On May 5, 2026 INmune Bio Inc. (NASDAQ: INMB) ("INmune Bio"), a clinical-stage biotechnology company, and Anthony Nolan, a pioneering UK-based charity that set up the world’s first stem cell register and is now driving forward cell therapy advancements, reported the signing of an amended and restated Material Transfer and License Agreement. This expanded collaboration secures the long-term provision of high-quality umbilical cord tissue to power INmune Bio’s CORDStrom platform, the industry’s most advanced Mesenchymal Stromal Cell (MSC) technology designed to deliver consistent, scalable, and "off-the-shelf" cellular therapies which are suitable for supply in UK, EU and US, as well as other global regions.

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The restated agreement, effective April 29, 2026, solidifies the partnership between Anthony Nolan’s Cell Therapy and Laboratory Services, which draws on 50 years of pioneering innovation, research and expertise, and INmune Bio’s international and domestic entities to support the development of human medicinal products subject to global regulatory oversight, including the FDA, EMA, and MHRA.

Solving the MSC Consistency Challenge

While MSCs have long shown therapeutic promise, the industry has struggled with donor variability and manufacturing inconsistency. CORDStrom addresses these hurdles by utilizing umbilical cord-derived MSCs which are tested, screened and pooled to create standardized "MSC Banks". By leveraging Anthony Nolan’s Cell Therapy & Laboratory Services’ world-class procurement and screening infrastructure, INmune Bio ensures that every CORDStrom product meets rigorous "Materials Acceptance Criteria," including precise neonatal weight and maternal age specifications, to ensure the highest reproducibility whilst ensuring regulatory compliance.

A Robust Pipeline: From RDEB to Oncology

The collaboration is initially focused on several high-impact "Initial Indications" and next-generation therapeutic candidates:

● Recessive Dystrophic Epidermolysis Bullosa (RDEB): Development of CORDStrom as a transformative treatment for this devastating skin-fragility disorder.

● CORDStrom-col7a: A next-generation systemic treatment for EB designed to address the underlying genetic deficiencies of the disease.

● CORDStrom-TRAIL (Oncology): Targeted expansion into solid tumors, utilizing the platform’s immunomodulatory capabilities to combat cancer.

● Inflammatory & Degenerative Diseases: The platform will also be deployed to address the massive unmet needs in Osteoarthritis and Systemic Lupus Erythematosus (SLE).

Management Commentary

"We view CORDStrom as a tremendous platform that finally solves the fundamental challenge of understanding MSCs as a drug," said David Moss, CEO of INmune Bio. "By partnering with Anthony Nolan’s Cell Therapy & Laboratory Services, we are combining the most advanced MSC cell platform with the most reliable source of cellular starting material. This collaboration allows us to move beyond the limitations of traditional cell therapy and provide consistent, high-potency treatments for patients suffering from RDEB, cancer, and chronic inflammatory conditions. We remain hugely grateful to the volunteer donors who provide the UC for our program and who consent to UK and US testing to make CORDStrom universally available".

"Anthony Nolan is committed to supporting the development of innovative cell and gene therapies to help more patients survive and thrive," said Nicola Alderson, COO of Anthony Nolan. "This partnership with our Cell Therapy and Laboratory Services allows our donor materials to reach their full potential within a cutting-edge manufacturing platform, facilitating the development of medicinal products that meet the highest ethical and regulatory standards for patients worldwide".

Agreement Terms

The agreement includes rigorous provisions for traceability and quality management, ensuring that all materials are handled in accordance with Good Manufacturing Practice (GMP) and Human Tissue Authority (HTA) standards as INmune Bio prepares for commercial approval of CORDStrom.

(Press release, INmune Bio, MAY 5, 2026, View Source [SID1234665119])

On May 5, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported it will present new treatment comparison results evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18. An additional oral presentation will include new insights into research of intravesical recombinant BCG (rBCG) in BCG-naïve patients.

