Overview
- TickerPDSB on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersBerkeley Heights, United States2
- Incorporated inDE3
- Business address303A College Road East, Princeton, Nj 085403
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI5493002KU8ACFTSMC9352
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 46475962
See how the biggest companies compare on our leaderboards
Versamune® products, including PDS0101 (Versamune® HPV), PDS0103, and others, alone or in combination with PDS01ADC ( formerly known as PDS0301/M9241/NHS-IL-12) , as well as Infectimune® based products and the future success of such trials;4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development expenses | $19.0M | $22.6M |
| General and administrative expenses | $12.5M | $13.8M |
| Total operating expenses | $31.5M | $36.3M |
| Loss from operations | -$31.5M | -$36.3M |
| Interest income | $1.2M | $2.5M |
| Interest expense | -$5.3M | -$4.7M |
| Interest income (expenses), net | -$4.1M | -$2.2M |
| Loss before income taxes | -$35.7M | -$38.5M |
| Benefit for income taxes | $1.2M | $869.2K |
| Net loss | -$34.5M | -$37.6M |
| Comprehensive loss | -$34.5M | -$37.6M |
| Net loss per share, basic (in dollars per share) | -$0.74 | -$1.03 |
| Net loss per share, diluted (in dollars per share) | -$0.74 | -$1.03 |
| Weighted average common shares outstanding, basic (in shares) | 46.4M shares | 36.5M shares |
| Weighted average common shares outstanding, diluted (in shares) | 46.4M shares | 36.5M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 9 quarters (quarterly), latest first.10
| Period ending | 2025-12-31 | 2025-09-30 | 2025-06-30 | 2025-03-31 | 2024-12-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $26.7M | $41.7M | |||
| Prepaid expenses and other assets | $1.5M | $3.4M | |||
| Total current assets | $28.3M | $45.1M | |||
| Prepaid expenses | $2.0M | $0 | |||
| Property and equipment, net | $120.2K | $142.0K | |||
| Financing lease right-of-use assets | $123.5K | $162.2K | |||
| Total assets | $30.5M | $45.4M | |||
| Accounts payable | $3.6M | $1.7M | |||
| Accrued expenses | $742.2K | $2.8M | |||
| Current portion of notes payable | $5.1M | $12.5M | |||
| Financing lease obligation - short term | $36.2K | $61.1K | |||
| Total current liabilities | $9.5M | $17.1M | |||
| Note payable, net of current portion | $11.7M | $9.2M | |||
| Financing lease obligation-long term | $25.7K | $61.9K | |||
| Total liabilities | $21.2M | $26.4M | |||
| Common stock, $0.00033 par value, 150,000,000 shares authorized at December 31, 2025 and December 31, 2024, 54,878,233 shares and 37,987,380 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $18.1K | $12.5K | |||
| Additional paid-in capital | $225.8M | $201.1M | |||
| Accumulated deficit | -$216.6M | -$182.1M | |||
| Total stockholders' equity | $9.3M | $9.5M | $16.0M | $22.4M | $19.0M |
| Total liabilities and stockholders' equity | $30.5M | $45.4M | |||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |||
| Common stock, shares authorized (in shares) | 150.0M shares | 150.0M shares | |||
| Common stock, shares issued (in shares) | 54.9M shares | 38.0M shares | |||
| Common stock, shares outstanding (in shares) | 54.9M shares | 38.0M shares |
| Period ending | 2025-12-31 | 2025-09-30 | 2025-06-30 | 2025-03-31 | 2024-12-31 | 2024-09-30 | 2024-06-30 | 2024-03-31 | 2023-12-31 |
|---|---|---|---|---|---|---|---|---|---|
| Cash and cash equivalents | $26.7M | $41.7M | |||||||
| Prepaid expenses and other assets | $1.5M | $3.4M | |||||||
| Total current assets | $28.3M | $45.1M | |||||||
| Prepaid expenses | $2.0M | $0 | |||||||
| Property and equipment, net | $120.2K | $142.0K | |||||||
| Financing lease right-of-use assets | $123.5K | $162.2K | |||||||
| Total assets | $30.5M | $45.4M | |||||||
| Accounts payable | $3.6M | $1.7M | |||||||
| Accrued expenses | $742.2K | $2.8M | |||||||
| Current portion of notes payable | $5.1M | $12.5M | |||||||
| Financing lease obligation - short term | $36.2K | $61.1K | |||||||
