UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2023
or
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 000-29089
Agenus Inc.
(exact name of registrant as specified in its charter)
Delaware
06-1562417
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
3 Forbes Road, Lexington, Massachusetts 02421
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code:
(781) 674-4400
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
Common stock, par value $0.01
AGEN
The Nasdaq Capital Market
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. Yes ☒ No ☐
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). Yes ☒ No ☐
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
☐
Accelerated filer
☒
Non-accelerated filer
Smaller reporting company
Emerging growth company
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 November 3, 2023: 381,495,471 shares.
Nine Months Ended September 30, 2023
Table of Contents
Page
PART I
ITEM 1.
Financial Statements:
2
Condensed Consolidated Balance Sheets as of September 30, 2023 (Unaudited) and December 31, 2022
Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2023 and 2022 (Unaudited)
3
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2023 and 2022 (Unaudited)
4
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022 (Unaudited)
6
Notes to Unaudited Condensed Consolidated Financial Statements
7
ITEM 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations
18
ITEM 3.
Quantitative and Qualitative Disclosures About Market Risk
24
ITEM 4.
Controls and Procedures
PART II
Legal Proceedings
26
ITEM 1A.
Risk Factors
ITEM 5.
Other Information
27
ITEM 6.
Exhibits
Signatures
28
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)
September 30, 2023(unaudited)
December 31, 2022
ASSETS
Cash and cash equivalents
$
106,305
178,674
Short-term investments
—
14,684
Accounts receivable
1,030
2,741
Prepaid expenses
15,886
13,829
Other current assets
2,329
3,194
Total current assets
125,550
213,122
Property, plant and equipment, net of accumulated amortization and depreciation of $60,750 and $54,075 at September 30, 2023 and December 31, 2022, respectively
139,679
133,017
Operating lease right-of-use assets
30,018
31,269
Goodwill
24,666
25,467
Acquired intangible assets, net of accumulated amortization of $17,444 and $16,148 at September 30, 2023 and December 31, 2022, respectively
4,497
6,228
Other long-term assets
11,062
4,453
Total assets
335,472
413,556
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current portion, long-term debt
387
575
Current portion, liability related to sale of future royalties and milestones
98,500
83,510
Current portion, deferred revenue
4,994
12,269
Current portion, operating lease liabilities
2,559
1,943
Accounts payable
40,871
40,939
Accrued liabilities
37,629
38,259
Other current liabilities
13,416
11,457
Total current liabilities
198,356
188,952
Long-term debt, net of current portion
12,720
12,584
Liability related to sale of future royalties and milestones, net of current portion
167,070
187,753
Deferred revenue, net of current portion
1,143
Operating lease liabilities, net of current portion
63,166
63,326
Other long-term liabilities
8,309
14,700
Commitments and contingencies
STOCKHOLDERS’ DEFICIT
Series A-1 convertible preferred stock; 31,620 shares designated, issued, and outstanding at September 30, 2023 and December 31, 2022; liquidation value of $33,833 at September 30, 2023
0
Common stock, par value $0.01 per share; 800,000,000 shares authorized; 381,381,803 and 305,573,397 shares issued at September 30, 2023 and December 31, 2022, respectively
3,814
3,056
Additional paid-in capital
1,777,480
1,644,658
Accumulated other comprehensive income (loss)
(1,028
)
915
Accumulated deficit
(1,909,378
(1,709,907
Total stockholders’ deficit attributable to Agenus Inc.
