{"success":true,"data":{"pressRelease":{"id":"168785","rtpr_id":"nBw83g8QFa-20261014","ticker":"COYA","exchange":"NASDAQ","all_tickers":["COYA"],"title":"Coya to Initiate Open-Label Extension of Phase 2/3 ALSTARS Trial of COYA 302 in ALS","author":"Business Wire","published_at":"2026-10-14T12:00:00.735Z","article_body":"Coya to Initiate Open-Label Extension of Phase 2/3 ALSTARS Trial of COYA 302\nin ALS\n\n * OLE planned in response to requests from ALSTARS investigators and\nparticipants\n * Eligible participants completing 48 weeks of treatment will have the\nopportunity to continue receiving COYA 302\n * Cash runway guidance remains unchanged into the second half of 2027, beyond\nanticipated ALSTARS topline data readout in early Q2\nCoya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a\nclinical-stage biotechnology company developing biologics intended to enhance\nT-cell (Treg) function in patients with neurodegenerative disorders, today\nannounced plans to initiate an open-label extension (OLE) of the Phase 2/3\nALSTARS Trial (NCT07161999\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07161999%3Fterm%3DNCT07161999%26viewType%3DCard%26rank%3D1&esheet=54621305&newsitemid=20261014378134&lan=en-US&anchor=NCT07161999&index=1&md5=b63c41492470768498e7885210351e1d)\n) evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis\n(ALS).\n\nCoya plans to initiate the OLE in response to requests from ALSTARS\ninvestigators and study participants. The OLE will provide participants who\ncomplete the 48-week treatment period with the opportunity to continue\nreceiving COYA 302, while enabling the collection of longer-term efficacy and\nsafety data. Coya expects the OLE to begin in November 2026 as the first\ncohort completes the 48-week treatment period.\n\n“The strong interest from investigators and participants in continuing\ntreatment beyond the current 48-week study period underscores the importance\nof providing continued access to COYA 302 for eligible participants in the\nALSTARS trial,” said Fred Grossman, DO, FAPA, President and Chief Medical\nOfficer of Coya. “The open-label extension will also provide an opportunity\nto further characterize the long-term safety, tolerability, and potential\ntreatment effects of COYA 302 in people living with ALS. We are deeply\ngrateful to the patients, families, and investigators whose commitment makes\nthis important research possible.”\n\nConcurrent with the anticipated initiation of the OLE, Coya expects to\nprioritize resources toward the ongoing clinical development of COYA 302 in\nALS and assuring timely completion of important near-term milestones in the\nALSTARS trial. With this prioritization, the planned initiation of the Phase 2\nclinical trial evaluating COYA 302 in frontotemporal dementia (FTD),\npreviously anticipated in the second half of 2026, is now expected in 2027.\n\n“As we continue to advance and expand the ALSTARS trial, we believe\nprioritizing our resources behind COYA 302 in ALS is the appropriate\nnear-term, fiscal, and operational strategy for our Company,” said David\nSnyder, Chief Financial Officer of Coya.\n\nThe Company’s cash runway guidance remains unchanged, with existing cash\nresources expected to fund operations into the second half of 2027, beyond the\nanticipated ALSTARS topline data readout.\n\nAbout Amyotrophic Lateral Sclerosis (ALS)\n\nALS is a progressive neurodegenerative disease that attacks motor neurons in\nthe brain and spinal cord that control voluntary muscles, including those\nneeded to speak, swallow and breathe. The disease progresses rapidly, with\npatients experiencing an average decline of approximately one point per month\non the ALS Functional Rating Scale-Revised (ALSFRS-R), and 20% to 30% of\npatients dying within two years of diagnosis despite available therapies.\nApproximately 90% of ALS cases are sporadic, occurring in people with no\nfamily history of the disease. Current approved therapies provide only a\nmodest treatment effect and slow, but do not stop, disease progression and\nfunctional decline, underscoring the significant unmet need for new treatment\noptions that can meaningfully alter the course of the disease.