Q3 2023 Clearside Biomedical Inc Earnings Call
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Speaker 1: Ladies and gentlemen, thank you for your patience. This conference will begin momentarily.
Speaker 1: Once again, thank you for your patience and this conference will begin momentarily.
[music].
Speaker 1: Greetings and welcome to the Clearside Biomedical 3rd Quarter 2023 Financial Results and Corporate Update Code
Greetings and welcome to the clear sight biomedical third quarter 2023 financial results and corporate update call.
Speaker 1: At this time, all participants are on a listen-only mode, and a question-and-answer session will follow the formal presentation.
At this time all participants are in a listen only mode.
A question and answer session will follow the formal presentation.
Speaker 1: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded.
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.
Speaker 1: Jenny Kobin of Clearside Investor Relations. Mom, the floor is yours.
Jenny Colby of care site Investor Relations ma'am the floor is yours.
Speaker 2: Good afternoon, everyone, and thank you for joining us on the call today.
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.
Speaker 2: Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements.
Speaker 2: 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 Security Litigation Reform Act of 1995.
Statements for purposes of the private Securities Litigation Reform Act of 1995 actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of our annual report on form 10.
Speaker 2: 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 10K for the year ended December 31, 2022, our quarterly report on Form 10Q for the quarter ended September 30, 2023 to be filed today, and our other SEC filings available on our website..
K for the year ended December 31, 2020 to our quarterly report on Form 10-Q for the quarter ended September 30th 2023 to be filed today and our other SEC filings available on our website.
Speaker 2: 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.
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.
Speaker 2: On today's call, we have George Ladesque, our Chief Executive Officer, and Charlie Dugnan, our Chief Financial Officer. After our formal remarks, we will open the call for your questions. I would now like to turn the call over to George.
On today's call we have George look that's gay, our Chief Executive Officer, and Charlie Deignan, Our Chief Financial Officer. After our formal remarks, we will open the call for your questions I would now like to turn the call over to George.
Yeah.
Thanks, Jenny and good afternoon, everyone.
Speaker 3: Today I'm excited to discuss several recent value creating achievements related to our super coroidal platform. We've had two weeks of really good news.
I am excited to discuss several recent value, creating achievements related to our Super Choroidal platform. We've had two weeks of really good news.
Speaker 3: We completed enrollment in ODYSSEY, our Phase 2B wet A&E clinical trial, with top-line data expected in the third quarter of 2024. We announced a new partnership with Biopris Pharmaceuticals to expand our external development pipeline with a plasma calocrine inhibitor for the treatment of diabetic macular edema.
We completed enrollment in Odyssey, our phase two be wet AMD clinical trial with topline data expected in the third quarter of 2024, we.
We announced a new partnership with Biocryst pharmaceuticals to expand our external development pipeline with a plasma <unk> inhibitor for the treatment of diabetic macular edema.
Speaker 3: Both of our other supercoroidal collaboration partners, Regenexx Bio and Aura Biosciences, recently presented positive safety and efficacy data through Phase II with their respective compounds using our SES microinjector.
Both of our other Super Choroidal collaboration partners were Giants bio and Aura Biosciences recently presented positive safety and efficacy data through phase two with their respective compounds using our SCS microinjection.
That's where our XI pure partners.
<unk> has been granted permanent category, one CPT code in the U S.
Facilitate better access and adoption of the product.
The Arctic vision completed enrollment in their phase III clinical trials are kato's also known as <unk> and uveitis macular edema in China.
Speaker 3: Arctic Vision completed enrollment in their phase 3 clinical trials, Arkeidus, also known as Xyper, in uveitic macular edema in China.
Speaker 3: So let me discuss, let me start with discussing our lead program, CLSAS.
So let me discuss let me start with discussing our lead program CLSA.
Last month, we completed recruitment in our Odyssey phase two b clinical trial evaluating the safety and efficacy of CLSA X are highly potent tyrosine kinase inhibitor delivered by our patented SCS micro injector.
Speaker 3: Last month we completed recruitment in our Odyssey Phase IIb clinical trial evaluating the safety and efficacy of CLSAX, our highly potent tyrosine kinase inhibitor delivered by our patented SCS micron.
Speaker 3: As a reminder, OBSI is a randomized double-mast active-controlled multi-center study in participants with wet A and D.
As a reminder, honestly is a randomized double masked active controlled multicenter study participants with wet AMD.
Speaker 3: One of the most encouraging aspects of our CLSA program is the feedback that we received from the medical.
One of the most encouraging aspects of our CLSA. Its program is the feedback that we received from the medical community.
Speaker 3: Multiple leading retinal physicians have presented data from our OASIS Phase 1-2a clinical trial of CLSAx in WebAMD at top ophthalmic meetings, including the recent AAO, ASRS, and Retina Society meetings.
Multiple leading retinal physicians have presented data from our Oasis phase one two clinical trial with CLSA acts in wet AMD topical ophthalmic meetings, including the recent E O S RFS and retina Society meetings.
These presentations highlighted the excellent safety profile stable vision and reduced frequency of injections observed for up to six months.
Speaker 3: These presentations highlighted the excellent safety profile, stable vision, and reduced frequency of injections observed for up to six months.
