Item 1. Financial Statements
Item 1. Financial Statements
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDA TED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
June 30, 2024
(unaudited)
December 31, 2023
ASSETS
Cash and cash equivalents
$
93,723
$
76,110
Accounts receivable
719
25,836
Prepaid expenses
2,207
8,098
Other current assets
3,355
2,372
Total current assets
100,004
112,416
Property, plant and equipment, net of accumulated amortization and depreciation of
$ 68,137 and $ 61,943 at June 30, 2024 and December 31, 2023, respectively
127,569
133,421
Operating lease right-of-use assets
28,964
29,606
Goodwill
24,748
24,723
Acquired intangible assets, net of accumulated amortization of $ 18,032 and
$ 17,688 at June 30, 2024 and December 31, 2023, respectively
4,136
4,411
Other long-term assets
6,994
9,336
Total assets
$
292,415
$
313,913
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current portion, long-term debt
$
13,425
$
146
Current portion, liability related to sale of future royalties and milestones
146,549
132,502
Current portion, deferred revenue
9
18
Current portion, operating lease liabilities
2,296
2,587
Accounts payable
50,843
61,446
Accrued liabilities
41,208
45,283
Other current liabilities
16,336
13,915
Total current liabilities
270,666
255,897
Long-term debt, net of current portion
—
12,768
Liability related to sale of future royalties and milestones, net of current portion
184,169
124,556
Deferred revenue, net of current portion
1,143
1,143
Operating lease liabilities, net of current portion
55,786
62,511
Other long-term liabilities
1,490
5,420
Commitments and contingencies
STOCKHOLDERS’ DEFICIT
Series A-1 convertible preferred stock; 31,620 shares designated, issued, and
outstanding at June 30, 2024 and December 31, 2023; liquidation value
of $ 33,993 at June 30, 2024
0
0
Common stock, par value $ 0.01 per share; 800,000,000 shares authorized;
21,126,226 and 19,718,662 shares issued and outstanding at
June 30, 2024 and December 31, 2023, respectively
211
197
Additional paid-in capital
1,830,114
1,796,095
Accumulated other comprehensive loss
( 1,001
)
( 955
)
Accumulated deficit
( 2,070,635
)
( 1,955,668
)
Total stockholders’ deficit attributable to Agenus Inc.
( 241,311
)
( 160,331
)
Non-controlling interest
20,472
11,949
Total stockholders’ deficit
( 220,839
)
( 148,382
)
Total liabilities and stockholders’ deficit
$
292,415
$
313,913
See accompanying notes to unaudited condensed consolidated financial statements.
2
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS O F OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in thousands, except per share amounts)
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Revenue:
Research and development
$
267
$
2,489
$
267
$
5,101
Service revenue
660
739
898
1,923
Non-cash royalty revenue related to the sale of future royalties
22,582
22,068
50,349
41,174
Total revenues
23,509
25,296
51,514
48,198
Operating expenses:
Cost of service revenue
( 115
)
( 254
)
( 222
)
( 2,548
)
Research and development
( 36,771
)
( 59,285
)
( 80,696
)
( 116,402
)
General and administrative
( 16,816
)
( 20,415
)
( 33,672
)
( 38,653
)
Contingent purchase price consideration fair value adjustment
—
( 8
)
—
398
Operating loss
( 30,193
)
( 54,666
)
( 63,076
)
( 109,007
)
Other income (expense):
Non-operating income (expense)
7,141
( 244
)
6,036
( 204
)
Interest expense, net
( 31,745
)
( 18,520
)
( 61,211
)
( 35,112
)
Net loss
( 54,797
)
( 73,430
)
( 118,251
)
( 144,323
)
Dividends on Series A-1 convertible preferred stock
( 54
)
( 53
)
( 107
)
( 107
)
Less: net loss attributable to non-controlling interest
( 1,716
)
( 4,414
)
( 3,284
)
( 7,053
)
Net loss attributable to Agenus Inc. common stockholders
$
( 53,135
)
$
( 69,069
)
$
( 115,074
)
$
( 137,377
)
Per common share data:
Basic and diluted net loss attributable to Agenus Inc. common stockholders
$
( 2.52
)
$
( 3.93
)
$
( 5.56
)
$
( 8.22
)
Weighted average number of Agenus Inc. common shares outstanding:
