect.
The trial is a multicenter sequential cohort open label single dose dose escalation phase one study that will evaluate the maximum tolerated dose maximum feasible dose safety and efficacy of a single administration of 186 Arnelle via Intraventricular catheter.
For the Leptomeningeal metastases treatment following standard surgical radiation or chemotherapy treatment in these patients.
Primary endpoint of this study is the incidence and severity of adverse events.
Serious adverse events and dose limiting toxicities, if any secondary endpoints include overall response rate duration of response progression free survival.
Survival.
Additionally, we received we have received fast FDA fast track designation.
86, <unk> for the treatment of Leptomeningeal metastases.
Following <unk> IND from the FDA last year and fourth quarter of last year. The company began screening and consenting patients in respect that one phase one trial.
In patients with lesser augment and Joel metastases.
Regarding pediatric brain cancer based on our pre IND meeting feedback received in 2021.
We expect to submit an IND for phase one trial with <unk>.
86, <unk> this year for the treatment of pediatric brain cancer and to investigate the use of Arnelle on kids with brain cancer at.
At this point I'll stop and turn the call over to Andrew for a brief review of the full year financial results Andrew.
Thank you and good afternoon, everyone.
These refer to our press release issued earlier today for a summary of our financial results for the full year ended December 31 2021.
As of December 31, 2021, cash and cash equivalents were $18 4 million compared to $8 3 million as of December 31, 2020.
Cash used in operations for the 12 months ended December 31, 2021 was $10 3 million compared to $8 4 million in 2020.
But the main changes between 2020 and 2021 are as follows.
In 2021 through early 2022, the company strengthened its balance sheet by raising approximately $28 5 million of capital.
As of January 31, 2022, the company's cash balance was approximately $23 million.
At our 2021 run rate that represents over two years of operating cash.
Research and development expenses were $5 3 million for the full year 2021, as compared to $2 7 million in 2020.
This increase is primarily due to continued CMC development Arnelle to GMP standards. This development remains on track to be completed by summer of this year 2022.
Please also note that the company continues to leverage the five year NCI Grant awarded in 2020 funding peak clinical activities.
G&A expense was $6 9 million for 2021 as compared to $6 4 million. In 2020. This increase is primarily due to expenses for new patent filings professional fees related to the <unk> transaction together together with other legal expenses and employee recruiting fees.
Interest expense decreased by approximately 400000 2021 from $1 3 million in 2020 to 907000 2021.
This decrease cost reflects the $5 million of principal paid off in 2020.
300000 in 2021 these.
These payments reduced the remaining principal Oxford below $4 million at December 31, 2021.
Net loss for 2021 was $13 4 million as compared to a net loss of $8 2 million in 2020.
Excluding the book gains on the warrants of $2 3 million.
We reported in the first quarter of 2020, the change in net loss reflects the incremental R&D and G&A spend as mentioned earlier.
And now I'll turn it back to Mark.
Thanks, gentlemen.
Before we move on to Q&A, Let me just summarize some key milestones anticipated for 2000.
'twenty two.
I think we've touched on most of these already.
First of all with respect to the.
The 186.
Respect clinical trial in recurrent GBM.
Regarding the 186 RNA drug availability.
The CMC activities for our Enel remain on track to complete this plan.
And to have GMP phase III drug supply available by mid 2022.
We currently plan a CMC focused FDA meeting in the second quarter of 2022.
Clarify and resolve the open CMC issues that may exist as of that time.
We also plan a clinically focused FDA meeting.
Mid year.
The proposed phase II clinical plan proudly signed using eight eight ml and $22 three military recommended phase II dose is Dr. Franz noted.
We also plan to explore the use of real world data.
Which is ongoing in the clinical and regulatory plan to accelerate phase III enrollment and potentially reduce trial costs.
In 2022.
We plan to continue to report phase one data and provided enrollment updates in an ongoing manner.
In the current phase <unk> trial.
Regarding the respect one of the six Arnelle Belem trial.
