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Tempus Launches the PRECISION Challenge, a National Program Opening Its Foundation Model Work to the Broader Research Community

Tempus Launches the PRECISION Challenge, a National Program Opening Its Foundation Model Work to the Broader Research Community

Inaugural program provides unprecedented access to Tempus’ library of de-identified multimodal data and models, scalable compute infrastructure and direct funding to catalyze clinical and technical breakthroughs

CHICAGO–(BUSINESS WIRE)–
Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced the launch of the PRECISION Challenge, a national initiative engineered to accelerate the next generation of oncology breakthroughs leveraging its foundational model. The PRECISION Challenge aims to unlock breakthroughs in oncology at scale by providing access to data, funding, and expertise to multidisciplinary teams around the world who seek to make bold advances in cancer treatment and improve patient outcomes.

The PRECISION Challenge will provide selected participants with an unprecedented ecosystem of resources, combining direct financial funding with scientific and analytical infrastructure. Program recipients will gain structured access to Tempus’ proprietary, de-identified data library—one of the world’s largest repositories of clinical, molecular, and imaging data—alongside a suite of Tempus’ foundation models, agentic tooling, and compute infrastructure in the Lens Workspaces environment, designed to accelerate biological discovery from multimodal real world data.

As part of the PRECISION Challenge, Tempus and a group of external advisors will identify specific clinical and technical challenges for the research community to address, focused on advancing precision medicine in oncology by leveraging Tempus’ large multimodal foundation model.

The program will provide staged funding and compute resources tied to research milestones and demonstrated progress:

  • Proof of Concept Grant: $25,000 in funding and an allocation for compute to support early-stage development and feasibility testing.
  • “Level-Up” Grant: $75,000 in funding and an allocation for compute to support more advanced development, such as demonstrating clinical performance, achieving model lock, or validating reproducibility.
  • Additional rounds of funding and advanced computing resources will be available to further advance selected projects, including support for validation studies and external publication.

“Oncology research is no longer bottlenecked solely by scientific hypotheses, but by immediate access to high-fidelity data and the massive computational power required to interpret it,” said Ezra Cohen, MD, and Chief Medical Officer of Oncology at Tempus. “With the PRECISION Challenge, we are opening Tempus capabilities and allowing the broader research community to access the vast investments we have made in building our foundation model. We will embark on this effort collaboratively to address the fundamental questions in oncology that, before now, were impossible to address.”

Tempus will announce the opening of applications for the inaugural cohort of the PRECISION Challenge in the coming months. Researchers and investigators are encouraged to apply.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding expected outcomes and benefits of Tempus’ PRECISION Challenge. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: the intended use of Tempus’ products and services; Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Tempus

Hanah Heintzelman

[email protected]

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Research Technology Health Technology Professional Services General Health Health Data Management Science Oncology Artificial Intelligence

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GRAIL Reports Full Results From NHS-Galleri Trial Demonstrating Substantial Reduction in Stage IV Cancer Diagnoses at 2026 ASCO Annual Meeting

PR Newswire


No Reduction Observed in Combined Primary Endpoint of Stage III/IV Cancers in Aggregate; However, Decreases Observed Beyond the Prevalent Screening Round
 


Annual Galleri

®

Blood Test Reduced Stage IV Diagnoses of 12 Prespecified Cancers by 22% and 26% in the Second and Third Screening Rounds, Respectively


Galleri Increased Cancer Detection Rate by Four-Fold When Added to Standard of Care Screening and Reduced Cancer Diagnosis Through Emergency Presentation by 25%


Annual Testing With Galleri Increased Stage I-II Cancer Diagnoses by 16% When Added to Standard of Care


GRAIL to Host Analyst Call From 2026 ASCO Annual Meeting

MENLO PARK, Calif., May 30, 2026 /PRNewswire/ — GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced detailed clinical utility, performance and safety results from its landmark NHS-Galleri trial in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting1.

The NHS-Galleri trial is the first and only randomized, controlled trial of a multi-cancer early detection (MCED) test and evaluated annual screening with the Galleri ® test in England’s National Health Service (NHS) over three years in 142,250 demographically representative participants aged 50 to 77 at enrollment. GRAIL collaborated with NHS England on the objectives of this study, based on NHS priorities to reduce Stage III and IV cancers.

“The goal of multi-cancer early detection is to find more cancers earlier, when they are more treatable and potentially curable, so that patients have the chance of living longer and more productive lives,” said Josh Ofman, MD, MSHS, President and CEO-Elect at GRAIL. “The NHS-Galleri trial provides a wealth of data that support the use of the Galleri test to reduce the burden of metastatic Stage IV cancer and increase the number of cancers found earlier through screening at population scale. Importantly, Galleri found more Stage I and II cancers than all cancers found through NHS’ existing single cancer screenings combined. By the third round of screening in this trial, Stage IV cancer diagnoses fell by more than a quarter, when treatment with curative intent may be possible.”

Finding Cancers Earlier
The NHS-Galleri trial evaluated a combined primary endpoint of Stage III and IV diagnoses in a pre-specified group of 12 deadly cancers2 when the Galleri test was added to standard of care screening in England (breast, bowel, cervical and high risk lung cancers) versus standard of care screening alone; however, there was no statistically significant difference within a 1-year follow up window after the last appointment. Follow-up will continue, with further results published as available.

Sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs at GRAIL, explained the reasons behind the Stage III and IV result: “We saw a substantial decrease in Stage IV cancers, but this was outweighed by an overall increase in the number of Stage III cancers, particularly in the prevalent screening round. We believe the Stage III increase was driven in part by a number of Stage IV cancers being shifted to earlier stages, including at Stage III, and the fact that many more cancers overall were found earlier through screening in the intervention arm, while the equivalent cancers may not yet have been diagnosed in the control arm. We would expect to see more of these as yet undiagnosed late stage cancers being found in the control arm with longer follow up. In addition, the trial has revealed just how much undiagnosed and uninvestigated Stage III cancer is already prevalent in the population before any screening commences. Finding these cancers earlier means we can start treating those patients with the urgency needed and, in many cases, with the opportunity of curative intent.”

One of the aims of screening is to reduce the incidence of metastatic late stage cancer. In the Galleri arm, Stage IV cancer diagnoses decreased with each year of sequential screening, with a 9% reduction in the first (“prevalent”) screening round, a 22% reduction in the second round, and a 26% reduction in the third round in the pre-specified group of 12 cancers. The prevalent round detects undiagnosed cancers already present in the population at the time of initial screening, while subsequent “incident” rounds detect cancers that develop or progress between screening rounds and become detectable. Thus, the incident rounds most closely approximate the likely steady-state impact of an annual screening program. Overall, in this pre-specified secondary endpoint, a 14% reduction in Stage IV cancers was observed. These results were nominally statistically significant. Similar reductions of 20% or more were observed in the second and third screening rounds for all stageable cancers.

“As a lung cancer doctor, I see the clinical importance of diagnosing cancer at an earlier stage, when treatment is more likely to be curative,” said Professor Charles Swanton, thoracic medical oncologist at University College London Hospital, and one of the NHS-Galleri trial’s chief investigators. “The NHS-Galleri trial tested whether adding the Galleri blood test to NHS screening could reduce the combined number of cancers diagnosed at Stage III or IV over three years. The primary endpoint was not met. However, a pre-specified secondary endpoint did show a greater than 20% reduction in Stage IV cancers, with the effect strengthening by the third year of screening. The Stage IV reduction is clinically meaningful because for many cancers there is a real gulf in outlook between a Stage IV diagnosis and one caught earlier. The hope is that for more patients the conversation can be about treating cancer with curative intent rather than managing it palliatively.”

Within the overall trend of Stage IV reduction, in an exploratory analysis, meaningful reductions in Stage IV diagnoses were observed in cancer types where 5-year survival is substantially higher when diagnosed at Stage III versus IV. For example, Stage IV diagnoses were reduced by 57.1% in esophageal cancer and 34.4% in colorectal cancer in the incident rounds. The five-year survival rates in England are significantly higher in Stage III than Stage IV for each of these cancers: 24.7% vs 6.2% for esophageal cancer, 64.2% vs 11.0% for colorectal cancer.

“For most cancer patients, there is a real difference between being diagnosed and being treated with a possibility of a cure versus being diagnosed at Stage IV and only being offered treatment that could manage symptoms and side effects or potentially prolong life for months or a few years. This is why it is critical to detect cancer at earlier stages, especially before distant metastases. Patients live longer when they are diagnosed before their cancer spreads to other parts of the body,” said Sally Werner, RN, BSN, MSHA, Chief Executive Officer at Cancer Support Community, a global nonprofit advocacy organization. “The Galleri study results show promise and bring hope to people concerned about cancer that it might be detected earlier, improving patient outcomes and allowing more patients treatment options that offer potential cures. The fact that this screening is available with a simple blood test that could be done at any healthcare visit could make this a game changer in increased screening and earlier diagnosis, which could reduce a large portion of the persistent cancer disparities we see.”

