Q1 2022 Clearside Biomedical Inc Earnings Call
Operator: Good afternoon everyone, this is your operator. Your conference will begin momentarily, and this is your operator. Your conference will begin momentarily. Good day and thank you for standing by. Welcome to the Clearside Biomedical First Quarter 2022 Financial Results and Corporate Update Conference. At this time, all participants are in a listen-only mode.
Good afternoon, everyone. This is your operator your conference will begin momentarily. Please continue to standby.
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Once again this is your operator the conference will begin momentarily. Please continue to standby.
[music].
Good day, and thank you for standing by welcome to the beer side bio medical first quarter 2022 financial results incorporate update conference call. This time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer.
To ask a question during that session you will need to press star one on your telephone if you require any further assistance. Please press star zero and now it is my pleasure to hand, the conference over to your first speaker today, Jenny Cobin, yes.
Operator: Thank you. And now, it is my pleasure to hand the conference over to you. Jenny Kobin, and Vessel Relations.
Jenny Kobin: Thank you. Please go ahead. Good afternoon, everyone.
Your side Investor Relations. Thank you. Please go ahead.
Jenny Kobin: And thank you for joining us on the call today. Before we begin, I would like to remind you that during today's call, we will be making certain forward looking statements. Various remarks that we make during this call about the company's future expectations, plans and prospects constitute forward looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our annual report on Form 10-K for the year ended December 31, 2021, and our other SEC filings available on our website.
Good afternoon, everyone and thank you for joining us on the call today before we begin I would like to remind you that during today's call we will be making certain forward looking statements. Various remarks that we make during this call about the company's future expectations plans and prospects constitute forward looking statements for purposes.
Jenny Kobin: In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so even if our views change.
Of the private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of our annual report on Form 10-K for the year ended December 31st 2021, and our other SEC filings available on our website.
In addition, any forward looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements in the future. We specifically disclaim any obligation to do so even if our views change.
George Lasezkay: On today's call, we have George Lasezkay, our Chief Executive Officer, Dr. Thomas Chula, our Chief Medical Officer and Chief Development Officer, and Charlie Deignan, our Chief Financial Officer. After our formal remarks, we will open the call for your questions. I would now like to turn the call over to George.
On today's call, we have George lasers, ASCII, our Chief Executive Officer, Dr. Thomas Ciulla, Our Chief Medical Officer, and Chief Development Officer, and Charlie Deignan, Our Chief Financial Officer. After our formal remarks, we will open the call for your questions I would now like to turn the call over to George.
George Lasezkay: Thank you, Jenny. We continue to make steady progress in 2022. In March, we were pleased that Bausch & Lomb announced their U.S. launch of Xipir in the United States as the first therapy approved for macular edema associated with uveitis, a potentially blinding condition, ahead of the official launch. Bausch worked closely with hundreds of retinal specialists throughout the country, to train them on the use of our SCS microinjector, and to build interest in using Zypyr to treat their uveitic macular edema patients.
Thank you Jenny.
We continue to make steady progress in 2022.
In March we were pleased that Bausch and Lomb announced their U S launch of <unk> here in the United States as the first therapy approved for macular edema associated with uveitis are potentially blinding conditions.
Ahead of the official launch Bausch worked closely with hundreds of retinal specialists throughout the country to.
To train them on the use of our SCS micro injector and to build interest in using <unk> to treat their uveitis macular edema patients.
George Lasezkay: Bausch is very active at medical meetings with both a commercial and medical presence at the events, including five presentations at Arvo last week. Bausch continues to be a thoughtful and progressive partner, and we are confident in the strength and capabilities of their commercial team to advance this supracaroidal therapy to patients in need. Our China-based development and commercialization partner, Arctic Vision, also continues to progress in its development of Xypyr, which they refer to as ARVN-001, and the brand name Arcada.
Bausch is very active at medical meetings with both a commercial and medical presence at the events, including five presentations at ARVO last week.
<unk> continues to be a thoughtful and progressive partner and we are confident in the strength and capabilities of their commercial team to advance the supercoil therapy to patients in need.
Our China based development and commercialization partner Arctic Vision also continues to progress in its development of Zipcar, which they referred to as a RV and 001 and the brand name Arcadis.
George Lasezkay: They are currently enrolling two trials in China, a confirmatory phase 3 trial in macular edema associated with uveitis, and a phase one clinical trial for the treatment of diabetic macular edema. We look forward to their continued progress in these two programs. The approval of Xiphyr in the U.S. validates delivery into the supercoroidal space by our proprietary SCS microinjector and supports our strategy to focus on small-molecule suspension, our lead internal suprachoroidal pipeline product candidate, CLSA, combines our proprietary small-molecule suspension of the tyrosine kinase inhibitor exsidinib, with delivery by our SCS microinjector, as Tom will discuss in more detail.
They are currently enrolling two trials in China.
Our confirmatory phase III trial in macular edema associated with UBI. This Andrew.
And the phase one clinical trial for the treatment of diabetic macular edema.
We look forward to their continued progress in these two programs.
The approval of <unk> in the U S validates delivery into the supercritical space by our proprietary SCS microinjection and supports our strategy to focus on small molecule suspensions.
Our lead internal Supercoil pipeline product candidate C. L. S. A X combines our proprietary small molecule suspension of the tyrosine kinase inhibitor at Sydney.
With delivery by our SCS microinjection.
As Tom will discuss in more detail we.
George Lasezkay: We continue to make progress on our Phase 1-2a OASIS clinical trial targeting patients with WET-AND. Oasis is a single-dose escalating study, to explore the safety and tolerability from 30 micrograms to 1 milligram, which is an over 30 fold range of dose.
We continue to make progress on our phase one two way Oasis clinical trial targeting patients with wet AMD.
Oasis is a single dose escalating study.
To explore the safety and Tolerability from 30 micrograms to one milligram, which is an over 30 fold range of doses.
George Lasezkay: Our Safety Monitoring Committee reviewed one-month initial safety data from Cohort 3 and we are pleased to report that there were no dose-limiting toxicities observed at the 0.5 milligram dose. As a result, we are now enrolling patients in Cohort 4 at a higher dose of one milligram, while simultaneously continuing our Cohort 3 enrollment. We are targeting up to 25 patients in total from all four OASIS cohorts. This expanded enrollment of Cohort 3 and the addition of Cohort 4 will allow us to collect more CLS-AX patient data in order to help guide our selection of the most appropriate dosing protocol for our planned Phase 2b clinical trial. We now expect to report safety and tolerability data from both Cohorts 3 and 4 in the fourth quarter of this year.
