Key Highlights

  • Net loss per share was USD 0.40 against an estimate of USD -0.48, on a USD 32.0 million net loss.
  • Research and development expense was USD 25.5 million against USD 1.4 million in the third quarter of 2025.
  • The Phase 1/1b CLARITY-101 trial of DMR-001 started in the quarter with Australian approval and has since received FDA clearance.
  • Cash and marketable securities were USD 528.5 million, which management said funds operations into the second half of 2029.

How does a clinical-stage company with no Revenue turn a USD 528.5 million balance into trial activity? Damora Therapeutics (NASDAQ:DMRA) answered with a third quarter in which it started the Phase 1/1b CLARITY-101 trial of DMR-001 and reported a net loss of USD 32.0 million, or USD 0.40 per share, against an estimate of USD -0.48. Revenue was zero, and the net loss compares with USD 3.1 million a year earlier.

DMR-001 and the CLARITY-101 Trial

The company develops antibody therapies for blood disorders driven by mutant calreticulin, with three candidates: DMR-001, DMR-002 and DMR-003. It began the CLARITY-101 trial of DMR-001 in essential thrombocythemia and myelofibrosis patients after receiving health authority approval in Australia, and it has since received FDA clearance to start in the United States. Enrollment is ongoing.

Management described a starting dose of 100 mg given subcutaneously once monthly and an adaptive design for dose selection. It targets two proof-of-concept readouts beginning mid-2027, expansion cohorts in 2027 and, subject to the results, the start of Phase 3 development as early as mid-2028. Additional regulatory applications for DMR-001 are planned for the fourth quarter of 2026. A first regulatory submission for DMR-002 is planned for the fourth quarter of 2026 and for DMR-003 in 2027.

Further preclinical data on non-Type 1 mutCALR have been accepted for the American Society of Hematology meeting in December 2026.

Spending and the Paragon Agreements

Operating expenses were USD 36.9 million against USD 3.2 million. Research and Development was USD 25.5 million, which included USD 8.0 million of preclinical and clinical trial activities, USD 7.9 million of chemistry, Manufacturing and control, and USD 2.3 million for the amortized cost of a Warrant obligation to Paramora. General and administrative expense was USD 11.4 million against USD 1.7 million.

Services from Paragon Therapeutics accounted for USD 7.2 million of research and development expense in the quarter and USD 34.5 million for nine months. On November 3, 2026, the company entered into a license agreement with Paragon covering DMR-001 and DMR-002, with up to USD 22.0 million per licensed product in specified milestones, inclusive of earlier payments, and tiered royalties in the low to mid single-digit percentages. A USD 2.5 million payment is due on first human dosing in a Phase 1 trial of a licensed product.

Funding, Cash and Share Count

Cash, cash equivalents and marketable securities were USD 528.5 million at September 30, against an accumulated Deficit of USD 578.3 million. Nine-month net loss was USD 90.9 million against USD 9.1 million, and cash used in operations was USD 59.7 million. Financing provided USD 330.5 million, primarily from a February 2026 offering and an at-the-market program.

The February offering sold 16,644,737 shares at USD 19.00 per share for net proceeds of approximately USD 295.5 million. The at-the-market program allows sales of up to USD 150.0 million, and the company reported sales of 1,407,823 shares at a weighted average price of USD 25.05 for net proceeds of USD 34.3 million. On July 16, 2026, it changed its Jurisdiction of incorporation from Delaware to the Cayman Islands.

Figures Worth Comparing

A net loss of USD 32.0 million sits alongside research and development expense of USD 25.5 million, cash and marketable securities of USD 528.5 million and nine-month operating cash use of USD 59.7 million.

Management named a set of dated items: the fourth quarter 2026 regulatory submission for DMR-002, the December 2026 hematology meeting presentation, expansion cohorts and the first proof-of-concept readouts from mid-2027, and a DMR-003 submission in 2027. It also said substantial additional funding is required beyond the period its current cash covers.