On November 5, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the third quarter of 2026.

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John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:

"Our strong third quarter results and raised full-year guidance reflect continued rapid global growth and leadership in hematology, anchored by our foundational BTK inhibitor BRUKINSA, which drives powerful and sustained responses in patients, and now joined by our next-generation BCL2 inhibitor BEQALZI. We look forward to multiple catalysts in the coming months from one of the deepest pipelines in oncology, spanning hematology and solid tumors, accelerated by our differentiated capabilities in R&D, manufacturing, and commercialization."

(Amounts in thousands of U.S. dollars and unaudited)

Three Months Ended Nine Months Ended
September 30, September 30,
2026 2025 % Change 2026 2025 % Change
Net product revenues $ 1,855,057 $ 1,395,013 33 % $ 5,022,180 $ 3,805,619 32 %
Other revenue $ 34,758 $ 17,271 101 % $ 86,144 $ 39,244 120 %
Total revenue $ 1,889,815 $ 1,412,284 34 % $ 5,108,324 $ 3,844,863 33 %
GAAP income from operations $ 418,675 $ 163,114 157 % $ 993,624 $ 262,101 279 %
Adjusted income from operations* $ 612,226 $ 341,184 79 % $ 1,529,649 $ 755,486 102 %
GAAP net income $ 384,706 $ 124,841 208 % $ 849,070 $ 220,431 285 %
Adjusted net income* $ 538,735 $ 303,663 77 % $ 1,358,274 $ 692,622 96 %
GAAP basic EPS per ADS $ 3.38 $ 1.13 199 % $ 7.58 $ 2.03 273 %
Adjusted basic EPS per ADS* $ 4.74 $ 2.76 72 % $ 12.12 $ 6.38 90 %
GAAP diluted EPS per ADS $ 3.28 $ 1.09 201 % $ 7.30 $ 1.96 272 %
Adjusted diluted EPS per ADS* $ 4.59 $ 2.65 73 % $ 11.68 $ 6.14 90 %
Free Cash Flow* $ 473,532 $ 354,469 34 % $ 1,069,423 $ 561,916 90 %

Third Quarter 2026 Financial Results
Product Revenue totaled $1.9 billion for the third quarter of 2026, representing growth of 33% compared to the prior-year period.
•BRUKINSA: Global sales totaled $1.4 billion for the third quarter of 2026, representing growth of 34% compared to the prior-year period; U.S. sales of BRUKINSA totaled $1.0 billion in the third quarter of 2026, representing growth of 36% compared to the prior-year period.
•TEVIMBRA (tislelizumab): Global sales totaled $243 million in the third quarter of 2026, representing growth of 28% compared to the prior-year period.
•Amgen in-licensed products: Global sales totaled $167 million in the third quarter of 2026, representing growth of 26% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the third quarter of 2026 was 88%, compared to 86% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA, which was offset by a non-cash intangible asset impairment charge of $22 million associated with our decision to discontinue promotion of POBEVCY. On an adjusted basis, which does not include depreciation and amortization, or the impairment charge, gross margin as a percentage of product sales increased to 90%, from 86% in the comparable period of the prior year.
Operating Expenses
The following table summarizes operating expenses for the third quarter of 2026:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 2026 Q3 2025 % Change Q3 2026 Q3 2025 % Change
Research and development $ 660,784 $ 523,662 26 % $ 586,168 $ 445,904 31 %
Selling, general and administrative $ 593,460 $ 528,998 12 % $ 503,719 $ 434,484 16 %
Total operating expenses $ 1,254,244 $ 1,052,660 19 % $ 1,089,887 $ 880,388 24 %

The following table summarizes operating expenses for the year-to-date period ended September 30, 2026, and 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 YTD 2026 Q3 YTD 2025 % Change Q3 YTD 2026 Q3 YTD 2025 % Change
Research and development $ 1,814,288 $ 1,530,445 19 % $ 1,586,022 $ 1,311,156 21 %
Selling, general and administrative $ 1,741,771 $ 1,526,199 14 % $ 1,476,386 $ 1,271,650 16 %
Total operating expenses $ 3,556,059 $ 3,056,644 16 % $ 3,062,408 $ 2,582,806 19 %

Research and Development (R&D) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing early clinical programs into late stage and preclinical programs into the clinic.
Selling, General and Administrative (SG&A) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth.
Net Income and Basic/Diluted Earnings Per Share
GAAP net income for the third quarter of 2026 was $385 million, an increase of $260 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $539 million, an increase of $235 million over the prior-year period.

