PART I - FINANCIAL INFORMATION This section presents Agenus Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis for specified periods [ITEM 1. Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) Agenus Inc.'s unaudited condensed consolidated financial statements for specified periods are presented [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased and stockholders' equity shifted to a deficit by September 30, 2022 Condensed Consolidated Balance Sheet Highlights | Metric | September 30, 2022 (Unaudited) (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :------------------------------- | | Total Assets | $429,019 | $465,958 | | Cash and cash equivalents | $208,354 | $291,931 | | Total Current Liabilities | $173,073 | $156,943 | | Total Stockholders' (Deficit) Equity | $(11,836) | $47,909 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total revenues decreased substantially, resulting in a significant operating loss for the nine months ended September 30, 2022 Condensed Consolidated Statements of Operations Highlights | Metric | Nine Months Ended September 30, 2022 (in thousands) | Nine Months Ended September 30, 2021 (in thousands) | | :---------------------------------------------------- | :-------------------------------------------------- | :-------------------------------------------------- | | Total Revenues | $69,638 | $275,404 | | Operating (Loss) Income | $(121,670) | $79,774 | | Net (Loss) Income Attributable to Agenus Inc. common stockholders | $(149,140) | $41,427 | | Basic Net (Loss) Income Per Common Share | $(0.54) | $0.19 | [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) Equity changes show a significant decline in total equity, driven by net losses and an accumulated deficit Condensed Consolidated Stockholders' Equity Highlights | Metric | September 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :---------------------------------------------------- | :-------------------------------- | :------------------------------- | | Total Stockholders' (Deficit) Equity | $(11,836) | $47,909 | | Accumulated Deficit | $(1,638,814) | $(1,489,833) | | Additional Paid-In Capital | $1,614,836 | $1,520,212 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash flow shifted from generation to usage for the nine months ended September 30, 2022, compared to the prior year Condensed Consolidated Cash Flow Highlights | Metric | Nine Months Ended September 30, 2022 (in thousands) | Nine Months Ended September 30, 2021 (in thousands) | | :---------------------------------------------------- | :-------------------------------------------------- | :-------------------------------------------------- | | Net cash (used in) provided by operating activities | $(128,035) | $33,072 | | Net cash used in investing activities | $(27,227) | $(29,851) | | Net cash provided by financing activities | $72,057 | $153,659 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(83,577) | $156,693 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's business, liquidity, accounting policies, and specific financial statement items [Note A - Business, Liquidity and Basis of Presentation](index=11&type=section&id=Note%20A%20-%20Business%2C%20Liquidity%20and%20Basis%20of%20Presentation) This note describes Agenus as a clinical-stage immuno-oncology company, outlining its pipeline, liquidity, funding, and financial statement basis - Agenus is a clinical-stage immuno-oncology (I-O) company advancing a pipeline of immune checkpoint antibodies, adoptive cell therapies (MiNK Therapeutics), and neoantigen vaccines (SaponiQx) to fight cancer and infections[518](index=518&type=chunk) - The lead asset, botensilimab (Fc-enhanced CTLA-4), showed significant activity in 'cold tumors' (e.g., MSS CRC) in combination with balstilimab (PD-1), with worldwide studies initiated in 2022 and a pancreatic cancer trial expected by year-end 2022[518](index=518&type=chunk) Cash, Cash Equivalents & Short-term Investments | Metric | September 30, 2022 (in millions) | December 31, 2021 (in millions) | | :---------------------------------------- | :------------------------------- | :------------------------------ | | Cash, cash equivalents & short-term investments | $218.2 | $306.9 | | Change from Dec 31, 2021 | $(88.7) | N/A | - The company had an accumulated deficit of **$1.6 billion** as of September 30, 2022[519](index=519&type=chunk) - Current cash resources of **$218.2 million** are projected to be sufficient for more than one year from the issuance date of the financial statements[520](index=520&type=chunk) - Potential future funding sources include collaborations, milestone payments, third-party agreements, asset sales, project financing, and equity sales[521](index=521&type=chunk) [Note B - Net (Loss) Income Per Share](index=12&type=section&id=Note%20B%20-%20Net%20(Loss)%20Income%20Per%20Share) This note details basic and diluted net (loss) income per common share, with diluted EPS equaling basic EPS during net loss periods Net (Loss) Income Per Common Share | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :---------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net (loss) income attributable to Agenus Inc. common stockholders (in thousands) | $(54,275) | $178,499 | $(149,140) | $41,427 | | Basic Net (loss) income per common share | $(0.19) | $0.76 | $(0.54) | $0.19 | | Diluted Net (loss) income per common share | $(0.19) | $0.72 | $(0.54) | $0.18 | - For periods with a net loss attributable to common stockholders (e.g., nine months ended September 30, 2022), diluted loss per common share is identical to basic loss per common share, as potentially dilutive securities are anti-dilutive[527](index=527&type=chunk) Anti-Dilutive Securities | Anti-Dilutive Securities (in thousands) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :-------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Warrants | 1,980 | — | 1,980 | 1,980 | | Stock options | 36,207 | 6,661 | 36,207 | 20,852 | | Non-vested shares | 403 | 53 | 403 | 176 | | Series A-1 convertible preferred stock | 333 | — | 333 | 333 | [Note C - Investments](index=13&type=section&id=Note%20C%20-%20Investments) This note breaks down cash equivalents and short-term investments, primarily money market funds and U.S. Treasury Bills Investment Portfolio Breakdown | Investment Type | September 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :-------------------------------- | :------------------------------- | | Institutional money market funds | $180,167 | $219,903 | | U.S. Treasury Bills | $19,801 | $34,989 | | Total | $199,968 | $254,892 | - Minimal unrealized holding gains or losses were recorded for the three and nine months ended September 30, 2022 and 2021, due to the short-term nature of these investments[531](index=531&type=chunk) - As of September 30, 2022, **$190.1 million** was classified as cash equivalents and **$9.9 million** as short-term investments[532](index=532&type=chunk) [Note D - Goodwill and Acquired Intangible Assets](index=13&type=section&id=Note%20D%20-%20Goodwill%20and%20Acquired%20Intangible%20Assets) This note details changes in goodwill and acquired intangible assets, their amortization periods, and estimated future expense Goodwill and Acquired