{"success":true,"data":{"pressRelease":{"id":"109408","rtpr_id":"nGNX5fPwrv","ticker":"DMRA","exchange":"NASDAQ","all_tickers":["DMRA"],"title":"Damora Therapeutics Initiates Phase 1/1b CLARITY-101 Clinical Trial of DMR-001 in Patients with Mutant Calreticulin-Driven Essential Thrombocythemia and Myelofibrosis","author":"Globe Newswire","published_at":"2026-08-05T12:00:02.586Z","article_body":"-- DMR-001 is a highly potent, long-acting antibody therapy targeting Type 1\nand non-Type 1 mutant calreticulin (mutCALR), designed for convenient\nonce-monthly subcutaneous dosing --\n\n-- In preclinical studies, DMR-001 demonstrated up to 30-fold greater potency\nand an approximately five-fold longer half-life than a reference anti-mutCALR\nantibody, supporting its best-in-class potential --\n\nWALTHAM, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Damora Therapeutics, Inc.\n(NASDAQ: DMRA), a biotechnology company working to fundamentally redefine care\nfor patients with blood disorders, today announced the initiation of the\nglobal Phase 1/1b CLARITY-101 clinical trial of DMR-001, an investigational\nmonoclonal antibody therapy designed to selectively target mutant calreticulin\n(mutCALR), in patients with mutCALR-driven essential thrombocythemia (ET) and\nmyelofibrosis (MF), based on receipt of health authority approval.\n\n“We’re excited to announce the initiation of our first clinical trial of\nDMR-001, a potentially best-in-class mutCALR-targeted therapy,” said Becker\nHewes, M.D., Chief Medical Officer of Damora Therapeutics. “In preclinical\nstudies, DMR-001 showed a differentiated profile that we believe can translate\ninto deeper, more durable disease control with the simplicity and convenience\nof a once-monthly subcutaneous injection. The achievement of this important\nclinical milestone furthers Damora’s commitment to solving important medical\nneeds in hematology, beginning with DMR-001’s potential to redefine\ntreatment for the tens of thousands of patients living with mutCALR-driven\nmyeloproliferative neoplasms.”\n\nDavid Ross, M.D., Ph.D., Associate Professor of Haematology at Flinders\nMedical Centre in Adelaide, South Australia, and an investigator on the Phase\n1/1b CLARITY-101 study, added: “Targeting the root cause of mutCALR-driven\ndisease is one of the most exciting frontiers in myeloproliferative neoplasms\ntoday and has the potential to be the first disease modifying treatment for\npatients with this disease. DMR-001’s broad activity and convenient\nadministration makes it a potentially compelling new therapy for patients with\nET and MF.”\n\nOverview of the CLARITY-101 study in mutCALR-driven ET and MF\n\nThe Phase 1/1b CLARITY-101 trial is a global, open-label, multi-center, dose\nescalation and dose expansion study designed to evaluate the safety,\ntolerability and preliminary efficacy of DMR-001.\n\nThe Phase 1 dose escalation portion of the trial is designed to rapidly\nidentify a recommended dose for further development, with a starting dose of\n100 mg monthly (as a subcutaneous injection), which is predicted to be in the\nrange of therapeutic exposure. Additionally, the trial utilizes an adaptive\nBayesian design enabling cohort enrichment during dose escalation. Eligible\npatients include adults with a documented CALR mutation and ET resistant,\nrefractory or intolerant to at least one prior cytoreductive therapy or MF\nresistant, refractory or intolerant to at least one JAK inhibitor.\n\nThe planned Phase 1b expansion portion of the trial will further evaluate the\nsafety and efficacy of DMR-001 in additional populations and settings,\nincluding in early-line disease and in combination with other therapies.\n\nDamora continues to expect to report initial data from the trial beginning\nmid-2027.\n\nDMR-001: a highly potent, long-acting mutCALR targeted therapy with\nbest-in-class potential\n\nDMR-001 is a highly potent, long-acting monoclonal antibody therapy designed\nto selectively target CALR mutations, a known disease driver in ET and MF. In\nthese diseases, CALR mutations create an abnormal protein that binds to and\ncontinuously activates the thrombopoietin receptor (TpoR), driving the\nuncontrolled blood cell production, clotting and bleeding risk, and bone\nmarrow scarring that characterize these diseases. DMR-001 is designed to block\nthis interaction while leaving normal, wild-type calreticulin untouched, an\nimportant distinction intended to minimize off-target effects.\n\nDMR-001 was specifically engineered for highly potent inhibition of both Type\n1 and non-Type 1 CALR mutations, including Type 2 mutations. It also\nincorporates a YTE modification that extends half-life to support optimized\ntarget coverage and convenient, infrequent subcutaneous dosing. In addition,\nDMR-001 features an Fc-null design that eliminates Fc-mediated immune effector\nfunction, an approach intended to support a favorable safety profile.