On May 6, 2026 Novavax, Inc. (Nasdaq: NVAX) reported its financial results and operational highlights for the first quarter ended March 31, 2026.

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"Novavax continued to make significant progress executing our corporate strategy which is comprised of partnering our technology, capital-efficient R&D innovation and a lean operating platform. In 2026, we signed a new, Matrix-M license with Pfizer for up to two vaccine candidates and secured four additional MTAs with a growing list of large pharmaceutical and innovative biotech companies," said John C. Jacobs, President and Chief Executive Officer, Novavax. "With these agreements in place, our partners have the right to evaluate Matrix in over 30 unique fields of experimentation targeting more than 50% of the projected over $100B market for infectious disease and oncology vaccines and immuno-therapeutics. In addition, Novavax continued to advance our own R&D efforts with the selection of our C. difficile vaccine candidate as our next potential asset to advance to the clinic as early as 2027."

First Quarter 2026 and Recent Highlights

Key Business Highlights

•In January 2026, Novavax entered into a license agreement with Pfizer for use of Novavax’s Matrix-M adjuvant in vaccine development. Under the terms of the agreement, Pfizer was granted a non-exclusive license for Matrix-M use in two infectious disease areas.

◦Novavax received an upfront payment of $30 million in the first quarter of 2026 and has the potential for up to $500 million in additional development and sales milestones. In addition, Novavax is eligible to receive high-mid-single digit percentage royalties on sales from products incorporating Matrix-M.
◦Pfizer will be solely responsible for the development and commercialization of its products utilizing Matrix-M, and Novavax will be responsible for the supply of Matrix-M.
◦This partnership has the potential to generate billions of dollars of revenue for Novavax over the life of the agreement.

•In 2026, Novavax continued to expand its Matrix-M partnering efforts with global pharmaceutical companies and innovative biopharma companies.
◦In April, Novavax signed a new material transfer agreement (MTA) with a top ten global pharmaceutical company who is also a global leader in oncology to explore Matrix-M in a broad array of oncology targets, as well as antibiotic resistant bacterial infections and other infectious diseases.
◦In April, Novavax signed a new MTA with an existing pharmaceutical partner for evaluation of Matrix-M in nine additional, identified disease areas.
◦In February, Novavax expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an innovative oncology company.

•In total, Novavax now has MTA collaborations and/or license agreements with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the right to explore Matrix-M in over 30 unique fields of experimentation across both infectious diseases and oncology.
◦The goal of our MTA collaborations is to enable exploration of Matrix-M with the intent of entering into deeper partnership via formal license agreements, that in turn results in the advancement of partner’s R&D clinical work toward the potential commercialization of innovative vaccines.
▪The broad utility of our technology has resulted in several companies exploring Matrix-M for application in the same high-potential markets, including infectious disease areas such as cytomegalovirus, Epstein-Barr Virus, pneumococcal, and RSV; and also includes overlap in oncology areas such as colorectal cancer, head and neck cancer and pancreatic cancer.
▪Existing partners under license and MTA agreements, have the right to address fields of experimentation that cover over 50% of the global market opportunity for infectious disease and oncology vaccines and immunotherapeutics, which is projected to grow to over $100 billion by the early 2030s.

•In April, Sanofi announced positive Phase 4 results from the COMPARE study, a head-to-head study showing that Nuvaxovid demonstrated statistically significant lower side effects compared to Moderna’s mNEXSPIKE across all pre-specified endpoints, reinforcing Nuvaxovid’s well-established and differentiated reactogenicity profile ahead of the fall season.

•Continued to progress Novavax R&D innovation in support of our growth strategy
◦Clostridioides difficile colitis (C. difficile) vaccine candidate prioritized as potential next asset to enter the clinic as early as 2027.
◦Preliminary preclinical data generated by Novavax on its varicella-zoster virus (shingles) and respiratory syncytial virus early-stage assets were positive and provide path forward for informing the Company’s future antigen design and adjuvant work.
•Ongoing adjuvant research is intended to expand the utility of our technology by creating new adjuvants tailored to foster specific differentiated immune properties for certain diseases that may require unique immune responses.

•Novavax continued to progress its cost reduction program to create a more lean and agile organization.
◦Targeting full year Non-GAAP combined R&D and Selling, General and Administrative (SG&A) expenses of $325 million for full year 2026 and $225 million for full year 2027, each period at the midpoint of the guidance range.
◦Improving the 2028 target for full year Non-GAAP combined R&D and SG&A expenses to between $150 million and $200 million. This reflects an anticipated expense reduction of over $200 million and over 50% when compared to full year 2025.

