Damora Therapeutics to Present New Preclinical Data Highlighting Potentially Best-in-Class Pan-Mutant Activity of DMR-001 in Mutant Calreticulin (mutCALR)-driven Myeloproliferative Neoplasms (MPN) at the American Society of Hematology (ASH) 2026 Annual Meeting

The preclinical comparison covered 10 non-Type 1 CALR mutations, including Type 2, extending the previously presented dataset.

Rhea-AI Summary

Damora Therapeutics (NASDAQ: DMRA) announced new preclinical DMR-001 results showing an average 95-fold improvement in anti-proliferative potency versus a reference antibody.

The head-to-head studies tested a panel of 10 non-Type 1 CALR mutations, including Type 2, and measured inhibition of cell proliferation. The findings extend previously presented activity against Type 1 and Type 2 mutations. A poster will present the data at the ASH Annual Meeting on December 12, 2026.

DMR-001 is being evaluated in the ongoing CLARITY-101 Phase 1/1b trial for mutant CALR-driven essential thrombocythemia and myelofibrosis, both blood disorders. A separate trial-in-progress poster on December 13 will describe its dose-escalation design. Damora expects the design to expedite selection of a recommended dose for planned Phase 1b expansion cohorts.

Positive

• Minor pointDMR-001 showed an average 95-fold improvement in preclinical anti-proliferative potency versus a reference antibody across 10 non-Type 1 CALR mutations.
• Minor point. Forward-looking: it has not happened yet and may not happen.Damora plans rapid dose escalation to higher DMR-001 doses in the ongoing CLARITY-101 trial.
• Minor point. Forward-looking: it has not happened yet and may not happen.Damora expects the trial design to expedite recommended-dose selection for planned Phase 1b expansion cohorts.

Negative

• None.

Key Figures

Average anti-proliferative potency improvement: 95-fold Starting dose: 100 mg

Average anti-proliferative potency improvement

95-fold

Head-to-head versus a reference anti-mutCALR antibody across 10 non-Type 1 CALR mutations

Starting dose

100 mg

CLARITY-101 Phase 1 dose escalation; once-monthly subcutaneous injection

Historical Context

1 past event · Latest: Aug 10

1 event

1. Aug 10

   Preclinical results

   24h Move

   +2.8%

   Earlier EHA data reported 26-fold greater Type 2 proliferation inhibition, providing a same-program benchmark.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

anti-proliferative potency, adaptive bayesian design, subcutaneous injection, myeloproliferative neoplasms, +1 more

5 terms

anti-proliferative potency medical

"95-fold improvement in anti-proliferative potency"

A laboratory measure of how effectively a drug candidate or compound stops cells from multiplying; it is usually reported as the concentration that produces a specified level of growth inhibition (commonly IC50 or EC50) in a particular cell line and assay. The numeric potency depends on the test system and conditions, so a lower concentration value indicates stronger anti‑proliferative activity in that specific experiment but does not by itself prove effectiveness or safety in living organisms.

adaptive bayesian design technical

"including the adaptive Bayesian design of the Phase 1 dose escalation portion"

A clinical trial framework that uses Bayesian probability to update beliefs as data arrives and adapt the study’s course in real time — for example by changing doses, adding or dropping study arms, or stopping early for success or futility. Think of it like a GPS that re-routes as traffic data comes in. For investors, it can speed development, reduce costs and late-stage failure risk, and provide earlier signals that affect valuation and go/no-go decisions.

subcutaneous injection medical

"100 mg once-monthly by subcutaneous injection"

A subcutaneous injection is a method of delivering a medicine or vaccine by inserting a small needle just under the skin into the thin layer of fat beneath the outer skin. For investors, administration by subcutaneous injection matters because it influences patient convenience, dosing frequency, manufacturing complexity and distribution costs, all of which affect how widely a treatment is adopted and how it is priced—like choosing a product that customers can easily use at home versus one that needs a clinic visit.

myeloproliferative neoplasms medical

"mutCALR-driven myeloproliferative neoplasms"

Myeloproliferative neoplasms are a group of blood cancers caused by the bone marrow producing too many of one or more types of blood cells, which can crowd out normal cells and impair blood flow. Investors pay attention because these conditions create clear medical needs and predictable markets for diagnostics, therapies and follow-up care—similar to a failing factory that creates demand for repair services and replacement parts—affecting drug development, regulatory milestones and potential sales.

essential thrombocythemia medical

"mutCALR-driven essential thrombocythemia (ET) and myelofibrosis (MF)"

Essential thrombocythemia is a chronic blood disorder in which the body produces too many platelets, the cells that help blood clot; this imbalance raises the risk of dangerous clots, bleeding, and long-term complications such as stroke or heart attack. It matters to investors because it creates demand for long-term therapies, affects clinical trial design and regulatory review for new drugs, and can influence a company’s revenue and risk profile if treatments prove effective or face safety challenges.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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-- Building on previously presented DMR-001 preclinical data in Type 1 and Type 2 CALR mutations,
new data to highlight strong activity against additional non-Type 1 mutations --

-- Trial-in-progress presentation to highlight the ongoing CLARITY-101 Phase 1/1b trial of DMR-001 in mutCALR-driven essential thrombocythemia (ET) and myelofibrosis (MF) --

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 the acceptance of preclinical data highlighting the best-in-class potential of DMR-001 for poster presentation at the 2026 ASH Annual Meeting and Exposition. DMR-001 is an investigational pan-mutant, long-acting, Fc-null mutCALR therapy currently being evaluated as a potential treatment for patients with mutCALR-driven ET and MF in the CLARITY-101 Phase 1/1b clinical trial.