Relative Incidence Rate of Combined Stage III/IV Cancers Decreased After the First Round of Screening in the Pre-Specified Group of 12 Cancers; Relative Incidence Rate of Stage IV Cancers Decreased Each Screening Round.


Stage III/IV Cancers Diagnosed


Stage IV Cancers Diagnosed


Incidence Rate Ratio


Intervention vs Control

(% Difference)


Incidence Rate Ratio


Intervention vs Control

(% Difference)

After 3 Screening Rounds

1.03 (0.92, 1.14)

p=0.6324

⬆3%

0.86 (0.744, 0.998)

⬇14%

First Screening Round (Prevalent)

1.19 (0.98, 1.43)


⬆19%

0.91 (0.71, 1.18)

⬇9%

Second Screening Round (Incident)

0.95 (0.77, 1.17)


⬇5%

0.78 (0.57, 1.06)

⬇22%

Third Screening Round (Incident)

0.88 (0.73, 1.07)


⬇12%

0.74 (0.57, 0.95)


⬇26%

Along with the decrease in Stage IV cancer incidence, Stage I and II cancers diagnosed increased by 16% for the 12 prespecified cancer types after three rounds of screening, including large increases in many types typically diagnosed late, such as ovarian, esophageal, pancreatic and liver cancers. 

Nigel, 70, from the North East of England, took part in the NHS-Galleri trial and was diagnosed with Stage I head and neck cancer after receiving a cancer signal detected Galleri test result. “The fact that the cancer was Stage I meant it had likely been caught much earlier than would have otherwise been the case,” Nigel said. “The surgery was less invasive, so that aided my recovery. And the horror stories I was presented with about the number of days in hospital and having to learn to drink and eat again – luckily none of that happened in my case.”

Finding More Cancers With Robust Performance and Favorable Safety
The addition of the Galleri test to standard-of-care cancer screenings led to a four-fold increase in screen-detected cancers and a 21% decrease in the number of clinically detected cancers after symptomatic presentation. Further, the addition of MCED screening was associated with cancers diagnosed after emergency presentation decreasing by 25%.

Eric Sue, M.D., a primary care physician of internal medicine at the Sue Medical Group in Los Angeles, noted: “There is a distinct difference between the objectives of a therapeutic drug trial and those of a cancer screening trial, where the totality of the data must be carefully considered. In the NHS-Galleri trial, the observed greater than 20% reduction in stage IV cancer diagnoses and the four-fold increase in cancer detection compared with standard screening alone are both highly compelling findings. Shifting cancers away from metastatic presentation toward earlier-stage detection—while identifying substantially more cancers overall—creates more opportunities to intervene when curative treatment may still be possible and, most importantly, where the opportunity to reduce cancer mortality may be greatest.”

The Galleri test’s performance – positive predictive value (PPV), specificity and Cancer Signal of Origin (CSO) accuracy – was consistent with the range previously reported from GRAIL’s North American studies. Over three screening rounds, 1,801 participants (0.91%) had a positive MCED test result and 937 were diagnosed with cancer, for a cancer detection rate of 0.48%. PPV was 52.0% overall and 58.0% in the first screening round. Specificity was 99.55%, resulting in a low false positive rate of 0.45%. CSO accuracy was 92.5%. Episode sensitivity – the ability to detect cancers that were diagnosed within 12 months after each Galleri screening blood draw – was 54.7% for the 12 prespecified cancer types and 30.7% across all cancer types.

“Our current recommended screening tests only find around 14% of newly diagnosed cancers each year in the US and around 6% in England. In finding four times as many cancers compared to the standard screening programs combined, we are identifying many more asymptomatic patients with undiagnosed disease months or even years earlier than currently possible,” said Kumar. “Galleri represents a potential transformational shift in cancer detection, moving us to a more comprehensive proactive approach. As treatment options continue to advance, screening frameworks must evolve in parallel. Multi-cancer early detection provides an opportunity to reshape screening around an evolving goal: detecting more cancers when there is an opportunity for cure.”

There were no serious related adverse events reported in the trial, reaffirming the safety profile of the test.

The results of the NHS-Galleri trial will be submitted for publication in a peer-reviewed medical journal.

“We are deeply grateful to the more than 142,000 participants who took part in this study, as well as to the NHS, The Cancer Prevention Trials Unit at Queen Mary University of London, Cancer Alliances, investigators, and clinical teams whose dedication made this landmark trial possible,” said Professor Richard Neal, Professor of Primary Care at University of Exeter, General Practitioner, St. Leonard’s Practice, and one of the NHS-Galleri trial’s chief investigators.

GRAIL to Host Analyst Call From 2026 ASCO Annual Meeting 
GRAIL will host an analyst call to discuss clinical study results presented at ASCO tomorrow, Sunday, May 31, 2026, beginning at 4 p.m. PT/6 p.m. CT.

A link to the live webcast and recorded replay will be available at the investor relations section of GRAIL’s website at investors.grail.com. Please register for the live event at https://grail-asco-2026-analyst-call.open-exchange.net/.

About the NHS-Galleri Trial (NCT05611632; ISRCTN91431511)

The NHS-Galleri trial is the first and only prospective, randomized, controlled trial to assess the clinical utility and performance of a multi-cancer early detection test for population screening when added to standard care. The trial recruited more than 140,000 asymptomatic participants, aged 50 to 77, and was conducted in partnership with the NHS in England. Participants provided three blood samples over two years, about 12 months apart. The primary objective of the NHS-Galleri trial was to show a reduction in late-stage (III-IV) cancers in people who received the Galleri test compared with those who did not. This was measured in three clinically important groups of cancers, focusing first in a pre-specified group of 12 cancer types that together represent approximately two-thirds of cancer deaths in England and the United States. Secondary objectives include reduction in stage IV cancer; performance of the Galleri test, including positive predictive value and false positive rate; increase in overall cancer detection rate; safety; and healthcare resource utilization.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL’s targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, Calif. with locations in Washington, D.C., North Carolina, and London. 

For more information, visit grail.com.

About Galleri

®


The Galleri® multi-cancer early detection (MCED) test screens for more than 50 cancer types, including many deadly cancers that currently lack screening options, such as pancreatic, ovarian and liver/bile duct cancers3. The Galleri test is the only MCED test clinically proven through a randomized controlled trial to increase earlier cancer detection (Stage I-III) and reduce Stage IV diagnoses – enabling more patients to have curative treatment4. When added to standard-of-care screening, the Galleri test reduced Stage IV diagnosis by more than 20% after the first year of screening across all stageable cancers4,*. The Galleri test increased cancer detection by screening four times versus standard of care screening alone4. The Galleri test has the lowest false positive rate among MCED tests** and the ability to predict the Cancer Signal of Origin with greater than 90% accuracy, helping guide efficient diagnostic evaluation5,*. The Galleri test is backed by a robust clinical evidence program, with more than 380,000 participants across multiple studies, including the NHS-Galleri trial, the first and only randomized controlled trial for an MCED test. The Galleri test has delivered consistent performance across these studies. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.

For more information, visit galleri.com.

**A statistically significant reduction was not observed in combined stage III–IV diagnoses across three screening rounds for the 12 deadly cancers.

**Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance.

Important Galleri Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal Detected does not rule out cancer. A test result of Cancer Signal Detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False positive (a cancer signal detected when cancer is not present) and false negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information

The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed — and its performance characteristics were determined — by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes. 

GRAIL Forward Looking Statements

This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “should,” “would,” or “will,” the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include statements related to the potential benefits, uses and impacts of the Galleri test, plans for future follow up of the trial and expectations of future data or results we may see from such follow up, extrapolation of trends in the results, comparability of the results to a real world setting, including the similarity of the incidence rounds to steady state screening, the potential survival benefits of Galleri screening, benefits of population screening with Galleri, the applicability of the NHS-Galleri results to the commercial or FDA versions of the Galleri test, and plans to submit the results for publication, among others. 

These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2025. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.

Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results, financial condition and success in our business strategies and operations may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.

1 Swanton C. NHS-Galleri: Primary Results From a Randomised Controlled Trial to Assess the Clinical Utility of a Multi-Cancer Early Detection (MCED) Test in Population Screening [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29-June 2.
2 The 12 cancer types include anus, bladder, colorectal, esophagus, head and neck, liver/bile duct, lung, lymphoma, myeloma/plasma cell neoplasm, ovary, pancreas, stomach.
3 Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806
4 Swanton C. NHS-Galleri: Primary Results From a Randomised Controlled Trial to Assess the Clinical Utility of a Multi-Cancer Early Detection (MCED) Test in Population Screening [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29-June 2.
5 GRAIL, Inc. False positive rate. [Data on file: GR-2025-0256]

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SOURCE GRAIL, Inc.