Speaker 3: These presentations also created significant interest in our program from clinical trial participants, investigators, and sites that helped drive strong recruitment for our Odyssey Phase II B trial. The completion of recruitment is a critical accomplishment for us as the final participants in the study advance to randomization, either to the CLS-AX treatment arm or the on-label of Fliverset comparator.
These presentations also created significant interest in our program from clinical trial participants investigators and sites that helped drive strong recruitment for our Odyssey phase two b trial the.
The completion of recruitment is a critical accomplishment for us as the final participants in the study advanced to randomization either through the CLSA ex treatment.
The on label a flavor soft comparator arm.
Speaker 3: We expect randomization to be completed by the middle of December 2023, and we remain on track to report top line data from Odyssey in the third quarter of 2024.
We expect randomization to be completed by the Middle of December 2023, and we remain on track to report topline data from occupancy in the third quarter of 2024.
Speaker 3: Our goals for the ODYSSEY trial are to demonstrate an excellent safety profile, stable visual acuity, and a lower treatment burden in the CLSAx arm. The efficacy and safety results from ODYSSEY will then guide our pivotal phase three development program for CLSAx.
Our goals for the Odyssey trial are to demonstrated excellent safety profile stable visual acuity and a lower treatment burden and the CLSA XR.
Efficacy and safety results from Odyssey will then guide our pivotal phase III development programs for CLS Ax.
Speaker 3: We believe that differentiated mechanism of action and high potency of equipment
We believe the differentiated mechanism of action and high potency of it.
Combined with safe and reliable delivery into the Super Gorilla space has the potential to be a best in class approach for long term maintenance therapy for individuals with wet AMD.
Speaker 3: combined with safe and reliable delivery into the supercoroidal space, has the potential to be a best in class approach for long-term maintenance therapy for individuals with wet AMD.
Speaker 3: We were thrilled to start this month by announcing our new global licensing partnership with BioCRISP Pharmacy.
We were thrilled to start this month by announcing our new global licensing partnership with Biocryst Pharmaceuticals.
Speaker 3: This collaboration expands the reach and demonstrates the versatility of our supercoronal injection platform by adding another compound to be delivered with our proprietary SDS microinjector. The agreement includes $5 million in an upfront licensee, plus the potential for future milestone payments and sales.
This collaboration expands our reach and demonstrates the versatility of our supercritical injection platform by adding another compound to be delivered with our proprietary SCS micro injector.
The agreement includes $5 million in an upfront license fee plus the potential for future milestone payments and sales royalties.
The partnership with Biocryst is focused on the development of their proprietary small molecule a boiler staff to be administered via the supercoil injection for the treatment of diabetic macular edema.
Speaker 3: The partnership with Biochrist is focused on the development of their proprietary small molecule, Orlistat, to be administered via the supercoital injection for the treatment of diabetic macular edema. DME is the most common cause of vision loss in individuals with diabetes, and we believe there's a significant market opportunity in this indication.
He is the most common cause of vision loss in individuals with diabetes and we believe there's a significant market opportunity in this indication.
Speaker 3: Avoralistat has high potency and low solubility, which are characteristics that are well suited for supercoronal administration and important to achieving potential efficacy with reduced dosing frequency.
A waterless that has high potency low solubility.
Or characteristics that are well suited for Super Gorilla administration, an important to achieving potential efficacy with reduced dosing frequency.
Speaker 3: Delivering a Borlastat into the suprachoidal space and behind the visual field could allow a Borlastat to inhibit plasma calocrine directly at the location where the edema forms with a desirable durability of effect.
Delivering of Orlistat supercoil space behind the visual field could allow a orlistat too inhibited plasma calcarine directly at the location, where the demob forums with a desirable durability of effect.
Speaker 3: Biocris expects to continue conducting formulation and non-clinical work into 2024 and begin clinical trials in 2025.
Biocryst expects to continue conducting formulation of non clinical work into 2024 and begin clinical trials in 2025.
The versatility of our Supercoil injection platform was on display at this month's American Academy of Ophthalmology Medical meeting, where two of our other partners for <unk> bio in Aura Biosciences presented very promising data with their respective compounds utilizing our SCS micro injector.
Speaker 3: The versatility of our supercoital injection platform was on display at this month's American Academy of Ophthalmology medical meeting, where two of our other partners, Regenexx Bio and Oral Biosciences, presented very promising data with their respective compounds utilizing our SES micro-injection.
<unk> reported the results of their phase two altitude trial evaluating their gene therapy, a BBB, our gx 314 in diabetic retinopathy.
Speaker 3: Regenexx Bio reported the results of their Phase 2 Altitude Trial evaluating their gene therapy ABBB RGX314 in diabetic retinopathy, the leading cause of vision loss in adults between 24 and 75 years of age worldwide.
Leading cause of vision loss in adults between 24 75 years of age worldwide.
314 continues to be well tolerated and 50 patients from dose levels, one and two with no drug related serious adverse events at the second dose level, three 2014 prevented disease progression and reduce vision threatening events and non proliferative diabetic retinopathy at one year.
