SEC Form 10-Q filed by PDS Biotechnology Corporation
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(
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(Registrant’s telephone number)
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(Former name, former address and former fiscal year, if changed since last report)
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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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The
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Large accelerated filer ☐
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Accelerated filer ☐
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Smaller Reporting Company
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Emerging growth company
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Page
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Part I — Financial Information
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Item 1.
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Financial Statements (Unaudited):
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3
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4
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5
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6
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7
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Item 2.
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17
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Item 3.
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32
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Item 4.
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33
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Part II — Other Information
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33
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Item 1.
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33
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Item 1A.
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33
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Item 2.
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33
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Item 3.
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33
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Item 4.
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33
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Item 5.
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33
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Item 6.
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33
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34
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35
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PART 1.
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FINANCIAL INFORMATION
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ITEM 1.
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FINANCIAL STATEMENTS
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June 30, 2024
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December 31, 2023
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ASSETS
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(unaudited)
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Current assets:
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Cash and cash equivalents
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$
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$
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||||
Prepaid expenses and other assets
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Total current assets
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Property and equipment, net
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Financing lease right-to-use assets
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Total assets
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$
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$
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||||||
Current liabilities:
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||||||||
Accounts payable
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$
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$
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Accrued expenses
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Note payable - short term
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||||||||
Financing lease obligation-short term
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Total current liabilities
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Noncurrent liabilities:
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Note payable, net of debt discount
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Financing lease obligation-long term
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Total liabilities:
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$
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$
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Commitments and contingencies (Note 9)
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STOCKHOLDERS’ EQUITY
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||||||||
Common stock, $
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Additional paid-in capital
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||||||
Accumulated deficit
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(
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)
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(
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)
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Total stockholders’ equity
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||||||
Total liabilities and stockholders’ equity
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$
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$
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Three Months Ended June 30,
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Six Months Ended June 30,
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|||||||||||||||
2024
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2023
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2024
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2023
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|||||||||||||
Operating expenses:
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||||||||||||||||
Research and development expenses
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$
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$
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$
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$
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||||||||
General and administrative expenses
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Total operating expenses
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Loss from operations
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(
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)
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(
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)
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(
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)
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(
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)
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||||||||
Interest income (expenses), net
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||||||||||||||||
Interest income
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Interest expense
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( |
) | ( |
) | ( |
) | ( |
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Interest income (expenses), net | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Loss before income taxes |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Benefit for income taxes |
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Net loss and comprehensive loss
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(
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)
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(
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)
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(
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)
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(
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)
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||||||||
Per share information:
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||||||||||||||||
Net loss per share, basic and diluted
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$
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(
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)
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$
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(
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)
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$
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(
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)
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$
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(
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)
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||||
Weighted average common shares outstanding, basic, and diluted
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Common Stock
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||||||||||||||||||||
Shares
Issued
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Amount
