Q4 2023 Clearside Biomedical Inc Earnings Call

[music].

Greetings and welcome to the career side Biomedical Q4, 2023 financial results and corporate update call.

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<unk> and answer session will follow the formal presentation.

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I will turn the conference over to your host Jenny Coben appear site Investor Relations Jenny you may begin.

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.

Ward looking statements for purposes of the private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of our annual report on Form 10-K for the year ended December 31, 2023 that will be filed today and.

Our other SEC filings available on our website.

In addition, any forward looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements in the future. We specifically disclaim any obligation to do so even if our views change.

On today's call we have George was SK, 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.

Thank you Jenny and good afternoon, everyone.

The tremendous progress that we accomplished in 2023 has propelled us into 2024 and positioned us for an important year.

Last year, we advanced our clinical development program in wet AMD meeting, our targeted timeline and budget.

February 2023, we reported positive results from our Oasis extension study that supported initiation for a phase <unk> clinical trial Odyssey.

Later that year, we initiated and completed enrollment in Odyssey again on our targeted timeline and budget.

This rapid enrollment was primarily a result of significant enthusiasm from physicians because of the compelling aspects ample potential clinical impact of the program.

During 2023, each of our licensing partners reported excellent progress in their clinical development programs.

Programs collectively there are now four assets in clinical development with Super Choroidal delivery five different indications and.

In addition, we were pleased to announce a new collaboration with Biocryst pharmaceuticals to utilize our SCS micro injector to deliver their proprietary compounds, our board and the staff to treat diabetic macular edema.

This adds both on other assets and another indication to our collaboration pipeline.

As we look ahead 2024 will be a critical year for clear sight as we execute on two key areas of focus.

First the primary data readout for our Odyssey phase two b trial will occur in third quarter of this year.

Second we and our partners expect to continue demonstrating the benefits of drug delivery into the security space with our SCS microinject or device technology.

I'll start with Odyssey, a randomized double masked active controlled clinical trial in participants with wet AMD.

We are utilizing our patented super choroidal injection technology to look or CLS ax or small molecule suspension of the tyrosine kinase inhibitor.

Our proven delivery method combined with a differentiated mechanism of action and high potency of VIX. It.

Offers the potential for CLS ax to be a long term maintenance therapy for wet AMD patients.

And obviously, we're looking to replicate the excellent safety profile stable vision and reduced frequency of injections over six months that we observed in our Oasis extension study.

The efficacy and safety results from Odyssey will support the design of our pivotal phase III development program for CLS Ax.

Yeah.

With our focus on extending treatment duration utilizing super core the delivery of small molecules I think it's relevant to highlight recent positive real world outcomes from ZIP your usage.

This analysis was presented by Dr. Michael singer at the Macula Society meeting last month.

This presentation Doctor singer evaluated nearly 800 eyes utilizing the American Academy of Ophthalmology, Iris registry and open source claims data.

This real world data showed excellent durability were over 75% of eyes did not require re treatment for six months. After just one dose subside here.

Durability is consistent with the ZIP your preclinical pharmacokinetic data and the data from our phase III Peachtree clinical trial.

Importantly, we believe this analysis validates clear sides approach to extend its small molecule drug release and reduce treatment burden for patients by delivering drug directly to the supercritical space with our SCS microinjection.

As we look back over the last several years I'm thrilled with the progress we have seen leading to the adoption and acceptance of Super Choroidal delivery.

And the original pioneers in this space. We are proud of the clear sized technology has led the way for this important and innovative approach for delivering of drugs behind the visual appeal directly to the retina.

The supercritical injection procedure now has a permanent category one CPT code available to help facilitate better access adoption and insurance coverage.

This CPT code is a major milestone for the procedure itself.

Our proprietary SCS micro injector continues to enable reliable simple in office nonsurgical drug delivery as shown with its use in multiple ongoing clinical trials and with our commercially approved products out there.

Most importantly, our SCS microinjection, he's demonstrated a positive safety profile with over 2000 injections performed to date.

We believe the strong safety profile is due in part to the fact that drug delivery by SCS injection is compartmentalized and supercritical space keeping away from non disease tissues and entirely behind the visual field.

We do not put drug into the vitreous and we do not place physical inserts or gels and the vitreous that rely on complete bio erosion over time.

