On November 4, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and immune diseases, reported financial results for the third quarter ended September 30, 2026, and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.

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"In October, we showed for the first time that robust and durable HIF-2α inhibition from casdatifan can address the needs of patients at every line of kidney cancer therapy: rapid and sustained disease control in the first line, durable benefit and potential survival advantage in the second line, even after a prior TKI-inclusive therapy, and nearly three years of median overall survival in late-line patients who had exhausted multiple therapies," said Terry Rosen, Ph.D., chief executive officer of Arcus. "With PEAK-1 enrollment nearing completion and PEAK-20 set to begin by year-end, we are building the registrational evidence to make casdatifan the backbone of treatment across the continuum of care for clear cell renal cell carcinoma."

Casdatifan (HIF-2α inhibitor)

Development Strategy and Upcoming Milestones:

Arcus’s development strategy is to enable utilization of casdatifan as a backbone therapy in clear cell renal cell carcinoma (ccRCC) across each line of therapy. The strategy builds on existing standards of care in each setting. In the first line, Arcus plans to develop the first and only HIF-2α inhibitor-based tyrosine kinase inhibitor (TKI)-sparing therapy. Arcus also plans to develop consecutive casdatifan-containing regimens for the second- and late-line settings that are enabled by the uniquely robust HIF-2α inhibitory profile of casdatifan.
•First-line ccRCC:
▪Initiation of PEAK-20, a Phase 3 study evaluating casdatifan plus ipilimumab and nivolumab, is expected in the fourth quarter of 2026.
▪Cohorts for casdatifan in combination with anti-PD-x/VEGF bispecifics ivonescimab (sponsored by Arcus in ARC-20), pumitamig (in the BMS-sponsored Phase 1/2 ROSETTA RCC-208 study) and tivunatamig (in the Pfizer-sponsored Phase 1b/2 Symbiotic-GU-08 study) are expected to begin prior to the end of the year.
▪Arcus expects to initiate a new cohort evaluating casdatifan in combination with anti-PD-1 and axitinib in the first half of 2027. This cohort is designed to support the initiation of the PEAK-21 Phase 3 study evaluating casdatifan plus anti-PD-1 and axitinib in first-line ccRCC.

•Second-line ccRCC:
▪Enrollment of PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib, is expected to be complete in the next two to three months.
•Late-line ccRCC:
▪Arcus will initiate a randomized ARC-20 cohort evaluating casdatifan plus tivozanib versus tivozanib alone in patients who received two or more lines of prior therapy, including a belzutifan-containing regimen in the fourth quarter of 2026.
Upcoming Data Expected in 2027:
•First-line ccRCC:

◦More mature PFS and OS data for the ARC-20 cohorts evaluating casdatifan plus zimberelimab and casdatifan plus zimberelimab and ipilimumab.

◦Early efficacy and safety data for the ARC-20 cohort evaluating casdatifan plus ivonescimab.
•Second-line ccRCC:

◦More mature OS data for the ARC-20 cohort evaluating casdatifan plus cabozantinib in second-line ccRCC.
•Late-line ccRCC:

◦Early efficacy and safety data for the randomized ARC-20 cohort evaluating casdatifan plus tivozanib versus tivozanib.
Recent Data Update:

In October, Arcus presented new data from multiple cohorts of the ARC-20 platform study, which showed that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. All cohorts had a data cut-off (DCO) of Sept. 4, 2026, and the key data are summarized below.
•First-line ccRCC:
◦Casdatifan plus zimberelimab (anti-PD-1) (n=30; 11.5 months median follow-up): The combination demonstrated landmark PFS of 86% at 6 months and 69% at 12 months, a 50% confirmed objective response rate (cORR) and a 6.7% rate of primary progression. These results exceeded third-party benchmarks* for pembrolizumab monotherapy and for ipilimumab plus nivolumab in this setting.

◦Casdatifan plus ipilimumab plus zimberelimab (n=31; 3 months median follow-up): One patient (4%) experienced primary progression among 24 patients with at least one scan. Safety data for the regimen were consistent with those observed in other cohorts or prior studies for the individual agents. These safety data will support initiation of the registrational trial PEAK-20 in first-line ccRCC.

