Q2 2021 Clearside Biomedical Inc Earnings Call
Good day, everyone and thank you for standing by and welcome to the clear side. The biomedical second quarter of 2021 financial results and corporate update call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question during the <unk>.
Operator: Welcome to the Clearside Biomedical 2nd Quarter 2021 Financial Results and Corporate Update call. At this time, all participants are in a listen-only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press Star 1 on your telephone. And please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Ms. Jenny Kobin, Clearside Investor Relations. Please, go ahead.
You will need to press star 1 on your telephone.
And please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over your speaker today, Ms. Jenny Kogan Glucide Investor Relations. Please go ahead.
Jenny R. Kobin: 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 of the Private Securities Litigation Reform Act of 1995. However, 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, 2020, and our other SEC filings available on our
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.
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 2020.
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.
Jenny R. 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.
Change on today's call, we have George Lizabeth gay, 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 up for your questions. During our call today, Dr. Chew low will discuss the key reserve.
Jenny R. Kobin: 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 to your questions. During our call today, Dr. Chula will discuss the key results from Cohort 1 of our Phase 1-2a clinical trial for CLSA-X that we announced last month. Slides related to this data are available on our website as supporting materials for this Earnings Call webcast. Now, I'd like to turn the call over to George.
<unk> from cohort 1 of our phase 1.2 a clinical trial for C. L. S. A X that we announced last month slides related to this data are available on our website as supporting materials for this earnings call webcast now I'd like to turn the call over to George.
George M. Lasezkay: Thank you, Jenny. Good afternoon, everyone, and thank you for joining us on the call today. We continue to demonstrate our position as the leader in the supercorroidal space with multiple clinical trials in several different ophthalmic indications, a new drug application for Zypyr, currently under FDA review, and recent positive results from our CLS-AX wet AMD clinical trial. We are the first company to develop a clinically tested, non-surgical, repeatable, micro-injection technology designed to unlock the potential clinical benefits of administering drugs into the supracaroteal space.
Thank you Jenny.
Good afternoon, everyone and thank you for joining us on the call today.
We continue to demonstrate our position as the leader in Supercoil space with multiple clinical trials in several different ophthalmic indications on new drug application for XI tier currently under FDA review and.
In a recent positive results from our CLS Ax wet AMD clinical trial.
We are the first company to develop a clinically tested nonsurgical repeatable micro injection technology designed to unlock the potential clinical benefits of administering drugs into the super cooler space.
George M. Lasezkay: We have over 85 global patents to protect our platform technology, which includes patents covering our proprietary SES microinjector, as well as the delivery of therapeutic agents into the supercoronal space. Internally, our research team has proven our capabilities to transform existing small molecule drugs into proprietary suspensions for delivery into the supracarotid space to target back-of-the-eye diseases. Our first product candidate, Xypyr, is a proprietary suspension of trine spinelotacetamide for the potential treatment of patients with macular edema associated with uveitis, if approved.
We have over 85 global patents to protect our platform technology, which includes patents covering our proprietary SCS microinject or as well as the delivery of therapeutic agents into the Super core EDA space.
Internally our research team has proven our capabilities to transform existing small molecule drugs into proprietary suspensions for delivery into the supercritical space to target back of the eye diseases.
Our first product candidate <unk>.
Proprietary suspension of triamcinolone, acetonide, but the potential treatment of patients with macular edema associated with uveitis.
If approved.
Excuse me <unk> is now under review by the U S. FDA with a <unk> action date of October 32021.
George M. Lasezkay: Zyper is now under review by the US FDA with a PDUFA action date of October 30, 2021. If approved, Xipir will be our first commercial product, the first therapy approved for macular edema associated with uveitis, and the first product ever approved for supracaroidal administration. Zypr will be sold in the U.S. and Canada by Bausch Health and Bausch & Lomb, its leading global eye health business.
If approved <unk> will be our first commercial product the first therapy approved for macular edema associated with uveitis.
And the first product ever approved for Super Choroidal administration.
Ciber will be sold in the U S and Canada by our partner Bausch health and Bausch and Lomb, its leading global eye health business.
George M. Lasezkay: In addition, Arctic Vision, our partner in Greater China and South Korea, is planning a confirmatory phase three clinical trial in macular edema associated with uveitis to begin in China later this year with the ultimate goal of commercializing Zype here in that region. The lead clinical development candidate in our pipeline is CLSA-X, which combines our proprietary suspension of the tyrosine kinase inhibitor ExibNib for suprachoroidal delivery with our STS microinjection, as Tom will discuss in detail.
In addition, Arctic vision, our partner in greater China, and South Korea is planning a confirmatory phase III clinical trial in macular edema associated with uveitis to begin in China. Later this year with the ultimate goal of commercializing Zip here in that region.
Our lead clinical development candidate in our pipeline and CLS Ax, which combines our proprietary suspension of the tyrosine kinase inhibitor acceptance for <unk>.
Supercoil delivery with our S T S micro injector.
As Tom will discuss in detail, we achieved are safety and tolerability objectives in cohort 1 of our phase 1.2 a oasis trial in patients with wet AMD.
George M. Lasezkay: We achieved our safety and tolerability objectives in Cohort 1 of our Phase 1-2a OASIS trial in patients with wet AMD. We are now enrolling Cohort 2 and expect to complete recruitment this month with data by the end of this year. With the pan-VEGF attributes of exsidinib delivered to the suprachoroidal space, we have the opportunity to improve the treatment of patients with wet AMD, as we believe CLSAx may offer improved safety and efficacy, as well as prolonged durability by reducing the frequency of patient injections.
For now enrolling cohort 2 and expect to complete recruitment this month with data by the end of this year.
With the Pan VEGF attributes of exiting delivered to the Super Gorilla space, we have the opportunity to improve the treatment of patients with wet AMD as we believe CLSA ex may offer improved safety and efficacy as well as prolonged durability by reducing the frequency of patient injections.
George M. Lasezkay: The clinical experience with our SCS microinjector is unparalleled. Clearside has tested it in over 1,200 supercorroidal injections in multiple global clinical trials in a variety of retinal disorders. The safety profile of our supercoroidal injections is comparable to intravitreal injections with no procedure-related serious adverse events to date.
The clinical experience with our S. T S micro injector is unparalleled.
Mirror side, we've tested it in over 1200, Supercoil injections in multiple global clinical trials in a variety of retinal disorders.
The safety profile of our Supercoil injections is comparable to inter betrayal injections with no procedure related serious adverse events to date in.