Since the Super Choroidal injection allows for drug to flow behind the retina to the back of the eye. This limits the risk of vitreous floaters, vitriol or anterior chamber toxicity or possibly impairing your interfering with the patient's vision.

To date, we've established multiple partnerships with leading biopharma companies, who have elected to utilize our SCS microinject or over others.

It's.

We believe that Supercoil delivery may become the delivery method of choice for gene therapy and ophthalmology.

Utilizing our S. T S micro injector, our partner regenerative bio as demonstrated in their wet AMD clinical trial that there were zero cases of inflammation observed in patients who received just seven weeks of prophylactic topical steroids.

In contrast, recently reported data from other gene therapies in development using intra vitriol delivery have shown inflammation. Despite prophylactic steroid treatments up over 20 weeks. These steroid regimens and involved injections oral medications and in some cases extended release steroid inserts.

So we're excited about the progress <unk> has made in their two programs use utilizing our SCS micro injector in diabetic retinopathy, where <unk> presented data last November from their altitude trial, showing that <unk> hundred 14 prevented disease progression and non prolific proliferative Dr patients at one year.

And whether a M D. They presented data in January 2024 from their aviate trial, showing that patients treated with 314 continues to demonstrate stable vision and retinal anatomy with a meaningful reduction in treatment burden at six months.

Regina expire expects to share new program and data updates the altitude trial in Q2 of this year and for the a b a trial in mid 2024.

Or a biosciences chose to exclusively use supercritical deliberate over intra vitriol injection for their phase III Compass trial, which is evaluating the safety and efficacy of belts are first line treatment in adults or early stage choroidal melanoma.

The design of this trial is covered under a special protocol assessment written agreement with the FDA.

Or it is currently enrolling participants in their compass trial.

We're also looking forward to continued progress by our Asia Pacific partner Arctic vision, who's developing sites here, which they have branded as our cases.

This year will include completion of their phase III trial in China, and uveitis macular edema and data from their phase <unk> trial. In addition, they plan to announce the results of their new drug application submission in Australia, and additional NDA submissions in other Asia Pacific territories.

In our most recent partnership development, we expanded the use of the SCS microinjection or with a new small molecule last November we entered into an exclusive worldwide license with Biocryst pharmaceuticals to use our SCS microinjection for the delivery of their proprietary plasma collar crime inhibitor award was step for D&B.

This partnership provided us with an upfront license fee of $5 million. Additionally, the agreement includes 77 and a half million in potential clinical regulatory and post approval sales based milestone payments and tiered mid single digit royalties on net project net product sales.

We are working closely with the Biocryst team as we collaboratively conduct formulation of non clinical work this year with a target of Biocryst initiating clinical work in 'twenty 'twenty fives.

We are very encouraged by the continued progress in all five Supercoil development collaboration programs.

I'll now turn over the call to our CFO, Charlie Deignan to provide financial update Charlie.

Thank you George and good afternoon, everyone.

Financial results for the fourth quarter and year end 2023 were published earlier in our press release and are available on our website. Therefore, I will only provide a summary of our financial status on today's call.

As of December 31, 2023, our cash and cash equivalents totaled approximately $29 million.

Subsequent to the end of the fourth quarter, we completed a registered direct offering of stock and warrants, which generated $15 million in gross proceeds.

With this combined cash balance we believe we will have sufficient resources to fund our planned operations into the third quarter of 2025.

This takes us through the anticipated data readout for the Odyssey trial this year and supports our planning for CLS Ax Phase III program.

In terms of Investor outreach, we will be participating in the upcoming Needham Healthcare conference and citizen JMP Securities Life Science Conference, we look forward to keeping the investment community updated on our progress.

I will now turn the call back over to George for his closing remarks.

Thanks, Charlie.

I highlighted we have two key areas of focus this year.

We expect to complete our Odyssey phase two b clinical trial in wet AMD and report topline data in the third quarter of this year, we believe that the data readout may demonstrate that CLS ax could be a valuable addition to the treatment regimen for patients with wet AMD.

In addition, we will continue our leadership in the Super Choroidal space as we.

And our partners generate additional data demonstrating the benefits of drug delivery with our SCS micro injector.

