Agenus(US:AGEN)2023-11-08 16:00Financial Performance - Research and development revenue for Q3 2023 was approximately $3.4 million, down from $4.6 million in Q3 2022, primarily due to deferred revenue recognition under Gilead Collaboration Agreements[98] - Non-cash royalty revenue from GSK increased by $11.1 million to approximately $20.4 million for Q3 2023, compared to $9.2 million in Q3 2022, driven by higher vaccine sales and milestone achievements[100] - Research and development expenses rose 12% to $51.4 million for Q3 2023, up from $46.0 million in Q3 2022, primarily due to increased third-party services and personnel costs[101] - General and administrative expenses increased by 4% to $18.9 million for Q3 2023, compared to $18.1 million in Q3 2022, mainly due to higher personnel costs[102] - Interest expense, net increased to approximately $18.6 million for Q3 2023 from $15.6 million in Q3 2022, attributed to higher non-cash interest and finance lease expenses[103] - Non-cash royalty revenue for the nine months ended September 30, 2023, increased by $34.5 million to approximately $61.5 million, compared to $27.0 million for the same period in 2022[105] - Research and development expenses for the nine months ended September 30, 2023, increased by 26% to $167.8 million from $133.4 million in the same period of 2022[106] - General and administrative expenses for the nine months ended September 30, 2023, rose by 3% to $57.6 million, compared to $56.0 million in the same period of 2022[108] - Interest expense, net for the nine months ended September 30, 2023, increased to approximately $53.7 million from $44.5 million in the same period of 2022[110] - Net cash used in operating activities for the nine months ended September 30, 2023, was $183.8 million, compared to $128.0 million for the same period in 2022[125] Assets and Funding - As of September 30, 2023, the company had an accumulated deficit of $1.9 billion and cash, cash equivalents, and short-term investments of $106.3 million[113][118] - The company anticipates additional funding from a milestone payment expected by the end of 2023 and is in discussions to sell non-strategic assets valued at approximately $65.0 million[120] - Cash, cash equivalents, and short-term investments at September 30, 2023, totaled $106.3 million, which are subject to interest rate fluctuations[127] Research and Development - The lead asset, botensilimab, showed a 12-month overall survival rate of 74% in a Phase 1 study of 70 patients with refractory microsatellite stable metastatic colorectal cancer, compared to a median overall survival of 12.9 months for standard care[82] - The botensilimab/balstilimab combination received Fast Track designation from the FDA for treating non-MSI-H/dMMR metastatic colorectal cancer patients without active liver involvement[83] - The company aims to file its first biologics license application for the botensilimab/balstilimab combination in colorectal cancer by mid-2024[83] - MiNK Therapeutics, a subsidiary, is developing unmodified and engineered iNKT cell therapies, with a Phase 1 trial showing a 42% tumor reduction in a patient with metastatic gastric cancer[97] - The company has a pipeline of novel allogeneic iNKT therapies for treating cancer and other immune-mediated diseases[83] - The company has established collaborations with several firms, resulting in over a dozen antibody programs currently in pre-clinical or clinical development[84] Collaborations and Milestones - The company is eligible to receive up to $315 million in potential milestone payments from Incyte, along with royalties on future sales, following the termination of certain programs[85] - Under the collaboration with Merck, the company is eligible for up to $85 million in potential milestone payments and royalties on future sales for a monospecific antibody targeting ILT4[86] Investment and Risk Management - The investment policy prohibits investing in structured investment vehicles and asset-backed commercial paper, focusing on preserving principal and maintaining liquidity[129] - The investment policy specifies credit quality standards and limits credit exposure from any single issue or issuer[129] - The company does not invest in derivative financial instruments, indicating no material market risk exposure related to derivatives[129] - The company does not currently employ specific strategies to manage foreign currency exchange rate risks, which are primarily concentrated in the British Pound, Euro, and Swiss Franc[126] - There has been no material change to the company's interest rate exposure since the last annual report[128] - The company’s interest income fluctuates with changes in interest rates due to the nature of its investments[127] - Approximately 0.9% of cash used in operations for the nine months ended September 30, 2023, was from foreign subsidiaries, down from 1.7% for the year ended December 31, 2022[126] Future Outlook - Future cash generation will depend on achieving regulatory approval and market acceptance of product candidates[125]