George M. Lasezkay: In addition, we have published data that indicates the suprachoroidal injection procedure utilizing our SCS microinjector is well accepted by physician investigators and could readily be adopted in clinical practice by retinal specialists. Furthermore, our technology is currently being used in three separate clinical trials being conducted by our two clinical development partners, Regenexx Bio and OroBioStem. Regenexx BIO is delivering its AAV-based gene therapy with our STS microinjector in two ongoing phase 2 clinical trials in wet AMD and diabetic retinopathy, potentially transforming gene therapy delivery into an office-based non-surgical treatment option.
In addition, we have published data that indicates the supercoil injection procedure utilizing our S. E. S. Micro injector is well accepted by physician investigators and could readily be adopted in clinical practice by retinal specialists.
Further our technology is currently being used in 3 separate clinical trials being conducted by our 2 clinical development partners for <unk> bio and Aura Biosciences for.
For <unk> bio is delivering its AAV based gene therapy with our S. T S. Micro injector in 2 ongoing phase II clinical trials in wet AMD and diabetic retinopathy potentially transforming gene therapy delivery into an office based non surgical treatment option.
George M. Lasezkay: As Tom will discuss shortly, Regenexx Bio continues to make meaningful progress on both of these programs, and OroBiosciences is delivering their viral-like drug conjugate into the suprachoroidal space to treat choroidal melanoma, again, using our SCS microinjector. We are excited about the progress to date with our partners and look forward to future results from these trials. As such, we believe we are the leader in developing small-molecule supracaroidal products and the partner of choice for the delivery of a variety of other therapeutic agents into the supracaroidal space. I will now turn the call over to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to delve into our CLSAX data and review our partners' programs. Tom?
As Tom will discuss shortly Regenesis bio continues to make meaningful progress on both of these programs and aura Biosciences is delivering their viral like drug conjugate into the Super Gorilla space to treat choroidal melanoma again, using our SCS microinjection.
We are excited about the progress to date with our partners and look forward to future results from these trials.
As such we believe we are the leader in developing small molecule supercoil products and the partner of choice for the delivery of a variety of other therapeutic agents into the supercritical space.
I will now turn the tall the call over to Dr. Tom Ciulla, Our Chief Medical Officer, and Chief Development Officer to delve into our CLSA X data and review our partners' programs.
Tom Chula: Thank you, George, and good afternoon, everyone. Today, I'm going to focus primarily on our CLS-AX clinical program and the positive safety results we reported last month from cohort one of our OASIS Phase I-IIa clinical trial in patients with wet AMD. As Jenny mentioned at the outset of the call, slides related to this data are available on our website at Supporting Materials for this webcast. CLSA-X is our proprietary suspension of excitinib delivered via our SCS microinjector into the supracortal space.
Thank you George and good out.
And on everyone today on the focus primarily on our CLSA acts clinical program and positive safety results. We reported last month from cohort 1 of our Oasis phase 1 to a clinical trial in patients with wet AMD as Jenny mentioned at the outset of the call slides related to this data are available on our website.
Supporting materials for this webcast.
C O S. A X is our proprietary suspension of exiting it delivered via our SCS microinjection for the supercritical space.
Tom Chula: In this program, we are marrying a very highly potent tyrosine kinase inhibitor with the potential benefits of supracortal delivery. Importantly, excitinib is designed to inhibit all of the VEGF receptors as opposed to the currently improved agents that bind only to VEGFase.
And this program we are marrying a very highly potent tyrosine kinase inhibitor with the potential benefits of Supercoil delivery.
Importantly, exit inhibitor designed to inhibit all of the VEGF receptors as opposed to the currently approved agents that buying only the bedroom.
And with our proprietary SCS microinject or were you able to specifically target the affected cori retinal tissue as rapidly and they can compartmentalize that therapy away from unaffected tissues for potential safety benefits.
Tom Chula: And with our proprietary SCS microinjector, we're able to specifically target the affected core retinal tissues rapidly, and we can compartmentalize our therapy away from unaffected tissues for potential safety benefits. We've seen the benefits of supercoronal delivery with our first product candidate, Xypyr, and now some preliminary signs of benefit in our first data set with CLSAF. As a reminder, the design of our Phase 1-2A clinical trial is an open-label study to establish the safety and tolerability of escalating doses of CLSA-X in patients suffering from wet AMD.
We've seen the benefits of Super credit delivery with our first can't product candidate XI peer analysis on preliminary signs of benefit in our first dataset with CLS Ax.
As a reminder, the design of our phase 1.2 a clinical trial is an open label study to establish the safety and Tolerability of escalating doses of CLSA X in patients suffering from wet AMD. The study involves 3 cohorts of approximately 5 patients each and we start of cohort 1 in a very logos in order to establish.
Tom Chula: The study involved three cohorts of approximately five patients each, and we started cohort one at a very low dose in order to establish a floor of safety. Now, I'd like to walk you through the details of a patient's journey in our trial. Patients have a diagnosis of lead AMD for which they've received a minimum of two prior anti-digest injections. Patients have active disease with suboptimally controlled choroidal neovascularization despite multiple doses of the antidigesteric.
It's on for safety.
Now I'd like to walk you through the details of the patient journey in our trial patients have a diagnosis of wet AMD for which they received a minimum of 2 prior anti digest injections.
Patients have active disease with suboptimal controlled choroidal Neovascular innovation, despite multiple doses of the anti Digest Paragon.
Tom Chula: Once deemed potentially eligible for our trial, patients are screened, which includes standard visual acuity testing and imaging that is ultimately assessed by an independent mass reading system. The patient receives a single dose of Fliversep, and the reading center confirms eligibility. One month later, the patient returns, undergoes the same assessments, and then receives a supracortial dose of CLSAF. Patients have been monitored monthly for three months. What I like about this trial design is that it allows us to assess patients in a crossover fashion.
<unk> potentially eligible for our trial patients are screened which includes standard visual acuity testing and everything that is ultimately a SaaS by an independent masked reading center. The patient received a single dose on the flavors out in the reading center confirms eligibility 1 months later the patient returns undergoes the same assessments.
Net receipts of supercritical Delta CLS Ax patients have been monitored monthly for 3 months.
What I like about this trial design is that it allows us to assess the patients on a crossover fashion, where first able to assess how patients perform 1 month after treatment with a flipper set then compare how the same patients performed 1 month after treatment with CLS Ax.
Tom Chula: We are first able to assess how patients perform one month after treatment with the Flivr set and then compare how the same patients perform one month after treatment with CLS-AS. In Cohort 1, the patients' average age was 82, and each was highly treatment experienced. On average, patients had 26 prior anti-ZHF injections and received nine injections on average in the year prior to screening. Let me walk you through the summary of the data for each of the most important components we monitor in the trial.
