PART I - FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for Agenus Inc., along with disclosures on market risk and internal controls [ITEM 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents Agenus Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows, with detailed explanatory notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202024%20%28Unaudited%29%20and%20December%2031%2C%202023) Total assets decreased while total liabilities and stockholders' deficit increased from December 2023 to June 2024, driven by current assets and royalty liabilities | Metric | June 30, 2024 (thousands) | December 31, 2023 (thousands) | | :----------------------------------- | :-------------------------- | :---------------------------- | | Total current assets | $100,004 | $112,416 | | Total assets | $292,415 | $313,913 | | Total current liabilities | $270,666 | $255,897 | | Total liabilities and stockholders' deficit | $292,415 | $313,913 | | Total stockholders' deficit | $(220,839) | $(148,382) | - Cash and cash equivalents increased to **$93.7 million** at June 30, 2024, from $76.1 million at December 31, 2023[10](index=10&type=chunk) - Accounts receivable significantly decreased from **$25.8 million to $0.7 million**[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202024%20and%202023%20%28Unaudited%29) Net loss decreased for both three and six months ended June 30, 2024, due to lower operating expenses and higher non-operating income | Metric (thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $23,509 | $25,296 | $51,514 | $48,198 | | Operating loss | $(30,193) | $(54,666) | $(63,076) | $(109,007) | | Net loss | $(54,797) | $(73,430) | $(118,251) | $(144,323) | | Net loss attributable to Agenus Inc. common stockholders | $(53,135) | $(69,069) | $(115,074) | $(137,377) | | Basic and diluted net loss per common share | $(2.52) | $(3.93) | $(5.56) | $(8.22) | - Research and development expenses decreased significantly by **38% for the three months** and **31% for the six months** ended June 30, 2024, compared to the prior year[11](index=11&type=chunk) - Non-cash royalty revenue increased for both periods, reaching **$22.6 million (3 months)** and **$50.3 million (6 months)** in 2024[11](index=11&type=chunk) [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Deficit](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Deficit%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202024%20and%202023%20%28Unaudited%29) Total stockholders' deficit significantly increased from December 2023 to June 2024, primarily due to net losses, partially offset by equity sales | Metric (thousands) | December 31, 2023 | June 30, 2024 | | :----------------------------------- | :---------------- | :------------ | | Common stock, par value $0.01 per share (shares) | 19,718,662 | 21,126,226 | | Additional paid-in capital | $1,796,095 | $1,830,114 | | Accumulated deficit | $(1,955,668) | $(2,070,635) | | Total stockholders' deficit | $(148,382) | $(220,839) | - Net loss for the six months ended June 30, 2024, was **$(118,251) thousand**, contributing to the accumulated deficit[12](index=12&type=chunk) - Additional paid-in capital increased by **$34.0 million**, reflecting proceeds from shares sold at market and share-based compensation[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202024%20and%202023%20%28Unaudited%29) Cash used in operating activities decreased, leading to a net increase in cash, cash equivalents, and restricted cash due to financing activities | Metric (thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(76,371) | $(118,569) |\n| Net cash provided by (used in) investing activities | $(8) | $(10,972) |\n| Net cash provided by financing activities | $93,913 | $94,513 |\n| Net increase (decrease) in cash, cash equivalents and restricted cash | $17,578 | $(35,469) |\n| Cash, cash equivalents and restricted cash, end of period | $97,357 | $145,874 | - Operating cash outflow decreased by **$42.2 million**, largely due to adjustments for non-cash royalty revenue and non-cash interest expense, and favorable changes in accounts receivable and prepaid expenses[16](index=16&type=chunk) - Financing activities provided **$93.9 million**, including proceeds from the Ligand Purchase Agreement ($73.9 million) and sale of equity ($19.2 million)[16](index=16&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes explain Agenus's business, liquidity, accounting policies, and specific financial items including debt, royalties, and equity [Note A – Business, Liquidity and Basis of Presentation](index=12&type=section&id=Note%20A%20%E2%80%93%20Business%2C%20Liquidity%20and%20Basis%20of%20Presentation) Agenus, a clinical-stage biotech, faces