Q2 2023 Clearside Biomedical Inc Earnings Call
Our Asia Pacific partner Arctic Vision continues to move forward in two indications with their development of site, which they refer to as our cadence.
For the first indication of uveitis macular edema Arctic vision is currently enrolling a confirmatory phase III trial in China, if positive the data will Arctic to apply for marketing approval in China.
In addition, Arctic recently announced that the therapeutic goods administration of Australia has formally accepted its new drug application for Super Choroidal use of our cadence for the treatment of view regarding the Redeemer.
The acceptance of the NDA in Australia as an additional validation of the Super Gorilla administration being an innovative recognized form of ophthalmic drug delivery and another step towards the global commercialization of <unk>.
The second indication of Arctic is diabetic macular edema Arctic has completed a phase one clinical trial and we expect them to report the data from the trial later this year.
This data could provide helpful insight into the potential for broadening the use of <unk> in other indications.
We're excited about the progress Arctic vision has made to expand the use of <unk> and we look forward to further updates from them.
We also continue to work closely with our partners developing breakthrough technologies to deliver gene therapy, and ocular oncology treatment utilizing supercool it'll delivery with our SCS microinjection.
Earlier this month <unk> announced updates on its a b b B R. E X 314 program for the treatment of wet AMD and diabetic retinopathy being developed in collaboration with Abbvie in.
In July <unk> buyout presented interim data from the phase 288, and altitude trials, demonstrating supercritical delivery of $3 40 administered to patients with prophylactic steroid eyedrops resulted in zero cases of intra ocular inflammation.
Additional data from regenerate smile on both trials is expected over the next six months interim efficacy data from the altitude trial in diabetic retinopathy is planned for the American Academy of Ophthalmology meeting in November of 2023, and the interim efficacy data on the a b a trial in wet AMD.
As expected to be presented at the Hawaiian eye and retina meeting in January 2024.
Our oncology partner Aura Biosciences announced their progress last week with their drug candidate Bell Saar for the treatment of choroidal melanoma.
They're a global phase III clinical trials expected to dose the first patient in the second half of 2023 and is designed as a superiority trial comparing bell Saar versus sham with the primary endpoint is time to tumor progression.
Or has qualified trial sites globally with multiple sites ready to enroll patients in the U S.
In addition, or expects to present updated efficacy data in the second half of 2023. The phase II data will include 12 months median follow up of patients treated with the therapeutic regimen intended to be used in the global phase III trial.
With that summary of our programs I'll now turn the call over to our CFO , Charlie Deignan for a financial update.
Thank you George and good afternoon, everyone. Our financial results for the second quarter were published earlier in our press release and are available on our website. Therefore, I will just provide a summary of our financial status.
As of June 32023, our cash and cash equivalents totaled approximately $35 million, we continue to prudently manage our cash as we move forward with our programs and we have worked to fine tune our budget over the next year based on our current outlook. We now expect to have sufficient resources to fund our planned operations into the third quarter of <unk>.
24.
Over the next few months, we look forward to participating in several investor conferences, including the H C. Wainwright Ophthalmology conference. This Wednesday, they can't our global Health Care Conference in September and the Jones trading Health care Summit in October we look forward to keeping you updated on our progress.
I will now turn the call back over to George for his closing remarks.
Thanks, Charlie <unk>.
In closing our state of the art Super Choroidal injection technology continues to advance globally.
CLS Ax is targeting a large market opportunity in wet AMD with a new mechanism. This new mechanism of action utilizing pan VEGF inhibition, and a unique supercoil delivery using our SCS microinjection.
We are confident in our phase two B Odyssey trial design and the potential for CLS ax to offer patients a therapy that will maintain their vision, while reducing the burden of frequent injections. Our current partners are making meaningful progress as well and then reporting encouraging clinical data across their respective programs.
We continue to receive positive feedback on our SCS micro injector and the potential advantages of drug delivery to the Super Gorilla space.
We remain very active within the medical community at scientific meetings and in ongoing discussions with key opinion leaders in the treatment of back of the eye diseases.
<unk> has pioneered drug delivery behind the visual field to treat retinal disorders.
We will continue to explore opportunities to expand the use of our supercritical injection technology platform.
Now like the operator to open the call for questions.
Thank you.
At this time, we will be conducting a question and answer session.
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One moment, please while we poll for questions.
Thank you.
Our first question is coming from John Walsh with JMP Securities. Your line is life.
Hey, Thanks for taking my questions and the update a couple for me George.
Sure.
Almost 30 sites are open now wondering if you still feel good about that number if you think you'll add more do you have enough and then also I think he commented that patients are being dosed can you tell us how many have been dosed so far in the study.
Okay. John our goal was 30 and we're very close to 30, we felt comfortable with 30, we have a lot of interests. We may enroll a few extra over 30, that's possible, but right now our goal is 30 and we're just about there. So we're feeling very good with that.
In terms of updates we have reported that we've begun the randomization process. So we've had multiple patients be randomized between the CLSA ex arm and the a flavor some arm, but at this point in time, we're not giving updates on the actual number of patients in the trial.
Operator: Thank you.
Operator: Ladies and gentlemen, thank you for your patience. This conference will begin shortly. Once again, thank you for your patience, and this conference will begin shortly. Thank you.
Operator: And welcome to the Clearst Biomedical Second Quarter, 2003, Financial Results and Corporate Update. At this time, all participants are in a listen-only mode. We will have a question and answer session following the formal presentation. If anyone should require operator assistance during the conference, please press Star Zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host. Jenny Corbyn, head of investor relations. You may begin.
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. 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 Factor section of our N report on Form 10K for the year ended December 31, 2021, and 2022, our quarterly report on Form 10Q for the quarter ending June 30, 2020, and our other SEC filings available on our website.
Okay and then.
An interesting nuance and the design for Odyssey is the ability to re dose CLS ax, depending on when someone hits rescue criteria.
I'm wondering about your modeling about how many patients you think will be re dose with CLSA eggs are rescued with eylea.
Just on the <unk> data I think.
Could give us a lot of interesting information, we're not going to get from other studies.
Yeah, well, yeah listen we've designed this trial in a way that we think are where we're going to be ever.
There are a lot of success in getting this to be a four to six month treatment and I'm very hopeful and I expect a high degree of success of getting the vast majority of the patients towards six months I don't believe unless there's some deviations from protocol I would be.
