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PDS Biotechnology Corporation (PDSB)
NASDAQ:PDSB

PDS Biotechnology (PDSB) AI Stock Analysis

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PDSB

PDS Biotechnology

(NASDAQ:PDSB)

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Neutral 51 (OpenAI - 5.2)
Rating:51Neutral
Price Target:
$1.00
▲(0.81% Upside)
The score is held down primarily by weak financial performance (no revenue, ongoing losses, substantial cash burn, and a reduced equity base versus debt). Partially offsetting this are moderately improving technical momentum and generally positive clinical/regulatory updates from the earnings call and recent corporate events, though funding and trial-timing risks remain key.
Positive Factors
Strong Phase 2 efficacy (VERSATILE-002)
Robust mOS in VERSATILE-002 versus historical controls provides durable clinical proof-of-concept for PDS0101. Strong survival data supports regulatory discussions, partnership interest, and long-term commercial positioning in HPV16 HNSCC, reducing scientific risk through late-stage development.
Regulatory pathway advancement (PFS amendment)
Amending VERSATILE-003 to use PFS as a primary endpoint can materially shorten time to an approvable signal, lowering development duration and costs. Structurally this could de‑risk the timeline to market and improve cash efficiency, even while mOS remains the full approval endpoint.
Strengthened intellectual property
New composition‑of‑matter and methods patents in Japan extend global exclusivity into the 2040s. Durable IP protection enhances long‑term commercial upside, supports licensing/partnering leverage, and deters generic competition across key markets for a future approved product.
Negative Factors
No product revenue, persistent losses
Zero revenue and substantial recurring operating losses mean ongoing reliance on external capital. Over multiple quarters this structurally increases dilution and constrains strategic choices, forcing prioritization of programs and potentially slowing development absent durable funding or partner revenue streams.
Eroded equity base and material debt
Sharply reduced equity alongside meaningful debt weakens financial flexibility and increases leverage risk. Structurally this limits capacity to absorb trial delays or fund expansions, heightens refinancing needs, and may force dilutive financings or unfavorable terms with partners or lenders.
High cash burn and funding dependence
Rapid depletion of cash and reliance on equity financings are durable operational risks. Continuous burn pressures runway, increases likelihood of further dilution, and can delay trials or regulatory activities if new capital is slow or costly, constraining long‑term program execution.

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:Nov 13, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 26, 2026
Earnings Call Sentiment Neutral
The earnings call presents a balanced view with significant achievements in clinical trial progress and strategic amendments to enhance regulatory approval processes. However, financial challenges and a temporary trial pause highlight ongoing operational and funding hurdles.
Q3-2025 Updates
Positive Updates
Completion of VERSATILE-002 Trial
The VERSATILE-002 trial was completed, showing a median overall survival of 39.3 months for patients with HPV16 positive head and neck cancer, significantly higher than historical data.
Amendment to VERSATILE-003 Trial
A strategic decision was made to amend the VERSATILE-003 trial to include progression-free survival as a primary endpoint, potentially accelerating regulatory submission.
Positive Financial Adjustments
The net loss decreased to $9 million from $10.7 million in the prior year, primarily due to lower operating expenses.
Industry Recognition and External Validation
PDS Biotechnology's approach was validated by multiple clinical investigators and institutions, with significant interest in the rapidly growing HPV16 positive head and neck cancer market.
Negative Updates
Challenges in Funding
The cash balance decreased from $41.7 million at the beginning of the year to $26.2 million as of September 30, 2025, although additional funds were raised through the sale of common stock and warrants.
Trial Protocol Pause
The VERSATILE-003 trial was temporarily paused to discuss protocol amendments with the FDA, potentially delaying progress.
Increased Net Interest Expense
Net interest expense increased from $500,000 to $900,000 due to lower interest income from cash deposits.
Company Guidance
During the call, PDS Biotechnology Corporation provided guidance on their clinical trials and financial performance. They announced the completion of the VERSATILE-002 trial, highlighting a median overall survival (MOS) of 39.3 months for patients with a combined positive score (CPS) of ≥1, and a progression-free survival (PFS) of 10.3 months in the same group. The decision to amend the VERSATILE-003 trial to include PFS as a primary endpoint alongside MOS was discussed, with a meeting requested with the FDA to finalize this amendment. Financially, the company reported a net loss of $9 million for Q3 2025, a decrease from the previous year's $10.7 million, attributed to lower operating expenses. They closed the quarter with a cash balance of $26.2 million, down from $41.7 million at the start of the year.

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
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
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
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 Revenue0.000.000.000.000.000.00
Gross Profit-15.13K-59.79K-57.33K0.000.000.00
EBITDA-30.71M-33.75M-40.09M-40.74M-21.43M-14.89M
Net Income-34.88M-37.61M-42.94M-40.85M-16.92M-14.85M
Balance Sheet
Total Assets34.71M45.36M59.39M77.01M67.20M30.89M
Cash, Cash Equivalents and Short-Term Investments26.20M41.69M56.56M73.82M65.24M28.84M
Total Debt17.97M21.83M23.85M23.47M490.35K610.26K
Total Liabilities25.25M26.35M33.26M33.01M3.99M3.76M
Stockholders Equity9.45M19.00M26.13M44.00M63.21M27.13M
Cash Flow
Free Cash Flow-32.28M-35.06M-33.64M-25.71M-12.49M-13.15M
Operating Cash Flow-32.28M-35.03M-33.64M-25.71M-12.49M-13.15M
Investing Cash Flow0.00-29.00K0.000.000.000.00
Financing Cash Flow8.73M20.19M16.38M34.29M48.89M29.83M

