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PDSBNasdaq

PDS Biotechnology Corp

Biopharma developer (SEC filing verified)·Phase 3·Princeton, NJ, United States·CEO: Dr. Frank K. Bedu-Addo Ph.D.
OncologyImmunologyInfectious Disease

PDSB evidence brief

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BioSniper AI · PDSB

PDS Biotechnology Corp (PDSB) is a clinical-stage biopharmaceutical company developing immunotherapies for cancer and infectious diseases, currently prioritizing its PDS0301 candidate after discontinuing a Phase 3 trial of PDS0101.

Key risk: Going concern uncertainty

4.3/10

BioSniper Score

Based on 5 of 6 signals

Market Cap

$11.8M

Cash Runway

6.5 mo

Lead Asset

infectimune

Financial data as of Jun 30, 2026.

Tracking 5 pipeline candidates · 2 clinical trials · 1 catalyst for PDS Biotechnology Corp.

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AI OverviewAI overview is shown in English only.

PDS Biotechnology Corp (PDSB) is a clinical-stage biopharmaceutical company developing immunotherapies for cancer and infectious diseases, currently prioritizing its PDS0301 candidate after discontinuing a Phase 3 trial of PDS0101.

  • As of June 30, 2026, PDS Biotechnology had $5.6 million in cash and cash equivalents and an accumulated deficit of $233.7 million [sec_mda · as of 2026-08-13].
  • The company has concluded that substantial doubt exists about its ability to continue as a going concern [sec_mda · as of 2026-08-13].
  • PDS Biotechnology recently discontinued the VERSATILE-003 Phase 3 clinical trial of PDS0101 and strategically refocused on developing PDS0301 [sec_mda · as of 2026-08-13].
  • The company has not generated any product revenue to date and expects to continue incurring losses as it advances its product candidates [sec_mda · as of 2026-05-14].

What works

  • PDS Biotechnology is advancing PDS0301, a mid-clinical-stage immunotherapy candidate, which may address unmet medical needs if successfully developed and approved [sec_mda · as of 2026-08-13].
  • The company holds intellectual property rights related to its Versamune® and Infectimune® platforms, which could provide competitive advantages if products are commercialized [sec_mda · as of 2026-08-13].

What to weigh

  • PDS Biotechnology has a going concern risk, with only $5.6 million in cash as of June 30, 2026, and a history of significant operating losses [sec_mda · as of 2026-08-13].
  • The discontinuation of the VERSATILE-003 Phase 3 trial may increase investor uncertainty and make it more difficult to obtain financing on acceptable terms [sec_mda · as of 2026-08-13].
  • The company is dependent on raising additional capital to fund its planned Phase 2b clinical trial for PDS0301 and maintain operations, with no assurance of securing such financing [sec_mda · as of 2026-08-13].

From the filings

Quoted directly from source documents.

  • Going concern risk due to low cash balance

    As of June 30, 2026, we had $5.6 million in cash and cash equivalents, and we have concluded that substantial doubt exists about our ability to continue as a going concern.

    SEC MD&A · August 13, 2026

  • Strategic refocus from PDS0101 to PDS0301

    the Company's recent strategic refocus to prioritize the development of PDS0301 and to discontinue the VERSATILE-003 Phase 3 clinical trial of PDS0101 may not achieve the anticipated benefits and involves significant risks and uncertainties;

    SEC MD&A · August 13, 2026

  • Accumulated deficit and no product revenue

    As of June 30, 2026, we had an accumulated deficit of $233.7 million.

    SEC MD&A · August 13, 2026

  • Dependence on external financing

    Our ability to advance PDS0301 through its planned Phase 2b clinical trial and to maintain operations is dependent upon our ability to raise additional capital.

    SEC MD&A · August 13, 2026

Catalyst timeline

  • 2029-02-01 · Phase3_Topline · pds0101 — Phase 3 Topline: A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Topline data from the Phase 3 trial of PDS0101 in combination with pembrolizumab is expected, though the trial has been discontinued; the catalyst date may be subject to change.
Risks & what to watch (4)

Key risks

  • Going concern uncertaintySubstantial doubt about ability to continue as a going concern due to low cash reserves [sec_mda · as of 2026-08-13].
  • Dependence on financingRequires additional capital to fund PDS0301 Phase 2b trial and operations; no assurance of availability [sec_mda · as of 2026-08-13].
  • Clinical and regulatory riskPDS0301 is in mid-clinical development; may not obtain regulatory approval or be commercialized [sec_mda · as of 2026-08-13].
  • No product revenueCompany has not generated any product revenue and expects continued losses [sec_mda · as of 2026-05-14].

What to watch

  • Initiation and progress of the planned Phase 2b clinical trial for PDS0301 [sec_mda · as of 2026-08-13].
  • Ability to raise additional capital through equity, debt, or strategic partnerships to fund operations [sec_mda · as of 2026-08-13].
  • Potential impact of the discontinued VERSATILE-003 trial on investor sentiment and financing prospects [sec_mda · as of 2026-08-13].

Sources: SEC filings · SEC MD&A · Generated August 29, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 5 of 6 signals · derived from public data

Cash Runway1.8

6.5 months

Financial Health0.5

OCF -$3M · Net income -$10M

Pipeline Maturity8.5

Lead: Phase 3

Pipeline Breadth8.5

5 candidates

Catalyst Momentum2.0

1 upcoming, next in ~886d

Insider SignalN/A

No insider transactions in the last 180 days

Runway

Catalysts

Pipeline

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

41

Total value held

$4.1M

Showing top 10 of 41 institutional holders of PDS Biotechnology Corp. Open the full 13F history after sign-in.

Short Interest

as of May 22, 2026
% of float
3.2%
Days to cover
1.4
Shares short
1,705,936
Daily short volume
-

Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →

PDSB short interest

Governance

Frequently asked questions

What is the AI investment thesis for PDS Biotechnology Corp?

PDS Biotechnology Corp (PDSB) is a clinical-stage biopharmaceutical company developing immunotherapies for cancer and infectious diseases, currently prioritizing its PDS0301 candidate after discontinuing a Phase 3 trial of PDS0101.

What is PDS Biotechnology Corp's next catalyst?

PDS Biotechnology Corp's next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-" — expected February 1, 2029.

Who is the CEO of PDS Biotechnology Corp?

Dr. Frank K. Bedu-Addo Ph.D. is the chief executive officer of PDS Biotechnology Corp (PDSB).

Where is PDS Biotechnology Corp headquartered?

PDS Biotechnology Corp (PDSB) is headquartered in Princeton, NJ, United States.

What therapeutic areas does PDS Biotechnology Corp focus on?

PDS Biotechnology Corp develops therapies across Oncology, Immunology, Infectious Disease.

925 companies232,681 SEC filings21,419 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.