(129,112
(61,278
Non-controlling interest
13,820
6,376
Total stockholders’ deficit
(115,292
(54,902
Total liabilities and stockholders’ deficit
See accompanying notes to unaudited condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in thousands, except per share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
Revenue:
Research and development
3,414
4,573
8,515
13,220
Royalty sales milestone
7,934
25,250
Service revenue
540
1,041
2,464
4,167
Non-cash royalty revenue related to the sale of future royalties
20,360
9,224
61,534
27,001
Total revenues
24,314
22,772
72,513
69,638
Operating expenses:
Cost of service revenue
(303
(308
(2,851
(2,875
(51,443
(46,011
(167,846
(133,412
General and administrative
(18,909
(18,105
(57,562
(55,971
Contingent purchase price consideration fair value adjustment
398
950
Operating loss
(46,341
(41,645
(155,348
(121,670
Other income (expense):
Non-operating income
442
537
238
9,654
Interest expense, net
(18,633
(15,607
(53,745
(44,538
Net loss
(64,532
(56,715
(208,855
(156,554
Dividends on Series A-1 convertible preferred stock
(53
(160
(159
Less: net loss attributable to non-controlling interest
(2,331
(2,493
(9,384
(7,573
Net loss attributable to Agenus Inc. common stockholders
(62,254
(54,275
(199,631
(149,140
Per common share data:
Basic and diluted net loss attributable to Agenus Inc. common stockholders
(0.16
(0.19
(0.57
(0.54
Weighted average number of Agenus Inc. common shares outstanding:
Basic and diluted
378,152
286,854
349,167
274,170
Other comprehensive loss:
Foreign currency translation loss
(311
(1,505
(1,943
(848
Other comprehensive loss
Comprehensive loss
(62,565
(55,780
(201,574
(149,988
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(Amounts in thousands)
Series A-1
Convertible
Preferred Stock
Common Stock
Treasury Stock
Number ofShares
ParValue
AdditionalPaid-InCapital
Numberof Shares
Amount
AccumulatedOtherComprehensiveIncome (Loss)
Non-controllingInterest
AccumulatedDeficit
Total
Balance at December 31, 2022
32
305,574
(2,639
(68,254
(70,893
Other comprehensive income
Share-based compensation
4,566
919
5,485
Shares sold at the market
33,785
338
60,245
60,583
Issuance of director deferred shares
250
980
983
Issuance of shares for services
132
1
317
318
Vesting of nonvested shares
5
Exercise of stock options and employee share purchases
197
327
45
374
Issuance of subsidiary shares for employee bonus
726
Issuance of shares for employee bonus
2,716
4,198
(10
(2,429
1,796
Retirement of treasury shares
(996
10
2,429
2,419
Balance at March 31, 2023
341,663
3,417
1,715,291
917
5,427
(1,778,161
(53,109
(4,414
(69,016
(73,430
(1,634
5,154
888
6,042
24,557
246
42,001
42,247
17
MiNK stock dividend
(14,888
14,888
MiNK stock purchases
405
(640
(235
285
1,928
19
3,061
(7
(1,642
1,438
(673
1,642
1,635
Balance at June 30, 2023
367,492
3,675
1,751,024
(717
16,434
(1,847,177
(76,761
(62,201
4,601
935
5,536
13,304
133
20,217
20,350
Payment of CEO payroll in shares
893
(1,221
(328
198
310
312
63
(1
Employee share purchases
299
404
410
Balance at September 30, 2023
381,383
Balance at December 31, 2021
256,899
2,569
1,520,212
1,492
13,469
(1,489,833
47,909
(2,279
(48,325
(50,604
(522
4,205
742
4,947
7,039
70
19,112
19,182
21
80
81
143
136
367
368
3,845
38
6,245
(1,347
(3,380
2,903
(13
1,347
3,380
3,367
Balance at March 31, 2022
266,741
2,667
1,550,239
970
11,932
(1,538,158
27,650
(2,801
(46,434
(49,235
1,179
3,818
797
4,615
15,782
158
28,079
28,237
Issuance of shares for milestone achievement
180
498
500
20
Exercise of stock options
14
294
363
(100
(251
114
100
251
Balance at June 30, 2022
282,862
2,829
1,583,030
2,149
10,222
(1,584,592
13,638
(54,222
3,614
820
4,434
11,753
117
27,713
27,830
67
259
460
463
Balance at September 30, 2022
294,951
2,949
1,614,836
644
8,549
(1,638,814
(11,836
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
8,387
5,057
17,408
14,078
Non-cash royalty revenue
(61,534
(27,001
Non-cash interest expense
55,977
44,629
Loss (gain) on sale of assets
49
(6,601
Gain on partial forgiveness of liability
(2,791
Change in fair value of contingent obligations
(398
(950
Other, net
581
Changes in operating assets and liabilities:
1,308
(7,079
(1,765
3,659
1,339
Deferred revenue
(7,269
(7,855
Accrued liabilities and other current liabilities
12,518
(2,524
Other operating assets and liabilities
(1,122
14,558
Net cash used in operating activities
(183,800
(128,035
Cash flows from investing activities:
Purchases of plant and equipment
(9,731
(38,716
Proceeds from sale of property, plant and equipment
350
10,002
Purchase of long-term investment
(5,396
Cash paid for business acquisition
(3,652
Purchases of available-for-sale securities
(14,647
(14,861
Proceeds from sale of available-for-sale securities
30,000
20,000
Net cash provided by (used in) investing activities
576
(27,227
Cash flows from financing activities:
Net proceeds from sale of equity
123,179
75,249
Proceeds from employee stock purchases and option exercises
807
845
Purchase of treasury shares to satisfy tax withholdings
(4,566
(3,789
Purchase of subsidiary shares
(564
Payment of finance lease obligation
(6,305
(248
Net cash provided by financing activities
112,551
72,057
Effect of exchange rate changes on cash
(696
(372
Net decrease in cash, cash equivalents and restricted cash
(71,369
(83,577
Cash, cash equivalents and restricted cash, beginning of period
181,343
294,600