Intangible Assets Summary | Metric | September 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :-------------------------------- | :------------------------------- | | Goodwill | $23,936 | $24,876 | | Acquired Intangible Assets, Net | $6,877 | $8,488 | - Goodwill decreased by **$940 thousand** from December 31, 2021, to September 30, 2022, primarily due to foreign currency translation adjustment[43](index=43&type=chunk)[534](index=534&type=chunk) - The weighted average amortization period for finite-lived intangible assets is **9 years**[535](index=535&type=chunk) - Estimated amortization expense for acquired intangibles: **$0.6 million** for remainder of 2022, **$1.8 million** for 2023, **$0.7 million** for 2024, and **$0.6 million** for each of 2025 and 2026[535](index=535&type=chunk) [Note E - Debt](index=14&type=section&id=Note%20E%20-%20Debt) This note outlines the company's debt obligations, primarily 2015 Subordinated Debentures, with a significant portion reclassified to current Debt Obligations Summary | Debt Instrument | September 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :-------------------------------- | :------------------------------- | | Current Portion, Long-term Debt | $13,458 | $728 | | Long-term Debt, Net of Current Portion | $— | $12,823 | | Total Outstanding Debt Principal | $13,500 | $13,800 | - The principal amount of outstanding debt was **$13.5 million** as of September 30, 2022, primarily from the 2015 Subordinated Notes[46](index=46&type=chunk)[537](index=537&type=chunk) - A significant portion of the 2015 Subordinated Debentures was reclassified from long-term to current portion, reflecting its due date in February 2023[8](index=8&type=chunk)[46](index=46&type=chunk)[537](index=537&type=chunk) [Note F – Liability Related to the Sale of Future Royalties and Milestones](index=14&type=section&id=Note%20F%20%E2%80%93%20Liability%20Related%20to%20the%20Sale%20of%20Future%20Royalties%20and%20Milestones) This note details accounting for the sale of future GSK royalties to HCR, including non-cash royalty revenue, interest expense, and a sales milestone Future Royalties and Milestones Liability | Metric | Nine Months Ended September 30, 2022 (in thousands) | | :---------------------------------------------------- | :-------------------------------------------------- | | Liability related to sale of future royalties and milestones - beginning balance (Dec 31, 2021) | $254,105 | | Non-cash royalty revenue | $(27,001) | | Non-cash interest expense recognized | $44,469 | | Liability related to sale of future royalties and milestones - ending balance (Sept 30, 2022) | $271,573 | | Less: unamortized transaction costs | $(312) | | Liability related to sale of future royalties and milestones, net | $271,261 | - The company sold 100% of its worldwide rights to receive royalties from GSK on sales of QS-21 Stimulon adjuvant to HCR in January 2018 for **$190.0 million**, accounted for as a liability[540](index=540&type=chunk) - The final **$25.3 million** milestone under the HCR Royalty Purchase Agreement was achieved in Q2 2022, as GSK vaccine sales exceeded **$2.75 billion**, with royalty sales milestone revenue of **$7.9 million** recognized in Q3 2022[540](index=540&type=chunk)[542](index=542&type=chunk) - The estimated effective annual interest rate over the life of the HCR agreement decreased to **24.9%** (life of contract rate of **22.4%**) during the nine months ended September 30, 2022[543](index=543&type=chunk) [Note G - Accrued Liabilities](index=15&type=section&id=Note%20G%20-%20Accrued%20Liabilities) This note breaks down accrued liabilities, showing a decrease primarily due to reductions in payroll, contract manufacturing, and research services Accrued Liabilities Breakdown | Accrued Liability Type | September 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :-------------------------------- | :------------------------------- | | Payroll | $9,697 | $14,206 | | Professional fees | $6,429 | $6,433 | | Contract manufacturing costs | $1,302 | $5,824 | | Research services | $6,557 | $8,550 | | Other | $4,965 | $7,078 | | Total | $28,950 | $42,091 | [Note H - Fair Value Measurements](index=15&type=section&id=Note%20H%20-%20Fair%20Value%20Measurements) This note discusses fair value measurement of Level 3 contingent purchase price considerations and outstanding debt Fair Value of Contingent Purchase Price and Debt | Metric | September 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :-------------------------------- | :------------------------------- | | Contingent purchase price considerations | $739 | $1,689 | | Fair value of outstanding debt | $13,400 | $13,600 | | Principal amount of outstanding debt | $13,500 | $13,800 | - Contingent purchase price considerations are Level 3 liabilities, valued using a Monte Carlo simulation based on share price and credit spread[546](index=546&type=chunk) Unobservable Inputs for Contingent Purchase Price | Unobservable Input | September 30, 2022 | December 31, 2021 | | :-------------------------------- | :----------------- | :---------------- | | Period of time to achieve milestones (in years) | 2.25 | 2.50 | | Credit spread | 9.4% | 5.4% | [Note I - Revenue from Contracts with Customers](index=16&type=section&id=Note%20I%20-%20Revenue%20from%20Contracts%20with%20Customers) This note details revenue recognition from collaboration agreements, disaggregating revenue by type and region, and providing contract liability information Revenue by Type | Revenue Type | Nine Months Ended Sep 30, 2022 (in thousands) | Nine Months Ended Sep 30, 2021 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $13,220 | $242,265 | | Royalty sales milestone | $25,250 | $— | | Non-cash royalties | $27,001 | $28,903 | | Total Revenues | $69,638 | $275,404 | - Research and development revenue for the nine months ended September 30, 2022, included a **$5.0 million** milestone and **$7.1 million** from deferred revenue recognition related to Gilead Collaboration Agreements[553](index=553&type=chunk) - Deferred research and development revenue of **$7.0 million** and **$7.7 million** is expected to be recognized for the remainder of 2022 and 2023, respectively[555](index=555&type=chunk) Contract Liabilities (Deferred Revenue) | Contract Liabilities (Deferred Revenue) | Balance at beginning of period (in thousands) | Additions (in thousands) | Deductions (in thousands) | Balance at end of period (in thousands) | | :-------------------------------------- | :------------------------------------------ | :----------------------- | :------------------------ | :------------------------------------ | | Nine months ended September 30, 2022 | $23,625 | $162 | $(7,956) | $15,831 | [Note J - Share-based Compensation Plans](index=18&type=section&id=Note%20J%20-%20Share-based%20Compensation%20Plans) This note describes the company's share-based compensation plans, including stock options and non-vested stock, and recognized expense - As of September 30, 2022, approximately **$33.0 million** of total unrecognized share-based compensation expense related to stock options and subsidiary plans is expected to be recognized over a weighted average period of **2.2 