On cohort 1 the patients average age was 82.
And he was highly treatment experienced on average patients had 26 prior anti VEGF injections and received 9 injections on average in the year prior to screening.
Let me walk you through the summary of the data for each of the most important components, we monitoring the trial.
Tom Chula: Starting with safety, we're pleased to report that no study suspension or stopping rules were met. There were no serious adverse events, and importantly, there were no signs of inflammation, vitreous haze, interocular pressure, safety signals, vasculitis, or individual dispersion of CLSAF. There were two treatment-emergent adverse events that were assessed as unrelated to CLSA-X, one with atrial fibrillation and one with subconscientival hemorrhage assessed to be related to the subconscientival lidocaine anesthetic injection.
Starting with safety. We're pleased to report that no study suspension of stopping rules from that there were no serious adverse events and importantly, there were no signs of inflammation vitreous haze interactive a pressure safety signals vasculitis, where interventional dispersion of CLSA X. They were 2 treatment emergent adverse events that were assessed as.
Related to CLS Ax, 1 with atrial fibrillation and 1 was sub constant title hemorrhage assessed to be related to the subconjunctival lidocaine anesthetic injection.
Moving now to the outcomes related to best corrected visual acuity at baseline prior to CLS Ax administration. The mean best corrected visual acuity score was 59 letters with the range of 29 to 74.
Tom Chula: Moving now to the outcomes related to best corrected visual acuity, at baseline, prior to CLSAx administration, the mean best corrected visual acuity score was 59 letters with a range of 29 to 74. In Cohort 1, we observed important changes in best-corrected visual acuity. One month after receiving flibrisept, three patients worsened, and three improved, all within three letters. Therefore, on average, they worsened by 0.2 letters, indicating that there was no mean change in best-corrected visual acuity for patients treated with flibrisept.
In cohort 1 we observe important changes in best corrected visual acuity.
1 month after receiving a flipper set 3 patients worth inventory improve all within 3 letters. Therefore on average they worsened by 0.2 letters, indicating that there was no mean change in best corrected visual acuity for patients treated with <unk>.
In contrast, 1 month after receiving our CLS ax dose 5 of 6 patients improve by for more letters with the main improvement for the entire.
Body of 6 patients up for 0.7 letters.
Tom Chula: In contrast, one month after receiving a CLSA-X dose, five of six patients improved by four or more letters, with the mean improvement for the entire body of six patients of 4.7 letters. This was statistically significant on post hoc analysis with a p-value of 0.029. Regarding central subfield thickness of the macula, patients had a mean CFT of 231 microns just prior to receiving CLSAF. I would like to highlight here that this is essentially a normal value and creates a floor effect with CST.
This was statistically significant on post hoc analysis with a P value of 0.0 to 9.
Regarding central subfield thickness of the macula patients had a mean T. S. T of 231 microns just prior to receiving CLSA next I would like to highlight here that this is essentially a normal value and creates a floor effect with C. S. T. In other words, if patients start on average with normal values they are unlikely to improve.
Importantly, the mean P. S T with stable 1 month post CLS Ax.
Durability is an important component of our treatment plan and we were encouraged by the preliminary signs of potential durability that we saw on cohort 1 and is highly treatment experienced patients, especially given the low starting dose of CLS Ax, we have 3 criteria to determine if patients need additional therapy. These include a loss of 10 or more letters.
Tom Chula: In other words, if patients start on average with normal values, they are unlikely to improve. Importantly, the mean CST was stable one month post-CLS-AS. Durability is an important component of our treatment plan, and we were encouraged by the preliminary signs of potential durability that we saw in Cohort 1 in these highly treatment experienced patients, especially given the low starting dose of CLSAF. We have three criteria to determine if patients need additional therapy. These include a loss of 10 or more letters from best-measured visual acuity at any point in the trial, an increase in CFT by greater than 75 microns, or a vision-threatening macular hemorrhage.
On best measured visual acuity at any point in the trial and increase in C. S T by greater than 75, microns and or a vision threatening macular hemorrhage.
With the best corrected visual acuity measurement I'd like to emphasize that we are assessing from the patient's best division at any point in the trial, including after receiving a flipper set for CLS Ax as a result patients are more likely to be retreated in our trial, which is focused on safety.
Importantly in cohort 1 accurate feeding CLS ax at 1 month no patients required additional treatment at 2 months for patients required re treatment of liver cells at 3 months, 2 patients or 33% of the patients did not require additional treatment.
Tom Chula: With the best corrective visual acuity measurement, I'd like to emphasize that we are assessing from the patient's best vision at any point in the trial, including after receiving FLIBRASEP or CLS-AX. As a result, patients are more likely to be retreated in our trial, which is focused on safety. Importantly, in Cohort 1, after receiving CLSEx, at one month, no patients required additional treatment.
In these 2 patients their vision actually improve.
1 by 5 letters and 1 by 7 letters.
With these results from cohort 1 we have now advanced to cohort 2 at a dose of 0.1 milligram. This is a 3.3 fold increase compared to the cohort 1 data and ultimately we expect the cohort 3 dose of 0.3 milligrams, which is a 10 fold increase over the cohort 1 dose and.
In cohorts 2 and 3 we're also adding a 3 month extension study to follow patients over a longer period of time.
Tom Chula: At two months, four patients required re-treatment with the Flivr system. At three months, two patients, or 33% of the patients, did not require additional treatment. In these two patients, their vision actually improved one by five letters and one by seven letters.
As George mentioned, we're very pleased with the progress in enrollment for cohort 2 and expect to complete recruitment. This month, we expect to report data from cohort 2 by the end of the year.
With respect to partner programs as George mentioned organic style continues to advance their programs utilizing our SCS microinjection in both of their phase II clinical trials evaluating the efficacy safety and Tolerability of supercritical delivery of their gene therapy agent Rdx 3.2014, the first try.
Tom Chula: With these results from Cohort 1, we have now advanced to Cohort 2 at a dose of 0.1 mg. This is a 3.3-fold increase compared to the Cohort 1 data. And ultimately, we expect a Cohort 3 dose of 0.3 mg, which is a 10-fold increase over the Cohort 1 data. In cohorts 2 and 3, we're also adding a 3-month extension study to follow patients over a longer period of time. As George mentioned, we're very pleased with the progress in enrollment for Cohort 2 and expect to complete recruitment this month.
Trial entitled Aviate, the targeting the treatment of patients with severe wet AMD, who are responsive to anti VEGF treatment.
