On January 11, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported select, preliminary, unaudited results for the fourth quarter and full year ended December 31, 2025.

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Full Year 2025 Select, Preliminary, Unaudited Financial Results

Revenue of ~$1.27 billion, representing ~83% growth year-over-year, including ~30% organic growth (excluding Ambry)
Diagnostics revenue of ~$955 million, representing ~111% growth year-over-year, driven by Oncology volume growth of ~26% and Hereditary volume growth of ~29%
Data and applications revenue of ~$316 million, representing ~31% growth year-over-year, driven by ~38% growth in Insights (Data Licensing)
Fourth Quarter 2025 Select, Preliminary, Unaudited Financial Results

Revenue of approximately ~$367 million, an increase of approximately 83% year-over-year
Diagnostics revenue of ~$266 million, representing ~121% growth year-over-year, driven by Oncology volume growth of ~29% and Hereditary volume growth of ~23%
Data and applications revenue of ~$100 million, representing ~25% year-over-year growth, with Insights growing ~68%, excluding the impact of the AstraZeneca warrant in Q4 of 2024.
"2025 was an exceptional year for Tempus with the strength of both of our product lines exceeding our initial expectations for the year," said Eric Lefkofsky, Founder and CEO of Tempus. "Within Diagnostics, year-over-year volume growth of our genomics (oncology) offering accelerated for the third consecutive quarter hitting the highest unit growth rate we have seen in years. Our Data and Application business is performing even better with record revenue of ~$100 million in the fourth quarter, achieving full-year growth of ~31%, with our data licensing business growing ~38%. We enter 2026 in an exceptionally strong position with both of our main businesses accelerating in growth and delivering the financial leverage inherent in our platform. With AI as a catalyst across all of our products, we couldn’t be more excited for 2026."

This announcement comes ahead of the Company’s presentation today at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of the presentation and our updated investor deck can be found on Tempus’ investor relations website at investors.tempus.com.

Tempus has not completed preparation of its financial statements for the fourth quarter or full year 2025. The estimates disclosed in this release for the fourth quarter and year ended December 31, 2025, are preliminary, and unaudited and inherently uncertain, and therefore subject to change as Tempus completes preparation of its financial results for these periods. Tempus is in the process of completing its customary year-end close and review procedures for the quarter and year ended December 31, 2025, and there can be no assurance that final results for these periods will not differ from these estimates, and any such difference may be material. During the preparation of Tempus’ consolidated financial statements for the year ended December 31, 2025, Tempus or its independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Tempus plans to report its complete fourth quarter and full year 2025 financial results during its earnings call in February 2026.

(Press release, Tempus, JAN 11, 2026, View Source [SID1234661927])

On January 11, 2026 Johnson & Johnson (NYSE:JNJ) reported new longer follow-up results from the investigational Phase 1b/2 OrigAMI-1 study evaluating amivantamab-vmjw, a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET, in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. The encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer. Results were presented during a poster session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers (ASCO GI) Symposium (Abstract #166).1

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"These results show the potential of amivantamab combined with chemotherapy to deliver meaningful and durable benefit for people with advanced colorectal cancer, including for those with liver metastases who have historically faced poorer outcomes," said Dr. Filippo Pietrantonio,* M.D., Head of the Gastrointestinal Oncology Unit, IRCCS Foundation, National Cancer Institute, Milan, Italy. "Seeing patients maintain responses for extended periods, some beyond two years, is a powerful sign of progress in a disease where sustained efficacy has been hard to achieve and speaks to the promise of this treatment approach."

