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Cellectar Biosciences (CLRB)
NASDAQ:CLRB
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Cellectar Biosciences
(NASDAQ:CLRB)
34Underperform
Positive Factors
Clinical Trial Results
Cellectar reported the full data set from its pivotal CLOVER WaM P2b study, demonstrating a major response rate of 56.4%, which exceeds the 20% protocol stat hurdle.
Financial Performance
The company has $34M in cash (above the market cap of ~$10M) and with reduced opex, should have runway into late 2025 and paths forward with earlier-stage assets on what is viewed as a de-risked PDC platform.
Regulatory Approval
Cellectar recently held a meeting with the FDA, which confirmed a clear path to accelerated approval for Iopofosine-131 in Waldenstrom’s macroglobulinemia.
Negative Factors
Financial Outlook
The price target for Cellectar Biosciences has been lowered to $1, which could imply challenges or adjustments in the company's outlook.
Regulatory Challenges
Cellectar announced that after discussions with FDA, the agency is requiring a confirmatory study to support accelerated approval for Iopofosine-131 in Waldenstrom’s macroglobulinemia (WM).
Cellectar Biosciences (CLRB) vs. S&P 500 (SPY)
Market Cap
$13.57M
Dividend YieldN/A
Average Volume (3M)1.28M
Price to Earnings (P/E)―
Beta (1Y)1.71
Revenue GrowthN/A
EPS Growth56.38%
CountryUS
Employees11
SectorHealthcare
Sector Strength71
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.51
Shares Outstanding46,079,876
10 Day Avg. Volume818,951
30 Day Avg. Volume1,276,157
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
Price to Cash Flow (P/CF)-0.40
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
$1.00Price Target Upside244.83% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
Cellectar Biosciences Business Overview & Revenue Model
Company DescriptionCellectar Biosciences, Inc., a clinical biopharmaceutical company, focuses on the discovery, development, and commercialization of drugs for the treatment of cancer. Its lead phospholipid drug conjugate (PDC) candidate is CLR 131 (iopofosine I-131), which is in Phase 2 clinical study in patients with relapsed or refractory (r/r) Waldenstrom's macroglobulinemia and B-cell malignancies; Phase 2B clinical study in r/r multiple myeloma (MM) patients; and Phase I study for various pediatric cancers, r/r head and neck cancers, and R/R MM. The company also develops CLR 1900, a PDC chemotherapeutic program that is in the preclinical development stage to treat solid tumors. It has collaborative PDC programs with Avicenna Oncology GMBH to develop CLR 2000 Series; Orano Med to develop CLR 12120 Series; IntoCell Inc; and LegoChemBio. The company was founded in 2002 and is headquartered in Florham Park, New Jersey.
How the Company Makes MoneyCellectar Biosciences makes money primarily through the development and commercialization of its targeted cancer therapies. The company's revenue model is largely dependent on the successful advancement of its drug candidates through clinical trials and eventual approval by regulatory bodies. Additionally, Cellectar may generate revenue through partnerships, licensing agreements, and collaborations with larger pharmaceutical companies, enabling shared development costs and promotional activities. These partnerships can provide upfront payments, milestone payments, and royalties on sales upon successful commercialization of their therapies.
Cellectar Biosciences Financial Statement Overview
Summary
Cellectar Biosciences faces severe financial challenges, marked by zero revenue, consistent operational losses, and reliance on external financing. The balance sheet reflects negative equity in 2023, and cash flow issues persist due to continuous negative free cash flow.Income Statement
Cellectar Biosciences has consistently reported zero revenue over the years, indicating a lack of commercialized products. The company operates at a loss, with significant negative net income each year. The EBIT and EBITDA margins are negative, reflecting operational challenges and lack of profitability.10
Very Negative
Balance Sheet
The company exhibits a high dependency on equity financing, as seen in fluctuating stockholder's equity and negative equity in 2023. The debt-to-equity ratio is low, indicating limited use of debt, but the overall financial position is weak due to ongoing losses and negative equity in recent years.25
Negative
Cash Flow
Cellectar Biosciences shows recurring negative free cash flow, indicating insufficient cash generation from operations. The company relies on financing activities to sustain operations, as evidenced by large financing cash inflows. Operating cash flow has been consistently negative, reflecting operational inefficiencies.30
Negative
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| 0.00 | -192.38K | -238.87K | -227.64K | -207.93K | EBIT |
| -51.78M | -38.96M | -28.81M | -24.13M | -15.29M | EBITDA |
| -51.78M | -38.77M | -28.67M | -23.98M | -15.15M | Net Income Common Stockholders |
| -44.58M | -37.98M | -28.60M | -23.97M | -14.76M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 23.29M | 9.56M | 19.87M | 35.70M | 57.17M | Total Assets |
| 25.47M | 12.08M | 21.59M | 37.20M | 58.66M | Total Debt |
| 494.00K | 552.98K | 603.83K | 301.74K | 421.64K | Net Debt |
| -22.79M | -9.01M | -19.26M | -35.40M | -56.74M | Total Liabilities |
| 11.18M | 25.85M | 6.08M | 4.16M | 3.86M | Stockholders Equity |
| 14.29M | -15.16M | 15.51M | 33.05M | 54.79M |
| Cash Flow | Free Cash Flow | |||
| -47.69M | -33.24M | -25.45M | -22.71M | -14.00M | Operating Cash Flow |
| -47.58M | -32.38M | -25.22M | -22.57M | -13.93M | Investing Cash Flow |
| -104.19K | -864.04K | -225.97K | -141.36K | -62.35K | Financing Cash Flow |
| 61.41M | 22.94M | 9.61M | 1.25M | 60.55M |
Cellectar Biosciences Technical Analysis
Neutral
0.29
Price Trends
0.31
Negative
0.47
Negative
1.31
Negative
Market Momentum
-0.02
Positive
46.51
Neutral
64.99
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CLRB, the sentiment is Neutral. The current price of 0.29 is below the 20-day moving average (MA) of 0.31, below the 50-day MA of 0.31, and below the 200-day MA of 1.31, indicating a bearish trend. The MACD of -0.02 indicates Positive momentum. The RSI at 46.51 is Neutral, neither overbought nor oversold. The STOCH value of 64.99 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for CLRB.