In their second quarter earnings announcement yesterday, they reported on all 3 of their cohorts from the trial for cohort 1 they will report interim data at the Retina Society scientific meeting that will take place from September 29 for October 2nd half this year.
For cohort 2 they expect to report interim data in the fourth quarter of 2021.
And for cohort 3 day is completed dosing in patients who are positive for neutralizing antibodies.
Tom Chula: We expect to report data from Cohort 2 by the end of the year. With respect to partner programs, as George mentioned, Regenexx Bio continues to advance their programs utilizing our SDS microinjectors in both of their Phase II clinical trials, evaluating the efficacy, safety, and tolerability of supercortical delivery of their gene therapy agent, RGX314. The first trial, entitled AVIATE, is targeting the treatment of patients with severe wet AMD who are responsive to anti-digestive treatment.
The second Archie extra 14 clinical trial is a phase III trial for the treatment of diabetic retinopathy entitled altitude for this trial <unk> bio has completed enrollment of diabetic retinopathy patients in cohort 1 and expect to report initial data in the fourth quarter of 2021.
<unk> bio has also reported that enrollment of patients in cohort 2 has begun.
They have also announced plans to enroll diabetic retinopathy patients on a third cohort of altitude, which will evaluate RG <unk> hundred 14 in patients who are positive for neutralizing antibodies as in previous cohorts patients will not receive prophylactic immune suppressive corticosteroid therapy before or after administration of RPX screen for 14.
Tom Chula: In their second quarter earnings announcement yesterday, they reported on all three of their cohorts in the trial. For Cohort 1, they will report interim data at the Retina Society Scientific Meeting that will take place from September 29 to October 2 of this year. For Cohort 2, they expect to report interim data in the fourth quarter of 2021, and for Cohort 3, they have completed dosing in patients who are positive for neutralizing antibodies.
The continued progress by we can expire with very encouraging and we look forward to their data presentations later this year.
In addition, we're very excited about the status of our clinical development programs and the progress from our partners.
We will remain active within the retina physician community over the second half of the year as we plan to have presentations at the retina Society meeting the meeting of the American Society of retina specialists and the American Academy of Ophthalmology medical meeting as long as participation and other ophthalmic industry events.
Intimately, we believe that CLS Ax may improve the overall patient experience with a more durable treatment and a favorable tolerability profile and we look forward to keeping you updated.
I'll now turn the call over to our CFO, Charlie Deignan to review our financial results.
Thanks, Tom on.
Financial results for the second quarter were published this afternoon in our press release and are available on our website. Therefore, I'll I will summarize our current financial status for.
Tom Chula: The second RGX-314 clinical trial is a phase 2 trial for the treatment of diabetic retinopathy entitled Alpha-T. For this trial, Regenexx Bio has completed enrollment of diabetic retinopathy patients in Cohort 1 and expects to report initial data in the fourth quarter of 2021. Regenexx also reported that enrollment of patients in Cohort 2 has begun. They have also announced plans to enroll diabetic retinopathy patients in the third cohort of Altitude, which will evaluate RGX314 in patients who are positive for neutralizing antibodies. As in previous cohorts, patients will not receive prophylactic immune suppressive corticotherapy before or after administration of RGX314.
Our cash on cash equivalents as of June 30th 2021 total approximately $26 million. This includes approximately $7 million in aggregate net proceeds from the use of our ATM facility in the quarter, providing an additional quarter of cash runway.
Our quarterly cash burn is primarily due to the work on the activities related to our CLSA X program and obtaining approval for <unk>.
Investments in our broader research pipeline, we're also incorporating into our operating plans.
Based on our current funding of planned spend we expect to have sufficient resources to fund our operations into the second quarter of 2022.
Tom Chula: The continued progress by Regenexx Bio is very encouraging, and we look forward to their data presentations later this year. In addition, we're very excited about the status of our clinical development programs and the progress from our partners. We will remain active within the retina physician community over the second half of the year, as we plan to have presentations at the Retina Society meeting, the meeting of the American Society of Retina Specialists, and the American Academy of Ophthalmology Medical Meeting, as well as participation in other ophthalmic industry events.
Importantly, this estimate does not include additional milestone payments, we may receive under our current partnership agreements.
<unk> is approved we expect to receive up to $15 million from Bausch and lomb and approval and prelaunch milestones.
Additionally, we will receive a milestone payment from Arctic vision of $4 million.
Thus, we may receive nearly $20 million of non dilutive funding before the end of this year.
We appreciate the interest and support from our shareholders and the broader investment community and we look for chip participating in investor events. This month, the Wedbush pack growth Health care Conference Tomorrow, and the H C. Wainwright Ophthalmology Conference next week I will now turn the call back over to George for his closing remarks.
Tom Chula: Ultimately, we believe that CLSAx may improve the overall patient experience with a more durable treatment and a favorable tolerability profile, and we look forward to keeping you updated. I will now turn the call over to our CFO, Charlie Deignan, to review our financial results. Thanks, Tom. Our financial results for the second quarter were published this afternoon in our press release and are available on our website. Therefore, I will summarize our current financial status. Our cash and cash equivalents as of June 30, 2021 totaled approximately $26 million.
Thanks, Charlie.
We believe clear side is well positioned for future growth with the potential approval of XI Pierre <unk>.
Recent positive data from our Oasis study targeting large wet AMD market and.
Multiple clinical and commercial partnerships with top companies in their respective fields.
Our innovative platform makes us the clear leader in the delivery of drugs into the Super growth space with a reliable non surgical office based treatment approach, we continue to make meaningful progress as we execute on our internal corporate milestones worked closely with our partners and look forward to making a difference for patients suffering from a broad range of potential.
Charles A. Deignan: This includes approximately $7 million in aggregate net proceeds from the use of our ATM facility in the quarter, providing an additional quarter of cash burn. Our quarterly CAS burn is primarily due to work on the activities related to our CLSAx program and obtaining approval for CYPIR. Investments in our broader research pipeline are also incorporated into our operating plan. Based on our current funding and planned spend, we expect to have sufficient resources to fund our operations into the second quarter of 2022.
<unk> blinding diseases.
I would now like to ask the operator to open the call up for questions.
Thank you that's our CEO Joseph S K.
Despite as a reminder to all our participants to ask a question. Please press star 1.
Let's begin with our first question is coming from.
Charles A. Deignan: Importantly, this estimate does not include additional milestone payments we may receive under our current partnership agreements. If Xipir is approved, we expect to receive up to $15 million from Bausch & Lomb for approval and pre-launch milestones. Additionally, we will receive a milestone payment from Arctic Vision of $4 million. Thus, we may receive nearly $20 million of non-dilutive funding before the end of this year.
