News Release Details

-- CLARITY-101 Phase 1/1b clinical trial initiated and cleared by multiple global regulatory authorities, including
the U.S. Food and Drug Administration (FDA) --

-- New preclinical data highlighting DMR-001’s potentially best-in-class pan-mutant CALR (mutCALR) activity
to be presented at the American Society of Hematology (ASH) 2026 Annual Meeting --

-- Strong financial position with $528.5 million in cash, cash equivalents, and marketable securities as of
September 30, 2026, expected to fund operations into 2H 2029 --

WALTHAM, Mass., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Damora Therapeutics, Inc. (NASDAQ: DMRA), a biotechnology company working to fundamentally redefine care for patients with blood disorders, today announced its operating and financial results for the quarter ended September 30, 2026, and recent corporate highlights.

“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 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 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 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 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 3^rd 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)
• 9^th 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 http://ir.damoratx.com. Replays of the webcasts will be archived on the Damora Therapeutics website for 30 days following the presentations.

About Damora Therapeutics

Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for patients with blood disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for disease-modifying treatments. With multiple programs with best-in-class potential, our goal is to rapidly bring forward optimized therapies with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes. For more information, visit www.damoratx.com or follow us on LinkedIn.

Forward-Looking Statements

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s design, conduct, enrollment and timing of the CLARITY-101 trial, including identification of a recommended dose for Phase 1b expansion cohorts and the timing of clinical proof-of-concept datasets; the timing and outcome of regulatory submissions for DMR-001, DMR-002 and DMR-003; the planned presentation of data at the ASH Annual Meeting; the therapeutic potential, differentiation and potential best-in-class profile of the Company’s product candidates; the Company’s strategy and goals; and the sufficiency of the Company’s cash, cash equivalents and marketable securities to fund operations into the second half of 2029. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including: the risk that preclinical results may not be predictive of clinical results; the Company’s ability to enroll patients and complete clinical trials on expected timelines; the risk that regulatory authorities may delay, condition or not clear the Company’s submissions or trials; the Company’s reliance on third parties, including contract research organizations and manufacturers; the Company’s ability to obtain, maintain and enforce intellectual property rights; competition; the Company’s need for additional capital and the risk that it uses its capital resources sooner than expected; general economic, market and geopolitical conditions; and the other risks described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, and its other SEC filings. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update them except as required by law.

Investor/Media Contact:

Jim Baker
Chief Corporate Affairs Officer
Investors: investors@damoratx.com 
Media: media@damoratx.com

DAMORA THERAPEUTICS, INC.
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DAMORA THERAPEUTICS, INC.
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Source: Damora Therapeutics, Inc.