going concern doubt despite cash reserves, relying on future funding for its cancer immunotherapy programs - Agenus is a clinical-stage biotechnology company developing cancer immunotherapies through antibody therapeutics, adoptive cell therapies (MiNK Therapeutics), and vaccine adjuvants (SaponiQx)[19](index=19&type=chunk) | Metric | June 30, 2024 (millions) | | :------------------- | :----------------------- | | Cash and cash equivalents | $93.7 | | Accumulated deficit | $2,100 | | Subordinated notes maturing Feb 2025 | $13.0 | - The company has implemented cost-saving measures, including prioritizing its lead asset (botensilimab), postponing other programs, and reducing its workforce by approximately **25% in August 2023**. The CEO has elected to receive salary and bonuses in stock[24](index=24&type=chunk) [Note B – Net Loss Per Share](index=14&type=section&id=Note%20B%20%E2%80%93%20Net%20Loss%20Per%20Share) Basic and diluted net loss per share are identical due to net loss, rendering potentially dilutive securities anti-dilutive - Basic and diluted net loss per common share are identical because the company reported a net loss, rendering potentially dilutive securities anti-dilutive[31](index=31&type=chunk) | Anti-Dilutive Securities (thousands) | Three and Six Months Ended June 30, 2024 | Three and Six Months Ended June 30, 2023 | | :----------------------------------- | :--------------------------------------- | :--------------------------------------- | | Warrants | 965 | 99 | | Stock options | 3,367 | 2,220 | | Non-vested shares | 38 | 27 | | Series A-1 convertible preferred stock | 17 | 17 | [Note C – Investments](index=15&type=section&id=Note%20C%20%E2%80%93%20Investments) Cash equivalents and short-term investments primarily consist of institutional money market funds, classified as cash equivalents | Investment Type (thousands) | June 30, 2024 (Fair Value) | December 31, 2023 (Fair Value) | | :-------------------------- | :------------------------- | :----------------------------- | | Institutional money market funds | $92,243 | $70,485 | | Total | $92,243 | $70,485 | - All listed investments are classified as cash equivalents on the condensed consolidated balance sheets[33](index=33&type=chunk) [Note D – Goodwill and Acquired Intangible Assets](index=15&type=section&id=Note%20D%20%E2%80%93%20Goodwill%20and%20Acquired%20Intangible%20Assets) Goodwill remained stable, while acquired intangible assets decreased due to amortization of intellectual property and finite-lived assets | Asset (thousands) | June 30, 2024 (Net Carrying Amount) | December 31, 2023 (Net Carrying Amount) | | :-------------------------- | :---------------------------------- | :-------------------------------------- | | Goodwill | $24,748 | $24,723 | | Acquired intangible assets, net | $4,136 | $4,411 | - The weighted average amortization period for finite-lived intangible assets is **9 years**[34](index=34&type=chunk) - Amortization expense for acquired intangibles is estimated at **$0.3 million** for the remainder of 2024[34](index=34&type=chunk) [Note E – Debt](index=16&type=section&id=Note%20E%20%E2%80%93%20Debt) Total outstanding debt increased slightly, with a significant portion of 2015 Subordinated Notes classified as current due to near-term maturity | Debt Instrument (thousands) | June 30, 2024 (Current Portion) | December 31, 2023 (Current Portion) | | :-------------------------- | :------------------------------ | :---------------------------------- | | Debentures | $146 | $146 | | 2015 Subordinated Notes | $12,866 | $0 (long-term portion: $12,768) | | Other | $413 | $0 | | Total Current Portion | $13,425 | $146 | - The principal amount of outstanding debt was **$13.6 million** at June 30, 2024, and **$13.1 million** at December 31, 2023[36](index=36&type=chunk) [Note F – Liability Related to the Sale of Future Royalties and Milestones](index=16&type=section&id=Note%20F%20%E2%80%93%20Liability%20Related%20to%20the%20Sale%20of%20Future%20Royalties%20and%20Milestones) Liability for future royalties and milestones significantly increased due to new Ligand proceeds and non-cash interest, partially offset by royalty revenue | Metric (thousands) | Period from December 31, 2023 to June 30, 2024 | | :------------------------------------------------- | :--------------------------------------------- | | Beginning balance | $257,296 | | Proceeds from sale of future royalties and milestones | $63,879 | | Non-cash royalty revenue | $(50,349) | | Non-cash interest expense recognized | $61,134 | | Ending balance, net | $330,718 | [Healthcare Royalty Partners (HCR)](index=16&type=section&id=Healthcare%20Royalty%20Partners) Agenus sold GSK royalty