Basic and diluted
21,062
17,569
20,715
16,717
Other comprehensive income (loss):
Foreign currency translation income (loss)
$
70
$
( 1,634
)
$
( 46
)
$
( 1,632
)
Other comprehensive income (loss)
70
( 1,634
)
( 46
)
( 1,632
)
Comprehensive loss
$
( 53,065
)
$
( 70,703
)
$
( 115,120
)
$
( 139,009
)
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)
Series A-1
Convertible
Preferred Stock
Common Stock
Treasury Stock
Number of
Shares
Par
Value
Number of
Shares
Par
Value
Additional
Paid-In
Capital
Number
of Shares
Amount
Accumulated
Other
Comprehensive
Income (Loss)
Non-controlling
Interest
Accumulated
Deficit
Total
Balance at December 31, 2023
32
$
0
19,718
$
197
$
1,796,095
—
$
—
$
( 955
)
$
11,949
$
( 1,955,668
)
( 148,382
)
Net loss
—
—
—
—
—
—
—
—
( 1,568
)
( 61,886
)
( 63,454
)
Other comprehensive loss
—
—
—
—
—
—
—
( 116
)
—
—
( 116
)
Share-based compensation
—
—
—
—
3,477
—
—
—
719
—
4,196
Shares sold at the market
—
—
1,249
13
17,158
—
—
—
—
—
17,171
Payment of CEO payroll in shares
—
—
7
—
89
—
—
—
—
—
89
Vesting of nonvested shares
—
—
8
—
—
—
—
—
—
—
—
Exercise of stock options and employee share purchases
—
—
12
—
166
—
—
—
7
—
173
Balance at March 31, 2024
32
$
0
20,994
$
210
$
1,816,985
—
$
—
$
( 1,071
)
$
11,107
$
( 2,017,554
)
$
( 190,323
)
Net loss
—
—
—
—
—
—
—
—
( 1,716
)
( 53,081
)
( 54,797
)
Other comprehensive income
—
—
—
—
—
—
—
70
—
—
70
Share-based compensation
—
—
—
—
8,449
—
—
—
841
—
9,290
Shares sold at the market
—
—
117
1
1,989
—
—
—
—
—
1,990
Issuance of warrants, net of expenses
—
—
—
—
6,983
—
—
—
—
—
6,983
Vesting of nonvested shares
—
—
2
—
—
—
—
—
—
—
—
Payment of CEO payroll in shares
—
—
11
—
114
—
—
—
—
—
114
MiNK private placement stock sale
—
—
—
—
( 4,434
)
—
—
—
10,234
—
5,800
Exercise of stock options
—
—
2
—
28
—
—
—
6
—
34
Balance at June 30, 2024
32
$
0
21,126
$
211
$
1,830,114
—
$
—
$
( 1,001
)
$
20,472
$
( 2,070,635
)
$
( 220,839
)
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)
Series A-1
Convertible
Preferred Stock
Common Stock
Treasury Stock
Number of
Shares
Par
Value
Number of
Shares
Par
Value
Additional
Paid-In
Capital
Number
of Shares
Amount
Accumulated
Other
Comprehensive
Income (Loss)
Non-controlling
Interest
Accumulated
Deficit
Total
Balance at December 31, 2022
32
$
0
15,278
$
153
$
1,647,561
—
$
—
$
915
$
6,376
$
( 1,709,907
)
$
( 54,902
)
Net loss
—
—
—
—
—
—
—
—
( 2,639
)
( 68,254
)
( 70,893
)
Other comprehensive income
—
—
—
—
—
—
—
2
—
—
2
Share-based compensation
—
—
—
—
4,566
—
—
—
919
—
5,485
Shares sold at the market
—
—
1,689
17
60,566
—
—
—
—
—
60,583
Issuance of director deferred shares
—
—
13
1
982
—
—
—
—
—
983
Issuance of shares for services
—
—
7
—
318
—
—
—
—
—
318
Vesting of nonvested shares
—
—
—
—
—
—
—
—
—
—
—
Exercise of stock options and employee share purchases
—
—
10
—
329
—
—
—
45
—
374
Issuance of subsidiary shares for employee bonus
—
—
—
—
—
—
—
—
726
—
726
Issuance of shares for employee bonus
—
—
136
1
4,224
( 1
)
( 2,429
)
—
—
—
1,796
Retirement of treasury shares
—
—
( 50
)
( 1
)
( 9
)
1
2,429
—
—
—
2,419
Balance at March 31, 2023
32
$
0
17,083
$
171
$
1,718,537
—
$
—
$
917
$
5,427
$
( 1,778,161
)
$
( 53,109
)
Net loss
—
—
—
—
—
—
—
—
( 4,414
)
( 69,016
)
( 73,430
)
Other comprehensive loss
—
—
—
—
—
—
—
( 1,634
)
—
—
( 1,634
)
Share-based compensation
—
—
—
—
5,154
—
—
—
888
—
6,042
Shares sold at the market
—
—
1,227
12
42,235
—
—
—
—
—
42,247
Vesting of nonvested shares
—
—
—
—
—
—
—
—
—
—
—
MiNK stock dividend
—
—
—
—
( 14,888
)
—
—
—
14,888
—
—
MiNK stock purchases
—
—
—
—
405
—
—
—
( 640
)
—
( 235
)
Issuance of subsidiary shares for employee bonus
—
—
—
—
—
—
—
—
285
—
285
Issuance of shares for employee bonus
—
—
96
1
3,079
—
( 1,642
)
—
—
—
1,438
Retirement of treasury shares
—
—
( 33
)
—
( 7
)
—
1,642
—
—
—
1,635
Balance at June 30, 2023
32
$
0
18,373
$
184
$
1,754,515
—
$
—
$
( 717
)
$
16,434
$
( 1,847,177
)
$
( 76,761
)
See accompanying notes to unaudited condensed consolidated financial statements .
