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 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 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.
2

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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 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended September 30, 2025, and provided an update on corporate progress.

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"Our diverse clinical and preclinical RAS(ON) inhibitor programs continue to make encouraging progress and deliver on important milestones," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Backed by robust operational capabilities and a strong financial position, we feel growing momentum in support of our goal to establish new global standards of care for people living with RAS-addicted cancers, including pancreatic, lung and colorectal cancers."

The company reported significant progress on its near-term strategic priorities:

Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC)

RASolute 302, a global Phase 3 clinical trial of daraxonrasib in patients with previously treated PDAC, is winding down enrollment globally as the company nears completion of enrollment at all U.S. and international sites. The trial remains on track for an expected data readout in 2026.

For daraxonrasib in pancreatic cancer, the FDA recently granted an Orphan Drug Designation as well as a Commissioner’s National Priority Voucher supporting accelerated review, in addition to the previously awarded Breakthrough Therapy Designation.

RASolve 301, a global Phase 3 trial of daraxonrasib in patients with previously treated NSCLC, is now enrolling patients in Europe and Japan in addition to the U.S.

Advance daraxonrasib into earlier line randomized pivotal trials in patients with PDAC and NSCLC

The company recently disclosed new clinical results supporting initiation of RASolute 303, a global Phase 3 registrational trial of daraxonrasib in first line metastatic PDAC. The company remains on track to initiate the trial this year. The trial will evaluate daraxonrasib as monotherapy and in combination with gemcitabine nab-paclitaxel (GnP), each compared with GnP alone. The company expects to share updated daraxonrasib monotherapy and daraxonrasib plus GnP combination data, each in patients with first line PDAC, including preliminary durability, in the first half of 2026.

The company has initiated RASolute 304, a Phase 3 trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and is currently activating trial sites. The trial will evaluate patients who have received surgery and perioperative chemotherapy per standard of care, who will be randomized to either observation or daraxonrasib monotherapy for two years. The primary endpoint is disease-free survival, with secondary endpoints of overall survival and safety.

The company remains on track to initiate a registrational trial in 2026 evaluating daraxonrasib in patients with first line metastatic RAS mutant NSCLC in combination with pembrolizumab and chemotherapy.

Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination

New elironrasib monotherapy data presented recently at the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics (Triple Meeting) showed encouraging response rate and progression-free survival in patients with RAS G12C NSCLC who had previously been treated with a KRAS G12C(OFF) inhibitor. The company continues to expand enrollment in this and other elironrasib monotherapy and combination trials as it explores options for continued development of this differentiated and promising RAS(ON) G12C-selective inhibitor.

In addition, at the Triple Meeting the company presented encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib, the company’s G12D-selective inhibitor, and daraxonrasib in models of KRAS G12D PDAC, furthering the rationale for this RAS(ON) inhibitor doublet as a therapeutic strategy.

With zoldonrasib’s differentiated profile, the company believes this G12D-selective inhibitor has the potential to contribute as a key component of combination regimens in first line PDAC with current standard of care chemotherapy and/or with daraxonrasib as a RAS(ON) inhibitor doublet. The company expects to initiate a registrational trial for a zoldonrasib combination in patients with first line metastatic PDAC in the first half of 2026 and one or more additional pivotal combination trials in 2026 that incorporate either zoldonrasib or elironrasib.

Zoldonrasib is also being evaluated in a Phase 1 monotherapy expansion cohort in patients with previously treated NSCLC as well as in combination regimens, including zoldonrasib with pembrolizumab or daraxonrasib, in NSCLC.

Progress earlier stage pipeline, including advancing next-generation innovations from the company’s highly productive discovery organization

RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track toward planned initiation of a Phase 1 trial in Q1 2026.

Clinical Collaboration Updates
The company has several discovery and clinical collaborations exploring a range of combinations of a RAS(ON) inhibitor with inhibitors of novel targets, including vopimetostat (TNG462), a PRMT5 inhibitor, under an agreement with Tango Therapeutics, and ivonescimab, a bi-specific PD-1/VEGF inhibitor, under an agreement with Summit Therapeutics.

Other Corporate Updates

In support of the company’s growing late-stage development activities and commercialization plans, the company recently announced the appointment of Alan Sandler, M.D. as chief development officer, Alicia Gardner as senior vice president and general manager for the U.S. region, and Gerwin Winter as senior vice president and general manager of the European region.

Financial Highlights

Third Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $1.93 billion as of September 30, 2025. This balance includes the receipt of the first royalty monetization tranche of $250 million in June 2025 from the company’s partnership with Royalty Pharma, and there remains an additional $1.75 billion in future committed capital under this arrangement.

R&D Expenses: Research and development expenses were $262.5 million for the quarter ended September 30, 2025, compared to $151.8 million for the quarter ended September 30, 2024. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for daraxonrasib, zoldonrasib and elironrasib, and personnel-related expenses and stock-based compensation expense related to additional headcount.

