{"success":true,"data":{"pressRelease":{"id":"160413","rtpr_id":"nGNX3GHtt9-20261005","ticker":"LSTA","exchange":"NASDAQ","all_tickers":["LSTA"],"title":"Marea Therapeutics, a Subsidiary of Lisata Therapeutics, Announces First Patient Dosed in Phase 2 Clinical Trial of MAR002, a Potential Best-in-disease Investigational Therapy for the Treatment of Acromegaly","author":"Globe Newswire","published_at":"2026-10-05T12:00:01.442Z","article_body":"Trial follows promising MAR002 Phase 1 clinical trial results that\ndemonstrated deep and durable IGF-1 suppression with PK properties that may\nenable dosing as infrequently as once every two weeks, compared to the daily\nsubcutaneous injections required by the current standard of care\n\nBy directly blocking growth hormone signaling at the receptor level, MAR002\nhas the potential to deliver meaningful biochemical control for a broad\npopulation of acromegaly patients\n\nSOUTH SAN FRANCISCO, Calif. and LIBERTY CORNER, N.J., Oct. 05, 2026 (GLOBE\nNEWSWIRE) -- Marea Therapeutics, LLC (“Marea”), a subsidiary of Lisata\nTherapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage\nbiotechnology company harnessing the latest advances in human genetics to\ndevelop first-in-class, next-generation medicines for cardioendocrine\ndiseases, today announced the first patient has been dosed in its Phase 2\nclinical trial of MAR002 for the treatment of acromegaly.\n\nAcromegaly is a rare, chronic, progressive endocrine disorder caused by\nprolonged exposure to excess growth hormone (GH), most commonly due to a\nGH-secreting pituitary adenoma, resulting in elevated insulin-like growth\nfactor-1 (IGF-1). It leads to the abnormal enlargement of the hands, feet, and\nfacial features, and if left untreated, can result in severe organ damage,\nsystemic complications, and early mortality.\n\nMAR002 is a first-in-class allosteric monoclonal antibody investigational\ntherapy targeting the growth hormone receptor (GHR). Data from a\nfirst-in-human Phase 1 study with MAR002 presented at the 2026 Annual Meeting\nof the Endocrine Society (ENDO) in June 2026 demonstrated compelling\nproof-of-mechanism with deep and durable IGF-1 suppression and pharmacokinetic\n(PK) properties that may enable dosing as infrequently as once every two\nweeks, compared to the daily subcutaneous injections required by the current\nstandard of care.\n\n“Treating our first acromegaly patient with MAR002 represents an important\nmilestone for Marea Therapeutics,” said Josh Lehrer, M.D., president and\nchief operating officer of Lisata Therapeutics and chief executive officer of\nMarea Therapeutics. “We believe MAR002 has a potential best-in-class profile\nand, if approved, could be transformative for the majority of acromegaly\npatients who cannot achieve disease control with current therapies. We are\nfocused on clinical execution to rapidly advance this product candidate to\nacromegaly patients who need new treatment options.”\n\n“People living with acromegaly often face years of symptoms before receiving\na diagnosis, and even after diagnosis, many continue to struggle with the\nlong-term burden of managing this chronic disease,” said Jill Sisco,\npresident of Acromegaly Community, Inc. “The advancement of new treatment\noptions that have the potential to provide effective disease control while\nreducing treatment burden offers hope for the acromegaly community. We are\nencouraged to see continued investment in investigational therapies like\nMAR002 that aim to address the needs and priorities of people living with this\ncondition and expand treatment options.”\n\nThis study intends to enroll approximately 72 participants with acromegaly\nacross three MAR002 dose arms, after an initial 900 mg loading dose, compared\nto placebo, with a primary endpoint of IGF-1 reduction following 10 weeks of\ntreatment. After completing the 10-week treatment period, eligible\nparticipants will have an option to enroll in an open-label extension clinical\ntrial.\n\nAbout Acromegaly \nAcromegaly is an orphan disease characterized by the excess secretion of\ngrowth hormone (GH) from a benign pituitary adenoma. Acromegaly affects\napproximately 30,000 patients in the U.S. If left untreated, acromegaly is\nhighly morbid, leading to significant comorbidities such as GH-induced insulin\nresistance and diabetes, and serious cardiovascular pathology. The median\nlifespan of patients can be shortened by 10 years without effective therapy,\nand incomplete IGF-1 normalization is associated with increased mortality.