Xencor(US:XNCR)2023-11-07 23:00Clinical Development - The company is advancing a broad portfolio of clinical-stage XmAb® drug candidates, currently enrolling Phase 1 or Phase 2 studies for seven candidates targeting various cancers and one for autoimmune disease [127]. - Vudalimab, a bispecific antibody targeting PD-1 and CTLA-4, is undergoing a Phase 2 study for metastatic castration-resistant prostate cancer (mCRPC), with plans to evaluate it as a first-line treatment for non-small cell lung cancer by the end of 2023 [128]. - XmAb564, an engineered IL-2-Fc fusion protein, showed durable, dose-dependent expansion of regulatory T cells in a Phase 1a study, and is currently in a Phase 1b study for atopic dermatitis or psoriasis [129][130]. - XmAb819, targeting ENPP3 and CD3, is in a Phase 1 study for advanced clear cell renal cell carcinoma (RCC) [131]. - XmAb808, a bispecific antibody for solid tumors, is in a Phase 1 study in combination with pembrolizumab, demonstrating strong potentiation of cytotoxic activity [132]. - Amgen is advancing Xaluritamig (AMG 509), a bispecific antibody for prostate cancer, with encouraging interim clinical results presented at the ESMO Congress [147]. - Gilead initiated a Phase 2 study with two antibody candidates developed using the company's Fc technologies, resulting in a $6.0 million milestone [153]. - Janssen submitted an IND for a bispecific candidate developed under a collaboration agreement, resulting in a $7.5 million milestone payment, with a Phase 1 study expected to start in 2023 or early 2024 [148][149]. Financial Performance - The company earned $6.6 million in estimated royalties from the commercialization of Monjuvi® (tafasitamab) for the nine months ended September 30, 2023 [143]. - Ultomiris generated $20.0 million in sales milestone in Q3 2023, contributing to a total of $53.4 million in milestones and royalties for the nine months ended September 30, 2023 [151]. - Total revenues for Q3 2023 were $59.2 million, a 31.9 million increase from $27.3 million in Q3 2022 [161]. - Research collaboration revenue increased to $21.1 million for the nine months ended September 30, 2023, up from $2.1 million in the same period of 2022 [169]. - Milestone revenue for the nine months ended September 30, 2023 was $61.0 million, a significant increase from $5.0 million in 2022 [169]. - Royalties decreased to $41.5 million for the nine months ended September 30, 2023, down from $135.9 million in 2022, reflecting a decline of $94.4 million [169]. - The net loss for Q3 2023 was $24.2 million, an improvement from a net loss of $32.8 million in Q3 2022 [161]. - As of September 30, 2023, the accumulated deficit was $445.3 million, primarily due to expenses related to product candidate development and research activities [160]. Research and Development Expenses - Research and development expenses for Q3 2023 were $64.9 million, an increase of $11.6 million compared to $53.3 million in Q3 2022 [163]. - Research and development expenses increased by $41.3 million to $189.4 million for the nine months ended September 30, 2023, compared to $148.1 million in 2022, primarily due to increased spending on new development programs [174]. - Total external research and development expenses rose to $86.0 million in 2023 from $66.5 million in 2022, an increase of $19.5 million [174]. Cash and Funding - Cash used in operating activities was $96.1 million for the nine months ended September 30, 2023, compared to cash provided of $48.9 million in 2022, reflecting a decrease of $145.0 million [178]. - As of September 30, 2023, the company had $541.4 million in cash, cash equivalents, receivables, and marketable debt securities, down from $613.5 million at the end of 2022 [182]. - The company expects existing cash and potential milestone payments to fund operations into 2027, based on current operating plans [187]. - The company has a sales agreement to issue and sell up to $200 million of common stock, but has not sold any shares under this agreement to date [185]. Operating Expenses - Total operating expenses for the nine months ended September 30, 2023 were $227.3 million, up from $182.8 million in 2022, reflecting an increase of $44.5 million [169]. - General and administrative expenses increased by $3.2 million to $37.9 million for the nine months ended September 30, 2023, compared to $34.7 million in 2022 [175]. - Other expense, net was $3.4 million for the nine months ended September 30, 2023, up from $2.2 million in 2022, primarily due to unrealized losses from equity investments [176]. Revenue Generation - The company has not generated revenue from product sales to date and does not expect to do so until regulatory approval is obtained [186]. - The company received $215.0 million from a sale of royalties and milestones related to Ultomiris and Monjuvi on November 3, 2023 [191].