years**[566](index=566&type=chunk) Share-based Compensation Expense and Fair Values | Metric | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Weighted average grant-date fair values of stock options granted | $1.77 | $2.83 | | Total share-based compensation expense (in thousands) | $13,996 | $14,139 | Non-vested Stock Activity | Non-vested Stock Activity | Non-vested Shares (count) | Weighted Average Grant Date Fair Value | | :-------------------------------- | :------------------------ | :------------------------------------- | | Outstanding at December 31, 2021 | 1,018,051 | $2.39 | | Granted | 4,432,830 | $2.48 | | Vested | (4,316,962) | $2.58 | | Forfeited | (731,167) | $1.81 | | Outstanding at September 30, 2022 | 402,752 | $2.34 | [Note K – Restricted Cash](index=19&type=section&id=Note%20K%20%E2%80%93%20Restricted%20Cash) This note reports non-current restricted cash for facility leases and reconciles cash, cash equivalents, and restricted cash - Non-current restricted cash remained at **$2.7 million** as of both September 30, 2022, and December 31, 2021[571](index=571&type=chunk) - This restricted cash is comprised of letters of credit required under two facility leases[571](index=571&type=chunk) Reconciliation of Cash, Cash Equivalents, and Restricted Cash | Metric | Nine Months Ended Sep 30, 2022 (in thousands) | Nine Months Ended Sep 30, 2021 (in thousands) | | :---------------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Cash and cash equivalents (Beginning Period) | $291,931 | $99,871 | | Restricted cash (Beginning Period) | $2,669 | $2,634 | | Cash, cash equivalents and restricted cash (Beginning Period) | $294,600 | $102,505 | | Cash and cash equivalents (End of Period) | $208,354 | $256,529 | | Restricted cash (End of Period) | $2,669 | $2,669 | | Cash, cash equivalents and restricted cash (End of Period) | $211,023 | $259,198 | [Note L – Equity](index=19&type=section&id=Note%20L%20%E2%80%93%20Equity) This note details equity activities, including net proceeds from 'at the market' offerings and increased authorized common stock - Received net proceeds of approximately **$75.2 million** from the sale of **34.6 million** common shares in 'at the market' offerings during the nine months ended September 30, 2022, at an average price of **$2.24** per share[575](index=575&type=chunk) - Stockholders approved an increase in authorized common stock from **400,000,000** to **800,000,000** shares, effective August 5, 2022[576](index=576&type=chunk) [Note M – Related Party Transactions](index=20&type=section&id=Note%20M%20%E2%80%93%20Related%20Party%20Transactions) This note discloses a clinical trial services contract with Protagenic Therapeutics, Inc., a related party with Agenus' CEO holding significant interest - A wholly-owned subsidiary of Agenus approved a **$1.3 million** contract with Protagenic Therapeutics, Inc. for clinical trial services[577](index=577&type=chunk) - Dr. Garo H. Armen, Agenus' CEO, is Executive Chairman of and holds a greater than **10%** equity interest in Protagenic[577](index=577&type=chunk) [Note N - Recent Accounting Pronouncements](index=20&type=section&id=Note%20N%20-%20Recent%20Accounting%20Pronouncements) This note discusses ASU 2017-04, simplifying goodwill impairment, and notes no other material impact from recent pronouncements - ASU 2017-04 (Intangibles – Goodwill and Other) will eliminate the requirement to calculate the implied fair value of goodwill for impairment charges, instead basing it on the excess of a reporting unit's carrying amount over its fair value[578](index=578&type=chunk) - The guidance is effective for the company in the first quarter of fiscal 2023, with no material impact anticipated absent any goodwill impairment[578](index=578&type=chunk) [Note O – Subsequent Events](index=20&type=section&id=Note%20O%20%E2%80%93%20Subsequent%20Events) This note reports net proceeds from 'at the market' offerings received after the September 30, 2022, reporting period - From October 1, 2022, through November 4, 2022, the company received net proceeds of approximately **$22.3 million** from the sale of **9.9 million** common shares under the Sales Agreement[579](index=579&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition and results, including business overview, historical performance, R&D, and liquidity [Forward Looking Statements](index=21&type=section&id=Forward%20Looking%20Statements) This subsection cautions that forward-looking statements are subject to inherent risks and uncertainties that could cause actual results to differ materially - The report contains forward-looking statements identifiable by words such as 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe,' 'will,' 'potential,' 'opportunity,' 'future'[582](index=582&type=chunk) - These statements are based on current expectations and involve inherent risks and uncertainties that could cause actual outcomes to differ materially from current expectations[582](index=582&type=chunk) - Investors are cautioned not to place significant reliance on forward-looking statements, which should be evaluated in light of all information in the document and are not updated or revised after the document's date[583](index=583&type=chunk) [Overview](index=21&type=section&id=Overview) This section provides an overview of Agenus Inc.'s clinical-stage immuno-oncology business, detailing its pipeline, capabilities, product candidates, and collaborations - Agenus is a clinical-stage immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies (MiNK), and neoantigen vaccines (SaponiQx) to combat cancer and infections[585](index=585&type=chunk) - The company's I-O portfolio includes multiple antibody discovery platforms, lead candidate botensilimab (AGEN1181), the saponin-based vaccine adjuvant platform (QS-21 STIMULON™) under SaponiQx, and allogeneic iNKT cell therapies under MiNK[586](index=586&type=chunk) - Botensilimab (AGEN1181) is advancing in multiple clinical programs, with worldwide trials initiated in microsatellite stable colorectal cancer (MSS CRC) and melanoma in 2022, and a pancreatic cancer trial expected by the end of 2022[587](index=587&type=chunk) - The Biologics License Application (BLA) for balstilimab monotherapy for second-line cervical cancer was withdrawn in October 2021, following FDA recommendation due to a competitor's full approval[589](index=589&type=chunk) - Agenus has collaborations with Bristol-Myers Squibb (BMS), Betta Pharmaceuticals, Gilead Sciences, Incyte Corporation, Merck Sharpe & Dohme (Merck), and Recepta Biopharma SA for various antibody programs and potential milestone payments[590](index=590&type=chunk)[591](index=591&type=chunk)[592](index=592&type=chunk)[593](index=593&type=chunk) - SaponiQx was launched in September 2021 for novel adjuvant discovery and vaccine design, partnering with Ginkgo Bioworks, and its QS-21 Stimulon adjuvant is a key component in GSK's Shingrix vaccine, with a **$25.25 million** milestone achieved in Q2 2022[595](index=595&type=chunk) - MiNK Therapeutics completed an IPO in October 2021, raising **$40.0 million**, and is developing AGENT-797 iNKT cell therapies with data readouts planned by the end of 2022[597](index=597&type=chunk) [Historical Results of