For the third quarter of 2026, basic and diluted earnings per share were $0.26 and $0.25 per share and $3.38 and $3.28 per American Depositary Share (ADS), respectively, compared to $0.09 and $0.08 per share and $1.13 and $1.09 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.36 and $0.35 per share and $4.74 and $4.59 per ADS, respectively, compared to $0.21 and $0.20 per share and $2.76 and $2.65 per ADS in the prior-year period.
Free Cash Flow for the third quarter of 2026 was $474 million, representing an increase of $119 million over the prior-year period.
For further details on BeOne’s Third Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the third quarter of 2026 filed with the U.S. Securities and Exchange Commission.
Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
Prior FY 2026 Guidance
Current FY 2026 Guidance1
Total revenue $6.6B – $6.8B $6.9B – $7.0B
GAAP gross margin % High-80% range High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.8B – $5.0B $4.9B – $5.0B
GAAP operating income2
$1.0B – $1.1B $1.2B – $1.3B
Non-GAAP operating income2,3
$1.7B – $1.8B $1.9B – $2.0B

1 Assumes November 1, 2026 foreign exchange rates.
2 Does not assume any potential new, material business development activity or unusual/non-recurring items.
3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.
BeOne’s total revenue guidance for full year 2026 of $6.9 billion to $7.0 billion reflects performance through the third quarter and the Company’s expectations for the remainder of the year. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth.
The Company is providing the following additional guidance on items impacting net income and earnings per ADS:
•Other income (expense): Estimated range of $25 million to $50 million in expense, includes interest amortization from the Royalty Pharma arrangement.
•Income tax outlook: Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized. The Company continues to evaluate and assess the magnitude but expects the reversal will occur in the fourth quarter of 2026. See Form 10-Q for additional updates.
•Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
Third Quarter 2026 Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Received U.S. Food and Drug Administration (FDA) Priority Review designation for the Phase 3 MANGROVE filing.
•Completed Phase 3 MANGROVE regulatory submissions in the EU and China.
•29 abstracts accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2026 Annual Meeting, including interim analysis results from the Phase 3 MANGROVE study in first-line mantle cell lymphoma (MCL) to be presented during the Plenary Scientific Session.

BEQALZI (sonrotoclax)
•10 abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026.
TEVIMBRA (tislelizumab)
•Received Japan regulatory approval for the treatment of adult patients with first-line nasopharyngeal cancer.

ZIIHERA (zanidatamab) for which BeOne holds commercialization rights in select markets
•Presented Phase 3 survival data reinforcing benefit of ZIIHERA-containing regimens in first-line HER2+ gastroesophageal adenocarcinoma (GEA) at the European Society for Medical Oncology Congress 2026 (ESMO 2026).
•Received U.S. Food and Drug Administration (FDA) approval for TEVIMBRA-based regimen for first-line HER2+ GEA.

Select Clinical-Stage Programs
Hematology
•6 Tacabrutideg abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026.
•Tacabrutideg (BTK CDAC): Pivotal Phase 2 portion of CaDAnCe-101 met its primary endpoint of overall response rate in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
•BG-75202 (KAT6 A/B inhibitor): First patient enrolled into monotherapy cohort for the Phase 1 study for the treatment of adult patients with acute myeloid leukemia.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x4-1BB bispecific antibody):
◦Updated data presented at ESMO (Free ESMO Whitepaper) 2026.
◦Received Orphan Drug Designation from the European Commission and awarded Innovation Passport, enabling entry to the UK’s Innovative Licensing and Access Pathway, in hepatocellular carcinoma (HCC).
•BG-85738 (RAS ONi): First patient enrolled in the Phase 1 study of advanced solid tumors with RAS mutations.
Lung Cancer
•BG-C477 (CEA ADC):
◦Disclosed first clinical data at ESMO (Free ESMO Whitepaper) 2026.
◦Received FDA Fast Track Designation for the treatment of patients with advanced or metastatic CEA-high non-small cell lung cancer whose disease has progressed following prior systemic therapy.
•BGB 58067 (MTA-cooperative PRMT5 inhibitor): Disclosed first clinical data at ESMO (Free ESMO Whitepaper) 2026.

Breast and Gynecological Cancers
•BG-C9074 (B7-H4 ADC): Initiated Starstone-301 Phase 3 study in combination with bevacizumab for the treatment of adult patients with first-line ovarian cancer in maintenance setting.

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Regulatory submission in Japan for the treatment of adult patients with first-line MCL.
Q4 2026
TEVIMBRA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
1H 2027
ZIIHERA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
1H 2027
Tacabrutideg(BGB-16673)
•Phase 2 potential submission for the treatment of adult patients with R/R CLL.
Mid 2027
•CaDAnCe-306: Phase 3 study initiation for R/R CLL in combination with BEQALZI
1H 2027
BGB-B2033
(GPC3x4-1BB bispecific antibody)
•GroundBBreaker-301 Phase 3 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-201 potentially pivotal single-arm Phase 2 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-302 pivotal Phase 3 study initiation in first-line hepatocellular carcinoma
1H 2027

Corporate Updates
•Announced a multi-part collaboration with Revolution Medicines, including a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.

•Announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines for American patients while strengthening the Company’s U.S manufacturing footprint.
•Announced the renewal of a partnership with the BeOne Care Foundation and The Max Foundation, a leading global health nonprofit organization, to expand access to BRUKINSA for the treatment of adult patients with CLL in low- and middle-income countries through 2028.

