MiNK Therapeutics, Inc 10-Q for FY2026 Q3
MiNK Therapeutics, Inc. (INKT)
About this 10-Q
MiNK Therapeutics, Inc filed this 10-Q on November 12, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).
MiNK Therapeutics reported $7.5 million in cash as of September 30, 2026 and substantial doubt about its ability to continue as a going concern; it also recognized first pre-commercial agenT-797 revenue of approximately $0.2 million. AI summary
Headline figures
Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $200K
- compared with $0 a year earlier
- Net loss
- $2.55M
- compared with a net loss of $2.89M a year earlier
- Diluted EPS
- -$0.50
- compared with -$0.65 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
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 |
(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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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, a 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
As of November 9, 2026, the registrant had
Table of Contents
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Page |
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PART I. |
1 |
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Item 1. |
1 |
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Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 |
1 |
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2 |
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3 |
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5 |
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Notes to Unaudited Interim Condensed Consolidated Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
14 |
Item 3. |
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Item 4. |
20 |
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PART II. |
21 |
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Item 1. |
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Item 1A. |
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Item 5. |
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Item 6. |
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23 |
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
MINK THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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September 30, |
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December 31, |
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ASSETS |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Equipment, net of accumulated depreciation of $ |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Related party note |
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Other current liabilities |
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Total current liabilities |
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Due to related parties |
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STOCKHOLDERS’ DEFICIT |
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Common stock, par value $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
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( |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ deficit |
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( |
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Total liabilities and stockholders’ deficit |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
1
MINK THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Pre-commercial product revenue |
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$ |
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$ |
— |
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$ |
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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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Change in fair value of related party note |
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Operating loss |
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( |
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( |
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( |
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( |
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Other income (expense), net: |
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Interest income, net |
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Other income (expense), net |
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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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Per common share data: |
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Basic and diluted net loss per common share |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted average number of common shares outstanding |
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Other comprehensive income (loss): |
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Foreign currency translation gain (loss) |
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$ |
( |
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$ |
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$ |
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$ |
( |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
See accompanying notes to unaudited condensed consolidated financial statements.
2
MINK THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(Unaudited)
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Common Stock |
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Treasury Stock |
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Accumulated |
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Number of |
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Par |
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Additional |
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Number of |
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Amount |
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Other |
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Accumulated |
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Total |
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Balance at December 31, 2025 |
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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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Other comprehensive income |
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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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Grant and recognition 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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Shares sold at the market |
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— |
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— |
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— |
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— |
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Exercise of stock options and employee share purchases |
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— |
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— |
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— |
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— |
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— |
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Vesting of nonvested shares |
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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 shares for certain employee bonuses |
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( |
) |
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( |
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— |
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— |
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Retirement of treasury shares related to employee withholding |
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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, 2026 |
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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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Other comprehensive loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Grant and recognition 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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Shares sold at the market |
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— |
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— |
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— |
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— |
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Vesting of nonvested shares |
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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, 2026 |
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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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Other comprehensive loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Grant and recognition 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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Vesting of nonvested shares |
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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, 2026 |
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$ |
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$ |
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— |
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$ |
— |
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$ |
( |
) |
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$ |
( |
) |
|
$ |
( |
) |
|||
See accompanying notes to unaudited condensed consolidated financial statements.
3
MINK THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(Unaudited)
|
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Common Stock |
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Treasury Stock |
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Accumulated |
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Number of |
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Par |
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Additional |
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Number of |
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Par |
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Other |
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Accumulated |
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Total |
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Balance at December 31, 2024 |
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$ |
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$ |
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— |
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$ |
— |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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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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( |
) |
Other comprehensive loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Issuance of shares for services |
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— |
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— |
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— |
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— |
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— |
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Share retirement |
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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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Employee share purchases |
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— |
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— |
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— |
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— |
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— |
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|||
Grant and recognition 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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Recognition of parent 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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Balance at March 31, 2025 |
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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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( |
) |
Other comprehensive loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Option exercises |
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— |
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— |
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— |
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— |
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— |
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|||
Vesting of nonvested shares |
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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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Grant and recognition 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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||
Recognition of parent 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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Balance at June 30, 2025 |
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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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( |
) |
Other comprehensive income |
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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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||
Grant and recognition 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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||
Shares sold at the market |
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— |
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— |
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— |
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— |
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Exercise of stock options and employee share purchases |
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— |
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— |
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— |
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— |
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||||
Vesting of nonvested shares |
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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 shares for certain employee bonuses |
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— |
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|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
|
|||
Retirement of treasury shares |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Balance at September 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|||
See accompanying notes to unaudited condensed consolidated financial statements.
4
MINK THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Depreciation |
|
|
|
|
|
|
||
Share-based compensation |
|
|
|
|
|
|
||
Loss on disposal of assets |
|
|
|
|
|
|
||
Change in fair value of related party note |
|
|
|
|
|
|
||
Interest accrued on related party note |
|
|
|
|
|
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Prepaid expenses |
|
|
( |
) |
|
|
( |
) |
Accounts payable |
|
|
|
|
|
|
||
Accrued liabilities and other current liabilities |
|
|
( |
) |
|
|
|
|
Other operating assets and liabilities |
|
|
|
|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchases of plant and equipment |
|
|
( |
) |
|
|
— |
|
Net cash used in investing activities |
|
|
( |
) |
|
|
— |
|
Cash flows from financing activities: |
|
|
|
|
|
|
||
Net proceeds from sale of equity |
|
|
|
|
|
|
||
Repayment of related party note |
|
|
( |
) |
|
|
— |
|
Payment for shares to satisfy tax withholdings |
|
|
( |
) |
|
|
— |
|
Proceeds from employee stock purchases and option exercises |
|
|
|
|
|
|
||
Net cash provided by (used in) financing activities |
|
|
( |
) |
|
|
|
|
Effect of exchange rate changes on cash |
|
|
( |
) |
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
( |
) |
|
|
|
|
Cash and cash equivalents, beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents, end of period |
|
$ |
|
|
$ |
|
||
Supplemental cash flow information: |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
Supplemental disclosures - non-cash activities: |
|
|
|
|
|
|
||
Issuance of common stock, $ |
|
$ |
|
|
$ |
|
||
See accompanying notes to unaudited condensed consolidated financial statements.
