Core Insights - Agenus Inc. is participating in the B. Riley Virtual Healthcare Conference on January 18th, where Dr. Garo Armen will engage in a fireside chat and investor one-on-ones [1] - The fireside chat is scheduled for 3:00 p.m. ET on January 18th, and a replay will be available on the company's website afterward [1] Company Overview - Agenus is a leading immuno-oncology company focused on treating cancer and infectious diseases with a diverse pipeline of immunological agents [2] - The company's mission is to broaden the patient population benefiting from cancer immunotherapy through combination approaches, utilizing a wide range of antibody therapeutics, adoptive cell therapies, and adjuvants [2] - Agenus is headquartered in Lexington, MA, and provides regular updates that may be important to investors via its website and social media channels [2]

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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 06-1562417 (I.R.S. Employer Identif ...

Financial Data and Key Metrics Changes - The company ended Q3 2023 with a cash balance of $100.63 million, down from $193.4 million at the end of the previous year [23] - For Q3 2023, the company recognized revenue of $24.3 million, resulting in a net loss of $64.5 million, while the net loss for the nine months of 2023 totaled $208.9 million [23] Business Line Data and Key Metrics Changes - The company is focusing on three key priorities: submitting a biologics license application for colorectal cancer, prioritizing clinical programs for rapid approval, and reallocating resources to achieve these goals [6][9] - The Phase II clinical trial in MSS-CRC has shown a 24% overall response rate, with a median overall survival rate exceeding 21 months, significantly better than the standard of care [11][19] Market Data and Key Metrics Changes - The company is addressing an urgent unmet need in the colorectal cancer market, particularly for patients with advanced disease, by initiating a compassionate use program [7][8] - The company is also expanding its clinical trials to include earlier lines of therapy, potentially changing treatment paradigms for colorectal cancer [12] Company Strategy and Development Direction - The company aims to submit its first biologics license application in mid-2024, focusing on late-stage colorectal cancer [6][10] - The strategic focus includes advancing clinical programs in refractory pancreatic cancer and new adjuvant settings in colorectal cancer [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Botensilimab to provide significant benefits over existing therapies, particularly in challenging cancer types [17][19] - The company is optimistic about securing additional cash through milestone payments and asset sales, which are expected to total approximately $200 million [9][10] Other Important Information - The company is in advanced discussions for potential structured financing and corporate collaborations with larger pharmaceutical or biotech companies [10][48] - Management emphasized the importance of rapid development and the need for substantial financial commitments from potential partners [48] Q&A Session Summary Question: When can we expect initial Phase II data for the MSS CRC study? - Management indicated that data from the first 70 patients has been disclosed, with further data needing cleanup before publication, ideally around the time of the BLA submission [27] Question: What is the regulatory bar for the randomized CRC study? - The company needs to demonstrate a meaningful improvement over standard care, with current response rates showing a significant advantage [32] Question: What is the updated cash guidance? - The company expects a cash burn of approximately $40 million for Q4 and anticipates bringing in around $200 million through non-stock issuance transactions by mid-next year [38] Question: What is the plan for CRC patients in the Phase III confirmatory study? - The company is exploring options for both second and first-line studies, with ongoing discussions with the FDA to determine the best path forward [40][51]

Part I - Financial Information [Financial Statements](index=2&type=section&id=ITEM%201.%20Financial%20Statements%3A) This section presents the unaudited condensed consolidated financial statements for Agenus Inc. as of June 30, 2023, and for the three and six-month periods then ended, including Balance Sheets, Statements of Operations, Statements of Stockholders' Equity (Deficit), Statements of Cash Flows, and accompanying notes Condensed Consolidated Balance Sheets As of June 30, 2023, Agenus reported a decrease in total assets driven by reduced cash, an increase in total liabilities, and a widened stockholders' deficit reflecting the period's net loss Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $143,205 | $178,674 | | Total current assets | $170,735 | $213,122 | | Total assets | $383,593 | $413,556 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $204,068 | $188,952 | | Liability related to sale of future royalties and milestones, net | $266,920 | $271,263 | | Total liabilities | $460,354 | $468,458 | | Total stockholders' deficit | ($76,761) | ($54,902) | Condensed