Clearside Biomedical Q1 2024 Earnings Call Transcript

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May 9, 2024

There are 6 speakers on the call.

Operator

Greetings, and welcome to the Clearside Biomedical First Quarter 2024 Financial Results and Corporate Update Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host, Remi Bernorda, Clearside Investor Relations.

Operator

Please go ahead.

Speaker 1

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 Factors section of our annual report on Form 10 ks for the year ended December 31, 2023, that was filed March 12, 2024 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.

Speaker 1

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 Lizeskay, our Chief Executive Officer Doctor. Victor Chong, our Chief Medical Officer and Charlie Danan, our Chief Financial Officer. After our formal remarks, we will open the call for questions. I would now like to turn the call over to George.

Speaker 2

Thank you, Remi, and good afternoon, everyone. As we near the midpoint of 2024, I'm excited with the progress we have made to date, which has positioned Clearside for an important year. Recently, we added 2 key positions to our team who are having an immediate and meaningful impact on our organization. In March, we welcomed Doctor. Victor Chong as our Chief Medical Officer.

Speaker 2

Victor is a well respected board certified retinal specialist with more than 25 years of experience advancing drug candidates through all stages of development, including the development of ranimizumab and aflibercept for wet AMD. Most recently, Victor served as Global Head of Retina at Johnson and Johnson and prior to that he was Global Head of Medicine in Retinal Health at Boehringer Ingelheim. Victor's extensive experience is extremely valuable as he spearheads our product development led by the upcoming ODiSI data analysis and the planning for our CLS A X Phase 3 program. Victor will be discussing these shortly. Last month, we also added seasoned biotech executive, Tony Gibney to our Board of Directors.

Speaker 2

Tony has a deep understanding of the biotechnology business and combined with recent and relevant ophthalmology experience at IVERIC Bio, where he was Chief Business and Strategy Officer. Tony has broad expertise in collaborations, finance and M and A that will help guide our strategic and business develop initiatives as we explore future value creating opportunities at Clearside. These personnel additions are important as we continue to build on our leadership position in suprachoroidal delivery. Our SES microinjector technology has been used in thousands of injections in the clinic and continues to demonstrate a strong safety record that includes no cases of end alphamidis to date. As the pioneers in delivery to the suprachoroidal space, we are proud of the breadth and depth of our pipeline that includes our internally developed assets as well as those from our collaborators in a broad range of retinal diseases.

Speaker 2

With that, I'd like to now introduce our new Chief Medical Officer, Victor Chong, who will provide his perspectives on joining Clearside and our programs. Victor?

Speaker 3

Thank you, George,

Speaker 4

and good afternoon, everyone. Let me begin by saying it is a pleasure to speak with all of you today as a member of the ClearSign team. I have been on board for almost 2 months now, and I'm extremely excited by the prospect of our drug device technology as well as our border pipeline. I wanted to share some of the reason I chose to join ClearSign from J&J. First, I believe the suprachoroidal platform is an important, but undervalued approach to treat retinal diseases.

Speaker 4

KSI is leading the way in the suprachoroidal delivery by a very big margin, including having the only FDA approve the product for suprachoroidal use. With my background as a physician scientist, combined with almost a decade in large pharma, I look forward to leading our team as we approach our AUTOSCE data readout and begin plumbing our Phase 3 program for CLS A X. And finally, I can utilize my translational expertise in advancing new molecules into the clinic. I see many opportunity to see our company's device and formulation platform to potentially expand our pipeline into area such as geographic atrophy. Today, I want to focus on CLS A X, standard differentiators for the drug and the AUSY clinical trial.

Speaker 4

The current wet AMD market is driving more than $12,000,000,000 annually in sales, while the existing approved therapy are effective, including furosemab and high dose ofilacem, they are delivered individually and only last up to 4 months in some patients. We believe CLS A X may extend the time between doses for up to 6 months for most patients, which could meaningfully reduce the treatment burden for patients, caregivers and payers. I found the OTHCY trial to be a compelling design that is differentiated from many of the other mixed phase wet AMD study. First, the trial was designed to allow retreatment with our own drug candidate if needed 5 to 6 months, which is similar to the anti VEGF currently on the market. In addition, the protocol mandates participants in the CRS ax arm to be redosed at month 6, if not previously retreated.