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Additional
Paid-in
Capital
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Accumulated
Deficit
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Total Equity
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||||||||||||||||
January 1, 2023
|
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$
|
|
$
|
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$
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(
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)
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$
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|
||||||||||
Stock-based compensation expense
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–
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|||||||||||||||
Issuances of common stock from the Sales Agreement, net |
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|||||||||||||||
Net loss
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–
|
|
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(
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)
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(
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)
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|||||||||||||
Balance - March 31, 2023
|
|
$
|
|
$
|
|
$
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(
|
)
|
$
|
|
||||||||||
Stock based compensation expense
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–
|
|
|
|
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|||||||||||||||
Issuances of common stock, from exercise of stock options
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|||||||||||||||
Issuance of common stock for consulting agreement |
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Issuances of common stock from the Sales Agreement, net |
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Net loss
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–
|
|
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(
|
)
|
(
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)
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|||||||||||||
Balance - June 30, 2023
|
|
$
|
|
$
|
|
$
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(
|
)
|
$
|
|
Common Stock
|
||||||||||||||||||||
Shares
Issued
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Amount
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Additional
Paid-in
Capital
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Accumulated
Deficit
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Total Equity
|
||||||||||||||||
January 1, 2024
|
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$
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$
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$
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(
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)
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$
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|
||||||||||
Stock-based compensation expense
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–
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|||||||||||||||
Issuances of common stock from the Sales Agreement, net |
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|||||||||||||||
Issuances of common stock, from exercise of stock options | ||||||||||||||||||||
Net loss
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–
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(
|
)
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(
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)
|
|||||||||||||
Balance - March 31, 2024
|
|
$
|
|
$
|
|
$
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(
|
)
|
$
|
|
||||||||||
Stock-based compensation expense
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–
|
|
|
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|||||||||||||||
Issuances of common stock for consulting agreement |
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Net loss
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–
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|
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(
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)
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(
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)
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|||||||||||||
Balance - June 30, 2024
|
|
$
|
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$
|
|
$
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(
|
)
|
$
|
|
Six Months Ended June 30,
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||||||||
2024
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2023
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|||||||
Cash flows from operating activities:
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||||||||
Net loss
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$
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(
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)
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$
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(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
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||||||||
Stock-based compensation expense
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Issuance of shares in consulting agreement |
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Amortization of debt discount
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Depreciation expense
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Operating lease expense
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Finance lease depreciation expense
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Changes in assets and liabilities:
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||||||||
Prepaid expenses and other assets
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(
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)
|
|||||
Accounts payable
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(
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)
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|
|||||
Accrued expenses
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(
|
)
|
(
|
)
|
||||
Operating lease liabilities
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(
|
)
|
|||||
Net cash used in operating activities
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(
|
)
|
(
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)
|
||||
Cash flows from investing activities:
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||||||||
Purchase of equipment |
( |
) | ||||||
Net cash used in investing activities
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( |
) | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from exercise of stock options
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||||||||
Payments of finance lease obligations
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(
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)
|
( |
) | ||||
Proceeds from issuance of common stock, net of issuance costs
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||||||||
Net cash provided by financing activities
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|||||||
Net increase in cash and cash equivalents
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(
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)
|
|||||
Cash and cash equivalents at beginning of period
|
|
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||||||
Cash and cash equivalents at the end of period | $ | $ | ||||||
Supplemental information of cash and non-cash transactions:
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||||||||
Cash paid for interest
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$
|
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$
|
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(A) |
Unaudited interim financial statements:
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(B) |
Use of estimates:
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(C) |
Significant risks and uncertainties:
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(D) |
Cash equivalents and concentration of cash balance:
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(E) |
Research and development:
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(F) |
Patent costs:
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(G) |
Stock-based compensation:
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(H) |
Net loss per common share:
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As of June 30,
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||||||||
2024
|
2023
|
|||||||
Stock options to purchase Common Stock
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|
||||||
Warrants to purchase Common Stock
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||||||
Total
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(I) |
Income taxes:
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(J)
|
Fair value of financial instruments:
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● |
Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the
measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.
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● |
Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g.,
quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models
or other valuation methodologies.
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● |
Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using
pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.
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(K)
