Evaxion to present new data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia, at the EHA 2026 Congress

On May 12, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, will report the functional characterization of EVX-04, an off-the-shelf therapeutic acute myeloid leukemia (AML) vaccine, in a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress taking place in Stockholm, Sweden, June 11-14, 2026.

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The new preclinical data will represent another step towards clinical testing of EVX-04. Evaxion plans to submit a clinical trial application in the second half of 2026.

"We are happy with the progression of the EVX-04 program and are looking forward to sharing new data at the EHA (Free EHA Whitepaper) 2026 Congress, one of the most important events in the hematology field. This will be a great opportunity for us to discuss the data and development plans for EVX-04 with both scientific experts and potential business partners," says Birgitte Rønø, CSO & COO of Evaxion.

Presentations details:
Abstract title: Preclinical characterization of EVX-04, an AI-designed off-the-shelf cancer vaccine targeting endogenous retroviral antigens in acute myeloid leukemia
Poster#: PS2306
Session: Poster session 2
Date/Time: June 13, 2026, at 18:45-19:45 CET/12:45-13:45 ET
Presenter: Søren Vester Kofoed, Research Scientist at Evaxion

About EVX-04
Developed with our AI-Immunology platform, EVX-04 targets non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome. These antigens are selectively expressed in specific tumors but absent in normal tissue, making them highly attractive therapeutic cancer targets.

Using sequencing data from AML patients, our AI-Immunology platform first identified ERV tumor antigens and then mined these to determine smaller fragments with the potential for immune recognition. From the five million ERV antigens fragments discovered, AI-Immunology combined and selected 16 optimal sets of ERV fragments based on their cross-patient relevance and immunogenic potential. All 16 ERV fragments included in EVX-04 elicit a specific immune response and EVX-04 prevents tumor growth in preclinical tumor models.

The data-driven target selection ensures that EVX-04 provides broad tumor coverage regardless of immune and tumor ERV antigen differences across patients. Thus, EVX-04 is developed as an off-the-shelf vaccine preproduced and ready for immediate administration after diagnosis. The same concept is broadly applicable across cancers where immunotherapies remain inadequate and conserved immunogenic antigens can be identified.

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).

AML is the most frequent leukemia. It occurs across all age groups; however, it is predominantly a disease observed in older adults with a median age at diagnosis of 68 years.

Approximately 50% of AML patients are considered fit for intensive chemotherapy and stem cell transplantation. This combination is associated with a long-term overall survival rate of only 40% in younger patients and less than 10% in fit older patients.

For the approximately 50% not fit for intensive treatment, typically the elderly, the standard of care is low-intensity chemotherapy. Remissions are, however, short lived with a 3‐year overall survival rate at only 25% reported (Kantarjian et al. 2025).

(Press release, Evaxion, MAY 12, 2026, View Source [SID1234665536])

Enterome presents Phase 2 indolent non-Hodgkin lymphoma data at EHA showing EO2463 induces B cell target-specific CD8 T-cell expansion correlating with clinical outcomes

On May 12, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-target in vivo immune therapies shown to induce a rapid, long-lasting and potent expansion of specific memory T-cells to fight cancer, reported it will present highly encouraging data for its lead OncoMimics immunotherapy EO2463 in indolent NHL at the Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.

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OncoMimics closely mimic tumor-associated antigens (TAAs) of solid tumors, or cell lineage markers in B cell malignancies. Clinical data from the ongoing SIDNEY Phase 2 trial show that EO2463 rapidly induced therapeutically relevant levels of target-specific CD8 T-cells via in vivo expansion that correlate with clinical efficacy. Given that the levels of EO2463 and B cell target specific CD8 T-cells correlate with objective tumor responses, these measures have the potential to be developed as predictive biomarkers.

"The data presented in this abstract further strengthen confidence in EO2463 as a unique treatment-candidate for indolent NHL across different disease settings. It is exciting that EO2463 induced expansions of specific CD8 T-cells – which is easily measured – can be envisioned as potential biomarkers for clinical outcomes for patients treated with EO2463," said Jan Fagerberg, Chief Medical Officer at Enterome.

"EO2463 is particularly well-suited for patients in the watch-and-wait setting, who are currently being monitored, but usually do not receive any other treatment. EO2463 is well-tolerated, easy to administer and has shown robust tumor-specific immunogenic activity, as well as clear monotherapy objective responses in clinical testing. We are actively engaged in the regulatory process to further advance the candidate drug into a Phase 3 registrational trial," said Pierre Belichard, Chief Executive Officer of Enterome.

While patients in the watch-and-wait setting often have visibly swollen lymph nodes, no treatment other than watchful waiting is indicated under the current standard of care, as long as there are no troublesome symptoms. Nevertheless, these patients often are understandably anxious about their disease, which usually progresses.