Our safety monitoring committee reviewed one month initial safety data from cohort three and we are pleased to report that there were no dose limiting toxicities observed at the 0.5 milligram dose.
As a result, we are now enrolling patients in cohort four at a higher dose of one milligram, while simultaneously continuing our cohort three enrollment.
Targeting up to 25 patients in total from all four Oasis cohorts.
This expanded enrollment of cohort three and the addition of cohort four will allow us to collect more CLSA ex patient data in order to help guide our selection of the most appropriate dosing protocol for our planned phase two b clinical trial.
We now expect to report safety and Tolerability data from both cohorts three and four in the fourth quarter of this year.
George Lasezkay: This will allow us to report a more comprehensive set of patient data as we will be able to include the complete analysis from all four dosing cohorts of the OASIS trial, in addition to the detailed individual patient data from the final two cohorts. I will now turn the call over to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to discuss our research and development updates. Tom will provide more details on the OASIS study and address the progress made by our partners. Tom?
This will allow us to report a more comprehensive set of patient data as we will be able to include the complete analysis from all four dosing cohorts of the Oasis trial. In addition to the detailed individual patient data from the final two cohorts.
I will now turn the call over to Dr. Tom Ciulla, Our Chief Medical Officer, and Chief Development Officer to discuss our research and development update.
Tom will provide more details on the Oasis study and address the progress made by our partners Tom.
Tom Chula: Thank you, George, and good afternoon, everyone. For my segment of today's call, I'm gonna focus primarily on our progress at CLSAx and on our OASIS clinical trial and highlight the programs by our development partners. As a reminder, CLSA-X is a proprietary suspension of Exitinib for supracortial injections and is currently being studied for the treatment of patients with wet AMD. Our approach combines two key differentiators. First, excitinib is a tyrosine kinase inhibitor with broad VEGF blockade that we believe may have efficacy advantages over existing VEGF-A focused therapies due to its high potency and pan-VEGF inhibition. Second, delivery via our office-based SCS microinjector expands the supracortal space circumferentially and posteriorly to deliver drugs directly to the macular. This occurs since a natural pressure gradient drives injectate towards the lower-pressured posterior supracortial sphincter.
Thank you George and good afternoon, everyone.
For my segment of todays call I'm going to focus primarily on our progress at CLSA X and on our <unk> clinical trial and highlight the programs by our development partners.
Tom Chula: In OASIS, the primary endpoints were met in cohorts 1 and 2. CLSAx was well-tolerated with no serious adverse events. There were no treatment-emergent adverse events related to Aflibirsep, CLSAx, or the supracortial injection procedure, and there was no dispersion of drug into the vitreous. In addition, there were no adverse events related to intraocular pressure, inflammation, or vasculitis.
As a reminder, CLSA acts as our proprietary suspension of exiting them to Super <unk> injection and is currently being studied for the treatment of patients with wet AMD.
Our approach combines two key differentiators.
First exit NIM is a tyrosine kinase inhibitor with broad VEGF blockade that we believe may have efficacy advantages over existing veg F. A focused therapies due to its high potency and Pan VEGF inhibition.
Second delivery via our office States SCS micro injector expands a supercritical space circumferential and posteriorly to deliver drugs directly to the macula.
This occur since a natural pressure, creating it drives inject take towards the lower pressured posteriorly supercritical space.
And a weight as the primary endpoints were met in cohorts, one and two.
CLSA X was well tolerated with no serious adverse events there were no treatment emergent adverse events related to sliver step CLS ax or the Super <unk> injection procedure and there was no dispersion of drug into the vitreous.
In addition, there were no adverse events related to interactively pressure inflammation or vasculitis.
Tom Chula: As George mentioned, we announced today that our Safety Monitoring Committee reviewed one-month initial safety data from Cohort 3. The OASIS trial continues to demonstrate positive safety results with no dose-limiting toxicities observed at the 0.5 milligram dose. As a result, we are now enrolling patients in Cohort 4 at the higher dose of one milligram, which is doubled, and the Cohort 3 Go. Simultaneously, we're continuing our cohort three enrollment, and we are targeting up to 25 patients in total from all four OASIS cohorts.
As George mentioned, we announced today that our safety monitoring Committee reviewed one month initial safety data from cohort three.
The Oasis trial continues to demonstrate positive safety results with no dose limiting toxicities observed at the 0.5 milligram dose.
As a result, we are now enrolling patients in cohort four at the higher dose of one milligram, which is double the cohort three dose samad.
Simultaneously, we are continuing our cohort three enrollment and we are targeting up to 25 patients in total from all four oasis cohorts.
Tom Chula: This expanded enrollment of Cohort 3 and the addition of Cohort 4 will allow us to collect more CLSAx patient data in order to help guide our selection of the most appropriate dosing protocol for our planned Phase 2b clinical trial. I'd like to note that we are encouraged by the growing interest in this trial, and as a result, we have recently doubled the number of clinical trials to 10. We now expect to report safety and tolerability data from both Cohorts 3 and 4 in the fourth quarter of this year.
This expanded enrollment of cohort three and the additional cohort four will allow us to collect more CLSA X patient data in order to help guide our selection of the most appropriate dosing protocol for our planned phase <unk> clinical trial.
I'd like to note that we are encouraged by the growing interest in this trial and as a result, we have recently doubled the number of clinical trials to 10.
We now expect to report safety and Tolerability data from both cohorts three and four in the fourth quarter of this year.
Tom Chula: This will allow us to report a more comprehensive set of patient data, as we'll be able to include the complete analysis from all four dosing cohorts of the OASIS trial, in addition to the detailed individual patient data from the final two cohorts. To wrap up the discussion on OASIS, I want to emphasize that we've established very stringent criteria in our protocol for patient enrollment that differs from many of our peers. Unlike similar trials ongoing in the wet AMD space, particularly those assessing TKIs, we are only enrolling highly treatment-experienced patients with active disease, verified by the independent reading. Although these persistently active cases represent more difficult-to-treat patients, we believe that by including only patients with persistent active disease, despite prior anti-VEGF therapy, we can better assess the biologic effect of CLSAF.
This will allow us to report a more comprehensive set of patient data as we'll be able to include the complete analysis from all four dosing cohorts of the Oasis trial. In addition to the detailed individual patient data from the final two cohorts.