Consolidated Statements of Operations and Comprehensive Loss For Q2 and H1 2023, Agenus reported increased total revenues but a widened net loss compared to 2022, primarily driven by higher research and development expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $25,296 | $20,926 | $48,198 | $46,867 | | Research and development expense | ($59,285) | ($44,960) | ($116,402) | ($87,404) | | General and administrative expense | ($20,415) | ($18,914) | ($38,653) | ($37,866) | | Operating loss | ($54,666) | ($44,565) | ($109,007) | ($80,027) | | Net loss | ($73,430) | ($49,235) | ($144,323) | ($99,839) | | Net loss per share (basic & diluted) | ($0.20) | ($0.17) | ($0.41) | ($0.35) | Condensed Consolidated Statements of Cash Flows For H1 2023, net cash used in operating activities increased, while financing activities provided substantial cash, primarily from equity sales, resulting in an overall net decrease in cash Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($118,569) | ($95,844) | | Net cash used in investing activities | ($10,972) | ($11,591) | | Net cash provided by financing activities | $94,513 | $43,834 | | **Net decrease in cash** | **($35,469)** | **($63,546)** | Notes to Unaudited Condensed Consolidated Financial Statements The notes provide detailed information on the company's business, liquidity, accounting policies, and financial statement line items, including its immuno-oncology focus, liquidity assessment, royalty liability, and equity offering proceeds - The company is a clinical-stage company focused on immuno-oncology, with key assets including **botensilimab** (an Fc-enhanced CTLA-4 antibody), which received FDA Fast Track designation for non-MSI-H metastatic colorectal cancer[18](index=18&type=chunk)[24](index=24&type=chunk) - Management believes its cash resources of **$157.9 million** as of June 30, 2023, are sufficient to fund operations for more than one year from the financial statement issuance date[22](index=22&type=chunk) - The company recognized **$41.2 million** in non-cash royalty revenue and **$36.8 million** in non-cash interest expense in H1 2023 related to the HCR Royalty Purchase Agreement[37](index=37&type=chunk) - During H1 2023, the company received net proceeds of approximately **$102.8 million** from the sale of **58.3 million shares** of common stock through at-the-market offerings[67](index=67&type=chunk) - Subsequent to the quarter end, from July 1 to August 4, 2023, the company sold an additional **13.2 million shares** for net proceeds of approximately **$20.3 million**[76](index=76&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, covering business overview, operational results, R&D expenses, liquidity, and future funding plans Overview Agenus is a clinical-stage immuno-oncology company with a pipeline of antibodies, cell therapies, and vaccine adjuvants, with its lead program botensilimab in Phase 2 trials and a planned BLA filing in 2024, supported by strategic partnerships - The company's lead asset is **botensilimab**, an Fc-enhanced CTLA-4 antibody, which in combination with balstilimab (PD-1) showed a median Overall Survival of **20.9 months** in a subset of colorectal cancer patients[83](index=83&type=chunk) - Agenus plans to file its first Biologics License Application (BLA) for the botensilimab/balstilimab combination in colorectal cancer in **2024**[84](index=84&type=chunk) - Incyte has notified Agenus of its intent to terminate the OX40, GITR, and an undisclosed target program, with rights reverting to Agenus upon termination in **October 2023** and **May 2024**[86](index=86&type=chunk) Results of Operations The analysis of operations highlights a significant increase in R&D expenses for both the three and six-month periods ended June 30, 2023, driven by the advancement of antibody programs, alongside a substantial rise in non-cash royalty revenue Comparison of Results for the Three Months Ended June 30 (in millions) | Item | 2023 | 2022 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | R&D Expense | $59.3 | $45.0 | +32% | Increased third-party services for antibody programs and higher headcount. | | G&A Expense | $20.4 | $18.9 | +8% | Increased personnel-related expenses due to higher headcount. | | Non-cash royalty revenue | $22.1 | $0.1 | +$22.0M | Achievement of final sales milestone under HCR agreement. | Comparison of Results for the Six Months Ended June 30 (in millions) | Item | 2023 | 2022 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | R&D Revenue | $5.1 | $8.6 | -41% | 2022 included a $5.0M milestone from Gilead. | | R&D Expense | $116.4 | $87.4 | +33% | Increased third-party services for antibody programs and higher headcount. | | G&A Expense | $38.7 | $37.9 | +2% | Increased personnel costs, partially offset by lower professional fees. | | Non-cash royalty revenue | $41.2 | $17.8 | +131% | Increased net sales of GSK's vaccines containing QS-21 adjuvant. | Research and Development Programs For the first six months of 2023, Agenus's R&D expenses primarily focused on antibody programs, with significant allocations also to cell therapies, vaccine adjuvants, and other research initiatives R&D Expenses by Program for Six Months