On November 4, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and announced financial results for the third quarter ended September 30, 2026.

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"We are entering an important period for Vir Bio, with meaningful catalysts across both hepatitis delta and oncology," said Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology. "We look forward to reporting topline ECLIPSE 1 data this quarter as we advance our goal to address the significant unmet need for patients with a therapy that can drive hepatitis delta virus to undetectable. In oncology, VIR-5500 achieved proof of concept and received FDA Fast Track designation, supporting our plans with Astellas to advance the program into pivotal trials next year. With momentum across both areas, we believe Vir Bio is well positioned to deliver meaningful value for patients and stakeholders."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

The Company will present expanded Phase 2 SOLSTICE results in oral presentations at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026 on November 8.
Topline data from the pivotal ECLIPSE 1 trial are expected in the fourth quarter of 2026. ECLIPSE 1 is a Phase 3 trial evaluating the safety and efficacy of monthly subcutaneous administration of elebsiran and tobevibart compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited.
Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.
Data from ECLIPSE 1, ECLIPSE 2 and ECLIPSE 3 will be part of a comprehensive global filing package.
Oncology

VIR-5500/ASP6958

U.S. FDA granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC).
VIR-5500 has achieved proof of concept, reinforcing the scientific rationale for advancing the program into late-stage development. The Company expects multiple pivotal trials to begin in 2027.
VIR-5500 is currently being evaluated in a Phase 1 trial (NCT05997615) as a monotherapy and combination therapy across six dose expansion cohorts. Indications include taxane naïve mCRPC, radioligand therapy naïve mCRPC, radioligand therapy exposed mCRPC and metastatic hormone sensitive prostate cancer (mHSPC).
VIR-5818

The Phase 1 trial (NCT05356741) evaluating VIR-5818, a HER2-targeted PRO-XTEN dual-masked TCE, safety and pharmacokinetics, with dose escalation and signal-finding components, has enrolled patients with a variety of HER2-expressing cancers. Following recent feedback from the FDA, the Company intends to add backfill cohorts in a more homogeneous patient population in the monotherapy arm of the study to determine optimal dose and schedule. This is aligned with the FDA’s Project Optimus, an initiative to reform the dose optimization and dose selection paradigm in oncology drug development.
Dose escalation of VIR-5818 in combination with pembrolizumab, a PD1 inhibitor, is ongoing.
The Company expects to present data at a future scientific conference.
VIR-5525

The Phase 1 trial (NCT06960395) of VIR-5525, an EGFR-targeted PRO-XTEN dual-masked TCE, continues enrollment as expected, both as a monotherapy and in combination with pembrolizumab.
Preclinical Pipeline Candidates

The Company plans to host a virtual research investor event during the first quarter of 2027 to provide investors with a comprehensive view of its oncology strategy, including information on new development candidates from its preclinical pipeline.
The Company announced a collaboration and license agreement with Gilead to discover and engineer three novel PRO-XTEN dual-masked TCE development candidates targeting selected solid tumor-associated antigens. Under the agreement, Gilead will have an exclusive license to develop and commercialize the novel TCEs.
The Company received $90 million in cash consideration, including a $65 million upfront payment and a $25 million equity investment at a 30% premium, and is eligible to receive up to $45 million in potential near-term preclinical milestones. The Company also has the potential to receive up to $1.74 billion in further development, regulatory and commercial milestones, along with tiered royalties on net sales.
Corporate Update

The Company appointed Aziz Sawaf, MBEE, MBA, CFA, as its Executive Vice President and Chief Financial Officer.
The Company appointed David Liu, M.D., Ph.D., as its Executive Vice President and Chief Medical Officer.
The Company appointed Suzanne Topalian, M.D., to its Board of Directors and as a member of the Science and Technology Committee.
Third Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2026, the Company had approximately $901.3 million in cash, cash equivalents and investments, representing a decrease of $106.5 million during the third quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were $80.0 million, which included $4.4 million of non-cash stock-based compensation expense, compared to $151.5 million for the same period in 2025, which included $5.5 million of non-cash stock-based compensation expense. The decrease was primarily driven by a non-recurring $75.0 million milestone expense in the third quarter of 2025 due upon VIR-5525 achieving "first in human dosing" along with the recognition of cost recoveries in connection with the Company’s collaborations with Astellas and Norgine in the third quarter of 2026. The decrease was partially offset by higher manufacturing costs associated with the Company’s oncology and CHD programs.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2026 were $24.4 million, which included $6.0 million of non-cash stock-based compensation expense, compared to $22.2 million for the same period in 2025, which included $5.8 million of non-cash stock-based compensation expense. The increase was primarily due to higher advisory and legal fees.