BeOne’s Earnings Results Webcast

The Company’s earnings conference call for the third quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Thursday, November 5, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.

(Press release, BeOne Medicines, NOV 5, 2026, View Source [SID1234674298])

On November 5, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended September 30, 2026.

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"CAR T has transformed what’s possible in medicine, but toxicity and treatment complexity have kept its full potential out of reach for too many patients," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. "We believe 2027 will be an important year for cema-cel and the field, with upcoming ALPHA3 data expected to provide important insights into the potential for CAR T to be integrated into existing practice patterns, earlier in the course of a patient’s disease and closer to where they receive care. At the same time, our ALLO-329 data set to be released next week will begin to address an equally important question in autoimmune disease: whether we can deliver meaningful clinical benefit with less reliance on chemotherapy-based conditioning. Both programs reflect our conviction that the future of CAR T will be shaped not only by what these therapies can do, but by how we make them more accessible and practical for patients."

Cema-Cel: Pivotal ALPHA3 Trial in 1L Consolidation in LBCL
Cemacabtagene ansegedleucel (cema-cel) is being evaluated in ALPHA3, the first pivotal, randomized trial in LBCL designed to assess whether minimal residual disease (MRD)-guided treatment following first-line therapy can delay or prevent clinical relapse.

Enrollment momentum continues, supported by expanded site participation, increasing MRD screening activity, strong investigator engagement, and brisk enrollment in the Asia-Pacific region following the positive interim futility analysis reported earlier this year. The growing ALPHA3 network includes community oncology practices, where the majority of patients with LBCL receive treatment, reinforcing the potential for cema-cel to expand CAR T access beyond traditional treatment centers.

Early clinical experience has demonstrated the feasibility of outpatient cema-cel administration, including at community practices with limited or no prior CAR T experience. Together with the integration of MRD testing to identify patients at risk of relapse, these findings support the potential for ALPHA3 to establish a new treatment paradigm that brings CAR T earlier in the course of disease and closer to where patients receive care.

The Company continues to anticipate its next clinical update in mid-2027, with trial enrollment expected to be completed by year-end 2027.

Cema-Cel: Advancing Commercial Readiness and Patient Access
As the ALPHA3 program advances, Allogene has begun laying the groundwork for potential commercialization of cema-cel, with an early focus on payer coverage, reimbursement and treatment-site readiness to support broader patient access. To lead these efforts, the Company appointed Rocio Manghani, MPH, as Vice President, Market Access, Evidence & Strategy. Ms. Manghani brings extensive cell therapy commercialization experience from Kite, Gamida Cell and Orca Bio, including expertise in payer coverage, reimbursement, evidence generation and launch operations. Her appointment underscores Allogene’s commitment to addressing access barriers early and preparing to bring CAR T to patients where they receive care.

Further informing this strategy, an abstract accepted for online publication in November in connection with the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and in the supplemental issue of Blood will highlight findings from a survey of 152 U.S. hematologists and oncologists examining barriers to CAR T adoption and opportunities to expand access through allogeneic therapy.

Building on these insights, Allogene plans to host an in-person event at ASH (Free ASH Whitepaper) exploring how cema-cel could help overcome longstanding barriers to CAR T adoption. The discussion will explore how earlier intervention guided by MRD testing, combined with the potential for treatment in community practices, could expand access to CAR T. Additional event details will be announced at a later date.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease
ALLO-329 is a next-generation, dual-targeting anti-CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger technology. The product was designed to address allogeneic rejection by targeting activated CD70-positive patient T cells, with the goal of optimizing the benefit-risk profile while reducing or eliminating the need for conventional chemotherapy-based lymphodepletion (LD).

The ongoing Phase 1 RESOLUTION trial is a dose-escalation study evaluating ALLO-329 across multiple autoimmune indications, including systemic sclerosis (scleroderma), idiopathic inflammatory myopathies (myositis) or systemic lupus erythematosus (lupus). The trial incorporates a parallel evaluation of three conditioning approaches: no LD, cyclophosphamide alone and fludarabine plus cyclophosphamide. The design of RESOLUTION is intended to help distinguish the contribution of ALLO-329 from that of chemotherapy-based conditioning and inform selection of a treatment regimen that minimizes the burden and toxicity of LD without compromising efficacy.

Allogene will present updated clinical and translational data from RESOLUTION at the 2026 American College of Rheumatology (ACR) Convergence on November 9, 2026. The presentation will build upon the published nine-patient abstract with an expanded patient population, longer follow-up and results across three dose levels and three LD approaches.

The expanded dataset will provide a more comprehensive assessment of ALLO-329’s emerging safety and efficacy, with a focus on scleroderma, while offering new insights into the relationship between conditioning intensity and treatment response. Enrollment and dose escalation continue as the Company evaluates additional dose levels and conditioning approaches to inform selection of a potential Phase 2 regimen.