Speaker 3: 314 continues to be well-tolerated in 50 patients from dose levels 1 and 2 with no drug-related serious adverse events. At the second dose level, 314 prevented disease progression and reduced vision-threatening events in non-proliferative diabetic retinopathy at one year.
<unk> bio has indicated they believe are one time in office supercritical injection of $3 14 gene therapy has the potential to stabilize and improve diabetic retinopathy severity score and reduce the long term risk of vision threatening events.
Speaker 3: Regenexx Bio has indicated they believe that a one-time in-office suprachoroidal injection of 314 gene therapy has the potential to stabilize and improve diabetic retinopathy severity score and reduce the long-term risk of vision-threatening events.
Speaker 3: or a biosciences reported positive clinical efficacy updates from its ongoing phase two clinical trial, the supercroyal administration of Belsar for the first line treatment of early stage cruoidal melanoma.
Or a biosciences reported positive clinical efficacy updates from its ongoing phase II clinical trial with supercritical administration of belts are for the first line treatment early stage choroidal melanoma.
Speaker 3: Their phase two trial is assessing the safety and preliminary efficacy of single and multiple ascending doses of Belsar for up to three cycles of treatment.
Their phase two trial is assessing the safety and preliminary efficacy of single and multiple ascending doses of bell Saar for up to three cycles of treatment.
Speaker 3: Phase II data with 90% of their patients at 12 months of following.
Phase II data with 90% of their patients at 12 months of follow up.
Speaker 3: demonstrated 80% tumor control and 90% visual acuity preservation for patients that have been treated with three cycles of Belsar and that meet the phase three enrollment criteria.
Demonstrated 80% tumor control and 90% visual acuity preservation for patients that had been treated with three cycles of bell SAR and that meet the phase III enrollment criteria.
Speaker 3: Safety profile continues to be favorable with no significant or treatment related serious adverse events.
Safety profile continues to be favorable with no significant or treatment related serious adverse events. This is very encouraging as most of these patients had tumors close to the phobia or optic disk and would likely have experienced severe irreversible vision loss with the current standard of care.
Speaker 3: This is very encouraging as most of these patients had tumors close to the phobia or optic disc and would likely have experienced severe and irreversible vision loss with the current standard of care. ORH has also announced agreement with the FDA under a special protocol assessment for the design and planned analysis of their Phase III COMPASS trial.
It has also announced agreement with the FDA under a special protocol assessment for the design and planned analysis of their phase III trial.
Speaker 3: plan to dose the first patient in this trial this quarter.
We plan to dose the first patient in this trial this quarter.
Speaker 3: In addition to the R&D progress over the last few months, our commercial partnership with Zypeer have also announced important achievements.
In addition to the R&D progress over the last few months, our commercial partnership. Besides here have also announced the important achievements.
Speaker 3: Dr. Long announced that the American Medical Association has granted a new current procedural terminology or CPT code for Zypyr with support from the American Academy of Ophthalmology and the American Society of Retina Specialists.
Bausch and Lomb announced that the American Medical Association has granted a new current procedural terminology, our CPT code for <unk> with support from the American Academy of Ophthalmology, and the American Society of retina specialists.
Speaker 3: Category 1 code for the supracarotid injection procedure will help facilitate better access and adoption of CYPR in the United States. The new CPT Category 1 code will be effective on January 1, 2024, replacing the current miscellaneous Category 3 code.
Category, one code for the Super Gorilla injection procedure will help facilitate better access and adoption of sites here in the United States.
New CPT category, one code will be effective on January one 2020 for replacing the current miscellaneous category three code.
Speaker 3: At AAO, Bashamam also presented survey data on positive physician experience using Zyper in the treatment of uveitic macular edema, indicating that physicians found Zyper supracaroidal injection easy to learn with patient outcomes consistent with clinical trial data.
At a O Bausch and Lomb also presented survey data on positive physician experience using <unk> in the treatment of UBI <unk> macular edema, indicating that physician style XI appears supercoil injection easy to learn with patient outcomes consistent with clinical trial data.
Our Asia Pacific partner Arctic Vision also accomplished a major milestone with completion of enrollment in China of its phase III randomized double blind placebo controlled clinical trial with zeit peers in uveitis macular edema.
Speaker 3: Our Asia-Pacific partner, Arctic Vision, also accomplished a major milestone with completion of enrollment in China of its Phase III randomized double-blind placebo-controlled clinical trial with Zyper in uveitic macular edema.
Speaker 3: As a reminder, Zaipeer is referred to as Arcadis in China.
As a reminder, XI peer is referred to as our cadence in China.
Speaker 3: If positive, the data from the Phase III trial will allow Arctic Vision to apply for marketing approval in China. In addition, earlier this year Arctic Vision applied for marketing approval of Arcadis in Australia.
If positive data from the phase III trial will allow Arctic vision to apply for marketing approval in China. In addition earlier this year Arctic vision applied for marketing approval of our cases in Australia.
Speaker 3: We appreciate the commitment of both BaShalom and Arctic Vision to expand the use of Xipir and look forward to further updates.
We appreciate the commitment of both Bausch and Lomb and Arctic vision to expand the use of <unk> and look forward to further updates I will now turn over the call to our CFO, Charlie Deignan to provide the financial update Charlie.
