Exelixis Inc. reports developments from its oncology business, including commercial performance for the cabozantinib franchise and clinical and regulatory updates across cancer programs. The company discovers, develops and commercializes cancer medicines, with CABOMETYX® (cabozantinib) as its flagship commercial product and COMETRIQ® also part of its cabozantinib portfolio.
Recurring updates include quarterly financial results, product revenue trends, financial guidance, pipeline milestones and investor conference presentations. Exelixis also discusses zanzalintinib, an investigational oral kinase inhibitor, and a broader pipeline of small molecules and biotherapeutics targeting additional tumor types and indications.
Exelixis (Nasdaq: EXEL) has entered a new licensing agreement with Catalent (NYSE: CTLT) for three oncology programs aimed at developing antibody-drug conjugates (ADCs) for various solid tumors. Exelixis will pay $30 million upfront for rights to the biologics programs and will fund the development until candidate selection. This collaboration enhances Exelixis’ biologics pipeline, targeting cancers including bladder, breast, and ovarian. Catalent's SMARTag technology will support the development, potentially improving treatment options for cancer patients.
Exelixis has entered into an exclusive agreement with Sairopa for the clinical development of ADU-1805, a monoclonal antibody targeting SIRPα, expected to improve immune response against tumors. An IND filing is anticipated in Q1 2023, which could expand Exelixis' clinical pipeline. The agreement includes a $40 million upfront payment and potential milestone payments totaling $70 million. ADU-1805 shows promise against multiple tumor types and might have a better safety profile than existing therapies.
Exelixis has formed an exclusive collaboration with Cybrexa Therapeutics to acquire CBX-12, a novel peptide-drug conjugate designed to enhance cancer treatment efficacy while reducing toxicity. The collaboration underscores Exelixis' commitment to expanding its clinical pipeline. Exelixis will pay an upfront fee of $60 million plus potential milestone payments up to $642.5 million. Initial data from a Phase 1 trial of CBX-12 indicate promising anti-tumor activity, including complete response in a patient with ovarian cancer, highlighting its potential in treating diverse tumors.
Exelixis reported Q3 2022 total revenues of $411.7 million, a 25% year-over-year increase, driven mainly by cabozantinib franchise revenues of $366.5 million, which showed 39% growth year-over-year. GAAP diluted EPS was $0.23, and non-GAAP diluted EPS was $0.31. R&D expenses rose to $198.8 million due to increased clinical trial costs. The company provided updated 2022 financial guidance, expecting total revenues between $1.575 billion and $1.600 billion, with net product revenues of $1.375 billion to $1.400 billion.
Exelixis announced initial results from the JEWEL-101 phase 1 study of XB002, a next-generation tissue factor-targeting antibody-drug conjugate. Presented at a recent symposium, XB002 was well-tolerated, with pharmacokinetic analysis indicating stability and low free payload levels. A total of 19 patients were enrolled at escalating doses, with no dose-limiting toxicities reported. The study aims to evaluate XB002's efficacy in patients with advanced solid tumors, with a particular focus on those with limited treatment options.
Exelixis, Inc. (Nasdaq: EXEL) will release its third quarter 2022 financial results on November 1, 2022, after market close. A conference call and webcast will follow at 5:00 p.m. ET to discuss the results and provide a business update. Access to the event will be available on the company’s website. Exelixis focuses on developing new cancer therapies, with products like CABOMETYX, COMETRIQ, COTELLIC, and MINNEBRO. The company aims to maximize its pipeline potential through ongoing investments and partnerships.
Exelixis has expanded its collaboration with Bristol-Myers Squibb to include a fixed-dose combination of nivolumab and relatlimab in the ongoing phase 1b STELLAR-002 clinical trial. This trial is evaluating XL092, Exelixis' next-generation oral tyrosine kinase inhibitor (TKI), combined with immune checkpoint inhibitors for advanced solid tumors. The study aims to determine the optimal dosing regimen across various combinations, enhancing treatment options for patients.
Exelixis announced promising results from the dose-escalation phase of the STELLAR-001 trial, evaluating XL092 as a treatment for advanced solid tumors. The trial showed that XL092 alone and in combination with atezolizumab displayed manageable safety profiles and preliminary clinical activity, especially in heavily pretreated renal cell carcinoma patients. Notably, tumor reduction was observed in 71% of single-agent XL092 patients. The next step involves expanding the trial using the recommended dose of 100 mg across various solid tumors.
Exelixis announced positive results from the COSMIC-313 trial, evaluating cabozantinib in combination with nivolumab and ipilimumab for advanced renal cell carcinoma (RCC). The trial demonstrated a significant reduction in disease progression or death, achieving a hazard ratio of 0.73. Median progression-free survival was not yet reached with the triplet therapy versus 11.3 months for the dual therapy. However, no significant overall survival benefit was noted at interim analysis, prompting continuation for further analysis. The safety profile was consistent with known drug effects.
Exelixis, Inc. (Nasdaq: EXEL) will participate in investor conferences in September. The company is scheduled to present at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 4:05 p.m. ET in New York City, and at the BofA Securities Global Healthcare Conference on September 15, 2022, at 2:10 p.m. BST in London. Webcast access is available on the Exelixis website, with replays provided for 30 days. Exelixis focuses on oncology and has four commercially available products to address difficult-to-treat cancers.