- Upcoming Presentations at Angiogenesis and Macula Society Conferences to Feature CLS-AX Sub-Group Analyses from ODYSSEY Wet AMD Trial - - CLS-AX Targets Flexible Dosing of Biologics with Duration of Tyrosine Kinase Inhibitors - ALPHARETTA, Ga., Jan. 28, 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 recent and upcoming presentations at ...

- Upcoming Presentations at Angiogenesis and Macula Society Conferences to Feature CLS-AX Sub-Group Analyses from ODYSSEY Wet AMD Trial - - CLS-AX Targets Flexible Dosing of Biologics with Duration of Tyrosine Kinase Inhibitors -  ALPHARETTA, Ga., Jan. 28, 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 recent and upcoming presentations at o ...

- ARCATUS®, Branded as XIPERE® in the U.S., is the First Globally Approved Suprachoroidal Therapy - - Continued Global Expansion of Clearside’s Suprachoroidal Space Injection Platform Featuring its Commercially Proven SCS Microinjector® - ALPHARETTA, Ga., Jan. 22, 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 Arctic Vision’s new drug ...

ALPHARETTA, Ga., Dec. 19, 2024 (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 the official journal of The Royal College of Ophthalmologists, Eye, published a summary of critical insights into drug development and regulatory processes based on a presentation at the prestigious annual Edridge Green Lecture by Clearside’s Chief Medical Office ...

Shares of Clearside Biomedical, Inc. (CLSD) have been struggling lately and have lost 5.6% over the past two weeks. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts abo ...

Zacks Rating Upgrade - Clearside Biomedical has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a powerful force impacting stock prices [1] - The Zacks rating system is highly useful for individual investors as it tracks the Zacks Consensus Estimate for current and future years, providing a more objective measure compared to Wall Street analysts' subjective ratings [2][3] Earnings Estimate Revisions and Stock Price Correlation - Changes in a company's future earnings potential, reflected in earnings estimate revisions, are strongly correlated with near-term stock price movements [4] - Institutional investors use earnings estimates to calculate the fair value of a company's shares, and their bulk investment actions lead to price movements [4] - For Clearside Biomedical, rising earnings estimates and the consequent rating upgrade indicate an improvement in the company's underlying business, which should push the stock higher [5] Zacks Rank System and Earnings Estimate Revisions - The Zacks Rank system uses four factors related to earnings estimates to classify stocks into five groups, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7] - Tracking earnings estimate revisions can be rewarding, as empirical research shows a strong correlation between these revisions and near-term stock movements [6] Clearside Biomedical's Earnings Estimates - For the fiscal year ending December 2024, Clearside Biomedical is expected to earn -$0.52 per share, a change of 1.9% from the year-ago reported number [8] - Over the past three months, the Zacks Consensus Estimate for Clearside Biomedical has increased by 6.6% [8] Zacks Rating System's Superiority - The Zacks rating system maintains an equal proportion of 'buy' and 'sell' ratings for its universe of over 4000 stocks, with only the top 5% receiving a 'Strong Buy' rating and the next 15% receiving a 'Buy' rating [9] - Clearside Biomedical's upgrade to a Zacks Rank 2 positions it in the top 20% of Zacks-covered stocks, indicating superior earnings estimate revision features and potential for market-beating returns in the near term [10]