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These analyses are clinically relevant for urologists managing an increasingly complex NMIBC treatment landscape, particularly among patients with BCG-unresponsive disease. In the context of limited direct comparative data, cross-trial analyses may provide important context to inform treatment selection and sequencing. By evaluating ANKTIVA + BCG relative to other available options, these data may help characterize comparative efficacy and durability of response within current treatment paradigms.

Dr. Soon-Shiong will be presenting on "The Role of IL15 in the Urological Setting" where he will discuss the mechanisms driving T cell and NK cell activation, examine current clinical evidence, and outline emerging combination approaches in bladder and prostate cancer.

"At AUA 2026, we are advancing the conversation around bladder cancer treatment with new comparative analyses that help contextualize the clinical value of ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS with or without papillary disease," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "These findings, along with emerging insights into recombinant BCG, reflect our commitment to expanding treatment options and addressing critical challenges such as BCG supply constraints. We also continue to prioritize research advancing next-generation immunotherapies for patients with urological cancers, including bladder and prostate cancers, and look forward to sharing this research at the upcoming AUA Annual Meeting."

Oral Presentations

The phase 1/2 ResQ133A-NMIBC trial: A study of intravesical recombinant Mycobacterium Bacillus Calmette Guérin (rBCG) in BCG naïve participants with non-muscle invasive bladder cancer
Meeks J. Oral Podium Presentation: Clinical Trials in Progress: Bladder Cancer, Sunday, May 17, 9:16 am – 9:24 am EDT, The Square, Learning Lab, Hall B, Walter E. Washington Convention Center
Indirect Treatment Comparison of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and Nadofaragene Firadenovec-vncg in patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Edwards B. Oral Podium Presentation PD25-15. Session PD25: Bladder Cancer: Non-invasive V, Monday, May 18, 8:52 am – 9:00 am EDT, Room 206, Walter E. Washington Convention Center
Poster Presentation

An Indirect Treatment Comparison (ITC) of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and TAR-200 in patients with BCG-unresponsive, Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Flanders S. Poster IP50-12. Session IP50: Bladder Cancer: Non-invasive IV, Sunday, May 17, 7:00 am – 9:00 am EDT, Room 146A, Walter E. Washington Convention Center
ImmunityBio Product Theater Presentation

Dr. Soon-Shiong will provide an update on the company’s efforts to expand BCG access and advance research in the BCG naïve setting, and will discuss the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer.

The Role of IL15 in the Urological Setting
Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Saturday, May 16, 1:30 pm EDT, Product Theater booth 2701, Walter E. Washington Convention Center
About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, MAY 5, 2026, View Source [SID1234665118])

On May 5, 2026 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported a business update and announced financial results for the first quarter ended March 31, 2026.

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"This was a transformational quarter for IDEAYA, with positive topline results from the OptimUM-02 registrational trial in first line HLA*A2-negative metastatic uveal melanoma to enable the company’s first NDA submission for potential U.S. accelerated approval. We look forward to a catalyst rich second half of 2026, including targeted clinical data updates for the darovasertib combination in HLA*A2-positive mUM, IDE849 in DLL3-positive solid tumors, and IDE034, our potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, in multiple large solid tumor indications. Finally, clinical dose escalation is advancing rapidly for our potential first-in-class KAT6/7 dual inhibitor, IDE574, and our PRMT5 inhibitor, IDE892, with the goal of initiating clinical expansion and combination trials with IDE892 in MTAP-deleted PDAC and NSCLC in the second half of this year," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Selected Pipeline Developments and Corporate Updates