Net Loss: Net loss for the third quarter of 2026 was $96.3 million, or $0.57 per share, basic and diluted, compared to a net loss of $163.1 million, or $1.17 per share, basic and diluted for the same period in 2025.

2026 Financial Guidance

Based on our current operating plans, the Company continues to expect its cash, cash equivalents and investments to fund operations into the second half of 2028.

Conference Call

Vir Biotechnology will host its third quarter 2026 financial results conference call at 4:30 p.m. ET / 1:30 p.m. PT today. A live webcast will be available at View Source and will be archived for 30 days.

About the ECLIPSE Registrational Program

ECLIPSE is a registrational program to evaluate the efficacy and safety of the elebsiran and tobevibart regimen in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the regimen in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) evaluates the efficacy and safety of the regimen compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) evaluates the efficacy and safety of switching to the regimen in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 3 (NCT07142811) evaluates the regimen compared to bulevirtide in bulevirtide-naïve patients, and it is designed to provide important data to help establish access and reimbursement in key markets. ECLIPSE 1, 2 and 3 are pivotal trials designed to generate a comprehensive data package in support of potential submission to global regulatory agencies.

About Elebsiran and Tobevibart

Elebsiran and tobevibart are investigational agents being evaluated as a novel combination regimen administered monthly as two separate sequential subcutaneous injections for the treatment of chronic hepatitis delta (CHD). The combination is designed to disrupt the hepatitis delta virus (HDV) life cycle at multiple points by addressing both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg.

Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting HBsAg. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life.

About Chronic Hepatitis Delta (CHD)

CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 Because ongoing hepatitis delta virus (HDV) replication drives disease progression, achieving undetectable virus, as defined by HDV RNA TND (target not detected), is considered an important virologic marker associated with improved clinical outcomes in CHD.4 Individuals with CHD who have detectable HDV RNA are at a higher risk of experiencing any liver-related event, including developing compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and mortality, compared to patients with undetectable HDV RNA.4 There are currently limited approved treatments in the U.S. and globally.

About VIR-5500, VIR-5818 and VIR-5525

VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO‑XTEN masking technology and target PSMA, HER2 and EGFR, respectively.

About PRO-XTEN Dual-masked T-cell Engagers (TCEs)

T-cell engagers (TCEs) are powerful anti-tumor agents designed to direct the immune system, specifically T-cells, to destroy cancer cells. TCEs have become an important treatment option for blood cancers, but their usage in solid tumors has been limited due to toxicity. The universal PRO-XTEN masking technology is designed to extend the half-life of the molecule and to keep TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By extending the half-life and confining activity to the tumor microenvironment, the PRO-XTEN technology could limit toxicity, widen the therapeutic index of TCEs, and potentially enable less frequent dosing regimens.

About Advanced Prostate Cancer

Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.5 Many patients develop metastatic hormone sensitive prostate cancer (mHSPC) following definitive treatment for localized prostate cancer or present with metastatic disease at initial prostate cancer diagnosis.6 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).7 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.8 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.

(Press release, Vir Biotechnology, NOV 4, 2026, View Source [SID1234674225])

On November 4, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported its financial results for the third quarter and nine months ended September 30, 2026, and provided an update on clinical and operational progress.

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"This quarter marked a period of meaningful momentum for Summit, highlighted by AstraZeneca’s $2 billion strategic equity investment and the expansion of our network of clinical collaborations with AstraZeneca, Daiichi Sankyo, and several others," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "These commitments underscore ever growing confidence in ivonescimab’s potential across a broad range of solid tumors."

