PDS Biotechnology (PDSB) refocuses on PDS0301 as cash falls to $5.6M
Rhea-AI Filing Summary
PDS Biotechnology Corporation reported second quarter 2026 results and outlined a strategic refocus. Management is prioritizing lead program PDS0301, a tumor-targeted IL-12 immunocytokine, and will cease further internal investment in PDS0101, including discontinuation of the VERSATILE-003 Phase 3 trial, while seeking partnerships or other externally funded paths for PDS0101.
For the quarter ended June 30, 2026, net loss was $9.8 million, or $0.18 per share, versus $9.4 million, or $0.21 per share, a year earlier. Research and development expenses declined to $3.3 million from $4.2 million, and general and administrative expenses declined to $3.2 million from $3.4 million, leading to total operating expenses of $6.5 million versus $7.6 million. Net interest expense increased to $3.3 million, largely due to a non-cash loss on retirement of debt.
At June 30, 2026, cash and cash equivalents were $5.6 million. Working capital was $(5.3) million, total stockholders’ equity was $(3.6) million, and accumulated deficit reached $233.7 million, reflecting ongoing losses despite reduced operating spending.
Positive
- Total operating expenses fell to $6.5 million from $7.6 million, driven by lower research and development and general and administrative costs, indicating tighter cost control.
- Research and development expenses decreased to $3.3 million from $4.2 million, primarily from lower clinical, manufacturing and personnel costs, extending the utility of limited capital resources.
Negative
- Cash and cash equivalents declined to $5.6 million from $26.7 million over six months, significantly reducing liquidity.
- Working capital swung to $(5.3) million from $18.8 million, signaling near-term balance sheet pressure.
- Total stockholders’ equity turned negative at $(3.6) million compared with $9.3 million at year-end 2025, reflecting cumulative losses and a weakened capital position.
- Net interest expense rose to $3.3 million from $2.1 million in the quarter, mainly due to a non-cash loss on retirement of debt, adding to overall net loss.
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 Q2 2026: $9,750,575
Net loss per share Q2 2026: $0.18
Total operating expenses Q2 2026: $6,496,734
+5 more
8 metrics
Net loss Q2 2026
$9,750,575
Net loss and comprehensive loss for the three months ended June 30, 2026
Net loss per share Q2 2026
$0.18
Basic and diluted net loss per share for the three months ended June 30, 2026
Total operating expenses Q2 2026
$6,496,734
Total operating expenses for the three months ended June 30, 2026
Net interest expense Q2 2026
$3,253,841
Interest income (expense), net for the three months ended June 30, 2026
Cash and cash equivalents
$5,596,254
Cash and cash equivalents as of June 30, 2026
Working capital
$(5,332,283)
Working capital as of June 30, 2026
Total stockholders’ equity
$(3,579,739)
Total stockholders’ equity as of June 30, 2026
Weighted average shares Q2 2026
55,659,669
Weighted average common shares outstanding, basic and diluted, three months ended June 30, 2026
Key Terms
immunocytokine, tumor microenvironment, working capital, accumulated deficit, +2 more
6 terms
immunocytokine medical
"PDS0301, its tumor-targeted IL-12 immunocytokine, as its lead development program"
An immunocytokine is a lab-designed medicine that fuses a targeting antibody with an immune signaling protein so the immune response is directed to specific cells or tissue. Think of it as a guided package that brings a signal to rally the body's defenses where needed; investors pay attention because this targeted approach can improve effectiveness, reduce side effects, and strongly influence clinical results, approvals, and commercial value.
tumor microenvironment medical
"designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing"
The tumor microenvironment is the immediate area surrounding a cancer cell, made up of nearby cells, blood vessels, and support structures that influence how the cancer grows and spreads. It functions like a bustling neighborhood that can either help or hinder the tumor’s development. For investors, understanding changes in this environment can signal the effectiveness of treatments and potential shifts in a cancer-related market.
working capital financial
"Working capital | | $ | (5,332,283 | ) | | $ | 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 | | $ | (233,706,135 | ) | | $ | (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.
going concern financial
"the Company’s ability to continue as a going concern; the anticipated benefits of the Company"
Going concern is the accounting assumption that a company will keep operating and meeting its obligations for the foreseeable future. The phrase matters most when a company or its auditors disclose substantial doubt about it, a formal warning that the business may not have enough resources to continue without raising money, restructuring, or selling assets. That language in a filing or press release signals elevated financial risk.
loss on retirement of debt financial
"increase was primarily due to a non-cash charge for loss on retirement of debt, partially offset"
Earnings Snapshot
Net loss Q2 2026: $9,750,575
Quarter and six months ended June 30, 2026
Net loss Q2 2026
$9,750,575
Compared with $9,434,208 for Q2 2025
Total operating expenses Q2 2026
$6,496,734
Compared with $7,623,351 for Q2 2025
Net loss six months 2026
$17,099,631
Compared with $17,923,175 for six months 2025
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What strategic change did PDSB announce for its pipeline?
