On November 5, 2025 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the third quarter of 2025 and raised full year 2025 guidance for Portfolio Receipts."We delivered strong third quarter 2025 results, raised our full year guidance and are on track to deliver another year of double-digit top-line growth," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "In addition, we had an especially active past few months for deals, expanding our portfolio with three innovative therapies and increasing our Capital Deployment to $2.0 billion for the year. Furthermore, we hosted our Investor Day in September, where we highlighted the rapid growth in the royalty market, the powerful competitive advantages that underscore our leadership, our sustainable and attractive returns and our goal to be the premier capital allocator in life sciences with consistent, compounding growth.

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"Double-digit growth in Royalty Receipts and Portfolio Receipts

•Royalty Receipts grew 11% to $811 million in the third quarter of 2025, primarily driven by Voranigo, Tremfya and the cystic fibrosis franchise. •Portfolio Receipts increased by 11% to $814 million. Significant Capital Deployment in recent months strengthens portfolio •Acquired a royalty on Amgen’s Imdelltra for up to $950 million; entered into a funding agreement on obexelimab with Zenas BioPharma for up to $300 million; and acquired a royalty on Alnylam’s Amvuttra for $310 million.•Repurchased four million Class A ordinary shares for $152 million in the third quarter, with total share repurchases of $1.2 billion in the first nine months of 2025.Positive clinical and regulatory updates across royalty portfolio•Revolution Medicines’ daraxonrasib: positive initial data in first-line metastatic pancreatic cancer supporting Phase 3 initiation in the fourth quarter of 2025; FDA awarded Commissioner’s National Priority Voucher with goal of accelerating development and review.•Roche’s trontinemab: initiated the Phase 3 program for Alzheimer’s disease. Raising financial guidance for full year 2025 (excludes contribution from future transactions)•Royalty Pharma expects 2025 Portfolio Receipts to be between $3,200 million and $3,250 million (previously $3,050 million to $3,150 million), representing expected growth of 14% to 16% (previously 9% to 12%).Financial & Liquidity Summary
Three Months Ended September 30,
(unaudited)
($ and shares in millions)
2025
2024
Change
Portfolio Receipts
814
735
11%
Net cash provided by operating activities
703
704
(0)%
Adjusted EBITDA (non-GAAP)*
779
679
15%
Portfolio Cash Flow (non-GAAP)*
657
617
6%
Weighted average Class A ordinary shares outstanding – diluted
560
593
(6)%

*See "Liquidity and Capital Resources" section. Adjusted EBITDA and Portfolio Cash Flow are non-GAAP liquidity measures calculated in accordance with the credit agreement.
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Portfolio Receipts Highlights
Three Months Ended September 30,
(unaudited)
($ in millions)
2025
2024
Change
Products:
Marketers:
Therapeutic Area:
Cystic fibrosis franchise
Vertex
Rare disease
222
207
7%
Trelegy
GSK
Respiratory
96
91
6%
Tysabri
Biogen
Neuroscience
68
68
(0)%
Evrysdi
Roche
Rare disease
52
48
8%
Xtandi
Pfizer, Astellas
Cancer
50
43
15%
Tremfya
Johnson & Johnson
Immunology
49
34
44%
Imbruvica
AbbVie, Johnson & Johnson
Cancer
41
46
(11)%
Promacta
Novartis
Hematology
38
42
(9)%
Voranigo
Servier
Cancer
33
—
n/a
Cabometyx/Cometriq
Exelixis, Ipsen, Takeda
Cancer
21
19
15%
Spinraza
Biogen
Rare disease
14
14
(4)%
Erleada
Johnson & Johnson
Cancer
12
10
23%
Trodelvy
Gilead
Cancer
12
11
6%
Other products(5)
102
98
3%
Royalty Receipts
811
732
11%
Milestones and other contractual receipts
3
3
0%
Portfolio Receipts
814
735
11%

Amounts shown in the table may not add due to rounding.Royalty Receipts was $811 million in the third quarter of 2025, an increase of 11% compared to $732 million in the third quarter of 2024. The increase was primarily driven by Voranigo, Tremfya and the cystic fibrosis franchise. Portfolio Receipts was $814 million in the third quarter of 2025, an increase of 11% compared to $735 million in the third quarter of 2024, primarily driven by the same Royalty Receipts increases noted above. Liquidity and Capital ResourcesRoyalty Pharma’s liquidity and capital resources are summarized below:As of September 30, 2025, Royalty Pharma had cash and cash equivalents of $939 million and total debt with principal value of $9.2 billion, primarily comprised of $8.8 billion of unsecured notes with a weighted average duration of approximately 13 years and an attractive weighted-average cost of debt of 3.75%. This outstanding total debt includes $2.0 billion of senior unsecured notes (2025 Notes) issued in September 2025 with a weighted average coupon rate of 5.16%. Additionally, Royalty Pharma repaid $1.0 billion of senior unsecured notes upon maturity in August 2025.In January 2025, Royalty Pharma announced a new share repurchase program under which it may repurchase up to $3.0 billion of its Class A ordinary shares. Royalty Pharma repurchased approximately four million Class A ordinary shares for $152 million in the third quarter and 35 million shares for $1.2 billion for the first nine months of 2025. The weighted-average number of diluted Class A ordinary shares outstanding for the third quarter of 2025 was 560 million as compared to 593 million for the third quarter of 2024.

