Education
About Us
Working with TipRanks
Follow Us
PDS Biotechnology Corporation (PDSB)
NASDAQ:PDSB
Top Page
PDS Biotechnology
(NASDAQ:PDSB)
42Neutral
Positive Factors
Clinical Trial Progress
The company announced the start of its Phase 3 VERSATILE-003 study, a pivotal trial to evaluate the safety and efficacy of Versamune HPV in combination with pembrolizumab as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma.
Clinical Trial Results
The combination therapy in VERSATILE-002 appeared to provide a clear clinical benefit, particularly in terms of objective response rate and survival metrics, potentially positioning the therapy to become the first HPV targeted immunotherapy for HNSCC.
Regulatory Approval
The FDA recently announced clearance of an IND application to investigate the combination of Versamune MUC1 and PDS01ADC in MUC1-positive advanced colorectal carcinoma.
Negative Factors
Financial Needs
The company expressed a need to explore additional funding opportunities to complete select ongoing operations, including the VERSATILE-003 trial.
PDS Biotechnology (PDSB) vs. S&P 500 (SPY)
Market Cap
$49.03M
Dividend YieldN/A
Average Volume (3M)1.02M
Price to Earnings (P/E)―
Beta (1Y)2.49
Revenue GrowthN/A
EPS Growth25.51%
CountryUS
Employees25
SectorHealthcare
Sector Strength78
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.03
Shares Outstanding45,395,850
10 Day Avg. Volume299,297
30 Day Avg. Volume1,021,490
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)-1.60
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
$8.75Price Target Upside733.33% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
PDS Biotechnology Business Overview & Revenue Model
Company DescriptionPDS Biotechnology Corporation, a clinical-stage biopharmaceutical company, focuses on developing multifunctional cancer immunotherapies. Its lead product candidate is PDS0101 (HPV16), which is in Phase II clinical trial provides a first line treatment for the recurrent/metastatic head and neck cancer, human papillomavirus associated malignancies, and cervical cancer. The company is also developing various product candidates, which are in preclinical trials, including PDS0102 T-cell receptor gamma alternate reading frame protein (TARP) for treating prostate and breast cancers; PDS0103 (MUC-1) for ovarian, colorectal, lung, and breast cancers; and PDS0104, which include Tyrosinase-related protein 2 for the treatment of melanoma. In addition, it is developing PDS0201 for treating tuberculosis; PDS0202, an influenza vaccine candidate; and PDS0203, a vaccine for the prevention of COVID-19. The company has a license and collaboration agreements with National Institutes of Health, Merck Eprova AG, The U.S. Department of Health and Human Services, and MSD International GmbH. PDS Biotechnology Corporation was founded in 2005 and is based in Florham Park, New Jersey.
How the Company Makes MoneyPDS Biotechnology primarily generates revenue through strategic partnerships, collaborations, and licensing agreements with larger pharmaceutical companies and research institutions. These partnerships often involve milestone payments and royalties based on the development and commercialization of their Versamune®-based products. Additionally, the company may receive funding from government grants and research subsidies aimed at supporting advancements in cancer immunotherapy and vaccine development. As a clinical-stage company, PDS Biotech is still in the process of moving its products through clinical trials, with the potential for future revenue from product sales upon successful market approval.
PDS Biotechnology Financial Statement Overview
Summary
PDS Biotechnology's financial performance is typical of an early-stage biotech with no revenue and significant R&D expenditures. Its strong cash position provides a buffer, but ongoing negative cash flow and increasing leverage pose financial risks.Income Statement
PDS Biotechnology has reported no revenue over the last several years, indicating that the company is still in the development phase common to biotech firms. The absence of revenue and persistent negative EBIT and net income show ongoing operational losses. This is typical for biotech companies in early stages, but it poses significant financial risks if such trends continue without the introduction of revenue-generating products.15
Very Negative
Balance Sheet
The company's balance sheet shows a relatively strong cash position with significant cash and short-term investments exceeding total debt, resulting in negative net debt, which is a positive indicator of liquidity. However, the equity has been declining due to ongoing losses, and the debt-to-equity ratio has increased over time, indicating rising leverage. The company’s equity ratio remains positive, reflecting more assets funded by equity than debt, but the trend suggests potential future financial strain.40
Negative
Cash Flow
Free cash flow is consistently negative, reflecting high cash burn typical of biotech firms without revenue. Operating cash flow is negative and significantly exceeds net income, suggesting that operational activities consume more cash than they generate. The reliance on financing activities for cash flow stability poses a risk if external funding becomes less accessible.25
Negative
| Breakdown | |||||
| TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| -43.94K | 0.00 | -57.33K | -49.08K | -246.39K | -176.29K | EBIT |
| -39.37M | -36.32B | -43.05M | -41.67M | -21.44M | -14.90M | EBITDA |
| -36.61M | -36.32B | -40.08M | -41.62M | -21.19M | -14.67M | Net Income Common Stockholders |
| -40.56M | -39.35B | -42.94M | -40.85M | -16.92M | -14.85M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 130.19M | 41.69B | 56.56M | 73.82M | 65.24M | 28.84M | Total Assets |
| 134.09M | 45.36B | 59.39M | 77.01M | 67.20M | 30.89M | Total Debt |
| 5.30M | 12.62B | 23.85M | 23.47M | 490.35K | 610.26K | Net Debt |
| -124.89M | -29.07B | -32.71M | -50.35M | -64.75M | -28.23M | Total Liabilities |
| 11.62M | 26.35B | 33.26M | 33.01M | 3.99M | 3.76M | Stockholders Equity |
| 122.48M | 19.00B | 26.13M | 44.00M | 63.21M | 27.13M |
| Cash Flow | Free Cash Flow | ||||
| -35.28M | -35.03B | -33.64M | -25.71M | -12.49M | -13.15M | Operating Cash Flow |
| -35.25M | -35.03B | -33.64M | -25.71M | -12.49M | -13.15M | Investing Cash Flow |
| -29.00K | -29.00M | 0.00 | 0.00 | 0.00 | 0.00 | Financing Cash Flow |
| 30.78M | 20.19B | 16.38M | 34.29M | 48.89M | 29.83M |
PDS Biotechnology Technical Analysis
Negative
1.05
Price Trends
1.37
Negative
1.68
Negative
2.49
Negative
Market Momentum
-0.05
Positive
34.26
Neutral
14.51
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PDSB, the sentiment is Negative. The current price of 1.05 is below the 20-day moving average (MA) of 1.25, below the 50-day MA of 1.37, and below the 200-day MA of 2.49, indicating a bearish trend. The MACD of -0.05 indicates Positive momentum. The RSI at 34.26 is Neutral, neither overbought nor oversold. The STOCH value of 14.51 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for PDSB.
