Q2 2021 Plus Therapeutics Inc Earnings Call
We opened for your questions. Following the presentation. If you would like to ask a question at that time. Please press star 1 on your telephone keypad. If at any point. Your question has been answered you may remove yourself from the queue by pressing the pound key.
Ask that you please pickup your handset to allow optimal sound quality.
If you should require operator assistance, please press star zero.
Before we begin we want to advise you that over the course of the call and question and answer session forward looking statements will be made regarding events trends business prospects and financial performance, which may affect plus therapeutics as future operating results and financial position.
All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the risk factors section included in plus therapeutics as annual reports on form 10-K, and quarterly reports on form 10-Q filed with the Securities and Exchange Commission from time to time plus.
Therapeutics advises you to review these risk factors in considering such statements plus therapeutics assumes no responsibility to update or revise any forward looking statements to reflect events trends or circumstances. After the date they are made.
It is now my pleasure to turn the floor over to Dr. Marc Hedrick, plus therapeutics as President and Chief Executive Officer, Sir you may begin.
Great. Thank you very much Kathryn.
Good afternoon, everyone and thank you once again for taking the time to join US today as we provide an overview of recent business highlights and.
And discuss our 2021 second quarter financial results.
Joining me on the call today is Mr. Andrew Sims, our Chief Financial Officer.
But before Andrew provides a summary of our financial performance I would like to provide an update on the companys business activities since our last call.
Last quarter I provided a detailed overview of the company and I'll refer you back to that description, but.
But in summary for those new to the company plus therapeutics is a clinical stage pharmaceutical company developing innovative targeted radio therapeutics for rare and difficult to treat cancers.
Our lead drug is Arnelle Iranian Nana life of films.
This is a proprietary liposome encapsulated.
Encapsulated radionuclide that has delivered local regionally via targeted 3 dimensional convection enhanced delivery directly to the tumor.
The active agent is there any 186 isotope, which is a dual energy emitter, releasing both cancer, killing data particles, which are high energy electrons and.
The gamma particles, which are useful for imaging and dosimetry.
<unk> is a unique isotope in part because of its energy profile.
Its beta energy has a short pathway, which gives 1 precision.
Low dose rate, which provides a margin of safety.
And a high energy density.
Which is particularly toxic for highly mitotic cells.
Which can overwhelm DNA repair mechanism that can also contribute to radio resistance.
Thus far we've shown that we can successfully delivered 20 times of radiation dose 1 can deliver with traditional external beam radiation.
Our initial indication for our Enel is recurrent glioblastoma, which affects approximately 12 to 13000 patients annually in the U S and about the same number of patients in the EU.
It is the most common and lethal form of brain cancer in the treatment of this devastating disease remains a significant medical challenge.
Published studies indicate that external beam radiation provides the best incremental improvement in survival of all therapies currently used for Glioblastoma and it remains an essential component of multimodal therapy for both Glioblastoma and in fact, many other cancers.
In theory.
Leo Blastoma.
And frankly any tumor can be fundamentally controlled if a sufficient dose of radiation can be delivered to a particular tumor.
<unk> is currently under evaluation in the U S respect GBM trial, which is a dual phase 1 and 2 multicenter sequential cohort open label volume in dose escalation study of the <unk>.
<unk> Tolerability and distribution of 186 Arnelle.
The trial is currently funded to a significant degree from the U S National Cancer Institute.
In short the trial is progressing nicely and we have now moved into an eighth dosing cohort.
As a reminder, in November 2020 at the Society for Neuro oncology annual meeting we provided an interim analysis of the first 5 dosing cohorts in 15 patients and in March of 2021, and our bio Europe corporate presentation, we updated those interim results.
To include cohorts, 6 and that data can be found on our website.
Subsequently following the successful completion of cohort 6 and without any dose limiting toxicities that day.
Data safety monitoring board recommended enrolling an additional cohort of 3 patients or a cohort 7 at the same volume in radiation dose, but with a higher maximum convection flow rate specifically at 'twenty micro liters per minute.
Then in June of this year, we announced that through cohort 7 no dose limiting toxicities have been observed in the SMB recommended proceeding to the next dosing cohort.
Presenting a 40% increase in both volume and radiation dose.
So specifically, where we are now at <unk>.
We're introducing a volume of $12.3 low leaders a radiation dose of $31.2 militaries.