Three Months Ended September 30,
(unaudited)
($ in millions)
2025
2024
Portfolio Receipts
814
735
Payments for operating and professional costs
(34)
(55)
Adjusted EBITDA (non-GAAP)
779
679
Interest paid, net
(123)
(62)
Portfolio Cash Flow (non-GAAP)
657
617

Amounts may not add due to rounding.•Adjusted EBITDA (non-GAAP) was $779 million in the third quarter of 2025. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.•Portfolio Cash Flow (non-GAAP) was $657 million in the third quarter of 2025. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments. Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $1.0 billion in the third quarter of 2025, consisting primarily of upfront payments for the Imdelltra and obexelimab funding agreements (see ‘Royalty Transactions’) and research and development funding for litifilimab. Capital Deployment for the first nine months of 2025 amounted to $1.7 billion.The table below details Capital Deployment by category:Capital Deployment
Three Months Ended September 30,
Nine Months Ended September 30,
(unaudited)
(unaudited)
($ in millions)
2025
2024
2025
2024
Purchases of available for sale debt securities
—
—
(75)
(150)
Acquisitions of financial royalty assets
(962)
(1,195)
(964)
(2,009)
Acquisitions of other financial assets
—
—
—
(18)
Development-stage funding payments
(51)
(1)
(402)
(2)
Milestone payments
—
—
(269)
(50)
Investments in equity method investees
—
—
—
(11)
Contributions from legacy non-controlling interests – R&D
(0)
0
0
1
Capital Deployment
(1,013)
(1,195)
(1,709)
(2,239)

Royalty TransactionsDuring 2025, Royalty Pharma has announced new transactions of up to $3.8 billion. The announced transactions amount reflects the entire amount of capital committed for new transactions year to date, including potential future milestones. Recent transactions include:•In November 2025, Royalty Pharma acquired a royalty interest in Alnylam’s Amvuttra from Blackstone for $310 million. Amvuttra is an approved RNAi therapeutic for the treatment of transthyretin (TTR) amyloidosis with cardiomyopathy and for hereditary TTR amyloidosis with polyneuropathy.•In September 2025, Royalty Pharma acquired a synthetic royalty on obexelimab from Zenas BioPharma for an upfront payment of $75 million and up to $225 million in milestone payments contingent on the achievements of certain clinical and regulatory events. Obexelimab is in Phase 3 development for the treatment of immunoglobulin G4-related disease and in Phase 2 development for relapsing multiple sclerosis and systemic lupus erythematosus.•In August 2025, Royalty Pharma acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for an upfront payment of $885 million. BeOne Medicines has the option to sell to Royalty Pharma additional royalties on Imdelltra for up to $65 million within twelve months from the acquisition date. Imdelltra is approved for the treatment of extensive-stage small cell lung cancer.The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.Key Developments Relating to the Portfolio The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.
litifilimab
In October 2025, Biogen announced that both litifilimab Phase 3 studies for systemic lupus erythematosus are fully enrolled with expected data readout for both studies now accelerated to the second half of 2026.
obexelimab
In October 2025, Zenas BioPharma announced positive results from the Phase 2 trial of obexelimab in relapsing multiple sclerosis, which demonstrated a highly statistically significant 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions over week 8 and week 12 compared with placebo. Zenas anticipates reporting 24-week data in relapsing multiple sclerosis in the first quarter of 2026.
trontinemab
In September 2025, Roche announced that it initiated its Phase 3 program for trontinemab in early symptomatic Alzheimer’s disease. Additionally, Roche announced plans to initiate a Phase 3 study in preclinical Alzheimer’s disease, in people at high risk of cognitive decline.
Airsupra
In September 2025, AstraZeneca announced that the FDA approved a supplemental New Drug Application (sNDA) for Airsupra to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared to albuterol.
daraxonrasib
In September 2025, Revolution Medicines announced positive Phase 1 results from its clinical trials evaluating daraxonrasib as a monotherapy and daraxonrasib in combination with chemotherapy in first-line (1L) metastatic pancreatic ductal adenocarcinoma (PDAC). These data support Revolution Medicines’ plan to initiate a Phase 3 trial for daraxonrasib in 1L metastatic PDAC in the fourth quarter of 2025. In October 2025, the FDA granted a non-transferrable voucher for daraxonrasib under the Commissioner’s National Priority Voucher (CNPV) pilot program, which accelerates review times to 1-2 months.
Skytrofa
In July 2025, Ascendis announced the FDA approved Skytrofa for the once-weekly treatment of adults with growth hormone deficiency.
Cabometyx
In July 2025, Ipsen announced that the European Commission (EC) approved Cabometyx for previously treated advanced neuroendocrine tumors.

