On November 5, 2025 Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, reported third quarter 2025 financial results and provided business updates.

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"Following constructive feedback from the FDA, we are working to finalize our SER-155 Phase 2 study protocol for the prevention of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) for hematological malignancies," said Thomas DesRosier and Marella Thorell, co-Chief Executive Officers of Seres. "As we prepare for the next phase of SER-155 development, we continue our efforts aimed at securing the funding needed to conduct the Phase 2 study. We expect to be ready to rapidly operationalize the study once financing is in place, and we expect to obtain interim efficacy and safety results within 12 months of the study start. If these results are consistent with our prior successful Phase 1b study, and supportive of continued development, we believe this milestone should be a significant value-creating event for the Company and shareholders. Based on our on-going engagement with the medical community and assessment of the commercial landscape, we remain highly enthusiastic about the broad potential for SER-155—in allo-HSCT and other medically vulnerable populations."

Mr. DesRosier and Ms. Thorell continued, "In addition to SER-155 development in allo-HSCT, we are expanding our understanding of the broader SER-155 therapeutic opportunity through an ongoing investigator-sponsored study in immune checkpoint related enterocolitis, initiated by the investigator at Memorial Sloan Kettering Cancer Center, and we look forward to obtaining initial efficacy results in early 2026. Additionally, during the third quarter, we implemented cost-reduction measures, including decreasing our workforce. Considering these actions and our current operating plans, we expect to fund operations through the second quarter of 2026, providing flexibility to advance our strategic priorities."

Recent Highlights

SER-155 and Bloodstream Infection (BSI) Prevention

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Efforts are ongoing to obtain capital and other resources to support the SER-155 Phase 2 study. The Company is evaluating a range of potential deal structures that could leverage Seres’ live biotherapeutics expertise and success, as demonstrated by bringing VOWST, the first FDA-approved oral microbiome therapeutic, from early development through FDA approval.

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The Company received constructive feedback from the FDA during the third quarter and is working to finalize the planned Phase 2 study protocol for SER-155 in allo-HSCT, which previously received Breakthrough Therapy designation. The study is expected to enroll approximately 248 participants and incorporate an adaptive design and an interim data analysis when approximately half of the enrolled participants have reached the primary endpoint. The Company expects to obtain the interim clinical results within 12 months following study initiation, which it believes will facilitate timely engagement with the FDA on the design of a Phase 3 study, and inform development in adjacent medically vulnerable patient populations. The Company believes that positive results from the Phase 2 study, if achieved, could create significant value and enable advancement into a single Phase 3 trial to support registration.

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In the third quarter, CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria, awarded Seres a grant of up to $3.6 million, representing the second grant the Company has received from CARB-X. The funds will support the development of an oral liquid formulation of SER-155, potentially expanding patient access for medically vulnerable populations who cannot be dosed with oral capsules.

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In October, Seres presented an oral presentation at IDWeek 2025. The presentation included new post-hoc analysis from the completed SER-155 Phase 1b study describing differences between the SER-155 and placebo groups, including the bacterial and fungal organisms causing BSIs, BSI event clinical outcomes, antibacterial prophylaxis use, and patterns of antimicrobial resistance (AMR) among the bacterial BSI organisms. These new data illustrated that BSIs occurred despite antibacterial prophylaxis, and that BSI bacteria exhibited AMR. Resistance to multiple antibacterial agents was observed only in the BSI bacteria from placebo-treated participants, two of whom had fatal outcomes related to their BSIs. These new data further support the potential of SER-155 as an innovative alternative approach to the significant unmet medical need for prevention of BSIs in HSCT patients, especially those BSIs associated with AMR that increase the risk of morbidity and mortality.

Development of Biotherapeutics for the Treatment of Inflammatory and Immune Diseases

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The Company is collaborating with Memorial Sloan Kettering Cancer Center on an investigator-sponsored trial (IST) which is evaluating SER-155 in participants with immune checkpoint related enterocolitis (irEC). Enrollment is anticipated to be completed by the end of 2025, with clinical readout expected in early 2026. IrEC is among the most frequent and severe immune-related adverse events (irAEs) in recipients of immune checkpoint-inhibitor therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. Immune checkpoint inhibitors can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. Supportive data from this IST could provide further support for the expansion of indications that may be well suited for our biotherapeutic approach.