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Immatics Presents Clinical Activity of IMA203CD8 PRAME Cell Therapy in Hard-to-Treat Gynecologic Cancers at 2026 ASCO Annual Meeting

  • One-time infusion of IMA203CD8 PRAME cell therapy in the ongoing Phase 1 dose escalation/dose expansion trial achieved anti-tumor activity in platinum-resistant ovarian cancer and in uterine cancer with a 63% objective response rate (ORR), 50% confirmed ORR (cORR), including four complete responses, and longest ongoing response at 12 months
  • Additional Phase 1 data for IMA203CD8 in heavily pretreated patients with synovial sarcoma showed deep and durable responses with a 67% ORR and 64% cORR, including one complete response, and ongoing responses up to ~3 years
  • IMA203CD8 demonstrated a manageable and consistent tolerability profile across patient populations
  • Clinical anti-tumor activity observed across tumor types (ovarian carcinoma, uterine cancer, melanoma, synovial sarcoma) with distinct biology and differing levels of PRAME expression, including lower PRAME levels in ovarian carcinoma
  • Clinical profile of IMA203CD8 supports continued development in gynecologic cancers and expansion into other PRAME-positive solid tumors
  • Determination of recommended phase 2 dose (RP2D) remains expected in 2026

Houston, Texas and Tuebingen, Germany, May 30, 2026 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, today announced updated Phase 1 data for its IMA203CD8 PRAME TCR T-cell therapy in gynecologic cancers and synovial sarcoma at the Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago, IL, USA. One-time infusion of IMA203CD8 demonstrated meaningful clinical activity across different tumor types as well as manageable tolerability. The broad expression of PRAME in more than 50 cancers further supports the continued development of IMA203CD8 in multiple PRAME-positive solid tumors.

The updated Phase 1 results in gynecologic cancers will be presented on May 30, 2026, during the Rapid Oral Abstract Session – Gynecologic Cancer from 8:00-9:30 am CDT by Antonia Busse, M.D., Charité Medical University Hospital, Berlin, Germany (Abstract ID 5509). Presentation slides are accessible in the ‘Events & Presentations’ section of the Investors & Media section of the Company’s website. Phase 1 data in synovial sarcoma will be presented on May 31, 2026, during the Rapid Oral Abstract Session – Sarcoma from 4:30-6:00 pm CDT by Dejka M. Araujo M.D., The University of Texas MD Anderson Cancer Center (Abstract ID 11516). Presentation slides will be accessible on May 31, 2026.

“These clinical data in ovarian cancer, uterine cancer and synovial sarcoma, along with previously released data in melanoma, further reinforce our aim to develop IMA203CD8 in PRAME-positive cancers beyond melanoma. PRAME is expressed in more than 50 cancers, and the compelling anti-tumor activity observed in these historically hard-to-treat indications supports its promise as a broadly applicable target,” said Cedrik Britten, M.D., Ph.D., Chief Medical Officer at Immatics. “We are encouraged by the consistency of response signals observed with IMA203CD8 and remain focused on advancing IMA203CD8 in gynecologic cancers with the potential to broaden development to other indications in a tumor-agnostic approach to deliver meaningful outcomes to patients.” 


Next development steps:


The clinical activity observed in ovarian cancer, a tumor type generally associated with lower levels of PRAME expression, together with the observed activity across tumor types with different and distinct tumor microenvironments, supports the broad applicability of IMA203CD8 across solid tumors with differing levels of PRAME and tumor biology, starting with ovarian and uterine cancer. Updated data from the ongoing study, including durability follow-up at the RP2D, are planned for presentation in the second half of 2026. Immatics is expanding clinical evaluation of IMA203CD8 into additional PRAME-positive solid tumor indications to more fully assess its therapeutic potential.


Highlights of Immatics’ clinical data on IMA203CD8 presented at ASCO 2026


Gynecologic cancers:


Patient population:
Heavily pretreated patient population with limited treatment options

  • As of March 30, 2026, 27 heavily pretreated patients with gynecologic cancers received a one-time infusion of IMA203CD8 in the ongoing Phase 1 dose escalation/dose expansion trial (NCT03686124).
  • The median total infused dose across seven escalating dose levels was 3.3×109 TCR T cells (range 0.5×109 – 12.5×109 TCR T cells) for ovarian carcinoma and 3.2×109 TCR T cells (range 1.3×109 – 10.1×109 TCR T cells) for uterine cancer.
  • All patients were heavily pretreated, including at least one prior line of platinum-based regimen. Patients with ovarian carcinoma had a median of four lines of systemic treatment (range 1-7), patients with uterine cancer had a median of two lines (range 1-3).
  • The efficacy-evaluable1 patient population included 26 patients, 19 of whom were treated at clinically relevant doses (≥DL4c, median 5.4 x109 TCR T cells, range 1.4 – 12.5): 17 with ovarian carcinoma and two with uterine cancer

Safety:
Treatment with IMA203CD8 showed predictable and manageable tolerability

  • IMA203CD8 demonstrated manageable tolerability in the 27 enrolled patients.
  • The most frequent treatment-emergent adverse events (TEAE) were anticipated cytopenias associated with lymphodepletion.
  • Expected and manageable cytokine release syndrome (CRS) was mostly low-grade and was consistent with the mechanism of action (Grade 1: 44%, Grade 2: 44%, Grade 3: 7%).
  • Immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) were infrequently observed (any Grade: 7%, each).
  • No IMA203CD8-related Grade 5 events occurred.
  • Based on the manageable tolerability profile, the Company expects to determine the recommended Phase 2 dose (RP2D) in 2026.

Anti-tumor activity:
A one-time infusion of IMA203CD8 PRAME cell therapy showed anti- tumor activity in gynecologic cancers at clinically relevant doses (≥DL4c)

  • Objective response rate (ORR): 63% (12/19), confirmed ORR (cORR)2: 50% (9/18)
    • Including two confirmed and two unconfirmed complete responses
    • 89% (8/9) of confirmed responses were ongoing as of the data cutoff with longest ongoing response at 12 months post infusion (metabolic complete response)
    • Responses were observed with and without low-dose IL-2
  • Tumor reduction: 78% (14/18)
  • Disease Control Rate (DCR) at week 6: 68% (13/19)
  • Median duration of response (mDOR), median progression free survival (mPFS) and median overall survival (mOS) were not reached, with median follow-up times (mFU) of 3.9, 5.3 and 5.3 months, respectively

* For those patients who achieved a (c)CR with <100% changes from baseline, target lesions were lymph nodes that resolved to <10 mm. + Patient had a PR prior to CR. BOR, best overall response; (c)CR: (confirmed) complete response; (c)ORR, (confirmed) objective response rate; PD, progressive disease; (c)PR, (confirmed) partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.


Synovial sarcoma:

  • As of the March 30, 2026 data cutoff, 12 heavily pretreated patients with synovial sarcoma, who had received a median of two prior lines of systemic therapy (range, 1-5), were treated with a one-time infusion of IMA203CD8.
  • The safety profile was manageable and consistent with the mechanism of action.
  • The most frequent TEAEs were anticipated cytopenias associated with lymphodepletion. CRS events were expected, manageable and predominantly Grade 1/2.
  • No IMA203CD8-related Grade 5 events were observed.

A one-time infusion of IMA203CD8 showed promising anti-tumor activity with deep and durable response in synovial sarcoma across all doses (median 1.59 × 10⁹ TCR T cells; range: 0.89–10.00 × 10⁹):

  • ORR: 67% (8/12), cORR: 64% (7/11)
    • 4 ongoing responses, including 1 confirmed complete response, with longest response ongoing at ~ 3 years
  • Tumor reduction: 92% (11/12)
  • DCR at week 6: 100% (12/12)
  • mDOR: 14.8 months (3.7, 31.8+) at mFU of 31.0 months

About IMA203CD8 PRAME Cell Therapy

IMA203CD8 is Immatics’ PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. The co-transduction of CD8αβ alongside the PRAME TCR adds functional CD4+ T cells designed to boost anti-tumor activity. IMA203CD8 is currently being evaluated in a Phase 1 clinical trial in solid tumors expressing PRAME.

About PRAME

PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and three combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy, IMA402 PRAME bispecific as monotherapy, in combination with immune checkpoint inhibitors, in combination with IMA401 MAGEA4/8 bispecific as well as anzu-cel in combination with Moderna’s PRAME mRNA designed to enhance cell therapy.

About Immatics

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on LinkedIn and Instagram.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, observations from the Company’s clinical trials, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND, CTA or BLA filings, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.

For more information, please contact:

Media

Trophic Communications
Phone: +49 151 74416179
[email protected]

Immatics N.V.

Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
[email protected]

1 All patients who received IMA203CD8 infusion and had at least one post-baseline scan, progressive disease or death.
2 cORR excludes one patient with ongoing unconfirmed response at data cutoff.

