PDS Biotech (Nasdaq: PDSB) trims Q1 loss as R&D spending falls
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
PDS Biotechnology reported first quarter 2026 results and a clinical pipeline update. Net loss was about $7.3 million, or $0.13 per share, improving from a loss of $8.5 million, or $0.21 per share, a year earlier.
Research and development expenses fell to $3.5 million from $5.8 million, mainly from lower clinical and manufacturing costs, while general and administrative expenses edged down to $3.1 million. Cash and cash equivalents were $21.7 million as of March 31, 2026, with long‑term debt of $10.6 million and stockholders’ equity of $3.9 million.
Management highlighted progress on the amended VERSATILE‑003 Phase 3 trial in HPV16‑positive head and neck cancer and ongoing Phase 2 studies of PDS01ADC in metastatic colorectal and advanced castration‑resistant prostate cancers.
Positive
- None.
Negative
- None.
Insights
Loss narrows on lower R&D spending, but balance sheet remains thin.
PDS Biotechnology cut its Q1 2026 net loss to $7.3M from $8.5M, driven mainly by lower research and development costs, which fell to $3.5M from $5.8M. General and administrative expenses also declined slightly.
Cash and cash equivalents decreased to $21.7M, down from $26.7M at year‑end, while total stockholders’ equity dropped to $3.9M. Long‑term debt remained significant at $10.6M, and the accumulated deficit widened to nearly $224M, underscoring ongoing funding needs typical for a late‑stage immunotherapy company.
On the clinical side, the company is working to restart enrollment in the amended VERSATILE‑003 Phase 3 trial and continues multiple phase 2 studies of PDS01ADC. Subsequent updates in future quarters will clarify whether reduced R&D spending reflects efficiency gains or slower development pace.
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.
Key Figures
Net loss Q1 2026: $7,349,055
Net loss Q1 2025: $8,488,966
R&D expenses Q1 2026: $3,457,032
+5 more
8 metrics
Net loss Q1 2026
$7,349,055
Net loss and comprehensive loss for quarter ended March 31, 2026
Net loss Q1 2025
$8,488,966
Net loss and comprehensive loss for quarter ended March 31, 2025
R&D expenses Q1 2026
$3,457,032
Research and development expenses for quarter ended March 31, 2026
Total operating expenses Q1 2026
$6,521,087
Total operating expenses for quarter ended March 31, 2026
Cash and cash equivalents
$21,660,496
Balance as of March 31, 2026
Long-term debt
$10,605,985
Long-term debt as of March 31, 2026
Total stockholders’ equity
$3,892,643
Stockholders’ equity as of March 31, 2026
Weighted average shares
55,496,279 shares
Weighted average common shares outstanding basic and diluted Q1 2026
Key Terms
working capital, accumulated deficit, pivotal clinical trial, Phase 3 trial, +1 more
5 terms
working capital financial
"Working capital | | $ | 12,739,152 | | | $ | 18,770,871 |"
Working capital is the money a business has available to cover its daily expenses, like paying bills and buying supplies. It’s like the cash in your wallet that helps you handle everyday costs; having enough ensures the business can operate smoothly without running into money shortages.
accumulated deficit financial
"Accumulated deficit | | $ | (223,955,560 | ) | | $ | (216,606,504 | )"
Accumulated deficit is the running total of a company’s past net losses minus any profits, showing how much the business has eaten into its own funds over time—think of it like a bank account that’s been overdrawn by repeated shortfalls. It matters to investors because a large accumulated deficit reduces the cushion that protects owners and creditors, can limit dividends or borrowing, and signals how much funding the company may need to reach profitability.
pivotal clinical trial medical
"The Company has initiated a pivotal clinical trial to advance its lead program"
A pivotal clinical trial is a late-stage medical study designed to provide the main evidence regulators use to decide whether a drug or medical device can be approved and sold; think of it as the product’s final exam. For investors, the trial’s outcome is critical because a clear pass can unlock regulatory approval, market access and future revenue, while failure can halt commercialization and materially affect a company’s valuation.
