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PDS Biotechnology
(NASDAQ:PDSB)
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Rating:51Neutral
Price Target:
$0.97
â–²(338.64% Upside)
Action:Reiterated
Date:10/22/26
Overall score is held down primarily by weak financial performance (no revenue, sustained cash burn, and a sharply worsened TTM balance sheet with negative equity and high debt). Technicals are mixed but not broken, and corporate events provide a meaningful positive offset through stronger clinical momentum and financing/debt actions. Valuation provides limited support due to negative earnings and no dividend.
Positive Factors
PDS0301 Clinical Progress
Encouraging Phase 2 results give PDS0301 a potentially differentiated position in difficult-to-treat metastatic colorectal cancer, particularly where immunotherapies have struggled. The data support advancement toward a registrational Phase 3 program and may improve the company’s ability to attract partners or funding.
Negative Factors
No Product Revenue
Without approved products or recurring sales, PDS remains dependent on financing, collaborations, licensing arrangements, and milestone receipts to fund operations. This makes revenue generation highly uncertain over the next several quarters and leaves the business reliant on successful clinical and partnering outcomes.
Read all positive and negative factors
Positive Factors
Negative Factors
PDS0301 Clinical Progress
Encouraging Phase 2 results give PDS0301 a potentially differentiated position in difficult-to-treat metastatic colorectal cancer, particularly where immunotherapies have struggled. The data support advancement toward a registrational Phase 3 program and may improve the company’s ability to attract partners or funding.
Read all positive factors
PDS Biotechnology (PDSB) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$100.86M
Dividend YieldN/A
Average Volume (3M)33.82M
Price to Earnings (P/E)―
Beta (1Y)3.00
Revenue GrowthN/A
EPS Growth30.16%
CountryUS
Employees21
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.64
Shares Outstanding105,005,430
10 Day Avg. Volume9,766,944
30 Day Avg. Volume33,818,961
Financial Highlights & Ratios
PEG Ratio0.04
Price to Book (P/B)3.86
Price to Sales (P/S)0.00
P/FCF Ratio-1.29
Enterprise Value/Market Cap0.47
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-1.76
Forecast
1Y Price Target
$5.00Price Target Upside2172.73% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering1
EPS Forecast (FY)-0.45
Revenue Forecast (FY)N/A
PDS Biotechnology Business Overview & Revenue Model
Company Description
PDS Biotechnology Corporation is a clinical-stage biopharmaceutical firm dedicated to advancing innovative, multi-functional immunotherapies to combat cancer. Its primary drug candidate, PDS0101 (HPV16), is currently undergoing Phase II clinical t...
How the Company Makes Money
PDS Biotechnology is a clinical-stage company and does not have recurring product sales from approved therapies (null). Its revenue, when recognized, primarily comes from collaborations, strategic partnerships, and related arrangements such as lic...
PDS Biotechnology Earnings Call Summary
Earnings Call Date:May 13, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Nov 12, 2026
Earnings Call Sentiment Positive
The call conveyed meaningful clinical and intellectual property progress: a strategic protocol amendment for VERSATILE-003 that reduces patient count (~28.6%) and time to an interim readout, peer-reviewed and encouraging clinical data for PDS01ADC, strengthened IP extending PDS0101 protection into the 2040s, and established manufacturing processes. Financially, operating expenses and net loss improved year-over-year. Key risks include a relatively modest cash balance ($21.7M), continued unprofitability with rising interest expense, the need for OS data for full approval and additional confirmatory trials, and competition in the HPV16 head and neck space. On balance, the operational and clinical positives outweigh the near-term financial and development risks.Positive Updates
Protocol amendment for VERSATILE-003 to enable faster path to approval
Amended trial to add progression-free survival (PFS) as an interim co-primary endpoint while retaining overall survival (OS) for full approval; randomization changed from 2:1 to 1:1 and planned enrollment reduced from ~350 to ~250 patients (≈28.6% reduction), expected to shorten duration and lower trial costs and time to an interim readout.
Negative Updates
Cash balance and potential runway considerations
Cash on hand was $21.7M as of March 31, 2026; management did not provide explicit runway or guidance on financing needs, which could raise near-term funding questions given ongoing late-stage and development activities.
Read all updates
Q1-2026 Updates
Positive
Negative
Protocol amendment for VERSATILE-003 to enable faster path to approval
Amended trial to add progression-free survival (PFS) as an interim co-primary endpoint while retaining overall survival (OS) for full approval; randomization changed from 2:1 to 1:1 and planned enrollment reduced from ~350 to ~250 patients (≈28.6% reduction), expected to shorten duration and lower trial costs and time to an interim readout.