Details of the poster presentation:

Abstract: PF938
Title: EO2463 (EO) an off-the-shelf multi-target peptide immunotherapy: in vivo CD8 T-cell expansion kinetics correlates with efficacy in patients (pts) with follicular (FL) and marginal zone (MZL) lymphoma
Presenting Author: Jose Caetano (JC) Villasboas, MD Mayo Clinic
Session date: 12 June 2026
Presentation time: 1845 CEST

Indolent non-Hodgkin lymphoma, is a group of difficult to treat chronic conditions with relapses – such as follicular lymphoma and marginal zone lymphoma – characterized by slow progression and few symptoms, and reduced life expectancy. It is usually diagnosed by the appearance of swollen lymph nodes, and the early stages of the disease can be characterized by a lack of troublesome symptoms such as night sweats, fever or weight loss. There is a widespread consensus among leading investigators on the need for a well-tolerated and effective monotherapy to stop or slow progression for patients in the watch-and-wait setting.

EO2463 is an innovative, off-the-shelf OncoMimics active immunotherapy that combines four synthetic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or cell linage markers (e.g. as observed in B cell lymphomas). These antigens induce a fast and potent in vivo expansion of cytotoxic memory CD8 T-cells, primed by gut bacteria, and cross-reactive with TAAs/B cell markers. Because the peptides are "non-self", OncoMimics avoid the self-tolerance that limits many cancer immunotherapies to enable rapid, potent, and durable responses to tumors. The synthetically produced peptides are designed in silico, mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

(Press release, Enterome, MAY 12, 2026, View Source [SID1234665535])

Disc Medicine Announces Multiple Presentations Across Portfolio at the European Hematology Association (EHA) 2026 Congress

On May 12, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported that it will present data from multiple programs in its hematology portfolio, including an oral presentation of data from the RALLY-MF phase 2 trial of DISC-0974 in anemia of myelofibrosis (MF), at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, which will be held in Stockholm, Sweden on June 11-14, 2026.

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"We look forward to presenting an update from our RALLY-MF trial at EHA (Free EHA Whitepaper), highlighting consistently strong anemia response rates across MF subpopulations and background therapies" said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "We will also present updates on our EPP program, including new data from the HELIOS open label extension study of bitopertin in EPP and data from the European cohort of the EPP LIGHT survey, ahead of the expected readout of the APOLLO Phase 3 trial of bitopertin in EPP later this year."

The oral presentation of data from the Phase 2 RALLY-MF study in patients with anemia of MF will cover N=61 patients with data through April 27, 2026. At the time of the abstract deadline, there were N=43 evaluable patients. Major response rates among evaluable patients at the abstract cutoff were 54% (15/28) for the non-transfusion dependent cohort, 67% (6/9) for the lightly transfused (TD Low) cohort, and 50% (3/6) for the heavily transfused (TD High) cohort. Overall response (major response + minor response) was 70%, with similar response regardless of concomitant JAK inhibitor therapy. Additional data and analyses will be included in the presentation at EHA (Free EHA Whitepaper).

Management will host a call following the EHA (Free EHA Whitepaper) meeting to review highlights of the presented data and next steps for the company on Monday, June 15 at 8:00am EDT. Please register for the event on the Events and Presentations page of Disc’s website (View Source).

Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.

Details of Presentations and Abstracts:

DISC-0974 Oral Presentation:

Abstract Number: S306
Abstract Title: RALLY-MF: Initial efficacy of a phase 2 study of DISC-0974, an anti-hemojuvelin antibody, to treat anemia in myelofibrosis
Session Title: S430 From erythropoiesis to transfusion practice
Session Details: Friday, June 12 (5:15pm – 6:30pm CEST / 11:15am – 12:30pm EDT)
Presenting Author: Naseema Gangat, M.B.B.S.

Bitopertin Abstracts:

Abstract Code: PS2394 (Poster Presentation)
Abstract Title: Additional safety and efficacy results from HELIOS: A phase 2, open-label, long-term extension study of bitopertin in erythropoietic protoporphyria
Session Details: Saturday, June 13 (6:45pm – 7:45pm CEST / 12:45pm – 1:45pm EDT)
Presenting Author: Amy Dickey, M.D., MSc

Abstract Code: PB4415 (Publication Only)
Abstract Title: Erythropoietic protoporphyria life impact and genetic health trajectory (EPP LIGHT) study: a cross-sectional survey of adults and adolescents in Europe

DISC-3405 Abstract:

Abstract Code: PF909 (Poster Presentation)
Abstract Title: RESTORE-PV – a phase 2 open-label study evaluating the safety and efficacy of the anti-TMPRSS6 monoclonal antibody DISC-3405 in participants with polycythemia vera
Session Details: Friday, June 12 (6:45pm – 7:45pm CEST / 12:45pm – 1:45pm EDT)
Presenting Author: Naseema Gangat, M.B.B.S.

(Press release, Disc Medicine, MAY 12, 2026, View Sourcenews-releases/news-release-details/disc-medicine-announces-multiple-presentations-across-3 [SID1234665534])

Delcath Systems to Participate at the H.C. Wainwright 4th Annual BioConnect Investor Conference

On May 12, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that management will be attending the H.C. Wainwright 4th Annual BioConnect Investor Conference on Tuesday, May 19, 2026 at Nasdaq in New York, NY.