\n\nAbout the ALSTARS Trial\n\nThe ALSTARS Trial is a Phase 2/3, randomized, multi-center, double-blind,\nplacebo-controlled study designed to evaluate the efficacy and safety of COYA\n302 in patients with ALS. Approximately 120 subjects will be randomized 1:1:1\nto receive one of two pre-specified dosing regimens of COYA 302 or placebo\nduring a 24-week double-blind treatment phase. Patients who complete the\n24-week placebo-controlled phase enter a 24-week blinded active-treatment\nextension phase; patients receiving COYA 302 continue their assigned regimen,\nwhile placebo patients are re-randomized to one of the two COYA 302 dosing\nregimens, providing up to 48 weeks of data on COYA 302.\n\nThe primary endpoint is change in disease severity over time, measured by the\nAmyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total\nscore from baseline to Week 24 compared with placebo. Study objectives include\nevaluation of efficacy, safety and tolerability, biological activity, and\nbiomarker levels.\n\nParticipants who complete the 48-week treatment period will be eligible to\nenroll in an open-label extension (OLE) to continue receiving COYA 302.\n\nTo learn more about the study, please visit ALSTARS Trial\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftrials.coyatherapeutics.com%2Fclinical-programs%2Falstars-trial-study-of-coya-302-for-the-treatment-of-als%2F&esheet=54621305&newsitemid=20261014378134&lan=en-US&anchor=ALSTARS+Trial&index=2&md5=3844155f95f080bdca49661b1dc88e23)\n.\n\nAbout COYA 302\n\nCOYA 302 is an investigational and proprietary biologic combination therapy\nwith a dual immunomodulatory mechanism of action intended to enhance the\nanti-inflammatory function of regulatory T cells (Tregs) and suppress the\ninflammation produced by activated monocytes and macrophages. COYA 302\ncomprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is\nbeing developed for subcutaneous administration for the treatment of patients\nwith ALS and other neurodegenerative diseases. These mechanisms may have\nadditive or synergistic effects.\n\nCoya is currently conducting the ALSTARS Trial, a Phase 2/3, randomized,\nmulti-center, double-blind, placebo-controlled study to evaluate the efficacy\nand safety of COYA 302 for the treatment of ALS (Identifier: NCT07161999).\n\nCOYA 302 is an investigational product not yet approved by the FDA or any\nother regulatory agency.\n\nAbout Coya Therapeutics, Inc.\n\nHeadquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a\nclinical-stage biotechnology company developing proprietary treatments focused\non the biology and potential therapeutic advantages of regulatory T cells\n(“Tregs”) to target systemic inflammation and neuroinflammation.\nDysfunctional Tregs underlie numerous conditions, including neurodegenerative,\nmetabolic, and autoimmune diseases. This cellular dysfunction may lead to\nsustained inflammation and oxidative stress resulting in lack of homeostasis\nof the immune system.\n\nCoya’s investigational product candidate pipeline leverages multiple\ntherapeutic modalities aimed at restoring the anti-inflammatory and\nimmunomodulatory functions of Tregs. Coya’s therapeutic platforms include\nTreg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell\ntherapy.\n\nFor more information about Coya, please visit www.coyatherapeutics.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fprotect.checkpoint.com%2Fv2%2Fr01%2F___http%3A%2F%2Fwww.coyatherapeutics.com___.YzJ1OnN0b3V0OmM6b2ZmaWNlMzY1X2VtYWlsc19hdHRhY2htZW50OjEyYjk1MzM2YThlNjg2ZWJkMjgyMzgzNWY4MTczM2Q1Ojc6MzMwMDoxMTBiNjk0MDA1MjBhYmJkNjczMTQ1OTJkNjYzZmQzNjQ3ODc4OTFkYjFkZWFlZmQxOTAzYjEwNWMyNmZkMzQzOnA6VDpG&esheet=54621305&newsitemid=20261014378134&lan=en-US&anchor=www.coyatherapeutics.com&index=3&md5=89b6cb8ceb5e47355be06a3b792d03ec)\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Statements in this press\nrelease that are not statements of historical fact are forward-looking\nstatements. Such forward-looking statements include, without limitation,\nstatements regarding: the commencement of the OLE, the commencement of the\nPhase 2 clinical trial evaluating COYA 302 in FTD, the timing of topline data\nfrom the double-blind treatment phase; expectations of Coya Therapeutics, Inc.