\nDespite its severity, acromegaly is often under or misdiagnosed, with an\naverage time from symptom onset to diagnosis of approximately eight years.\n\nAbout MAR002\nMAR002 is a potent and selective half-life-extended, allosteric, human\nmonoclonal growth hormone receptor antagonist (GHRA) antibody being developed\nfor the treatment of acromegaly. The in vivo PK and PD properties of MAR002\nhave been observed to be predictable and typical of a half-life extended human\nantibody, showing a long duration of action compatible with infrequent\nsubcutaneous dose administration in humans. These characteristics support its\npotential to offer an effective and convenient treatment for patients with\nacromegaly, if approved.\n\nAbout Marea Therapeutics\nMarea Therapeutics is a clinical-stage biotechnology company harnessing the\nlatest advances in human genetics to develop first-in-class, next-generation\nmedicines for cardioendocrine diseases. The company’s lead product\ncandidate, MAR001, is in Phase 2b clinical development for the treatment of\nsevere hypertriglyceridemia (sHTG), a condition characterized by very high\ntriglyceride levels. The company is also advancing MAR002 in Phase 2 clinical\ndevelopment for the treatment of acromegaly. To learn more, please visit\nwww.mareatx.com and follow us on LinkedIn and X.\n\nAbout Lisata Therapeutics\nLisata Therapeutics is a clinical-stage pharmaceutical company. Following its\nacquisition of Marea, Lisata’s lead product candidate is MAR001, which is in\nPhase 2b clinical development for the treatment of severe hypertriglyceridemia\n(sHTG), a condition characterized by very high triglyceride levels. The\ncompany is also advancing MAR002 for the treatment of acromegaly.\n\nCautionary Note Regarding Forward-Looking Statements\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, concerning Lisata and Marea. These forward-looking statements\ninclude, but are not limited to, express or implied statements relating to the\ncompany’s expectations, hopes, beliefs, intentions or strategies regarding\nthe future including, without limitation, statements regarding expectations\nregarding or plans for the company’s pipeline, including its ongoing\nclinical trials, research and development programs and the expected timing for\nkey milestones; and the potential benefits of its product candidates,\nincluding MAR002 and MAR001. In addition, any statements that refer to\nprojections, forecasts or other characterizations of future events or\ncircumstances, including any underlying assumptions, are forward-looking\nstatements. The words “opportunity,” “potential,” “milestones,”\n“pipeline,” “can,” “goal,” “aim,” “strategy,”\n“target,” “seek,” “anticipate,” “achieve,” “believe,”\n“contemplate,” “continue,” “could,” “estimate,” “expect,”\n“intends,” “may,” “might,” “plan,” “possible,”\n“predict,” “project,” “should,” “will,” “would” and\nsimilar expressions (including the negatives of these terms or variations of\nthem) may identify forward-looking statements, but the absence of these words\ndoes not mean that a statement is not forward-looking. 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 heading “Risk Factors” in\nthe company’s most recent Annual Report on Form 10-K for the year ended\nDecember 31, 2025, filed with the Securities and Exchange Commission (the\n“SEC”) on March 12, 2026, as well as discussions of potential risks,\nuncertainties, and other important factors included in other filings by the\ncompany from time to time, as well as risk factors associated with companies,\nsuch as Marea, that operate in the biotechnology industry. Should one or more\nof these risks 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 herein 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. Except to\nthe extent required by applicable law, the company does not undertake or\naccept any duty to release publicly any updates or revisions to any\nforward-looking statements. This press release does not purport to summarize\nall of the conditions, risks and other attributes of an investment in the\ncompany.\n\nLisata:\n\nInvestors and Media:\nJohn Menditto\njmenditto@lisata.com\n\nMarea:\n\nMedia:\n1AB\nKatie Engleman\nkatie@1abmedia.com   \n\nInvestors:\nMeru Advisors\nLauren Glaser\nlglaser@meruadvisors.