5
MINK THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(1) Business and Liquidity
MiNK Therapeutics, Inc. (“MiNK” or the “Company”) is a clinical-stage biopharmaceutical company pioneering the discovery, development and manufacturing of allogeneic, off-the-shelf, invariant natural killer T (“iNKT”) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer cells. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells, and suppress graft-versus-host-disease. MiNK’s proprietary platform is designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. As such, the Company believes that its approach represents a highly versatile application for therapeutic development in cancer and immune diseases. MiNK is leveraging its platform and manufacturing capabilities to develop a wholly owned or exclusively licensed pipeline of both native and engineered iNKT cells.
Since its inception in 2017, MiNK has incurred losses and expects to continue incurring operating losses and negative cash flows in the future until it is able to generate sales and profits. As of September 30, 2026, MiNK had an accumulated deficit of $
Management continually monitors MiNK's liquidity position and adjusts spending as needed in order to preserve liquidity. To support its liquidity requirements, the Company will require additional funding. Potential sources of additional funding for the Company include: (1) seeking strategic partnerships and collaborations, as well as out-licensing opportunities, for the Company's portfolio programs and product candidates, (2) exploring avenues for securing non-dilutive financing, such as grants, collaborations, and providing fee-based services to strengthen the Company's balance sheet, and (3) potential of equity or debt financing options.
MiNK’s product candidates are in various stages of development and additional expenditures will be required if the Company starts new trials, encounters delays in its programs, applies for regulatory approvals, continues development of its technologies, expands its operations, and/or brings its product candidates to market. The eventual total cost of each clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, and number of patients. The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain. Because all of the Company’s programs are at an early stage of clinical development, the Company is unable to reliably estimate the cost of completing its research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.
(2) Significant Accounting Policies
Revenue Recognition
We account for revenue in accordance with ASC 606, Revenue from Contracts with Customers ("ASC 606").
For the three and nine months ended September 30, 2026,
In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods and services. To achieve this core principle, we apply the following five steps:
1) Identify the contract with the customer
A contract with a customer exists when (i) the Company enters into an enforceable contract with a customer that defines each party's rights regarding the goods or service to be transferred and identifies the related payment term, (ii) the contract has commercial substance, and (iii) the Company determines the collection of substantially all consideration for goods and services that are transferred is probable based on the customer's intent and ability to pay the promised consideration. The Company applies judgment in determining the customer's intent and ability to pay, which is based on a variety of factors including the customer's historical payment experience, or in the case of a new customer, published credit and financial information pertaining to the customer.
6
2) Identify the performance obligations in the contract
Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both capable of being distinct, whereby the customer can benefit from the good or service either on its own or together with other available resources, and are distinct in the context of the contract, whereby the transfer of the good or service is separately identifiable from other promises in the contract. To the extent a contract includes multiple promised goods and services, the Company must apply judgment to determine whether the promised goods and services are capable of being distinct and are distinct in the context of the contract. If these criteria are not met, the promised goods and services are accounted for as a combined performance obligation.
3) Determine the transaction price
The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company's judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes.
4) Allocate the transaction price to performance obligations in the contract
If the contract contains a single performance obligation, the entire transaction price is allocated to that single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation or to a distinct service that forms part of a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative stand-alone selling prices.
5) Recognize revenue when or as the Company satisfies a performance obligation
The Company satisfies performance obligations either over time or at a point in time. Revenue is recognized over time if either 1) the customer simultaneously receives and consumes the benefits provided by the entity's performance, 2) the entity's performance creates or enhances an asset that the customer controls as the asset is created or enhanced, or 3) the entity's performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date. If the entity does not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring the control of a promised good or service to a customer.
Pre-commercial Product: The Company recognizes revenue when the customer obtains control of the product at delivery. Revenue is calculated as the amount invoiced to the customer.
The Company’s significant accounting policies are disclosed in the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2026. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies, other than those related to revenue recognition as disclosed above.
Financial Statement Preparation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual consolidated financial statements. In the opinion of the Company’s management, the condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of the Company’s financial position and operating results. All significant intercompany transactions and accounts have been eliminated in consolidation. Operating results for the three and nine months ended September 30, 2026, are not necessarily indicative of the results that may be expected for the year ending December 31, 2026.
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amount of expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that it believes to be reasonable under the circumstances. Actual results could differ materially from those estimates.
For the Company’s foreign subsidiaries, the local currency is the functional currency. Assets and liabilities of its foreign subsidiaries are translated into U.S. dollars using rates in effect at the balance sheet date while expenses are translated into U.S. dollars using average exchange rates during the period. The cumulative translation adjustment resulting from changes in exchange rates are
7
included in the condensed consolidated balance sheets as a component of accumulated other comprehensive loss in total stockholders’ deficit.
