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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 49 (OpenAI - 5.2)
Rating:49Neutral
Price Target:
$1.00
▼(-5.66% Downside)
Action:ReiteratedDate:04/15/26
The score is held down primarily by very weak financial performance (pre-revenue losses, significant 2025 leverage deterioration, and negative cash flow indicating heightened funding/liquidity risk). Technicals are supportive with price above major moving averages and a positive MACD, but overbought signals (RSI/Stoch) add near-term risk. Earnings-call updates on FDA-aligned trial changes and encouraging clinical data provide a meaningful offset, while valuation remains unattractive due to negative earnings and no dividend support.
Positive Factors
Durable Clinical Efficacy (PDS0101)
A near-40 month median OS in a recurrent/metastatic head and neck cohort signals a clinically durable benefit versus historical standards. Durable survival benefits strengthen regulatory credibility, commercial differentiation, and the long-term market potential of PDS0101 if Phase 3 confirms these results.
Negative Factors
Severely Deteriorated Balance Sheet
A sudden, extreme increase in leverage dramatically reduces financial flexibility and raises refinancing/default risk. Structural balance sheet strain constrains the firm's ability to fund trials organically and forces reliance on dilutive financings or costly capital, impacting long-term execution.
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Positive Factors
Negative Factors
Durable Clinical Efficacy (PDS0101)
A near-40 month median OS in a recurrent/metastatic head and neck cohort signals a clinically durable benefit versus historical standards. Durable survival benefits strengthen regulatory credibility, commercial differentiation, and the long-term market potential of PDS0101 if Phase 3 confirms these results.
Read all positive factors

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

PDS Biotechnology Business Overview & Revenue Model

Company Description
PDS 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 treat...
How the Company Makes Money
PDS Biotechnology does not generate meaningful recurring revenue from commercial product sales because its lead programs are in clinical development and, to the extent publicly disclosed, it has not reported ongoing product commercialization. Its ...

PDS Biotechnology Earnings Call Summary

Earnings Call Date:Mar 30, 2026
(Q4-2025)
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% Change Since: |
Next Earnings Date:May 20, 2026
Earnings Call Sentiment Positive
The call conveyed meaningful clinical and IP progress — notably strong VERSATILE-002 survival data, promising early PDS01ADC signals, and FDA alignment on a protocol amendment that may accelerate regulatory timelines. Financials showed cost reductions and an improved net loss, but were tempered by a relatively small cash balance, higher net interest expense, and limited disclosure of the revised Phase III sample size and powering details. Overall, the positives around clinical momentum, patent protection into the 2040s, and decreased operating expenses outweigh the financial and execution uncertainties noted.
Positive Updates
Strong Phase II Clinical Results (VERSATILE-002)
VERSATILE-002 showed a median overall survival (OS) of 39.3 months in patients with PD-L1 CPS/TPS ≥1 (95% CI lower bound 23.9 months, upper bound not yet estimable). Management described this as the first recurrent/metastatic head and neck population to report a median OS near 40 months, supporting the durability of PDS0101.
Negative Updates
Limited Cash Balance / Potential Runway Concern
Cash balance as of December 31, 2025 was $26.7M. Management did not provide forward financial guidance or explicit runway assumptions, creating uncertainty about near-term funding needs given upcoming trial activities and reinitiation costs.
Read all updates
Q4-2025 Updates
Negative
Strong Phase II Clinical Results (VERSATILE-002)
VERSATILE-002 showed a median overall survival (OS) of 39.3 months in patients with PD-L1 CPS/TPS ≥1 (95% CI lower bound 23.9 months, upper bound not yet estimable). Management described this as the first recurrent/metastatic head and neck population to report a median OS near 40 months, supporting the durability of PDS0101.
Read all positive updates
Company Guidance
Management said the key guidance was that VERSATILE‑003 has been amended to make progression‑free survival (PFS) an earlier interim primary endpoint after the FDA raised no objections following the standard 30‑day review, driven by VERSATILE‑002 data (n=53) showing a median overall survival of 39.3 months (95% CI 23.9–NE) and robust PFS; the amendment could shorten the trial by as much as ~1 year, with the first PFS readout anticipated in about 1.5 years and two PFS analyses planned (one at completion of recruitment and a second ~6 months later), both powered to detect statistically significant differences (new sample size not disclosed). Management expects brisk enrollment (no sites lost during the pause and strong site interest) and said R&D spend will pick up once the trial restarts but did not provide formal 2026 financial guidance; reported FY2025 results included a net loss of $34.5M ($0.74/share) vs $37.6M ($1.03) in FY2024, R&D $19.0M vs $22.6M, G&A $12.5M vs $13.8M, total operating expenses $31.5M vs $36.3M, net interest expense $4.1M vs $2.2M, and cash of $26.7M at 12/31/2025. Additional clinical/IP metrics noted: PDS01ADC in mCRPC showed median PFS 9.6 months, median PSA decline 40% (6/16 ≥50%), and PDS0101 IP protection extended into the 2040s.

