Agenus Inc 10-Q for FY2024 Q1
Agenus Inc (AGEN)
About this 10-Q
Agenus Inc filed this 10-Q on May 7, 2024, covering the quarter ended March 31, 2024 (FY2024 Q1).
Headline figures
Quarter ended March 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $28.01M
- up 22.3% from $22.9M a year earlier
- Net loss
- $63.45M
- compared with a net loss of $70.89M a year earlier
- Diluted EPS
- -$3.04
- compared with -$4.31 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
For the quarterly period ended
or
For the transition period from to
Commission File Number:
(exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code:
(
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class |
Trading symbol(s) |
Name of each exchange on which registered |
The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
Number of shares outstanding of the issuer’s Common Stock as of May 3, 2024:
Agenus Inc.
Three Months Ended March 31, 2024
Table of Contents
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PART I |
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ITEM 1. |
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Condensed Consolidated Balance Sheets as of March 31, 2024 (Unaudited) and December 31, 2023 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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ITEM 2. |
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Management's Discussion and Analysis of Financial Condition and Results of Operations |
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ITEM 3. |
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ITEM 4. |
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PART II |
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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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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
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March 31, 2024 |
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December 31, 2023 |
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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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Accounts receivable |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Property, plant and equipment, net of accumulated amortization and depreciation of |
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Operating lease right-of-use assets |
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Goodwill |
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Acquired intangible assets, net of accumulated amortization of $ |
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Other long-term assets |
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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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Current portion, long-term debt |
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$ |
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$ |
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Current portion, liability related to sale of future royalties and milestones |
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Current portion, deferred revenue |
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Current portion, operating lease liabilities |
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Accounts payable |
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Accrued liabilities |
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Other current liabilities |
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Total current liabilities |
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Long-term debt, net of current portion |
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Liability related to sale of future royalties and milestones, net of current portion |
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Deferred revenue, net of current portion |
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Operating lease liabilities, net of current portion |
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Other long-term liabilities |
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STOCKHOLDERS’ DEFICIT |
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Series A-1 convertible preferred stock; |
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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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Accumulated deficit |
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Total stockholders’ deficit attributable to Agenus Inc. |
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Non-controlling interest |
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Total stockholders’ deficit |
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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.
2
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in thousands, except per share amounts)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Revenue: |
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Research and development |
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$ |
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$ |
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Service revenue |
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Non-cash royalty revenue related to the sale of future royalties |
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Total revenues |
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Operating expenses: |
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Cost of service revenue |
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Research and development |
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General and administrative |
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Contingent purchase price consideration fair value adjustment |
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Operating loss |
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Other income (expense): |
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Non-operating income (expense) |
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Interest expense, net |
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Net loss |
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Dividends on Series A-1 convertible preferred stock |
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Less: net loss attributable to non-controlling interest |
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Net loss attributable to Agenus Inc. common stockholders |
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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 attributable to Agenus Inc. common stockholders |
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$ |
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$ |
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Weighted average number of Agenus Inc. common shares outstanding: |
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Basic and diluted |
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Other comprehensive income (loss): |
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Foreign currency translation income (loss) |
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$ |
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$ |
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Other comprehensive income (loss) |
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Comprehensive loss |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(Unaudited)
(Amounts in thousands)
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Series A-1 |
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Convertible |
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Preferred Stock |
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Common Stock |
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Treasury Stock |
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Number of |
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Par |
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Number of |
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Par |
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Additional |
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Number |
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Amount |
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Accumulated |
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Non-controlling |
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Accumulated |
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Total |
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Balance at December 31, 2023 |
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$ |
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$ |
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$ |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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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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Share-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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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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— |
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— |
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— |
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Payment of CEO payroll in 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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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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Exercise of stock options and employee share purchases |
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— |
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— |
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Balance at March 31, 2024 |
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$ |
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$ |
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$ |
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— |
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$ |
— |
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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.
4
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(Unaudited)
(Amounts in thousands)
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Series A-1 |
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Convertible |
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Preferred Stock |
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Common Stock |
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Treasury Stock |
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Number of |
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Par |
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Number of |
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Par |
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Additional |
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Number |
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Amount |
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Accumulated |
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Non-controlling |
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Accumulated |
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Total |
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Balance at December 31, 2022 |
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$ |
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$ |
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$ |
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— |
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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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— |
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Share-based compensation |
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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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Issuance of director deferred shares |
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— |
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Issuance of shares for services |
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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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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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Issuance of subsidiary shares for employee bonus |
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— |
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— |
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— |
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— |
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Issuance of shares for employee bonus |
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— |
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— |
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( |
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— |
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Retirement of treasury shares |
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— |
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— |
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Balance at March 31, 2023 |
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$ |
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$ |
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$ |
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— |
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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.