Cash, cash equivalents and restricted cash, end of period
109,974
211,023
Supplemental cash flow information:
Cash paid for interest
2,532
847
Supplemental disclosures - non-cash activities:
Purchases of plant and equipment in accounts payable and accrued liabilities
8,546
Issuance of common stock, $0.01 par value, in connection with payment for services
630
120
Insurance financing agreement
707
933
Issuance of common stock, $0.01 par value, for payment of certain employee bonuses
7,288
6,634
Issuance of common stock, $0.01 par value, for milestone achievement
1,011
Lease right-of-use assets obtained in exchange for new operating lease liabilities
9,148
Lease right-of-use assets obtained in exchange for new finance lease liabilities
4,812
648
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2023
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 good manufacturing practice (GMP) 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 encompass various areas such as product research, preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of collaborations. Our strategy includes developing and commercializing product candidates through existing and new collaborations.
Our cash, cash equivalents and short-term investments at September 30, 2023 were $106.3 million, a decrease of $87.1 million from December 31, 2022. Cash and cash equivalents of our subsidiary, MiNK, at June 30, 2023, were $10.6 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.
We have incurred losses since our inception. As of September 30, 2023, we had an accumulated deficit of $1.9 billion.
We have financed our operations 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 $106.3 million at September 30, 2023, plus additional funding we anticipate from the achievement of a milestone under an existing partnership, will be sufficient to satisfy our liquidity requirements for at least one year from when these financial statements were issued. This milestone will be triggered upon dosing the first patient in a clinical trial which is currently screening patients and is expected to occur by end of 2023. However, until this event occurs, in accordance with the relevant 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.
In addition to the expected milestone payment by end of 2023, we are in active discussions to sell two non-strategic assets expected to close in the first half of 2024 with an estimated aggregate value of approximately $65.0 million. These transactions could extend our cash resources well beyond 2024. We are also in advanced discussions for a potential structured financing for
botensilimab/balstilimab, as well as a potential corporate collaboration with a large pharma or biotech company. None of these sources of cash involve equity or debt issuance.
Management continues to address the Company’s liquidity position and has the 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., Incyte Corporation, and Merck Sharpe & Dohme; out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties; additional third-party agreements; asset sales; 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 nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. 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, 2022 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 in total stockholders’ equity (deficit).
In 2023, we deconsolidated certain foreign subsidiaries and recognized a gain of $132,000, 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 September 30, 2023 and 2022, as they would be anti-dilutive (in thousands):
Three and Nine Months Ended September 30,
Warrants
1,980
Stock options
44,034
36,207
Non-vested shares
697
403
Series A-1 convertible preferred stock
333
8
Note C - Investments
Cash equivalents and short-term investments consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
Cost
EstimatedFair Value
Institutional money market funds
71,605
149,856
U.S. Treasury Bills
24,877
29,522
96,482
179,378
As a result of the short-term nature of these investments, there were minimal unrealized holding gains or losses for the three and nine months ended September 30, 2023 and 2022.
Of the investments listed above, all were classified as cash equivalents on our condensed consolidated balance sheets as of September 30, 2023. As of December 31, 2022, $164.7 million were classified as cash equivalents and $14.7 million as short-term investments 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 nine months ended September 30, 2023 (in thousands):
Balance, December 31, 2022
Disposals
(805
Foreign currency translation adjustment
Balance, September 30, 2023
Acquired intangible assets consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
As of September 30, 2023
Amortizationperiod (years)
Gross carrying amount
Accumulated amortization
Net carryingamount
Intellectual property
7-15 years
16,841
(15,099
1,742
Trademarks
4-4.5 years
1,182
(1,139
43
Other
2-7 years
1,860
(1,206
654
In-process research and development
Indefinite
2,058
21,941
(17,444
As of December 31, 2022
16,790
(13,782
3,008
1,272
2-6 years
2,278
(1,227
1,051
2,036
22,376
(16,148
The weighted average amortization period of our finite-lived intangible assets is 9 years. Amortization expense related to acquired intangibles is estimated at $0.1 million for the remainder of 2023, $0.5 million for the years ending December 31, 2024, 2025 and 2026 and $0.4 million for the year ending December 31, 2027.
