A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months. ALPHARETTA, Ga., April 01, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS), announced today that George Lasezkay, PharmD, JD, President and Chief Executive Office ...

Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash and cash equivalents totaled approximately $20 million, which is expected to fund operations into the fourth quarter of 2025 [36] - The company is actively pursuing options to fund the CLS-AX Phase 3 program, including potential partnerships with third parties [36] Business Line Data and Key Metrics Changes - The company reported positive results from the ODYSSEY Phase 2b wet AMD clinical trial, leading to a successful end of Phase 2 meeting with the FDA regarding planned Phase 3 activities for CLS-AX [7][29] - The SCS Microinjector has been used for over 15,000 suprachoroidal injections, indicating strong interest from retinal specialists and pharmaceutical companies [6] Market Data and Key Metrics Changes - The wet AMD market represents over $12 billion in annual sales, with the company positioning CLS-AX as a maintenance treatment to capture a significant share [31] - The company’s partner, Arctic Vision, achieved regulatory milestones in the Asia-Pacific region, with product approvals in Australia and Singapore, and a new drug application under review in China [9] Company Strategy and Development Direction - The company aims to maximize the commercial potential of CLS-AX through a pivotal Phase 3 program designed to reduce regulatory risk and enhance market competitiveness [29][30] - The strategy includes targeting treatment-naive patients to potentially expand the commercial value of CLS-AX [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase 3 trial design and its potential to demonstrate the efficacy of CLS-AX, emphasizing the importance of reducing variability in patient selection [29][84] - The company is optimistic about the broad applicability of suprachoroidal delivery in treating serious retinal diseases, with ongoing evaluations of small molecules for geographic atrophy [32] Other Important Information - The company is the only TKI in development with multi-dosing data from its Phase 2b trial and the ability to re-dose before six months, which is seen as a significant differentiator [29] - The company is preparing for participation in upcoming healthcare conferences to further engage with stakeholders [36] Q&A Session Summary Question: How might the amendments to the planned Phase 3 improve results from Phase 2? - Management believes that excluding patients with higher disease variability will lead to better results in the general population [45][46] Question: How long will it take to enroll the treatment-naive population? - Enrollment is expected to take around 12 months, based on recent trials [48] Question: What is the estimated cost of the Phase 3 program? - While specific costs were not disclosed, similar Phase 3 trials have been around $55 million to $60 million [55] Question: How will the redosing criteria work? - Redosing will rely on OCT biomarkers, with a focus on intraretinal fluid, and will be distinct from rescue criteria [95][100] Question: Will the inclusion criteria impact enrollment speed? - Management anticipates minimal impact on enrollment speed, estimating that less than 10% of patients would be rejected based on the new criteria [84]

Core Viewpoint - Clearside Biomedical, Inc. is conducting a conference call to discuss its Q4 2024 financial results and corporate updates, indicating a focus on future expectations and company performance [1]. Group 1: Company Overview - The conference call is hosted by Jenny Kobin from Investor Relations, highlighting the company's commitment to transparency and communication with stakeholders [2][3]. - The call includes key participants such as the CEO George Lasezkay, Chief Medical Officer Victor Chong, and CFO Charlie Deignan, indicating a comprehensive leadership presence [1]. Group 2: Forward-Looking Statements - The company will be making forward-looking statements regarding its future expectations, plans, and prospects, which are subject to various important factors that could lead to actual results differing materially from these statements [4]. - It is emphasized that these forward-looking statements reflect the company's views as of the date of the call and may not be updated in the future, indicating a cautious approach to future projections [5].

