Key Highlights

• The CLARITY-101 Phase 1/1b clinical trial of DMR-001 was initiated, with enrollment underway at multiple sites

• FDA cleared the Investigational New Drug application for DMR-001, enabling U.S. trial enrollment

• Cash, cash equivalents, and marketable securities totaled $528.5 million as of September 30, 2026

• New preclinical data demonstrating DMR-001's pan-mutant CALR activity will be presented at ASH 2026

Damora Therapeutics Inc(NASDAQ:DMRA), a Waltham, Massachusetts-based biotechnology company focused on redefining care for patients with blood disorders, reported its third quarter 2026 financial results and recent corporate highlights on November 4, 2026. The company is developing a pipeline of therapies targeting mutant calreticulin (CALR)-driven diseases, including essential thrombocythemia and myelofibrosis.

CLARITY-101 Trial Progress

The headline development for the quarter was the initiation of the CLARITY-101 Phase 1/1b clinical trial, which is evaluating DMR-001 in patients with mutant CALR-driven essential thrombocythemia (ET) and myelofibrosis (MF). Enrollment in the Phase 1 dose escalation portion is underway at multiple clinical sites. The company received FDA clearance of its Investigational New Drug application during the quarter, enabling trial enrollment in the United States.

Regulatory submissions have been or are planned to be submitted in additional geographies by the end of 2026 to expand the trial globally. The company expects two proof-of-concept readouts beginning mid-2027, marking a critical milestone in the clinical development of DMR-001.

President and CEO Jennifer Jarrett described the pace of execution as urgent, noting that the company has initiated enrollment at multiple sites, achieved U.S. regulatory clearance, and advanced submissions to international regulators since the trial's initiation.

ASH 2026 Data Presentations

Damora secured acceptance of two abstracts for poster presentation at the American Society of Hematology (ASH) 2026 Annual Meeting and Exposition in December. The presentations are expected to highlight new preclinical data on DMR-001's pan-mutant activity, demonstrating activity across the full range of CALR mutations, not just the most common Type 1 and Type 2 variants.

Previous preclinical data had established DMR-001's binding affinity and anti-proliferative potency against Type 1 and Type 2 CALR mutations. The new dataset extends this profile, with the company describing the results as indicative of potentially differentiated pan-mutant activity. A summary of the CLARITY-101 trial design will also be presented at ASH.

Broader Pipeline and Financial Position

Beyond DMR-001, Damora is developing DMR-002 and DMR-003, which target additional aspects of mutant CALR-driven disease. The broader pipeline positions the company to address medical needs across the spectrum of myeloproliferative neoplasms, though these programs remain in earlier stages of development.

The company ended Q3 2026 with $528.5 million in cash, cash equivalents, and marketable securities, a position expected to fund operations into the second half of 2029. This extended runway gives Damora the financial flexibility to advance the CLARITY-101 trial through multiple proof-of-concept readouts without near-term Capital needs.

What to Watch

Damora enters the final months of 2026 with its lead program advancing through early clinical development and two upcoming data presentations at a major hematology conference. The mid-2027 timeframe for proof-of-concept data from CLARITY-101 represents the next inflection point for the company, while the expanding geographic footprint of the trial could accelerate enrollment timelines. The ASH presentations in December will provide the first public look at the expanded preclinical dataset supporting DMR-001's differentiated profile.