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Share Name | Share Symbol | Market | Type |
---|---|---|---|
PDS Biotechnology Corporation | NASDAQ:PDSB | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.12 | -3.05% | 3.82 | 2.80 | 6.00 | 4.07 | 3.85 | 4.03 | 142,022 | 05:00:00 |
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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) |
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)) |
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
|
|
Press Release dated May 15, 2024.
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||
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document).
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PDS BIOTECHNOLOGY CORPORATION
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Date: May 15, 2024
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By: /s/ Frank Bedu-Addo, Ph.D.
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Name: Frank Bedu-Addo, Ph.D.
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||
Title: President and Chief Executive Officer
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• |
Hosted a Key Opinion Leader event on May 8, 2024 during which prominent experts in head and neck squamous cell cancer (“HNSCC”) discussed positive,
updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. A replay of the event can be found here.
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• |
Announced updated results from the VERSATILE-002 Phase 2 trial evaluating first line treatment of patients with HPV16-positive recurrent or metastatic HNSCC using Versamune® HPV + KEYTRUDA® (pembrolizumab) (n=53).
|
o |
Median overall survival is 30 months; Published results for immune checkpoint inhibitors are 7-18 months.
|
o |
The cohort met its primary endpoint of best overall response (BOR).
|
o |
BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1)
and <25% (CPS≥20).
|
■ |
CPS is used to assess PD-L1 expression
|
o |
Progression free survival is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.
|
o |
VERSATILE-002 data to date indicate a durable response in first line recurrent or metastatic HNSCC patients with CPS≥1.
|
o |
The combination of Versamune® HPV + pembrolizumab was well tolerated.
|
• |
Announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first line treatment
in HPV16-positive recurrent or metastatic HNSCC.
|
o |
PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune® HPV + PDS01ADC +
an investigational ICI conducted by the National Cancer Institute.
|
o |
Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.
|
o |
The randomized second part of the trial will include an interim data readout with overall survival as its primary endpoint.
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• |
Further strengthened management with the addition of Stephan Toutain, M.S., MBA, as Chief Operating Officer. Mr. Toutain brings extensive operational and commercial experience to PDS Biotech.
|
• |
Company received patents granted by the Israel Patent Office and IP Australia that will extend protections for the Company’s novel investigational T cell activating Versamune® platform through
Dec. 2038 and Nov. 2036, respectively.
|
o |
The Israel Patent Office granted patent No. 275154 titled, “Methods and compositions comprising cationic lipids for stimulating type I interferon genes,” extending protections for compositions
using the Versamune® platform and comprising of cationic lipid for activating type I interferons. This patent covers all formulations and compositions that include Versamune to activate a T cell response.
|
o |
IP Australia granted patent No. 2016354590 titled, “Lipids as synthetic vectors to enhance antigen processing and presentation ex-vivo in dendritic cell therapy.” This patent covers the use of
Versamune® compositions that reduce the populations of immune suppressive cells in the tumor and its application for the development of dendritic cell-based approaches to immunotherapy.
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Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Operating expenses:
|
||||||||
Research and development expenses
|
$
|
6,704,164
|
$
|
5,843,686
|
||||
General and administrative expenses
|
$
|
3,393,463
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$
|
3,578,728
|
||||
Total operating expenses
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$
|
10,097,627
|
$
|
9,422,414
|
||||
Loss from operations
|
$
|
(10,097,627
|
)
|
$
|
(9,422,414
|
)
|
||
Interest income (expense), net
|
||||||||
Interest income
|
$
|
668,895
|
$
|
729,341
|
||||
Interest expense
|
$
|
(1,174,745
|
)
|
$
|
(966,845
|
)
|
||
Interest income (expense), net
|
$
|
(505,850
|
)
|
$
|
(237,504
|
)
|
||
Net loss and comprehensive loss
|
$
|
(10,603,477
|
)
|
$
|
(9,659,918
|
)
|
||
Per share information:
|
||||||||
Net loss per share, basic and diluted
|
$
|
(0.30
|
)
|
$
|
(0.32
|
)
|
||
Weighted average common shares outstanding basic and diluted
|
34,815,870
|
30,428,053
|
March 31,
2024
|
December 31,
2023
|
|||||||
Cash and cash equivalents
|
$
|
66,634,417.00
|
$
|
56,560,517.00
|
||||
Working Capital
|
$
|
53,622,075.00
|
$
|
45,425,100.00
|
||||
Total assets
|
$
|
69,006,366.00
|
$
|
59,390,082.00
|
||||
Long term Debt
|
$
|
16,651,420.00
|
$
|
19,506,183.00
|
||||
Accumulated Deficit
|
$
|
(155,104,092.00
|
)
|
$
|
(144,500,613.00
|
)
|
||
Total stockholders’ equity
|
$
|
37,183,045.00
|
$
|
26,130,949.00
|
Document and Entity Information |
May 15, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | May 15, 2024 |
Entity File Number | 001-37568 |
Entity Registrant Name | PDS BIOTECHNOLOGY CORPORATION |
Entity Central Index Key | 0001472091 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 26-4231384 |
Entity Address, Address Line One | 303A College Road East |
Entity Address, City or Town | Princeton |
Entity Address, State or Province | NJ |
Entity Address, Postal Zip Code | 08540 |
City Area Code | 800 |
Local Phone Number | 208-3343 |
Title of 12(b) Security | Common Stock, par value $0.00033 per share |
Trading Symbol | PDSB |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
1 Year PDS Biotechnology Chart |
1 Month PDS Biotechnology Chart |
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