•Second-line ccRCC, casdatifan plus cabozantinib (n=43; 21.3 months median follow-up): PFS (median of 14.5 months) and OS (median not reached) substantially exceeded benchmarks for cabozantinib monotherapy, including in patients on casdatifan plus cabozantinib who had progressed on a prior TKI therapy (median PFS of 16.5 months). TKI-pretreated patients represent approximately 60% of second-line patients in current practice and derive substantially diminished benefit from subsequent TKI therapies relative to patients who have not received a prior TKI therapy. Subgroup data, recently presented at ESMO (Free ESMO Whitepaper), from both the belzutifan plus lenvatinib (median PFS of 10.9 months) and cabozantinib (median PFS of 7.5 months) arms of LITESPARK-011 that analyzed PFS for patients previously treated with an immunotherapy plus TKI combination reinforced this unmet need and the opportunity that the casdatifan plus cabozantinib regimen presents for this patient population.

•Late-line ccRCC, casdatifan monotherapy (n=121, four pooled cohorts; 28 months median follow-up): Casdatifan demonstrated unprecedented median OS of 35 months, a median PFS of 13 months and cORR of 36% in heavily pretreated patients, 52% of whom had received at least three prior lines of therapy. Casdatifan showed improvements across each of the key efficacy measures relative to data from benchmark studies with a first-generation HIF-2α inhibitor. In addition, new translational data demonstrated a correlation between pharmacodynamic markers of HIF-2α inhibition and OS.

•Across cohorts, no unexpected safety signals were observed at the time of DCO. Safety data for all the regimens were consistent with those observed in other cohorts or prior studies of each individual molecule.

Quemliclustat (small-molecule CD73 inhibitor)

•An interim analysis for PRISM-1, the fully enrolled Phase 3 trial of quemliclustat plus gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma, will be conducted in the fourth quarter of 2026.

Immunology Portfolio

•AB102 (oral, MRGPRX2 antagonist): Arcus initiated a first-in-human healthy volunteer study in August 2026.
•TNF inhibitor (oral, TNFR1-selective), CCR6 antagonist (oral) and CD89 monoclonal antibody: Development candidates are progressing through preclinical development, with potential to enter the clinic in 2027.
•Additional programs: STAT6 inhibitor (oral) and CD40L inhibitor (oral) programs are each expected to deliver IND-ready candidates in 2027.

Financial Results for Third-Quarter 2026:

•Cash, Cash Equivalents and Marketable Securities were $694 million as of September 30, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Based on the existing business plan, Arcus believes that its cash, cash equivalents and marketable securities as of September 30, 2026, together with $288 million gross proceeds from its October equity financing will be sufficient to fund its planned level of operations into 2029.

•Revenues were $9 million for the third-quarter 2026, compared to $26 million for the same period in 2025. The decrease in revenues was primarily driven by lower revenues related to activities under the Gilead Collaboration as they wind down or reach completion, partially offset by increased revenues related to programs under the Taiho Collaboration Agreement. Arcus expects to recognize GAAP revenue of between $70 million and $75 million for the full year 2026.

•Research and Development (R&D) Expenses were $117 million for the third-quarter 2026, compared to $141 million for the same period in 2025. The decrease was due to (i) late-stage development activities decreasing primarily due to the wind-down of Phase 3 studies related to domvanalimab and the completion of enrollment of PRISM-1, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind-down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan; partially offset by (iii) partnership reimbursements decreasing primarily due to a shift towards programs fully funded by us. Non-cash stock-based compensation expense was $9 million for the third-quarter 2026, compared to $7 million for the same period in 2025. For the third-quarters 2026 and 2025, Arcus recognized gross reimbursements of $12 million and $28 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.

R&D expenses have declined as we have wound down studies related to domvanalimab, implemented streamlining initiatives across our R&D operations in connection with this wind-down and realized efficiencies across our programs outside the Gilead collaboration. We expect R&D expenses to remain relatively consistent in the near term, as increased investment in the development of casdatifan and the advancement of our small-molecule immunology programs continues to offset the decreases in our other programs.

•General and Administrative (G&A) Expenses were $23 million for the third-quarter 2026, compared to $27 million for the same period in 2025. The decrease was primarily due to streamlining initiatives Arcus has undertaken across its operations. Non-cash stock-based compensation expense was $7 million for the third-quarter 2026, compared to $7 million for the same period in 2025.
•Net Loss was $128 million for the third-quarter 2026, compared to $135 million for the same period in 2025.