| Total current liabilities | $9.5M | $17.1M | |||||||
| Note payable, net of current portion | $11.7M | $9.2M | |||||||
| Financing lease obligation-long term | $25.7K | $61.9K | |||||||
| Total liabilities | $21.2M | $26.4M | |||||||
| Common stock, $0.00033 par value, 150,000,000 shares authorized at December 31, 2025 and December 31, 2024, 54,878,233 shares and 37,987,380 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $18.1K | $12.5K | |||||||
| Additional paid-in capital | $225.8M | $201.1M | |||||||
| Accumulated deficit | -$216.6M | -$182.1M | |||||||
| Total stockholders' equity | $9.3M | $9.5M | $16.0M | $22.4M | $19.0M | $22.0M | $30.9M | $37.2M | $26.1M |
| Total liabilities and stockholders' equity | $30.5M | $45.4M | |||||||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |||||||
| Common stock, shares authorized (in shares) | 150.0M shares | 150.0M shares | |||||||
| Common stock, shares issued (in shares) | 54.9M shares | 38.0M shares | |||||||
| Common stock, shares outstanding (in shares) | 54.9M shares | 38.0M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$34.5M | -$37.6M |
| Stock-based compensation expense | $4.1M | $6.8M |
| Issuance of shares in consulting agreements | $298.5K | $267.0K |
| Amortization of debt discount | $1.6M | $1.2M |
| Loss on retirement of debt | $1.1M | $0 |
| Depreciation expense | $21.8K | $21.1K |
| Finance lease amortization expense | $38.7K | $38.7K |
| Prepaid expenses and other current assets | -$173.6K | -$870.3K |
| Accounts payable | $1.9M | -$5.3M |
| Accrued expenses | -$2.1M | $416.5K |
| Operating lease liabilities | $0 | $0 |
| Net cash used in operating activities | -$27.8M | -$35.0M |
| Purchase of equipment | $0 | -$29.0K |
| Net cash used in investing activities | $0 | -$29.0K |
| Proceeds from issuance of pre-funded warrants | $1.0M | $0 |
| Proceeds from issuance of warrants | $5.3M | $0 |
| Proceeds from exercise of pre-funded warrants | $100 | $0 |
| Proceeds from exercise of stock options | $0 | $774.1K |
| Payments of finance lease obligations | -$61.1K | -$55.8K |
| Loan principal payments | -$6.7M | -$3.1M |
| Loan repayment | -$19.0M | $0 |
| Net proceeds from issuance of loan | $18.2M | $0 |
| Proceeds from issuance of common stock, net of issuance costs | $9.7M | $0 |
| Proceeds from issuance of common stock from at-the-market program, net of issuance costs | $4.3M | $22.6M |
| Net cash provided by financing activities | $12.8M | $20.2M |
| Net (decrease) increase in cash and cash equivalents | -$15.0M | -$14.9M |
| Cash paid for interest | $2.9M | $3.6M |
No quarter-by-quarter statement was filed.
Corporate structure
PDS Biotechnology Corp sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of PDS Biotechnology Corp
- Nant Capital, LLC Filed SCHEDULE 13D on PDS Biotechnology Corp, latest Sep 21, 2026
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on PDS Biotechnology Corp, latest Aug 14, 2025 (2 filings since May 15, 2025)
- BlackRock Filed SC 13G/A on PDS Biotechnology Corp, latest May 8, 2024 (2 filings since Jan 29, 2024)
- PDS Biotechnology Corp Berkeley Heights, New Jersey, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What PDS Biotechnology Corp reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $295.9K10 Dec 31, 2025 | $295.9K10 Dec 31, 2024 | 0% |
| Accumulated depreciation | $175.7K10 Dec 31, 2025 | $153.9K10 Dec 31, 2024 | +14.2% |
| Property and equipment, net | $120.2K10 Dec 31, 2025 | $142.0K10 Dec 31, 2024 | −15.4% |
| Finance-lease assets | $123.5K10 Dec 31, 2025 | $162.2K10 Dec 31, 2024 | −23.8% |
Real estate and locations
| Item | Latest | A year before | Change |
|---|---|---|---|
| Area of real estate | 11,200 sq ft9 Dec 31, 2024 | 11,200 sq ft8 Dec 31, 2023 | 0% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $26.7M10 Dec 31, 2025 | $41.7M10 Dec 31, 2024 | −35.9% |
Properties, in its own words
We maintain a month-to-month lease for our research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton, NJ 08540.