Darovasertib in Uveal Melanoma

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On April 13th IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib (darovasertib combination) in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM).
o
The trial met its primary endpoint, with the combination reducing the risk of disease progression by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR).
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On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses, was observed in patients treated with the darovasertib combination versus 5.8% in the ICT arm (p-value: <0.0001) with a median duration of response (DOR) of 6.8 months.
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Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm.
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The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug.
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IDEAYA will provide complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in Chicago, Illinois, and plans to submit a manuscript for publication in the second half of 2026. A new drug application (NDA) submission to the U.S. Food and Drug Association (FDA) is planned in the second half of 2026 to support a potential U.S. accelerated approval.
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The FDA has agreed to review IDEAYA’s NDA under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program, which allows an applicant to pre-submit components of its NDA for review before the complete filing is submitted to provide a more efficient review process and ensure safe and effective treatments are available to patients as early as possible.
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IDEAYA has completed enrollment of approximately 100 HLA*A2-positive mUM patients in the single-arm Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib. The company plans to present data at a major medical conference from over 85 efficacy-evaluable HLA*A2-positive mUM patients in the second half of 2026.
o
Data will include updated ORR, PFS, and OS results, which will be used to support a potential regulatory submission to the FDA to expand the labeled use of darovasertib and/or guideline inclusion to enable the use of the darovasertib combination in HLA*A2-positive mUM patients.
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In collaboration with Servier, IDEAYA successfully completed a Type C meeting with the U.S. FDA to align on the Phase 3 registrational design of the OptimUM-11 trial evaluating darovasertib in combination with crizotinib in the adjuvant setting of primary uveal melanoma. The trial will enroll approximately 450 primary uveal melanoma patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to treatment with darovasertib combined with crizotinib for 12-months or observation. The primary endpoint is superiority by relapse-free survival (RFS). OptimUM-11 is a global trial being conducted as part of IDEAYA’s partnership with Servier and is expected to initiate in the first half of 2026.
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IDEAYA is continuing site activation and patient enrollment in the Phase 3 OptimUM-10 trial of neoadjuvant darovasertib in primary uveal melanoma. Full enrollment in the trial is estimated to be complete by the end of 2027, revised from prior guidance of first half of 2027.
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IDEAYA is targeting to provide a clinical data update from the ongoing Phase 2 OptimUM-09 trial at a medical conference in the second half of 2026.
ADC / DDR combinations

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IDE849 (DLL3 TOP1 ADC): targeting to provide a clinical data update from the ongoing IDEAYA-sponsored global Phase 1/2 trial of IDE849 in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) by the end of 2026. The company is planning to initiate a monotherapy registrational trial by the end of 2026.
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In April, IDEAYA entered into a clinical collaboration agreement with AstraZeneca plc to evaluate the efficacy and safety of IDE849 in combination with Imfinzi (durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor, in extensive-stage SCLC. IDEAYA will sponsor the clinical combination trial; AstraZeneca will supply Imfinzi at no cost.
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Achieved first-patient-in (FPI) in Phase 1 combination trial of IDE849 and IDE161, IDEAYA’s proprietary inhibitor of poly(ADP-ribose) glycohydrolase (PARG). Data from this trial are intended to help evaluate the potential synergy between TOP1 and PARG inhibition to drive deeper, more durable anti-tumor responses in patients
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IDEAYA’s China-region partner, Jinagsu Hengrui Pharmaceuticals Co. Ltd., is targeting to initiate Phase 3 registrational trials in China in 2027 for IDE849 in SCLC and provide a clinical update from their Phase 1 trial in SCLC and NEC at a medical conference in the second half of 2026.
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IDE034 (B7H3/PTK7 bispecific TOP1 ADC): achieved FPI in Phase 1 dose escalation trial to evaluate IDE034 in solid tumors, and is targeting to provide a clinical data update by the end of 2026. IDE034 is a potentially first-in-class B7H3/PTK7 bispecific TOP1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats.
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Patient dosing triggered a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies.
MTAP pathway

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IDE892 (PRMT5): achieved FPI in Phase 1 dose escalation trial of IDE892 in MTAP-deleted solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). IDEAYA is planning to initiate a Phase 1 combination cohort with IDE397, its proprietary MAT2A inhibitor, in MTAP-deleted cancers in mid-2026 and expansion in the second half of 2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.
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In March, IDEAYA announced it will deprioritize clinical activity with Gilead evaluating the combination of IDE397 and Trodelvy and conclude enrollment in the Phase 1/2 trial in MTAP-deleted urothelial and lung cancers.
Other programs