And we're staying at the same maximum flow rate of 'twenty micro liters per minute.
As announced this a M.
The first patient in the additional cohort has been successfully treated.
And I think it might be helpful. At this point and the product development cycle to provide a summary of what we have learned thus far in the respect GBM trial and then consider next steps.
So specifically what we've learned is that hemispheric, they're 1 sided.
Super tutorial, which is into the.
And to the upper part of the brain.
Highly targeted and continuously infused or converted volumes of up to $12.3 milliliters and $31..2 millet curious of radiation has been well tolerated thus far.
Up to 4 catheters can be successfully placed for delivery day.
Best accommodate a variety of tumor sizes and geometries.
Tumors up to approximately 25, Ccs and with various morphologies can be treated.
Our enel seems thus far to be safe, despite delivering up to 740 gray of absorbed radiation to the tumor.
Which by the way is 20 times the radiation typically delivered by external beam radiation therapy in the recurrent setting.
Patients receiving prior Bevacizumab did not convert as well as bev nave patients.
And in the past we elected to focus the current trial only on Bev naive patients.
Furthermore, because of the very substantial doses of radiation administered.
When the tumor dies, we found that induces local swelling or edema, which we can observe what MRI scans, which is so called pseudo progression, which is very obvious to see on imaging.
So traditional imaging analysis looking at response criteria is suboptimal and of lesser value in this particular clinical situation.
Although the phase 1 is not designed nor powered for efficacy.
Day.
<unk> to 'twenty 2 treated patients are still alive, which is obviously a good thing.
But because many of those patients had been treated relatively recently and at the higher dosing cohorts and volume cohorts. It understandably makes efficacy determinations today at challenging enterprise.
As to the issue of overall survival.
Can say is that we have observed increases in both convicted volumes and radiation.
Dosage seem to correlate with better tumor coverage and higher tumor absorbed doses.
And this in term seems to correlate with overall survival.
As I mentioned 822 patients remain alive and 3 of 22 patients have survived to 30 months or more.
Our average survival for a current GBM with standard of care is only about 8% to 10 months.
This present cohort should complete enrollment this year and later this year, we intend to provide a comprehensive update with safety and efficacy data as of that time point, including our updated proposed next steps for the clinical investigation of <unk> in recurrent GBM.
As mentioned last quarter. The go forward clinical development plan depends in part on the observed safety outcomes in the present data.
<unk> dosing cohort and the evolving efficacy data readout from the data set as a whole.
There is the potential to further dose escalate following the current dose cohort dosing cohort as a protocol provides for another 33% increase in volume and radiation dose.
Growing the current cohort 8.
Besides dose escalation or perhaps in conjunction with dose escalation, we could potentially implement implement further changes to the delivery parameters as we have done previously.
It's also possible that the company, maintaining the present dose and delivery parameters to be acceptable to move forward and we could expand the enrollment at this present dose to generate further efficacy data to better inform empower a follow on phase III Registrational trial.
As mentioned previously.
CMC activities and the availability of cgmp investigational drug product is the primary hard gating item for a phase III Registrational trial.
Therefore, CMC activities are a top priority for us.
Our team continues to make excellent progress towards submission and is simultaneously laying the groundwork for commercial readiness.
The team has been focused on cgmp drug product development test method validation material characterization and supply chain planning.
To that end, we have formally engaged with key suppliers for both critical materials and contract development work.
Longer term manufacturing relationships will be key to commercial success and our team continues to make nice progress in developing those strategic partnerships.
For example, pure mall in vitro and Europe Europeans are to just name a few and others are forthcoming.
So we remain on track without delay to have the key CMC activities completed by year end and stability testing complete thereafter, such that we should be ready with cgmp.
By mid 2022.
Switching gears a bit.
Last quarter, we noted that 2 pre IND meetings had been requested from the FDA to discuss expanding the clinical indications for <unk>.
Both are complete and based on the positive FDA feedback, we intend to move forward and filing <unk> for both indications.
The first is let them in NGL metastases and increasingly common secondary cancer complication occurring as a result of increasing overall survive survival rates that we are seeing for a variety of primary solid and hematologic tumors.
LTM effects over about 100000 patients per year in the U S and patients can present with a broad range of signs and symptoms due to simultaneous involvement of multiple areas of the cranial final axis.