Allogene will host a webinar on November 9, 2026, at 6:00 a.m. PT/9:00 a.m. ET to review the updated clinical and translational findings, prior to the ACR poster presentation later that day.

Next-Generation Pipeline: Advancing the Dagger Platform
Allogene will highlight its leadership in allogeneic CAR T at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, November 4–8, 2026, through two invited presentations and a preclinical poster showcasing the breadth and continued evolution of its platform.

On November 5, Jeff McLeroy, M.D., Vice President, Head of Safety and Pharmacovigilance, discussed clinical findings from the Phase 1 TRAVERSE trial of ALLO-316 in renal cell carcinoma, including evidence of durable responses, CAR T expansion and tumor infiltration in patients with advanced disease. On November 6, Dr. Roberts will present Allogene’s broader vision for allogeneic CAR T as a platform designed to improve patient access across oncology and autoimmune disease, highlighting the Company’s clinical programs and the potential to bring cell therapy into more treatment settings.

Complementing these presentations, the Company will present preclinical data evaluating a novel off-the-shelf DLL3/CD70 dual CAR T product candidate for small cell lung cancer and other neuroendocrine tumors. The findings suggest that careful selection of the genomic location for site-specific-integration of the CAR can improve CAR T-cell performance in controlling tumors. Confirming and extending observations presented earlier this year with BCMA, the data show pairing the DLL3 CAR with a CAR targeting CD70 can enhance resistance to the immune-mediated rejection, illustrating that Dagger technology can be coupled with other CARs. These findings reinforce the potential of the Dagger technology as a versatile foundation for Allogene’s next-generation pipeline, supporting the development of off-the-shelf CAR T therapies across additional targets for both hematological and solid tumors as well as autoimmune disease.

2026 Third Quarter Financial Results
•Research and development expenses were $41.9 million for the third quarter of 2026, which includes $2.9 million of non-cash stock-based compensation expense.
•General and administrative expenses were $12.9 million for the third quarter of 2026, which includes $4.2 million of non-cash stock-based compensation expense.
•Net loss for the third quarter of 2026 was $50.4 million, or $0.15 per share, including non-cash stock-based compensation expense of $7.0 million.
•The Company had $388.9 million in cash, cash equivalents, and investments as of September 30, 2026.

Based on its cash, cash equivalents, and investments as of September 30, 2026, the Company continues to project its cash runway into 2029. Guidance for operating expense in 2026 is expected to be approximately $165 million. GAAP Operating Expenses are expected to be approximately $225 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, NOV 5, 2026, View Source [SID1234674297])

On November 5, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the release of a new investor presentation, "The Ampligen Opportunity," highlighting the potential for Ampligen (rintatolimod) to complement emerging RAS-targeted therapies in pancreatic cancer, including Revolution Medicines’ Rasonque (daraxonrasib).

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The presentation examines recent advances in pancreatic cancer treatment and the scientific rationale for combining RAS inhibition with immune stimulation to potentially enhance and extend clinical benefit. It also highlights previously reported Ampligen clinical observations, the ongoing Phase 2 DURIPANC program and anticipated 2027 milestones.

AIM Chief Executive Officer Thomas K. Equels states: "Ampligen has been demonstrated to be a powerful innate immunomodulator with broad-spectrum anti-tumor proliferation effects, while the RAS-targeted therapy daraxonrasib represents a new and promising development which, I believe, will likely become a first-line therapy for pancreatic cancer. I see great potential in bringing the two together. While daraxonrasib targets the signaling pathways that drive tumor growth, Ampligen is designed to stimulate innate and adaptive immune responses, which helps set Ampligen apart among late-stage clinical trials for pancreatic cancer. We believe these potentially complementary mechanisms of action provide a compelling foundation for investigating how Ampligen might enhance and prolong the benefits of targeted RAS treatment, which is especially significant because of daraxonrasib’s potential to become the standard of care therapy for pancreatic cancer in the very near future."

Key Highlights from the Investor Presentation

Daraxonrasib’s Phase 3 Results and the Potential for Complementary Treatment Strategies

The presentation highlights results from the randomized Phase 3 RASolute 302 study evaluating daraxonrasib against investigators’ choice of chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma.

In the overall study population, daraxonrasib demonstrated:

Median overall survival of 13.2 months versus 6.7 months with chemotherapy (hazard ratio: 0.40).
Median progression-free survival of 7.2 months versus 3.6 months with chemotherapy (hazard ratio: 0.49).
These findings underscore the progress being made in RAS-targeted treatment and the opportunity to investigate strategies that may further extend disease control.

Complementary Mechanisms Support Further Investigation

Daraxonrasib inhibits RAS(ON) signaling involved in tumor growth, while Ampligen is an investigational Toll-like receptor 3 (TLR3) agonist designed to stimulate innate and adaptive immune responses.

