PDSB PDS Biotechnology Corp

CIK 0001472091 50 ready 8-Ks latest September 22, 2026, 8:05 AM ET RSS · JSON

Activity: NORMAL 4 filings / 30d vs 3 baseline Risk accumulating: repeated leadership change (6)

Ready 8-Ks 50

Latest filing October 6, 2026, 8:05 AM ET

Top materiality 0.90

Event mix other_material ×28 · regulatory ×7 · earnings ×6

Sentiment 26 pos · 3 neg · 21 neu

Latest earnings ▼ miss 2025-Q3

Executive change recent →

SHENANIGAN SCORE 2 / 7 see the board

Recent 8-K filings for PDSB

Highest-materiality recent filing

PDS Biotech Submits FDA Protocol Amendment for Phase 3 VERSATILE-003, PFS Endpoint for Accelerated Approval

January 9, 2026, 6:59 PM ET regulatory materiality 0.90 positive item 8.01 item 9.01

On January 9, 2026, PDS Biotech submitted a protocol amendment to the FDA for its Phase 3 VERSATILE-003 trial.
The amendment changes progression free survival (PFS) to a primary endpoint for earlier evaluation, potentially enabling accelerated approval of PDS0101.

Read filing →

September 22, 2026, 8:05 AM ET other material materiality 0.65 positive item 8.01 item 9.01

PDS Biotech publishes Phase 2 VERSATILE-002 results in JAMA Oncology; mOS 39.3 months in ICI-naive HNSCC

mOS of 39.3 months for CPS≥1 ICI-naive patients vs 17.9 months for pembrolizumab SOC.
September 14, 2026, 4:10 PM ET other material materiality 0.85 positive item 1.02 item 5.02 item 7.01 item 8.01 item 9.01 ◈ executive_change ×2

PDS Biotech completes $11.3M PIPE led by Nant; adds Soon-Shiong and Banaag to board

Initial closing: issued 16,502,870 shares, 23,498,156 pre-funded warrants, 20,000,514 common warrants; gross $11.3M.
September 8, 2026, 8:35 AM ET other material materiality 0.85 positive item 1.01 item 3.02 item 7.01 item 9.01

PDS Biotech raises up to $22.55M in PIPE led by Nant; Soon-Shiong to join board

PIPE raises up to $22.55M: $11.55M initial closing at $0.2825/unit, plus $11M milestone (Nant $10M, AB Group $1M) upon Phase 3 protocol submission.
September 4, 2026, 5:25 PM ET debt materiality 0.60 neutral item 1.01 item 2.03 item 9.01

PDS Biotechnology amends $6M promissory note with YA II PN, adding mandatory redemption and extended cure period

Amendment to $6,000,000 promissory note dated June 15, 2026 with YA II PN, Ltd.
August 25, 2026, 4:08 PM ET leadership materiality 0.70 negative item 2.05 item 5.02 ◈ executive_change

PDS Bio cuts 36% of workforce, removes COO Toutain; $842K charge

Board approved Aug 6, 2026; RIF affects ~36% of workforce; notified Aug 21, 2026; Q3 completion.
August 19, 2026, 4:52 PM ET leadership materiality 0.60 neutral item 5.02 ◈ executive_change ×3

PDS Biotech CFO Lars Boesgaard resigns; interim CFO and PIO appointed

Lars Boesgaard resigns as CFO, PFO and PAO effective Sept 12, 2026, to pursue other professional endeavors.
August 13, 2026, 8:35 AM ET other material materiality 0.80 positive item 2.02 item 9.01

PDS Biotech refocuses on PDS0301, discontinues PDS0101 Phase 3 trial; Q2 net loss $9.8M

Q2 2026 net loss $9.8M ($0.18/share) vs $9.4M ($0.21) year-ago; cash $5.6M at June 30.
August 11, 2026, 8:30 AM ET other material materiality 0.85 neutral item 7.01 item 9.01