5
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED S TATEMENTS OF CASH FLOWS
(Unaudited)
(Amounts in thousands, except per share amounts)
Six Months Ended June 30,
2024
2023
Cash flows from operating activities:
Net loss
$
( 118,251
)
$
( 144,323
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
6,737
5,535
Share-based compensation
8,185
11,527
Non-cash royalty revenue
( 50,349
)
( 41,174
)
Non-cash interest expense
61,263
36,920
Loss on disposal of assets, net
9
49
Gain on lease terminations
( 5,475
)
—
Other, net
1,056
( 149
)
Changes in operating assets and liabilities:
Accounts receivable
25,121
1,021
Prepaid expenses
5,890
5,427
Accounts payable
( 8,718
)
7,969
Deferred revenue
( 9
)
( 4,439
)
Accrued liabilities and other current liabilities
( 386
)
8,135
Other operating assets and liabilities
( 1,444
)
( 5,067
)
Net cash used in operating activities
( 76,371
)
( 118,569
)
Cash flows from investing activities:
Purchases of plant and equipment
( 496
)
( 6,279
)
Proceeds from sale of plant and equipment
—
350
Purchase of long-term investment
—
( 5,396
)
Sale of long-term investment
488
—
Purchases of available-for-sale securities
—
( 14,647
)
Proceeds from sale of available-for-sale securities
—
15,000
Net cash provided by (used in) investing activities
( 8
)
( 10,972
)
Cash flows from financing activities:
Net proceeds from sale of equity
19,161
102,829
Net proceeds from sale of subsidiary shares in private placement
5,800
—
Proceeds from Ligand Purchase Agreement, net of expenses
73,851
—
Proceeds from employee stock purchases and option exercises
207
397
Purchase of treasury shares to satisfy tax withholdings
—
( 4,566
)
Purchase of subsidiary shares
—
( 236
)
Payment of finance lease obligation
( 5,106
)
( 3,911
)
Net cash provided by financing activities
93,913
94,513
Effect of exchange rate changes on cash
44
( 441
)
Net increase (decrease) in cash, cash equivalents and restricted cash
17,578
( 35,469
)
Cash, cash equivalents and restricted cash, beginning of period
79,779
181,343
Cash, cash equivalents and restricted cash, end of period
$
97,357
$
145,874
Supplemental cash flow information:
Cash paid for interest
$
1,193
$
1,705
Supplemental disclosures - non-cash activities:
Purchases of plant and equipment in accounts payable and
accrued liabilities
$
—
$
4,762
Issuance of common stock, $ 0.01 par value, in connection with payment for services
—
318
Insurance financing agreement
612
707
Issuance of stock options for payment of certain employee bonuses
4,966
—
Issuance of common stock, $ 0.01 par value, for payment of certain employee bonuses
—
7,288
Issuance of subsidiary stock options for payment of certain employee bonuses
540
—
Issuance of subsidiary shares for certain employee bonuses
—
1,011
Lease right-of-use assets obtained in exchange for new operating lease liabilities
105
287
Lease right-of-use assets obtained in exchange for new finance lease liabilities
122
4,635
6
See accompanying notes to unaudited condensed consolidated financial statements.
7
AGENUS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CO NSOLIDATED FINANCIAL STATEMENTS
June 30, 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:
• Multiple antibody discovery platforms, including proprietary display technologies, to identify future antibody candidates.
• Antibody candidate programs, including our lead assets, botensilimab (a multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody, also known as AGEN1811) and balstilimab (a programmed death receptor-1 (PD-1) blocking antibody).
• Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpcQS-21”).
• A pipeline of novel allogeneic invariant natural killer T cell therapies for treating cancer and other immune-mediated diseases, controlled by MiNK.
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 June 30, 2024 were $ 93.7 million, an increase of $ 17.6 million from December 31, 2023 . Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2024, were $ 5.8 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.
As of June 30, 2024, we had an accumulated deficit of $ 2.1 billion and $ 13.0 million of subordinated notes maturing in February 2025 . 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 $ 93.7 million at June 30, 2024, plus additional funding we may receive from multiple other sources, including out-licensing and/or partnering opportunities, will be sufficient to satisfy our liquidity requirements through the end of the year and into 2025. We are also in discussions with other parties to participate in the Purchase and Sale Agreement (see Note F) for up to an additional $ 125.0 million under the same terms as the Ligand transaction. In addition, we are 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 out-licensing and/or partnering opportunities for our portfolio programs
8
and product candidates with multiple parties; additional third-party agreements; asset sales; further royalty monetization; project financing, and/or sales of equity securities.
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 six months ended June 30, 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 $ 0.01 , at a ratio of 1-for-20 with a record date of April 12, 2024 (the “Reverse Stock Split”). 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. See Note L for further details.
In the quarters ended June 30, 2024 and 2023, we deconsolidated certain foreign subsidiaries and recognized gains of approximately $ 185,000 and $ 132,000 , respectively, included in "Other income (expense)" on our condensed consolidated statements of operations and comprehensive loss.
Note B – Net Loss Per Share
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. The following securities (listed on an as-if-converted-to-Common-Stock basis) have been excluded from the computation of diluted weighted average shares outstanding as of June 30, 2024 and 2023, as they would be anti-dilutive (in thousands):
Three and Six Months Ended June 30,
2024
2023
Warrants
965
99
Stock options
3,367
2,220
Non-vested shares
38
27
Series A-1 convertible preferred stock
17
17
9
Note C – Investments
Cash equivalents and short-term investments consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):
June 30, 2024
December 31, 2023
Cost
Estimated
Fair Value
Cost
Estimated
Fair Value
Institutional money market funds
$
92,243
$
92,243
$
70,485
$
70,485
Total
$
92,243
$
92,243
$
70,485
$
70,485
As a result of the short-term nature of these investments, there were minimal unrealized holding gains or losses for the three and six months ended June 30, 2024 and 2023.
