On February 24, 2026 Pfizer Inc. (NYSE: PFE) reported that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial (NCT04607421).

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BRAFTOVI in combination with cetuximab and mFOLFOX6 was granted accelerated approval by the FDA in December 2024 based on objective response rate (ORR) results, one of the BREAKWATER trial’s dual primary endpoints. The conversion from accelerated approval to full approval is based on significant benefit in outcomes for both progression-free survival (PFS), the trial’s other primary endpoint, and overall survival (OS), a key secondary endpoint, from the Phase 3 portion of the study that evaluated BRAFTOVI in combination with cetuximab and mFOLFOX6, as well as the ORR results from the Cohort 3 portion of the study, which evaluated BRAFTOVI in combination with cetuximab and FOLFIRI.

"This landmark approval, achieved through the robust clinical benefit demonstrated in the BREAKWATER trial, validates that this targeted therapy can impact outcomes for people living with an aggressive, hard-to-treat cancer," said Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer. "As the only targeted combination regimen shown to deliver a significant improvement in certain outcomes for patients with BRAF V600E‑mutant metastatic colorectal cancer, BRAFTOVI is uniquely positioned to redefine first‑line treatment and establish a new standard of care. This approval reinforces our leadership in bringing differentiated, potentially practice‑changing cancer therapies to patients and healthcare providers who urgently need improved options."

"This approval gives oncologists confidence to use encorafenib plus cetuximab in combination with fluorouracil-based chemotherapy as a first-line standard of care for patients with BRAF V600E-mutant metastatic colorectal cancer," said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. "The BREAKWATER study demonstrated that these targeted combination regimens provided statistically significant benefit, providing the robust evidence we need to make treatment decisions that can meaningfully impact patient outcomes."

In the BREAKWATER study, the safety profile of both combination regimens continued to be consistent with the known safety profile of each respective agent in the regimen. No new safety signals were identified. The most common side effects (≥25%) in the mFOLFOX6 regimen were peripheral neuropathy, nausea, fatigue, diarrhea, decreased appetite, rash, vomiting, hemorrhage, abdominal pain, arthralgia, pyrexia, and constipation. The most common side effects (≥25%) in the FOLFIRI regimen were nausea, diarrhea, fatigue, vomiting, alopecia, constipation, abdominal pain, decreased appetite, and rash.

Among patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6, 14% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI. There was no substantial difference in chemotherapy discontinuation due to side effects in the BRAFTOVI in combination with cetuximab and mFOLFOX6 arm compared with the chemotherapy, with or without bevacizumab arm. Among patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, 9% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI.

The BRAFTOVI combination regimen with mFOLFOX6 is also under regulatory review in Europe, where Pierre Fabre Laboratories has exclusive commercialization rights, and was recently approved for use in several other countries.

About BREAKWATER
BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with mFOLFOX6 or FOLFIRI (both fluorouracil-based chemotherapies) in participants with previously untreated BRAF V600E-mutant mCRC.

Phase 3 Analysis: BRAFTOVI in combination with cetuximab and mFOLFOX6:
Patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX, with or without bevacizumab (control arm) (n=243). The dual primary endpoints for these study groups are ORR and PFS as assessed by BICR. OS is a key secondary endpoint.

At the time of the PFS primary analysis, BRAFTOVI in combination with cetuximab and mFOLFOX6 significantly reduced the risk of disease progression or death by 47% compared to chemotherapy with or without bevacizumab (hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41, 0.68; p<0.0001) as assessed by blinded independent central review (BICR). Median PFS was 12.8 months (95% CI, 11.2, 15.9) with the BRAFTOVI combination regimen compared to 7.1 months (95% CI, 6.8, 8.5) with chemotherapy with or without bevacizumab. In a second interim analysis of median OS, BRAFTOVI plus cetuximab and mFOLFOX6 significantly reduced the risk of death by 51% compared to chemotherapy, with or without bevacizumab (HR 0.49; 95% CI, 0.38, 0.63; p<0.0001). Median OS doubled from 15.1 months with chemotherapy, with or without bevacizumab (95% CI, 13.7, 17.7) to 30.3 months (95% CI, 21.7, Not Estimated) with the BRAFTOVI combination regimen. These data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in the New England Journal of Medicine.

Cohort 3 Analysis: BRAFTOVI in combination with cetuximab and FOLFIRI:
In Cohort 3, patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab and FOLFIRI (n=73) or FOLFIRI, with or without bevacizumab (control arm) (n=74). The primary endpoint of Cohort 3 is ORR as assessed by BICR. PFS is a key secondary endpoint; OS is a secondary endpoint summarized descriptively.