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/da63f6aa-3c32-4a68-9476-7d4e40cec64d)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3GHtt9-20261005","title":"Marea Therapeutics, a Subsidiary of Lisata Therapeutics, Announces First Patient Dosed in Phase 2 Clinical Trial of MAR002, a Potential Best-in-disease Investigational Therapy for the Treatment of Acromegaly","author":"Globe Newswire","ticker":"LSTA","created":"2026-10-05T12:00:01.442Z","tickers":["LSTA"],"exchange":"NASDAQ","article_body":"Trial follows promising MAR002 Phase 1 clinical trial results that\ndemonstrated deep and durable IGF-1 suppression with PK properties that may\nenable dosing as infrequently as once every two weeks, compared to the daily\nsubcutaneous injections required by the current standard of care\n\nBy directly blocking growth hormone signaling at the receptor level, MAR002\nhas the potential to deliver meaningful biochemical control for a broad\npopulation of acromegaly patients\n\nSOUTH SAN FRANCISCO, Calif. and LIBERTY CORNER, N.J., Oct. 05, 2026 (GLOBE\nNEWSWIRE) -- Marea Therapeutics, LLC (“Marea”), a subsidiary of Lisata\nTherapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage\nbiotechnology company harnessing the latest advances in human genetics to\ndevelop first-in-class, next-generation medicines for cardioendocrine\ndiseases, today announced the first patient has been dosed in its Phase 2\nclinical trial of MAR002 for the treatment of acromegaly.\n\nAcromegaly is a rare, chronic, progressive endocrine disorder caused by\nprolonged exposure to excess growth hormone (GH), most commonly due to a\nGH-secreting pituitary adenoma, resulting in elevated insulin-like growth\nfactor-1 (IGF-1). It leads to the abnormal enlargement of the hands, feet, and\nfacial features, and if left untreated, can result in severe organ damage,\nsystemic complications, and early mortality.\n\nMAR002 is a first-in-class allosteric monoclonal antibody investigational\ntherapy targeting the growth hormone receptor (GHR). Data from a\nfirst-in-human Phase 1 study with MAR002 presented at the 2026 Annual Meeting\nof the Endocrine Society (ENDO) in June 2026 demonstrated compelling\nproof-of-mechanism with deep and durable IGF-1 suppression and pharmacokinetic\n(PK) properties that may enable dosing as infrequently as once every two\nweeks, compared to the daily subcutaneous injections required by the current\nstandard of care.\n\n“Treating our first acromegaly patient with MAR002 represents an important\nmilestone for Marea Therapeutics,” said Josh Lehrer, M.D., president and\nchief operating officer of Lisata Therapeutics and chief executive officer of\nMarea Therapeutics. “We believe MAR002 has a potential best-in-class profile\nand, if approved, could be transformative for the majority of acromegaly\npatients who cannot achieve disease control with current therapies. We are\nfocused on clinical execution to rapidly advance this product candidate to\nacromegaly patients who need new treatment options.”\n\n“People living with acromegaly often face years of symptoms before receiving\na diagnosis, and even after diagnosis, many continue to struggle with the\nlong-term burden of managing this chronic disease,” said Jill Sisco,\npresident of Acromegaly Community, Inc. “The advancement of new treatment\noptions that have the potential to provide effective disease control while\nreducing treatment burden offers hope for the acromegaly community. We are\nencouraged to see continued investment in investigational therapies like\nMAR002 that aim to address the needs and priorities of people living with this\ncondition and expand treatment options.”\n\nThis study intends to enroll approximately 72 participants with acromegaly\nacross three MAR002 dose arms, after an initial 900 mg loading dose, compared\nto placebo, with a primary endpoint of IGF-1 reduction following 10 weeks of\ntreatment. After completing the 10-week treatment period, eligible\nparticipants will have an option to enroll in an open-label extension clinical\ntrial.\n\nAbout Acromegaly \nAcromegaly is an orphan disease characterized by the excess secretion of\ngrowth hormone (GH) from a benign pituitary adenoma. Acromegaly affects\napproximately 30,000 patients in the U.S. If left untreated, acromegaly is\nhighly morbid, leading to significant comorbidities such as GH-induced insulin\nresistance and diabetes, and serious cardiovascular pathology. The median\nlifespan of patients can be shortened by 10 years without effective therapy,\nand incomplete IGF-1 normalization is associated with increased mortality.