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. On today's call, we have George Leszeste, our chief executive officer, and Charlie Degnan, our chief financial officer. After our formal remarks, we will open the call to your questions. I would now like to turn the call over to George.
Very surprised if we have any rescues that are less than 12 weeks and the CLSA excellent.
Sure.
That was our expectation is there's a b very few if any.
Early early stage restaurants in less than 12 weeks after the first CLSA yuks dose, which if you remember we've.
George M. Lasezkay: The last six months have demonstrated that ClearSight is the clear leader in delivering agents to the supercroyal space. We have a proprietary supercroyal space injection technology that utilizes our patented SCS microinjection.
We've got the three loading doses and we're dosing CLSA eggs at the second loading doses flavor subs. So we're doing a flavor said on label for both groups in terms of loading and then were going.
Switching to the flavor some arm there being dosed every two months on label in.
George M. Lasezkay: We're able to deliver small molecules and gene therapy behind the visual field, targeting multiple retinal diseases. We have the first and only FDA-approved SES product with Zype, and we have four external validating SCS delivery collaborations, as well as an early stage internal research and development pipeline.
In the CLSA Exxon.
And the dose.
At least every six months with CLS ax, unless supplemental therapies required earlier, but I really don't anticipate.
Any significant number of patients being rescued before 12 weeks after the initial dose.
George M. Lasezkay: Importantly, as we expand our development opportunities, both internally and with our partners, our versatile therapeutic platform continues to grow. Together with our licensing partners, there are now six ongoing SCS trials in five different indications utilizing four potential therapies. ClearSight's lead internal clinical development program is CLSAX, our proprietary suspension of Dixydnidna delivered into the supercorrital space. DLSAX is targeting the multi-billion dollar market for WET AMD.
Okay, I think I think.
This is really the oasis data really gives us that kind of encouragement again, we have to run the trial, we have to do you know at Carryout.
The trial according to the protocol, but if we run it according to the protocol and based on what we saw on the Oasis I think there'll be very few.
Can you talk about the opportunity for extended with CLS ax versus potentially looking at a treatment naive population a subsequent study and I'll hop back in the queue. Thanks again, okay.
George M. Lasezkay: So, let me take a moment to talk about the market opportunity and why we believe we can truly make a difference in the lives of the millions of patients suffering from this facility. AMD is a crowded arena for the development of new products mainly due to the large and growing market as a result of the aging population, particularly in the U.S. With the higher demand, there's room for new treatments that provide significant improvement over current therapies, including reducing the treatment burden for patients and their caregivers.
Okay. John just real quick could you repeat that again I just missed the last part of them.
How do you think about the treat and extend opportunity like you're studying now or potentially looking at a treatment naive population and a subsequent study.
Well you know like I said that we're going to make sure that everybody in the CLSA our XR.
Get a dose at six months, if they didn't require one earlier I think.
Our real hope is that there'll be people that are being treated at six months that by virtue of looking at V. C. D. H changes in CST changes.
George M. Lasezkay: Based on the label for existing marketed products for wet AMD, Lucentis is recommended to be dosed 12 times, Ilea 2 milligrams six times a year, and recently approved bovismo up to six times per year. In contrast, we believe that CLSAX may be up to twice a year treatment for wet AMD. This matters because it has been well documented that patient compliance is a challenge, and therefore, a treatment option where patients maintain their vision with less frequent dosing may achieve and prove patient outcomes.
Don't require it so we're looking at a multiple dose therapy, but we're also going to be looking at the biological indicators the anthemic orange indicators.
And being able to report out whether it was they really met.
I met a need and so we worked what we're trying to do here is we're really trying to determine what the proper fixed dose is to go into phase III, because I believe that we need to go into phase III with a fixed dosing regimen, you know flip RSO has a fixed dosing regimen, but physicians quite often used to treat and extend.
George M. Lasezkay: ZLFAX could reduce the onerous treatment burden for patients who currently require frequent dosing and numerous office visits with existing approved drugs. CLSAX has the potential to be a better maintenance treatment option based on three main differentiating factors. CLSA-X utilizes Exidinidin, which is the most highly potent tyrosine kinase inhibitor, delivering 10 times more potency than other TKIs in pre-clinical studies. Second, CLSAX is administered supercaroidally using our proprietary SCS microinjector. This delivery mechanism does not require surgery and does not require an implant inserted into the eye.
George M. Lasezkay: It's delivered by physicians in their offices and has proven to be safe and reliable both commercially and in multiple clinical trials. And thirdly, in our Oasis Phase 1-2A clinical trial, we showed that a single administration of CLSAX demonstrated a favorable safety profile with no signs of inflammation. In terms of duration, in the extension study of OASIS in higher dose cohorts with a single dose of CLSAX, two-thirds of the participants did not need supplemental treatment for six months or more.
I think patients are going to be coming into the office are they're not going to come into the office twice a year once a year they are going to be coming back every couple of months every other month.
And.
You know if they come in at six months after getting their CLSA ex those in practice. If it was approved and there D. C. B a stable in the CST is stable I think it'll be just like any other therapy that people feel comfortable drilling treat and extend.
I'm not sure if that's completely responsive to your question, but I really look forward to seeing fixed dosing regimen, where we can clearly as I mentioned in the opening remarks I mean, if you look at on label now in EBIT.
With the lifestyle, which was just recently approved.
Doses every four months at a maximum.
And there's a number of people that have to be dosed after floor loading doses at every two months three months I think if we're in the four to five months.
Five to six month category, that's a major improvement for patients and I think even at that point doctors will still look to treat and extend.
George M. Lasezkay: Also, these participants experienced a 77 to 85% reduction in treatment burden, as measured by the number of anti-vechef treatments they received during the six months compared to the six-month period prior to entering the OASIS trial. Importantly, we also observe signs of biological effect with stable mean, best correct the visual acuity of BCBA, and stable mean central subfield thickness or CST.
Pass that so we may be going past 567 months and the number of patients.
That is all we have to own the data and we have we really have to go into phase III I believe with fixed dosing regimen.
Rather than.
The way it was done in the past, where there's a kind of a treat and extend and we'll see how far we go our goal is to really set up that the fixed dosing regimen.
George M. Lasezkay: Encouraged by the promising Oasis results and following the FDA draft guidance for drug development for treatments for WET AMD, last quarter, we initiated Odyssey, a randomized double-masked multi-center phase 2B clinical trial for participants with WET AMD. The overall objective for the trial is to evaluate the safety, efficacy, and duration of CLSA-X treatment for participants with wet hair. The other arm in the trial is the current standard of care, Ilea, or a flibber.
