{"success":true,"data":{"pressRelease":{"id":"51750","rtpr_id":"nGNE5BnJjG","ticker":"HRTIS","exchange":"Nasdaq Helsinki","all_tickers":["HRTIS"],"title":"Herantis reports positive FDA feedback and finalizes Phase 2a study design for HER-096","author":"Globe Newswire","published_at":"2026-06-02T09:57:42.070Z","article_body":"* FDA considered the planned HER-096 Phase 2a study design appropriate\n* Study design finalized; approximately 100 patients to be enrolled\n* More than 50% of Phase 2 funding secured or identified\nEspoo, Finland, 2 June 2026: Herantis Pharma Plc (“Herantis”), a\nclinical-stage company developing disease-modifying therapies to stop the\nprogression of Parkinson’s disease, today provides an update on preparations\nfor the Phase 2a proof-of-concept efficacy study of HER-096, its lead\ncandidate for the treatment of Parkinson's disease, ahead of its webcast being\nhosted later today at 13.00 EEST (12:00 CEST).\n\nHerantis recently completed a pre-IND meeting with the U.S. Food and Drug\nAdministration (FDA) to discuss the planned clinical development of HER-096.\nThe FDA raised no concerns regarding the Company's chemistry, manufacturing\nand controls (CMC) information or preclinical data package and confirmed that,\nbased on the current data package, Herantis would be in a position to activate\nU.S. clinical sites should an Investigational New Drug (IND) application be\nsubmitted. The FDA considered the Phase 2a trial design appropriate for the\ncurrent stage of development and discussions also included the endpoint\nstrategy for future clinical studies.\n\nThe Phase 2a study is designed to evaluate the efficacy, safety and\ntolerability of HER-096 in patients with early-stage Parkinson's disease and\nis expected to provide the first evidence of its potential to deliver\nmeaningful clinical benefit in patients. The randomized, double-blind,\nplacebo-controlled study is expected to enroll approximately 100 newly\ndiagnosed Parkinson’s disease patients who are not receiving symptomatic\nmedication across multiple sites in Europe. Patients will receive twice-weekly\nsubcutaneous dosing of HER-096 or placebo for six months, followed by a\nsix-month open-label extension. The study will use a Digital Motor Score (DMS)\nas its primary endpoint, complemented by established clinical assessments,\nimaging and biomarker analyses. The integration of Indivi's digital biomarker\nplatform is intended to provide objective and continuous assessments of\ndisease progression and treatment response.\n\nHerantis has appointed CTC Clinical Trial Consultants AB (CTC) as the clinical\nCRO to support the execution of the Phase 2a study. CTC brings extensive\nexperience in Parkinson's disease clinical trials and will support study\nstart-up, site management and operational execution across participating study\ncenters.\n\nHerantis has already secured significant support for the program through the\npreviously announced €8 million Horizon Europe grant and the potential for\nfurther investment from the European Innovation Council (EIC) Fund. Over 50%\nof the funding required to execute the Phase 2 study has been secured or\nidentified. The Company continues to evaluate financing alternatives to\nsupport advancement into Phase 2, including strategic partnerships, equity\nfinancing and non-dilutive funding.\n\nAntti Vuolanto, CEO of Herantis Pharma, said: “The successful outcome of our\nFDA meeting is an important milestone as we advance HER-096 towards Phase 2\ndevelopment. Together with our positive Phase 1b data, encouraging biomarker\nfindings and Horizon Europe grant support, the FDA feedback strengthens our\nconfidence in the program and our development strategy. With the study design\nnow finalized and our CRO partner selected, we have taken a significant step\ntowards initiating the Phase 2a proof-of-concept efficacy study. We look\nforward to initiating the study and generating data that will further evaluate\nHER-096's potential as a disease-modifying treatment for Parkinson's\ndisease.”\n\nWebcast details\nHerantis' management team will host a webcast today, Tuesday 2 June 2026, at\n13.00 EEST (12.00 CEST), during which the Company will provide further details\non the study design, the FDA feedback and recent corporate developments.