Colorectal cancer is the third most commonly diagnosed cancer worldwide, and a leading cause of cancer-related death.2 While traditionally seen in older adults, incidence is rising in people under 50.3 More than half of patients will eventually develop metastatic disease, with liver involvement in roughly 70 percent of cases. In this setting, resistance to current first-line therapies often develops early, shortening the time patients can benefit.4 For those with RAS/BRAF wild-type metastatic colorectal cancer with disease progression, second-line options remain limited, with historical response rates of 32 to 36 percent and median progression-free survival (PFS) of 5.4 to 6.4 months using EGFR inhibitors and chemotherapy.5,6,7,8,9,10 Research has shown that MET alterations are a frequent cause of resistance to EGFR-inhibition, highlighting a need for new approaches that target both pathways simultaneously.11

Detailed Study Results

Cohorts D and E of the Phase 1b/2 OrigAMI-1 study evaluated intravenous amivantamab as monotherapy or in combination with either FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. Patients were confirmed to be negative for KRAS, NRAS, BRAF and EGFR mutations, and did not have HER2 amplification. They could have received one prior line of systemic therapy in the metastatic setting, and prior treatment with an EGFR inhibitor was not permitted. The primary endpoint was safety, and secondary endpoints included overall response rate (ORR), duration of response (DOR), clinical benefit rate, and PFS. Overall survival was assessed as an exploratory endpoint.1

At a median follow-up of 16 months (range, 1.2-29.5), amivantamab plus FOLFOX (n=20) or FOLFIRI (n=23) achieved a confirmed ORR of 51 percent (95 percent confidence interval [CI], 36-67) across the study, with responses observed early and a median time to first response of 8.3 weeks (range, 7.3-20.3), along with a median DOR of 9.3 months (95 percent CI, 5.8-14.7). Median PFS was 9.2 months (95 percent CI, 5.4-12.9), and median overall survival was not estimable (NE) (95 percent CI, 16.2-NE). In the first-line subgroup, ORR was 73 percent (95 percent CI, 53-86), with median DOR not yet reached at the time of data cutoff (95 percent CI, 7.3-NE). Among 11 patients treated in the first-line subgroup, four were able to proceed to curative intent surgery. In the second-line subgroup (n=32), ORR was 44 percent (95 percent CI, 26-62) and median DOR was 7.4 months (95 percent CI, 5.4-14.5). More than one-third of patients treated in the second-line setting remained on therapy for over one year, and three patients have stayed on amivantamab treatment for more than two years. In patients with liver metastases (n=30), the study showed notable activity, with an ORR of 57 percent (95 percent CI, 37-75) and a median PFS of 11.3 months (95 percent CI, 5.9-16.4).1

The safety profile remained consistent with prior reports of amivantamab plus chemotherapy in colorectal cancer and with the known safety profiles of the individual agents. Treatment-emergent adverse events were primarily related to EGFR and MET inhibition and known chemotherapy-associated effects. Four patients (9 percent) discontinued therapy due to treatment-related adverse events. The most common Grade 3 or higher event was neutropenia, and no new safety signals were observed.1

"Treatment for metastatic colorectal cancer has remained largely unchanged for many years, underscoring the need for new strategies," said Kiran Patel, M.D., Vice President, Global Head, Solid Tumor Clinical Development and Companion Diagnostics, Johnson & Johnson Innovative Medicine. "We are drawing on our scientific leadership in EGFR-driven lung cancer to evaluate the potential of amivantamab, and its dual-targeting of EGFR and MET, in colorectal cancer and other solid tumors driven by these pathways."

Pivotal Phase 3 studies, including the global, randomized OrigAMI-2 and OrigAMI-3 studies evaluating subcutaneous amivantamab with FOLFOX and FOLFIRI, are underway to further evaluate the potential of amivantamab-based regimens in both first- and second-line colorectal cancer.

About the OrigAMI-1 Study

OrigAMI-1 (NCT05379595) is an open-label, Phase 1b/2 study assessing the efficacy and safety of RYBREVANT plus mFOLFOX6 or FOLFIRI in anti-EGFR-naïve RAS/BRAF WT mCRC. Eligible patients were wild-type (WT) for KRAS, NRAS or BRAF genes based on circulating tumor DNA testing. Additionally, patients were required to have no amplification of the ERBB2/HER2 gene. In the RYBREVANT and chemotherapy cohorts, patients were either treatment-naïve or had received at least one prior line in the metastatic setting (no EGFR inhibitor treatment). The primary endpoint of the combination cohorts was to characterize the safety and confirm the dose of RYBREVANT plus mFOLFOX6 or FOLFIRI. Response was assessed by the investigator per RECIST v1.1.12

About Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide, accounting for approximately 10 percent of all cancer cases, and is the second leading cause of cancer-related deaths worldwide.2 While it predominantly affects older individuals, recent research suggests that colorectal cancer is now being diagnosed in adults under the age of 50 at record rates.3

Left-sided colorectal cancer, which represents approximately 65 percent of cases, often has distinct characteristics that influence treatment strategies. Around half of colorectal cancer patients have mutations in the RAS genes, with KRAS being the most common mutation. While tumors with normal RAS and BRAF genes generally respond better to EGFR inhibitors, those with RAS and BRAF mutations – particularly on the left side – are associated with poorer outcomes.13

About RYBREVANT

RYBREVANT (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.14

RYBREVANT is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.

RYBREVANT is approved in the U.S., Europe and other markets around the world in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

RYBREVANT is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR TKI.

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) is approved in the U.S., Europe and other markets around the world in combination with LAZCLUZE for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)§15 include amivantamab-vmjw (RYBREVANT) across multiple treatment settings, including its recent inclusion as a NCCN Category 1 preferred option when used with lazertinib (LAZCLUZE) for first-line treatment of people with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations; see the latest NCCN Guidelines for NSCLC for complete information. †‡

The NCCN Guidelines for Central Nervous System Cancers also identify amivantamab-vmjw (RYBREVANT)-based regimens, including the combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.†‡

In addition to the Phase 1b/2 OrigAMI-1 study, RYBREVANT is being studied in multiple clinical trials, including:

The Phase 3 MARIPOSA (NCT04487080) study assessing RYBREVANT in combination with LAZCLUZE versus osimertinib and versus LAZCLUZE alone in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations.16
The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of RYBREVANT (with or without LAZCLUZE) and carboplatin-pemetrexed versus carboplatin-pemetrexed alone in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations after disease progression on or after osimertinib.17
The Phase 3 PAPILLON (NCT04538664) study assessing RYBREVANT in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.18
The Phase 3 PALOMA-3 (NCT05388669) study assessing LAZCLUZE with subcutaneous (SC) amivantamab compared to RYBREVANT in patients with EGFR-mutated advanced or metastatic NSCLC.19
The Phase 2 PALOMA-2 (NCT05498428) study assessing SC amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.20
The Phase 1 PALOMA (NCT04606381) study assessing the feasibility of SC amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for SC amivantamab delivery.21
The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT in patients with advanced NSCLC.22
The Phase 1/1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT in combination with LAZCLUZE and LAZCLUZE as a monotherapy in patients with advanced NSCLC with EGFR mutations.23
The Phase 1/2 METalmark (NCT05488314) study assessing RYBREVANT and capmatinib combination therapy in locally advanced or metastatic NSCLC.24
The Phase 1/2 swalloWTail (NCT06532032) study assessing RYBREVANT and docetaxel combination therapy in patients with metastatic NSCLC.25
The Phase 1/2 PolyDamas (NCT05908734) study assessing RYBREVANT and cetrelimab combination therapy in locally advanced or metastatic NSCLC.26
The Phase 2 SKIPPirr (NCT05663866) study exploring how to decrease the incidence and/or severity of first-dose infusion-related reactions with RYBREVANT in combination with LAZCLUZE in relapsed or refractory EGFR-mutated advanced or metastatic NSCLC.27
The Phase 2 COPERNICUS (NCT06667076) study combining developments in treatment administration and prophylactic supportive care in representative US patients with common EGFR-mutated NSCLC treated with SC amivantamab in combination with LAZCLUZE or chemotherapy.28
The Phase 2 COCOON (NCT06120140) study assessing the effectiveness of a proactive dermatologic management regimen given with first-line RYBREVANT and LAZCLUZE in patients with EGFR-mutated advanced NSCLC.29
The Phase 3 OrigAMI-2 (NCT06662786) study assessing subcutaneous amivantamab and mFOLFOX6 or FOLFIRI in patients with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer.30
The Phase 3 OrigAMI-3 (NCT06750094) study assessing subcutaneous amivantamab and FOLFIRI in patients with KRAS/NRAS and BRAF wild-type recurrent, unresectable or metastatic colorectal cancer after disease progression on chemotherapy.31
The Phase 1b/2 OrigAMI-4 (NCT06385080) study assessing RYBREVANT monotherapy and in addition to standard-of-care therapeutic agents in patients with recurrent/metastatic head and neck squamous cell carcinoma.32
The Phase 3 OrigAMI-5 (NCT07276399) study assessing SC amivantamab with pembrolizumab and carboplatin in patients with recurrent/metastatic head and neck squamous cell carcinoma.33
The legal manufacturer for RYBREVANT is Janssen Biotech, Inc.