To wrap up the discussion on wages I want to emphasize that we've established very stringent criteria in our protocol for patient enrollment that differs from many of our peers.
Like similar trials ongoing in the wet AMD space, particularly those assessing teekay is we're only enrolling highly treatment experienced patients with active disease verified by the independent Reading Center.
Although these persistently active cases represent more difficult to treat patients, we believe that by including only patients with persistent acted this week disease. Despite higher anti VEGF therapy, we can better assess biologic effect of CLSA ex.
Tom Chula: Importantly, this will facilitate dosing selection and help de-risk our later stage clinical trials for CLSAX. As OASIS progresses, we are simultaneously in the initial planning stages for our Phase 2b clinical trial. The OASIS data compilation will help finalize this trial design and protocol so that we can then proceed to this next clinical development stage. Next, I'd like to provide a partner update. At ARBO, Regenexx Bio reported data from both of their phase 2 gene therapy trials using our SDS microinjector to deliver their product candidate RGX314 into the subretinal, into the supracortal space. Both the AVH study targeting wet AMD and the ALTITUDE study targeting diabetic retinopathy have generated promising results to date.
Importantly, this will facilitate dosing selection selection and help derisk. Our later stage clinical trials for CLS Ax.
As a waitress progresses, we are simultaneously in the initial planning stages for a phase two b clinical trial the.
The Oasis data compiled <unk> will help finalize the trial design and protocol. So that we can then proceed to this next clinical development stage.
Next I'd like to provide a partner update at ARVO, which Nx bio reported data from both of their phase III gene therapy trials, using our SCS microinjection <unk> to deliver their product candidate RG <unk> suite 14 into the sub retinal into Super portal space.
Both the Aviate study targeting wet AMD and the altitude study targeting diabetic retinopathy has generated positive promising results to date.
Tom Chula: Last week, Cogenex Bio also announced timing and status updates on their trial. For AV8, enrollment is expected to be complete in the first half of 2022. Cohorts 4 and 5 are evaluating RGX314 at a third dose level of 1 times 10 to the 12th genome copies per eye. Cohort 5 is evaluating RGX314 in patients who are neutralizing antibody positive.
Last week with Jack's pile also announced timing and status updates on their trials.
For Aviate enrollment is expected to be complete in the first half of 2022.
Cohorts four and five are evaluating Archie ex suite 14 at a third dose level of one times 10 to the 12 genome copies per eye.
Cohort five is evaluating <unk> hundred 14 in patients who have neutralizing antibody positive.
Tom Chula: For altitude, enrollment is now complete. Cohorts 2 and 3 are evaluating RGX314 at an increased dose level of 5 times 10 to the 11th genome copies per eye, with cohort 3 evaluating RGX314 in patients who are neutralizing antibody positive. As a reminder, last month Regenexx Bio presented positive interim data from the ALTITUDE trial. Of the patient's dose of RGX314 in cohort 1, 47% demonstrated a two-step or greater improvement from baseline on the ETDRS diabetic retinopathy severity scale at six months, compared to 0% in the observational control group.
For altitude enrollment is now complete.
Cohorts, two and three evaluating RG <unk> 14 at an increased dose level of five times 10 to 11 genome copies per eye with cohort three evaluating RG extra 14th in patients who have neutralizing antibody positive.
As a reminder, last month <unk> bio presented positive interim data from the alpha to trial.
Of the patients dosed with <unk> hundred 14 in cohort, 147%, 47% demonstrated that two step or greater improvement from baseline on the E. T T. Eric D. R. S. Diabetic retinopathy severity scale at six months compared to zero percent in the observational control group.
Tom Chula: The continued progress by Regenexx Bio is very encouraging, and we look forward to their ongoing clinical trial results. Over the past two months, we've been very active at medical meetings, including presentations at Sonoma I, the Vitbuckle Society, the WET-AMD and DME Drug Development Summit, ASCRS, and of course ARVO last week. At Arvo, Dr. Viral Kinsara presented an overview of our preclinical data highlighting the targeting, compartmentalization, and durability of supercordial injected small molecule suspension, demonstrating the versatility of our technology platform.
The continued progress Biogen expire was very encouraging and we look forward to their ongoing clinical trial results.
Over the past two months, we've been very active at medical meetings, including presentations at Sonoma I did the buckle society, the wet AMD and DNA drug development summit a S E. R S and of course ARVO last week.
At ARVO, Dr. Boral Consol represented an overview of our preclinical data highlighting the targeting compartmentalization and durability of Super corridor, you injected small molecule suspensions, demonstrating the versatility of our technology platform.
Tom Chula: As George mentioned, Baoshan Lan is also very active at these meetings with several data presentations on Xi'an Pier. At Arvo, Bausch focused presentations on Xipir's approved indication of macular edema associated with uveitis. And at the upcoming Retina World Congress, their presentations will focus on specifics around the Xipir Phase III pH-3 trial. Bosch also continues to reach out broadly to train the U.S. retina and uveitis specialists on the use of our technology platform.
As George mentioned Bausch and Lomb is also very active at these meetings with several data presentations and type here.
At ARVO Bausch focused presentations on XI peers approved indication of macular edema associated with uveitis and at the upcoming retina World Congress their presentations will focus on specifics around the XI pier phase III Peachtree trial bumps.
<unk> also continues to reach out broadly to train the U S retina and uveitis specialists on the use of our technology platform.
Tom Chula: Tomorrow, I look forward to joining several of my retina physician colleagues to speak on a panel entitled New Pathways in Retinal Diseases at the Retina World Congress. With that, I'll now turn the call over to our CFO, Charlie Deignan, to review our financial results. Thank you, Tom. Our financial results for the first quarter were published this afternoon in our press release and are available on our website.
Tomorrow I look forward to joining several of my retina physicians colleagues to speak on a panel entitled New pathways in retinal diseases at the retina World Congress.
With that I'll now turn the call over to our CFO , Charlie Deignan to review our financial results.
Thank you Tom.
Our financial results for the first quarter were published this afternoon in our press release and are available on our website.
Charlie Deignan: Therefore, I will summarize our current financial status. We reported in March, Xipir's approval, provided significant non-diluted funding for Clearside. We received a total of $20 million of revenues from BASILOM related to milestone payments, with the final $10 million of these payments received in the first quarter of 2022.
Therefore, I will summarize our current financial status.
We reported a March zipcar's approval.