The most common tumors, giving rise to <unk>, our breast cancer lung cancer melanoma gastrointestinal malignancies.
And then cancers of unknown primary.
There are no great current treatment options available.
And the growth of treatment.
And patients had been limited primarily to stabilizing or improving neurologic function <unk> symptoms and improving quality of life.
Median survival in this patient population is approximately and generously about 4 to 6 months if treated.
And the planned forthcoming trial, we intend to treat with Arnelle VN and dwelling subcutaneous reservoir called into my reservoir that sits under the skin and communicate directly with the ventricle and the left from an NGL or cerebral spinal fluid space and this is commonly place in these patients and it makes day.
<unk> a much more straightforward issue that we have in our current GBM trial.
The trial will be an open label multi site dose escalation trial evaluating feasibility safety dose and potential efficacy.
We plan to submit the IND for respect <unk> trial by Q3, perhaps his latest Q4.2021 and commence enrollment as soon as possible thereafter, the principal investigator will be Dr. Andrew Brenner.
Professor of research at the division of Hematology and medical oncology and clinical investigator at the Institute for drug development at the Mays Cancer Center University of Texas, San Antonio and MD Cancer Center is also co leader of the experimental and developmental Therapeutics program there.
Additionally, we believe there is an opportunity to help patients with pediatric brain cancer with Arnelle and based on our pre IND meeting feedback we intend to submit an IND later this year or in early 'twenty 2.2020 to investigate the use of our enel on kids with brain cancer.
The details of that trial will be finalized later in 2021.
The Pi for that trial will be Doctor Ashley plant. The Khokhar research scholar and attending physician in neuro oncology assistant Professor of Pediatrics at the lead trial site, which is Hillary children's hospital in Chicago at the Northwestern University School of Medicine.
Finally, I'd like to point out that we have been working diligently for some months that take our corporate communications to a new level that includes in all areas, including public relations Investor Relations and scientific and clinical communications Youll.
You will see the fruits of that work over the remainder of the year, but today you can find the first part of that which is our clinical trial micro site for the respect trials that can be found it respect trials dot com.
The front end is intended to educate and eliminate potential patients and family members with GBM.
On the back end that you won't see is a sophisticated compliant patient referral network to help match, our clinical trials with patients that may be better candidates and fill us facilitate that process of connecting them with the clinical trials.
Clinical trial site and much more to come in that regard.
So at this point I'll stop and turn the call over to my colleague Andrew for a brief review of the first quarter financial results Andrew.
Thank you Marc and good afternoon, everyone.
Please refer to our press release issued earlier today for a summary of our financial results for the second quarter ended June 32021.
As of June 32021, cash and cash equivalents were $17.2 million compared to $8.3 million as of December 31, 2020 cash.
Cash used in operations for the 6 months of 2021 was approximately $5.4 million compared to $2.9 million in 2020.
This difference is mainly due to timing differences on when certain accounts payable and accrued expenses were paid in 2020 in particular relating to the legacy government contract together with increased R&D spend.
There were no revenues in the 6 months of 2021 as compared to approximately 303000 in the same period last year.
This decrease was due to the closeout of the legacy government contract as previously disclosed.
Research and development expenses were $2.2 million for the first 6 months of 2021 as compared to $1.3 million for 2020.
The increase was anticipated and reflects additional arnelle CMC development costs.
<unk> cgmp drug product.
G&A expense was $2.8 million for the first 6 months of 2021 as compared to $3 million for 2020.
The decrease was primarily driven by a reduction due to tight management of professional and other fees.
Interest expense decreased for the 6 months of 2021 to approximately 476000 from approximately 601000 for the same period in 2020.
Reflecting the pay down of debt principle that $4.3 million in 2020.
Net loss for the 6 months to June 2021 was $5.5 million as compared to a net loss of $2.9 million for the equivalent period in 2020.
The net loss was consistent year on year, but excluding the book gains on the warrants reported in the first quarter of 2020.
As noted in our quarterly filing this required of transaction was eliminated in the second quarter on a quarter of 2020 from the series E warrants were amended.
And now I'll turn it back to you Mark great Andrew Thank slot. So before we go into Q&A, Let me just summarize the milestones we anticipate over the next few quarters.
First of all with respect to the respect GBM trial, we intend to complete the current cohort and presented a comprehensive trial update in Q4 this year.