INDICATIONS

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:

in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION14,34

CONTRAINDICATIONS

RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO

RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).

Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.

Infusion-Related Reactions with RYBREVANT

RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.

RYBREVANT as a Single Agent

In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.

Interstitial Lung Disease/Pneumonitis

RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with LAZCLUZE

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.

RYBREVANT as a Single Agent

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE

RYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).

Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.

Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.

Dermatologic Adverse Reactions

RYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.

RYBREVANT with LAZCLUZE

In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.

RYBREVANT as a Single Agent

In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).

When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.

If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity.

Ocular Toxicity

RYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.

RYBREVANT with LAZCLUZE

In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.

RYBREVANT as a Single Agent

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.

Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.

Embryo-Fetal Toxicity

Based on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.

ADVERSE REACTIONS

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).

Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).

Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

RYBREVANT with Carboplatin and Pemetrexed

In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).

In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

RYBREVANT as a Single Agent

In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

LAZCLUZE DRUG INTERACTIONS

Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

Please see full Prescribing Information for RYBREVANT FASPRO, RYBREVANT and LAZCLUZE.

(Press release, Johnson & Johnson, JAN 11, 2026, https://www.prnewswire.com/news-releases/rybrevant-amivantamab-vmjw-longer-term-results-show-promising-and-durable-responses-in-difficult-to-treat-colorectal-cancer-302656931.html [SID1234661925])

On January 11, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported a business update including an overview of key corporate objectives for 2026. The company will review these updates during its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:45pm PST.

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"2025 was a year of execution, marked by broad pipeline advancement, commercial readiness activities for darovasertib, and the filing of four INDs resulting in nine clinical programs. Our deep pipeline and cash runway into 2030 enable IDEAYA to advance key combinations and to address multiple indications with high unmet need, including uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we plan to advance four registrational trials, including for IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic settings of uveal melanoma. These trials for darovasertib are central to our strategy to save eyes, preserve vision, and extend lives for patients with uveal melanoma – one of the poorest prognosis indications in oncology where the majority of patients have no available FDA approved therapies," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

2026 Corporate Objectives

Darovasertib in uveal melanoma (UM)

Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM (mUM) are expected in Q1 ’26
Randomized PFS analysis is based on the first 130 PFS events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises approximately 313 patients randomized 2:1 to the treatment versus control arm. The topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States
Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 ’26
OptimUM-02 (mUM): full enrollment of 437 patients complete; overall survival (OS) data expected to support a filing for full approval in 1L HLA*A2-negative mUM
OptimUM-10 (neoadjuvant): complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 ’27
OptimUM-11 (adjuvant): initiate trial in collaboration with Servier in Q2 ’26
Complete enrollment of approximately 80 HLA*A2-positive mUM patients in ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib by Q2 ’26; data to support a potential real world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing in this patient subset
Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations

IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026
IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 ’26
IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 ’26
MTAP Pathway

IDE397 (MAT2A): provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026
IDE892 (PRMT5): initiate a Phase 1 monotherapy dose escalation trial in Q1 ’26 to enable a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 ’26
Submit an investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, by the end of 2026. With the CDKN2A candidate, IDEAYA plans to enable wholly owned combinations with IDE892 and IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and with IDE574, IDEAYA’s dual KAT6/7 inhibitor
Next Generation Therapies

IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 ’26
Corporate

~$1.1 billion in cash, cash equivalents and marketable securities as of 9/30/25; expected to fund current operating plan into 2030
Darovasertib commercial readiness activities advancing in the United States and globally with their partner, Servier
IDEAYA’s updated corporate presentation reflecting its 2026 corporate guidance is available on its website under the Investor Relations section: View Source