As of both June 30, 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 six months ended June 30, 2024 (in thousands):
Balance, December 31, 2023
$
24,723
Effect of foreign currency
25
Balance, June 30, 2024
$
24,748
Acquired intangible assets consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):
As of June 30, 2024
Amortization
period
(years)
Gross carrying
amount
Accumulated
amortization
Net carrying
amount
Intellectual property
7 - 15 years
$
16,841
$
( 15,354
)
$
1,487
Trademarks
4 - 4.5 years
1,226
( 1,226
)
—
Other
2 - 7 years
2,044
( 1,452
)
592
In-process research and development
Indefinite
2,057
—
2,057
Total
$
22,168
$
( 18,032
)
$
4,136
As of December 31, 2023
Amortization
period
(years)
Gross carrying
amount
Accumulated
amortization
Net carrying
amount
Intellectual property
7 - 15 years
$
16,841
$
( 15,184
)
$
1,657
Trademarks
4 - 4.5 years
1,213
( 1,185
)
28
Other
2 - 7 years
1,988
( 1,319
)
669
In-process research and development
Indefinite
2,057
—
2,057
Total
$
22,099
$
( 17,688
)
$
4,411
The weighted average amortization period of our finite-lived intangible assets is 9 years. Amortization expense related to acquired intangibles is estimated at $ 0.3 million for the remainder of 2024, $ 0.5 million for the years ending December 31, 2025 and 2026, $ 0.4 million for the year ending December 31, 2027 and $ 0.3 million for the year ending December 31, 2028.
10
Note E – Debt
Debt obligations consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):
Debt instrument
Balance at
June 30,
2024
Current Portion:
Debentures
$
146
2015 Subordinated Notes
12,866
Other
413
Total
$
13,425
Debt instrument
Balance at
December 31,
2023
Current Portion:
Debentures
$
146
Long-term Portion:
2015 Subordinated Notes
12,768
Total
$
12,914
As of June 30, 2024 and December 31, 2023, the principal amount of our outstanding debt balance was $ 13.6 million and $ 13.1 million, respectively.
Note F – Liability Related to the Sale of Future Royalties and Milestones
The following table shows the activity within the liability account in the six months ended June 30, 2024 (in thousands):
Period from
December 31, 2023 to
June 30, 2024
Liability related to sale of future royalties and milestones - beginning balance
$
257,296
Proceeds from sale of future royalties and milestones
63,879
Non-cash royalty revenue
( 50,349
)
Non-cash interest expense recognized
61,134
Liability related to sale of future royalties and milestones - ending balance
331,960
Less: unamortized transaction costs
( 1,242
)
Liability related to sale of future royalties and milestones, net
$
330,718
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 100 % of Antigenics’ worldwide rights to receive royalties from GlaxoSmithKline (“GSK”) on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant. At closing, we received gross proceeds of $ 190.0 million from HCR. Although we sold all of our rights to receive royalties on sales of GSK’s vaccines containing QS-21, as a result of our obligation to HCR, we are required to account for the $ 190.0 million in proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be recognized into revenue in proportion to the royalty payments from GSK to HCR over the estimated life of the HCR Royalty Purchase Agreement. The liability is classified between the current and non-current portion of liability related to sale of future royalties and milestones in the condensed consolidated balance sheets based on the estimated royalty payments to be received by HCR in the next 12 months from the financial statement reporting date.
During the six months ended June 30, 2024 , we recognized $ 50.3 million of non-cash royalty revenue, and we recorded $ 59.6 million of related non-cash interest expense related to the HCR Royalty Purchase Agreement.
11
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 amount of future royalty payments to be received by HCR. The sum of these amounts less the $ 190.0 million proceeds we received will be recorded as interest expense over the life of the HCR Royalty Purchase Agreement. Periodically, we assess the estimated royalty payments to be paid to HCR from GSK, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability, and the related recognition of interest expense. During the six months ended June 30, 2024 , our estimate of the effective annual interest rate over the life of the agreement decreased to 48.6 %, which results in a life of contract interest rate of 26.6 %.
Ligand Pharmaceuticals
In May 2024, we and certain wholly-owned subsidiaries, entered into a Purchase and Sale agreement (the "Ligand Purchase Agreement") with Ligand Pharmaceuticals Incorporated ("Ligand"). Pursuant to the terms of the Ligand Purchase Agreement, Ligand will receive (i) 31.875 % of the development, regulatory and commercial milestone payments we were then eligible to receive under our agreements with Bristol-Myers Squibb Company ("BMS"), UroGen Pharma Ltd., Gilead Sciences, Inc. ("Gilead"), Merck Sharpe & Dohme and Incyte Corporation ("Incyte"), (the “Covered License Agreements”) (ii) 18.75 % of the royalties the Company receives under the Covered License Agreements; and (iii) a 2.625 % synthetic royalty on worldwide net sales of botensilimab and balstilimab (collectively the “Purchased Assets”).