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IDE574 (KAT6/7): achieved FPI in Phase 1 dose escalation trial of IDE574 in solid tumors including breast, prostate, colorectal and lung cancer. IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8, which are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation.
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Following termination of the Collaboration, Option and License Agreement with GlaxoSmithKline in 2025, IDEAYA plans to discontinue development of IDE275, a small molecule inhibitor of Werner helicase (WRN), and IDE705, a small molecule inhibitor of Pol-Theta helicase (POLQ). The company is currently evaluating strategic options for these assets.
Corporate

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In February, IDEAYA announced the appointment of Dr. Theodora (Theo) Ross into the newly created role of Chief Development Officer. Dr. Ross will be responsible for leading early clinical development for IDEAYA’s emerging oncology pipeline and play a crucial role in guiding the company’s long-term R&D strategy. She joins IDEAYA from AbbVie, where she served as Vice President, Head of Early Oncology R&D and Site Head for the Bay Area.
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As of March 31, 2026, IDEAYA had $972.9 million of cash, cash equivalents and marketable securities; current cash runway guidance into 2030 remains unchanged.
Financial Results for the Quarter Ended March 31, 2026

As of March 31, 2026, IDEAYA had cash, cash equivalents and marketable securities of approximately $972.9 million, compared to $1.05 billion as of December 31, 2025. The decrease was primarily driven by net cash used in operations.

Collaboration revenue for the three months ended March 31, 2026, totaled $6.6 million compared to $10.9 million for the three months ended December 31, 2025. Collaboration revenue was recognized for the performance obligations satisfied through March 31, 2026 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of March 31, 2026, the remaining balance for the research and development services performance obligations is $155.3 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.

Research and development (R&D) expenses for the three months ended March 31, 2026 totaled $95.7 million compared to $86.6 million for the three months ended December 31, 2025. The increase was primarily driven by higher clinical trial and personnel-related expenses to support our programs.

General and administrative (G&A) expenses for the three months ended March 31, 2026 totaled $19.4 million compared to $18.8 million for the three months ended December 31, 2025. The increase was primarily due to higher personnel-related expenses to support company growth and darovasertib commercial preparation activities.

The net loss for the three months ended March 31, 2026, was $98.5 million compared to the net loss of $83.3 million for the three months ended December 31, 2025. Total stock compensation expense for the three months ended March 31, 2026, was $14.5 million compared to $11.8 million for the three months ended December 31, 2025.

(Press release, Ideaya Biosciences, MAY 5, 2026, View Source [SID1234665117])

On May 5, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2026, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

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"Exelixis made significant progress in the first quarter of 2026 as we remain focused on our goal of building next-generation oncology franchises," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "Our first New Drug Application for zanzalintinib, for its initial potential indication in previously treated metastatic colorectal cancer, was accepted by U.S. regulatory authorities and is under active review, with a target action date of December 3, 2026. We also completed the expansion of our GI Sales team to accelerate cabozantinib’s momentum in neuroendocrine tumors and prepare for potential future indications with zanzalintinib. As the cabozantinib franchise continues to grow and we execute across seven ongoing or soon-to-start pivotal studies for zanzalintinib, we remain committed to strengthening our leadership in GU and GI oncology to improve standards of care for patients and drive long-term value for our shareholders."

Dr. Morrissey continued: "Our R&D organization is on track to deliver multiple milestones this year across our zanzalintinib pivotal development program. We expect key data readouts from STELLAR-303 and STELLAR-304, advancing enrollment in STELLAR-311, and initiation of STELLAR-316. We recently initiated STELLAR-201, a phase 2 study of zanzalintinib in recurrent meningioma, and in April our collaborator Merck initiated LITESPARK-034, the second phase 3 pivotal trial under our clinical collaboration evaluating zanzalintinib in combination with WELIREG in advanced renal cell carcinoma. Today, we also announced two additional zanzalintinib studies: STELLAR-202, a planned phase 2 trial in lung cancer, and a new expansion cohort within the ongoing STELLAR-002 phase 1b/2 study evaluating zanzalintinib in combination with docetaxel in castration-resistant prostate cancer. Finally, we expect to complete our current $750 million stock repurchase program this month and initiate an additional $750 million program authorized by our Board in May 2026."