We remain steadfastly committed to developing new treatments and collaborating with leading health care companies to improve vision for individuals living with sight threatening diseases.

I would now like to ask the operator to open the call for questions.

Thank you at this time, we'll be conducting a question and answer session.

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And the first question today is coming from Annabel <unk> from Stifel Annabel Your line of life.

Hi, Thanks for taking my question and congratulations on the rapid enrollment that's great.

It was hoping maybe you can clarify.

It's something for me I guess, it's a little bit more bigger picture, but you know I'm little confused as to how each of these phase two trials were designed not just yours, but just in general the.

T K R inhibitors, yeah, obviously yours is a loading dose or two.

Q I lay a loading doses then you treat them I plan has three ocular therapeutics is now doing.

The superiority trial and I guess, you know one of the other things you noted.

Is that yours is not powered for non inferiority or statistical significance and just it's just really to identify duration. So I guess the question is how are we supposed to read all of these data and really understand how it fits into the Ava.

Evolving landscape for Teekay is and at what point do you think there might be some harmonization of all these trials not just for our clarification, but for physicians, who need to choose between these different treatments right as a maintenance therapy. So I was hoping maybe you can.

Sort of discussed this a little bit more big picture.

Well, it's a it's an interesting point that you raise there does need to be so.

I mean, I'm not sure there needs to be but perhaps there will be some harmonization over time, we're in the process right now and.

And about our phase II trial is three loading doses just to be clear I think I heard you say something right.

Alright, three loading doses or your injection yeah, sorry, yeah, we are our injection of CLSA Xs concurrent with the second loading dose and then there's a third loading dose a month later yeah.

Ocular really kind of throws a cirrhosis.

For a loop a little bit yeah, that'll because they're they're just basically doing one dose of each theirs and upload or SAB and then.

Waiting to see who needs to be retreated and I understand.

Learning more and more about why they've done it that way, but where we're in the process now to try to harmonize things. We're in the process now will begin it over the next couple of months to discuss what our pivotal program would look like.

And so youre right about what we're looking at Odyssey is we wanted we want to measure duration, where do we think the best.

Dosing regimen would be to go into phase III, but that doesn't really get to your question, which is how do we harmonized. How these teekay eyes are being used because each one of us is using some uplift per sub or some anti VEGF, but slightly differently, we're timing our teekay I administrations slightly.

Differently.

And it looks like I point is going for non inferiority ocular is clearly going to superiority.

Those trials are.

Very different in design.

And when we disclose our phase III, we'll see if we batch up with one or the other we come up with a third design. So I can appreciate where you're having a bit of a problem, but as we learn more about how the teekay is work.

And where they fit in our I think you'll begin to see this.

Come together and I don't think that's necessarily the the loading doses are going to be that big a deal over time to harmonize, but the thing is with ocular you know theyre going after treatment naive patients.

And so.

You know I'm a little bit.

I'm, a little bit puzzled why they didn't do a bigger you know more on label loading dose with a blip of subs, but I think I understand why they are trying to do with this way and we'll see what happens, but I can't guarantee we're going to harmonize, but I think over time, what you will see between the three different studies.

I think you will see that the tyrosine kinase inhibitors as a group.

Are going to be a very important addition to the treatment.

Alternatives that physicians have for their wet AMD patients.

Patients in particular, I think youre going to see that I don't think we're.

I think that's going to be very clear that we have a place in that.

Treatment regimen and.

You have to wait for the data to come out, but I think if you talk to the other two companies I think they would believe the same thing and most of the physicians that we talk to believe that as well. So we have to go out and we have to demonstrate it we may all demonstrated in a slightly different way what do you think youre going to see that the tyrosine kinase inhibitors have duration of effect.

Mechanistically, they're very competitive or excuse me not competitive.

They they conform very nicely with anti VEGF, a because they don't compete and they kind of helped supplement the answer.

Beth just a mechanism of action by blocking receptors instead of just.

No binding with circulating bad yet so there's a theoretical reason why they should work I think we've all seen data in our clinical trials that indicate that they have extended duration and I think as we go through all of our additional clinical trials the place for the Teekay guys, there's going to be very clear.

Okay got it and if I can just.

And one more question to that is here.

M D.

Discuss this left more of the retinal community does it seem that the Teekay is a kind of landing in this.