"Our global clinical development program for ivonescimab continues to broaden, with the announcement of ivonescimab combination collaborations with Datroway and sone-ve, alongside new studies in bladder cancer with HARMONi-GU1, in biliary tract cancer with EA2251, and in kidney cancer with SMT112-216 and Arcus’ ARC-20 platform study," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. "We are encouraged by the statistically significant overall survival results recently presented from Akeso’s HARMONi-2 study in PD-L1–positive advanced NSCLC and HARMONi-GI1 study in BTC, and we look forward to the upcoming initial HARMONi-3 data in first-line squamous NSCLC."

Clinical & Operational Updates

Clinical and operational progress continues with ivonescimab, a novel, potentially first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

Summit in-licensed ivonescimab from Akeso Inc. in January 2023. In total, over 5,000 patients have been treated with ivonescimab in clinical studies globally, and over 100,000 patients have been treated in the commercial setting with ivonescimab in China, as noted and updated by Akeso. Summit has exclusive rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China.
Summit is currently developing ivonescimab in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), urothelial carcinoma (UC), and renal cell carcinoma (RCC), specifically conducting multiregional Phase II or Phase III clinical trials in the following proposed indications or settings:
HARMONi (Phase III): ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI);
HARMONi-3 (Phase III): ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non-squamous tumors;
HARMONi-7 (Phase III): ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression;
HARMONi-GI3 (Phase III): ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC;
HARMONi-GU1 (Phase II / III): ivonescimab plus the antibody-drug conjugate (ADC) enfortumab vedotin (EV) in previously untreated patients with first-line metastatic UC; and
SMT112-216 (Phase II): multiple ivonescimab-based combination treatment regimens in first line patients with metastatic clear cell RCC (ccRCC) (SMT112-216 is also referred to as AK112-216 in China).
HARMONi

In January 2026, the U.S. Food and Drug Administration (FDA) accepted for filing Summit’s Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The BLA was submitted based on the results of the global Phase III HARMONi trial. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. The HARMONi study has dual primary endpoints: progression-free survival (PFS) and overall survival (OS). HARMONi met its PFS primary endpoint, becoming the first global Phase III study of an immunotherapy-based regimen to show a statistically significant PFS improvement in this setting. In the primary analysis for OS, ivonescimab in combination with chemotherapy showed a positive trend without achieving a statistically significant result. As previously disclosed, the FDA noted that a statistically significant OS benefit is necessary to support marketing authorization in this setting. Considering the safety and efficacy profile of the current FDA-approved options for patients in this setting – none of which have demonstrated a statistically significant OS benefit – as well as the continued positive, regionally consistent data of this Phase III multiregional study, and discussions with key opinion leaders and physicians who have administered ivonescimab to patients, Summit believes that ivonescimab is a potential treatment option with a favorable benefit-risk profile.
In September 2026, updated OS results from HARMONi were presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026). With longer follow-up, western patients replicated the survival improvement seen in Asian patients, further reinforcing the regional consistency of the efficacy results observed in the HARMONi study. The updated June 2026 analysis continued to show consistent, favorable OS results, with an OS hazard ratio of 0.76 (95% CI: 0.61 – 0.95; nominal p=0.0151) in the global intention-to-treat (ITT) population. An OS hazard ratio of 0.76 was demonstrated in the western patient subgroup (95% CI: 0.52 – 1.10), which was consistent with the ITT population and Asian subgroup. In this most recent analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were noted in this latest HARMONi data cut. These results have been made available to the FDA.
HARMONi-3

Enrollment in both the squamous and non-squamous NSCLC cohorts of the global HARMONi-3 study is complete. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the fourth quarter of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for OS independent of PFS is planned for the first half of 2027. For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.
HARMONi-7