First Quarter 2026 Financial Results

Total revenues for the quarter ended March 31, 2026 were $610.8 million, as compared to $555.4 million for the comparable period in 2025.

Total revenues for the quarter ended March 31, 2026 included net product revenues of $555.0 million, as compared to $513.3 million for the comparable period in 2025. The increase in net product revenues was primarily due to an increase in sales volume.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $55.8 million for the quarter ended March 31, 2026, as compared to $42.2 million for the comparable period in 2025. The increase in collaboration revenues was primarily related to higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen) and higher milestone-related revenues recognized in the quarter, partially offset by lower development cost reimbursements earned.
Research and development expenses for the quarter ended March 31, 2026 were $199.9 million, as compared to $212.2 million for the comparable period in 2025. The decrease in research and development expenses was primarily related to decreases in clinical trial costs and manufacturing costs to support our development candidates, partially offset by an increase in license and other collaboration costs.
Selling, general and administrative expenses for the quarter ended March 31, 2026 were $139.6 million, as compared to $137.2 million for the comparable period in 2025. The increase in selling, general and administrative expenses was primarily related to increases in marketing activities, legal and advisory fees, and personnel expenses, partially offset by a decrease in corporate giving.

Provision for income taxes for the quarter ended March 31, 2026 was $57.2 million, as compared to $46.1 million for the comparable period in 2025.

GAAP net income for the quarter ended March 31, 2026 was $210.5 million, or $0.81 per share, basic and $0.79 per share, diluted, as compared to GAAP net income of $159.6 million, or $0.57 per share, basic and $0.55 per share, diluted, for the comparable period in 2025. GAAP net income per share for the quarter ended March 31, 2026 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended March 31, 2026, as compared to the comparable period in 2025, as a result of the stock repurchase programs.
Non-GAAP net income for the quarter ended March 31, 2026 was $232.8 million, or $0.90 per share, basic and $0.87 per share, diluted, as compared to non-GAAP net income of $179.6 million, or $0.64 per share, basic and $0.62 per share, diluted, for the comparable period in 2025.

Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented.
Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.
2026 Financial Guidance
Exelixis is maintaining the previously provided financial guidance for fiscal year 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).
Total revenues
$2.525 billion – $2.625 billion
Net product revenues
$2.325 billion – $2.425 billion(1)
Cost of goods sold, % of net product revenues 3.5% – 4.5%
Research and development expenses
$875 million – $925 million(2)
Selling, general and administrative expenses
$575 million – $625 million(3)
Effective tax rate 21% – 23%

Cabozantinib Highlights

Net product revenues generated by the cabozantinib franchise in the U.S. were $555.0 million during the first quarter of 2026, with net product revenues of $552.8 million from CABOMETYX (cabozantinib) and $2.2 million from COMETRIQ (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners, Ipsen and Takeda Pharmaceutical Company Limited, during the quarter ended March 31, 2026, Exelixis earned $45.9 million in royalty revenues.

Zanzalintinib Highlights

FDA Acceptance of NDA for Zanzalintinib in Combination with Atezolizumab for Previously Treated Metastatic CRC, Based on Positive Results of STELLAR-303 Phase 3 Pivotal Trial. In February 2026, Exelixis announced that the U.S. FDA accepted its NDA for zanzalintinib as a treatment for patients with metastatic CRC, when used in combination with atezolizumab. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026. The NDA was based on positive results from the STELLAR-303 phase 3 pivotal trial, in which zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intention-to-treat (ITT) population. An OS benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy.

The trial is proceeding to the planned final analysis of the other dual primary endpoint, OS in patients without liver metastases (NLM), which is expected in mid-2026, depending on event rates.

Topline Results for STELLAR-304 Phase 3 Pivotal Trial Expected in Second Half of 2026. Today, Exelixis announced that the company expects topline results from the STELLAR-304 trial in the second half of 2026, depending on event rates. 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 renal cell carcinoma (RCC). The primary endpoints of the trial are progression-free survival (PFS) as assessed by blinded independent radiology committee and objective response rate (ORR) per RECIST 1.1, with OS as the secondary endpoint.