Provided significant non dilutive funding, Chris clear sight, we received a total of $20 million of revenues from Bausch and lomb related to milestone payments with the final $10 million of these payments received in the first quarter 2022.
Charlie Deignan: Going forward, we will primarily receive payments related to sales-based milestones in rural, As a reminder, for our agreement with Thales, we do not receive any revenue for the first $45 million in product sales, are cash and cash equivalents as of March 31st, 2022 for approximately $34 million. This capital will be utilized to advance our clinical development pipeline anchored by CLSA. With our current operations and planned spend on our broader R&D pipeline, we expect to have sufficient resources to fund our operations for at least the next 12 months.
Going forward, we will primarily receive payments related to sales based milestones and royalties.
As a reminder, for our agreement with <unk>, we do not receive any revenues for the first $45 million in product sales.
Our cash and cash equivalents as of March 31, 2022, or approximately $34 million. This.
This capital will be utilized to advance our clinical development pipeline anchored by CLS Ax.
With our current operations and planned spend on a broader R&D pipeline, we expect to have sufficient resources to fund our operations for at least the next 12 months.
Charlie Deignan: We continue to be involved within the investment community and we look forward to participating in the upcoming JMP Healthcare Conference next month and keeping abreast of our progress. I will now turn the call back over to George for his closing remarks.
We continue to be involved within the investment community and we look forward to participating in the upcoming JMP Healthcare conference next month, and keeping abreast of our progress I will now turn the call back over to George for his closing remarks.
George Lasezkay: Thank you, Charlie. With the FDA approval of Xipir last year, and the use of our STS injection technology platform in six ongoing super coroidal clinical trials, We continue to solidify our position as the leader in delivering drugs into the supercoronal space. Our technology platform, which combines the SES microinjector with a variety of therapeutic modalities, is truly an innovative approach in treating retinal diseases by allowing unparalleled access to the back of the eye through the supracarotidal space.
Thank you Charlie.
With the FDA approval of XI pure last year and the use of our SCS injection technology platform in six ongoing Super Choroidal clinical trials.
We continued to solidify our position as the leader in delivering drugs into the Super Gorilla space.
Our technology platform, which combines the S X S. C S micro injector with a variety of therapeutic modalities is truly an innovative approach in treating retinal diseases by allowing unparalleled access to the back of the eye through the Super Choroidal space.
George Lasezkay: We believe 2022 will be another year of advancement for Clearside. We expect the final data readout of our OASIS clinical trial in Q4 of this year. This will position us to gear up the Phase IIb trial by the end of this year and enable us to begin enrolling patients soon thereafter. We're excited to keep moving forward as we believe CLSAx may be a promising treatment option for patients suffering from wet A&D.
We believe in 2022 will be another year of advancement for clear side, we expect the final data readout of our Oasis clinical trial in Q4 of this year.
This will position us to gear up the phase two b trial by the end of this year and enable us to begin enrolling patients soon thereafter.
We're excited to keep moving forward as we believe CLSA X may be a promising treatment option for patients suffering from wet AMD. We also look forward to the additional progress and data readouts from all our clinical development and commercialization partners throughout the remainder of the year.
George Lasezkay: We also look forward to the additional progress and data readouts from all our clinical development and commercialization partners throughout the remainder of the year. I would now like to ask the operator to open the call for questions. We will now begin the question and answer session, if you would like to ask a question. Crestar 1, Onion Zettles Foundation, Again, please press star followed by the number one on your telephone. If you wish to withdraw from the key, just press the pad.
I would now like to ask the operator to open the call for questions.
Thank you Sir we will now begin the question and answer session. If you would like to ask a question. Please press star one on your telephone keypad again. Please press star followed by the number one on your telephone keypad.
Wish to withdraw from the key just press pankey. Please standby, while we compile the Q&A roster.
Operator: Stand by while we compile the, The first question is from Zegby Jalaw with Frothcap. Thank you for taking my question and congrats on the progress. I think the first question for me here is just about the expectations for efficacy in cohort four. I know you mentioned that you were essentially doubling the dose from cohort three to cohort four. And so I was just wondering if we should expect some sort of efficacy from that cohort based on your preclinical studies. Tom, I think that's best directed to you. Sure, thanks for the question, Sigba.
Your first question is from Zigbee Gela with Roth Capital Partners. Please go ahead.
Thank you for taking my question and congrats on the I think the first question here is just about the expectation for efficacy in cohort four I know you mentioned that you have essentially doubling.
Go ahead.
I was just wondering.
We should expect.
Okay.
Cohort based on your preclinical studies.
Tom I think that's the.
Best directed to you.
Sure. Thanks for the question SYGMA well as you know our first priority in this phase one two a study remains safety.
Tom Chula: Well, as you know, our first priority in this Phase 1-2A study remains safety. As you know, excitinib is a well-established small molecule, and we don't expect, inflammation based on our preclinical studies, as well as the fact that it's not a biologic. And so far, as we reported in cohorts one and two, there's been a very robust safety profile. And this allows us to continue to escalate, as we've announced, up to a milligram in cohort four, as we've discussed in prior calls. Ixitinib has already been shown by independent labs to successfully inhibit corneal, retinal, and choroidal angiogenesis in a variety of animal models, all published from a variety of labs.
As you know its hitting it with a well established small molecule and we don't expect.
Our information based on our.
Preclinical studies as well as the fact that it's not a biologic in so far as we reported in cohorts one and two.
There has been a very robust safety profile and this allows us to continue to escalate as we have announced up two milligrams in cohort four.
As we've discussed in prior.
Carl.
Its citizens has already been shown by independent labs to successfully inhibit corneal retinal and choroidal angiogenesis in a variety of animal models, all published from a variety of labs and so basically.
Tom Chula: And so basically, leveraging its highly potent pan-VEGF effect with our microinjector to achieve very high and immediate, and the Cochlear-Retinal Tissues, while minimizing exposure to the front of the eye. So we think this has real potential to show efficacy. And as we escalate, we expect to start to see some results. Biologic Signal.
Leveraging its highly potent pan betcha effect.
There are micro injector to achieve very high immediate.
Targeted level in the <unk>.
Korea retinal tissues, while minimizing exposure to the front of the eye. So so we think.
This has real potential to show efficacy.
And you know as we escalate, we expect to start to see some.
Biologic signals.
Tom Chula: I also mentioned in my prepared remarks that, are trials enrolling patients who are treatment-experienced yet show some activity based on an independent reading center confirmation. So, in essence, we're enrolling those difficult-to-treat refractories, cases. And this sets a little bit of a higher bar, but also allows us to assess for these biologic signals and make a better informed assessment, choice of dose in our upcoming Phase 2B trial. Thanks, Tom.
