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]

Core Insights - Clearside Biomedical, Inc. is advancing the treatment of multiple macular diseases through its suprachoroidal drug delivery platform, highlighted by positive clinical data for its lead program, CLS-AX [1][2] Presentation Highlights - Six presentations at the ARVO 2025 Meeting showcased the efficacy and safety of CLS-AX, particularly its ability to maintain stable best corrected visual acuity (BCVA) while reducing injection frequency in patients with neovascular age-related macular degeneration (nAMD) [1][5] - The Phase 2b ODYSSEY trial demonstrated that CLS-AX offers durability and therapeutic potential, achieving its primary outcome [5] - The suprachoroidal delivery method is positioned as a transformative approach for treating retinal diseases, with Clearside recognized as a leader in this field [2][5] Technological Innovations - Clearside has developed a machine learning algorithm for imaging the suprachoroidal space (SCS) post-drug delivery, enhancing patient data evaluation [5] - The SCS Microinjector, designed for targeted drug delivery, has completed over 15,000 injections, establishing a clinically validated training program [5][9] Product Development - CLS-AX is a proprietary suspension of axitinib, a tyrosine kinase inhibitor, which has shown a positive safety profile in clinical trials and aims to provide prolonged and targeted delivery for retinal diseases [8][10] - The company is also planning a Phase 3 trial for CLS-AX and evaluating other small molecules for potential long-acting treatments [10]

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) [3] - The company utilizes a patented SCS Microinjector for targeted and compartmentalized delivery of therapies, aiming to improve patient outcomes in sight-threatening eye diseases [3] - Clearside's lead program, CLS-AX (axitinib injectable suspension), is in development for treating neovascular age-related macular degeneration (wet AMD), with planning for a Phase 3 program underway [3] Product Development - Clearside has developed its first product, XIPERE (triamcinolone acetonide injectable suspension), which is approved for suprachoroidal use and available in the U.S. through a commercial partner [3] - The company is also evaluating various small molecules for potential long-acting treatment of geographic atrophy (GA) [3] - Clearside strategically partners its SCS injection platform with other companies utilizing ophthalmic therapeutic innovations [3] Financial Information - The company will report its first quarter 2025 financial results on May 14, 2025, after the close of financial markets [1] - There will be no conference call hosted for this quarter [1]

Clearside Biomedical (CLSD) Conference Summary Company Overview - Clearside Biomedical focuses on delivering drugs to the back of the eye through the suprachoroidal space, positioning itself as a leader in this innovative approach [3][4] - The company has successfully navigated the FDA regulatory pathway and has conducted over 15,000 injections using its SCS Microinjector [3] Core Products and Pipeline - The internal pipeline includes CLS AX, a phase three ready asset for wet age-related macular degeneration (AMD), and preclinical candidates for geographic atrophy [4] - Collaborations with partners include: - Bausch + Lomb commercializing XIPERE for uveitic macular edema - AbbVie REGENX entering phase three for diabetic retinopathy with gene therapy - Aura in phase three for choroidal melanoma - BioCrysta preparing for clinical trials for diabetic macular edema (DME) [4] Suprachoroidal Space Advantages - The suprachoroidal injection method is less invasive compared to traditional intravitreal injections, reducing the risk of complications such as endophthalmitis [6][7] - The method allows for more contained drug delivery, potentially leading to less inflammation and better targeting of ocular conditions [10] CLS AX Candidate Insights - CLS AX targets the ocular anti-VEGF market, which is valued at approximately $101 billion [12] - The drug aims to extend the duration of treatment effects from the current average of 1-4 months to 3-6 months, providing a significant improvement in patient management [12][14] - The use of a TKI (tyrosine kinase inhibitor) instead of biologics differentiates CLS AX from competitors, allowing for more flexible dosing schedules [13][14] Phase Two Data and Phase Three Design - In phase two trials, approximately two-thirds of patients requiring frequent injections were able to maintain vision for six months without additional therapy [16] - The company plans to adjust the phase three trial design based on learnings from phase two, including earlier redosing and aligning with real-world clinical practices [26][42] - The focus will be on a general patient population rather than just the most active patients, which may provide a more accurate representation of treatment efficacy [40] Financial Considerations - As of the end of the previous year, Clearside Biomedical reported approximately $20 million in cash, which is expected to support the initiation of phase three trials [46] - The projected cost for each phase three study is estimated to be between $55 million and $60 million [46] Market Dynamics - The competitive landscape includes other companies using intravitreal methods, which may have limitations in terms of frequency and invasiveness [21][24] - The company acknowledges the importance of flexible dosing options, as seen with competitors like Vabismo, which has gained traction due to its every four-week option [24] Conclusion - Clearside Biomedical is positioned to leverage its innovative suprachoroidal delivery method and promising pipeline to capture significant market share in the ocular treatment space, with a focus on patient-centric approaches and real-world applicability in its clinical trials [49]

Wall Street expects a year-over-year increase in earnings on higher revenues when Clearside Biomedical, Inc. (CLSD) reports results for the quarter ended March 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they mi ...

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) [3] - The company utilizes a patented SCS Microinjector for an in-office, repeatable, non-surgical procedure aimed at delivering 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, targeting 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 Citizens Life Sciences Conference on May 7, 2025, at 1:00 p.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]

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 ...