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Clearside Biomedical (CLSD)
NASDAQ:CLSD
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Clearside Biomedical
(NASDAQ:CLSD)
45Neutral
Positive Factors
Competitive Advantage
CLS-AX offers flexible maintenance dosing every 3 to 6 months, which could be an improvement over current therapies.
FDA Approval
FDA has approved the proposed phase 3 program for CLS-AX in wAMD.
Trial Results
The Phase 2b ODYSSEY trial of CLS-AX in wet AMD reported positive topline results.
Negative Factors
Financial Runway
The cash available at the end of 2024 provides a financial runway only into the fourth quarter of the following year.
Funding Needs
The company needs to raise capital to fund the Phase 3 program.
Investment Requirements
Each phase 3 trial is expected to require a significant investment of $55MM-$60MM and take 2-3 years to report results.
Clearside Biomedical (CLSD) vs. S&P 500 (SPY)
Market Cap
$69.41M
Dividend YieldN/A
Average Volume (3M)206.78K
Price to Earnings (P/E)―
Beta (1Y)1.70
Revenue Growth-79.77%
EPS Growth10.85%
CountryUS
Employees32
SectorHealthcare
Sector Strength76
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.47
Shares Outstanding77,143,875
10 Day Avg. Volume157,278
30 Day Avg. Volume206,778
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)9.90
Price to Cash Flow (P/CF)-3.20
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$5.80Price Target Upside574.42% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
Clearside Biomedical Business Overview & Revenue Model
Company DescriptionClearside Biomedical, Inc., a biopharmaceutical company, focuses on the revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space. The company offers XIPERE, a triamcinolone acetonide suprachoroidal injectable suspension for the treatment of uveitis macular edema. It also develops CLS-AX, an axitinib injectable suspension for suprachoroidal injection, which is in Phase 1/2a clinical trial; and CLS-301, an integrin inhibitor suspension for the treatment of diabetic macular edema and macular degeneration. The company has a collaboration with Bausch Health, Arctic Vision, REGENXBIO, Inc., and Aura Biosciences. Clearside Biomedical, Inc. was incorporated in 2011 and is headquartered in Alpharetta, Georgia.
How the Company Makes MoneyClearside Biomedical makes money primarily through the development and commercialization of its pharmaceutical products. The company generates revenue through licensing agreements, partnerships, and collaborations with other pharmaceutical companies. These partnerships often involve milestone payments, royalties, and sharing of development costs. Additionally, Clearside may earn income from the sale of its proprietary drug candidates once they receive regulatory approval. The company's revenue streams are closely tied to the successful advancement of its pipeline and strategic alliances that facilitate broader market access for its therapies.
Clearside Biomedical Financial Statement Overview
Summary
Clearside Biomedical's financials demonstrate significant challenges, with declining revenues, consistent losses, and a strained balance sheet. The company's reliance on external financing, negative equity, and inability to generate positive cash flows present substantial financial risks.Income Statement
The company has experienced declining revenue over the years, with total revenue dropping to zero by 2024. This is coupled with persistent negative net income, indicating operational challenges. The absence of revenue growth and consistent losses suggest significant difficulties in generating profit.25
Negative
Balance Sheet
The company's balance sheet shows a negative stockholders' equity, indicating financial instability. High liabilities relative to assets and negative equity highlight potential solvency concerns. The debt-to-equity ratio is not calculable due to negative equity, but the high total liabilities reflect leverage risks.20
Very Negative
Cash Flow
The cash flow statement indicates negative free cash flow and operating cash flow over the years, reflecting challenges in cash generation from operations. Though financing activities provided some relief, reliance on external funding is unsustainable long-term.30
Negative
| Breakdown | |||||
| TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 7.70M | 0.00 | 8.23M | 1.33M | 29.57M | 7.89M |
| Gross Profit | |||||
| 7.66M | 0.00 | 7.87M | 1.12M | 29.40M | 7.89M |
| EBIT | |||||
| -24.65M | -28.88M | -24.84M | -30.28M | -627.00K | -17.93M |
| EBITDA | |||||
| -22.23M | -28.88M | -23.06M | -29.46M | -449.00K | -17.93M |
| Net Income Common Stockholders | |||||
| -31.88M | -34.35M | -32.48M | -34.07M | 376.00K | -18.03M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 525.00K | 20.02M | 28.92M | 48.26M | 30.44M | 17.29M |
| Total Assets | |||||
| 710.00K | 25.13M | 34.02M | 51.30M | 42.90M | 19.32M |
| Total Debt | |||||
| 268.00K | 703.00K | 43.00M | 1.28M | 675.00K | 1.98M |
| Net Debt | |||||
| -257.00K | -19.32M | 14.08M | -46.97M | -29.76M | -15.31M |
| Total Liabilities | |||||
| 1.24M | 63.98M | 49.93M | 40.70M | 4.93M | 10.56M |
| Stockholders Equity | |||||
| -532.00K | -38.85M | -15.91M | 10.61M | 37.98M | 8.76M |
| Cash Flow | Free Cash Flow | ||||
| -19.60M | -24.70M | -19.91M | -13.61M | -10.73M | -13.18M |
| Operating Cash Flow | |||||
| -18.95M | -24.70M | -18.14M | -13.37M | -10.73M | -13.12M |
| Investing Cash Flow | |||||
| -10.06M | -638.00K | -1.78M | -246.00K | 0.00 | -55.00K |
| Financing Cash Flow | |||||
| 14.10M | 16.44M | 414.00K | 31.33M | 23.78M | 7.87M |
Clearside Biomedical Technical Analysis
Negative
0.86
Price Trends
0.95
Negative
0.98
Negative
1.07
Negative
Market Momentum
<0.01
Positive
44.41
Neutral
13.79
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CLSD, the sentiment is Negative. The current price of 0.86 is below the 20-day moving average (MA) of 0.94, below the 50-day MA of 0.95, and below the 200-day MA of 1.07, indicating a bearish trend. The MACD of <0.01 indicates Positive momentum. The RSI at 44.41 is Neutral, neither overbought nor oversold. The STOCH value of 13.79 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for CLSD.