We believe our current facilities are suitable and adequate to meet our current needs.
Item 2 of the 10-K filed Mar 30, 2026.4
Leadership
Who has led PDS Biotechnology Corp, and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerFrank Bedu-Addo Mar 25, 2019 to now13
- Chief executive officerBrian A. Leuthner Sep 30, 2015 to Mar 18, 201914
- PresidentFrank Bedu-Addo Mar 25, 2019 to now13
- PresidentBrian A. Leuthner Feb 18, 2016 to Mar 18, 201915
- Chief financial officerLars Boesgaard Dec 4, 2023 to now16
- Chief financial officerVoorhees Seth Van Jan 6, 2021 to Jun 17, 202117
- Chief financial officerMathew C. Hill Oct 20, 2021 to Jan 6, 202318
- Chief financial officerMichael N. King Jul 6, 2020 to Dec 9, 202019
- Chief financial officerAndrew Saik Nov 2, 2017 to Feb 19, 202020
- Chief financial officerAndrew J. Einhorn Sep 30, 2015 to Mar 13, 201721
- Chief operating officerStephan Toutain Mar 3, 2026 to now22
Board members and other officers (35)
- Chief Medical OfficerKirk Shepard V. Jan 23, 2024 to now23
- Chief Operations OfficerStephan Toutain May 2, 2024 to now24
- Principal Accounting OfficerJanetta Trochimiuk Mar 25, 2020 to now25
- Chief Scientific OfficerGregory Conn Mar 25, 2019 to now26
- Chief Medical OfficerLauren Wood Mar 25, 2019 to Jan 6, 202327
- SVP Regulatory AffairsAlyssa Wyant Feb 24, 2017 to Jan 3, 201928
- Chief Acct. & Op., Asst. Sec.Albert N. Marchio Ii. Sep 30, 2015 to Dec 31, 201829
- Vice Pres., Tech. Op. & Manu.Alpaslan Yaman Sep 30, 2015 to Mar 15, 201730
- Chief Medical OfficerHerbert J. Faleck Sep 30, 2015 to Dec 31, 201831
- Chief Scientific OfficerR. Loch Macdonald Sep 30, 2015 to Mar 22, 201832
- V.P., Global Reg. AffairsRenu Vaish Sep 30, 2015 to Jun 20, 201633
- Senior VP, GC and SecretaryW. Bradford Middlekauff Nov 2, 2015 to Mar 18, 201934
- Board memberArnold James Banaag Sep 21, 2026 to now35
- Board memberShiong Patrick Soon Sep 21, 2026 to now36
- Board memberKamil Ali-Jackson Feb 24, 2020 to now37
- Board memberIlian Iliev Apr 9, 2020 to now38
- Board memberOtis Brawley Nov 6, 2020 to now39
- Board memberDelyle W. Bloomquist Mar 25, 2019 to Jun 25, 202040
- Board memberFrank Bedu-Addo Mar 25, 2019 to now13
- Board memberGregory Gene Freitag Mar 25, 2019 to now41
- Board memberRichard Sykes Mar 25, 2019 to Jun 25, 202442
- Board memberSteve C. Glover Apr 10, 2019 to now43
- Board memberAndrew Saik Jun 7, 2019 to Feb 19, 202044
- Board memberRosemary A. Crane Sep 19, 2017 to Mar 18, 201945
- Board memberLiam Ratcliffe Jun 23, 2016 to Mar 18, 201946
- Board memberAnders D. Hove Sep 30, 2015 to Oct 8, 201547
- Board memberIsaac Blech Sep 30, 2015 to Mar 18, 201948
- Board memberJames Healy Sep 30, 2015 to Jun 21, 201749
- Board memberJames J. Loughlin Sep 30, 2015 to Jul 1, 201950
- Board memberKurt G. Conti Sep 30, 2015 to Mar 30, 201851
- Board memberR. Loch Macdonald Sep 30, 2015 to Mar 18, 201932
- Board memberRobert J. Spiegel Sep 30, 2015 to Mar 18, 201952
- Board memberSol J. Barer Sep 30, 2015 to Mar 18, 201953
- Board memberBrian A. Leuthner Oct 8, 2015 to Mar 18, 201954
- General counselSpencer D. Brown Jun 3, 2022 to now55
Former names
- Edge Therapeutics, Inc.Sep 16, 2009 to Mar 18, 20193
Timeline
- Oct 6, 20268-K Other events56
- Sep 22, 20268-K Other events57
- Sep 21, 20268-K Other events58
- Sep 14, 20268-K Ended a material agreement; Executive or director change; Regulation FD disclosure59