I also mentioned in my prepared remarks that.
Our.
Trials enrolling patients who are treatment experienced yet show some activity based on independent Reading Center confirmation.
So in essence, we're enrolling those difficult to treat refractory <unk>.
Cases, and this sets up a little bit of a higher bar, but also allows us to.
SaaS for these biologic signals and make a better informed.
Choice of dose in our upcoming phase III trial.
Tom Chula: And then as a follow-up to that, I was just wondering, you know, just given the evolving competitive landscape, have you guys decided, to some degree, if you'll be pursuing these pre-treated patients or treatment-aided patients? And then the last bit here is just if you can comment on, you know, what are some of the additional factors driving this growing interest, you know, in the program? I know you guys are doing a lot of things simultaneously.
Thanks, Tom and then as a follow up to that I was just wondering you know just given the evolving competitive landscape have you guys decided to some degree it you'll be pursuing be pretreated patients.
<unk> patients and then the last eight years.
If you can comment on you know what it's going to be additional factors driving this well in inches hanging out and.
The program I know you guys are doing a lot of things simultaneously you're presenting at conferences you know bausch is training.
Tom Chula: You're presenting at conferences, you know, Bausch is training, you know, folks across the country. So I suppose you can just comment on the plethora of activities that you think are kind of driving, you know, this growing interest in the CLSCx program. Thanks again.
So they were across the country. So I suppose you can just comment on the plethora of activity that you think are kind of driving you know there's this growing interest in B C. L. Anthrax program. Thanks again.
Tom Chula: Sure. So, you know, with respect to your first question, whether, This is primarily going to be used in treatment-naive patients or in treatment-experienced patients. We're still working that out. It has potential to be used in both populations, but we're still working out the best approach. As we've discussed previously, It's sitting in a T county.
Sure So with respect to your first question weather.
This is primarily primarily going to be used in treatment naive patients who are treatment experienced patients were still working that out.
It has potential to be used.
In both populations, but we're going to we're still working out the best approach.
As we've discussed previously.
Tom Chula: It's very broad. Pan-VEGF inhibition, so it has potential to be more efficacious than current therapies and may actually have a role in treating these somewhat refractory patients, however, it also could potentially be used as primary monotherapy in the future and again, we're working that out. And then with respect to your second question, you know, why the growing interest? And I think I think, you know, the answer is several fold, I think our approval of Zypeer helps to support our platform.
It's sitting at a tea county is very broad.
Our Pan VEGF inhibition, so it has potential to be more efficacious than current therapies and they actually.
Have a role in treating these somewhat refractory patients.
However, it also could potentially be used as primary.
Mono therapy in the future and again, we're working that out and then with respect to your second question why the growing interest.
And I think I think the.
Answers is several fold.
I think our approval XI Pierre <unk>.
Helps to support.
Our platform.
Tom Chula: There's been lots of interest in the retina community to be trained with the microinjector. Bausch is planning to train all U.S. retina and uveitis specialists, and I think the adoption of training has gone well so far.
There has been lots of interest in the retina community.
To be trained with the micro injector Bausch is planning to train.
O U S.
Retina, and uveitis specialists and I think.
The adoption of training has gone well so far.
Tom Chula: So Regenexx Bio has reported some very encouraging results in both of their Phase II studies, which has attracted further interest, especially because it's a gene therapy, which always attracts interest. Aura has gone public, and there's a lot of interest in their Phase II trial using our FCS microinjector to treat chordal melanoma, which is the most common, interocular malignancy in adults. And that historically has had not very good treatment with radiation therapy.
Also rejects bio has reported some very encouraging results in both of their phase III studies, which has attracted a further interest recession, because it's a gene therapy, which always attracts interests.
Ora has gone public.
And.
There's a lot of interest in their phase III trial, using our SCS microinjection to treat choroidal melanoma.
Which is the most common.
Intraocular malignancy in adults and that historically has had.
Not very good treatment with radiation therapy, so so I think.
Tom Chula: So, so I think. All of those factors have generated interest. And then finally, as you mentioned, We've been very active at a variety of retina congresses and also in publications which has furthered the interest. Thanks again, Kyle.
All of those factors have generated interest and then finally as you mentioned.
We've been very active at a variety of retina Congresses and also in our publications, which is perfect.
Further the interest.
Thanks again Tom.
Yeah.
Operator: Your next question is from John Wolleben with... Hey, thanks for taking the question. I'm just wondering about, you know, what data we're going to get in the fourth quarter, I'm guessing it might be six months follow up from cohort three and three months from cohort four. And previously had planned on starting that phase to be by year end. So I was hoping to get an update on, you know, what data and follow up we'll get in the fourth quarter. And then, you know, how much time will you need to make a decision?
Your next question is from John Mulligan with JMP Securities. Please go ahead.
Hey, Thanks for taking the question.
Just wondering about what data were to get in the fourth quarter I'm guessing that might be six month follow up from cohort three in three months from cohort four and previously you had planned on starting that phase to be by year end. So I was hoping to get an update on.
Data and follow up we'll get.
In the fourth quarter, and then you know.
How much time will you need to make a decision and is it going to be primarily based on that three months.
I'm point.
Tom Chula: And is it going to be primarily based on that three month time point? Yeah, so, so great question. As we, as we discussed in our prepared remarks, we're enrolling cohorts. 3 and 4 simultaneously.
Yeah, So great question.
As we discussed in our prepared remarks, we are enrolling cohorts.
Tom Chula: So that data will be presented, at the same time, along with the totality of the data, including Cohorts 1 and 2. I believe at that time we will be able to present the extension study from Cohort 2, but I don't think we'll have... Data from the Extension Study in Cohorts 3 and 4, informing our Phase 2B study, we will have. The three-month data from each of the cohorts, which will help inform, and we'll have some of the extension data. And so we'll use that to help inform the trial design for our Phase 2b study. Got it.
Three and four simultaneously.
That data will be presented.
At the same time, along with the totality of the data.
Including cohorts, one and two.
I believe at that time, we will be able to present the extension study from cohort two.
But I don't.
I don't think we'll have data from the extension study in cohorts three and four.
In terms of.
Informing our phase II B study.
Right.
We will have.
The three month data from each of the cohorts, which will help inform and it will have some of the extension data.
And so we'll use that to help inform that.