Operations](index=23&type=section&id=Historical%20Results%20of%20Operations) This section compares financial performance for the three and nine months ended September 30, 2022, versus 2021, highlighting revenue, expense, and net income shifts [Three months ended September 30, 2022 compared to the three months ended September 30, 2021](index=23&type=section&id=Three%20months%20ended%20September%2030%2C%202022%20compared%20to%20the%20three%20months%20ended%20September%2030%2C%202021) For the three months ended September 30, 2022, R&D revenue decreased substantially, a new royalty sales milestone was recognized, R&D expenses increased, and G&A expenses decreased Revenue Comparison (Three Months) | Revenue Type (in thousands) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Change | | :-------------------------------- | :------------------------------ | :------------------------------ | :----- | | Research and development | $4,573 | $238,986 | $(234,413) | | Non-cash royalty revenue | $9,224 | $12,593 | $(3,369) | | Royalty sales milestone | $7,934 | $— | $7,934 | - Research and development revenue decreased significantly due to **$220.0 million** from a BMS license and milestone in Q3 2021, compared to **$4.5 million** from Gilead deferred revenue in Q3 2022[598](index=598&type=chunk) - Research and development expense increased **7%** to **$46.0 million** (2022) from **$42.9 million** (2021), driven by a **$1.0 million** increase in personnel expenses and a **$5.1 million** increase in subsidiary activities, partially offset by a **$3.2 million** decrease in third-party services[601](index=601&type=chunk) - General and administrative expense decreased **15%** to **$18.1 million** (2022) from **$21.4 million** (2021), primarily due to a **$4.4 million** decrease in professional fees and a **$1.2 million** decrease in personnel-related expenses[602](index=602&type=chunk) - Net interest expense decreased to **$15.6 million** (2022) from **$16.6 million** (2021) due to decreased non-cash interest from the HCR Royalty Purchase Agreement[604](index=604&type=chunk) [Nine months ended September 30, 2022 compared to the nine months ended September 30, 2021](index=24&type=section&id=Nine%20months%20ended%20September%2030%2C%202022%20compared%20to%20the%20nine%20months%20ended%20September%2030%2C%202021) For the nine months ended September 30, 2022, R&D revenue declined substantially, a new royalty sales milestone was recognized, R&D and G&A expenses moderately increased, and non-operating income rose Revenue Comparison (Nine Months) | Revenue Type (in thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Research and development | $13,220 | $242,265 | $(229,045) | | Non-cash royalty revenue | $27,001 | $28,903 | $(1,902) | | Royalty sales milestone | $25,250 | $— | $25,250 | - Research and development revenue decreased significantly, primarily due to a **$220.0 million** upfront license fee and milestone from BMS in 2021, compared to a **$5.0 million** milestone and **$7.7 million** deferred revenue from Gilead in 2022[605](index=605&type=chunk) - Research and development expense increased **7%** to **$133.4 million** (2022) from **$125.1 million** (2021), driven by a **$5.0 million** increase in personnel expenses and an **$11.9 million** increase in subsidiary activities, partially offset by a **$9.2 million** decrease in third-party services[609](index=609&type=chunk) - General and administrative expense increased **3%** to **$56.0 million** (2022) from **$54.4 million** (2021), primarily due to a **$6.5 million** increase in subsidiary activities, partially offset by a **$4.2 million** decrease in professional fees[610](index=610&type=chunk) - Non-operating income increased by **$7.6 million** to **$9.7 million** (2022) from **$2.1 million** (2021), mainly due to a **$6.6 million** gain on sale of property, plant and equipment and a **$2.8 million** gain on partial forgiveness of a liability[611](index=611&type=chunk) - Net interest expense decreased to **$44.5 million** (2022) from **$49.1 million** (2021) due to decreased non-cash interest from the HCR Royalty Purchase Agreement[612](index=612&type=chunk) [Research and Development Programs](index=26&type=section&id=Research%20and%20Development%20Programs) This section details R&D expense allocation across antibody programs, vaccine adjuvants, and cell therapies, emphasizing substantial future expenditures for development and regulatory approvals Research and Development Expenses by Program | Research and Development Program | Nine Months Ended September 30, 2022 (in thousands) | Year Ended December 31, 2021 (in thousands) | | :--------------------------------------- | :-------------------------------------------------- | :------------------------------------------ | | Antibody programs | $93,897 | $141,266 | | Vaccine adjuvant (QS-21 Stimulon) | $7,323 | $5,912 | | Cell therapies | $18,288 | $15,507 | | Other research and development programs | $13,904 | $15,923 | | Total research and development expenses | $133,412 | $178,608 | - Significant additional expenditures will be required for new clinical trials, program delays, regulatory approvals, technology development, expansion of operations, and bringing product candidates to market[615](index=615&type=chunk) - The total cost and timing for completing R&D programs and achieving market entry or partnering arrangements are uncertain due to the various stages of product candidates' development[615](index=615&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses historical operating losses, current cash position, and future financing strategies to support development and commercialization efforts - The company has incurred annual operating losses since inception, with an accumulated deficit of **$1.6 billion** as of September 30, 2022[616](index=616&type=chunk) Cash, Cash Equivalents & Short-term Investments | Metric | September 30, 2022 (in millions) | December 31, 2021 (in millions) | | :---------------------------------------- | :------------------------------- | :------------------------------ | | Cash, cash equivalents & short-term investments | $218.2 | $306.9 | | Change from Dec 31, 2021 | $(88.7) | N/A | - Current cash resources of **$218.2 million** are believed to be sufficient to satisfy liquidity requirements for more than one year from the issuance date of the financial statements[620](index=620&type=chunk) - Future funding is expected from collaborations, out-licensing, milestone payments, third-party agreements, asset sales, project financing, and equity securities sales[621](index=621&type=chunk) Cash Flow from Operating Activities | Cash Flow Metric | Nine Months Ended September 30, 2022 (in millions) | Nine Months Ended September 30, 2021 (in millions) | | :--------------------------------------- | :------------------------------------------------- | :------------------------------------------------- | | Net cash (used in) provided by operating activities | $(128.0) | $33.1 | - Future cash requirements include supporting clinical trial and regulatory efforts, and continuing other research and development programs, with estimated total payments to third-party providers of **$497.5 million** over the term