Earnings

Damora Starts DMR-001 Trial and Licenses Two Assets

The Tip Desk · November 10, 2026 · 4 min read

The company booked $7.2 million of Paragon-related research and development expense in the three months ended September 30, 2026, as it opened CLARITY-101 and locked in worldwide rights to two antibody programs.

Damora Therapeutics (DMRA), a clinical-stage biotech developing antibody therapies for mutant calreticulin-driven blood cancers, initiated its Phase 1/1b CLARITY-101 trial of lead candidate DMR-001 in essential thrombocythemia and myelofibrosis patients in the third quarter of 2026 after receiving health-authority approval in Australia, and has since received FDA clearance to begin the trial in the United States.

The prior quarter had said only that the trial had been initiated with approval in the first country. Patient enrollment is ongoing. The company said it has submitted and plans to submit additional regulatory applications for DMR-001 in the fourth quarter of 2026 to expand the trial to additional geographies and enable two proof-of-concept readouts beginning mid-2027. Expansion cohorts are planned for 2027 in multiple ET and MF populations. Subject to trial results, the company plans to initiate Phase 3 development of DMR-001 as early as mid-2028.

CLARITY-101 uses an adaptive Bayesian design with a starting dose of 100 mg administered subcutaneously once monthly, which the company said is expected to be in the range of anticipated therapeutic exposure based on preclinical data. At the June 2026 European Hematology Association congress, the company presented preclinical data showing DMR-001 had 26-fold greater inhibition of cell proliferation in Type 2 mutCALR and a 5-fold longer half-life versus an internally generated reference antibody, with a non-human primate half-life of 15 days versus 3.1 days. Additional preclinical data on potency against non-Type 1 mutCALR have been accepted for presentation at the American Society of Hematology meeting in December 2026.

On November 3, 2026, Damora entered a license agreement with Paragon Therapeutics granting an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize antibodies and products targeting mutCALR under the DMR-001 and DMR-002 research programs. The company said it has paid Paragon development-candidate milestone payments of $1.5 million with respect to each of those products and is obligated to make a $2.5 million milestone payment upon first dosing of a human in a Phase 1 trial of a licensed product. Under the related option agreement, Damora is obligated to pay Paragon up to $22.0 million per licensed product upon specified development, clinical and regulatory milestones, inclusive of payments already made.

Guidance for the first regulatory submission for DMR-002 was tightened from the second half of 2026 to the fourth quarter of 2026. The company still plans a first regulatory submission for DMR-003 in 2027.

For the three months ended September 30, 2026, Damora recognized $7.2 million of research and development expenses in connection with services provided by Paragon under the Paragon Option Agreement, compared with $5.8 million in the three months ended June 30, 2026, after a $17.0 million spike in the three months ended March 31, 2026. For the nine months ended September 30, 2026, those Paragon-related costs were $34.5 million. The company recorded a Denmark research-and-development tax credit of $0.1 million in the nine months ended September 30, 2026, versus $0.7 million in the nine months ended September 30, 2025.

The company said it expects research and development expenses to increase substantially for the foreseeable future as it continues to invest in its programs, including manufacturing and clinical trials. General and administrative expenses are also expected to increase substantially as it increases headcount and incurs public-company costs.

In February 2026, Damora sold 16,644,737 ordinary shares at $19.00 a share, including full exercise of the underwriters’ option, for net proceeds of approximately $295.5 million. It said it intends to use those proceeds to advance preclinical studies, clinical trials and manufacturing in support of its antibody programs, as well as for additional research and development, working capital and general corporate purposes. On July 16, 2026, the company changed its jurisdiction of incorporation from Delaware to the Cayman Islands and said it will continue to be treated as a U.S. corporation for U.S. tax purposes.

More on DMRA

August 10, 2026 Earnings Damora Starts DMR-001 Phase 1/1b After First Approval

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