Cellectar Biosciences Risk Analysis
Cellectar Biosciences disclosed 40 risk factors in its most recent earnings report. Cellectar Biosciences reported the most risks in the “Tech & Innovation” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Cellectar Biosciences Peers Comparison
Overall Rating
UnderperformOutperform
Sector (50)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
51 Neutral | $11.93M | ― | -24.59% | ― | 603.12% | 68.27% | |
50 Neutral | $5.51B | 2.95 | -43.70% | 2.78% | 16.94% | 3.59% | |
44 Neutral | $13.52M | ― | 291.66% | ― | ― | ― | |
42 Neutral | $15.12M | ― | -122.28% | ― | ― | ― | |
35 Underperform | $17.40M | ― | -77.48% | ― | ― | 47.73% | |
34 Underperform | $13.57M | ― | -4693.38% | ― | ― | 56.38% | |
28 Underperform | $14.12M | ― | -462.31% | ― | ― | 56.88% |
* Healthcare Sector Average
Performance Comparison
CLRB
Cellectar Biosciences
0.29
-3.02
-91.24%
CANF
Can-Fite BioPharma
1.26
-0.82
-39.42%
GOVX
GeoVax Labs
0.85
-0.68
-44.44%
AKTX
Akari Therapeutics
1.20
0.04
3.45%
SLGL
Sol-Gel Technologies
0.50
-0.44
-46.81%
ELEV
Elevation Oncology
0.31
-4.08
-92.94%
Cellectar Biosciences Earnings Call Summary
Earnings Call Date: Mar 13, 2025 | % Change Since: -9.38% | Next Earnings Date: May 7, 2025
Earnings Call Sentiment Neutral
The earnings call presented a mixed outlook with significant clinical success and progress in regulatory alignment for iopofosine, alongside financial strengthening efforts. However, these positive aspects were countered by regulatory delays affecting the NDA submission, increased SG&A expenses, strategic restructuring, and compliance challenges with NASDAQ listing requirements.Highlights
Impressive Clinical Outcomes in CLOVER-WaM Study
Iapopacine demonstrated a 98.2% clinical benefit rate, 83.6% overall response rate, and a major response rate of 58.2% in the treatment of relapsed/refractory Waldenstrom's macroglobulinemia.
Regulatory Progress for Iopofosine
Alignment achieved with FDA on the design of a Phase 3 study required for market approval, setting a clear path for NDA submission and market approval.
Financial Strengthening Efforts
Execution of multiple financial transactions, generating $44.1 million from warrant exercise and $19.4 million from inducement financing, increasing cash and cash equivalents to $23.3 million by the end of 2024.
Potential Non-Dilutive Funding and Market Opportunity
Ongoing evaluation of inbound collaborations and licensing deals for iapopacine, driven by its significant market potential.
Pipeline Expansion and Innovation
Advancement of alpha emitter for pancreatic cancer and Auger emitter for triple negative breast cancer, showcasing the versatility of the PDC platform.
Lowlights
Regulatory Setback for NDA Submission
Delay in submission of the new drug application for iopofosine under the accelerated approval process adversely impacted stock price.
Increased SG&A Expenses
Selling, general, and administrative expenses for the full year 2024 were $25.6 million, compared to $11.7 million in the prior year, driven by pre-commercialization initiatives.
Cost-Saving Measures Due to Delays
Implemented a cost savings strategic restructuring, reducing headcount by approximately 60%, to drive savings of approximately $7.5 million annually.
NASDAQ Listing Compliance Challenges
Fell below NASDAQ's continued listing requirements, exploring options including a possible reverse stock split for compliance.
Company Guidance
During the call, Cellectar Biosciences provided guidance on several key metrics and future plans. The company reported a 98.2% clinical benefit rate, an 83.6% overall response rate, and a 58.2% major response rate from their CLOVER-WaM study for iapopacine I-131 in treating relapsed/refractory Waldenstrom's macroglobulinemia (WM). Financially, Cellectar ended 2024 with $23.3 million in cash and equivalents, up from $9.6 million at the end of 2023, and implemented a cost-saving restructuring to extend their cash runway into Q4 2025. They plan to initiate a Phase 3 study for iopofosine, aligning with the FDA on the study design for accelerated approval, estimating the trial to cost $40-$45 million and enroll 100 patients per arm. Additionally, their IND filings for CLR 121225 and CLR 121125 studies are planned, each costing around $4.5 million. They are also exploring non-dilutive funding options and licensing deals to support these initiatives.Cellectar Biosciences Corporate Events
Executive/Board ChangesRegulatory Filings and Compliance
Cellectar Biosciences Enhances CEO and COO Severance Benefits
Neutral
Mar 17, 2025
On March 12, 2025, Cellectar Biosciences’ board approved amendments to the employment agreements of its CEO and COO, enhancing their severance benefits in the event of a change in control. Additionally, on March 11, 2025, the board adopted new by-laws to align with Delaware law, revising stockholder nomination procedures and reducing the quorum requirement for meetings.
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.