PDS Biotechnology refocused its strategy to prioritize PDS0301, its tumor-targeted IL-12 immunocytokine, as the lead program and will stop internal investment in PDS0101, including the VERSATILE-003 Phase 3 trial, while seeking partnerships for further PDS0101 development.
What was PDSB’s net loss for the second quarter of 2026?
PDS Biotechnology reported a net loss of $9.8 million, or $0.18 per share, for the three months ended June 30, 2026, compared with a net loss of $9.4 million, or $0.21 per share, for the same period in 2025.
How did operating expenses change for PDSB in Q2 2026?
Total operating expenses decreased to $6.5 million from $7.6 million a year earlier, as research and development expenses fell to $3.3 million and general and administrative expenses declined to $3.2 million, mainly from lower clinical, manufacturing, personnel and professional fees.
What is PDSB’s cash position and working capital as of June 30, 2026?
As of June 30, 2026, PDS Biotechnology held $5.6 million in cash and cash equivalents and reported working capital of $(5.3) million, highlighting constrained short-term liquidity compared with year-end 2025 balances.
What happened to PDSB’s debt and equity levels in 2026?
By June 30, 2026, PDS Biotechnology’s long-term debt was reduced to $0 from $11.7 million, but total stockholders’ equity fell to $(3.6) million from $9.3 million, reflecting cumulative losses despite debt elimination.
How is PDSB positioning PDS0101 after its strategic review?
PDS Biotechnology will no longer fund PDS0101 internally, including stopping the VERSATILE-003 Phase 3 trial, but intends to pursue strategic partnerships or other externally funded opportunities to continue PDS0101’s development.
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): August 13, 2026
(Exact Name of Registrant as Specified in Charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(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):
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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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.
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On August 13, 2026, PDS Biotechnology Corporation (the “Company”) issued a press release announcing a business
update and its financial results for the quarter ended June 30, 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.
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(d) Exhibits.
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Exhibit
Number
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Description
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99.1
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Press Release dated August 13, 2026.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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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.
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PDS BIOTECHNOLOGY CORPORATION
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Date: August 13, 2026
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By: /s/ Frank Bedu-Addo, Ph.D.
Name: Frank Bedu-Addo, Ph.D.
Title: President and Chief Executive Officer
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Exhibit 99.1
PDS Biotech Reports Second Quarter 2026 Financial Results
PRINCETON, N.J., August 13, 2026 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage biotechnology company focused on
developing targeted immunotherapies for cancer, today provided a business and clinical programs update and reported financial results for the quarter ended June 30, 2026.
Clinical and Corporate Update
| • |
Announced publication of positive clinical and immunological biomarker data from Stage 1 of the NCI-led metastatic colorectal cancer (mCRC) Phase 2, open-label, single-center,
non-randomized clinical trial evaluating PDS0301 (formerly PDS01ADC), the Company’s tumor-targeted IL-12 immunocytokine. The clinical trial results, published in the March 2026 issue of the Journal of Clinical Oncology (JCO) Oncology
Advances, included:
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Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS0301, the ORR was 35% (7/20)
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24-month survival rate approximately 80%; in the parallel trial without PDS0301, the 24-month survival rate was approximately 35%
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Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS0301, the PFS was 8.1 months
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On August 11, 2026, the Company issued a shareholder letter outlining its strategic refocus to prioritize PDS0301, its tumor-targeted IL-12 immunocytokine, as
its lead development program. As part of this strategy, the Company will cease further internal investment in PDS0101, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intends to pursue strategic partnerships or other
externally funded opportunities for the continued development of PDS0101. The Company believes that concentrating its capital and development resources on PDS0301, while maintaining financial discipline and preserving the potential value of
PDS0101 through partnerships, may provide the strongest path toward
creating long-term value for patients and shareholders.
Second Quarter 2026 Financial Results
Reported net loss was $9.8 million, or $0.18 per basic and diluted share, for the three months ended June 30, 2026, compared to $9.4 million, or $0.21 per basic and
diluted share, for the three months ended June 30, 2025.
Research and development expenses were $3.3 million for the three months ended June 30, 2026, compared to $4.2 million for the three months ended June 30, 2025. The
decrease was primarily attributable to lower clinical trial costs, manufacturing costs and personnel costs, partially offset by higher stock-based compensation expense.
General and administrative expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.4 million for the three months ended June 30, 2025. The
decrease was primarily attributable to a decrease in professional fees.
