Phase 3 trial shift and cash update for PDS Biotech (NASDAQ: PDSB)
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
PDS Biotechnology reported full-year 2025 results and detailed progress in its cancer immunotherapy pipeline. Net loss narrowed to $34.5 million, or $0.74 per share, from $37.6 million, or $1.03, in 2024 as operating expenses declined.
Research and development spending fell to $19.0 million and general and administrative expenses to $12.5 million, bringing total operating expenses down to $31.5 million. Cash and cash equivalents were $26.7 million at year-end, with total stockholders’ equity of $9.3 million and long-term debt of $11.7 million.
The company updated its PDS0101 Phase 3 VERSATILE-003 trial, incorporating progression-free survival as an interim primary endpoint, which it expects will shorten trial duration and reduce costs while keeping overall survival for full approval. PDS Biotech also highlighted new U.S. and Japanese patents that extend Versamune® platform protection into the 2040s.
Positive
- None.
Negative
- None.
Insights
PDS Biotech reduced its 2025 loss, advanced key trials, but ended the year with modest cash and equity.
PDS Biotechnology reported a smaller 2025 net loss of $34.5 million versus $37.6 million in 2024, driven by lower research, manufacturing, and personnel costs. Total operating expenses dropped to $31.5 million, showing tighter spending as programs move into later-stage development.
Cash and cash equivalents were $26.7 million against long-term debt of $11.7 million and stockholders’ equity of $9.3 million, indicating a balance sheet that may require future funding as clinical work continues. Net interest expense rose to $4.1 million, partly from non-cash debt extinguishment.
On the clinical side, the Phase 3 VERSATILE-003 amendment uses progression-free survival as an interim primary endpoint, which the company expects will shorten trial duration and reduce costs while preserving overall survival for full approval. Expanded intellectual property, including new U.S. and Japanese patents extending Versamune® protection into the 2040s, supports longer-term commercialization potential if the lead programs succeed.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 30, 2026
(Exact Name of Registrant as Specified in Charter)
|
|
|
|
|
(State or Other Jurisdiction of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
(Address of Principal Executive Offices, and Zip Code)
(800 ) 208-3343
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
|
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which
registered
|
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐
| Item 2.02 |
Results of Operation and Financial Condition.
|
On March 30, 2026, PDS Biotechnology Corporation (the “Company”) issued a press release announcing a business update and its
financial results for the year ended December 31, 2025. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information set forth in this Current Report on Form 8-K (including
Exhibit 99.1) is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of the section, nor
shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 |
Financial Statements and Exhibits.
|
(d) Exhibits.
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press Release dated March 30, 2026.
|
|
|
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document).
|
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
|
PDS BIOTECHNOLOGY CORPORATION
|
||
|
Date: March 30, 2026
|
|
By: /s/ Frank Bedu-Addo, Ph.D.
|
|
Name: Frank Bedu-Addo, Ph.D.
|
||
|
Title: President and Chief Executive Officer
|
Exhibit 99.1
PDS Biotech Reports Full Year 2025 Financial Results and Provides Update on PDS0101 Phase 3 Program and PDS01ADC Clinical Advancement
Filed Phase 3 Amendment Incorporates PFS as Interim Primary Endpoint Expected to Shorten Trial Duration and Reduce Costs
Conference Call and Webcast Today at 8:00 am Eastern Time
PRINCETON, N.J., March 30, 2026 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming
how the immune system targets and kills cancers, today provided a business and clinical programs update and reported financial results for the quarter and year ended December 31, 2025.
"The fourth quarter capped a year of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, financial discipline, and intellectual
property portfolio," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "Building on the compelling topline data from our VERSATILE-002 Phase 2 trial, we believe the VERSATILE-003 protocol amendment has the potential to create a more
efficient path to accelerated approval — shortening the trial's duration, reducing costs, and accelerating our timeline to regulatory submission — while preserving overall survival as the basis for full approval. For patients living with
HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible."
Dr. Bedu-Addo added: “Combined with early data from one of our PDS01ADC Phase 2 programs and expanded patent protections for the Versamune® platform extending into the
2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026."
Clinical and Corporate Update
| • |
Amended the VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free
survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA
approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.
|
| • |
Presented encouraging early results from an NCI-led trial investigating PDS01ADC, the
Company's investigational IL-12 tumor-targeted immunocytokine, at the AACR special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer (mCRPC) the majority of whom received third-line
treatment options — the combination of PDS01ADC and docetaxel demonstrated encouraging median PFS of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% decline.
|
Strengthened the intellectual property estate for PDS0101 with
new patents granted in the U.S. and Japan. The new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across
major markets.
Full Year 2025 Financial Results
Net loss for the year ended December 31, 2025, was approximately $34.5 million, or $0.74 per basic and diluted share, compared to a net loss of $37.6 million, or $1.03 per
basic and diluted share for the year ended December 31, 2024.
Research and development expenses for the year ended December 31, 2025, were $19.0 million, compared to $22.6 million for the year ended December 31, 2024. The decrease of
$3.6 million was primarily attributable to decreases in manufacturing costs of $2.5 million and personnel costs of $1.8 million, partially offset by an increase in clinical costs of $0.7 million.
General and administrative expenses for the year ended December 31, 2025, were $12.5 million, compared to $13.8 million for the year ended December 31, 2024. The $1.3
million decrease was primarily attributable to a decrease in personnel costs.
Total operating expenses for the year ended December 31, 2025, were $31.5 million compared to $36.3 million for the year ended December 31, 2024.