Speaker 3: I'll now turn over the call to our CFO , Charlie Degnan, to provide a financial update.
Yes.
Speaker 4: Thank you, George, and good afternoon, everyone. Our financial results for the third 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.
Thank you, Georgia and good afternoon, everyone. Our financial results for the third 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.
Speaker 4: As of September 30th, 2023, our cash and cash equivalents totaled approximately $29 million. Subsequent to the end of the third quarter, we entered into the licensing agreement with Biocredit.
As of September 30th 2023, our cash and cash equivalents totaled approximately $29 million subsequent to the ended the third quarter, we entered into the licensing agreement with Biocryst.
Speaker 4: We will receive $5 million in non-dilutive capital in the form of an upfront license fee. With this combined cash balance, we believe we have sufficient resources to fund our planned operations into the fourth quarter of 2024, which moves us past the expected completion of our Odyssey trial and the related top-line data analysis.
We will receive a $5 million in non dilutive capital in the form of an upfront license fee.
With this combined cash balance we believe we have sufficient resources to.
To fund our planned operations into the fourth quarter of 2024, which moves us past the expected completion of our Odyssey trial and the related topline data announcement.
Speaker 4: In terms of investor outreach, we look forward to participating in the Stiefel Healthcare Conference on Wednesday of this week and BTIG's third annual ophthalmology day later this month. We look forward to keeping the investment community updated on our progress, and I'll now turn the call back over to George for his closing remarks.
In terms of Investor outreach, we look forward to participating in the Stifel Healthcare conference on Wednesday of this week and <unk> third annual Ophthalmology day later this month.
We look forward to keeping the investment community updated on our progress and I'll now turn the call back over to George for his closing remarks.
Thanks, Charlie.
Speaker 3: Thanks, Charlie. The level of awareness and usage of supracarotidal administration continues to grow with the progress from both our internal programs and our supracarotidal development commercialization partners. When it comes to the adoption of new therapeutic treatments, we know that safety is the top priority for physicians and their patients.
The level of awareness and usage of Supercoil administration continues to grow with the progress from both our internal programs and our Super Choroidal development and commercialization partners. When it comes to the adoption of new therapeutic treatments. We know that safety is the top priority for physicians and their patients are super Choroidal approach is already proven.
Speaker 3: Our suprachoroidal approach is already a proven method of delivery with a very clean safety profile, both commercially and in clinical development. Including our new partnership with BioCryst, we now have five collaboration partners actively targeting the suprachoroidal space for treatment of multiple serious retinal diseases using our STS microinjector. We believe this represents significant future value for ClearSide and for our shareholders.
With the delivery with a very clean safety profile, both commercially and in clinical development include.
Including our new partnership with Biocryst, We now have five collaboration partners actively targeting the Super Gorilla space for treatment of multiple serious retinal diseases using our SCS micro injector. We believe this represents significant future value for clear side and for our shareholders.
Speaker 3: I would now like to ask the operator to open up the call for questions.
I would now like to ask the operator to open up the call for questions.
Speaker 1: Thank you. At this time we will be conducting our question and answer session.
Thank you at this time, we will be conducting our question and answer session.
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One moment, please while we poll for questions.
Speaker 1: Thank you. Our first question is coming from Serge Bellinger with Needham & Company. Your line is live.
Thank you.
Our first question is coming from Serge Belanger with Needham and company your line of sight.
Hey, good afternoon, thanks for taking my questions.
Speaker 5: Hi, good afternoon. Thanks for taking my questions. And congrats on the recent developments. I guess first one on the ODYSSEY trial, you completed enrollment. I think your target was 60 patients. Just curious if you.
Congrats on the recent developments.
I guess the first one on the Odyssey trial, you completed enrollment I think your.
Target was 60 patients just curious if you.
Speaker 5: Overshot that number and you're assuming some level of attrition to get through a 36 trial 36 week trial and then secondly maybe just talk about
Overshot that number and youre, assuming some level of attrition to get through our 36 trial 36 week trial.
And then secondly, maybe just talk about.
Speaker 5: potential inflection points for the Regenexx and AuraBytes, Aura partnership. Thank you.
Potential inflection points for our there'll be genex and or a bias or a.
Partnership Thank you.
Sure. Thanks, Serge let me take the first one we had a very healthy recruitment rate and an Odyssey Ah.
Speaker 3: Sure. Thanks, Serge. Let me take the first one. We had a very healthy recruitment rate in Odyssey. We had 32 sites signed up. 30 sites recruited at least one subject. So we had really good participation across all our sites. We were very happy about that.
We had 32 sites signed up 30 sites recruited at least one.
Subject.
So we had really good participation across all our sites are.
We're very happy about that.
Speaker 3: We have our target, as you know, was 60 patients and 2 to 1 randomization, 40 into the CLS-AX group, and 20 in the on-label liver cell comparator group.
We have our target as you know was 60 patients two to one randomization 40 into the CLSA ex group in 'twenty in the on label or sub comparator group and when.
