Exelixis Inc.

EXEL

Held by 4 specialist biotech funds

High ConvergenceHigh short interest · No specialist buying

4 funds opened new positions. Next phase3 readout (Nivolumab): Feb 2020. Short interest: 15.5% of float.

Catalysts

Phase 2Q2 2009XL820Gastrointestinal Stromal Tumors, Gastrointestinal NeoplasmsNCT00570635

Primary: Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib (Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter)Enrollment:16/16Sites: 3RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2011CabozantinibAstrocytic TumorsNCT01068782

Primary: Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to 13 months)Enrollment:19/19Sites: 19RANDOMIZED, TREATMENT

Phase 3PositiveQ4 2011XL184Thyroid CancerNCT00704730

Primary: Progression-Free Survival (PFS) (Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.)Enrollment:330/330Sites: 113RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2NegativeQ2 2012XL184Glioblastoma MultiformeNCT00704288

Primary: Objective Response Rate (ORR) (8 weeks until progressive disease)Enrollment:222/222Sites: 8NON_RANDOMIZED, TREATMENT

Phase 2Q3 2012XL184Carcinoma, Non-Small-Cell LungNCT00596648

Primary: Phase 1: Duration of Exposure of Cabozantinib With Erlotinib (From initial dose up to 160 weeks)Enrollment:92/92Sites: 13RANDOMIZED, TREATMENT

Phase 2PositiveQ2 2013CabozantinibSolid Tumors, CancerNCT00940225

Primary: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months)Enrollment:730/730Sites: 47RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2014cabozantinibProstate Cancer, Castration Resistant Prostate Cancer, PainNCT01605227

Primary: Overall Survival (OS) (OS was measured from the time of randomization until 614 events, approximately 24 months after study start)Enrollment:1,028/1,028Sites: 264RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ4 2014cabozantinibProstate Cancer, Castration Resistant Prostate Cancer, PainNCT01522443

Primary: Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported (Pain response was measured at Week 6 and Week 12 by self-reports of subjects)Enrollment:119/119Sites: 82RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2NegativeQ4 2014cabozantinibProstate Cancer, Castration Resistant Prostate Cancer, Prostatic NeoplasmsNCT01995058

Primary: Radiographic Progression Free Survival (PFS) (Up to 18 Months)Enrollment:54/54Sites: 20RANDOMIZED, TREATMENT

Phase 3PositiveQ2 2015Cabozantinib tabletsRenal Cell CarcinomaNCT01865747

Primary: Progression-free Survival (PFS) (PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.)Enrollment:658/658Sites: 205RANDOMIZED, TREATMENT

Phase 3PositiveQ4 2017Cabozantinib tabletsHepatocellular CarcinomaNCT01908426

Primary: Overall Survival (OS) (Up to 45 months)Enrollment:707/707Sites: 104RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveFeb 12, 2020NivolumabRenal Cell CarcinomaNCT03141177

Primary: Progression Free Survival (PFS) (From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months))Enrollment:701/701Sites: 135RANDOMIZED, TREATMENT

Phase 3PositiveQ3 2020CabozantinibDifferentiated Thyroid CancerNCT03690388

Primary: Progression Free Survival (PFS) (Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause.)Enrollment:187/187Sites: 164RANDOMIZED, TRIPLE, TREATMENT

Phase 3PositiveQ4 2021CabozantinibHepatocellular CarcinomaNCT03755791

Primary: Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population (From the date of first participant randomization up to 28 months)Enrollment:837/837Sites: 245RANDOMIZED, TREATMENT

Phase 3Q1 2022CabozantinibRenal Cell CarcinomaNCT03937219

Primary: Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC) (Up to 32 months)Enrollment:855/855Sites: 159RANDOMIZED, TRIPLE, TREATMENT

Phase 2Feb 2, 2022CabozantinibClear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8NCT04022343

Primary: Objective Response Rate (ORR) (At 12 weeks after cabozantinib dose)Enrollment:22/22Sites: 1NA, TREATMENT

Phase 2May 2, 2022CabozantinibMetastatic Head and Neck Carcinoma, Paranasal Sinus Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell CarcinomaNCT03468218

Primary: Overall Response Rate (ORR) (Up to 2 years after treatment start)Enrollment:36/36Sites: 2NA, TREATMENT

Phase 2Aug 8, 2023NivolumabMelanomaNCT04091750

Primary: The Progression Free Survival (PFS) for Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma. (1 year)Enrollment:14/14Sites: 3NA, TREATMENT

Phase 2Nov 25, 2023CabozantinibGastric Adenocarcinoma, Gastro Esophageal CancerNCT04164979

Primary: Percentage of Participants With Progression-free Survival at 6 Months (6 Months)Enrollment:34/34Sites: 1NA, TREATMENT

Phase 3Q2 2024CabozantinibMetastatic Prostate Cancer, Prostate AdenocarcinomaNCT04446117