(Press release, Arcus Biosciences, NOV 4, 2026, View Source [SID1234674192])

On November 4, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that the Company’s research examining a mechanism of resistance to CAR T-cell therapy and the potential of DNase I to reverse this process has been selected for oral presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The conference will take place December 12-15, 2026, in New Orleans, Louisiana, and virtually.

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The presentation will examine how extracellular chromatin released during CAR T-cell killing establishes a self-reinforcing resistance niche and how DNase I reverses this process. By investigating a resistance mechanism that arises during CAR T-cell killing itself, the research addresses a central challenge in the field: understanding how the response to tumor-cell destruction may create conditions that limit continued treatment activity.

The research will be featured in the session "Overcoming Resistance and Escape in CAR-T Cell Therapy," bringing this work to an audience focused on the biological barriers to effective CAR T-cell treatment and approaches to addressing them.

Oral Presentation Details

Title: Extracellular chromatin released during CAR T-cell killing establishes a self-reinforcing resistance niche reversed by DNase I
Presenter: Alexey Stepanov, Ph.D., Institute Investigator, Department of Integrative Structural and Computational Biology, Scripps Research, La Jolla, CA, United States
Publication Number: 427
Session: 702. CAR-T Cell Therapies: Basic and Translational: Overcoming Resistance and Escape in CAR-T Cell Therapy
Date: Saturday, December 12, 2026
Presentation Time: 4:00-4:15 PM Central Time
Session Time: 4:00-5:30 PM Central Time
Location: Ernest N. Morial Convention Center, Room 343-345, New Orleans, Louisiana

The 68th ASH (Free ASH Whitepaper) Annual Meeting brings together the global hematology community to share advances in research and clinical care. For more information, please visit the conference website.

(Press release, Xenetic Biosciences, NOV 4, 2026, View Source [SID1234674185])

On November 4, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the third quarter ended September 30, 2026.

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"Xencor’s lead CD3 T-cell engaging bispecific antibody, XmAb819, has demonstrated compelling clinical data in advanced clear cell renal cell carcinoma, and our plans for moving XmAb819 into earlier lines of treatment as a monotherapy and in combination with anti-PD(L)1 are underway, with evaluation of XmAb819 in additional ENPP3-positive tumor types also ongoing. We expect that the accelerating tempo of clinical development for XmAb819, and across our portfolio, may present multiple opportunities for continued momentum into the new year and throughout 2027. Based on our plans, by the end of 2027 we anticipate XmAb819 will be the third XmAb 2+1 bispecific antibody to enter a potential registration-enabling study, following xaluritamig and ASP2138," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "For our autoimmune portfolio, next week at the ACR Convergence conference we will present early dose-escalation data from the Phase 1 study of our CD20 x CD3 B-cell depleting T-cell engager, plamotamab, which we are evaluating in patients with rheumatoid arthritis following standard-of-care treatments."

"For our two TL1A-targeting development programs, enrollment in XENITH-UC, the global Phase 2b study of XmAb942, is on track for the primary endpoint analysis in the second half of 2027, and for our novel TL1A x IL23p19 bispecific, XmAb412, we plan to present healthy participant data in the first half of 2027."

Wholly Owned Pipeline Overview

XmAb819 (ENPP3 x CD3), a potential first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC) and other tumors with high ENPP3 expression, including colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma

•As previously disclosed, in the first half of 2027 Xencor plans to engage with the FDA regarding a potential accelerated approval pathway for XmAb819 in subsets of patients with advanced ccRCC who have exhausted standard-of-care treatment options. Subject to regulatory feedback, by the end of 2027 Xencor also plans to initiate a global randomized Phase 3 study evaluating XmAb819 against tivozanib in patients with advanced ccRCC previously treated with one PD-(L)1 inhibitor and at least one VEGF receptor tyrosine kinase inhibitor (VEGFR TKI).