Speaker 3: When we terminated our recruitment, we were, we had exceeded that slightly. So, we're a little over that goal. We may have some attrition, as you normally do during the conduct of a clinical trial. But right now, we're very happy with where we are. We got more than 60 in the trial. And so, we're very grateful and very thankful to the sites and the KOLs and the investigators that participated.
When we terminated our recruitment we were we had exceeded that slightly so we're a little over that goal. We may have some attrition as you normally do during the conduct of the clinical trial, but right now we're very happy with where we are.
We got more than 60 in the trial and.
So, we're very grateful and very thankful to the to the sites and the Kols and investigators.
That participated with them.
Speaker 3: Like I said, it was a really very, very robust screening and
You said it was a really a very very robust screening and and.
Speaker 3: and recruitment program and we were glad for everybody's participation.
In recruitment.
Graham and we were glad for everybody's participation.
Your.
Your other questions were.
Speaker 5: regarding potential inflection points for the Regenexx, Bio, and Aura, please.
Regarding a potential inflection points for the rejects bio in for a passion.
Speaker 3: Well, you know, the most important one is I'll start with Aura first.
Well you know the most important one is I'll start with our first as you know ours already got the SBA or going into phase III do you think the FDA looked at their phase two data I felt very comfortable about that and they're looking to recruit their first patient so.
Speaker 3: is you know ours already got the SBA for going to phase three. I think the FDA looked at their phase two data, felt very comfortable about that and they're looking to recruit their first patient. So the start of phase three is going to be very meaningful to them as well as to us and that should happen sometime this quarter. We're very hopeful on that and they are going to be not restricted to the United States. They're going outside the United States as well to to do their recruitment.
The phase III.
Gotta be very meaningful to them as well as to us and that should happen sometime in this quarter or very hopeful on that and they are going to be not restricted to the United States are going outside the United States as well to to do the recruitment offer rejects you know theyre rejects bio comes in two stages. The first of the art.
Speaker 3: For Regenexx, you know, their Regenexx bio comes in two stages. First, they're DR from their altitude trial, and then they'll have their wet AMD data, I think, early next year.
From their altitude trial, and then they'll have their wet AMD data I think early next year, but we were very very happy with what they were reporting in terms of what they saw in phase II for diabetic retinopathy.
Speaker 3: But we were very, very happy with what they were reporting in terms of what they saw in phase two for diabetic retinopathy. So the next big inflection point is them making a decision as to exactly when and how they're going to go into phase three.
So the next big inflection point as them, making a decision as to exactly when and how they're going to go into phase III, but I think that data amongst the very encouraging to them and you'd have to ask them a little bit more what they.
Speaker 3: But I think that data looks very encouraging to them and you'd have to ask them a little bit more what, you know, they're, they're the ones that really know their plans, but.
They're the ones that really know their plans, but then declaring a startup phase III in one or both of those indications would be a very.
Speaker 3: then declaring a start of phase three in one or both of those indications would be helpful.
Speaker 3: very meaningful, certainly for them and for AbbVie, but would be very meaningful for ClearSide.
A very meaningful certainly put them in for Abbvie, but it would be very meaningful for clear side as well.
Speaker 3: But we'll see what they say when they take more questions on that and they put together their final clinical development plan.
Well, we'll see what they say when they when they take more questions on that and they put together their final clinical development plans.
Speaker 3: I think we were very encouraged by what we saw in their phase two data in DR.
I think we were very encouraged by what we saw in the phase two data in D. R.
Thank you.
Thank you.
Speaker 1: Our next question is coming from John Wallaban with JMP Securities. Your line is now open.
Our next question is coming from John Walsh with JMP Securities. Your line is nice.
Speaker 6: Hey, thanks for taking the question. A couple on the BioCRISP partnership, just wondering about your current responsibilities and the handoff to BioCRISP, I think you said sometime a bit next year. Wondering what kind of work's been done already, and then what else do you think needs to get done before getting this in the DME patients? And then I have a follow-up on CLC-AX.
Hey, Thanks for taking the question.
A couple on the Biocryst partnership just wondering about your current responsibilities and the handoff to a biocryst I think you said sometime mid next year wondering what kind of works been done already and then what else do you think needs to get done before getting this into the <unk> patients and then I have a follow up on a few effects.
Sure.
Speaker 3: And remind me of the follow-up, John , so I'll forget as I'm talking about this. But in terms of BioCRISP, we have been working with BioCRISP for some time on formulation work and some early preclinical work that encouraged them to move ahead and take the license. That kind of work will continue into next year, as I said in my prepared remarks.
And remind me of the follow up John.
Forgetting so I'm talking about this but in terms of Biocryst, we had been working with Biocryst with some for some time on formulation work and some early preclinical work that encourage them to move ahead and take the license that.
That kind of work will continue into next year as I said in my prepared remarks.
Speaker 3: We will be collaborative with them, probably through next year, doing IND-enabling studies. But the real handoff will really probably be at IND.
We will be collaborative with them probably through next year doing R&D, enabling studies, but the real handoff.
<unk>.
We're really probably be at the IMD and they will take it forward from there. So we are we're going to work with them some more animal studies and some fine tuning of formulation.
Speaker 3: So we are, we're going to work with them on some more animal studies.