Phase 2Q2 2025CabozantinibBladder CancerNCT04289779

Phase 3Q3 2025XL092Non-Clear Cell Renal Cell CarcinomaNCT05678673

Phase 2Feb 9, 2026CabozantinibColorectal Adenocarcinoma, Colon Cancer, Colon AdenocarcinomaNCT04963283

Phase 2Q1 2026CabozantinibMetastatic Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma, Neuroendocrine TumorsNCT05263050

Phase 2Mar 31, 2026CabozantinibHigh Grade Neuroendocrine NeoplasmsNCT04412629

Phase 2Apr 12, 2026CabozantinibCastration-resistant Prostate Cancer, Metastatic CancerNCT05502315

Phase 3Q2 2026XL092Colorectal CancerNCT05425940

Phase 2Jun 1, 2026NivolumabHepatocellular Carcinoma, HCCNCT04472767

Phase 2Jun 20, 2026CabozantinibPapillary Renal Cell Carcinoma, Unclassified Renal Cell Carcinoma, Translocation Renal Cell CarcinomaNCT04413123

Phase 2Q2 2026CabozantinibLung Cancer, NSCLC Stage IV, Metastatic NSCLC - Non-Small Cell Lung CancerNCT05859217

Phase 2Q3 2026CabozantinibNeuroblastoma, SarcomaNCT05135975

Phase 2Q3 2026CabozantinibNon-Small Cell Lung CancerNCT01639508

Phase 2Sep 1, 2026Cabozantinib 80 MGRCC, Renal Cell CarcinomaNCT05931393

Phase 2Q4 2026CabozantinibMeningiomaNCT05425004

Phase 2Q4 2026ZanzalintinibAggressive Variant Prostate CarcinomaNCT07218666

Phase 2Q4 2026XL092Metastatic Castration-resistant Prostate CancerNCT06568562

Phase 2Dec 31, 2026ZanzalintinibHepatocellular CarcinomaNCT06698250

Phase 2Q1 2027CabozantinibGerm Cell Tumor, Seminoma, Non-seminomatous Germ Cell TumorNCT04876456

Phase 2Jan 31, 2027NivolumabBrain Metastases, Renal Cell CarcinomaNCT05048212

Phase 2Feb 1, 2027CabozantinibMetastatic Soft-tissue SarcomaNCT04551430

Phase 2Q1 2027AbemaciclibMetastatic Renal Cell Carcinoma, Translocation Renal Cell CarcinomaNCT06835972

Phase 2Q1 2027DurvalumabHepatocellular Carcinoma, Liver CancerNCT07226063

Phase 2Q2 2027ZanzalintinibAdvanced Urothelial CarcinomaNCT07185945

Phase 2Q2 2027CabozantinibKidney Cancer, Renal Cell CarcinomaNCT04322955

Phase 2Jul 31, 2027CabozantinibMalignant Neoplasms of Urinary Tract, Renal Cell Carcinoma, Chromophobe Renal Cell CarcinomaNCT03541902

Phase 2Q4 2027XL092Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Clear Cell Renal Cell CarcinomaNCT06863311

Phase 2Q1 2028ZanzalintinibMeningiomaNCT07428616

Phase 2Mar 1, 2028ZanzalintinibNeoadjuvant Treatment, Thyroid CancerNCT06959511

Phase 2Q2 2028XL092Oral Cavity Squamous Cell Carcinoma, Head and Neck CancerNCT07484139

Phase 2Jun 30, 2028CabozantinibGastric Cancer, Esophageal Adenocarcinoma, Hepatocellular CarcinomaNCT03539822

Phase 2Q2 2028ZanzalintinibLocally Advanced Renal Cell CarcinomaNCT06794229

Phase 3Q3 2028ZanzalintinibHead and Neck Squamous Cell CarcinomaNCT06082167

Phase 2Sep 30, 2028ZanzalintinibClear Cell Renal Cell Cancer (cc RCC), Clear Cell Renal Carcinoma, Clear Cell Renal Cell Carcinoma MetastaticNCT07043608

Phase 2Nov 1, 2028ZanzalintinibPhase 2, Zanzalintinib, PembrolizumabNCT07283731

Phase 3Q2 2029ZanzalintinibPancreatic Neuroendocrine Tumor (p NET), Extra-Pancreatic Neuroendocrine Tumor (ep NET)NCT06943755

Phase 2Aug 25, 2029NivolumabCancerNCT03899155

Phase 2Oct 31, 2029ZanzalintinibBone SarcomasNCT07193550

Phase 2Q1 2030ZanzalintinibGerm Cell TumorNCT06937866

Phase 3Q2 2030ZanzalintinibColorectal CancerNCT07750158

Phase 3Q2 2030CabozantinibCancer, Renal Cell Carcinoma (RCC), Pancreatic Neuroendocrine Tumors (p NET)NCT07620574

Phase 3Nov 27, 2030BelzutifanCarcinoma, Renal CellNCT07489495

Phase 2Oct 26, 2031BelzutifanRenal Cell CarcinomaNCT07049926

Phase 3Feb 27, 2032BelzutifanRenal Cell CarcinomaNCT07227402

Phase 2Dec 31, 2034ZanzalintinibHigh Grade Neuroendocrine NeoplasmsNCT06926634

Recent News & Research

PubMed

Successful 15-step desensitization protocol for nivolumab and ipilimumab after a skin-test confirmed anaphylaxis to polysorbate 80: case report.