Summit’s global Phase III HARMONi-7 trial continues to enroll, with enrollment expected to be completed in 2027.
In September 2026, interim OS data for HARMONi-2, an Akeso-sponsored Phase III study evaluating ivonescimab monotherapy in a similar setting to Summit’s HARMONi-7 trial, was presented WCLC 2026. In this protocol-specified interim analysis of OS, a secondary endpoint in the HARMONi-2 study, ivonescimab monotherapy demonstrated a statistically significant and clinically meaningful improvement compared to pembrolizumab monotherapy, achieving a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.95; p=0.009). A clinically meaningful benefit was demonstrated across important clinical subgroups, including those with PD-L1 low expression (PD-L1 Score 1-49%) and PD-L1 high expression (PD-L1 Score ≥ 50%), along with those with squamous and non-squamous histologies. In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile, which was consistent with previous Phase III studies of ivonescimab and no additional safety signals were noted. HARMONi-2 evaluated monotherapy ivonescimab compared to monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-2 is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.
HARMONi-GI3

Summit is continuing to enroll the HARMONi-GI3 study, which is expected to include 900 patients. The enrollment rate has exceeded initial estimations and is currently expected to complete in Q3 2027.
HARMONi-GU1

In August 2026, the company announced the planned initiation of the global, multi-regional Phase II / III HARMONi-GU1 trial expanding ivonescimab’s global registration-enabling clinical development program to now include UC, or bladder cancer. Global clinical trial site activations for and enrollment in HARMONi-GU1 have begun for the Phase II portion of this study.
SMT112-216

In October 2026, Summit announced the initiation and opening of trial sites for SMT112-216, a randomized, open-label, global Phase II study of ivonescimab in previously untreated advanced ccRCC, the most common type of kidney cancer. The study, also referred to as AK112-216, is being conducted in collaboration with Summit’s partner, Akeso. Participants will be randomized to receive ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or nivolumab plus ipilimumab as an established standard-of-care comparator regimen. Cadonilimab is an investigational PD-1 x CTLA-4 bispecific antibody developed by Akeso. This study, in addition to collaborative work being performed by Arcus combining ivonescimab with the HIF2α inhibitor, casdatifan, will be used to inform registration-enabling studies in first-line ccRCC with ivonescimab. SMT112-216 has begun enrollment and plans to enroll approximately 100 patients at clinical trial sites in the U.S. and China.
Additional Ivonescimab Development Updates