Speaker 3: and fine-tuning the formulation. But once that's done, the IND is filed. It's their molecule and they're...
But once that's done the Ind's filed its their molecule in their product to take forward.
Speaker 3: So, got it. That's it. I'm Biochrist. So, now, remind me of the follow-up.
So got it that's it on Biocryst. So now remind me the follow up.
Speaker 6: To your comments, it does seem like we're at, you know, getting to a critical mass on supercorroidal news flow and then also in the TKI space and what AMD with some readouts coming soon with expectations there. Can you remind us of what you want to see in Odyssey and what you think a competitive profile will be and how, you know, any competitive dynamics may change that before Odyssey reads out?
[laughter].
To your comment it does seem like we're at.
Getting to a critical math on Super Choroidal news flow in that also.
PKI space in wet AMD.
With some readouts coming soon with expectations. There can you remind us of what you want to see an Odyssey and what you think a competitive profile will be.
And how competitive dynamics may change that before Odyssey reads out.
Well I've said this before I've said this to you are you almost a year ago I remember us sitting together and I'm talking about this and he said I I I hope that I point has good readout on their data I think ocular.
Speaker 3: Well, I've said this before, I've said this to you almost a year ago, I remember us sitting together and talking about this, and I said, I hope that iPoint has good readout on their data. I think Ocular, I hope the same thing for Ocular too. I think all three of the companies really are in a position that we're trying to prove that tyrosine kinase inhibitors have a place.
Hope the same thing per occupant too I think all three of the companies really are in a position that we're trying to prove the tyrosine kinase inhibitors have a place where all coming at it slightly differently. There's two titles in kinase inhibitors three different waves of administering them Oh, our chief medical a consultant the retina.
Speaker 3: We're all coming at it slightly differently. There's two tyrosine kinase inhibitors, three different ways of administering them. You know, our chief medical consultant, our retina consultant, Tom Shula, we still talk to on a regular basis, always said people knew that tyrosine kinase inhibitors would have a place. It was just a matter of how to deliver them properly. So I think all of us have that approach and we're looking forward to that. I think that we believe in talking to our KOLs and our.
Shelton, Tom Ciulla, we still talk to on a regular basis always said people knew that tyrosine kinase inhibitors would have a place and its just a matter of how to deliver them properly. So.
I think all of us have have that approach and we're looking forward to that I think that we believe in talking to our our kols and our.
Our medical consultants.
Speaker 3: that if we have maintenance therapy that can guarantee a patient.
We have maintenance therapy that can guarantee on patients.
Speaker 3: four to six months, we think we have a very good product to be part of the overall treatment paradigm for wet AMD.
Four to six months.
We think we have a very good product to be to be part of the overall treatment paradigm for wet AMD patients.
Speaker 3: Personally, in our trial, I'm hopeful and very encouraged. I just believe that we're going to get more than that.
Personally in our trial on booking com.
Hopeful and I'm very encouraged I, just believe that we're going to get more than that we're going to get at least five to six months, but the data will be the data, but I think anything any <unk>.
Speaker 3: least five to six months. But, you know, the data will be the data. I think anything, any kind of data
Any kind of data that supports.
Speaker 3: that if the dosing is four to six months, five to six months, when you look at where the anti-VEGF A's are right now, they can't really guarantee any, everybody gets to four months. They can't even guarantee everybody gets to three months if you look at the Bovizmo label and even the high-dose IVA label. So we look at this as we believe we're going to have it this extended duration. We think it's going to have a place.
But it's the dosing is four to six months, 5% to six months when you look at where the anti budget as our right now they can't really guarantee and everybody gets to four months. They can't even guarantee everybody. It's three months, if you look into the lifestyle label and even the high dose Eylea label. So we we look at.
This is we believe we're gonna habit. This extended duration, we think it's gonna have a place and the other thing I would say to you is I keep telling people I look at the future of wet AMD in particular is more like a cancer chemotherapy and that there'll be different mechanisms of action different places, where the drugs work in the retina.
Speaker 3: And the other thing I would say to you is, you know, I keep telling people I look at the future of what AMD in particular is more like cancer chemotherapy in that there'll be different mechanisms of action.
Speaker 3: different places where the drugs work in the retina, and I think combination therapy is really going to be very important for a number of the patients right now. We know that anti-VEGF only underserves a certain amount of our patients. There's a certain number of patients that don't respond very well, don't respond at all, or over time become somewhat refractive to this VEGF system.
And I think combination therapy is really going to be a very important for a number of the patients right. Now we know that anti VEGF, a only underserved a certain amount of our patients. There's a certain number of patients that don't respond very well don't respond at all or over time becomes somewhat refractive too.
That single mechanism of action. So we think there's a very good place for a different mechanism of action in our particular case, we think we have a very safe and reliable way to administer it.
Speaker 3: So we think there's a very good place for a different mechanism of action. In our particular case, we think we have a very safe and reliable way to administer it. It doesn't cause any problems in the front of the eye in terms of impairment of vision or anterior chamber toxicity, and certainly no systemic problems. So we think we have a very good chance to become an important part of treating the wet AMD patient population as long as we're in that five, six month duration.