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Encouraging Global Phase II Ivonescimab Data in First-Line Metastatic Colorectal Cancer Presented at ASCO 2026

Encouraging Global Phase II Ivonescimab Data in First-Line Metastatic Colorectal Cancer Presented at ASCO 2026

Promising Data Further Support Continued Expansion of Ivonescimab Clinical Development in mCRC

Overall Study Population Achieved ORR of 70.8% and DCR of 100.0%; Responses Consistent Across Ivonescimab Dose Levels Combined with Chemotherapy

Acceptable and Manageable Safety Profile for Ivonescimab Regimen; No New Safety Signals Observed

MIAMI–(BUSINESS WIRE)–
Summit Therapeutics Inc. (NASDAQ: SMMT) today presented new results from the AK112-206 trial (NCT05382442), a global, open-label, multicenter Phase II study in first-line metastatic colorectal cancer (mCRC) co-sponsored by Summit and Akeso, featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab. The data were presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

The presentation, entitled “Ivonescimab with Oxaliplatin + Fluorouracil + Leucovorin Calcium for Patients with Unresectable Metastatic Colorectal Cancer: A Phase 2 Study,” detailed interim results of the multiregional extension portion of the study evaluating ivonescimab combined with mFOLFOX6 chemotherapy in patients with unresectable microsatellite stable (MSS) mCRC who were previously untreated for metastatic disease. Patients (n=49) were randomized (1:1) to receive ivonescimab (10 or 20 mg/kg; n=24, n=25, respectively) plus mFOLFOX6 once every two weeks. The data cut-off for this analysis was March 31, 2026 (10 or 20 mg/kg median follow-up: 9.9 months, 9.8 months, respectively).

In this U.S.- and China-based Phase II cohort of treatment-naïve patients with mCRC, patients receiving ivonescimab in combination with standard-of-care doublet chemotherapy mFOLFOX6 demonstrated an objective response rate (ORR) of 70.8% across both arms in evaluable patients (n=48). This result is encouraging compared to historical performance of standard-of-care regimens combining bevacizumab with FOLFOX chemotherapy from prior studies. Treatment responses in the ivonescimab 20 mg/kg arm were more durable than in the ivonescimab 10 mg/kg arm, with a duration of response landmark estimate at 9 months of 79.1% vs. 41.5%, respectively. While progression-free survival (PFS) analysis is still immature in this study, the landmark 9-month PFS rate was 76.1% for those patients receiving 20 mg/kg of ivonescimab.

The safety profile of ivonescimab combined with chemotherapy in this study is comparable to rates observed in historical studies with chemotherapy and anti-VEGF antibodies. In total including both arms, 20.4% of patients experienced serious treatment-related adverse events (TRAEs) associated with either ivonescimab or chemotherapy. There were no ivonescimab-related deaths and one ivonescimab-related discontinuation, supporting the tolerability and ability to manage adverse events.

“In this expansion cohort of treatment-naïve patients with metastatic colorectal cancer, the addition of ivonescimab to mFOLFOX6 delivered deep and durable response rates that compare favorably to historical benchmarks seen with chemotherapy alone or in combination with anti-VEGF therapies,” said David Berz, M.D., Ph.D., medical oncologist, Founder of Valkyrie Clinical Trials and an investigator in the AK112-206 study. “While progression-free survival remains immature, the high proportion of patients who were progression-free at nine months is encouraging, and the safety profile was consistent with established standards of care. These results support the potential of this dual-targeted approach to improve outcomes in this difficult-to-treat population and warrant further investigation.”

Ivonescimab continues to demonstrate an acceptable and manageable safety profile with no new safety signals observed in this study. This was consistent with previous studies of ivonescimab, including Phase II data in mCRC, and evidencing the potential for a favorable benefit-risk profile for ivonescimab plus mFOLFOX6 in this setting. In this study, adverse events were manageable: all patients experienced at least one treatment-emergent adverse event (TEAE) related to either ivonescimab or chemotherapy with the most common events on both dosing arms being decreased neutrophil count, decreased white blood cell count, and anemia.

“Metastatic colorectal cancer remains a significant area of unmet need, where many patients continue to face limited durable treatment options,” said Allen S. Yang, M.D., Ph.D., Chief R&D Strategy Officer of Summit. “These data add to the growing body of evidence supporting the potential of ivonescimab as a differentiated PD-1 / VEGF bispecific, and we are committed to advancing its development across multiple tumor types where we believe it may meaningfully improve patient outcomes.”

Summit is currently conducting HARMONi-GI3 (NCT07228832), a global Phase III clinical trial evaluating ivonescimab in combination with mFOLFOX6 chemotherapy compared with bevacizumab plus mFOLFOX6 chemotherapy in patients with first-line unresectable mCRC. This study is featured at this year’s ASCO Annual Meeting in a Trials-in-Progress (TiP) presentation entitled, “A Randomized, Active-Controlled Phase 3 Study of Ivonescimab + FOLFOX Versus Bevacizumab + FOLFOX as First-Line Treatment of Metastatic Colorectal Cancer: HARMONi-GI3.”

About Colorectal Cancer

Colorectal cancer (CRC), which includes cancers of the colon and rectum, is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related death, with approximately 1.9 million new cases and more than 900,000 deaths reported globally in 2022.1 In the U.S., CRC remains a significant health burden, with an estimated 158,850 new cases and 55,230 deaths projected in 2026.2 Prognosis is highly dependent on stage at diagnosis: while overall 5-year survival is approximately 65%, patients with metastatic disease have substantially poorer outcomes, with 5-year survival rates of approximately 13% for metastatic colon cancer and 18% for metastatic rectal cancer.2,3 These data underscore the urgent need for improved treatment options for patients with metastatic CRC (mCRC).

CRC is biologically heterogeneous, with tumors broadly classified based on microsatellite status. Approximately 80–85% of colorectal cancers are microsatellite stable (MSS), also referred to as mismatch repair–proficient (pMMR) tumors.4 MSS/pMMR colorectal tumors are typically characterized by lower tumor mutational burden and an immune-cold phenotype, with limited responsiveness to immune checkpoint inhibitors.5,6 In metastatic disease, they represent the overwhelming majority of cases, accounting for approximately 95% of tumors.5 As a result, most patients with mCRC are not eligible for currently approved immunotherapy monotherapies and are treated with chemotherapy-based regimens, often in combination with targeted therapies such as anti-VEGF and anti-EGFR agents.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third- generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering.

HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A, with a manageable safety profile in each study.

HARMONi-A was a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

About Summit Therapeutics Inc.

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol “SMMT”). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX.

References:

  1. World Health Organization. Colorectal cancer fact sheet. February 13, 2026. Accessed May 19, 2026.
  2. National Cancer Institute, Surveillance, Epidemiology, and End Results (SEER) Program. Cancer Stat Facts: Colorectal Cancer. Accessed May 19, 2026.
  3. American Cancer Society. Survival Rates for Colorectal Cancer (based on SEER 2014–2020 data). January 13, 2026. Accessed May 19, 2026.
  4. Colorectal Cancer Alliance. Microsatellite Stability Biomarker (MSS). Accessed May 19, 2026.
  5. Lieu CH. The use of immunotherapy in metastatic microsatellite-stable colorectal cancer. Hematol Oncol. 2022;20(12).
  6. Han YJ, Shao CY, Yao Y, et al. Immunotherapy of microsatellite stable colorectal cancer: resistance mechanisms and treatment strategies. Postgrad Med J. 2024;100:373–381.

Summit Forward-Looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.

Summit Investor Relations & Media Contacts:

Nathan LiaBraaten

Senior Director, Investor Relations

Tracy Jones

Director, Media & Public Relations

[email protected]

[email protected]

KEYWORDS: Florida Illinois United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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ENZAMET Trial Shows Veracyte’s Decipher Prostate Test Identifies Which Patients Benefit from Adding Chemotherapy in Metastatic Prostate Cancer

ENZAMET Trial Shows Veracyte’s Decipher Prostate Test Identifies Which Patients Benefit from Adding Chemotherapy in Metastatic Prostate Cancer

Study provides first Level 1B evidence for genomic-guided decisions on triplet therapy in advanced disease

Additional ASCO data reinforce Decipher Prostate’s utility in high-risk localized disease

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced results from the ENZAMET trial presented at the 2026 ASCO Annual Meeting. The analysis demonstrates that the Decipher Prostate test identifies which men with metastatic prostate cancer benefit from adding the chemotherapy docetaxel to standard hormonal therapy (ADT plus enzalutamide), known as triplet therapy, and who can safely avoid it, providing the first Level 1B 1 evidence for a genomic test guiding this decision. Complementary data presented at the meeting also reinforce Decipher Prostate’s clinical utility in high-risk localized disease.

Approximately 334,000 men are diagnosed with prostate cancer annually in the United States, including about 30,000 who present with metastatic disease at diagnosis.2, 3 While recent treatment advances have improved outcomes, clinicians still lack precision tools to guide chemotherapy decisions in this setting.

“For the first time, the ENZAMET trial analysis shows that a genomic test can guide the decision to add chemotherapy to standard of care hormonal therapy in metastatic prostate cancer,” said Prof. Christopher Sweeney, M.B.B.S., DHS., Lead Investigator, South Australian Immunogenomics Cancer Institute, Adelaide University. “Decipher Prostate identifies which patients benefit from treatment intensification, and which can be safely spared chemotherapy, giving clinicians an actionable, evidence-based answer.”

