On November 3, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported that five abstracts – one oral and four poster presentations – have been accepted for presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting, to be held December 6-9, 2025 in Orlando, FL. The data feature new clinical and translational analyses of RYTELO (imetelstat) across lower-risk myelodysplastic syndromes/neoplasms (LR-MDS) and myelofibrosis (MF).

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"The ASH (Free ASH Whitepaper) 2025 presentations reflect growing scientific momentum around imetelstat and telomerase inhibition," said Joseph E. Eid, M.D., Executive Vice President, Research and Development and Chief Medical Officer of Geron. "Across multiple analyses, we continue to see evidence of imetelstat’s potential to deliver durable and biologically meaningful outcomes in both lower-risk MDS and myelofibrosis. We look forward to presenting these data and continuing to inform physicians and patients on the benefits of RYTELO."

Accepted Presentations

Oral Presentation (LR-MDS)

Abstract #490: Correlation between Treatment-Emergent Cytopenias and Clinical Response with Imetelstat (IME) in Patients (Pts) with Lower-Risk Myelodysplastic Syndromes (LR-MDS): Analysis from the IMerge Trial
Presenter : Amer Zeidan, MBBS, MHS, Chief of the Division of Hematologic Malignancies and Professor of Medicine at Yale University
Presentation Date and Time: December 7, 2025, 10:00-10:15 AM ET
"In hematology, the emergence of cytopenias can reflect a therapy’s biological activity within the bone marrow," said Amer Zeidan, Chief of the Division of Hematologic Malignancies and Professor of Medicine at Yale University. "Our analysis explores how early treatment-emergent cytopenias with imetelstat are on target and may relate to clinical response, helping to inform how we interpret treatment patterns and patient management in this setting. Together with other studies being presented at ASH (Free ASH Whitepaper), these findings continue to build a deeper scientific understanding of telomerase inhibition and its relevance in myeloid malignancies."

Poster Presentation (LR-MDS)

Publication #2074: Long-Term Outcomes from Randomized, Double-Bind, Placebo-Controlled, Phase 3 IMerge Trial of Imetelstat for Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Presenter: Valeria Santini, M.D., Associate Professor of Hematology at the University of Florence Medical School
Session Date and Time: December 6, 2025, 5:30 PM – 7:30 PM ET
This abstract evaluates long-term follow-up data from the IMerge trial, which is the foundation of imetelstat’s approval in the U.S. and EU. Although the 42-month landmark analysis was not pre-specified, the totality of the data and the results of an overall survival OS analysis (≥42 months) suggest a favorable trend for imetelstat in OS, progression-free survival and time to progression to AML, compared to placebo.

Poster Presentations (MF)

Publication #5585: Correlation between Interleukin (IL)-8 and Tumor Necrosis Factor (TNF)-Alpha Levels and Overall Survival in Patients (Pts) with Myelofibrosis (MF) Relapsed or Refractory (R/R) to a Janus-Associated Kinase Inhibitor (JAKi) Treated with Imetelstat (IME) in the IMbark Trial
Presenter: John Mascarenhas, M.D., Professor of Medicine at the Icahn School of Medicine at Mount Sinai
Session Date and Time: December 8, 2025, 6:00 PM – 8:00 PM ET
This abstract is a new exploratory analysis using data from the Phase 2 IMbark trial of imetelstat in relapsed/refractory MF. This hypothesis-generating analysis identified dose-dependent reductions in specific inflammatory cytokines with imetelstat from baseline which, taken together with previously presented data, suggests potential disease-modifying activity in MF.

Publication #2052: IMproveMF: Phase 1b Trial of Imetelstat Plus Ruxolitinib in Patients with Intermediate-2 or High-Risk Myelofibrosis
Presenter: John Mascarenhas, M.D., Professor of Medicine at the Icahn School of Medicine at Mount Sinai
Session Date and Time: December 6, 2025, 5:30 PM – 7:30 PM ET
This abstract is sharing the trial design for the expansion portion of the IMproveMF Phase 1b trial of imetelstat and ruxolitinib in high-risk MF. The first treatment visit has occurred, and enrollment is ongoing.