Phase 3 trial medical
"restarting enrollment in the amended VERSATILE-003 Phase 3 trial"
A Phase 3 trial is a large, late-stage test of a new drug or medical treatment done on many people to make sure it really works and is safe. For investors, it matters because a successful Phase 3 usually means the company can ask regulators to sell the product and could earn lots of money, while failure can sharply reduce the company’s value.
forward-looking statements regulatory
"This communication contains forward-looking statements (including within the meaning of Section 21E"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Earnings Snapshot
Net loss: $7,349,055
Q1 2026
Net loss
$7,349,055
R&D expenses
$3,457,032
G&A expenses
$3,064,055
Total operating expenses
$6,521,087
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): May 13, 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 May 13, 2026, PDS Biotechnology Corporation (the “Company”) issued a press release announcing a business update and its
financial results for the quarter ended March 31, 2026. 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 May 13, 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: May 13, 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 First Quarter 2026 Financial Results and Provides Clinical Programs and Corporate Update
Investor Webcast Scheduled for 8:00 am ET
PRINCETON, N.J., May 13, 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 ended March 31, 2026.
“During the first quarter, we made meaningful clinical and regulatory progress across our clinical pipeline,” said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech.
“We work towards restarting enrollment in the amended VERSATILE-003 Phase 3 trial. With regards to PDS01ADC, we have completed enrollment in the metastatic colorectal cancer trial, and the advanced castration resistant prostate cancer trial
continues to recruit well”.
Dr. Bedu-Addo continued: “We believe the progress achieved during the quarter reflects the continued advancement and maturation of our clinical portfolio. We remain
focused on advancing potentially differentiated immunotherapy candidates designed to address significant unmet medical needs for patients with difficult-to-treat cancers”.
Clinical and Corporate Update
| • |
Amended 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.
|
| • |
Announced publication of positive clinical and immunological biomarker data from Stage 1 of
NCI-led Metastatic Colorectal Cancer (mCRC) trial evaluating PDS01ADC, the Company’s tumor-targeted IL-12 immunocytokine. The results, published in the March issue of Journal of Clinical Oncology (JCO) Oncology Advances, included:
|
| o |
Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20)
|
| o |
24-month survival rate approximately 85%; in the parallel trial without PDS01ADC, the 24-month survival rate was approximately 40%
|
| o |
Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS01ADC, the PFS was 8.1 months
|
| • |
Presented encouraging early results from an NCI-led trial investigating PDS01ADC 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.
|
First Quarter 2026 Financial Results
Reported net loss for the quarter ended March 31, 2026, was approximately $7.3 million, or $0.13 per basic and diluted share, compared to a net loss of $8.5 million, or
$0.21 per basic and diluted share for the quarter ended March 31, 2025.
Research and development expenses for the quarter ended March 31, 2026, were $3.5 million, compared to $5.8 million for the quarter ended March 31, 2025. The decrease was
primarily due to lower clinical and manufacturing costs.
General and administrative expenses for the year ended March 31, 2026, were $3.1 million, compared to $3.3 million for the year ended March 31, 2025. The decrease was
primarily due to lower professional fees.
Total operating expenses for the year ended March 31, 2026, were $6.5 million compared to $9.1 million for the quarter ended March 31, 2025.
Net interest expense was $0.8 million for the quarter ended March 31, 2026, compared to $0.6 million for the quarter ended March 31, 2025.
The Company’s cash balance as of March 31, 2026, was $21.7 million.