Got it alright, thanks again.
Sure.
Thank you.
Our next question is coming from Andreas <unk> with Wedbush Securities. Your line is life.
Hi, Andres good I'm good.
Good afternoon. This is Carol I actually I'm, Brian for Airlines.
Hi, sorry, I can't see anything.
It's okay.
Okay No worries, thank you for taking our questions.
George M. Lasezkay: Our goals for the Odyssey trial are to demonstrate similar visual acuity outcomes with a lower treatment burden for CLSAX and to obtain the necessary clinical data to determine a desired CLSAX fixed dosing regimen for a Phase 3 wet AMD clinical development program. We are pleased that the trial is off to a solid start and is progressing as planned. Multiple participants have been randomized to receive either CLSAX or Flivers.
Can you discuss your targeted timeline for enrollment and honesty and how enrollment is progressing and our.
Are you seeing any impact from the availability of that Theres now and then second can you just discuss the powering assumptions for Odyssey.
Okay sure the powering assumption, we're not conducting a non inferiority trial, we're not conducting a superiority trial. So there really isn't a powering assumption in here what we're looking at is a liver cell.
George M. Lasezkay: Clinical trial sites have been eager to be part of the trial, and we have nearly all of our plan 30 sites currently open to enrolled participants in the trial. As a reminder, Odyssey is expected to enroll a total of 60 participants randomized to either CLSAX, 1 milligram, or Aflibersab, 2 milligrams, a 2-1 randomization schedule. This means that there are expected to be 40 participants in the CLSA-X arm and 20 participants in the Aflibib arm.
Label and see what over the 36 week 36 weeks.
How those patients in the <unk> arm due in terms of Keith.
Keeping a stable B C. B a N G. S. T and then we're going to look at the C. S. CLSA ex arm and what we're trying to do is to see whether the V. C. B as in C. S. Teams are similar between the two groups and what are what our ideal dosing regimen would be a fixed basis going into phase.
George M. Lasezkay: The treatment period is a total of 30%. In the trial, CLSAX will be administered by supercroyal injection using a clear-sized S-CS microinjectin, and a fliberset will be administered by intravitreal injection. The primary outcome measures for the trial are the mean change in BCBA over the 36-week period, as well as the assessment of safety and tolerability of CLSA. The secondary outcome measurements are treatment burden as measured by total injections, including the need for supplemental therapy over the trial duration, and other changes in visual function in ocular anatomy such as CST. One important component of Odyssey is the eligibility criteria.
<unk> III should it be every four months should it be every five months should it be every six months, maybe can we go longer than that.
So there's not this is not set up as a trial that has sufficient patients to have a powered outcome. As you would think of in a non inferiority trial in particular, so we think that the phase II design here in terms of total patients that are in and the treatment arm is very consistent with weigh a number of the <unk>.
Recent phase II trials had been run we're not looking to convert this into a phase III. We're looking to run a standard phase two b trial here trying to compare an estimation.
George M. Lasezkay: Our inclusion criteria is designed to ensure that participants in our trial have active disease at screening. Eligible participants will be treatment experienced and will undergo diagnostic imaging after the screening visit, followed by mass reading center confirmation of persistent active disease. This level of specificity is to ensure that participants are in need of treatment, will likely respond to, and benefit from treatment with anti-vegetative therapy.
On an estimation basis, how well, we're doing and where we should go into phase III on a fixed dosing.
Terms of the enrollment.
As I've mentioned in the press release and in the opening remarks, we were nearly at the 30 targeted sites that we want we have all of our previous sites from Oasis are included in Odyssey. So we have very good people that are very experienced with CLSA X already in.
George M. Lasezkay: We believe this will allow the proper assessment of the potential advantages of CLSAX in patients with wet AMD. We further believe CLSAX will demonstrate the ability to maintain visual acuity with a longer duration of action in order to reduce the treatment burden for patients with wet A&D. We are confident in our overall trial design and the potential success of Odyssey, and we look forward to reporting top-line data in the third quarter of 2024.
We'll be closing that out soon and then on enrollment we're not going to give enrollment updates per se, but what we are not changing is R. R.
Disclosure regarding when we think topline data is going to be available. We're still looking at third quarter of next year and.
The way, we've been able to enroll sites and as we see enrollment of participants going on we're still very comfortable with Q3 of 2024 in terms of topline data.
George M. Lasezkay: Moving on to Zypier, we continue to receive positive feedback from clinicians regarding the use of Zypire with patients. Our North American Commercial Partner for Zypure, Baosun Lom, continues to conduct product education and training sessions for healthcare providers, with more than 1,200 retinal specialists trained to date. These sessions have been well attended and well received.
Okay, great. Thank you so much and congrats on the progress.
Yeah.
<unk>. Our next question is coming from Sean Kim with Jones trading your line is life.
Yeah, Hi, Thank you for taking my questions I guess first question for me.
My first question is that in.
Light of recent safety issues reported create an FDA approved therapy in geographic atrophy.
George M. Lasezkay: Physicians report that the supercroyal injection procedure utilizing the SES microinjecter is easy to learn and that Zypire is highly effective in treating their patients with macular edema associated with UVI. Looking forward, Bauchin Lam is focused on increasing engagement with UVitis specialists across the country and working on reimbursement parameters that will make it simpler for physicians to use IPIR for their patients. Our Asia-Pacific partner, Arctic Vision, continues to move forward in two indications with their development of Zypure, which they refer to as archaeth.
Could you please remind us if there hasn't been any retinal vasculitis or put it with Danielle supercritical injections, given thus far.
And a related question is just in comparison to ensure virtual injections, where they just broke royal truck delivery approach might be intrinsically.
More likely or less prone to causing retinal vasculitis and related adverse effects.
George M. Lasezkay: For the first indication of UVI Dicmacular edema, Arctic Vision is currently enrolling a confirmatory phase three trial in China. If positive, the data will allow Arctic to apply for marketing approval. In addition, Arctic recently announced that the Therapeutic Goods Administration of Australia has formally accepted its new drug application for the supercorial use of Arcadus for the treatment of uweiotic macular edema. The acceptance of the NDA in Australia is an additional validation of the supercorial administration, being an innovative, recognized form of ophthalmic drug delivery, and another step towards the global commercialization of Zyze.