\n\nPreclinical DMR-001 data presented at the European Hematology Association\n(EHA) 2026 Congress highlights DMR-001’s best-in-class potential. In\nhead-to-head preclinical studies, DMR-001 demonstrated up to 30-fold higher\nbinding affinity for mutCALR compared to a reference anti-mutCALR antibody,\nwith the largest gains observed against Type 2 mutations — historically the\nmore difficult mutCALR subtype to target — where DMR-001 was up to 26-fold\nmore potent at inhibiting disease-driving cell growth. In addition, DMR-001\ndemonstrated an approximately five-fold longer half-life in non-human primates\n(15 days vs. 3.1 days), supporting a target dosing schedule of once every four\nweeks or longer by subcutaneous injection.\n\nDMR-001 is an investigational therapy and has not been approved by any\nregulatory authority for any indication.\n\nAbout mutCALR-driven Myeloproliferative Neoplasms\n\nCALR mutations are the primary disease driver in 25 percent of ET cases and 35\npercent of MF cases, representing approximately 42,000 patients in the U.S.\nalone. These mutations — most commonly a Type 1 deletion or Type 2 insertion\nin the CALR gene — produce an abnormal protein that continuously switches on\nblood cell growth signals, driving complications such as blood clots,\nbleeding, and life-threatening bone marrow fibrosis, as well as debilitating\nsymptoms including fatigue, headaches, problems concentrating, and extremity\npain. There are no approved mutCALR-targeted therapies, and the current\nstandard of care in ET and MF primarily relies on symptom-directed treatments\nthat do not address the underlying cause of disease.\n\nAbout Damora Therapeutics\n\nDamora Therapeutics is an innovative biotechnology company that aims to\nfundamentally redefine care for people with hematologic disorders. We are\nadvancing a new generation of biologics to treat mutCALR-driven\nmyeloproliferative neoplasms, including ET and MF, where there is significant\nmedical need for disease-modifying treatments. With multiple programs with\nbest-in-class potential on track to enter clinical development in 2026, our\ngoal is to rapidly bring forward optimized therapies with broad mutation\ncoverage and exceptional convenience to dramatically improve patient outcomes.\nFor more information, visit www.damoratx.com or follow us on LinkedIn.\n\nForward-Looking Statements\n\nCertain statements in this press release, other than purely historical\ninformation, may constitute “forward-looking statements” within the\nmeaning of the federal securities laws, including for purposes of the safe\nharbor provisions under the United States Private Securities Litigation Reform\nAct of 1995. These forward-looking statements include, but are not limited to,\nexpress or implied statements relating to the Company’s expectations, hopes,\nbeliefs, intentions or strategies regarding the future of its assets, pipeline\nand business including, without limitation, the Company’s plans for\nenrollment in the CLARITY-101 Phase 1/1b trial and that results from\npreclinical studies of DMR-001 may translate into deeper, more durable disease\ncontrol with the simplicity and convenience of a once-monthly subcutaneous\ninjection. In addition, any statements that refer to projections, forecasts or\nother characterizations of future events or circumstances, including any\nunderlying assumptions, are forward-looking statements. These forward-looking\nstatements are based on current expectations and beliefs concerning future\ndevelopments and their potential effects. There can be no assurance that\nfuture developments affecting the Company will be those that have been\nanticipated. These forward-looking statements involve a number of risks,\nuncertainties (some of which are beyond the Company’s control) or other\nassumptions that may cause actual results or performance to be materially\ndifferent from those expressed or implied by these forward-looking statements.\nThese risks and uncertainties include, but are not limited to, those\nuncertainties and factors described under the headings “Risk Factors,”\n“Cautionary Information Regarding Forward-Looking Statements” or\n“Cautionary Statement Regarding Forward-Looking Statements” in the\nCompany’s most recent filings with the SEC. Should one or more of these\nrisks or uncertainties materialize, or should any of the Company’s\nassumptions prove incorrect, actual results may vary in material respects from\nthose projected in these forward-looking statements. Nothing in this press\nrelease should be regarded as a representation by any person that the\nforward-looking statements set forth therein will be achieved or that any of\nthe contemplated results of such forward-looking statements will be achieved.