Xencor(US:XNCR)2025-11-05 21:03Drug Development and Clinical Trials - The company is conducting Phase 1 and Phase 2 studies for a broad portfolio of XmAb drug candidates targeting serious diseases, including cancer [106]. - XmAb819 demonstrated a 25% partial response rate and a 70% disease control rate in a Phase 1 study with 69 heavily pre-treated patients [112]. - XmAb942, an investigational anti-TL1A antibody, showed a human half-life of over 71 days, supporting a 12-week dosing interval during maintenance treatment [116]. - Zenas BioPharma's obexelimab met the primary endpoint in the Phase 2 MoonStone trial for relapsing multiple sclerosis, utilizing the company's XmAb technology [124]. - Amgen initiated the Phase 3 Xalience study of xaluritamig in chemotherapy-naïve metastatic castration-resistant prostate cancer in Q3 2025 [126]. - Astellas presented the first clinical data from ASP2138 for CLDN18.2-positive cancers at the ESMO congress in October 2025 [127]. - XmAb657 demonstrated over 99.98% B-cell reduction in non-human primate studies, with a half-life estimated at 15 days, indicating potential for durable B-cell depletion [119]. - The company is evaluating plamotamab in rheumatoid arthritis after receiving regulatory authorization for a Phase 1b study in Q2 2025 [117]. Financial Performance - Total revenue for the three months ended September 30, 2025, increased by $3.2 million, and for the nine months, it increased by $39.6 million compared to the same periods in 2024, primarily driven by revenue recognition from Alexion and Incyte license agreements [138]. - Non-cash royalty revenue from Alexion was $18.7 million for the three months ended September 30, 2025, compared to $15.7 million in 2024, and $51.0 million for the nine months ended September 30, 2025, compared to $42.1 million in 2024 [140]. - Research and development expenses decreased by $3.9 million for the three months and $2.0 million for the nine months ended September 30, 2025, compared to the same periods in 2024, primarily due to lower stock-based compensation [145]. - Other income increased by $33.7 million for the three months and $63.6 million for the nine months ended September 30, 2025, compared to the same periods in 2024, driven by realized and unrealized gains from marketable equity securities [147]. - Cash flow used in operating activities was $83.4 million for the nine months ended September 30, 2025, a decrease of $68.9 million compared to $152.4 million in 2024, primarily due to higher milestone receipts [149]. - As of September 30, 2025, the company had $633.9 million in cash, cash equivalents, and marketable debt securities, down from $706.7 million as of December 31, 2024 [151]. - Total operating expenses for the three months ended September 30, 2025, were $68.5 million, a decrease of $4.5 million compared to $72.9 million in 2024 [137]. - The operating loss for the three months ended September 30, 2025, was $47.5 million, an improvement of $7.7 million compared to $55.2 million in 2024 [137]. - The company recognized $2.3 million in non-cash royalty revenue from Incyte for the three months ended September 30, 2025, compared to $2.1 million in 2024 [143]. - The FDA approved Incyte's supplemental biologics license application in June 2025, triggering a $25.0 million milestone payment to the company [142]. Future Outlook and Financial Strategy - The company aims to retain major economic interests in partnerships, including profit-sharing and co-development options [121]. - The company expects to continue receiving payments for research and development services, but future milestone and contingent payments remain uncertain [153]. - Current financial resources are believed to be sufficient to fund operations for at least the next twelve months [154]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained [155]. - Operating expenses are expected to increase due to ongoing clinical and preclinical development of product candidates [155]. - Existing cash, cash equivalents, marketable securities, and potential milestone payments are projected to fund operating expenses and capital expenditures into 2028 [157]. - There were no material changes to specific contractual obligations during the three and nine months ended September 30, 2025 [158]. - There have been no material changes in the company's exposure to market risk since the last annual report [160]. Capital Raising Activities - The company has entered into a Sales Agreement to offer and sell up to $200.0 million in shares of common stock, with no shares issued as of September 30, 2025 [152].