- Sep 8, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure60
- Sep 4, 20268-K Entered a material agreement; New debt or obligation61
- Aug 25, 20268-K Exit or restructuring costs; Executive or director change62
- Aug 19, 20268-K Executive or director change63
- Aug 14, 20268-K Bylaws or fiscal year changed; Shareholder vote64
- Aug 13, 20268-K Results of operations65
- Aug 11, 20268-K Regulation FD disclosure66
- Jul 31, 20268-K Listing notice or transfer67
- Mar 25, 2019New chief executive Frank Bedu-Addo becomes CEO13
- Sep 30, 2015New chief executive Brian A. Leuthner becomes CEO14
- Jan 22, 2009Founded PDS Biotechnology Corp is founded2
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.19) a share, on Nov 13, 2025.68
When it reported results
- Aug 13, 2026Reported quarterly or annual results65
- May 13, 2026Reported quarterly or annual results69
- Mar 30, 2026Reported quarterly or annual results70
- Nov 13, 2025Reported quarterly or annual results71
- Nov 12, 2025Reported quarterly or annual results72
- Aug 13, 2025Reported quarterly or annual results73
- May 14, 2025Reported quarterly or annual results74
- Mar 27, 2025Reported quarterly or annual results75
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
304 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 162 major events, 66 insider forms, 5 large holders, 49 other. The latest 20:
- Oct 14, 2026S-3 EDGAR
- Oct 6, 20268-K EDGAR
- Sep 22, 20268-K EDGAR
- Sep 21, 2026SCHEDULE 13D EDGAR
- Sep 21, 20263 EDGAR
- Sep 21, 20263 EDGAR
- Sep 21, 20268-K EDGAR
- Sep 18, 20263 EDGAR
- Sep 14, 20268-K EDGAR
- Sep 8, 20268-K EDGAR
- Sep 4, 20268-K EDGAR
- Aug 25, 20268-K EDGAR
- Aug 19, 20268-K EDGAR
- Aug 14, 20268-K EDGAR
- Aug 13, 202610-Q EDGAR
- Aug 13, 20268-K EDGAR
- Aug 11, 20268-K EDGAR
- Jul 31, 20268-K EDGAR
- Jul 21, 2026EFFECT EDGAR
- Jul 21, 2026424B4 EDGAR
The 304 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
3 open-market trades by officers, directors and large owners since October 2021: 3 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Feb 28, 2025 | Freitag Gregory GeneDirector | Buy | 15,060 | $1.66 | $25.0K | Form 4 |
| Feb 28, 2025 | Glover Stephen C.Director | Buy | 15,061 | $1.66 | $25.0K | Form 4 |
| Dec 13, 2021 | HILL MATTHEW CChief Financial Officer | Buy | 3,100 | $8.99 | $27.9K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Nant Capital, LLCSCHEDULE 13D, 1 filing Sep 21, 202676
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 2 filings May 15, 2025 to Aug 14, 202577
- BlackRockSC 13G/A, 2 filings Jan 29, 2024 to May 8, 202478
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Frank Bedu-Addo, Ph.D.Chief Executive Officer | 61 | $615.3K | $828.3K79 |
| 2025 | Kirk Shepard, M.D.Chief Medical Officer | 75 | $463.5K | $677.3K79 |
| 2025 | Stephan ToutainChief Operating Officer | 60 | $463.5K | $673.6K79 |
| 2024 | Frank Bedu-Addo, Ph.D.Chief Executive Officer | 61 | $597.0K | $2.3M79 |
| 2024 | Kirk Shepard, M.D.Chief Medical Officer | 75 | $426.3K | $1.3M79 |
| 2024 | Stephan ToutainChief Operating Officer | 60 | $300.0K | $939.8K79 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 52. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Vanguard Capital Management LLC | 1,699,315 | $1.5M | 0.0% | +68,226 |
| Focus Partners Wealth | 642,177 | $565.8K | 0.0% | New |
| Quantinno Capital Management LP | 642,177 | $565.8K | 0.0% | New |
| BlackRock, Inc. | 607,639 | $535.4K | 0.0% | +53,591 |