\nYou should not place undue reliance on forward-looking statements in this\npress release, which speak only as of the date they are made and are qualified\nin their entirety by reference to the cautionary statements herein. The\nCompany does not undertake or accept any duty to make any updates or revisions\nto any forward-looking statements.\n\nInvestor and Media Contact\n\nJim Baker\nChief Corporate Affairs Officer\ninvestors@damoratx.com\nmedia@damoratx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/547722cf-495b-4464-97a9-35bea3fa5d15)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX5fPwrv","title":"Damora Therapeutics Initiates Phase 1/1b CLARITY-101 Clinical Trial of DMR-001 in Patients with Mutant Calreticulin-Driven Essential Thrombocythemia and Myelofibrosis","author":"Globe Newswire","ticker":"DMRA","created":"2026-08-05T12:00:02.586Z","tickers":["DMRA"],"exchange":"NASDAQ","article_body":"-- DMR-001 is a highly potent, long-acting antibody therapy targeting Type 1\nand non-Type 1 mutant calreticulin (mutCALR), designed for convenient\nonce-monthly subcutaneous dosing --\n\n-- In preclinical studies, DMR-001 demonstrated up to 30-fold greater potency\nand an approximately five-fold longer half-life than a reference anti-mutCALR\nantibody, supporting its best-in-class potential --\n\nWALTHAM, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Damora Therapeutics, Inc.\n(NASDAQ: DMRA), a biotechnology company working to fundamentally redefine care\nfor patients with blood disorders, today announced the initiation of the\nglobal Phase 1/1b CLARITY-101 clinical trial of DMR-001, an investigational\nmonoclonal antibody therapy designed to selectively target mutant calreticulin\n(mutCALR), in patients with mutCALR-driven essential thrombocythemia (ET) and\nmyelofibrosis (MF), based on receipt of health authority approval.\n\n“We’re excited to announce the initiation of our first clinical trial of\nDMR-001, a potentially best-in-class mutCALR-targeted therapy,” said Becker\nHewes, M.D., Chief Medical Officer of Damora Therapeutics. “In preclinical\nstudies, DMR-001 showed a differentiated profile that we believe can translate\ninto deeper, more durable disease control with the simplicity and convenience\nof a once-monthly subcutaneous injection. The achievement of this important\nclinical milestone furthers Damora’s commitment to solving important medical\nneeds in hematology, beginning with DMR-001’s potential to redefine\ntreatment for the tens of thousands of patients living with mutCALR-driven\nmyeloproliferative neoplasms.”\n\nDavid Ross, M.D., Ph.D., Associate Professor of Haematology at Flinders\nMedical Centre in Adelaide, South Australia, and an investigator on the Phase\n1/1b CLARITY-101 study, added: “Targeting the root cause of mutCALR-driven\ndisease is one of the most exciting frontiers in myeloproliferative neoplasms\ntoday and has the potential to be the first disease modifying treatment for\npatients with this disease. DMR-001’s broad activity and convenient\nadministration makes it a potentially compelling new therapy for patients with\nET and MF.”\n\nOverview of the CLARITY-101 study in mutCALR-driven ET and MF\n\nThe Phase 1/1b CLARITY-101 trial is a global, open-label, multi-center, dose\nescalation and dose expansion study designed to evaluate the safety,\ntolerability and preliminary efficacy of DMR-001.\n\nThe Phase 1 dose escalation portion of the trial is designed to rapidly\nidentify a recommended dose for further development, with a starting dose of\n100 mg monthly (as a subcutaneous injection), which is predicted to be in the\nrange of therapeutic exposure. Additionally, the trial utilizes an adaptive\nBayesian design enabling cohort enrichment during dose escalation. Eligible\npatients include adults with a documented CALR mutation and ET resistant,\nrefractory or intolerant to at least one prior cytoreductive therapy or MF\nresistant, refractory or intolerant to at least one JAK inhibitor.\n\nThe planned Phase 1b expansion portion of the trial will further evaluate the\nsafety and efficacy of DMR-001 in additional populations and settings,\nincluding in early-line disease and in combination with other therapies.\n\nDamora continues to expect to report initial data from the trial beginning\nmid-2027.\n\nDMR-001: a highly potent, long-acting mutCALR targeted therapy with\nbest-in-class potential\n\nDMR-001 is a highly potent, long-acting monoclonal antibody therapy designed\nto selectively target CALR mutations, a known disease driver in ET and MF. In\nthese diseases, CALR mutations create an abnormal protein that binds to and\ncontinuously activates the thrombopoietin receptor (TpoR), driving the\nuncontrolled blood cell production, clotting and bleeding risk, and bone\nmarrow scarring that characterize these diseases. DMR-001 is designed to block\nthis interaction while leaving normal, wild-type calreticulin untouched, an\nimportant distinction intended to minimize off-target effects.