Maintenance treatment sort of domain or is ocular therapeutics is essentially going to blow that out that theyre looking at treatment naive.

Yeah, what's the how does it what's their mindset as far as where anti VEGF.

It serves and where Teekay is well be best served.

Uh huh.

We're we've studied this in where everybody has studied this that may be ocular will.

Change things again, theyre going treatment naive so we'll see how that works in particular, we'll see how it works early on in their therapy and the first couple of months after they put their insert in but.

I think most people right now would look at us and the way where most of US have been studying this is more maintenance therapy than than a first line monotherapy.

But that you know maybe ocular will will show that where theyre doing their trial I don't know, but I can tell you that I think most people look at this as extended duration maintenance therapy is where we go and the two drugs are mechanistically, they anti VEGF, a and the Teekay I should work very nicely they should.

Complement one another I always draw the comparison I believe to a cancer chemotherapy or EBIT antidepressant therapy is youre trying to effect an outcome better vision improved you know are treating cancer better vision.

Intriguing people, who are depressed and making not depressed and so physicians have multiple approaches in cancer chemotherapy and any depressant.

They haven't really had that they've had multiple different approaches to the same mechanism of action from the old days of Mackie just go on the Lucentis go into <unk> and even to buy small so they're principally going after bids anti VEGF a approach that allows for the over expression of C. N E.

It doesn't get taken care of that doesn't account for binding all of the circulating bad jobs that a that circulating so I think that the two drugs could work very nicely together.

Finding circulating budget they are blocking a C and D. If theres over expression at the receptor level. So I see them as I I think position should look at this and I think companies should look at this as a real opportunity to add complementary therapy to wet AMD rather than seeing it.

One, replacing the other necessarily and over time as it gains usage, we'll see what happens, but I think right from the start I think it's a very complementary approach and I think patients will be the main beneficiary of this complementary approach.

Okay, great. Thank you.

Sure.

Thank you. The next question is coming from John <unk> from JMP, John Your line is live.

Hey, Joe.

Hi, This is Katherine on for Joe.

Hum.

Question for art.

The Odyssey trial, and just how the population compares to other mid stage wet AMD studies I know you talked about occupancy generally.

Some color on that and then another one just on what how you think about safety Supercoil administration approach on that side.

That compares to other wet AMD candidates.

Okay.

Odyssey.

We made a very determined attempt to enroll patients who had been diagnosed with wet AMD.

Had had some treatment experience so they were more or less lately treatment experienced so they weren't patients that were naive.

And importantly, we've tried to make sure that they either had the presence of inter retinal fluid or sub retinal fluid or bolt or leakage.

That was documented on fluorescein angiography, so what we did was.

And I don't know that other any of the other teekay I companies have done this but we we made a very concerted effort to make sure that the patients that we were enrolled had had some experience.

But we're clearly had fluid on enrolling into the trial.

You did not want to enroll and tried very hard not to enroll patients who had been diagnosed but were dry.

And that's certainly been the case to some degree in previous trials by other companies and.

Because the dry patient can get in there and kind of artificially.

Inflate your positive results because you can see a drive patient and they may not require any any real intervention for many months. So we wanted to make sure that the patients that are in our trial had fluid required therapy had responded to.

To some degree in the past, but weren't like our Oasis Ah patients that were our Kols would call anti VEGF a ethics they were responsive, but they were super they needed.

A lot more anti VEGF intervention than you might expect so they were getting their lucentis or eylea is far more frequently than you would expect so we wanted patients that had some response had some experience there but werent.

Overly dependent on a lot of anti VEGF and when enrolled in the trial. They had the presence documented presence of fluid documented by independent Reading Center.

So that's that's one thing we've tried to do I don't know that the other companies have been that.

That careful about that that enrollment criteria, but that was very important to us and we believe that's the right thing for us to do.

You had a second question on safety that was unsafe.

We've had very good luck.

With.

The Super Choroidal injection from a safety perspective, we've looked at it over time.

Compared to inter betrayal injections in terms of complications in patients who we find them. They're essentially the same a week, we had no particular safety issues that I'm aware of in the OE.

Oasis our phase one two a trial.

From an injection procedure point of view, our safety results in Oasis were.

Very very good we had no inflammation no dose limiting.