And it's our intention to alert folks of the timing of that as soon as we're able.
Also at that time, we intend to provide an update on next steps in the clinical development of our Enel for GBM based on the evolving dataset.
Upon completion of the current trial and data analysis and end of phase 2 meeting with the FDA is likely to help finalize the pivotal trial plan.
Regarding the CMC activities for R&M we.
We plan to complete key cgmp manufacturing activities and we remain on track to begin stability testing later this year with GNP investigational drug product anticipated to be available around mid 2022.
At the end of the year 2021, we anticipate possibly requesting a type C. FDA meeting to clarify and resolve any open CMC issues that may exist at that time.
Regarding the respect <unk> trial.
IND submission is planned for Q3, Q4, 2021 and enrollment to begin following approval.
We will provide a formal update on that trial once we share back from the FDA, perhaps at our next quarterly earnings call.
Regarding pediatric brain tumor therapy, an IND submission is planned for later in 2021 to follow the <unk> IND submission, which could be as late as early 2022 and as mentioned we will provide a formal update on that trial once we hear back from the FDA.
In terms of business development activities, we continue to be quite active.
Both in CMC, and then assessing in licensing and out licensing opportunities and we will provide updates and an ongoing matter.
If and when we have news to report on that front.
So Catherine with that I think let's move to Q&A.
Okay.
The floor is now opened for questions. At this time, if you have a question or comment. Please press star 1 on your Touchtone phone. If any point. Your question is answered you may remove yourself from the queue by pressing the pound key.
Again, we do ask that you pose your question you. Please pickup your handset to provide optimal sound quality.
Thank you. Our first question is coming from Jason Mccarthy with Maxim Group. Please go ahead.
Hi, everyone.
Dave on the line for Jason Thanks for taking my questions.
Just Rob curiosity here are you currently or do you intend on holding any meetings with ex U S regulators to discuss the path to potential approval outside of the U S or do you plan on initiating any clinical trials in any assets.
Territories.
Okay I appreciate the question right now we don't.
It doesn't mean that won't change I think we want to really stick to U S approval and our CMC activities.
Over the course of the remainder of the year I think after we get through 2021 and the <unk>.
Pivotal plan starts coming together.
Then we will begin exploring in earnest potentially broadening that trial to include international sites or separate clinical trials.
Okay.
And then earlier in the call you mentioned that.
With respect to.
Population that was being evaluated respect trial, you mentioned that patients who had previously received bevacizumab.
Conduct evolves Berber naive patients so am I correct in saying that you guys are now currently focusing on GB.
GBM patients who are emphasizing that day.
The target patient population basically yes, yes that is true we excluded them.
Maybe about 9 months ago.
Doesn't mean, we can't treat them, but but what it means to me is that we will likely have to change the delivery parameters, perhaps the volume and the rate.
2.
To improve the.
The coverage of the tumor.
And Thats, something we can address downstream but.
In terms of.
And this to market as quickly as we can and we're going to exclude those patients.
Okay.
That makes sense and then you mentioned something about a potential day 1.
2 are either a meeting with the FDA regarding potential phase 1.2 trial could that would that be.
Potentially happening in 2021.
My guess is that's going to be at 2022 events.
I think we're going to have to wait and see what cohort 8 looks like and look at the evolving efficacy and safety data and then make a determination about whether we.
We continue to dose escalate.
I think thats, probably unlikely, but it's possible and right now we are delivering.
Pretty significant volumes in radiation doses, such that theoretically we think we can create.
Create a radiation cloud covering the tumor and the microscopic disease.
This fear of about 7 centimeters in diameter. So we're I think we're getting pretty close to the Max but once we have a look at the data.
We see what efficacy looks like the safety looks like we'll make a determination about whether to to escalate or not or whether to go into the next phase and as I mentioned that could include an expansion cohort.
Moving onto the next trial.
Okay. Thanks for the additional color I appreciate it.
You bet I appreciate the question.
Our next question comes from Sean Lee with H C. Wainwright Your line is open.
Good afternoon, Mark and Andrew and thanks for taking my questions.
So my first question is on the current cohort.
Core day like you mentioned deal with the.
Volume of dosing you can able to great fears about 7 centimeters. So what percentage of GBM patients do you think that's sufficient to cover and do you believe that do you feel that.
You have to go to a higher dose cohort later on.
