SABS 10-Q
SAB Biotherapeutics, Inc. (SABS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___________________ to ___________________
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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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The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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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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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 1, 2024, the registrant had
Table of Contents
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Page |
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PART I. |
2 |
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Item 1. |
2 |
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2 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
3 |
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Condensed Consolidated Statements of Changes In Stockholders’ Equity |
4 |
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6 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
7 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
28 |
Item 3. |
41 |
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Item 4. |
41 |
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PART II. |
43 |
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Item 1. |
43 |
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Item 1A. |
43 |
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Item 2. |
43 |
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Item 3. |
43 |
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Item 4. |
43 |
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Item 5. |
43 |
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Item 6. |
44 |
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45 |
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i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited).
SAB Biotherapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
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September 30, |
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December 31, |
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(Unaudited) |
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Assets |
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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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Short-term investments |
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Accrued interest receivable |
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Prepaid expenses and other current assets |
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Total current assets |
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Deferred issuance cost |
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Long-term prepaid assets |
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Operating lease right-of-use assets |
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Financing lease right-of-use assets |
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Property, plant and equipment, net |
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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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Notes payable |
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Operating lease liabilities, current portion |
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Finance lease liabilities, current portion |
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Deferred grant income |
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Accrued expenses and other current liabilities |
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Total current liabilities |
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Operating lease liabilities, noncurrent |
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Finance lease liabilities, noncurrent |
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Warrant liabilities |
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Total liabilities |
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Stockholders’ equity |
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Preferred stock; $ |
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Common stock; $ |
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Treasury stock, at cost; |
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( |
) |
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( |
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Additional paid-in capital |
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Accumulated other comprehensive income |
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Accumulated deficit |
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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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*The condensed consolidated balance sheets' common stock share amounts have been retroactively adjusted to account for the Company's Reverse Stock Split, effective January 5, 2024.
See accompanying notes to the condensed consolidated financial statements
2
SAB Biotherapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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Three Months Ended September 30, |
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For The Nine Months Ended September 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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Revenue |
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$ |
— |
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$ |
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$ |
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$ |
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Total revenue |
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— |
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Operating expenses |
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Research and development |
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General and administrative |
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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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Other income (expense) |
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Changes in fair value of warrant liabilities |
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( |
) |
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Interest expense |
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( |
) |
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( |
) |
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( |
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( |
) |
Interest income |
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Other income |
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Total other income (expense) |
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( |
) |
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Loss before income taxes |
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( |
) |
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( |
) |
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( |
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( |
) |
Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
Other comprehensive income: |
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Unrealized gain, change in fair value of available-for-sale securities, net of tax |
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$ |
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$ |
— |
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$ |
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$ |
— |
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Foreign currency translation |
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$ |
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— |
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— |
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Total comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Loss per common share attributable to the Company’s shareholders |
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Basic and diluted loss per common share |
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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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*The condensed consolidated balance sheets' common stock share amounts have been retroactively adjusted to account for the Company's Reverse Stock Split, effective January 5, 2024.
See accompanying notes to the condensed consolidated financial statements
3
SAB Biotherapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes In Stockholders’ Equity
(Unaudited)
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Common stock |
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Preferred Stock |
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Treasury Stock |
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Shares |
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Amount |
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Shares |
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Amount |
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Additional |
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Shares |
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Amount |
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Accumulated |
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Accumulated Other Comprehensive Income (Loss) |
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Total Stockholders’ |
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Balance at December 31, 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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$ |
( |
) |
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$ |
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$ |
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Stock-based compensation |
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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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Issuance of common stock for exercise of stock options |
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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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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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— |
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( |
) |
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— |
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( |
) |
Foreign currency translation |
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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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( |
) |
Unrealized gain (loss), change in fair value of available-for-sale securities |
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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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( |
) |
Balance at March 31, 2024 |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
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||||||
Stock-based compensation |
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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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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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— |
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( |
) |
|
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— |
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( |
) |
Foreign currency translation |
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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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||
Unrealized gain (loss), change in fair value of available-for-sale securities |
|
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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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Balance at June 30, 2024 |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
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||||||
Stock-based compensation |
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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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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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— |
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( |
) |
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— |
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( |
) |
Foreign currency translation |
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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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||
Unrealized gain, change in fair value of available-for-sale securities |
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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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Balance at September 30, 2024 |
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( |
) |
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( |
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( |
) |
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*The condensed consolidated balance sheets' common stock share amounts have been retroactively adjusted to account for the Company's Reverse Stock Split, effective January 5, 2024.
See accompanying notes to the condensed consolidated financial statements.
4
SAB Biotherapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes In Stockholders’ Equity
(Unaudited)
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Common stock |
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Treasury Stock |
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Shares |
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Amount |
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Additional |
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Shares |
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Amount |
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Accumulated |
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Total Stockholders’ |
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Balance at December 31, 2022 |
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( |
) |
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( |
) |
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( |
) |
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Issuance of common stock for exercise of stock options |
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— |
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— |
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— |
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— |
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Professional fees settled with warrants |
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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 |
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— |
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— |
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— |
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— |
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— |
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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 at March 31, 2023 |
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( |
) |
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( |
) |
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( |
) |
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Issuance of common stock for settlement of accrued liabilities and professional fees |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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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 at June 30, 2023 |
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( |
) |
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( |
) |
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( |
) |
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Issuance of common stock for exercise of stock |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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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 at September 30, 2023 |
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( |
) |
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( |
) |
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( |
) |
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||||
*The condensed consolidated balance sheets' common stock share amounts have been retroactively adjusted to account for the Company's Reverse Stock Split, effective January 5, 2024.
See accompanying notes to the condensed consolidated financial statements.
5
SAB Biotherapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
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|
2023 |
|
||
Cash flows from operating activities: |
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||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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|
|
|
||
Amortization of finance right-of-use assets |
|
|
|
|
|
|
||
Stock-based compensation expense |
|
|
|
|
|
|
||
Gain on sale of equipment |
|
|
— |
|
|
|
( |
) |
Changes in fair value of warrant liabilities |
|
|
( |
) |
|
|
|
|
Accretion of discounts on short-term investments |
|
|
( |
) |
|
|
— |
|
Professional fees settled with equity instruments |
|
|
— |
|
|
|
|
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
||
Accrued interest receivable |
|
|
( |
) |
|
|
— |
|
Accounts receivable |
|
|
— |
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Operating lease right-of-use assets and liabilities, net |
|
|
( |
) |
|
|
|
|
Accounts payable |
|
|
|
|
|
( |
) |
|
Deferred grant income |
|
|
( |
) |
|
|
|
|
Accrued expense and other current liabilities |
|
|
|
|
|
( |
) |
|
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities: |
|
|
|
|
|
|
||
Proceeds from the sale of equipment |
|
|
— |
|
|
|
|
|
Purchases of equipment |
|
|
( |
) |
|
|
( |
) |
Purchases of investment securities |
|
|
( |
) |
|
|
— |
|
Sales and maturities of investments |
|
|
|
|
|
— |
|
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Payment of deferred issuance costs |
|
|
( |
) |
|
|
— |
|
Payments of notes payable |
|
|
( |
) |
|
|
( |
) |
Principal payments on finance leases |
|
|
( |
) |
|
|
( |
) |
Proceeds from exercise of stock options |
|
|
|
|
|
|
||
Net cash used in financing activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Effect of exchange rate changes on cash and cash equivalents |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
||
Net decrease in cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
Cash and cash equivalents |
|
|
|
|
|
|
||
Beginning of period |
|
|
|
|
|
|
||
End of period |
|
$ |
|
|
$ |
|
||
Supplemental cash flow information: |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental information on non-cash investing and finance activities: |
|
|
|
|
|
|
||
Settlement of accrued liabilities through the issuance of common stock |
|
$ |
— |
|
|
$ |
|
|
Right-of-use assets obtained in exchange for operating lease liabilities |
|
$ |
|
|
$ |
— |
|
|
See accompanying notes to the condensed consolidated financial statements.
6
SAb Biotherapeutics, Inc. and subsidiaries
Notes to condensed consolidated FINANCIAL statements (Unaudited)
(1) Nature of Business
SAB Biotherapeutics, Inc., a Delaware corporation (“SAB” or “SAB Biotherapeutics”, and together with its subsidiaries, the “Company”), is a clinical-stage biopharmaceutical company focused on the development of human polyclonal immunotherapeutic antibodies, or human immunoglobulins (“hIgG”), to address immune system disorders and infectious diseases. The Company’s antibodies are both target-specific and polyclonal, meaning they are comprised of multiple hIgGs and can bind to multiple sites on specific immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders. The Company’s lead candidate, SAB-142 is a human anti-thymocyte globulin (“ATG”) focused on preventing or delaying the progression of type 1 diabetes (“T1D”).
Australian Research and Development Tax Credit
In June 2023, the Company formed a new subsidiary in Australia, SAB BIO PTY LTD, a proprietary limited company (“SAB Australia”), primarily to conduct preclinical and clinical activities for product candidates. SAB Australia’s research and development activities qualify for the Australian government’s tax credit program, which provides a
Liquidity and Going Concern
The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has experienced net losses, negative cash flows from operations and, as of September 30, 2024, had an accumulated deficit of $
The Company will need to raise additional capital to fund its operations, to continue to execute its strategy and to continue as a going concern. In the future, the Company may seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative or other funding arrangements. Should the Company seek additional financing from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.
The Company currently expects that its cash and cash equivalents of $
(2) Summary of Significant Accounting Policies
A summary of the significant accounting policies applied in preparation of the accompanying condensed consolidated financial statements is set forth below.
Basis of presentation
The financial statements have been prepared in conformity with U.S. Generally Accepted Accounting Principles (“GAAP” or “U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
Emerging growth company status
The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended (the “Securities Act”), as modified by the Jumpstart our Business Startups Act of 2012, (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the
7
Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company’s financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.
Principles of consolidation
The accompanying condensed consolidated financial statements include the results of the Company and its wholly owned subsidiaries, SAB Sciences, Inc., SAB Capra, LLC, Aurochs, LLC, and SAB Australia. Intercompany balances and transactions have been eliminated in consolidation.
Significant risks and uncertainties
The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to, the results of research and development efforts, clinical trial activities of the Company’s product candidates, the Company’s ability to obtain regulatory approval to market its product candidates, competition from products manufactured and sold or being developed by other companies, and the Company’s ability to raise capital.
The Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and obtaining and protecting intellectual property.
Use of estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses and the disclosure of contingent assets and liabilities in the financial statements. The Company has used significant estimates in its determination of stock-based compensation assumptions, determination of the fair value of the Private Placement Warrant liabilities, determination of the incremental borrowing rate (“IBR”) used in the calculation of the Company’s right of use assets and lease liabilities, estimation of clinical and other accruals and the valuation allowance on deferred tax assets. Actual amounts realized may differ from these estimates.