5
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Amounts in thousands, except per share amounts)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Share-based compensation |
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Non-cash royalty revenue |
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( |
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Non-cash interest expense |
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Loss disposal of assets, net |
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Other, net |
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( |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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Prepaid expenses |
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|
|
||
Accounts payable |
|
|
( |
) |
|
|
|
|
Deferred revenue |
|
|
( |
) |
|
|
( |
) |
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 |
|
|
( |
) |
|
|
( |
) |
Sale of long-term investment |
|
|
|
|
|
— |
|
|
Purchases of available-for-sale securities |
|
|
— |
|
|
|
( |
) |
Proceeds from sale of available-for-sale securities |
|
|
— |
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
|
|
|
( |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
||
Net proceeds from sale of equity |
|
|
|
|
|
|
||
Proceeds from employee stock purchases and option exercises |
|
|
|
|
|
|
||
Purchase of treasury shares to satisfy tax withholdings |
|
|
— |
|
|
|
( |
) |
Payment of finance lease obligation |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Effect of exchange rate changes on cash |
|
|
( |
) |
|
|
( |
) |
Net decrease in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
( |
) |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, end of period |
|
$ |
|
|
$ |
|
||
Supplemental cash flow information: |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
Supplemental disclosures - non-cash activities: |
|
|
|
|
|
|
||
Purchases of plant and equipment in accounts payable and |
|
$ |
— |
|
|
$ |
|
|
Issuance of common stock, $ |
|
|
— |
|
|
|
|
|
Insurance financing agreement |
|
|
|
|
|
|
||
Issuance of common stock, $ |
|
|
— |
|
|
|
|
|
Issuance of subsidiary options for payment of certain employee bonuses |
|
|
|
|
|
— |
|
|
Issuance of subsidiary shares for certain employee bonuses |
|
|
— |
|
|
|
|
|
Lease right-of-use assets obtained in exchange for new operating lease liabilities |
|
|
|
|
|
|
||
Lease right-of-use assets obtained in exchange for new finance lease liabilities |
|
|
|
|
|
|
||
See accompanying notes to unaudited condensed consolidated financial statements.
6
AGENUS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2024
Note A – Business, Liquidity and Basis of Presentation
Agenus Inc. (including its subsidiaries, collectively referred to as “Agenus,” the “Company,” “we,” “us,” and “our”) is a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents. Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc. (“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc. (“SaponiQx”)). We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.
In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and current good manufacturing practice ("cGMP") manufacturing. We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards. Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.
Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:
Our business activities include product research, preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.
Our cash and cash equivalents at March 31, 2024 were $
As of March 31, 2024, we had an accumulated deficit of $
We are also in discussions with several other parties to participate in the Purchase and Sale Agreement for up to an additional $125.0 million under the same structure as the Ligand transaction. In addition, we are also in discussions with several potential corporate collaborators. These transactions could also extend our cash resources. However, because the completion of such transactions is not entirely within our control, in accordance with accounting guidance 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 Agenus 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 continues to address the Company’s liquidity needs and can exercise its flexibility to adjust spending as needed in order to preserve liquidity. In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by
7
approximately
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 10 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 our management, the condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results. All significant intercompany transactions and accounts have been eliminated in consolidation. Operating results for the three months ended March 31, 2024, are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. For further information, refer to our consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”).
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 amounts of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
For our foreign subsidiaries, the local currency is the functional currency. Assets and liabilities of our foreign subsidiaries are translated into U.S. dollars using rates in effect at the balance sheet date while revenues and 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 included in the consolidated balance sheets as a component of accumulated other comprehensive income (loss) in total stockholders’ deficit.
On April 4, 2024, we executed a reverse stock split of our issued and outstanding common stock, par value $
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our Amended and Restated Directors’ Deferred Compensation Plan, or “DDCP”). Diluted loss per common share is calculated by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our DDCP) plus the dilutive effect of outstanding instruments such as warrants, stock options, non-vested shares and convertible preferred stock. Because we reported a net loss attributable to common stockholders 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 Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Warrants |
|
|
|
|
|
|
||
Stock options |
|
|
|
|
|
|
||
Non-vested shares |
|
|
|
|
|
|
||
Series A-1 convertible preferred stock |
|
|
|
|
|
|
||
8
Note C – Investments
Cash equivalents and short-term investments consisted of the following as of March 31, 2024 and December 31, 2023 (in thousands):
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||||||||||
|
|
Cost |
|
|
Estimated |
|
|
Cost |
|
|
Estimated |
|
||||
Institutional money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
As a result of the short-term nature of these investments, there were minimal unrealized holding gains or losses for the three months ended March 31, 2024 and 2023.
As of both March 31, 2024 and December 31, 2023, all of the investments listed above were classified as cash equivalents on our condensed consolidated balance sheets.