(Press release, Ideaya Biosciences, JAN 11, 2026, View Source [SID1234661924])

On January 11, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported an update on its latest progress, developments plans and expected 2026 milestones, which it will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

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"We are excited to have opened our Phase 1/2a trial in the US for MP0712, our Radio-DARPin targeting DLL3, and look forward to seeing initial clinical data in 2026. Our half-life optimized approach allows us to capitalize on the rapid target internalization to deposit more radiation compared to peptide-like approaches, affording us the ambition to become a leader in alpha-targeted radiotherapy in SCLC," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Next to MP0726 targeting MSLN for ovarian cancer, we are working on 4 additional radiotherapy programs and will update on progress in H1 2026. In addition to our Radio-DARPin pipeline, we are progressing MP0317 and MP0533 in clinical trials, ideally led by investigators, and planning first Switch-DARPin candidates for development."

Cash and Cash Equivalents:
As of December 31, 2025, Molecular Partners reports cash and cash equivalents of CHF 93.1 million (unaudited). Based on current operating assumptions, this will be sufficient to fund operating expenses and capital expenditure requirements until 2028. The Company will provide full 2025 financial results on March 12, 2026.

Key current program status updates include:

MP0712 & Radio-DARPin pipeline

MP0712, the Company’s lead Radio-DARPin Therapy (RDT) based on 212Pb and targeting the tumor-associated protein delta-like ligand 3 (DLL3), is being developed with strategic partner Orano Med, pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Investigational New Drug (IND) application has been cleared and a Phase 1/2a trial has now started (ClinicalTrials.gov: NCT07278479). A first site is open and dosing of the first patient is expected in Q1 2026. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended phase 2 dose for MP0712. The study contains an imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from the study in 2026.

Molecular Partners presented new data on MP0712 at the Targeted Radiopharmaceuticals (TRP) Summit Europe in November 2025, highlighting first encouraging images of a patient receiving MP0712 carrying the diagnostic isotope 203Pb. The images, obtained through a Named Patient Access Program for compassionate care at NuMeRI in South Africa show targeted delivery of MP0712 into tumors and limited exposure in healthy organs such as kidney and liver, as intended. The NuMeRI team, led by Prof. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Congress (TWC) in January 2026.

The Company’s second RDT program MP0726, co-developed with Orano Med, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeted therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. The Company is planning to progress several Radio-DARPin programs towards first-in-human imaging, including MP0726.

Furthermore, Molecular Partners announced in December 2025 the formation of a scientific advisory board (SAB) to accelerate the development of its targeted radiotherapeutics. The SAB, chaired by globally recognized nuclear medicine expert Prof. Ken Herrmann, will be instrumental in guiding Molecular Partners strategic direction as it transitions and evolves from early clinical validation to full clinical development of its targeted alpha radiotherapies.

Molecular Partners has designed its Radio-DARPins as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions and have the potential to unlock a broad range of solid tumor targets for radiopharmaceuticals.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 in combination with standard-of-care for the treatment of patients with advanced cholangiocarcinoma is now open with two sites activated (NCT07036380). The first patient was treated in early 2026, additional sites are being activated and patients are in screening. The study is a randomized, multicenter study in France and aims to recruit 75 patients (50 in the experimental arm, 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with standard-of-care, which comprises the immunotherapy durvalumab (an anti-PD-L1 checkpoint inhibitor) plus gemcitabine-cisplatin-based chemotherapy.

MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company completed a Phase 1 dose escalation study of MP0317 in patients with advanced solid tumors with 46 patients treated across 9 dose levels, and has presented comprehensive biomarker analyses from the trial at SITC (Free SITC Whitepaper) 2024 showing tumor-localized CD40 activation and tumor microenvironment remodeling. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057).

Data presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025 showed that densified dosing appears tolerable, and leads to markedly improved serum exposure in cycle 1 and encouraging preliminary antitumor activity, in particular in patients with low bone marrow blast count at baseline. Cohort 10 is currently dosing patients, with an update on the program foreseen in H1 2026.