Ended June 30, 2023 (in thousands) | Research and Development Program | Expense | | :--- | :--- | | Antibody programs | $82,402 | | Cell therapies | $9,292 | | Vaccine adjuvant (QS-21 STIMULON) | $7,816 | | Other research and development programs | $16,892 | | **Total R&D Expenses** | **$116,402** | Liquidity and Capital Resources As of June 30, 2023, Agenus maintained substantial cash resources despite a history of operating losses, primarily funding operations through partnerships, royalty sales, and equity issuances, with management assessing current liquidity as sufficient for over one year - The company had cash, cash equivalents, and short-term investments of **$157.9 million** at June 30, 2023[117](index=117&type=chunk) - Agenus raised **$123.1 million** in net proceeds from its at-the-market (ATM) equity offering program between January 1, 2023, and August 4, 2023[114](index=114&type=chunk) - Management has concluded that current cash resources are sufficient to satisfy liquidity needs for more than one year from the report's issuance date[118](index=118&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposures are foreign currency exchange rate and interest rate fluctuations, which are not currently managed with derivative instruments or hedging - Primary market risks are foreign currency exchange rate fluctuations (mainly British Pound, Euro, Swiss Franc) and interest rate changes on its **$157.9 million** cash and investment portfolio[123](index=123&type=chunk)[124](index=124&type=chunk) - The company does not currently employ derivative instruments or hedging strategies to manage market risk exposures[123](index=123&type=chunk)[126](index=126&type=chunk) [Controls and Procedures](index=26&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective[127](index=127&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[128](index=128&type=chunk) Part II - Other Information [Legal Proceedings](index=27&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - Agenus is not party to any material legal proceedings[131](index=131&type=chunk) [Risk Factors](index=27&type=section&id=ITEM%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 - No material changes have been made to the risk factors described in the **2022 Form 10-K**[132](index=132&type=chunk) [Other Information](index=27&type=section&id=ITEM%205.%20Other%20Information) During the second quarter of 2023, none of the company's directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No directors or executive officers adopted or terminated a Rule 10b5-1 trading plan during the quarter ended June 30, 2023[133](index=133&type=chunk) [Exhibits](index=27&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications pursuant to the Securities Exchange Act of 1934 and the Sarbanes-Oxley Act of 2002, as well as Inline XBRL documents

Financial Data and Key Metrics Changes - The company ended Q1 2023 with cash, cash equivalents, and short-term investments of $189.2 million, down from $193.4 million as of December 31, 2022 [16] - Revenue for Q1 2023 was recognized at $22.9 million, with a net loss of $70.9 million, which included non-cash expenses of $24.9 million [16] Business Line Data and Key Metrics Changes - The botensilimab program has shown response rates of up to 50% in highly refractory cancers across nine solid tumor types, indicating significant clinical progress [5][6] - In colorectal cancer, the 12-month overall survival rate for patients treated with the bot/bal combination was reported at 63%, significantly higher than the standard-of-care rate of 25% [11] - In ovarian cancer, the overall response rate was 33%, with a disease control rate of 67% [13] Market Data and Key Metrics Changes - The company is focusing on expanding its clinical pipeline, particularly in colorectal, melanoma, and pancreatic cancers, with ongoing Phase 2 studies expected to conclude enrollment in 2023 [8] - The FDA granted Fast Track Designation for the balstilimab combination for treating non-MSI high colorectal patients without active liver metastasis, indicating a significant unmet medical need [8] Company Strategy and Development Direction - The company aims to revolutionize cancer treatment through innovative therapies like botensilimab, which targets both cold and hot tumors [5][6] - There is a commitment to advancing clinical programs and exploring partnerships to maximize the potential of botensilimab and the overall pipeline [19] - The focus is on delivering high-quality medicines and ensuring patient access to innovative treatments [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical programs and the potential impact on patient outcomes [17] - The company is actively exploring discussions with potential partners to enhance its capabilities and maximize the therapeutic potential of its pipeline [19] Other Important Information - The company has presented updates at major medical conferences, showcasing the clinical data generated from its programs [10][12] - The company is also exploring additional programs in combination therapies to expand the therapeutic potential of botensilimab [13] Q&A Session Summary Question: What should be expected at ASCO for AGEN2373? - Management