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On Wednesday, JMP Securities analyst Jonathan Wolleben reaffirmed a Market Outperform rating on Clearside Biomedical (NASDAQ:CLSD) stock, with a steady price target of $5.00. The micro-cap biotech company, currently trading at $0.80 with a market capitalization of $61.5 million, has seen analyst targets ranging from $4.00 to $8.00, according to InvestingPro data. Wolleben’s outlook is tied to the company’s upcoming pivotal trials for its wet Age-Related Macular Degeneration (AMD (NASDAQ:AMD)) treatment, CLS-AX, set to commence in the second half of 2025.
Clearside Biomedical is gearing up for significant clinical trials, which will test CLS-AX against the current standard treatment, Eylea. These trials are designed to be non-inferiority studies with flexible dosing regimens, a strategy that mirrors successful programs for other treatments like Vabysmo and Eylea HD. Despite showing impressive gross profit margins of 91%, InvestingPro analysis indicates the company is rapidly burning through cash, with comprehensive research reports available for deeper insights into the company’s financial health.
The analyst pointed out that CLS-AX’s design allows for earlier re-dosing intervals, setting it apart from other Tyrosine Kinase Inhibitor (TKI) programs. This feature could lend the drug a more adaptable label, providing physicians with the ability to tailor treatments to individual needs while also potentially extending the time between treatments.
Wolleben also noted that while the Phase 2 results of CLS-AX were competitive, there is potential for improved durability in Phase 3. He attributes this to the possibility of enrolling patients who are easier to treat, such as those who have not previously received treatment for wet AMD, compared to the Phase 2 trials that included patients with active disease.
The trial’s design will be stricter in terms of inclusion and exclusion criteria, aiming to reduce variability among patients. This could contribute to more consistent and reliable trial outcomes, as the company seeks to demonstrate the efficacy and safety of CLS-AX for wet AMD treatment. With a beta of 2.04 and a strong current ratio of 4.44, the company maintains adequate liquidity for its operations, though investors should note the stock’s significant volatility. Clearside Biomedical’s stock price target remains unchanged at $5.00, as the company approaches a critical phase in its development program.
In other recent news, Clearside Biomedical reported its fourth-quarter 2024 earnings, revealing a significant revenue beat with $306,000 compared to the forecasted $130,140. The company’s earnings per share (EPS) matched expectations at -0.1. Stifel analysts maintained a "Buy" rating and set a price target of $8.00, noting the company’s rapid progress toward Phase 3 trials for its drug CLS-AX, designed for wet age-related macular degeneration (wAMD). JMP Securities also reiterated a Market Outperform rating with a $5.00 price target, highlighting the upcoming pivotal trials for CLS-AX, which aim to demonstrate its flexible dosing regimen. Clearside Biomedical’s partnered portfolio is advancing, with Arctic Vision receiving approvals for Arcatus in Australia and Singapore, and a collaboration with ABBV/RGNX leading to the progression of ABBV-RGX-314 into Phase 3 trials for diabetic retinopathy in 2025. The company ended 2024 with $20 million in cash, expected to fund operations into late 2025, while actively seeking additional capital for its Phase 3 trials. Analysts emphasized the strategic steps Clearside Biomedical is taking to advance its CLS-AX treatment through the pivotal stages of clinical development.
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