rights to HCR for $190 million, recognizing non-cash royalty revenue and interest expense, with an effective annual interest rate of 48.6% - Agenus sold **100% of its worldwide rights** to receive royalties from GSK on sales of vaccines containing STIMULON QS-21 adjuvant to HCR for **$190.0 million** in January 2018[38](index=38&type=chunk) | Metric (thousands) | Six Months Ended June 30, 2024 | | :------------------------- | :----------------------------- | | Non-cash royalty revenue | $50,300 | | Non-cash interest expense | $59,600 | | Effective annual interest rate | 48.6% | [Ligand Pharmaceuticals](index=18&type=section&id=Ligand%20Pharmaceuticals) Agenus received $75 million from Ligand for future milestones and royalties, recognizing $63.9 million as a liability and $1.6 million in non-cash interest expense - Agenus sold portions of future milestone payments, royalties from Covered License Agreements, and a synthetic royalty on botensilimab and balstilimab to Ligand for **$75.0 million gross proceeds** in May 2024[41](index=41&type=chunk)[43](index=43&type=chunk) | Component (thousands) | Allocation of Gross Proceeds | | :-------------------------- | :--------------------------- | | Liability related to sale of future royalties and milestones | $63,879 | | Ligand Warrant | $7,098 | | Purchaser Upsize Option | $4,023 | | Total | $75,000 | - Non-cash interest expense of **$1.6 million** was recorded related to the Ligand Purchase Agreement for the three and six months ended June 30, 2024, with an estimated effective annual interest rate of **27.9%**[48](index=48&type=chunk)[50](index=50&type=chunk) [Note G – Accrued and Other Current Liabilities](index=20&type=section&id=Note%20G%20%E2%80%93%20Accrued%20and%20Other%20Current%20Liabilities) Accrued liabilities decreased due to reduced payroll and professional fees, while other current liabilities increased, driven by 'Other' liabilities | Accrued Liabilities (thousands) | June 30, 2024 | December 31, 2023 | | :------------------------------ | :------------ | :---------------- | | Payroll | $12,685 | $14,512 | | Professional fees | $5,818 | $7,101 | | Research services | $8,037 | $10,807 | | Total Accrued Liabilities | $41,208 | $45,283 | | Other Current Liabilities (thousands) | June 30, 2024 | December 31, 2023 | | :------------------------------------ | :------------ | :---------------- | | Finance lease liabilities | $9,367 | $10,457 | | Other | $6,969 | $3,458 | | Total Other Current Liabilities | $16,336 | $13,915 | [Note H – Fair Value Measurements](index=20&type=section&id=Note%20H%20%E2%80%93%20Fair%20Value%20Measurements) Assets and liabilities are measured at fair value across Level 1, 2, and 3, with cash equivalents as Level 1 and Ligand option as Level 3 | Asset/Liability (thousands) | June 30, 2024 (Fair Value) | Level 1 | Level 2 | Level 3 | | :---------------------------------- | :------------------------- | :------ | :------ | :------ | | Cash equivalents | $92,243 | $92,243 | $— | $— | | Long-term investments | $1,493 | $1,493 | $— | $— | | Ligand purchaser upsize option | $4,023 | $— | $— | $4,023 | | Contingent purchase price considerations | $318 | $— | $— | $318 | - The Ligand purchaser upsize option is a **Level 3 liability**, valued based on scenario analysis and market participant assumptions[53](index=53&type=chunk)[54](index=54&type=chunk) - Contingent purchase price considerations are **Level 3 liabilities**, valued using Monte Carlo simulations of share price and other factors[55](index=55&type=chunk) [Note I – Revenue from Contracts with Customers](index=22&type=section&id=Note%20I%20%E2%80%93%20Revenue%20from%20Contracts%20with%20Customers) Total revenues increased due to higher non-cash royalty revenue, despite a significant decrease in research and development revenue | Revenue Type (thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $267 | $2,489 | $267 | $5,101 | | Service revenue | $660 | $739 | $898 | $1,923 | | Non-cash royalty revenue | $22,582 | $22,068 | $50,349 | $41,174 | | Total revenues | $23,509 | $25,296 | $51,514 | $48,198 | - Non-cash royalty revenue increased due to higher net sales of GSK's vaccines containing STIMULON QS-21 adjuvant, including AREXVY[125](index=125&type=chunk)[131](index=131&type=chunk) - No revenue was recognized from the Gilead Collaboration Agreement for the three and six months ended June 30, 2024, compared to **$2.0 million and $4.4 million**, respectively, in 2023[58](index=58&type=chunk)[124](index=124&type=chunk)[130](index=130&type=chunk) [Note J – Share-based Compensation Plans](index=24&type=section&id=Note%20J%20%E2%80%93%20Share-based%20Compensation%20Plans) Stockholders approved more shares for