\n\nDMR-001 was specifically engineered for highly potent inhibition of both Type\n1 and non-Type 1 CALR mutations, including Type 2 mutations. It also\nincorporates a YTE modification that extends half-life to support optimized\ntarget coverage and convenient, infrequent subcutaneous dosing. In addition,\nDMR-001 features an Fc-null design that eliminates Fc-mediated immune effector\nfunction, an approach intended to support a favorable safety profile.\n\nPreclinical DMR-001 data presented at the European Hematology Association\n(EHA) 2026 Congress highlights DMR-001’s best-in-class potential. In\nhead-to-head preclinical studies, DMR-001 demonstrated up to 30-fold higher\nbinding affinity for mutCALR compared to a reference anti-mutCALR antibody,\nwith the largest gains observed against Type 2 mutations — historically the\nmore difficult mutCALR subtype to target — where DMR-001 was up to 26-fold\nmore potent at inhibiting disease-driving cell growth. In addition, DMR-001\ndemonstrated an approximately five-fold longer half-life in non-human primates\n(15 days vs. 3.1 days), supporting a target dosing schedule of once every four\nweeks or longer by subcutaneous injection.\n\nDMR-001 is an investigational therapy and has not been approved by any\nregulatory authority for any indication.\n\nAbout mutCALR-driven Myeloproliferative Neoplasms\n\nCALR mutations are the primary disease driver in 25 percent of ET cases and 35\npercent of MF cases, representing approximately 42,000 patients in the U.S.\nalone. These mutations — most commonly a Type 1 deletion or Type 2 insertion\nin the CALR gene — produce an abnormal protein that continuously switches on\nblood cell growth signals, driving complications such as blood clots,\nbleeding, and life-threatening bone marrow fibrosis, as well as debilitating\nsymptoms including fatigue, headaches, problems concentrating, and extremity\npain. There are no approved mutCALR-targeted therapies, and the current\nstandard of care in ET and MF primarily relies on symptom-directed treatments\nthat do not address the underlying cause of disease.\n\nAbout Damora Therapeutics\n\nDamora Therapeutics is an innovative biotechnology company that aims to\nfundamentally redefine care for people with hematologic disorders. We are\nadvancing a new generation of biologics to treat mutCALR-driven\nmyeloproliferative neoplasms, including ET and MF, where there is significant\nmedical need for disease-modifying treatments. With multiple programs with\nbest-in-class potential on track to enter clinical development in 2026, our\ngoal is to rapidly bring forward optimized therapies with broad mutation\ncoverage and exceptional convenience to dramatically improve patient outcomes.\nFor more information, visit www.damoratx.com or follow us on LinkedIn.\n\nForward-Looking Statements\n\nCertain statements in this press release, other than purely historical\ninformation, may constitute “forward-looking statements” within the\nmeaning of the federal securities laws, including for purposes of the safe\nharbor provisions under the United States Private Securities Litigation Reform\nAct of 1995. These forward-looking statements include, but are not limited to,\nexpress or implied statements relating to the Company’s expectations, hopes,\nbeliefs, intentions or strategies regarding the future of its assets, pipeline\nand business including, without limitation, the Company’s plans for\nenrollment in the CLARITY-101 Phase 1/1b trial and that results from\npreclinical studies of DMR-001 may translate into deeper, more durable disease\ncontrol with the simplicity and convenience of a once-monthly subcutaneous\ninjection. In addition, any statements that refer to projections, forecasts or\nother characterizations of future events or circumstances, including any\nunderlying assumptions, are forward-looking statements. These forward-looking\nstatements are based on current expectations and beliefs concerning future\ndevelopments and their potential effects. There can be no assurance that\nfuture developments affecting the Company will be those that have been\nanticipated. These forward-looking statements involve a number of risks,\nuncertainties (some of which are beyond the Company’s control) or other\nassumptions that may cause actual results or performance to be materially\ndifferent from those expressed or implied by these forward-looking statements.