In September 2026, Summit entered into a clinical trial collaboration with AstraZeneca to evaluate ivonescimab in combination with AstraZeneca’s Claudin 18.2-targeting ADC, sonesitatug vedotin, also referred to as sone-ve, in certain gastrointestinal cancer settings. Each company will contribute their respective compound for the combination studies to be conducted, and the parties will jointly contribute to the costs of such studies, which are intended to be sponsored by AstraZeneca. The collaboration does not include upfront payments, milestone payments, or royalty sharing provisions. Each company will retain development and commercial rights to their respective molecules.
Additionally in September 2026, the company executed a non-binding Memorandum of Understanding with AstraZeneca whereby the two companies intend to enter into an agreement to conduct clinical trials combining ivonescimab with multiple AstraZeneca cancer medicines, including AstraZeneca’s leading portfolio of antibody-drug conjugates (ADCs). The companies intend to share clinical development costs of potential future studies. Each company will retain their current development and commercial rights to their respective molecules, and the agreement is mutually non-exclusive. The memorandum of understanding does not include upfront payments, milestone payments, or royalty sharing provisions.
In October 2026, Summit announced a clinical trial collaboration with AstraZeneca and Daiichi Sankyo to evaluate ivonescimab in combination with the TROP2-directed ADC datopotamab deruxtecan (Datroway) across multiple solid tumor settings, intending to include breast and lung cancer. The companies intend to begin with a Phase III trial in first-line triple-negative breast cancer (TNBC). The collaboration does not include upfront payments, milestone payments, or royalty sharing provisions.
In October 2026, HARMONi-GI1, an Akeso-sponsored Phase III study evaluating ivonescimab plus chemotherapy in patients with BTC, was presented as part of the Presidential Symposium at the 2026 European Society for Medical Oncology Annual Congress (ESMO 2026). Ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in OS when compared to durvalumab in combination with chemotherapy, with a hazard ratio of 0.75 (95% CI: 0.61, 0.92; p=0.0031). In the HARMONi-GI1 study, ivonescimab plus chemotherapy demonstrated an acceptable and manageable safety profile which was consistent with previous Phase III studies of ivonescimab plus chemotherapy. No additional safety signals were identified.
Summit plans to continue further expansion of the global clinical development program for ivonescimab, including additional Phase III studies, in additional settings and tumor types. The company will continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond NSCLC, CRC, UC, RCC, BTC, and head and neck squamous cell carcinoma (HNSCC).
In addition to the multiregional studies conducted and sponsored by Summit, Akeso is enrolling several single-region Phase III studies exclusively in China in multiple indications outside of NSCLC, including BTC, TNBC, HNSCC, small cell lung cancer, CRC, and pancreatic cancer.
Summit’s clinical trial collaborations continue to progress as planned.
In the second quarter of 2025, the company announced a clinical collaboration with Revolution Medicines, Inc. (RevMed) to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. As previously announced, the initial study under this collaboration, sponsored by RevMed, began enrolling patients in the first quarter of 2026.
In the first quarter of 2026, Summit announced a clinical collaboration with GORTEC, a European Head and Neck Oncology and Radiotherapy Group based in France, to evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a randomized three-arm study. The Phase III study, GORTEC 2024-04 ILLUMINE (NCT07264075), is sponsored by GORTEC and is intended to be conducted in multiple countries in Europe and in China; Summit may consider the expansion of this study into the United States. ILLUMINE began enrolling patients in the second quarter of 2026.
In the first quarter of 2026, the company announced a clinical collaboration with GSK plc to evaluate ivonescimab in combination with GSK’s novel B7-H3 ADC, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is currently enrolling.
In July 2026, Summit announced a clinical collaboration with Arcus Biosciences, Inc. to evaluate ivonescimab in combination with Arcus’ novel HIF-2α inhibitor, casdatifan, in ccRCC. Initial data from the study under this collaboration agreement is expected to be generated by mid-2027.
In September 2026, as noted above, Summit announced a clinical collaboration with AstraZeneca to evaluate ivonescimab in combination with sone-ve in certain gastrointestinal cancer settings.
In October 2026, as noted above, Summit announced a clinical trial collaboration with AstraZeneca and Daiichi Sankyo to evaluate ivonescimab in combination with Datroway across multiple solid tumor settings, intended to include breast and lung cancer. The companies intend to begin with a Phase III trial in first-line TNBC.
In October, 2026, Summit announced a clinical collaboration with ECOG-ACRIN Cancer Research Group to evaluate ivonescimab in combination with chemotherapy compared to pembrolizumab or durvalumab in combination with chemotherapy in advanced biliary tract cancer (BTC) in a registration-enabling Phase II / III clinical study, EA2251. The primary endpoint for the study is OS and activation of U.S. clinical trial sites is expected to begin in the fourth quarter of 2026.
Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit has agreed to support more than 65 ISTs, of which 26 have started and are actively enrolling.
Financial Highlights

On October 5, 2026, AstraZeneca completed a $2.0 billion strategic equity investment in Summit. The equity investment will support continued acceleration of the development of ivonescimab. Pursuant to the terms of the Securities Purchase Agreement entered into by Summit and AstraZeneca, AstraZeneca purchased an aggregate of approximately 108,955 shares of preferred stock convertible into shares of common stock of Summit at a 1:1,000 ratio. The investment by AstraZeneca totaled $2.0 billion. At the conversion ratio, the investment represents a common stock price equal to $18.36, representing a premium over the closing trading price on the day the investment was announced. For additional details on the financial terms, please refer to the Summit press release issued on September 28, 2026.

Third quarter 2026 financial highlights are as follows:

Cash and Cash Equivalents and Short-term Investments

Aggregate cash and cash equivalents and short-term investments were $629.8 million and $713.4 million at September 30, 2026 and December 31, 2025, respectively.
During the third quarter of 2026, the company raised $94.1 million in gross proceeds through its ATM facility.
GAAP and Non-GAAP Operating Expenses