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Seres continues to explore potential R&D partnerships to advance development of its investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease.

Financial Results

The Company has classified all historical operating results for the VOWST business within discontinued operations in the consolidated statements of operations for the comparative periods presented (three and nine months ended September 30, 2024). There is no activity in the current period related to discontinued operations.

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Seres reported net income from continuing operations of $8.2 million for the third quarter of 2025, as compared to a net loss from continuing operations of $51.0 million for the same period in 2024. The net income of $8.2 million is comprised primarily of a $22.5 million loss from operations offset by a $27.2 million gain on sale of VOWST resulting primarily from the $25 million installment payment received, as expected, from Nestle during the third quarter. The net loss of $51.0 million in 2024 is primarily comprised of a $29.2 million loss from operations plus a $23.4 million loss on the extinguishment of the Oaktree debt, which was retired at completion of the VOWST sale in September 2024.

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Research and development (R&D) expenses for the third quarter of 2025 were $12.6 million, compared with $16.5 million for the third quarter of 2024. The decrease in R&D expenses was primarily driven by a decrease in personnel and related costs, a decrease in platform investments, and a reduction in clinical expenses resulting from completion of the SER-155 Phase 1b study.

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General and administrative (G&A) expenses for the third quarter of 2025 were $9.5 million, compared with $12.7 million for the third quarter of 2024. The decrease in G&A expenses was primarily a result of lower personnel and related expenses, including IT-related expenses.

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Manufacturing services expenses were $0.7 million for the third quarter of 2025. These costs relate to the provision of manufacturing services under the Transition Services Agreement (TSA) with Nestlé, which began in the fourth quarter of 2024. The reimbursement received from Nestlé related to these expenses is recognized in other income.

Cash Runway

As of September 30, 2025, Seres had $47.6 million in cash and cash equivalents. Based on the Company’s current cash position, VOWST transaction-related obligations, and current operating plans, the Company expects to fund operations through the second quarter of 2026. The Company continues to evaluate further opportunities to extend its cash runway.

Conference Call Information

Seres’ management will host a conference call today, November 5, 2025, at 8:30 a.m. ET. The conference call may be accessed by calling 1-800-715-9871 (international callers dial 1-646-307-1963) and referencing the conference ID number 8471287. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com. A webcast replay will be available on the Seres website shortly after the event and will be archived for at least 21 days.

About SER-155

SER-155 is an investigational, oral, live biotherapeutic designed to decolonize gastrointestinal (GI) pathogens, improve epithelial barrier integrity, and induce immune homeostasis, to prevent bacterial bloodstream infections, including those that can harbor antimicrobial resistance (AMR), as well as other pathogen associated negative clinical outcomes, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

SER-155 has been evaluated in a Phase 1b placebo-controlled study in patients undergoing allo-HSCT, which demonstrated a significant reduction in both bacterial bloodstream infections (BSIs) (77% relative risk reduction) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia. SER-155 has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allo-HCST and Fast Track designation for reducing the risk of infection and graft-versus-host disease in patients undergoing allo-HCST. The early development of the program was supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria.

(Press release, Seres Therapeutics, NOV 5, 2025, View Source [SID1234659475])

On November 5, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and announced financial results for the third quarter ended September 30, 2025.