PDS Biotechnology Financial Statement Overview

Summary
Financial profile is weak: the company is essentially pre-revenue with persistent operating losses (roughly ~$15M–$43M in 2020–2024 and ~-$36.8M in 2025). Balance sheet risk increased materially in 2025 with total debt rising to ~$5.19B while equity fell to ~$9.3M (debt-to-equity ~561x). Cash flow is consistently negative with an extreme reported deterioration in 2025 (operating/free cash flow roughly -$27.8B), indicating elevated liquidity and funding risk.
Income Statement
12
Very Negative
Balance Sheet
18
Very Negative
Cash Flow
10
Very Negative
BreakdownDec 2025Dec 2024Dec 2023Dec 2022Mar 2022
Income Statement
Total Revenue0.000.000.000.000.00
Gross Profit-60.52K-59.79K-57.33K0.000.00
EBITDA-30.30M-33.75M-40.09M-40.74M-21.43M
Net Income-34.50M-37.61M-42.94M-40.85M-16.92M
Balance Sheet
Total Assets30.49M45.36M59.39M77.01M67.20M
Cash, Cash Equivalents and Short-Term Investments26.71M41.69M56.56M73.82M65.24M
Total Debt5.19B21.83M23.85M23.47M490.35K
Total Liabilities21.24M26.35M33.26M33.01M3.99M
Stockholders Equity9.25M19.00M26.13M44.00M63.21M
Cash Flow
Free Cash Flow-27.75B-35.06M-33.64M-25.71M-12.49M
Operating Cash Flow-27.75B-35.03M-33.64M-25.71M-12.49M
Investing Cash Flow0.00-29.00K0.000.000.00
Financing Cash Flow12.77B20.19M16.38M34.29M48.89M

PDS Biotechnology Technical Analysis

Technical Analysis Sentiment
Positive
Last Price1.06
Price Trends
50DMA
0.71
Positive
100DMA
0.80
Positive
200DMA
0.95
Positive
Market Momentum
MACD
0.10
Negative
RSI
74.21
Negative
STOCH
91.49
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 1.06 is above the 20-day moving average (MA) of 0.74, above the 50-day MA of 0.71, and above the 200-day MA of 0.95, indicating a bullish trend. The MACD of 0.10 indicates Negative momentum. The RSI at 74.21 is Negative, neither overbought nor oversold. The STOCH value of 91.49 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
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$60.84M-1.18-241.96%29.95%
47
Neutral
$24.99M-2.03-1.04%1.18%
46
Neutral
$30.70M-0.45-310.89%49.43%
43
Neutral
$28.07M-3.81-197.68%78.60%
40
Underperform
$9.85M-3,346.34-526.36%-2.46%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PDSB
PDS Biotechnology
1.06
0.02
1.92%
TPST
Tempest Therapeutics
2.25
-5.00
-68.97%
LTRN
Lantern Pharma
2.33
-1.16
-33.24%
CALC
CalciMedica
0.62
-0.92
-59.68%
SNTI
Senti Biosciences
0.93
-2.91
-75.83%

PDS Biotechnology Corporate Events

Business Operations and StrategyProduct-Related Announcements
PDS Biotech Reports Promising Interim Data in Colorectal Cancer
Positive
Apr 15, 2026
On April 15, 2026, PDS Biotechnology announced that interim data from Stage 1 of a National Cancer Institute-led Phase 2 trial of its tumor-targeted IL-12 immunocytokine PDS01ADC in metastatic colorectal cancer were published in the March 10, 2026...
Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Highlights PDS0101 Data in Updated Presentation
Positive
Feb 23, 2026
On February 23, 2026, PDS Biotechnology updated its corporate presentation, highlighting clinical data from its lead program PDS0101, which targets HPV16-positive head and neck cancers that currently lack approved targeted therapies. The company r...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
PDS Biotechnology Updates VERSATILE-003 Trial for Accelerated Approval
Positive
Feb 20, 2026
On February 20, 2026, PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer, adding progression-free survival as an interim primary endpoint ...
Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Highlights Promising Phase 2 Prostate Cancer Data
Positive
Jan 28, 2026
On January 28, 2026, PDS Biotechnology announced that the National Cancer Institute presented preliminary Phase 2 results for its investigational IL-12 tumor-targeted immunocytokine PDS01ADC at an American Association for Cancer Research conferenc...
Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Secures Key Patent Strengthening PDS0101 Protection
Positive
Jan 22, 2026
On January 22, 2026, PDS Biotechnology announced that the U.S. Patent Office issued a Notice of Allowance for a new U.S. patent covering technology underlying its lead asset PDS0101, a cancer immunotherapy based on the company’s Versamune pl...
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: Apr 15, 2026