Poster Presentation (Investigator Sponsored: HR-MDS and AML)

Publication #5115: A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients with Advanced Myelodysplastic Neoplasms or AML Failing HMA-based Therapy: Interim Analysis Results of the IMpress Study
Presenter: Lionel Ades, M.D., Ph.D., Professor of Hematology, Paris University – Hospital Saint-Louis
Session Date and Time: December 8, 2025, 6:00 – 8:00 PM ET
This abstract presents interim results from an investigator-led study exploring imetelstat in high-risk MDS. The results suggest that imetelstat has limited single agent activity in this group, with one patient remaining on study.

Dr. Zeidan has served as a consultant for Geron and has received honoraria. The views expressed in this press release and in the presentation are his own and do not necessarily reflect those of his employer.

(Press release, Geron, NOV 3, 2025, View Source [SID1234659257])

On November 3, 2025 Genmab A/S (Nasdaq: GMAB) reported that more than 20 abstracts evaluating epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, across lines of therapy and B-cell non-Hodgkin’s lymphoma (NHL) subtypes, will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), in Orlando, Florida, and online, December 6-9.

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Data from the epcoritamab development program will showcase its expanding clinical profile and potential utility in earlier lines of therapy with a fixed treatment duration. Presentations include three oral sessions supporting the potential of epcoritamab in the first- and second-line setting in patients with follicular lymphoma (FL) and two oral presentations evaluating epcoritamab in the first-line setting in patients with diffuse large B-cell lymphoma (DLBCL). Additionally, two oral presentations will summarize the efficacy and safety of epcoritamab as monotherapy and in combination for patients with Richter transformation (RT).

"The breadth and depth of data evaluating epcoritamab at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting spotlight the growing body of clinical evidence supporting the potential of epcoritamab and underscore our commitment to developing epcoritamab as a potential core therapy across a range of B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We look forward to sharing our data at ASH (Free ASH Whitepaper), including the full pivotal results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma."

2025 R&D Update and ASH (Free ASH Whitepaper) Data Review
On Thursday, December 11 at 11:00 a.m. ET/5:00 p.m. CEST, Genmab will host its 2025 R&D Update and ASH (Free ASH Whitepaper) Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

All abstracts accepted for presentation have been published and may be accessed on the ASH (Free ASH Whitepaper) website. The following abstracts evaluating epcoritamab have been accepted for presentation at ASH (Free ASH Whitepaper):

Oral Presentations

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
63 Vitolo et al., Fixed-duration epcoritamab monotherapy induces high response and MRD-negativity rates in elderly patients with newly diagnosed large B-cell lymphoma (LBCL) and comorbidities: results from EPCORE DLBCL-3 Oral December 6, 9:30 – 11:00 AM (Presentation: 10:00 AM – 10:15 AM)

64 Cheah et al., Epcoritamab + R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL: results from the EPCORE NHL-2 trial Oral December 6, 9:30 – 11:00 AM (Presentation: 10:15 – 10:30 AM)
464* Merryman et al., Rituximab and epcoritamab as first-line therapy for patients with high-tumor burden follicular lymphoma: Results of a multicenter phase II trial Oral December 7, 9:30-11:00 AM
(Presentation: 9:45 – 10:00 AM)
465 Leslie et al., Epcoritamab with rituximab + lenalidomide (R2) and epcoritamab maintenance deliver deep and durable remissions in previously untreated (1L) follicular lymphoma (FL): 3-year outcomes from EPCORE NHL-2 arms 6 and 7 Oral December 7, 9:30 – 11:00 AM (Presentation: 10:00 – 10:15 AM)
466 Falchi et al., Primary phase 3 results from the EPCORE FL-1 trial of epcoritamab with rituximab and lenalidomide (R2) versus R2 for relapsed or refractory follicular lymphoma Oral December 7, 9:30 AM – 11:00 AM (Presentation: 10:15 – 10:30 AM)
1015 Thompson et al., Epcoritamab combinations demonstrate promising efficacy in patients (pts) with Richter transformation (RT): first results from arms 2B (epcor + lenalidomide [LEN]) and 2C (epcor + R-CHOP) of the phase 1b/2 EPCORE CLL-1 trial Oral December 8, 4:30 – 6:00 PM (Presentation: 4:30 – 4:45 PM)
1017 Kater et al., Epcoritamab monotherapy demonstrates promising efficacy in patients with Richter transformation (RT): 2-year follow-up results from arm 2A of the phase 1b/2 EPCORE CLL-1 trial Oral December 8, 4:30 – 6:00 PM (Presentation: 5:00 – 5:15 PM)