9
Note E - Debt
Debt obligations consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
Debt instrument
Balance atSeptember 30,2023
Current Portion:
Debentures
146
241
Long-term Portion:
2015 Subordinated Notes
13,107
Balance atDecember 31,2022
429
13,159
As of September 30, 2023 and December 31, 2022, the principal amount of our outstanding debt balance was $13.4 million and $13.6 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 nine months ended September 30, 2023 (in thousands):
Period fromDecember 31, 2022 to September 30, 2023
Liability related to sale of future royalties and milestones - beginning balance
271,560
Non-cash interest expense recognized
55,797
Liability related to sale of future royalties and milestones - ending balance
265,823
Less: unamortized transaction costs
(253
Liability related to sale of future royalties and milestones, net
265,570
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 QS-21 STIMULON 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 nine months ended September 30, 2023, we recognized $61.5 million of non-cash royalty revenue, and we recorded $55.8 million of related non-cash interest expense related to the HCR Royalty Purchase Agreement.
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 nine months ended September 30, 2023, our estimate of the effective annual interest rate over the life of the agreement increased to 29.4%, which results in a life of contract interest rate of 23.4%.
Note G - Accrued and Other Current Liabilities
Accrued liabilities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
Payroll
10,853
15,872
Professional fees
6,250
6,946
Contract manufacturing costs
3,822
1,848
Research services
11,387
7,074
5,317
6,519
Other current liabilities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
Finance lease liabilities
10,190
7,952
3,226
3,505
11
Note H - Fair Value Measurements
Assets and liabilities measured at fair value are summarized below (in thousands):
Description
Quoted Prices inActiveMarkets forIdentical Assets(Level 1)
SignificantOtherObservableInputs(Level 2)
SignificantUnobservableInputs(Level 3)
Assets:
Cash equivalents (Note C)
Long-term investments
4,682
101,164
Liabilities:
Contingent purchase price considerations
476
164,694
Short-term investments (Note C)
14,689
179,383
Contingent purchase price consideration
874
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 September 30, 2023 and December 31, 2022, of $0.5 million and $0.9 million, respectively, 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 September 30, 2023 and December 31, 2022 was $13.1 million and $13.2 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 September 30, 2023 and December 31, 2022 was $13.4 million and $13.6 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. We remain eligible to receive a $50.0 million exercise fee and, if exercised, up to $520.0 million in aggregate potential milestones.
12
Collaboration Revenue
For the three months ended September 30, 2023 and 2022, we recognized approximately $2.9 million and $4.5 million, respectively, of research and development revenue based on the partial satisfaction of the over time performance obligations as of quarter end.
For the nine months ended September 30, 2023, we recognized approximately $7.2 million of research and development revenue based on the partial satisfaction of the over time performance obligations as of period end. For the nine months ended September 30, 2022, we recognized research and development revenue of $5.0 million related to the achievement of a milestone and $7.1 million based on the partial satisfaction of the over time performance obligations as of period end.
We expect to recognize deferred research and development revenue of $5.0 million for the remainder of 2023 related to performance obligations that are unsatisfied or partially unsatisfied as of September 30, 2023.
Disaggregation of Revenue
The following table presents revenue (in thousands) for the three and nine months ended September 30, 2023 and 2022, disaggregated by geographic region and revenue type. Revenue by geographic region is allocated based on the domicile of our respective business operations.
Three months ended September 30, 2023
United States
Rest of World
Revenue Type
Research and development services
447
Other services
Clinical product revenue
116
Recognition of deferred revenue
2,851
Non-cash royalties
23,774
Three months ended September 30, 2022
121
4,452
21,731
Nine months ended September 30, 2023
1,158
7,241
70,049
Nine months ended September 30, 2022
License fees and milestones
5,000
1,154
7,066
65,471
13
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):
Balance at beginning of period
Additions
Deductions
Balance at end of period
Contract liabilities:
13,412
22
(7,297
6,137
The change in contract liabilities is primarily related to the recognition of $7.2 million of revenue related to the Gilead Collaboration Agreements during the nine months ended September 30, 2023. Deferred revenue related to the Gilead Collaboration Agreements of $5.0 million as of September 30, 2023, which was comprised of the $142.5 million initial transaction price, less $137.5 million of license and collaboration revenue recognized from the effective date of the contract, will be recognized as the combined performance obligation is satisfied.