(3) Net Loss Per Share
Basic loss per common share is calculated by dividing the net loss by the weighted average number of common shares outstanding. Diluted loss per common share is calculated by dividing net loss by the weighted average number of common shares outstanding plus the dilutive effect of outstanding instruments such as stock options. Because the Company reported a net loss for all periods presented, diluted loss per common share is the same as basic loss per common share, as the effect of utilizing the fully diluted share count would have reduced the net loss per common share.
|
|
Three and Nine Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Stock options |
|
|
|
|
|
|
||
Non-vested shares |
|
|
|
|
|
|
||
(4) Cash and Cash Equivalents
Cash equivalents consisted of the following as of September 30, 2026 and December 31, 2025 (in thousands):
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||||||||||
|
|
Cost |
|
|
Estimated Fair Value |
|
|
Cost |
|
|
Estimated Fair Value |
|
||||
Institutional money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
(5) Accrued and Other Current Liabilities
Accrued liabilities consisted of the following as of September 30, 2026 and December 31, 2025 (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
Payroll |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Research services |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Other current liabilities of $
(6) Share-based Compensation Plans
The Company primarily uses the Black-Scholes option pricing model to value options granted to employees and non-employees, as well as options granted to members of the Company’s Board of Directors. All stock option grants have
8
A summary of option activity for the nine-month period ended September 30, 2026 is presented below:
|
|
Options |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested or expected to vest at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The weighted average grant-date fair values of options granted during the nine months ended September 30, 2026 and 2025 were $
On June 18, 2025, at the Company's annual meeting of stockholders, the Company’s stockholders approved a one-time exchange of options to purchase shares of the Company’s common stock issued under the 2021 Plan and the 2018 Plan that were held by the Company’s executive officers, other employees, consultants, and non-employee directors, for new options to purchase shares of the Company’s common stock (the “Option Exchange”). Pursuant to the Option Exchange, eligible options were cancelled in exchange for an equal number of new options to purchase shares of common stock with an exercise price equal to the fair market value of the Company’s common stock at the time of the Option Exchange and a term of the option that extends ten years from the date of grant. An eligible stock option generally included any outstanding stock option that had an exercise price equal to or greater than $
As of September 30, 2026, there was $
A summary of non-vested stock activity for the nine-month period ended September 30, 2026 is presented below:
|
|
Nonvested |
|
|
Weighted |
|
||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Outstanding at September 30, 2026 |
|
|
|
|
$ |
|
||
As of September 30, 2026, there was $
During the nine months ended September 30, 2026,
9
For the nine months ended September 30, 2025, stock based compensation expense also includes expense related to awards to employees of the Company from the Agenus 2019 Equity Incentive Plan.
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
(7) Revenue from Contracts with Customers
Pre-commercial Product Revenue
During the three months ended September 30, 2026, the Company began recognizing pre-commercial product revenue for agenT-797 supplied in Brazil on a paid, per-patient basis under a physician-initiated named-patient access program. Each patient request is subject to case-by-case authorization by Brazilian regulatory authorities. agenT-797 has not received marketing authorization from the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, or "ANVISA").
For the three and nine months ended September 30, 2026, we recognized approximately $
Disaggregation of Revenue
The following table presents revenue for the three and nine months ended September 30, 2026, disaggregated by geographic region and revenue type. Revenue by geographic region is allocated based on the domicile of our respective business operations.
|
|
Three Months Ended September 30, |
|
|||||||||
|
|
United States |
|
|
Rest of World |
|
|
Total |
|
|||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Pre-commercial product revenue |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
Nine Months Ended September 30, |
|
|||||||||
|
|
United States |
|
|
Rest of World |
|
|
Total |
|
|||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Pre-commercial product revenue |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Contract Balances
Contract liabilities primarily relate to contracts where we received payments but have not yet satisfied the related performance obligations. The advance consideration received from customers is a contract liability until the underlying performance obligations are transferred to the customer. As of September 30, 2026, we do
(8) Related Party Transactions
Until the completion of its Initial Public Offering (“IPO”), the Company relied on Agenus for all of its working capital requirements. For the periods presented, certain of the Company’s operations were fully integrated with Agenus, including, but not limited to, corporate functions such as finance, human resources, information technology and certain legal functions. The Company’s condensed consolidated financial statements reflect all costs of doing business related to these operations.
