- Proven In-Office, Repeatable, Non-Surgical Procedure for the Targeted Delivery of a Wide Variety of Therapies for Serious Retinal Diseases - - CLS-AX Phase 3-Ready Asset with Global Investigator Support and FDA Alignment on Pivotal Trial Program in wet AMD - - Validated Delivery Platform with Five Commercial and Late-Stage Development Suprachoroidal Licensing Collaborations - ALPHARETTA, Ga., July 17, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutio ...

Core Insights - Clearside Biomedical is advancing the delivery of therapies to the back of the eye through its proprietary suprachoroidal space (SCS) injection platform, which will be highlighted at the upcoming Clinical Trials at the Summit (CTS) Meeting [1][2] Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on improving patient outcomes by utilizing its SCS injection platform for targeted delivery of therapies to treat sight-threatening eye diseases [7] - The company’s lead product, CLS-AX (axitinib injectable suspension), is in development for neovascular age-related macular degeneration (wet AMD) and is preparing for a Phase 3 program [7] Technology and Innovation - The SCS Microinjector is a patented device that allows for in-office, repeatable, non-surgical procedures to deliver a variety of therapies directly to the macula, retina, or choroid [5][7] - CLS-AX is designed as a longer-acting therapy that achieves pan-VEGF blockade, potentially offering advantages over existing anti-VEGF therapies by targeting different levels of the angiogenesis cascade [4][5] Clinical Development - The company is showcasing multiple presentations related to its SCS delivery platform and its development partners at the CTS Meeting, including updates on CLS-AX for neovascular AMD and ABBV-RGX-314 for diabetic retinopathy [3][4] - Early clinical trials for CLS-AX have shown it to be well tolerated with a positive safety profile, indicating its potential for prolonged duration and targeted delivery [4]

Clearside Biomedical, Inc. (CLSD) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a ...

Summary of Clearside Biomedical Conference Call Company Overview - Clearside Biomedical focuses on delivering therapeutic agents to the suprachoroidal space, pioneering a proprietary injection procedure and device for this purpose [4][5] - Established partnerships with Oral Biosciences and REGENXBIO for developing treatments for choroidal melanoma and retinal diseases [5][6] - Commercialization partnerships with Bausch and Lomb and Arctic Vision for their FDA-approved product XIPERE, which delivers triamcinolone to the suprachoroidal space [6] Core Product and Development - XIPERE has shown better performance in terms of duration and effect than predicted by pharmacokinetic models, leading to increased acceptance among physicians [10][14] - Development of CLS AX (axitinib) for wet AMD, with successful completion of phase 2b ODICEY trial, positioning it as a phase 3 ready product [7][8] - The product aims for flexible dosing with a duration comparable to biologics, targeting a market need for variability in patient responses [16][26] Competitive Landscape - CLS AX is positioned against current TKI competitors that offer a six-month duration, with Clearside aiming for a three to six-month duration to accommodate patient variability [15][21] - The company believes its product has a better efficacy profile due to a lower IC50 and a more favorable redosing criteria compared to competitors [19][20] - Emphasis on the absence of ocular serious adverse events (SAEs) in their trials, which contrasts with some competitors [20] Regulatory Strategy - The phase 3 trial is designed to last two years, with a primary endpoint at 52 weeks, allowing for two cycles of treatment [31][32] - The trial design aims to minimize variability by excluding patients with high variability in results, which has been accepted by regulatory agencies [39][42] - The company is focused on a non-inferiority design with good masking to mitigate regulatory risks associated with treatment failures [48][49] Funding and Future Plans - Ongoing outreach to strategic partners and potential investors to fund the advancement of CLS AX into phase 3 trials [50] - The company is exploring various funding options, including combinations of investors and strategic partnerships [50] Additional Insights - The acceptance of suprachoroidal injections is increasing, with over 15,000 injections performed and more than 100 peer-reviewed publications supporting the procedure [14] - The company believes that the flexibility in dosing frequency will be appealing to physicians and align with real-world clinical practices [44][45]

Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS) to improve patient outcomes [3] - The company utilizes a patented SCS Microinjector for an in-office, repeatable, non-surgical procedure aimed at targeted delivery of therapies to the macula, retina, or choroid [3] - Clearside is developing a pipeline of small molecule product candidates for administration via its SCS Microinjector, with its lead program, CLS-AX, in development for treating neovascular age-related macular degeneration (wet AMD) [3] Product Development - The company is planning a Phase 3 program for its lead product, CLS-AX (axitinib injectable suspension) [3] - Clearside is also evaluating various small molecules for potential long-acting treatment of geographic atrophy (GA) [3] - The first product developed by Clearside, XIPERE (triamcinolone acetonide injectable suspension), has been approved for suprachoroidal use and is available in the U.S. through a commercial partner [3] Upcoming Events - Management will participate in a fireside chat at the Stifel 2025 Virtual Ophthalmology Forum on May 27, 2025, at 9:00 a.m. ET [1] - A live and archived webcast of the event will be accessible on the Clearside website under the Investors section, with the archive available for three months [2]

PART I [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited Q1 2025 financials reflect a net loss improvement, yet declining cash and increased deficit raise substantial doubt about going concern [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased, liabilities increased, and stockholders' deficit widened as of March 31, 2025 Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,628 | $20,020 | | Total current assets | $15,964 | $21,274 | | **Total assets** | **$19,668** | **$25,126** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $5,012 | $4,794 | | Liability related to the sales of future royalties, net | $53,440 | $51,767 | | **Total liabilities** | **$65,578** | **$63,981** | | **Total stockholders' deficit** | **($45,910)** | **($38,855)** | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) Net loss improved in Q1 2025 to $8.2 million, driven by higher revenue and lower R&D expenses Consolidated Statements of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | License and other revenue | $2,330 | $230 | | Research and development | $4,463 | $5,615 | | General and administrative | $2,824 | $2,824 | | Loss from operations | ($5,205) | ($8,209) | | **Net loss** | **($8,223)** | **($11,763)** | | **Net loss per share — basic and diluted** | **($0.11)** | **($0.17)** | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations improved, but financing activities shifted to a net use, leading to a cash decrease Consolidated Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,830) | ($7,851) | | Net cash used in investing activities | ($9) | ($57) | | Net cash (used in) provided by financing activities | ($553) | $14,343 | | **Net (decrease) increase in cash and cash equivalents** | **($6,392)** | **$6,435** | | **Cash and cash equivalents, end of period** | **$13,628** | **$35,355** | [Notes to the Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) Notes highlight significant liquidity concerns, raising substantial doubt about the company's ability to continue as a going concern - The company's financial condition raises **substantial doubt** about its ability to continue as a going concern. Cash and cash equivalents as of May 15, 2025, are expected to fund operations only into the **fourth quarter of 2025**[29](index=29&type=chunk) - In February 2024, the company raised net proceeds of **$13.9 million** through a registered direct offering of common stock and warrants[24](index=24&type=chunk) - The company sold rights to future royalties and milestone payments from key license agreements to HCR in exchange for up to **$65 million**. As of March 31, 2025, the liability related to this sale was **$53.4 million**[54](index=54&type=chunk)[60](index=60&type=chunk) - The company has exclusive license agreements with Bausch + Lomb for XIPERE in the U.S. and Canada, Arctic Vision in the Asia Pacific region, and BioCryst for use of the SCS Microinjector with