Exelixis (EXEL) Q1 FY26 earnings call: guidance and Q&A

Given the recent miss from the LITESPARK-012 study (triplet therapy), what are your updated thoughts or learnings for the ZANZA plus belzutifan development program, specifically LITESPARK-033 and LITESPARK-034?

Management stated that triplet therapy in clear cell RCC is challenging. Their strategy for ZANZA is to establish it as the next franchise molecule and top TKI combination therapy in clear cell RCC for the 2030s, with multiple ongoing trials (LITESPARK-033, LITESPARK-034, STELLAR-304) and exploration of novel, orthogonal IO combinations, including their own bispecific XB628.

“triplet therapy in clear cell renal cell carcinoma is not an easy game our strategy is really focused on trying to establish a standard of care that covers multiple possible outcomes based on trials that are going on now.”

asked by Kyuwon Choi · answered by Dana Aftab

Cabo failed as monotherapy in NSCLC and OS in pancreatic cancer. Can you expand on the rationale for testing ZANZA combo therapies in STELLAR-202 (NSCLC) and STELLAR-002 (prostate)?

For STELLAR-202 in squamous NSCLC, the rationale comes from the CONTACT-01 study where a subgroup of squamous patients showed substantial benefit from cabozantinib plus atezolizumab. ZANZA has also shown it can sensitize patients to IO. For STELLAR-002 in mCRPC, a small Phase I study of cabozantinib with docetaxel showed favorable outcomes, providing rationale for exploring this combination, which could open opportunities for chemo or ADC-based therapies in other solid tumors.

“We've already shown that ZANZA can sensitize patients to benefit with IO in the STELLAR-303 trial, a population of colorectal cancer patients that have historically been refractory to treatment with IO.”

asked by Yaron Werber · answered by Dana Aftab

What are the quantifiable metrics for CABO sales in NET and for the upcoming ZANZA CRC launch?

For CABO in NET, the company reported its highest new patient starts ever in Q1, and CABO is the market leader in the 2nd-line plus oral segment. They expedited GI sales force expansion to further penetrate the community. For ZANZA in CRC, the 3rd-line plus setting represents approximately 23,000 patients in the U.S. and a $1.5 billion market opportunity at contemporary pricing. The focus is on optimizing the initial launch and expanding the CRC franchise with earlier studies like STELLAR-316.

“The 3rd line plus setting, as I mentioned, is 23,000 patients. As we look at that market in terms of contemporary pricing, that's a $1.5 billion opportunity.”

asked by Sudan Loganathan · answered by P. Haley

Can you provide more color on the updated STELLAR-304 data readout timing, specifically if slower event accrual reflects better disease control, and how success is defined across histologies given the heterogeneous population?

Management stated they would not speculate on the reasons for the slower event accrual but confirmed top-line results are still expected in the second half of 2026. They emphasized that STELLAR-304 is the first Phase III trial specifically for non-clear cell RCC, a high unmet need population with no current Level 1 evidence for standard of care, presenting a huge opportunity for ZANZA plus nivolumab.

“Regarding that, the slight change in timing for events, I really don't want to speculate on what's driving that. We're just in the late stages of collecting events.”

asked by Sean Laaman · answered by Dana Aftab

How do you balance the broad ZANZA development strategy with buybacks and potential M&A, especially given the significant cash flows?

The company views this as a capital allocation strategy across R&D, BD, and share repurchases. They are financially strong with significant cash flows, allowing them to execute on all three. They continuously prioritize R&D projects, actively look for BD opportunities, and continue share buybacks, including the new $750 million authorization, because they believe ZANZA's opportunity is undervalued.

“We have a lot of things going on here that allows us to execute on all those three elements of R&D investments, BD investments, and share buybacks. From a share buyback perspective, we believe that zanzalintinib is a great opportunity and that that opportunity is not really being appreciated generally, and we think we're undervalued, so we're going to continue to buy back shares.”

asked by Silvan Tuerkcan · answered by Christopher Senner

Beyond STELLAR-311, how are you envisioning building out the ZANZA franchise in NETs, considering evolving treatments like radiopharmaceuticals and ADCs?

STELLAR-311 targets earlier lines of therapy in NETs against everolimus. Beyond this, the company is developing a small molecule SSTR2 agonist, with an IND filing expected later this year, which could be combined with ZANZA for functional tumors. They are also developing XB773, a DLL3-targeted ADC, which showed promising data at AACR and could be explored in combination with ZANZA for neuroendocrine carcinomas, demonstrating multiple approaches to address this patient population.

“We're developing a small molecule that we hope to file an IND on later this year. That could be a novel approach to offer in combination with ZANZA. If the STELLAR-311 trial is successful, we might do that type of combination in the future.”

asked by Leonid Timashev · answered by Dana Aftab