Conference Call Details
| • |
Date: May 13, 2026
|
| • |
Time: 8:00 a.m. Eastern Time
|
| • |
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
|
| • |
Conference I.D.: 13760368
|
| • |
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, PDS01ADC, PDS0103 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)
|
March 31,
|
December 31,
|
|||||||
|
2026
|
2025
|
|||||||
|
Cash and cash equivalents
|
$
|
21,660,496
|
$
|
26,711,969
|
||||
|
Working capital
|
$
|
12,739,152
|
$
|
18,770,871
|
||||
|
Total assets
|
$
|
24,663,026
|
$
|
30,494,083
|
||||
|
Long term debt
|
$
|
10,605,985
|
$
|
11,733,350
|
||||
|
Accumulated deficit
|
$
|
(223,955,560
|
)
|
$
|
(216,606,504
|
)
|
||
|
Total stockholders’ equity
|
$
|
3,892,643
|
$
|
9,251,833
|
||||
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
|
Three Months Ended Mar 31,
|
||||||||
|
2026
|
2025
|
|||||||
|
Operating expenses:
|
||||||||
|
Research and development expenses
|
$
|
3,457,032
|
$
|
5,830,999
|
||||
|
General and administrative expenses
|
3,064,055
|
3,274,759
|
||||||
|
Total operating expenses
|
$
|
6,521,087
|
$
|
9,105,758
|
||||
|
Loss from operations
|
$
|
(6,521,087
|
)
|
$
|
(9,105,758
|
)
|
||
|
Interest income (expense)
|
||||||||
|
Interest income
|
$
|
186,814
|
$
|
377,849
|
||||
|
Interest expense
|
(1,014,782
|
)
|
(930,878
|
)
|
||||
|
Interest income (expense), net
|
$
|
(827,968
|
)
|
$
|
(553,028
|
)
|
||
|
Loss before income taxes
|
$
|
(7,349,055
|
)
|
$
|
(9,658,786
|
)
|
||
|
Benefit from income taxes
|
-
|
1,169,820
|
||||||
|
Net loss and comprehensive loss
|
$
|
(7,349,055
|
)
|
$
|
(8,488,966
|
)
|
||
|
Per share information:
|
||||||||
|
Net loss per share, basic and diluted
|
$
|
(0.13
|
)
|
$
|
(0.21
|
)
|
||
|
Weighted average common shares outstanding basic and diluted
|
55,496,279
|
40,521,001
|
||||||
FAQ
How did PDS Biotechnology (PDSB) perform financially in Q1 2026?
PDS Biotechnology reported a net loss of about $7.3 million, or $0.13 per share, for Q1 2026. This improved from a net loss of $8.5 million, or $0.21 per share, in Q1 2025 as operating expenses declined.
What were PDS Biotechnology’s operating expenses in Q1 2026?
Total operating expenses were $6.5 million in Q1 2026, down from $9.1 million a year earlier. Research and development expenses fell to $3.5 million, while general and administrative expenses declined to about $3.1 million, reflecting lower clinical, manufacturing, and professional costs.
What is PDS Biotechnology’s cash position as of March 31, 2026?
As of March 31, 2026, PDS Biotechnology held $21.7 million in cash and cash equivalents. Working capital stood at roughly $12.7 million, with total assets of about $24.7 million, long‑term debt of $10.6 million, and stockholders’ equity of $3.9 million.
How did PDS Biotechnology’s R&D and G&A expenses change year over year?
Research and development expenses decreased to $3.5 million in Q1 2026 from $5.8 million in Q1 2025, mainly due to lower clinical and manufacturing costs. General and administrative expenses dipped slightly to about $3.1 million from $3.3 million, driven by reduced professional fees.
What clinical programs did PDS Biotechnology highlight in its Q1 2026 update?
The company emphasized progress on the amended VERSATILE‑003 Phase 3 trial in advanced HPV16‑positive head and neck cancer. It also reported completed enrollment in a metastatic colorectal cancer trial of PDS01ADC and continued recruitment in an advanced castration‑resistant prostate cancer trial.
What is PDS Biotechnology’s lead immunotherapy program?
PDS Biotechnology’s lead investigational immunotherapy, PDS0101, targets HPV16‑positive head and neck cancers. It is being developed in combination with a standard‑of‑care immune checkpoint inhibitor and in a triple regimen with PDS01ADC and a checkpoint inhibitor in advanced cancer settings.