Our goal is to complete enrollment in the at least the initial cohort of three patients this year.
Regarding the pediatric brain cancer trial, we plan to submit an IND in 2022 and initiate this trial soon thereafter.
Regarding our recently acquired rights to the 188.
<unk> band Radio Embolization therapy technology.
We plan to complete the technology transfer and other key CMC and FDA IND, enabling studies for this asset in 2022.
Yeah.
So at this point.
Move to Q&A.
And David.
I'll turn it over to you.
Thank you for the <unk>.
Floor is now open for questions. At this time, if you have a question or comment. Please press the star and one on your telephone keypad. If at any point. Your question has been answered humira remove yourself from the queue by pressing the pound key.
Again, we do ask that while you pose your question you. Please pickup your handset to provide optimal sound quality.
Well live questions. Keith we have previously received a question by email from Justin Walsh with B Riley This will be asked by Andrew saying.
Thanks, David first question is from Justin can you remind us how much of a barrier to potential adoption would you expect physician training to be <unk>, well equipped to make use of the asset.
Yes so.
There is a barrier, but it's 100% soluble.
And we've got two two years of experience under our belt working with this novel technology.
And how do we think about it in a couple of ways first of all there is the neuro surgical aspect.
And the second part is the case planning aspect.
But it is really about getting getting radiation on the tumor so in terms of the neuro surgical aspect.
So essentially getting the.
There are surgically getting the catheters in the tumor leverages existing.
And true.
Biopsy technology.
Permanent placement and hospitals.
Our surgical services.
The technology itself self allows very precise delivery within about one millimeter. So.
And actually there are many neuro navigation systems that allow.
Sort of geospatial delivery technology.
Sweet prefer the brain labs technology, that's the one that we've used.
<unk> gone through the full training.
Although I am a neurosurgeon that create additional surges.
After a day of trading at the 100% capable of doing that so far.
So part of that I don't know.
Sure.
What initially was worried about maybe two years ago, when we acquired the asset is.
How about case planning how do we ensure that we can reliably cover the tumor with the appropriate amount of radiation.
I think the.
The stories adequately told in their clinical trial data if you look back at cohorts one through four Justin.
We are only able to cover the tumor with adequate radiation greater than 100 gray adequate radiation.
40% of the time, but if you look at the latter cohorts.
I think I referred to this in the script cohorts five to seven where we've got more volume.
We've gotten a higher radiation doses potentially more catheters higher flow rate et cetera, we're able to cover the tumors with therapeutic radiation about 80 plus percent of the time and those cohorts.
And I am increasingly comfortable we're going to able to get that to 90% of greater I think thats achievable.
So.
In terms of implementation of the case planning.
Okay.
Currently and through the clinical trials, we will do that centrally we think it's really important for quality control perspective, we do that and we do that corporately in consultation with the treating neurosurgeon.
And that may be the model going forward commercially, but we just don't know.
But.
Basically we're very confident now.
Those barriers are well on the way to the or had been solved.
And second question is can you provide some additional color on the regulatory precedent for using a synthetic control arm what are some of the potential advantages and disadvantage that trial design approach.
Norman will you mind answering that.
Be happy to thanks.
It's a great question by Justin.
Okay.
I will jump right to the bottom line that this this real world data and the synthetic control arm data already has established precedent successfully for interaction with the FDA.
Folks on the call may be aware of Celsius ovation, one study in ovarian cancer.
With the Gen one asset.
And also the medicine.
Medicina and Glioblastoma.
So.
This approach has been used successfully.
With.
We currently have less of it with both seeber and Cedar drug review groups within FDA and I'll spend one second if you allow me to go over in general why an FCA real world approach will be valuable, particularly focusing out of our application.
So the first thing we will do is.
Take advantage of this existing data and Theres significant data with the.
With the group World expert group were dealing with on this.
For understanding of our early phase <unk> single arm trial data that Mark mentioned.
This.
Mark mentioned that this doesn't have as phase ones are designed not to have the.
