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Clearside Biomedical (CLSD) Upgraded to Buy: Here's What You Should Know
ZACKS· 2025-05-29 17:01
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 ...
Clearside Biomedical (CLSD) 2025 Conference Transcript
2025-05-27 14:02
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]
Clearside Biomedical to Participate in a Fireside Chat at the Stifel 2025 Virtual Ophthalmology Forum
GlobeNewswire· 2025-05-21 11:05
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]
Clearside Biomedical(CLSD) - 2025 Q1 - Quarterly Report
2025-05-15 20:05
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 ...
Clearside Biomedical, Inc. (CLSD) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-14 22:35
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(CLSD) - 2025 Q1 - Quarterly Results
2025-05-14 20:10
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 ...
Clearside Biomedical Announces First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire· 2025-05-14 20:05
- 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 ...
Clearside Biomedical Data Featured in Six Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting
GlobeNewswire· 2025-05-09 11:05
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 ...
Clearside Biomedical to Report First Quarter 2025 Financial Results on Wednesday, May 14, 2025
GlobeNewswire· 2025-05-08 11:05
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) 2025 Conference Transcript
2025-05-07 18:00
Clearside Biomedical (CLSD) 2025 Conference May 07, 2025 01:00 PM ET Speaker0 Welcome to day one of the Citizens Life Sciences Conference. My name is John Walden, senior analyst here. We're pleased to have Clearside Biomedical represented by CMO Victor Chong and CFO Charlie Dignan. So thanks for joining us guys. Thank you. Speaker1 Great to be here. Speaker0 So, for those who may not be as familiar with the story, you talk to us about what you're working on at Clearside? Speaker1 Yeah, I'll just give a quic ...