Doesn't cause any problems in the front of the eye in terms of impermanent vision or anterior chamber toxicity and certainly no systemic problems. So we think we have a very good chance to become an important part of treating the wet AMD patient population.
As long as we're in that five to six month duration.
That's helpful context, Thanks, George I appreciate the color sure.
Speaker 1: Thank you. Our next question is coming from Jack Padovano with Stiefel. Your line is.
Thank you. Our next question is coming from Jack Padovano with Stifel. Your line is life.
Speaker 7: Hi, this is Jack calling on for Annabelle. Thanks for taking our question. So, for Odyssey, have you powered the study to see non-inferiority at 3 months or 6 months? And how are you now accounting for rescue treatment? Because I know that in the OASIS study, there were some patients who were rescued per protocol and there were some others who were rescued because the investigator got a little nervous. So, how are you handling that?
Hi, This is Jack calling on for Annabel. Thanks for taking our question Hi, Jack So for Odyssey.
Have you powered the study to see non inferiority at three months or six months.
And how are you now accounting for rescue treatment, because I know that in the Oasis study there were some patients who were rescued per protocol and there were some others who were rescued because the investigator got a little nervous.
So how are you handling that.
Okay.
First of all let me make a clarifying remark about powering. This is not this trial is not designed to be a non inferiority trial is not designed to be a superiority trial.
Speaker 3: First of all, let me make a clarifying remark about powering. This is not this trial is not designed to be a non inferiority trial. It is not designed to be a superior.
Speaker 3: What we're doing is just comparing two groups, what we have single dose, what we're trying to determine is what is the optimal duration of effect.
What we're doing is just comparing two groups.
We have a single dose what we're trying to determine is what is the optimal duration of effect that we would then go into establishing a phase III trial that would be powered appropriately.
Speaker 3: that we would then go in to establishing a phase three trial.
Speaker 3: that would be powered appropriately either for non-inferiority or superiority.
Either for non inferiority or superiority compared to standard of care and we're still not even really sure what the standard of care might be by the time, we get there we don't know what ever buys more will be included in the standard of care like Lucentis and like Eylea are currently now. So we're just trying to we're trying to do is see how well can how far can we go how much.
Speaker 3: compared to standard of care. And we're still not even really sure what the standard of care might be by the time we get there. We don't know whether Robizumab will be included in the standard of care like Lucentis and like Ileah are currently now. So we're just trying to, we're trying to do to see how well can, how far can we go? How much duration can we affect?
Duration can we affect.
Speaker 3: and not be substantially different than the kind of best corrected visual acuity in the comparator.
And not be substantially different than the kind of best corrected visual acuity and the comparator group. So it's not really powered.
Speaker 3: So it's not really powered, statistically speaking, it's not powered for non-inferiority or superiority. What we tried to do, and you're right about OASIS, and I was looking at the OASIS data again the other day, and in our two high-dose cohorts, the half milligram and the milligram, and we're using the one milligram in ODYSSEY, actually,
Statistically speaking, it's not powered for non inferiority or superiority, what we tried to do and you're right about Oasis, we and I was looking at the Oasis data again, the other day and then our two high dose cohorts, the five milligram and the milligram and we're using the one milligram at Odyssey.
Actually the.
Speaker 3: Most of the off-protocol or early rescues happen one month in.
Most of the off protocol or early rescues happen one month in.
Speaker 3: to our highest dose, and it didn't happen in the lower dose, the 0.5.
Two our highest dose and it didn't happen in <unk>.
The lower dose the 0.5.
Speaker 3: For some odd reason, I think that was just a matter of small numbers and randomization and what have you, but we were very concerned about that because we thought, well, in some cases the doctors didn't have a lot of experience with this and they pulled the trigger early even though we had very strict criteria. It was the first time they were using CLSAx, they may not have known what to expect.
For some odd reason I think that was just a matter of small numbers and randomization and what have you, but so but we were very concerned about that because we thought well in some cases, the doctors didn't have a lot of experience with this and they pull the trigger early even though we had very strict criteria.
It's the first time they were using CLSA X. They may not have known what to expect a couple of things I would say about off trial protocol treatments that our study design with the three loading doses, giving CLSA ex with the second loading dose we think will help.
Speaker 3: A couple of things I would say about off-protocol treatments now. Our study design with the three loading doses, giving CLSAx with the second loading dose, we think will help prevent those off-protocol near-term supplemental treatments.
Prevent those off protocol near term supplemental treatments.
Speaker 3: Second, this time around, we spent a lot of time in multiple meetings, training the site investigators, going over the OASIS data, and really training them that
This time around we spent a lot of time in multiple meetings training the site investigators going over the Oasis data and really training them, but you know the CLSA acts as they don't have to worry about it too much early on they need to stick strictly to the criteria that we've given them in terms of rescue or supplemental therapy and I think.
Speaker 3: You know, the CLSA-X, they don't have to worry about it too much early on. They need to stick strictly to the criteria that we've given them in terms of rescue or supplemental therapy. And I think the increased familiarity with many of these physicians that were in the previous, a number of them were in the previous OASIS trial. Now with that increased familiarity, with the change in the study design, with the loading doses, I think that we're going to do a very good job of minimizing off-protocol early retreat. Thank you very much.