\nThese risks and uncertainties include, but are not limited to, those\nuncertainties and factors described under the headings “Risk Factors,”\n“Cautionary Information Regarding Forward-Looking Statements” or\n“Cautionary Statement Regarding Forward-Looking Statements” in the\nCompany’s most recent filings with the SEC. Should one or more of these\nrisks or uncertainties materialize, or should any of the Company’s\nassumptions prove incorrect, actual results may vary in material respects from\nthose projected in these forward-looking statements. Nothing in this press\nrelease should be regarded as a representation by any person that the\nforward-looking statements set forth therein will be achieved or that any of\nthe contemplated results of such forward-looking statements will be achieved.\nYou should not place undue reliance on forward-looking statements in this\npress release, which speak only as of the date they are made and are qualified\nin their entirety by reference to the cautionary statements herein. The\nCompany does not undertake or accept any duty to make any updates or revisions\nto any forward-looking statements.\n\nInvestor and Media Contact\n\nJim Baker\nChief Corporate Affairs Officer\ninvestors@damoratx.com\nmedia@damoratx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/547722cf-495b-4464-97a9-35bea3fa5d15)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-05T12:00:03.084190702Z","server_sent_at_ms":1785931203084},"received_at":"2026-08-05T12:00:03.134Z","source_url":"https://www.globenewswire.com/news-release/2026/08/05/3339271/0/en/damora-therapeutics-initiates-phase-1-1b-clarity-101-clinical-trial-of-dmr-001-in-patients-with-mutant-calreticulin-driven-essential-thrombocythemia-and-myelofibrosis.html"},"analysis":{"id":"98411","press_release_id":"109408","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Damora Therapeutics initiated the global Phase 1/1b CLARITY-101 clinical trial of DMR-001 for patients with mutant calreticulin-driven essential thrombocythemia and myelofibrosis.\n\nThe trial will evaluate the antibody therapy's safety and efficacy, utilizing a dose escalation design starting at 100 mg monthly, with initial data expected in mid-2027.\n\nPreclinical studies indicate DMR-001 offers a 30-fold potency increase and five-fold longer half-life compared to a reference antibody, supporting best-in-class potential.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Damora advances lead asset DMR-001 into Phase 1/1b with best-in-class preclinical data."},"keyFigures":{"drugName":"DMR-001","phaseOfTrial":"Phase 1/1b","customDimensions":{"starting_dose":"100 mg monthly","us_patient_population":42000,"potency_increase_vs_reference":"30-fold","half_life_increase_vs_reference":"5-fold"}},"quotedText":"We’re excited to announce the initiation of our first clinical trial of DMR-001, a potentially best-in-class mutCALR-targeted therapy","namedEntities":{"people":[{"name":"Becker Hewes","role":"Chief Medical Officer"},{"name":"David Ross","role":"Investigator; Associate Professor of Haematology at Flinders Medical Centre"},{"name":"Jim Baker","role":"Chief Corporate Affairs Officer"}],"products":["DMR-001"],"companies":[{"name":"Damora Therapeutics, Inc.","ticker":"DMRA"},{"name":"Flinders Medical Centre","relationship":"clinical trial site"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Initiation of the first-in-human Phase 1/1b trial for the company's lead asset DMR-001 is a significant de-risking milestone for a clinical-stage biotech, validating preclinical data and advancing the pipeline."},"tickerRelevance":{"others":[],"primary":"DMRA"},"globalImportance":25,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"clinical_trial_initiation","sectorWeight":"biotech"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Damora Therapeutics initiated the global Phase 1/1b CLARITY-101 clinical trial of DMR-001 for patients with mutant calreticulin-driven essential thrombocythemia and myelofibrosis.\n\nThe trial will evaluate the antibody therapy's safety and efficacy, utilizing a dose escalation design starting at 100 mg monthly, with initial data expected in mid-2027.\n\nPreclinical studies indicate DMR-001 offers a 30-fold potency increase and five-fold longer half-life compared to a reference antibody, supporting best-in-class potential.","key_figures":{"drugName":"DMR-001","phaseOfTrial":"Phase 1/1b","customDimensions":{"starting_dose":"100 mg monthly","us_patient_population":42000,"potency_increase_vs_reference":"30-fold","half_life_increase_vs_reference":"5-fold"}},"named_entities":{"people":[{"name":"Becker Hewes","role":"Chief Medical Officer"},{"name":"David Ross","role":"Investigator; Associate Professor of Haematology at Flinders Medical Centre"},{"name":"Jim Baker","role":"Chief Corporate Affairs Officer"}],"products":["DMR-001"],"companies":[{"name":"Damora Therapeutics, Inc.","ticker":"DMRA"},{"name":"Flinders Medical Centre","relationship":"clinical trial site"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-05T16:40:00.753Z","global_importance":25,"audience_relevance":30,"importance_components":{"tickerTier":"small-cap","eventGravity":"clinical_trial_initiation","sectorWeight":"biotech"}},"durationMs":167358,"modelName":"glm-4.7"}}