Molecular Partners plans to support the exploration of MP0533 in combination, both in patients with relapsed/refractory disease as well as in front-line, and has been approached by several consortia expressing interest in conducting such studies. The Company is actively engaging with key opinion leaders and regulators to shape the next phase of development, and anticipates updating the clinical plan for MP0533 in H1 2026.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted atigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

Switch-DARPin (next-generation immune cell engagers)

Molecular Partners designed a logic-gated Switch-DARPin TCE to achieve conditional tumor-localized immune activation targeting MSLN and epithelial cell adhesion molecule (EpCAM), which are highly co-expressed in ovarian cancer and other solid tumors. The Switch-DARPin TCE is designed to unmask the CD3-engaging DARPin ("Switch" on) and to activate T cells only upon binding to both MSLN and EpCAM. This Switch-DARPin is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Based on the encouraging pre-clinical data presented in 2025 at AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper), the Company intends to nominate a lead Switch-DARPin candidate for development in H1 2026 and will provide an update on the program at AACR (Free AACR Whitepaper) 2026.

J.P. Morgan Presentation Details:

Presenter: Molecular Partners CEO Patrick Amstutz
Time: January 15, 2026, at 10:30-11:10AM PT (19:30-20:10 CET)
Location: The Westin St. Francis San Francisco, CA, USA.

A webcast will be accessible on the Molecular Partners website, under the Events tab.

(Press release, Molecular Partners, JAN 11, 2026, View Source [SID1234661922])

On January 11, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported its preliminary unaudited financial results for the fiscal year 2025, provided financial guidance for fiscal year 2026 and delivered an update on its business. Exelixis anticipates 2026 will be a significant year of clinical, regulatory and commercial progress as the company grows its current cabozantinib business, works toward building a potential second commercial franchise with zanzalintinib and moves its earlier stage pipeline forward. As outlined at its December 2025 R&D Day, the company seeks to leverage its diverse pipeline and key clinical collaborations to build next-generation oncology franchises that can improve standards of care for patients with cancer.

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Preliminary Fiscal Year 2025 Financial Results & 2026 Financial Guidance

Exelixis is providing the following preliminary unaudited 2025 financial results and financial guidance for 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer (CRC). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis’ New Drug Application (NDA) for this proposed indication, when used in combination with atezolizumab (Tecentriq).

Fiscal Year 2025

Fiscal Year 2026 Guidance

Total revenues

~ $2.320 billion

$2.525 billion – $2.625 billion

Net product revenues

~ $2.123 billion

$2.325 billion – $2.425 billion(1)

Cost of goods sold, % of net product revenues

~ 3.7%

3.5% – 4.5%

Research and development expenses

~ $825 million(2)

$875 million – $925 million(3)

Selling, general and administrative expenses

~ $520 million(4)

$575 million – $625 million(5)

Effective tax rate

n/a(6)

21% – 23%

Ending cash and marketable securities(7)

~ $1.65 billion

n/p

(1)

Exelixis’ 2026 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 3.0% for both CABOMETYX and COMETRIQ effective on January 1, 2026.

(2)

Includes $40.8 million of non-cash stock-based compensation expense.

(3)

Includes $50.0 million of non-cash stock-based compensation expense.

(4)

Includes $72.2 million of non-cash stock-based compensation expense.

(5)

Includes $75.0 million of non-cash stock-based compensation expense.

(6)

Preliminary results not yet available.

(7)

Cash and marketable securities are composed of cash, cash equivalents and marketable securities. Fiscal year 2026 guidance not provided (n/p).

The preliminary 2025 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Fiscal Year 2025 Financial Results are planned for release after market on Tuesday, February 10, 2026.

"Exelixis enters 2026 with a strong and growing commercial business, the opportunity to bring a potential second oncology franchise to market and an exciting pipeline of novel small molecules and biotherapeutics," said Michael M. Morrissey, Ph.D., President & CEO, Exelixis. "Our momentum accelerated throughout 2025, driven by the continued strong commercial performance of CABOMETYX in renal cell carcinoma and advanced neuroendocrine tumors. We also achieved major milestones with the first positive pivotal data readout and subsequent U.S. regulatory filing for zanzalintinib, our next potential franchise molecule, and drove meaningful pipeline progress."