PDS Biotech refocuses on PDS0301 in mCRC; discontinues PDS0101 Phase 3 trial

PDS0301 showed 71% ORR at 6 months and 80% 24-month survival in MSS/pMMR mCRC with liver metastases.
July 31, 2026, 4:15 PM ET regulatory materiality 0.70 negative item 3.01

PDS Biotechnology receives Nasdaq deficiency notice for bid price below $1.00

Received deficiency letter on July 30, 2026 for failing to meet minimum bid price of $1.00 for 30 consecutive business days.
June 2, 2026, 3:35 PM ET regulatory materiality 0.65 positive item 8.01

PDS Biotech regains Nasdaq minimum bid price compliance as of June 2, 2026

Nasdaq notified PDS Biotech on June 2, 2026 that it regained compliance with the $1.00 minimum bid price rule.
May 13, 2026, 7:05 AM ET earnings materiality 0.65 positive item 2.02 item 9.01 ◈ Earnings Releases

PDS Biotech Q1 net loss $7.3M ($0.13/sh); VERSATILE-003 amended with PFS endpoint

Net loss $7.3M ($0.13 per share) vs $8.5M ($0.21) YoY; revenue not reported.
May 1, 2026, 7:59 PM ET debt materiality 0.65 neutral item 1.01 item 1.02 item 2.03 item 3.02 ◈ Debt Financings◈ Material Agreements

PDS Biotechnology issues $6M promissory note and warrant to YA II PN, redeems existing debentures

Entered $6M promissory note at 10% interest, 12-month maturity, issued at $5.76M (96% of face).
April 15, 2026, 7:59 PM ET other material materiality 0.75 positive item 8.01 item 9.01

PDS Biotech reports 78% ORR for PDS01ADC in MSS mCRC liver metastases trial

Stage 1 of Phase 2 NCI-led trial: 77.8% ORR (7/9) with PDS01ADC plus HAIP vs 35% in parallel study without PDS01ADC.
March 30, 2026, 7:59 PM ET earnings materiality 0.75 positive item 2.02 item 9.01 ◈ Earnings Releases

PDS Biotech reports FY2025 net loss of $34.5M, updates PDS0101 Phase 3 with interim PFS endpoint

Net loss of $34.5M ($0.74/share) vs $37.6M ($1.03/share) in 2024; cash $26.7M at year-end.
March 3, 2026, 6:59 PM ET regulatory materiality 0.75 negative item 3.01 ◈ Listing & Compliance Notices

PDS Biotechnology receives Nasdaq bid price deficiency notice; 180 days to cure

Stock closed below $1.00 for 30 consecutive business days, triggering Nasdaq Listing Rule 5550(a)(2) deficiency.
February 20, 2026, 6:59 PM ET regulatory materiality 0.70 positive item 8.01 item 9.01

PDS Biotech amends Phase 3 VERSATILE-003 trial to add PFS endpoint for potential accelerated approval of PDS0101

Adopted protocol amendment for Phase 3 VERSATILE-003 trial adding progression-free survival as interim primary endpoint.
January 28, 2026, 6:59 PM ET other material materiality 0.65 positive item 8.01 item 9.01

PDS Biotech: NCI-led Phase 2 study of PDS01ADC shows median PFS 9.6 months in mCRPC

Median PFS of 9.6 months (range 4.3-32.2) for PDS01ADC plus docetaxel in 3rd-line mCRPC patients.
January 22, 2026, 6:59 PM ET other material materiality 0.65 positive item 8.01 item 9.01

PDS Biotech receives U.S. patent allowance for PDS0101 with 20-year market protection

U.S. Patent Office issued Notice of Allowance for PDS0101 (Application 16/210,750) covering cationic lipid compositions.
January 9, 2026, 6:59 PM ET regulatory materiality 0.90 positive item 8.01 item 9.01

PDS Biotech Submits FDA Protocol Amendment for Phase 3 VERSATILE-003, PFS Endpoint for Accelerated Approval