G&A Expenses: General and administrative expenses were $52.8 million for the quarter ended September 30, 2025, compared to $24.0 million for the quarter ended September 30, 2024. The increase was primarily due to increases in personnel-related expenses and stock-based compensation expense associated with additional headcount, an increase in commercial preparation activities, and increased legal expenses.

Net Loss: Net loss was $305.2 million for the quarter ended September 30, 2025, compared to net loss of $156.3 million for the quarter ended September 30, 2024.

Financial Guidance
The company reiterates its full year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million.

Webcast
Revolution Medicines will host a webcast this afternoon, November 5, 2025, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, NOV 5, 2025, View Source [SID1234659473])

On November 5, 2025 Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, reported business updates and financial results for its third quarter ended September 30, 2025.

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Recursion will host a (L)earnings Call on November 5, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm GMT from Recursion’s X, LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: View Source

"Recursion continues to deliver on our internal pipeline, our strategic partnerships and the continued building and refinement of the Recursion OS. On the partnership front, we are proud to announce that with the option of our second neuro map in the Roche and Genentech collaboration, we’ve achieved over $500 million in upfront and milestone payments from our partners to date as we continue to deliver novel insights and advance programs for some of the toughest disease areas," said Chris Gibson, Co-Founder and CEO of Recursion. "This is only the beginning of the returns we expect to see on the investment in our platform. With a strong cash runway through the end of 2027, we look forward to delivering on our pipeline and proving that building an end-to-end AI-enabled platform—combining massive proprietary datasets with industry-leading supercomputing capabilities and sophisticated AI models—is the critical infrastructure we need to realize real change in our industry."

Summary of Business Highlights

Portfolio – Internal and Partnered Programs
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"Our progress this quarter underscores the power of translating the Recursion OS into meaningful pipeline momentum," said Najat Khan, Chief R&D and Chief Commercial Officer of Recursion. "We continued to advance our clinical programs, with REC-4881 in the TUPELO study moving toward additional data later this year. We also progressed REC-617 into its first combination study and nominated REC-7735 as a new development candidate. On the partnered side, the delivery of our first-in-kind microglia map with Roche and Genentech highlights how phenomics can open new frontiers in neuroscience and other complex disease areas. These are the kinds of bold but pragmatic steps — in our own programs and through collaborations — that will be essential as we work to turn our platform insights into transformative medicines for patients."

Internal Pipeline Updates:
•REC-617 (CDK7):
◦Recursion announced progress in its ELUCIDATE Phase 1/2 trial evaluating REC-617, a precision-designed oral CDK7 inhibitor. The monotherapy dose-escalation study established the maximum tolerated dose (MTD) at 10 mg once-daily, demonstrating a manageable safety profile and preliminary anti-tumor activity consistent with the December 2024 update.
◦As of September 29, 2025, 29 heavily pre-treated patients with advanced solid tumors had received REC-617 across six dose levels. Treatment was generally well tolerated, with the most common dose-limiting toxicities (DLTs) being nausea and thrombocytopenia. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 27.6% of patients (n=8), with no Grade 4/5 TRAEs reported. Only 6.9% (n=2) discontinued due to a TRAE. Importantly, REC-617 demonstrated rates of GI-related toxicities consistent with best-in-class potential. Specifically, common GI toxicities with REC-617 treatment were diarrhea (69%), nausea (41%), and vomiting (28%). Toxicities reported for samuraciclib treatment also included diarrhea (82%), nausea (77%), and vomiting (80%) (Coombes et al, 2023).
◦REC-617 has shown early anti-tumor activity, including one confirmed partial response and five cases of stable disease. Pharmacokinetic data support dose-proportional exposure, rapid absorption, and a short half-life (~5 hours), in line with its design as a selective, reversible CDK7 inhibitor.

◦The ELUCIDATE study has now expanded into 2L+ platinum-resistant ovarian cancer (PROC), with a Phase 2 monotherapy cohort ongoing and a Phase 1 combination arm initiated. Combination regimens include bevacizumab plus paclitaxel or pegylated liposomal doxorubicin (PLD). Recursion is also leveraging Recursion OS insights to explore additional indications and dosing regimens for expansion cohorts.
•REC-7735 (PI3Kα H1047R):
◦Recursion announced progress on REC-7735, with nomination as a Development Candidate and IND-enabling studies now underway. REC-7735 is a precision-designed PI3K⍺ H1047R inhibitor generated using the Recursion OS. In preclinical studies, REC-7735 demonstrated significant tumor regressions at low doses, outperforming approved agents, while maintaining high selectivity (>100-fold) over wild-type PI3K⍺ to reduce the risk of dose-limiting hyperglycemia.
◦With a differentiated preclinical efficacy and tolerability profile, REC-7735 has the potential to be a best-in-class PI3K⍺ H1047R inhibitor for breast and other solid tumors harboring this mutation.