The ENZAMET findings build on prior validation in the STAMPEDE and CHAARTED trials, where Decipher Prostate identified patients most likely to benefit from adding docetaxel to ADT alone. ENZAMET advances that evidence with the first demonstration that the test predicts chemotherapy benefit when added to doublet therapy (ADT plus an ARPI).

Metastatic Disease: Identifying Which Men Benefit from Chemotherapy

The ENZAMET trial is an international, randomized Phase III study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Researchers performed a pre-specified biomarker analysis using the Decipher Prostate test in 634 patients to assess whether the test could predict benefit from adding chemotherapy to standard hormonal therapy with a median follow-up of 5.6 years.

Results showed:

  • Improved outcomes guided by Decipher Prostate: Patients with higher Decipher scores (>0.85) and high-volume disease who received triplet therapy had clinically meaningful better survival compared to those on standard hormonal therapy alone.
  • Patients can be spared from chemotherapy: Patients with lower Decipher scores showed no benefit from adding chemotherapy, suggesting it may be safely avoided.
  • Practice-changing evidence: The treatment-by-biomarker interaction was statistically significant (p=0.043), providing Level 1B evidence for the test’s predictive value.
  • Overcoming aggressive disease: Patients with higher Decipher scores who received triplet therapy had more aggressive disease features, yet achieved comparable survival to lower-risk patients on doublet therapy, suggesting chemotherapy offset the poor prognostic effects of aggressive disease biology.

Localized Disease: Identifying Which High-Risk Patients Need Treatment Intensification

Complementing the ENZAMET findings, a combined analysis of four mature NRG/RTOG trials presented at ASCO 2026 adds to Decipher Prostate’s growing body of evidence into high-risk localized prostate cancer.

Key findings include:

  • Improved prognostic accuracy: Decipher Prostate significantly improved prognostic accuracy for survival outcomes compared to clinical variables alone.
  • Refined risk classification: Combining NCCN clinical risk classification with Decipher Prostate reclassified approximately 1 in 4 patients.
  • Expanded population for treatment intensification: Results also show many more clinically high-risk patients may benefit from intensification with ARPI.

“Decipher Prostate is the most validated transcriptomic test across the full prostate cancer continuum – from active surveillance through metastatic disease,” said Elai Davicioni, Ph.D., Veracyte’s Medical Director, Urology. “For clinicians, that means a clearer answer at every decision point. For patients, it means greater confidence that their treatment is guided by the biology of their disease, and not guesswork.”

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company with a vision to transform cancer care for patients around the world. The company’s molecular tests assess the unique biology of each patient’s tumor to help clinicians answer essential questions about cancer care. Veracyte’s Diagnostics Platform combines broad genomic and clinical data, advanced bioinformatics and AI, and a powerful evidence-generation engine to support continued innovation and pipeline development. The company’s portfolio includes the Afirma® Genomic Sequencing Classifier test, Decipher® Bladder Genomic Classifier test, Decipher® Prostate Genomic Classifier test, Prosigna® Breast Risk of Recurrence test, and the TrueMRD™ Monitoring Test for MIBC. For more information, visit Veracyte’s website or follow the company on LinkedIn or X (Twitter).

About ANZUP

ANZUP is the leading cancer-cooperative clinical trials group that brings together all of the professional disciplines and groups involved in researching and treating urogenital cancers and conduct high quality cancer research. ANZUP’s mission is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers towards our vision of living life without fear of cancer. ANZUP identifies gaps in evidence and areas of clinical need, collaborates with the best clinicians and researchers in genitourinary cancer and communicates frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to statements regarding the potential clinical utility and benefits of Veracyte’s Decipher Prostate Test; the ability of Decipher Prostate to identify patients with metastatic prostate cancer who may benefit from treatment intensification, and those who may safely avoid such treatment; the extent to which results from the ENZAMET trial and other studies may influence clinical decision-making; the predictive and prognostic performance of Decipher Prostate across the prostate cancer continuum; and the adoption and use of Decipher Prostate in clinical practice. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” “ultimately,” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on February 26, 2026, as well as in other documents that we may file from time to time with the Securities and Exchange Commission. Copies of these documents, when available, may be found in the Investors section of our website at investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

References:

  1. Simon, R. M., Paik, S. & Hayes, D. F. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst101, 1446–1452 (2009). https://doi.org/10.1093/jnci/djp335
  2. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
  3. https://www.cdc.gov/united-states-cancer-statistics/publications/prostate-cancer.html

 

Investors:

Kelly Gura

[email protected]

Media:

Molly Cornbleet

[email protected]

+1 858-742-1258

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Managed Care Research Radiology Pharmaceutical Oncology Medical Devices Infectious Diseases Genetics Clinical Trials Science Biotechnology Nursing Health

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Incyte’s Pivotal frontMIND Trial Showed Tafasitamab (Monjuvi®/Minjuvi®) Combination Significantly Prolonged Progression-free Survival, Reducing the Risk of Disease Progression or Death by 25% in Patients with Previously Untreated, High-risk DLBCL

Incyte’s Pivotal frontMIND Trial Showed Tafasitamab (Monjuvi®/Minjuvi®) Combination Significantly Prolonged Progression-free Survival, Reducing the Risk of Disease Progression or Death by 25% in Patients with Previously Untreated, High-risk DLBCL

  • The Phase 3 frontMIND study evaluated tafasitamab (Monjuvi®/Minjuvi®) and lenalidomide in addition to R-CHOP, the current standard of care, compared with R-CHOP alone in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL)
  • Positive trends toward progression-free survival (PFS) benefit with tafasitamab and lenalidomide plus R-CHOP (Tafa-Len-R-CHOP) were observed acrossprespecified subgroups, including in patients with centrally confirmed lymphoma subtypes and both cell-of-origin (COO) molecular subtypes
  • The frontMIND data support the submission of global regulatory applications for tafasitamab and lenalidomide added to R-CHOP for previously untreated DLBCL
  • The data are being presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet*

WILMINGTON, Del.–(BUSINESS WIRE)–
Incyte (Nasdaq:INCY) today announced positive results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) versus R-CHOP alone as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Eligible patients had an International Prognostic Index (IPI) score of 3-5, or, for patients ≤60 years of age, an age-adjusted IPI (aaIPI) of 2-3.

The oral presentation of these data is taking place at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2, 2026, in Chicago (Abstract #LBA7000. Session: Oral Abstract Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia. May 30, 4:00 – 7:00 p.m. ET [3:00 – 6:00 p.m. CDT]) with simultaneous publication in The Lancet*.

“The Phase 3 frontMIND results mark a potential inflection point in the treatment of patients with previously untreated, high-risk DLBCL and HGBL, where outcomes have remained largely unchanged for decades,” said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development, Incyte. “These findings support Tafa-Len-R-CHOP as a potential new standard of care option in the first-line treatment of DLBCL, with benefit observed across both cell-of-origin (COO) molecular subtypes, and we look forward to advancing our global regulatory filings as we seek to bring this option to patients.”

The results build on previously reported topline data indicating the trial met its primary endpoint of progression-free survival (PFS) by investigator assessment.

The data demonstrate that Tafa-Len-R-CHOP resulted in a statistically significant and clinically meaningful improvement in PFS, with a 25% reduction in risk of disease progression or death among patients treated with Tafa-Len-R-CHOP compared with R-CHOP alone (HR 0.75 [P=0.0194]; 95% CI, 0.59–0.96; median follow-up of 35.2 months).

  • A PFS increase of 8.2% was seen at 2 years (71.1% with Tafa-Len-R-CHOP vs 62.9% with R-CHOP).

  • A PFS increase of 6.6% was seen at 3 years (67.3% with Tafa-Len-R-CHOP vs 60.7% with R-CHOP).

  • Additionally, point estimates suggested trends toward PFS advantage with Tafa-Len-R-CHOP are broadly consistent across prespecified subgroups, including patients with centrally confirmed lymphoma subtypes and across COO molecular subtypes (ABC [Activated B-cell-like] and GCB [Germinal Center B-cell-like]).

Treatment with Tafa-Len-R-CHOP also significantly improved the key secondary endpoint of event-free survival (EFS) compared to R-CHOP alone (HR 0.79 [P=0.0260] 95% CI, 0.64-0.97; median follow-up of 35.4 months). Additionally, interim overall survival (OS) analysis demonstrated a positive trend toward improvement (HR=0.85 [P=0.2703] 95% CI, 0.63–1.14, median follow-up of 35.9 months), with final analysis planned after additional follow-up.

“For years, R-CHOP has remained the standard first-line therapy for DLBCL, yet nearly 40% of patients experience disease progression or relapse after initial treatment, underscoring the need for innovation,” said Dr. Georg Lenz, University Hospital Münster and principal investigator of the frontMIND study. “The frontMIND study shows that adding tafasitamab and lenalidomide to R-CHOP improved outcomes, including in patients with high-risk disease, who have historically faced poor prognoses and limited treatment options. These results suggest that this regimen could help broaden the first-line treatment options for this patient population.”

Tafa-Len-R-CHOP was generally well tolerated, and safety was consistent with the expected safety profile of adding Tafa-Len to R-CHOP.