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Leases:
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(L)
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New accounting standards:
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Fair Value Measurements at Reporting Date Using
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||||||||||||||||
Total
|
Quoted Prices in
Active Markets
(Level 1)
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Quoted Prices in
Inactive Markets
(Level 2)
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Significant
Unobservable Inputs
(Level 3)
|
|||||||||||||
As of June 30, 2024: (unaudited)
|
||||||||||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
As of December 31, 2023
|
||||||||||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
$
|
|
$
|
|
As of June 30,
|
||||||||
2024
|
2023
|
|||||||
Cash paid for operating lease liabilities
|
$
|
|
$
|
|
As of June 30,
|
||||||||
2024
|
2023
|
|||||||
Cash paid for finance lease liabilities
|
$
|
|
|
$ |
|
|
Year ended December 31,
|
||||
2024
|
$
|
|
||
2025
|
|
|||
2026
|
|
|||
2027
|
|
|||
2028 and after
|
|
|||
Total future minimum lease payments
|
|
|||
Less imputed interest
|
(
|
)
|
||
Remaining lease liability
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$
|
|
As of
June 30, 2024
|
As of
December 31, 2023
|
|||||||
Accrued research and development
|
$
|
|
$
|
|
||||
Accrued professional fees
|
|
|
||||||
Accrued compensation
|
|
|
||||||
Accrued interest on debt
|
||||||||
Accrued rent | ||||||||
Total
|
$
|
|
$
|
|
Three Months Ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Stock-Based Compensation
|
||||||||||||||||
Research and development
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
General and administrative
|
|
|
|
|
||||||||||||
Total
|
$
|
|
$
|
|
$
|
|
$
|
|
Three Months Ended June 30
|
Six Months Ended June 30,
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
Weighted
Average
|
Weighted
Average
|
Weighted
Average
|
Weighted
Average
|
|||||||||||||
(unaudited)
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(unaudited)
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|||||||||||||||
Volatility
|
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%
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%
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%
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%
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||||||||
Risk-Free Interest Rate
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%
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%
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%
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%
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Expected Term in Years
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||||||||||||
Dividend Rate
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||||||||||||
Fair Value of Option on Grant Date
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$
|
|
$
|
|
$
|
|
$
|
|
Number
of Shares
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Weighted
Average
Exercise Price
|
Weighted Average
Remaining
Contractual
Life in Years
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Aggregate
Intrinsic Value
|
|||||||||||||
Options outstanding at December 31, 2023
|
|
$
|
|
|
$
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||||||||||
Granted
|
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Exercised
|
(
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)
|
|
|||||||||||||
Forfeited and expired
|
(
|
)
|
|
|||||||||||||
Options outstanding at June 30, 2024
|
|
$
|
|
|
$
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||||||||||
Vested and expected to vest at June 30, 2024
|
|
$
|
|
|
$
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||||||||||
Exercisable at June 30, 2024
|
|
$
|
|
|
$
|
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ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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● |
the Company’s ability to protect its intellectual property rights;
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● |
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;
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● |
the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its clinical and 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 clinical and product candidates;
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● |
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;
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● |
the timing for the Company or its partners to initiate the planned clinical trials for its Versamune® products, including PDS0101, PDS0103, and others, alone or in
combination with PDS01ADC, as well as Infectimune® based clinical candidates and the future success of such trials;
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● |
the successful implementation of the Company’s research and development programs and collaborations, including any collaboration trials concerning the Company’s Versamune®, PDS01ADC and Infectimune® based clinical
and 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 clinical and product candidates;
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● |
the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current clinical candidates, including statements regarding the timing of initiation, pace of
enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data
reported in an abstract, and receipt of interim 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;
|
● |
expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization of the Company’s clinical and product candidates;
|
● |
any Company statements about its understanding of clinical and product candidates’ mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any
collaboration trials; the acceptance by the market of the Company’s clinical and product candidates, if approved;
|
● |
the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s clinical and product
candidates; and
|
● |
other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising
from or related to those listed under Part II, Item 1A. Risk Factors.
|
● |
Confirmed and unconfirmed response rates thus far (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved ICIs, used as monotherapy for recurrent or
metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)
|
● |
Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%
|
● |
Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients
|
● |
Progressive/ongoing disease was reported in 4/17 (23.5%) patients
|
● |
Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of Keytruda® (range 1-18)
|
● |
There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)
|
● |
No patients required dose interruption or reduction on the combination treatment
|
● |
No patients discontinued the combination treatment
|
● |
At 9 months of follow up (median not yet achieved):
|
● |
Progression free survival (PFS) rate was 55.2%
|
● |
Overall survival (OS) rate was 87.2%
|
● |
No control or comparative studies have been conducted between ICIs and PDS0101
|
● |
Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone.
|
● |
Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in
patients with similar PD-L1 levels.
|
● |
A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)
|
● |
Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously
reported at ASCO 2022 (7/17 patients). To date these responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.
|
● |
15/34 patients (44.1%) had stable disease.
|
● |
9/34 patients (26.5%) had progressive disease.
|
● |
4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No Grade 4 or higher TRAEs were observed.
|
● |
24-month overall survival (OS) rate of 74%; published 24-month survival rate of less than 30% for approved ICI.
|
● |
12-month OS rate of 80%; published results of 30-50% with approved ICIs.
|
● |
Tumor shrinkage seen in 60% (31/52) of patients.
|
● |
Confirmed overall response rate ORR of 27% (14/52) to date.
|
● |
Median progression-free survival (PFS) of 8.1 months to date; published results of 2-3 months PFS with approved ICIs.
|
● |
13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE; published results report 13-17%
Grade 3-5 TRAE with approved ICI monotherapy.
|
● |
60% (33/55) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (22/55) have CPS score >20 (who generally have a
higher response to Keytruda®).
|
● |
Median overall survival of 30 months; published results for ICIs are 7-18 months.
|
● |
Confirmed overall response rate ORR of 34% (18/53) to date; published results for comparable patients receiving treatment with ICIs are less than 20%.
|
● |
Confirmed complete responses, partial responses and stable disease according to RECIST v1.1 were seen in 75.5% of patients.
|
● |
Median progression-free survival (PFS) of 6.3 months to date; published results of 2-3 months PFS with approved ICIs.
|
● |
The combination of PDS0101 and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and
2% (1/62) experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.
|
● |
60% (32/53) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a
higher response to Keytruda®).
|
● |
Median Overall Survival of 30 months, consistent with data presented our key opinion leader event in May of 2024, which was based on a data cut as of November 30, 2023.
|
● |
27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died.
|
● |
The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of patients continue to be followed for survival.
|
● |
Objective response (OR = >30% tumor reduction) was seen in 88% (7/8) of patients with ICI naive disease; 4/7 (57%) patients’ responses are ongoing (median 17 months).