Group 1 - Clearside Biomedical reported a quarterly loss of $0.10 per share, better than the Zacks Consensus Estimate of a loss of $0.13, representing an earnings surprise of 23.08% [1] - The company posted revenues of $0.31 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 13.33%, but down from $6.35 million year-over-year [2] - The stock has increased approximately 7.4% since the beginning of the year, contrasting with the S&P 500's decline of -2.9% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.13 on revenues of $0.2 million, and for the current fiscal year, it is -$0.54 on revenues of $5.23 million [7] - The Medical - Biomedical and Genetics industry is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Product Development and Approval - The company focuses on a novel suprachoroidal injection platform for targeted therapy delivery to the back of the eye, potentially improving vision in patients with sight-threatening eye diseases [20]. - The first product, XIPERE, was approved by the FDA in October 2021, marking a significant milestone as the first approved therapeutic delivered into the suprachoroidal space [21]. - The suprachoroidal injection method offers benefits such as non-surgical procedures, lower administration frequency, and improved safety profiles compared to traditional intravitreal injections [25]. - A permanent Category 1 CPT code for suprachoroidal injection was granted on January 1, 2024, which may enhance access and insurance coverage for the procedure [26]. - The clinical development pipeline includes CLS-AX, a proprietary suspension of axitinib for wet AMD, which has completed two clinical trials and is positioned for further development [38][39]. - CLS-AX has shown up to eleven times higher drug levels in affected tissues compared to intravitreal administration, indicating potential efficacy benefits [43]. - CLS-AX demonstrated a 77% - 85% reduction in treatment burden compared to the average monthly injections in the six months prior to administration [48]. - In the ODYSSEY trial, 100% of participants went 3 months without additional treatment, and 67% went 6 months before mandatory re-dosing [52]. - The ODYSSEY trial achieved primary and secondary outcomes, including mean change from baseline in BCVA and treatment burden measured by total injections [50]. - CLS-AX was well-tolerated with no serious adverse events reported throughout the 36-week trial [54]. - The company plans to initiate two pivotal Phase 3 trials in the second half of 2025, pending funding [56]. - Arctic Vision completed enrollment in a Phase 3 trial for ARCATUS in China for uveitic macular edema [66]. - Arctic Vision announced positive topline results from its Phase 3 uveitic macular edema clinical trial in China in July 2024 [66]. Financial Performance and Funding - The company incurred a net loss of $34.4 million in 2024 and $32.5 million in 2023, expecting significant expenses and operating losses in the coming years [187]. - The company has an accumulated deficit of $355.3 million as of December 31, 2024, with cash and cash equivalents of $20.0 million, raising substantial doubt about its ability to continue as a going concern [197]. - The company expects its existing cash and cash equivalents to fund operating expenses into the fourth quarter of 2025, but substantial additional funding will be needed thereafter [191]. - A registered direct offering in February 2024 raised approximately $15.0 million through the sale of 11,111,111 shares of common stock and accompanying warrants [195]. - The company has sold rights to receive certain royalty and milestone payments for up to $65 million under various license agreements, which may impact future revenue streams [196]. - The company is looking to selectively partner its proprietary technology for use with novel gene therapies to expand its development pipeline [76]. - The company relies on additional financing to achieve its business objectives, and failure to secure such financing could delay or cease drug development programs [194]. Market Potential and Competition - Approximately 20 million individuals in the U.S. aged 40 and older are affected by AMD, with a projected increase to 22 million by 2050, highlighting the market potential for effective treatments [40]. - The current anti-VEGF market for retinal diseases generated approximately $14.3 billion in global sales in 2020, underscoring the significant market opportunity [40]. - CLS-AX faces competition from established anti-VEGF drugs, including Lucentis and Avastin, which are approved for various ocular conditions [99]. - The SCS Microinjector