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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 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.
Exelixis reported total revenues of $419.4 million for Q2 2022, marking a 9% increase from $385.2 million in Q2 2021. The cabozantinib franchise generated $347.0 million in revenues, reflecting a 22% year-over-year growth. GAAP diluted EPS was $0.22, while non-GAAP diluted EPS was $0.28. Research and development expenses rose to $199.5 million, up from $148.8 million in the prior year. Exelixis maintains its 2022 revenue guidance of $1.525 billion to $1.625 billion.
Exelixis, Inc. (Nasdaq: EXEL) will release its Q2 2022 financial results on August 9, 2022, post-market close. A conference call is scheduled for 5:00 p.m. ET to discuss the results and provide a business update. Investors can access the event via Exelixis’s website. The company, founded in 1994, is focused on developing new cancer therapies, with four products currently marketed. Exelixis is a member of the S&P MidCap 400 index, reflecting its status as a profitable mid-sized company.
Exelixis reported that its COSMIC-313 trial met its primary endpoint, showing a significant improvement in progression-free survival (PFS) for patients with advanced kidney cancer when treated with cabozantinib, nivolumab, and ipilimumab. However, the secondary endpoint of overall survival (OS) did not demonstrate a significant benefit, prompting further analysis. Exelixis plans to consult with the FDA regarding a potential regulatory submission. The trial, involving 855 patients, will continue until the next OS analysis.
Exelixis has entered into an exclusive license agreement with Ryvu Therapeutics to develop targeted therapies using Ryvu’s STING agonist technology. Exelixis will pay an upfront fee of $3 million for rights to Ryvu’s small molecules, aiming to integrate these into its antibody-drug conjugates (ADCs). Exelixis will oversee research, development, and commercialization while Ryvu offers expertise during initial phases. This partnership enhances Exelixis’ biotherapeutics pipeline and aims to create effective cancer treatments.
Exelixis (NASDAQ: EXEL) will participate in a pre-recorded fireside chat at the William Blair Biotech Focus Conference 2022, available on-demand starting July 11, 2022. Investors can access the webcast on www.exelixis.com under the News & Events section. Replays will be available for 30 days. Founded in 1994, Exelixis focuses on developing treatments for challenging cancers and has several products on the market, including CABOMETYX® and COMETRIQ®. They are committed to advancing cancer therapies through innovative drug discovery.
Exelixis has initiated the STELLAR-303 trial, a pivotal phase 3 study for XL092, an oral tyrosine kinase inhibitor. This trial assesses the efficacy of XL092 combined with atezolizumab versus regorafenib in approximately 600 patients with metastatic colorectal cancer (CRC) not exhibiting microsatellite instability-high or mismatch repair-deficiency. The primary endpoint is overall survival, with secondary endpoints including progression-free survival. This study addresses a critical treatment gap for patients who have not responded to standard therapies.