*Investigator-led trial

Poster Presentations

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
1820 Noorani et al., Optimal dose of epcoritamab in combination with lenalidomide and rituximab in relapsed or refractory follicular lymphoma – analysis of pharmacokinetics and exposure-response relationships of EPCORE FL-1 phase 3 study Poster December 6, 5:30 – 7:30 PM
1955 Falchi et al., Fixed-duration epcoritamab + R-CHOP in patients with newly diagnosed DLBCL and high IPI scores (3-5) led to sustained remissions and disease-free survival beyond 3-years: results from the EPCORE NHL-2 trial Poster December 6, 5:30 – 7:30 PM
1959 Torres Lopez et al., Outpatient administration of epcoritamab monotherapy for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL): results from the EPCORE NHL-6 by race and ethnicity Poster December 6, 5:30- 7:30 PM
1960 Thieblemont et al., Epcoritamab (epcore) monotherapy offers long-term disease control in large B-cell lymphoma (LBCL): NHL-1 subgroup analysis in patients with prior chimeric antigen receptor T-cell (CAR T) therapy from the 3-year follow-up Poster December 6, 5:30 – 7:30 PM
2721 Park et al., Barriers to receiving CAR T-cell treatment among patients with non-Hodgkin lymphoma who were deemed eligible for CAR T-cell therapy Poster December 6, 5:30 – 7:30 PM
3565 Robinson et al., Phenotype and functional state of endogenous T-cells support T-cell engager therapy in the post-CAR T setting Poster December 7, 6:00 – 8:00 PM
3566 Takacs et al., Exposure to epcoritamab is associated with improved T-cell functionality and dynamic changes in CD8+ T-cells in diffuse large B-cell lymphoma: insights from EPCORE NHL-6 Poster December 7, 6:00 – 8:00 PM
3736 Brody et al., Epcoritamab + GemOx achieves durable >2-year remissions in relapsed/refractory (R/R) 2L+ diffuse large B-cell lymphoma (DLBCL): long-term data reinforce clinical potential of the regimen across a diverse patient population Poster December 7, 6:00 -8:30 PM
4481 Xavier et al., Underreporting of prognostic factors in real-world studies for bispecifics in relapsed or refractory diffuse large B-cell lymphoma Poster December 7, 6:00 – 8:00 PM
5511 Cheah et al., Durable responses in patients with large B-cell lymphoma and 3+ prior lines of therapy who either paused or discontinued epcoritamab monotherapy while in complete response Poster December 8, 6:00 – 8:00 PM
5513 Karimi et al., Sustained remissions beyond 4 years with epcoritamab monotherapy: long-term follow-up results from the pivotal EPCORE NHL-1 trial in patients with relapsed or refractory large B-cell lymphoma Poster December 8, 6:00 – 8:00 PM
5357 Vitolo et al., Fixed-duration epcoritamab in combination with bendamustine + rituximab (BR) for first-line (1L) treatment of follicular lymphoma (FL): 3-year results from EPCORE NHL-2 arm 3 demonstrate deep and durable responses with manageable safety Poster December 8, 6:00 – 8:00 PM
5370 Linton et al., HRQoL in relapsed/refractory follicular lymphoma patients treated with epcoritamab in combination with rituximab plus lenalidomide (E+R2): primary results of patient-reported outcomes from the EPCORE FL-1 trial Poster December 8, 6:00 – 8:00 PM
5393 Strati et al., EPCORE FL-2 phase 3 trial of epcoritamab with rituximab and lanalidomide (R2) vs chemoimmunotherapy (CIT) in previously untreated follicular lymphoma (FL): trial in progress Poster December 8, 6:00 – 8:00 PM