GAAP operating expenses were $214.6 million for the third quarter of 2026, compared to $234.2 million for the same period of the prior year. The decrease in GAAP operating expenses was due to the decrease in stock-based compensation expense of $83.1 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025, offset by an increase primarily in R&D expenses driven by the expansion of clinical studies and development costs related to ivonescimab.
Non-GAAP operating expenses were $166.9 million for the third quarter of 2026, compared to $103.4 million for the same period of the prior year. The increase in Non-GAAP operating expenses was primarily driven by the expansion of clinical studies and development costs related to ivonescimab.
GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses were $169.1 million for the third quarter of 2026, compared to $131.1 million for the same period of the prior year. The increase was driven by the expansion of clinical studies and development costs related to ivonescimab, offset by the decrease in stock-based compensation expense of $16.7 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP R&D expenses were $145.2 million for the third quarter of 2026, compared to $90.5 million for the same period of the prior year. The increase was primarily driven by the expansion of clinical studies and development costs related to ivonescimab.
GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $45.5 million for the third quarter of 2026, compared to $103.1 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $66.4 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP G&A expenses were $21.7 million for the third quarter of 2026, compared to $12.9 million for the same period of the prior year. The increase was primarily driven by the expansion of infrastructure and our headcount to support the development of ivonescimab.
GAAP and Non-GAAP Net Loss

GAAP net loss in the third quarter of 2026 and 2025 was $208.4 million or $(0.26) per basic and diluted share, and $231.8 million or $(0.31) per basic and diluted share, respectively.
Non-GAAP net loss in the third quarter of 2026 and 2025 was $160.7 million or $(0.20) per basic and diluted share, and $101.0 million or $(0.13) per basic and diluted share, respectively.

(Press release, Summit Therapeutics, NOV 4, 2026, View Source [SID1234674224])

On November 4, 2026 Verismo Therapeutics, a clinical-stage CAR T cell therapy company pioneering a novel multi-chain KIR-CAR platform technology, reported that clinical data from its ongoing Phase 1 CELESTIAL-301 trial (NCT06544265) of SynKIR-310 have been selected for an oral presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 12-15, 2026, in New Orleans. The oral presentation will include updated clinical and pharmacokinetic/pharmacodynamic correlative data across SynKIR-310 dose cohorts 1 through 3 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) following at least two prior lines of therapy.

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In the initial clinical readout, SynKIR-310 showed an 80% objective response rate (4 of 5 evaluable patients) and a 60% complete response rate across dose cohorts 1 and 2, and the median duration of response in patients with a complete response was not reached with one patient in continued complete response at the 12-month assessment. No cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was reported in any patient treated at the first two dose levels, and no dose-limiting toxicities were observed. Three of the six treated patients received SynKIR-310 in the outpatient setting. Additional data will be presented at the ASH (Free ASH Whitepaper) 2026 oral session in December.

Verismo will also present two additional preclinical poster abstracts — a novel CD19/CD20 dual-targeted KIR-CAR and a head-to-head preclinical comparison of SynKIR-310 against single-chain CAR T designs. The dual-targeted construct (Yucel et al.) addresses antigen heterogeneity — a leading cause of relapse after conventional CD19 CAR T — and shows substantially reduced cytokine levels versus a single-chain benchmark. In the head-to-head comparison (Blair et al.), SynKIR-310 achieved deeper tumor control than single-chain CD19 CAR T designs with substantially lower cytokine production.

ASH 2026 — Clinical Oral Presentation

Title: First-in-human evaluation of SynKIR-310 employing a novel multi-chain KIR-based CAR demonstrates promising antitumor activity and no reported CRS or ICANS in patients with high-risk B-NHL
Presenter: Michael Tees, M.D., Colorado Blood Cancer Institute
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities
Session Date and Time: Dec 13, 2026: 5:45 – 6:00 PM
Location: Ernest N. Morial Convention Center, New Orleans, Louisiana
Publication Number: 708
Full Abstract: View Source
Full Clinical Data Readout: Released at the time of presentation

ASH 2026 — Preclinical Poster Presentations

Poster 1 — Novel CD19/CD20 Dual-Targeted KIR-CAR
Title: CD19/20 dual targeted killer immunoglobulin-like receptor (KIR)-based CAR T eliminates antigen-heterogenous B cell lymphomas with reduced cytokine secretion and adaptable ex vivo or in vivo gene delivery
Presenter: Nora Yucel, Ph.D., Verismo Therapeutics
Session: 702. CAR-T Cell Therapies: Basic and Translational
Session Date and Time: Dec 14, 2026: 6 – 8 PM
Full Abstract: View Source