Note D – Goodwill and Acquired Intangible Assets
The following table sets forth the changes in the carrying amount of goodwill for the three months ended March 31, 2024 (in thousands):
Balance, December 31, 2023 |
|
$ |
|
|
Effect of foreign currency |
|
|
( |
) |
Balance, March 31, 2024 |
|
$ |
|
Acquired intangible assets consisted of the following as of March 31, 2024 and December 31, 2023 (in thousands):
|
|
As of March 31, 2024 |
|
|||||||||||
|
|
Amortization |
|
Gross carrying |
|
|
Accumulated |
|
|
Net carrying |
|
|||
Intellectual property |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Trademarks |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Other |
|
|
|
|
|
|
( |
) |
|
|
|
|||
In-process research and development |
|
Indefinite |
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
As of December 31, 2023 |
|
|||||||||||
|
|
Amortization |
|
Gross carrying |
|
|
Accumulated |
|
|
Net carrying |
|
|||
Intellectual property |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Trademarks |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Other |
|
|
|
|
|
|
( |
) |
|
|
|
|||
In-process research and development |
|
Indefinite |
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
The weighted average amortization period of our finite-lived intangible assets is
9
Note E – Debt
Debt instrument |
|
Balance at |
|
|
Current Portion: |
|
|
|
|
Debentures |
|
$ |
|
|
2015 Subordinated Notes |
|
|
|
|
Other |
|
|
|
|
Total |
|
$ |
|
|
Debt instrument |
|
Balance at |
|
|
Current Portion: |
|
|
|
|
Debentures |
|
$ |
|
|
Long-term Portion: |
|
|
|
|
2015 Subordinated Notes |
|
|
|
|
Total |
|
$ |
|
|
As of March 31, 2024 and December 31, 2023, the principal amount of our outstanding debt balance was $
Note F – Liability Related to the Sale of Future Royalties and Milestones
The following table shows the activity within the liability account in the three months ended March 31, 2024 (in thousands):
|
|
Period from |
|
|
Liability related to sale of future royalties and milestones - beginning balance |
|
$ |
|
|
Non-cash royalty revenue |
|
|
( |
) |
Non-cash interest expense recognized |
|
|
|
|
Liability related to sale of future royalties and milestones - ending balance |
|
|
|
|
Less: unamortized transaction costs |
|
|
( |
) |
Liability related to sale of future royalties and milestones, net |
|
$ |
|
|
Healthcare Royalty Partners
In January 2018, we, through our wholly-owned subsidiary Antigenics, LLC (“Antigenics”), entered into a Royalty Purchase Agreement (the “HCR Royalty Purchase Agreement”) with Healthcare Royalty Partners III, L.P. and certain of its affiliates (collectively, “HCR”). Pursuant to the terms of the HCR Royalty Purchase Agreement, we sold to HCR
During the three months ended March 31, 2024, we recognized $
As royalties are remitted to HCR from GSK, the balance of the recorded liability will be effectively repaid over the life of the HCR Royalty Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total
10
amount of future royalty payments to be received by HCR. The sum of these amounts less the $
Note G – Accrued and Other Current Liabilities
Accrued liabilities consisted of the following as of March 31, 2024 and December 31, 2023 (in thousands):
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Payroll |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Contract manufacturing costs |
|
|
|
|
|
|
||
Research services |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Other current liabilities consisted of the following as of March 31, 2024 and December 31, 2023 (in thousands):
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Finance lease liabilities |
|
$ |
|
|
$ |
|
||
Other |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Note H – Fair Value Measurements
Assets and liabilities measured at fair value are summarized below (in thousands):
Description |
|
March 31, 2024 |
|
|
Quoted Prices in |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents (Note C) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent purchase price considerations |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Description |
|
December 31, 2023 |
|
|
Quoted Prices in |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents (Note C) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent purchase price consideration |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
11
Long-term investments are included in "Other long-term assets" in our condensed consolidated balance sheets.
We measure our contingent purchase price considerations at fair value. The fair values of our contingent purchase price considerations at both March 31, 2024 and December 31, 2023, of $
Note I – Revenue from Contracts with Customers
Gilead Collaboration Agreement
On December 20, 2018, we entered into a series of agreements with Gilead Sciences, Inc. (“Gilead”) focused on the development and commercialization of up to five novel immuno-oncology therapies. Pursuant to the terms of the license agreement, the option and license agreements and the stock purchase agreement we entered into with Gilead (collectively, the “Gilead Collaboration Agreements”), at the closing of the transaction on January 23, 2019, we received an upfront cash payment from Gilead of $
Collaboration Revenue
Disaggregation of Revenue
The following table presents revenue (in thousands) for the three months ended March 31, 2024 and 2023, 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 March 31, 2024 |
|
|||||||||
|
|
United States |
|
|
Rest of World |
|
|
Total |
|
|||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Other services |
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
|
|
Three months ended March 31, 2023 |
|
|||||||||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Research and development services |
|
|
|
|
|
— |
|
|
|
|
||
Other services |
|
|
— |
|
|
|
|
|
|
|
||
Recognition of deferred revenue |
|
|
|
|
|
— |
|
|
|
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Contract Balances
12
Contract assets primarily relate to our rights to consideration for work completed in relation to our research and development services performed but not billed at the reporting date. The contract assets are transferred to receivables when the rights become unconditional. Currently, we do not have any contract assets which have not transferred to a receivable. We had
The following table provides information about contract liabilities from contracts with customers (in thousands):
Three months ended March 31, 2024 |
|
Balance at beginning of period |
|
|
Additions |
|
|
Deductions |
|
|
Balance at end of period |
|
||||
Contract liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deferred revenue |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
We also recorded a $
During the three months ended March 31, 2024, we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods.