e-Publications

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
7251 Johnson et al., Epcoritamab monotherapy provides superior efficacy vs non-anthracycline-containing regimens in newly diagnosed elderly DLBCL patients deemed unsuitable for anthracycline-containing regimens: a match-adjusted comparative efficacy analysis Publication NA
7942 Graff et al., Operational efficiencies and cost savings of using one bispecific antibody FDA-approved for both R/R 3L+ DLBCL and FL Publication NA
8075 Ali et al., Effectiveness of epcoritamab in a heterogeneous population with relapsed/refractory diffuse large B-cell lymphoma including post-chimeric antigen receptor T-cell therapy patients: insights from the real-world epcoritamab patient characteristics and outcomes research (Real-EPCOR) study Publication NA
The safety and efficacy of epcoritamab have not been established for these investigational uses.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, NOV 3, 2025, View Source [SID1234659256])

On November 3, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it will present new and updated data for CAR T-cell therapy candidate, GLPG51011, at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, FL, December 6-9, 2025.

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Two abstracts, including one oral presentation, will feature new and updated Phase 2 data in relapsed/refractory mantle cell lymphoma (R/R MCL) and R/R large B-cell lymphoma (R/R DLBCL) for GLPG5101, Galapagos’ proprietary cell therapy candidate in R/R non-Hodgkin lymphoma (NHL). Galapagos will also host a company showcase, titled: Fast, Fresh, Fit: Unlocking the Potential of Cell Therapy through a Transformative, Scalable, and Accessible Approach to Impact More Patients Globally.

"We are excited to present promising new clinical data for our CD19 CAR T-cell therapy candidate in R/R mantle cell lymphoma and diffuse large B-cell lymphoma, two indications with high unmet medical need," said Omotayo Fasan, MBBS, MRCP, Clinical Development Program Head, Oncology. "The data continue to support the hypothesis that the rapid delivery of fresh, fit, early-memory enriched CAR-T cells could improve outcomes for patients."

The data to be presented are summarized below:

The oral presentation on GLPG5101, Galapagos’ CD19 CAR-T candidate, will feature new and updated Phase 2 data in patients with high-risk R/R MCL. The results demonstrate high rates of complete response and minimal residual disease negativity, and durable responses, with low rates of severe grade toxicities (cut-off date: September 2, 2025).
The poster presentation on GLPG5101, Galapagos’ CD19 CAR-T candidate, will feature new and updated Phase 2 data in R/R DLBCL. The data demonstrate high complete response rates, a low dropout rate, and mainly low-grade toxicities in patients with R/R DLBCL (cut-off date: September 2, 2025).
The oral and poster presentations demonstrate the feasibility of the manufacturing platform, enabling rapid delivery of fresh, early-memory enriched CAR T-cell products with a median vein-to-vein time of seven days. The data show robust in-vivo expansion, durable persistence, high complete response rates, and a low incidence of high-grade toxicities, supporting outpatient administration.
The dates and times for the accepted abstracts are as follows:

Abstract title Authors (Presenter) Presentation date/time
Galapagos-driven original abstracts
High complete response rates and minimal residual disease (MRD) negativity, with durable responses, in high-risk mantle cell lymphoma (MCL) with GLPG5101, a fresh, early memory-enriched CAR T-cell therapy with a 7-day vein-to-vein time: Results from the ATALANTA-1 MCL cohort Marie José Kersten, Joost S.P. Vermaat, Pim G.N.J. Mutsaers, Maria T. Kuipers, Evelyne Willems, Sébastien Anguille, Tim J.A. Dekker, Caron Jacobson, Michael R. Bishop, Peter Vandenberghe, Guillaume Dachy, Andreas Klein, Jon Arnason, Stavros Milatos, Chiara Lobetti-Bodoni, Eva Santermans, Sandra Blum, Kirsten Van Hoorde, Maike Spoon, Omotayo Fasan, and Martin Dreyling Oral presentation number: 662
Date: Sunday, December 7, 2025
Time: 4:45 pm – 5:00 pm EST (session 4:30 – 06:00 EST)
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological – Novel Treatments for and Insights into Mantle Cell Lymphoma
Location: OCCC – Tangerine Ballroom F2