| Geode Capital Management, LLC | 587,139 | $517.4K | 0.0% | −73,089 |
| Vanguard Fiduciary Trust Co | 357,144 | $314.6K | 0.0% | +49,833 |
| Militia Capital Management LLC | 331,800 | $292.3K | 0.1% | New |
| Citadel Advisors LLC | 323,801 | $285.3K | 0.0% | New |
| Morgan Stanley | 313,922 | $276.6K | 0.0% | +310,000 |
| Blair William & Co/il | 300,000 | $264.3K | 0.0% | No change |
| Jane Street Group, LLC | 279,664 | $246.4K | 0.0% | New |
| Renaissance Technologies LLC | 252,200 | $222.2K | 0.0% | +31,400 |
| Inspirion Wealth Advisors, LLC | 188,995 | $165.2K | 0.0% | +7,000 |
| Marshall Wace, Llp | 147,171 | $129.5K | 0.0% | New |
| State Street Corp | 133,333 | $117.5K | 0.0% | No change |
| Northern Trust Corp | 126,502 | $111.5K | 0.0% | +17,609 |
| Wells Fargo & Company/mn | 109,000 | $96.0K | 0.0% | −1,500 |
| Commonwealth Equity Services, LLC | 92,997 | $81.9K | 0.0% | +2,200 |
| Iron Gate Global Advisors LLC | 70,406 | $62.0K | 0.0% | −4,616 |
| Bank of New York Mellon Corp | 68,491 | $60.3K | 0.0% | −820 |
| Tempus Wealth Planning, LLC | 61,800 | $54.5K | 0.0% | No change |
| Two Sigma Securities, LLC | 41,391 | $36.5K | 0.0% | +9,910 |
| Susquehanna International Group, Llp | 36,328 | $32.0K | 0.0% | +14,276 |
| Raymond James Financial Inc | 33,819 | $29.8K | 0.0% | +23,583 |
| XTX Topco Ltd | 33,098 | $29.2K | 0.0% | −3,113 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How PDS Biotechnology Corp is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARPDS Biotechnology Corp1
- CIK0001472091
- Employer ID (EIN)26-42313844
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address303A College Road East, Princeton, NJ 085401
- Phone800-208-33431
- Shares outstanding55,971,338 as of Aug 6, 202612
- Public float$60.1M as of Jun 30, 20254
- AuditorKPMG LLP, Short Hills, New Jersey PCAOB ID 185; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceSep 16, 20091
- Filings787 in all: 8-K (278), 4 (219), 3 (42), 10-Q (33), CORRESP (23), S-8 (17), SC 13G/A (13), DEF 14A (12)1
All 46 form types
DEFA14A (12), UPLOAD (12), 10-K (11), EFFECT (9), 424B5 (8), 425 (7), S-3 (7), SC 13G (7), D (6), 4/A (5), 8-K/A (5), DRS/A (5), SC 13D/A (5), ARS (4), CT ORDER (4), DRSLTR (4), S-1/A (4), SC 13D (4), 424B4 (3), PRE 14A (3), S-1 (3), 10-K/A (2), 424B2 (2), 424B3 (2), DEFR14A (2), FWP (2), 144 (1), 8-A12B (1), CERTNAS (1), D/A (1), DRS (1), S-1MEF (1), S-3/A (1), S-4 (1), S-4/A (1), SCHEDULE 13D (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 30, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Jun 26, 2026
Latest 8-K (8-K) Oct 6, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.00033 per share | PDSB | NASDAQ |
From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks PDS Biotechnology Corp names in Item 1A of its 10-K filed Mar 30, 2026: 68 risks under these headings, as written.4
- Risks Related to Our Business, Financial Position and Capital Requirements
- We have a limited operating history and have never generated any product revenue.
- We have incurred significant losses since our inception and expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
- We are dependent on the success of our Versamune®, PDS01ADC and Infectimune® products, which are still in clinical development, and if our Versamune®, PDS01ADC and Infectimune® products do not receive regulatory approval or are not successfully commercialized, our business may be harmed.
