Damora Starts DMR-001 Phase 1/1b After First Approval
The company received health-authority clearance in the first country and is completing additional DMR-001 filings in the second half of 2026 to expand the trial globally.
Damora Therapeutics (DMRA) initiated its Phase 1/1b trial of DMR-001 in patients with essential thrombocythemia and myelofibrosis after receiving health-authority approval in the first country, converting a mid-2026 submission plan into an active first-in-human study.
The biopharmaceutical company, which develops antibodies against mutant calreticulin in myeloproliferative neoplasms, plans to complete additional regulatory submissions for DMR-001 in the second half of 2026 to expand the trial globally and enable two proof-of-concept readouts beginning mid-2027. The trial uses an adaptive Bayesian design with a 100 mg once-monthly subcutaneous starting dose, and the company plans to initiate expansion cohorts next year in multiple ET and MF patient populations. Subject to those results, it plans to start Phase 3 development of DMR-001 as early as mid-2028.
On April 28, 2026, Damora exercised the Paragon Option to obtain an exclusive worldwide license to DMR-002, its second mutCALR candidate, after already holding that license for DMR-001 since December 2025. It still holds the option on DMR-003, a mutCALR and CD3 bispecific T-cell engager. The company plans first regulatory submissions for DMR-002 in the second half of 2026 and for DMR-003 in 2027.
At the European Hematology Association 2026 Congress, Damora presented preclinical data for DMR-001 against an internally generated reference antibody. DMR-001 showed 26-fold greater inhibition of cell proliferation in Type 2 mutCALR and a 5-fold longer half-life in non-human primates, with a 15-day NHP half-life versus 3.1 days for the reference. Predicted dosing is subcutaneous and monthly rather than intravenous every two weeks. Those comparisons are preclinical and may not predict results in humans.
Research and development expenses tied to Paragon services were $5.8 million for the three months ended June 30, 2026, down from $17.0 million in the three months ended March 31, 2026. For the six months ended June 30, 2026, those Paragon-related R&D costs were $17.8 million. The company expects research and development expenses to increase substantially for the foreseeable future as programs advance into clinical development.
During the three and six months ended June 30, 2026, Damora sold an aggregate of 1,240,400 shares under its at-the-market program at $24.16 a share for net proceeds of $29.3 million, after reporting no ATM sales in the three months ended March 31, 2026. The ATM agreement, entered February 10, 2026 and amended August 10, 2026, allows sales of up to $150.0 million. In February, the company also closed an underwritten offering of 16,644,737 shares at $19.00 a share, including full exercise of the underwriters’ option, for net proceeds of about $295.5 million. The proceeds will be used to advance preclinical studies, clinical trials and manufacturing, as well as for working capital.
On March 10, 2026, the company changed its name from Galecto, Inc. to Damora Therapeutics, Inc. On July 16, 2026, it redomesticated from Delaware to the Cayman Islands, remaining a U.S. corporation for Internal Revenue Code purposes.
The company believes there is at least a $5 billion addressable U.S. market for mutCALR-driven ET and MF, with CALR mutations driving about a quarter of ET cases and about 35% of MF cases. It is developing DMR-001, an Fc-null antibody, DMR-002, an afucosylated antibody, and DMR-003, a bispecific T-cell engager, to cover the full spectrum of mutCALR-driven MPNs.