On January 9, 2026, PDS Biotech submitted a protocol amendment to the FDA for its Phase 3 VERSATILE-003 trial.
December 2, 2025, 6:59 PM ET other material materiality 0.65 positive item 8.01 item 9.01

PDS Biotech schedules FDA Type C meeting to discuss accelerated approval for PDS0101 in HNSCC

FDA accepted Type C meeting request; meeting scheduled for December 2025.
November 13, 2025, 6:59 PM ET earnings materiality 0.80 neutral item 2.02 item 9.01

PDS Biotech Q3 net loss $9.0M; Phase 2 mOS 39.3 months; seeks accelerated approval

Q3 net loss $9.0M ($0.19/share) vs $10.7M ($0.29) YoY; R&D expenses down to $4.6M.
November 12, 2025, 6:59 PM ET other material materiality 0.65 neutral item 1.01 item 2.02 item 7.01 item 8.01 item 9.01

PDS Biotech launches up to $11.1M registered direct offering; Sep 30 cash $26.2M

Offering of 5.8M shares (or pre-funded warrants) at $0.91 with warrants exercisable at $1.00 per share.
November 10, 2025, 6:59 PM ET other material materiality 0.65 positive item 8.01 item 9.01

PDS Biotech reports positive translational data for PDS0101 and PDS01ADC at SITC 2025

Translational study of PDS0101 combo in 50 patients shows multiple serum biomarkers predict clinical benefit accurately.
October 29, 2025, 7:59 PM ET regulatory materiality 0.75 positive item 8.01 item 9.01

PDS Biotech requests FDA meeting to discuss expedited approval for PDS0101 in HPV16+ HNSCC

Final VERSATILE-002 data: median PFS 6.3 months, median OS 39.3 months in recurrent/metastatic HPV16+ HNSCC.
September 18, 2025, 7:59 PM ET other material materiality 0.80 positive item 8.01 item 9.01

PDS Biotech reports 29.5-month median OS in low PD-L1 head and neck cancer cohort

Median overall survival (mOS) of 29.5 months in CPS 1-19 cohort from VERSATILE-002 Phase 2 trial.
August 25, 2025, 7:59 PM ET other material materiality 0.85 positive item 8.01 item 9.01

PDS Biotech reports mOS 39.3 months in VERSATILE-002 Phase 2 vs 17.9 months standard of care

Median overall survival of 39.3 months (lower bound 23.9) in CPS≥1 patients with HPV16+ HNSCC; standard pembrolizumab ± chemo mOS is 17.9 months.
August 13, 2025, 7:59 PM ET earnings materiality 0.75 neutral item 2.02 item 9.01

PDS Biotech reports Q2 net loss $9.4M, clinical updates on PDS0101 and PDS01ADC

Net loss $9.4M ($0.21/dil share) vs $8.3M ($0.23) in Q2 2024.
June 2, 2025, 7:59 PM ET other material materiality 0.70 positive item 8.01 item 9.01

PDS Biotech reports durable 30.0-month median OS from VERSATILE-002 in HPV16+ HNSCC

Median overall survival (mOS) steady at 30.0 months with ~4.5 months additional follow-up; lower 95% CI increased to 23.9 months.
May 22, 2025, 7:59 PM ET other material materiality 0.75 positive item 8.01 item 9.01

PDS Biotech reports positive extended follow-up data for Versamune HPV Phase 2 in head and neck cancer

VERSATILE-002: mOS of 39.3 months (CPS≥20) vs ~15 months for pembrolizumab; median follow-up 18.4 months.
May 14, 2025, 7:59 PM ET earnings materiality 0.70 positive item 2.02 item 9.01

PDS Biotech Q1 net loss $8.5M; Phase 3 VERSATILE-003 trial underway

Net loss of $8.5M ($0.21 per share) in Q1 2025 vs $10.6M ($0.30) in Q1 2024; R&D expenses fell to $5.8M.
May 2, 2025, 7:59 PM ET debt materiality 0.75 neutral item 1.01 item 1.02 item 2.03 item 3.02 item 9.01 ◈ Debt Financings

