DMR-001 / Damora Therapeutics - LARVOL DELTA

Discovery and Characterization of DMR-001, an Fc-Null, Half-Life–Optimized Monoclonal Antibody Selectively Targeting Mutant Calreticulin (SOHO 2026) - "DMR-001 is a potent, selective mutCALR-targeted mAb with activity across both major CALR mutation subtypes and demonstrates the potential to treat patients with MPNs using infrequent subcutaneous dosing. These data support the initiation of clinical trials with DMR-001 as a differentiated therapeutic candidate for patients with essential thrombocythemia or myelofibrosis. CALR: calreticulin, Fc: fragment crystallizable, KD: dissociation constant, mAb: monoclonal antibody, STAT3: signal transducer and activator of transcription 3, STAT5: signal transducer and activator of transcription 5, t1/2: half-life, TpoR: thrombopoietin receptor."

Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • CALR • MPL • STAT5

Anticipated Milestones (GlobeNewswire) - "DMR-002 (Fc enhanced, half-life extended anti-mutCALR monoclonal antibody): first regulatory submission expected in the second half of 2026; DMR-003 (T-cell engager anti-mutCALR/CD3 bispecific antibody): first regulatory submission expected in 2027; Two clinical proof-of-concept datasets for DMR-001 (Fc null, half-life extended anti-mutCALR monoclonal antibody) anticipated beginning mid-2027."

CALR • IND • New trial • Myeloproliferative Neoplasm

Presented DMR-001 preclinical data at the EHA 2026 Congress (Abstract PF873), highlighting its best-in-class potential. (GlobeNewswire) - "In head-to-head preclinical studies versus a reference anti-mutCALR antibody, DMR-001 showed up to 30-fold higher binding affinity for mutCALR, 26-fold greater inhibition of cellular proliferation in Type 2 mutCALR, and five-fold longer half-life in non-human primates. Based on these data, DMR-001 is predicted to have robust activity across mutCALR subtypes with convenient once-monthly subcutaneous dosing."

CALR • Preclinical • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm

Damora Therapeutics, Inc…announced the initiation of the global Phase 1/1b CLARITY-101 clinical trial of DMR-001, an investigational monoclonal antibody therapy designed to selectively target mutant calreticulin (mutCALR), in patients with mutCALR-driven essential thrombocythemia (ET) and myelofibrosis (MF), based on receipt of health authority approval. (The Manila Times) - "Damora continues to expect to report initial data from the trial beginning mid-2027."

CALR • P1 data • Trial status • Essential Thrombocythemia • Myelofibrosis

DISCOVERY AND CHARACTERIZATION OF DMR-001, AN FC-NULL, HALF-LIFE OPTIMIZED MONOCLONAL ANTIBODY SELECTIVELY TARGETING MUTANT CALRETICULIN (EHA 2026) - "Summary/Conclusion DMR-001 is a potent, selective mutCALR-targeted mAb with activity across both major CALR mutation subtypes and demonstrates the potential to treat patients with MPNs using infrequent subcutaneous dosing. These data support the initiation of clinical trials with DMR-001 as a differentiated therapeutic candidate for patients with ET and MF."

Cardiovascular • Essential Thrombocythemia • Fibrosis • Hematological Disorders • Hematological Malignancies • Immunology • Myelofibrosis • Myeloproliferative Neoplasm • Thrombocytosis • Thrombosis • CALR • MPL • STAT5

Anticipated Milestones (GlobeNewswire) - "Damora anticipates the following upcoming milestones across its mutCALR programs...: (i) DMR-002: first regulatory submission expected in the second half of 2026; (ii) DMR-003: first regulatory submission expected in 2027; (iii) Two clinical proof-of-concept datasets for DMR-001 anticipated beginning mid-2027."

CALR • Clinical data • IND • Essential Thrombocythemia • Myelofibrosis

Program Updates (GlobeNewswire) - "On track to make the first regulatory submission for DMR-001 in mid-2026 enabling the initiation of a global Phase 1/1b trial in patients with mutCALR-driven ET and MF patients. The Phase 1/1b trial is designed to rapidly identify a recommended dose and initiate expansion cohorts in multiple ET and MF patient populations....DMR-001 preclinical data abstract accepted for presentation at the upcoming 2026 European Hematology Association (EHA) Congress....Presented data are expected to highlight potency, half-life and anti-mutCALR activity in preclinical models, showcasing the best-in-class potential of DMR-001."

CALR • IND • New P1 trial • Preclinical • Essential Thrombocythemia • Myelofibrosis

The company plans to file IND or CTA submissions for DMR-001 in mid-2026 and start a Phase 1 trial in ET and MF, with proof‑of‑concept readouts expected beginning mid‑2027. (StockTitan.net) - "The company plans to file IND or CTA submissions for DMR-001 in mid-2026 and start a Phase 1 trial in ET and MF, with proof‑of‑concept readouts expected beginning mid‑2027."

CALR • IND • New P1 trial • Essential Thrombocythemia • Myelofibrosis

Damora anticipates the following upcoming milestones across its mutCALR programs (GlobeNewswire) - "Submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) or a clinical trial application (CTA) to a regulatory authority in another country for DMR-001 in mid-2026; Submit an IND or CTA for DMR-002 in the second half of 2026; Submit an IND or CTA for DMR-003 in 2027; Present two clinical proof-of-concept datasets for DMR-001 beginning mid-2027."

CALR • IND • New trial • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm

Galecto Announces Name Change to Damora Therapeutics with Mission to Fundamentally Redefine Care for Patients with Blood Disorders (GlobeNewswire) - "Combined with gross proceeds of approximately $316 million from the Company’s recently closed public offering in February 2026, Damora plans to rapidly advance its pipeline of mutant calreticulin (mutCALR)-targeted therapeutics in essential thrombocythemia (ET) and myelofibrosis (MF), beginning with lead program DMR-001....The Company’s additional anti-mutCALR pipeline therapies, DMR-002 and DMR-003, enable portfolio optionality to address the full spectrum of patients with mutCALR-driven MPNs."

CALR • Financing • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm

DMR-001, a potentially best-in-class mutant calreticulin (“mutCALR”) targeting monoclonal antibody, on track for IND submission in mid-2026 with anticipated first-in-human dosing via subcutaneous administration (GlobeNewswire) - "...Ph1 clinical proof-of-concept data for DMR-001 anticipated in 2027."

CALR • First-in-human • IND • P1 data • Essential Thrombocythemia • Myelofibrosis

An IND submission for DMR-001, with anticipated first-in-human administration via subcutaneous administration, is expected to occur in mid-2026 (GlobeNewswire)

CALR • First-in-human • IND • Essential Thrombocythemia • Myelofibrosis

Galecto Announces Acquisition of Damora Therapeutics (GlobeNewswire) - "The acquisition gives the combined company a pipeline covering a broad spectrum of hematological cancers and leverages the deep expertise of both teams, and positions Galecto to advance Damora’s complementary assets for people living with blood cancers....The private placement resulted in gross proceeds to Galecto of approximately $284.9 million and is expected to fund operations into 2029, enabling advancement of Damora’s lead program, DMR-001, through key Phase 1 proof-of-concept data expected in 2027, as well as pipeline programs, DMR-002 and DMR-003, into Phase 1 studies."

M&A • P1 data • Essential Thrombocythemia • Myelofibrosis