The most common treatment-emergent adverse events (TEAEs) in the Tafa-Len-R-CHOP group were neutropenia (70.7%), anemia (46.3%) and peripheral neuropathy (40.6%). Any grade TEAEs were similar in both treatment arms (98.6% vs 97.1%). More Grade ≥3 TEAEs occurred with Tafa-Len-R-CHOP (86.7%) vs R-CHOP alone (76.1%). The most common Grade 3 TEAEs in the Tafa-Len-R-CHOP group were anemia (22.8%), thrombocytopenia (13.1%) and neutropenia (12.4%). The most common Grade 3 TEAEs with R-CHOP alone were anemia (15.9%), febrile neutropenia (8.7%) and thrombocytopenia (6.7%).

Importantly, the incremental safety events observed with Tafa-Len-R-CHOP were well managed and did not interfere with the delivery of the R-CHOP backbone. Rates of TEAEs leading to discontinuation of all study treatment were similar between the two groups (5.2% for Tafa-Len-R-CHOP and 5.4% for R-CHOP alone). Although a higher rate of fatal TEAEs was observed with Tafa-Len-R-CHOP (5.9% vs 3.8% with R-CHOP), there were fewer overall deaths with Tafa-Len-R-CHOP (82 [18.5%]) compared to R-CHOP (97 [21.7%]), consistent with the positive trend observed in OS.

The frontMIND data support the submission of global regulatory applications for tafasitamab and lenalidomide in addition to R-CHOP for previously untreated DLBCL.

About Diffuse Large B-cell Lymphoma (DLBCL)

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases.1 It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin and brain.2 Each year, approximately 24,000 people in the U.S. and up to 36,000 people in Europe are diagnosed with DLBCL.3,4 With about 40% of these patients not responding to initial therapy or relapsing thereafter,5,6 there is a high medical need for new, effective therapies, particularly for high-risk patients.

About frontMIND

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).

The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP alone.

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).

For more information about the frontMIND trial, please visit https://www.clinicaltrials.gov/study/NCT04824092.

About Tafasitamab (Monjuvi®/Minjuvi®)

Tafasitamab (Monjuvi®/Minjuvi®) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency (EMA) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb® is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

  • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
  • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
  • Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

  • Feeling tired or weak

  • Diarrhea

  • Cough

  • Fever

  • Swelling of lower legs or hands

  • Respiratory tract infection

  • Decreased appetite

These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

  • Have an active infection or have had one recently.

  • Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

  • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

  • Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

About Incyte®

Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Incyte Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding whether and when tafasitamab may provide a successful treatment option for patients with DLBCL and HGBL, the potential and promise suggested by the Phase 3 frontMIND results, the potential for Tafa-Len-R-CHOP to become a new standard of care option in the first-line treatment of DLBCL, Incyte’s plans to advance its global regulatory filings for tafasitamab and Incyte’s aspirations and goals as set forth under the heading “About Incyte”.

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including Incyte’s ability to demonstrate the efficacy and safety of its products and product candidates; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

_________________________

*The Lancet publication is embargoed until 3:00 p.m. CT (4:00 p.m. ET) on Saturday, May 30. Post embargo link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00866-4/fulltext [thelancet.com]

1 Wang S. Epidemiology and etiology of diffuse large B-cell lymphoma. Semin Hematol. 2023 Nov;60(5):255-266.

2 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.

3 Chihara D, et al. Clin Lymphoma Myeloma Leuk. 2022;22(12):e1092-e1099.

4 GLOBOCAN 2020 Cancer Today.

5 Swerdlow SH, et al. Blood. 2016;127(20):2375-2390.

6 Kanas G, et al. Leuk Lymphoma. 2021;63:54-63.

 

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Tempus Introduces ‘Preview’: Bridging the Critical Time Gap Between Diagnostic Order and Definitive Results

Tempus Introduces ‘Preview’: Bridging the Critical Time Gap Between Diagnostic Order and Definitive Results

CHICAGO–(BUSINESS WIRE)–
Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced the introduction of Tempus Preview, an application providing rapid, clinically significant insights that close the gap between the time of order and delivery of insights. Representing a significant paradigm shift in precision oncology workflows, Tempus Preview offers preliminary results in the critical window between when a diagnostic test is ordered and when final sequencing results are delivered by surfacing key mutation predictions within approximately 24 hours of tissue receipt.

The initial days following an advanced cancer diagnosis are critical for strategic treatment planning, yet clinicians have traditionally been forced to operate in an information vacuum while awaiting comprehensive genomic profiling results. Tempus Preview fundamentally redefines this diagnostic timeline. By combining Tempus’ multimodal data and advanced AI capabilities applied directly to the earliest touchpoints of the laboratory workflow, Tempus equips care teams to access early, clinically significant, information that can help inform complex decisions for patients and shorten the time between receipt of final molecular results and implementation of a personalized treatment plan.

At launch, Tempus Preview will focus exclusively on high-impact biomarkers where early insights can be critical, including:

  • Surfacing patients more likely to harbor microsatellite instability (MSI-H), a biomarker linked to improved response to immune checkpoint inhibitors and potential hereditary risk factors, in colorectal, endometrial, prostate, and esophagogastric cancers.

  • Predicting EGFR mutations in non-small cell lung cancer (NSCLC), a biomarker that infers response to targeted therapy, but often lacks response to frontline immunotherapy.

  • Highlighting increased probability of potential rare, yet clinically significant FGFR fusions in hepatobiliary and bladder cancers, that may indicate potential response to targeted therapy and improved patient prognosis if gene fusions are present.

Shortly thereafter, Tempus Preview will expand to other critical biomarkers.

Tempus Preview’s biomarker predictions are powered by Paige Predict, an advanced AI model that analyzes standard H&E images to provide genomic insights. Paige Predict, trained on millions of slides, has been validated for clinical use as part of Tempus’ laboratory-developed test.

“At Tempus, our unique combination of a diagnostic lab and an advanced data platform enables us to build AI models powered by our unparalleled depth of real-world data,” said Eric Lefkofsky, Founder and CEO of Tempus. “That foundation creates a powerful flywheel: every insight strengthens our models, and every model helps generate more clinically meaningful insights for providers and patients. Tempus Preview brings this intelligence directly into the clinical workflow, delivering early, clinically relevant information within one day of sample receipt, which for many patients can mean the difference in how they are treated. This is our AI flywheel in action: transforming complex information into timely insights, delivered to physicians when they need them most.”

Additional details on Tempus Preview can be found here.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding potential impact of Tempus Preview. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: the intended use of Tempus’ products and services; Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Hanah Heintzelman

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TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate Cancer

TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate Cancer

  • First PARP inhibitor + ARPI combination to show consistent rPFS improvement in HRR gene‑altered metastatic hormone‑sensitive prostate cancer, including both BRCA and non‑BRCA alterations
  • There was an estimated 77% probability of remaining progression-free at three years with TALZENNA plus XTANDI
  • Detailed results from pivotal TALAPRO-3 study presented at ASCO 2026 and published in The New England Journal of Medicine

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced detailed results from the pivotal Phase 3 TALAPRO-3 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). These results will be presented today in a late-breaking oral presentation (Abstract LBA5007) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in TheNew England Journal of Medicine.

TALZENNA plus XTANDI demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus XTANDI (Hazard Ratio [HR] of 0.48; 95% Confidence Interval [CI], 0.36–0.65; p ˂ 0.0001). At three years, radiographic progression-free survival (rPFS) rates were estimated at 77% in patients treated with TALZENNA plus XTANDI versus 56% in patients treated with placebo plus XTANDI. With a median follow-up of over 37 months, median rPFS was not reached in the TALZENNA plus XTANDI arm and was 46 months with placebo and XTANDI.

The rPFS benefit observed with TALZENNA plus XTANDI was consistent across pre-specified groups with various patient and disease characteristics, including age, Gleason score, geographic region, prostate-specific antigen (PSA) level, and BRCA vs. non-BRCA HRR gene alteration status. At three years, rPFS rates were estimated at 77% vs. 49% in patients with cancer harboring BRCA alterations (HR, 0.37; 95% CI, 0.22–0.61) and 76% vs. 60% in patients with cancer with non-BRCA alterations (HR, 0.57; 95% CI, 0.39–0.82), compared with placebo plus XTANDI.

“Delaying progression to castration‑resistant disease, the most symptomatic and lethal phase of prostate cancer, remains a significant challenge to patients with mCSPC – especially to those with HRR gene alterations, who often experience poorer outcomes,” said Neeraj Agarwal, M.D., FASCO, Presidential Chair of Cancer Research at Huntsman Cancer Institute at the University of Utah and global lead investigator for TALAPRO-3. “With more than three years of follow‑up and median radiographic progression‑free survival not reached, TALZENNA plus XTANDI demonstrated durable disease control across a broad HRR‑altered population, including patients with BRCA and non‑BRCA alterations. These findings underscore the importance of genetic testing as part of routine care and highlight the potential for TALZENNA plus XTANDI to meaningfully improve the outcomes of patients with HRRm mCSPC.”