\n(the “Company”) regarding the potential benefits, effectiveness, and\nsafety of its product candidates; the significance and potential benefits\nassociated with the FDA’s Fast Track designation for COYA 302; the\nCompany’s ability to advance its product candidates through the preclinical\nand clinical development processes; the Company’s expectations regarding\nquality, timing, and availability of data from the Company’s clinical\ntrials; the timing of announcements, updates and results of the Company’s\nclinical trials and related data; the Company’s future results of operations\nand financial position, including cash runway; and the potential therapeutic\nbenefits and economic value of the Company’s product candidates. These\nforward-looking statements are based on the beliefs of the management of the\nCompany as well as assumptions made by and information currently available to\nthe Company. Such statements reflect the current views of the Company with\nrespect to future events and are subject to known and unknown risks and\nuncertainties. In light of these risks and uncertainties, the events or\ncircumstances referred to in the forward-looking statements may not occur.\nThese and other factors that may cause the Company’s actual results to\ndiffer from current expectations are discussed in the Company’s filings with\nthe Securities and Exchange Commission (the “SEC”), including the section\ntitled “Risk Factors” in the Company’s Annual Report on Form 10-K for\nthe year ended December 31, 2025. You are cautioned not to place undue\nreliance on these forward-looking statements, which speak only as of the date\nthis press release is given. Except as required by law, the Company undertakes\nno obligation to publicly update any forward-looking statements, whether as a\nresult of new information, future events or otherwise.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261014378134/en/\n(https://www.businesswire.com/news/home/20261014378134/en/)\n\nInvestor Contact\nDavid Snyder, CFO\ndavid@coyatherapeutics.com (mailto:david@coyatherapeutics.com) \n\nMedia Contacts\nRusso Partners\nDavid Schull\nDavid.Schull@russopartnersllc.com (mailto:David.Schull@russopartnersllc.com) \n858-717-2310\n\nRachelle Babb\nrachelle.babb@russopartnersllc.com (mailto:rachelle.babb@russopartnersllc.com)\n\n929-325-7559\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw83g8QFa-20261014","title":"Coya to Initiate Open-Label Extension of Phase 2/3 ALSTARS Trial of COYA 302 in ALS","author":"Business Wire","ticker":"COYA","created":"2026-10-14T12:00:00.735Z","tickers":["COYA"],"exchange":"NASDAQ","article_body":"Coya to Initiate Open-Label Extension of Phase 2/3 ALSTARS Trial of COYA 302\nin ALS\n\n * OLE planned in response to requests from ALSTARS investigators and\nparticipants\n * Eligible participants completing 48 weeks of treatment will have the\nopportunity to continue receiving COYA 302\n * Cash runway guidance remains unchanged into the second half of 2027, beyond\nanticipated ALSTARS topline data readout in early Q2\nCoya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a\nclinical-stage biotechnology company developing biologics intended to enhance\nT-cell (Treg) function in patients with neurodegenerative disorders, today\nannounced plans to initiate an open-label extension (OLE) of the Phase 2/3\nALSTARS Trial (NCT07161999\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07161999%3Fterm%3DNCT07161999%26viewType%3DCard%26rank%3D1&esheet=54621305&newsitemid=20261014378134&lan=en-US&anchor=NCT07161999&index=1&md5=b63c41492470768498e7885210351e1d)\n) evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis\n(ALS).\n\nCoya plans to initiate the OLE in response to requests from ALSTARS\ninvestigators and study participants. The OLE will provide participants who\ncomplete the 48-week treatment period with the opportunity to continue\nreceiving COYA 302, while enabling the collection of longer-term efficacy and\nsafety data. Coya expects the OLE to begin in November 2026 as the first\ncohort completes the 48-week treatment period.\n\n“The strong interest from investigators and participants in continuing\ntreatment beyond the current 48-week study period underscores the importance\nof providing continued access to COYA 302 for eligible participants in the\nALSTARS trial,” said Fred Grossman, DO, FAPA, President and Chief Medical\nOfficer of Coya. “The open-label extension will also provide an opportunity\nto further characterize the long-term safety, tolerability, and potential\ntreatment effects of COYA 302 in people living with ALS. We are deeply\ngrateful to the patients, families, and investigators whose commitment makes\nthis important research possible.”