Dr. Morrissey continued: "To achieve our goal of becoming a top-5 solid tumor oncology company, Exelixis is pursuing a multi-franchise approach that fosters innovation, manages risk and maximizes the value of our portfolio for all our stakeholders. Building on the cabozantinib experience, we aim to establish lasting franchises in renal cell carcinoma, neuroendocrine tumors and colorectal cancer where our products can be successful as monotherapies or in combination, including with other Exelixis pipeline assets. Through careful prioritization and disciplined investments in high-value opportunities, we are confident we can drive sustained near- to mid-term growth while returning capital to shareholders and improving the standards of care for patients with cancer."

Anticipated Cabozantinib Milestones

Growth and Acceleration of Cabozantinib Commercial Franchise. Exelixis expects cabozantinib franchise growth to continue in 2026, building on the product’s position as the leading tyrosine kinase inhibitor (TKI) and oral therapy in renal cell carcinoma (RCC) and neuroendocrine tumors (NET). As of the third quarter 2025, in RCC, CABOMETYX (cabozantinib) was the market leader as the number one TKI monotherapy and the most prescribed TKI in combination with immunotherapy (IO). The accelerating uptake in NET builds on the March 2025 U.S. regulatory approval of CABOMETYX for two new NET indications, advanced pancreatic and extra-pancreatic NET (pNET and epNET), based on results from the CABINET study. As of the third quarter 2025, CABOMETYX was the leading oral therapy in the second-or-later line (2L+) NET market, with broad uptake across 2L+ patient types and practice settings. Based on this success and with additional gastrointestinal (GI) cancer opportunities ahead, Exelixis is expediting the full buildout of its GI sales team to accelerate growth in NET and prepare for potential future indications for zanzalintinib in GI cancers.

Anticipated Zanzalintinib Milestones

Ongoing U.S. Regulatory Review in CRC. Exelixis is preparing for the potential first commercial launch of zanzalintinib for the treatment of patients with previously treated CRC, when used in combination with atezolizumab. The regulatory filing was based on positive results from the phase 3 STELLAR-303 pivotal trial, which met one of its dual primary endpoints, with the combination of zanzalintinib and atezolizumab demonstrating a statistically significant reduction in the risk of death versus regorafenib in the intention-to-treat population at the final analysis. An overall survival (OS) benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy.

STELLAR-303 CRC Study Final Analysis of Second Dual Primary Endpoint of OS in Patients without Liver Metastases Expected Mid-2026. In 2025, a prespecified interim analysis of STELLAR-303’s other dual primary endpoint, OS in patients without liver metastases (non-liver metastases or NLM), showed a trend favoring the combination; however, these data were immature at the data cutoff. The trial is proceeding to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates.

Topline Results for STELLAR-304 Anticipated Mid-2026. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell RCC. The primary endpoints in the trial are progression-free survival (PFS) and objective response rate (ORR). STELLAR-304 completed enrollment in May 2025. Topline results expected in mid-2026, based on current event rates.

Enrollment Progress for STELLAR-311 Trial of Zanzalintinib in Advanced NET. Exelixis is actively enrolling patients in the phase 2/3 STELLAR-311 pivotal trial, which is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin, who have received up to one prior line of therapy. Initiated in June 2025, STELLAR-311 is the first study to randomize a small molecule against an active control in this setting, with the potential to broadly redefine oral treatment options for these patients. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review.