The total amounts payable to Ligand are subject to a 50 % reduction in the event total payments to Ligand exceed a specified return hurdle. The synthetic royalty is subject to a reduction if annual worldwide net sales exceed a specified level, and a cap on annual worldwide net sales if annual worldwide net sales exceed a higher specified level. The synthetic royalty can increase by 1 % based on the occurrence of certain future events.
In consideration for the sale of the Purchased Assets, we received gross proceeds of $ 75.0 million, less $ 0.9 million in reimbursable expenses, on the closing date. In addition, Ligand has a time-based option to invest an additional $ 25.0 million on a pro rata basis ("Purchaser Upsize Option").
In connection with the sale of the Purchased Assets, we issued to Ligand a warrant (the "Ligand Warrant") to purchase 867,052 shares of our common stock, at an exercise price equal to $ 17.30 per share. See Note L - Equity for further detail.
The $ 75.0 million in gross proceeds was allocated to the identified components as follows:
June 30, 2024
Liability related to sale of future royalties and milestones
$
63,879
Ligand Warrant
7,098
Purchaser Upsize Option
4,023
Total Ligand Purchase Agreement gross proceeds
$
75,000
As a result of our significant continuing involvement in the generation of the cash flows of the Purchased Assets, we are required to account for $ 63.9 million of the proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be recognized into revenue in proportion to the royalty and milestone payments paid to Ligand over the estimated life of the Ligand Purchase Agreement.
The Purchaser Upsize Option is considered a freestanding financial instrument as it is separately exercisable and can be legally transferred from the Ligand Purchase Agreement. As such, it is accounted for as a written option which is accounted for as a liability at fair value and remeasured at each balance sheet date with changes in fair value recorded in earnings.
The Ligand Warrant is considered a freestanding financial instrument that as it is separately exercisable and can be legally transferred from the Ligand Purchase Agreement was determined to be equity-classified under ASC 815.
To allocate the proceeds, the Purchaser Upsize Option liability and equity-classified Ligand Warrants were recognized based on their fair values and the residual was allocated to a liability related to the sale of future royalties and milestones on our condensed consolidated balance sheets.
During the three and six months ended June 30, 2024, we recorded $ 1.6 million of non-cash interest expense related to the Ligand Purchase Agreement.
As royalties are remitted to us and milestone and sales are earned from the Purchased Assets, the balance of the recorded liability will be effectively repaid over the life of the Ligand Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future payments to be received under the Ligand Purchase Agreement. The sum of these amounts less the $ 63.9 million proceeds allocated to the liability related to sale of future royalties and milestones will be recorded as interest expense over the life of the Ligand Purchase Agreement. Periodically, we assess the estimated royalty and milestone payments to be received and sales to be earned under the Ligand Purchase Agreement, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability,
12
and the related recognition of interest expense. As of June 30, 2024, our estimate of the effective annual interest rate over the life of the agreement was 27.9 %.
Note G – Accrued and Other Current Liabilities
Accrued liabilities consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):
June 30, 2024
December 31, 2023
Payroll
$
12,685
$
14,512
Professional fees
5,818
7,101
Contract manufacturing costs
7,595
7,613
Research services
8,037
10,807
Other
7,073
5,250
Total
$
41,208
$
45,283
Other current liabilities consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):
June 30, 2024
December 31, 2023
Finance lease liabilities
$
9,367
$
10,457
Other
6,969
3,458
Total
$
16,336
$
13,915
Note H – Fair Value Measurements
Assets and liabilities measured at fair value are summarized below (in thousands):
Description
June 30, 2024
Quoted Prices in
Active
Markets for
Identical Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Assets:
Cash equivalents (Note C)
$
92,243
$
92,243
$
—
$
—
Long-term investments
1,493
1,493
—
—
Total
$
93,736
$
93,736
$
—
$
—
Liabilities:
Ligand purchaser upsize option (Note F)
$
4,023
$
—
$
—
$
4,023
Contingent purchase price considerations
318
—
—
318
Total
$
4,341
$
—
$
—
$
4,341
Description
December 31, 2023
Quoted Prices in
Active
Markets for
Identical Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Assets:
Cash equivalents (Note C)
$
70,485
$
70,485
$
—
$
—
Long-term investments
3,222
3,222
—
—
Total
$
73,707
$
73,707
$
—
$
—
Liabilities:
Contingent purchase price consideration
$
318
$
—
$
—
$
318
Total
$
318
$
—
$
—
$
318
Long-term investments are included in "Other long-term assets" in our condensed consolidated balance sheets.
We are required to measure the Purchaser Upsize Option issued under the Ligand Purchase Agreement at fair value. The fair value of the Purchaser Upsize Option at June 30, 2024 included in "Other current liabilities" in our condensed consolidated balance sheets, is based on significant inputs not observable in the market, which require it to be reported as a Level 3 liability within the fair
13
value hierarchy. The valuation of this liability is determined based on a scenario analysis and uses assumptions we believe would be made by a market participant.
We measure our contingent purchase price considerations at fair value. The fair values of our contingent purchase price considerations at both June 30, 2024 and December 31, 2023, of $ 0.3 million, included in "Other long-term liabilities" in our condensed consolidated balance sheets, are based on significant inputs not observable in the market, which require them to be reported as Level 3 liabilities within the fair value hierarchy. The valuation of these liabilities use assumptions we believe would be made by a market participant and are mainly based on estimates from a Monte Carlo simulation of our share price, as well as other factors impacting the probability of triggering the milestone payments. Share price was evolved using a geometric Brownian motion, calculated daily for the life of the contingent purchase price considerations.