Enrollment Progress for STELLAR-311 Phase 2/3 Pivotal Trial. Exelixis is continuing to actively enroll patients in the STELLAR-311 phase 2/3 pivotal trial. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced neuroendocrine tumors, regardless of site of origin, who have received up to one prior line of therapy. The primary endpoint of the trial is PFS per RECIST 1.1 as assessed by blinded independent central review.
Collaboration Agreement with Natera for STELLAR-316 Phase 3 Pivotal Trial. In January 2026, Exelixis announced a collaboration with Natera, a global leader in cell-free DNA and precision medicine, for STELLAR-316, the planned, Exelixis-sponsored phase 3 pivotal trial. STELLAR-316 will evaluate zanzalintinib, with and without an immune checkpoint inhibitor, in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease. The primary endpoint of STELLAR-316 will be disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Natera will provide its Signatera assay to identify MRD+ patients for trial enrollment. Exelixis expects to initiate STELLAR-316 in mid-2026.

Initiation of LITESPARK-034 Phase 3 Pivotal Trial as Part of Clinical Development Collaboration with Merck. In April 2026, Exelixis’ collaborator Merck, known as MSD outside of the United States and Canada, initiated LITESPARK-034, a global phase 3 pivotal trial evaluating zanzalintinib in combination with WELIREG (belzutifan) versus WELIREG and placebo in second-line or later advanced RCC patients who have progressed on or after both programmed death-ligand 1 (PD-1/L1) and vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapies in sequence or in combination. LITESPARK-034 is the second of two Merck-sponsored phase 3 pivotal trials of zanzalintinib and WELIREG in RCC under the companies’ clinical development collaboration. Merck initiated the first trial, LITESPARK-033, in December 2025. LITESPARK-033 is evaluating the combination of zanzalintinib and WELIREG versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting.
Initiation of STELLAR-201 Phase 2 Trial in Recurrent Meningioma. Today, Exelixis announced it has initiated STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. The primary endpoint of the trial is ORR, with secondary endpoints including PFS, duration of response (DOR) and OS. Pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy for this form of cancer where patients have few effective treatment options.

Expansion of Zanzalintinib Clinical Development Program. Today, Exelixis announced two additional studies for zanzalintinib, including STELLAR-202, a planned phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous non-small cell lung cancer, and an additional expansion cohort in the ongoing phase 1b/2 STELLAR-002 study evaluating zanzalintinib in combination with docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease. Exelixis expects to initiate STELLAR-202 and open the expansion cohort of STELLAR-002 in the second half of 2026.

Corporate Highlights

Zanzalintinib and Cabozantinib Data Presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2026). Zanzalintinib and cabozantinib will be the subject of numerous presentations at ASCO (Free ASCO Whitepaper) 2026, which is being held from May 29 through June 2 in Chicago. Notable presentations will include an analysis of the contribution of atezolizumab to the efficacy of the combination of zanzalintinib plus atezolizumab in patients with previously treated metastatic CRC in the phase 3 STELLAR-303 trial, as well as a subgroup analysis from the phase 3 CABINET pivotal trial regarding hormone functional status.

October 2025 Stock Repurchase Program (SRP) Update and Announcement of New $750 million SRP Authorized in May 2026. As of the end of the first quarter of 2026, Exelixis repurchased $590.6 million of the company’s stock, at an average price of $43.14 per share under the current SRP authorized in October 2025 (October 2025 SRP). Exelixis expects to complete the remainder of the October 2025 SRP in May 2026, fulfilling its commitment to purchase a total of $750 million of the company’s stock under the October 2025 SRP before December 31, 2026. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.59 billion of the company’s common stock, retiring 86.8 million shares, at an average price of $29.86 per share, as of the end of the first quarter of 2026.