- We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our Versamune®, PDS01ADC and Infectimune® based products.
- Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
- Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness issued pursuant to the transactions contemplated by that certain securities purchase agreement with JGB, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.
- Our future success depends on our ability to retain executive officers and attract, retain and motivate qualified personnel.
- If we fail to obtain or maintain adequate coverage and reimbursement for PDS0101 or PDS01ADC, our ability to generate revenue could be limited.
- Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- We will need to expand our organization, and may experience difficulties in managing this growth, which could disrupt operations.
- Our employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
The other 57 risks
- Our business and operations would suffer, and could be negatively affected, in the event of system failures or cyberattacks.
- Our failure to comply with international data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
- Our failure to comply with state and/or national data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
- If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock. Further, we continue to incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.
- Periodic reporting requirements under the Exchange Act and compliance with the Sarbanes-Oxley Act of 2002, including establishing and maintaining acceptable internal control over financial reporting, are costly and may increase substantially and, as a smaller reporting company, we may take advantage of reduced reporting requirements which may make our common stock less attractive to investors.
- We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.
- Risks Related to Clinical Development, Regulatory Approval and Commercialization
- Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome, and if they fail to demonstrate safety and efficacy to the satisfaction of the FDA, or similar regulatory authorities, we will be unable to commercialize Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.
- Clinical drug development is a lengthy and expensive process, with an uncertain outcome. If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs, experience delays in completing, or ultimately be unable to complete, the development of our product candidates or be unable to obtain marketing approval.
- Enrollment and retention of subjects in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
- The successful development of immunotherapies is highly uncertain.
- We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
- We face significant competition from other biotechnology and biopharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- PDS0101 and PDS01ADC may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.
- If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, PDS0101 and PDS01ADC, and our ability to generate revenue will be impaired.
- If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less safe or effective than previously believed or causes undesirable side effects that were not previously identified, our ability, or that of any future collaborators, to market the drug could be compromised.
- We rely, and intend to continue to rely, on third parties to conduct our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased costs or we may be unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.
- Even if we obtain FDA approval in the United States, we may never obtain approval for or commercialize PDS0101 or PDS01ADC in any other jurisdiction, which would limit our ability to realize each product’s full market potential.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more subject data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
- The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, interim results of a clinical trial do not necessarily predict final results, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.
- Our product candidates are in various stages of development and we will not be able to commercialize our product candidates if our preclinical studies do not produce successful results and/or our clinical trials do not demonstrate the safety and efficacy of our product candidates; early results and early understanding of product candidate potential may not be predictive of later success.
- Even if we obtain regulatory approval, we will still face extensive ongoing regulatory requirements, and PDS0101, PDS01ADC and other candidates may face future development and regulatory difficulties.
- Even if PDS0101 or PDS01ADC receives licensure, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- If we fail to comply with federal and state healthcare regulatory laws, including in our relationships with healthcare providers and customers and third-party payors, we could face criminal prosecution and sanctions, substantial civil penalties, damages, fines, disgorgement, exclusion from participation in governmental healthcare programs, contractual damages, reputational harm, and the curtailment of our operations, any of which could harm our business.
- Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives, which could harm our business.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of PDS0101 and PDS01ADC.
- If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing PDS0101, PDS01ADC and other product candidates, if approved.
- If we obtain approval to commercialize PDS0101, PDS01ADC or other product candidates outside of the United States, a variety of risks associated with international operations could harm our business.
- Recently enacted and future healthcare legislation, regulations, and policy initiatives may increase the difficulty and cost for us to obtain marketing approval of and commercialize PDS0101, PDS01ADC or other product candidates and affect the prices we may obtain and our profitability.
- Risks Related to Our Dependence on Third Parties
- We have no manufacturing, sales, marketing or distribution capability and we must rely upon third parties for such.
- We intend to rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- If we are unable to establish or manage strategic collaborations in the future, our revenue and drug development may be limited.
- We enter into various contracts in the normal course of our business in which we may be obligated to indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.
- The failure of third parties to meet their contractual, legal, regulatory, and other obligations could adversely affect our business.
- Our business could be adversely affected by the effects of health epidemics, pandemics, or outbreaks of infectious diseases in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and/or maintain patent protection for our Versamune®, Versamune® in combination with PDS01ADC platforms, PDS0101, other Versamune® based Products or Infectimune®, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
- We may have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
- We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, or defend our products and methods against the property rights of others, which could be expensive, time consuming and unsuccessful.
- Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- General Market Risk Factors
- Our stock price is expected to be volatile, and the market price of our common stock may drop in the future.
- We are required to meet the Nasdaq Capital Market’s continued listing requirements and other Nasdaq rules, and if we fail to meet such rules and requirements, we may be subject to delisting. Delisting could negatively affect the price of our common stock, which could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.
- We do not anticipate that we will pay any cash dividends in the foreseeable future.
- Future sales of shares by existing stockholders could cause our stock price to decline.
- Because the Merger resulted in an ownership change under Section 382 of the Code for Edge, pre-merger U.S. net operating loss carryforwards and certain other tax attributes will be subject to limitations.
- Our effective tax rate may increase in the future, including as a result of tax legislation changes, which may have a material adverse effect on our business, financial condition and results of operations.
- Changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition.
- Anti-takeover provisions under Delaware law could make an acquisition more difficult and may prevent attempts by our stockholders to replace or remove our current or future management.
- Provisions in our amended and restated bylaws could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- We are currently operating in a period of global economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical conflicts, natural and man-made disasters, global health emergencies and uncertainties in regulatory developments and legislative actions, which could adversely affect our business, financial condition and results of operations.
- The political and economic environment in the United States could materially impact our business operations and financial performance, and uncertainty surrounding the potential legal, regulatory and policy changes by a new U.S. presidential administration may directly affect us and the global economy.
- Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data.
- Disruptions at the FDA, the SEC and other government agencies caused by funding shortages, government shutdowns or global health emergencies or their inability to hire, retain or deploy key leadership and other personnel, could prevent new or modified products from being developed, approved or commercialized in a timely manner or at all or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our operations.
- Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.
- Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
Legal proceedings
The information in Note 11 to the Consolidated Financial Statements contained in Part IV, Item 15 of this Annual Report on Form 10-K is incorporated herein by reference. There are no matters which constitute material pending legal proceedings to which we are a party other than those incorporated into this item by reference from Note 11 to our Consolidated Financial Statements for the year ended December 31, 2025 contained in this Annual Report on Form 10-K.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15SEC EDGARBrian A. Leuthner, President
- 16
- 17
- 18
- 19
- 20SEC EDGARAndrew Saik, Chief financial officer
- 21
- 22
- 23
- 24
- 25
- 26
- 27SEC EDGARLauren Wood, Chief Medical Officer
- 28SEC EDGARAlyssa Wyant, SVP Regulatory Affairs
- 29
- 30
- 31
- 32
- 33
- 34
- 35SEC EDGARArnold James Banaag, Board member
- 36SEC EDGARShiong Patrick Soon, Board member
- 37SEC EDGARKamil Ali-Jackson, Board member
- 38SEC EDGARIlian Iliev, Board member
- 39SEC EDGAROtis Brawley, Board member
- 40SEC EDGARDelyle W. Bloomquist, Board member
- 41SEC EDGARGregory Gene Freitag, Board member
- 42SEC EDGARRichard Sykes, Board member
- 43SEC EDGARSteve C. Glover, Board member
- 44SEC EDGARAndrew Saik, Board member
- 45SEC EDGARRosemary A. Crane, Board member
- 46SEC EDGARLiam Ratcliffe, Board member
- 47SEC EDGARAnders D. Hove, Board member
- 48SEC EDGARIsaac Blech, Board member
- 49SEC EDGARJames Healy, Board member
- 50SEC EDGARJames J. Loughlin, Board member
- 51SEC EDGARKurt G. Conti, Board member
- 52SEC EDGARRobert J. Spiegel, Board member
- 53SEC EDGARSol J. Barer, Board member
- 54SEC EDGARBrian A. Leuthner, Board member
- 55SEC EDGARSpencer D. Brown, General counsel
- 56SEC EDGAROther events
- 57SEC EDGAROther events
- 58SEC EDGAROther events
- 59
- 60
- 61
- 62
- 63SEC EDGARExecutive or director change
- 64
- 65SEC EDGARResults of operations
- 66SEC EDGARRegulation FD disclosure
- 67SEC EDGARListing notice or transfer
- 68NasdaqNasdaq calendar
- 69
- 70
- 71
- 72
- 73
- 74
- 75
- 76
- 77
- 78
- 79