Clearside Biomedical Risk Analysis
Clearside Biomedical disclosed 69 risk factors in its most recent earnings report. Clearside Biomedical reported the most risks in the “Finance & Corporate” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Clearside Biomedical Peers Comparison
Overall Rating
UnderperformOutperform
Sector (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
54 Neutral | $1.01B | ― | -95.21% | ― | 9.03% | -25.00% | |
54 Neutral | $7.22B | ― | -80.35% | ― | ― | -10.89% | |
48 Neutral | $6.36B | 1.09 | -49.92% | 2.63% | 17.17% | 0.95% | |
48 Neutral | $316.84M | ― | -43.42% | ― | -5.97% | -25.87% | |
45 Neutral | $69.41M | ― | 91.63% | ― | -79.77% | 10.85% | |
34 Underperform | $112.85M | ― | -58.54% | ― | ― | -47.28% | |
27 Underperform | $27.36M | ― | -388.29% | ― | ― | 38.50% |
* Healthcare Sector Average
Performance Comparison
CLSD
Clearside Biomedical
0.86
-0.43
-33.33%
EYPT
EyePoint Pharmaceuticals
4.61
-16.12
-77.76%
MDGL
Madrigal Pharmaceuticals
314.39
65.75
26.44%
ALDX
Aldeyra Therapeutics
1.89
-2.49
-56.85%
OCUL
Ocular Therapeutix
6.36
-1.63
-20.40%
KALA
Kala Pharmaceuticals
4.24
-3.38
-44.36%
Clearside Biomedical Earnings Call Summary
Earnings Call Date: Mar 27, 2025 | % Change Since: -16.50% | Next Earnings Date: May 8, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant progress in clinical trials and regulatory approvals, particularly in the Asia-Pacific region. However, the company faces challenges in securing funding for its Phase 3 program, which is crucial for its future success. The sentiment is positive due to the strong trial results and strategic partnerships, despite the funding and enrollment challenges.Highlights
Positive Results from ODYSSEY Phase 2b Trial
Clearside's ODYSSEY Phase 2b wet AMD clinical trial showed positive results, leading to a successful end of Phase 2 meeting with the FDA. The company is aligned on a pivotal Phase 3 program for CLS-AX, setting it up for potential commercial success.
Regulatory Progress and Partnerships in Asia-Pacific
Arctic Vision achieved several regulatory milestones in the Asia-Pacific region with ARCATUS/XIPERE, including approval in Australia and Singapore and a new drug application under review in China. A commercial collaboration with Santen Pharmaceuticals was also established.
Strong Financial Position
As of December 31, 2024, the company had cash and cash equivalents totaling approximately $20 million, with resources to fund operations into the fourth quarter of 2025.
Lowlights
Funding Required for Phase 3 Program
Clearside is actively pursuing options to fund the CLS-AX Phase 3 program, indicating the need for additional financial resources or partnerships to commence the trial.
Potential Enrollment Challenges
The Phase 3 trial design for CLS-AX includes specific criteria that may exclude patients with high variability, which might affect enrollment speed.
Company Guidance
During the Clearside Biomedical Fourth Quarter 2024 Financial Results and Corporate Update Call, the company provided detailed guidance on its Phase 3 plans for the CLS-AX treatment for wet AMD. The pivotal Phase 3 program will consist of two non-inferiority trials, aiming to enroll treatment-naive patients, with a planned duration of enrollment of around 12 months. The design includes a personalized treatment interval (PTI) assessment at weeks 12, 16, and 20 to determine dosing regimens of every 12, 16, 20, or 24 weeks. The trials will use advanced OCT biomarkers to guide redosing, with an emphasis on reducing variability by excluding participants with significant non-disease-related visual acuity changes prior to randomization. The total cost of the trials is estimated at $55-$60 million each, with Clearside actively exploring funding options, including potential partnerships. The company also highlighted its strategic focus on suprachoroidal delivery, with ongoing collaborations and a robust pipeline, despite reporting cash and cash equivalents of approximately $20 million as of December 31, 2024.Clearside Biomedical Corporate Events
Business Operations and StrategyFinancial Disclosures
Clearside Biomedical Reports 2024 Financial Results and Updates
Neutral
Mar 27, 2025
On March 27, 2025, Clearside Biomedical announced its financial results for the fourth quarter and full year 2024, alongside a corporate update. The company reported a decrease in license and other revenue, attributing it to prior year milestone payments, and a net loss increase due to reduced revenue. Clearside highlighted its successful End-of-Phase 2 meeting with the FDA for CLS-AX in wet AMD, and its Asia-Pacific partner’s regulatory progress for ARCATUS® in China. The company also noted multiple collaborations and advancements in its suprachoroidal delivery platform, including Phase 3 plans for diabetic retinopathy and ocular oncology trials, positioning itself for potential pipeline expansion and strategic partnerships.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.