The fair value of our outstanding debt balance at June 30, 2024 and December 31, 2023 was $ 13.4 million and $ 13.0 million, respectively, based on the Level 2 valuation hierarchy of the fair value measurements standard using a present value methodology that was derived by evaluating the nature and terms of each note and considering the prevailing economic and market conditions at the balance sheet date. The principal amount of our outstanding debt balance at June 30, 2024 and December 31, 2023 was $ 13.6 million and $ 13.1 million, respectively.
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 $ 120.0 million and Gilead made a $ 30.0 million equity investment in Agenus. On November 6, 2020, we received notice from Gilead that it was returning AGEN1423 to us and voluntarily terminating the applicable license agreement. The termination was effective as of February 4, 2021. In the third quarter of 2021 we ceased development of AGEN1223 and in October 2021 the AGEN1223 option and license agreement was formally terminated. The AGEN2373 option and license agreement and the stock purchase agreement remain in full force and effect. As of June 30, 2024, we remained eligible to receive a $ 50.0 million exercise fee and, if exercised, up to $ 520.0 million in aggregate potential milestones. On August 5, 2024, Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated, see Note P.
Collaboration Revenue
No revenue was recognized for the three and six months ended June 30, 2024. For the three and six months ended June 30, 2023, we recognized approximately $ 2.0 million and $ 4.4 million, respectively, of research and development revenue based on the partial satisfaction of the over time performance obligations as of quarter end.
Disaggregation of Revenue
The following table presents revenue (in thousands) for the three and six months ended June 30, 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.
14
Three months ended June 30, 2024
United States
Rest of World
Total
Revenue Type
Clinical product revenue
$
267
$
—
$
267
Other services
—
660
660
Non-cash royalties
22,582
—
22,582
$
22,849
$
660
$
23,509
Three months ended June 30, 2023
Revenue Type
Research and development services
$
444
$
—
$
444
Other services
—
739
739
Recognition of deferred revenue
2,045
—
2,045
Non-cash royalties
22,068
—
22,068
$
24,557
$
739
$
25,296
Six months ended June 30, 2024
United States
Rest of World
Total
Revenue Type
Clinical product revenue
$
267
$
—
$
267
Other services
—
898
898
Non-cash royalties
50,349
—
50,349
$
50,616
$
898
$
51,514
Six months ended June 30, 2023
Revenue Type
Research and development services
$
711
$
—
$
711
Other services
—
1,923
1,923
Recognition of deferred revenue
4,390
—
4,390
Non-cash royalties
41,174
—
41,174
$
46,275
$
1,923
$
48,198
Contract Balances
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 no asset impairment charges related to contract assets in the period. 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 for research and development services or licenses bundled with other promises is a contract liability until the underlying performance obligations are transferred to the customer.
The following table provides information about contract liabilities from contracts with customers (in thousands):
Six months ended June 30, 2024
Balance at beginning of period
Additions
Deductions
Balance at end of period
Contract liabilities:
Deferred revenue
$
1,161
$
5
$
( 14
)
$
1,152
During the six months ended June 30, 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. No ne of the costs to obtain or fulfill a contract were capitalized.
15
Note J – Share-based Compensation Plans
In June 2024, our stockholders approved an amendment to our Amended and Restated 2019 Equity Incentive Plan (the "2019 EIP") that increased the maximum number of shares of our common stock available for issuance under our 2019 EIP by 3.0 million shares.
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 10-year terms and generally vest ratably over a 3 or 4 -year period.
A summary of option activity for the six months ended June 30, 2024 is presented below:
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic
Value
Outstanding at December 31, 2023
2,141,360
$
65.00
Granted
1,344,896
12.87
Exercised
( 2,204
)
12.26
Forfeited
( 18,392
)
47.60
Expired
( 98,369
)
63.39
Outstanding at June 30, 2024
3,367,291
$
44.17
7.49
$
5,572,918
Vested or expected to vest at June 30, 2024
3,367,291
$
44.17
7.49
$
5,572,918
Exercisable at June 30, 2024
2,022,962
$
57.29
6.49
$
1,832,720
The weighted average grant-date fair values of stock options granted during the six months ended June 30, 2024 and 2023 were $ 11.53 and $ 29.80 , respectively.
During the six months ended June 30, 2024, all options were granted with exercise prices equal to the market value of the underlying shares of common stock on the grant date other than certain awards dated January 16, 2024 and January 17, 2024. In January 2024, our Board of Directors approved certain awards subject to forfeiture in the event stockholder approval was not obtained for an amendment to our 2019 EIP. This approval was obtained in June 2024. Accordingly, these awards have a grant date of June 2024, with an exercise price as of the date the Board of Director's approved the awards in January 2024.
As of June 30, 2024 , there was approximately $ 24.7 million of total unrecognized share-based compensation expense related to these stock options and stock options granted under subsidiary plans which, if all milestones are achieved, will be recognized over a weighted average period of 1.5 years.
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.