First Quarter 2026 Total Revenue

First quarter 2025 Nuvaxovid sales included $603 million of non-cash sales related to the close-out of two APA agreements.

First Quarter
$ in millions Q1 2026 Q1 2025 Change %
NuvaxovidTM Sales1
$10 $608 ($598) (98%)
Supply Sales2
33 14 19 139%
Product Sales 42 622 ($579) (93%)
Sanofi3
49 40 9 21%
Pfizer 30 0 30 NM
Serum 7 4 3 65%
Other Partners4
11 0 11 NM
Licensing, Royalties and Other Revenue 97 45 52 116%
Total Revenue $140 $667 ($527) (79%)

Notes
1.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.
2.Supply Sales includes sales of finished product, adjuvant and other supplies from Novavax to its license partners.
3.Sanofi includes revenue recognized under the license agreement including upfront payments, milestones, royalties and transition services reimbursement.
4.Other Partners include upfront payments, royalties and milestone revenue under licensing agreements including Takeda and SK bioscience.

First Quarter 2026 Financial Results

•Total revenue for the first quarter of 2026 was $140 million, a 79% decrease compared to $667 million in the same period in 2025. Higher Nuvaxovid product sales for the first quarter of 2025 were primarily due to $603 million of non-cash sales revenue recognized with the close-out of two Advance Purchase Agreements (APA). Licensing Royalty and Other revenue of $97 million in the first quarter of 2026 included $30 million related to the Pfizer Matrix-M agreement signed in January 2026.

•Cost of sales for the first quarter of 2026 was $31 million, compared to $14 million in the same period in 2025.

•Research and development (R&D) expenses for the first quarter of 2026 were $95 million, compared to $89 million in the same period in 2025. The higher R&D costs were primarily associated with COVID-19 postmarketing commitment studies and annual strain change activities. R&D expenses reimbursed by partners in the first quarter of 2026 were $28 million. Non-GAAP R&D expenses, net of partner reimbursement, were $68 million in the first quarter of 2026, a 13% decrease when compared to $78 million in the same period in 2025. The lower Non-GAAP R&D expenses were driven by the ongoing Novavax cost reduction program as it streamlines operations to make targeted R&D investments.

•Selling, General and Administrative (SG&A) expenses for the first quarter of 2026 were $29 million, a 40% decrease compared to $48 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 first quarter of 2026 was $9 million, compared to net income of $519 million in the same period in 2025. First quarter of 2025 net income benefited from $603 million of non-cash sales related to the close-out of two APA agreements.

•Cash, cash equivalents, marketable securities and restricted cash (Cash) were $795 million as of March 31, 2026, compared to $751 million as of December 31, 2025. In February 2026, Novavax announced a $330 million credit facility with MidCap Financial, including an initial capital draw of $50 million. The credit facility was put in place to further strengthen Novavax’s balance sheet and provide access to non-dilutive capital as Novavax advances its growth strategy.

Financial Framework

Reiterates Full Year 2026 Financial Guidance

Novavax reiterates its Full Year 2026 Financial Guidance for Combined R&D and SG&A Expenses and Non-GAAP Combined R&D and SG&A Expenses and expects to achieve the following results:
$ in millions
Full Year 2026
(as of May 6, 2026)
Combined R&D and SG&A Expenses
$380 – $420
Less: R&D Reimbursements
($70 – $80)
Non-GAAP Combined R&D and SG&A Expenses
$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.

Reiterates Full Year 2026 Revenue Framework

For 2026, Novavax reiterates its 2026 Revenue Framework and expects to achieve Adjusted Total Revenue4 of between $230 million and $270 million. 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.

$ in millions
Full Year 2026
(as of May 6, 2026)
Nuvaxovid Product Sales1
$35 – $45
Adjusted Supply Sales2
$40 – $50
Adjusted Licensing, Royalties and Other Revenue3
$155 – $175
Adjusted Total Revenue4
$230 – $270
Sanofi Supply Sales, Sanofi Royalties and Sanofi Milestones
No guidance