We primarily use the Black-Scholes option pricing model to value stock options granted to employees and non-employees, including stock options granted to members of our Board of Directors. However, the fair value of stock option market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. All stock options have
A summary of option activity for the three months ended March 31, 2024 is presented below:
|
|
Options |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding at December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
Vested or expected to vest at March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
Exercisable at March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
The weighted average grant-date fair values of stock options granted during the three months ended March 31, 2024 and 2023 were $
As of March 31, 2024, there was approximately $
Certain employees and consultants have been granted non-vested stock. The fair value of non-vested market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. The fair value of other non-vested stock is calculated based on the closing sale price of our common stock on the date of issuance.
13
A summary of non-vested stock activity for the three months ended March 31, 2024 is presented below:
|
|
Non-vested |
|
|
Weighted |
|
||
Outstanding at December 31, 2023 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Outstanding at March 31, 2024 |
|
|
|
|
$ |
|
||
As of March 31, 2024, there was approximately $
During the three months ended March 31, 2024,
The impact on our results of operations from share-based compensation for the three months ended March 31, 2024 and 2023, was as follows (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
||
Note K – Restricted Cash
As of both March 31, 2024, and December 31, 2023, we maintained non-current restricted cash of $
The following table provides a reconciliation of cash, cash equivalents and restricted cash that sums to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):
|
|
Three Months Ended March 31, 2024 |
|
|
Three Months Ended March 31, 2023 |
|
||||||||||
|
|
Beginning of Period |
|
|
End of Period |
|
|
Beginning of Period |
|
|
End of Period |
|
||||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash, cash equivalents and restricted cash |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note L – Equity
On March 14, 2024, we filed a Post-effective Amendment to an Automatic Shelf Registration Statement on Form POSASR (file no. 333-272911) and a Post-Effective Amendments for Registration Statement on Form POS AM (file no. 333-272911) (together, the “Registration Statement”). The Registration Statement included both a base prospectus that covered the potential offering, issuance and sale from time to time of up to $
During the three months ended March 31, 2024, we received net proceeds of approximately $
Note M – Non-controlling Interest
14
Non-controlling interest recorded in our condensed consolidated financial statements as of March 31, 2024 and December 31, 2023, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
MiNK Therapeutics, Inc. |
|
|
% |
|
|
% |
||
SaponiQx, Inc. |
|
|
% |
|
|
% |
||
Changes in non-controlling interest for the periods ended March 31, 2024 and December 31, 2023, were as follows (in thousands):
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Beginning balance |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Net loss attributable to non-controlling interest |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Other items: |
|
|
|
|
|
|
||
Distribution of subsidiary shares to Agenus stockholders |
|
|
— |
|
|
|
|
|
Purchase of subsidiary shares |
|
|
— |
|
|
|
( |
) |
Issuance of subsidiary shares for employee bonus |
|
|
— |
|
|
|
|
|
Issuance of subsidiary shares for employee stock purchase plan and exercise of options |
|
|
|
|
|
|
||
Subsidiary share-based compensation |
|
|
|
|
|
|
||
Total other items |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Ending balance |
|
$ |
|
|
$ |
|
||
Distribution of subsidiary shares to Agenus stockholders
On
On
Purchase of subsidiary shares
During the year ended December 31, 2023, we purchased
Note N – Related Party Transactions
In 2023, our Audit and Finance Committee approved a contract between Avillion Life Sciences LTD ("Avillion") and Agenus for the performance of up to $
Note O – Recent Accounting Pronouncements
Recently Issued, Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 requires incremental annual and quarterly disclosures about segment measures of profit or loss as well as significant segment expenditures. It also requires public entities with a single reportable segment to provide all segment disclosures required by the amendments and all existing segment disclosures in Topic 280. ASU 2023-07 is
15
effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. As we have a single reportable segment, we expect the adoption of this standard to result in increased disclosures in the notes to our consolidated financial statements.
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 public business entities, ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. We are currently evaluating the impact that ASU 2023-09 will have on the notes to our consolidated financial statements.
No other new accounting pronouncement issued or effective during the three months ended March 31, 2024 had or is expected to have a material impact on our consolidated financial statements or disclosures.
Note P – Subsequent Events
Reverse Stock Split
On April 3, 2024, our stockholders approved a proposal to amend our Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect a reverse stock split of our issued and outstanding common stock at a ratio of
All common share, per share and related information included in the accompanying financial statements and footnote disclosures have been adjusted retroactively, where applicable, to reflect the Reverse Stock Split.
Purchase Agreement
On May 6, 2024, we, and certain wholly-owned subsidiaries, entered into a Purchase and Sale Agreement (the “Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”) for the sale to Ligand of (i)
The total amounts payable to Ligand are subject to a
In consideration for the sale of the Purchased Assets, we will receive $
The Purchase Agreement contains customary representations, warranties and agreements by us and Ligand, indemnification obligations of the parties and certain other obligations of the parties. As part of the transaction, we will grant Ligand security over certain assets related to the Purchased Assets pursuant to security agreements, subject to certain customary exceptions. Closing of the transaction is subject to customary conditions, including execution of customary ancillary documents for a transaction of this type. The transaction is expected to close in May 2024.