of related activities[622](index=622&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section identifies foreign currency exchange rate risk in major European currencies and discusses interest rate exposure on cash and investments, noting investment policy - The primary market risk exposure is foreign currency exchange rate risk, with concentrations in the Euro, Swiss Franc, and British Pound due to foreign subsidiaries' operations[624](index=624&type=chunk) - The company does not currently employ specific strategies like derivative instruments or hedging to manage foreign currency exposures[624](index=624&type=chunk) - Cash, cash equivalents, and short-term investments (**$218.2 million** at September 30, 2022) are exposed to interest rate changes, with interest income fluctuating accordingly[625](index=625&type=chunk) - The investment policy aims to preserve principal, maintain liquidity, and maximize yields, prohibiting investments in structured investment vehicles and asset-backed commercial paper[625](index=625&type=chunk) [ITEM 4. Controls and Procedures](index=28&type=section&id=ITEM%204.%20Controls%20and%20Procedures) This section details the evaluation of disclosure controls and procedures, concluding their effectiveness, and reports no material changes in internal control [Evaluation of Disclosure Controls and Procedures](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2022, ensuring timely and accurate reporting - Management, including the Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of disclosure controls and procedures[628](index=628&type=chunk) - It was concluded that as of September 30, 2022, the disclosure controls and procedures were effective and designed to ensure timely and appropriate communication and reporting of required information[628](index=628&type=chunk) [Changes in Internal Control Over Financial Reporting](index=28&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) No material changes occurred in internal control over financial reporting during the three months ended September 30, 2022 - No change in internal control over financial reporting occurred during the three months ended September 30, 2022, that materially affected or is reasonably likely to materially affect internal control over financial reporting[629](index=629&type=chunk) PART II - OTHER INFORMATION This section provides additional information on legal proceedings, risk factors, and exhibits [ITEM 1. Legal Proceedings](index=29&type=section&id=ITEM%201.%20Legal%20Proceedings) This section discloses two ongoing legal proceedings between Agenus and Recepta Biopharma SA regarding a 2016 collaboration agreement - Agenus is involved in two legal proceedings with Recepta Biopharma SA regarding a 2016 collaboration agreement[631](index=631&type=chunk) - Agenus filed a case in Massachusetts in January 2022, alleging material breach and breach of implied covenant of good faith and fair dealing by Recepta[631](index=631&type=chunk) - Recepta filed a counterclaim in Brazil in August 2022, obtaining an ex parte temporary injunction related to certain aspects of the agreement[631](index=631&type=chunk) - Agenus does not expect the outcome of these litigations to have a material impact on its business[631](index=631&type=chunk) [ITEM 1A. Risk Factors](index=29&type=section&id=ITEM%201A.%20Risk%20Factors) This section outlines principal risks and uncertainties that could materially affect the company's business, financial condition, and future growth, covering various operational and financial aspects [Summary of Risk Factors](index=29&type=section&id=Summary%20of%20Risk%20Factors) This summary provides a high-level overview of key risk categories impacting the company, including financial, development, commercialization, manufacturing, third-party, regulatory, IP, operational, and stock performance - Risks include historical net losses, need for additional financing, and potential dilution for stockholders[632](index=632&type=chunk) - Product development risks involve dependency on botensilimab, changes in clinical trial data, adverse events, patient enrollment difficulties, and strain on limited resources[632](index=632&type=chunk) - Commercialization risks encompass regulatory approval delays, undesirable side effects, intense competition, market acceptance challenges, unfavorable pricing/reimbursement, limited market opportunities, and lack of commercial experience[633](index=633&type=chunk) - Manufacturing and supply risks include challenges in production, high costs, and reliance on third-party manufacturers[634](index=634&type=chunk) - Reliance on third parties poses risks related to their performance in developing and commercializing antibody programs[636](index=636&type=chunk) - Government regulation risks involve uncertain approval processes, compliance with healthcare laws, impact of reform measures, and international operational complexities[636](index=636&type=chunk) - Intellectual property risks include challenges in obtaining/enforcing patents, compliance with licenses, global protection, changes in patent law, confidentiality, and potential infringement lawsuits[637](index=637&type=chunk) - Business operations risks cover managing growth, legal claims, IT security breaches, and the success of subsidiary MiNK Therapeutics[637](index=637&type=chunk) - Common stock risks include price volatility, no cash dividends, and anti-takeover provisions[638](index=638&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=31&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section details the company's history of net losses, ongoing need for substantial additional capital for R&D and commercialization, and potential adverse effects of future financing - Agenus has incurred net losses since its inception, with a net loss of **$156.6 million** for the nine months ended September 30, 2022, and anticipates continued significant losses[642](index=642&type=chunk) - The company requires substantial additional capital to fund ongoing research and development, preclinical and clinical testing, supply chain development, regulatory approvals, and commercialization efforts[646](index=646&type=chunk)[647](index=647&type=chunk) - As of September 30, 2022, cash, cash equivalents, and short-term investments totaled **$218.2 million**, projected to be sufficient for more than one year, but additional capital will be needed to complete current clinical development programs[648](index=648&type=chunk) - Future funding may come from public/private equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements, which could lead to stockholder dilution, restrictive covenants, or relinquishing rights to technologies[649](index=649&type=chunk)[653](index=653&type=chunk) - Outstanding debt of **$13.5 million** (principal) as of September 30, 2022, including **$13.0 million** from 2015 Subordinated Notes due February 2023; default could materially and adversely affect liquidity[661](index=661&type=chunk) [Risks Related to the Development of Our Product Candidates](index=34&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) This section highlights significant risks in product candidate development, including dependency on clinical-stage