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The following fair value hierarchy classifies the inputs to valuation techniques that would be used to measure fair value into one of three levels:
Level 1: Unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions.
Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to the short-term nature of their maturities, such as cash and cash equivalents, accrued interest receivable, accounts payable, notes payable, accrued expenses, and other current liabilities.
8
The Company accounts for warrants to purchase its common stock par value of $
Deferred Issuance Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance.
As of September 30, 2024, the Company had $
Cash, cash equivalents, and restricted cash
Cash and cash equivalents are comprised of cash and highly liquid investments with original maturities of 90 days or less at the date of purchase. Cash equivalents consist primarily of exchange-traded money market funds.
The Company is exposed to credit risk in the event of default by the financial institutions or the issuers of these investments to the extent the amounts on deposit or invested are in excess of amounts that are insured.
Short-term investments
The Company accounts for short-term investments in accordance with ASC Topic 320, Investments - Debt and Equity Securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such determinations at each reporting period.
At September 30, 2024, the Company’s short-term investments consisted of U.S. treasury securities with original maturity exceeding 90 days and investments in exchange traded mutual funds. The Company classifies these securities as current. The Company considers all of its securities for which there is a determinable fair market value, and there are no restrictions on the Company’s ability to sell within the next twelve months, as available-for-sale securities.
The Company recognizes the change in fair value of available-for-sale equity securities within other income in the condensed consolidated statement of operations and comprehensive loss, and available-for-sale debt securities are measured at fair value with unrealized gains and losses reported in accumulated other comprehensive income in the condensed consolidated statement of operations and comprehensive loss.
The Company reviews its investments at each reporting date to identify and evaluate whether a decline in fair value below the amortized cost basis of available-for-sale debt securities is due to credit-related factors and determines if such unrealized losses are the result of credit losses that require impairment. Factors considered in determining whether an unrealized loss is the result of a credit loss or other factors include the extent to which the fair value is less than the cost basis, any changes to the rating of the security by a rating agency, the financial condition and near-term prospects of the issuer, any historical failure of the issuer to make scheduled interest or principal payments, any adverse legal or regulatory events affecting the issuer or issuer’s industry, any significant deterioration in economic condition and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value.
The Company did
Concentration of credit risk
The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the three and nine months ended September 30, 2024 and 2023.
9
Lease liabilities and right-of-use assets
The Company is party to certain contractual arrangements for equipment, lab space, and an animal facility, which meet the definition of leases under Financial Accounting Standards Board (“FASB”) ASC Topic 842, Leases (“ASC 842”). In accordance with ASC 842, the Company recorded right-of-use assets and related lease liabilities for the present value of the lease payments over the lease terms. The Company’s IBR was used in the calculation of its right-of-use assets and lease liabilities.
The Company elected not to apply the recognition requirements of ASC 842 to short-term leases, which are deemed to be leases with a lease term of twelve months or less. Instead, the Company recognized lease payments in the Condensed Consolidated Statements of Operations on a straight-line basis over the lease term and variable payments in the period in which the obligation for these payments was incurred. The Company elected this policy for all classes of underlying assets.
Research and development expenses
Expenses incurred in connection with research and development activities are expensed as incurred. These include licensing fees to use certain technology in the Company’s research and development projects, fees paid to consultants and various entities that perform certain research and testing on behalf of the Company, and expenses related to animal care, research-use equipment depreciation, salaries, benefits, and stock-based compensation granted to employees in research and development functions.
During the three and nine months ended September 30, 2024 and 2023, the Company had contracts with multiple contract research organizations (“CRO”) to complete studies as part of research grant agreements. These costs include upfront, milestone and monthly expenses as well as reimbursement for pass through costs. All research and development costs are expensed as incurred except when the Company is accounting for nonrefundable advance payments for goods or services to be used in future research and development activities. In these cases, these payments are capitalized at the time of payment and expensed in the period the research and development activity is performed. As actual costs become known, the Company will adjust the accrual; such changes in estimate may result in a material change in the Company’s clinical study accrual, which could also materially affect reported results of operations. For the three and nine months ended September 30, 2024 and 2023, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials.
Property, Plant and Equipment
The Company records property, plant, and equipment at cost less depreciation and amortization. Depreciation is calculated using straight-line methods over the following estimated useful lives:
Animal facility equipment |
|
Laboratory equipment |
|
Leasehold improvements |
|
Office furniture and equipment |
|
Vehicles |
Repairs and maintenance expenses are expensed as incurred.
Impairment of long-lived assets
The Company reviews the recoverability of long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset may not be recoverable. If necessary, the Company compares the estimated undiscounted future net cash flows to the related asset’s carrying value to determine whether there has been an impairment. If an asset is considered impaired, the asset is written down to fair value, which is based either on discounted cash flows or appraised values in the period the impairment becomes known. The Company believes that long-lived assets are recoverable, and
Stock-based compensation
FASB ASC Topic 718, Compensation– Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions in which employee and non-employee services are acquired. The Company recognizes compensation cost relating to stock-based payment transactions using a fair-value measurement method, which requires all stock-based payments to employees, directors, and non-employee consultants, including grants of stock options, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of common stock based on the closing market price at closing on the date of the grant.
10
In determining the fair value of stock-based awards, the Company utilizes the Black-Scholes option-pricing model, which uses both historical and current market data to estimate fair value. The Black-Scholes option-pricing model incorporates various assumptions, such as the value of the underlying common stock, the risk-free interest rate, expected volatility, expected dividend yield, and expected life of the options. For awards with performance-based vesting criteria, the Company estimates the probability of achievement of the performance criteria and recognizes compensation expense related to those awards expected to vest. No awards may have a term in excess of
Income taxes
Deferred income taxes reflect future tax effects of temporary differences between the tax and financial reporting basis of the Company’s assets and liabilities measured using enacted tax laws and statutory tax rates applicable to the periods when the temporary differences will affect taxable income. When necessary, deferred tax assets are reduced by a valuation allowance, to reflect realizable value, and all deferred tax balances are reported as long-term on the condensed consolidated balance sheet. Accruals are maintained for uncertain tax positions, as necessary.
The Company uses a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The Company has elected to treat interest and penalties related to income taxes, to the extent they arise, as a component of income taxes.
Revenue recognition
The Company’s revenue is primarily generated through grants from government and other (non-government) organizations.
Grant revenue is recognized during the period that the research and development services occur, as qualifying expenses are incurred, or conditions of the grants are met. Deferred grant income represents grant proceeds received by the Company prior to the period in which the research and development services occur, as qualifying expenses are incurred, or conditions of the grants are met. The Company concluded that payments received under these grants represent conditional, nonreciprocal contributions, as described in ASC 958, Not-for-Profit Entities, and that the grants are not within the scope of ASC 606, Revenue from Contracts with Customers, as the organizations providing the grants do not meet the definition of a customer. Expenses for grants are tracked by using a project code specific to the grant, and the employees also track hours worked by using the project code.
Foreign Currency Translations and Transactions
Assets and liabilities of the Company's foreign subsidiary are translated at the year-end exchange rate. Operating results of the Company's foreign subsidiary are translated at average exchange rates during the period. Translation adjustments have no effect on net loss and are included in “Accumulated other comprehensive income, net” in the accompanying Condensed Consolidated Balance Sheets.
Comprehensive income (loss)
Comprehensive income (loss) includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The components of comprehensive loss for the three and nine months ended September 30, 2024 consist of net loss, foreign currency translation adjustments from its subsidiaries not using the U.S. dollar as their functional currency, and unrealized gains and losses on available-for-sale debt securities.
The Company had no items of comprehensive loss other than its net loss for the three and nine months ended September 30, 2023.
Litigation
From time to time, the Company is involved in legal proceedings, investigations and claims generally incidental to its normal business activities. In accordance with U.S. GAAP, the Company accrues for loss contingencies when it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Legal costs in connection with loss contingencies are expensed as incurred.
Earnings per share
In accordance with ASC 260, Earnings per Share (“ASC 260”), basic net income (loss) per share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of common stock
11
outstanding during the period. Diluted net income (loss) per share attributable to common stockholders is computed by dividing the diluted net income (loss) attributable to common stockholders by the weighted-average number of common stock outstanding for the period including potential dilutive common shares such as stock options.
Segment reporting
In accordance with ASC 280, Segment Reporting, the Company’s business activities are organized into
Australian Research and Development Tax Credit
The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997, as long as eligibility criteria are met. Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed.
Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time and it is included in other income in the condensed consolidated statements of operations.
Retroactive Adjustments for Common Stock Reverse Split
On January 5, 2024, the Company completed a 1-for-10 reverse stock split of the Company’s common stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, every ten of the Company’s issued shares of common stock were automatically combined into one issued share of common stock, without any change to the par value per share. All share and per share numbers in this Form 10-Q have been adjusted to reflect the Reverse Stock Split.
(3) New accounting standards
Accounting Pronouncements Not Yet Adopted
In November 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 requires the disclosure of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), along with a description of other segment items by reportable segment and any additional profit or loss measures used by the CODM in resource allocation decisions. The ASU mandates that all currently required annual disclosures under Topic 280 also be included in interim periods and applies to entities with a single reportable segment. The amendments are effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years starting after December 15, 2024. The Company is currently evaluating the impact of this ASU on its disclosures within the condensed consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
(4) Revenue
During the three and nine months ended September 30, 2024 and 2023, the Company recognized revenue from the following grants:
Government grants
There was
12
National Institute of Health - National Institute of Allergy and Infectious Disease (“NIH-NIAID”) (Federal Award #1R41AI131823-02) – this grant was for approximately $
NIH-NIAID through Geneva Foundation (Federal Award #1R01AI132313-01, Subaward #S-10511-01) – this grant was for approximately $
US Department of Defense (“DoD”), Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (“JPEO”) through Advanced Technology International – this grant was for a potential of $
The grants for the Company’s Rapid Response contract with JPEO (the “JPEO Rapid Response Contact”) are cost reimbursement agreements, with reimbursement of qualified direct research and development expense (labor and consumables) with an overhead charge (based on actual, reviewed quarterly) and a fixed fee (
On August 3, 2022, the Company received notice from the DoD terminating the JPEO Rapid Response contract (the “JPEO Rapid Response Contract Termination”). The Company engaged in negotiations with the DoD to compensate the Company for services provided prior to the JPEO Rapid Response Contract Termination and costs the Company would be expected to bear in future periods. A termination and settlement proposal was submitted to the DoD on September 9, 2022; the Company submitted a final invoice on December 15, 2022; and received payment from the DoD on or about January 12, 2023. The terms of the arrangement provide for a cost-reimbursable structure, and state that the parties will work in good faith equitable reimbursement for work performed toward accomplishment of the tasks provided in the agreement. At this time, other than certain deferred obligations (presented within deferred grant income within the Company’s condensed consolidated unaudited balance sheet) potentially payable to the DoD solely due to subsequent negotiations with third-party vendors, the Company believes and has been advised there is a reasonable, good faith basis for the position that no present or future obligations exist. Revenue recognized subsequent to the JPEO Rapid Response Contract Termination relates to satisfaction of residual obligations under the termination and settlement agreement—see Note 2, Summary of Significant Accounting Policies for further information about the Company’s established revenue recognition process.