\n\nConcurrent with the anticipated initiation of the OLE, Coya expects to\nprioritize resources toward the ongoing clinical development of COYA 302 in\nALS and assuring timely completion of important near-term milestones in the\nALSTARS trial. With this prioritization, the planned initiation of the Phase 2\nclinical trial evaluating COYA 302 in frontotemporal dementia (FTD),\npreviously anticipated in the second half of 2026, is now expected in 2027.\n\n“As we continue to advance and expand the ALSTARS trial, we believe\nprioritizing our resources behind COYA 302 in ALS is the appropriate\nnear-term, fiscal, and operational strategy for our Company,” said David\nSnyder, Chief Financial Officer of Coya.\n\nThe Company’s cash runway guidance remains unchanged, with existing cash\nresources expected to fund operations into the second half of 2027, beyond the\nanticipated ALSTARS topline data readout.\n\nAbout Amyotrophic Lateral Sclerosis (ALS)\n\nALS is a progressive neurodegenerative disease that attacks motor neurons in\nthe brain and spinal cord that control voluntary muscles, including those\nneeded to speak, swallow and breathe. The disease progresses rapidly, with\npatients experiencing an average decline of approximately one point per month\non the ALS Functional Rating Scale-Revised (ALSFRS-R), and 20% to 30% of\npatients dying within two years of diagnosis despite available therapies.\nApproximately 90% of ALS cases are sporadic, occurring in people with no\nfamily history of the disease. Current approved therapies provide only a\nmodest treatment effect and slow, but do not stop, disease progression and\nfunctional decline, underscoring the significant unmet need for new treatment\noptions that can meaningfully alter the course of the disease.\n\nAbout the ALSTARS Trial\n\nThe ALSTARS Trial is a Phase 2/3, randomized, multi-center, double-blind,\nplacebo-controlled study designed to evaluate the efficacy and safety of COYA\n302 in patients with ALS. Approximately 120 subjects will be randomized 1:1:1\nto receive one of two pre-specified dosing regimens of COYA 302 or placebo\nduring a 24-week double-blind treatment phase. Patients who complete the\n24-week placebo-controlled phase enter a 24-week blinded active-treatment\nextension phase; patients receiving COYA 302 continue their assigned regimen,\nwhile placebo patients are re-randomized to one of the two COYA 302 dosing\nregimens, providing up to 48 weeks of data on COYA 302.\n\nThe primary endpoint is change in disease severity over time, measured by the\nAmyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total\nscore from baseline to Week 24 compared with placebo. Study objectives include\nevaluation of efficacy, safety and tolerability, biological activity, and\nbiomarker levels.\n\nParticipants who complete the 48-week treatment period will be eligible to\nenroll in an open-label extension (OLE) to continue receiving COYA 302.\n\nTo learn more about the study, please visit ALSTARS Trial\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftrials.coyatherapeutics.com%2Fclinical-programs%2Falstars-trial-study-of-coya-302-for-the-treatment-of-als%2F&esheet=54621305&newsitemid=20261014378134&lan=en-US&anchor=ALSTARS+Trial&index=2&md5=3844155f95f080bdca49661b1dc88e23)\n.\n\nAbout COYA 302\n\nCOYA 302 is an investigational and proprietary biologic combination therapy\nwith a dual immunomodulatory mechanism of action intended to enhance the\nanti-inflammatory function of regulatory T cells (Tregs) and suppress the\ninflammation produced by activated monocytes and macrophages. COYA 302\ncomprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is\nbeing developed for subcutaneous administration for the treatment of patients\nwith ALS and other neurodegenerative diseases. These mechanisms may have\nadditive or synergistic effects.\n\nCoya is currently conducting the ALSTARS Trial, a Phase 2/3, randomized,\nmulti-center, double-blind, placebo-controlled study to evaluate the efficacy\nand safety of COYA 302 for the treatment of ALS (Identifier: NCT07161999).