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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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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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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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| Item 2.02 |
Results of Operation and Financial Condition.
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| Item 9.01 |
Financial Statements and Exhibits.
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Exhibit
Number
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Description
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|
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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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PDS BIOTECHNOLOGY CORPORATION
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||
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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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| • |
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:
|
| o |
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)
|
| o |
24-month survival rate approximately 80%; in the parallel trial without PDS0301, the 24-month survival rate was approximately 35%
|
| o |
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
|



|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
|
2026
|
2025
|
2026
|
2025
|
|||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development expenses
|
$
|
3,265,586
|
$
|
4,212,918
|
$
|
6,722,618
|
$
|
10,043,918
|
||||||||
|
General and administrative expenses
|
3,231,148
|
3,410,433
|
6,295,203
|
6,685,191
|
||||||||||||
|
Total operating expenses
|
$
|
6,496,734
|
$
|
7,623,351
|
$
|
13,017,821
|
$
|
16,729,109
|
||||||||
|
Loss from operations
|
$
|
(6,496,734
|
)
|
$
|
(7,623,351
|
)
|
$
|
(13,017,821
|
)
|
$
|
(16,729,109
|
)
|
||||
|
Interest income (expense)
|
||||||||||||||||
|
Interest income
|
$
|
125,405
|
$
|
333,624
|
$
|
312,219
|
$
|
711,473
|
||||||||
|
Interest expense
|
(3,379,246
|
)
|
(2,144,481
|
)
|
(4,394,029
|
)
|
(3,075,359
|
)
|
||||||||
|
Interest income (expense), net
|
$
|
(3,253,841
|
)
|
$
|
(1,810,857
|
)
|
$
|
(4,081,810
|
)
|
$
|
(2,363,886
|
)
|
||||
|
Loss before income taxes
|
$
|
(9,750,575
|
)
|
$
|
(9,434,208
|
)
|
$
|
(17,099,631
|
)
|
$
|
(19,092,995
|
)
|
||||
|
Benefit from income taxes
|
-
|
-
|
-
|
1,169,820
|
||||||||||||
|
Net loss and comprehensive loss
|
$
|
(9,750,575
|
)
|
$
|
(9,434,208
|
)
|
$
|
(17,099,631
|
)
|
$
|
(17,923,175
|
)
|
||||
|
Per share information:
|
||||||||||||||||
|
Net loss per share, basic and diluted
|
$
|
(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
|
||||||||||||
|
June 30,
2026
|
December 31,
2025
|
|||||||
|
Cash and cash equivalents
|
$
|
5,596,254
|
$
|
26,711,969
|
||||
|
Working capital
|
$
|
(5,332,283
|
)
|
$
|
18,770,871
|
|||
|
Total assets
|
$
|
8,807,213
|
$
|
30,494,083
|
||||
|
Long term debt
|
$
|
-
|
$
|
11,733,350
|
||||
|
Accumulated deficit
|
$
|
(233,706,135
|
)
|
$
|
(216,606,504
|
)
|
||
|
Total stockholders’ equity
|
$
|
(3,579,739
|
)
|
$
|
9,251,833
|
|||