programs, uncertain trial outcomes, adverse events, patient enrollment, and resource strain - The business is highly dependent on the success of clinical-stage programs, particularly botensilimab and its combination therapies, which require significant additional clinical development and regulatory approval[663](index=663&type=chunk)[664](index=664&type=chunk) - Preliminary or interim clinical data may change materially in final results, and positive early results are not necessarily predictive of success in later trials or sufficient for regulatory approval[671](index=671&type=chunk)[672](index=672&type=chunk) - Clinical trials may reveal significant adverse events or a lack of sufficient efficacy, which could inhibit regulatory approval or market acceptance of product candidates[676](index=676&type=chunk)[677](index=677&type=chunk)[679](index=679&type=chunk) - Difficulties in enrolling patients in clinical trials or staffing shortages at clinical trial sites could delay or adversely affect clinical development activities[683](index=683&type=chunk)[686](index=686&type=chunk)[687](index=687&type=chunk) - Simultaneously advancing multiple product candidates (antibodies, cell therapies, vaccine adjuvants) creates a significant strain on limited human and financial resources, potentially preventing successful advancement of any candidate[688](index=688&type=chunk)[689](index=689&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=37&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) This section addresses substantial hurdles in commercializing product candidates, including regulatory delays, side effects, competition, market acceptance, pricing, and reimbursement - Failure or delays in obtaining required regulatory approvals for product candidates will materially impair the ability to commercialize them and generate revenue[690](index=690&type=chunk)[691](index=691&type=chunk)[692](index=692&type=chunk) - The novel nature of product candidates creates further challenges in obtaining regulatory approval, potentially requiring additional confirmatory trials even after accelerated approval[693](index=693&type=chunk)[694](index=694&type=chunk)[696](index=696&type=chunk) - Product candidates may cause undesirable side effects, which could delay or prevent regulatory approval, limit the commercial profile of an approved label, or lead to significant negative consequences post-marketing approval[700](index=700&type=chunk)[701](index=701&type=chunk)[704](index=704&type=chunk) - The company faces significant competition from major pharmaceutical and specialized biotechnology companies with superior products, manufacturing capabilities, and resources, potentially limiting demand and pricing power[705](index=705&type=chunk)[706](index=706&type=chunk)[707](index=707&type=chunk)[709](index=709&type=chunk)[710](index=710&type=chunk)[711](index=711&type=chunk)[712](index=712&type=chunk)[713](index=713&type=chunk)[714](index=714&type=chunk)[716](index=716&type=chunk) - Even if approved, product candidates may fail to achieve sufficient market acceptance by physicians, patients, and third-party payors, hindering commercial success[720](index=720&type=chunk)[722](index=722&type=chunk) - Unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives could adversely affect the business by limiting coverage and profitability[723](index=723&type=chunk)[724](index=724&type=chunk)[725](index=725&type=chunk)[726](index=726&type=chunk)[727](index=727&type=chunk)[728](index=728&type=chunk) - Market opportunities for product candidates may be limited to specific patient populations, and estimates of target populations may be inaccurate, potentially hindering profitability[729](index=729&type=chunk)[730](index=730&type=chunk) - The company has no experience in marketing, selling, and distributing products or performing commercial compliance, requiring significant capital and time to build these functions, with no assurance of success[731](index=731&type=chunk)[732](index=732&type=chunk) [Risks Related to Manufacturing and Supply](index=45&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Supply) This section details complexities and risks in manufacturing novel product candidates, including high costs, delays, defects, scale-up challenges, and reliance on third-party manufacturers - The manufacturing process for certain product candidates is complex, novel, and not yet validated for commercial production, leading to potentially higher costs and lower reliability[735](index=735&type=chunk)[736](index=736&type=chunk) - Manufacturing processes are susceptible to logistical issues, interruptions, contamination, equipment failure, and inconsistencies, which could result in reduced yields, lot failures, product defects, or recalls[737](index=737&type=chunk) - Scaling up manufacturing to commercial levels presents risks such as cost overruns, problems with process reproducibility, stability issues, and timely availability of raw materials[738](index=738&type=chunk) - The company owns and operates a clinical scale manufacturing facility, which is costly and time-consuming, and any performance failure could delay clinical development or marketing approval[742](index=742&type=chunk) - Dependence on suppliers for components and materials, with few alternative sources, creates risks of supply disruption, increased costs, and delays in meeting demand[747](index=747&type=chunk)[749](index=749&type=chunk) - Reliance on third-party manufacturers for clinical and commercial supplies increases the risk of insufficient quantities, unacceptable costs, and potential failures in regulatory compliance[750](index=750&type=chunk)[751](index=751&type=chunk)[753](index=753&type=chunk) [Risks Related to Our Reliance on Third Parties](index=48&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section details the company's significant dependence on collaborations with partners for antibody program development and commercialization, outlining risks of partner performance, agreement terminations, and alliance management - Agenus is dependent on collaborations with BMS, Gilead, Incyte, and Betta Pharmaceuticals to further develop and commercialize certain antibody programs[757](index=757&type=chunk) - The BMS License Agreement for AGEN1777 involves an upfront payment and potential milestones up to **$1.36 billion**, but BMS controls development, and there's no assurance milestones will be achieved or the agreement won't be terminated[758](index=758&type=chunk)[759](index=759&type=chunk) - The Gilead Collaboration Agreements saw Gilead return AGEN1423 and terminate the option for AGEN1223, while the AGEN2373 option remains, with potential milestones up to **$5.0 million** before exercise, a **$50.0 million** exercise fee, and up to **$520.0 million** in additional milestones if exercised[760](index=760&type=chunk) - The Incyte collaboration converted to royalty-bearing programs, with Incyte funding all development and Agenus eligible for up to **$500.0 million** in milestones, but risks include Incyte's control over development and potential termination[762](index=762&type=chunk)[763](index=763&type=chunk)[764](index=764&type=chunk) - Failure to enter into or maintain