Speaker 4

Valium D is a chronic disease and retreatment disease, ZENZO. This multi dosing data will help inform our CLFAAX Phase 3 development program. 2nd, the trial duration of 36 weeks allow us to follow patient beyond 6 months. This is close to the duration required for Pramimipone by the FDA for Phase 3 trial in wet AMD. It allows us to translate our CLS A X Phase 2b results to Phase 3 trial design more easily.

Speaker 4

And finally, Odysee is treating patients with confirmed active disease. So we will have a data set on patients who definitely need retreatment. I'm pleased to report that Odysee is progressing as planned and we expect to have top line results at the end of Q3 of this year. Our target profile for CLSAX is to maintain the shared acuity without the need for retreatment for potentially up to 6 months. We expect that the final Phase 2b data will provide important insights to create a robust Phase 3 development program for CLS I'm looking forward to this journey at TSI and will now turn the call over to our CFO, Charlie Dicken to provide a financial update.

Speaker 3

Thank you, Victor, and good afternoon, everyone. Our financial results for the Q1 2024 were published earlier in our press release and are available on our website. Therefore, I will just provide a summary of our financial status on today's call. As of March 31, 2024, our cash and cash equivalents totaled approximately $35,000,000 We believe we have sufficient resources to fund our planned operations into the Q3 of 2025. This takes us through the anticipated data readout for the ODiSI trial this year and supports planning our CLS A X Phase 3 program.

Speaker 3

We will be participating in the Citizens JMP Securities Life Sciences Conference next week and we look forward to keeping you updated on our progress. I will now turn the call over to George for his closing remarks.

Speaker 2

Thank you, Charlie. We expect 2024 will be a transformative year for Clearside. We are committed to maintaining our leadership role in the suprachoroidal space as we and our partners generate additional clinical data demonstrating the potential benefits of drug delivery with our SCS microinjector. We believe that the data readout from ODiSI later this year will demonstrate that CLS A X could be a valuable addition to the treatment regimen in the multi $1,000,000,000 wet AMD market. Our efforts in developing suprachoroidal drug delivery have the potential to change the treatment paradigm for serious retinal diseases and provide a lasting positive impact for patients, physicians and our shareholders.

Speaker 2

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

Operator

Your first question comes from John Wollobin with JMP Securities. Your line is open.

Speaker 2

Hey, good afternoon and thanks for taking the questions. Hi, George. I was hoping to just get a reminder on what constitutes active disease as the inclusion criteria for Odysee and how that differs from other mid stage weather and do trials? Okay. I think, Victor, I think that's a great question for you.

Speaker 2

So why don't you take that one?

Speaker 4

Yes, John, how are you? On the protocol that we would require the patient that still have subretinal fluid or intraocular fluid or the fluid in angiogram showing leakage. So that is what we would define as still remain have active disease, because some patients would have been treated and then they were already dry and might not need further treatment.

Speaker 2

Okay. And can you talk a little bit about how you think about CLSAX in comparison to the other TKIs in development? And then also what is the we talk a lot about durability, but how do you feel about the data package you'll provide and what is most important for investors to keep in mind as they're interpreting the readout in 3Q?

Speaker 4

Yes. So when you say comparing different company that 2 TKI in play, ekizumab is the one that we have sharing with both of our critics and the Iporn have another TKI. And in terms of that we believe that anti VEGF is most important and among the anti VEGF, the IC50 is a little bit lower in ezizumab and in other words that they are much more potent. In terms of sorry, I missed the second question. Can you just quickly repeat that?

Speaker 2

We talk about durability as a key thing to look at in these late stage trials, like should we worry more about BCGA, burden of treatment, if you had to think about the endpoints you'll be giving us, what should we focus on?

Speaker 4

Yes. So I think that's a very good question. But I think that at the moment, we are still waiting for our Phase 2 results. At the same time, that would help us to inform our Phase 3 design. But I think that as I mentioned in my webcast discussion earlier already that at least that we have data that have the treatment.

Speaker 4

So every patient in Odyssey will be at least retreated once, even if they have been doing okay up until 6 months. So that recruitment data will get us to 9 months and longer and also our trial is also 9 months. So again, that's closer to the FDA requirement for the timing endpoint. Obviously, visual acuity end of the day is the most important and I think that will be something that we will be focusing on how that we can measure the risk of acuity that will require that will meet the requirement of FDA as well as other agencies around the world.