In September 2021, the Company entered into an Intellectual Property Assignment and License Agreement with Agenus (the “New Assignment and License Agreement”), upon which the prior intercompany agreement between Agenus and MiNK was terminated. Pursuant to the New Assignment and License Agreement, Agenus assigned to the Company certain patent rights and know-how related to its iNKT cell platform, product candidates and other patents and know-how related to its business. In addition to the patent rights assigned to the Company by Agenus, the Company also received an exclusive, royalty-free, sublicensable license to research, develop, manufacture and commercialize certain licensed technology in the field. The New Assignment and License Agreement further provides for the Company to grant Agenus a field-limited, non-exclusive, royalty-free license under the assigned patent rights, subject to MiNK’s discretion and provided such access would not reasonably result in a disruption of planned MiNK activities. Agenus has also agreed to provide the Company with Agenus’ biological material upon written request in order for the Company to use such material in its development activities of a combination therapy. Agenus may withhold the transfer of biological
10
material, including, but not limited to, checkpoint modulating antibodies, for various reasons, including if such transfer would reasonably result in a disruption of planned Agenus activities. For any materials Agenus does share with the Company, the parties have agreed to enter into a separate agreement governing the transfer and providing for joint ownership of the data. Agenus has agreed that during the full term of the New Assignment and License Agreement, and for
Effective April 1, 2022, the Company entered into an Amended and Restated Intercompany Services Agreement (the “New Intercompany Agreement”) with Agenus, which amended and restated the Intercompany General & Administrative Agreement between the Company and Agenus dated September 10, 2021 (the “Prior Intercompany Agreement”). Under the New Intercompany Agreement, Agenus provides the Company with certain general and administrative support, including, without limitation, financial, facilities management, human resources and information technology administrative support (the “Agenus Services”), and the Company and Agenus provide each other with certain research and development services (the “R&D Services”) and other support services, including legal and regulatory support (the “Shared Services”). The Company is required to pay
Allocated Agenus services primarily include payroll related expenses, facility costs, insurance and stock-based compensation, and are included in the accompanying condensed consolidated financial statements based on certain estimates and allocations described above. Under the Prior Intercompany Agreement, the allocation methods primarily included time devoted to activities and headcount-based allocations. Agenus business services and occupancy costs were allocated to the Company based on the Company’s headcount as a percentage of Agenus’ and the Company was required to pay
Allocation of Agenus services, net, of approximately $
On February 12, 2024, the Company and Agenus entered into a Convertible Promissory Note Purchase Agreement (the "Purchase Agreement") pursuant to which the Company issued to Agenus a convertible promissory note in the principal amount of up to $
The Note carries an annual interest rate of
11
In March 2024, MiNK received $
In January 2023, the Company's Chief Executive Officer (“CEO” or “Dr. Buell”), became an employee of Agenus in the role of Chairman of the Executive Council, and she was appointed to the Agenus Board of Directors in June 2024. As an employee of Agenus, Dr. Buell is paid $
Dr. Buell's spouse is a partner in the law firm of Wolf, Greenfield & Sachs, P.C. (“Wolf Greenfield”), which provided legal services to the Company during the periods ended September 30, 2026 and 2025, and continues to do so. For the three and nine months ended September 30, 2026, the Company expensed Wolf Greenfield fees totaling approximately $
(9) Equity
At the Market Sales Agreement
On July 15, 2025, the Company entered into an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley Securities, Inc., as sales agent (the “Sales Agent”) to sell shares of the Company’s common stock, from time to time through the Sales Agent, at a maximum aggregate offering price of $
In the nine months ended September 30, 2026, the Company sold approximately
(10) Segments
MiNK is managed and operated as
MiNK's serves as its Chief Operating Decision Maker (“CODM”) and is responsible for reviewing company performance and making decisions regarding resource allocation.
The following table presents selected financial information related to the Company's single reportable segment for the three and nine months ended September 30, 2026 and 2025 (in thousands):
12
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Pre-commercial product revenue |
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
External expenses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Payroll related expenses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other operating expenses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Operating loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
In the table above, “Other operating expenses” includes items such as the allocation of Agenus Services, depreciation and amortization expense, stock-based compensation expense, fair value adjustments and expenses related to certain foreign subsidiaries.
(11) Contingencies
The Company may currently be, or may become, a party to legal proceedings. While the Company currently believes that the ultimate outcome of any of these proceedings will not have a material adverse effect on its financial position, results of operations, or liquidity, litigation is subject to inherent uncertainty and consumes both cash and management attention. See Note 5 for a discussion of the default judgment obtained by the Walloon Region.
(12)
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires incremental annual disclosures around income tax rate reconciliations, income taxes paid and other related disclosures. For the Company, ASU 2023-09 is effective for fiscal years beginning after December 15, 2025. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. The Company is currently evaluating the impact that ASU 2023-09 will have on the notes to its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (DISE). This new guidance requires all public entities to incorporate disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. Public entities must adopt ASU 2024-03 prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. The Company is currently evaluating the impact that ASU 2024-03 will have on its consolidated financial statements.
No other new accounting pronouncement issued or effective during the nine months ended September 30, 2026 had or is expected to have a material impact on the Company’s consolidated financial statements or disclosures.
13
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 unaudited condensed consolidated financial statements and related notes thereto included in this Quarterly Report and our audited consolidated financial statements and related notes thereto for the year ended December 31, 2025, included in our Form 10-K (the “Annual Report”) filed with the SEC on March 31, 2026. This discussion contains forward-looking statements based upon current plans, expectations, and beliefs involving risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled “Risk Factors” in our Annual Report as may be updated from time to time in our other filings with the SEC.
Overview
MiNK Therapeutics, Inc. (“we,” “us,” “our,” or “Company” ) is focused on developing innovative treatments for cancer and immune-mediated diseases using allogeneic, ex-vivo expanded invariant natural killer T ("iNKT") cells. Amid a broader industry renaissance in innate immunity—highlighted by surging investment and clinical activity in NK, γδ T, and iNKT-based therapies—iNKT cells represent a distinct T cell (“T”) population that uniquely bridges innate and adaptive immunity. They combine durable memory responses characteristic of adaptive T cells with the rapid, MHC-independent cytolytic capabilities of natural killer ("NK") cells. We believe this dual functionality enables direct tumor killing via CD1d and stress ligands, potent orchestration of the tumor microenvironment through activation of dendritic cells and NK cells, elimination of immunosuppressive myeloid populations, and restoration of exhausted T-cell function—all while naturally suppressing graft-versus-host disease ("GvHD"). We believe this combination positions iNKT cells as a promising platform for allogeneic therapy, given their natural homing capabilities, tumor clearance potential, and efficacy against infected cells.