PDS Biotechnology Risk Analysis
PDS Biotechnology disclosed 52 risk factors in its most recent earnings report. PDS Biotechnology 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
PDS Biotechnology Peers Comparison
Overall Rating
UnderperformOutperform
Sector (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
50 Neutral | $118.60M | ― | -124.10% | ― | 9.22% | 60.01% | |
48 Neutral | $6.86B | 1.11 | -50.22% | 2.47% | 16.71% | 1.53% | |
46 Neutral | $63.99M | ― | -273.36% | ― | 194.23% | 45.50% | |
43 Neutral | $2.58B | ― | -74.17% | ― | ― | -43.10% | |
42 Neutral | $49.03M | ― | -166.65% | ― | ― | 25.51% | |
42 Neutral | $86.76M | ― | -54.21% | ― | -78.55% | -0.92% | |
41 Neutral | $297.65M | ― | -55.13% | ― | -86.25% | 36.10% |
* Healthcare Sector Average
Performance Comparison
PDSB
PDS Biotechnology
1.05
-2.24
-68.09%
NKTR
Nektar Therapeutics
0.60
-0.72
-54.55%
FATE
Fate Therapeutics
0.68
-6.29
-90.24%
ADAP
Adaptimmune Therapeutics
0.32
-1.03
-76.30%
ALLO
Allogene Therapeutics
1.38
-2.67
-65.93%
IMVT
Immunovant
15.78
-15.06
-48.83%
PDS Biotechnology Earnings Call Summary
Earnings Call Date: Mar 27, 2025 | % Change Since: -15.32% | Next Earnings Date: May 14, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted several significant achievements, including the initiation of a pivotal Phase 3 trial and promising Phase 2 results, as well as successful fundraising efforts. However, challenges such as increased net interest expenses and the need for further capital to complete the trial were noted, indicating a balanced outlook.Highlights
Initiation of VERSATILE-003 Phase 3 Clinical Trial
PDS Biotech initiated the VERSATILE-003 Phase 3 clinical trial for first line recurrent and/or metastatic HPV16-positive head and neck squamous cell carcinoma. The trial involves approximately 350 patients and aims to demonstrate the efficacy of Versamune HPV + pembrolizumab.
Promising Results from VERSATILE-002 Phase 2 Study
The VERSATILE-002 Phase 2 study showed a median overall survival of 30 months, an objective response rate improvement from 26% to 36%, and a disease control rate improvement from 70% to 77%.
FDA Clearance for MUC1 IND Application
FDA cleared the IND application for the combination of Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer, representing a significant development for PDS Biotech.
Decreased Net Loss for 2024
Net loss for 2024 was $37.6 million, down from $42.9 million in 2023, primarily due to decreased operating expenses.
Successful Fundraising
PDS Biotech completed an up to $22 million registered direct offering, with $11 million upfront and potential for an additional $11 million from warrant exercises.
Lowlights
Increased Net Interest Expense
Net interest expense for 2024 increased to $2.2 million from $1.3 million in 2023 due to increased debt interest and lower interest income.
Funding Challenges
The current funding environment is challenging, and the company does not have enough funding to complete the Phase 3 trial, necessitating stepwise capital raising.
Company Guidance
During the PDS Biotech Fourth Quarter and Full Year 2024 Earnings Conference Call, the management team provided insights into their clinical and financial progress. They highlighted the initiation of the VERSATILE-003 Phase 3 clinical trial for HPV16-positive head and neck cancer, with a design including 350 patients and a 2:1 randomization. The trial aims to improve upon the median overall survival of 17.9 months seen with pembrolizumab alone, with past data showing a median overall survival of 30 months for their combination therapy. Key metrics from the VERSATILE-002 Phase 2 trial show improvements such as a 36% objective response rate, a 77% disease control rate, and a 21% complete or near-complete response rate. Financially, the company reported a net loss of $37.6 million for 2024, down from $42.9 million in 2023, primarily due to decreased operating expenses. The company also raised $11 million in a direct offering and plans further funding to support the VERSATILE-003 trial.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.