Poster 2 — SynKIR-310 vs. Single-Chain CAR T Preclinical Comparison
Title: CD19-targeted multi-chain killer immunoglobulin receptor (KIR)-based CAR T demonstrate an enhanced benefit-risk profile over single-chain CAR T
Presenter: Megan Blair, Ph.D., Verismo Therapeutics
Session: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational
Session Date and Time: Dec 14, 2026: 6 – 8 PM
Full Abstract: View Source

About the KIR-CAR Platform

The KIR-CAR platform is a multi-chain T cell therapy that has shown highly effective solid tumor treatment in otherwise CAR-resistant animal models with hard-to-treat tumors. Using NK cell-derived killer immunoglobulin-like receptor (KIR) and DAP12 to split the target binding and T cell activation signals provides a novel paired immune-receptor activation that is independent from CD3 signaling and does not require additional co-stimulation. KIR-CAR enables sustained cell receptor expression in T cells, and induces deeper, more durable tumor treatments. Together, this multi-chain cell signaling platform provides the potential to deliver effective patient treatments by minimizing the background activation and early T cell exhaustion observed in conventional single-chain CAR T therapy, with potential to treat patients with both solid and hematologic tumors. The KIR-CAR platform is adaptable to both ex vivo and in vivo delivery modalities.

(Press release, Verismo Therapeutics, NOV 4, 2026, View Source [SID1234674223])

On November 4, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Robert Wenham, M.D., Chair of the Gynecologic Oncology Program at Moffitt Cancer Center ("Moffitt") and principal investigator of Anixa’s ongoing Phase 1 clinical trial evaluating its novel CAR-T therapy for recurrent ovarian cancer, will present at the ESMO (Free ESMO Whitepaper) (European Society of Medical Oncology) Immuno-Oncology & Advanced Therapies Congress 2026, being held December 14–16, 2026, in London.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Dr. Wenham’s presentation, titled "Phase 1 clinical trial of autologous T-cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer," will take place on Monday, December 14, 2026.

Anixa’s Phase 1, dose-escalating clinical trial (ClinicalTrials.gov NCT05316129), conducted at Moffitt, is evaluating the safety, tolerability, and preliminary signs of efficacy of liraltagene autoleucel, or lira-cel, a novel CAR-T therapy targeting the follicle-stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells but has limited expression in healthy tissues.

The Company recently announced completion of treatment of the fifth cohort in the trial, in which patients received 1×10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, representing a 100-fold increase over the dose administered to the first patient in the study. Following routine safety verification, the Company anticipates advancing to a sixth cohort at a dose of 1×10⁸ CAR-positive cells/kg, representing a 1,000-fold increase over the initial dose of 1×10⁵ CAR-positive cells/kg.

To date, no dose-limiting toxicities have been observed in the study. The Company has also reported encouraging preliminary clinical observations, including the first patient exhibiting stable disease 90 days following treatment and four patients surviving more than one year after treatment, including one patient who has survived beyond two years.

"We are pleased that Dr. Wenham will be presenting our ovarian cancer CAR-T clinical program at this important international immuno-oncology conference," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Our trial continues to advance through progressively higher dose levels as well as lymphodepletion, and we are encouraged by the safety profile and preliminary clinical observations reported to date. The completion of our fifth cohort represents another important step in evaluating this novel approach to treating recurrent ovarian cancer. We look forward to sharing our progress with the international oncology community as we continue working with our colleagues at Moffitt to advance this promising therapy."

The ESMO (Free ESMO Whitepaper) Immuno-Oncology & Advanced Therapies Congress brings together leading researchers, clinicians, and oncology experts from around the world to discuss advances in cancer immunotherapy and emerging therapeutic approaches. The international meeting focuses on the latest scientific and clinical developments in immuno-oncology, including cellular therapies, novel immune-targeting strategies, and the challenges of extending the benefits of immunotherapy to a broader range of cancers.