Ongoing Phase 1 Study in Patients with Advanced ccRCC

•Expansion cohorts evaluating intravenous doses to support selection of a dose for the planned Phase 3 pivotal study for patients with advanced ccRCC have completed enrollment. Expansion cohort results were presented at the European Society For Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2026. As of the October 1, 2026, data-cut, the efficacy-evaluable cohort at the 400 mcg/kg intravenous (IV) dose (n=11) reported five confirmed partial responses for a confirmed objective response rate of 45.5% per investigator assessment (RECIST v1.1), with one unconfirmed partial response for an unconfirmed objective response rate of 55%. Xencor has selected the 400 mcg/kg IV dose as the proposed IV recommended Phase 3 dose (RP3D) for advanced clinical development, based on maturing data from the 11 patients reported and from additional patients who have enrolled into this expansion cohort. As of the September 1, 2026 data-cut, which served as the foundation for the results presented at the ESMO (Free ESMO Whitepaper) 2026 Congress, XmAb819 was generally well tolerated in the combined expansion dose cohorts (n=68) with a manageable safety profile and a 5.9% rate of treatment discontinuation due to related treatment-emergent adverse events. Xencor plans to present additional results from the 400 mcg/kg IV cohort in the first half of 2027.

•Dose escalation of subcutaneous administration in advanced ccRCC is ongoing, and Xencor plans to present results in the first half of 2027.

Proof-of-Concept Sub-Studies to Enable Expansion of Development Are Ongoing

•Part C of the ongoing Phase 1 study is enrolling patients with ENPP3+ advanced papillary RCC, colorectal cancer and non-small cell lung cancer.

•Part D of the ongoing Phase 1 study is enrolling patients with IMDC intermediate- to poor-risk advanced ccRCC, who have progressed after nivolumab in combination with ipilimumab as a first-line treatment and who are naïve to VEGFR TKI therapy.

•Part F of the ongoing Phase 1 study is planned as a safety study for the combination of XmAb819 with nivolumab to potentially enable front-line development.

XmAb541 (CLDN6 x CD3) in combination with XmAb808 (B7-H3 x CD28), in Phase 1 clinical development for T-cell engagement of Claudin-6 expressing tumors, including high-grade serous ovarian cancer
•The Phase 1 dose-escalation study of XmAb541 and XmAb808 is ongoing and expected to reach the combination’s target dose range in 2027.

XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in clinical development for patients with inflammatory bowel disease

•Xencor is conducting the XENITH-UC Study, a global Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderately to severely active UC, whose disease has progressed after at least one conventional or advanced therapy.

•Enrollment expectations continue to support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint analysis of the 12-week induction period in the second half of 2027. The primary endpoint of XENITH-UC is the percentage of patients achieving clinical remission defined by the modified Mayo score at week 12.

XmAb412 (TL1A x IL23p19), a potential best-in-class, extended half-life bispecific antibody for dual targeting of inflammatory pathways in autoimmune and inflammatory disease, in Phase 1 development and enrolling healthy participants
•XmAb412 robustly suppresses both TL1A and IL-23 inflammatory pathways and is predicted to have a human half-life between 60 and 70 days. XmAb412 supports a high-concentration, low-viscosity and citrate-free formulation suitable for subcutaneous dosing. XmAb412 is Xencor’s first novel bispecific antibody developed using the XenLock platform.
•The first-in-human study of XmAb412 is ongoing, and Xencor plans to present initial data from the study in the first half of 2027.
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment
•Early dose-escalation data from the Phase 1b study were accepted for presentation during the American College of Rheumatology (ACR) Convergence conference in November 2026. A poster titled "Phase 1 Study of Plamotamab, a Bispecific CD20xCD3 T-cell Engager, in Adult Patients With Rheumatoid Arthritis: Interim Results" will be presented during the poster session "Rheumatoid Arthritis – Treatment Poster B" on Monday, November 9, 10:30 a.m. – 12:30 p.m. ET (Abstract 1417).
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 dose escalation, enrolling healthy participants and patients with idiopathic inflammatory myopathies, systemic sclerosis and Sjögren’s disease
•Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in the second half of 2026.
Recent Partnership Developments