BRAFTOVI plus cetuximab and FOLFIRI demonstrated a clinically meaningful and statistically significant improvement in confirmed ORR assessed by BICR compared to patients receiving FOLFIRI with or without bevacizumab (64% vs 39%, odds ratio =2.76, p=0.0011). These data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium. Detailed PFS results from Cohort 3 will be submitted for presentation at an upcoming medical meeting.

About Colorectal Cancer (CRC)
CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022.1 It is the second leading cause of cancer-related deaths.2 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women.2 In the U.S. alone, an estimated 158,850 people will be diagnosed with cancer of the colon or rectum in 2026, and approximately 55,000 are estimated to die from the disease each year.3 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat, and up to 50% of patients with localized disease eventually develop metastases.4

BRAF mutations are estimated to occur in 8-12% of people with mCRC and are associated with a poor prognosis for these patients.5 The BRAF V600E mutation is the most common BRAF mutation, and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present.5-7 Despite the high unmet need in BRAF V600E-mutant mCRC, prior to the BRAFTOVI accelerated FDA approval in this indication on December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E-mutant mCRC.8,9

About BRAFTOVI (encorafenib)
BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC.

Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea).

INDICATION AND USAGE

BRAFTOVI (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.

IMPORTANT SAFETY INFORMATION

Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for recommended dosing and additional safety information.

WARNINGS AND PRECAUTIONS

New Primary Malignancies: New primary malignancies, cutaneous and noncutaneous, can occur. In the BREAKWATER trial, the following cutaneous malignancies occurred in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6: melanocytic nevus in 5.6%, skin papilloma in 3%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4%. In patients who received BRAFTOVI in combination with cetuximab and FOLFIRI, skin papilloma occurred in 2.8% and keratoacanthoma in 1.4% of patients. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of noncutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive noncutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment.

Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-authorized test prior to initiating BRAFTOVI.

Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hepatotoxicity: Hepatotoxicity can occur. In the BREAKWATER trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.6% for alkaline phosphatase, 1.3% each for ALT and AST. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 1.5% each for ALT and AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hemorrhage: Hemorrhage can occur. In the BREAKWATER trial, hemorrhage occurred in 34% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, hemorrhage occurred in 21% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. In BREAKWATER, the incidence of uveitis among patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 was 0.4%. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In the BREAKWATER trial, an increase of QTcF >500 ms was measured in 4% (9/226) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, an increase of QTcF >500 ms was measured in 1.5% (1/65) of patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.

Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab and mFOLFOX6 or FOLFIRI. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for additional risk information.

Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose.

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.

ADVERSE REACTIONS
BRAF V600E mutation-positive mCRC, in combination with cetuximab and mFOLFOX6

Serious adverse reactions occurred in 46% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (4.7%), pyrexia (3.9%), sepsis (3.4%), and abdominal pain (3.4%)
Fatal intestinal obstruction occurred in 0.9%, and fatal large intestinal perforation and gastrointestinal perforation occurred in 0.4% (each) in patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6
Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: peripheral neuropathy (64% vs 53% and 57%), nausea (54% vs 50% and 44%), fatigue (53% vs 41% and 45%), diarrhea (42% vs 50% and 44%), decreased appetite (38% vs 27% and 30%), rash (36% vs 6% and 5%), vomiting (36% vs 22% and 17%), hemorrhage (34% vs 21% and 15%), abdominal pain (32% vs 31% and 30%), arthralgia (32% vs 6% and 7%), pyrexia (29% vs 16% and 17%), and constipation (27% vs 23% and 25%)
Most common laboratory abnormalities (≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: increased lipase (53% vs 28% and 23%), decreased neutrophil count (37% vs 35% and 33%), decreased hemoglobin (19% vs 6% and 7%), decreased white blood cell count (12% vs 8% and 6%), and increased glucose (11% vs 2% and 1%)
BRAF V600E mutation-positive mCRC, in combination with cetuximab and FOLFIRI

Serious adverse reactions occurred in 39% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI. Serious adverse reactions in >3% of patients included febrile neutropenia (5.6%) and infusion related reaction (4.2%)
Fatal gastrointestinal perforation occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI
Most common adverse reactions (>25%, all grades) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were nausea (61% vs 57%), diarrhea (55% vs 49%), fatigue (47% vs 50%), vomiting (47% vs 31%), alopecia (35% vs 22%), constipation (31% vs 29%), abdominal pain (30% vs 22%), decreased appetite (30% vs 32%), and rash (27% vs 1.5%)
Most common laboratory abnormalities (≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were: decreased neutrophil count (30% vs 32%), increased lipase (22% vs 12%), decreased white blood cell count (20% vs 6%), and decreased hemoglobin (10% vs 3%)
DRUG INTERACTIONS

Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose.

Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.

Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.

Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.

Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.

View the full Prescribing Information. There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly.

(Press release, Pfizer, FEB 24, 2026, View Source [SID1234662952])

On February 24, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter and year ended December 31, 2025.

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Fourth quarter revenue of $367.2 million, up 83.0% year-over-year with 33.5% organic growth (excluding Ambry)
Diagnostics revenue of $266.9 million in the fourth quarter, representing 121.6% growth year-over-year, driven by Oncology volume growth of 29% and Hereditary volume growth of 23%
MRD volume was ~4,700 tests in the fourth quarter, up 56% quarter-over-quarter
Data and Applications revenue of $100.4 million in the fourth quarter, representing 25.1% year-over-year growth, with Insights (data licensing) growing 69.5%, excluding the impact of the AstraZeneca warrant in Q4 of 2024
Ended the year with over $1.1 billion in Total Remaining Contract Value and 126% Net Revenue Retention
$759.7 million in cash and marketable securities as of December 31, 2025
Revenue guidance of $1.59 billion for 2026 and expect full year 2026 Adjusted EBITDA of approximately $65 million
"In 2025, Tempus continued to set the standard for what it means to be a technology company operating in the healthcare space," said Eric Lefkofsky, Founder and CEO of Tempus. "The strength of our unit growth in diagnostics along with the accelerating growth of our data business is proof that we are unique in this space. As the network effects from our investments in AI continue to compound, we expect to not only drive significant growth over the next several years, but to also enhance the lives of millions of patients around the world."

Fourth Quarter Summary Results:

Revenue increased 83.0% year-over-year to $367.2 million in the fourth quarter.
Diagnostics generated $266.9 million of revenue in the quarter, representing 121.6% year-over-year growth, with Oncology volume growth of 29% year-over-year and Hereditary volume growth of 23%.
Data and Applications generated $100.4 million of revenue in the quarter, representing 25.1% year-over-year growth, with Insights growing 69.5% (excluding the impact of the AstraZeneca warrant in Q4 of 2024).
Gross profit increased 94.7% year-over-year to $237.7 million, led by strong performance in Diagnostics.
Net loss was ($54.2 million), which included $48.7 million of stock compensation expense and related employer payroll taxes in the fourth quarter, compared to a net loss of ($13.0 million) in the fourth quarter of 2024 and a net loss of ($80.0 million) in the third quarter of 2025.
Adjusted EBITDA improved to $12.9 million in the fourth quarter, compared to ($7.8 million) in the fourth quarter of 2024 and $1.5 million in the third quarter of 2025.
Full Year 2025 Summary Results:

Revenue increased 83.4% year-over-year to $1.3 billion in 2025.
Diagnostics generated $955.4 million of revenue, or 111.5% year-over-year growth, with Oncology volume growth of 26% year-over-year and Hereditary volume growth of 29%.
Data and Applications generated $316.4 million of revenue, accelerating 30.9% year-over-year, with Insights growth of 38.0%.
Ended the year with over $1.1 billion in remaining Total Contract Value and Net Revenue Retention of 126%.
Gross profit increased to $797.9 million, representing 109.4% growth year-over-year.
Net loss was ($245.0 million), which included $136.3 million of stock compensation expense and related employer payroll taxes.
Adjusted EBITDA improved $97.3 million year-over-year to ($7.4 million), even after the acquisitions of Paige AI and OneOme.
Recent Operational Highlights

Launched Paige Predict, an AI-powered digital pathology suite that analyzes standard H&E slides to predict 123 biomarkers across 16 cancer types, helping clinicians make informed testing decisions even when tissue samples are limited, which improves Tempus’ ability to render insights across its genomic tests.
Announced results from a new study demonstrating that Tempus’ AI-driven Immune Profile Score (IPS) test more accurately predicts immunotherapy outcomes across various cancers than conventional biomarkers, identifying potential responders—including 13% of colorectal and 17% of rare cancer patients—who would otherwise be overlooked by standard testing.
Entered a multi-year strategic collaboration with NYU Langone Health, centered on a prospective observational study that uses serial molecular profiling to track cancer evolution and treatment resistance, with the goal of developing AI-powered diagnostic tools and personalized therapies.
Selected by Northwestern Medicine to expand genomic testing access to oncology patients across the health system, leveraging Tempus’ full suite of DNA, RNA, liquid biopsy, and MRD tests to enable more personalized cancer care and clinical trial design.
Fourth Quarter and Full Year 2025 Financial Results