\n\nCOYA 302 is an investigational product not yet approved by the FDA or any\nother regulatory agency.\n\nAbout Coya Therapeutics, Inc.\n\nHeadquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a\nclinical-stage biotechnology company developing proprietary treatments focused\non the biology and potential therapeutic advantages of regulatory T cells\n(“Tregs”) to target systemic inflammation and neuroinflammation.\nDysfunctional Tregs underlie numerous conditions, including neurodegenerative,\nmetabolic, and autoimmune diseases. This cellular dysfunction may lead to\nsustained inflammation and oxidative stress resulting in lack of homeostasis\nof the immune system.\n\nCoya’s investigational product candidate pipeline leverages multiple\ntherapeutic modalities aimed at restoring the anti-inflammatory and\nimmunomodulatory functions of Tregs. Coya’s therapeutic platforms include\nTreg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell\ntherapy.\n\nFor more information about Coya, please visit www.coyatherapeutics.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fprotect.checkpoint.com%2Fv2%2Fr01%2F___http%3A%2F%2Fwww.coyatherapeutics.com___.YzJ1OnN0b3V0OmM6b2ZmaWNlMzY1X2VtYWlsc19hdHRhY2htZW50OjEyYjk1MzM2YThlNjg2ZWJkMjgyMzgzNWY4MTczM2Q1Ojc6MzMwMDoxMTBiNjk0MDA1MjBhYmJkNjczMTQ1OTJkNjYzZmQzNjQ3ODc4OTFkYjFkZWFlZmQxOTAzYjEwNWMyNmZkMzQzOnA6VDpG&esheet=54621305&newsitemid=20261014378134&lan=en-US&anchor=www.coyatherapeutics.com&index=3&md5=89b6cb8ceb5e47355be06a3b792d03ec)\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Statements in this press\nrelease that are not statements of historical fact are forward-looking\nstatements. Such forward-looking statements include, without limitation,\nstatements regarding: the commencement of the OLE, the commencement of the\nPhase 2 clinical trial evaluating COYA 302 in FTD, the timing of topline data\nfrom the double-blind treatment phase; expectations of Coya Therapeutics, Inc.\n(the “Company”) regarding the potential benefits, effectiveness, and\nsafety of its product candidates; the significance and potential benefits\nassociated with the FDA’s Fast Track designation for COYA 302; the\nCompany’s ability to advance its product candidates through the preclinical\nand clinical development processes; the Company’s expectations regarding\nquality, timing, and availability of data from the Company’s clinical\ntrials; the timing of announcements, updates and results of the Company’s\nclinical trials and related data; the Company’s future results of operations\nand financial position, including cash runway; and the potential therapeutic\nbenefits and economic value of the Company’s product candidates. These\nforward-looking statements are based on the beliefs of the management of the\nCompany as well as assumptions made by and information currently available to\nthe Company. Such statements reflect the current views of the Company with\nrespect to future events and are subject to known and unknown risks and\nuncertainties. In light of these risks and uncertainties, the events or\ncircumstances referred to in the forward-looking statements may not occur.\nThese and other factors that may cause the Company’s actual results to\ndiffer from current expectations are discussed in the Company’s filings with\nthe Securities and Exchange Commission (the “SEC”), including the section\ntitled “Risk Factors” in the Company’s Annual Report on Form 10-K for\nthe year ended December 31, 2025. You are cautioned not to place undue\nreliance on these forward-looking statements, which speak only as of the date\nthis press release is given. Except as required by law, the Company undertakes\nno obligation to publicly update any forward-looking statements, whether as a\nresult of new information, future events or otherwise.