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PDS Biotechnology Corporation (PDSB)
NASDAQ:PDSB
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PDS Biotechnology (PDSB) AI Stock Analysis

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PDSB

PDS Biotechnology

(NASDAQ:PDSB)

Rating:50Neutral
Price Target:
PDSB's overall score reflects the typical high-risk, high-reward nature of early-stage biotech firms. The company's strong clinical progress and cash position are significant positives, but financial sustainability and valuation concerns due to ongoing losses and reliance on external funding temper the outlook. Technical indicators suggest some positive momentum, albeit with caution.
Positive Factors
Clinical Trial Progress
The colorectal cancer cohort of the Phase 2 PDS01ADC study met criteria for expansion into Stage 2 following encouraging Stage 1 results.
Market Opportunity
PDS01ADC could represent a significant advancement in solid tumor intervention, while also being a notable commercial and value generating opportunity for PDS and investors.
Therapy Efficacy
The Versamune HPV + pembrolizumab combination exceeds current benchmarks for median overall survival and objective response rates in HPV16+ R/M HNSCC.
Negative Factors
Financial Uncertainty
The need to explore additional funding opportunities may create uncertainty and concern regarding the company's financial health and ability to sustain ongoing operations.
Funding Concerns
The company expressed a need to explore additional funding opportunities to complete select ongoing operations, including the VERSATILE-003 trial.

PDS Biotechnology (PDSB) vs. SPDR S&P 500 ETF (SPY)

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 Earnings Call Summary

Earnings Call Date:Aug 13, 2025
(Q2-2025)
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% Change Since: |
Next Earnings Date:Nov 12, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in clinical trials and promising data in the oncology segment, particularly with the advancement of VERSATILE-003 and positive results from VERSATILE-002. However, financial challenges were noted, including an increased net loss and a decreased cash balance. While the clinical outlook is promising, financial concerns remain a consideration.
Q2-2025 Updates
Positive Updates
Advancement of VERSATILE-003 Phase III Clinical Trial
PDS Biotech continued to advance its VERSATILE-003 Phase III clinical trial, focusing on HPV16-positive head and neck cancer, with a specific design targeting a significant unmet medical need.
Positive Data from VERSATILE-002 Trial
Updated data from the VERSATILE-002 trial demonstrated durable clinical benefit of PDS0101, with median overall survival steady at 30 months, and no new safety signals emerging.
Colorectal Cancer Cohort Expansion
The colorectal cancer cohort of the Phase II clinical trial with PDS01ADC met the criteria for expansion to Stage 2 following promising Stage 1 results, indicating potential for more effective treatments in this difficult-to-treat cancer.
Preclinical Efficacy of Novel Flu Vaccine
Preclinical efficacy and immune response data for a novel universal flu vaccine were featured at the American Association of Immunologists Immunology 2025 Annual Meeting.
Reduction in Operating Expenses
Total operating expenses decreased to $7.6 million compared to $8.7 million for the same period last year, primarily due to lower personnel costs and lower professional fees.
Negative Updates
Increased Net Loss
Net loss increased to approximately $9.4 million for the quarter ended June 30, 2025, compared to $8.3 million for the same period in 2024, primarily due to higher net interest expenses.
Decreased Cash Balance
The cash balance decreased to $31.9 million as of June 30, 2025, compared to $41.7 million as of December 31, 2024, indicating a reduction in available financial resources.
Higher Net Interest Expenses
Net interest expenses increased to $1.8 million for the quarter ended June 30, 2025, compared to $0.5 million for the same period in 2024, primarily due to debt repayment costs.
Company Guidance
During the PDS Biotech Second Quarter 2025 Earnings Conference Call, the management team provided guidance on their clinical programs and financial performance. They highlighted the advancement of the VERSATILE-003 Phase III clinical trial targeting HPV16-positive head and neck cancer, with a trial design that includes approximately 350 patients in a 2:1 randomization between the PDS0101-pembrolizumab combination arm and a pembrolizumab-only control arm. Emphasizing the significance of their approach, they reported that the median overall survival in the VERSATILE-002 trial remained steady at 30 months, and the lower limit of the 95% confidence interval increased to 23.9 months. Financially, PDS Biotech reported a net loss of approximately $9.4 million for Q2 2025, compared to $8.3 million in Q2 2024, with total operating expenses of $7.6 million and a cash balance of $31.9 million as of June 30, 2025. They also announced the expansion of a Phase II trial cohort for metastatic colorectal cancer following promising response rates.