We also recorded a $1.0 million receivable as of September 30, 2023, for research and development and other services provided.
During the nine months ended September 30, 2023, 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. None of the costs to obtain or fulfill a contract were capitalized.
Note J - Share-based Compensation Plans
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 nine months ended September 30, 2023 is presented below:
Options
WeightedAverageExercisePrice
WeightedAverageRemainingContractualTerm(in years)
AggregateIntrinsicValue
Outstanding at December 31, 2022
35,984,967
3.51
Granted
10,440,674
2.26
Exercised
(46,750
1.68
Forfeited
(1,438,712
2.50
Expired
(906,590
3.50
Outstanding at September 30, 2023
44,033,589
3.25
6.76
Vested or expected to vest at September 30, 2023
Exercisable at September 30, 2023
27,981,624
3.59
5.84
The weighted average grant-date fair values of stock options granted during the nine months ended September 30, 2023 and 2022 were $1.44 and $1.77, respectively.
As of September 30, 2023, there was approximately $27.3 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 1.9 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 nine months ended September 30, 2023 is presented below:
Non-vestedShares
WeightedAverageGrant DateFair Value
355,802
5,304,201
2.35
Vested
(4,728,222
2.45
(235,000
2.11
696,781
1.85
As of September 30, 2023, there was approximately $1.1 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 2.3 years.
During the nine months ended September 30, 2023, 449,391 shares were issued under the 2019 Employee Stock Purchase Plan, 46,750 shares were issued as a result of stock option exercises and 84,414 shares were issued as a result of the vesting of non-vested stock. Additionally, 4,643,808 shares were issued as payment for certain employee bonuses, with 1,668,767 of those shares being withheld to cover taxes, resulting in a net share issuance of 2,975,041.
The impact on our results of operations from share-based compensation for the three and nine months ended September 30, 2023 and 2022, was as follows (in thousands):
1,464
1,200
4,853
3,731
4,072
3,234
12,210
10,265
Total share-based compensation expense
17,063
13,996
Note K – Restricted Cash
As of September 30, 2023, and December 31, 2022, we maintained non-current restricted cash of $3.7 million and $2.7 million, respectively. This amount is included within “Other long-term assets” in our condensed consolidated balance sheets and is comprised of 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):
Nine Months Ended September 30, 2022
Beginning of Period
End of Period
291,931
208,354
Restricted cash
2,669
3,669
Cash, cash equivalents and restricted cash
Note L – Equity
On June 23, 2023, we filed an Automatic Shelf Registration Statement on Form S-3ASR (file no. 333-272911) (the “Registration Statement”). The Registration Statement included both a base prospectus that covered the potential offering, issuance and sale from time to time 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 184,638,269 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
15
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 nine months ended September 30, 2023, we received net proceeds of approximately $20.4 million and $123.2 million from the sale of approximately 13.3 million and 71.6 million shares of our common stock, respectively, in at-the-market offerings under the Sales Agreement.
Note M – Non-controlling Interest
Non-controlling interest recorded in our condensed consolidated financial statements as of September 30, 2023 and December 31, 2022, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.
MiNK Therapeutics, Inc.
37
%
SaponiQx, Inc.
30
Changes in non-controlling interest for the periods ended September 30, 2023 and December 31, 2022, were as follows (in thousands):
Beginning balance
Net loss attributable to non-controlling interest
(10,582
Other items:
Distribution of subsidiary shares to Agenus stockholders
(1,861
Issuance of subsidiary shares under employee stock purchase plan
48
Subsidiary share-based compensation
2,742
3,195
Total other items
16,828
3,489
Ending balance
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 0.0146 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.
During the nine months ended September 30, 2023, we purchased 408,518 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 member of our Board of Directors, is chief executive officer of Avillion. For the nine months ended September 30, 2023, approximately $450,000 related to these services is included in “Research and development” expense in our condensed consolidated statements of operations.