Net interest expense was $4.1 million for the year ended December 31, 2025, compared to $2.2 million for the year ended December 31, 2024. The change was primarily due to
non-cash expenses related to extinguishment of debt, as well as lower interest income on the Company’s cash balances.
The Company’s cash balance as of December 31, 2025, was $26.7 million.
Conference Call Details
| • |
Date: March 30, 2026
|
| • |
Time: 8:00 a.m. Eastern Time
|
| • |
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
|
| • |
Conference I.D.: 13759288
|
| • |
Webcast: Click Here
|
| • |
CallMeTM: Click Here (available 15 minutes prior to the call)
|
After the live webcast, the event will be archived on PDS Biotech’s website for six months.
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the
immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy
PDS0101 is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
For more information, please visit www.pdsbiotech.com
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of
1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future
plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements
generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,”
“project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future
performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the
Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its
operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s
technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s
successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product
candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune® HPV), PDS01ADC,
PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the
future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding
response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected
expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the
final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs
and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important
factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other
factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements
are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a
result of new information, future events or otherwise.
Versamune® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Jude Gorman / Kiki Torpey
Collected Strategies
PDS-CS@collectedstrategies.com
---tables to follow---
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Selected Balance Sheet Data
(Unaudited)
|
December 31,
|
||||||||
|
2025
|
2024
|
|||||||
|
Cash and cash equivalents
|
$
|
26,711,969
|
$
|
41,689,591
|
||||
|
Working capital
|
$
|
18,770,871
|
$
|
27,967,242
|
||||
|
Total assets
|
$
|
30,494,083
|
$
|
45,358,657
|
||||
|
Long term debt
|
$
|
11,733,350
|
$
|
9,204,755
|
||||
|
Accumulated deficit
|
$
|
(216,606,503
|
)
|
$
|
(182,110,999
|
)
|
||
|
Total stockholders’ equity
|
$
|
9,251,833
|
$
|
19,004,848
|
||||
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
|
Year Ended December 31,
|
||||||||
|
2025
|
2024
|
|||||||
|
Operating expenses:
|
||||||||
|
Research and development expenses
|
$
|
19,025,831
|
$
|
22,565,524
|
||||
|
General and administrative expenses
|
12,518,127
|
13,755,671
|
||||||
|
Total operating expenses
|
$
|
31,543,958
|
$
|
36,321,195
|
||||
|
Loss from operations
|
$
|
(31,543,958
|
)
|
$
|
(36,321,195
|
)
|
||
|
Interest income (expense)
|
||||||||
|
Interest income
|
$
|
1,217,241
|
$
|
2,514,816
|
||||
|
Interest expense
|
(5,338,607
|
)
|
(4,673,174
|
)
|
||||
|
Interest income (expense), net
|
$
|
(4,121,366
|
)
|
$
|
(2,158,358
|
)
|
||
|
Loss before income taxes
|
$
|
(35,665,324
|
)
|
$
|
(38,479,553
|
)
|
||
|
Benefit from income taxes
|
1,169,820
|
869,169
|
||||||
|
Net loss and comprehensive loss
|
$
|
(34,495,504
|
)
|
$
|
(37,610,384
|
)
|
||
|
Per share information:
|
||||||||
|
Net loss per share, basic and diluted
|
$
|
(0.74
|
)
|
$
|
(1.03
|
)
|
||
|
Weighted average common shares outstanding basic and diluted
|
46,384,280
|
36,452,707
|
||||||
FAQ
How did PDSB’s net loss change in 2025 compared with 2024?
PDS Biotechnology’s net loss improved in 2025, narrowing to $34.5 million from $37.6 million in 2024. Loss per share declined to $0.74 from $1.03, reflecting reduced operating expenses in both research and development and general and administrative areas.
What were PDSB’s key operating expenses for full-year 2025?
In 2025, PDS Biotechnology reported $19.0 million in research and development expenses and $12.5 million in general and administrative expenses. Total operating expenses were $31.5 million, down from $36.3 million in 2024, indicating tighter cost control while advancing clinical programs.
What is notable about PDSB’s PDS0101 Phase 3 VERSATILE-003 trial update?
PDS Biotechnology amended its Phase 3 VERSATILE-003 trial to use progression-free survival as an interim primary endpoint. The company expects this change to shorten trial duration and reduce costs, while still relying on overall survival as the basis for potential full regulatory approval.
What was PDSB’s cash position and balance sheet at December 31, 2025?
At December 31, 2025, PDS Biotechnology held $26.7 million in cash and cash equivalents and total assets of $30.5 million. Long-term debt stood at $11.7 million, accumulated deficit at $216.6 million, and stockholders’ equity at $9.3 million.
How did interest income and expense affect PDSB’s 2025 results?
In 2025, PDS Biotechnology generated $1.2 million of interest income and incurred $5.3 million of interest expense. Net interest expense rose to $4.1 million from $2.2 million in 2024, largely due to non-cash debt extinguishment and lower interest income on cash balances.
What new intellectual property protections did PDSB secure for Versamune and PDS0101?
PDS Biotechnology strengthened its IP by gaining new U.S. and Japanese patents for PDS0101 and the Versamune® platform. The company states that the U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s, supporting potential long-term commercialization.
Filing Exhibits & Attachments
4 documents
Pds Biotechnology Corporation
NASDAQ:PDSB
PDSB Rankings
PDSB Latest News
PDSB Latest SEC Filings
Mar 30, 2026
[10-K] PDS Biotechnology Corp Files Annual Report