Well I'll take the first part of the question first as far as I know certainly with CLS Ax, we've had no.
No events, no indication of any kind of inflammation, including retinal vasculitis.
So that is covering both the product itself CLSA X.
The tyrosine kinase inhibitors as well as the injection technique and the injection procedure, we've not seen any of that and as far as I'm aware we.
We don't have any significant reports or any reports at all of retinal vasculitis I'd have to double check that to be sure, but there's nothing that comes to mind.
George M. Lasezkay: The second indication for Arctic is diabetic macular edema. Arctic has completed a phase one clinical trial, and we expect them to report the data from the trial later this year. This data could provide helpful insight into its potential.
And our partners trials or in our previous trials getting <unk> approved.
That was a significant problem certainly if you look at the injection procedure itself using our SCS micro injector.
Charles A. Deignan: Broaden the use of Zipir and other indications. We're excited about the progress Arctic Vision has made to expand the use of Zypire, and we look forward to further updates. We also continue to work closely with our partners developing breakthrough technologies to deliver gene therapy and ocular oncology treatment, utilizing supercroyal delivery with our FCS microinjection. Earlier this month, Regenics Bio announced updates on its ABBBRGX 314 program for the treatment of wet AMD and diabetic retinopathy being developed in collaboration with Ebb.
It's been very reliable safe they're repeatable.
The physicians that are trained on it find it once they're trained on it and training doesn't take all that long, it's not that complicated but it is important.
Once they're trained they find it an easy procedure, a very acceptable procedure and very comparable no sense to from a patient experience and a physician experience to introduce trail injections.
So retinal vasculitis is just not come up as a as a problem that I can recall any of our clinical trials for our partners clinical trials now.
Charles A. Deignan: In July, Regenics Bio presented interim data from the Phase 2, AB8, and Altitude trials, demonstrating that supercaroidal delivery of 314, administered to patients with prophylactic steroid eyedrops resulted in zero cases of intraocular inflammation. Additional data from Regenics Bio on both trials is expected over the next six months. Interim efficacy data from the altitude trial and diabetic retinopathy are planned for the American Academy of Ophthalmology meeting in November of 2023, and the interim efficacy data from the ABA trial in wet AMD is expected to be presented at the Hawaiian Eye and Retina Conference in January 2024.
Now to be fair rejects bio had did have some inflammation and some other earlier trials.
They recently reported that though with the topic.
Topical steroids and in their phase II trial, and believers in wet AMD, they've seen no signs of inflammation and that's certainly not heard of any reports of rescue retinal vasculitis.
Okay. That's helpful. Thank you and related to the hottest trial, if I understand correctly.
One of the goals for data to try to find a fixed dosing schedule.
The phase III.
So my question is what end point or dictate.
Charles A. Deignan: Our oncology partner, Ora Biosciences, announced their progress last week with their drug candidate Belsar for the treatment of caroidal melanoma. Their global phase three clinical trials are expected to dose the first patient in the second half of 2023, and the trial is designed as a superiority trial comparing Belsar versus sham with the primary endpoint being time to tumor progression. It has qualified trial sites globally with multiple sites ready to enroll patients in the U.S.
In total for phase III would it be.
CPA that or change or would it be more of a totality of data across different efficacy combs.
I think the most important and certainly from the Fda's point perspective, the most important endpoint would be B C. The B C. D E. They certainly wanted us.
Dr Chambers at the F D a.
It's very focused first and foremost on vision.
<unk> vision.
Charles A. Deignan: In addition, ORA expects to present updated efficacy data in the second half of 2023; the phase two data will include 12 months of median follow-up of patients treated with the therapeutic regimen intended to be used in the global phase three trial. With that summary of our programs, I'll now turn the call over to our CFO, Charlie Degman, for a financial opportunity.
Preservation of vision improvement and so I think the real.
Most important factor would be the V C b a stability.
For the the duration.
How long can we keep that B C V a stable without requiring any kind of supplemental and intervention. So I think that's the most important thing other things like C. S. T are important.
George M. Lasezkay: Thank you, George, and good afternoon, everyone. Our financial results for the second quarter were published earlier in our press release and are available on our website. Therefore, I would just provide a summary of our financial status. As of June 30th, 2019, our cash and cash equivalents totaled approximately $35 million. We continue to prudently manage our cash as we move forward with our programs, and we have worked to fine-tune our budget for the next year.
But I think the CBA is the most important factor.
Okay Gotcha.
Just a quick follow up on that is.
I'm just curious as to what your expectations might be for the percept control arm in terms of that piece, if you change three or six months specifically in the target population.
It's a trial.
I I'm.
I'm not sure what to expect.
George M. Lasezkay: Based on our current outlook, we now expect to have sufficient resources to fund our planned operations into the third quarter of 2024. Over the next few months, we look forward to participating in several investor conferences, including the AC Wainwright Ophthalmology Conference this Wednesday, the Cantor Global Healthcare Conference in September, and the Jones Trading Healthcare Summit in October. We look forward to keeping you updated on our progress. I will now turn the call back over to George for his closing remarks. Thanks, Charlie.
DCP regarding.
Regarding the CPA I would hope that I would expect that with so much I would hope, but I would expect the patients are.
The difficult patients that go into that and they get and they get dosed appropriately on label with a flavor. So they'll have a similar.
Outcome there'll be a similar overall outcome to what you've seen with a flipper set dose of <unk>.
<unk> before in the hands of other people I don't know why it would be any different in our hands than other people. We look at we looked at Talbot buys note did versus uplift using <unk> as their control in phase III and we saw how <unk> did.
George M. Lasezkay: In closing, our state-of-the-art supercaroidal injection technology continues to advance. CLSAX is targeting a large market opportunity in wet AMD with a new mechanism of action utilizing Pan-BedGF innovation and a unique supercroidal delivery using our SCS microRNA. We are confident in our Phase 2B Odyssey trial design and the potential for CLSAX to offer patients therapy that will maintain their vision while reducing the burden of frequent and general. Our current partners are making meaningful progress as well and are then reporting encouraging clinical data across their respective programs.
Against that and we think that we can do as well against the us as well against the flavors that is bought by month did against a flipper set but we believe that our dosing interval is going to be longer than the buys most turned out to be in their phase III. So.
I don't expect any difference in the way of liver SAB flipper set patients respond to a flipper set other than what you've seen in other trials in wet AMD.