avoralstat[80](index=80&type=chunk)[83](index=83&type=chunk)[87](index=87&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses CLS-AX development and Q1 2025 financials, highlighting reduced net loss but significant going concern risks [Overview and Clinical Development](index=23&type=section&id=Overview%20and%20Clinical%20Development) The company focuses on its SCS platform, with lead candidate CLS-AX for wet AMD showing positive Phase 2b results and preparing for Phase 3 - The company's lead product candidate, CLS-AX (axitinib), is being developed for wet AMD. The ODYSSEY Phase 2b trial demonstrated durability, with **67%** of participants going **6 months** without needing additional treatment before mandatory re-dosing[103](index=103&type=chunk)[107](index=107&type=chunk) - An End-of-Phase 2 meeting with the FDA was completed in Q1 2025, gaining alignment on the Phase 3 program for CLS-AX. The company is preparing to initiate two pivotal trials in **H2 2025**, contingent on securing funding[111](index=111&type=chunk) - The company is also evaluating two small molecules in preclinical models for the potential treatment of geographic atrophy (GA)[112](index=112&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Q1 2025 saw increased license revenue and decreased R&D expenses, leading to a reduced net loss compared to Q1 2024 Comparison of Results of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | License and other revenue | $2,330 | $230 | $2,100 | | Research and development | $4,463 | $5,615 | ($1,152) | | General and administrative | $2,824 | $2,824 | $0 | | **Loss from operations** | **($5,205)** | **($8,209)** | **$3,004** | | **Net loss** | **($8,223)** | **($11,763)** | **$3,540** | - The **$1.2 million** decrease in R&D expenses was primarily due to a **$1.8 million** reduction in costs for the CLS-AX program following the completion of the ODYSSEY trial, partially offset by a **$0.4 million** increase in costs for the GA program[140](index=140&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, cash was $13.6 million, expected to fund operations only into Q4 2025, raising substantial doubt about going concern - The company had cash and cash equivalents of **$13.6 million** as of March 31, 2025[145](index=145&type=chunk)[146](index=146&type=chunk) - Based on current plans, the company expects its cash to fund planned operating expenses and capital expenditure requirements into the **fourth quarter of 2025**[158](index=158&type=chunk) - The company will require **additional capital** to complete the clinical development of CLS-AX and has stated these factors raise **substantial doubt** about its ability to continue as a going concern[158](index=158&type=chunk)[159](index=159&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Clearside Biomedical is not required to provide quantitative and qualitative disclosures about market risk[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective** as of the end of the period covered by the report (March 31, 2025)[167](index=167&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[168](index=168&type=chunk) PART II [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings, pending or threatened, that could adversely affect its business - The company reports **no material legal proceedings**[170](index=170&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the comprehensive risk factors detailed in the company's Annual Report on Form 10-K for FY2024 - The report directs investors to review the risk factors described in the company's Annual Report on Form 10-K for the year ended December 31, 2024[171](index=171&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or issuer purchases during the period - There were **no unregistered sales** of equity securities or **no issuer purchases** of equity securities in the quarter[172](index=172&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - **No directors or officers** adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter[173](index=173&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including Sarbanes-Oxley certifications and Inline XBRL documents - The report includes standard exhibits, such as Sarbanes-Oxley certifications (31.1, 31.2, 32.1) and XBRL data files[175](index=175&type=chunk)