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261014378134/en/\n(https://www.businesswire.com/news/home/20261014378134/en/)\n\nInvestor Contact\nDavid Snyder, CFO\ndavid@coyatherapeutics.com (mailto:david@coyatherapeutics.com) \n\nMedia Contacts\nRusso Partners\nDavid Schull\nDavid.Schull@russopartnersllc.com (mailto:David.Schull@russopartnersllc.com) \n858-717-2310\n\nRachelle Babb\nrachelle.babb@russopartnersllc.com (mailto:rachelle.babb@russopartnersllc.com)\n\n929-325-7559\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-14T12:00:00.870975982Z","server_sent_at_ms":1791979200870},"received_at":"2026-10-14T12:00:00.922Z","source_url":"https://www.businesswire.com/news/home/20261014378134/en/"},"analysis":{"id":"157047","press_release_id":"168785","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["FTD Phase 2 trial start delayed from H2 2026 to 2027, suggesting resource constraints","cash runway only into H2 2027, leaving potential future financing needs after topline data"],"eventType":"clinical_trial","narrative":"Coya Therapeutics plans to initiate an open-label extension of the Phase 2/3 ALSTARS trial of COYA 302 in ALS, beginning in November 2026, letting participants who complete 48 weeks continue treatment.\n\nConcurrent with the OLE, Coya is prioritizing resources on the ALS program, pushing the planned Phase 2 trial of COYA 302 in frontotemporal dementia from the second half of 2026 into 2027.\n\nCash runway guidance is unchanged, with existing resources funding operations into the second half of 2027, beyond the anticipated ALSTARS topline readout in early Q2 2027.","sentiment":"mixed","agentHooks":{"shouldPost":false,"suggestedAngle":"OLE opening supports patient retention ahead of the early-Q2 2027 ALSTARS topline readout, but the FTD delay hints at capital prioritization."},"keyFigures":{"drugName":"COYA 302","phaseOfTrial":"Phase 2/3","customDimensions":{"ole_start":"November 2026","cash_runway":"into the second half of 2027","topline_readout":"early Q2 2027","alstars_subjects":120,"ftd_trial_timing":"delayed from H2 2026 to 2027"}},"quotedText":"The open-label extension will also provide an opportunity to further characterize the long-term safety, tolerability, and potential treatment effects of COYA 302 in people living with ALS.","namedEntities":{"people":[{"name":"Fred Grossman","role":"President and Chief Medical Officer"},{"name":"David Snyder","role":"Chief Financial Officer"}],"products":["COYA 302"],"companies":[{"name":"Coya Therapeutics, Inc.","ticker":"COYA","relationship":"filer"},{"name":"Russo Partners","relationship":"media relations agency"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Opening an open-label extension of the pivotal ALS trial is a modestly positive operational step, but it is paired with a delay of the FTD Phase 2 trial into 2027, signaling resource constraints. Cash runway guidance was unchanged, limiting financial impact."},"tickerRelevance":{"others":[],"primary":"COYA"},"globalImportance":25,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"note":"mixed signal -- positive OLE offset by FTD delay","tickerTier":"small-cap clinical-stage biotech","eventGravity":"trial operational update, not data readout"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"mixed","material_impact_score":2,"narrative":"Coya Therapeutics plans to initiate an open-label extension of the Phase 2/3 ALSTARS trial of COYA 302 in ALS, beginning in November 2026, letting participants who complete 48 weeks continue treatment.\n\nConcurrent with the OLE, Coya is prioritizing resources on the ALS program, pushing the planned Phase 2 trial of COYA 302 in frontotemporal dementia from the second half of 2026 into 2027.\n\nCash runway guidance is unchanged, with existing resources funding operations into the second half of 2027, beyond the anticipated ALSTARS topline readout in early Q2 2027.","key_figures":{"drugName":"COYA 302","phaseOfTrial":"Phase 2/3","customDimensions":{"ole_start":"November 2026","cash_runway":"into the second half of 2027","topline_readout":"early Q2 2027","alstars_subjects":120,"ftd_trial_timing":"delayed from H2 2026 to 2027"}},"named_entities":{"people":[{"name":"Fred Grossman","role":"President and Chief Medical Officer"},{"name":"David Snyder","role":"Chief Financial Officer"}],"products":["COYA 302"],"companies":[{"name":"Coya Therapeutics, Inc.","ticker":"COYA","relationship":"filer"},{"name":"Russo Partners","relationship":"media relations agency"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-14T12:00:11.371Z","global_importance":25,"audience_relevance":25,"importance_components":{"note":"mixed signal -- positive OLE offset by FTD delay","tickerTier":"small-cap clinical-stage biotech","eventGravity":"trial operational update, not data readout"}},"durationMs":6404,"modelName":"glm-5.3-flashx"}}