Interim overall survival (OS) results showed a strong trend toward improved OS, a key secondary endpoint, with median OS not reached in either treatment arm (HR, 0.77; 95% CI, 0.56–1.04; p = 0.09). TALZENNA plus XTANDI also improved time to PSA progression (HR, 0.51; 95% CI, 0.37–0.71; p < 0.0001) and time to subsequent anti-cancer therapy (HR, 0.51; 95% CI, 0.38–0.70; p < 0.0001) vs. placebo plus XTANDI. The trial remains ongoing, and OS will be formally assessed at the final analysis.

In TALAPRO-3, the safety profile of TALZENNA plus XTANDI was consistent with the known profiles of each agent, and no new safety signals were identified. The most common treatment-emergent adverse events (TEAEs) in the TALZENNA plus XTANDI group were anemia, fatigue, decreased neutrophil count, and asthenia. The most common grade 3 or higher TEAE was anemia, reported by 51% in the TALZENNA plus XTANDI group and 3% in the control group. Five percent of patients discontinued TALZENNA due to anemia. TEAEs were generally manageable with dose modifications and supportive care as needed.

“Men with HRR gene-mutated metastatic prostate cancer face significant challenges, with faster disease progression and limited treatment options, making it critical to intervene as early in the course of disease as possible,” said Jeff Legos, Chief Oncology Officer, Pfizer. “The benefit seen with TALZENNA plus XTANDI across a full spectrum of HRR gene alterations reinforces its potential to fundamentally change clinical practice, giving patients significantly more time before disease progression as compared to the current standard of care.”

Prostate cancer is the second most common cancer in men worldwide, with an estimated 1.5 million new cases diagnosed globally1 and 330,000 new cases anticipated in the United States in 2026.2 mCSPC is a form of advanced prostate cancer that has spread beyond the prostate but is still sensitive to androgen deprivation therapy.3 Approximately 5–10% of newly diagnosed cases are mCSPC,4,5 and up to 30% of these patients harbor HRR gene alterations.6

TALZENNA plus XTANDI in HRR gene-mutated mCSPC is an investigational treatment regimen. The results from TALAPRO-3 are being discussed with global health authorities to potentially expand the combination regimen’s existing indication. TALZENNA plus XTANDI is currently approved in more than 60 countries, including in the U.S. for adults with HRR gene-mutated mCRPC and in the European Union for adults with mCRPC in whom chemotherapy is not clinically indicated.

Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries.

About TALAPRO-3

The Phase 3 TALAPRO-3 trial is a multicenter, randomized, double-blind, placebo-controlled study that enrolled 599 patients with mCSPC (with ≤3 months of ADT [chemical or surgical] with or without an approved ARPI in the mCSPC setting) at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients with histologically/cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell, or signet cell features and with alterations in one or more HRR genes (as per HRR12 gene panel) in the trial were randomized to receive TALZENNA 0.5 mg/day plus XTANDI 160mg/day, or placebo plus XTANDI 160mg/day.

The primary endpoint of the trial is investigator-assessed rPFS, defined as the time from the date of randomization to radiographic progression in soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or in bone per Prostate Cancer Working Group 3 (PCWG3) criteria by investigator assessment, or death, whichever occurs first. Secondary endpoints include OS, objective response rate, duration of response, and patient-reported outcomes.

For more information on the TALAPRO-3 trial (NCT04821622), go to www.clinicaltrials.gov.

About TALZENNA® (talazoparib)

TALZENNA is an oral inhibitor of poly ADP-ribose polymerase (PARP), which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death.

TALZENNA was initially approved in the U.S., EU, and multiple other regions as a single agent for the treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative locally advanced or metastatic breast cancer.

TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023. The combination was also approved by the European Commission in January 2024 for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. TALZENNA in combination with XTANDI is approved in more than 60 countries, indications vary by country.

TALZENNA® (talazoparib) Indication in the U.S.

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:

HRR gene-mutated mCRPC:

  • In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Breast Cancer:

  • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.

TALZENNA® (talazoparib) Important Safety Information

WARNINGS and PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide. The durations of TALZENNA treatment in these 5 patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA.

Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 48%, 19%, and 9% of patients receiving TALZENNA and enzalutamide. Forty-two percent of patients (216/511) required a red blood cell transfusion, including 25% (127/511) who required more than one transfusion. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 8%, 3%, and 0.4% of patients.

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics.

Embryo-Fetal Toxicity TALZENNA can cause fetal harm when administered to pregnant women. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 4 months following the last dose of TALZENNA.

ADVERSE REACTIONS

Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).

The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%).

Clinically relevant adverse reactions in <10% of patients who received TALZENNA with enzalutamide included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%) and stomatitis (2%).

DRUG INTERACTIONS

Coadministration with P-gp inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor.

Coadministration with BCRP inhibitors Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions.

USE IN SPECIFIC POPULATIONS

Males of Reproductive Potential Based on animal studies, TALZENNA may impair fertility.

Renal Impairment The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 – 59 mL/min) is 0.35 mg taken orally once daily with enzalutamide. The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 – 29 mL/min) is 0.25 mg taken orally once daily with enzalutamide. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

Please see full U.S. Prescribing Information and Patient Information for TALZENNA® (talazoparib) at www.TALZENNA.com.

About XTANDI® (enzalutamide)

XTANDI (enzalutamide) is an androgen receptor pathway inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 80 countries, including in the United States, European Union and Japan. Over 1.5 million patients have been treated with XTANDI globally.7

About XTANDI® (enzalutamide) and Important Safety Information

XTANDI (enzalutamide) is indicated for the treatment of patients with:

  • castration-resistant prostate cancer (CRPC)

  • metastatic castration-sensitive prostate cancer (mCSPC)

  • nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)

Important Safety Information

Warnings and Precautions

Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.

Interference with Immunoassay Measurement of Digoxin XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving XTANDI and digoxin.

Adverse Reactions (ARs)

In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.

Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.

Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI. Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Please access this link for XTANDI’S US Full Prescribing Information for additional safety information.

About Pfizer Oncology

At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

About the Pfizer/Astellas Collaboration

In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI® (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

Disclosure Notice

The information contained in this release is as of May 30, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer Oncology, TALZENNA and XTANDI, including their potential benefits, the TALAPRO-3 results, and plans to discuss the results with global health authorities to potentially expand the TALZENNA indication, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of TALZENNA in combination with XTANDI;the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the TALAPRO-3 trial will meet the key secondary endpoint for overall survival; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for TALZENNA, XTANDI or a combination may be filed in any jurisdictions for any potential indications; whether and when any such applications for TALZENNA, XTANDI or a combination that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether TALZENNA, XTANDI or a combination will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of TALZENNA, XTANDI or a combination; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

References

  1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

  2. American Cancer Society. Key statistics for prostate cancer. Prostate Cancer Facts. Available at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html.Last accessed May 2026.

  3. Troy SP, Jakubowski CD, Gartrell BA. Packing the punch: Current and emerging treatment strategies in metastatic castration-sensitive prostate cancer. Curr Urol Rep. 2025;26(1):50. doi:10.1007/s11934-025-01272-6

  4. Freedland SJ, Hong A, El-Chaar N, et al. Survival benefit associated with first-line androgen receptor pathway inhibitors for de novo metastatic castration-sensitive prostate cancer. Prostate Cancer Prostatic Dis. 2026;179:167-174.

  5. Piombino C, Oltrecolli M, Tonni E, et al. De novo metastatic prostate cancer: Are we moving toward a personalized treatment? Cancers. 2023;15:4945.

  6. Olmos D, Lorente D, Jambrina A, et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Ann Oncol. 2025;36:1190-202. doi:10.1016/j.annonc.2025.05.534

  7. Data on file. Northbrook, IL: Astellas Inc.

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Immunome Announces Detailed Phase 3 RINGSIDE Data for Varegacestat in Adults with Progressing Desmoid Tumors at the 2026 ASCO Annual Meeting

Immunome Announces Detailed Phase 3 RINGSIDE Data for Varegacestat in Adults with Progressing Desmoid Tumors at the 2026 ASCO Annual Meeting

  • Varegacestat treatment resulted in statistically significant improvements in primary and all key secondary efficacy endpoints

  • Varegacestat demonstrated statistically significant improvement in worst pain intensity at week 12, with a clinically significant difference observed as early as the first evaluation at week 4

  • Progression-free survival benefit was consistent across prespecified patient subgroups, including tumor location, baseline tumor size, patient age and prior systemic desmoid tumor therapy

  • New Drug Application (NDA) for varegacestat submitted to the U.S. Food and Drug Administration (FDA) in April 2026, with Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) planned by the end of 2026

BOTHELL, Wash.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced detailed efficacy and safety results from RINGSIDE, the global, randomized, double-blind, placebo-controlled Phase 3 trial of varegacestat in patients with progressing desmoid tumors. The data are being presented today in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Immunome submitted an NDA for varegacestat to the FDA in April 2026.