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(Press release, Delcath Systems, MAY 12, 2026, View Source [SID1234665533])

Curis Provides First Quarter 2026 Business Update

On May 12, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported its business update and financial results for the quarter ended March 31, 2026.

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Operational Highlights

TakeAim Lymphoma

Emavusertib is currently undergoing testing in combination with the Bruton’s tyrosine kinase inhibitor (BTKi) ibrutinib in the TakeAim Lymphoma Phase 1/2 open-label, single arm expansion trial in patients with Relapsed or Refractory (R/R) Primary CNS Lymphoma (PCNSL) (CA-4948-101, NCT03328078). Patient enrollment in this study is currently ongoing. As a result of discussions with FDA and EMA, the ongoing phase 1/2 study is intended to support filings for accelerated approval of emavusertib in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both FDA and EMA in PCNSL.
TakeAim CLL

Emavusertib is also being tested in the recently initiated open label TakeAim CLL Phase 2 clinical trial of emavusertib in combination with the BTKi zanubrutinib in patients with Chronic Lymphocytic Leukemia (CLL) (CA-4948-203, NCT07271667). The goal of combining emavusertib with a BTKi is to enable a dual blockade of NF-kB, a key driver of disease in CLL and NHL, by inhibiting both the TLR and BCR pathways. The current standard of care is the use of BTK inhibitors, which block the BCR pathway and can deliver high response rates, though typically only partial responses. Previous clinical studies have shown that adding emavusertib, which blocks the TLR pathway, to a BTKi regimen can enable patients with NHL to achieve deeper responses, including complete remission or undetectable minimal residual disease (MRD) and the potential for time-limited treatment, outcomes which represent the potential for a paradigm shift in the management of CLL.
Solid Tumors

Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis, presented a poster with initial clinical data in gastric and esophageal cancer at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2026. In this study, patients are treated with emavusertib in combination with FOLFOX and anti-PD1 +/- trastuzumab as first-line therapy for metastatic or unresectable gastroesophageal cancers. The poster titled A phase I trial of emavusertib (CA-4948) in combination with FOLFOX/ PD-1 inhibitor +/- trastuzumab as first-line treatment for untreated unresectable gastric and esophageal cancer showed results for 16 evaluable patients demonstrating a manageable toxicity profile and encouraging preliminary results.
Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis will have an abstract titled A phase I trial of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC) available online at View Source on May 21, 2026 at 5:00 PM EDT.
Upcoming Milestones

Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL combination study with zanubrutinib by mid-2026, with data expected in December 2026.
Also, the Company expects updated emavusertib clinical data from the TakeAim Lymphoma combination study with ibrutinib in patients with R/R PCNSL in the first half of 2027.
Corporate

On January 9, 2026, the Company announced the closing of a private placement (the "January 2026 PIPE Financing") with gross proceeds of up to $80.8 million, including initial gross proceeds of approximately $20.2 million with three series of warrants (A, B, and C) which can be exercised for up to $20.2 million each according to the terms and conditions of the financing agreement. All three series of warrants are exercisable at $0.75 per share, subject to conditions defined in the financing agreement with respect to the Series B warrants, and have the following termination conditions:

Series A warrants terminate on January 8, 2031;
Series B warrants terminate 30 days after the Company announces dosing of the fifth patient in the Phase 2 clinical trial in CLL, subject to conditions defined in the financing agreement; and
Series C warrants terminate on July 8, 2027.
First Quarter 2026 Financial Results

For the quarter ended March 31, 2026, Curis reported a net loss of $24.2 million, or $1.25 per share on both a basic and diluted basis, as compared to a net loss of $10.6 million, or $1.25 per share on both a basic and diluted basis in 2025.

There were no revenues for the quarter ended March 31, 2026 due to the sale of Erivedge royalties to Oberland in the fourth quarter of 2025. Revenues, net were $2.4 million for the quarter ended March 31, 2025, comprising royalty revenues from Genentech and Roche’s net sales of Erivedge.

Research and development expenses were $6.4 million and $8.5 million for the quarters ended March 31, 2026 and 2025, respectively. The decrease was primarily attributable to lower employee related and manufacturing costs.

General and administrative expenses were $5.1 million and $4.0 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was primarily attributable to expenses associated with the January 2026 PIPE Financing, partially offset by lower employee related costs.

Other expense, net was $12.7 million and $0.5 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was attributable to the change in fair value of the warrant liability associated with the January 2026 PIPE Financing, partially offset by no expense related to the sale of future royalties in 2026.

As of March 31, 2026, Curis’s cash and cash equivalents totaled $15.0 million, and the Company had approximately 40.0 million shares of common stock outstanding.

Cash Runway Guidance

Curis believes its cash and cash equivalents as of March 31, 2026 of $15.0 million, together with anticipated gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE Financing Series B Warrants upon the public announcement of dosing the 5th CLL patient in our TakeAim CLL study expected later this year, should enable the Company’s planned operations into the second half of 2027.

Conference Call Information

Curis management will host a conference call today, May 12, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed here on the Curis website in the Investors section.

(Press release, Curis, MAY 12, 2026, View Source [SID1234665532])