indicated that AGEN2373 is an important product with complementary attributes to patient care, focusing on T-cell activation and memory generation [23] Question: What are the criteria for moving into a randomized trial in non-small cell lung cancer? - Management noted that they are expanding the cohort of lung cancer patients to confirm response rates and are planning a randomized Phase 3 trial based on encouraging early data [30][31] Question: Can you comment on the Fast Track Designation and other regulatory mechanisms? - Management stated that they are keeping regulatory agencies informed about developments and emphasized the meaningful responses seen in heavily pretreated patients [36][38] Question: What is the expected sample size for the randomized trial in non-small cell lung cancer? - Management has not disclosed specific numbers but assured that it will not be excessively large [45] Question: What are the benchmarks for the melanoma cohort study? - Management expects to complete enrollment in the first half of 2023, with data anticipated later in the year [47]

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's financial performance, condition, and related disclosures for the reporting period [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The financial statements for the three months ended March 31, 2023, show a net loss of $70.9 million, an increase from the $50.6 million loss in the same period of 2022. Total assets remained stable at approximately $412.9 million. The company ended the quarter with $164.8 million in cash and cash equivalents, down from $178.7 million at the end of 2022, with cash used in operations totaling $58.5 million [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets provide a snapshot of the company's financial position at specific reporting dates Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 (Unaudited) | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $164,819 | $178,674 | | Total current assets | $205,689 | $213,122 | | **Total assets** | **$412,854** | **$413,556** | | Total current liabilities | $190,898 | $188,952 | | Liability related to sale of future royalties and milestones | $269,386 | $271,263 | | **Total liabilities** | **$465,963** | **$468,458** | | Total stockholders' deficit | ($53,109) | ($54,902) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement outlines the company's revenues, expenses, and resulting net loss for the three-month periods Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | | :--- | :--- | :--- | | Total revenues | $22,902 | $25,941 | | Research and development expense | ($57,118) | ($42,442) | | General and administrative expense | ($18,237) | ($18,953) | | **Operating loss** | **($54,341)** | **($35,461)** | | **Net loss** | **($70,893)** | **($50,604)** | | Net loss per share (Basic & Diluted) | ($0.22) | ($0.19) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement details the cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (in thousands) | Activity | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($58,526) | ($52,391) | | Net cash used in investing activities | ($11,489) | ($7,533) | | Net cash provided by financing activities | $56,250 | $16,038 | | **Net decrease in cash** | **($13,855)** | **($44,222)** | | Cash at end of period | $167,488 | $250,378 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a clinical-stage immuno-oncology firm, its liquidity position, which management deems sufficient for over a year, and key accounting policies. Significant items include revenue recognition from collaborations like Gilead, the accounting for the HCR royalty sale which generated $19.1 million in non-cash revenue, proceeds from 'at-the-market' equity offerings, and subsequent events including further equity sales and a stock dividend of its subsidiary MiNK - The company is a clinical-stage immuno-oncology firm focused on antibodies, adoptive cell therapies (via MiNK), and vaccine adjuvants (via SaponiQx)[17](index=17&type=chunk) - As of March 31, 2023, the company had cash, cash equivalents, and short-term investments of **$189.2 million**. Management believes these resources are sufficient to fund operations for more than one year[19](index=19&type=chunk)[20](index=20&type=chunk) - In Q1 2023, the company recognized **$19.1 million** in non-cash royalty revenue and **$17.2 million** in non-cash interest expense related to the 2018 sale of future royalties to Healthcare Royalty Partners (HCR)[33](index=33&type=chunk)[34](index=34&type=chunk) - During Q1 2023, the company raised approximately **$60.6 million** in net proceeds from the sale of **33.8 million shares** through its 'at-the-market' (ATM) offering[59](index=59&type=chunk) - Subsequent to the quarter's end, from April 1 to May 5, 2023, an additional **$13.6 million** was raised through the sale of **9.2 million shares** via the ATM agreement. The company also paid a stock dividend of **5.0 million shares** of its subsidiary MiNK to Agenus stockholders[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on immuno-oncology, highlighting its lead asset botensilimab and key collaborations. For Q1 2023, R&D expenses increased by 35% to $57.1 