A summary of non-vested stock activity for the six months ended June 30, 2024 is presented below:
Non-vested
Shares
Weighted
Average
Grant Date
Fair Value
Outstanding at December 31, 2023
27,163
$
37.20
Granted
24,906
14.38
Vested
( 10,154
)
31.17
Forfeited
( 4,000
)
41.72
Outstanding at June 30, 2024
37,915
$
23.35
As of June 30, 2024 , there was approximately $ 1.4 million of unrecognized share-based compensation expense related to these non-vested shares and non-vested shares granted under subsidiary plans which will be recognized over a period of 3.3 years.
16
During the six months ended June 30, 2024 , 11,816 shares were issued under the 2019 Employee Stock Purchase Plan, 10,152 shares were issued as a result of the vesting of non-vested stock and 2,204 shares were issued as a result of stock option exercises.
The impact on our results of operations from share-based compensation for the three and six months ended June 30, 2024 and 2023, was as follows (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Research and development
$
4,722
$
1,656
$
6,036
$
3,389
General and administrative
4,568
4,386
7,450
8,138
Total share-based compensation expense
$
9,290
$
6,042
$
13,486
$
11,527
Note K – Restricted Cash
As of June 30, 2024, and December 31, 2023 , we maintained non-current restricted cash of $ 3.6 million and $ 3.7 million, respectively. This amount is included within “Other long-term assets” in our condensed consolidated balance sheets and is comprised of deposits under letters of credit required under our facility leases.
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):
Six Months Ended June 30, 2024
Six Months Ended June 30, 2023
Beginning of Period
End of Period
Beginning of Period
End of Period
Cash and cash equivalents
$
76,110
$
93,723
$
178,674
$
143,205
Restricted cash
3,669
3,634
2,669
2,669
Cash, cash equivalents and restricted cash
$
79,779
$
97,357
$
181,343
$
145,874
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 $ 300.0 million of common stock, preferred stock, warrants, debt securities and units of Agenus and a prospectus supplement for the potential offer and sale of up to 6,725,642 shares of common stock (the “Placement Shares”) in “at the market” offerings pursuant to an At Market Issuance Sales Agreement by and between Agenus and B. Riley Securities, Inc. (the “Sales Agent”), dated as of July 22, 2020 (the “Sales Agreement”). Sales pursuant to the Sales Agreement will be made only upon our instruction to the Sales Agent, and we cannot provide assurances that we will issue any additional Placement Shares pursuant to the Sales Agreement.
During the three and six months ended June 30, 2024 , we received net proceeds of approximately $ 2.0 million and $ 19.2 million, from the sale of approximately 117,000 and 1.4 million shares of our common stock, respectively, in at-the-market offerings under the Sales Agreement.
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 1-for-20 (the “Reverse Stock Split”). On April 4, 2024, we filed a Certificate of Eighth Amendment (the “Certificate of Amendment”) to our Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the Reverse Stock Split. Pursuant to the Certificate of Amendment, the Reverse Stock Split became effective at 12:01 a.m., Eastern Time, on April 12, 2024. As of the opening of trading on April 12, 2024, our common stock began trading on a post-split basis under CUSIP number 00847G 804.
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.
In connection with the Purchase Agreement described in Note F, on May 6, 2024, we issued to Ligand a warrant to purchase 867,052 shares of our common stock, at an exercise price equal to $ 17.30 per share . The exercise price of the Ligand Warrant and the
17
number of shares issuable upon exercise of the Ligand Warrant are subject to adjustments for stock splits, combinations, stock dividends or similar events. The Ligand Warrant is exercisable until May 6, 2029 .
Note M – Non-controlling Interest
Non-controlling interest recorded in our condensed consolidated financial statements as of June 30, 2024 and December 31, 2023, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.
June 30, 2024
December 31, 2023
MiNK Therapeutics, Inc.
45
%
37
%
SaponiQx, Inc.
30
%
30
%
Changes in non-controlling interest for the periods ended June 30, 2024 and December 31, 2023, were as follows (in thousands):
June 30, 2024
December 31, 2023
Beginning balance
$
11,949
$
6,376
Net loss attributable to non-controlling interest
( 3,284
)
( 11,676
)
Other items:
Sale of subsidiary shares in private placement
10,234
—
Distribution of subsidiary shares to Agenus stockholders
—
14,888
Purchase of subsidiary shares
—
( 2,546
)
Issuance of subsidiary shares for employee bonus
—
1,011
Issuance of subsidiary shares for employee stock purchase plan and exercise of options
13
71
Subsidiary share-based compensation
1,560
3,825
Total other items
11,807
17,249
Ending balance
$
20,472
$
11,949
Sale of subsidiary shares in private placement
On May 13, 2024, MiNK entered into a Stock Purchase Agreement with a certain investor (the “Purchaser”), pursuant to which MiNK issued and sold an aggregate of 4,640,000 shares of its Common Stock (the “MiNK Common Shares”), at a purchase price of $ 1.25 per share. The aggregate purchase price paid by the Purchaser for the MiNK Common Shares was approximately $ 5.8 million, net of offering expenses. The transaction closed on May 14, 2024.
Distribution of subsidiary shares to Agenus stockholders
On March 29, 2023 , our Board of Directors declared a stock dividend (the "Dividend") consisting of an aggregate of 5.0 million shares (the "Dividend Stock") of common stock, par value $ 0.00001 per share, of MiNK held by Agenus to record holders of Agenus' common stock, par value $ 0.01 per share as of the close of business on April 17, 2023 (the "Record Date").