George M. Lasezkay: We continue to receive positive feedback on our SES micro-injector and the potential advantages of drug delivery to the supercroyal space. We remain very active in the medical community at scientific meetings and in ongoing discussions with key opinion leaders in the treatment of back of the eye disease. Clerside has pioneered drug delivery behind the visual field to treat retinal disorders. We will continue to explore opportunities to expand the use of our supercroidal injection technology platform. I'd like the operator to open the call for questions.
But that enrolled a similar population.
Okay. So it really does come down to the enrollment what kind of patients are you putting in if you're putting in patients that really don't have.
Strong signs of active disease.
You know those patients are going to do really really well because they may not required any real entry mentioned to begin with and there's lots of literature little talk about patients that are relatively dry, but diagnosed with the disease, but no active signs.
No signs of active disease might go for a long period of time between injections, but we're trying to make sure that the two groups have people that are responsive to anti that jeff's and have active disease when theyre.
Operator: Thank you. At this time, we will be conducting a question and answer session. If you'd like to ask a question, please press Star 1 on your telephone keyboard. A confirmation tone will indicate your line is in the question, and you may press Star 2 if you would like to remove your question from the list. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. Thank you. The first question is coming from John Wallabin with JMP Security.
And then I think the outcome in new floater subgroup will be.
Operator: Your line is:
Pretty consistent with history.
Okay, great. Thank you sure.
Thank you.
Our next question is coming from Rohit <unk> with Needham <unk> Company. Your line is life.
Hi, This is Robert on for Serge Thanks for taking our questions.
Sallie, Hey, how's it going or you're still evaluating new potential new collaborations for the SCS micro injector platform.
Jonathan Patrick Wolleben: Hey, thanks for taking the questions and the updates. A couple from me, George.
And then in the current cash balance sufficient to get us to a top line readout of Odyssey. Thanks.
George M. Lasezkay: You mentioned almost 30 sites are open now. I was wondering if you still feel good about that number, if you think you'll add more, if you have enough, and then also, I think you commented that patients are being dosed. Can you tell us how many have been dosed so far in the study? Okay, John. Our goal was 30, and we're very close to 30. We feel comfortable with 30. We have a lot of interests.
Alright, I'll take the first part of that question and I'll, let Charlie take the second.
Yes.
We are in discussions with the.
Other companies about potentially partnering and various disease states or with various therapeutic agents that we think might be useful delivered super core Italy.
George M. Lasezkay: We may enroll a few extra over 30. That's possible. But right now, our goal is 30, and we're just about there. So we're feeling very good about that. In terms of updates, we have reported that we've begun the randomization process, and so we've had multiple patients randomized between the CLSAX arm and the Fliversib arm, but at this point in time, we're not giving updates on the actual number of patients in the trial.
We conduct those kind of business development activities.
Activities on a regular ongoing basis.
We don't jump into them lightly we want to make sure they're very strategic and very positive for us and would be a positive for the company and so we need to make sure that we have the right terms are the right partner.
And it fits our strategy for partnering we typically try to partner in areas, where the the collaborator has technologies that we cannot access that we don't have any expertise in for example, gene therapy that is not a core competency of us.
George M. Lasezkay: Okay, and then an interesting nuance in the design for Odyssey is the ability to redose CLSAX depending on when, you know, someone hits rescue criteria. Wondering about your modeling about how many patients you think will be redosed with CLSAX or rescued with ILEA based on the Oasis data. I think this could give us a lot of interesting information.
Claire side. So that's why we partner in the year and look to partner in the area of gene therapies in particular.
But there could be other small molecules that.
That are proprietary to other companies that want to be put into our super choroidal delivery system, and we're certainly open to that and and we have.
George M. Lasezkay: We're not going to get from other TKI studies. Yeah, listen, we've designed this trial in a way that we think we're going to have a lot of success in getting this to be a four to six month treatment. And I'm very hopeful, and I expect a high degree of success in getting the vast majority of patients towards six months. I don't believe, unless there are deviations from protocol, I would be.
A constant set of conversations with people trying to put together the right deal that makes sense for us as well as for them.
Charlie I'll, let you take the cash runway.
Hey, Robert.
Yeah. So as we set our data is coming a plan to kind of Q3 next year and our cash.
It can get us into Q3 next year that's.
George M. Lasezkay: Very surprised if we have any rescues that are less than 12 weeks old in the CLSAX. There, you know, what our expectation is there will be very few, if any, early stage rescues after the first CLSA-A-X dose, which, if you remember, we've got the three loading doses, and we're dosing CLSAX at the second loading dose of a Fliber SED. So we're doing a Fliber SED on-label for both groups in terms of loading, and then we're going to switch to in the Fliberset arm, they're being dosed every two months on label in the CLSA-X arm. We're going to dose at least every six months with CLSAX unless supplemental therapy is required. But I really don't anticipate any significant number of patients being rescued before 12 weeks after Okay.
So we'd want a cushion.
And we can't until we finish enrollment no exactly within the quarter.
Data will come but.
We will continue to look to extend our runway.
Past hiring.
When the data comes in and that's what we're doing now is looking at all until dilutive and non dilutive ways to extend our runway.
Great. Thank you.
Thank you.
Our next question is.
It is coming from Jack Padovano with Stifel. Your line is nice.
Hi, This is Jack calling in for Annabel.
Jack.
Jay.
Just a quick question from me could you briefly go over again some of the economics with your partners and if Theres any chance that you might be able to see some additional near term expected catalysts or milestones from them.
George M. Lasezkay: I think the OASIS data really gives us that kind of encouragement. But again, we have to run the trial. We have to carry out the trial according to the protocol. But if we run according to the protocol and based on what we saw in OAS, I think there'll be very few. Can you talk about the opportunity for treatment and extension with TLSAX versus potentially looking at a treatment-naived population of subsequent study? And I'll hop back in the queue. Thanks again. Okay. John, just real quick, did you repeat that again? I just missed the last part of that.
Charlie is that something you would want or yes.
Sure. So you know as a reminder.
You know, we haven't announced our we're not allowed to announce particular milestones, but you know as some of these or.
Our collaborators are getting into phase three you know typically there's a phase III development milestones that go with them, but that's that would affect our EPS and revenues, but just don't forget that when we monetized our royalties with.
HCR healthcare royalty.