|
● |
With ICI resistant patients: PDS01ADC dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC at 8
mcg/kg achieving an OR; 4/6 (67%) patients’ responses are ongoing (median 12 months).
|
● |
Tumor reduction was seen in 45% (10/22) of patients with ICI resistant disease, including patients receiving high or low dose PDS01ADC.
|
● |
In ICI resistant patients treated with high or low dose PDS01ADC, survival outcomes were similar (p=0.96 by Kaplan Meier analysis). At a median of 12 months of follow up 17/22 (77%) of patients were alive.
|
● |
In ICI naïve patients 6/8 (75%) were alive at median 17 months of follow up.
|
● |
Similar OR and survival were seen across all types of HPV16-positive cancers.
|
● |
Preliminary safety data: 13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.
|
● |
Survival data: 66% (19/29) of HPV16-positive ICI resistant patients in the cohort were alive at a median follow up of 16 months.
|
● |
Safety profile: 48% (24/50) patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no Grade 5 treatment-related AEs.
|
● |
HPV16-positive ICI naïve patients: 75% (6/8) were alive at a median follow up of 25 months and 38% (3/8) of responders had a complete response.
|
● |
Median OS was 21 months in 29 checkpoint inhibitor resistant patients who received the triple combination. The reported historical median OS in patients with ICI resistant disease is 3-4 months seen with
checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI resistant head and neck cancer.
|
● |
In ICI naïve subjects, 75% remain alive at a median follow-up of 27 months. As a result, median OS had not yet been reached. Historically, median OS for similar patients with platinum experienced ICI naïve
disease is 7-11 months.
|
● |
Objective response rate (ORR) in ICI resistant patients who received the optimal dose of the triple combination is 63% (5/8). In current approaches ORR is reported to be less than 10%.
|
● |
ORR in ICI naïve patients with the triple combination is 88%. In current approaches ORR is reported to be less than 25% with FDA-approved ICIs in HPV-positive cancers.
|
● |
Safety data had not changed since October’s update. 48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 (severe) AEs, compared
with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.
|
● |
75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival (OS) in similar patients is 7-11 months
|
● |
12-month survival rate in (ICI) resistant patients of 72%
|
● |
Median OS in ICI resistant HPV-positive patients of approximately 20 months; published median OS is 3.4 months
|
● |
9 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer. This included 78% (7/9) of treated patients with
advanced cervical cancer (FIGO stage III or IV).
|
● |
100% (9/9) of patients treated with the combination of PDS0101 and CRT had an objective response.
|
● |
89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of
residual disease. One patient who had a CR died from an event unrelated to either their underlying disease or treatment.
|
● |
1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.
|
● |
As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8 T cells. This increase was not seen in patients who did not receive PDS0101. The increase in HPV16-specific T cells generated by
the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.
|
● |
The data affirms that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.
|
● |
Toxicity of PDS0101 remains limited to low-grade local injection site reactions.
|
● |
Earlier and greater proportion of ctDNA clearance with PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3% clearance after 3 weeks vs. 30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs. 53.1% with SOC (p=0.0179).
|
● |
Baseline ctDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement; 100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes.
|
● |
Phase II Study Evaluating ICI Naïve and Resistant Patients with HPV-positive malignancies treated with PDS01ADC, PDS0101 and bintrafusp alfa.
|
● |
A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination with the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated with Androgen Deprivation
Therapy
|
● |
A Phase I/II Study of PDS01ADC in Combination with Docetaxel in Adults with Metastatic Castration Sensitive and Castration Resistant Prostate Cancer
|
● |
Phase I/II of PDS01ADC going forward as a Monotherapy in Advanced Kaposi Sarcoma
|
● |
Phase I/II of PDS01ADC in Combination of with a Histone Deacetylase (HDAC) Inhibitor in ICI resistant MUC1-positive colon and bladder cancers among others
|
● |
Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.
|
● |
All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.
|
● |
Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells, proliferating CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10 (IL-10).
|
● |
The changes in immune responses with the combination were independent of the PDS01ADC dose.
|
● |
the timing and costs of our planned clinical trials;
|
● |
the timing and costs of our planned preclinical studies of our Versamune® platform;
|
● |
the outcome, timing and costs of seeking regulatory approvals;
|
● |
the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;
|
● |
the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other
intellectual property rights; and
|
● |
the extent to which we license or acquire other products and technologies.
