Highest-materiality recent filing
PDS Biotechnology closes $6M promissory note, warrant, and $50M ATM facility
Closed $6M promissory note with YA II PN, Ltd.; net proceeds $5.76M after 4% OID.
PDS Biotech schedules 2026 annual meeting for August 10
2026 annual meeting of stockholders set for August 10, 2026.
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.
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.
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).
Filing indicates only an updated investor presentation (Exhibit 99.1) was published.
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.
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.
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.
PDS Biotechnology updates corporate presentation deck; no material new disclosures
Filed corporate presentation dated February 2026 under Item 8.01.
Adopted protocol amendment for Phase 3 VERSATILE-003 trial adding progression-free survival as interim primary endpoint.
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.
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.
On January 9, 2026, PDS Biotech submitted a protocol amendment to the FDA for its Phase 3 VERSATILE-003 trial.
PDS Biotech receives broad Japanese patent for lead candidate PDS0101
Japan Patent Office issued Patent No. 7783866 for PDS0101 covering broad composition of matter and methods of use.
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.
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.
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.
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.
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.
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.
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.
PDS Biotechnology files routine corporate presentation update; no material new information disclosed
Company updated its investor presentation deck on August 25, 2025 (Exhibit 99.1).
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.
Stage 1 of NCI-led Phase 2 trial for PDS01ADC + FUDR/HAIP in metastatic colorectal cancer met RECIST v1.1 criteria for expansion.
PDS Biotechnology updates corporate presentation; no financial or clinical data disclosed
Filed 8-K on June 25, 2025, with updated corporate presentation as Exhibit 99.1.
PDSB stockholders approve amendment increasing equity plan shares by 3.14M
Stephen Glover and Gregory Freitag elected as Class A directors at annual meeting.
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.
VERSATILE-002: mOS of 39.3 months (CPS≥20) vs ~15 months for pembrolizumab; median follow-up 18.4 months.
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.
PDS Biotech reports preclinical flu vaccine data with Infectimune at IMMUNOLOGY2025
Infectimune-based flu vaccine elicited multifunctional, influenza-specific CD4 T cells with cytotoxic characteristics in preclinical studies.
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.
Director Sir Richard Sykes to retire at PDS Biotechnology's 2025 Annual Meeting
Sir Richard Sykes notified the Board on April 22, 2025, of his retirement.
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.
FDA cleared IND for Versamune MUC1 (formerly PDS0103) + PDS01ADC to treat MUC1-positive unresectable metastatic colorectal carcinoma in failed prior treatment.
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.
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.
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.
Versamune® HPV + CRT achieved 100% HPV16 ctDNA clearance at 3-4 months vs 50% with CRT alone in cervical cancer.
PDS Biotech Reaffirms Guidance to Initiate VERSATILE-003 Phase 3 Trial in Q1 2025
FDA cleared amended trial design for VERSATILE-003 Phase 3 trial of Versamune HPV plus pembrolizumab in HPV16-positive R/M HNSCC.
PDS Biotech reports Q3 net loss $10.7M; modifies Phase 3 trial design to cut costs
Net loss of $10.7M ($0.29/share) vs $10.8M ($0.35/share) in Q3 2023; operating expenses declined slightly.
PDS Biotech: 84.4% 36-month OS in cervical cancer trial of Versamune HPV + chemoradiation
36-month OS rate 84.4% (all patients) vs ~64% historical; 100% in 8 patients receiving all 5 doses.
PDS Biotech reports updated VERSATILE-002 trial data: mOS 30 months, ORR 36%
Median overall survival 30 months vs published 12-18 months for pembrolizumab alone.
PDS Biotechnology posts updated corporate presentation; no new specifics disclosed
Filed Form 8-K to update the corporate presentation deck on September 16, 2024.
PDS Biotech Q2 net loss narrows to $8.3M; FDA aligned on Phase 3 trial for Versamune HPV in HNSCC
Net loss $8.3M ($0.23/share) vs $11.5M ($0.37/share) YoY; R&D expenses down 44% to $4.5M.
PDS Biotechnology enters $50M ATM equity offering program with B. Riley and H.C. Wainwright
New at-the-market sales agreement allows up to $50M in common stock through B. Riley Securities and H.C. Wainwright.
PDS Biotech to present updated Versamune HPV Phase 2 data at ASTRO 2024
Updated IMMUNOCERV Phase 2 data for Versamune® HPV (PDS0101) with chemoradiation in locally advanced cervical cancer accepted for oral presentation at ASTRO 2024.
PDS Biotech to announce Q2 2024 results on August 13, 2024
Company will report Q2 2024 financial results and provide business update before market open on August 13, 2024.
PDS Biotech VERSATILE-002 abstract accepted for ESMO 2024 presentation
Abstract on first-line Versamune HPV + KEYTRUDA in HPV16-positive recurrent/metastatic HNSCC accepted for ESMO.
Received official FDA minutes supporting Phase 3 trial of Versamune HPV + pembrolizumab for first-line recurrent/metastatic HPV16-positive HNSCC.
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.
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”).
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”).
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.
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.
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 ”).
Janetta Trochimiuk, the Company’s controller, will serve as the interim principal accounting officer
Frank Bedu-Addo, the Company’s Chief Executive Officer, will serve as the Company’s interim principal financial officer
On September 30, 2021, PDS Biotechnology Corporation (the “ Company ”) delivered a notice of termination without cause to Seth Van Voorhees and removed him from his position as the Company’s Chief Financial Officer, principal financial officer and principal accounting officer.
Max materiality 0.90 · Median 0.68 · Most common event other_material