\n\nAttendees are invited to pre-register and join the online event using the\nfollowing link: https://herantis.videosync.fi/update-on-phase-2-preparation\n\nQuestions can be submitted throughout the webcast event and a recording will\nbe available on the Company’s website following the event.\n\nFor more information, please contact:\n\nHerantis Pharma Plc\nAntti Vuolanto, CEO\nTel: +358407517329\n\nTone Kvåle, CFO\nTel: +47 915 19576\nEmail: ir@herantis.com\n\nICR Healthcare\n(https://www.globenewswire.com/Tracker?data=dFiw4HzbydzqBB6R29dOIsP1UZ7oe0mXm-1j2T1rvYz5PE9fZ8l7FiEtezo1iFgZb29BfGUkSUxVgXrTY7oGm-bIPBpoirO4dsnrBqn6oNZJH6O_sswW6bWelaL1xS7o)\nSarah Elton-Farr, Stephanie Cuthbert, Phillip Marriage\nTel: +44 20 3709 5700\nEmail: herantispharma@icrhealthcare.com\n\nCertified Advisor:\nUB Corporate Finance Ltd\nTel: +358 9 25 380 225\nEmail: ubcf@unitedbankers.fi\n\nAbout Herantis Pharma Plc\n\nHerantis Pharma Plc is a clinical-stage biotechnology company developing\ndisease-modifying therapies for Parkinson’s disease. The Company’s lead\nproduct, HER-096, is a first-in-class small peptide that combines the\nneuroprotective mechanism of cerebral dopamine neurotrophic factor (CDNF),\nwith the convenience of subcutaneous administration. In a Phase 1b clinical\ntrial, HER 096 was shown to be generally safe and well tolerated in\nParkinson’s disease patients.\n\nHerantis is listed on the Nasdaq First North Growth Market Finland.\n\nCompany website: www.herantis.com\n\nForward-looking statements\nThis release includes forward-looking statements which are not historical\nfacts but statements regarding future expectations instead. These\nforward-looking statements include without limitation, those regarding\nHerantis’ future financial position and results of operations, the\nCompany’s strategy, objectives, future developments in the markets in which\nthe Company participates or is seeking to participate or anticipated\nregulatory changes in the markets in which the Company operates or intends to\noperate. In some cases, forward-looking statements can be identified by\nterminology such as “aim,” “anticipate,” “believe,”\n“continue,” “could,” “estimate,” “expect,” “forecast,”\n“guidance,” “intend,” “may,” “plan,” “potential,”\n“predict,” “projected,” “should” or “will” or the negative of\nsuch terms or other comparable terminology. By their nature, forward-looking\nstatements involve known and unknown risks, uncertainties and other factors\nbecause they relate to events and depend on circumstances that may or may not\noccur in the future. Forward-looking statements are not guarantees of future\nperformance and are based on numerous assumptions. The Company’s actual\nresults of operations, including the Company’s financial condition and\nliquidity and the development of the industry in which the Company operates,\nmay differ materially from (and be more negative than) those made in, or\nsuggested by, the forward-looking statements contained in this company\nrelease. Factors, including risks and uncertainties that could cause these\ndifferences include, but are not limited to risks associated with\nimplementation of Herantis’ strategy, risks and uncertainties associated\nwith the development and/or approval of Herantis’ drug candidates, ongoing\nand future clinical trials and expected trial results, the ability to\ncommercialize drug candidates, technology changes and new products in\nHerantis’ potential market and industry, Herantis’ freedom to operate in\nrespect of the products it develops (which freedom may be limited, e.g., by\ncompetitors’ patents), the ability to develop new products and enhance\nexisting products, the impact of competition, changes in general economy and\nindustry conditions, and legislative, regulatory and political factors. In\naddition, even if Herantis’ historical results of operations, including the\nCompany’s financial condition and liquidity and the development of the\nindustry in which the Company operates, are consistent with the\nforward-looking statements contained in this company release, those results or\ndevelopments may not be indicative of results or developments in subsequent\nperiods.","article_body_html":"","raw_payload":{"data":{"id":"nGNE5BnJjG","title":"Herantis