|
Three Months Ended
June 30,
|
Increase ( Decrease)
|
|||||||||||||||
2024
|
2023
|
$ Amount
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
4,528
|
$
|
8,005
|
$
|
(3,477
|
)
|
(43
|
)%
|
|||||||
General and administrative expenses
|
4,156
|
4,691
|
(535
|
)
|
(11
|
)%
|
||||||||||
Total operating expenses
|
8,684
|
12,696
|
(4,012
|
)
|
(32
|
)%
|
||||||||||
Loss from operations
|
(8,684
|
)
|
(12,696
|
)
|
4,012
|
(32
|
)%
|
|||||||||
Interest income (expense), net
|
(513
|
)
|
(245
|
)
|
(268
|
)
|
109
|
%
|
||||||||
Benefit from income taxes
|
869
|
1,406
|
(537
|
)
|
(38
|
)%
|
||||||||||
Net loss and comprehensive loss
|
$
|
(8,328
|
)
|
$
|
(11,535
|
)
|
$
|
(3,207
|
)
|
(28
|
)%
|
Six Months Ended
June 30,
|
Increase (Decrease)
|
|||||||||||||||
2024
|
2023
|
$ Amount
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
11,232
|
$
|
13,849
|
$
|
(2,617
|
)
|
(19
|
)%
|
|||||||
General and administrative expenses
|
7,550
|
8,270
|
(720
|
)
|
(9
|
)%
|
||||||||||
Total operating expenses
|
18,782
|
22,119
|
(3,337
|
)
|
(15
|
)%
|
||||||||||
Loss from operations
|
(18,782
|
)
|
(22,119
|
)
|
3,337
|
(15
|
)%
|
|||||||||
Interest income (expense), net
|
(1,019
|
)
|
(482
|
)
|
(537
|
)
|
111
|
%
|
||||||||
Benefit from income taxes
|
869
|
1,406
|
(537
|
)
|
(38
|
)%
|
||||||||||
Net loss and comprehensive loss
|
$
|
(18,932
|
)
|
$
|
(21,195
|
)
|
$
|
(2,264
|
)
|
(11
|
)%
|
Six Months Ended June 30,
|
||||||||
2024
|
2023
|
|||||||
Net cash used in operating activities
|
$
|
(18,796
|
)
|
$
|
(18,003
|
)
|
||
Net cash used in investing activities
|
(29
|
)
|
-
|
|||||
Net cash provided by financing activities
|
19,998
|
4,808
|
||||||
Net increase (decrease) in cash and cash equivalents
|
$
|
1,173
|
$
|
(13,195
|
)
|
● |
the initiation, progress, timing, costs and results of our planned clinical trials;
|
● |
the effects of health epidemics, pandemics, or outbreaks of infectious diseases, on our business operations, financial condition, results of operations and cash flows;
|
● |
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory
authorities;
|
● |
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
|
● |
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us now or in the future;
|
● |
the effect of competing technological and market developments;
|
● |
the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our products on our own; and
|
● |
the initiation, progress, timing and results of our commercialization of our clinical and product candidates, if approved, for commercial sale.
|
ITEM 3: |
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
|
ITEM 4: |
CONTROLS AND PROCEDURES
|
PART II. |
OTHER INFORMATION
|
ITEM 1. |
LEGAL PROCEEDINGS
|
ITEM 1A. |
RISK FACTORS
|
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES
|
ITEM 4. |
MINE SAFETY DISCLOSURES
|
ITEM 5. |
OTHER INFORMATION
|
ITEM 6. |
EXHIBITS
|
Exhibit
Number
|
Exhibit Description
|
|
Amendment to the Eighth Amended and Restated Certificate of Incorporation (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on June 24, 2024, and
incorporated by reference herein).
|
||
Executive Employment Agreement by and between Stephan F. Toutain and PDS Biotechnology Corporation, effective as of May 1, 2024 (filed as Exhibit 10.3 to the Registrant’s
Quarterly Report on Form 10-Q filed on May 15, 2024, and incorporated by reference herein).
|
||
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
||
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
||
101.INS*
|
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
|
|
101.SCH*
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents.
|
|
101.CAL*
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF*
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB*
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE*
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
104
|
Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101).
|
* |
Filed herewith (unless otherwise noted as being furnished herewith)
|
+ |
Indicates management compensatory plan or arrangement.
|
PDS Biotechnology Corporation
|
||
August 13, 2024
|
By:
|
/s/ Frank Bedu-Addo
|
Frank Bedu-Addo, Ph.D.
|
||
President and Chief Executive Officer
(Principal Executive Officer)
|
||
August 13, 2024
|
By:
|
/s/ Lars Boesgaard
|
Lars Boesgaard
|
||
Chief Financial Officer
|
||
(Principal Financial and Accounting Officer)
|