Revenue Category
Revenue Framework Footnotes
Nuvaxovid Product Sales1
$35 million to $45 million in Nuvaxovid Product Sales by Novavax under existing APA and commercial agreements.
Adjusted Supply Sales2
$40 million to $50 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.
Adjusted Licensing, Royalties and Other Revenue3
◦$70 million to $80 million in R&D Reimbursement. Under the Sanofi co-exclusive licensing agreement (CLA), Novavax is eligible to receive reimbursement for costs incurred related to select R&D and technology transfer activities during the transition performance period.
◦$50 million to $60 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
◦$35 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.
Adjusted Total Revenue4
◦Adjusted Total Revenue is a Non-GAAP Financial Measure. Adjusted Total Revenue is total revenue excluding Sanofi Supply Sales, Sanofi Royalties and Sanofi. 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 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.
•Novavax is eligible to receive up to $350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi influenza-COVID-19 combination products.
•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 host its quarterly conference call today at 8:30 a.m. Eastern Time (ET). To join the call without operator assistance, you may register and enter your phone number at View Source to receive an instant automated call back. You may also dial direct to be entered into the call by an operator. The dial-in numbers for the conference call are (888) 880-3330 (Domestic) or (+1) (646) 357-8766 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 11:30 a.m. ET on May 6, 2026, until 11:59 p.m. ET on May 13, 2026. To access the replay by telephone, dial (800) 770-2030 (Domestic) or (+1) (609) 800-9909 (International) and use passcode 1309751#.

A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events. A replay of the webcast will be available on the Novavax website until June 6, 2026.

(Press release, Novavax, MAY 6, 2026, View Source [SID1234665192])

On May 6, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the first quarter ended March 31, 2026.

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First Quarter Updates and Recent Business Highlights

Ronde-cel: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma (LBCL)

Ronde-cel is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) designation in the third- and later-line (3L+) and second-line (2L) settings, as well as Fast Track designation for the treatment of adults with relapsed/refractory large B-cell lymphoma (R/R LBCL). Two pivotal trials for ronde-cel in LBCL are underway.

The ongoing PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi‑cohort trial, is ongoing. Additional data from this trial are expected in the second half of 2026, and pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in 2027. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.
In February 2026, patient dosing commenced in PiNACLE-H2H, the first-of-its-kind Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in patients with R/R LBCL in the 2L setting. The trial’s primary endpoint is event-free survival.

LYL273: A next-generation guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers

LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. In November 2025, Lyell acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced mCRC in a Phase 1 trial conducted in the U.S. following proof of concept in 15 patients in China. The FDA granted LYL273 Fast Track designation for the treatment of mCRC.

The U.S. Phase 1 clinical trial is continuing to enroll patients to determine the recommended Phase 2 dose. In March 2026, dosing commenced at Dose Level 3 (3 x 106 CAR T cells/kg). A data update focused on safety from this trial is expected in the first half of 2026, with a second data update including clinical outcomes expected in the second half of 2026.

Additional Business Highlights

In March 2026, Lyell closed the second $50 million tranche of its July 2025 equity private placement, following the successful achievement of a clinical milestone in PiNACLE. In the second tranche of the financing, which completed the total $100 million private placement, shares of common stock were sold at a purchase price of $25.61 per share.
In March 2026, Smital Shah was appointed Chief Financial and Business Officer.

First Quarter 2026 Financial Results

Lyell reported a net loss of $24.2 million for the first quarter ended March 31, 2026, compared to a net loss of $52.2 million for the same period in 2025. The $28.0 million decrease in net loss was primarily due to a $17.6 million gain on our Securities Purchase Agreement put/call asset relating to our July 2025 equity private placement. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the Securities Purchase Agreement put/call asset and success payment liabilities, decreased by $8.5 million to $37.8 million for the first quarter ended March 31, 2026, compared to $46.3 million for the same period in 2025 primarily due to the decreased headcount from the successful technology transfer of ronde-cel to the Company’s LyFE Manufacturing CenterTM (LyFE) in 2025.

GAAP and Non-GAAP Operating Expenses

Research and development (R&D) expenses were $36.6 million for the first quarter ended March 31, 2026, compared to $43.4 million for the same period in 2025. The $6.8 million decrease was primarily due to a $7.5 million reduction in personnel expenses, partially offset by a $3.4 million increase in clinical trials activity and outside services. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation, for the first quarter ended March 31, 2026 were $34.4 million compared to $41.1 million for the same period in 2025.
General and administrative (G&A) expenses were $9.6 million for the first quarter ended March 31, 2026 compared to $14.0 million for the same period in 2025. The $4.5 million decrease was primarily due to a $4.0 million reduction in personnel‑related expenses, including a $1.5 million decrease in stock-based compensation expense. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the first quarter ended March 31, 2026 were $7.5 million compared to $10.4 million for the same period in 2025.