\nDespite its severity, acromegaly is often under or misdiagnosed, with an\naverage time from symptom onset to diagnosis of approximately eight years.\n\nAbout MAR002\nMAR002 is a potent and selective half-life-extended, allosteric, human\nmonoclonal growth hormone receptor antagonist (GHRA) antibody being developed\nfor the treatment of acromegaly. The in vivo PK and PD properties of MAR002\nhave been observed to be predictable and typical of a half-life extended human\nantibody, showing a long duration of action compatible with infrequent\nsubcutaneous dose administration in humans. These characteristics support its\npotential to offer an effective and convenient treatment for patients with\nacromegaly, if approved.\n\nAbout Marea Therapeutics\nMarea Therapeutics is a clinical-stage biotechnology company harnessing the\nlatest advances in human genetics to develop first-in-class, next-generation\nmedicines for cardioendocrine diseases. The company’s lead product\ncandidate, MAR001, is in Phase 2b clinical development for the treatment of\nsevere hypertriglyceridemia (sHTG), a condition characterized by very high\ntriglyceride levels. The company is also advancing MAR002 in Phase 2 clinical\ndevelopment for the treatment of acromegaly. To learn more, please visit\nwww.mareatx.com and follow us on LinkedIn and X.\n\nAbout Lisata Therapeutics\nLisata Therapeutics is a clinical-stage pharmaceutical company. Following its\nacquisition of Marea, Lisata’s lead product candidate is MAR001, which is in\nPhase 2b clinical development for the treatment of severe hypertriglyceridemia\n(sHTG), a condition characterized by very high triglyceride levels. The\ncompany is also advancing MAR002 for the treatment of acromegaly.\n\nCautionary Note Regarding Forward-Looking Statements\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, concerning Lisata and Marea. These forward-looking statements\ninclude, but are not limited to, express or implied statements relating to the\ncompany’s expectations, hopes, beliefs, intentions or strategies regarding\nthe future including, without limitation, statements regarding expectations\nregarding or plans for the company’s pipeline, including its ongoing\nclinical trials, research and development programs and the expected timing for\nkey milestones; and the potential benefits of its product candidates,\nincluding MAR002 and MAR001. In addition, any statements that refer to\nprojections, forecasts or other characterizations of future events or\ncircumstances, including any underlying assumptions, are forward-looking\nstatements. The words “opportunity,” “potential,” “milestones,”\n“pipeline,” “can,” “goal,” “aim,” “strategy,”\n“target,” “seek,” “anticipate,” “achieve,” “believe,”\n“contemplate,” “continue,” “could,” “estimate,” “expect,”\n“intends,” “may,” “might,” “plan,” “possible,”\n“predict,” “project,” “should,” “will,” “would” and\nsimilar expressions (including the negatives of these terms or variations of\nthem) may identify forward-looking statements, but the absence of these words\ndoes not mean that a statement is not forward-looking. 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 heading “Risk Factors” in\nthe company’s most recent Annual Report on Form 10-K for the year ended\nDecember 31, 2025, filed with the Securities and Exchange Commission (the\n“SEC”) on March 12, 2026, as well as discussions of potential risks,\nuncertainties, and other important factors included in other filings by the\ncompany from time to time, as well as risk factors associated with companies,\nsuch as Marea, that operate in the biotechnology industry. Should one or more\nof these risks 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 herein 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. Except to\nthe extent required by applicable law, the company does not undertake or\naccept any duty to release publicly any updates or revisions to any\nforward-looking statements. This press release does not purport to summarize\nall of the conditions, risks and other attributes of an investment in the\ncompany.