Previously published research involving Ampligen has demonstrated immune modulation involving dendritic cells and T-cell responses. AIM believes these distinct mechanisms support further investigation of whether Ampligen could enhance anti-tumor immune activity alongside RAS inhibition.

The proposed combination remains investigational, and its safety, efficacy and potential to improve outcomes beyond daraxonrasib alone have not been established.

Previously Reported Ampligen Clinical Observations Provide an Encouraging Foundation

The presentation highlights findings from a Netherlands government-approved Named Patient Program evaluating Ampligen following FOLFIRINOX chemotherapy in patients with advanced pancreatic cancer.

In this nonrandomized program, 57 Ampligen-treated patients were compared with 27 historical controls. Exploratory findings included:

Median overall survival of 19.7 months versus 12.5 months in historical controls.
Median progression-free survival of 12.6 months versus 8.6 months in historical controls.
Median overall survival of 34.8 months in an Ampligen-treated subgroup with a baseline neutrophil-to-lymphocyte ratio of 4.5 or less, versus 19.3 months among Ampligen-treated patients with higher ratios.
DURIPANC Program Advancing Toward Key 2027 Clinical Milestones

AIM’s ongoing Phase 1/2 DURIPANC study is evaluating Ampligen in combination with durvalumab (Imfinzi) in patients with metastatic pancreatic cancer who achieved stable disease following FOLFIRINOX chemotherapy.

The study enrolled 28 patients across Phase 1 and Phase 2. The Phase 2 primary endpoint is clinical benefit rate at 24 weeks. To date, the clinical trial has met each milestone on schedule.

Previously reported interim findings include encouraging tolerability, with only three Grade 3 immune-related adverse events; consistently high patient-reported quality of life; and preliminary evidence of coordinated innate and adaptive immune activation.

AIM anticipates the following milestones:

Q1 2027: Phase 2 topline results evaluating clinical benefit rate at 24 weeks.
Q3 2027: Additional analyses of overall survival, progression-free survival, quality of life and immune responses.
These findings are expected to help inform future development opportunities, including the potential design of a pivotal Phase 3 trial.

Exploring the Potential to Extend RAS-Targeted Treatment Benefits

The presentation also outlines a proposed development strategy to investigate whether adding Ampligen to ongoing daraxonrasib treatment, or as a post-daraxonrasib maintenance therapy, could strengthen anti-tumor immune responses and potentially extend disease control.

Potential evaluations include safety, biological activity, treatment timing, progression-free survival and duration of response. This proposed strategy is not an established clinical trial protocol, and additional research would be required to evaluate the combination.

Positioning Ampligen for the Evolving Pancreatic Cancer Treatment Landscape

As RAS-targeted therapies continue to advance, AIM believes Ampligen’s immunomodulatory mechanism and existing clinical observations provide a foundation for exploring complementary treatment strategies.

With anticipated DURIPANC milestones in 2027, the Company remains focused on generating additional clinical evidence while evaluating opportunities to expand Ampligen’s potential role in pancreatic cancer treatment.

The Company’s new investor presentation, "The Ampligen Opportunity," is available here.

About Ampligen

Ampligen (rintatolimod) is an investigational immunomodulatory drug that acts through Toll-like receptor 3 (TLR3) signaling. It is being investigated for its potential to stimulate innate and adaptive immune responses across multiple disease settings, including cancer. In pancreatic cancer, research has demonstrated immune modulation involving dendritic-cell-mediated T-cell responses. Ampligen is not approved by the U.S. Food and Drug Administration for the treatment of pancreatic cancer.

(Press release, AIM ImmunoTech, NOV 5, 2026, View Source [SID1234674296])

On November 5, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the third quarter ended September 30, 2026.

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"The third quarter was a record for our product revenue, outperforming our entire 2025 total in just three months. This growth was driven by the U.S. commercial launch of AQVESME in thalassemia, where broadening demand is translating into a durable base of patients on therapy," said Brian Goff, Chief Executive Officer, Agios. "This launch has built the commercial foundation for our largest indication opportunity with mitapivat – sickle cell disease. Our conviction in mitapivat for patients with sickle cell disease is grounded in the robust efficacy and safety data generated to date and we are launch-ready ahead of our PDUFA goal date of February 1, 2027. With this commercial infrastructure, alongside a strong balance sheet and a disciplined operating model, Agios is well positioned for sustained growth as a focused, rare hematology company."