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"Our third quarter demonstrated exceptional execution across our clinical portfolio," said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. "We completed ECLIPSE 1 enrollment approximately two months ahead of schedule and continue to see strong momentum across ECLIPSE 2 and 3, positioning us well for our hepatitis delta regulatory submissions. We are excited to provide guidance for a comprehensive VIR-5500 data update in the first quarter of 2026, and we recently expanded into first-line prostate cancer with our ARPI combination study. These achievements reflect our team’s commitment to delivering transformative therapies to patients with significant unmet medical needs."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

The ECLIPSE 1 Phase 3 trial has completed enrollment approximately two months ahead of the Company’s internal projections. Primary completion is expected in the fourth quarter of 2026, with topline data expected in the first quarter of 2027. ECLIPSE 1 evaluates the combination of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or in other regions where its use is limited.
The ECLIPSE 2 Phase 3 trial continues enrolling well, and topline data are expected in the first quarter of 2027. ECLIPSE 2 evaluates the switch to the combination of tobevibart and elebsiran in participants who have not achieved undetectable hepatitis delta virus RNA with bulevirtide treatment.
The ECLIPSE 3 Phase 2b trial is progressing ahead of schedule with strong enrollment momentum, and topline data are expected in the first quarter of 2027. ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.
Following positive data presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2024, the Company will present Week 48 endpoint results from its SOLSTICE Phase 2 clinical study, in patients with CHD at AASLD The Liver Meeting 2025. The oral presentation will take place on Sunday, November 9.
Solid Tumors

VIR-5500, a PRO-XTEN dual-masked T-cell engager (TCE) targeting prostate-specific membrane antigen (PSMA), continues to advance through Phase 1 dose escalation as a monotherapy in heavily pre-treated patients with metastatic castration-resistant prostate cancer (mCRPC) and has demonstrated promising early anti-tumor activity and a favorable safety profile.
First patient dosed in Phase 1 clinical study of VIR-5500 in combination with ARPIs in first-line mCRPC.
The Company plans to share a comprehensive VIR-5500 data update in late-line patients in the first quarter of 2026.
VIR-5818, a PRO-XTEN dual-masked TCE targeting HER2, continues in a Phase 1 dose escalation study in combination with pembrolizumab.
VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development and is being evaluated in multiple tumor types, including metastatic colorectal cancer (CRC).
VIR-5525, a PRO-XTEN dual-masked TCE targeting EGFR, continues enrollment in the Phase 1 trial as expected.
VIR-5525 leverages learnings from VIR-5500 and VIR-5818 and is being evaluated in a variety of EGFR-expressing solid tumors in areas of high unmet need, such as non-small cell lung cancer, CRC, head and neck squamous cell carcinoma, and cutaneous squamous cell carcinoma.
Preclinical Pipeline Candidates

Harnessing the Company’s deep immune system expertise combined with its discovery and engineering platform and proprietary dAIsY (data AI structure and antibody) AI engine, the Company continues to advance multiple undisclosed PRO-XTEN masked TCEs directed toward validated targets with potential application across a number of solid tumors.
Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2025, the Company had $810.7 million in cash, cash equivalents and investments, representing a decrease of approximately $81.4 million during the third quarter of 2025.

Revenues: Total revenues for the third quarter of 2025 were $0.2 million compared to $2.4 million for the same period in 2024.

Cost of Revenue: The change in cost of revenue for the third quarter of 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses (R&D): R&D expenses for the third quarter of 2025 were $151.5 million, which included $5.5 million of non-cash stock-based compensation expense, and $75.0 million of milestone payments paid from restricted cash, compared to $195.2 million for the same period in 2024, which included $8.9 million of non-cash stock-based compensation expense and $102.8 million of license expenses. The decrease was primarily driven by lower license expenses and cost savings from previously announced restructuring initiatives, partially offset by higher clinical expenses from our ECLIPSE registrational program for CHD and progression of our oncology programs.

The $75.0 million milestone payment to former shareholders of Amunix Pharmaceuticals, Inc. was triggered by VIR-5525 achieving first-in-human dosing and was paid from restricted cash held in escrow since the execution of the license agreement with Sanofi S.A. (Sanofi), therefore having no impact on our reported cash position or runway. The prior year license expenses were primarily due to the recognition of the $102.8 million Sanofi upfront payment as in-process research and development expense in the third quarter of 2024.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the third quarter of 2025 were $22.2 million, which included $5.8 million of non-cash stock-based compensation expense, compared to $25.7 million for the same period in 2024, which included $7.8 million of non-cash stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net: The Company incurred no restructuring, long-lived assets impairment and related charges, net for the third quarter of 2025 compared to $12.7 million for the same period in 2024. The decrease was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.