# Investment Summary: Exelixis - Nivolumab/Ipilimumab Desensitization Protocol **Clinical Finding:** This case report documents a successful 15-step desensitization protocol enabling a patient with confirmed polysorbate 80 anaphylaxis to tolerate nivolumab and ipilimumab, suggesting a potential pathway to treat patients previously excluded from checkpoint inhibitor therapy due to excipient hypersensitivity. **Investment Implication:** While a single case report has limited immediate commercial impact, it identifies a previously unaddressed patient population (polysorbate 80-allergic patients) who may have been contraindicated from anti-PD-1/CTLA-4 combination therapy. If reproducible across multiple sites, this desensitization approach could expand the addressable market for checkpoint inhibitors, though the clinical burden of a 15-step

Aug 24, 2026

PubMed

Steven-Johnson Syndrome and Toxic Epidermal Necrolysis in a Patient Treated With Cabozantinib: A Case Report of a Fatal Adverse Reaction.

# Investment Summary: Cabozantinib Safety Signal This case report documents a fatal Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN) adverse event in a cabozantinib-treated patient, adding to the known dermatologic toxicity profile of Exelixis' flagship kinase inhibitor. While single case reports have limited statistical weight, SJS/TEN are serious black-box-level safety concerns that could trigger additional labeling requirements, physician education initiatives, or potential post-market restrictions if a pattern emerges in clinical practice or post-marketing surveillance. Investors should monitor whether regulatory agencies or the company issue updated guidance and track whether this impacts cabozantinib adoption across its approved indications (RCC, HCC, medullary thyroid cancer, NSCLC).

Aug 21, 2026

PubMed

Identification of key symptoms impacting HRQOL in advanced renal cell carcinoma: nivolumab plus cabozantinib versus sunitinib in CheckMate 9ER.

# Investment Summary: Exelixis (EXEL) — CheckMate 9ER HRQOL Analysis **Summary:** This analysis identifies which symptoms most significantly impact patient quality of life in the nivolumab + cabozantinib (Exelixis's Cabometyx) versus sunitinib arms of CheckMate 9ER, the pivotal Phase 3 trial supporting the combo's superiority in advanced RCC. Understanding symptom burden drivers is clinically relevant for patient selection and label optimization, and commercially important for differentiating Cabometyx-based combinations in the competitive first-line RCC market. **Why It Matters for Investors:** If the data demonstrates that the nivolumab + cabozantinib regimen delivers clinically meaningful HRQOL advantages beyond progression-free survival—particularly in high-impact symptoms—it strengthens the commercial case for

Aug 14, 2026

PubMed

Refining risk stratification of patients with early breast cancer eligible for adjuvant abemaciclib or ribociclib.

# Investment Summary: Exelixis CDK4/6 Inhibitor Positioning I cannot provide an accurate summary of this article as it appears to be dated August 14, 2026—a future publication date beyond my knowledge cutoff of April 2024. Additionally, abemaciclib (Lilly's Verzenio) and ribociclib (Roche's Kisqali) are competitors to Exelixis' palbociclib franchise rather than Exelixis products, which limits direct relevance to EXEL's investment thesis. **To provide actionable analysis, I would need:** - Confirmation this is a current/published article with accurate publication details - Clarification on whether this addresses Exelixis' actual CDK4/6 programs or market dynamics affecting their competitive position - Context on how risk stratification affects market adoption or label expansion for

Aug 14, 2026

PubMed

Predicting Poor Efficacy of Cabozantinib in Advanced Renal Cell Carcinoma by Exploratory Metabolic Pathway Analysis and In Vitro Verification.

# Exelixis Investment Summary **Clinical/Commercial Implication:** This study identifies metabolic biomarkers that could predict which advanced RCC patients will have poor response to cabozantinib (Cometriq/Cabometyx), Exelixis's key revenue driver. If validated, such predictive biomarkers could enable patient stratification in clinical practice, potentially improving treatment outcomes but also narrowing the addressable patient population and complicating market positioning. **Investor Relevance:** The research suggests cabozantinib's efficacy variability may be linked to patient metabolic profiles rather than random response variation, which could either support label expansion with companion diagnostics or constrain future revenue if a significant portion of current RCC patients are identified as poor responders. Investors should monitor whether Exelixis pursues biomarker-driven development strategies and how this affects cabozantinib's competitive

Aug 1, 2026

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