PASADENA, Calif.--
Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical firm focused on engineered antibodies for
cancer and other severe diseases, has released its financial outcomes for the third quarter ending September 30, 2024. They also provided insights into their recent business and clinical-stage program developments.
In September, Xencor presented updates on their XmAb® bispecific T-cell engagers in oncology and introduced new autoimmune programs. These include bispecific antibodies like
plamotamab and
XmAb657, targeting B-cell depletion, and
XmAb942, an anti-
TL1A antibody aimed at
inflammatory bowel disease (IBD). XmAb942 has moved into a Phase 1 dose-escalation study in healthy volunteers. According to Bassil Dahiyat, Ph.D., president and CEO of Xencor, the company is striving to focus on programs that leverage their protein engineering capabilities while reducing exposure to biological uncertainties, thereby enhancing clinical success opportunities. They are optimistic about Amgen's progress with xaluritamig, a STEAP1 x CD3 T-cell engager for prostate cancer, which is set to enter Phase 3 trials later this year.
Xencor has announced new clinical development plans for plamotamab (CD20 x CD3) and introduced new drug candidates including XmAb657 (CD19 x CD3) for treating autoimmune and inflammatory diseases. Plamotamab and XmAb657 potentially address significant unmet needs in autoimmune diseases through targeted B-cell depletion. XmAb942 (Xtend™ anti-TL1A) and another drug candidate from the XmAb TL1A x IL-23 program aim to meet the needs of patients with IBD, such as Crohn’s disease and ulcerative colitis.
On September 12, 2024, Xencor closed an underwritten public offering of common stock and pre-funded warrants, raising $201.3 million in gross proceeds.
For their internal clinical-stage programs, XmAb942 showed preclinical data during United European Gastroenterology Week, and a Phase 1 first-in-human study began dosing healthy volunteers. Xencor expects initial data from this study's single-ascending dose portion in the first half of 2025.
In the case of plamotamab (CD20 x CD3), Xencor completed a Phase 1 clinical study in hematologic cancers. They plan to present data from subcutaneous dosing cohorts in non-Hodgkin’s lymphoma patients at the 66th American Society of Hematology Annual Meeting. Xencor intends to evaluate plamotamab in rheumatoid arthritis in patients who have not responded to standard treatments, with plans to initiate a Phase 1b/2a proof-of-concept study in the first half of 2025.
XmAb808 (B7-H3 x CD28) has shown dose-limiting toxicities in the highest dose cohort of its ongoing Phase 1 study, causing one patient to experience an infusion-related reaction and another to suffer immune-related hepatitis. Despite this, maximum tolerated dose has not been defined yet. Xencor is analyzing the data and continuing dose escalation per protocol.
XmAb819 (ENPP3 x CD3) showed initial evidence of anti-tumor activity in a Phase 1 dose-escalation study in advanced clear cell renal cell carcinoma patients. The treatment duration for several patients surpassed one year. Xencor expects to reach target dose levels by the year-end and will provide a clinical update in the first half of 2025.
Amgen, Xencor's collaboration partner, shared results from a Phase 1 study of xaluritamig at the European Society for Medical Oncology Congress in September 2024. The study, focused on metastatic castration-resistant prostate cancer (mCRPC), showed a median overall survival of 17.7 months, with a PSA90 rate of 45.1% observed in high-dose cohorts. Amgen plans to begin a Phase 3 study in patients with post-taxane mCRPC in Q4 2024.
Financially, Xencor reported $754.3 million in cash, equivalents, and marketable debt securities as of September 30, 2024, compared to $697.0 million on December 31, 2023. Revenues for Q3 2024 were $10.7 million, down from $59.2 million in Q3 2023. Research and development expenses decreased to $58.2 million from $64.9 million, while general and administrative expenses rose to $14.8 million from $12.5 million. Xencor reported a net loss of $45.1 million for Q3 2024, compared to $24.3 million in Q3 2023.
Looking ahead, Xencor anticipates ending 2024 with $690-$710 million in cash, funding operations and R&D into 2028. The company continues to advance its engineered antibody treatments for cancer and other severe diseases, utilizing its XmAb technology to create novel therapeutic mechanisms.
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