competes with devices from Everads Therapy, Ltd and Uneedle B.V., which are in early-stage clinical development [104]. - Future competition may arise from biosimilar anti-VEGF products as they gain approval and enter the market [101]. Regulatory Environment - The FDA regulates the company's drug and device products under the Food, Drug and Cosmetic Act, which includes extensive requirements for clinical testing and approval [123]. - The clinical trial process includes three phases, with Phase 1 focusing on safety, Phase 2 on efficacy, and Phase 3 on further demonstrating clinical efficacy [128][131]. - The FDA review process for a New Drug Application (NDA) typically takes 10 months, but can be expedited to 6 months under priority review [134]. - Post-approval, the FDA imposes ongoing regulations, including requirements for recordkeeping and reporting of adverse experiences [135]. - The company may pursue development of drugs under Section 505(b)(2) NDAs, which allows reliance on existing studies for approval [141]. - The company may seek orphan drug designation for products in the future, but there is no guarantee of obtaining such designation or exclusivity [151]. - The company must comply with various regulatory requirements in foreign markets, which may differ from U.S. regulations and could involve longer approval times [152]. Intellectual Property and Licensing - The company has a robust intellectual property portfolio with 34 issued U.S. patents and over 80 international patents related to the SCS Microinjector and its applications [27]. - The patent estate includes 34 granted U.S. patents and 21 pending applications, with expiration dates ranging from 2027 to 2042 [109]. - The BioCryst License Agreement will expire upon the expiration of the royalty term in each country, with specific termination rights for both parties [87]. - The company has entered into a Purchase and Sale Agreement for up to $65 million, selling rights to receive royalty and milestone payments under various license agreements [89]. - The company received an upfront license fee of $5.0 million from BioCryst Pharmaceuticals for the SCS Microinjector, with potential additional payments of up to $30.0 million in clinical and regulatory milestones [86]. Compliance and Legal Risks - The federal Anti-Kickback Statute prohibits offering or receiving remuneration to induce purchases under federal healthcare programs [155]. - The federal civil False Claims Act prohibits knowingly presenting false claims for payment to the federal government [157]. - The company faces potential penalties under HIPAA for violations related to the privacy and security of protected health information [162]. - The EU GDPR imposes strict requirements for processing personal data, with fines up to €20 million or 4% of annual global revenue [163]. - The company may face significant adverse consequences if unable to lawfully transfer personal data from the EEA or UK to the U.S. [164]. - Compliance with the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) increases compliance costs and potential liability for the company [165]. - The company faces challenges due to increased federal and state regulation of payments and transfers of value to healthcare professionals, which may impact its business operations [167]. Employment and Organizational Structure - The company has 32 full-time employees as of December 31, 2024, with no representation by labor unions [181]. - The company has incurred significant losses since inception and may never achieve or maintain profitability, with financial results expected to fluctuate significantly [187]. Risks in Drug Development - The company faces significant risks in drug development, including the uncertainty of achieving regulatory approval and market acceptance for its product candidates [210]. - Clinical drug development is lengthy and expensive, with high risks of failure, making it uncertain when or if product candidates will receive regulatory approval [215]. - Preclinical and early clinical trial outcomes may not predict later success, and many companies have failed to obtain marketing approval despite satisfactory early results [216]. - Unforeseen events during clinical trials could delay or prevent marketing approval, including acceptance by physicians and patients, competition, and reimbursement issues [217]. - Regulatory or institutional review boards may not authorize the commencement of clinical trials, leading to potential delays [218]. - The ODYSSEY trial was delayed due to FDA draft guidance, necessitating a reassessment of the original protocol design [219].