And efficacy control arm will be able to rectify that with the synthetic control arm.
Setting the enrollment criteria that we had in that phase one.
So with this phase one we believe will have will begin and we will be generating additional data.
Beyond the very impressive overall survival data that's been reported that the snow annual meeting last year.
Demonstrating.
Our strong overall survival benefit with the synthetic control arm.
Validation.
This all leads to the capability to analyze and justify advancement to phase II with FDA and as you heard from both Mark and I, We plan on approaching FTE by mid year for this phase III pivotal advancement.
The <unk>.
Availability as a control arm means that the randomization for control acid treatment will not be one to one that will encourage these unfortunate patients to enroll in our studies, it's always a personal decision.
Ah patients understandably would like active treatment.
<unk> turns accelerates development.
Faster to market and commercialization and change development costs for.
The market I don't know if you have anything else that are on the edge, but I think that that's a lot of the reasons why.
This approach I think is valuable and we have great expectations for it.
Helping move development, even faster than anticipated.
Great. Thank you maybe just a follow up question, so David I'll turn it back to you for further questions.
Okay.
Of course, we will take our first phone question from Joanne Lee with Maxim Group. Please go ahead. Your line is open.
Hi, This is joanne thanks for taking the question and congratulations on the progress this quarter, especially on the positive data presented at the ethanol.
Kevin.
Greater overall survival.
The higher dose cohort could.
Could you briefly I know you touched on this but could you repeat the dosing strategy for the next trial will it be at or above 100, gray and at what volume and if you could shed some color on what extension of overall survival will be considered meaningful in the recurrent GBM setting, particularly as the survival goalposts keep moving.
Yes, I'll take that thank you Joanne so.
The first part of your question so the dosing plan.
We started back up so we've bifurcated the trial continue to phase one and continue the current dose escalation scheme.
And Thats.
I can walk you through that the degree of interest in what that is but right now where we're dosing cohorts.
Now, which is about 12 Ccs of volume I think 31 millet curious irradiation.
The.
Kind of moving into the phase II kind of the other half of the bifurcation plan is to take the prior dose at which we have six patients, which is where the trials design sufficient to move into a phase two.
Recommend recommended dose, which is at $8 eight Ccs and I think about 'twenty one military so we've got no DLT.
We've got a very acceptable safety profile.
The dosimetry data from the clinical trial shows that we can.
Cover not only the tumor.
But also a rim.
Brain tissue that appears normal by imaging, but we know is very likely to harbor microscopic.
Disease, and we need to treat them as well to get long term survival benefit. So we think that that debt.
At eight $821 three military dose, we'll treat about 50, this perhaps up to 75%.
Typical recurrent GBM. So we think thats, a totally appropriate dose to take into phase III for the small to medium sized tumors based on the data we have thus far.
We will continue to dose escalate in the effort to potentially treat tumors that are larger or have more complex morphologies that are difficult to get with the current volume.
And dosage.
So as to the.
The target in terms of the amount of radiation so.
Sure.
We've been carefully derived the fact that 100 gray our greater seems too.
B therapeutics.
And only 23 patients at this point, but it looks like there's a pretty clear biologic signal as we dose escalated and it's interesting as I mentioned on the script that.
The preclinical data showed exactly the same thing that you start seeing a statistically significant improvement in survival. When you deliver over 100 grade to the tumor and the interesting thing is we're now delivering 740 Greg.
And we're able to do that with seemingly pretty good safety profile.
So thats the plan going forward. If you have any further follow up questions happy to try to address those.
Great and just regarding the trial size them recurrent GBM can you do a registration study with a single arm 100 patients and get approval.
We've seen traffic gain approval in other indications in a severe unmet need setting through that pathway and just as a follow up you mentioned that used to be synthetic control. The next trial could you give us some details around that decision.
Approach, we've observed that JD mall opened recently and particularly in GBM.
Yes so.
Yes.
Too early to tell what the.
