Damora Therapeutics (DMRA) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Market and unmet need

• mutCALR affects ~25% of ET and ~35% of MF patients; the U.S. MPN opportunity was estimated at >$5B, with no disease-modifying options for mutCALR patients.

• Existing mutCALR antibody data support the therapeutic approach, with activity concentrated in type 1 mutations; non-type 1 patients represent about half the population.

• DMR-001 is an Fc-null, pan-mutant antibody designed for longer half-life and every-four-week subcutaneous dosing.

DMR-001 and CLARITY-101

• Phase I CLARITY-101 is underway in the U.S. and Australia; the global protocol allows up to 250 patients and uses Bayesian dose escalation.

• The study includes ET, MF and pre-fibrotic MF, with single-agent evaluation and possible ruxolitinib combinations; expansions can proceed by disease population as evidence matures.

• Starting dose is 100 mg, described as within the therapeutic range; only a few dose levels are expected before expansion.

• Early clinical assessments will test human half-life and PK translation, plus activity across mutation types; two proof-of-concept readouts are anticipated beginning mid-2027.

• Phase III initiation is anticipated in mid-2028; an auto-injector is also in development.

Development strategy and endpoints

• ET and MF will both be evaluated in Phase I; prioritization and treatment lines will depend on emerging data, with interest in developing for earlier-stage patients.

• For ET, the team may mirror a complete hematologic response primary endpoint at 24 weeks and VAF as a key secondary endpoint; MF endpoints may evolve to include VAF or transfusion independence.

• Key questions include DMR-001 activity in non-type 1 mutations and whether anti-mutCALR treatment should be combined with a JAK inhibitor in MF.

• The team expects to assess both monotherapy and potential combinations, and use the data to shape the registration program.