(5) Earnings per share
The following is a reconciliation of the numerator and denominator used to calculate basic earnings per share and diluted earnings per share for the three and nine months ended September 30, 2024 and 2023:
|
|
Three Months Ended September 30, |
|
|
For The Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Calculation of basic and diluted loss per share |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to the Company’s shareholders |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average common shares outstanding – |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The Company’s potentially dilutive securities, which include stock options, restricted stock awards, common stock warrants, earnout shares, and contingently issuable earnout shares have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.
13
|
|
For The Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Stock options and awards |
|
|
|
|
|
|
||
Convertible Debt |
|
|
— |
|
|
|
|
|
Common Stock Warrants (1) |
|
|
|
|
|
|
||
Series A Preferred Stock (2) |
|
|
|
|
|
— |
|
|
Preferred Stock Warrants (3) |
|
|
|
|
|
— |
|
|
Contingently issuable Earnout Shares from unexercised Rollover |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
(6) Property, plant and equipment
As of September 30, 2024 and December 31, 2023, the Company’s property, plant and equipment was as follows:
|
|
September 30, |
|
|
December 31, |
|
||
Laboratory equipment (1) |
|
$ |
|
|
$ |
|
||
Animal facility leasehold improvements |
|
|
|
|
|
|
||
Animal facility equipment |
|
|
|
|
|
|
||
Construction-in-progress |
|
|
|
|
|
|
||
Leasehold improvements (1) |
|
|
|
|
|
|
||
Vehicles |
|
|
|
|
|
|
||
Office furniture and equipment (1) |
|
|
|
|
|
|
||
Total Property, plant and equipment, gross |
|
|
|
|
|
|
||
Less: accumulated depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
Property, plant and equipment, net |
|
$ |
|
|
$ |
|
||
(1) The Company re-classed $
Depreciation and amortization expense was $
(7) Leases
The Company has an operating lease for lab space from Sanford Health, under a lease that started in June 2014 and initially ended in June 2019, at which time the lease was extended through August 2024. This lease can be terminated with
14
modification under ASC 842 - Leases and the right-of-use asset and lease liability were remeasured at the modification date of October 1, 2022. The October 2022 lease amendment reduced the lease payment to approximately $
The Company entered into a lease for office, laboratory, and warehouse space in November 2020, which was amended in July 2022 to add additional administrative and lab space. This amended lease has a
The Company entered into a lease for office space in April 2024. The Company leased
The Company has the following finance leases:
The lease agreements do not require material variable lease payments, residual value guarantees or restrictive covenants.
The amortizable lives of the operating lease assets are limited by their expected lease terms. The amortizable lives of the finance lease assets are limited by their expected lives, as the Company intends to exercise the purchase options at the end of the leases. The following is the estimated useful lives of the finance lease assets:
Animal Facility |
|
Equipment |
|
Land |
Indefinite |
The Company’s weighted-average remaining lease term and weighted-average discount rate for operating and finance leases as of September 30, 2024 are:
|
|
Operating |
|
|
Finance |
|
||
Weighted-average remaining lease term (years) |
|
|
|
|
||||
Weighted-average discount rate (percentage) |
|
|
% |
|
|
% |
||
15
The table below reconciles the undiscounted future minimum lease payments under non-cancelable leases with terms of more than one year to the total lease liabilities recognized on the condensed consolidated balance sheets as of September 30, 2024:
|
|
Operating |
|
|
Finance |
|
||
2024 — remaining |
|
$ |
|
|
$ |
|
||
2025 |
|
|
|
|
|
|
||
2026 |
|
|
|
|
|
|
||
2027 |
|
|
|
|
|
|
||
2028 |
|
|
|
|
|
|
||
Thereafter |
|
|
|
|
|
|
||
Undiscounted future minimum lease payments |
|
|
|
|
|
|
||
Less: Amount representing interest payments |
|
|
( |
) |
|
|
( |
) |
Total lease liabilities |
|
|
|
|
|
|
||
Less current portion |
|
|
( |
) |
|
|
( |
) |
Noncurrent lease liabilities |
|
$ |
|
|
$ |
|
||
Operating lease expense was approximately $
Finance lease costs for the three and nine months ended September 30, 2024 included approximately $
Cash payments under operating leases were approximately $
(8) Accrued Expenses and Other Current Liabilities
As of September 30, 2024 and December 31, 2023, accrued expenses and other current liabilities consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||
Payroll and employee-related costs |
|
$ |
|
|
$ |
|
||
Accrued research and development expenses |
|
|
|
|
|
|
||
Accrued legal fees |
|
|
|
|
|
|
||
Accrued financing fees payable |
|
|
|
|
|
|
||
Accrued interest |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
(9) Notes Payable
8% Unsecured Convertible Note
Pursuant to the fourth amendment to the Company’s lease with Sanford Health, the Company and Sanford Health agreed to a period of abated rent (the “Abated Rent”) from October 1, 2022 to September 30, 2023. In exchange for the Abated Rent, effective as of October 1, 2022, the Company issued to Sanford Health an
Pursuant to the 8% Unsecured Convertible Note, the Company shall pay the sum of approximately $
16
The Company incurred approximately $
Insurance Financing Note
The Company obtained financing for certain Director & Officer liability insurance policy premiums. The agreement assigns First Insurance Funding (“Lender”) a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies including (a) all returned or unearned premiums, (b) all additional cash contributions or collateral amounts assessed by the insurance companies in relation to the financed policies and financed by Lender, (c) any credits generated by the financed policies, (d) dividend payments, and (e) loss payments which reduce unearned premiums. If any circumstances exist in which premiums related to any Financed Policy could become fully earned in the event of loss, Lender shall be named a loss-payee with respect to such policy.
The total premiums, taxes and fees financed is approximately $
(10) Stockholders’ Equity
Authorized and Outstanding Capital Stock
The total number of shares of the Company’s authorized capital stock is
Series A Preferred Stock
On September 29, 2023, the Company entered into a securities purchase agreement (the “September 2023 Purchase Agreement”) with certain accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement (the “September 2023 Offering”), (i)
On October 3, 2023, the Company closed on the issuance of the
The Company recorded $
Subject to the terms and limitations contained in the Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Voting Preferred Stock (the “Certificate of Designation”):
17
Prior to the extended mandatory exercise time of certain Preferred Tranche A Warrants, certain investors informed the Company that they would not exercise such warrants. Certain other investors in the offering agreed to assume and exercise
In connection with the September 2023 Offering, the Company issued an aggregate of
The following is a summary of the terms of the Series A Preferred Stock:
Dividends. At all times while shares of Series A Preferred Stock are issued and outstanding, holders of Series A Preferred Stock shall be entitled to receive dividends on shares of Series A Preferred Stock equal (on an as-if-converted-to-Common- Stock basis) to and in the same form as dividends actually paid on shares of the Common Stock.
For information pertaining to the Company’s outstanding warrants to purchase shares of the Company’s preferred stock, see Note 12, Warrants.
Earnout Shares
On October 22, 2021 (the “Closing Date”), the Company consummated the business combination (the “Business Combination”) contemplated by the agreement and plan of merger, dated as of June 21, 2021, as amended on August 12, 2021, made by and among Big Cypress Acquisition Corp., a Delaware corporation (“BCYP”), Big Cypress Merger Sub Inc., a Delaware corporation (“Merger Sub”), the Company, and Shareholder Representative Services LLC, a Colorado limited liability company, solely in its capacity as the representative, agent and attorney-in-fact of the SAB Stockholders (the “Business Combination Agreement ”). Upon closing of the
18
Business Combination, Merger Sub merged with SAB Biotherapeutics, with SAB Biotherapeutics as the surviving company of the merger. Upon closing of the Business Combination, BCYP changed its name to “SAB Biotherapeutics, Inc.”.
Additionally, the Business Combination Agreement included an earnout provision whereby the shareholders of SAB Biotherapeutics shall be entitled to receive additional consideration (“Earnout Shares”) if the Company meets certain Volume Weighted Average Price (“VWAP") thresholds, or a change in control with a per share price exceeding the VWAP thresholds within a five-year period immediately following the Closing.
The Earnout Shares shall be released in four equal increments as follows:
Pursuant to the terms of the Business Combination Agreement, SAB Biotherapeutics’ securityholders (including vested option holders) who own SAB Biotherapeutics securities immediately prior to the Closing Date will have the contingent right to receive their pro rata portion of (i) an aggregate of
The Earnout Shares are indexed to the Company’s equity and meet the criteria for equity classification. On the Closing Date, the fair value of the
Sales Agreement
As previously disclosed, on January 26, 2024, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), relating to shares of common stock. In accordance with the terms of the Sales Agreement, the Company may offer and sell shares of our common stock having an aggregate offering price of up to $
(11) Stock Option Plans
On August 5, 2014, the Company approved a stock option grant plan (the “2014 Equity Incentive Plan”) for employees, directors, and non-employee consultants, which provides for the issuance of options to purchase common stock. As of September 30, 2024, there were
The Company adopted the 2021 Omnibus Equity Incentive Plan (as amended, the “2021 Equity Incentive Plan”, and collectively with the 2014 Equity Incentive Plan, the “Equity Compensation Plans”), which reserved
19
Plan Amendment”). As of September 30, 2024, there were up to
The expected term of the stock options was estimated using the “simplified” method, as defined by the SEC’s Staff Accounting Bulletin No. 107, Share-Based Payment. The volatility assumption was determined by examining the historical volatilities for industry peer companies, as the Company does not have sufficient trading history for its common stock. The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the options. The dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has never paid dividends on its common stock and does not anticipate paying dividends on its common stock in the foreseeable future. Therefore, the Company has assumed no dividend yield for purposes of estimating the fair value of the options.