The trial size looks like Trump budget, and so forth, but as we've said previously and I think we still believe this we have no reason to believe differently that approximately 100 patients. It's about the size of that trial.
As we've mentioned previously we have.
Designation for that indication.
And we have fast track status for the program with FDA.
We believe based on the data and what we have.
What we know about the breakthrough designation pathway that that may be an alternative here as well.
So that's kind of what we're thinking right now the synthetic control arm.
As Norman mentioned that might be able to offset the total number of patients we randomize.
And kind of to your follow up question on the synthetic control arm Norman alluded to this that medicina.
<unk> received.
The approval from the FDA that go into a phase III design, using a real world synthetic control arm.
To have a control group that is an amalgam of those.
Patients that have been randomized to.
To the control group, but to supplement that with real world data that are identically matched to the enrollment and.
The exclusion criteria inclusion criteria to the trial.
There is an increasingly well worn path to the FDA, where they've accepted it particularly in diseases like GBM.
And I think we're increasingly more confident that we think that that's going to be useful here as well.
Okay very helpful. Thanks again.
Thank you.
We will take our next question from Sean Lee with H C. Wainwright. Please go ahead. Your line is open.
Good afternoon, guys and thanks for taking my questions. So I just have a couple on your clinical development plans. So the first question is you guys mentioned you wanted to try a re dosing of patients now.
Within the same phase.
Phase one study or two expansion cohort for that.
Hey, Sean Mark it would be a separate protocol it would be.
To be outside.
The phase one design in the sense that it covers it and so forth.
So.
I don't plan that we don't plan to back it into that.
Okay.
Yes.
Yes.
The NCI framework.
So it would be a separate protocol, but under the IND and thats been submitted.
We.
We haven't heard back from the FDA about that.
But with.
Our ability to move forward with that.
Hi, Steve.
<unk>.
Patients are you, particularly looking to re dose and what sort of oil.
Kind of doses will you be starting the month.
So.
Yes. It is.
Great question so.
It is.
Almost impossible to eradicate GBM and that's kind of why were.
We've seen in a dose escalation trial that even though we've had a number of long term survivors when survivor.
100 and the.
Weeks out almost three years that we still can eradicate it.
So they're kind of two patients or the patients where maybe the before apology of the tumors is not ideal.
Difficult to cover the tumor the anatomic location is challenging and so forth and we know right off the bat that there might be a little bit of area, that's going to be at risk for recurrence based on the dosimetry data Thats, one type of patient, where we know right off the bat that there may be may be a problem, we want to be hypervigilant on recurrent so we could retreat those patients.
The other type of patient is where we've got good coverage.
<unk> does well.
Seeing none.
Safety and potentially efficacy signal in that particular patient, but if that if the disease comes back as it typically does we want to be ready to retreat them.
So the plan is to take the.
The request from the FDA to take the cohort six dose that's the one we're taking a recommended phase II, where we have.
Six patients treated.
That would be the maximum dose we can potentially go down based on the size of that.
The image to recurrent tumor.
But that would be the plan maximum dose going into that re treatment protocol.
I see thanks for that.
In terms of.
So we do testing these treatments and also testing higher doses in the phase one study if you do see some improved outcomes from these.
Treatments would you delay your phase III, so that to incorporate these or are you happy with that.
$8 eight mill that you guys are kind of law.
Yes, we're happy with that I think it's it's tumor size dependent.
I think we've mentioned this before and again I have talked about this.
On Sept as you want to cover the tumor.
And what.
What appears to be normal brain because 90%.
Of of patients.
Patients that.
90% of the recurrences will occur in two centimeter rim around the primary tumor. So we want to cover that that's very much at tumor size issue.
So at higher volumes and higher doses, we can treat we can treat bigger tumors.
So.
So thats the rationale in the dose escalation arm is to continue to escalate and be able to treat those higher tumors.
But in the retreat meant context.
These patients get imaged every 60 days. So we think that we can be vigilant and aggressive and jumping on anything that we think might be recurrent disease and be able to knock that down and the volume requirement would be the dose and the radiation dose requirement would be perhaps a bit less than what we would treat in the first recurrence.