Additional Ongoing and Planned Pivotal Trials for Zanzalintinib. In addition to the ongoing Exelixis-sponsored STELLAR-303, -304, and -311 trials, additional zanzalintinib pivotal trials include:

LITESPARK-033, which is evaluating the combination of zanzalintinib and WELIREG (belzutifan) versus cabozantinib in first-line advanced RCC following IO administered in the adjuvant setting. LITESPARK-033 was initiated in December 2025 and is the first Merck-sponsored pivotal trial of zanzalintinib and belzutifan in RCC under the companies’ clinical development collaboration. A second Merck-sponsored pivotal trial of zanzalintinib and belzutifan in RCC is anticipated to begin in early 2026. Details of this anticipated study are forthcoming.
STELLAR-316, which will evaluate the potential of zanzalintinib, with and without an immune checkpoint inhibitor, to keep patients disease-free in the adjuvant CRC setting. As currently proposed, the study will enroll patients with resected stage II/III CRC who have completed definitive therapy and tested positive for molecular residual disease (MRD), but do not have radiographic evidence of disease. The primary endpoint of STELLAR-316 is disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Exelixis recently announced a collaboration with Natera, a global leader in cell-free DNA and precision medicine, in which Natera will provide its Signatera assay to identify MRD-positive patients for enrollment in the trial. Exelixis expects to initiate STELLAR-316 in mid-2026.
STELLAR-201, which will evaluate zanzalintinib in recurrent meningioma, the most common primary intracranial neoplasm for which there are currently no approved systemic therapies. The study is planned to enroll patients with Grade I/II/III meningioma with relapse/progression following radiation/surgery or who are not candidates for radiation/surgery. The proposed primary endpoint of the trial is ORR, with secondary endpoints including duration of response, PFS and OS. Pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy approved for this form of cancer. Exelixis expects to initiate STELLAR-201 in mid-2026, and a confirmatory phase 3 study is also being planned.
Anticipated R&D Milestones

Progress of Phase 1 Clinical Programs for XL309, XB010, XB628 and XB371. Exelixis is advancing ongoing phase 1 clinical trials for XL309 (USP1 inhibitor), XB010 (5T4-targeting ADC), XB628 (PD-L1 + NKG2A bispecific) and XB371 (TF-targeting ADC). If phase 1 data are supportive, Exelixis plans to progress these molecules into full development as part of its strategy to build next-generation oncology franchises across tumor types and novel combination regimens, including with zanzalintinib and other therapeutic modalities. Combination opportunities of particular development interest highlighted at the December 2025 R&D Day include zanzalintinib plus XB628 in both advanced RCC and CRC.

Two Potential IND Applications in 2026. Exelixis anticipates advancing two programs into clinical development this year:

XL557 is an orally bioavailable small molecule Somatostatin Receptor 2 agonist. Somatostatin analogs are widely used in the first- and second-line NET treatment settings, but currently available therapies are administered via injection and pose associated challenges. Exelixis believes XL557 has the potential to become a best-in-class molecule that could serve NET patients across all lines of treatment as a monotherapy and potentially in combination with zanzalintinib.
XB773 is an antibody-drug conjugate (ADC) consisting of an exatecan payload conjugated to a monoclonal antibody targeting DLL3, a transmembrane protein that is expressed in neuroendocrine carcinomas such as small cell lung cancer and neuroendocrine prostate cancer. Exelixis believes XB773 could be a best-in-class molecule with better payload delivery compared to competitor ADCs and potential for improved therapeutic benefit, as well as strong combination potential that would facilitate its use in earlier lines and settings.
Corporate Updates

Stock Repurchase Program (SRP) Update. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.16 billion of the company’s common stock, retiring 76.7 million shares, at an average price of $28.14 per share, as of the end of fiscal year 2025. In October 2025, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s common stock before December 31, 2026. Exelixis has begun executing stock repurchases under the October 2025 SRP, which is the fifth such program to be undertaken by the company since March 2023. Stock repurchases under this program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions or any combination of such methods. The timing and amount of any stock repurchases under the SRP will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The program does not obligate Exelixis to acquire any amount of its common stock, and the SRP may be modified, suspended or discontinued at any time without prior notice.

Presentation and Webcast

Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company’s preliminary fiscal year 2025 financial results, 2026 financial guidance and key priorities and milestones for 2026 during the company’s presentation at the J.P. Morgan 2026 Healthcare Conference beginning at 5:15 p.m. PT / 8:15 p.m. ET on Monday, January 12, 2026.

To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A replay will also be available at the same location for at least 30 days.

(Press release, Exelixis, JAN 11, 2026, View Source [SID1234661921])