George M. Lasezkay: How do you think about the treat and extend opportunity like you're studying now or potentially looking at a treatment in the population and a subsequent study? Well, you know, like I said, we're going to make sure that everybody in the CLSA-X-Arm gets a dose at six months if they didn't require one earlier. I think our real hope is that there will be people that are being treated at six months who, by virtue of looking at B-CBA changes and CST changes, really don't require it.
As milestones will get wrapped up and go towards the cap we have to pay if you remember we took $32 $5 million from them and we'll have to pay two and a half times add backs. So approximately 180 $81 million. So those any milestones that come in we will go directly to HCR <unk>.
Partnered programs.
Thanks to answer your question yes.
Thank you. Our next question is coming from E. Chen with H C. Wainwright your line of sight.
George M. Lasezkay: So we're looking at multiple dose therapy, but we're also going to be looking at the biological indicators, the end-ploidy comical indicators, and being able to report out whether it was really met a need.
Thank you for taking my questions.
Partner <unk> recently reported some progress with their candidate for what a D. A I don't know if you can come on whether they're a candidate in the future could potentially become.
George M. Lasezkay: And so what we're trying to do here is really try to determine what the proper fixed dose is to go into phase three because I believe that we need to go into phase three with a fixed dosing regimen. You know, Flibresa has a fixed dosing regimen, but physicians quite often use the treatment extent. I think patients are going to be coming into the office. They're not going to come into the office twice a year or once a year.
The competitor to C O S X.
Hum.
Take that question.
I suppose it could it.
It depends I think.
You know there is I understand their therapy their therapy. It is a.
As a gene therapy that generates a lucentis type molecule.
And.
Again, what C O S. A X does has a different mechanism of action than what rejects.
The Regenesis slash Abbvie product would.
Alright, so that's it's pretty much standard anti VEGF therapy.
George M. Lasezkay: They're going to be coming back every couple of months, every other month. And, you know, if they come in at six months after getting their CLSA dose in practice, if it was approved, and their BCBA is stable and the CST is stable, I think it'll be just like any other therapy that people feel comfortable doing Treat and extent. I'm not sure if that's completely responsive to your question, but I really look forward to seeing a fixed dosing regimen where we can clearly, as I mentioned in the opening remarks, I mean, if you look at OnLabel now, even with Bivismo, which was just recently approved, that dose is every four months at a maximum, you know, and there's a number of people have to be dosed after four loading doses at every two months or three months.
Just like Eylea, but by Isabelle etcetera and Lucentis.
They're there I think they are.
Potential claim to fame is theyre going to last a long time and binding.
The circulating that Jeff.
From our perspective, we're taking a different mechanism mechanistic approach and that is we're blocking the veg F receptors, one two and three.
So any circulating bed, Jeff, including if it's not completely bound theres still circulating bad jobs and they are binding again bench at a and in many cases, there's an over expression of patients. Once you start to buy in the veg F a especially on.
George M. Lasezkay: I think if we're in four to five months, five to six months, That's a major improvement for patients. And I think even at that point, doctors will still look to treat and extend past that. So we may be going past five, six, seven months in number of patients. That is helping George. We have to see the data, and we really have to go into phase three, I believe, with a fixed dosing registry rather than the way it was done in the past, where there's a kind of treat and extend, and we'll see how far we go. Our goal is to really set up that fixed dosing. Got it. All right. Thanks again.
Our longer term treatment after a couple of years getting better Jeff anti VEGF therapy that theres, an over expression of <unk> in particular, which can cause.
Potential Neovasc organization.
So I think while it's potentially competitive and that theyre going after wet AMD as are we with CLSA X I think they could be complementary if you want to put a positive spin on it I think they'd be complementary because the mechanisms are different.
And.
There's would unlikely based mechanistically unlikely to address any of those patients that become resistant to VEGF anti VEGF therapy.
Operator: Thank you. Our next question is coming from Andreas Argaritas, with Red Bush securities. What's your line?
Andreas Argyrides: Hi Andreas. Good afternoon. This is Caroline, actually. I'm for Andreus.
And because in many cases over expression of <unk>, while our mechanism through using a tyrosine kinase inhibitor with block all three bed, Jeff AR receptors. So even if there was over expression of <unk> and <unk>, we would be blocking the interaction of that gypsy any at the receptor sites. So I think.
Andreas Argyrides: Hi. Sorry, I can't see anything. It's up. It's okay. No worries. Thank you for taking our questions. We have just two from us. Can you discuss your targeted timeline for enrollment in Odyssey and how enrollment is progressing? Are you seeing any impact from the availability of the Pizmo? And then, second, can you just discuss the powering assumptions for us?
George M. Lasezkay: Thank you.
There's room for multiple products I often refer to this area is starting to develop the characteristics all of them.
Cancer therapy, where there's multiple approaches multiple products used for that particular cancer and I think it could be that the two products end up being able to be used together rather than just competing straight up for for.
George M. Lasezkay: Okay, sure. The powering assumption: we're not conducting a non-inferiority trial. We're not conducting a superiority trial. So there really isn't a powering assumption here.
For all wet AMD patients. So I think there's room for both.
George M. Lasezkay: What we're looking at is a late philibib on late, to see how, over the 36 weeks, those patients in the Fliberstab arm do in terms of keeping a stable BCBA and CST. And then we're going to look at the CLSA-X arm. And what we're trying to do is to see whether the BCBAs and the CSTs are similar between the two groups and what our ideal dosing regimen would be on a fixed basis going into phase three. Should it be every four months? Should it be every five months? Should it be every six months?
And we'll see.
The proof will be in the clinical data for both products.
Thanks. The next question is unknown.
I don't know if you can comment on the prescription bought enough design here, whether your quarterly license revenue is co related to the prescription volume.
Okay, I'll, let Charlie handle that lapses.
We don't we don't have a prescription information I think.
George M. Lasezkay: Maybe we can go long? Okay, so this is not set up as a trial that has sufficient patients to have a powered outcome, as you would think of in a non-superiority trial in particular. So we think that the phase two design here, in terms of total patients that are in the treatment arm, is very consistent with the way a number of recent phase two trials have been run. We're not looking to convert this into phase three.
Those of you that track.
Retina trials as a typical to get so we can't give any guidance or trends on sales, we're contractually obligated to buy or not to discussing lets say do so until they start reporting out publicly the sales side I can't help you with that.
Got it and lastly could you.
The common.