Yeah. So.
That's a great question and it really gets into the therapeutic strategy of these patients.
As you know Sean with GBM.
Typically metastasized it kills patients by local growth.
If it's left untreated a growth like the Wii.
You can surgically extirpate these tumors, but the problem is about.
About 90% of the recurrences occur within a 2 centimeter in around the 2 mercy a microscopic disease that you can image, but you know instinctively is there and it's likely going to be the catalysts for the current so.
Our our concept is that if we could treat tumors that are roughly around 3 centimeters.
<unk> cover.
For the 2 centimeter rim around that which kind of accounts for a sphere and thats an idealized.
Geometry. These tumors don't often occur spheres, but you can cover about 2 centimeter rim around a 3 centimeter tumor.
You can.
Theoretically not only ablate.
The tumor which is.
Feel pretty confident we can do that reliably, but with capture that microscopic disease in our view thats, where youre really going to see some potential improvements in efficacy and then that might help downstream if patients do recur. For example, we've had patients that have growth beyond 30 months, where they too rich.
<unk>, we could potentially.
Entertainment concept of early re treatment.
Essentially play whack, a mole and.
1 can.
Sort of.
Think about the <unk>.
What's possible here.
In theory might be able to turn this into a chronic disease.
Certainly more chronic than it is today.
That acute killer. So that's how we look around and look at it. So yes, you can cover a tumor that's 7 centimeters, but practically that just doesn't make any sense I think the sweet spot is going to be kind of a 3 centimeter tumor with a win rim of 1 to $2.7 meters of.
Brain disease, but has microscopic disease, it's going to be the basis of a recurrence.
I see thanks for that.
In terms of the next study.
And you mentioned, you're likely to pursue a phase II pivotal study. So would you be looking to something towards the special protocol assessment with the FDA, but would you be pursuing say a breakthrough therapy designation what are your plans on that on the regulatory side.
Yes, I think all those are possible and those are in our planning and it's just going to be kind of based on the data.
And I think we'll kind of know more around.
Q3, or more likely Q4 of this year.
And that's assuming that we stay on the same enrollment cadence we've been on and get cohorts fully enrolled and then the other thing is.
And as I mentioned, we have a lot of patients that we've treated relatively recently that are still alive.
So a bit more.
As it relates to the evolving efficacy signal.
I see.
My final question from.
Coming all out in the pediatric brain cancer study so what's still left to do the 40 day initiate these studies and also would you wait until you have the new GMP manufactured.
Before we initiate these studies where would you go with your current stock.
Yeah on the latter question. We can go ahead and begin those studies today with our current manufacturing.
Protocol, which is sufficient for a phase 1 trial.
As to timing on those.
I would think about those.
Sequentially.
<unk> is the priority.
And so what's left there really is to finalize the IMD.
As mentioned, it's going to be Q3 may be a Q4 event.
And then submitting that and then it really depends on timing depends on the feedback we receive we've already got a couple of sites identified a number of others that we are investigating we've identified.
Hi.
And the pie is at a site that we're already working with and should be a relatively straightforward path to kick that trail off assuming.
We've come to agreement with the FDA regarding pediatric brain cancer.
Similarly, we have identified the pie to lead trial site, we're working with them to develop the protocol.
But.
We're just bandwidth constrained so that won't go in until after <unk>, which is likely going to be.
Filing data maybe.
Towards the end of the year, so we probably won't.
Be able to be too definitive about.
The startup timing until early next year.
I see thanks for the additional color on the volume.
Thank you Sean.
We'll go now to Edward with ascending capital your line is open.
Yes, thank you for providing us the very thorough update my question is on funding.
Mainly you've been able to fund most of your studies, so far with various grants.
You know what the funding plan will be if you do move to a pivotal study.
Yes.
And so I appreciate the question.
We're going to win per.
<unk> is in a good cash position today.
We're really.
Blessed and fortunate to have the majority of our.
Of our clinical trial covered by the NCI really fixed pressure off our.
Our needs to.
To raise capital.
The management management's philosophy is we like to stay at no less than 24 months of forward looking cash and we're pretty close to that right now we intend to stay there.
I think it just.
Goodbye otic hygiene to have appropriate tools in place to allow us to be opportunistic and raise capital.
When the stars in line.
Done that.
Stanley and but.
<unk>.