PDS Biotechnology Financial Statement Overview

Summary
PDS Biotechnology's financials are typical of an early-stage biotech firm, with no revenue and ongoing losses due to high R&D costs. The strong cash position provides some immediate liquidity relief, but the negative cash flow and increasing debt highlight the need for future revenue generation. The reliance on external financing is a risk without clear paths to profitability.
Income Statement
15
Very Negative
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.
Balance Sheet
40
Negative
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.
Cash Flow
25
Negative
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue59.07K0.000.000.000.000.00
Gross Profit-15.86K-59.79K-57.33K-49.08K-246.39K-176.29K
EBITDA-33.05M-33.75M-40.09M-40.69M-21.19M-14.67M
Net Income-35.50M-37.61M-42.94M-40.85M-16.92M-14.85M
Balance Sheet
Total Assets47.03M45.36M59.39M77.01M67.20M30.89M
Cash, Cash Equivalents and Short-Term Investments39.98M41.69M56.56M73.82M65.24M28.84M
Total Debt18.96M21.83M23.85M23.47M490.35K610.26K
Total Liabilities24.67M26.35M33.26M33.01M3.99M3.76M
Stockholders Equity22.36M19.00M26.13M44.00M63.21M27.13M
Cash Flow
Free Cash Flow-34.15M-35.06M-33.64M-25.71M-12.49M-13.15M
Operating Cash Flow-34.12M-35.03M-33.64M-25.71M-12.49M-13.15M
Investing Cash Flow-29.00M-29.00K0.000.000.000.00
Financing Cash Flow7.50M20.19M16.38M34.29M48.89M29.83M

PDS Biotechnology Technical Analysis

Technical Analysis Sentiment
Positive
Last Price1.25
Price Trends
50DMA
1.23
Positive
100DMA
1.31
Negative
200DMA
1.46
Negative
Market Momentum
MACD
0.01
Negative
RSI
53.73
Neutral
STOCH
29.17
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PDSB, the sentiment is Positive. The current price of 1.25 is above the 20-day moving average (MA) of 1.19, above the 50-day MA of 1.23, and below the 200-day MA of 1.46, indicating a neutral trend. The MACD of 0.01 indicates Negative momentum. The RSI at 53.73 is Neutral, neither overbought nor oversold. The STOCH value of 29.17 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 3 New Risks
1.
Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness under our venture loan and security agreement with Horizon and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business. Q3, 2022
2.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, an ongoing military conflict between Russia and Ukraine, and record inflation. Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from the conflict in Ukraine, geopolitical tensions, or record inflation. Q3, 2022
3.
Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions. Q3, 2022

PDS Biotechnology Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
61
Neutral
$336.42M3.64108.21%18.01%306.76%
51
Neutral
$7.86B-0.33-41.39%2.23%23.26%-2.03%
50
Neutral
$57.83M-156.16%25.26%
45
Neutral
$59.96M-195.55%-0.11%43.47%
40
Neutral
$72.66M-347.64%-38.31%-36.91%
40
Underperform
$74.19M-45.57%-61.41%
36
Underperform
$42.15M-47.87%18.86%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PDSB
PDS Biotechnology
1.25
-1.76
-58.47%
CTMX
CytomX Therapeutics
2.08
0.83
66.40%
CUE
Cue Biopharma
0.79
0.13
19.70%
STRO
Sutro Biopharma
0.95
-3.33
-77.80%
PMVP
PMV Pharmaceuticals
1.49
-0.02
-1.32%
ACRV
Acrivon Therapeutics, Inc.
1.34
-6.86
-83.66%

PDS Biotechnology Corporate Events

Private Placements and FinancingBusiness Operations and Strategy
PDS Biotechnology Enters $20M Securities Purchase Agreement
Neutral
May 2, 2025

On April 30, 2025, PDS Biotechnology Corporation entered into a Securities Purchase Agreement to sell Senior Secured Convertible Debentures and warrants for a total purchase price of $20 million. The proceeds were used to retire the company’s existing debt under the Horizon Loan, with the remainder allocated for general corporate purposes. This agreement includes restrictions on variable rate transactions and imposes certain financial covenants, impacting the company’s financial strategy and market positioning.

Spark’s Take on PDSB Stock

According to Spark, TipRanks’ AI Analyst, PDSB is a Neutral.

PDSB’s overall score reflects the typical high-risk, high-reward nature of early-stage biotech firms. The company’s strong clinical progress and cash position are significant positives, but financial sustainability and valuation concerns due to ongoing losses and reliance on external funding temper the outlook. Technical indicators suggest some positive momentum, albeit with caution.

To see Spark’s full report on PDSB stock, click here.

Executive/Board ChangesShareholder Meetings
PDS Biotechnology Director Sir Richard Sykes Retires
Neutral
Apr 24, 2025

On April 22, 2025, Sir Richard Sykes, a member of the Board of Directors of PDS Biotechnology Corporation, announced his retirement and decision not to seek re-election at the company’s 2025 Annual Meeting of Stockholders. This change in the board’s composition may impact the company’s strategic direction and governance, potentially influencing its market positioning and stakeholder relations.

Spark’s Take on PDSB Stock

According to Spark, TipRanks’ AI Analyst, PDSB is a Underperform.

PDS Biotechnology’s stock score reflects a challenging financial position typical of early-stage biotech companies, with no revenue and high R&D expenses. Despite a strong cash position, the firm faces significant funding challenges. Technical analysis indicates a bearish trend, while valuation metrics highlight the lack of profitability. The earnings call provided some positive developments, such as promising trial results and fundraising, but also underscored financial challenges, balancing the overall outlook.

To see Spark’s full report on PDSB stock, click here.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

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.Date of analysis: May 01, 2025