Read all positive updates
Company Guidance
Management guided that the VERSATILE‑003 amendment adopts progression‑free survival as an interim co‑primary endpoint (retaining overall survival for full approval) to enable a potential accelerated approval, changes randomization from 2:1 to 1:1 and reduces planned enrollment from ~350 to ~250 patients to shorten duration, lower external and internal costs and speed an interim readout (sites remained engaged and enrollment is restarting); they reiterated PDS0101’s differentiators (only late‑stage HPV16 HNSCC regimen that is subcutaneous and requires just five doses) and noted new U.S. and Japanese patents extending PDS0101 market protection into the 2040s. Financial metrics include cash of $21.7M as of March 31, 2026, a Q1 net loss of ~$7.3M ($0.13 per share) versus $8.5M ($0.21) year‑ago, R&D of $3.5M (vs $5.8M), G&A of $3.1M (vs $3.3M), total operating expenses of $6.5M (vs $9.1M) and net interest expense of $0.8M (vs $0.6M); operational guidance also highlighted an established Versamune manufacturing process with CMC validation/scale‑up ahead of a BLA and that PDS01ADC data (JCO Oncology Advances, NCI/AACR) support advancement—colorectal Stage 2 is fully enrolled with additional data expected by year‑end.PDS Biotechnology Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
6
Very Negative
Cash Flow
9
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Mar 2022 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | -59.79K | -57.33K | 0.00 | 0.00 |
| EBITDA | -27.10M | -30.30M | -12.69M | -40.08M | -40.74M | -21.43M |
| Net Income | -33.67M | -34.50M | -37.61M | -42.94M | -40.85M | -16.92M |
Balance Sheet | ||||||
| Total Assets | 8.81M | 30.49M | 45.36M | 59.39M | 77.01M | 67.20M |
| Cash, Cash Equivalents and Short-Term Investments | 5.60M | 26.71M | 41.69M | 56.56M | 73.82M | 65.24M |
| Total Debt | 4.36M | 16.93M | 21.83M | 23.85M | 23.47M | 490.35K |
| Total Liabilities | 12.39M | 21.24M | 26.35M | 33.26M | 33.01M | 3.99M |
| Stockholders Equity | -3.58M | 9.25M | 19.00M | 26.13M | 44.00M | 63.21M |
Cash Flow | ||||||
| Free Cash Flow | -16.78M | -27.75M | -35.06M | -33.64M | -25.71M | -12.49M |
| Operating Cash Flow | -16.78M | -27.75M | -35.03M | -33.64M | -25.71M | -12.49M |
| Investing Cash Flow | 0.00 | 0.00 | -29.00K | 0.00 | 0.00 | 0.00 |
| Financing Cash Flow | -9.49M | 12.77M | 20.19M | 16.38M | 34.29M | 48.89M |
PDS Biotechnology Technical Analysis
Positive
0.22
Price Trends
0.65
Positive
0.75
Positive
0.82
Positive
Market Momentum
0.14
Positive
57.86
Neutral
15.13
Positive
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 0.22 is below the 20-day moving average (MA) of 1.05, below the 50-day MA of 0.65, and below the 200-day MA of 0.82, indicating a bullish trend. The MACD of 0.14 indicates Positive momentum. The RSI at 57.86 is Neutral, neither overbought nor oversold. The STOCH value of 15.13 is Positive, 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
UnderperformOutperform
Sector (51)
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% | |
51 Neutral | $100.86M | -1.94 | -708.20% | ― | ― | 30.16% | |
42 Neutral | $9.73M | -0.12 | -1270.11% | ― | ― | 69.34% | |
42 Neutral | $7.85M | -0.17 | 3398.40% | ― | ― | 15.37% | |
41 Neutral | $9.80M | -0.42 | -456.35% | ― | ― | 9.68% | |
40 Underperform | $6.77M | -0.12 | -1539.97% | ― | ― | 80.28% |
* Healthcare Sector Average
PDSB
PDS Biotechnology
1.24
0.32
34.93%
TPST
Tempest Therapeutics
0.53
-9.79
-94.88%
LTRN
Lantern Pharma
0.68
-3.02
-81.51%
CALC
CalciMedica
1.15
-14.20
-92.51%
SNTI
Senti Biosciences
0.22
-1.78
-89.15%
PDS Biotechnology Corporate Events
Business Operations and StrategyExecutive/Board ChangesPrivate Placements and FinancingProduct-Related Announcements
PDS Biotechnology highlights oncology pipeline and PDS0301 progress
Positive
Oct 21, 2026
On October 20, 2026, PDS Biotechnology updated its corporate presentation to highlight progress in its oncology pipeline and strategic refocus around PDS0301, a proprietary IL-12 immunocytokine. In an NCI-led Phase 2 trial in microsatellite stable...