•Amgen: Amgen is advancing two Phase 3 studies of xaluritamig, a STEAP1 x CD3 XmAb 2+1 bispecific T-cell engager, in patients with metastatic castration-resistant prostate cancer (mCRPC). In August 2026, Amgen announced the completion of enrollment in XALute, a Phase 3 study evaluating xaluritamig as a monotherapy in patients with mCRPC previously treated with taxane-based chemotherapy. The Phase 3 XALience study is evaluating xaluritamig in combination with abiraterone versus investigator’s choice therapy in patients with chemotherapy-naive mCRPC. Multiple earlier-phase studies are also evaluating xaluritamig as a monotherapy or in combination across additional prostate cancer treatment settings. At the ESMO (Free ESMO Whitepaper) 2026 Congress, Amgen presented results from a Phase 1 study of xaluritamig monotherapy and xaluritamig in combination with abiraterone in patients with mCRPC who have not yet received taxane-based chemotherapy. Amgen demonstrated that four- to six-hour fully outpatient monitoring after cycle 1 step-up dosing was feasible, supporting the potential for a more convenient administration setting. Xencor is eligible to receive up to $225 million in future milestone payments and tiered royalties on net sales that range from mid- to high-single digit percentages.

•Astellas: In August 2026, Astellas announced that the first patient had been dosed in a Phase 3 clinical trial evaluating ASP2138 in combination with chemotherapy and pembrolizumab as a first-line treatment in adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors are Claudin 18.2 (CLDN18.2)-positive and HER2-negative, which triggered a $25.0 million milestone payment. ASP2138 is an investigational subcutaneously administered bispecific antibody designed to bind to CLDN18.2, a protein expressed on certain tumor cells, and CD3-positive T cells. ASP2138 utilizes Xencor’s XmAb 2+1 multivalent format. Xencor is eligible to receive up to $207.5 million in future milestone payments and tiered royalties on net sales that range from high-single to low-double digit percentages.

•Zenas BioPharma: Zenas submitted a Biologics License Application (BLA) to the FDA for obexelimab for the treatment of IgG4-related disease (IgG4-RD) in May 2026, which was accepted for review in August 2026. In the third quarter of 2026, Zenas’ partner Bristol Myers Squibb submitted a marketing authorization application for obexelimab in IgG4-RD in Japan, which triggered a $2.5 million milestone payment. Obexelimab targets CD19 with its variable domain and uses an XmAb Immune Inhibitor Fc Domain. In November 2021, Xencor licensed obexelimab to Zenas, and under the license agreement, Xencor is eligible to receive up to $447.5 million in future milestone payments and tiered royalties on net sales that range from mid-single-digit to mid-teen percentages, dependent on geography. As of September 30, 2026, Xencor owned 1.0 million shares of common stock in Zenas.
Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $480 million and $500 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations into 2029.

Financial Results for the Third Quarter Ended September 30, 2026

Cash, cash equivalents and marketable debt securities totaled $555.7 million as of September 30, 2026, compared to $610.8 million as of December 31, 2025. Under the settlement agreement with Alexion, Xencor received $52.5 million in August 2026 and is entitled to receive a final payment of $52.5 million in the third quarter of 2027. In addition, Xencor received $66.9 million in cash proceeds from the sales of an equity security.

Revenue for the third quarter ended September 30, 2026 was $116.5 million, compared to $21.0 million for the same period in 2025. Revenue earned in the third quarter of 2026 was primarily due to royalty revenue from Alexion and Incyte and milestone revenue from Astellas.

Research and development (R&D) expenses for the third quarter ended September 30, 2026 were $84.3 million, compared to $54.4 million for the same period in 2025. Increased R&D spending for the third quarter of 2026 compared to 2025 is primarily due to higher external and internal costs associated with development programs, partially offset by lower stock-based compensation expense in the current period.

General and administrative (G&A) expenses for the third quarter ended September 30, 2026 were $9.4 million, compared to $14.2 million for the same period in 2025. Decreased G&A spending for the third quarter of 2026 compared to 2025 is primarily due to a non-recurring recovery of legal expenses.

Other income, net, for the third quarter ended September 30, 2026 was $16.4 million, compared to $41.5 million for the same period in 2025. Decreased other income, net, for the third quarter of 2026, compared to 2025, is primarily due to lower unrealized gains on an equity security.

Net income attributable to Xencor for the third quarter ended September 30, 2026 was $39.4 million, or $0.50 on a fully diluted per share basis, compared to a net loss of $6.0 million, or $(0.08) on a fully diluted per share basis, for the same period in 2025.

(Press release, Xencor, NOV 4, 2026, View Source [SID1234674184])

On November 4, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the third quarter ended September 30, 2026.