additional significant licensing, distribution, or collaboration agreements on favorable terms could hinder development efforts, increase timelines, and necessitate reliance on other financing mechanisms[768](index=768&type=chunk)[772](index=772&type=chunk)[773](index=773&type=chunk)[774](index=774&type=chunk)[775](index=775&type=chunk) - Reliance on third parties (CROs) to conduct clinical trials means limited control over their activities, posing risks of delays, unreliable data, and non-compliance with regulatory requirements, which could harm financial results and commercial prospects[776](index=776&type=chunk)[777](index=777&type=chunk)[779](index=779&type=chunk)[780](index=780&type=chunk) [Risks Related to Government Regulation](index=52&type=section&id=Risks%20Related%20to%20Government%20Regulation) This section details the extensive and unpredictable regulatory landscape, including approval processes, new regulations, healthcare fraud laws, pricing, reimbursement, data privacy, and international trade - The regulatory approval process for product candidates in the U.S., EU, and other jurisdictions is lengthy, time-consuming, and inherently unpredictable, with no guarantee of obtaining marketing approval[782](index=782&type=chunk)[783](index=783&type=chunk) - The novel nature of product candidates creates further challenges in obtaining regulatory approval, potentially requiring extensive clinical trials and facing disagreement from regulatory authorities on development plans or data sufficiency[783](index=783&type=chunk)[784](index=784&type=chunk)[785](index=785&type=chunk)[787](index=787&type=chunk) - Breakthrough Therapy or Fast Track Designations, even if granted, do not guarantee a faster development, regulatory review, or approval process, nor do they increase the likelihood of marketing approval[790](index=790&type=chunk)[791](index=791&type=chunk)[794](index=794&type=chunk) - The company's relationships with healthcare providers, physicians, and third-party payors are subject to extensive anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could lead to investigations, litigation, criminal sanctions, and civil penalties[801](index=801&type=chunk)[803](index=803&type=chunk)[805](index=805&type=chunk)[806](index=806&type=chunk)[808](index=808&type=chunk)[809](index=809&type=chunk) - Ongoing regulatory obligations and continued review post-approval may result in significant additional expenses and potential penalties if the company fails to comply with requirements or experiences unanticipated problems with its product candidates[811](index=811&type=chunk)[812](index=812&type=chunk)[813](index=813&type=chunk)[814](index=814&type=chunk)[815](index=815&type=chunk)[816](index=816&type=chunk) - Healthcare insurance coverage and reimbursement may be limited or unavailable, and unfavorable pricing regulations or healthcare reform measures could make it difficult to sell product candidates profitably[819](index=819&type=chunk)[820](index=820&type=chunk)[821](index=821&type=chunk)[822](index=822&type=chunk)[823](index=823&type=chunk)[824](index=824&type=chunk)[825](index=825&type=chunk) - International operations are subject to complex laws and regulations, including the Foreign Corrupt Practices Act (FCPA), anti-money laundering, export control, and sanctions, requiring costly compliance programs and exposing the company to penalties for violations[843](index=843&type=chunk)[844](index=844&type=chunk)[845](index=845&type=chunk)[846](index=846&type=chunk)[848](index=848&type=chunk) - The ability to use net operating losses (NOLs) and research and development credits to offset future taxable income may be subject to limitations due to ownership changes and the need to achieve profitability[864](index=864&type=chunk)[865](index=865&type=chunk) [Risks Related to Our Intellectual Property](index=64&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section details the critical importance and challenges of protecting intellectual property, including patent enforcement, crowded landscapes, infringement risks, and safeguarding trade secrets and trademarks - Inability to obtain and enforce patent protection for product candidates and related technology could materially harm the business, as patent applications may not issue, or issued patents may be challenged, narrowed, or invalidated[866](index=866&type=chunk)[867](index=867&type=chunk)[868](index=868&type=chunk)[869](index=869&type=chunk)[871](index=871&type=chunk)[872](index=872&type=chunk)[873](index=873&type=chunk)[874](index=874&type=chunk)[875](index=875&type=chunk)[876](index=876&type=chunk)[877](index=877&type=chunk)[878](index=878&type=chunk) - The patent landscapes in antibody, vaccine, adjuvant, and adoptive cell therapy fields are crowded, increasing the risk of third-party patents impacting freedom to operate and requiring potentially costly licenses[873](index=873&type=chunk)[874](index=874&type=chunk) - Failure to comply with obligations under intellectual property licenses with third parties could result in the loss of critical license rights important to the business[889](index=889&type=chunk)[891](index=891&type=chunk) - Protecting intellectual property rights globally is expensive and challenging, as patentability requirements and enforcement vary significantly by country, potentially limiting the ability to prevent infringement[892](index=892&type=chunk)[893](index=893&type=chunk) - Changes in U.S. patent law or its interpretation could diminish the value of patents, increasing uncertainty regarding the ability to protect inventions[897](index=897&type=chunk)[898](index=898&type=chunk) - Inability to protect the confidentiality of proprietary information (trade secrets) could adversely affect the value of technology and competitive position, potentially requiring costly litigation[898](index=898&type=chunk)[899](index=899&type=chunk)[900](index=900&type=chunk)[901](index=901&type=chunk) - The company's commercial success depends on operating without infringing third-party patents and proprietary rights, and patent litigation is costly, time-consuming, and unpredictable, potentially leading to significant liabilities or market exclusion[904](index=904&type=chunk)[906](index=906&type=chunk)[907](index=907&type=chunk)[908](index=908&type=chunk)[909](index=909&type=chunk)[910](index=910&type=chunk) - Failure to obtain patent term extension and/or data exclusivity for product candidates could allow competitors to obtain earlier approval of competing products, materially harming the business[922](index=922&type=chunk)[924](index=924&type=chunk) [Risks Related to Business Operations, Employee Matters and Managing Growth](index=74&type=section&id=Risks%20Related%20to%20Business%20Operations%2C%20Employee%20Matters%20and%20Managing%20Growth) This section addresses operational risks, including managing growth, product liability, key personnel reliance, cybersecurity threats, and the disruptive impact of natural disasters or public health crises - Managing significant growth and consolidation efforts across multiple locations, including headcount changes and office closures, may lead to operational disruptions, increased expenses, and delayed