In connection with the sale of the Purchased Assets, we issued to Ligand a warrant (“Warrant”) to purchase
16
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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,” “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, 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 ability to commercialize our product candidates, the activities of our licensees, 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, anticipated sources of funds 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 in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. 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.
ASV®, Agenus™, MiNK™, Prophage™, Retrocyte Display™ and STIMULON™ are trademarks of Agenus Inc. and its subsidiaries. All rights reserved.
Overview
We are a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents. Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc. (“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc. (“SaponiQx”)). We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.
In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and current good manufacturing practice ("cGMP") manufacturing. We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards. Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.
Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:
We regularly evaluate development, commercialization, and partnering strategies for each product candidate based on various factors, including pre-clinical and clinical trial results, competitive positioning, funding requirements, and available resources. Our lead program, botensilimab (AGEN1181), is progressing through multiple clinical programs designed to support accelerated
17
development as a monotherapy and in combination with balstilimab. In April 2023, botensilimab in combination with balstilimab received Fast Track designation from the U.S. Food and Drug Administration ("FDA") for the treatment of patients with not-microsatellite instability-high ("MSI-H")/deficient mismatch repair ("dMMR") metastatic colorectal cancer with no active liver involvement. Patients targeted with this designation are heavily pretreated with standard of care chemotherapy, anti-VEGF and anti-EGFR if RAS wild type. We completed enrollment of patients with refractory MSS mCRC non-active liver metastases ("NLM") in a Phase 1 trial (n~150) and randomized Phase 2 trial (n~230) in October 2023. We are pursuing a global regulatory strategy and aim to initiate submission of a biologics license application ("BLA") to the FDA for a potential accelerated approval by the end of 2024, followed by a planned submission to the European Medicines Agency.
We have established collaborations with several companies, including Bristol-Myers Squibb Company (“BMS”), Betta Pharmaceuticals Co., Ltd. (“Betta”), UroGen Pharma Ltd. ("UroGen"), Gilead Sciences, Inc. (“Gilead”), Incyte Corporation (“Incyte”), and Merck Sharpe & Dohme (“Merck”). These collaborations, along with our internal programs, have resulted in over a dozen antibody pre-clinical or clinical development programs.
Pursuant to our collaboration agreement with Incyte, we have exclusively licensed to Incyte monospecific antibodies targeting GITR, OX40, TIM-3 and LAG-3, which Incyte is currently advancing in various clinical trials, as well as an additional undisclosed target that Incyte is advancing in preclinical studies. Under the terms of our agreement, Incyte is responsible for all future development expenses, and we are eligible to receive up to an additional $315.0 million in potential milestone payments plus royalties on any future sales. Incyte has terminated the OX40 program, effective October 2023, and has notified us of their intent to terminate both the GITR program and undisclosed program, effective May 2024. Upon termination, the rights to the OX40, GITR, and undisclosed programs revert back to us.
Pursuant to our collaboration and license agreement with Merck, we exclusively licensed to Merck a monospecific antibody targeting ILT4 (MK-4830), which Merck advanced in a Phase 2 clinical trial. Merck is responsible for all future development expenses, and we are eligible to receive up to an additional $85.0 million in potential milestone payments, as well as royalties on future sales. In 2024 Merck notified us that the further clinical development of MK-4830 will be limited to a neoadjuvant ovarian study of MK-4830 in combination with pembrolizumab and chemotherapy with or without bevacizumab that is ongoing.
In September 2018, we, through our wholly-owned subsidiary, Agenus Royalty Fund, LLC, entered into a royalty purchase agreement (the “XOMA Royalty Purchase Agreement”) with XOMA (US) LLC (“XOMA”). Pursuant to the terms of the XOMA Royalty Purchase Agreement, XOMA purchased 33% of all future royalties and 10% of all future milestone payments that we are entitled to receive from Incyte and Merck, net of certain of our obligations to a third party. After taking into account our obligations under the XOMA Royalty Purchase Agreement, as of March 31, 2024, we remain eligible to receive up to $283.5 million and $76.5 million in potential development, regulatory, and commercial milestones from Incyte and Merck, respectively.
In December 2018, we entered into collaboration agreements with Gilead for the development and commercialization of up to five novel I-O therapies (the “Gilead Collaboration Agreements”). Gilead received worldwide exclusive rights to our bispecific antibody, AGEN1423, and the exclusive option to license AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody. Gilead elected to return AGEN1423 to us in November 2020 and terminated the license agreement. We ceased development of AGEN1223 in the third quarter of 2021, and the option and license agreement for AGEN1223 were formally terminated in October 2021. The AGEN2373 option agreement remains in place, and we are responsible for developing the program until the option decision point. If Gilead exercises the option, we may opt-in to share development and commercialization costs in the United States in exchange for a 50:50 profit (loss) share and revised milestone payments. In March 2022, we received a $5.0 million clinical milestone under the AGEN2373 option agreement. Pursuant to the terms of the AGEN2373 option agreement, we remain eligible to receive a $50.0 million option exercise fee and up to an additional $520.0 million in aggregate milestone payments, as well as royalties on future sales.