Three Months Ended
December 31, 2025

Year Ended
December 31, 2025

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

367,211

$

1,271,789

Year-over-year growth

83.0

%

83.4

%

Gross profit

$

237,713

$

797,897

Loss from operations

$

(61,413

)

$

(252,872

)

Net loss

$

(54,166

)

$

(245,028

)

Adjusted EBITDA

$

12,893

$

(7,385

)

Net loss per share attributable to common shareholders, basic and diluted

$

(0.30

)

$

(1.41

)

Non-GAAP net loss per share

$

(0.04

)

$

(0.61

)

Financial Outlook and Guidance

Tempus is providing full year 2026 revenue guidance of approximately $1.59 billion, which represents ~25% annual growth. We expect 2026 Adjusted EBITDA to be ~$65 million.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, February 24, 2026 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 4652845
United States – New York: (646) 307-1963
USA & Canada – Toll-Free: (800) 715-9871
Live webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, FEB 24, 2026, View Source [SID1234662951])

On February 24, 2026 AbCellera (Nasdaq: ABCL) reported financial results for the full year 2025. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"In 2025, AbCellera successfully delivered on all its corporate priorities, transitioned to a clinical-stage biotech company, and ended the year with approximately $700 million in available liquidity to execute on our strategy," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "We entered 2026 with a fully built platform, a growing pipeline with multiple potential first-in-class programs and important near-term clinical readouts, and sufficient liquidity to fund well beyond the next three years of pipeline investments."

FY 2025 Business Summary

Earned $75.1 million in total revenue.
Generated a net loss of $146.4 million, compared to a net loss of $162.9 million in 2024.
Advanced two programs, ABCL635 and ABCL575, into clinical trials:
ABCL635 entered the Phase 2 portion of a Phase 1/2 clinical trial at the end of 2025.
ABCL575 is progressing through a Phase 1 clinical trial.
Advanced two development candidates, ABCL688 and ABCL386, into IND/CTA-enabling activities.
Completed multi-year platform investments and opened clinical manufacturing facility.
Expanded the leadership team with the appointment of Sarah Noonberg, M.D., Ph.D., as Chief Medical Officer.
Reached a cumulative total of 104 partner-initiated program starts with downstreams.
Reporting a cumulative total of 19 molecules to have reached the clinic.
Business Metrics

Cumulative Metrics

December 31, 2024

December 31, 2025

Change %

Partner-initiated program starts with downstreams

96

104

8 %

Molecules in the clinic

16

19

19 %

In 2025, AbCellera started discovery on eight additional partner-initiated programs with downstreams to reach a cumulative total of 104 partner-initiated program starts with downstreams (up from 96 on December 31, 2024). AbCellera and its partners have advanced a cumulative total of 19 molecules into the clinic (up from 16 on December 31, 2024).

Discussion of FY 2025 Financial Results

Revenue – Total revenue was $75.1 million, compared to $28.8 million in 2024.
Research & Development (R&D) Expenses – R&D expenses were $186.8 million, compared to $167.3 million in 2024. A greater proportion of R&D expenses are used on internal programs, including $21.0 million of specific investments in internal programs in 2025.
Sales, General & Administrative (SG&A) Expenses – SG&A expenses were $83.2 million, compared to $85.5 million in 2024.
Net Loss – Net loss of $146.4 million, or $(0.49) per share on a basic and diluted basis, compared to net loss of $162.9 million, or $(0.55) per share on a basic and diluted basis, in 2024.
Liquidity – $561 million of total cash, cash equivalents, and marketable securities and approximately $135 million in available non-dilutive government funding, bringing total available liquidity to approximately $700 million to execute on AbCellera’s strategy.
Q4 Highlights and Financial Results

Initiated Phase 2 portion of ABCL635 clinical trial.
Advanced ABCL386 into IND/CTA-enabling activities.
Reporting the advancement of one molecule into the clinic by a partner.
Revenue for the fourth quarter of 2025 was $44.9 million, primarily related to an upfront settlement payment from our patent litigation, representing 60% of total revenue for 2025.
Operating expenses totaled $73.4 million in the fourth quarter, or 25% of the total for 2025, and included investments made in co-development and internal programs.
The net loss for the fourth quarter was $8.9 million, or $(0.03) per share, on a basic and diluted basis.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

(Press release, AbCellera, FEB 24, 2026, View Source [SID1234662950])

On February 24, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer, reported that it intends to offer $200,000,000 of shares of its common stock in an underwritten public offering. In addition, Vir Biotechnology intends to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the proposed offering will be offered by Vir Biotechnology. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, Leerink Partners, Evercore ISI and Barclays are acting as book-running managers for the offering.