Other Income: Other income for the third quarter of 2025 was $10.5 million compared to $17.8 million for the same period in 2024. The decrease was primarily driven by lower interest income.

Provision for Income Taxes: The provision for income taxes for the third quarter of 2025 was nominal.

Net Loss: Net loss for the third quarter of 2025 was $163.1 million, or $1.17 per share, basic and diluted, compared to a net loss of $213.7 million, or $1.56 per share, basic and diluted for the same period in 2024.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund operations into mid-2027.

Conference Call

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

(Press release, Vir Biotechnology, NOV 5, 2025, View Source [SID1234659492])

On November 5, 2025 Bristol Myers Squibb (NYSE: BMY) reported that it has priced a public offering (the "Offering") of senior unsecured notes in a combined aggregate principal amount of €5 billion (collectively, the "Notes"). The Notes will be issued by Bristol Myers Squibb’s wholly-owned subsidiary, BMS Ireland Capital Funding Designated Activity Company, in five tranches: (i) €750,000,000 aggregate principal amount of 2.973% Notes due 2030, (ii) €1,150,000,000 aggregate principal amount of 3.363% Notes due 2033, (iii) €1,150,000,000 aggregate principal amount of 3.857% Notes due 2038, (iv) €750,000,000 aggregate principal amount of 4.289% Notes due 2045, and (v) €1,200,000,000 aggregate principal amount of 4.581% Notes due 2055. The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by Bristol-Myers Squibb Company. Bristol Myers Squibb expects that the closing of the Offering will occur on November 10, 2025, subject to the satisfaction of customary closing conditions.

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On November 3, 2025, Bristol Myers Squibb commenced a tender offer (the "Tender Offer") to purchase, for cash, various series of its outstanding notes (the "Tender Offer Notes"). Bristol Myers Squibb intends to use the net proceeds of the Offering, together with approximately $3.0 billion of cash on hand, (i) to fund the Tender Offer and/or other repurchase, repayment or redemption of the notes subject to the Tender Offer, (ii) to pay fees and expenses in connection therewith and with the Offering and (iii) to the extent of any remaining proceeds, for general corporate purposes. The Offering is not contingent on the consummation of the Tender Offer or the purchase of any of the Tender Offer Notes in connection therewith.

Citigroup Global Markets Limited, Barclays Bank PLC, BNP PARIBAS, J.P. Morgan Securities plc and Société Générale are acting as joint lead managers and joint book-running managers for the Offering.

The Offering of the Notes is being made pursuant to an effective shelf registration statement (including a prospectus and preliminary prospectus supplement) (File Nos. 333-283810 and 333-283810-01) filed with the U.S. Securities and Exchange Commission (the "SEC"). You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Bristol Myers Squibb, any underwriter or any dealer participating in the Offering will arrange to send you the prospectus and the preliminary prospectus supplement (or, if available, the prospectus supplement) if you request it by contacting Bristol Myers Squibb Investor Relations or Citigroup Global Markets Limited at +1 800-831-9146, Barclays Bank PLC at +1 888-603-5847, BNP PARIBAS at +44 0-20-7595-8222, J.P. Morgan Securities plc (for non-U.S. investors) at +44-20 7134-2468 or J.P. Morgan Securities LLC (for U.S. investors) at (212) 834-4533 (call collect) and Société Générale at +1 855-881-2108.

(Press release, Bristol-Myers Squibb, NOV 5, 2025, View Source [SID1234659460])

On November 5, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported financial results for the quarter ended September 30, 2025 and provided a corporate update.

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"We are continuing our strategic alternatives process with the goal of maximizing value for stockholders," said Stephen Brady, president and chief executive officer of Tempest. "In addition, we look forward to the start of the TPST-1495 Phase 2 in collaboration with the NCI and the Cancer Prevention Clinical Trials Network and remain confident in the potential of amezalpat to transform the treatment of first-line HCC and bring meaningful benefit to patients and their families."