Limiting toxicities, but if you just look at the injection procedure itself, we had no issues there.

And so the safety from Super Gorilla injection, it's Ben.

Very good.

With proper training the physicians do it well, it's it's not really a big issue for them. The prep time for patients is basically the same as it would be for an interim vitriol injection that we don't see anything.

And there was no demonstrable difference in safety between Super Cortland interim vitriol, when we've gone back and looked at.

Quite a number of clinical trials.

And compare them both so we feel very good about the safety of the procedure itself, we feel very good about the safety of the Teekay I exiting the itself.

And.

So that's.

Hopefully that's an answer to your question.

Thank you so much that's really helpful. Yeah sure no problem.

Okay.

Thank you and the next question is coming from Serge Belanger from Needham and company. Sir Your line is live.

Hi, everyone. This is John on for Serge and thank you for taking our questions.

I'd like to hit on a couple of different points.

First going back to the Oasis trial.

I had mentioned.

Slightly higher degree of.

The need for off protocol or early rescues.

<unk> said, the one milligram dose.

And knowing this coming into Odyssey.

And if you have any.

Kind of color at least at this point.

Whether or not your expectations there being reflected.

While the trial stands now.

And then kind of moving past Odyssey in wet AMD are you guys starting to explore any additional indications for the use of CLSA ex whether it be.

<unk> are things like diabetic retinopathy.

Well, let me answer the last one first right now we don't have any plans to look into D. M. E. R. D R.

For CLS Ax, so we're focusing entirely our efforts on wet AMD.

If I go back to the early off protocol rescues that were seen in Oasis. When we looked at that there were a couple of things.

First of all it was an open label trial. So there was no blinding involved and it was the first time that people had injected.

<unk> tyrosine kinase inhibitor into the Super Curdle space and these wet AMD patients. So there was a little bit of nervousness, I think and it was kind of site specific when we really looked at it.

There was no. Good reason why one milligram should have desalt protocol early rescue centre half milligram didn't.

And I mean, theres no logical reason for that but when we looked at the cohort for that one milligram dose it seem to be more of a site specific.

Issue.

And I think there was a little nervousness about injecting and not having any experience with tyrosine kinase inhibitors and kind of jumping the gun on some early rescues after that first couple of early rescues.

Cohort four with the one milligram dose basically.

In cohorts three and four as they had about the same they had a couple of block protocol rescues.

The the majority were in the first month and that cohort four and I think that was the best we can tell it was kind of a site specific issue or particular investigator. So we we've designed our Odyssey trial too.

Not that we don't talk about expectations, our expectations is we should not see.

A were.

Very limited number of off protocol, which we worked very hard with our sites and through our training and our materials and our onsite people to make sure that they are very well educated in terms of the the re treatment criteria.

In addition, this Odyssey trial has three loading doses a flipper SAB as I was talking about with Anabelle earlier, and we think that that and dosing on the second.

The second loading dose, we think will eliminate any nervousness about our very early rescue. So we we really don't have an expectation of early rescues here, we have an expectation that the patients are going to do quite well on this regimen and we're gonna see extended duration of.

Of treatment and just to be very clear I have no insight into that and totally blinded on the data. So I have no idea, what's whether our expectations are being met or not so.

Those were my expectations I don't know, whether theyre being met but we'll find out later this year.

Great Yeah. Thanks for the clarification on that and if I can just follow up real quickly.

Do you guys have any color on how the experian is performing so far regarding volume and sales.

Is up here.

Yeah, Charlie I'll, let you handle that one if you want.

So again as we talked previously.

Announcer sales.

Well, we we.

We can't get ahead of them.

Until they get past that $45 million.

We don't have any revenues to report yet.

Great. Thank you.

Thank you and at this time I would now like to turn the call back to clear sight CEO George <unk> for closing remarks.

And at this time I would now like to hand, the call back to George was asking for closing remarks.

Yeah, George maybe haven't Claudia you got it yeah I'm here.

Sorry, I was on mute.

Okay, well I want to thank everybody for joining us on the call. This afternoon. We certainly appreciate your continued interest in clear side and we look forward to update you on our progress operator, you may now discontinued.

Thank you. This does conclude today's conference you may disconnect. Your lines at this time and have a wonderful day. Thank you for your participation.

Yeah.