“Previously presented preclinical data combined with new results expected at the ASH Annual Meeting support DMR-001’s potential to set a new bar for pan-mutant activity in mutCALR-driven myeloproliferative neoplasms,” said Becker Hewes, M.D., Chief Medical Officer of Damora Therapeutics. “At ASH, we will provide insight for the first time on DMR-001’s activity across the breadth of non-Type 1 mutations, including Type 2 and other noncanonical mutations, which together represent nearly half of the overall population with mutCALR-driven disease. These data further strengthen our conviction in DMR-001’s best-in-class potential and reinforce our commitment to rapidly advance ongoing DMR-001 clinical development.”

Previously presented DMR-001 preclinical data highlighted its potentially best-in-class binding affinity and anti-proliferative potency against Type 1 and Type 2 CALR mutations. Building on this dataset, new preclinical data accepted for poster presentation at ASH further demonstrate DMR-001’s pan-mutant activity, with robust inhibition of additional noncanonical, non-Type 1 mutations.

Specifically, in head-to-head preclinical studies versus a reference anti-mutCALR 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 abstract highlighting the ongoing CLARITY-101 Phase 1/1b trial, including the adaptive Bayesian design of the Phase 1 dose escalation portion, was accepted for poster presentation at the ASH meeting. Features including a starting DMR-001 dose of 100 mg once-monthly by subcutaneous injection, a plan for rapid escalation to higher doses, and enrichment enabling cohort backfilling are expected to enable expedited identification of a recommended dose for planned Phase 1b expansion cohorts in multiple ET and MF populations.

DMR-001 ASH Presentations

Presentation title: DMR-001, a clinical-stage mutant calreticulin (mutCALR) targeted therapy for mutCALR-driven myeloproliferative neoplasms, shows potent preclinical activity against type 1 and non-type 1 calreticulin mutations
Session title: Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster I
Abstract number: 13746
Session date & time: Saturday, December 12, 2026, 5:30 pm – 7:30 pm CT
Location: Hall F

Presentation title: A Phase 1/1b study of DMR-001, a mutant calreticulin (CALR)-targeted antibody in myeloproliferative neoplasms (MPNs) (CLARITY-101): A trial in progress
Session title: Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Abstract number: 13906
Session date & time: Sunday, December 13, 2026, 6:00 pm – 8:00 pm CT
Location: Hall F

About DMR-001

DMR-001 is a highly potent, pan-mutant, long-acting monoclonal antibody therapy designed to selectively target mutCALR, a known disease driver in ET and MF. In these diseases, CALR mutations create an abnormal protein that binds to and continuously activates the thrombopoietin receptor (TpoR), driving the uncontrolled blood cell production, clotting and bleeding risk, and bone marrow scarring that characterize these diseases. DMR-001 is designed to block this interaction while leaving normal, wild-type calreticulin untouched, an important distinction intended to minimize off-target effects.

DMR-001 was specifically engineered for highly potent inhibition of both Type 1 and non-Type 1 CALR mutations, including Type 2 CALR mutations. It also incorporates a YTE modification that extends half-life to support optimized target coverage and convenient, infrequent subcutaneous dosing. In addition, DMR-001 features an Fc-null design that eliminates Fc-mediated immune effector function, an approach intended to support a favorable safety profile.

DMR-001 is an investigational therapy and has not been approved by any regulatory authority for any indication.

About mutCALR-driven Myeloproliferative Neoplasms

CALR mutations are the primary disease driver in 25 percent of ET cases and 35 percent of MF cases, representing approximately 42,000 patients in the U.S. alone. These mutations — most commonly a Type 1 deletion or Type 2 insertion in the CALR gene — produce an abnormal protein that continuously switches on blood cell growth signals, driving complications such as blood clots, bleeding, and life-threatening bone marrow fibrosis, as well as debilitating symptoms including fatigue, headaches, problems concentrating, and extremity pain. There are no approved mutCALR-targeted therapies, and the current standard of care in ET and MF primarily relies on symptom-directed treatments that do not address the underlying cause of disease.

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 expectations, hopes, beliefs, intentions or strategies regarding the future of its assets, pipeline and business, including, without limitation, statements regarding the Company’s planned presentations at the 2026 ASH Annual Meeting; the potential of DMR-001, including its best-in-class and pan-mutant potential; the design, conduct, and timing of the CLARITY-101 Phase 1/1b trial, including identification of a recommended dose and planned Phase 1b expansion cohorts; and the Company’s clinical development plans. 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 June 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 and Media Contact

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Damora Therapeutics report about DMR-001's new preclinical results?

DMR-001 showed an average 95-fold improvement in anti-proliferative potency versus a reference anti-mutCALR antibody in head-to-head preclinical studies. The comparison covered a panel of 10 non-Type 1 CALR mutations, including Type 2. These are preclinical findings, not patient treatment results.

How is Damora's CLARITY-101 trial dosing DMR-001?

CLARITY-101 starts DMR-001 at 100 mg once-monthly by subcutaneous injection, with a plan for rapid escalation to higher doses. Its Phase 1 portion uses an adaptive Bayesian dose-escalation design and enrichment enabling cohort backfilling. Damora expects these features to expedite recommended-dose identification for planned Phase 1b expansion cohorts.