Third Quarter 2026 and Recent Corporate Highlights
•Mitapivat (PYRUKYND and AQVESME) Commercial Performance and Update –
o$48.7 million in U.S. net revenue and $6.6 million in ex-U.S. net revenue in the third quarter of 2026
•U.S. net revenue increased 20% sequentially, driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia in late January 2026.
•Ex-U.S. net revenue increased 74% sequentially, driven primarily by early access programs in Europe following the late May 2026 approval of PYRUKYND (mitapivat) in thalassemia in the European Union. This robust, early momentum underscores the strong global opportunity for mitapivat, which the company is advancing through capital-efficient partnerships with Avanzanite Bioscience B.V. in Europe and NewBridge Pharmaceuticals in the Gulf Cooperation Council (GCC) region.

oAQVESME demand continues to expand following the January 2026 U.S. commercial launch in thalassemia
•In the third quarter, 177 AQVESME prescriptions with completed Agios start forms (ASFs) were written by Risk Evaluation and Mitigation Strategy (REMS)-certified U.S. physicians, bringing cumulative prescriptions to 619 as of September 30, 2026.
•An additional 48 cumulative prescriptions had ASFs in process as of September 30, 2026, which are not included in the reported metric above.
•Demand continues to broaden, with deeper penetration in transfusion-dependent patients and expansion into the larger non-transfusion dependent population. Approximately 75% of patients remain on AQVESME after six months of treatment.

•Operating Model Update –
oOver the course of 2026, Agios reviewed its operating model, and will have reduced its R&D headcount by over 100 roles by year-end, representing a more than 35% decrease compared with 2025. The company expects the associated cost savings of these reductions to be realized in 2027.

Research and Development (R&D) Highlights
•Mitapivat (pyruvate kinase [PK] activator) –
oSickle Cell Disease –
•Agios announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its mitapivat sickle cell disease supplemental New Drug Application (sNDA) by three months, from November 1, 2026, to February 1, 2027.
•The FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell disease. The FDA classified Agios’ response to this information request as a major amendment to the sNDA, resulting in the three-month review extension.
•Agios will continue its labeling discussions with the FDA as part of the ongoing sNDA review, including elements of a potential REMS.

•American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2026) –
oAgios announced that 14 abstracts led by Agios and external collaborators have been accepted for presentation and publication at ASH (Free ASH Whitepaper) 2026, taking place December 12-15, 2026, in New Orleans, Louisiana. These include three oral presentations featuring new data across mitapivat clinical programs.
oNew clinical data from the RISE UP Phase 3 trial of mitapivat in sickle cell disease shows durable hemoglobin improvements for up to 115 weeks (over two years) with continued treatment. Additional post-hoc RISE UP analyses show the potential for mitapivat to improve measures of kidney function and cardiac remodeling in this population, which may reflect its unique dual activation of two pyruvate kinase isoforms: PKR, expressed in red blood cells, and PKM2, expressed in organ tissues.
oThe first clinical data for AG-236 from a Phase 1 trial in healthy volunteers support every-six-month dosing in polycythemia vera, supporting a potential best-in-class profile.

Third Quarter 2026 Financial Results
For the quarter ended September 30, 2026, net loss was $65.0 million, compared to net loss of $103.4 million for the quarter ended September 30, 2025.
•Net product revenue from U.S. sales of mitapivat (PYRUKYND and AQVESME) for the third quarter of 2026 was $48.7 million, compared to $12.3 million for the third quarter of 2025.

•Net product revenue from ex-U.S. sales of mitapivat (PYRUKYND) for the third quarter of 2026 was $6.6 million, compared to $0.6 million for the third quarter of 2025.

•Cost of sales for the third quarter of 2026 was $2.5 million.

•Research and Development (R&D) expenses were $73.5 million for the third quarter of 2026, compared to $86.8 million for the third quarter of 2025, driven primarily by reductions in spend associated with mitapivat and tebapivat process development and certain clinical trials.

•Selling, General and Administrative (SG&A) expenses were $56.5 million for the third quarter of 2026, compared to $41.3 million for the third quarter of 2025, due to an increase in activities supporting the U.S. commercial launch of AQVESME in thalassemia and preparation for the potential U.S. commercial launch of mitapivat in sickle cell disease.

•Cash, cash equivalents and marketable securities were $907.0 million as of September 30, 2026, compared to $1.2 billion as of December 31, 2025. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to execute the U.S. commercial launch of AQVESME in thalassemia, prepare for the potential U.S. commercial launch of mitapivat in sickle cell disease, and progress the company’s pipeline. Agios’ goal is to achieve non-Generally Accepted Accounting Principles (GAAP) profitability in 2028.

Third Quarter 2026 Conference Call Information
Agios will host a conference call and live webcast today, November 5, 2026, at 8:00 a.m. ET to discuss the company’s third quarter 2026 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, NOV 5, 2026, View Source [SID1234674295])

On November 5, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported financial results for the third quarter ended September 30, 2026, and highlighted progress preparing its global randomized Phase 3 ROBBIN trial of botensilimab (BOT), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, before surgery in patients with high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer.

