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])

On November 3, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that it has secured a $30 million funding commitment from Yorkville Advisors Global.

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Under the terms of the agreement, CytoDyn has the right to sell, and Yorkville has the obligation to purchase up to $30 million worth of CytoDyn’s common stock over the next 36 months. CytoDyn, at its sole discretion, will control the timing of all sales of common stock to Yorkville, and there are no warrants, derivatives, or other share classes associated with the funding arrangement. CytoDyn is not obligated to utilize any of the $30 million available, there are no minimum commitments or minimum use penalties, and the arrangement does not impose any restrictions on the Company’s operating activities.

"This funding commitment from Yorkville is a solid step in the right direction for CytoDyn," said Robert E. Hoffman, CFO of CytoDyn. "We will utilize this underlying commitment to further develop our program centered around the ability of leronlimab to upregulate PD-L1. This type of discretionary arrangement allows us continued flexibility as we look to bring in additional capital, whether it be through additional financings or strategic partnerships."

For more information on the funding commitment secured from Yorkville, including key terms and conditions of the agreement, please see CytoDyn’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed on November 3, 2025.

(Press release, CytoDyn, NOV 3, 2025, View Source [SID1234659252])

On November 3, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported new clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Updated data will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 6-9 in Orlando, Florida, as an oral presentation on Monday, December 8, at 11:45 a.m. ET.

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"AML is among the largest hematology indications for which a T cell engager is not available, so we are pleased to share new data for CLN-049 that demonstrate compelling potential for patients with relapsed or refractory AML, a population that urgently needs new treatment options," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "As detailed in the abstract, initial results from our Phase 1 study showed clinically meaningful anti-leukemic activity, including complete responses, with a composite complete response (CRc) rate of 31% at the highest dose level explored thus far. Importantly, responses were also observed regardless of baseline genetic risk, even among patients with TP53-mutated AML where prognosis is notably poor. In the broad population of patients with relapsed or refractory AML and MDS assessed, the safety profile was manageable. These initial results demonstrate CLN-049’s broad potential to offer a potent, flexible, and differentiated therapeutic strategy. We look forward to sharing updated data at ASH (Free ASH Whitepaper)."

"AML remains a devastating and poor prognosis disease with fragmented treatment options, particularly for relapsed or refractory patients," said Mohammad Maher Abdul Hay, MD, Director, Clinical Leukemia Program, Perlmutter Cancer Center, and Director, Blood & Marrow Transplantation and Cellular Therapy Program, NYU Langone Health. "CLN-049 has the potential to be widely applicable to a broad population because it targets the extracellular domain of both mutated and non-mutated FLT3, expressed on malignant blasts in more than 80% of patients with AML. These initial results point to the potential of a FLT3-directed T cell engager to expand treatment options for patients through a unique approach, and are especially encouraging from the dose escalation phase of an ongoing study."Oral Presentation Details

Title: Preliminary Anti-leukemia Activity from A Phase 1 Study of CLN-049, a Novel Anti-FLT3 x Anti-CD3 Bispecific T-Cell Engager, in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Menin Inhibitors and FLT3 Inhibitors in AML
Session Date: December 8, 2025
Session Time: 10:30 a.m.-12:00 p.m. ET

Room: OCCC – Chapin Theater (320)

Publication Number: 768

Efficacy Results

As of the June 2025 data cutoff, 40 patients (34 AML, 6 MDS) were enrolled without regard to FLT3 cell surface expression across 7 cohorts (target dose range 1.5-12 μg/kg), and 29 patients with AML were efficacy evaluable (≥1 response assessment). Patients with AML had received a median of 2 prior therapies (range: 1-8).

For AML, response was assessed using ELN 2022 criteria. Efficacy endpoints include complete response (CR) rate, composite complete response (CRc) rate (CR/CRi/CRh), and overall response rate (ORR) (CRc + MLFS + PR).

CLN-049 achieved promising anti-leukemic activity in this heavily pretreated AML population:

•
Anti-leukemic activity was observed at target doses ≥6 μg/kg (n=23, all AML), with a CRc rate of 30%, and ORR of 57%.
•
At the highest target dose studied thus far of 12 μg/kg (n=13), CRc rate was 31% and ORR was 69%.
•
In 9/23 patients achieving bone marrow blasts <5%, 33% (n=3) patients were MRD negative by flow cytometry; relapse was not observed in MRD-negative patients, and 1 patient has remained on study for >6 months.
•
Responses were observed in patients with AML regardless of baseline genetic risk. Notably, among 5 patients with TP53-mutated AML treated at 12 μg/kg, 4 responses (2 CRh, 2 MLFS) were observed.

Dose escalation continues in this ongoing Phase 1 study.

Safety Results

As of the June 2025 data cutoff, the data indicate a manageable safety profile in a broad population of patients with r/r AML and MDS (n=40):

•
The most common treatment-emergent adverse events (TEAEs) included cytokine release syndrome (CRS) (40%), infusion-related reaction (35%), and febrile neutropenia, pneumonia, stomatitis, white blood cell count decrease (17.5% each).
•
All CRS events were limited to Grade 1 or 2; the majority occurred after a step-up dose (SUD) or target dose 1. One case of Grade 1 ICANS was reported in association with Grade 2 CRS after a 6 μg/kg SUD. Neither CRS nor ICANS led to treatment discontinuation.

•
Grade ≥3 TEAEs occurring in >10% of patients included febrile neutropenia, white blood cell count decrease (17.5% each), and pneumonia (12.5%).
Live and Virtual Investor Event

Cullinan Therapeutics will host an in-person event for analysts and institutional investors on Monday, December 8, at 8:00 p.m. ET, during which David Sallman, MD, Associate Member, Myeloid Section Head, Moffitt Cancer Center & Research Institute, will participate in a discussion of the CLN-049 data shared at the 2025 ASH (Free ASH Whitepaper) Annual Meeting and Exposition with members of Cullinan Therapeutics management. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, MD, MBA, Chief Medical Officer.

Investors and analysts are invited to register to attend in person by emailing Nick Smith, Head of Investor Relations ([email protected]). A webcast will be available via the events page of the Company’s investor relations website at View Source

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 bispecific T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common form of acute leukemia in adults.1,2 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.3 Each year in the U.S., approximately 22,000 people are diagnosed with AML, and about half as many lives are lost to the disease.4 Globally, AML affects an estimated 144,000 people annually, with approximately 130,000 deaths.

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.4,6 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.7,8 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.8 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.