the 2019 EIP, with total share-based compensation expense increasing to $13.5 million - Stockholders approved an amendment to the 2019 EIP, increasing available shares by **3.0 million**[64](index=64&type=chunk) | Stock Option Activity (six months ended June 30, 2024) | Number of Options | Weighted Average Exercise Price | | :----------------------------------------------------- | :---------------- | :------------------------------ | | Outstanding at December 31, 2023 | 2,141,360 | $65.00 | | Granted | 1,344,896 | $12.87 | | Outstanding at June 30, 2024 | 3,367,291 | $44.17 | | Share-based Compensation Expense (thousands) | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :------------------------------------------- | :------------------------------- | :----------------------------- | | Research and development | $4,722 | $6,036 | | General and administrative | $4,568 | $7,450 | | Total | $9,290 | $13,486 | [Note K – Restricted Cash](index=26&type=section&id=Note%20K%20%E2%80%93%20Restricted%20Cash) Non-current restricted cash of $3.6 million is held for facility lease letters of credit, included in other long-term assets | Metric (thousands) | June 30, 2024 | December 31, 2023 | | :----------------- | :------------ | :---------------- | | Restricted cash | $3,634 | $3,669 | - Restricted cash is primarily comprised of deposits under letters of credit required under facility leases[72](index=72&type=chunk) [Note L – Equity](index=26&type=section&id=Note%20L%20%E2%80%93%20Equity) Agenus completed a 1-for-20 reverse stock split, issued a warrant to Ligand, and raised $19.2 million from at-the-market offerings - A **1-for-20 reverse stock split** became effective on April 12, 2024, retroactively adjusting all common share and per share data[29](index=29&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) - Net proceeds of approximately **$19.2 million** were received from the sale of 1.4 million common shares in at-the-market offerings during the six months ended June 30, 2024[75](index=75&type=chunk) - A warrant to purchase **867,052 shares of common stock** at an exercise price of $17.30 per share was issued to Ligand Pharmaceuticals on May 6, 2024[44](index=44&type=chunk)[77](index=77&type=chunk) [Note M – Non-controlling Interest](index=28&type=section&id=Note%20M%20%E2%80%93%20Non-controlling%20Interest) Non-controlling interest increased to $20.5 million, driven by subsidiary share sales and share-based compensation, partially offset by net loss | Metric (thousands) | June 30, 2024 | December 31, 2023 | | :----------------------------------- | :------------ | :---------------- | | Beginning balance | $11,949 | $6,376 | | Net loss attributable to non-controlling interest | $(3,284) | $(11,676) | | Sale of subsidiary shares in private placement | $10,234 | $0 | | Subsidiary share-based compensation | $1,560 | $3,825 | | Ending balance | $20,472 | $11,949 | - MiNK Therapeutics, Inc. and SaponiQx, Inc. represent **45% and 30% non-controlling interests**, respectively, as of June 30, 2024[79](index=79&type=chunk) [Sale of subsidiary shares in private placement](index=28&type=section&id=Sale%20of%20subsidiary%20shares%20in%20private%20placement) MiNK Therapeutics, a subsidiary, sold 4.64 million common shares in a private placement, generating approximately $5.8 million net proceeds - MiNK Therapeutics sold **4,640,000 shares** of its Common Stock at $1.25 per share in a private placement, generating approximately **$5.8 million net proceeds**[81](index=81&type=chunk) [Distribution of subsidiary shares to Agenus stockholders](index=28&type=section&id=Distribution%20of%20subsidiary%20shares%20to%20Agenus%20stockholders) Agenus distributed 5.0 million MiNK common shares as a stock dividend to its shareholders on May 1, 2023 - Agenus distributed **5.0 million shares of MiNK common stock** as a stock dividend on May 1, 2023, at a ratio of **0.292 MiNK shares per Agenus common share**[82](index=82&type=chunk)[83](index=83&type=chunk) [Purchase of subsidiary shares](index=28&type=section&id=Purchase%20of%20subsidiary%20shares) Agenus purchased 446,494 MiNK common shares through open market transactions during 2023 - Agenus purchased **446,494 shares of MiNK common stock** in open market transactions during the year ended December 31, 2023[84](index=84&type=chunk) [Note N – Related Party Transactions](index=28&type=section&id=Note%20N%20%E2%80%93%20Related%20Party%20Transactions) No related party transaction expenses were incurred in Q2 2024, contrasting with $450,000 for clinical consulting in the prior year - No expenses were incurred in related party transactions for the three and six months ended June 30, 2024[86](index=86&type=chunk) - For