A discussion of non-GAAP financial measures, including reconciliations of the most comparable U.S. generally accepted accounting principles (GAAP) measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of March 31, 2026 were $261.0 million compared to $247.2 million as of December 31, 2025. Lyell believes that its current cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into the third quarter of 2027.

(Press release, Lyell Immunopharma, MAY 6, 2026, View Source [SID1234665191])

On May 6, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the Bank of America Securities 2026 Healthcare Conference. Kura management is scheduled to participate in a fireside chat at 6:00 p.m. ET / 3:00 p.m. PT on May 13, 2026.

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The live webcast and archived replay of the event may be accessed on the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, MAY 6, 2026, View Source [SID1234665190])

On May 6, 2026 IN8bio, Inc. (Nasdaq: INAB) ("IN8bio" or the "Company"), a clinical-stage biopharmaceutical company developing innovative gamma-delta ("γδ") T cell therapies for cancer and autoimmune diseases, reported a series of presentations at leading medical and scientific conferences in May and June 2026, including new clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. IN8bio will also host a Research and Development (R&D) Day on May 21, 2026, showcasing advances across its γδ T cell pipeline, including its novel T cell engager (TCE) and clinical γδ T cell therapy programs.

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"We look forward to sharing progress across our γδ T cell platforms at our R&D Day and several key meetings this quarter," said William Ho, Chief Executive Officer and Co-Founder of IN8bio. "These presentations highlight the progress we are making with our novel TCE program, complemented by translational advances in our clinical program supporting the observed survival benefits in DeltEx DRI treated glioblastoma (GBM) patients. The unique properties of γδ T cells enable them to address key challenges in TCE development and to meaningfully improve outcomes in difficult-to-treat cancers."

Presentation details are outlined below:

IN8bio 2026 R&D Day (New York, New York)
In-person and Virtual

Featuring presentations on our T cell engager (TCE) platform for autoimmune diseases and our clinical program in GBM, with a clinical perspective from renowned neuro-oncologist Dr. David Reardon, Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School.
Date and Time: May 21, 2026, 9:00 AM to 11:30 AM EDT
Register Online: View Source

International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting (Dublin, Ireland)
Poster Presentations

Title: Unraveling Complexity: The Impact, Interactions and Outcomes of a γδ T Cell Therapy in Glioblastoma
Poster Details: 1253
Presenter: Mariska ter Haak
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 PM to 2:30 PM EDT)
Title: Lean Infrastructure for CGT Early-Stage Companies: Leveraging Integrated Digital Platforms to Achieve Sustainable Operation Efficiency and Scalable Compliance
Poster Details: 801
Presenter: Guoling Chen
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 PM to 2:30 PM EDT)
American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting (Boston, MA)
Oral Presentation

Title: Challenging the Glioblastoma Status Quo: Could γδ T Cells Shift the Balance?
Abstract: 328
Presenter: Mariska ter Haak
Date and Time: May 14, 2026, 11:00 AM to 11:15 AM EDT
2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Chicago, IL)
Poster Presentation

Title: INB-200: Phase I study and characterization of gene-modified autologous gamma delta (γδ) T cells in newly diagnosed glioblastoma multiforme (GBM)
Poster Details: 442 (Abstract 552638)
Presenter: Louis B. Nabors, MD
Date/Time: June 1, 2026, 1:30 PM to 4:30 PM CT (2:30 PM to 5:30 PM EDT)
Following each conference, posters and presentation materials will be available in the Events and Presentations section of the Company’s investor website.

(Press release, In8bio, MAY 6, 2026, View Source [SID1234665189])

On May 6, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the first quarter ended March 31, 2026, and provided a business update.

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"We are proud to report another quarter of strong commercial performance, with KIMMTRAK generating $107 million in net revenues in Q1 2026," said Bahija Jallal, CEO of Immunocore. "The five-year overall survival (OS) data from our Phase 3 trial presented at AACR (Free AACR Whitepaper) is a landmark moment. It is the longest OS follow-up ever reported in a randomized trial in metastatic uveal melanoma and underscores the long-term benefit KIMMTRAK delivers to patients. In parallel, we are executing with discipline across our pipeline."

First Quarter Highlights (including post-period)

Financial Results

For the first quarter of 2026 (Q1 2026), total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK was $106.7 million, compared to $93.9 million for the same period in 2025. Q1 2026 sales were $67.4 million in the United States, $34.4 million in Europe, and $4.8 million in international regions. The increase in net product sales was due to increased volumes in the United States and Europe as well as global country expansion.