George M. Lasezkay: We're looking to run standard phase two B trials, trying to compare, on an estimation basis, how well we're doing and where we should go into phase three on a fixed dose. In terms of enrollment, as I mentioned in the press release and in the opening remarks, we were nearly at the 30 targeted sites that we want. We have all of our previous sites from Oasis included in Odyssey, so we have many people that are very experienced with CLSAX already in.
The potential timeline to for your partner to obtain the approval in Australia.
Well.
Our understanding of the filing in Australia is that it's typically it's very similar to the United States and that your expectation should be about a 12 month review two approval cycle and they filed.
A month or so ago, and so I would think it would be built in Pep news by this time next year.
That that's kind of an educated guess on my part, but we do we do understand the Australian process for approval runs about.
George M. Lasezkay: We'll be closing that out soon. And then on enrollment, we're not going to give enrollment updates per se, but what we are not changing is our disclosure regarding when we think top-line data is going to be available. We're still looking at the third quarter of next year, and the way we've been able to enroll sites, and as we see enrollment of participants going on, we're still very comfortable with Q3 of 2024 in terms of the top line. Okay, great. Thank you.
A similar timeline to the United States, which is about 12 months.
Got it.
Thank you.
Okay sure.
Thank you.
We have reached the end of our question and answer session. So I will now turn the call back over to Dr. <unk> for any closing comments you may have.
Thank you. Thank you all for joining us on the call. This afternoon. We really appreciate your continued interest in clear sight, we look forward to updating you on our progress throughout the year and at that.
George M. Lasezkay: Okay, great. Thank you so much and congratulations on the progress.
Operator: Thank you. Our next question is coming from Sean Kim with Jones Trading. Your line is: Yeah, hi, thank you for taking my questions. I guess the first question for me is: Hi.
Operator, you can now disconnect the call. Thank you again all.
Thank you Sir This concludes today's conference you may disconnect. Your lines at this time this time sorry, Amit.
Shawn Kim: My first question is that in light of recent safety issues reported with an FDA-approved therapy in geographic atrocity, would you please remind us if there has been any retinal fesculitis reported with any of the supercoyal injections given thus far? And a related question is, in comparison to individual injections, is the supercroyal drug deluxe? This approach might be intrinsically more likely or less prone to causing retinal vasculitis and related adversities.
We thank you for your participation.
Yeah.
George M. Lasezkay: Well, I think the first part of the question first: as far as I know, certainly with CLSA-X, we've had no, no events, no indication of any kind of inflammation, including retinolvascular. So that covers both the product itself, CLSAX, the tyrosine kinase inhibitor, as well as the injection technique and the injection procedure. We've not seen any of that.
George M. Lasezkay: And as far as I'm aware, we don't have any significant reports or any reports at all of retinal vascularitis. I'd have to double check that to be sure, but there's nothing that comes to mind in our partners' trials or in our previous trials getting Zypere approved, that that was a significant problem. Certainly, if you look at the injection procedure itself using our SES micro-injector, it's been very reliable, safe, and very repeatable. The physicians that are trained on it find it once they're trained on it, and the training doesn't take all that long. It's not that complicated, but it is important.
George M. Lasezkay: Once they're trained, they find it an easy procedure, a very acceptable procedure, and very comparable, in a sense, from a patient experience and a physician experience to intravitral injection. So retinal vascularitis has just not come up as a problem that I can recall in any of our clinical trials or with our partners. Now, to be fair, Regenics Biohead did cause some inflammation in some of their earlier trials, but they've recently reported that with the topical steroids in their phase two trial, which I believe was in wet A&D, they saw no signs of inflammation, and I've certainly not heard of any reports of retinal vasculitis.
George M. Lasezkay: Okay, that's helpful. Thank you.
Shawn Kim: And related to the Odyssey trial, if I understand correctly, one of the goals of the Autities trial is to define the fixed dosing schedule for potential phase three. So my question is, what end point would dictate that dosing interval for phase three? Would it be the BCBA letter change, or would it be more of a totality of data across different efficacy points? I think the most important thing
George M. Lasezkay: I think the most important, and certainly from the FDA's perspective, the most important endpoint would be the BCBA. They certainly want to, you know, Dr.
George M. Lasezkay: Chambers at the FDA is very focused, first and foremost, on vision, vision, preservation, or vision improvement. And so I think the real most important factor would be the BCBA stability for the duration. How long can we keep that BCBA stable without requiring any kind of supplemental intervention? So I think that's the most important thing. Other things like CST are important, but I think BCDA is the most important.
George M. Lasezkay: Okay, gotcha. And just a quick follow-up on that: just curious what your expectations might be for the FLB receptor control arm in terms of that BCDA change for six months, specifically in the target population for the audit trial.
George M. Lasezkay: I'm not sure what to expect. Regarding BCBA, I would hope that, I would expect, not so much I would hope, but I would expect if the patients are the typical patients that go into that and they get... and they get dosed appropriately on label with phlybosab, they'll have a similar outcome. There'll be a similar overall outcome to what you've seen with a flibibibus on labeled before in the hands of other people. I don't know why it would be any different in our hands, other people.
George M. Lasezkay: We looked at how Bavizmo did versus Fliversib using a Fliber Csib as their control in phase three, and we saw how Bavizum did against that. And we think that we can do as well against the fliberset as well against a Fliber Cep as Bavisem did against a Fliber Cep, but we believe that our dosing interval is going to be longer than Bavizmos turned out to be in their phase three. So I don't expect any difference between.
George M. Lasezkay: in the way Flibercept patients respond to a Flibercept other than what you've seen in other trials in WET AMD that enrolled a similar population. It really does come down to the enrollment. What kind of patients are you putting in? If you're putting in patients that really don't have strong signs of active disease, you know, those patients are going to do really, really well because they may not have required any real intervention to begin with. There is a lot of literature that will talk about patients that are relatively dry but diagnosed with the disease, but no active signs of, no active signs of active disease might go for a long period of time between
George M. Lasezkay: But we're trying to make sure that the two groups have people that are responsive to antibiotic jets and have active disease when they're. And then I think the outcome in the Eiffle subgroup will be pretty consistent with
Operator: Okay, great, thank you. Thank you. Our next question is coming from Rohit Basin with Needham and Company. Your line is life. Hi, this is Rohiton for Serge. Thanks for taking their questions. Are you still evaluating, how are you going? Are you still evaluating new potential collaborations for the SCS micro injector platform? And then, is the current cash balance sufficient to get us to a top-line readout of Odyssey?