Our approach includes advancing both native and engineered iNKT cell therapies, leveraging a pipeline composed of wholly owned or exclusively licensed assets. Additionally, we have developed a proprietary personalized neoantigen library to facilitate personalized T Cell Receptor ("TCR") development. This library enables us to identify patient-specific tumor neoantigens, which we use to create highly tailored TCR-based therapies. By harnessing these personalized neoantigen libraries, we aim to enhance precision, efficacy, and overall therapeutic outcomes for patients with various cancers and immune-mediated diseases. Our goal is to discover, develop and commercialize novel allogeneic, off-the-shelf, iNKT cell therapies to treat cancer and other immune-mediated diseases with high unmet need. We are employing iNKT cells in their native form, through our lead program agenT-797, in diseases where iNKT cells have demonstrated activity and accelerated approval pathways exist. These indications include, but are not limited to, critical pulmonary immune failure (including severe hypoxemic respiratory failure / pneumonia), GvHD, solid tumor cancers, and other severe immune-related diseases. Our discovery efforts are focused on applying our proprietary technologies to build a broad pipeline of engineered iNKT cells, including TCRs, CAR-iNKTs (such as MiNK-215 (FAP-CAR-iNKT) and MiNK-413 (BCMA-CAR-iNKT), and INKT cell engager technology.
Our business activities include product research and development, manufacturing, regulatory and clinical development, corporate finance, and support of our collaborations. To be successful, our product candidates require clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. We are a party to an Amended and Restated Intercompany Services Agreement (the “New Intercompany Agreement”) and an Intellectual Property Assignment and License Agreement with Agenus Inc. ("Agenus"). Under the New Intercompany Agreement, Agenus provides us with certain general and administrative support, including, without limitation, financial, facilities management, human resources and information technology administrative support, and we and Agenus provide each other with certain research and development services and other support services, including legal and regulatory support. We are also entitled to use Agenus’ business offices and laboratory space and equipment in exchange for us contributing a proportionate payment for the use of such facilities and equipment, and we will be covered by certain Agenus insurance policies, subject to certain conditions, including us paying the cost of such coverage. Under the Intellectual Property Assignment and License Agreement, Agenus exclusively assigned patent rights and know-how related to our technology to us. We also have a field-limited exclusive license under certain Agenus patents and know-how; and we retain the rights to expand a proprietary pipeline of products and technologies.
Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. agenT-797 is currently being evaluated in clinical trials for solid tumors and critical pulmonary immune failure, and an investigator-sponsored clinical trial for the prevention of GvHD is expected to schedule its first patient for dosing by December 2026. Having treated nearly 100 patients with agenT-797 across oncology and critical pulmonary immune failure, we have generated mechanistic and clinical insights that we believe support continued development of our iNKT platform beyond oncology into pulmonary diseases and autoimmune diseases, including graft-versus-host disease prevention.
Under the leadership of Dr. Terese C. Hammond, our Head of Inflammatory and Pulmonary Diseases, we are advancing a differentiated franchise in critical pulmonary immune failure with agenT-797, our off-the-shelf, allogeneic iNKT cell therapy.
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Building on the foundational Phase 1/2 data published in Nature Communications in February 2024 — which demonstrated >70% 30-day survival (80% in the veno-venous extracorporeal membrane oxygenation (“VV-ECMO”) subgroup) in mechanically ventilated patients with severe viral ARDS versus ~10% in contemporaneous controls, which was not a randomized comparison — we are now advancing agenT-797 in a randomized Phase 2 adaptive, placebo-controlled trial in patients with severe pneumonia and moderate-to-severe hypoxemic acute respiratory failure ("AHRF"). The study, which initiated in Lviv, Ukraine, in partnership with First Lviv Territorial Medical Union and UNBROKEN Ukraine, continues to enroll patients in Lviv and is being conducted under a U.S. investigational new drug application (“IND”). Activation of U.S. clinical sites is underway, and we expect to begin dosing at U.S. sites before the end of 2026. In August 2026, initial Day 28 observations from the first patients treated in the study were presented at the Military Health System Research Symposium (“MHSRS”), and comparative data from the randomized study are now expected in early 2027. We have refined the study as an adaptive Phase 2b/3 design, with an initial randomized stage of 124 patients and the ability to expand to up to 300 patients, and a proposed hierarchical endpoint of survival without VV-ECMO at Day 14, followed by all-cause mortality through Day 28. We plan to meet with the U.S. Food and Drug Administration (“FDA”) before the end of 2026 to discuss the proposed design, including whether the randomized stage could contribute to a registration-enabling Phase 3 trial, and we intend to pursue Regenerative Medicine Advanced Therapy (“RMAT”) designation. Our published results highlighted rapid inflammation resolution, rescue of exhausted T cells, and reduced secondary infections, which we believe support the broad therapeutic potential of iNKT cells in life-threatening respiratory conditions, including interstitial lung disease ("ILD"). Data presented at ASGCT 2026 in May 2026 further demonstrated that agenT-797 produces context-dependent immune reprogramming—driving anti-inflammatory benefit in ARDS from the same manufacturing donor batch, without genetic engineering — which we believe supports its broad therapeutic potential in life-threatening respiratory conditions, including ILD and idiopathic pulmonary fibrosis (“IPF”).
In cancer, our Phase 1 clinical trial enrolled 34 patients evaluating agenT-797 in refractory solid tumor cancers, as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors, pembrolizumab and nivolumab. Updated data presented at SITC 2025 demonstrated durable clinical activity, including complete remissions and long-term survivors (>2–3+ years) in heavily pretreated, checkpoint-refractory cancers such as metastatic testicular cancer, gastric cancer, thymoma, cholangiocarcinoma, renal cell carcinoma, and adenoid cystic carcinoma, with median overall survival of approximately 23 months in combination with anti-PD-1. These data showed that agenT-797, both as monotherapy and in combination with anti-PD-1 agents, produced meaningful disease control in the majority of heavily pretreated patients, including reductions in target and non-target lesions and prolonged disease stabilization. A detailed case report describing a durable confirmed partial response (42% tumor reduction with progression-free survival exceeding nine months) in a patient with chemotherapy- and PD-1-refractory gastric cancer following a single infusion of agenT-797 was published in Oncogene in January 2024 (Hadfield et al., 2024). Subsequently, a separate case report published in Oncogene in 2025 described a complete clinical, radiologic, and biochemical remission in a patient with heavily pretreated metastatic testicular (germ cell) cancer following a single infusion of agenT-797 in combination with anti-PD-1 therapy; the patient remains without evidence of disease more than two years post-treatment (Garmezy et al., 2025). agenT-797 also exhibited long-term persistence in peripheral blood (detected up to 6 months post-infusion), independent of HLA matching and without the need for lymphodepletion.
