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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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])

On November 5, 2026 Novavax, Inc. (Nasdaq: NVAX) reported its financial results and operational highlights for the third quarter ended September 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This quarter, we continued to execute across all three pillars of our strategy," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Our partner Sanofi initiated their Phase 3 influenza-COVID-19 combination vaccine trial vaccine trial in Europe, triggering a $125 million milestone payment. Our focused R&D efforts are building a growing body of data on what our technology can do in infectious disease, advancing our C. difficile candidate towards the clinic and exploring oncology as a potential new area of application. And we have been doing this while continuing to reduce expenses and operate with financial discipline. Over time, we believe this strategy can build a robust and profitable Novavax, with multiple partners and products, diversified revenue streams and a meaningful impact on global health."

Third Quarter 2026 and Recent Highlights

Key Business Highlights

In October 2026, Novavax earned a $125 million milestone payment with the initiation of Sanofi’s Phase 3 influenza-COVID-19 combination vaccine trial in Europe
Sanofi confirmed to Novavax their intent to initiate a U.S. Phase 3 CIC trial in 2027 to support U.S. approval. Novavax is eligible to receive an additional milestone of $225 million upon a U.S. commercial launch of a CIC vaccine following successful completion by Sanofi of clinical and U.S. FDA regulatory requirements.
Novavax is eligible to receive royalties in the high single digits to sub-teens as a percentage of Sanofi’s global net sales on a CIC product(s).
Manufacturing technology transfer to Sanofi for Nuvaxovid is expected to be completed in mid-2027, which would trigger a $75 million milestone payment to Novavax.
In August 2026, Novavax’s commercial partners received approvals for the XFG-adapted Nuvaxovid formulation in major markets, including the U.S., the EU and Japan.
Sanofi initiated commercial activities for the 2026–2027 COVID-19 vaccination season in the U.S. and select international markets.
Sanofi is expanding Nuvaxovid’s reach through physician engagement, pharmacy activation and direct-to-consumer outreach.
Novavax is eligible to receive royalties in the high teens to low twenties as a percentage of Sanofi’s global net sales for Nuvaxovid.
Takeda initiated commercial activities for the 2026–2027 COVID-19 vaccination season in Japan.
Novavax is eligible to receive an annual milestone payment and mid-to-high teens percentage of Takeda’s net sales in Japan each year.
Differentiated C. difficile (C. diff) vaccine program is anticipated to advance into the clinic as early as 2027.
Novavax presented preclinical data from its C. diff program showing robust immune responses and protection in lethal challenge models at the 9th International C. Difficile Symposium in September 2026.
Multiple scientific evaluations by Novavax, partners and material transfer agreement collaborations are underway. These are expected to add to the growing body of data relating to Matrix-M’s utility in infectious disease and its potential in oncology, which could enable future licensing opportunities.
Third Quarter 2026 Total Revenue

$ in millions

Q3 2026

Q3 2025

Change

%

Product Sales1

$ 26

$ 13

$ 12

91 %

Sanofi 2

19

48

(30)

(61 %)

Takeda

7

6

1

14 %

Serum

5

2

3

136 %

Other Partners3

11

0

11

100 %

Licensing, Royalties

and Other Revenue

43

57

(14)

(25 %)

Total Revenue

$ 68

$ 70

$ (2)

(3 %)

Notes

1.

Product Sales includes both Novavax’s Nuvaxovid sales and Supply sales. Nuvaxovid Sales reflects product sales where Novavax is the commercial market lead and records revenue related to the sales and distribution of its COVID-19 vaccine. Supply Sales includes sales of finished product, adjuvant and other supplies from Novavax to its license partners.

2.

Sanofi includes revenue recognized under the license agreement including upfront payments, milestones, royalties and transition services reimbursement.

3.

Other Partners in Q3 2026 reflects non-cash deferred royalty recognition related to SK bioscience prior sales of Nuvaxovid.