In November 2019, we entered into a license agreement with UroGen, granting them an exclusive, worldwide license (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions) to develop, manufacture, and commercialize zalifrelimab for the treatment of cancers of the urinary tract via intravesical delivery. We received an upfront payment of $10.0 million and are eligible to receive up to $200.0 million in milestone payments, as well as royalties on future sales.
In June 2020, we entered into a license and collaboration agreement (the “Betta License Agreement”) with Betta, pursuant to which we granted Betta an exclusive license to develop, manufacture and commercialize balstilimab and zalifrelimab in Republic of China, Hong Kong, Macau and Taiwan (“Greater China”). Under the terms of the Betta License Agreement, we received $15.0 million upfront and are eligible to receive up to $100.0 million in milestone payments plus royalties on any future sales in Greater China.
18
In May 2021, we entered into a License, Development, and Commercialization Agreement with BMS for our pre-clinical anti-TIGIT bispecific antibody program, AGEN1777. BMS received an exclusive worldwide license to develop, manufacture, and commercialize AGEN1777 and its derivatives. We retained an option to access the licensed antibodies for use in clinical studies in combination with certain pipeline assets. We received a non-refundable upfront cash payment of $200.0 million and, as of March 31, 2024, are eligible to receive up to $1.32 billion in development, regulatory, and commercial milestone payments, along with tiered royalties. BMS is responsible for all associated costs, and we have the option to co-fund a minority of global development costs in exchange for increased tiered royalties. We also have the option to co-promote AGEN1777 in the U.S. In October 2021, we achieved a $20.0 million milestone upon the dosing of the first patient in the AGEN1777 Phase 1 clinical trial and in December 2023, we announced that the first patient was dosed in an AGEN1777 Phase 2 clinical trial, triggering the achievement of a $25.0 million milestone. We received this milestone in January 2024.
In September 2021, we launched SaponiQx to lead innovation in novel adjuvant discovery and vaccine design, focusing on our saponin-based adjuvants. We are particularly dedicated to the development of the next-generation cultured plant cell QS-21. To support this initiative, we partnered with Ginkgo Bioworks, Inc. to develop SaponiQx’s saponin products from sustainably sourced raw materials. Our goal is to meet the demands of the vaccine industry, especially for pandemic vaccines.
Our bark extract QS-21 adjuvant is partnered with GSK and plays a vital role in multiple GSK vaccine programs. These programs are at various stages, including GSK’s approved shingles and RSV vaccines, SHINGRIX and AREXVY, which received FDA approval in the United States in October 2017 and May 2023, respectively.
In January 2018, we entered into a Royalty Purchase Agreement with Healthcare Royalty Partners III, L.P. and its affiliates (“HCR”). HCR purchased our worldwide rights to receive royalties from GSK on GSK’s sales of vaccines containing our QS-21 adjuvant. We do not incur clinical development costs for products partnered with GSK.
Under the agreement with HCR, we were entitled to receive milestone payments based on GSK’s vaccine sales. These milestones include $15.1 million upon GSK reaching $2.0 billion in last-twelve-months net sales prior to 2024 (the “First HCR Milestone”) and $25.25 million upon GSK reaching $2.75 billion in last-twelve-months net sales prior to 2026 (the “Second HCR Milestone”). We received the First HCR Milestone after GSK’s net sales of SHINGRIX for the twelve months ended December 31, 2019, exceeded $2.0 billion, and we received the Second HCR Milestone after GSK’s net sales of SHINGRIX for the twelve months ended June 30, 2022, exceeded $2.75 billion.
Our business activities include product research and preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.
In October 2021, we completed the initial public offering (“IPO”) of MiNK, which trades on the Nasdaq Capital Market under the ticker symbol “INKT”. MiNK is a clinical stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (“iNKT”) cell therapies to treat cancer and other life-threatening immune diseases. MiNK’s most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. Expansion of clinical programs is currently underway, notably a Phase 2 clinical trial in 2L gastric cancer at Memorial Sloan Kettering Cancer Center. MiNK is also evaluating agenT-797 as a variant-agnostic therapy for patients with viral acute respiratory distress syndrome (“ARDS”). In addition to its lead clinical program, MiNK announced a collaboration with ImmunoScape, Inc. ("ImmunoScape") to discover and develop next-generation T-cell receptor therapies against novel targets in solid tumors. MiNK will combine its unique, proprietary library of T cell antigens with ImmunoScape’s platform for rapid discovery of novel T cell receptor.