I see thanks for the clarification.
My last question is on the <unk>.
Pam products, so from the sounds of it.
Liver cancer may be one of the first indication that you guys go after with this product.
While it's fair.
Fairly rare cancer here in the U S. It's a very common one in Asia, especially in China, and Japan, and Taiwan clinically so something like an international collaboration to test in those countries to be something that you guys would consider.
Yes, I completely agree.
That's.
As consistent with our thinking as well.
In fact, we've already had partnering interest on that even as early as it is.
The.
But I think the cautionary note is that we're still early in the.
And the tech transfer.
And then the other IND, enabling studies, so I think we still have a year of work.
<unk>.
Ready.
Two.
Discuss.
Publicly the clinical trial plan.
But.
I don't see a scenario, where we wouldnt include a.
Yeah.
Trial plan that would not include sites in Asia Pacific region.
I see thanks, that's all I have.
Thanks, Sean.
As a reminder, if you'd like to ask a question today. Please press the star and one keys on your telephone keypad will.
We will take our next question from Ed Woo with <unk> capital. Please go ahead. Your line is open.
Yes, congratulations on the progress so far also touching back on the Pam product and what was your rationale in terms of what you guys really like about this and should we see this in terms of how does it I guess.
Balanced out with.
Our now 186.
In terms of priorities for the company.
Thanks for the question, we're very excited about the opportunity.
The delivery technology is very mature.
Individual.
Radiographic technologies used all that all the time as opposed to the.
<unk> hundred 86, which although very.
Confidence is going to work. It is it is sort of new novel technology.
The angiographic interventional technology is very mature very effective for solid Oregon targeting so I think that that's sort of the key thing that excited us about this.
I guess the other thing that is worth noting is.
This is very.
This technology is very much aligned with our current 186 are enel technology, its really an extension or a bolt on so it really does beef up our IP portfolio and we already have the expertise internally.
CMC perspective.
From a drug development and clinical perspective. So this is right up our alley.
As an add on technology as to the liver cancer issue, you're absolutely right, it's a rare disease.
Products that have been used for approximately 25 years commercially.
Pretty broadly.
Liver cancer area, but they have some significant shortcomings.
And so like the market is really right for a second generation.
Technology that carries a number of potential points of differentiation improvement.
Over though so.
So I think I think the next steps for us, though before we get too far down the road as I mentioned previously if the tech transfer complete.
Sure.
And then do some proof of concept CMC and ex vivo work on them and the scalability and consistency of the of the drug product before we get into the clinic, which we think is scheduled late late this year early next year.
Target hopefully.
In terms of balancing with the 186 technology.
It does a couple of things for us gives us.
Micro scale drug as opposed to a nanoscale.
Completely different mechanism of targeting that we have for the 186 and it allows us to gain.
A related experience in the 188 isotope, which is different than 186 188 actually made.
Not in a nuclear reactor, but it's much much easier to make a generator and has different.
Isotopic physical properties.
That provide different features and benefits.
And then the 186 technology. So it's a very logical expansion of our current 186 technology.
Great. Thank you for the explanation and I wish you guys. Good luck. Thank you.
Thanks, Ed.
And once again as a reminder, if you'd like to ask a question. Please press the star and <unk> on your telephone keypad.
And we can pause for a moment to allow further questions to queue.
Okay.
And there are no further questions on the line at this time I will turn the floor back to Dr. Hendrik for any additional or closing remarks.
Thank you David Let me just close by thanking everybody for joining us on the call today and thank.
Thank you.
Those listening to the recorded version.
On behalf of the board I'd like to thank our employees specifically our team members.
Welcome Dr Hua, France, the physicians, we work with and of course, we're always grateful for the patients who trust us.
Enter into our clinical trials. So thanks again for your participation and have a good evening bye bye.
This does conclude today's program. Thank you for your participation and you may now disconnect.
Okay.
[music].