On May 1, 2023 , we paid the Dividend and distributed 0.292 of a share of the Dividend Stock for each share of Agenus common stock outstanding as of the close of business on the Record Date. No fractional shares were issued in connection with the Dividend and the shareholders of Agenus who were entitled to receive fractional shares of the Dividend Stock received cash (without interest) in lieu of such fractional shares. Subsequent to the distribution of the Dividend Stock, we maintained a controlling voting interest in MiNK.
Purchase of subsidiary shares
During the year ended December 31, 2023, we purchased 446,494 shares of MiNK common stock in multiple open market transactions.
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 $ 450,000 of clinical consulting services. Allison Jeynes, a former member of our Board of Directors, is
18
chief executive officer of Avillion. No expenses were incurred in the three and six months ended June 30, 2024. For the three and six months ended June 30, 2023, approximately $ 222,000 and $ 450,000 , respectively, related to these services is included in “Research and development” expense in our condensed consolidated statements of operations.
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 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 six months ended June 30, 2024 had or is expected to have a material impact on our consolidated financial statements or disclosures.
Note P – Subsequent Events
At the Market Offerings
During the period of July 1, 2024 through August 5, 2024, we sold approximately 405,000 shares of our common stock under the Sales Agreement, totaling net proceeds of approximately $ 6.2 million.
BMS License Agreement Termination
In May 2021, we entered into a License, Development and Commercialization Agreement with BMS (the “BMS License Agreement”) pursuant to which we granted BMS an exclusive license to develop, manufacture and commercialize our proprietary TIGIT bispecific antibody program AGEN1777. Pursuant to the BMS License Agreement, we received a non-refundable upfront cash payment of $ 200.0 million.
On July 30, 2024 we received notice from BMS that it is returning AGEN1777 back to Agenus and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.
Under the terms of the BMS License Agreement, BMS has granted us, effective as of January 26, 2025 an exclusive, royalty-free and fully paid-up, worldwide, and sublicensable license to BMS’ know-how and patent rights that arose from activities performed under the BMS License Agreement to develop and manufacture AGEN1777. Additionally, BMS will assign to us all regulatory registrations, applications, authorizations, and approvals that BMS holds in connection with AGEN1777. We will not incur any early termination penalties as a result of the termination.
Incyte Collaboration Agreement
In January 2015, we entered into a collaboration with Incyte to discover, develop and commercialize novel immuno-therapeutics using our antibody platforms. The collaboration was initially focused on four immunotherapy programs targeting GITR, OX40, TIM-3 and LAG-3, and in November 2015, we expanded the alliance by adding three novel undisclosed immunotherapy targets. Pursuant to the terms of the original agreement, Incyte paid us $ 25.0 million in upfront cash. Targets under the collaboration were designated as either profit-share programs, where the parties shared all costs and profits equally, or royalty-bearing programs, where Incyte funded all costs, and we were eligible to receive milestones and royalties. Under the original collaboration agreement, programs targeting GITR, OX40 and two of the undisclosed targets were designated as profit-share programs, while the other targets were royalty-bearing programs. For each profit-share product, we were eligible to receive up to $ 20.0 million in future contingent development milestones. For each royalty-bearing product, we were eligible to receive (i) up to $ 155.0 million in future contingent development, regulatory, and commercialization milestones and (ii) tiered royalties on global net sales at rates generally ranging from 6 %- 12 %. In February 2017, we and Incyte amended the terms of the original collaboration agreement to, among other things, convert the GITR and OX40 programs from profit-share to royalty-bearing programs with royalties on global net sales at a flat 15 % rate for each. In addition, the profit-share programs relating to two undisclosed targets were removed from the collaboration, with one reverting to Incyte and one to
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Agenus (the latter being our Fc enhanced TIGIT program), each with royalties on global net sales at a flat 15 % rate. The remaining three royalty-bearing programs in the collaboration targeting TIM-3, LAG-3 and one undisclosed target remain unchanged, and there are no more profit-share programs under the collaboration. Pursuant to the amended agreement, we received accelerated milestone payments of $ 20.0 million from Incyte related to the clinical development of INCAGN1876 (GITR agonist) and INCAGN1949 (OX40 agonist). Incyte terminated the OX40 program, effective October 2023, and terminated both the GITR program and undisclosed program, effective May 2024. Upon termination, the rights to the OX40, GITR, and undisclosed programs reverted back to us.
On July 30, 2024, Incyte announced that it would discontinue further development of the LAG-3 and TIM-3 monoclonal antibodies.
Gilead Option and License Agreement Termination
In December 2018, we entered into a series of agreements with Gilead to collaborate on the development and commercialization of up to five novel I-O therapies. Pursuant to the collaboration agreements, Gilead received (i) worldwide exclusive rights to AGEN1423, a bispecific antibody, (ii) the exclusive option to license exclusively AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody, and (iii) the right of first negotiation for two additional, undisclosed programs. Gilead had the exclusive right to develop and commercialize AGEN1423, and we were eligible to receive potential development and commercial milestones of up to $ 552.5 million in the aggregate. In November 2020, Gilead elected to return AGEN1423 to us and voluntarily terminated the license agreement effective as of February 4, 2021. In October of 2021, Gilead elected to terminate the option to license AGEN1223.
On August 5, 2024 Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.