deucrictibant
In July 2025, Pharvaris announced that it anticipates topline data for the Phase 3 study (RAPIDe-3) evaluating deucrictibant for the on-demand treatment of hereditary angioedema attacks in the fourth quarter of 2025 and, pending positive data, expects to submit a New Drug Application (NDA) to the FDA in the first half of 2026.
CF Franchise
In July 2025, Vertex announced that the EC approved Alyftrek for people with cystic fibrosis ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

2025 Financial OutlookRoyalty Pharma has provided guidance for full year 2025, excluding new transactions and borrowings announced after the date of this release, as follows:
Provided November 5, 2025
Previous
Portfolio Receipts
$3,200 million to $3,250 million(Growth of ~+14% to 16% year/year)
$3,050 million to $3,150 million(Growth of ~+9% to 12% year/year)
Payments for operating and professional costs
~9% to 9.5% of Portfolio Receipts
~9% to 9.5% of Portfolio Receipts
Interest paid
$275 million
$275 million

The above Portfolio Receipts guidance represents expected growth of 14% to 16% in 2025. Royalty Pharma’s full year 2025 guidance reflects a negligible estimated foreign exchange impact to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2025.Payments for operating and professional costs in the second half of 2025 are expected to decrease due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025. Payments for operating and professional costs in 2025 include one-time payments amounting to approximately $70 million (>2% of 2025 Portfolio Receipts), comprised of transaction costs for the Internalization and other one-time items.Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedule for the term loan assumed as part of the internalization transaction. In 2025, total interest paid is anticipated to be approximately $275 million, including $7 million in the fourth quarter of 2025. These projections assume no additional debt financing in 2025. In the third quarter of 2025, Royalty Pharma collected interest of $7 million on its cash and cash equivalents, which partially offset interest paid. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 – $360 million(7), including interest payments on the $2.0 billion of senior unsecured notes issued in September 2025.

(Press release, Royalty Pharma , NOV 5, 2025, View Source [SID1234659474])

On November 5, 2025 Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, reported a major scientific breakthrough: its next-generation immune cell therapy led to complete regression of both primary and metastatic pancreatic tumors in humanized mouse models.

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The study was published in a new Brief Report in Vaccines on November 2, 2025. The peer-reviewed Brief Report details the development of a second-generation, clinical-grade DC construct that achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized models. Pancreatic cancer is one of the deadliest cancers, often diagnosed late and resistant to conventional treatments. Lunai’s therapy uses engineered dendritic cells — specialized immune cells created from stem cells — that are genetically enhanced to activate the body’s immune system against cancer. This publication details a second-generation, clinical-compliant version of this platform, with the provided evidence critical in advancing ongoing partnering conversations for the therapy.

This new publication builds on Lunai’s earlier study (Vaccines 2025 Jul 12;13(7):749; doi:10.3390/vaccines13070749), which first demonstrated potent anti-tumor activity of CD34+ hematopoietic stem cell (HSC)-derived DCs engineered to overexpress CD40L, CD93, and CXCL13 in humanized mouse models of pancreatic cancer. While the initial study utilized a research-grade lentiviral vector, the latest report describes an optimized, clinically compliant construct that preserves equivalent efficacy while improving design and manufacturing attributes to support future clinical translation.

The second-generation construct features a strong mammalian promoter and enhanced genetic elements to drive expression of key immune-modulating molecules. In preclinical humanized models, Lunai’s next-generation DC therapy triggered robust activation of cytotoxic T cells and NK cells and led to complete regression of both primary and metastatic pancreatic tumors. These findings mirrored the outcomes achieved with the original research-grade product. While the allogeneic DC product has been evaluated in pancreatic cancer models, its therapeutic potential extends to a broad range of solid tumors.

"These findings demonstrate that our vector optimization strategy maintains therapeutic potency while bringing our allogeneic DC platform to the threshold of IND-enabling studies," said David Weinstein, CEO of Lunai Bioworks. "This represents an important inflection point as we move from research innovation to clinical translation—positioning Lunai at the forefront of next-generation cell-based immunotherapies."

The full article, titled "Modified Hematopoietic Stem Cell-Derived Dendritic Cell Therapy Retained Tumor-Inhibitory Function and Led to Regression of Primary and Metastatic Pancreatic Tumors in Humanized Mouse Models," is available in Vaccines (View Source).

(Press release, Lunai Bioworks, NOV 5, 2025, View Source [SID1234659491])

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

•
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.

•
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.

•
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.

•
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

•
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.

•
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.

•
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.

•
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.

•
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.

•
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])