Financial Data and Key Metrics - Cash and cash equivalents totaled approximately $23.6 million as of September 30, 2024, with sufficient resources to fund operations into Q3 2025 [35] - The company is planning for the CLS-AX Phase 3 program and research work to expand the pipeline into geographic atrophy [35] Business Line Data and Key Metrics - CLS-AX demonstrated an 84% reduction in injection frequency after the initial dose, with 90% of participants not requiring additional treatment for up to 4 months, 81% up to 5 months, and 67% up to 6 months [22] - The ODYSSEY Phase 2b trial showed stable best-corrected visual acuity (BCVA) and central subfield thickness (CST) over 36 weeks, with BCVA within two letters from baseline at weeks 24 and 36 [21] - The company is evaluating small molecules for geographic atrophy, a market valued at over $20 billion, focusing on improving choroidal perfusion and moderating inflammatory cells [10][31] Market Data and Key Metrics - The company's SCS Microinjector has been used in over 10,000 injections, with commercial approval for XIPERE, the first FDA-approved product for suprachoroidal administration [11] - Partnerships with Arctic Vision, Santen Pharmaceuticals, REGENXBIO, AbbVie, Aura Biosciences, and BioCryst Pharmaceuticals are advancing suprachoroidal delivery programs [13][15][17][18] Company Strategy and Industry Competition - The company is positioning CLS-AX as a maintenance treatment for wet AMD, offering flexible dosing between 3 to 6 months, which aligns with current physician practices [26] - The company is the only TKI wet AMD program with repeat dosing data, providing a competitive advantage as it advances CLS-AX into Phase 3 [9] - The company is expanding its suprachoroidal platform, with significant interest from retinal specialists and biopharmaceutical companies [12] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the potential of CLS-AX in the wet AMD market, with positive safety and efficacy data from the ODYSSEY trial [7][20] - The company is focused on advancing its Phase 3 program for CLS-AX and exploring new opportunities in geographic atrophy [26][31] - Management highlighted the strategic validation of the suprachoroidal delivery platform through partnerships with global pharmaceutical companies [14] Other Important Information - The company has made key personnel changes, including appointing Tony Gibney as Chair of the Board of Directors and expanding Victor Chong's role to include Head of Research and Development [36][38] - The company plans to present additional data from the ODYSSEY trial at upcoming medical conferences, including APVRS, Floretina, and angiogenesis meetings [55] Q&A Session Summary Question: Feedback on AAO presentation and study design incorporating retreatment - The data presented at AAO was well-received, with positive feedback on the flexibility of dosing and the ability to retreat with CLS-AX rather than using supplemental aflibercept [42][43][45] Question: Phase 3 trial design and geographic atrophy program expansion - The Phase 3 trial design will likely be similar to the aflibercept high-dose faricimab design, with flexible dosing and a non-inferiority margin of 4.5 letters [51][52] - The company is targeting an end-of-Phase 2 meeting with the FDA in early 2025 and plans to start the Phase 3 trial in the second half of 2025 [51][54] - The geographic atrophy program is focusing on small molecules that improve choroidal perfusion and moderate inflammatory cells [53] Question: Additional data analysis from ODYSSEY - The company plans to share more data at upcoming medical conferences, including APVRS, Floretina, and angiogenesis meetings, to clarify areas of confusion and provide additional analysis [55] Question: FDA concerns on redosing CLS-AX within six months - The company has no concerns regarding FDA approval for redosing CLS-AX within six months, as the Phase 2 trial already demonstrated the safety and efficacy of multiple redoses [60] Question: Estimated cost of the Phase 3 program - The cost of the Phase 3 program is still being finalized and will be clearer after the end-of-Phase 2 meeting with the FDA [61] Question: Mechanism of geographic atrophy and IND submission timeline - Geographic atrophy is considered a choroidal disease, with damage occurring before retinal pigment epithelium (RPE) cell death. The company is working on small molecules that target the choroid and retina [62][63] - The timeline for IND submission is still under development, but the company is moving toward specific candidates for advancement [66]

Clearside Biomedical, Inc. (CLSD) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 28.57%. A quarter ago, it was expected that this company would post a loss of $0.14 per share when it actually produced a loss of $0.10, delivering a surprise of 28.57%.Over the last four quarters, the company h ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 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. | --- | --- | |--------------------------------------------------------------------------------------------------------------- ...

Exhibit 99.1 Clearside Biomedical Announces Third Quarter 2024 Financial Results and Provides Corporate Update - Recent ODYSSEY Phase 2b Trial of Suprachoroidal CLS-AX in Wet AMD Achieved All Primary and Secondary Outcomes - - Positive Topline Results Support Advancing CLS-AX to Phase 3 Targeting a Differentiated Flexible Dosing Approach Similar to a Biologic with the Potential Extended Duration of a Tyrosine Kinase Inhibitor (TKI) - - Recent Commercial Licensing Agreement for China by a Global Ophthalmic P ...