In May 2026, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s common stock by December 31, 2027 (May 2026 SRP). The newly authorized May 2026 SRP is the sixth such program undertaken by Exelixis since March 2023. Stock repurchases under these programs 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 programs 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 programs do not obligate Exelixis to acquire any amount of its common stock, and may be modified, suspended or discontinued at any time without prior notice.

Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended April 3, 2026 and April 4, 2025, are indicated as being as of and for the periods ended March 31, 2026 and March 31, 2025, respectively.

Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the first quarter of 2026 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, May 5, 2026.
To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.

(Press release, Exelixis, MAY 5, 2026, View Source [SID1234665116])

On May 5, 2026 Electra Therapeutics, a clinical stage biotechnology company pioneering therapies against novel targets for diseases in immunology and cancer, reported dosing of the first patient in a Phase 1 study of ipsoprubart (ELA026) in patients with T cell malignancies. Ipsoprubart, a first-in-class monoclonal antibody targeting signal regulatory proteins (SIRP) on immune cells, is designed to selectively deplete pathological T cells and myeloid cells, with the potential to inhibit tumor growth and survival through both direct tumor cell elimination and tumor microenvironment modulation.

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Initial evidence of anti-tumor activity in lymphoma, including T cell malignancies, was observed in a Phase 1b study of ipsoprubart in secondary hemophagocytic lymphohistiocytosis (sHLH), in patients whose disease was triggered by the underlying lymphoma. These findings supported advancement into a dedicated study in T cell malignancies, extending the clinical program for ipsoprubart beyond the ongoing pivotal study in sHLH. The Phase 1 study in T cell malignancies will evaluate safety and efficacy in patients treated with ipsoprubart monotherapy. T cell malignancies are a group of rare, aggressive lymphomas and leukemias arising from mature or immature T lymphocytes. More than 13,000 patients in the US are diagnosed annually with T cell malignancies and have limited effective treatment options that provide durable disease control.

"Our team has pioneered SIRP targeting as a therapeutic approach to selectively deplete pathological immune cells," said Kathy Dong, PharmD, MBA, President and CEO of Electra Therapeutics. "We are excited to follow the science and expand into T cell malignancies, where new treatment approaches are needed for patients and ipsoprubart has shown promising potential."

The open-label Phase 1 study will enroll adults with relapsed or ​refractory T cell malignancies. Patients may receive up to six cycles (24 weeks) of treatment with ipsoprubart. The study consists of two parts: Part 1 will enroll up to 24 patients to identify up to two dosing regimens with acceptable safety profiles; Part 2 will further evaluate these regimens in expansion cohorts. The primary endpoint is safety, including drug-related toxicities and treatment-emergent adverse events. Secondary endpoints include overall response rate, duration of response, and disease control rate. Additional details are available on clinicaltrials.gov (NCT07465835).

"The initiation of this study reflects strong interest from clinical investigators who were highly encouraged by the anti-tumor effect observed within weeks of treatment with ipsoprubart in the Phase 1b study in sHLH," said Kim‑Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics. "Patients with relapsed or refractory T cell malignancies have limited treatment options and poor outcomes. The promising activity observed in heavily treated patients, including responses to ipsoprubart monotherapy, supports our further evaluation in this setting."

Clinical Data for Ipsoprubart (ELA026) in Lymphomas, Including T Cell Malignancies
Anti-tumor activity of ipsoprubart in lymphoma was observed in a Phase 1b study in sHLH, including in patients whose disease was triggered by T cell malignancies. Among eight patients with lymphoma-associated sHLH, six of whom had T cell malignancies as the underlying trigger, the objective tumor response rate was 100% (8/8), with a complete response rate of 88% (7/8), including one durable complete response achieved with ipsoprubart monotherapy in a T cell lymphoma patient refractory to more than five lines of prior therapy. These findings were first reported in a presentation titled "ELA026, a Monoclonal Antibody Targeting SIRP‑expressing Myeloid Cells and T Lymphocytes, Demonstrates Broad Anti-Tumor Activity in Patients with Lymphoma" at the International Conference on Malignant Lymphoma in 2025.

(Press release, Electra Therapeutics, MAY 5, 2026, View Source [SID1234665115])