reports positive FDA feedback and finalizes Phase 2a study design for HER-096","author":"Globe Newswire","ticker":"HRTIS","created":"2026-06-02T09:57:42.070Z","tickers":["HRTIS"],"exchange":"Nasdaq Helsinki","article_body":"* FDA considered the planned HER-096 Phase 2a study design appropriate\n* Study design finalized; approximately 100 patients to be enrolled\n* More than 50% of Phase 2 funding secured or identified\nEspoo, Finland, 2 June 2026: Herantis Pharma Plc (“Herantis”), a\nclinical-stage company developing disease-modifying therapies to stop the\nprogression of Parkinson’s disease, today provides an update on preparations\nfor the Phase 2a proof-of-concept efficacy study of HER-096, its lead\ncandidate for the treatment of Parkinson's disease, ahead of its webcast being\nhosted later today at 13.00 EEST (12:00 CEST).\n\nHerantis recently completed a pre-IND meeting with the U.S. Food and Drug\nAdministration (FDA) to discuss the planned clinical development of HER-096.\nThe FDA raised no concerns regarding the Company's chemistry, manufacturing\nand controls (CMC) information or preclinical data package and confirmed that,\nbased on the current data package, Herantis would be in a position to activate\nU.S. clinical sites should an Investigational New Drug (IND) application be\nsubmitted. The FDA considered the Phase 2a trial design appropriate for the\ncurrent stage of development and discussions also included the endpoint\nstrategy for future clinical studies.\n\nThe Phase 2a study is designed to evaluate the efficacy, safety and\ntolerability of HER-096 in patients with early-stage Parkinson's disease and\nis expected to provide the first evidence of its potential to deliver\nmeaningful clinical benefit in patients. The randomized, double-blind,\nplacebo-controlled study is expected to enroll approximately 100 newly\ndiagnosed Parkinson’s disease patients who are not receiving symptomatic\nmedication across multiple sites in Europe. Patients will receive twice-weekly\nsubcutaneous dosing of HER-096 or placebo for six months, followed by a\nsix-month open-label extension. The study will use a Digital Motor Score (DMS)\nas its primary endpoint, complemented by established clinical assessments,\nimaging and biomarker analyses. The integration of Indivi's digital biomarker\nplatform is intended to provide objective and continuous assessments of\ndisease progression and treatment response.\n\nHerantis has appointed CTC Clinical Trial Consultants AB (CTC) as the clinical\nCRO to support the execution of the Phase 2a study. CTC brings extensive\nexperience in Parkinson's disease clinical trials and will support study\nstart-up, site management and operational execution across participating study\ncenters.\n\nHerantis has already secured significant support for the program through the\npreviously announced €8 million Horizon Europe grant and the potential for\nfurther investment from the European Innovation Council (EIC) Fund. Over 50%\nof the funding required to execute the Phase 2 study has been secured or\nidentified. The Company continues to evaluate financing alternatives to\nsupport advancement into Phase 2, including strategic partnerships, equity\nfinancing and non-dilutive funding.\n\nAntti Vuolanto, CEO of Herantis Pharma, said: “The successful outcome of our\nFDA meeting is an important milestone as we advance HER-096 towards Phase 2\ndevelopment. Together with our positive Phase 1b data, encouraging biomarker\nfindings and Horizon Europe grant support, the FDA feedback strengthens our\nconfidence in the program and our development strategy. With the study design\nnow finalized and our CRO partner selected, we have taken a significant step\ntowards initiating the Phase 2a proof-of-concept efficacy study. We look\nforward to initiating the study and generating data that will further evaluate\nHER-096's potential as a disease-modifying treatment for Parkinson's\ndisease.”\n\nWebcast details\nHerantis' management team will host a webcast today, Tuesday 2 June 2026, at\n13.00 EEST (12.00 CEST), during which the Company will provide further details\non the study design, the FDA feedback and recent corporate developments.