Final design.
For our phase II study.
Tom Chula: And Tom, you talked a little bit about the duration and the suspension thing in the supercoronal space and your prepared remarks. Wondering if with the higher dosing, does that change the volume administered or the suspension in any way that gives longer duration as well? Just wondering how to think about, you know, how higher dosing may affect duration of effect here. Yeah, that's a great question. So we're injecting the same volume, but a higher concentration. And basically, you can think of the supercorridor space as nature's drug depot. And we're essentially loading it up with more drugs. And so it should provide more durability.
Got it and Tom you talked a little bit about.
B.
Duration.
And the suspension of staying in the supercritical space in your prepared remarks wondering if with the higher dosing does that change the.
Volume administered or the suspension in any way that gives longer duration as well I was wondering how to think about you know how higher dosing may effect duration of effect here.
Yeah, that's a great question.
So we're injecting the same volume, but at a higher concentration and.
Basically you can think of the supercritical space is new.
Nature's drug depot, and we're essentially loading it up with more drug and so it should provide more durability.
Tom Chula: It also has potential to provide more efficacy. Although this is not an efficacy study, we have, you know, a higher likelihood of seeing a biologic effect. And then with respect to safety, and of course, this is a safety study. It's not the primary goal here.
Also has potential to provide.
More efficacy. Although this is not an efficacy study we have.
You know a higher likelihood of seeing a biological effect and then with respect to safety and of course. This is a safety study with primary <unk>.
Tom Chula: As I mentioned, we've had a very robust safety profile so far. Our preclinical studies support this dose. And again, since this is a small molecule and not a biologic and a small molecule that's been well characterized, we don't anticipate major safety issues. But of course, we have to do the trial to prove that.
Here as I mentioned, we had a very robust safety profile, so far our preclinical studies support this dose.
And.
Again since this is a small molecule and not a biologic.
And a small molecule that's been well characterized.
We don't anticipate.
Major safety issues, but of course, we have to do a trial to prove that.
Tom Chula: Very helpful. Thanks for taking the question. Your next question is from Yi Chen. Thank you for taking my questions. At this point, would you be able to comment on... Initial commercial feedback was like here and when do you expect the initial sales to exceed? 45 million marks.
Very helpful. Thanks for taking the questions.
Yes.
Yes.
Your next question is from <unk> Chen with H C. Wainwright. Please go ahead.
Yes.
Thank you for taking my questions.
At this point, how would you be able to comment on the.
The initial commercial feedback was like a year and when do you expect the initial sales to exceed the.
A 45 minute Mark sought after royalties.
Thank you.
Charlie Deignan: [inaudible] Thanks for the question. We've been very happy with what Bosch has been doing so far. They focused initially on training, which we agree with. They've trained hundreds of retinal physicians so far. And we'll continue to train more. It's been, you know, they've been doing a slow rollout on this. So we think that their approach makes perfect sense.
Thanks for the question.
We've been very happy with what Bosch has been doing so far they focused initially on training, which we agree with.
They trained hundreds of retinal physicians so far.
And we'll continue to train more.
It's been you know they've been doing a slow rollout on this so we think that their approach that makes perfect sense.
Charlie Deignan: They've got this multi-step approach to training and rolling it out, getting people used to the product, getting people used to using the product. And so we're very happy with what they've done so far and what we do know of their plans. What we don't know is we have no insight into their forecasts.
They've got this multi step approach.
<unk> training and rolling it out and people used to the product getting people used to using the product and so we're very happy with what they've done so far and what we do know of their plans and what we don't know.
We have no insight into their forecast so.
Charlie Deignan: So, It's very hard to answer the question that you asked about the $45 million in cumulative sales. Charlie, do you have anything more to add to that? Yeah, I agree. You know, we can't get ahead of Bausch, and, you know, we'll let them provide guidance for the product. Okay, when you start to receive the raw taste, do you expect the raw taste to be based on, Curling Quarters like yourselves, or there will be a quarter or maybe two quarters.
You talked very hard to answer answered. The question that you asked about the 45 million cumulative sales.
Charlie do you have anything more to add to that.
Yeah I agree.
We can't get out at 1000, well, let them provide guidance for the products.
Okay. When you when you start to receive royalties do you expect the royalties to be placed on them.
The.
The current quarter of like yourselves, or if there will be a quarter or two quarter lag.
Charlie Deignan: So, we're still working through the accounting of that, but it most likely, you know, we'll we receive, we'll receive, well, the reports, you know, 60 days after the end of the quarter. So the question is, do we put an estimate in or use a quarter in arrears? But we're still working through that accounting. Okay, thank you. Your next question is from Serge. Serge Belanger for the Needham, please.
So we're still working through the <unk>.
The accounting of that but it most likely will we receive.
Well, we received royalty reports 60 days after the end of the quarter. So the question is do we put an estimate in.
Or use a quarter in arrears, but.
We're still working through.
That accounting.
Okay. Thank you.
Yes.
Your next question is from Sarah.
Bellinger with Needham. Please go ahead.
Hi, good afternoon.
Operator: Hi, good afternoon. I guess a couple questions for Tom first. Based on the, Safety Assessment of Cohort 3. There was no dose-limiting toxicity, so just curious how the one milligram dose was chosen and whether there are any restrictions, either from a volume perspective or formulation, to go higher than that.
Just a couple of questions for Tom first.
Based on the.
Safety assessment of cohort three.
There was no dose limiting toxicity. So just curious how the one milligram dose was chosen and whether there are any restrictions either from a.
Volume perspective or formulation.
To go higher than that.
Tom Chula: And then, secondly, there's a bit of change here in how you intend to report the data. You want to report both cohorts at the same time in the fourth quarter. Just curious what that was driven by, if it was a slower enrollment or just to have a more substantial, Data Readout, one time, thanks. Thanks for the question Serge. The Safety Monitoring Committee only reviewed the one-month safety data from Cohort 3. , and Dr. David B. .
And then secondly.
Tom Chula: . . . . . . . . . . .
There's a bit of a change here and how you intend to report the data.
You want to report that both cohorts at the same time and in the fourth quarter.
Just curious what that was driven by if it was a slower enrollment or just.
To have a more substantial.
Data read out.
One time.
Thanks for the question Serge.
As I mentioned.
The safety monitoring committee I'm only reviewed the one month safety data.
From cohort three.
CLSA dosing.
They determined that there was no dose limiting toxicity.
I agree that we could move forward with a higher dose of one milligram.