High complete response rates, low dropout rate, and low-grade toxicities in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) receiving GLPG5101, a fresh, early memory-enriched CAR T-cell therapy with a 7-day vein-to-vein time: Results from the ATALANTA-1 DLBCL cohort  Joost S.P. Vermaat, Pim G.N.J. Mutsaers, Sébastien Anguille, Maria T. Kuipers, Evelyne Willems, Tim J.A. Dekker, Peter Vandenberghe, Guillaume Dachy, Caron Jacobson, Michael R. Bishop, Martin Dreyling, Andreas Klein, Jon Arnason, Stavros Milatos, Harini Kothari, Daniela Buglio, Sandra Blum, Leonardo Chicaybam, Eva Santermans, Omotayo Fasan, and Marie José Kersten Poster presentation number: 5940
Date: Monday, December 8, 2025
Time: 06:00 pm – 08:00 pm EST
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Location: OCCC – West Halls B3–B4

Galapagos company showcase
Omotayo Fasan – VP, Clinical Development Program Head, Oncology Date: Saturday, December 6, 2025
Time: 1:30 pm – 1:45 pm EST
Location: Room W208AB – Level 2 – Orange County Convention Center (West Building)
About GLPG5101 and ATALANTA-1 (EudraCT 2021-003272-13; NCT 06561425)

GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are currently being evaluated in the ATALANTA-1 Phase 1/2 study in eight hematological malignancies with high unmet need. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×106 (DL1), 110×106 (DL2) and 250×106 (DL3) CAR+ viable T-cells. The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response Rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe.

(Press release, Galapagos, NOV 3, 2025, View Source [SID1234659255])

On November 3, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the Company generated revenue of $851 million for the third quarter ended September 30, 2025, compared to $709 million for the same period of 2024.

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"Exact Sciences continues to advance our mission to prevent cancer and detect it earlier through a relentless focus on patients," said Kevin Conroy, chairman and CEO. "Our third quarter results reflect the power of our patient-centric platform and our trusted brands, Cologuard and Oncotype DX. The momentum we are building is fueling growth, advancing innovative new tests like Cancerguard, and strengthening our financial performance."

Third quarter 2025 financial results

For the three-month period ended September 30, 2025, as compared to the same period of 2024 (where applicable):

Total revenue was $851 million, an increase of 20% on a reported and core revenue basis
Screening revenue was $666 million, an increase of 22%
Precision Oncology revenue was $184 million, an increase of 13%
Gross margin was 69%, and adjusted gross margin was 71%
Net loss was $20 million, or $0.10 per share, an improvement of $19 million and $0.10 per share, respectively
Adjusted EBITDA was $135 million, an increase of $37 million or 37%, and adjusted EBITDA margin was 16%, an increase of 200 basis points
Operating cash flow was $220 million and free cash flow was $190 million, an increase of 59% and 69%, respectively,
Cash, cash equivalents, and marketable securities were $1.00 billion at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

Platform and pipeline advancements

In September 2025, Exact Sciences launched its Cancerguard multi-cancer early detection (MCED) test as a laboratory-developed test. Cancerguard is the first multi-cancer early detection test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited. The test is supported by data from robust test-development studies, such as DETECT-A and ASCEND 2, involving more than 20,000 participants, including the first-ever prospective interventional MCED trial. The Company brings the test to patients in the United States through its large commercial organization and unique ExactNexusTM technology platform.

To support patient access to Cancerguard, the Company recently announced an agreement with Quest Diagnostics to enable blood collection at the company’s approximately 7,000 patient access sites across the U.S., including through its patient service centers and in-office phlebotomists in provider offices, as well as mobile phlebotomy services for at-home collections.