\n\nAttendees are invited to pre-register and join the online event using the\nfollowing link: https://herantis.videosync.fi/update-on-phase-2-preparation\n\nQuestions can be submitted throughout the webcast event and a recording will\nbe available on the Company’s website following the event.\n\nFor more information, please contact:\n\nHerantis Pharma Plc\nAntti Vuolanto, CEO\nTel: +358407517329\n\nTone Kvåle, CFO\nTel: +47 915 19576\nEmail: ir@herantis.com\n\nICR Healthcare\n(https://www.globenewswire.com/Tracker?data=dFiw4HzbydzqBB6R29dOIsP1UZ7oe0mXm-1j2T1rvYz5PE9fZ8l7FiEtezo1iFgZb29BfGUkSUxVgXrTY7oGm-bIPBpoirO4dsnrBqn6oNZJH6O_sswW6bWelaL1xS7o)\nSarah Elton-Farr, Stephanie Cuthbert, Phillip Marriage\nTel: +44 20 3709 5700\nEmail: herantispharma@icrhealthcare.com\n\nCertified Advisor:\nUB Corporate Finance Ltd\nTel: +358 9 25 380 225\nEmail: ubcf@unitedbankers.fi\n\nAbout Herantis Pharma Plc\n\nHerantis Pharma Plc is a clinical-stage biotechnology company developing\ndisease-modifying therapies for Parkinson’s disease. The Company’s lead\nproduct, HER-096, is a first-in-class small peptide that combines the\nneuroprotective mechanism of cerebral dopamine neurotrophic factor (CDNF),\nwith the convenience of subcutaneous administration. In a Phase 1b clinical\ntrial, HER 096 was shown to be generally safe and well tolerated in\nParkinson’s disease patients.\n\nHerantis is listed on the Nasdaq First North Growth Market Finland.\n\nCompany website: www.herantis.com\n\nForward-looking statements\nThis release includes forward-looking statements which are not historical\nfacts but statements regarding future expectations instead. These\nforward-looking statements include without limitation, those regarding\nHerantis’ future financial position and results of operations, the\nCompany’s strategy, objectives, future developments in the markets in which\nthe Company participates or is seeking to participate or anticipated\nregulatory changes in the markets in which the Company operates or intends to\noperate. In some cases, forward-looking statements can be identified by\nterminology such as “aim,” “anticipate,” “believe,”\n“continue,” “could,” “estimate,” “expect,” “forecast,”\n“guidance,” “intend,” “may,” “plan,” “potential,”\n“predict,” “projected,” “should” or “will” or the negative of\nsuch terms or other comparable terminology. By their nature, forward-looking\nstatements involve known and unknown risks, uncertainties and other factors\nbecause they relate to events and depend on circumstances that may or may not\noccur in the future. Forward-looking statements are not guarantees of future\nperformance and are based on numerous assumptions. The Company’s actual\nresults of operations, including the Company’s financial condition and\nliquidity and the development of the industry in which the Company operates,\nmay differ materially from (and be more negative than) those made in, or\nsuggested by, the forward-looking statements contained in this company\nrelease. Factors, including risks and uncertainties that could cause these\ndifferences include, but are not limited to risks associated with\nimplementation of Herantis’ strategy, risks and uncertainties associated\nwith the development and/or approval of Herantis’ drug candidates, ongoing\nand future clinical trials and expected trial results, the ability to\ncommercialize drug candidates, technology changes and new products in\nHerantis’ potential market and industry, Herantis’ freedom to operate in\nrespect of the products it develops (which freedom may be limited, e.g., by\ncompetitors’ patents), the ability to develop new products and enhance\nexisting products, the impact of competition, changes in general economy and\nindustry conditions, and legislative, regulatory and political factors. In\naddition, even if Herantis’ historical results of operations, including the\nCompany’s financial condition and liquidity and the development of the\nindustry in which the Company operates, are consistent with the\nforward-looking statements contained in this company release, those results or\ndevelopments may not be indicative of results or developments in subsequent\nperiods."