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The clinical foundation for ROBBIN has strengthened through two independent, peer-reviewed Phase 2 studies of short-course BOT+BAL before surgery. NEST, published in Clinical Cancer Research in August, and the multicenter UNICORN study, published in Nature Medicine on November 2, 2026, each reported pathologic complete responses in approximately 30% of patients with MSS colon cancer treated with neoadjuvant BOT+BAL. Neither study reported colon cancer recurrences in the BOT+BAL cohorts at the respective data cutoffs, with median follow-up of 32.2 and 23.5 months across NEST-1 and NEST-2 and 19.2 months in the UNICORN MSS cohort. The depth of response and encouraging follow-up strengthen our confidence in advancing BOT+BAL in the curative-intent setting, where ROBBIN will test whether treatment before surgery can prevent recurrence and increase the potential for cure.

Long-term outcomes in advanced, metastatic cancer add another dimension to the BOT+BAL evidence. In the Phase 1b C-800-01 program that enrolled more than 400 patients with advanced, metastatic solid tumors, extended follow-up of 123 heavily pretreated patients with MSS metastatic colorectal cancer without active liver metastases demonstrated 33% three-year overall survival, presented at ESMO (Free ESMO Whitepaper) GI 2026 in July and subsequently published in Clinical Cancer Research. The heavily pretreated recurrent ovarian cancer cohort, in which patients had received a median of four prior therapies and nearly three-quarters had platinum-resistant or refractory disease, demonstrated 48% estimated overall survival at three years, unchanged from the two-year estimate, as presented at International Gynecologic Cancer Society (IGCS) 2026 Meeting. The durability observed in refractory disease strengthens the rationale for investigating BOT+BAL before surgery, when the primary tumor and tumor-draining lymph nodes remain intact and may provide an opportunity to generate a broader immune response.

"We have moved beyond planning ROBBIN to mobilizing investigators and activating sites around the world in preparation for patient enrollment," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "The strong investigator engagement in Madrid and São Paulo, together with the peer-reviewed NEST and UNICORN publications, strengthens our confidence in the potential of BOT+BAL to change outcomes for patients with MSS colon cancer. We have a clear registrational path and financing aligned with key development milestones anticipated in 2027. Our priority is to bring BOT+BAL earlier in the treatment of cancer, before surgery and other systemic therapies, with the goal of preventing recurrence and increasing the potential for cure."

Armen continued, "At the same time, patients with advanced cancer need better options today. We continue to see growing international demand for BOT+BAL through France’s AAC program and physician-initiated named-patient programs. Armenia’s decision to grant the first marketing authorizations for BOT and BAL anywhere in the world marks an important step in bringing treatment options to patients with advanced disease who need it today."

Third Quarter and Recent Business Highlights

Global investigator support advances ROBBIN Phase 3 readiness

Investigator and site meetings in Madrid alongside ESMO (Free ESMO Whitepaper) and in São Paulo brought together teams preparing to enroll ROBBIN across North America, Europe, South America and Asia. Site qualification and startup activities are advancing toward first patient dosing anticipated in the first quarter of 2027. ROBBIN, the global, randomized registrational Phase 3 trial is designed with feedback from the FDA to enroll approximately 850 patients and will evaluate event-free survival as its primary endpoint, with an interim pathologic response assessment of the first 100 patients enrolled anticipated in Q4 of 2027.

MSS disease accounts for approximately 85% of early-stage colorectal cancers.1,2 Despite important immunotherapy advances in mismatch repair-deficient disease (dMMR), patients with MSS colon cancer continue to rely principally on surgery followed by chemotherapy or observation, with no new curative-intent therapies approved for this population in more than two decades. ROBBIN addresses an estimated 38,000 newly diagnosed U.S. patients each year, representing an estimated annual U.S. total addressable market exceeding $7 billion.

Independent Neoadjuvant Evidence Strengthens the Curative-Intent Rationale

Two independent, peer-reviewed Phase 2 studies strengthen the rationale for short-course BOT+BAL before surgery in MSS colon cancer. NEST, published in Clinical Cancer Research, reported a 32% pathologic complete response rate in MSS tumors, with no observed colorectal cancer recurrences at median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2. UNICORN, published in Nature Medicine, reported a 29% pathologic complete response rate and 36% major pathologic response rate in its MSS BOT+BAL cohort, with no observed recurrences at 19.2 months of median follow-up. Although BOT alone produced some tumor regression in MSS disease, the deeper major and complete pathologic responses occurred with the BOT+BAL combination. Together with NEST’s longer follow-up, the multicenter UNICORN findings provide independent clinical and biological evidence strengthening the curative-intent rationale for ROBBIN. Importantly, neoadjuvant BOT+BAL did not delay planned surgery in NEST, and 98% of patients in UNICORN underwent surgery on schedule, with no new safety concerns identified.

Additional neoadjuvant evidence from the investigator-initiated NEOASIS study in the mismatch repair-deficient (dMMR) colon cancer cohort was presented at ESMO (Free ESMO Whitepaper) 2026. Following six weeks of BOT+BAL, 72% of 18 patients achieved a pathologic complete response and 83% achieved a major pathologic response. Although dMMR is a distinct molecular population from the MSS patients targeted by ROBBIN, the results add to the clinical experience with short-course treatment before surgery.