Total operating expenses were $6.5 million for the three months ended June 30, 2026, compared to $7.6 million for the three months ended June 30, 2025.
Net interest expenses were $3.3 million for the three months ended June 30, 2026, compared to $1.8 million for the three months ended June 30, 2025. The increase was
primarily due to a non-cash charge for loss on retirement of debt, partially offset by lower cash interest payments.
The Company’s cash balance as of June 30, 2026, was $5.6 million.
About PDS Biotechnology
PDS Biotechnology is a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer. Following a strategic review, the Company has
prioritized PDS0301, its investigational tumor-targeted interleukin-12 (IL-12) immunocytokine, as its lead development program. PDS0301 is designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing anti-tumor
immune activity while limiting systemic exposure. PDS0301 has been clinically evaluated across multiple solid tumors, including metastatic colorectal cancer and prostate cancer. The Company is focused on advancing PDS0301 in indications where its
tumor-targeted mechanism and potential to modify the tumor microenvironment may complement established and emerging cancer therapies and help address mechanisms of treatment resistance. PDS Biotechnology also owns the Versamune® platform, including
PDS0101, which has been evaluated in HPV16-positive cancers. Following its strategic review, the Company decided to prioritize its capital and development resources toward PDS0301 and intends to pursue strategic partnerships or other externally
funded opportunities for the continued development of PDS0101.
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 PDS0301 (formerly 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, PDS0301, 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; the anticipated benefits of the Company strategic refocus on PDS0301; the Company’s ability to identify, negotiate and consummate strategic partnerships or other externally funded opportunities for PDS0101; the Company’s ability to
preserve, realize or enhance the value of its development programs; the Company’s expectations regarding the timing, availability and sufficiency of capital resources to execute its business strategy; 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
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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Three Months Ended June 30,
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Six Months Ended June 30,
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|||||||||||||||
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2026
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2025
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2026
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2025
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Operating expenses:
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||||||||||||||||
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Research and development expenses
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$
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3,265,586
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$
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4,212,918
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$
|
6,722,618
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$
|
10,043,918
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||||||||
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General and administrative expenses
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3,231,148
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3,410,433
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6,295,203
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6,685,191
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||||||||||||
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Total operating expenses
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$
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6,496,734
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$
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7,623,351
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$
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13,017,821
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$
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16,729,109
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||||||||
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Loss from operations
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$
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(6,496,734
|
)
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$
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(7,623,351
|
)
|
$
|
(13,017,821
|
)
|
$
|
(16,729,109
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)
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||||
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Interest income (expense)
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||||||||||||||||
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Interest income
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$
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125,405
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$
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333,624
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$
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312,219
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$
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711,473
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||||||||
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Interest expense
|
(3,379,246
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)
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(2,144,481
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)
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(4,394,029
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)
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(3,075,359
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)
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||||||||
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Interest income (expense), net
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$
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(3,253,841
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)
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$
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(1,810,857
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)
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$
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(4,081,810
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)
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$
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(2,363,886
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)
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||||
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Loss before income taxes
|
$
|
(9,750,575
|
)
|
$
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(9,434,208
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)
|
$
|
(17,099,631
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)
|
$
|
(19,092,995
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)
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||||
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Benefit from income taxes
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-
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-
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-
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1,169,820
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||||||||||||
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Net loss and comprehensive loss
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$
|
(9,750,575
|
)
|
$
|
(9,434,208
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)
|
$
|
(17,099,631
|
)
|
$
|
(17,923,175
|
)
|
||||
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Per share information:
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||||||||||||||||
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Net loss per share, basic and diluted
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$
|
(0.18
|
)
|
$
|
(0.21
|
)
|
$
|
(0.31
|
)
|
$
|
(0.41
|
)
|
||||
|
Weighted average common shares outstanding basic and diluted
|
55,659,669
|
45,902,502
|
55,659,669
|
43,226,618
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||||||||||||
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Selected Balance Sheet Data
(Unaudited)
|
June 30,
2026
|
December 31,
2025
|
|||||||
|
Cash and cash equivalents
|
$
|
5,596,254
|
$
|
26,711,969
|
||||
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Working capital
|
$
|
(5,332,283
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)
|
$
|
18,770,871
|
|||
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Total assets
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$
|
8,807,213
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$
|
30,494,083
|
||||
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Long term debt
|
$
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-
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$
|
11,733,350
|
||||
|
Accumulated deficit
|
$
|
(233,706,135
|
)
|
$
|
(216,606,504
|
)
|
||
|
Total stockholders’ equity
|
$
|
(3,579,739
|
)
|
$
|
9,251,833
|
|||