16
During the nine months ended September 30, 2023, our Audit and Finance Committee approved, and we performed research and development manufacturing services totaling $256,000 for Protagenic Therapeutics, Inc ("Protagenic"). We will be reimbursed for these services on an actual time and materials basis. Dr. Garo H. Armen, our CEO, is Executive Chairman of and has a greater than 10% equity interest in Protagenic.
Note O - Recent Accounting Pronouncements
Recently Issued and Adopted
In January 2017, the Financial Accounting Standards Board issued ASU 2017-04, Intangibles – Goodwill and Other (Topic 350) that will eliminate the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, an impairment charge will be based on the excess of a reporting unit’s carrying amount over its fair value. We adopted the standard on January 1, 2023. The adoption did not have a material impact on our consolidated financial statements.
No other new accounting pronouncement issued or effective during the nine months ended September 30, 2023 had or is expected to have a material impact on our consolidated financial statements or disclosures.
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, 2022 and in Part II-Item 1A within this Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.
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.
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 development as a monotherapy and in combination with balstilimab. In 2022, we initiated global Phase 2 trials for botensilimab in microsatellite stable colorectal cancer, melanoma, and pancreatic cancer. In October 2023, we completed enrollment of the Phase 2 microsatellite stable colorectal cancer trial. In April 2023, the botensilimab/balstilimab combination received Fast Track designation from the United States Food and Drug Administration (“FDA”) for the treatment of non-MSI-H/deficient mismatch repair (dMMR) metastatic colorectal cancer patients without active liver involvement. We intend to file our first biologics license application for the botensilimab/balstilimab combination in colorectal cancer in midyear 2024.
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 programs currently in pre-clinical or clinical development.
Our collaboration agreement with Incyte grants Incyte exclusive licenses for monospecific antibodies targeting GITR, OX40, TIM-3, LAG-3, and an undisclosed target. Incyte has been advancing these antibodies in clinical trials. 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. Incyte is responsible for all future development expenses for the remaining programs, and we are eligible to receive up to an additional $315.0 million in potential milestone payments, along with royalties on future sales.
Under our collaboration and license agreement with Merck, we have exclusively licensed a monospecific antibody targeting ILT4 to them, which is currently being 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 September 2018, through our subsidiary Agenus Royalty Fund, LLC, we entered into a royalty purchase agreement (the “XOMA Royalty Purchase Agreement”) with XOMA (US) LLC ("XOMA"). Pursuant to the 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, after satisfying our obligations to a third party. As of September 30, 2023, 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, after accounting for our obligations under the XOMA Royalty Purchase Agreement.
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. All three assets are currently in clinical development. 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.
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 are eligible to receive up to $1.36 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.
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 GlaxoSmithKline (“GSK”) and plays a vital role in multiple GSK vaccine programs. These programs are at various stages, including GSK’s approved shingles vaccine, SHINGRIX, which received FDA approval in the United States in October 2017.
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.
Agenus' subsidiary MiNK completed an initial public offering in October 2021 and is publicly traded on Nasdaq under the symbol INKT. MiNK is a clinical-stage precision oncology company developing unmodified and engineered INKT cell therapies for cancer and other immune-mediated diseases. Their lead product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. A Phase 1 clinical trial for the treatment of solid tumors as a monotherapy and in combination with approved checkpoint inhibitors (KEYTRUDA® and OPDIVO®) has been initiated and enrolled, and data was presented in April at the American Association for Cancer Research Annual Meeting. The presentation showcased the activity of agenT-797 alone and in combination with anti-PD-1, with a 42% tumor reduction in a patient with metastatic gastric cancer who had no response to prior anti-PD-1 therapy or standard chemotherapy. Benefit was seen in additional solid tumor types, including durable disease stabilization and biomarker responses in NSCLC, testicular, and appendiceal cancers, that were refractory to anti-PD-1. MiNK is also evaluating agenT-797 as a variant-agnostic therapy for patients with viral acute respiratory distress syndrome, and top-line data from a Phase 1 clinical trial demonstrated a 77% survival rate in older, mechanically ventilated patients with COVID-19 respiratory failure. Through an assignment and license agreement with Agenus, MiNK owns the INKT technology and has the rights to develop a proprietary pipeline of engineered CAR-INKTs, TCRs, and INKT bispecific engagers.