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"We delivered solid third quarter results supported by strong profitability and cash generation," said Marc Stapley, chief executive officer of Veracyte. "Afirma outperformed, while Decipher Prostate volume was below our expectations. We remain confident in the long-term outlook of our business and expect a number of evidence-based catalysts to support growth in our core franchises while also advancing our breast and bladder strategies. As we execute on these opportunities, our differentiated financial profile enables us to continue investing in the business to drive long-term growth."

Key Financial Highlights
For the three-month period ended September 30, 2026, as compared to the same period in 2025:
•Increased total revenue by 15% to $151.8 million and testing revenue by 15% to $146.4 million, driven by Decipher Prostate growth of 12% to $92.3 million and Afirma growth of 19% to $51.5 million.
•Increased total volume by 15% to 52,744 tests and testing volume by 13% to 49,498 tests, driven by approximately 29,900 Decipher Prostate tests, as well as approximately 19,100 Afirma tests. Volume for each test grew 12% year-over-year.
•Increased product revenue by 40% to $4.6 million, driven by strong adoption of Prosigna IVD following the release of the phase III OPTIMA trial results at ASCO (Free ASCO Whitepaper).
•Recorded GAAP net income of $31.5 million, or 20.8% of revenue, and delivered adjusted EBITDA of $41.2 million, or 27.2% of revenue.
•Generated $40.3 million of cash from operations to end the quarter with $370.5 million of cash, cash equivalents, and short-term investments as of September 30, 2026.
Key Business Highlights
•Acquired Convergent Genomics, Inc., expanding our urology portfolio with a urinary tumor DNA testing platform to help guide bladder cancer care across the patient journey.
•Secured Medicare reimbursement for our Prosigna Breast Risk of Recurrence (ROR) test in the U.S. for eligible patients diagnosed with early-stage hormone-receptor positive (HR+) breast cancer.
•Further expanded the clinical evidence of the Decipher Prostate test, with new predictive evidence supporting its use with treatment intensification decisions across intermediate-risk and very high-risk prostate cancer.
•Surpassed a key milestone, with more than 1 million patients served to date with Veracyte’s tests.
•Announced that the Board of Directors has authorized a share repurchase program for up to $100 million of common stock.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Third Quarter 2026 Financial Results

Total revenue for the third quarter of 2026 was $151.8 million, an increase of 15% compared to $131.9 million reported in the third quarter of 2025. Testing revenue was $146.4 million, an increase of 15% compared to $127.8
million in the third quarter of 2025, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $4.6 million, an increase of 40% compared to $3.3 million in the third quarter of 2025, driven by strong adoption of Prosigna IVD following the release of the phase III OPTIMA trial results at ASCO (Free ASCO Whitepaper). Biopharmaceutical and other revenue was $0.7 million, compared to $0.8 million in the third quarter of 2025.

Total gross margin for the third quarter of 2026 was 71%, compared to 69% in the third quarter of 2025. Non-GAAP gross margin was 74%, compared to 73% in the third quarter of 2025.

Operating expenses were $90.5 million for the third quarter of 2026 compared to $68.3 million in the third quarter of 2025. Non-GAAP operating expenses grew 24% to $72.9 million compared to $58.6 million in the third quarter of 2025.

GAAP Net income for the third quarter of 2026 was $31.5 million, an increase of $12.4 million compared to the third quarter of 2025. Diluted net earnings per common share was $0.38, an improvement of $0.14 compared to the third quarter of 2025. Non-GAAP diluted net earnings per common share was $0.51, flat compared to the third quarter of 2025. Net cash provided by operating activities in the first nine months of 2026 was $121.3 million, an improvement of $37.6 million compared to the same period in 2025.

Adjusted EBITDA for the third quarter of 2026 was $41.2 million, an improvement of 4% compared to the third quarter of 2025, representing 27.2% of revenue.