Stock Options
Stock option activity for employees and non-employees under the Equity Compensation Plans for the nine months ended September 30, 2024 was as follows:
|
|
Options |
|
|
Weighted |
|
|
Weighted Average Remaining Contractual Life (periods) |
|
|
Aggregate Intrinsic Value |
|
||||
Outstanding options, December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Forfeited |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Exercised |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding options, September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options vested and exercisable, September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Total unrecognized compensation cost related to non-vested stock options as of September 30, 2024 was approximately $
The weighted average grant date fair value of options granted during the three and nine months ended September 30, 2024, was $
During the three months ended September 30, 2023,
The estimated fair value of stock options granted to employees and consultants during the three and nine months ended September 30, 2024 and 2023, were calculated using the Black-Scholes option-pricing model using the following assumptions:
|
|
Three Months Ended September 30, |
|
For The Nine Months Ended September 30, |
||||||||||||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||||
Expected volatility |
|
|
% |
|
* |
% |
|
|
% |
|
|
% |
||||||
Weighted-average volatility |
|
|
|
% |
|
* |
% |
|
|
|
% |
|
|
|
% |
|||
Expected dividends |
|
— |
|
% |
|
* |
% |
|
— |
|
% |
|
— |
|
% |
|||
Expected term (in periods) |
|
|
|
|
* |
|
|
|
|
|
|
|
||||||
Risk-free rate |
|
|
% |
|
* |
% |
|
|
% |
|
|
% |
||||||
*
Restricted Stock
Stock award activity for employees and non-employees under the Equity Compensation Plans for the nine months ended September 30, 2024 was as follows:
20
|
|
Number of shares |
|
|
Weighted |
|
||
Unvested as of December 31, 2023 |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
$ |
|
|
Unvested as of September 30, 2024 |
|
|
|
|
$ |
|
||
At September 30, 2024, the Company had an aggregate of $
Stock-based compensation expense
Stock-based compensation expense for the three and nine months ended September 30, 2024 and 2023 was as follows:
|
|
Three Months Ended September 30, |
|
|
For The Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
(12) Warrants
Public Warrants
Each whole Public Warrant entitles the holder to purchase
Once the warrants become exercisable, the Company may call the warrants for redemption:
If the Company calls the warrants for redemption as described above, management will have the option to require any holder that wishes to exercise its warrant to do so on a “cashless basis.” If management takes advantage of this option, all holders of warrants would pay the exercise price by surrendering their warrants for that number of shares of common stock equal to the quotient obtained by dividing (x) the product of the number of shares of common stock underlying the warrants, multiplied by the excess of the “fair market value” (defined below) over the exercise price of the warrants by (y) the fair market value. The “fair market value” shall mean the average reported last sale price of the common stock for the 10 trading days ending on the third trading day prior to the date on which the notice of redemption is sent to the holders of warrants.
Private Placement Warrants
The Private Placement Warrants and the common stock issuable upon the exercise of the Private Placement Warrants were not transferable, assignable or saleable until after the completion of the Company's merger transaction in 2021. Additionally, the Private Placement Warrants are exercisable on a cashless basis and will be non-redeemable as long as they are held by the initial purchasers or their permitted transferees. If the Private Placement Warrants are held by someone other than the initial purchasers or their permitted transferees, the Private Placement Warrants will be redeemable by the Company and exercisable by such holders on the same basis as the Public Warrants.
21
PIPE Warrants and PIPE Placement Agent Warrants
In December 2022, the Company entered into a securities purchase agreement with certain institutional and accredited investors for the sale by the Company of
2023 Ladenburg Agreement Warrants
On March 21, 2023, the Company entered into a settlement agreement with Ladenburg Thalmann & Co. Inc. (“Ladenburg”), effective March 23, 2023 (the “2023 Ladenburg Agreement”, regarding the action brought by Ladenburg, the “Ladenburg Action”). In connection with the 2023 Ladenburg Agreement, on March 24, 2023, the Company (i) issued the Ladenburg Warrants to purchase up to
September 2023 Purchase Agreement Warrants
As of September 30, 2024, the Company had outstanding
Both the Preferred Tranche B Warrants and Preferred Tranche C Warrants were classified as derivative liabilities because they are redeemable for cash upon occurrence of a Fundamental Transaction, (as defined in the Forms for such warrants), which may be outside the control of the Company.
For more information see Note 10, Stockholders’ Equity.
Preferred PIPE Placement Agent Warrant
On November 21, 2023, the Company issued to Chardan Capital Markets LLC, the placement agent for the September 2023 Offering, a warrant to purchase
22
The following table summarizes warrant activity for the nine months ended September 30, 2024:
|
|
Outstanding |
|
|
Warrants Issued |
|
|
Warrants Exercised |
|
|
Warrants Forfeited |
|
|
Outstanding |
|
|||||
Transaction |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Business Combination Public Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Private Placement Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
PIPE Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
PIPE Placement Agent Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Ladenburg Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Preferred Tranche B Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Preferred Tranche C Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Preferred PIPE Placement Agent Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Presentation and Valuation of the Warrants — Liability Classified Warrants
Public Warrants and Private Placement Warrants
The Public Warrants and Private Placement Warrants are accounted for as liabilities in accordance with ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity and were presented within warrant liabilities on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023. The initial fair value of the warrant liabilities was measured at fair value at the Closing Date, and changes in the fair value of the warrant liabilities were presented within changes in fair value of warrant liabilities in the condensed consolidated statements of operations for nine months ended September 30, 2024 and 2023.
On the Closing Date, the Company established the fair value of the Private Placement Warrants utilizing both the Black-Scholes Merton formula and a Monte Carlo Simulation (the “MCS”) analysis. Specifically, the Company considered an MCS to derive the implied volatility in the publicly-listed price of the Public Warrants. The Company then considered this implied volatility in selecting the volatility for the application of a Black-Scholes Merton model for the Private Placement Warrants. The Company determined the fair value of the Public Warrants by reference to the quoted market price.
The Public Warrants were classified as a Level 1 fair value measurement, due to the use of the quoted market price, and the Private Placement Warrants held privately by assignees of Big Cypress Holdings LLC, were classified as a Level 3 fair value measurement, due to the use of unobservable inputs. See Note 13, Fair Value Measurements, for changes in fair value of the Private Placement Warrants.
The key inputs into the valuations as of September 30, 2024 and December 31, 2023 were as follows:
|
|
September 30, |
|
|
December 31, |
|
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected term remaining (periods) |
|
|
|
|
|
|
||
Implied volatility |
|
|
% |
|
|
% |
||
Closing common stock price on the measurement date |
|
$ |
|
|
$ |
|
||
Preferred Warrants
Should the Company enter into or be party to a fundamental transaction, the Company will be required to purchase all outstanding Warrants from the holders by paying cash in an amount equal to the Black Scholes Value of the unexercised portion of each Preferred Warrant. As a result, the Preferred Warrants are accounted for as derivative liabilities in accordance with ASC 480 and ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity and were presented within warrant liabilities on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023. The initial fair value of the warrant liabilities was measured at fair value at the Closing Date, and changes in the fair value of the warrant liabilities were presented within changes in fair value of warrant liabilities in the condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2024 and 2023.
The Company established the fair value of the Preferred Warrants utilizing the Black-Scholes Merton formula.
All tranches of the Preferred Warrants were classified as Level 3 fair value measurements, due to the use of unobservable inputs. See Note 13, Fair Value Measurements, for changes in fair value of the Preferred Warrants.
23
The key inputs utilized in determining the fair value of each Preferred Tranche B Warrant as of September 30, 2024 and December 31, 2023 were as follows:
|
|
September 30, |
|
|
December 31, |
|
||
Risk-free interest rate (1) |
|
|
% |
|
|
% |
||
Expected term remaining (periods) (1) |
|
|
|
|
|
|
||
Implied volatility |
|
|
% |
|
|
% |
||
Underlying Stock Price (Preferred Series A) |
|
$ |
|
|
$ |
|
||
The key inputs utilized in determining the fair value of each Preferred Tranche C Warrant as of September 30, 2024 and December 31, 2023 were as follows:
|
|
September 30, |
|
|
December 31, |
|
||
Risk-free interest rate (1) |
|
|
% |
|
|
% |
||
Expected term remaining (periods) (1) |
|
|
|
|
|
|
||
Implied volatility |
|
|
% |
|
|
% |
||
Underlying Stock Price (Preferred Series A) |
|
$ |
|
|
$ |
|
||
Equity Classified Warrants
The Company determined the Ladenburg Warrants, PIPE Warrants, PIPE Placement Agent Warrants, and Preferred PIPE Placement Agent Warrants met all necessary criteria to be accounted for as equity in accordance with ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity. As such, they are presented within additional paid-in capital within Company’s condensed consolidated statements of changes in stockholders’ equity and condensed consolidated balance sheets.
Warrants classified as equity are initially measured at fair value. Subsequent changes in fair value are not recognized as long as the warrants continue to be classified as equity.
The initial fair value of each PIPE Warrant and PIPE Placement Agent Warrant issued was determined using the Black-Scholes option-pricing model. All relevant terms and conditions for the PIPE Warrant and PIPE Placement Agent Warrant are identical with the exception of the exercise prices of $
The initial fair value of each Ladenburg Warrant issued and exercisable at $
The key inputs into the valuations as of the 2023 Ladenburg Agreement initial measurement date, March 21, 2023, were as follows:
|
|
Initial Measurement |
|
|
Risk-free interest rate |
|
|
% |
|
Expected term remaining (periods) |
|
|
|
|
Implied volatility |
|
|
% |
|
Closing common stock price on the measurement date |
|
$ |
|
|
Upon initial measurement, the fair value of each Ladenburg Warrant was determined to be $
The initial fair value of each Preferred PIPE Placement Agent Warrant issued and exercisable at $
The key inputs into the valuations as of the October 3, 2023 initial measurement date were as follows:
24
|
|
Initial Measurement |
|
|
Risk-free interest rate |
|
|
% |
|
Expected term remaining (periods) |
|
|
|
|
Implied volatility |
|
|
% |
|
Closing common stock price on the measurement date |
|
$ |
|
|
Upon initial measurement, the fair value of each Preferred PIPE Placement Agent Warrant was determined to be $
(13) Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The following fair value hierarchy classifies the inputs to valuation techniques that would be used to measure fair value into one of three levels:
Level 1: Unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions.
The following tables present information about the Company's assets and liabilities that are measured at fair value on a recurring basis at September 30, 2024 and December 31, 2023, and indicate the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
|
|
As of September 30, 2024 |
|
|||||||||||||
|
|
Total |
|
|
Quoted |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Short-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Mutual funds |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Public Warrant liability |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
||||
Private Placement Warrant liability |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Preferred Warrants |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
As of December 31, 2023 |
|
|||||||||||||
|
|
Total |
|
|
Quoted |
|
|
Significant |
|
|
Significant |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Public Warrant liability |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Private Placement Warrant liability |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Preferred Warrants |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
25
The following table provides a summary of the changes in Level 3 fair value measurements for the Private Placement Warrant liability:
|
|
|
|
|
Balance, December 31, 2023 |
|
$ |
|
|
Change in fair value of Private Placement Warrant liability |
|
|
|
|
Balance, March 31, 2024 |
|
|
|
|
Change in fair value of Private Placement Warrant liability |
|
|
|
|
Balance, June 30, 2024 |
|
|
|
|
Change in fair value of Private Placement Warrant liability |
|
|
( |
) |
Balance, September 30, 2024 |
|
$ |
|
|
The following table provides a summary of the changes in Level 3 fair value measurements for the Preferred Warrant liabilities:
Balance, December 31, 2023 |
|
$ |
|
|
Change in fair value of the Preferred Warrant liabilities |
|
|
( |
) |
Balance, March 31, 2024 |
|
|
|
|
Change in fair value of the Preferred Warrant liabilities |
|
|
( |
) |
Balance, June 30, 2024 |
|
|
|
|
Change in fair value of the Preferred Warrant liabilities |
|
|
|
|
Balance, September 30, 2024 |
|
$ |
|
As of September 30, 2024 and December 31, 2023, the Company did
The Company believes that the carrying amounts of its cash and cash equivalents, accrued interest receivable, notes payable, accrued expenses and other current liabilities approximate their fair values due to their near-term maturities.