PDS Biotechnology Technical Analysis

Technical Analysis Sentiment
Positive
Last Price0.99
Price Trends
50DMA
0.88
Positive
100DMA
0.98
Positive
200DMA
1.14
Negative
Market Momentum
MACD
<0.01
Negative
RSI
60.84
Neutral
STOCH
83.36
Negative
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 0.99 is above the 20-day moving average (MA) of 0.90, above the 50-day MA of 0.88, and below the 200-day MA of 1.14, indicating a neutral trend. The MACD of <0.01 indicates Negative momentum. The RSI at 60.84 is Neutral, neither overbought nor oversold. The STOCH value of 83.36 is Negative, 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 0 New Risks

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
52
Neutral
$38.14M-1.93-104.58%1.18%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$52.15M-1.21-221.81%29.95%
51
Neutral
$83.29M-3.32-526.36%-2.46%
48
Neutral
$145.36M-2.06-4.76%8.09%
48
Neutral
$30.23M-0.32-394.62%78.60%
43
Neutral
$13.85M-0.29-405.03%49.43%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PDSB
PDS Biotechnology
0.99
-0.42
-29.57%
TPST
Tempest Therapeutics
2.88
-9.46
-76.66%
MRSN
Mersana Therapeutics
29.08
11.08
61.56%
LTRN
Lantern Pharma
3.39
-0.50
-12.85%
CALC
CalciMedica
5.33
2.31
76.49%
SNTI
Senti Biosciences
1.08
-2.85
-72.52%

PDS Biotechnology Corporate Events

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
PDS Biotechnology Updates Phase 3 Trial Design for PDS0101
Positive
Jan 9, 2026

On January 9, 2026, PDS Biotechnology announced it had submitted a protocol amendment to the U.S. Food and Drug Administration for its Phase 3 VERSATILE-003 trial of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer, following a constructive Type C meeting with the agency in December 2025. The amendment designates progression-free survival as the primary endpoint that can be evaluated earlier, potentially shortening trial duration and supporting an accelerated approval pathway, while median overall survival and safety remain key requirements for full approval, a move underpinned by positive final results from the earlier VERSATILE-002 study showing promising survival and durable progression-free outcomes.

The most recent analyst rating on (PDSB) stock is a Hold with a $0.80 price target. To see the full list of analyst forecasts on PDS Biotechnology stock, see the PDSB Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Secures New Patent for PDS0101
Positive
Dec 9, 2025

On December 9, 2025, PDS Biotechnology Corporation announced that the Japan Patent Office issued a new patent for PDS0101, expanding its intellectual property estate. This development strengthens the company’s global IP portfolio, providing patent and market protections for PDS0101 into the 2040s, and supports the company’s growth as it advances its pipeline worldwide.

The most recent analyst rating on (PDSB) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on PDS Biotechnology stock, see the PDSB Stock Forecast page.

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
PDS Biotechnology Gains FDA Meeting for PDS0101 Approval
Positive
Dec 2, 2025

On December 2, 2025, PDS Biotechnology announced that the FDA accepted its request for a Type C Meeting to discuss an accelerated approval pathway for its PDS0101 treatment in HPV16-positive head and neck cancer. This meeting, scheduled for December 2025, aims to explore amendments to the Phase 3 VERSATILE-003 trial, potentially expediting the treatment’s availability to patients based on positive results from the VERSATILE-002 trial.

The most recent analyst rating on (PDSB) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on PDS Biotechnology stock, see the PDSB Stock Forecast page.

Business Operations and StrategyPrivate Placements and Financing
PDS Biotechnology Announces $11.1M Securities Purchase Agreement
Neutral
Nov 12, 2025

On November 11, 2025, PDS Biotechnology Corporation announced a securities purchase agreement to raise up to $11.1 million through the sale of common stock and warrants, with the offering expected to close on November 12, 2025. The proceeds will support the company’s ongoing VERSATILE-003 Phase 3 clinical trial and other research and development activities, potentially impacting its operational capabilities and market position.

The most recent analyst rating on (PDSB) stock is a Buy with a $5.00 price target. To see the full list of analyst forecasts on PDS Biotechnology stock, see the PDSB Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Announces Positive Data at Cancer Meeting
Positive
Nov 10, 2025

On November 10, 2025, PDS Biotechnology Corporation announced positive clinical and translational data at the 2025 Society for Immunotherapy of Cancer Annual Meeting. The data showcased immune-driven mechanisms and biomarkers explaining the strong clinical activity of their investigational therapies PDS0101 and PDS01ADC. These findings, part of a collaboration with the National Cancer Institute, highlight the therapies’ ability to activate immune responses, including natural killer and memory T cells, which are crucial for long-term tumor control. The results support the company’s regulatory strategy and ongoing clinical trials, reinforcing the scientific foundation of their immunotherapy platforms.

The most recent analyst rating on (PDSB) stock is a Buy with a $5.00 price target. To see the full list of analyst forecasts on PDS Biotechnology stock, see the PDSB Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Seeks FDA Meeting for PDS0101 Approval
Positive
Oct 29, 2025

On October 29, 2025, PDS Biotechnology announced its request for a meeting with the FDA to explore an expedited approval pathway for its immunotherapy drug PDS0101, targeting HPV16-positive head and neck cancer. This decision follows promising results from the VERSATILE-002 trial, showing significant median progression-free and overall survival rates, and aims to amend the ongoing VERSATILE-003 trial to include progression-free survival as an earlier primary endpoint. This strategic move could potentially accelerate the drug’s availability to patients, positioning PDS Biotechnology as a leader in providing innovative cancer treatments.

The most recent analyst rating on (PDSB) stock is a Buy with a $5.00 price target. To see the full list of analyst forecasts on PDS Biotechnology stock, see the PDSB Stock Forecast page.

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: Jan 09, 2026