},"type":"article","timestamp":"2026-06-02T09:57:42.155400811Z","server_sent_at_ms":1780394262155},"received_at":"2026-06-02T09:57:42.215Z","source_url":null},"analysis":{"id":"41182","press_release_id":"51750","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Company is evaluating financing alternatives including equity financing, indicating potential dilution risk to fund Phase 2."],"eventType":"clinical_trial","narrative":"Herantis Pharma received positive feedback from the FDA regarding its planned Phase 2a study design for HER-096, its lead candidate for Parkinson’s disease.\n\nThe FDA raised no concerns about the chemistry, manufacturing, and controls (CMC) or preclinical data, confirming the company can activate U.S. clinical sites upon IND submission.\n\nThe Phase 2a trial will enroll approximately 100 patients in Europe, using a Digital Motor Score as the primary endpoint, with over 50% of required funding already secured or identified.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Herantis de-risks HER-096 with positive FDA feedback on Phase 2a design; U.S. sites ready for activation."},"keyFigures":{"drugName":"HER-096","phaseOfTrial":"Phase 2a","customDimensions":{"patient_enrollment":100,"funding_secured_pct":"50%","horizon_europe_grant":"€8 million"}},"quotedText":"The successful outcome of our FDA meeting is an important milestone as we advance HER-096 towards Phase 2 development.","namedEntities":{"people":[{"name":"Antti Vuolanto","role":"CEO"},{"name":"Tone Kvåle","role":"CFO"}],"products":["HER-096","Digital Motor Score (DMS)"],"companies":[{"name":"Herantis Pharma Plc","ticker":"HRTIS","relationship":"filer"},{"name":"CTC Clinical Trial Consultants AB","relationship":"CRO partner"},{"name":"Indivi","relationship":"technology partner"},{"name":"European Innovation Council (EIC) Fund","relationship":"potential funder"},{"name":"UB Corporate Finance Ltd","relationship":"certified advisor"},{"name":"ICR Healthcare","relationship":"IR advisor"}],"dollarAmounts":[{"amount":"€8 million","context":"Horizon Europe grant"}]},"materialImpact":{"score":3,"reasoning":"Positive FDA feedback on Phase 2a study design and finalization of the trial protocol are significant de-risking milestones for a clinical-stage biotech. However, this is a pre-IND/design update, not a trial completion or binary regulatory approval, warranting a moderate score."},"tickerRelevance":{"others":[],"primary":"HRTIS"},"globalImportance":25,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"clinical_milestone","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"low","retailFavoriteBoost":0}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Herantis Pharma received positive feedback from the FDA regarding its planned Phase 2a study design for HER-096, its lead candidate for Parkinson’s disease.\n\nThe FDA raised no concerns about the chemistry, manufacturing, and controls (CMC) or preclinical data, confirming the company can activate U.S. clinical sites upon IND submission.\n\nThe Phase 2a trial will enroll approximately 100 patients in Europe, using a Digital Motor Score as the primary endpoint, with over 50% of required funding already secured or identified.","key_figures":{"drugName":"HER-096","phaseOfTrial":"Phase 2a","customDimensions":{"patient_enrollment":100,"funding_secured_pct":"50%","horizon_europe_grant":"€8 million"}},"named_entities":{"people":[{"name":"Antti Vuolanto","role":"CEO"},{"name":"Tone Kvåle","role":"CFO"}],"products":["HER-096","Digital Motor Score (DMS)"],"companies":[{"name":"Herantis Pharma Plc","ticker":"HRTIS","relationship":"filer"},{"name":"CTC Clinical Trial Consultants AB","relationship":"CRO partner"},{"name":"Indivi","relationship":"technology partner"},{"name":"European Innovation Council (EIC) Fund","relationship":"potential funder"},{"name":"UB Corporate Finance Ltd","relationship":"certified advisor"},{"name":"ICR Healthcare","relationship":"IR advisor"}],"dollarAmounts":[{"amount":"€8 million","context":"Horizon Europe grant"}]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-02T09:58:25.115Z","global_importance":25,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap","eventGravity":"clinical_milestone","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"low","retailFavoriteBoost":0}},"durationMs":42886,"modelName":"george-droid-qwen-72b"}}