Financial Results

Third Quarter 2025

Tempest ended the quarter with $7.5 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by $4.1 million in net proceeds from the June 2025 registered direct offering, as well as $2.8 million in net proceeds from the company’s at-the-market offering program.
Net loss and net loss per share for the quarter were $3.5 million and $0.79, respectively, compared to $10.6 million and $5.32, respectively, for the same period in 2024.
Research and development expenses for the quarter were $0.6 million, compared to $7.6 million for the same period in 2024. The $7.0 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the quarter were $3.0 million, compared to $3.0 million for the same period in 2024, and were primarily related to consulting and professional services.
Year-to-Date

Cash used in operating activities for the nine months ended September 30, 2025 was $23.2 million.
Net loss and net loss per share for the nine months ended September 30, 2025 were $22.2 million and $5.71, respectively, compared to $28.0 million and $15.48, respectively, for the same period in 2024.
Research and development expenses for the nine months ended September 30, 2025 were $12.1 million, compared to $17.7 million for the same period in 2024. The $5.6 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the nine months ended September 30, 2025 were $10.4 million, compared to $10.4 million for the same period in 2024, and were primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the nine months ended September 30, 2025, as well as consulting and professional services.

(Press release, Tempest Therapeutics, NOV 5, 2025, View Source [SID1234659476])

On November 5, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that six abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025. The meeting is taking place November 5 – 9 at the Gaylord National Convention Center in National Harbor, Maryland.

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"We’re excited to join the oncology community at this year’s meeting and highlight our latest research and progress in advancing the immuno-oncology field," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "Our latest findings demonstrate the potential of integrated, data-driven approaches to refine biomarkers, improve prediction of immunotherapy response, and inform the development of next-generation tools for patient stratification."

This year, Tempus will highlight its latest scientific and clinical research findings via six poster presentations.