Our plan is to kind of stay at about.
18 to 24 months of cash build the 24, a little bit more if we can and then go out and raise additional capital once we get to a position where we're ready to embark upon a pivotal trial and raised sufficient capital such that we can go all the way to an approvable endpoint with.
With that cash without going back to our partner capital markets. So that's our plan.
24 months of cash as the baseline and raise additional cash when we need it when we need to get to a provable endpoint and be opportunistic in the meantime.
Great I was actually wondering will the Mci fund the pivotal study and also.
1 of the reasons you guys move to Texas was to get the state of Texas.
Cancer funding is that option for the pivotal study as well.
No I don't think.
The latter is not they'll fund up through phase 2 and we've got phase II covered the NCI grant covers.
True.
Phase <unk> design and it covers that that's up to 55 patients and we're at 22 now so there's still some runway there.
<unk>.
I think it's possible to get grant funding, but but frankly.
There's some trade offs with having grant funding as you're probably aware there is to some degree of loss of control. So my guess is.
As time is money and will very likely want to fund net trial ourselves for practical reasons.
Great well. Thank you for answering my question. Thank you good luck.
Appreciate it thanks.
Once again, if you do have a question you May press star 1 on your telephone keypad at this time, we will go now to <unk> with Octavian Your line is open.
Thank you. Thank you. Thank you gentlemen for the update and thank you for taking the call.
You mentioned towards the end of the update.
The BD and licensing activities.
Could you give us some guidance on the types of opportunity at the company from search out.
What the strategic goals and approach are vis vis the current pipeline for instance, what should we be expecting from the company.
And how are you guys thinking are focused on that aspect.
Corporate strategy.
<unk>.
Appreciate the question obviously the caveat is.
With BD is it's nothing is done till it's done but.
I can get into the strategy a bit and tell you where our focus is right now so our deal team is really active on 3 fronts and what you've seen if you've been following the news.
Over the last.
Maybe quarter or so is that.
We're very active on the CMC front, we are partnering with leading suppliers and providers.
And the most important of those we report publicly.
So that's a good measure of progress.
It's also not too early to think about things like.
Barriers to entry.
Exclusivity in terms of the supply chain interactions.
Further protections on that supply chain, and even reimbursement and ultimate margin. So those are all things that.
Our central to us and we're making progress along those fronts.
So that's that's kind of 0.1.0.2 is sort of in licensing.
We are very active in evaluating additional new technology.
In an effort to expand the.
Platform.
We really like the radio therapeutic space.
And also the pipeline.
And.
We are really focused on becoming increasingly more targeted now we.
As you know with the <unk> for GBM Thats delivered.
In a very targeted way, but it leverages convection enhanced delivery and imaging.
Need a brain surgery in a way to do that.
But we're also really looking beyond into other technologies and leveraging vascular access either arterial venous access.
Potential molecular targeting techniques.
We've got a core expertise.
In delivery and.
Doug formulation and radio therapeutics, and I'm very interested in expanding in the in the targeted delivery space and that's something that we've spent a lot of time evaluating potential opportunities.
Not to say that we're going to find something Thats comes pre funded like <unk> did within NIH Grant.
But 1 can dream.
And then finally.
Probably.
Much much much lesser net of time spent we are still evaluating opportunities to out license, our 2 legacy drugs, which I didn't mention but there is ongoing interest.
But frankly, we're just going to need to see the right economics for that to make sense for US right now so very active on those 3 levels.
We're going to.
Keep communicating and when something happens.
Let you know.
Great. Thank you. Thank you so much for the response to the opportunity.
I appreciate it.
We have no further questions at this time I would now like to turn the floor back over to Dr. Hedrick for any additional or closing remarks.
Awesome. Thank you Catharine so I just wanted to say thanks to everybody that joined us on the call and on behalf of the board I'd like to just take a moment.
As I do every quarter to say, thank you to our employees.
Our extended team members and now our multitude of academic collaborators with whom we work and that work so hard and they are so dedicated to finding solutions for GBM and other really tough narrowly cancers I'd also like to thank the patients and the doctors and the hospital staff, who we spend a lot of time with frankly.
That significantly contribute to making these clinical trials possible. So thanks again and please have a good evening.
Thank you. This does conclude today's conference call. Please disconnect. Your line at this time and have a wonderful day.
Yes.
No.
[music].