Tom Chula: We chose the one milligram dose because of our, preclinical studies support that dose with respect to safety. And it seemed that, you know, doubling was an appropriate amount of increase. And since we're, Since they assessed only the one-month safety data, we decided to.., continue to advance, and progressed the program as fast as possible, so we opened up recruitment to cohort four. And so since there's only a small gap between the end of cohort. 3, and Cohort 4, we thought it was prudent to report all the data. And I think, was there a question? Yeah, I just have one more.
We chose the one milligram dose because of our.
Preclinical studies.
Port that dose with respect to safety and it seemed that doubling.
It wasn't appropriate.
Amount of increase.
And.
Since we are.
Since they assessed only the one month.
The data we decided to.
Continue to advance.
And progressed the program as fast as possible. So we opened up recruitment to cohort four and so since theres only.
Small gap.
Between the end of cohort.
Three and cohort four.
Thought it was prudent to report all the data at one.
And I think makes sense.
<unk>.
Tom Chula: I guess with the launches right here.., of the supercruidal injection platform goes a little more mainstream with the launch of the product. Just curious if you think that could be the genesis of additional collaborations going forward. Well, go ahead, Tom, you can weigh in if you want.
Yeah, just had one more I guess with the.
The launches of <unk>.
Super Crudele injection platform goes a little more mainstream with the launch of the product just curious if you if.
If you think that could be the genesis of the additional collaborations going forward.
Well, we like.
Go ahead, Tom you can you can weigh in pure well without them.
Tom Chula: Well, I think, you know, clearly that helps support the platform. I think that patients are eager to be trained, to try that, have gotten a lot of unsolicited emails from physicians who have tried Zyper on their patients and are excited about the results. So certainly it does help support the platform. And, you know, I think that would, naturally tend to inspire this collaboration. And I'll turn this back over to George.
You know clearly that helps support the platform.
I think that these are eager to be trained.
To try it out.
Gotten a lot of.
Unsolicited emails from physicians who have.
Try and giant here in their patients and are excited about the results.
So certainly it does help.
Support the platform and I think that would.
It just naturally.
Tend to inspire.
Collaboration.
Turn this back over to George.
George Lasezkay: Yeah, the only thing I would add to what Tom was saying is that, It has increased interest by other companies in considering collaborations with us. I've mentioned on other calls that while partnering is not the lead concept in our strategy, we do have chats with a number of companies that are interested in potentially collaborating, and that really focuses on the approach of gene therapy, delivering gene therapy into the supercoronal space in areas not otherwise covered by the Regenexx bio, agreement. So we do have those conversations.
Yeah, the only thing I would add to what Tom was saying is that.
It has increased interest by other companies in and considering collaborations with US I've mentioned on other calls that while partnering is not.
The the lead concept in our strategy, we do have chats with a number of companies that are interested in potentially collaborating and that really focuses on our the approach of gene therapy.
Into the delivering gene therapy into the Super Kronos space.
In areas not otherwise covered by the <unk> bio.
George Lasezkay: It has sparked additional interest now that they've seen the injector system. Department of Diapere is approved and that physicians, a wide variety of physicians are being trained, that's, that is clearly made possible, other companies interested in talking about potential partnerships with us. Great, thank you. Your next question is from Adam. Hi, this is Stacey calling in for Annabel.
Agreement. So we do have those conversations it has sparked additional interest now that they've seen the injector system.
It's part of XI Pierre is approved and that physicians a wide variety of physicians are being trained.
That's that is clearly made.
Other companies are interested in talking about potential partnerships with us.
Great. Thank you.
Your next question is from animals.
With Stifel. Please go ahead.
Hi, This is stacy calling in for Annabel Congrats on all the Oasis.
Operator: Congrats on all the OASIS development and thanks for taking our questions. So on CLS-AX, given that you have the opportunity to push the dose higher in the fourth cohort, can you tell us whether you'll be seeking longer duration than three months? I realize that that's how often people go in to see their retina specialist, but the development market is pushing for six months or longer now. And also now that you're working with a pan-VEGF mechanism, is there any aspiration to have more efficacy than just a single anti-VEGF target? Could there possibly be anticipation for superiority? Thank you. You know, great question.
And then a question on CLS.
Given that you have the opportunity to push the dose higher in the fourth cohort can you tell us whether you'll be seeking a longer duration than three months.
That's how often people go.
Alright, and a specialist but.
And then Mark a question for six months or longer now.
Also now that you are working with a pan JAK mechanism is there any aspirations to have more efficacy than just the single anti VEGF target set there possibly.
Our anticipation for superiority. Thank you.
Tom Chula: So, you know, as we continue to escalate the dose, you know, we would naturally expect additional durability. I think that, There is interest in much longer duration, you know, six months and longer. I think for the vast majority of, what's approved and what's.., and Development. That's a bit aspirational.
Yeah, Great question so as.
We continue to escalate the dose.
We would naturally expect additional <unk>.
Durability.
I think that there is interest in much longer duration, you know six months and longer.
I think for the vast majority of.
What's approved and what's.
Tom Chula: I think the reality is that, Most of these injectable therapies last on the order of three months. And so, you know, it's possible that we may see more than that. And certainly, we're going to assess for that in our extension study. So that's, you know, our thoughts around durability. And with respect to efficacy, you know, as you touched upon with the pan-VEGF effect, we may actually have additional efficacy over a focused VEGF-A inhibitory strategy.
In development.
That's a good aspirational I think the reality is that.
Most of these injectable therapies.
On the order of three months.
And so it's possible that we may see more than that and certainly we're going to assess for that in our extension study.
So that's.
Our our thoughts around durability and with respect to efficacy.
You touched upon.
With the pen bed, yes.
We may actually have additions.
Additional efficacy over a focus that yesterday.
Inhibitory strategy and certainly with the supercritical injection platform we can.
Tom Chula: And certainly, with the supracortial injection platform, we can achieve very high levels in the targeted core retinal tissues very rapidly. And that may further leverage the pan-VEGF effect to enhance efficacy. But again, we're, you know, I don't want to get ahead of myself.
<unk> achieved very high levels and the targeted Corey retinal tissues.
Rapidly and that May further leverage them.
Can betcha effect to enhance efficacy, but again.
I don't want to get ahead of myself the waste to study is really about.
Tom Chula: The OASIS study is really about safety. These patients, as I mentioned, are all patients who have been treated in the past, and they have persistent active disease based on independent reading centers. So, these are difficult to treat refractory cases.
