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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Exact Name of Registrant as Specified in its Charter) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 Clearside Biomedical, Inc. Delaware 45-2437375 (State or other jurisdiction of incorporation or organi ...

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]

Exhibit 99.1 Clearside Biomedical Announces First Quarter 2025 Financial Results and Provides Corporate Update - Successful End-of-Phase 2 Meeting with FDA Led to Alignment on Phase 3 Program Design for CLS-AX in Wet AMD - - CLS-AX Targets Commercially Attractive Product Profile with Three-to-Six Month Flexible Maintenance Dosing - - Multiple Milestones Achieved by Commercial and Development Partners - - Use of Suprachoroidal Drug Delivery Featured in Over 15 Presentations at Major Ophthalmic Medical Meetin ...

- Successful End-of-Phase 2 Meeting with FDA Led to Alignment on Phase 3 Program Design for CLS-AX in Wet AMD - - CLS-AX Targets Commercially Attractive Product Profile with Three-to-Six Month Flexible Maintenance Dosing - - Multiple Milestones Achieved by Commercial and Development Partners - - Use of Suprachoroidal Drug Delivery Featured in Over 15 Presentations at Major Ophthalmic Medical Meetings This Year - ALPHARETTA, Ga., May 14, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a ...

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 ...

ALPHARETTA, Ga., May 08, 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 its first quarter 2025 financial results will be reported on Wednesday, May 14, 2025 after the close of the financial markets. The Company will not be hosting a conference call this quarter. Information about the Company’s quarterly ...

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]