Historical Results of Operations
Three months ended March 31, 2024 compared to the three months ended March 31, 2023
Research and development revenue
We did not recognize any research and development revenue in the three months ended March 31, 2024, but recognized research and development revenue of approximately $2.6 million during the three months ended March 31, 2023. Research and development revenues in the first quarter of 2023 primarily consisted of $2.3 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements
Non-cash royalty revenue related to the sale of future royalties
19
In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $8.7 million, to approximately $27.8 million for the three months ended March 31, 2024, from $19.1 million for the three months ended March 31, 2023, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant, including net sales of AREXVY, that GSK launched in the third quarter of 2023.
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 consultants, and administrative costs. Research and development expense decreased 23% to $43.9 million for the three months ended March 31, 2024 from $57.1 million for the three months ended March 31, 2023. Decreased expenses in the three months ended March 31, 2024 primarily relate to a $7.4 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $2.1 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $4.4 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $0.7 million increase in other research and development expenses.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 8% to $16.9 million for the three months ended March 31, 2024 from $18.2 million for the three months ended March 31, 2023. Decreased expenses in the three months ended March 31, 2024 primarily relate to $0.1 million decrease in professional fees and a $1.5 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $0.1 million increase in personnel related expenses, and a $0.2 million increase in other general and administrative expenses.
Interest expense, net
Interest expense, net increased to approximately $29.5 million for the three months ended March 31, 2024 from $16.6 million for the three months ended March 31, 2023, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR.
Research and Development Programs
For the three months ended March 31, 2024, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).
|
|
|
|
Three Months Ended March 31, |
|
|
Year Ended December 31, |
|
||||||||||
Research and |
|
Product |
|
2024 |
|
|
2023 |
|
|
2022 |
|
|
2021 |
|
||||
Antibody programs |
|
Various |
|
$ |
33,157 |
|
|
$ |
178,445 |
|
|
$ |
133,108 |
|
|
$ |
141,266 |
|
Vaccine adjuvant |
|
STIMULON cpcQS-21 |
|
|
586 |
|
|
|
10,296 |
|
|
|
10,789 |
|
|
|
5,912 |
|
Cell therapies |
|
Various |
|
|
2,668 |
|
|
|
16,283 |
|
|
|
24,300 |
|
|
|
15,507 |
|
Other research and development programs |
|
Various |
|
|
7,514 |
|
|
|
29,545 |
|
|
|
18,494 |
|
|
|
15,923 |
|
Total research and development expenses |
|
|
|
$ |
43,925 |
|
|
$ |
234,569 |
|
|
$ |
186,691 |
|
|
$ |
178,608 |
|
Research and development program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions and our review of the status of each program. 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 therapeutic 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.
20
Liquidity and Capital Resources
We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.0 billion as of March 31, 2024. We expect to incur significant 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. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through March 31, 2024, we have raised aggregate net proceeds of approximately $1.9 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.
We maintain an effective registration statement (the “Registration Statement”) covering up to $300.0 million of common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 6.7 million shares of our common stock from time to time in “at-the-market offerings” pursuant to an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley Securities, Inc. as our sales agent. During the three months ended March 31, 2024, we sold approximately 1.2 million shares of our common stock pursuant to the Sales Agreement, for aggregate net proceeds of $17.2 million. As of March 31, 2024, approximately 6.7 million shares remained available for sale under the Sales Agreement.
We have funded our operations largely from cash received from partners, royalty financing transactions and equity offerings. We transact at-the-market sales from time to time in order to manage our cash balances to make sure cash balances do not drop below a certain level based on our anticipated uses of cash. We execute at-the-market offerings based on market conditions and our stock price. We do not have in place a program whereby at-the-market offerings are executed automatically based on our trading volume.
As of March 31, 2024, we had debt outstanding of $13.8 million in principal. In November 2022, we amended all of the outstanding 2015 Subordinated Notes, extending the due date by two years to February 2025.
Our cash and cash equivalents at March 31, 2024 were $52.9 million, a decrease of $23.3 million from December 31, 2023. Cash and cash equivalents of our subsidiary, MiNK, at December 31, 2023, were $3.4 million. MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.
Since our founding we have financed our operations principally through income and revenues generated from corporate partnerships, advance royalty sales and proceeds from equity issuances. Based on our current plans and projections, we believe that our cash resources of $52.9 million as of March 31, 2024, plus the $75.0 million to be received from Ligand Pharmaceuticals and the exercise at their option of an additional $25.0 million under a Purchase and Sale Agreement (see Note P), plus additional funding we may receive from multiple other sources, including out-licensing and/or partnering opportunities, and the repayment of our subordinated notes, will be sufficient to satisfy our liquidity requirements through the end of the year and into 2025. Potential partnership and collaboration transactions along with potential accelerated approval of our lead products, botensilimab and balstilimab, and potential commercial revenues from these products, can extend our runway and allow us to be cash flow positive from our operations.