Business Operations and StrategyExecutive/Board Changes
PDS Biotechnology Reshapes Board with New Director Appointments
Positive
Oct 20, 2026
On October 18, 2026, four directors—Kamil Ali-Jackson, Stephen Glover, Gregory Freitag and Otis Brawley—resigned from PDS Biotechnology’s board, with the company stating the departures did not stem from disagreements over its ope...
Business Operations and StrategyProduct-Related Announcements
PDS Biotechnology Highlights PDS0301 Data in KOL Event
Positive
Oct 6, 2026
On October 6, 2026, PDS Biotechnology announced it will host a virtual key opinion leader event on October 15, 2026, featuring National Cancer Institute surgical oncologist Jonathan M. Hernandez, M.D. The session will review clinical outcomes from...
Business Operations and StrategyPrivate Placements and FinancingProduct-Related Announcements
PDS Biotech highlights strong Phase 2 PDS0101 results
Positive
Sep 22, 2026
On September 22, 2026, PDS Biotechnology reported that results from its VERSATILE-002 Phase 2 trial of HPV16-targeted immunotherapy PDS0101 plus pembrolizumab in recurrent or metastatic head and neck cancer were published in JAMA Oncology on Septe...
Business Operations and StrategyExecutive/Board ChangesPrivate Placements and FinancingProduct-Related Announcements
PDS Biotechnology Highlights Progress in Colorectal Cancer Programs
Positive
Sep 21, 2026
PDS Biotechnology Corporation is a clinical-stage oncology firm developing tumor-targeted immunotherapies using proprietary platforms aimed at solid tumors where treatment options are limited. Its pipeline is led by PDS0301, a fused IL-12 antibody...
Business Operations and StrategyExecutive/Board ChangesPrivate Placements and Financing
PDS Biotechnology Retires Debt and Secures New Financing
Positive
Sep 14, 2026
On September 14, 2026, PDS Biotechnology retired a $6 million Yorkville promissory note by paying about $4.6 million in outstanding principal and interest, eliminating the obligation without incurring early termination penalties and simplifying it...
Business Operations and StrategyExecutive/Board ChangesPrivate Placements and Financing
PDS Biotechnology Announces PIPE Financing and Strategic Alignment
Positive
Sep 8, 2026
On September 7, 2026, PDS Biotechnology entered a private placement financing agreement with accredited investors, structured as a PIPE that combines common shares, pre-funded warrants and common warrants, for expected gross proceeds of about $11....
Business Operations and StrategyDelistings and Listing ChangesPrivate Placements and Financing
PDS Biotechnology Amends Promissory Note, Tightens Financing Terms
Negative
Sep 4, 2026
On August 31, 2026, PDS Biotechnology entered into a First Amendment to a $6 million promissory note with YA II PN, Ltd., tightening how proceeds from its at-the-market equity program are remitted to the lender, including weekly reporting of net p...
Business Operations and StrategyExecutive/Board Changes
PDS Biotechnology Restructures Workforce and Leadership Team
Negative
Aug 25, 2026
On August 6, 2026, PDS Biotechnology’s board approved a significant reduction in force to better align operating expenses with its strategy around advancing PDS0301, beginning implementation and notifying affected employees on August 21, 202...
Business Operations and StrategyExecutive/Board ChangesShareholder Meetings
PDS Biotechnology Shareholders Approve Expanded Authorized Stock
Positive
Aug 14, 2026
On August 10, 2026, PDS Biotechnology held its 2026 annual meeting of stockholders, where shareholders approved an amendment to the company’s certificate of incorporation doubling authorized common stock to 300,000,000 shares from 150,000,00...
Business Operations and Strategy
PDS Biotechnology Refocuses Strategy Around Lead Asset PDS0301
Positive
Aug 11, 2026
On August 11, 2026, PDS Biotechnology announced a strategic refocus following a board-led review of its portfolio and capital allocation, prioritizing development of its tumor-targeted immunocytokine PDS0301 in metastatic colorectal cancer and oth...
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.