Third Quarter 2026 Financial Results

Total revenue for the third quarter of 2026 was $68 million, a 3% decrease compared to $70 million in the same period in 2025. Product sales of $26 million in the third quarter of 2026 were 91% higher than the same period in 2025 and consisted of Novavax’s supply sales of Nuvaxovid to Sanofi and Matrix-M to license partners. Licensing royalties and other revenue of $43 million in the third quarter of 2026 were 25% lower than the same period in 2025 driven primarily by a $42 million reduction year-over-year in research and development (R&D) reimbursement revenue as Novavax nears completion of its support of Sanofi Nuvaxovid clinical support for postmarketing commitments. The third quarter of 2026 includes $11 million in non-cash deferred royalty recognition related to prior Nuvaxovid sales by SK bioscience to the South Korean government.

Cost of sales for the third quarter of 2026 was $23 million, compared to $21 million in the same period in 2025.

R&D expenses for the third quarter of 2026 were $52 million, compared to $98 million in the same period in 2025. GAAP and Non-GAAP R&D expenses, decreased by 47% and 7%, respectively compared to the same period in 2025. R&D expenses reimbursed by partners in the third quarter of 2026 were $4 million. The lower R&D expenses were driven by the near completion of Sanofi clinical support for Nuvaxovid, decreased seasonal strain change support for Nuvaxovid and ongoing Novavax cost reduction program.

Selling, general and administrative (SG&A) expenses for the third quarter of 2026 were $24 million, a 25% decrease compared to $32 million for the same period in 2025. The decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus the ongoing general administrative cost reduction program.

Net loss for the third quarter of 2026 was $31 million, compared to a net loss of $202 million in the same period in 2025.

Cash, cash equivalents, marketable securities and restricted cash (Cash) were $627 million as of September 30, 2026, compared to $751 million as of December 31, 2025.
Financial Framework

Improves Full Year 2026 Financial Guidance

Novavax improved its Full Year 2026 Financial Guidance at mid-point by reducing Combined R&D and SG&A Expense guidance while maintaining Non-GAAP Combined R&D and SG&A Expense guidance and expects to achieve the following results:

$ in millions

Full Year 2026

(as of Nov 5 2026)

Full Year 2026

(as of Aug 6 2026)

Combined R&D and SG&A Expenses

$375 – $395

$370 – $410

Less: R&D Reimbursements

($60)

($60 – $70)

Non-GAAP Combined R&D and SG&A

Expenses

$315 – $335

$310 – $340

Non-GAAP Combined R&D and SG&A Expenses exclude R&D Reimbursements, which are amounts reimbursed by Novavax’s license partners. See "Non-GAAP Financial Measures" below. R&D Reimbursements are recorded as revenue under Licensing, Royalties and Other Revenue.

Raises Full Year 2026 Revenue Framework

For 2026, Novavax raised its 2026 Revenue Framework and expects to achieve the following results for Adjusted Total Revenue.

$ in millions

Full Year 2026

(as of Nov 5, 2026)

Full Year 2026

(as of Aug 6, 2026)

Nuvaxovid Product Sales1

$40 – $50

$35 – $45

Adjusted Supply Sales2

$50 – $60

$45 – $55

Sanofi CIC Milestone3

$125

No guidance

Adjusted Licensing, Royalties and

Other Revenue4

$170 – $180

$155 – $175

Adjusted Total Revenue5

$385 – $415

$235 – $275

Sanofi Supply Sales, Sanofi Royalties

and future Sanofi Milestones

No guidance

No guidance

Novavax transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 COVID-19 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi’s sales forecasts for certain revenue components, these are not included in the Full Year 2026 Revenue Framework.

Revenue Framework Footnotes

Revenue Category

Revenue Framework Footnotes

Nuvaxovid Product

Sales1

$40 million to $50 million in Nuvaxovid Product Sales by Novavax under existing Advance Purchase Agreements and commercial agreements. Expect to exclude from the 2027 Revenue Framework.