(Press release, Anixa Biosciences, NOV 4, 2026, View Source;advanced-therapies-congress-2026-302928923.html [SID1234674222])

On November 4, 2026 Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, reported that it will present two collaborative studies with Labcorp and CellCarta using its AI-powered pathology platform, Lunit SCOPE, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting, taking place November 4–8 in Phoenix, Arizona.

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The presentations mark Lunit’s sixth consecutive year of presenting research at SITC (Free SITC Whitepaper) since 2021. The ovarian cancer study examines histologic characteristics associated with homologous recombination deficiency (HRD), while the bladder cancer study explores spatial immune patterns associated with immunotherapy response.

The first study, conducted with Labcorp, examined histologic and immune characteristics associated with HRD in ovarian carcinomas using AI-powered pathology analysis. HRD is an important biomarker used to guide treatment with PARP inhibitors, but whether HRD-associated biological differences can be identified through routine histopathology remains an open research question.

Researchers analyzed 339 ovarian carcinoma whole-slide images, including 88 HRD and 251 HRP cases, using Lunit SCOPE IO to quantify 22 immune and morphological features, including immune phenotypes, cell densities, and characteristics of tumor and stromal compartments.

Molecular profiling using Labcorp’s OmniSeq INSIGHT assay showed that HRD tumors had higher tumor mutational burden (TMB) than HRP tumors. In the pathology analysis using Lunit SCOPE IO, HRD tumors showed approximately 1.5-fold higher mitotic cell density (p=0.002), along with significantly higher tumor cell density in cancer areas (p=0.031) and combined cancer and stromal compartments (p=0.016).

Across the cohort, immune phenotypes classified by Lunit SCOPE IO were also associated with genomic features, with inflamed tumors showing higher TMB than immune-desert and immune-excluded tumors (median 4.7 vs. 3.9 mutations per megabase; p=0.038).

The second study, conducted with CellCarta, examined associations between spatial immune organization and response to neoadjuvant atezolizumab, an anti-PD-L1 immunotherapy, in patients with muscle-invasive bladder cancer (MIBC).

Using tissue samples from the Phase II ABACUS study, researchers combined multiplex immunohistochemistry and spatial analysis to characterize immune cell populations and their interactions. As part of the study, tertiary lymphoid structures (TLS) in H&E-stained tissue were assessed by CellCarta pathologists and with Lunit SCOPE IO, while CellCarta’s spatial analysis technologies were used to examine tumor and immune cell populations and their spatial relationships.

Responders showed higher immune cell infiltration, greater immune cell diversity, and closer proximity between tumor cells and T cells. Significant colocalization of antigen-presenting cells and CD4-positive T cells was also observed, along with a trend toward more TLS being located closer to tumor cell nests. In contrast, nonresponders generally exhibited lower immune infiltration, with T cells located farther from tumor cells and predominantly displaying an exhausted phenotype.

These results suggest that spatial immune organization, beyond immune cell abundance alone, may offer insights into immunotherapy response and warrant further investigation as a potential source of predictive biomarkers.

Together, the studies illustrate how AI-powered pathology can contribute to different aspects of tumor microenvironment research, from identifying proliferation-related tissue features associated with HRD in ovarian cancer to supporting the assessment of immune structures alongside complementary spatial analysis in bladder cancer.

"AI-powered pathology is expanding how researchers can analyze tumor tissue and investigate cancer biology," said Brandon Suh, CEO of Lunit. "Through collaborations with global research partners such as Labcorp and CellCarta, we aim to deepen our understanding of the tumor microenvironment and advance the role of AI in precision oncology research."

Research Presentations at SITC (Free SITC Whitepaper) 2026:

1. Poster Presentation [#1024 / Nov. 7]: AI-based spatial profiling reveals histologic differences between homologous recombination-deficient and -proficient ovarian carcinomas

2. Poster Presentation [#476 / Nov. 7]: Spatial immune architecture and tumor–T cell proximity are associated with response to neoadjuvant atezolizumab in muscle-invasive bladder cancer

* Lunit SCOPE products are for research use only. Not for use in diagnostic procedures or decisions.

(Press release, Lunit, NOV 4, 2026, View Source [SID1234674221])