He says cash by Mispronounce, It Inc. Zigbee Gela from Roth Capital Partners. Please ask your question.
Thank you for taking my question.
The first 1 I'm just wondering if Tom can you just clarify on.
His statement around that the study be more likely to have patients each day.
Charles A. Deignan: We appreciate the interest and support from our shareholders and the broader investment community, and we look forward to participating in investor events this month. The Webb-Busch-Packbrook Healthcare Conference tomorrow, and the A.C. Wainwright Ophthalmology Conference next week. I will now turn the call back over to George for his closing remarks.
Thanks.
Sure. Thank you thanks question on check.
For the question was about our treatment criteria.
And as I mentioned in my prepared remarks, we have 3 criteria 1 of which is our losses of 10 letters and we measure the loss of 10 letters.
From.
Best measured within the trial.
Some other companies are measuring lost Ken letters from baseline so on our trial, where we had ah patients improve.
George M. Lasezkay: Thanks, Charlie. We believe Clearside is well-positioned for future growth with the potential approval of Xypyr, recent positive data from our OASIS study targeting the large wet AMD market, and multiple clinical and commercial partnerships with top companies in their respective fields. Our innovative platform makes us the clear leader in the delivery of drugs into the supracarotid space with a reliable, non-surgical, office-based treatment approach. We continue to make meaningful progress as we execute on our internal corporate milestones, work closely with our partners, and look forward to making a difference for patients suffering from a broad range of potentially blinding diseases. I would now like to ask the operator to open the call for me. Thank you. That's our CEO, George Lasezkay.
At the 1 month visit posting citizen that sets a higher bar from where we start our measurement of launch of letter. So theoretically in this example.
Patients could.
Gain.
Numerous letters after receiving exiting them for example, they could gain.
Let's say 9 letters.
And then they could on the next visit lose 11 letters.
And they would qualify for.
Treatment, but in essence they'd only be a couple of letters worse in baseline. So in other trials they would not have been treated in the south.
We've mentioned debt for patients were retreated at a.
Month to after exiting is actually 1 of those.
For patients would not have been treated for us.
Criteria of loss of 10 or more letters from baseline.
Thanks, Tom on on the other 1.
Can you just describe the details on the extension period in cohort 2 and correct them on possibly.
Operator: Well, at this point, as a reminder to all the participants, to ask a question, please press star 1. And to begin with, our first question is coming from... This is Chris Benck, mispronouncing your name.
Possibly glean from them.
Yes. Thank you for your question for the questions about the extension study that we.
To add to both cohorts 2 and 3 essentially will be following patients.
Zigby Jala: Zigby Jala from Roth Capital Partners. Please, ask your question. Thanks for taking my question. I just have a couple here.
For an additional 3 months to have the total follow up after exiting it.
B for 6 months post dosing.
Thank you and then the last 1 years just about expectations.
Tom Chula: The first one, I'm just wondering if Tom can just clarify his statement around this study being more likely to have patients be treated. We can't wait to see you. Sure, thank you for your questions, Jack. So the question is about our retreatment criteria. And as I mentioned in my prepared remarks, we have three criteria, one of which is a loss of 10 letters, and we measure the loss of 10 letters from best within the trial. Some other companies are measuring a loss of 10 letters from baseline.
For the readout by the end of the year I know you mentioned the data that we bid seasons, you mainly from China.
In terms of efficacy and I think the only thing with Dod Isa wishes wondering on kind of gives you confidence that this do from 3 fold increase could result, and greater durability and how you plan to leverage that data in terms of designing.
Future studies.
Tom Chula: So in our trial, where we had patients improve at the one-month visit post-excitement, that sets a higher bar from where we start our measurement of loss of letters. So theoretically, in this example, patients could. Andreas Argyrides, George Lasezkay, Rohit Bhasin, Yi Chen, Andreas Argyrides, Jack Padovano, George Lasezkay, Rohit Bhasin, Yi Chen, Andreas Argyrides, Jack Padovano, Clearside Biomedical Inc. Andreas Argyrides, George Lasezkay, Rohit Bhasin, Yi Chen, Andreas Argyrides, Jack Padovano, Thanks, Tom.
Yeah, Great question and the question about expected durability. So we're basing that on our preclinical studies and in our current corporate deck, we have some slides that debt.
Addressed this.
1 of the slides is from a paper, we just published in translational vision Science and technology. This is 1 of the official on ARVO journals. The association for research in vision and ophthalmology for reviewed.
Medline index on paper, but.
In that.
Journal article on also on our corporate deck.
We showed data in a rabbit PK models, where we have on.
Levels.
Tom Chula: And the other one here is, can you just describe the details of the extension period in Cohort 2 and Cohort 3, and what we can possibly glean from that? Yes, thank you for your questions. The extension study that we plan to add to both cohorts two and three. Essentially, we'll be following patients for an additional three months to have the total follow-up after excitinib be for six months post-dose.
Several orders of magnitude.
Greater than the IC 50 for the bedroom 2 receptor going out to 6 months. So I always want a car I always caution when I get this question that you know we know the rabbit model is not directly translatable to humans.
But but it's directionally important it gives us a lot of confidence that we can get multi multiple months of durability.
Once we achieve the correct dose.
Thanks, Tom Congrats team on all the price had been looking for it to the data that.
Tom Chula: And then the last one here is just about expectations for the readout by the end of the year. I know you mentioned the data that we did see was really encouraging in terms of efficacy, but I think the only thing was durability. So I was just wondering, what gives you confidence that this 3.3 fold increase could result in greater durability and how you plan to leverage that data in terms of designing future studies? Yeah, great question. A question about expected durability.
We are getting for him.
Thank you for your interest.
And our next question is from animal semi Stifel. Please go ahead.
Hi, Thanks for taking my question.
Touched on this and just the last question in terms of what level of Gerber life with like with the higher doses, but what are you actually aiming for.
For I guess another word for for free.
Spot, whether it'd be for class a 12 month.
Propulsion, so when you think about this.
Tom Chula: So we're basing that on our preclinical studies. And in our current corporate deck, we have some slides that address this. One of the slides is from a paper we just published in Translational Vision, Science, and Technology. This is one of the official ARVO journals, the Association for Research in Vision and Ophthalmology reviewed Medline Index paper. But in that journal article and also on our corporate deck, we showed data in our Rabbit PK model where we have levels several orders of magnitude greater than the IC50 for the VEGF2 receptor going out to six months. So I always want to caution when I get this question that the rabbit model is not directly translatable to humans, but it's directionally important.