PDS Biotech closes $22.2M convertible debenture + warrant financing; repays Horizon loan

Issued $22.2M face-value Senior Secured Convertible Debentures (net $20M) to buyers including JGB Partners LP.
March 27, 2025, 7:59 PM ET earnings materiality 0.75 neutral item 2.02 item 9.01

PDS Biotech reports FY2024 net loss $37.6M; initiates Phase 3 Versamune HPV trial

Net loss for FY 2024 was $37.6M ($1.03 per share), compared to $42.9M ($1.39 per share) in 2023; operating expenses decreased to $36.3M from $43.0M.
March 13, 2025, 7:59 PM ET regulatory materiality 0.70 positive item 8.01 item 9.01

PDS Biotech announces FDA clearance of IND for Versamune MUC1 + PDS01ADC to treat metastatic colorectal cancer

FDA cleared IND for Versamune MUC1 (formerly PDS0103) + PDS01ADC to treat MUC1-positive unresectable metastatic colorectal carcinoma in failed prior treatment.
March 7, 2025, 6:59 PM ET other material materiality 0.70 positive item 8.01 item 9.01

PDS Biotech initiates VERSATILE-003 Phase 3 trial for Versamune HPV in head and neck cancer

Phase 3 trial VERSATILE-003 now open to patient enrollment for HPV16-positive head and neck cancer.
February 28, 2025, 6:59 PM ET other material materiality 0.70 neutral item 1.01 item 8.01 item 9.01

PDS Biotech raises $11M in registered direct offering; warrants could add $11M

Gross proceeds of ~$11M upfront from sale of 7.33M shares and warrants; warrants exercisable at $1.50/share for 5 years.
February 26, 2025, 6:59 PM ET other material materiality 0.85 positive item 8.01 item 9.01

PDS Biotech reports mOS of 42.4 months in ICI-naïve patients in JAMA Oncology

Median overall survival 42.4 months in ICI-naïve patients vs. historical 7-12 months; for HPV16+ ICI-naïve, mOS not yet reached.

Executive changes

Appointed

James Banaag

Director

PDSB · PDS Biotechnology Corp

Effective: 2026-09-14
Filed: September 14, 2026, 4:10 PM ET

the Board of Directors (the “ Board ”) of the Company appointed Dr. Patrick Soon-Shiong and Mr. James Banaag as directors and new members of the Board to fill the vacancies on the Board created from the previously announced increase in the size of the Board from six to eight directors, effective as of the Initial Closing (as defined in the Purchase Agreement), which occurred on September 14, 2026.

Appointed

Patrick Soon-Shiong

Director

PDSB · PDS Biotechnology Corp

Effective: 2026-09-14
Filed: September 14, 2026, 4:10 PM ET

the Board of Directors (the “ Board ”) of the Company appointed Dr. Patrick Soon-Shiong and Mr. James Banaag as directors and new members of the Board to fill the vacancies on the Board created from the previously announced increase in the size of the Board from six to eight directors, effective as of the Initial Closing (as defined in the Purchase Agreement), which occurred on September 14, 2026.

Departed

Stephan Toutain

Chief Operating Officer

PDSB · PDS Biotechnology Corp

Effective: 2026-08-21
Filed: August 25, 2026, 4:08 PM ET

On August 21, 2026, the Company delivered a notice of termination without cause to Stephan Toutain and removed him from his position as the Company’s Chief Operating Officer.

Appointed (interim)

Janetta Trochimiuk

Principal Accounting Officer

PDSB · PDS Biotechnology Corp

Effective: 2026-09-12
Filed: August 19, 2026, 4:52 PM ET

On August 19, 2026, the board of directors of the Company appointed Janetta Trochimiuk, the Company’s Controller, as interim Principal Accounting Officer and Frank Bedu-Addo, Ph.D., the Company’s President and Chief Executive Officer, as interim Principal Financial Officer, each effective as of September 12, 2026.