Building on these encouraging results, a Phase 2 investigator-sponsored trial led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center was initiated (NCT06251973), evaluating the safety and efficacy of agenT-797 in combination with Agenus' botensilimab (an Fc-enhanced anti-CTLA-4 inhibitor) and balstilimab (anti-PD-1), together with ramucirumab and paclitaxel, in patients with previously treated, advanced esophageal, gastric, or gastro-esophageal junction ("GEJ") adenocarcinoma. Early translational data from the first patients in the ongoing Phase 2 combination study were presented at the inaugural AACR Advances in Cancer Immunotherapy (AACR IO) meeting in 2025. These data demonstrated that addition of agenT-797 to botensilimab and balstilimab drove robust immune activation, including elevated interferon-gamma (IFN-γ) levels, rapid tumor infiltration, CD8+ T-cell activation, and immune reprogramming in patients with PD-1-refractory gastroesophageal cancers. Updated clinical and translational data from the ongoing study were presented at the AACR Annual Meeting in April 2026 in San Diego, California. In heavily pretreated, checkpoint-refractory gastroesophageal adenocarcinoma patients, induction treatment with agenT-797 in combination with botensilimab and balstilimab prior to chemotherapy was associated with encouraging progression-free and overall survival outcomes, including emergence of a long-term survival tail in a population with historically poor expected outcomes. Translational analyses demonstrated coordinated immune activation, including elevated interferon-gamma (IFN-γ), enhanced CD8+ T-cell activation, tumor immune infiltration, and evidence of immune reprogramming in PD-1-refractory gastroesophageal cancers.
In addition, an investigator-sponsored Phase 2 study of agenT-797 in combination with botensilimab and balstilimab in patients with microsatellite-stable (“MSS”) colorectal cancer with liver metastases, led by Dr. Darren Sigal at Scripps, is enrolling patients. At the Society for Immunotherapy of Cancer (“SITC”) Annual Meeting in November 2026, we presented preclinical data from a human organoid model of MSS colorectal cancer liver metastases in which botensilimab and balstilimab alone did not produce significant tumor-cell killing, while the addition of agenT-797 shifted suppressive macrophages toward an antigen-presenting phenotype and enabled tumor-cell killing, supporting the rationale for this study.
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Through our paid named-patient access program, we are collaborating with Orphan Drug Consulting ("ODC") to support physician-initiated requests for agenT-797 for individually identified patients. The program expands access for patients with serious unmet medical need and provides MiNK with program revenue for product supplied. Each request is initiated by the treating physician and remains subject to case-by-case Brazilian regulatory authorization. The program is not a commercial launch or marketing authorization. ODC supports local regulatory submissions, importation, cold-chain logistics and pharmacovigilance. The product is supplied on a paid, per-patient basis in accordance with applicable Brazilian access regulations. During the three months ended September 30, 2026, we recognized our first pre-commercial product revenue of approximately $0.2 million from agenT-797 supplied under the program. Revenue under the program is expected to vary from period to period based on physician requests and case-by-case regulatory authorizations. The program is also establishing the operational infrastructure needed to support responsible access to agenT-797 in additional international markets.
In GvHD, MiNK and the University of Wisconsin–Madison have announced an investigator-sponsored Phase 1 clinical trial evaluating agenT-797 for the prevention of GvHD in patients undergoing allogeneic hematopoietic stem cell transplantation for high-risk leukemias and other blood cancers. The program is supported by non-dilutive funding, including an NIH STTR grant from the National Institute of Allergy and Infectious Diseases (NIAID) for preclinical development and the Mary Gooze Clinical Trial Award to the University of Wisconsin–Madison to directly fund enrollment, immune monitoring, and operations. The University of Wisconsin-Madison has informed us that it expects the first patient to be scheduled for dosing by December 2026.
In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced preclinical engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen ("BCMA"), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. MiNK-215 reported therapeutic activity in non-small cell lung cancer models, which resulted in substantial tumor elimination and improved survival compared to T cells alone. MiNK has presented data that showcased MiNK-215’s activity in preclinical colorectal cancer models. In human organoid models of colorectal cancer (CRC) with liver metastases, MiNK-215 potently enhanced tumor killing by T cells and was associated with depletion of immune suppressive FAP-expressing stellate cells and increased CD8+ T cell infiltration. Investigational new drug application (“IND”) enabling studies for MiNK-215 are underway.
At SITC 2026, in collaboration with Dr. Jesús Gil at Imperial College London, we also presented preclinical data showing that agenT-797 and MiNK-215 act as living senolytics, clearing therapy-induced senescent cells, with MiNK-215 additionally targeting the FAP-positive fibroblast stroma. Senescent and FAP-positive cells contribute to chronic inflammation and tissue remodeling associated with treatment resistance in cancer and with progression in fibrotic lung disease.