“Desmoid tumors can be locally aggressive, painful and unpredictable, creating a high disease burden for patients and a continued need for new treatment options,” said Mrinal M. Gounder, M.D., sarcoma medical oncologist and drug development specialist at Memorial Sloan Kettering Cancer Center, and the RINGSIDE primary investigator who is presenting the data. “The RINGSIDE data show a compelling progression-free survival benefit with varegacestat that is consistent across relevant patient subgroups, complemented by a high response rate and reduction in tumor volume. The data also show a rapid, clinically meaningful reduction in worst pain intensity, which is an important element for patients. These findings confirm varegacestat could become standard of care in the treatment of desmoid tumors.”

“The detailed RINGSIDE data presented at ASCO reinforce varegacestat’s differentiated efficacy and manageable safety profile,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. “The depth and consistency of benefit observed across RINGSIDE point to varegacestat’s potential to deliver a meaningful advance for patients with desmoid tumors. These results form the basis for the NDA we submitted in April 2026 and the planned MAA submission for Europe.”

RINGSIDE Key Clinical Data Presented at 2026 ASCO Meeting

As previously reported, the RINGSIDE trial met its primary endpoint and all key secondary endpoints. Varegacestat demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs. placebo, with an 84% reduction in the risk of disease progression or death (hazard ratio [HR] = 0.16, 95% confidence interval [CI]: 0.071, 0.375; p<0.0001). The PFS benefit observed with varegacestat vs. placebo was consistent across key subgroups, including tumor location, baseline tumor size, patient age and prior systemic desmoid tumor therapy.

As previously reported, the confirmed objective response rate (ORR) based on RECIST v1.1 was 56% with varegacestat vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review. Among responders treated with varegacestat, median time to response was 8.2 months (range: 2.6–28.0 months) vs. 16.7 months (range: 8.1–30.2 months) for responders receiving placebo.

Varegacestat achieved a statistically significant improvement in change in worst pain intensity score at week 12, as assessed with the Gounder/Desmoid Tumor Research Foundation Desmoid Tumor Symptom/Impact scale. At week 12, patients treated with varegacestat experienced a mean change from baseline of -2.24 (standard error [SE]: 0.27) compared with +0.18 (SE: 0.27) for patients receiving placebo, for a treatment difference of -2.42 (SE: 0.37; p<0.0001). A clinically significant difference of more than 2 points was observed as early as the first evaluation at week 4.

Varegacestat achieved a statistically significant improvement in change in tumor volume at week 24, as assessed by blinded independent central review. At week 24, patients treated with varegacestat had a mean change from baseline of -109.6 (SE: 40.64) compared with +122.8 (SE: 42.72) for patients receiving placebo, for a treatment difference of -232.4 (SE: 57.39; p<0.0001). In a previously reported exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, also as assessed by blinded independent central review.

Varegacestat was generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor class. The most common adverse events for participants in the treatment arm as opposed to the placebo arm were diarrhea (82% vs. 27%), fatigue (44% vs. 23%), rash (43% vs. 12%), nausea (35% vs. 26%) and cough (34% vs. 5%). Most (95%) adverse events were grade 1 or 2. Among premenopausal women receiving varegacestat, 20 of 36 (56%) had ovarian toxicity adverse events, which resolved in 11 women (55%), and there were no discontinuations due to ovarian toxicity. Dose reductions due to treatment-emergent adverse events occurred in 80% of patients treated with varegacestat vs. 9% with placebo. Treatment discontinuations due to adverse events occurred in 20% of patients treated with varegacestat vs. 7% with placebo. The median exposure was 20.3 months for patients receiving varegacestat vs. 11.1 months for placebo.

Oral Presentation Details

Abstract Title

RINGSIDE: A phase 3 randomized, placebo-controlled trial of varegacestat for treatment of progressing desmoid tumors

Session Type/Title

Oral Abstract Session – Sarcoma

Date and Time

May 30, 2026, 5:00 p.m.–5:12 p.m. CDT

Presenter

Mrinal M. Gounder, M.D., Memorial Sloan Kettering Cancer Center

Abstract Number

11506

The slides from Dr. Gounder’s oral presentation will be available on the Immunome website in the “Presentations” page of the Investor Relations section.

Financial Disclosure

Dr. Gounder has financial interests related to Immunome.

About the RINGSIDE Trial

The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (ClinicalTrials.gov Identifier: NCT04871282) evaluated the efficacy and safety of varegacestat in patients with progressing desmoid tumors. A total of 156 patients were randomized to receive varegacestat 1.2 mg daily or placebo until disease progression or death, representing the largest randomized study in this population. The primary endpoint of the trial was progression-free survival as assessed by blinded independent central review. Statistically controlled secondary endpoints were confirmed ORR using RECIST v1.1 and change in tumor volume at week 24, both determined by blinded independent central review, as well as change in pain intensity at week 12 as determined using a patient-reported outcome instrument. Additional secondary endpoints included duration of response, best reduction in tumor volume, patient-reported outcomes, and safety and tolerability. RINGSIDE includes an open-label extension phase, which is ongoing.

About Desmoid Tumors

Desmoid tumors (also known as aggressive fibromatosis or desmoid-type fibromatosis) are aggressive non-metastatic soft tissue tumors that are prone to recurrence. Approximately 1,000-1,650 people are diagnosed with desmoid tumors each year in the United States, and there are approximately 10,000-11,000 actively managed patients. Those affected face debilitating pain, deformity and, in some cases, life-threatening organ damage. The chronic pain and physical limitations associated with desmoid tumors lead to a high clinical burden and impaired quality of life. Although desmoid tumors are not considered cancerous, they often require systemic treatment to prevent permanent disability and alleviate disease burden.

About Varegacestat

Varegacestat (formerly AL102) is an investigational, oral, once-daily gamma secretase inhibitor. In December 2025, Immunome reported positive topline results for the Phase 3 RINGSIDE trial of varegacestat in adults with progressing desmoid tumors. Immunome submitted an NDA to the FDA for varegacestat in April 2026 and plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “advance,” “anticipate,” “if warranted,” “potential,” “plan,” “expect,” and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding: Immunome’s expected timing for submitting an MAA to the EMA by the end of 2026; the potential for varegacestat to become an important treatment option; Immunome’s efforts to bring medicine to patients; the potential of Immunome’s targeted oncology therapies to be first-in-class or best-in-class therapies; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that initial clinical results may not be indicative of subsequent results; the risk that Immunome’s NDA submission for varegacestat is delayed based on regulatory feedback or otherwise, and that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions, including the risk that the results of Immunome’s trials for varegacestat may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of varegacestat; the risks associated with the potential safety and other complications from varegacestat; the labelling for varegacestat, if approved; the scope, progress and expansion of developing and commercializing varegacestat, if approved; the size and growth of the market for varegacestat and the rate and degree of its market acceptance; the risk that Immunome will not be able to realize the benefits of its strategic transactions; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and advance its pipeline and successfully execute on its business plan; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission on May 12, 2026. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.

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Replimune Presents 3-Year Landmark Overall Survival Analysis from IGNYTE Clinical Trial During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting

WOBURN, Mass., May 30, 2026 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented 3-year landmark overall survival data from the IGNYTE clinical trial of RP1 plus nivolumab in patients with anti-PD-1 failed melanoma during an oral session at the 2026 American Society of Clinical Oncology annual meeting.

“The overall survival analysis from IGNYTE shows that nearly half of all treated patients in the study were alive at three years, including 83.5% of responders to RP1 plus nivolumab,” said Kostas Xynos, MD, PhD, MBA, Chief Medical Officer of Replimune. “This represents a durable benefit that is rarely seen in anti-PD-1-failed melanoma, a setting with historically limited treatment options.”

Key findings are detailed below.

Oral Presentation: A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial; Date/Time: May 30, 2026, 5:30 PM CDT; Location: E451; Abstract: 9518; Presenter: Michael Wong, MD, PhD

  • RP1 (vusolimogene oderparepvec) plus nivolumab achieved a median overall survival (mOS) of 32.9 months in patients with anti–PD-1–failed advanced melanoma, a population with limited treatment options.
  • At 3 years, 47.8% of all treated patients remained alive, rising to 83.5% among responders, underscoring the depth and durability of the treatment’s benefit.
  • The objective response rate (ORR) was 33.6%, with a median duration of response (DOR) of 24.8 months; 44.8% of responders maintained their response at 3 years.
  • Meaningful survival benefit was observed across all key patient subgroups, including those with varying disease stage, PD-L1 expression status, prior anti–CTLA-4 therapy, and primary or secondary anti–PD-1 resistance.
  • The combination continued to demonstrate a favorable and manageable safety profile over long-term follow-up, with predominantly Grade 1–2 constitutional side effects, no Grade 5 events, and no new safety signals identified.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

Forward Looking Statements

This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about dthe status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

Investor Inquiries

Chris Brinzey
ICR Healthcare
339.970.2843
[email protected]

Media Inquiries

Arleen Goldenberg
Replimune
917.548.1582
[email protected]