(14) Investments
The fair value and amortized cost of the Company’s available-for-sale debt securities, summarized by type of security, consisted of the following:
|
|
As of September 30, 2024 |
|
|||||||||||||
|
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
Short-term: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
There were
During the three and nine months ended September 30, 2024, the Company recognized unrealized gains of $
Accrued interest receivable, related to the above investment securities amounted to $
(15) Income Taxes
Due to current and prior year losses the Company does not expect to have any Income Tax Provision.
The Company continues to record a valuation allowance on its net deferred tax assets. The valuation increased by approximately $
26
(16) Related Party Transactions
For the three and nine months ended September 30, 2024 and 2023, there were no related party transactions with beneficial owners of
(17) Employee Benefit Plan
The Company sponsors a defined contribution retirement plan. All the Company’s employees are eligible to be enrolled in the employer-sponsored contributory retirement savings plan, which include features under Section 401(k) of the Internal Revenue Code of 1986, as amended, and provides for Company matching contributions. The Company’s contributions to the plan are determined by its Board of Directors, subject to certain minimum requirements specified in the plan. The Company has historically made matching contributions of
(18) Commitments and Contingencies
The Company is not a party to any litigation, and, to its best knowledge, no action, suit, or proceeding has been threatened against the Company which are expected to have a material adverse effect on its financial condition, results of operations or liquidity.
(19) Subsequent Events
The Company evaluated subsequent events through the date of issuance of these condensed consolidated financial statements. The Company has no subsequent events that occurred that would be required to be disclosed in, or would be recognized, in these condensed consolidated financial statements.
27
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the accompanying notes included in Part I, Item 1 of this Form 10-Q. Some of the information contained in this discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. As a result of many factors, including those factors set forth in the section titled “Risk Factors,” our actual results could differ materially from those discussed in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors.” Please also refer to the section titled “Special Note Regarding Forward Looking Statements.”
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q (this “Quarterly Report” or “Form 10-Q”) includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Exchange Act of 1934, as amended (the "Exchange Act"), that are not historical facts and involve risks and uncertainties that could cause actual results to differ materially from those expected and projected. All statements, other than statements of historical fact included in this Form 10-Q including, without limitation, statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. Words such as “expect,” “believe,” “anticipate,” “intend,” “estimate,” “seek” and variations and similar words and expressions are intended to identify such forward-looking statements. Such forward-looking statements involved known and unknown risks, relate to future events or future performance, but reflect management’s current beliefs, based on information currently available. A number of factors could cause actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking statements. In addition, historic results, including but not limited to those related to IND enabling GLP safety/toxicology of SAB-142; and Phase 1 & Phase 2a results of SAB-176; do not guarantee that future research or trials will suggest the same conclusions, nor that historic results referred to herein will be interpreted in the same manner due to future preclinical and clinical trial results or otherwise. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the sections entitled “Risk Factors” in this Quarterly Report, our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission (the “SEC”) and available at https://www.sec.gov/. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as expressly required by applicable law, we disclaim any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.
Company Overview
We are a clinical-stage biopharmaceutical company focused on the development of human polyclonal immunotherapeutic antibodies, or hIgG, to address immune system disorders and infectious diseases. Our antibodies are both target-specific and polyclonal, meaning they are comprised of multiple hIgGs and can bind to multiple sites on specific immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders. Our lead candidate, SAB-142 is a human ATG focused on preventing or delaying the progression of T1D. We recently initiated a Phase 1 trial of SAB-142 to establish its safety and pharmacokinetic profiles in human subjects.
In addition to SAB-142, we also have clinical stage assets targeting infectious diseases that have significant mortality and morbidity in the general population and in high-risk patients. To date, we have conducted seven clinical trials, including Phase 1, Phase 2 and Phase 3, totaling more than 700 individuals dosed with our proprietary hIgGs. In May of 2023, we received Fast Track Designation and Breakthrough Therapy Designation from the U.S. Food and Drug Administration (the “FDA”) Center for Biologics Evaluation and Research (“CBER”) for our SAB-176 immunoglobulin targeting multiple strains of influenza based upon positive clinical data from a Phase 2a trial.
More broadly, we believe that our proprietary platform, referred to as DiversitAb,™ holds the potential to generate additional novel therapeutic candidates to expand our pipeline. DiversitAb,™ utilizes the human immune response to generate the optimal repertoire of IgGs for drug targets of interest. We believe it is the only technology capable of producing disease-targeted, hIgG in large quantities without the need for human plasma donors. We have optimized genetic engineering in the development of transchromosomic cattle, or Tc Bovine, which produce hIgGs. Our engineering of the DiversitAb production system drives IgG1 production across our pipeline. As our lead program SAB-142 advances, we intend to expand our pipeline in complimentary indications through strategic utilization of our platform.
28
Recent Developments
SAB provided a clinical trial progress update on September 9, 2024 at the European Association for the Study of Diabetes Annual Meeting. The update confirmed that SAB-142 has completed Phase 1 enrollment of all planned cohorts in healthy volunteers and is progressing to enroll patients with type 1 diabetes in the last cohort of the study. Further, the target dose of SAB-142 2.5mg/kg is complete with no observation of serum sickness.
SAB has elected to add a T1D patient cohort to establish safety, tolerability, pharmacokinetic and immunogenicity profile of SAB-142 in patients with T1D prior to initiation of an upcoming Phase II SAFEGUARD study in patients with new-onset T1D.
SAB-142 believes that it remains on track for a topline Phase 1 data readout by the end of the year.
Corporate Strategy
We are focused on developing product candidates for disease targets where a differentiated approach has the greatest potential to be either first-in-class against novel targets or best-in-class against complex targets to treat diseases with significant unmet medical needs, including immune and autoimmune disorders including T1D. Our business strategy is focused on SAB-142 as a first-in-class, human, multi-target antibody treatment designed to provide superior efficacy and safety in delaying the onset or progression of T1D.
DiversitAb,™ represents the first technology of its kind to produce large-scale human high-titer and high-avidity antibodies across multiple modalities.
Leveraging our proprietary production system will help us advance a robust pipeline of differentiated hIgG-based therapies for the treatment of immune system disorders and infectious diseases. Our hIgGs have been safely demonstrated up through Phase 3 clinical trials with a patient safety database that includes over 700 patients who were safely administered our hIgG therapeutics.
We have a demonstrated regulatory pathway through each of the FDA, CBER, UK Medicines and Healthcare products Regulatory Agency (“MHRA”), and Australian Therapeutic Goods Administration (“TGA”). These organizations understand our science and are familiar with the multivalent and multitarget properties of our single vial drug products. This further streamlines our ability to develop new and novel drug products rapidly and efficiently where single target monoclonal antibodies (“mAbs”) cannot replicate or duplicate our drug product attributes.
Our Product Pipeline
SAB-142: Human Anti-Thymocyte Globulin for Type 1 Diabetes
The following table summarizes our drug candidate, SAB-142 and its existing clinical plan and proposed stages of development.
29
Figure 1. An overview of phased milestones for SAB-142, starting with Phase 1 study cohorts 1-5 starting end of 2023 through beginning of 2025, with Phase 1 topline results anticipated in late 2024. Phase 2 study POC/DRF is anticipated to begin in early 2025 with Phase 2 (SAFEGUARD) topline results expected at the end of 2027.
Figure 2. An overview of the SAB-142 pipeline, including potential future anticipated studies for other indications and anticipated milestones.
SAB-142 is a first-in-class, human, multi-target anti-thymocyte globulin treatment designed to provide superior efficacy and safety in delaying the onset or progression of T1D. SAB-142 is expected to reduce autoimmune β-cell destruction and delay progression or onset of T1D in patients with Stage 3 or Stage 2 T1D respectively.
In addition to potentially preserving beta cell function in early T1D patients, SAB-142 offers the potential of re-dosing when examining clinically meaningful indicators such as C-peptide levels and glycosylated hemoglobin (HbA1c), without the potential risk of inducing major immune reactions of analogous animal derived IgGs. The overall long-term safety profile of a low-dose ATG is supportive of the vision to use SAB-142 as a lifelong disease-modifying treatment without a risk of immunosuppression associated with clinically significant effects such as infections, malignancies or suppressed humoral response.
Mechanism of Action
Maintenance of the level of connecting peptide, a short 31 amino acid polypeptide that connects insulin’s A chain to its B chain in the proinsulin molecule, commonly referred to as C-peptide, is a validated surrogate endpoint for endogenous insulin production, essential for the prevention of progression of T1D. Placebo controlled trials with low-dose rabbit ATG, defined as a single dose of 2.5 milligram per kilogram (mg/kg), have shown statistically significant maintenance of C-peptide levels and thus a delay in progression of recent onset T1D.
Based on the results of a Phase 2 clinical trial conducted at the University of Florida, a single dose of rabbit ATG showed sustained benefit in T1D over a two-year period by maintaining significantly higher C-peptide levels than a placebo control. However, more than 65% of treated patients in this study acquired serum sickness due to the infusion of a non-human antibody, with symptoms that included rash, malaise, fever, and joint swelling. The symptoms often required treatment with steroids that control serum sickness but impair diabetes management and reduces the capacity to re-dose rabbit ATG when C-peptide levels begin to drop.
While the mechanism of action of our compound closely resembles rabbit ATG, SAB-142 has clear advantages that are fundamental for safe and reliable re-dosing required to delay disease progression. Data from more than 700 human subjects treated with antibodies produced by our platform support expectation of a zero serum sickness rate and zero incidence of neutralizing anti-drug antibodies (“ADA”) within the upcoming SAB-142 trials. There is an established regulatory path for T1D indications using the SAB-142 modality. We initiated the Phase 1 clinical study with the first patient dosed November 2023. Finally, our next steps will be to file a clinical trial application (“CTA”) in the European Union, and an investigational new drug (“IND”) application in the United States to expand the clinical trials to global jurisdictions.
30
Rabbit ATG shows therapeutic promise but offers problematic potential for adverse events that could inhibit long term disease modification and redosing; we believe those issues are resolved by SAB-142. SAB-142 represents an opportunity to offer a novel human alternative to rabbit- or equine-derived ATG IgGs with potential for safe and reliable re-dosing while avoiding the risk factors observed with currently available therapies.