the three and six months ended June 30, 2023, **$222,000 and $450,000**, respectively, were incurred for clinical consulting services from Avillion Life Sciences LTD, a company led by a former Agenus Board member[86](index=86&type=chunk) [Note O – Recent Accounting Pronouncements](index=30&type=section&id=Note%20O%20%E2%80%93%20Recent%20Accounting%20Pronouncements) New FASB ASUs on Segment Reporting and Income Taxes will require incremental disclosures, with Agenus currently evaluating their impact - ASU 2023-07 (Segment Reporting) requires incremental annual and quarterly disclosures about segment profit/loss and expenditures, and all segment disclosures for single reportable segments, effective for fiscal years beginning after **December 15, 2024**[87](index=87&type=chunk) - ASU 2023-09 (Income Taxes) requires incremental annual disclosures for income tax rate reconciliations and taxes paid, effective for fiscal years beginning after **December 15, 2024**[88](index=88&type=chunk) [Note P – Subsequent Events](index=30&type=section&id=Note%20P%20%E2%80%93%20Subsequent%20Events) Agenus sold $6.2 million in common stock and received termination notices for key collaboration agreements with BMS and Gilead - From July 1, 2024, to August 5, 2024, Agenus sold approximately **405,000 shares of common stock**, generating **$6.2 million in net proceeds**[90](index=90&type=chunk) - BMS notified Agenus on July 30, 2024, of its voluntary termination of the AGEN1777 license agreement, effective **January 26, 2025**, with rights reverting to Agenus[92](index=92&type=chunk)[93](index=93&type=chunk) - Gilead elected not to exercise its option to license AGEN2373 on August 5, 2024, formally terminating the agreement[98](index=98&type=chunk) - Incyte announced on July 30, 2024, that it would discontinue further development of LAG-3 and TIM-3 monoclonal antibodies[96](index=96&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and results for Q2 2024, covering revenue, expenses, R&D programs, liquidity, and going concern [Overview](index=33&type=section&id=Overview) Agenus, a clinical-stage biotech, focuses on cancer immunotherapies with botensilimab as its lead program, despite recent collaboration terminations - Agenus is a clinical-stage biotechnology company developing cancer immunotherapies, with integrated capabilities from target discovery to manufacturing[103](index=103&type=chunk)[104](index=104&type=chunk) - The lead program, botensilimab, in combination with balstilimab, received **Fast Track designation** from the FDA for metastatic colorectal cancer and is progressing towards a Phase 3 study[106](index=106&type=chunk) - Recent terminations include BMS License Agreement for AGEN1777 (effective Jan 2025), Gilead's option for AGEN2373 (Aug 2024), and Incyte's discontinuation of LAG-3 and TIM-3 monoclonal antibodies[108](index=108&type=chunk)[109](index=109&type=chunk)[111](index=111&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) [Historical Results of Operations](index=39&type=section&id=Historical%20Results%20of%20Operations) Details financial performance for Q2 2024 vs. 2023, showing decreased R&D/G&A expenses, increased non-cash royalty revenue, and higher interest expense [Three months ended June 30, 2024 compared to the three months ended June 30, 2023](index=39&type=section&id=Three%20months%20ended%20June%2030%2C%202024%20compared%20to%20the%20three%20months%20ended%20June%2030%2C%202023) Q2 2024 saw decreased R&D revenue, increased non-cash royalty revenue, reduced operating expenses, higher non-operating income, and sharply rising interest expense | Metric (thousands) | Q2 2024 | Q2 2023 | Change ($) | Change (%) | | :------------------------- | :------ | :------ | :--------- | :--------- | | Research and development revenue | $267 | $2,489 | $(2,222) | -89.3% | | Non-cash royalty revenue | $22,582 | $22,068 | $514 | 2.3% | | Research and development expense | $36,771 | $59,285 | $(22,514) | -38.0% | | General and administrative expense | $16,816 | $20,415 | $(3,599) | -17.6% | | Non-operating income (expense) | $7,141 | $(244) | $7,385 | >100% | | Interest expense, net | $31,745 | $18,520 | $13,225 | 71.4% | - R&D expense decrease was primarily due to a **$14.3 million reduction** in third-party services, a **$3.8 million decrease** in personnel, and a **$6.1 million decrease** in subsidiary activities[126](index=126&type=chunk) - Non-operating income benefited from a **$5.5 million gain** on early termination of two operating leases and UK R&D tax credits[128](index=128&type=chunk) [Six months ended June 30, 2024 compared to the six months ended June 30, 