Commercially what ophthalmologist smart 1 in terms of for.
First on monitoring.
Hum.
What what's your ability or your day.
Tom do you want on discuss that I mean are you sure.
We've talked about this internally and I think I think you can answer that question. Please give some directional guidance.
Sure. So the question is about.
Desired durability and you know the simple answer is you want the most possible but it's.
It's much more complicated than that I think first of all.
There are no approved agents that he has.
Very significant from a ability.
And.
Anything better than than several months will be better than what we have currently.
So I think the bar on <unk>.
Right now is rather low.
And then the other aspect to realize as debt right now the model involves.
Tom Chula: It gives us a lot of confidence that we can get multiple months of durability once we achieve the correct balance. Thanks, Tom. Congratulations to the team on all the progress and looking forward to the data from RegenixBio. Thank you very much. And our next question is from Annabel Samimy's people. Please go ahead.
The retina retina practice model involves patients returning to the physician for examination on.
Assessment and possible treatment.
So to go from the current system to say youre going to have.
No.
1 and done is really disruptive for the current system and it may not be.
You know it may not be completely realistic for all patients. So I think anything more than 3 to 4 months would be very meaningful in this current on setting.
Annabel Eva Samimy: Hi, thanks for taking my question. You touched on this in just the last question in terms of what level of durability you can expect with the higher doses, but what are you actually aiming for? I guess, in other words, is there a sweet spot, whether it be 6 months or 12 months, for patients when you think about this drug, commercially, and what ophthalmologists might want in terms of foot traffic and monitoring of patients? What durability do you think is ideal?
And certainly.
Somewhere between 3 to 6 months, what I think would be the sweet spot, where you could decrease the treatment burden, but also.
Patients will be coming back to the doctor anyway for reassessment.
And I think it's less disruptive to the current retina practice model.
The other aspect about on our therapy is that it is a pan JAK inhibitor and there is some evidence pre clinically and also clinically that tan Badger inhibition may have potential efficacy benefits over current focused VEGF a inhibition so on.
George M. Lasezkay: Tom, do you want to discuss that? I mean, we've talked about this internally, and I think you can answer that question, or at least give some directional guidance. Sure. So the question is about Desire Durability. And, you know, the simple answer is you want the most possible. But you know, it's much more complicated than that. I think, first of all, there are no approved agents that are very significant to the village.
We're obviously.
Targeting multi monitor ability, but we also have potential for.
Better efficacy outcomes and comment on that.
With with what <unk> seen so far to be on favorable safety profile.
Okay, Great and also you know as far as.
And on the program going for.
Are you thinking about excuse for trial design.
Tom Chula: And, you know, anything better than several months will be better than what we have currently. So, I think the bar right now is rather low. And then the other aspect to realize is that right now, the model involves patients returning to the physician for examination, assessment, and possible retreatment. So, to go from the current system and say you're going to have, you know, one and done is really disruptive to the current system, and it may not be, you know, it may not be completely realistic for all patients.
It seems like you're going to be able to find an appropriate debt.
Does this take once you trial.
But when you think about the next trials so you're looking at.
<unk> experienced patients.
These patients in combination.
With an active control with a placebo how are you thinking about this trial and I guess.
Following for that.
Comment.
Yeah.
How high is the bar, you're going to be looking for superiority or non inferiority.
Tom Chula: So, I think anything more than three to four months would be very meaningful in this current setting. And, you know, certainly somewhere between three to six months would be the sweet spot where you could decrease the treatment burden, but also patients will be coming back to the doctor anyway for reassessment. And I think it's less disruptive to the current retina practice. The other aspect of our therapy is that it is a PAN-VEGF inhibitor. And there is some evidence pre-clinically and also clinically that PAN-VEGF inhibition may have potential efficacy benefits over current focused VEGF-A inhibition.
Well before time it says anything on that I would just say that those are discussions we're having those are ongoing discussions on the company we haven't really.
Worked out our final plan on that but I am sure that Tom can give you some color around some.
Some of the issues at least there related to that trial design in the face to be worked on.
Hugh.
You stole my Thunder.
I also have I'm sorry go ahead.
It's very very data dependent.
We only have data from from our lowest dose cohort 1.
And obviously, we're going to be looking at cohorts 2 and 3 we will have a better idea about the durability.
Tom Chula: So we're obviously, you know, targeting multi-monitor ability, but we also have the potential for better efficacy outcomes in chronic therapy with what seems so far to be favorable safety. Okay, great. And also, you know, as far as the program going forward, how are you thinking about future trial design? Obviously, it seems like you're going to be able to find an appropriate dose with this Phase 1-2 trial. But when you think about the next trials, are you looking again at treatment-experienced patients, or naive patients in combination with an active control with a placebo? How are you thinking about this trial? Following that and your last comment, how high is the bar?
On the potential treatment effect and that will inform the next trial. So so as George mentioned.
We're having those discussions now and ultimately it'll be it'll be data dependent.
Great. Thank you.
And our next question is from address or your Ives of Wedbush Securities. Please ask your question.
Yes.
Thank you operator, good afternoon, everyone.
Thanks for taking our questions. This is on jewelry some silly on it.
Just a quick 1 here.
When it comes to.
Cohort, 1 and be patient.
Baseline characteristics.
Did how did those help inform a cohort twos.
Tom Chula: Are you gonna be looking for superiority or non-inferiority? Well, before Tom says anything about that, I would just say that those are discussions we're having, those are ongoing discussions in the company, and we haven't really worked out our final plan for that. But I'm sure that Tom can give you some color around some of the issues, at least, that are related to that trial design in Phase 2B. You stole my thunder.
The enrollment of cohort 2 patients from cohort 2.
Could you provide a little bit of color on that thanks.
Thanks for the commodity you yeah, yeah. Thanks for the question, we didn't change any other criteria.
For enrollment in cohort 2 generally in clinical trials, it's best not to not to change patient populations.
As this is being explored so so we kept our criteria on a very consistent on criteria vary.
A very.
Strict in terms of a b C D E patients requiring patients to have prior.
George M. Lasezkay: It's very data-dependent. You know, we only have data from our lowest-dose cohort one, and obviously, we're going to be looking at cohorts two and three, and we'll have a better idea about the durability, you know, the potential treatment effect, and that will inform the next trial. So, as George mentioned, you know, we're having those discussions now, and ultimately, it'll be data-dependent. And our next question is from Andreas Argyrides of Web Boost Securities. Please ask your question. Thank you, operator. Good afternoon, everyone. Thanks for taking our questions. This is Andreas. I'm for Liana.