In September 2026, our agenT-797 platform was selected as the therapeutic cell system for the Reversible Ambient Biostabilization team, led by Draper, within the Advanced Research Projects Agency for Health (“ARPA-H”) BioStabilization Systems (“BoSS”) program, which seeks to advance the storage of living medicines from cryogenic conditions toward room-temperature stability. ARPA-H has committed up to $87 million across the four-year program across all participants. We participate on a fixed-fee basis to supply cells and support testing.
With our vertically integrated manufacturing capabilities and experienced team, we are accelerating the development of accessible, off-the-shelf iNKT-based therapies with transformative potential across oncology, critical pulmonary immune failure, and GvHD.
Historical Results of Operations
Three Months Ended September 30, 2026 Compared to the Three Months Ended September 30, 2025
Revenue
We recognized approximately $0.2 million of pre-commercial product revenue for the three months ended September 30, 2026 from agenT-797 supplied on a paid, per-patient basis under our named-patient access program in Brazil. We did not recognize any revenue for the three months ended September 30, 2025.
Research and development expense
Research and development (“R&D”) expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of expert consultants, and administrative costs. R&D expense increased 58% to $1.8 million for the three months ended September 30, 2026 from $1.1 million for the three
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months ended September 30, 2025. The increased expense was primarily due to increased professional fees and other costs associated with both the timing of our clinical trials (the randomized study and U.S. site start up), pre-clinical activities and the manufacture of clinical trial materials.
General and administrative expense
General and administrative (“G&A”) expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense decreased 44% to $1.0 million for the three months ended September 30, 2026 from $1.8 million for the three months ended September 30, 2025. The decreased expense was primarily due to a decrease in professional fees inclusive of Legal Fees and audit and tax fees and other G&A costs related to stock option expenses.
Other income (expense), net
Other income, net decreased to approximately $13,000 for the three months ended September 30, 2026 from $241,000 of other income, net for the three months ended September 30, 2025, primarily due to foreign currency exchange losses in the three months ended September 30, 2025, compared to foreign currency exchange gains in the three months ended September 30, 2026.
Interest income, net
Interest income, net increased $17,000 for the three months ended September 30, 2026, from interest income, net of $55,000 for the three months ended September 30, 2025 to interest income, net of $72,000 for the three months ended September 30, 2026, primarily due to increased interest earned on our money market funds and the repayment of our related party note (the “Note”) in January 2026.
Nine Months Ended September 30, 2026 Compared to the Nine Months Ended September 30, 2025
Revenue
We recognized approximately $0.2 million of pre-commercial product revenue for the nine months ended September 30, 2026, all of which was recognized during the three months ended September 30, 2026, from agenT-797 supplied on a paid, per-patient basis under our named-patient access program in Brazil. We did not recognize any revenue for the nine months ended September 30, 2025.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of expert consultants, and administrative costs. R&D expense increased 15% to $4.9 million for the nine months ended September 30, 2026 from $4.2 million for the nine months ended September 30, 2025. The increased expense was primarily due to increased professional fees and other costs associated with both the timing of our clinical trials, pre-clinical activities and the manufacture of clinical trial materials.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense decreased 19% to $4.0 million for the nine months ended September 30, 2026 from $5.0 million for the nine months ended September 30, 2025. The decreased expense was primarily due to a decrease in share-based compensation expense, professional fees inclusive of Legal Fees and audit and tax fees and other G&A costs.
Other income (expense), net
Other income, net increased to approximately $87,000 for the nine months ended September 30, 2026 from $24,000 of other expense, net for the nine months ended September 30, 2025, primarily due to foreign currency exchange losses in the nine months ended September 30, 2025, compared to foreign currency exchange gains in the nine months ended September 30, 2026.
Interest income, net
Interest income, net increased $157,000 for the nine months ended September 30, 2026, from interest income, net of $69,000 for the nine months ended September 30, 2025 to interest income, net of $226,000 for the nine months ended September 30, 2026, primarily due to increased interest earned on our money market funds and a decrease in interest expense following the repayment of our related party note in January 2026.
17
Research and Development Programs
R&D program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions.
|
|
For the Nine Months Ended |
|
|
For the years ended December 31, |
|
||||||
|
|
2026 |
|
|
2025 |
|
|
2024 |
|
|||
Payroll and personnel costs |
|
$ |
2,058,415 |
|
|
$ |
3,389,016 |
|
|
$ |
4,634,647 |
|
Professional fees |
|
|
1,804,931 |
|
|
|
53,416 |
|
|
|
1,353,448 |
|
Forgiveness of liability |
|
|
— |
|
|
|
— |
|
|
|
(1,788,204 |
) |
Allocated services |
|
|
333,169 |
|
|
|
560,486 |
|
|
|
517,861 |
|
Materials and other |
|
|
698,760 |
|
|
|
1,754,569 |
|
|
|
1,618,323 |
|
Total |
|
$ |
4,895,275 |
|
|
$ |
5,757,487 |
|
|
$ |
6,336,075 |
|
Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new products is lengthy, expensive and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.
Liquidity and Capital Resources
We have incurred annual operating losses since inception in 2017, and we had an accumulated deficit of $165.1 million as of September 30, 2026. We expect to incur losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products.
On July 15, 2025, we entered into a Sales Agreement with B. Riley Securities, Inc., as sales agent (the “Sales Agent”) to sell shares of our common stock, from time to time through the Sales Agent, at a maximum aggregate offering price of $50.0 million. The issuances and sales under the Sales Agreement are pursuant to our registration statement on Form S-3 (File No. 333-268143) (the “2022 Registration Statement”) filed with the Securities and Exchange Commission on November 3, 2022, the base prospectus included in the 2022 Registration Statement, dated November 8, 2022, and a prospectus supplement, dated July 15, 2025. On November 7, 2025, we filed a registration statement on Form S-3 (File No. 333-291388) (the “2025 Registration Statement”) with the Securities and Exchange Commission to replace the 2022 Registration Statement. We sold approximately 313,478 shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2026 and received aggregate net proceeds totaling $4.4 million; no shares were sold during the three months ended September 30, 2026. As of September 30, 2026, approximately $30.6 million remained available under the Sales Agreement.