2023](index=41&type=section&id=Six%20months%20ended%20June%2030%2C%202024%20compared%20to%20the%20six%20months%20ended%20June%2030%2C%202023) H1 2024 saw significant R&D revenue decline, increased non-cash royalty revenue, decreased R&D/G&A expenses, and doubled interest expense | Metric (thousands) | H1 2024 | H1 2023 | Change ($) | Change (%) | | :------------------------- | :------ | :------ | :--------- | :--------- | | Research and development revenue | $267 | $5,101 | $(4,834) | -94.8% | | Non-cash royalty revenue | $50,349 | $41,174 | $9,175 | 22.3% | | Research and development expense | $80,696 | $116,402 | $(35,706) | -30.7% | | General and administrative expense | $33,672 | $38,653 | $(4,981) | -12.9% | | Non-operating income (expense) | $6,036 | $(204) | $6,240 | >100% | | Interest expense, net | $61,211 | $35,112 | $26,099 | 74.3% | - R&D expense decrease was primarily due to a **$21.7 million reduction** in third-party services, a **$5.9 million decrease** in personnel, and a **$10.5 million decrease** in subsidiary activities[132](index=132&type=chunk) - Non-operating income increased due to a **$5.5 million gain** on early lease terminations and UK R&D tax credits[134](index=134&type=chunk) [Research and Development Programs](index=41&type=section&id=Research%20and%20Development%20Programs) R&D expenses decreased to $80.7 million due to reduced antibody program costs, with substantial future expenditures anticipated for clinical trials | Program (thousands) | Six Months Ended June 30, 2024 | Year Ended December 31, 2023 | | :-------------------------- | :----------------------------- | :--------------------------- | | Antibody programs | $54,807 | $178,445 | | Vaccine adjuvant | $1,373 | $10,296 | | Cell therapies | $4,638 | $16,283 | | Other research and development programs | $19,878 | $29,545 | | Total research and development expenses | $80,696 | $234,569 | - The total cost of any particular clinical trial is dependent on factors such as trial design, length, number of sites, number of patients, and sponsorship[138](index=138&type=chunk) - The company cannot reliably estimate the cost or timing of completing R&D programs or bringing products to market due to the lengthy, expensive, and uncertain regulatory approval process[138](index=138&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and cash equivalents increased to $93.7 million, but Agenus faces going concern doubt due to accumulated deficit and reliance on future funding | Metric | June 30, 2024 (millions) | December 31, 2023 (millions) | | :------------------------ | :----------------------- | :--------------------------- | | Cash and cash equivalents | $93.7 | $76.1 | | Accumulated deficit | $2,100 | $1,955.7 | | Debt outstanding | $13.6 | $13.1 | - Net cash used in operating activities decreased to **$76.4 million** for the six months ended June 30, 2024, from $118.6 million in 2023[147](index=147&type=chunk) - The company relies on corporate partnerships, advance royalty sales, and equity issuances for funding and is actively pursuing additional funding through out-licensing, partnering, asset sales, and further royalty monetization[143](index=143&type=chunk)[144](index=144&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is foreign currency exchange rate exposure in GBP and EUR, with interest rate risk on cash equivalents mitigated by short-term investments - Primary market risk exposure is foreign currency exchange rate risk, concentrated in the British Pound and Euro[148](index=148&type=chunk) - The company does not currently employ specific strategies like derivative instruments or hedging to manage foreign currency exposures[148](index=148&type=chunk) - Cash and cash equivalents of **$93.7 million** are exposed to interest rate changes, but due to the short-term nature of money market fund investments, carrying value approximates fair value[149](index=149&type=chunk) [ITEM 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2024, with no material changes in internal control over financial reporting - Disclosure controls and procedures were effective as of June 30, 2024, ensuring timely and accurate reporting of information[152](index=152&type=chunk)[153](index=153&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2024[154](index=154&type=chunk) PART II - OTHER INFORMATION This section covers legal proceedings, updated risk factors, other information including trading plans and agreement terminations, and a list of exhibits and signatures [ITEM 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) Agenus is not a party to any material legal proceedings, but ordinary course claims could still have adverse effects - Agenus is not currently a party to any material legal proceedings[157](index=157&type=chunk) - Litigation, even if not material, can adversely affect the company due to defense/settlement costs and diversion of management resources[157](index=157&type=chunk) [ITEM 1A. Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors highlight high dependence on clinical-stage programs like botensilimab and the adverse impact of recent collaboration terminations - The business is highly dependent on the success of clinical-stage programs, particularly botensilimab and related combination therapies, which require significant additional clinical development and regulatory approval[159](index=159&type=chunk)[160](index=160&type=chunk) - Positive clinical results to date may not be predictive of final trial results or sufficient for regulatory approval, and the FDA has expressed concerns regarding accelerated approval for botensilimab[161](index=161&type=chunk)[162](index=162&type=chunk) - The termination of collaboration agreements with BMS (AGEN1777) and Gilead (AGEN2373) will delay or terminate clinical development, manufacturing, regulatory approval, and commercialization efforts for these assets, eliminating future milestone payments or royalties from these partners[164](index=164&type=chunk) [ITEM 5. Other Information](index=49&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated trading plans, and the Gilead Option and License Agreement for AGEN2373 was terminated [Trading Plans of Our Directors and Officers](index=49&type=section&id=Trading%20Plans%20of%20Our%20Directors%20and%20Of%20icers) No directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements in Q2 2024 - No directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2024[165](index=165&type=chunk) [Gilead Option and License Agreement Termination](index=49&type=section&id=Gilead%20Option%20and%20License%20Agreement%20Termination) Gilead terminated its option to license AGEN2373 on August 5, 2024, following previous terminations for AGEN1423 and AGEN1223 - Gilead elected not to exercise the option to license AGEN2373 on August 5, 2024, formally terminating the agreement[167](index=167&type=chunk) - This termination follows Gilead's previous decisions to return AGEN1423 (November 2020) and terminate the option for AGEN1223 (October 2021)[166](index=166&type=chunk) [ITEM 6. Exhibits](index=50&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with Form 10-Q, including corporate amendments, the Ligand agreement, and executive officer certifications - Includes Certificate of Eighth Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. filed on **April 5, 2024**[170](index=170&type=chunk) - Lists the Purchase and Sale Agreement with Ligand Pharmaceuticals Incorporated, dated **May 6, 2024**[170](index=170&type=chunk) - Contains certifications from the Principal Executive Officer and Principal Financial Officer pursuant to the Securities Exchange Act of 1934 and the Sarbanes-Oxley Act of 2002[170](index=170&type=chunk) [Signatures](index=54&type=section&id=Signatures) The report is signed by Christine M. Klaskin, VP, Finance, Principal Financial Officer, and Principal Accounting Officer, on August 8, 2024 - The report was signed by Christine M. Klaskin, VP, Finance, Principal Financial Officer, and Principal Accounting Officer, on **August 8, 2024**[175](index=175&type=chunk)[176](index=176&type=chunk)

Company Performance - Agenus reported a quarterly loss of $2.52 per share, significantly worse than the Zacks Consensus Estimate of a loss of $1.33, and an improvement from a loss of $4 per share a year ago, indicating a surprise of -89.47% [1] - The company posted revenues of $23.51 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 63.68%, and down from $25.3 million in the same quarter last year [1] - Over the last four quarters, Agenus has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [1] Stock Performance - Since the beginning of the year, Agenus shares have lost approximately 69.3%, contrasting with the S&P 500's gain of 9% [2] - The current consensus EPS estimate for the upcoming quarter is -$2.92 on revenues of $33.48 million, and for the current fiscal year, it is -$10.73 on revenues of $190.34 million [4] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Agenus belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [5] - Another company in the same industry, Urogen Pharma, is expected to report a quarterly loss of $0.82 per share, reflecting a year-over-year change of +20.4%, with revenues anticipated to be $23.69 million, up 12% from the previous year [5][6]

The market expects Agenus (AGEN) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on August 8, 2024, might help the stock move higher if these key numbers are better ...