The increase from American familiarity with many of these physicians that were in the previous away a number of them were in the previous away since trial now with it increased familiarity with the change in the study design with a loading doses I think that we're going to do a very good job of minimizing off protocol early re treatments.
Great. Thanks for the clarification.
Speaker 8: OK.
Okay.
Thank you once again, ladies and gentlemen, if you have any questions or comments. Please press star one on your phone at this time.
Speaker 1: Thank you. Once again, ladies and gentlemen, if you have any questions or comments, please press star one on your phone at this time.
Speaker 1: Our next question is coming from Yi Chen with HC Wainwright. Your line is live.
Our next question is coming from E. Chen with H C. Wainwright your line of sight.
Speaker 9: Thank you for taking my question. In view of the recent FDA draft guidance on wet AMD and the phase three trial design from your competitors, can you comment on what parts of the ODYSSEY trial design need to be changed in the future pivots?
Thank you for taking my question.
In view of the recent FDA draft guidance on wet AMD in the phase III trial design from your competitors.
Can you comment on what parts of the Odyssey trial design needs to be changed in the future pivotal trial.
Yeah.
Speaker 3: Well, thanks for the question. The answer is, I don't know right now, because we want to see what the data is that
Well thanks for the question.
The answer is I don't know right now because.
We wanted to see what the data is that.
Speaker 3: The data from the ODYSSEY trial will dictate a lot of how we go to the FDA and propose to do a phase three trial. I think the draft guidance, and we're waiting for the guidance to be finalized, by the way, the draft guidance, the phase three trials are probably going to have to be at least nine months long. They're going to have to have multiple dosing. And they're going to have to have some comparison to a standard of care that we know. I think there needs to be some clarification.
The data from the Odyssey trial will dictate a lot of how we go to the FDA and proposed to do a phase III trial.
I think the draft guidance and were waiting for the guidance to be finalized by the way the.
The draft guidance the phase III trials are probably going to have to be at least nine months long, they're going to have to have multiple dosing and theyre going to have to have some comparison to standard of care that we know where I think there needs to be some clarification is.
Speaker 3: part of the draft guidelines, and I know a number of companies have probably commented on this, about the dosing of the comparator to be the same dosing as the treatment. And I think that's been a question of how to deal with that when what you're trying to do is dose much less frequently than the standard of care. And we've seen Ocular go in a direction where they're saying, well, we're gonna give one dose of Oflibrizeb and one dose of our Exitinib.
Part of the draft guidelines and I know a number of companies that probably commented on this about the dosing of the comparator to be the same dosing and the treatment.
I think that that's been a question of how to deal with that.
When youre, what Youre trying to do is dose much less frequently than the standard of care.
Seeing the ocular go in a direction, where I'm, saying, what we're going to get one dose of a flavor so and wonder if some are exceeding them.
Speaker 3: A lot of questions about that trial design, what went into that trial design, what was the thinking and the conversations with the FDA. So it's a little early for us to do that. We're very committed to this current trial design of ODYSSEY as phase 2B. The way we set it up, we have talked to the FDA about this trial. We did make a change, because you may remember.
A lot of questions about that trial design, what went into that trial design and what was the thinking on the conversations with the FDA. So it's a little early for us to do that we're very committed to this current trial design of Odyssey phase two b the way we set it up but we have talked to the FDA about this trial, we did make a change since may.
I remember one of the things we were going to do is use buys though as a comparator.
Speaker 3: One of the things we were going to do is use BISMO as a comparator. In view of the draft guidelines, we moved it back to doing a Fluger SeB on-label. We think that makes sense. We think that's the thing that is the most relevant. Just compare yourself.
In view of the draft guidelines, we moved it back to doing a fluid reserve on label.
That makes sense and we think that's the thing that is the <unk>.
Most relevant comparing yourself to an on label standard of care and that's what we think makes the most sense.
Speaker 3: to an on-label standard of care. And that's what we think makes the most sense.
Speaker 3: We'll see what the data comes out of Odyssey as the data comes out, and as we evaluate that data, that will really guide how we go to the FDA with a proposal for care.
See what the data comes out of Odyssey as the data comes out and as we evaluate that data that will really guide how we go to the FDA with a proposal for phase III.
Thank you.
Speaker 1: Thank you. As we have no further questions in queue at this time, I will hand back to Mr. Lozewski for any closing remarks he may have.
Thank you as we have no further questions in queue. At this time I will hand back to Mr. <unk> for any closing remarks email.
Okay.
Yes.
Speaker 3: I want to thank everyone for joining us on the call this afternoon. We appreciate your continued interest in ClearSide and we look forward to updating you on our progress. Operator, you may now disconnect the call. Thank you.
I wanted to thank everyone for joining us on the call. This afternoon. We appreciate your continued interest in Claire side, and we look forward to updating you on our progress operator, you may now disconnect the call. Thank.
Thank you again.
Speaker 1: Thank you. This concludes today's conference and you may disconnect your lines at this time. We thank you for your participation.
Thank you. This concludes today's conference and you may disconnect. Your lines at this time, we thank you for your participation.