A novel multi-omic algorithm to predict real-world outcomes among patients with rare, advanced, solid cancers treated with off-label immune checkpoint inhibitors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 157
Summary: This study investigates the utility of the Immune Profile Score (IPS) as a molecular signature to predict the effectiveness of immune checkpoint inhibitor (ICI) therapy in rare, advanced solid cancers. Given the clinical unmet need for rare, heterogeneous cancers, the study evaluated 90 eligible patients from Tempus’ de-identified real-world database who had a rare, advanced solid cancer diagnosis and received off-label ICI treatment, excluding those with high TMB or MSI. Patients were further categorized as IPS-high or IPS-low. The findings demonstrated that IPS-high patients experienced significantly longer overall survival compared to those categorized as IPS-low. Importantly, IPS maintained its prognostic significance across all patient subgroups and clinically relevant confounders. These results support IPS as a pan-cancer biomarker capable of accurately stratifying ICI treatment outcomes and potentially supporting the label expansion of ICIs to various rare cancer types.
MAIT cell abundance within tumors are associated with key clinical characteristics across solid tumors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 133
Summary: An analysis of 190,189 patients, utilizing T-cell receptor (TCR) sequencing data from Tempus’ de-identified real-world database, investigated the prevalence and distribution of mucosal-associated invariant T (MAIT) cells across numerous solid tumor types. The study determined MAIT cell abundance using TCRα chains, with comparisons adjusting for overall T cell infiltration or total TCR’s detected where relevant. MAIT cell abundance was highest in tumors of mucosal origin, such as colorectal and gastroesophageal cancers, and higher MAIT cell levels were statistically significantly in younger patients, males, and non-smokers. Furthermore, the prevalence of MAIT cells showed associations with important clinical and molecular factors, including reduced MAIT cell abundance in PD-L1 high (TPS ≥50%; pan-cancer), microsatellite instability (MSI)-high (pan-cancer and colorectal cancer), and microbial factors such as lower bacterial load (pan-cancer). These findings suggest that MAIT cell prevalence may have important clinical implications and may serve as a promising biomarker and immunotherapy target.
TargetR: Automated multi-omics report framework for target characterization and validation of immunotherapy and targeted therapy candidates across cancers
Date/Time: Friday, November 7; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 1115
Summary: A detailed computational framework, TargetR, was developed by integrating public and real-world multi-omics datasets to accelerate the discovery and validation of immunotherapy targets. This approach unified pharmacologic, genomic, transcriptomic, and proteomic data, utilizing advanced analytics to assess target potential based on criteria such as normal tissue expression, mutational load, and copy number variation (CNV) correlation with expression. Validation of findings can then be performed using Tempus’ de-identified real-world database, which provides clinical features and outcome data. The framework generated an automated, user-friendly report with actionable insights, enabling the identification and prioritization of targets for treatments like bispecific T-cell engagers and CAR-T therapies, thereby supporting the development of next-generation immunotherapies.
A multi-omic immune profile score (IPS) stratifies real-world outcomes of microsatellite stable (MSS) advanced colorectal cancer patients treated with immune checkpoint inhibitors
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 134
Summary: This exploratory study investigated the potential of Tempus’ Immune Profile Score (IPS), a DNA- and RNA-based molecular signature, to act as a predictive biomarker for immune checkpoint inhibitor (ICI) benefit in patients with microsatellite stable (MSS) advanced colorectal cancer (CRC). Tempus’ de-identified real-world database was utilized to identify 46 eligible MSS CRC patients who received an ICI alone or ICI-containing regimen in the third line (3L) or beyond. Using pre-ICI tissue, patients were stratified into IPS-High versus IPS-Low groups. The results demonstrated a clinically meaningful improvement in real-world overall survival (rwOS) for the IPS-High group compared to the IPS-Low group. Furthermore, a comparison of IPS risk stratification on ICI therapy versus prior non-ICI regimen provided additional insight about IPS’s utility as an ICI-specific biomarker. This hypothesis-generating data address an unmet need for patients whom an ICI therapy and predictive biomarker are urgently needed.
Ultrahigh tumor mutational burden (TMB) is associated with improved survival outcomes in patients (Pts) treated with immune checkpoint inhibitors (ICIs)
Date/Time: Saturday, November 8, 2025; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 136
Summary: This research evaluates the prognostic value of defining an "ultrahigh" tumor mutational burden (TMB) threshold (≥40 mutations/MB) compared to the standard 10 mt/MB cutoff for patients receiving immune checkpoint inhibitor (ICI) therapy. Using Tempus Lens, the research team defined a cohort of 17,449 patients with five different cancer types (melanoma, lung, GI, non-melanoma skin, and uterine) from Tempus’ de-identified multimodal database. The analysis sought to compare real-world objective response rates (rwORR) and overall survival (rwOS) across low, high, and ultrahigh TMB groups. The findings indicate that patients in the ultrahigh TMB group experience significantly improved clinical outcomes, including enhanced rwORR and better rwOS. This ultrahigh TMB status is also linked to a distinct tumor microenvironment, specifically showing a higher degree of regulatory T cell and myeloid cell infiltration, suggesting that ultrahigh TMB may serve as a novel marker for predicting ICI responsiveness.
Impact of androgen receptor mutations on immune infiltration in castration resistant prostate cancer
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 140
Summary: A detailed analysis using Tempus’ de-identified real-world database examined the relationship between androgen receptor (AR) alterations and the immune microenvironment in 1,556 patients with castration-resistant prostate cancer (CRPC). The study specifically investigated AR mutations, amplifications, and ARv7 splicing detected via DNA (Tempus xT) and RNA (Tempus xR) sequencing. Over half of the CRPC patients exhibited these AR alterations, which were associated with significantly decreased immune infiltration and reduced expression of key immunotherapy targets like PD−1, PD−L1, and CTLA−4. Regression analysis confirmed this link to decreased immune infiltration was independent of tumor mutational burden (TMB) and tumor purity. These findings suggest that AR mutations contribute to a reduced immune response, potentially serving as a mechanism of resistance to treatment, and underscore the necessity of using AR status to stratify CRPC patients for immunotherapy.

(Press release, Tempus, NOV 5, 2025, View Source [SID1234659493])