Adjusted Supply

Sales2

$50 million to $60 million in Adjusted Supply Sales associated with collaborations with the Serum Institute on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum and Takeda and other partner related clinical and commercial supply sales.

Sanofi CIC Milestone3

$125 million milestone earned in October 2026 with the initiation of Sanofi’s Phase 3 influenza-COVID-19 combination vaccine trial in Europe.

Adjusted Licensing,

Royalties and Other Revenue4

•

$60 million in R&D Reimbursement. Under the Sanofi co-exclusive licensing agreement, Novavax is eligible to receive reimbursement for costs incurred related to select R&D and technology transfer activities during the transition performance period. $5 million expected in 2027.

•

$70 million to $80 million in Other Partner related revenue including royalties and milestones from Pfizer, Serum on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum and Takeda. Includes a $30 million upfront payment under the Pfizer agreement received in the first quarter of 2026.

•

$40 million amortization related to the $500 million Upfront Payment and the $50 million Database Lock Milestone. Revenue recognition will occur over the transition performance period. Less than $5 million expected in 2027 to complete amortization.

Adjusted Total

Revenue5

•

Adjusted Total Revenue is a Non-GAAP Financial Measure. Adjusted Total Revenue is total revenue excluding Sanofi Supply Sales, Sanofi Royalties and future Sanofi Milestones. See "Non-GAAP Financial Measures."

Components of Revenue excluded from the Full Year 2026 Revenue Framework are described below.

Sanofi Supply Sales

Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2026-2027 COVID-19 vaccination season and the reimbursement for this supply will be recorded as product sales.
Sanofi Royalties

Sanofi will lead commercial activities for the 2026-2027 COVID-19 vaccination season in select markets, including the U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi global net sales.
Sanofi Milestones

Novavax is eligible to receive a $75 million milestone payment related to the completion of the technology transfer of the Nuvaxovid manufacturing process to Sanofi that is expected to be completed in mid-2027.
Novavax is eligible to receive a one-time $225 million milestone on the first commercial sale of a CIC product in the U.S. following successful completion of clinical and U.S. FDA regulatory requirements by Sanofi.
For each new vaccine using Matrix-M, Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single digit sales royalties for 20 years.
Conference Call
Novavax will discuss third quarter 2026 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Thursday, November 5, 2026. Dial-in information can be found here. A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events.

(Press release, Novavax, NOV 5, 2026, View Source [SID1234674278])

On November 5, 2026 Molecular Partners AG (SIX, NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of medicines known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported it will hold presentations on its lead Radio-DARPin candidate MP0712, co-developed with Orano Med, at two upcoming scientific conferences, including the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Theranostics Conference, taking place November 4–7 in Bethesda, MD, USA and the IASLC/ASCO 2026 North America Conference on Lung Cancer (NACLC), taking place December 4–6 in Scottsdale, AZ, USA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Details of the presentations

2026 SNMMI Theranostics Conference

Title: How much Target Expression is Enough? Learnings from advancing MP0712, a DLL3 Radio-DARPin for SCLC, into the clinic
Format: Oral presentation
Presenter: Daniel Steiner, Ph.D., SVP Targeted Radio Therapeutics
Session: Future of Theranostics – Part 1
Date and time: Saturday, November 7, 8:40 – 9:00 am EST
Location: Bethesda North Marriott Hotel & Conference Center, Bethesda, Maryland

NACLC 2026

Title: [212Pb]Pb-MP0712 in patients with small cell lung cancer (SCLC) and other Delta-like ligand 3 (DLL3) expressing solid tumors: Initial dose escalation data from a first-in-human Phase 1/2a study
Format: Poster presentation
Presenting author: Ticiana Leal, M.D., Winship Cancer Institute of Emory University, Atlanta, GA
Date and time: Saturday, December 5, 2026, 4:15 – 5:45 pm MST
Location: Grand Hyatt Scottsdale Resort, Scottsdale, Arizona

The presentations will be made available on Molecular Partners’ website after the presentations.

(Press release, Molecular Partners, NOV 5, 2026, View Source [SID1234674196])