Research & development (R&D) expenses for Q1 2026 were $61.1 million, compared to $56.5 million for Q1 2025. This increase was primarily due to clinical expenses related to the progression of our Phase 3 trials, primarily PRISM-MEL-301.

Selling, general and administrative (SG&A) expenses for Q1 2026 were $37.9 million, compared to $40.2 million for Q1 2025. This decrease was primarily due to increases in forfeitures of share-based compensation.

Net income for Q1 2026 was $13.0 million compared to $5.0 million for Q1 2025.

The Q1 2026 diluted income per share was $0.25 compared to $0.10 for Q1 2025.

Cash, cash equivalents and marketable securities were $844.9 million as of March 31, 2026.

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in over 30 countries globally to date for HLA-A*02:01 positive people with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas as it plans to expand patient reach for KIMMTRAK, including continued US community and global market penetration in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

KIMMTRAK net product sales were $106.7 million for the first quarter ended March 31, 2026, representing an increase of 13.6%, as compared to the same period in 2025.
19.1% year-over-year sales growth in the United States with mean duration of treatment of 14 months.
4.9% year-over-year sales growth in Europe, driven by increased demand and launches in European markets.
Five-year overall survival (OS) data from the landmark Phase 3 trial of KIMMTRAK in patients with unresectable or mUM were presented in an oral session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 meeting, representing the longest follow-up reported for any T cell engager in a solid tumor. In this study of 378 patients, KIMMTRAK doubled the likelihood of being alive at five years with an OS rate of 16% versus 8% in the control arm (HR 0.67), while demonstrating a median OS of 21.6 months compared to 16.9 months for investigator’s choice.
The OS benefit with KIMMTRAK was observed regardless of known poor prognostic factors at baseline (high tumor burden [≥10cm]; elevated lactate dehydrogenase [LDH]) or tumor location (hepatic only; hepatic and extra-hepatic). OS benefit was also observed in patients with a best response of progressive disease, including those with >20% tumor growth as best change on treatment.
The data also confirmed that the OS benefit was primarily driven by KIMMTRAK rather than subsequent therapies. Among patients treated with KIMMTRAK who were alive at five years, nearly half (44%) received only KIMMTRAK, while among patients in the control arm alive at the same time point, 86% subsequently received KIMMTRAK.
2L+ advanced cutaneous melanoma

The Company is currently enrolling patients in the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026 with topline data expected as early as the second half of 2026.
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy). The primary endpoint of the randomized Phase 3 trial is Overall Survival (OS).
There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown, to date, an OS improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced HLA-A*02:01 positive CM patients.

Adjuvant uveal (or ocular) melanoma

The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
The Company estimates that the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients in the US and Europe.
PRAME portfolio
Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line, advanced cutaneous melanoma

The Company is enrolling HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.
Despite approved therapies, there remains a need for improved progression-free survival and OS, and there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients in the US and Europe.
Phase 1/2 clinical trials of brenetafusp and IMC-P115C (PRAME-A02 Half-Life Extended) in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination in platinum-resistant ovarian cancer (PROC) and in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic NSCLC cohorts, including combination in earlier-line NSCLC.
The Company is enrolling patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.
The Company expects to present Phase 1/2 data from both trials in the second half of 2026.

IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.
The Company expects to present initial data in 2027.
ImmTAV candidates for a functional cure in infectious diseases
The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a ‘functional cure’. The Company is studying an investigational candidate for people living with human immunodeficiency virus (HIV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

Patient enrollment continues at higher doses in the multiple ascending dose (MAD) part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.
Additional Phase 1 MAD data is expected to be presented in the second half of 2026.
Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

The Company filed a clinical trial application (CTA) for IMC-S118AI (PPI x PD1) in December 2025 and expects to begin the Phase 1 trial in the first half of 2026.
The Company plans to file a CTA or investigational new drug (IND) application for IMC-U120AI (CD1a x PD1) in the second half of 2026.
Corporate update

The Company will present the following two posters at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting:

Title: Phase 1 evaluation of the PRAME-targeted ImmTAC brenetafusp in advanced melanoma (Mel). (Abstract number: 9527)
Session: Melanoma/Skin Cancers (Poster Board: 243)
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Title: Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T-cell fitness in patients. (Abstract number: 2662)
Session: Developmental Therapeutics – Immunotherapy (Poster Board: 452)
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT

(Press release, Immunocore, MAY 6, 2026, View Source [SID1234665188])