Clearside Biomedical (CLSD) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants Victor Chong - Chief Medical Officer and EVP, Head of Research & DevelopmentGeorge Lasezkay - President and Chief Executive OfficerCharles Deignan - Chief Financial OfficerJon Wolleben - Managing DirectorDebanjana Chatterjee - DirectorVictor Chong - Chief Medical OfficerYi Chen - Managing Director, Equity ResearchEka G - Director - Equity Research Conference Call Participants Serge Belanger - Senior AnalystDani ...

Clearside Biomedical, Inc. (CLSD) Q4 2024 Earnings Conference Call March 27, 2025 04:30 PM ET Company Participants Jenny Coben - Investor Relations HostGeorge Ledeske - Chief Executive OfficerDaniel Gatua - Questioner, ShardaCharlie Degnan - Chief Financial OfficerAndreas Argarides (via Eka) - Questioner, OppenheimerDevanjana Chatterjee - Questioner, Jones TradingDr. Victor Chong - Chief Medical Officer and Head of Research and DevelopmentMr. Leszczyk - Conference Operator/ModeratorPaul - Questioner (Affili ...

Revenue Performance - License and other revenue for Q4 2024 was $0.3 million, a decrease of 95.2% compared to $6.3 million in Q4 2023[6] - Full year 2024 license and other revenue totaled $1.7 million, a decrease of 79.5% from $8.2 million in 2023[10] Research and Development Expenses - R&D expenses for Q4 2024 were $4.2 million, down 33.1% from $6.3 million in Q4 2023, primarily due to lower clinical trial costs[6] - R&D expenses for the full year 2024 were $18.6 million, down 10.6% from $20.8 million in 2023[10] Net Loss - Net loss for Q4 2024 was $7.3 million, or $0.10 per share, compared to a net loss of $4.8 million, or $0.08 per share, in Q4 2023[6] - Net loss for the full year 2024 was $34.4 million, or $0.47 per share, compared to a net loss of $32.5 million, or $0.53 per share, in 2023[10] Cash Position - As of December 31, 2024, cash and cash equivalents totaled $20.0 million, sufficient to fund operations into Q4 2025[6] Regulatory and Clinical Developments - Successful End-of-Phase 2 meeting with the FDA confirmed plans for Phase 3 trials of CLS-AX in wet AMD[3] - New Drug Application for ARCATUS® (XIPERE®) for uveitic macular edema accepted for review in China[3] - Multiple medical meetings highlighted the advantages of Clearside's SCS Microinjector® in retinal disease treatments[3]

Core Insights - Clearside Biomedical, Inc. has successfully completed an End-of-Phase 2 meeting with the FDA, aligning on Phase 3 plans for CLS-AX in the treatment of wet AMD [1][3] - The company’s Asia-Pacific partner, Arctic Vision, has had its New Drug Application for ARCATUS accepted for regulatory review in China [1][3] - Multiple presentations at medical meetings have highlighted the advantages of Clearside's suprachoroidal drug delivery system [1][8] Recent Developments - The FDA meeting confirmed key elements of the Phase 3 program for CLS-AX, including trial design and endpoints, based on positive Phase 2b results [3] - Arctic Vision's NDA for ARCATUS has been accepted in China, with previous approvals in Australia and Singapore [3] - Clearside's partners are advancing their suprachoroidal drug candidates into Phase 3 trials, including REGENXBIO and Aura Biosciences [3] Financial Performance - For Q4 2024, Clearside reported license and other revenue of $0.3 million, down from $6.3 million in Q4 2023 [4][5] - R&D expenses for Q4 2024 were $4.2 million, a decrease from $6.3 million in Q4 2023, attributed to lower clinical trial costs [4][5] - The net loss for Q4 2024 was $7.3 million, compared to a net loss of $4.8 million in Q4 2023 [4][5] Company Overview - Clearside Biomedical is focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, utilizing its patented SCS Microinjector [9] - The company is developing a pipeline of small molecule candidates, with its lead program, CLS-AX, targeting wet AMD [9] - Clearside has also developed XIPERE, which is commercially available in the U.S. through a partner [9]

Core Insights - Clearside Biomedical is advancing suprachoroidal drug delivery as a transformative method for treating macular diseases, with six abstracts accepted for presentation at the ARVO 2025 Meeting [1][2] Company Developments - The company’s proprietary formulation, CLS-AX, a suspension of axitinib, shows potential as a long-acting therapy for wet age-related macular degeneration (AMD), demonstrating durability and safety in clinical trials [2][5] - The SCS Microinjector allows for targeted delivery of therapeutics directly to the retina, enhancing the precision and applicability of treatments [1][6] - Clearside is planning a Phase 3 program for CLS-AX and is also evaluating other small molecules for treating geographic atrophy [7] Research and Presentations - Six abstracts related to the suprachoroidal drug delivery platform will be presented at the ARVO 2025 Meeting, covering topics such as the efficacy of CLS-AX and advancements in training models and segmentation algorithms [1][3][4] - Notable presentations include top-line results from the ODYSSEY Phase 2b study and a literature review on the evolving role of suprachoroidal drug delivery [3][4] Technology and Innovation - The SCS injection platform provides unprecedented access to the back of the eye, allowing for a non-surgical procedure that could improve patient outcomes [6][7] - The SCS Microinjector is designed with custom features to optimize drug administration, potentially reducing toxic effects on non-diseased cells [6]