Clinical Strategy
Immunological processes resulting in the breakdown of self-tolerance and gradual destruction of pancreatic beta cells by the patient’s own immune system preceding the clinical onset of disease oftentimes starts very early in patients’ lives, sometimes as early as in utero. The average age of clinical onset of T1D is 13 years old. Stage 1 is the start of T1D, marked by individuals having two or more diabetes-related autoantibodies and still normal blood sugar concentrations. In Stage 2, individuals have dysglycemia but without symptoms. Stage 3 is the time of a full clinical diagnosis. Unfortunately, when an individual is first diagnosed with clinical stage T1D, 50- 90% of pancreatic insulin-producing beta cells are already destroyed. Hence, it is critical to start therapy that preserves the remaining fully functional beta cells as soon as possible as it may provide the highest benefit throughout the patient’s lifetime.
In addition to the currently approved and ongoing Phase 1, we plan to bring this program to IND and CTA filings with global regulatory authorities by the mid-2024. As there are unmet medical needs globally for disease-modifying treatments of T1D, we plan to work with global health authorities and file clinical trial applications and clinical trial notifications in other countries to have a global footprint and reach patients with T1D worldwide. We anticipate topline results by the end of 2024. Topline data will include the safety data to support re-dosing along with proof of biological activity. Topline data will further enable global Phase 2 clinical proof of concept and dose-range finding trials in adults and even more importantly, in adolescent T1D population, another critical milestone for 2024 as T1D onset most often occurs in pediatric and adolescent patient populations.
SAB-176: Human Anti-Influenza Globulin for High-Risk Influenza
SAB-176 represents a comprehensive approach to treatment and prophylaxis (PreP and PEP) of high-risk patients with influenza as a broadly neutralizing -human polyclonal immunoglobulin therapeutic with several anti-viral mechanisms. SAB-176 was evaluated in an ascending dose, double-blind, randomized, placebo-controlled Phase 1 safety trial in 27 healthy volunteers in 2020. The FDA allowed us to initiate a Phase 1 trial in healthy adults based on the safety profile in the preclinical data set. A Safety Review Committee (“SRC”) monitored adverse events after each cohort was infused and recommended that each later cohort could be infused with the next highest dose according to the study protocol. Although anticipated adverse events were noted among the SAB-176 and placebo participants, no drug related serious adverse events (“SAEs”) were identified by the SRC.
In March 2024, SAB announced that the Navy Medical Research Command (“NMRC”) would be moving forward with a safety and tolerability study to evaluate SAB-176 pursuant to the Cooperative Research and Development Agreement governing the relationship between SAB and the NMRC, with funding for the study provided by the Henry Jackson Foundation.
Key Factors Affecting Our Results of Operations and Future Performance
We believe that our financial performance has been, and in the foreseeable future will continue to be, primarily driven by multiple factors as described throughout our analysis within Components of Results of Operations below, each of which presents growth opportunities for our business. These factors also pose important challenges that we must successfully address in order to sustain our growth and improve our results of operations. Our ability to successfully address these challenges is subject to various risks and uncertainties, including those described in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and supplemented with revised or additional risk factors in our Quarterly Reports on Form 10-Q, including any such risks included in “Part II, Item 1A, Risk Factors” herein.
Components of Results of Operations
Revenue
Our revenue has historically been generated through grants from government and other (non-government) organizations. We currently have no commercially approved products.
Grant revenue is recognized for the period that the research and development services occur, as qualifying expenses are incurred or conditions of the grants are met. We concluded that payments received under these grants represent conditional, nonreciprocal contributions, as described in ASC 958, Not-for-Profit Entities, and that the grants are not within the scope of ASC 606, Revenue from Contracts with Customers, as the organizations providing the grants do not meet the definition of a customer. Expenses for grants are tracked by using a project code specific to the grant, and the employees also track hours worked by using the project code.
31
Government grants
There was no revenue recognized from government grants for the three months ended September 30, 2024 and total revenue recognized from government grants was approximately $1.2 million for the nine months ended September 30, 2024, and $1.3 million and $1.9 million for the three and nine months ended September 30, 2023, respectively.
The National Institute of Health – National Institute of Allergy and Infectious Disease (“NIH-NIAID”) and Geneva Foundation grants, totaling approximately $4.2 million, were completed as of June 30, 2023. No grant income was recognized for these grants in the three and nine months ended September 30, 2024. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (“JPEO”) Rapid Response Contract (the “JPEO Rapid Response Contract”), initially awarded for up to $25 million and later expanded to $203.6 million, was terminated in 2022 (the “JPEO Rapid Response Contract Termination”). A final settlement was reached with the US Department of Defense (the “DoD”) in January 2023. Approximately $1.2 million in deferred grant income was recognized for the JPEO Rapid Response Contract in the nine months ended September 30, 2024. A remaining $115 thousand is expected to be recognized as wind-down activities are completed, subject to potential adjustments from negotiations with third-party vendors.
See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements for further information about our established revenue recognition process and Note 4, Revenue, to our condensed consolidated financial statemetns for further information about revenue recognized from government grants for the three and nine months ended September 30, 2024 and 2023.
Operating Expenses
Research and Development Expenses
Research and development expenses primarily consist of salaries, benefits, incentive compensation, stock-based compensation, laboratory supplies and materials for employees and contractors engaged in research and product development, licensing fees to use certain technology in our research and development projects, fees paid to consultants and various entities that perform certain research and testing on our behalf. Research and development expenses are tracked by target/project code. Indirect general and administrative costs are allocated based upon a percentage of direct costs. We expense all research and development costs in the period in which they are incurred.
Research and development activities consist of discovery research for our platform development and the indications we are working on. For SAB-142, Avance Clinical PTY, Ltd (“Avance”), acts as the contract research organization (“CRO”) overseeing our Phase 1 safety study. This study started in December 2023 and the terms of that agreement are subject to confidentiality and the status of the agreement is that it is current. For the three and nine months ended September 30, 2024 and 2023, we continued to incur costs to advance our progress towards commercialization of SAB-142. We expect to continue to incur substantial research and development expenses as we conduct discovery research to enhance our platform and work on our indications. We expect to hire additional employees and continue research and development and manufacturing activities. As a result, we expect that our research and development expenses will continue to increase in future periods and vary from period to period.
Major components within our research and development expenses are salaries and benefits (laboratory & farm), laboratory supplies, animal care, contract manufacturing, clinical trial expense, outside laboratory services, project consulting, and facility expenses. Our platform allows us to work on multiple projects with the same resources, as the research and development process of each product is very similar (with minimal differences in the manufacturing process).
Research and development expenses by component for the three and nine months ended September 30, 2024 and 2023:
|
|
Three Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Salaries & benefits |
|
$ |
2,754,884 |
|
|
$ |
1,625,985 |
|
Laboratory supplies |
|
|
377,933 |
|
|
|
174,012 |
|
Animal care |
|
|
130,369 |
|
|
|
112,421 |
|
Contract manufacturing |
|
|
— |
|
|
|
388,171 |
|
Clinical trial expense |
|
|
1,462,044 |
|
|
|
210,265 |
|
Outside laboratory services |
|
|
1,472,089 |
|
|
|
170,905 |
|
Project consulting |
|
|
182,387 |
|
|
|
16,585 |
|
Facility expense |
|
|
1,409,182 |
|
|
|
1,312,359 |
|
Other expenses |
|
|
41,857 |
|
|
|
9,015 |
|
Total research and development expenses |
|
$ |
7,830,745 |
|
|
$ |
4,019,718 |
|
32
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Salaries & benefits |
|
$ |
7,520,853 |
|
|
$ |
4,995,096 |
|
Laboratory supplies |
|
|
1,012,337 |
|
|
|
741,375 |
|
Animal care |
|
|
419,438 |
|
|
|
804,006 |
|
Contract manufacturing |
|
|
— |
|
|
|
388,171 |
|
Clinical trial expense |
|
|
2,897,710 |
|
|
|
367,301 |
|
Outside laboratory services |
|
|
4,562,728 |
|
|
|
539,279 |
|
Project consulting |
|
|
713,018 |
|
|
|
307,210 |
|
Facility expense |
|
|
5,346,609 |
|
|
|
3,975,518 |
|
Other expenses |
|
|
127,305 |
|
|
|
99,613 |
|
Total research and development expenses |
|
$ |
22,599,998 |
|
|
$ |
12,217,569 |
|
General and Administrative Expenses
General and administrative expenses primarily consist of salaries, benefits, and stock-based compensation costs for employees in our executive, accounting and finance, project management, corporate development, office administration, legal and human resources functions as well as professional services fees, such as consulting, audit, tax and legal fees, general corporate costs and allocated overhead expenses. General and administrative expenses also include rent and facilities expenses allocated based upon total direct costs. We expect that our general and administrative expenses will continue to increase in future periods, primarily due to increased headcount to support anticipated growth in the business and due to incremental costs associated with operating as a public company. These costs include expenses related to compliance with rules and regulations applicable to companies listed on a securities exchange, reporting obligations pursuant to SEC and stock exchange listing standards, public relations, insurance, and professional services. Additionally, we anticipate incurring expenses related to the remediation of material weaknesses in our internal control over financial reporting, which involve implementing new processes and engaging with a third-party firm. We expect these expenses to vary from period to period in absolute terms and as a percentage of revenue.
Nonoperating (Expense) Income
Gain (loss) on change in fair value of warrant liabilities
Gain (loss) on change in fair value of warrant liabilities consists of the changes in the fair value of the warrant liabilities.
Other Income (expense)
Other income primarily consists of income associated with the refundable portion of Australian research and development tax credits and dividend income from non-interest bearing short-term investments.
Interest income
Interest income consists of interest earned on our investments in debt securities, cash, and cash equivalents.
Interest expense
Interest expense consists primarily of interest related to abated rent and insurance financing.
