On November 4, 2026 Damora Therapeutics, Inc. (NASDAQ: DMRA), a biotechnology company working to fundamentally redefine care for patients with blood disorders, reported its operating and financial results for the quarter ended September 30, 2026, and recent corporate highlights.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Since we initiated the CLARITY-101 trial of DMR-001, we have continued to execute with urgency, initiating enrollment at multiple clinical sites, achieving U.S. FDA clearance of our DMR-001 investigational new drug (IND) application and advancing multiple regulatory submissions to rapidly bring the CLARITY-101 trial to additional regions of the world," said Jennifer Jarrett, President and Chief Executive Officer of Damora Therapeutics. "In addition, we are excited to present new preclinical data at ASH (Free ASH Whitepaper) that further strengthen DMR-001’s differentiated profile, including potentially best-in-class pan-mutant activity across the full range of CALR mutations. Together with our broader portfolio, including DMR-002 and DMR-003, Damora is exceptionally well positioned to address medical needs across the spectrum of patients with mutCALR-driven disease and become a leader in myeloproliferative neoplasms."
Recent Business Highlights
Achieved FDA clearance of an IND application for DMR-001, enabling initiation of the CLARITY-101 Phase 1/1b trial of DMR-001 in patients with mutCALR-driven essential thrombocythemia (ET) and myelofibrosis (MF) in the U.S. Enrollment of the Phase 1 dose escalation portion of the trial is ongoing at multiple clinical sites, and regulatory applications have been or are planned to be submitted in additional geographies by the end of 2026 to continue to expand the trial globally and enable two proof-of-concept readouts beginning mid-2027.
Received acceptance of two DMR-001 abstracts for poster presentation at the ASH (Free ASH Whitepaper) 2026 Annual Meeting and Exposition in December. The presentations are expected to highlight new preclinical data on DMR-001’s potentially best-in-class pan-mutant activity and a summary of the CLARITY-101 Phase 1/1b trial design. Read our press release here.
Previously presented preclinical data highlighted the potentially best-in-class binding affinity and anti-proliferative potency of DMR-001 against Type 1 and Type 2 CALR mutations. Building on this dataset, new preclinical data to be presented at ASH (Free ASH Whitepaper) further demonstrate DMR-001’s pan-mutant activity, with robust inhibition of additional noncanonical, non-Type 1 mutations. When compared to a reference antibody, DMR-001 showed an average 95-fold improvement in anti-proliferative potency against a panel of 10 non-Type 1 CALR mutations, including the Type 2 mutation. Additional preclinical data will be presented at the meeting.
In addition, a trial-in-progress poster on the CLARITY-101 Phase 1/1b trial design will highlight features including an adaptive Bayesian design, a DMR-001 starting dose of 100 mg once-monthly by subcutaneous injection, a plan for rapid escalation to higher doses, and enrichment enabling cohort backfilling. Together, these features are expected to enable rapid identification of a recommended dose for Phase 1b expansion cohorts in multiple ET and MF populations.
Executed a license agreement for DMR-001 and DMR-002 with Paragon Therapeutics pursuant to which Paragon granted Damora an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize certain antibodies and products targeting mutCALR.
Anticipated Milestones
DMR-001 (pan-mutant, long-acting, Fc-null anti-mutCALR monoclonal antibody):
Present new preclinical data highlighting DMR-001’s pan-mutant activity at the ASH (Free ASH Whitepaper) Annual Meeting in December.
Report two clinical proof-of-concept datasets from the CLARITY-101 trial beginning mid-2027.
DMR-002 (pan-mutant, long-acting, Fc-enhanced anti-mutCALR monoclonal antibody):
Complete the first regulatory submission for DMR-002 in the fourth quarter of 2026.
DMR-003 (T-cell engager anti-mutCALR/CD3 bispecific antibody):
Complete the first regulatory submission for DMR-003 in 2027.
Third Quarter 2026 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were approximately $528.5 million as of September 30, 2026. The Company anticipates that its cash, cash equivalents, and marketable securities will be sufficient to fund operations into the second half of 2029. Net cash used in operating activities was $17.2 million for the third quarter of 2026.
R&D Expenses: Research and development expenses were $25.5 million for the three months ended September 30, 2026, compared to $1.4 million for the three months ended September 30, 2025. The increase was primarily driven by increased preclinical research, manufacturing and personnel costs, including non-cash stock-based compensation charges of $2.3 million related to the Paramora warrant obligation and $2.2 million related to personnel.
G&A Expenses: General and administrative expenses were $11.4 million for the three months ended September 30, 2026, compared to $1.7 million for the three months ended September 30, 2025. The increase was primarily driven by increased personnel costs, along with increased professional fees and other general and administrative costs, including state taxes. Non-cash stock-based compensation (personnel-related) increased by $5.2 million for the three months ended September 30, 2026.
Total Other Income: Other income was $4.9 million for the three months ended September 30, 2026, compared to less than $0.1 million for the three months ended September 30, 2025. The increase of $4.8 million was due to increased interest income from higher cash, cash equivalents and marketable securities balances following the Company’s securities offering in February 2026 and sales under the Company’s ATM offering program, as well as a $0.8 million gain on the sale of intellectual property.
Net Loss: Net loss for the three months ended September 30, 2026, was $32.0 million, compared to $3.1 million for the three months ended September 30, 2025.
Upcoming Investor Conferences
Damora Therapeutics will participate in four upcoming investor conferences:
Guggenheim 3rd Annual Healthcare Innovation Conference on Monday, November 9, 2026, at 4:00 p.m. EST.
UBS Global Biopharma Conference 2026 on Tuesday, November 17, 2026, at 5:00 a.m. EST (10:00 a.m. GMT)
Jefferies Global Healthcare Conference on Wednesday, November 18, 2026, at 11:00 a.m. EST (4:00 p.m. GMT)
9th Annual Evercore Healthcare Conference on Monday, November 30, 2026, at 2:35 p.m. EST.
Live webcasts of the presentations will be available under "Events" in the Investors section of the Damora Therapeutics website at View Source Replays of the webcasts will be archived on the Damora Therapeutics website for 30 days following the presentations.
(Press release, Damora Therapeutics, NOV 4, 2026, View Source [SID1234674198])