Safety these patients as I mentioned.
All patients who have been treated in the past and they have persistent active disease based on independent Reading center. So these are these are difficult to treat refractory cases.
Tom Chula: And, you know, I just want to be cautious about putting guidance out there that we're going to see, better efficacy in this very small first-in-man single-dose escalating trial. But certainly, we're going to assess for all this and look for those six. Amazing. Thank you so much.
And.
You know I.
I just wanted to be cautious about putting guidance out there that we're going to see.
<unk> efficacy in this in this very small.
First in man single dose escalating trial, but certainly we're going to assess.
For all of this and look for those signals.
Amazing Thank you so much.
Tom Chula: Your last question is from Julian Harris. Hi, congrats on all the recent progress and thank you for taking my questions. Most of mine have already been asked and you've made some comments related to this topic already, but just wondering if you could talk more about how important you think brand recognition and general familiarity with your micro injector device is among physicians across all your opportunities from Zyper and beyond. Thanks. Tom, do you want to comment on that first? Sure, I can start.
Your last question is from Julian Harrison with B T. I D. Please go ahead.
Hi, Congrats on all the recent progress and thank you for taking my questions. Most of mine have already been asked and you've made some comments related to this topic already but just wondering if you could talk more about how important you think brand recognition and general familiarity with your micro injector device is among physicians.
First of all your opportunities.
From <unk> and beyond thanks.
Okay.
Tom do you want to comment on that first.
I can start and I think.
Tom Chula: You know, I think, When it comes to supracortal delivery, we're obviously the first in class, best in class. We've been very, very active in all of the retina congresses for the last four years. I think last year we had over 35 presentations at retina congresses. Very active in publications and speaking.
When it comes to soup supercritical delivery, where obviously the.
First in class best in class.
We've been very very active in all of the retina Congresses for the last.
For years, I think last year, we had over 35 presentations at retina Congresses.
Very active in publications and speaking.
Tom Chula: And I think we are building up a very good brand recognition and certainly the approval of the IPR and training of all the U.S. retina and uveitis specialists, enhances that. As I mentioned earlier, there's always a lot of interest in gene therapy. So I think Regenexx Bio's two phase two studies have attracted a lot of interest, and as have Aura's studies in colloidal melanoma.
And I think we are building up a very good brand recognition and certainly the approval of the IPR and training along the U S a retina and uveitis.
Lewis.
Enhances that.
As I mentioned earlier Theres always a lot of interest in gene therapy, So I think rejects bias.
Two phase III studies.
Have attracted a lot of interest in.
Tom Chula: So I think the brand recognition continues to develop. As George mentioned, We receive an increasing number of inbound calls and inquiries about, you know, potentially working with other companies. And I guess the last thing I want to say before turning it over to George is right now, If you include ARCTIC vision, which is assessing, DOSGA or wherever. Xi Peer in China, we currently have in clinical trials a corticosteroid being assessed with our SCS microinjector, a tyrosine kinase inhibitor being assessed with our microinjector, a gene therapy and a virus-like drug conjugate.
Yeah, as half or as Ah studies, and colloidal melanoma. So I think that the brand recognition continues to develop as George mentioned.
We receive an increasing number of inbound calls and inquiries about it.
You know potentially working with other company.
Companies are.
And I guess, the last thing on Wednesday before turning over to Georges is right now.
If you include Arctic vision, which is assessing P.
P O S T a R.
XI Pierre.
China.
We currently have in clinical trials.
Steroids are.
Being assessed with Rcs micro injector, a tyrosine kinase inhibitor being assessed their micro injector.
Gene therapy, and a virus like drug conjugate and I think that really.
Tom Chula: And I think that really enhances the brand, it really showcases the versatility of a platform, It's really, I think, a very exciting time for supracortal delivery. I wish I could add something to that, Tom, but I can't. I think that's I think that's the perfect answer to that. And that brand recognition will continue to grow, especially as those trials progress and especially as BAUSH continues its training program to train the vast majority of retinal specialists in the United States.
Really enhances the brand, but it really showcases the versatility of the platform and it's really I think a very exciting time.
Or supercritical delivery.
I wish I could add something to that time, but I can't I think that's I think that's a perfect answer to that.
And that brand recognition, we will continue to grow, especially as those trials progress and.
Especially as Bausch continues its training program to train.
The vast majority of retinal specialists in the United States. We're gonna have ended up with hundreds and hundreds and if not into over 1000 physicians at least in the United States.
Tom Chula: We're going to have we'll end up with hundreds and hundreds, and if not into over a thousand physicians, at least in the United States, that have been exposed to it. They've been exposed to the training on it.
That had been exposed to what they've been exposed to the training on it and.
George Lasezkay: And when you talk to them once they're trained, they're always amazed at the simplicity and the reliability of the delivery system. So, and again, just to emphasize what Tom said on the versatility, we've got four different therapeutic modalities and six different clinical trials right now. So, it really is demonstrating the versatility and the flexibility of the system as well as the reliability and ultimately the simplicity, but the reliability of the system. So, we're very excited about the growing awareness of the system and the approach. So, it's very exciting. Very rewarding. Exciting all around. Thank you very much. And that concludes the question.
When you talk to them once they're trained they're always amazed.
<unk> and the reliability of the <unk>.
Delivery system so.
And again just to emphasize what Tom said on the versatility, we've got four different therapeutic modalities in six different clinical trials right now so.
Yeah. It really is demonstrating the versatility and flexibility of the system as well as the reliability.
And ultimately.
The simplicity, but the reliability of the system. So we're very excited about the growing awareness.
The of the system and the approach.
It's very exciting for us very rewarding.
Exciting all around thank you very much.
Sure.
And that concludes the question and answer session I will now turn the call back over to George <unk>, President and CEO for any final comments.
George Lasezkay: I will now turn the call back. I just want to thank everybody for joining us on the call this afternoon. As always, we appreciate your continued interest in Clearside Biomedical and we look forward to updating you on our progress in the future. Operator, you may now disconnect the call and thank you again. Thank you, sir. Ladies and gentlemen, this concludes today's conference. [music]
I just want to thank everybody for joining us on the call. This afternoon.
As always we appreciate your continued interest in clear sight biomedical and we look forward to updating you on our progress in the future.
Operator, you may now disconnect the call and thank you again everyone.
Thank you, Sir ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect stay safe and well advocating.
[music].
Right.
[music].
Yes.