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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR For the transition period from _______ to __________ Commission File Number: 001-37783 Clearside Biomedical, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 45-2437375 (State ...

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 ...

Exhibit 99.1 Clearside Biomedical Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update - Successful End-of-Phase 2 Meeting with FDA Results in Alignment on Phase 3 Plans for CLS-AX in Wet AMD - - Asia-Pacific Partner's New Drug Application for ARCATUS® (XIPERE®) for Uveitic Macular Edema Accepted for Regulatory Review in China - - Multiple Medical Meeting Presentations Highlight Potential Advantages and Key Differentiators of Suprachoroidal Drug Delivery Utilizing Clea ...

- Successful End-of-Phase 2 Meeting with FDA Results in Alignment on Phase 3 Plans for CLS-AX in Wet AMD - - Asia-Pacific Partner’s New Drug Application for ARCATUS® (XIPERE®) for Uveitic Macular Edema Accepted for Regulatory Review in China - - Multiple Medical Meeting Presentations Highlight Potential Advantages and Key Differentiators of Suprachoroidal Drug Delivery Utilizing Clearside’s SCS Microinjector® - - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET - ALPHARETTA, Ga., March 2 ...

- Suprachoroidal Delivery Develops as Promising Mainstream Procedure for Treating Multiple Macular Diseases - - SCS Microinjector® Provides Targeted and Compartmentalized Delivery of Therapeutics Directly to the Retina - ALPHARETTA, Ga., March 24, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that six abstra ...

Core Insights - Clearside Biomedical is advancing its lead clinical program, CLS-AX, for the treatment of neovascular age-related macular degeneration (wet AMD) through its unique suprachoroidal delivery platform [2][10] - The company emphasizes the need for more sustainable and less frequent treatment options for wet AMD, highlighting the potential benefits of its innovative delivery method [3][4] Group 1: Clinical Program and Technology - CLS-AX is a proprietary injectable suspension of axitinib, a tyrosine kinase inhibitor (TKI), designed for suprachoroidal injection, which may offer advantages over existing therapies by achieving pan-VEGF blockade [7][8] - Recent clinical trials have shown that CLS-AX is well tolerated and has a positive safety profile, with the potential for prolonged duration and targeted delivery to affected tissue layers [8][9] - The suprachoroidal injection method could reduce the risk of complications such as endophthalmitis and cataract, which are associated with traditional intravitreal therapies [4][5] Group 2: Regulatory and Market Context - The wet AMD market is significant, valued at over $12 billion, and the company is preparing for a Phase 3 clinical trial following successful discussions with the FDA [5][10] - Clearside's regulatory strategies are informed by recent FDA guidance, which will shape the development of CLS-AX and its positioning in the market [5][6] - The company aims to transform treatment options for retinal diseases through its patented SCS Microinjector, which allows for targeted and compartmentalized drug delivery [9][10]