Upcoming Milestones:
•REC-4881 (MEK1/2): Additional data in FAP from the Phase 2 TUPELO study expected in December 2025
•REC-1245 (RBM39): Early Phase 1 safety and PK monotherapy data expected in 1H26
•REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 1H27
•REC-102 (ENPP1): Potential Phase 1 initiation expected in 2H26
•REC-7735 (PI3Kα H1047R): Potential Phase 1 initiation expected in 2H26
•Recursion is well on track for over $100 million in milestone payments by end of 2026
◦Programs are advancing towards potential development candidate designation over the next 12 months
◦Multiple neuroscience target validation programs advancing by leveraging the Recursion OS

Partnered Discovery Updates:
With the acceptance of the second neuro map and the $30 million milestone from Roche and Genentech, Recursion has now achieved more than $500 million in upfront and milestone payments from its partners. This milestone places Recursion among a small group of pre-commercial biotechnology companies to achieve such scale, underscoring the strength of its partnership strategy. These collaborations not only support the maintenance and expansion of the Recursion OS, but also provide access to insights from leading biopharma companies and the potential for future milestone payments exceeding $10 billion, as well as royalties across indications Recursion may not pursue independently.

•Roche and Genentech: Recursion announced that it has achieved a second $30 million milestone from its partner, Roche and Genentech. The payment follows the acceptance of a novel whole-genome phenotypic map ("phenomap") of microglial cells, which are critical for brain health and implicated in a wide range of neurodegenerative and neuroinflammatory diseases.
◦The milestone is part of a larger ongoing 10+ year collaboration to discover novel targets and develop potential therapeutic treatments for up to 40 programs in neuroscience and gastrointestinal oncology.
◦Together, Recursion, Roche and Genentech have identified a number of biological insights from the first neuroscience-focused phenomap, that could become novel targets of interest.
◦Roche and Genentech have already optioned an initial program in gastrointestinal oncology with additional potential targets/programs under exploration based off of 4 whole-genome GI oncology phenomaps accepted by the partner to date.
◦To date, Recursion has achieved $213 million in upfront and milestone payments through the collaboration.

•Sanofi: Recursion and Sanofi continue to advance multi-target collaboration for up to 15 best-in-class or first-in-class programs across oncology and immunology, with $130 million in upfront and milestone payments achieved to date. Each program has the potential for over $300 million in milestone payments.
◦Sanofi continues to leverage combined Recursion OS 2.0, including phenomics, to identify new program opportunities.
◦Recursion and Sanofi are further advancing and expanding their joint pipeline across oncology and immunology.
◦Several programs are continuing to advance towards potential lead series and development candidate designation over the next 12 months.

Platform
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Recursion OS 2.0: The platform is continuing to drive program development by integrating AI across multimodal biology, precision design, and clinical development—enabling faster, more efficient, and more innovative drug discovery and development.

Third Quarter 2025 Financial Results

•Cash Position: Cash, cash equivalents and restricted cash were $667.1 million as of September 30, 2025 compared to $603.0 million as of December 31, 2024. As of October 9, 2025, cash and cash equivalents was approximately $785 million (unaudited), following receipt of $387.5 million in net proceeds from the Company’s At-the-Market (ATM) facility during the third and fourth quarters of 2025, which is now fully utilized and completed. Based on current operating plans and with no additional financing, the Company’s expected cash runway extends through the end of 2027.
•Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was $5.2 million for the third quarter of 2025, compared to $26.1 million for the third quarter of 2024. The year over year change was primarily due to achievement of a $30 million milestone payment for the first phenomap from Roche and Genentech in August 2024, with the second $30 million milestone under the agreement achieved in October 2025, for which the company expects to recognize a portion as revenue in the fourth quarter of 2025.
•Research and Development Expenses: Research and development expenses were $121.1 million for the third quarter of 2025, compared to $74.6 million for the third quarter of 2024. The increase was primarily driven by the increase in acquired IPR&D purchases related to
the acquisition of full rights to REC-102, Recursion’s ENPP1 inhibitor, as well as the Company’s business combination with Exscientia in November 2024.
•General and Administrative Expenses: General and administrative expenses were $41.6 million for the third quarter of 2025 compared to $37.8 million for the third quarter of 2024. The increase compared to the prior period was primarily due to the inclusion of G&A expenses from the business combination with Exscientia.
•Net Loss: Net loss was $162.3 million for the third quarter of 2025, compared to a net loss of $95.8 million for the third quarter of 2024.
•Operational cash flows: Net cash used in operating activities was $325.7 million for the nine months ended September 30, 2025, compared to net cash used in operating activities of $243.7 million for the nine months ended September 30, 2024. The increase in cash used in operating activities was primarily driven by the inclusion of Exscientia’s operations, for which the business combination with Recursion closed in November 2024. This also included severance payments of $7.7 million in association with the restructuring activities announced in June 2025.

(Press release, Recursion Pharmaceuticals, NOV 5, 2025, View Source [SID1234659472])