LOS ANGELES, July 22, 2024 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Agenus Inc. ("Agenus" or "the Company") (NASDAQ: AGEN) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Agenus is the subject of a Benzinga report published on July 18, 2024. According to the ...

Loading...Loading...Thursday, Agenus Inc. AGEN announced the results of its end-of-Phase 2 meeting with the FDA to advance its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for adult patients with relapsed/refractory microsatellite-stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).The FDA discouraged the accelerated approval pathway and advised against submitting these results to support an Accelerated Approval based on its view that objective response rates ...

Company Overview - Agenus Inc. (AGEN) shares fell 58.8% on July 18 following the FDA's discouragement of the accelerated approval pathway for its immunotherapy combination botensilimab (BOT) and balstilimab (BAL) in treating relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) [1] - The FDA indicated that the objective response rate (ORR) from the phase II study may not translate into a survival benefit [1] Clinical Study Results - Interim data from a phase II study showed that the BOT/BAL combination at a dose of 75 mg BOT and 240 mg BAL achieved an ORR of 19.4%, with 90% of patients alive at this dosage [1] - The FDA has agreed on the dosing regimen for a phase III study, which includes BOT (75 mg) every six weeks for up to four doses and BAL (240 mg) every two weeks for up to two years [2] Future Developments - The FDA has proposed including a BOT monotherapy arm in the phase III study, and Agenus is seeking a partner in the U.S. for this study [2] - Apart from colorectal cancer, the BOT/BAL combination has shown clinical activity in other cancer types, including lung cancer, melanoma, and pancreatic cancers [3] Market Performance - Year-to-date, Agenus shares have declined 55.9%, contrasting with a 1.4% decline in the industry [2]

Core Viewpoint - Agenus Inc. is under investigation for potential securities fraud and unlawful business practices following a significant stock price drop after an unfavorable FDA meeting regarding its immunotherapy combination [1][2]. Group 1: Company Developments - On July 18, 2024, Agenus announced the results of its end-of-Phase 2 meeting with the FDA concerning its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for treating adult patients with relapsed/refractory microsatellite stable colorectal cancer [2]. - The FDA advised against the submission of results for Accelerated Approval, indicating that the objective response rates may not translate to a survival benefit [2]. Group 2: Market Reaction - Following the FDA's announcement, Agenus's stock price fell by $10.43 per share, representing a decline of 58.83%, closing at $7.30 per share on July 18, 2024 [2]. Group 3: Legal Context - Pomerantz LLP is investigating claims on behalf of investors of Agenus, focusing on potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Core Insights - Agenus (NASDAQ:AGEN) stock is experiencing a significant decline following the results from a Phase 2 clinical trial for its colorectal cancer treatment, botensilimab and balstilimab [1] - The FDA advised against seeking Accelerated Approval for the treatment due to the lack of evidence that the objective response rates translate to survival benefits, which delays the development process [1] - The company remains committed to exploring all possible pathways to make the treatment available, including potential partnerships for a successful Phase 3 trial [2] Stock Movement - AGEN stock is down 54.5% as of Thursday morning, with heavy trading volume of approximately 5.2 million shares, significantly above the daily average of about 763,000 shares [3]

Human life expectancy has doubled since the 1900s, mostly attributed to advancements in lifestyle, living standards and medicine. Thanks to biotech companies that produce transformative drugs and treatments, we now have the collective ability to combat diseases that used to bring entire nations down. And it’s getting better all the time. So, it’s no surprise that investors are looking at biotech stocks to buy. A lot of money is to be made, especially if their prices skyrocket. However, investing in biotech ...

Small-cap stocks could get a boost from the central bank's anticipated rate cuts in 2025. These three stocks may be a great way to get ahead of this catalyst.Small-cap and mid-cap stocks tend to be interest rate sensitive. The core reason is that many of these companies are dependent on debt instruments to meet their long-term financial obligations. Although the Federal Reserve is wobbling on a possible rate reduction this year due to sticky inflation, the central bank is widely expected to slash rates no l ...