Historical Results of Operations
Three months ended September 30, 2023 compared to the three months ended September 30, 2022
Research and development revenue
We recognized research and development revenue of approximately $3.4 million and $4.6 million during the three months ended September 30, 2023 and 2022, respectively. Research and development revenues in the third quarter of 2023 primarily consisted of $2.9 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements. Research and development revenues in the third quarter of 2022 primarily consisted of $4.5 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our QS-21 STIMULON 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 $11.1 million, to approximately $20.4 million for the three months ended September 30, 2023, from $9.2 million for the three months ended September 30, 2022, due to increased net sales of GSK’s vaccines containing our QS-21 STIMULON adjuvant and the achievement of the final sales milestone under the HCR agreement and the recognition of $7.9 million of these royalties as royalty milestone revenue in the three months ended September 30, 2022.
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 increased 12% to $51.4 million for the three months ended September 30, 2023 from $46.0 million for the three months ended September 30, 2022. Increased expenses in the three months ended September 30, 2023 primarily relate to a $5.8 million increase in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $1.7 million increase in personnel related expenses, and a $1.4 million increase in other research and development expenses. These increases were partially offset by a $3.5 million decrease in expenses attributable to the activities of our subsidiaries.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses increased 4% to $18.9 million for the three months ended September 30, 2023 from $18.1 million for the three months ended September 30, 2022. Increased expenses in the three months ended September 30, 2023 primarily relate to a $1.8 million increase in personnel related expenses, and a $0.4 million increase in other general and administrative expenses. These increases were partially offset by a $0.8 million decrease in professional fees and a $0.7 million decrease in expenses attributable to the activities of our subsidiaries.
Interest expense, net increased to approximately $18.6 million for the three months ended September 30, 2023 from $15.6 million for the three months ended September 30, 2022, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and increased interest expense recorded in connection with our finance leases, partially offset by increased interest income earned on our cash equivalents and short-term investments.
Nine months ended September 30, 2023 compared to the nine months ended September 30, 2022
We recognized research and development revenue of approximately $8.5 million and $13.2 million during the nine months ended September 30, 2023 and 2022, respectively. Research and development revenues in the first nine months of 2023 primarily consisted of $7.2 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements. Research and development revenues in the first nine months of 2022 primarily consisted of a $5.0 million milestone and $7.1 million related to the recognition of deferred revenue, both earned under our Gilead Collaboration Agreements.
In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our QS-21 STIMULON 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 $34.5 million, to approximately $61.5 million for the nine months ended September 30, 2023, from $27.0 million for the nine months ended September 30, 2022, due to increased net sales of GSK’s vaccines containing our QS-21 STIMULON adjuvant and the achievement of the final sales milestone under the HCR agreement and the recognition of approximately $25.3 million of these royalties as royalty milestone revenue in the nine months ended September 30, 2022.
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 increased 26% to $167.8 million for the nine months ended September 30, 2023 from $133.4 million for the nine months ended September 30, 2022. Increased expenses in the nine months ended September 30, 2023 primarily relate to a $27.6
million increase in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $5.3 million increase in personnel related expenses, primarily due to increased headcount, and a $2.4 million increase in other research and development expenses. These increases were partially offset by a $0.9 million decrease in expenses attributable to the activities of our subsidiaries.
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses increased 3% to $57.6 million for the nine months ended September 30, 2023 from $56.0 million for the nine months ended September 30, 2022. Increased expenses in the nine months ended September 30, 2023 primarily relate to a $3.8 million increase in personnel related expenses, largely due to increased headcount, and a $1.2 million increase in other general and administrative expenses. These increases were partially offset by a $2.0 million decrease in professional fees, primarily due to reduced consulting and external legal costs, and a $1.5 million decrease in expenses attributable to the activities of our subsidiaries.
Non-operating income (expense)
Non-operating income (expense) includes our foreign currency translation adjustment and other income or expense. Non-operating income decreased $9.4 million for the nine months ended September 30, 2023, from income of $9.7 million for the nine months ended September 30, 2022 to income of $0.2 million for the nine months ended September 30, 2023, primarily due to de minimis activity in the nine months ended September 30, 2023, compared to the recognition of a $6.6 million gain on the sale of property, plant and equipment and a $2.8 million gain on the partial forgiveness of a liability in the nine months ended September 30, 2022.
Interest expense, net increased to approximately $53.7 million for the nine months ended September 30, 2023 from $44.5 million for the nine months ended September 30, 2022, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and increased interest expense recorded in connection with our finance leases, partially offset by increased interest income earned on our cash equivalents and short-term investments.