33
Results of Operations
The following tables set forth our results of operations for the three months ended September 30, 2024 and 2023:
|
|
Three Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Revenue |
|
|
|
|
|
|
||
Grant revenue |
|
$ |
— |
|
|
$ |
1,267,361 |
|
Total revenue |
|
|
— |
|
|
|
1,267,361 |
|
Operating expenses |
|
|
|
|
|
|
||
Research and development |
|
|
7,830,745 |
|
|
|
4,019,718 |
|
General and administrative |
|
|
3,478,621 |
|
|
|
2,570,565 |
|
Total operating expenses |
|
|
11,309,366 |
|
|
|
6,590,283 |
|
Loss from operations |
|
|
(11,309,366 |
) |
|
|
(5,322,922 |
) |
Other income (expense) |
|
|
|
|
|
|
||
Changes in fair value of warrant liabilities |
|
|
6,171 |
|
|
|
178,758 |
|
Interest expense |
|
|
(78,036 |
) |
|
|
(69,700 |
) |
Interest income |
|
|
277,174 |
|
|
|
14,364 |
|
Other income |
|
|
754,647 |
|
|
|
97,183 |
|
Total other income (expense) |
|
|
959,956 |
|
|
|
220,605 |
|
Loss before income taxes |
|
|
(10,349,410 |
) |
|
|
(5,102,317 |
) |
Net loss |
|
$ |
(10,349,410 |
) |
|
$ |
(5,102,317 |
) |
The following tables set forth our results of operations for the nine months ended September 30, 2024 and 2023:
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Revenue |
|
|
|
|
|
|
||
Grant revenue |
|
$ |
1,207,712 |
|
|
$ |
1,933,980 |
|
Total revenue |
|
|
1,207,712 |
|
|
|
1,933,980 |
|
Operating expenses |
|
|
|
|
|
|
||
Research and development |
|
|
22,599,998 |
|
|
|
12,217,569 |
|
General and administrative |
|
|
11,509,394 |
|
|
|
8,917,960 |
|
Total operating expenses |
|
|
34,109,392 |
|
|
|
21,135,529 |
|
Loss from operations |
|
|
(32,901,680 |
) |
|
|
(19,201,549 |
) |
Other income (expense) |
|
|
|
|
|
|
||
Changes in fair value of warrant liabilities |
|
|
7,691,363 |
|
|
|
(96,172 |
) |
Interest expense |
|
|
(247,525 |
) |
|
|
(237,405 |
) |
Interest income |
|
|
1,149,624 |
|
|
|
100,920 |
|
Other income |
|
|
1,597,608 |
|
|
|
97,183 |
|
Total other income (expense) |
|
|
10,191,070 |
|
|
|
(135,474 |
) |
Loss before income taxes |
|
|
(22,710,610 |
) |
|
|
(19,337,023 |
) |
Income tax expense (benefit) |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(22,710,610 |
) |
|
$ |
(19,337,023 |
) |
Comparison of the three and nine months ended September 30, 2024 and 2023
Revenue
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Revenue |
|
$ |
— |
|
|
$ |
1,267,361 |
|
|
$ |
(1,267,361 |
) |
|
|
(100.0 |
)% |
Total revenue |
|
$ |
— |
|
|
$ |
1,267,361 |
|
|
|
|
|
|
|
||
Revenue decreased by approximately $1.3 million, or 100.0%, in the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, primarily due to the JPEO Rapid Response Contract Termination. There was no revenue for the three months ended September 30, 2024, as compared to $413 thousand for supplies and $855 thousand for contract manufacturing, for the three months ended September 30, 2023.
34
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Revenue |
|
$ |
1,207,712 |
|
|
$ |
1,933,980 |
|
|
$ |
(726,268 |
) |
|
|
(37.6 |
)% |
Total revenue |
|
$ |
1,207,712 |
|
|
$ |
1,933,980 |
|
|
|
|
|
|
|
||
Revenue decreased by $0.7 million, or 37.6%, in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due to the JPEO Rapid Response Contract Termination. Included in revenues for the nine months ended September 30, 2024, are closeout activities and charges of $1.2 million due to outside services for laboratory supply disposal, as compared to $0.5 million for supplies, $0.1 million for labor, and $1.4 million for contract manufacturing for the nine months ended September 30, 2023.
As a result of the JPEO Rapid Response Contract Termination, we expect future revenues to be lower as our primary pipeline development target of Type 1 diabetes remains independently financed as we explore potential partnerships, co-development opportunities, and licensing arrangements.
Research and Development
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Research and development |
|
$ |
7,830,745 |
|
|
$ |
4,019,718 |
|
|
$ |
3,811,027 |
|
|
|
94.8 |
% |
Total research and development expenses |
|
$ |
7,830,745 |
|
|
$ |
4,019,718 |
|
|
|
|
|
|
|
||
Research and development expenses increased by $3.8 million, or 94.8%, for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, primarily due to increases in outside lab services (year-over-year increase of $1.3 million, 595.8%, salaries and benefits (year-over-year increase of $1.1 million, 49.5%), overhead (year-over-year increase of $0.1 million, 16.8%), project consulting (year-over-year increase of $0.2 million, 300.5%), clinical trial costs (year-over-year increase of $1.3 million, 475.4%), laboratory supplies (year-over-year increase of $0.2 million, 67.7%), offset by a decrease in contract manufacturing (year-over-year decrease of $0.4 million, 100.0%).
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Research and development |
|
$ |
22,599,998 |
|
|
$ |
12,217,569 |
|
|
$ |
10,382,429 |
|
|
|
85.0 |
% |
Total research and development expenses |
|
$ |
22,599,998 |
|
|
$ |
12,217,569 |
|
|
|
|
|
|
|
||
Research and development expenses increased by $10.4 million, or 85.0%, for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due to increases in outside lab services (year-over-year increase of $4.0 million, 739.0%), salaries and benefits (year-over-year increase of $2.5 million, 41.5%), an out-of-period adjustment of $0.9 million of amortization expense, overhead (year-over-year increase of $0.5 million, 11.9%), project consulting (year-over-year increase of $0.4 million, 82.6%), clinical trial costs (year-over-year increase of $2.5 million, (814.2%), laboratory supplies (year-over-year increase of $0.3 million, 11.8%) offset by a decrease in animal care (year-over-year decrease of $0.4 million, 58.3%) and contract manufacturing (year-over-year decrease of $0.4 million, 100.0%).
General and Administrative
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
General and administrative |
|
$ |
3,478,621 |
|
|
$ |
2,570,565 |
|
|
$ |
908,056 |
|
|
|
35.3 |
% |
Total general and administrative expenses |
|
$ |
3,478,621 |
|
|
$ |
2,570,565 |
|
|
|
|
|
|
|
||
General and administrative expenses increased by $908 thousand, or 35.3%, in the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, primarily due to salaries and benefits (year-over-year increase of $883 thousand, 68.3%), project consulting (year-over-year increase of $159 thousand, 3.3%), human resources, legal, and other administrative support fees relating to IT (year-over-year increase of $15 thousand, 4.0%), offset by a decrease in insurance costs (year-over-year decrease of $149 thousand, 31.7%). We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We
35
anticipate incurring expenses related to the remediation of material weaknesses in our internal control over financial reporting, which involve implementing new processes and engaging with a third-party firm.
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
General and administrative |
|
$ |
11,509,394 |
|
|
$ |
8,917,960 |
|
|
$ |
2,591,434 |
|
|
|
29.1 |
% |
Total general and administrative expenses |
|
$ |
11,509,394 |
|
|
$ |
8,917,960 |
|
|
|
|
|
|
|
||
General and administrative expenses increased by $2.6 million, or 29.1%, in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due to salaries and benefits (year-over-year increase of $2.6 million, 72.3%), project consulting (year-over-year increase of $0.3 million, 36.7%), and other immaterial administrative support fees relating to IT and human resources, offset by a decrease in insurance costs (year-over-year decrease of $0.4 million, 29.8%). We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We anticipate incurring expenses related to the remediation of material weaknesses in our internal control over financial reporting, which involve implementing new processes and engaging with a third-party firm.
Non-operating Income
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Changes in fair value of warrant liabilities |
|
$ |
6,171 |
|
|
$ |
178,758 |
|
|
$ |
(172,587 |
) |
|
|
(96.5 |
)% |
Other income |
|
|
754,647 |
|
|
|
97,183 |
|
|
|
657,464 |
|
|
|
676.5 |
% |
Total non-operating income |
|
$ |
760,818 |
|
|
$ |
275,941 |
|
|
|
|
|
|
|
||
Total non-operating income increased by $0.5 million, or 175.7% in the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, primarily due to the other income attributable to the Australian research and development tax credit (year-over-year increase of $0.6 million) and dividend income received from non-interest bearing short-term investments (year-over-year increase of $0.1 million), offset by the change in fair value of warrant liabilities (year-over-year decrease of $0.2 million, 96.5%),
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Changes in fair value of warrant liabilities |
|
$ |
7,691,363 |
|
|
$ |
(96,172 |
) |
|
$ |
7,787,535 |
|
|
|
(8,097.51 |
)% |
Other income |
|
|
1,597,608 |
|
|
|
97,183 |
|
|
|
1,500,425 |
|
|
|
1,543.92 |
% |
Total non-operating income |
|
$ |
9,288,971 |
|
|
$ |
1,011 |
|
|
|
|
|
|
|
||
Total non-operating income increased by $9.3 million, or 918,690.41% in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due to the change in fair value of warrant liabilities (year-over-year increase of $7.8 million, 8,097.5%), and Australian research and development tax credit (year-over-year increase of $1.2 million) and income received from non-interest bearing short-term investments (year-over-year increase of $0.3 million).
Interest Expense
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Interest expense |
|
$ |
78,036 |
|
|
$ |
69,700 |
|
|
$ |
8,336 |
|
|
|
12.0 |
% |
Total interest expense |
|
$ |
78,036 |
|
|
$ |
69,700 |
|
|
|
|
|
|
|
||
Interest expense in the three months ended September 30, 2024 was consistent with interest expense in the three months ended September 30, 2023, with the added interest expense on the 8% Unsecured Convertible Note in the current fiscal period offset by lower interest expenses associated with our finance leases in the same period of the prior year.
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Interest expense |
|
$ |
247,525 |
|
|
$ |
237,405 |
|
|
$ |
10,120 |
|
|
|
4.3 |
% |
Total interest expense |
|
$ |
247,525 |
|
|
$ |
237,405 |
|
|
|
|
|
|
|
||
36
Interest expense in the nine months ended September 30, 2024 was consistent with interest expense in the nine months ended September 30, 2023, with the added interest expense on the 8% Unsecured Convertible Note in the current fiscal period offset by lower interest expenses associated with our finance leases in the same period of the prior year.
Interest Income
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Interest income |
|
$ |
277,174 |
|
|
$ |
14,364 |
|
|
$ |
262,810 |
|
|
|
1,829.64 |
% |
Total interest income |
|
$ |
277,174 |
|
|
$ |
14,364 |
|
|
|
|
|
|
|
||
Interest income increased by $0.3 million, or 1829.6%, during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, primarily due to interest earned on our investments in debt securities, along with higher interest earning cash and cash equivalent balances.
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% Change |
|
||||
Interest income |
|
$ |
1,149,624 |
|
|
$ |
100,920 |
|
|
$ |
1,048,704 |
|
|
|
1,039.14 |
% |
Total interest income |
|
$ |
1,149,624 |
|
|
$ |
100,920 |
|
|
|
|
|
|
|
||
Interest income increased by $1.0 million, or 1,039.14%, during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2024, primarily due to interest earned on our investments in debt securities, and higher interest earning cash, and cash equivalent balances.
Liquidity and Capital Resources
As of September 30, 2024 and December 31, 2023, we had $30.4 million and $56.6 million, respectively, of cash, cash equivalents, and investments.