2025 outlook

The Company has updated its full-year 2025 revenue and adjusted EBITDA guidance:

Prior guidance

November 3 update

Change at midpoint

Y/Y growth rate

Total revenue

$3.130 – $3.170 billion

$3.220 – $3.235 billion

$77.5 million

17%

Screening

$2.440 – $2.470 billion

$2.510 – $2.520 billion

$60.0 million

20%

Precision Oncology

$690 – $700 million

$710 – $715 million

$17.5 million

9%

Adjusted EBITDA

$455 – $475 million

$470 – $480 million

$10.0 million

47%

Third-quarter 2025 conference call & webcast

Company management will host a conference call and webcast on Monday, November 3, 2025, at 5 p.m. ET to discuss third-quarter 2025 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608. A replay of the webcast will be available at exactsciences.com. The webcast, conference call, and replay are open to all interested parties.

(Press release, Exact Sciences, NOV 3, 2025, View Source [SID1234659254])

On November 3, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported its R&D pipeline with the addition of EVX-04, an AI-designed precision cancer vaccine candidate. We will pursue clinical development of EVX-04, currently in preclinical development, as a new therapeutic vaccine against acute myeloid leukemia (AML).

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EVX-04 is designed to target non-conventional ERV (endogenous retrovirus) tumor antigens from the dark genome. These antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines.

Leveraging our proprietary AI-Immunology platform, Evaxion has identified ERV antigens in patient tumor sequencing data. Uniquely, the platform then selects optimal fragments from these antigens based on their potential to be effective vaccine targets across a wide range of patients.

By including multiple of these fragments in EVX-04, the vaccine is designed to be effective in all patients regardless of immune and tumor ERV antigen differences. This makes EVX-04 a so-called "off-the-shelf" vaccine preproduced and ready for immediate administration after diagnosis.

"We are very excited to select a lead candidate for our ERV-based precision cancer vaccine concept. Representing a completely novel approach, EVX-04 is a great example of how AI-Immunology enables us to design and develop new therapies that could lead to better outcomes for patients. This approach could enable broader use of cancer vaccines, including for patients who do not respond to conventional immunotherapies," says Birgitte Rønø, CSO and interim CEO of Evaxion.

New data to be presented at ASH (Free ASH Whitepaper) Meeting
New preclinical data demonstrates that EVX-04 induces strong T-cell responses and kill cancer cells. The data will be presented at an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Florida on December 6, 2025.

"The ASH (Free ASH Whitepaper) meeting is a fantastic opportunity for us to present the data and introduce EVX-04 to both scientists, doctors and potential business partners. We are thrilled to have been selected to do an oral presentation and are looking very much forward to share and discuss the data and concept," says Birgitte Rønø.

Presentation details
Abstract Title: Dark genome interrogation identifies novel antigens in acute myeloid leukemia – developing an off-the-shelf vaccine from machine learning to clinic
Abstract#: #278
Session: Emerging Tools, Techniques, and Artificial Intelligence in Hematology: MRD Assays and Novel Drug Discovery Pipelines
Location: Hyatt – Regency Ballroom R
Date/Time: December 6, 2025, at 2:00pm ET/20:00 CET
Presenter: Rasmus Villebro, Bioinformatics Manager at Evaxion

About ERVs
ERVs are remnants of ancient viruses lying dormant in our genome. ERVs are often overexpressed in cancer but not in healthy tissue, making them visible to the immune system and hence promising targets for cancer vaccines. AI-Immunology is crucial in allowing the identification of therapeutically relevant ERV tumor antigens from genomic patient tumor data.

About AML
AML is an aggressive hematologic malignancy characterized by the clonal expansion of undifferentiated myeloid precursor cells (AML blasts) in the bone marrow. The malignant proliferation leads to suppression of normal hematopoiesis, resulting in cytopenia, increased
susceptibility to infections, bleeding, and fatigue (Döhner et al. 2022).

If left untreated, the disease is fatal, often within weeks to months, with patients typically succumbing to infections within weeks to months.

(Press release, Evaxion Biotech, NOV 3, 2025, View Source [SID1234659253])