million due to advancing antibody programs, while G&A expenses decreased by 4%. The company's liquidity is supported by $189.2 million in cash and equivalents as of March 31, 2023, and ongoing 'at-the-market' equity sales, which management believes is sufficient to fund operations for over a year [Overview](index=17&type=section&id=Overview) This section provides a high-level summary of the company's strategic focus and key therapeutic programs - Agenus is a clinical-stage immuno-oncology company developing antibodies, adoptive cell therapies (via MiNK), and vaccine adjuvants (via SaponiQx)[69](index=69&type=chunk) - The lead program, botensilimab (AGEN1181), is advancing in multiple clinical trials for cancers such as colorectal, melanoma, and pancreatic cancer[70](index=70&type=chunk)[71](index=71&type=chunk) - The company maintains strategic collaborations with major pharmaceutical companies including Bristol-Myers Squibb (BMS), Gilead, Incyte, and Merck, which provide milestone payments and potential royalties[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing revenue streams and expense trends for the period Revenue and Expense Comparison (in millions) | Item | Q1 2023 | Q1 2022 | Change Driver | | :--- | :--- | :--- | :--- | | R&D Revenue | $2.6 | $6.7 | Decrease due to a $5.0M milestone from Gilead in Q1 2022 not recurring | | Non-cash Royalty Revenue | $19.1 | $17.6 | Increase due to higher net sales of GSK's vaccines containing QS-21 STIMULON | | R&D Expense | $57.1 | $42.4 | 35% increase due to advancement of antibody programs | | G&A Expense | $18.2 | $19.0 | 4% decrease due to reduced professional fees | R&D Program Expenses (in thousands) | Program | Three Months Ended March 31, 2023 | | :--- | :--- | | Antibody programs | $41,835 | | Vaccine adjuvant | $4,088 | | Cell therapies | $4,326 | | Other R&D programs | $6,869 | | **Total R&D expenses** | **$57,118** | [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's cash position, funding strategies, and ability to meet its financial obligations - The company had an accumulated deficit of **$1.8 billion** as of March 31, 2023, and has historically financed operations through partnerships, royalty sales, and equity issuances[90](index=90&type=chunk) - Cash, cash equivalents, and short-term investments were **$189.2 million** at March 31, 2023. Management believes this is sufficient to satisfy liquidity needs for more than one year[95](index=95&type=chunk)[96](index=96&type=chunk) - The company actively uses an 'at-the-market' (ATM) sales agreement, raising a total of **$74.2 million** in net proceeds from January 1 through May 5, 2023[91](index=91&type=chunk)[92](index=92&type=chunk) - Net cash used in operating activities was **$58.5 million** for the three months ended March 31, 2023, compared to **$52.4 million** for the same period in 2022[100](index=100&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are foreign currency exchange rate fluctuations, due to its international subsidiaries, and interest rate changes impacting its investment income. Agenus does not currently use derivative instruments for hedging. Its investment policy prioritizes principal preservation and liquidity, with investments primarily in money market funds and U.S. Treasury Bills - Primary market risk exposures are identified as foreign currency exchange rate risk and interest rate risk[101](index=101&type=chunk) - Foreign currency exposure is mainly concentrated in the British Pound, Euro, and Swiss Franc due to foreign subsidiaries. The company does not currently use hedging strategies[101](index=101&type=chunk) - The company's cash and investments of **$189.2 million** are exposed to interest rate changes. Due to the short-term nature of these investments (money market funds, U.S. Treasury Bills), the carrying value approximates fair value[102](index=102&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Principal Executive Officer and Principal Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2023. There were no material changes to the company's internal control over financial reporting during the quarter - Based on an evaluation, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[105](index=105&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[106](index=106&type=chunk) [PART II - OTHER INFORMATION](index=23&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides disclosures on legal proceedings, updated risk factors, and a list of filed exhibits [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it is not a party to any material legal proceedings - Agenus reports that it is not party to any material legal proceedings[108](index=108&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 - There have been no material changes to the risk factors described in the company's 2022 Form 10-K[109](index=109&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications (Exhibits 31.1, 31.2, 32.1) and XBRL data files - The report lists certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents, as exhibits[110](index=110&type=chunk)

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, 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 (I.R.S. Employer i ...