On treatment have had persistent activity based on our reading center.
And we essentially didn't didn't change any other criteria when we went into cohort.
2.
So let me rephrase. The question just so I ask it correctly from my perspective.
Or were the results from cohort 1 when you're able to enrich the patient selection for cohort 2 based on some of the results maybe that you saw in say patient subjects number 2 and 6 who were responders.
Durable responses.
Matching the criteria, but were you able to enrich the message.
Well no we.
We didn't.
Change criteria and I'm not sure what you mean by enriching, but we really kept the criteria the same that the clinical trial sites for the same.
Andreas Argyrides: Just a quick one here. When it comes to cohort 1 and the patient baseline characteristics, how did those help inform the enrollment of the patients in Cohort 2? Could you provide a little bit of color on that? Thanks for the question. We didn't change any of the criteria for enrollment or in cohort two.
We try to keep everything pretty much the same except for.
The dosing.
Okay.
I appreciate that thank you guys I'll jump back to mature.
And our next question is from <unk> Chen H C. Wainwright. Please go ahead.
Tom Chula: Generally, in clinical trials, it's best not to change patient populations, you know, as this is being explored. So we kept our criteria very consistent. Our criteria vary, very strict in terms of BCDA, patients have to have prior treatment, have to have persistent activity based on a reading center, and we essentially didn't change any of the criteria as we went into cohort. So, let me rephrase the question just so I ask it correctly from my perspective.
Yeah.
Thank you for taking my question I don't know if you can comment on.
Bush house commercial preference for the potential launch upside here once approved and how quickly they can access formularies.
Various insurance payers.
Yeah. Thanks for the question, but that's really a question better directed to 2 the bausch team.
Tom Chula: Was the results from Cohort 1 helpful in enriching the patient selection for Cohort 2 based on some of the results, maybe that you saw, say, patient subjects number 2 and 6 who were responders, you know, that had durable responses? Matching the criteria, but where you're able to enrich Well, you know, we didn't change the criteria, and I'm not sure what you mean by enriching, but we really kept the criteria the same, the clinical trial sites are the same, we tried to keep everything pretty much the same except for the dosage. Okay, I appreciate that. Thank you, guys. I'll jump back to you in a few.
We have not.
We've worked very closely with them on the preparation of the NDA for dealing with the F. D. A.
They're med affairs team in terms of injection training and all that but we have not.
<unk> really gotten into.
A little bit about what they think they're going to do with the product, but the kind of questions, you're asking especially accessing formularies and reimbursement related questions are really best address to abolish that's not something that we're really dealing with is this product once approved will be their product too.
Yi Chen: And our next question is from Yi Chen. HC Wainwright, please go ahead. Thank you for taking my question. I don't know if you can comment on Bosch's commercial preference for the potential launch of Zytea once approved and how quickly they can access formularies of various insurance payers. Yeah, thanks for the question, but that's really a question better directed to the Bausch team. We have not, and we've worked very closely with them on the preparation of the NDA, dealing with the FDA, their MedAffairs team in terms of injection training and all that, but we have not really gotten into, we know a little bit about what they think they're going to do with the product, but the kind of questions you're asking, especially accessing formularies and reimbursement-related questions, are really best addressed to Bausch.
To move forward and and to deal with all of those issues. So I think that's that's about a question best directed to them.
Got it has indicated that they would pursue other indications for <unk> once approved.
And how long do this do you have the option to do so.
If you're speaking about indications.
There's been discussions about additional indications on no decision's been made there but from those.
Yi Chen: That's not something that we're really dealing with, as this product, once approved, will be their product to move forward and deal with all of those issues. So I think that's a BOSH question that's directed at them.
Had exchange of information on additional indicate indications they can pursue an indication under the contract that we have with them a license agreement we have with them at any time, so there's no timing restrictions on there.
George M. Lasezkay: Got it. Has Bosch indicated that they would pursue other indications for dipyr once approved? And how long do they still have the option to do so?
On a reasonable timing.
Our restrictions on them in terms of when or if they would pursue additional indications they have the right to do that.
George M. Lasezkay: If you're speaking about indications, there have been discussions about additional indications. No decisions have been made there, but we've had an exchange of information on additional indications. They can pursue an indication under the contract that we have with them, the license agreement we have with them, at any time. So there's no timing restrictions on their, no reasonable timing, restrictions on them in terms of when or if they would pursue additional indications. They have the right to do that, but they are not an obligation to do so.
But but not an obligation to do that.
Got it thank you.
Okay.
And before I call the next questionnaire.
Actually I made at the other participants to ask a question. Please press star 1 now let's continue next is John Walden of JMP Securities. Please go ahead.
Hey, congrats on the progress on thanks for taking the question.
George M. Lasezkay: Got it. Thank you. And before I call the next questionnaire, as a reminder to all participants, to ask a question, please press star 1. And now we continue. Next is John Wolleben of J&P Securities. Please go ahead.
Thanks, Jeremy.
1 maybe for Tom on the CLSA X data.
Just wondering when we're looking at the <unk> CVA change when these patients would come in with pretty dry eyes, and we're not seeing.
A decrease on fluid would you expect to see increases like this from being a CPA or is this perhaps.
Jonathan Patrick Wolleben: Hey, congrats on the progress and thanks for taking the question. One question, maybe for Tom, on the CLSAx data. I'm just wondering when we're looking at the BCVA change, when these patients have come in with pretty dry eyes and we're not seeing a decrease in fluid, would you expect to see increases like this in BCVA or is this perhaps a function of being open label or some patient motivation? Or just wondering if you could comment on what might be going on mechanistically here to give the visual benefits. That's a great question, John.
A function of being open label or some patient motivation or just wondering if you could comment what might be going on mechanistically here to give the visual benefit.
Have a great go to Amazon Yep, that's great question, John on glad you asked it on.
It's well known among retina clinical triallist debt.
Central subfield thickness correlates really poorly with visual acuity, especially in wet AMD.
Tom Chula: I'm glad you asked it. You know, it's well known among retina clinical trialists that central subfield thickness correlates really poorly with visual acuity, especially in wet AMD. And so, I think it may suggest disease activity, but it doesn't really correlate with visual acuity.
On.
And so.
I think it may suggest disease activity.
But doesn't really correlate with visual acuity.
And so on.
It's not too surprising, especially because we were up against a floor effect that we really didn't see much change.
Tom Chula: And so, it's not too surprising, especially because we're up against a floor effect, that we really didn't see much change in the CF. And, you know, that is a function of the fact that we are recruiting patients who are highly treatment-experienced. So, I wouldn't have expected them to have, you know, very thick maculas.