Financing aligned with development milestones

The oversubscribed July private placement provided approximately $85 million in upfront gross proceeds, with milestone-aligned warrants that could provide up to approximately $255 million in additional gross proceeds if fully exercised. Based on the current operating plan, the upfront proceeds are expected to support ROBBIN initiation, regulatory activities and operations through the third quarter of 2027. Assuming full exercise of the warrants, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031.

Armenia grants first worldwide marketing authorizations for BOT+BAL

Shortly after quarter-end, Armenia’s Ministry of Health granted marketing authorizations for Botvymo (botensilimab) and Evamplix (balstilimab), each for use in combination with the other in adult patients with microsatellite stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received available standard therapies. These are the first marketing authorizations for either medicine anywhere in the world. The authorizations followed a rigorous review of the registration dossier and were supported by clinical evidence from the fully enrolled Phase 1b C-800-01 MSS metastatic colorectal cancer cohort and the randomized Phase 2 C-800-25 study, both reported in peer-reviewed publications. The milestone establishes an approved treatment pathway for eligible patients with advanced disease and provides a foundation for Agenus to pursue potential additional marketing authorizations in other Eurasian Economic Union member countries.

Growing international interest in authorized patient-access programs

Physician and patient interest in BOT+BAL continues to grow across authorized access pathways. In France, the national Autorisation d’Accès Compassionnel (AAC) program provides fully reimbursed, hospital-based access to eligible patients with MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. Physician-initiated paid named-patient programs provide additional access across select countries in Europe and South and Central America, where permitted by local regulations. Patients from outside these countries, including the United States, have also traveled to markets where authorized access is available to receive treatment.

Pre-commercial BOT+BAL product revenue from these programs was $6.0 million in the third quarter of 2026, compared with $6.4 million in the second quarter, and $17.0 million for the first nine months of 2026. These are non-promotional access programs, and recognized revenue can vary with country-specific pricing, reimbursement, taxation, distribution arrangements and timing; it does not necessarily move in proportion to physician inquiries or patient treatment activity.

Third Quarter 2026 Financial Results

Revenue. Total revenue for the third quarter of 2026 was $31.5 million, compared with $30.2 million for the third quarter of 2025, and included $6.0 million of pre-commercial BOT+BAL product revenue, compared with $6.4 million in the second quarter of 2026, and $25.5 million of non-cash royalty revenue, compared with $28.1 million in the second quarter. Total revenue for the first nine months of 2026 was $99.7 million, compared with $80.0 million for the same period in 2025, and included $17.0 million of product revenue and $82.7 million of non-cash royalty revenue. Non-cash royalty revenue relates to royalty interests Agenus previously monetized and does not generate cash for the company.

Operating income and net income. Operating income was $11.4 million for the third quarter, the third consecutive quarter of positive operating income, compared with an operating loss of $4.6 million in the third quarter of 2025. Net income was $2.8 million for the quarter and $41.4 million for the first nine months of 2026.

Cash and financing. Cash, cash equivalents and short-term investments were $86.9 million at September 30, 2026, compared with $18.7 million at June 30, 2026. The oversubscribed private placement completed in July provided approximately $85 million in upfront gross proceeds and includes milestone-aligned warrants that provide up to approximately $255 million in additional gross proceeds if fully exercised. Based on the current operating plan, the upfront proceeds are expected to support ROBBIN initiation, regulatory activities and operations through the third quarter of 2027. Assuming full exercise of the warrants, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031.

Financial Summary

($ in millions)

Metric

Q1 2026

Q2 2026

Q3 2026

YTD Q3 2026

Q3 2025

YTD Q3 2025

Pre-commercial product revenue

$4.6

$6.4

$6.0

$17.0

—

—

Non-cash royalty revenue

29.1

28.1

25.5

82.7

29.1

77.5

Service and other revenue

—

—

—

—

1.1

2.5

Total revenue

$33.7

$34.5

$31.5

$99.7

$30.2

$80.0

Operating income (loss)

$15.1

$11.3

$11.4

$37.8

$(4.6)

$(34.6)

Net income (loss)

$39.2

$(0.6)

$2.8

$41.4

$63.9

$7.5

Cash, cash equivalents and short-term investments

$35.0

$18.7

$86.9

$86.9

$3.5

$3.5

Upcoming Milestones

November 2026: BOT+BAL long-term survivor characteristics and translational research presentations at SITC (Free SITC Whitepaper) 2026
Q1 2027: ROBBIN Phase 3 initiation and first patient enrollment
Q2 2027: Anticipated 60 patients enrolled in ROBBIN (Series A Warrants milestone)
Second half of 2027: Anticipated interim pathologic response assessment from ROBBIN (Series B Warrants milestone)
2027: Additional clinical publications and updates as available, and potential additional regulatory submissions

(Press release, Agenus, NOV 5, 2026, View Source [SID1234674294])