Agenus Inc. (NASDAQ:AGEN) Q4 2022 Results Conference Call March 14, 2023 8:30 AM ET Company Participants Zack Armen - Head, Investor Relations Dr. Garo Armen - Chairman and Chief Executive Officer Dr. Steven O'Day - Chief Medical Officer Christine Klaskin - Vice President of Finance Conference Call Participants Matt Phillips - William Blair Mayank Mamtani - B. Riley Emily Bodnar - H.C. Wainwright Mike King - EF Hutton David Dai - SMBC Kelly Shi - Jefferies Operator Thank you for holding and welcome, everyon ...

Agenus Highlights - Agenus's Botensilimab is an Fc-enhanced anti-CTLA-4 antibody with broad franchise potential, showing unprecedented clinical responses in 9 cold and treatment-resistant cancers[6] - Agenus has a deep clinical pipeline addressing complementary mechanisms, with 12 clinical-stage antibody programs advancing in 12 unique combinations, by Agenus and through partnerships[6] - Agenus has a proven R&D engine with a track record of value creation through strategic partnerships, generating >$825 million in cash through partnerships, with potential $27 billion milestones remaining[6] Business Development and Financial Status - Agenus has received $825 million in cash from partnerships and transactions[12] - Agenus has $27 billion in potential future milestone payments, in addition to royalties[12] - Agenus had $218 million cash in hand as of September 30, 2022[24] Botensilimab Clinical Data - Botensilimab shows a 23% ORR in MSS CRC with 70 evaluable patients, versus 1-5% ORR for SOC[28] - Botensilimab shows a 26% ORR in Ovarian cancer with 19 evaluable patients, versus 3-10% ORR for SOC[28] - Botensilimab shows a 46% ORR in Sarcoma with 13 evaluable patients, versus 12-16% ORR for SOC[28] - Botensilimab shows a 60% ORR in PD-(L)1 Refractory NSCLC with 5 evaluable patients, versus 6-13% ORR for SOC[28] Partnered Programs - BMS-986442 (AGEN1777) has potential milestone payments of $134 billion and up to mid-teens royalties[12] - INCAGN1876, INCAGN2390, INCAGN2385 have potential milestone payments of $570 million and up to mid-teens royalties[12] - Zalifrelimab (local delivery in urinary tract) has potential milestone payments of $450 million and up to low double-digit royalties[12] - Balstilimab & zalifrelimab (Greater China) have potential milestone payments of $200 million and up to low-twenties royalties[12] - MK-4830 has potential milestone payments of $100 million[12]

Agenus Inc. (NASDAQ:AGEN) Q3 2022 Results Conference Call November 8, 2022 8:30 AM ET Company Participants Nico Frelick - Investor Relations Dr. Garo Armen - Chairman and Chief Executive Officer Christine Klaskin - Vice President of Finance Dr. Steven O'Day - Chief Medical Officer Dhan Chand - Scientific Director, Head of Drug Discovery Conference Call Participants David Dye - SNBC Matt Phipps - William Blair Mayank Mamtani - B. Riley Securities Kelly Shi - Jefferies Operator Thanks for holding, and welcome ...