We had a Note outstanding as of December 31, 2025 of $5.0 million in principal plus accrued and unpaid interest of approximately $179,000. In January 2026, in accordance with the terms of the Note, we repaid the Note in full.
Our cash and cash equivalents balance as of September 30, 2026 was $7.5 million. We believe that our cash and cash equivalents balance, plus anticipated funding, will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued. Because the completion of anticipated funding is not entirely within our control, we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes we will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Management continually monitors the Company's liquidity position and adjusts spending as needed in order to preserve liquidity. To support our liquidity requirements we will require additional funding. Potential sources of additional funding include: (1) seeking strategic partnerships and collaborations, as well as out-licensing opportunities, for our portfolio programs and product candidates, (2) exploring avenues for securing non-dilutive financing, such as grants, collaborations, and providing fee-based services to strengthen our balance sheet, and (3) potential equity or debt financing options.
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Net cash used in operating activities for the nine months ended September 30, 2026 and 2025 was $5.1 million and $3.9 million, respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, and our ability to enter into collaborations.
Forward-Looking Statements
This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” and “future,” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, and other important factors, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our named-patient access program and related revenue, the timing of clinical data and regulatory interactions, our ability to develop, including our ability to develop and obtain licensure of agenT-797, MiNK-215, and MiNK-413, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, our cash runway and anticipated sources of funds, our ability to operate as a going concern, as well as our plans, objectives, expectations, and intentions.
More detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements are included in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 as updated by Part II-Item 1A “Risk Factors” elsewhere in this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements other than as required by law.
JOBS Act
We currently qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.
We will remain an emerging growth company until December 31, 2026 (the last day of the fiscal year following the fifth anniversary of our initial public offering). For so long as we remain an emerging growth company, we are permitted, and intend, to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. We may choose to take advantage of some, but not all, of the available exemptions.
In addition, 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. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have 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, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.
We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
This item is not required for smaller reporting companies.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and management necessarily applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act) as of September 30, 2026. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of September 30, 2026 at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended September 30, 2026 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, from time to time, party to various claims and legal proceedings arising in the ordinary course of our business. Given that such proceedings are subject to uncertainty, there can be no assurance that any such legal proceedings, either individually or in the aggregate, will not have a material adverse effect on our business, results of operations, financial condition or cash flows. See Part I, Item 1, “Financial Statements (Unaudited)" – Note 5, Accrued and Other Current Liabilities, and Note 11, Contingencies, in this Quarterly Report, which are incorporated herein by reference.
Item 1A. Risk Factors.
Investing in our common stock involves a high degree of risk. In addition to the other information set forth in this Quarterly Report and in other documents that we file with the SEC, you should carefully consider the factors described in the section titled "Risk Factors" in our Form 10-K for the fiscal year ended December 31, 2025. There have been no material changes to the risk factors described in Part I, Item 1A of our 2025 Form 10-K. If any of the risk factors described in the Form 10-K actually materializes, our business, financial condition and results of operations could be materially adversely affected. In such an event, the market price of our common stock could decline and you may lose all or part of your investment. Additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business. We may disclose changes to such risk factors or disclose additional risk factors from time to time in our future filings with the SEC.
Item 5. Other Information.
Disclosure in lieu of reporting on a Current Report on Form 8-K.
Insider trading arrangements and policies
Trading Plans of Our Directors and Officers
During the quarter ended September 30, 2026, none of our directors or "officers" (as defined in Rule 16a-1(f) under the Exchane Act)
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Item 6. Exhibits.
Exhibit Number |
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Description |
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31.1* |
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31.2* |
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32.1** |
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101.INS |
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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. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
** Furnished herewith.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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MiNK Therapeutics, Inc. |
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Date: November 12, 2026 |
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By: |
/s/ Jennifer S. Buell, Ph.D. |
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Jennifer S. Buell, Ph.D. |
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President and Chief Executive Officer (Principal Executive Officer) |
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Date: November 12, 2026 |
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By: |
/s/ Melissa Orilall |
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Melissa Orilall |
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Principal Financial Officer and Controller |
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Exhibit 31.1
Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended
I, Jennifer S. Buell, certify that:
Date: November 12, 2026 |
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/s/ Jennifer S. Buell, Ph.D. |
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Jennifer S. Buell, Ph.D. |
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President, Chief Executive Officer and Principal Executive Officer |
Exhibit 31.2
Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended
I, Melissa Orilall, certify that:
Date: November 12, 2026 |
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/s/ Melissa Orilall |
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Melissa Orilall |
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Principal Financial Officer |
Exhibit 32.1
Certification
Pursuant to 18 U.S.C. Section 1350,
As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report on Form 10-Q of MiNK Therapeutics, Inc. (the “Company”) for the quarterly period ended September 30, 2026 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned to his/her knowledge hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
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/s/ Jennifer S. Buell, Ph.D. |
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Jennifer S. Buell, Ph.D. |
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President, Chief Executive Officer and Principal Executive Officer |
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/s/ Melissa Orilall |
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Melissa Orilall |
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Principal Financial Officer |
Date: November 12, 2026
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
The foregoing certification is being furnished to the Securities and Exchange Commission as an exhibit to the Report and should not be considered filed as part of the Report.