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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)

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Neutral 47 (OpenAI - 5.2)
Rating:47Neutral
Price Target:
$1.00
▼(-23.66% Downside)
Action:ReiteratedDate:05/02/26
The score is held down primarily by weak financial performance (pre-revenue, sustained losses, negative cash flow) and a materially riskier balance sheet in the latest period. Technicals are mixed but not strongly bearish, and the earnings call added support via meaningful clinical/regulatory progress, though near-term funding and execution risks remain.
Positive Factors
Clinical efficacy / proof-of-concept
Robust Phase II survival (median OS ~39.3 months) provides durable proof-of-concept for PDS0101 versus current standards. This clinical signal materially improves the probability of Phase III success, supports differentiation in HPV16+ HNSCC, and underpins long-term commercial and partnership value if replicated.
Negative Factors
Balance sheet leverage
A sudden and extreme rise in debt alongside collapse of equity creates acute solvency risk and sharply reduces financial flexibility. Such leverage constrains the firm's ability to fund clinical programs without onerous refinancing or dilution, increasing long-term execution and survival risk.
Read all positive and negative factors
Positive Factors
Negative Factors
Clinical efficacy / proof-of-concept
Robust Phase II survival (median OS ~39.3 months) provides durable proof-of-concept for PDS0101 versus current standards. This clinical signal materially improves the probability of Phase III success, supports differentiation in HPV16+ HNSCC, and underpins long-term commercial and partnership value if replicated.
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
Financials reflect a high-risk, pre-revenue biotech profile: essentially no revenue, persistent net losses, and consistently negative operating/free cash flow. The balance sheet shows a sharp deterioration in the latest period with extremely high leverage and very low equity, materially increasing solvency and liquidity 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 Price1.31
Price Trends
50DMA
0.74
Positive
100DMA
0.81
Positive
200DMA
0.95
Positive
Market Momentum
MACD
0.16
Negative
RSI
76.50
Negative
STOCH
88.96
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 1.31 is above the 20-day moving average (MA) of 0.84, above the 50-day MA of 0.74, and above the 200-day MA of 0.95, indicating a bullish trend. The MACD of 0.16 indicates Negative momentum. The RSI at 76.50 is Negative, neither overbought nor oversold. The STOCH value of 88.96 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%
48
Neutral
$28.54M-0.45-309.60%65.02%
47
Neutral
$69.77M-1.18-241.96%27.64%
45
Neutral
$23.74M-2.03-1.04%18.69%
41
Neutral
$30.70M-0.40-322.42%73.56%
40
Underperform
$9.90M-2,298.43-526.36%-66.83%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PDSB
PDS Biotechnology
1.25
-0.04
-3.10%
TPST
Tempest Therapeutics
1.99
-4.88
-71.03%
LTRN
Lantern Pharma
2.10
-2.01
-48.91%
CALC
CalciMedica
0.63
-1.38
-68.71%
SNTI
Senti Biosciences
0.99
-2.28
-69.79%

PDS Biotechnology Corporate Events

Business Operations and StrategyPrivate Placements and Financing
PDS Biotechnology Refinances Debt with New Note, Warrant
Positive
May 1, 2026
On April 30, 2026, PDS Biotechnology entered into a securities purchase agreement with YA II PN, LTD. under which it will issue a $6 million promissory note, sold at a discount, and a warrant for up to 2,158,274 common shares at $1.1824 per share,...
Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Highlights Progress in Versamune Oncology Pipeline
Positive
Apr 24, 2026
On April 24, 2026, PDS Biotechnology updated its corporate presentation, highlighting the advancement of its Versamune-based oncology pipeline led by PDS0101 for HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma. The com...
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 ...
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 02, 2026