Speaker 2

Okay, that's helpful. Thanks. Thanks again for taking the questions.

Speaker 4

Thank

Operator

you, John. Your next question comes from Jayav Mova with Stifel. Your line is open.

Speaker 5

Hi, thanks. This is Jayat. I'm calling in for Annabel. I have two questions for you. First question, realizing that you're still in Phase II trials with CLS ax, Have you given any further thought to the Phase III design in light of some of your competitors funding superiority trials on 2 standard of care?

Speaker 2

Well, let me say first that what we're doing now while we're waiting for our Phase 2b data to come in is we are undergoing internal planning for Phase 3 depending on how the data comes out. So we're already looking at that. We're discussing Phase 3 trial designs with our consultants. And that's all under evaluation at this time. But Victor, do you want to add anything to that?

Speaker 4

Yes. I think that, as I mentioned earlier, that we are still working on it. And there is a number of options that we are considering. At the end of the day that the key difference for us to somewhat is that we can retreat them based on our own drug. So that could be a major difference in the study design that some other PKI companies might not be able to do.

Speaker 4

So again, surrounding that is something that we would see how that we can maximize our advantage, at the same time providing future rational specialists in the future to use our drug more easily.

Speaker 5

Great. Thank you for that. And just one You

Speaker 2

had the second question?

Speaker 5

Yes, I did. Thank you. The second question was in regards to the FDA. Have they come any closer to establishing new clinical trial guidelines based on the shifting treatments paradigm mainly Bevizemel?

Speaker 2

You mean have they started to final or come close to finalizing their draft guidance, their previous draft guidance that was like over a year ago for wet AMD trials. Is that what you're talking about? Vicky, you might be more up to date on where you think the FDA is based on our recent conversations.

Speaker 4

Yes. I think that when the guideline are more than a year old and it is still not finalized and obviously that the community has some potential concern. But yes, that is not unusual for FDA have a draft guideline for a long time as well. So it's hard to predict, but that suggests that some of the point on the guideline was inconsistent with practice. So again, that is something that I think everyone discussing in multiple different conferences, multiple different platforms.

Speaker 4

But again, exactly when that draft guideline will become finalized or even or moving to interim, it's still difficult to be sure. And especially as you know that there is a recent leadership change in FDA as well that whether there might be late things as well.

Speaker 2

And obviously, as we go forward, before we announce any Phase III plans, we will have been engaged at least once, if not multiple times, with the agency to discuss Phase 3 trial design. So we'll get the most up to date reading from the agency and our conversations with them as our planning continues.

Speaker 5

Got it. Thank you. Thanks for your thoughtful answers.

Speaker 4

Okay.

Operator

I would now like to turn the call back to George Lazescay for any further remarks.

Speaker 2

Well, I want to thank everybody for being on the call today. We look forward to keeping you apprised of our progress. And with that, I would say that the operator, you can end the call.

Operator

This concludes today's Clearside Biomedical First Quarter 2024 Financial Results and Corporate Update Call.

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Key Takeaways

  • Clearside strengthened its leadership team by appointing Dr. Victor Chong as Chief Medical Officer and biotech veteran Tony Gibney to its Board, enhancing expertise in retinal drug development and strategic collaborations.
  • Its suprachoroidal microinjector has been used in thousands of injections with no reported endophthalmitis, reinforcing Clearside’s leadership in targeted retinal delivery.
  • The Phase 2 OdySey trial for CLS-AX in wet AMD is progressing as planned with topline data expected by end of Q3 2024, featuring a 36-week design and mandated 6-month retreatment to assess multi-dose durability.
  • As of March 31, 2024, Clearside held approximately $35 million in cash, funding operations into Q3 2025 and covering the OdySey readout and Phase 3 planning for CLS-AX.
  • CLS-AX aims to extend treatment intervals up to six months versus current 4-month anti-VEGF regimens, potentially reducing the burden on patients and payers in the >$12 billion wet AMD market.
AI Generated. May Contain Errors.
Earnings Conference Call
Clearside Biomedical Q1 2024
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