We intend to continue to invest in our business and, as a result, may incur operating losses in future periods. We expect to continue to invest in research and development efforts towards expanding our capabilities and expertise along our platform and the primary pipeline development targets we are working on, as well as building our business development team and marketing our solutions to partners in support of the growth of the business.
We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin commercialization of our products. As a result, we will require additional capital to fund our operations in order to support our long-term plans.
We have incurred operating losses for the past several years. While we intend to continue to keep operating expenses at a reduced level there can be no assurance that our current level of operating expenses will not increase or that other uses of cash will not be necessary. Based on our current level of operating expenses, existing resources will not be sufficient to cover operating cash needs through the twelve months following the date these financials are made available for issuance. We intend to seek additional capital through equity and/or debt financings, collaborative or other funding arrangements. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate our assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.
Sources of Liquidity
Since our inception, we have financed our operations primarily from revenue in the form of government grants and from equity financings.
Notes payable
8% Unsecured Convertible Note
Pursuant to the fourth amendment to our lease with Sanford Health, we agreed to a period of abated rent (the “Abated Rent”) from October 1, 2022 to September 30, 2023. In exchange for the Abated Rent, effective as of October 1, 2022, we issued to Sanford Health an 8% unsecured, convertible promissory note (the “8% Unsecured Convertible Note”).
37
Pursuant to the 8% Unsecured Convertible Note, we shall pay the sum of approximately $542 thousand (the “Principal”) plus accrued and unpaid interest thereon on September 30, 2024 (the “Maturity Date”). Simple interest shall accrue on the outstanding Principal from and after the date of the 8% Unsecured Convertible Note and shall be payable on the Maturity Date. The Company repaid the Principal of $542 thousand and total accrued interest of $87 thousand during the three months ended September 30, 2024. We incurred approximately $32 thousand and $36 thousand of interest expense for the three and nine months ended September 30, 2024 and 2023, respectively, related to the 8% Unsecured Convertible Note.
Insurance Financing Note
We obtained financing for certain Director & Officer liability insurance policy premiums. The agreement assigns First Insurance Funding (“Lender”) a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies including (a) all returned or unearned premiums, (b) all additional cash contributions or collateral amounts assessed by the insurance companies in relation to the financed policies and financed by Lender, (c) any credits generated by the financed policies, (d) dividend payments, and (e) loss payments which reduce unearned premiums. If any circumstances exist in which premiums related to any Financed Policy could become fully earned in the event of loss, Lender shall be named a loss-payee with respect to such policy.
The total premiums, taxes and fees financed is approximately $765 thousand with an annual interest rate of 7.96%. In consideration of the premium payment by Lender to the insurance companies or the Agent or Broker (as such terms are defined in the agreement with Lender), we unconditionally promise to pay Lender the amount financed plus interest and other charges permitted under the agreement. We paid the insurance financing note through installment payments with the last payment for the current note being September 22, 2024. We recognized no insurance financing note payable in its condensed consolidated balance sheet as of September 30, 2024 and recognized approximately $509 thousand of insurance financing note payable in its condensed consolidated balance sheet as of December 31, 2023. We incurred less than $1 thousand of interest expense related to the insurance financing note for the three months ended September 30, 2024 and 2023 and approximately $13 thousand and $13 thousand for the nine months ended September 30, 2024 and 2023, respectively.
Please refer to Note 9, Notes Payable, to our condensed consolidated unaudited financial statements for additional information on our debt.
Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023:
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Net cash used in operating activities |
|
$ |
(24,759,821 |
) |
|
$ |
(11,672,688 |
) |
Net cash used in investing activities |
|
|
(21,293,033 |
) |
|
|
(84,840 |
) |
Net cash used in financing activities |
|
|
(1,389,587 |
) |
|
|
(863,886 |
) |
Effect of exchange rate changes on cash and cash equivalents |
|
|
47,550 |
|
|
|
— |
|
Net decrease in cash and cash equivalents |
|
$ |
(47,394,891 |
) |
|
$ |
(12,621,414 |
) |
Operating Activities
Net cash used in operating activities increased by $13.1 million in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due to an increase in cash used in operating activities related to change in our operating assets and liabilities of $3.2 million and an increase in our net loss adjusted for non-cash items of $9.9 million. Year-over-year changes in cash used by operating activities is explained by shifts in the working capital balances as we continue to invest in the development of our lead product candidate, SAB-142.
Investing Activities
Net cash used by investing activities increased by $21.2 million in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due to an increase in purchases, sales and maturities of investment securities.
38
Financing Activities
Net cash used by financing activities increased by $0.5 million in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due payments of our convertible note and insurance financing agreement along with an increase in deferred issuance costs.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with third parties, including CROs.
As of September 30, 2024, there were no material changes outside of the ordinary course of business to our commitments and contractual obligations.
Income Taxes
Due to current and prior year losses we do not expect to have any Income Tax Provision.
We continue to record a valuation allowance on its net deferred tax assets. The valuation increased by approximately $6.8 million during the nine months ended September 30, 2024. We have not recognized any reserves for uncertain tax positions.
Going Concern
The accompanying unaudited condensed consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. We have experienced net losses, negative cash flows from operations and, as of September 30, 2024, and had an accumulated deficit of $112.8 million. We anticipate we will continue to generate losses for the foreseeable future and expect the losses to increase as we continue the development of, or seek regulatory approvals for, product candidates, and begin commercialization of products. As a result, we will require additional capital to fund operations in order to support our long-term plans.
We will need to raise additional capital to fund our operations, continue to execute our strategy, and continue as a going concern. In the future, we may seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative, or other funding arrangements. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.
We currently expect that our cash, cash equivalents, and short-term investments of $30.4 million as of September 30, 2024 will not be sufficient to fund our operating expenses and capital requirements for more than 12 months from the date the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern.
Off-Balance Sheet Arrangements
We did not have, for the periods presented, and we do not currently have, any off-balance sheet financing arrangements or any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities, that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Critical Accounting Policies and Estimates
We have prepared our condensed consolidated financial statements in accordance with U.S. GAAP. Our preparation of these condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue, expenses, and related disclosures. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from these estimates under different assumptions or conditions.
Our most critical accounting estimates and assumptions are included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 29, 2024 and our most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 filed with the SEC on August 8, 2024. There have been no significant changes to our critical accounting policies during
39
the three months ended September 30, 2024. See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements for further details.
JOBS Act Accounting Election
The Jumpstart Our Business Startups (“JOBS”) Act, enacted in April 2012, permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have and intend to continue to take advantage of all of the reduced reporting requirements and exemptions, including the longer phase-in periods for the adoption of new or revised financial accounting standards, for an emerging growth company under Section 107 of the JOBS Act.
We may use these provisions until the last day of our fiscal year in which the fifth anniversary of the completion of our initial public offering occurred. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenue exceeds $1.235 billion, or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.
We have elected to take advantage of certain of the reduced disclosure obligations in this Form 10-Q and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our shareholders may be different than the information you receive from other public companies in which you hold stock.
The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards, until those standards apply to private companies. We have elected to take advantage of the benefits of this extended transition period and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards. Until the date that we are no longer an emerging growth company or affirmatively and irrevocably opt out of the exemption provided by Section 7(a)(2)(B) of the Securities Act upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which we will adopt the recently issued accounting standard.
40
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Concentration of Credit Risk
We received 100% of our total revenue through grants from government organizations for the three and nine months ended September 30, 2024, respectively and the three and nine months ended September 30, 2023, respectively. To date, no receivables have been written off.
Interest Rate Risk
As of September 30, 2024 and December 31, 2023, we had cash, cash equivalents, U.S. treasury securities, investments in exchange traded mutual funds, and money market funds of $30.4 million and $56.6 million, respectively, all of which was maintained in bank accounts, money market funds, mutual funds, and U.S. treasury securities. Our primary exposure to market risk is to interest income volatility, which is affected by changes in the general level of interest rates. A 10% change in the market interest rates would not have a material effect on our business, financial condition, or results of operations.
Foreign Currency Risk
We conduct materially all of our business in U.S. dollars. We do not have any foreign currency or other derivative financial instruments. Our primary exposure to changes in foreign currency exchange rates relates mainly to SAB Australia. We do not currently hedge our foreign currency exchange rate risk. As of September 30, 2024 and December 31, 2023, our liabilities denominated in foreign currencies were not material. Accordingly, we do not believe a 10% increase or decrease in current exchange rates would have a material effect on our financial results.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer has evaluated the effectiveness of our disclosure controls and procedures. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on the evaluation as of September 30, 2024, our Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures were not effective as of September 30, 2024. Management has concluded that there is a material weakness in the design and operating effectiveness of the Company’s control environment surrounding insufficient documentation of the formalized processes and procedures that are critical to the accomplishment of financial reporting objectives.
Plan for Remediation of Material Weakness
We continue to work to strengthen our internal control over financial reporting and are committed to ensuring that such controls are designed and operating effectively. We are implementing process and control improvements to address the above material weakness as follows:
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We are committed to continuing to improve our internal control processes related to these matters and will continue to review our financial reporting controls and procedures. As we continue to evaluate and work to improve our internal control over financial reporting, we may take additional measures to address deficiencies or modify certain of the remediation measures described above.
Changes in Internal Control Over Financial Reporting
There were no changes, except for the remediation efforts described above, in our internal control over financial reporting that occurred during the three months ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently a party to any material litigation, nor are we aware of any pending or threatened litigation against us that we believe would materially affect our business, operating results, financial condition, or cash flows. Participants in our industry face frequent claims and litigation, including securities litigation, claims regarding patent and other intellectual property rights, and other liability claims. As a result, we may be involved in various legal proceedings from time to time in the future.
Item 1A. Risk Factors.
Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 29, 2024, which we strongly encourage you to review (the “2023 Annual Report”). There have been no material changes from the risk factors described in our 2023 Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
Rule 10b5-1 Trading Plans
During the three months ended September 30, 2024, none of the Company’s directors or officers (as defined in Rule 16a-1(f) of the Exchange Act)
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Item 6. Exhibits.
Exhibit Number |
Description |
Schedule/ Form |
File No. |
Exhibit |
Filing Date |
10.1¥ |
Employment Agreement between SAB Biotherapeutics, Inc. and Lucy To dated July 26, 2024 |
8-K |
001-39871 |
10.1 |
July 31, 2024 |
31.1* |
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31.2* |
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32.1* |
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32.2* |
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101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
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101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* Filed herewith.
¥ Denotes management contract or any compensatory plan, contract or arrangement.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
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SAB BIOTHERAPEUTICS, INC. |
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Date: November 6, 2024 |
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By: |
/s/ Samuel J. Reich |
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Samuel J. Reich |
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Chair and Chief Executive Officer (Principal Executive Officer) |
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By: |
/s/ Lucy To |
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Lucy To |
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Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
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