2026 Financial Outlook

Veracyte now expects 2026 total revenue guidance of $590 million to $593 million, representing 14% to 15% growth, compared to prior guidance of $590 million to $596 million. This reflects testing revenue of $571 million to $573 million, representing 16% growth, compared to prior guidance of $576 million to $582 million, with minimal revenue contribution from recently launched tests. Further, the company continues to expect adjusted EBITDA margin of greater than 26% for 2026.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA margin to expected GAAP net income margin, the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Share Repurchase Program

Veracyte announced today that its Board of Directors has authorized a share repurchase program for up to $100 million of its common stock. Under the repurchase program, the company may repurchase shares through open market purchases, privately negotiated transactions or by other methods from time to time. Any open market repurchases will be structured to comply with applicable federal securities laws, including the pricing and volume requirements of Rule 10b-18 under the Securities Exchange Act of 1934, as amended. The timing, manner, price, and amount of any repurchases will be determined at the company’s discretion based on a variety of factors, including market conditions, the trading price of the company’s common stock, the company’s financial condition and results of operations, capital requirements, general business conditions, alternative investment opportunities, and other factors the company deems relevant. The repurchase program does not obligate the company to acquire any specific number of shares, may be modified, suspended, or discontinued at any time without prior notice at the discretion of the Board of Directors, and will expire after 12 months. The company currently expects to fund the repurchase program from available cash and cash equivalents.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

(Press release, Veracyte, NOV 4, 2026, View Source [SID1234674183])

On November 4, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the third quarter ended September 30, 2026, and provided an overview of recent developments.

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"We delivered another strong quarter of execution, with ZUSDURI continuing to scale as growing repeat utilization, expanding community adoption, and broader physician engagement reinforce our confidence in the long-term commercial opportunity," said Liz Barrett, President and Chief Executive Officer of UroGen. "At the same time, we are strengthening the durability of our business through the advancement of UGN-103, which aims to build on the success of ZUSDURI and create opportunities to expand into additional patient populations. The U.S. Food and Drug Administration’s (FDA’s) acceptance of the UGN-103 New Drug Application (NDA) in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), together with our newly issued patent providing coverage into July 2044, further reinforce the long-term revenue potential of our bladder cancer portfolio. Looking ahead, our planned expansion into high-grade NMIBC with UGN-103, advancement of UGN-501 into the clinic, and strategic collaboration with IntraGel provide multiple opportunities for future growth. Together, we believe these achievements position UroGen to build a sustainable growth company and create meaningful long-term shareholder value."

Third Quarter 2026 and Recent Business Highlights:

ZUSDURI (mitomycin) for intravesical solution:

ZUSDURI achieved net product revenue of $68.0 million in the third quarter of 2026, representing 35% growth over the second quarter of 2026. As of September 30, 2026, UroGen reported:

1,538 activated sites of care, compared with 1,444 as of June 30, 2026

662 unique ZUSDURI prescribers, compared with 452 as of June 30, 2026

331 repeat ZUSDURI prescribers, compared with 204 as of June 20, 2026, representing approximately 50% of total prescribers, up from 45% as of June 30, 2026

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These trends reflect continued growth in both the breadth and depth of ZUSDURI adoption, with increasing repeat utilization reinforcing physician confidence and integration into routine clinical practice.

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UroGen’s new U.S. method-of-treatment patent covering the non-surgical treatment of recurrent LG-IR-NMIBC has been issued and listed in the FDA’s Orange Book for ZUSDURI. The patent is expected to provide coverage into July 2044 for ZUSDURI and, if approved, UGN-103, reinforcing the long-term commercial opportunity for the franchise.

JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC:

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Generated net product revenue of $21.0 million in the third quarter of 2026, compared with $25.7 million reported for the third quarter of 2025. Third-quarter 2026 results included a one-time unfavorable gross-to-net adjustment of approximately $1.5 million related to a Centers for Medicare and Medicaid Services (CMS) invoice for the discarded drug program that included a prior year true-up resulting in corresponding adjustments to the Company’s reserves. Results also reflected ongoing competitive clinical trial enrollment activity affecting JELMTYO patient starts in low-grade upper tract urothelial cancer (LG-UTUC).

Next-generation novel mitomycin-based formulations for urothelial cancer:
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In October 2026, the FDA accepted for review UroGen’s NDA for UGN-103 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027. The NDA is based on clinical data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter trial evaluating the efficacy and safety of UGN-103 in adult patients with recurrent LG-IR-NMIBC. The three-month complete response (CR) rate, the six-month duration of response (DOR), and the safety results observed in UTOPIA were consistent with those observed in the pivotal ENVISION trial of ZUSDURI. UroGen plans to submit 12-month DOR data from the UTOPIA trial to the FDA during the NDA review.