Appointed (interim)

Frank Bedu-Addo

Principal Financial Officer

PDSB · PDS Biotechnology Corp

Effective: 2026-09-12
Filed: August 19, 2026, 4:52 PM ET

On August 19, 2026, the board of directors of the Company appointed Janetta Trochimiuk, the Company’s Controller, as interim Principal Accounting Officer and Frank Bedu-Addo, Ph.D., the Company’s President and Chief Executive Officer, as interim Principal Financial Officer, each effective as of September 12, 2026.

Departed

Lars Boesgaard

Chief Financial Officer

PDSB · PDS Biotechnology Corp

Effective: 2026-09-12
Filed: August 19, 2026, 4:52 PM ET

On August 13, 2026, Lars Boesgaard submitted his resignation, effective as of September 12, 2026, as Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer of PDS Biotechnology Corporation (the “ Company ”) in order to pursue other professional endeavors.

Departed

Sir Richard Sykes

Director

PDSB · PDS Biotechnology Corp

Filed: April 24, 2025, 7:59 PM ET

On April 22, 2025, Sir Richard Sykes, a member of the Board of Directors (the “Board”) of PDS Biotechnology Corporation (the “Company”), notified the Company that he will retire and not stand for re-election as a director of the Company upon the expiration of his current term which expires at the Company’s 2025 Annual Meeting of Stockholders.

Appointed

Stephan F. Toutain

Chief Operations Officer

PDSB · PDS Biotechnology Corp

Effective: 2024-05-01
Filed: May 2, 2024, 7:59 PM ET

PDS Biotechnology Corporation (the “Company”) entered into an Executive Employment Agreement with Stephan F. Toutain (the “Employment Agreement”), pursuant to which Mr. Toutain will assume the role of the Company’s Chief Operations Officer, effective as of May 1, 2024 (the “Effective Date”).

Departed

Lauren V. Wood

Chief Medical Officer

PDSB · PDS Biotechnology Corp

Effective: 2024-01-22
Filed: January 22, 2024, 6:59 PM ET

Effective as of January 22, 2024, Lauren V. Wood, M.D. retired from her position as Chief Medical Officer of PDS Biotechnology Corporation (the “Company”).

Departed

Matthew Hill

Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer

PDSB · PDS Biotechnology Corp

Effective: 2023-12-01
Successor: Lars Boesgaard
Filed: November 28, 2023, 6:59 PM ET

On November 21, 2023, Matthew Hill submitted his resignation, effective December 1, 2023, as Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer of PDS Biotechnology Corporation (the “ Company ”) in order to pursue other professional endeavors.

Appointed

Lars Boesgaard

Chief Financial Officer

PDSB · PDS Biotechnology Corp

Effective: 2023-12-04
Filed: November 28, 2023, 6:59 PM ET

On November 28, 2023, the Company entered into an Executive Employment Agreement with Lars Boesgaard (the “ Employment Agreement ”), pursuant to which Mr. Boesgaard will assume the role of the Company’s Chief Financial Officer, effective as of December 4, 2023.

Appointed

Matthew Hill

Chief Financial Officer

PDSB · PDS Biotechnology Corp

Effective: 2021-10-18
Filed: October 6, 2021, 7:59 PM ET

On October 4, 2021, the Company entered into an Executive Employment Agreement with Matthew Hill (the “ Employment Agreement ”), pursuant to which Mr. Hill will be appointed as the Company’s Chief Financial Officer, effective as of October 18, 2021 (the “ Effective Date ”).

Earnings & guidance

2025-Q3 EPS reported -$0.60 vs consensus -$0.22 ▼ miss (-175.7%) filing →

Materiality & sentiment trend

Max materiality 0.90 · Median 0.68 · Most common event other_material

26 positive 3 negative 21 neutral

source · PDSB on sec.gov