We are also in discussions with several other parties to participate in the Purchase and Sale Agreement for an additional $125.0 million under the same structure as the Ligand transaction. In addition, we are also in discussions with several potential corporate collaborators. These transactions could also extend our cash resources. However, because the completion of such transactions is not entirely within our control, in accordance with accounting guidance 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 Agenus 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 continues to address the Company’s liquidity needs and can exercise its flexibility to adjust spending as needed in order to preserve liquidity. In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by approximately 25%. Our CEO, Dr. Garo Armen has elected to receive his base salary and any potential bonus payments in stock rather than cash. We continuously evaluate the likelihood of success of our programs. As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis. We expect our sources of funding to include payments from current collaborations which include milestones and royalty payments from companies, including Bristol-Myers Squibb Company, UroGen Pharma Ltd., Gilead Sciences, Inc., Merck Sharpe & Dohme and Incyte Corporation; out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties; additional third-party agreements; asset sales; further royalty monetization; project financing, and/or sales of equity securities.
21
Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs. Since inception, we have entered into various agreements with contract manufacturers, institutions, and clinical research organizations (collectively “third party providers”) to perform pre-clinical activities and to conduct and monitor our clinical studies and trials. Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be $649.8 million over the term of the related activities. Through March 31, 2024, we have expensed $574.5 million as research and development expenses and $533.4 million has been paid under these agreements. The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs.
Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaboration arrangements with academic and collaboration partners and licensees and by entering into new collaborations. As a result of our collaboration agreements, we will not completely control the efforts to attempt to bring those product candidates to market.
Net cash used in operating activities for the three months ended March 31, 2024 and 2023 was $38.2 million and $58.5 million, respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Forward Looking Statements” in Part I, Item 2 of this Quarterly Report on Form 10-Q and the risks highlighted in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our primary market risk exposure is foreign currency exchange rate risk. International revenues and expenses are generally transacted by our foreign subsidiaries and are denominated in local currency. Approximately 1.0% of our cash used in operations for both the three months ended March 31, 2024 and the year ended December 31, 2023, was from our foreign subsidiaries. We are exposed to foreign currency exchange rate fluctuation risk related to our transactions denominated in foreign currencies. We do not currently employ specific strategies, such as the use of derivative instruments or hedging, to manage these exposures. Our currency exposures vary but are primarily concentrated in the British Pound and Euro, in large part due to our subsidiaries, Agenus UK Limited and AgenTus Therapeutics Limited, both with operations in England, and AgenTus Therapeutics SA, a company formerly with operations in Belgium.
We had cash and cash equivalents at March 31, 2024 of $52.9 million, which are exposed to the impact of interest rate changes, and our interest income fluctuates as interest rates change. Additionally, in the normal course of business, we are exposed to fluctuations in interest rates as we seek debt financing and invest excess cash. Due to the short-term nature of our investments in money market funds, our carrying value approximates the fair value of these investments at March 31, 2024.
There has been no material change to our interest rate exposure and our approach toward interest rate and foreign currency exchange rate exposures, as described in our Annual Report on Form 10-K for the year ended December 31, 2023.
We invest our cash and cash equivalents in accordance with our investment policy. The primary objectives of our investment policy are to preserve principal, maintain proper liquidity to meet operating needs, and maximize yields. We review our investment policy periodically and amend it as deemed necessary. Currently, the investment policy prohibits investing in any structured investment vehicles and asset-backed commercial paper. Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer, or type of investment. We do not invest in derivative financial instruments. Accordingly, we do not believe that there is currently any material market risk exposure with respect to derivatives or other financial instruments that would require disclosure under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act. Based on this evaluation, our Principal Executive Officer and our Principal Financial Officer concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective and were designed to ensure that information we are required to disclose in the reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure, and is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules
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and forms. It should be noted that any system of controls is designed to provide reasonable, but not absolute, assurances that the system will achieve its stated goals under all reasonably foreseeable circumstances. Our Principal Executive Officer and Principal Financial Officer have each concluded that our disclosure controls and procedures as of the end of the period covered by this report are effective at a level that provides such reasonable assurances.
Changes in Internal Control Over Financial Reporting
There was no change 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 three months ended March 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Our results of operations and financial condition are subject to numerous risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K.
Item 5. Other Information
Trading Plans of Our Directors and Officers
During the quarter ended March 31, 2024, none of our directors or executive officers
Item 6. Exhibits
Exhibit No. |
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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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XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101) |
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AGENUS INC.
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.
Date: |
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May 7, 2024 |
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AGENUS INC. |
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/s/ CHRISTINE M. KLASKIN |
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Christine M. Klaskin VP, Finance, Principal Financial Officer, Principal Accounting Officer |
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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, Garo H. Armen, certify that:
Date: May 7, 2024 |
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/s/ GARO H. ARMEN, PH.D. |
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Garo H. Armen, Ph.D. |
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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, Christine M. Klaskin, certify that:
Date: May 7, 2024 |
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/s/ CHRISTINE M. KLASKIN |
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Christine M. Klaskin |
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VP, Finance and 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 Agenus Inc. (the “Company”) for the quarterly period ended March 31, 2024 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/ GARO H. ARMEN, PH.D. |
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Garo H. Armen, Ph.D. |
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Chief Executive Officer and Principal Executive Officer |
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/s/ CHRISTINE M. KLASKIN |
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Christine M. Klaskin |
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VP, Finance and Principal Financial Officer |
Date: May 7, 2024
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.