timelines[930](index=930&type=chunk)[931](index=931&type=chunk)[932](index=932&type=chunk) - The company faces an inherent risk of product liability exposure from clinical trials and commercial sales, with limited insurance coverage that may be insufficient to cover future claims[933](index=933&type=chunk)[935](index=935&type=chunk) - High reliance on key management personnel (Dr. Garo H. Armen, Dr. Jennifer Buell) and intense competition for skilled personnel pose risks to achieving strategic and operational objectives if these individuals or qualified replacements cannot be retained[936](index=936&type=chunk)[937](index=937&type=chunk)[938](index=938&type=chunk)[939](index=939&type=chunk) - Internal computer systems and those of third-party partners are vulnerable to security breaches, which could result in material disruptions, delays in regulatory approval, loss of data, and potential liabilities[940](index=940&type=chunk)[941](index=941&type=chunk)[943](index=943&type=chunk)[944](index=944&type=chunk) - Natural or man-made calamities (e.g., earthquakes, fires) or public health crises (e.g., COVID-19, Russia-Ukraine war) could disrupt business operations, supply chains, and strategic partners' activities, leading to substantial expenses and delays[945](index=945&type=chunk)[946](index=946&type=chunk)[947](index=947&type=chunk)[948](index=948&type=chunk)[950](index=950&type=chunk)[951](index=951&type=chunk)[952](index=952&type=chunk) - Failure to realize the anticipated benefits of strategic acquisitions and licensing transactions due to integration difficulties, unknown liabilities, and limited resources could adversely affect business and financial condition[952](index=952&type=chunk)[953](index=953&type=chunk)[954](index=954&type=chunk) - The subsidiary MiNK Therapeutics, despite its IPO, may not attract future external funding or achieve success in advancing product candidates through clinical development[954](index=954&type=chunk)[955](index=955&type=chunk) [Risks Related to Our Common Stock](index=78&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) This section addresses risks related to common stock, including price volatility, no cash dividends, potential dilution from future stock sales, and anti-takeover provisions - The trading volume and public trading price of the common stock have been volatile, influenced by various factors including operating losses, clinical trial results, regulatory delays, and general market conditions[958](index=958&type=chunk) - The company does not intend to pay cash dividends on its common stock in the foreseeable future; thus, the return on investment depends solely on stock price appreciation[962](index=962&type=chunk) - Failure to maintain effective internal controls and comply with changing corporate governance and public disclosure regulations could adversely affect operating results and stock price[963](index=963&type=chunk)[964](index=964&type=chunk)[965](index=965&type=chunk) - The sale of a significant number of shares by the company or stockholders (e.g., through 'at the market' offerings, equity incentive plans, warrants, options, convertible preferred stock) could cause the market price of common stock to decline and dilute existing investors[966](index=966&type=chunk)[967](index=967&type=chunk)[969](index=969&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change of control, potentially limiting the market price of common stock and frustrating stockholder attempts to replace management[970](index=970&type=chunk)[971](index=971&type=chunk)[972](index=972&type=chunk) - Management has broad discretion in the use of existing cash, cash equivalents, and investments, and ineffective application of these funds could harm the business and cause the stock price to decline[973](index=973&type=chunk) [ITEM 6. Exhibits](index=81&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, primarily Inline XBRL taxonomy extension documents and officer certifications - Includes Inline XBRL Taxonomy Extension Schema, Calculation, Definition, Label, and Presentation Linkbase Documents[976](index=976&type=chunk)[977](index=977&type=chunk)[978](index=978&type=chunk) - Contains the Cover Page Interactive Data File and the XBRL Instance Document[978](index=978&type=chunk)[979](index=979&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer, pursuant to Rules 13a-14(a) and 15d-14(a) and 18 U.S.C. Section 1350, are filed herewith[979](index=979&type=chunk) [Signatures](index=82&type=section&id=Signatures) This section formally concludes the report, confirming its due authorization and signing by the Principal Financial and Accounting Officer - The report was duly signed on November 8, 2022, on behalf of Agenus Inc. by Christine M. Klaskin, VP, Finance, Principal Financial Officer, and Principal Accounting Officer[981](index=981&type=chunk)

Agenus Inc. (NASDAQ:AGEN) Q2 2022 Earnings Conference Call August 9, 2022 8:30 AM ET Company Participants Ethan Lovell - Chief of External Affairs & Communications Officer Garo Armen - Chairman & Chief Executive Officer Christine Klaskin - Vice President-Finance Steven O'Day - Chief Medical Officer Dhan Chand - Scientific Director, Head of Drug Discovery Conference Call Participants Mayank Mamtani - B. Riley Securities Matt Phipps - William Blair Operator Good morning. My name is Abby and I will be your con ...

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 June 30, 2022 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 ...

Agenus Inc. (NASDAQ:AGEN) Q1 2022 Earnings Conference Call May 9, 2022 8:30 AM ET Company Participants Christine Klaskin - Vice President of Finance, Principal Financial Officer & Principal Accounting Officer Dhan Chand - Scientific Director & Head of Drug Discovery Ethan Lovell - Chief External Affairs and Communications Officer Garo Armen - Founder, Executive Chairman & Chief Executive Officer Steven O’Day - Chief Medical Officer Conference Call Participants Mayank Mamtani - B. Riley Securities Matthew Ph ...

Agenus Inc. (NASDAQ:AGEN) Q4 2021 Earnings Conference Call March 1, 2022 8:30 AM ET Company Participants Divya Vasudevan – Senior Director, Oncology Strategy and Investor Relations Garo Armen – Chairman and Chief Executive Officer Steven O'Day – Chief Medical Officer Chandresh Harjivan – Chief Operating Officer of SaponiQx Christine Klaskin – Vice President of Finance Conference Call Participants Jason Bouvier – Jefferies Mayank Mamtani – B. Riley Mike King – H.C. Wainwright Hunter Rogers – William Blair Op ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 (I.R.S. Employer i ...

Agenus Inc. (NASDAQ:AGEN) Q3 2021 Earnings Conference Call November 9, 2021 8:30 AM ET Company Participants Divya Vasudevan - Investor Relations Garo Armen - Chairman and Chief Executive Officer Jennifer Buell - Chief Executive Officer, MiNK Therapeutics Steven O’Day - Chief Medical Officer Christine Klaskin - Vice President, Finance Conference Call Participants Mayank Mamtani - B. Riley Securities Jason Bouvier - Jefferies Matt Phipps - William Blair Operator Good day and thank you for standing by. Welcome ...

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, 2021 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 incorpora ...