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UroGen plans to initiate the Phase 3 LONGVIEW-HR randomized, multicenter trial in the fourth quarter of 2026 evaluating adjuvant UGN-103 versus intravesical gemcitabine in patients with recurrent, papillary-only high-risk NMIBC who previously received Bacillus Calmette-Guérin (BCG) therapy. Enrollment is planned for approximately 300 patients, and the primary endpoint will evaluate disease-free survival (DFS).
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The Company also plans to initiate a non-registrational trial in 2027 evaluating the use of UGN-103 as adjuvant therapy in the newly diagnosed intermediate-risk NMIBC population.
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The ongoing Phase 3 clinical trial evaluating UGN-104 in LG-UTUC is expected to complete enrollment by the end of 2026 or in early 2027.

UGN-501 (investigational next-generation oncolytic virus) for use in high-grade non-muscle invasive bladder cancer:

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The FDA cleared UroGen’s Investigational New Drug (IND) application for UGN-501 in July 2026. In November 2026, the Company announced that the first patient began treatment with UGN-501 in the Phase 1 trial intended to evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501. The trial will initially evaluate UGN-501 in aqueous solution, with future development expected to explore delivery using UroGen’s RTGel technology.

Strategic Collaboration with IntraGel Therapeutics:

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In August 2026, UroGen entered into a strategic collaboration, licensing option and equity investment agreement with IntraGel Therapeutics. The agreement provides UroGen an exclusive option to evaluate and develop up to three future oncology products using IntraGel’s proprietary SRGel platform, a biodegradable, sustained-release depot technology, as well as an exclusive option to acquire worldwide rights to IntraGel’s Phase 2-ready investigational cisplatin therapy for locally advanced, inoperable head and neck cancer. UroGen also agreed to invest up to $7 million in IntraGel’s equity securities, of which $4 million was invested in the third quarter of 2026.

Third Quarter 2026 Financial Results

Revenue: Total revenue was $89.0 million in the third quarter of 2026, compared with $27.5 million in the third quarter of 2025. The increase was driven by the continued commercial launch of ZUSDURI.

Research and Development (R&D) Expenses: R&D expenses were $26.0 million in the third quarter of 2026, including non-cash share-based compensation expense of $0.9 million. This compares to $14.0 million, including non-cash share-based compensation expense of $0.7 million, in the same period in 2025. The increase in R&D expenses was primarily attributable to an increase in UGN-103 and UGN-104 clinical development costs, the PDUFA fee related to the UGN-103 NDA submission, and increased development costs related to UGN-501.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $47.2 million in the third quarter of 2026, including non-cash share-based compensation expense of $5.3 million. This compares to $37.6 million, including non-cash share-based compensation expense of $2.3 million, in the same period in 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities and an increase in overall commercial operations costs.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.5 million in the third quarter of 2026, compared with $4.6 million in the same period in 2025.

Interest Expense on Long-term Debt: Interest expense related to long-term debt was $4.8 million in the third quarter of 2026, compared with $3.4 million in the same period in 2025. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with refinancing long-term debt with Pharmakon Advisors, LP, offset by the lower interest rate.

Net Loss: UroGen reported a net loss of $1.5 million, or $0.03 per basic and diluted share, in the quarter ended September 30, 2026, compared with a net loss of $33.3 million, or $0.69 per basic and diluted share, in the third quarter of 2025.

Cash, Cash Equivalents and Marketable Securities: As of September 30, 2026, cash, cash equivalents and marketable securities totaled $90.5 million.

2026 JELMYTO Revenue and Company Operating Expense Guidance

UroGen is updating its full-year 2026 net product revenue guidance for JELMYTO to approximately $90 million, compared with its prior guidance range of $97 million to $101 million. The revised outlook reflects a one-time unfavorable gross-to-net adjustment of approximately $1.5 million related to a CMS discard drug provision true-up, as well as ongoing competitive clinical trial enrollment activity in the United States that has affected JELMYTO patient starts in low-grade upper tract urothelial cancer. The Company continues to expect full-year 2026 operating expenses to be in the range of $260 million to $270 million, with expenses anticipated toward the upper end of the range, including non-cash share-based compensation expense of $20 million to $24 million.

Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

(Press release, UroGen Pharma, NOV 4, 2026, View Source [SID1234674182])