Core Insights - Clearside Biomedical, Inc. reported a quarterly loss of $0.11 per share, which was better than the Zacks Consensus Estimate of a loss of $0.12, and an improvement from a loss of $0.17 per share a year ago [1] - The company achieved revenues of $2.33 million for the quarter ended March 2025, significantly surpassing the Zacks Consensus Estimate by 785.93%, compared to revenues of $0.23 million in the same quarter last year [2] - The stock has underperformed the market, losing about 5.3% since the beginning of the year, while the S&P 500 gained 0.1% [3] Financial Performance - Over the last four quarters, Clearside Biomedical has exceeded consensus EPS estimates four times and topped consensus revenue estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $0.26 million, and for the current fiscal year, it is -$0.45 on revenues of $1.19 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Clearside Biomedical belongs, is currently ranked in the top 30% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Clearside Biomedical's stock performance [5]

[Clearside Biomedical Q1 2025 Earnings Release](index=1&type=section&id=Clearside%20Biomedical%20Q1%202025%20Earnings%20Release) [Corporate Update and Program Highlights](index=1&type=section&id=Corporate%20Update%20and%20Program%20Highlights) Clearside Biomedical advanced CLS-AX to Phase 3, saw partner milestones, and featured its SCS Microinjector® platform in over 15 presentations - Reached alignment with the FDA on the **Phase 3 program design** for CLS-AX in wet AMD, targeting a **flexible three-to-six-month maintenance dosing schedule**, which is believed to offer a commercially compelling product profile[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) - Development partner BioCryst Pharmaceuticals received authorization to initiate its **first clinical trial in Australia** for avoralstat for Diabetic Macular Edema (DME), with **initial data expected in 2025**[2](index=2&type=chunk)[6](index=6&type=chunk) - Asia-Pacific partner Arctic Vision's New Drug Application (NDA) for ARCATUS® was **accepted for review in China** and **approved in both Australia and Singapore** for the treatment of uveitic macular edema (UME)[2](index=2&type=chunk)[6](index=6&type=chunk) - The company's suprachoroidal drug delivery platform was featured in **over 15 presentations** at major ophthalmic medical meetings, including ARVO 2025, indicating growing interest in the technology[1](index=1&type=chunk)[6](index=6&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Clearside reported increased Q1 2025 revenue to **$2.3 million**, reduced net loss to **$8.2 million**, and maintained **$13.6 million** in cash, funding operations into Q4 2025 Q1 2025 Statement of Operations Highlights (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | License and other revenue | $2,330 | $230 | | Research and development | $4,463 | $5,615 | | General and administrative | $2,824 | $2,824 | | Loss from operations | ($5,205) | ($8,209) | | Net loss | ($8,223) | ($11,763) | | Net loss per share | ($0.11) | ($0.17) | - The increase in revenue was primarily attributable to **$1.5 million** in milestones from partner Arctic Vision and **$0.8 million** in other revenue for training, services, and sales of SCS Microinjector kits[6](index=6&type=chunk) - The decrease in R&D expenses was primarily due to lower clinical trial costs following the completion of the ODYSSEY Phase 2b trial[6](index=6&type=chunk) Balance Sheet Summary (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $13,628 | $20,020 | | Total assets | $19,668 | $25,126 | | Total liabilities | $65,578 | $63,981 | - As of March 31, 2025, cash and cash equivalents totaled **$13.6 million**. The company believes it has sufficient resources to fund planned operations into the **fourth quarter of 2025**[9](index=9&type=chunk)

Core Insights - Clearside Biomedical has successfully completed an End-of-Phase 2 meeting with the FDA, leading to alignment on the Phase 3 program design for CLS-AX in wet AMD [1][5] - The company aims for a flexible three-to-six-month dosing label for CLS-AX, which is expected to be commercially attractive if approved [2][5] - Significant progress has been made by Clearside's partners in advancing their programs, including approvals and ongoing clinical trials [2][5] Recent Highlights - BioCryst Pharmaceuticals has received authorization to initiate its first clinical trial in Australia for avoralstat, targeting diabetic macular edema [5] - Arctic Vision's NDA for ARCATUS has been accepted for review in China, with approvals already granted in Australia and Singapore [5] - Over 15 presentations on suprachoroidal drug delivery were made at major ophthalmic medical meetings this year, showcasing advancements in retinal disease treatments [1][5] Financial Results - License and other revenue for Q1 2025 was $2.3 million, a significant increase from $0.2 million in Q1 2024, primarily due to license fees from partners [8][11] - R&D expenses decreased to $4.5 million in Q1 2025 from $5.6 million in Q1 2024, attributed to lower clinical trial costs [8][11] - The net loss for Q1 2025 was $8.2 million, or $0.11 per share, compared to a net loss of $11.8 million, or $0.17 per share, in Q1 2024 [8][11] Company Overview - Clearside Biomedical focuses on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, aiming to improve patient outcomes [6] - The company's lead program, CLS-AX, is in development for the treatment of wet AMD, with plans for a Phase 3 program underway [6] - Clearside has developed its first product, XIPERE, which is commercially available in the U.S. through a partner [6][9]

Strong Clinical Evidence Supports Use of the Suprachoroidal Platform in Expanding the Standard of Care for the Treatment of Multiple Macular DiseasesALPHARETTA, Ga., May 09, 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 presentations related to the Company’s lead program, CLS-AX (axitinib injectable ...