Yahoo Finance Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2023 Earnings Call Transcript
Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2023 Earnings Call Transcript March 13, 2024
Clearside Biomedical, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Greetings, and welcome to the Clearside Biomedical Q4 2023 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Jenny Kobin of Clearside Investor Relations. Jenny, you may begin.
Jenny Kobin: Good afternoon, everyone, and thank you for joining us on the call today. Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk 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 Lasezkay, 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.
George Lasezkay: 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 CLS-AX clinical development program in wet AMD, meeting our targeted time line and budget. In February 2023, we reported positive results from our OASIS extension study that supported initiation of our Phase IIb clinical trial ODYSSEY. Later that year, we initiated and completed enrolment in ODYSSEY again, on our targeted time line and budget. This rapid enrolment was primarily a result of significant enthusiasm from physicians because of the compelling aspects and potential clinical impact of the program. During 2023, each of our licensing partners reported excellent progress in their clinical development programs.
Collectively, there are now four assets in clinical development with suprachoroidal delivery for five different indications. In addition, we were pleased to announce a new collaboration with BioCryst Pharmaceuticals to utilize our SCS Microinjector to deliver their proprietary compound of orlistat to treat diabetic macular edema. This adds both another asset and another indication to our collaboration pipeline. As we look ahead, 2024 will be a critical year for Clearside as we execute on two key areas of focus. First, the primary data readout for our ODYSSEY Phase IIb trial will occur in third quarter this year. Second, we and our partners expect to continue demonstrating the benefits of drug delivery into the suprachoroidal space with our SCS Microinjector device technology.
I'll start with ODYSSEY, our randomized double-mask active controlled clinical trial in participants with wet AMD. We are utilizing our patented suprachoroidal injection technology to deliver CLS-AX, a small molecule suspension of the tyrosine kinase inhibitor axitinib. Our proven delivery method combined with the differentiated mechanism of action and high potency of axitinib offers the potential for CLS-AX to be a long-term maintenance therapy for wet AMD patients. In ODYSSEY, we are 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.
With our focus on extending treatment duration, utilizing suprachoroidal delivery of small molecules, I think it's relevant to highlight recent positive real-world outcomes from XIPERE usage. This analysis was presented by Dr. Michael Singer at the Macula Society Meeting last month. In his presentation, Dr. 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 where over 75% of eyes did not require retreatment for six months after just one dose of XIPERE. This durability is consistent with the XIPERE preclinical pharmacokinetic data and the data from our Phase III PH3 clinical trial. Importantly, we believe this analysis validates Clearside's approach to extended small molecule drug release and reduced treatment burden for patients by delivering drug directly to the suprachoroidal space with our SCS microinjector.
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 suprachoroidal delivery. As the original pioneers in the space, we are proud that Clearside's technology has led the way for this important and innovative approach for delivering of drugs behind the visual field directly to the retina. The suprachorodal injection procedure now has a permanent Category 1 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 microinjector 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 product, XIPERE.
Most importantly, our SCS microinjector has demonstrated a positive safety profile with over 2,000 injections performed to date. We believe this strong safety profile is due in part to the fact that drug delivery by SCS injection is compartmentalized in the suprachoroidal space, keeping it away from nondisease tissues and entirely behind the visual field. We do not put drug into the vitreous, and we do not place physical inserts or gels in the vitreous that rely on complete bio erosion over time. Since the suprachoroidal injection allows for drug to flow behind the retina to the back of the eye, this limits the risk of vitreous floaters, vitreal or anterior chamber toxicity or possibly impairing or interfering with the patients vision. To date, we've established multiple partnerships with leading biopharma companies who have elected to utilize our SCS Microinjector over other delivery methods.
We believe that suprachoroidal delivery may become the delivery method of choice for gene therapy and ophthalmology. Utilizing our SCS microinjector, our partner, REGENXBIO has 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 intravitreal delivery has shown inflammation despite prophylactic steroid treatments of over 20 weeks. These steroid regimens involve injections, oral medications and in some cases, extended release steroid inserts. So we're excited about the progress REGENXBIO has made in their two programs utilizing our SCS microinjector.
In diabetic retinopathy, REGENXBIO presented data last November from their altitude trial showing that RGX-314 prevented disease progression in nonproliferative DR patients at one year. In wet AMD, they presented data in January 2024 from their AAVIATE trial, showing that patients treated with 314 continued to demonstrate stable vision and retinal anatomy with a meaningful reduction in treatment burden at six months. REGENXBIO expects to share new program and data updates for their altitude trial in Q2 of this year and for the AAVIATE trial in mid-2024. Aura Biosciences chose to exclusively use suprachoroidal delivery over intravitreal injection for their Phase III CoMpass trial, which is evaluating the safety and efficacy of bel-sar first-line treatment in adults of early-stage choroidal melanoma.
The design of this trial is covered under a special protocol assessment written agreement with the FDA or is currently enrolling participants in the CoMpass trial. We are also looking forward to continued progress by our Asia Pacific partner, Arctic Vision, who's developing XIPERE, which they have branded as Arcadis. This year will include completion of the Phase III trial in China in uveitic macular edema and data from their Phase I DME 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 Microinjector with a new small molecule. Last November, we entered into an exclusive worldwide license with BioCryst Pharmaceuticals to use our SCS Microinjector for the delivery of their proprietary plasma kallikrein inhibitor, avoralstat for DME.
This partnership provided us with an upfront license fee of $5 million. Additionally, the agreement includes $77.5 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 and nonclinical work this year with a target of BioCryst initiating clinical work in 2025. We are very encouraged by the continued progress in all five suprachoroidal development collaboration programs. I will now turn over the call to our CFO, Charlie Deignan, to provide a financial update. Charlie?
Charlie Deignan: Thank you, George, and good afternoon, everyone. Our 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 totalled 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.
George Lasezkay: Thanks, Charlie. As I highlighted, we have two key areas of focus this year. We expect to complete our ODYSSEY Phase IIb clinical trial in wet AMD and report top line 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'll continue our leadership in the suprachoroidal space as we and our partners generate additional data demonstrating the benefits of drug delivery with our SCS microinjector. We remain steadfastly committed to developing new treatments and collaborating with leading health care companies to improve vision for individuals living with site-threatening diseases. I would now like to ask the operator to open the call for questions.
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