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 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.
Exelixis has announced a strategic partnership with BioInvent to develop novel antibodies aimed at cancer immunotherapy. This collaboration involves an upfront payment of $25 million from Exelixis for rights to select three targets utilizing BioInvent's advanced screening platform. Exelixis plans to leverage its expertise in antibody engineering to advance these therapies and is focused on expanding its biotherapeutics pipeline. The partnership aims to enhance both companies' capabilities in oncology therapeutics.
Better Therapeutics (NASDAQ: BTTX) has announced the appointment of Frank Karbe as President and CEO starting July 5, 2022. He replaces co-founder Kevin Appelbaum, who will continue until then. Karbe brings extensive experience, having previously raised approximately $2 billion at Myovant Sciences and over $4 billion at Exelixis. The company is poised for a potential FDA submission of its first digital therapeutic for type 2 diabetes, supported by positive trial data indicating significant improvements in patient outcomes.
Exelixis (Nasdaq: EXEL) announced participation in investor conferences in June 2022. The company will present at the William Blair 42nd Annual Growth Stock Conference on June 7, 2022, at 11:00 a.m. ET in Chicago, and at the 2022 Jefferies Healthcare Conference on June 8, 2022, at 1:30 p.m. ET in New York. Webcast links for the events can be found on Exelixis' website, where replays will also be available for 30 days.
Exelixis announced promising results from a phase 2 trial of cabozantinib combined with pembrolizumab in patients with recurrent or metastatic head and neck cancer. The trial achieved an objective response rate of 54% and an overall clinical benefit rate of 91%. At 10.6 months follow-up, one-year progression-free survival was 54%%, while one-year overall survival was 68.4%%. Side effects included fatigue and diarrhea, with a 25% discontinuation rate due to adverse events. The results will be presented at the ASCO Annual Meeting on June 3.