The shares described above are being offered pursuant to an automatically effective shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission, or the SEC, on November 3, 2023. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and may be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Evercore Group L.L.C., Attn: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474‑0200 or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Vir Biotechnology, FEB 24, 2026, View Source [SID1234662949])

On February 24, 2026 HekaBio K.K., (Headquarters: Chuo-ku, Tokyo) reported that the innovative solid tumor treatment device ‘Alpha DaRT (Diffusing Alpha Radiation Therapy),’ developed by Alpha Tau Medical Ltd. (Headquarters: Jerusalem, Israel) has received official approval in Japan. HekaBio led the approval process as the Designated Marketing Authorization Holder (DMAH) and will be responsible for launching the product in the Japanese market.
With this approval, Japan becomes the first country in the world outside of Israel to approve Alpha DaRT. The product will be available in Japan for the treatment of unresectable locally advanced or recurrent head and neck cancer, offering a new therapeutic option for cases where conventional treatments have been insufficient.
We would like to express our sincere appreciation to Dr. Jun Itami, who was affiliated with the National Cancer Center Hospital during the clinical trial and is currently serving as Director of the High-Precision Radiation Therapy Center at Shin-Matsudo Central General Hospital, as well as to all healthcare professionals for their valuable contributions throughout the approval process.

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Alpha DaRT: Technology, Mechanism of Action and Efficacy

Alpha DaRT involves inserting sources containing Ra-224(1) atoms fixed in a medical grade stainless-steel tube into solid tumors. As Ra-224 decays, daughter nuclides (Rn-220(2), Po-216(3), Pb-212(4), etc.) are distributed within the tumor tissue, releasing alpha particles that destroy the DNA double strands of tumor cells, leading to cell death.

Mechanism of Action:

Uses high-energy alpha particles to selectively destroy tumor cells locally.
Features:

Alpha particles induce irreversible double-strand DNA breaks, causing necrosis and apoptosis of cancer cells.
Due to the extremely short range of alpha particles in the body, the treatment is highly localized, minimizing impact on healthy tissue.
This technology enables drug-free cancer treatment by overcoming alpha particles’ short-range limitation through intratumoral placement of Radium-224 sources.
Comments

Dr. Jun Itami, Director, High-Precision Radiation Therapy Center, Shin-Matsudo Central General Hospital: "Results from this domestic clinical trial show that Alpha DaRT presents strong potential and meaningful progress in treating cancers unresponsive to standard therapies. Demonstrating the effectiveness of intratumoral alpha‑particle therapy—long considered challenging to implement—marks an important clinical milestone and introduces a new treatment option.
The confirmed safety and efficacy support consideration for real‑world clinical use and provide valuable direction for future studies aimed at expanding indications. Offering an additional therapy also carries psychological value for patients and families.
Although further confirmation and long‑term safety evaluation are required, these findings represent a significant step toward broader clinical application."

Uzi Sofer, CEO, Alpha Tau Medical: "Receiving Shonin approval in Japan is a significant milestone for Alpha Tau and for the Alpha DaRT platform. Japan has granted our first marketing approval outside of Israel, and is a country with deep clinical expertise in head and neck oncology. We are grateful to HekaBio for their leadership during this process, and to the six medical societies in Japan who have continually provided their support for the approval and future launch of Alpha DaRT in Japan. Our immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease. In parallel we anticipate initiating discussions shortly with the MHLW regarding potential reimbursement approaches for Alpha DaRT in Japan. We believe this approval represents an important first step toward broader clinical evaluation of Alpha DaRT, and look forward to discussing with the PMDA further potential clinical studies in Japan evaluating the use of Alpha DaRT in additional tumor types."

Robert E. Claar, CEO, HekaBio K.K.: "The Alpha DaRT program has been the primary focus for our team for 7 years, and we’re delighted to reach this Shonin milestone with Alpha Tau Medical for the benefit of patients in Japan. Along the way, we received strong and continuous support from medical professionals, regulators and the government of Japan to enable approval for this breakthrough therapy. An approval in Japan in advance of the US and Europe for a foreign-originated new category medical device is an extremely rare event, and we’re grateful to all of our partners who made this possible. Our team is enthusiastically preparing to launch Alpha DaRT to deliver hope and clinical benefit to patients in Japan."

(Press release, HekaBio, FEB 24, 2026, View Source [SID1234662948])