Rohit Bhasin: All right, I'll take the first part of that question and I'll let Charlie take the second. Yes, we are in discussions with other companies about potentially partnering in various disease states or with various therapeutic agents that we think might be useful delivered super corollarily. We conduct those kinds of business development activities on a regular, ongoing basis. We don't jump into them lightly.
George M. Lasezkay: We want to make sure they're very strategic, very positive for us, and would be a positive for the company. And so we need to make sure that we have the right terms, the right partner, and it fits our strategy for partnering. We typically try to partner in areas where the collaborator has technology that we cannot access or that we don't have any expertise in. For example, gene therapy is not a core competency of us or of Clarside.
George M. Lasezkay: So that's why we partner in the area, and look to partner in the area of gene therapies in particular. But there could be other small molecules that are proprietary to other companies that want to be put into our supercoral delivery system. And we're certainly open to that, and we have a constant stream of conversations with people trying to put together the right deal that makes sense for us as well. And Charlie, I'll let you take the cash run. Thanks, yeah, hey Rowan. Yeah, so our country, as we
Charles A. Deignan: Thanks, yeah, hey, Rowland. Yeah, so as we said, our data is coming, we plan to come in Q3 next year, and our cash can get us into Q3 of next year. That's, you know, obviously we'd want a cushion, and, you know, we can't until we finish enrollment, you know, exactly within the quarter. The data will come. But, you know, we will, you know, continue to look to extend our runway, you know, much past our, or when the data comes in. And, you know, that's what we're doing now; looking at all, you know, dilutive and non-dilutive ways to extend our runway.
Charles A. Deignan: Great. Thank you. Thank you. Our next question comes from Jack Padavano with Stiefel. Your line is, Hi, this is Jack calling in for Annabelle. Hi, Jack. Just a quick question from me. Could you briefly go over some of the economics with your partners again and see if there's any chance that you might be able to see some additional near-term expected catalysts or milestones from them?
Operator: Charlie, is that something you would want to address? Sure, so, you know, as a
Charles A. Deignan: Sure, so, you know, as a reminder, we haven't announced, or we're not allowed to announce, particular milestones, but, you know, as some of these, our collaborators are getting into phase three, typically, there are phase three development milestones to go with them. But, you know, that would affect our EPS and revenues, but, you know, just don't forget that when we monetized our royalties with HCR, healthcare royalty, those milestones will get wrapped up and go towards the cap we have to pay. If you remember, we took $32.5 million dollars from them, and we'll have to pay two and a half times that back, so approximately $181 million.
Charles A. Deignan: So those any milestones that come in will go directly to HCR on our partnered program. Thanks. That's your question? Yeah. Thank you. Our next question is coming from Yi Chen with H.C. Wainwrights. Your line is, Thank you for taking my questions. Your partner, Rejank Spau, recently reported some progress with their candidate for WAD&D. I don't know if you can comment on whether their candidate in the future could potentially become a competitor to CSAA.
Yi Chen: I'll take that question. I suppose it could. It depends, I think, as I understand their therapy, their therapy is a gene therapy that generates a Lucentus-type molecule, and, um, again, what CLSAX does is a different mechanism of action than what the Regenics slash ABB product would have. All right.
George M. Lasezkay: So it's pretty much standard anti-vagin therapy, just like Ilya, Babysmell, et cetera, and the sentes. There, I think their potential claim to fame is that they will last a long time in binding the circulating veg. From our perspective, we're taking a different mechanism, a mechanistic approach, and that is, we're blocking the VEF receptors 1, 2, So any circulating VEGF, including, you know, if it's not completely bound, they're still circulating VEGFF, and they bind again to VEGFA.
George M. Lasezkay: And in many cases, there's an overexpression of patients once you start to bind the VEFA, especially on a longer-term treatment after a couple of years of getting VEFA, anti-VGFA therapy, there's an overexpression of C and E in particular, which can cause potential neovascularization.
George M. Lasezkay: So I think that while it's potentially competitive, in that they're going after wet A&D, as are we with CLSAX, they could be complementary, if you want to put a positive spin on it. I think they'd be complementary because the mechanisms are different, and there would be unlikely, based mechanistically, unlikely to address any of those patients that become resistant to the anti-vege-fA therapy, and because in many cases, over-expression of C&E, while our mechanism, through using a pyrgyne kinase, would block all three VEGF receptors. So even if there was overexpression of C and E, we would be blocking the interaction of VEF C&E at the receptor side.
George M. Lasezkay: So I think there's room for multiple products. I often refer to this area as starting to develop the characteristics of cancer therapy, where there are multiple approaches, and multiple products used to treat particular cancers. And I think it could be that the two products end up being able to be used together, rather than just competing straight up for all wet AMD patients. So I think there's room for both, and we'll see. The proof will be in the clinical data for both products.
Yi Chen: Thanks. My next question is, I would like to know if you can comment on the prescription volume of Zypia and whether your quarterly licensed revenue is correlated to the prescription model.
Charles A. Deignan: Okay, I'll let Charlie handle that.
Charles A. Deignan: Yeah, so we don't have prescription information. I think, you know, those of you that track retina drugs find them difficult to get, so we can't give any guidance or trends on sales. We're contractually obligated to Bouch not to discuss unless they do so. Until they start reporting out publicly, the sales, I can't help you with that. Got it. And lastly, could you please comment on the... The potential timeline for your partner to obtain the approval of Zypia in Australia.
George M. Lasezkay: Well, our understanding of the filing in Australia is that it's typically very similar to the United States in that your expectation should be about a 12-month review to approval cycle. And they filed... a month or so ago. And so I would think it'd be, they'll have news by this time next year. That's kind of an educated guess on my part, but we do understand the Australian process for approval runs about, on a similar timeline to the United States, which is about 12.
Yi Chen: Got it.
Operator: Got it. Thank you. Okay, sure. Thank you. We have reached the end of our question and answer session, so I'll now turn the call back over to Dr. Luzeski for any closing comments he may have.
George M. Lasezkay: Thank you all for joining us on the call this afternoon. We really appreciate your continued interest in Clearside. We look forward to updating you on our progress throughout the year. And with that, Operator, you can now disconnect the call. Thank you again.
Operator: Thank you, sir. This concludes today's conference. You may disconnect your lines at this time. This time, sorry, and we thank you for your participation.