\n\nLisata:\n\nInvestors and Media:\nJohn Menditto\njmenditto@lisata.com\n\nMarea:\n\nMedia:\n1AB\nKatie Engleman\nkatie@1abmedia.com   \n\nInvestors:\nMeru Advisors\nLauren Glaser\nlglaser@meruadvisors.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/da63f6aa-3c32-4a68-9476-7d4e40cec64d)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-05T12:00:01.559352022Z","server_sent_at_ms":1791201601559},"received_at":"2026-10-05T12:00:01.608Z","source_url":null},"analysis":{"id":"148980","press_release_id":"160413","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Marea Therapeutics, a subsidiary of Lisata Therapeutics (LSTA), dosed the first patient in a Phase 2 trial of MAR002 for acromegaly.\n\nThe study plans to enroll roughly 72 participants across three dose arms versus placebo, with IGF-1 reduction after 10 weeks as the primary endpoint.\n\nPhase 1 data showed deep, durable IGF-1 suppression with potential dosing every two weeks versus the current standard of daily injections, supporting a best-in-disease thesis if it holds in Phase 2.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Lisata's subsidiary Marea advances MAR002 into Phase 2 for acromegaly with a differentiated every-two-week dosing profile."},"keyFigures":{"drugName":"MAR002","phaseOfTrial":"Phase 2","customDimensions":{"dosing":"once every two weeks potential vs daily injections for standard of care","dose_arms":3,"loading_dose":"900 mg","primary_endpoint":"IGF-1 reduction after 10 weeks of treatment","planned_enrollment":72}},"quotedText":"We believe MAR002 has a potential best-in-class profile and, if approved, could be transformative for the majority of acromegaly patients who cannot achieve disease control with current therapies.","namedEntities":{"people":[{"name":"Josh Lehrer, M.D.","role":"President and COO of Lisata Therapeutics; CEO of Marea Therapeutics"},{"name":"Jill Sisco","role":"President of Acromegaly Community, Inc."},{"name":"John Menditto","role":"Lisata investor and media contact"}],"products":["MAR002","MAR001"],"companies":[{"name":"Lisata Therapeutics, Inc.","ticker":"LSTA","relationship":"filer; parent of Marea Therapeutics"},{"name":"Marea Therapeutics, LLC","relationship":"subsidiary developing MAR002"},{"name":"Acromegaly Community, Inc.","relationship":"patient advocacy group"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"First patient dosed in a Phase 2 trial of subsidiary pipeline asset MAR002 for acromegaly. A routine pipeline milestone rather than a data readout; de-risking is modest and near-term revenue impact is nil."},"tickerRelevance":{"others":[],"primary":"LSTA"},"globalImportance":20,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"routine-pipeline-milestone","phaseOfAsset":"Phase 2","issuerAuthored":true}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Marea Therapeutics, a subsidiary of Lisata Therapeutics (LSTA), dosed the first patient in a Phase 2 trial of MAR002 for acromegaly.\n\nThe study plans to enroll roughly 72 participants across three dose arms versus placebo, with IGF-1 reduction after 10 weeks as the primary endpoint.\n\nPhase 1 data showed deep, durable IGF-1 suppression with potential dosing every two weeks versus the current standard of daily injections, supporting a best-in-disease thesis if it holds in Phase 2.","key_figures":{"drugName":"MAR002","phaseOfTrial":"Phase 2","customDimensions":{"dosing":"once every two weeks potential vs daily injections for standard of care","dose_arms":3,"loading_dose":"900 mg","primary_endpoint":"IGF-1 reduction after 10 weeks of treatment","planned_enrollment":72}},"named_entities":{"people":[{"name":"Josh Lehrer, M.D.","role":"President and COO of Lisata Therapeutics; CEO of Marea Therapeutics"},{"name":"Jill Sisco","role":"President of Acromegaly Community, Inc."},{"name":"John Menditto","role":"Lisata investor and media contact"}],"products":["MAR002","MAR001"],"companies":[{"name":"Lisata Therapeutics, Inc.","ticker":"LSTA","relationship":"filer; parent of Marea Therapeutics"},{"name":"Marea Therapeutics, LLC","relationship":"subsidiary developing MAR002"},{"name":"Acromegaly Community, Inc.","relationship":"patient advocacy group"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-05T12:00:21.907Z","global_importance":20,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap","eventGravity":"routine-pipeline-milestone","phaseOfAsset":"Phase 2","issuerAuthored":true}},"durationMs":5511,"modelName":"glm-5.3-flashx"}}