And the C S T a.
And that debt is a function of the fact that we are recruiting patients who are highly treatment experienced.
I wouldnt have expected them to have.
Very thick macula.
On the best corrected visual acuity on the hit on the other hand on average 59 letters at study entry.
So that's roughly in the 2060 range. So there's room for improvement there.
And even though there may be 1 coggins, a little bit of a floor effect, there's still room for improvement there. So I think that explains a little bit of this and obviously, we need more patients and more data to corroborate it.
Tom Chula: The best corrective visual acuity, on the other hand, averaged 59 letters at study entry. So, that's, you know, roughly in the 20-60 range. So, there's room for improvement there. And even though there may be, one could argue, there's a little bit of a floor effect, there's still room for improvement there.
Got it that's helpful.
And can you talk about when you are able to start dosing. The third cohort do you have to wait to see the second cohort data or is that something that can happen sooner.
Well as you know.
The sense of the trials.
Our form on trial.
We've been discussing the fact that we plan to have data by the end of the year.
Tom Chula: So, I think that explains a little bit of this. And obviously, we need more patients and more data to corroborate this. Got it, that's helpful. And can you talk about when you're able to start dosing the third cohort? Do you have to wait to see the second cohort data, or is that something that can happen sooner? Well, as you know, the sense of the trial is a four-month trial. We've been discussing the fact that we plan to have data by the end of the year.
We run that through our safety monitoring committee.
And then hope to start the third cohort.
At the beginning of next year and if it gets marked out the study timelines.
You can readily.
I guess, when we should be done with cohort 3.
Okay, and 1 last 1 if I may I think Charlie mentioned on the potential payments on the XI peer approval can you remind us on the development milestones that you're eligible for from rejects and maybe within the context of what you've already received on what triggered those <unk>.
Tom Chula: We will run that through our safety monitoring committee and then hope to start the third cohort at the beginning of next year. And if you just march out the study timelines, you could readily guess when we should be done with cohort 3. Okay, and one last one, if I may.
Appreciate it guys.
Charlie.
As to the rejects milestones I don't know that we've done anything other than Ah disclose the total milestones that might be available.
Tom Chula: I think Charlie mentioned the potential payments on the Zyper approval. Can you remind us of the development milestones that you're eligible for from Regenexx and maybe within the context of what you've already received and what triggered those? Appreciate it, guys. Charlie, as to the Regenexx milestones, I don't know that we've done anything other than disclose the total milestones that might be available. That's right.
That's right yeah.
$34 million in additional development milestones and then.
About $102 million in sales milestones.
That's all the detail.
We can give out on that.
Charles A. Deignan: We've, you know, there's $34 million in additional development milestones and then about $102 million in sales milestones. But that's all the detail we can give out on that. Okay, thanks again. And our next question is from Serge Belanger from Needham and Company. Please go ahead.
Okay. Thanks again.
And our next question is from Serge Belanger from Needham and company. Please go ahead.
Hey, good afternoon, thanks for taking my questions.
First 1 for Tom just a follow up on the prior questions related to the C. S T.
Serge D. Belanger: Good afternoon and thanks for taking my questions. First one for Tom, just a follow-up on the prior questions related to the CST. How important is it for CLSAx to show the ability to have an impact on CST?
How important is it for CLSA, thanks to <unk>.
So the ability to have an impact on on CST and it sounds like youre not tweaking the patient.
Tom Chula: And it sounds like you're not tweaking the patient entry criteria, so do you expect you'll be able to show some differences in the next couple of cohorts? Well, thanks for the question, Serge. It's a great follow-up question. Obviously, we're looking at multiple anatomic parameters. We're looking at angiographic parameters as well. And traditionally, in wet AMD trials, we've looked at lesion area, CNV area, leakage area, in addition to CFT. And there are other parameters as well that we'll have in the readings.
Entry criteria. So do you expect.
You'll be able to show some differences in the next couple of cohorts here.
Well.
Thanks, Thanks for the question Suraj, it's a great follow up question.
We're looking at a.
Multiple anatomic parameters.
We're looking at angiographic parameters as well.
And traditionally in wet AMD trials, we've looked at.
Lesion area C N V area leakage area.
In addition to C. S T.
And theres other parameters as well that were from the readings for so we'll have a really comprehensive battery.
Tom Chula: So we'll have a really comprehensive battery of anatomic assessments. CFT is nice because it's quick, it's non-invasive, it's convenient, and it's quite precise. But it really doesn't, you know, tell the whole picture with respect to best-corrected visual issues.
On anatomic assessments.
P. S. T is nice because it's quick it's non invasive it's convenient.
It's quite precise.
But it really doesn't.
Tell the whole picture with respect to the best corrected visual acuity.
Okay.
And I guess that's on for George.
Tom Chula: And I guess the next one for George. I think at the start of your prepared comments, you mentioned that Arctic Vision was starting a Phase 3 trial of Zype here in China. Just curious if there's any milestone payment associated with that for Clinical Development. There is, but it's nothing that we've disclosed due to the nature of the agreement. But that's phase three currently set to start this year in macular edema associated with uveitis.
To get the start of your prepared comments, you mentioned debt Arctic vision was starting on.
Phase III trial on site peer in China.
Just curious if there's any milestone payment associated with us.
That's net.
Clinical development.
There is but there is not a it's nothing that we've disclosed.
Due to the nature of the agreement.
But that's a that's a phase III currently Seth to start this year.
In macular edema associated with uveitis. There is a there is a milestone associated with that but I'm not 1 that we've been able to disclose the amount.
George M. Lasezkay: There is a milestone associated with that, but not one that we've been able to disclose the amount for. Okay, no problem. Thanks. And that concludes the question and answer session. At this point, I would like to turn it over to our CEO, Sir George Lasezkay. Thank you, and thank you all for joining us on the call this afternoon. We appreciate your continued interest in our company, Clearside, and we look forward to updating you on our progress in the future. Operator, you may now disconnect the call. Thank you all. Thank you. And this concludes today's conference call with the Clearside. Thank you everyone for participating. You may now all disconnect.
Okay.
Yes.
And that concludes the question and answer session. At this point I would like to turn it over to our CEO. So George This S K.
Thank you and thank you all for joining us on the call. This afternoon. We appreciate your continued interest in our company clear side and we look forward to updating you on our progress in the future. Operator, you may now disconnect. The call. Thank you all.
Thank you and disciplined today's conference call will be the clear side. Thank you everyone for participation you may now all disconnect.
[music].
Operator: ?? ??