Research and Development Programs
For the nine months ended September 30, 2023, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).
Year Ended December 31,
Research andDevelopment Program
Product
2021
2020
Antibody programs
Various
122,981
133,108
141,266
118,200
Vaccine adjuvant
STIMULON cpc QS-21
9,269
10,789
5,912
304
Cell therapies
12,853
24,300
15,507
11,022
Other research and development programs
22,743
18,494
15,923
13,091
Total research and development expenses
167,846
186,691
178,608
142,617
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.
Liquidity and Capital Resources
We have incurred annual operating losses since inception, and we had an accumulated deficit of $1.9 billion as of September 30, 2023. 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 September 30, 2023, 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 common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 184.6 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. We sold approximately 71.6 million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2023, for aggregate net proceeds totaling $123.2 million. As of September 30, 2023, approximately 171.3 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 September 30, 2023, we had debt outstanding of $13.4 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.
Based on our current plans and projections, we believe that our cash resources of $106.3 million as of September 30, 2023, plus additional funding we anticipate from the achievement of a milestone under an existing partnership, will be sufficient to satisfy our liquidity requirements for at least one year from when these financial statements were issued. This milestone will be triggered upon dosing the first patient in a clinical trial which is currently screening patients and is expected to occur by end of 2023. However, until this event occurs, in accordance with the relevant 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.
In addition to the expected milestone payment by end of 2023, we are in active discussions to sell two non-strategic assets expected to close in the first half of 2024 with an estimated aggregate value of approximately $65.0 million. These transactions could extend our cash resources well beyond 2024. We are also in advanced discussions for a potential structured financing for botensilimab/balstilimab, as well as a potential corporate collaboration with a large pharma or biotech company. None of these sources of cash involve equity or debt issuance.
Management continues to address the Company’s liquidity position and has the 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 BMS, UroGen, Gilead, Incyte, and Merck; out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties; additional third-party agreements; asset sales; royalty monetization; project financing, and/or sales of equity securities.
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 $601.3 million over the term of the related activities. Through September 30, 2023, we have expensed $519.8 million as research and development expenses and $500.7 million has been paid under these agreements. The timing of expense recognition and future payments related to these agreements is subject to the
23
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. For example, our collaboration with Incyte for the development, manufacture and commercialization of CPM antibodies against certain targets is managed by a joint steering committee, which is controlled by Incyte.
Net cash used in operating activities for the nine months ended September 30, 2023 and 2022 was $183.8 million and $128.0 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 2022 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 0.9% and 1.7% of our cash used in operations for the nine months ended September 30, 2023 and the year ended December 31, 2022, respectively, 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, Euro, and Swiss Franc, in large part due to our subsidiaries, Agenus UK Limited and AgenTus Therapeutics Limited, both with operations in England, AgenTus Therapeutics SA, a company formerly with operations in Belgium, and Agenus Switzerland a company formerly with operations in Switzerland.
We had cash, cash equivalents and short-term investments at September 30, 2023 of $106.3 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 and U.S. Treasury Bills, our carrying value approximates the fair value of these investments at September 30, 2023.
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, 2022.
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 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 September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
25
PART II - OTHER INFORMATION
Item 1.Legal Proceedings
We are not party to any material legal proceedings.
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, 2022. In addition to the risk factors described in Part I, Item 1A "Risk Factors" of our 2022 Form 10-K, please note the additional Risk Factor included below.
Substantial doubt exists as to our ability to continue as a going concern
We have financed our operations 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 $106.3 million at September 30, 2023, plus additional funding we anticipate from the achievement of a milestone under an existing partnership, will be sufficient to satisfy our liquidity requirements for at least one year from when these financial statements were issued. This milestone will be triggered upon dosing the first patient in a clinical trial which is currently screening patients and is expected to occur by end of 2023. However, until this event occurs, in accordance with relevant 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.
Item 5.Other Information
Trading Plans of Our Directors and Officers
During the quarter ended September 30, 2023, none of our directors or executive officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each item is defined in Item 408 of Regulation S-K.
Item 6.Exhibits
Exhibit No.
31.1
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.
31.2
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.
32.1
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Submitted herewith.
101.INS
XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101)
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:
November 9, 2023
/s/ CHRISTINE M. KLASKIN
Christine M. Klaskin
VP, Finance, Principal Financial Officer, Principal Accounting Officer