{"success":true,"data":{"pressRelease":{"id":"179643","rtpr_id":"nGNX9CdYPQ-20261026","ticker":"CYDY","exchange":"OTC","all_tickers":["CYDY"],"title":"CytoDyn Presents Updated Leronlimab Data in Metastatic Colorectal Cancer at ESMO Congress 2026","author":"Globe Newswire","published_at":"2026-10-26T12:30:00.631Z","article_body":"* Phase 2 CLOVER study enrolled 66 patients across seven sites in metastatic\ncolorectal cancer\n* Updated data show universal CCR5 expression, early ctDNA reductions and\nfavorable tolerability\nVANCOUVER, Washington, Oct. 26, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB:\nCYDY) (“CytoDyn” or the “Company”), a clinical-stage oncology company\nadvancing leronlimab, a first-in-class humanized monoclonal antibody targeting\nthe CCR5 receptor with therapeutic potential across multiple indications,\nincluding colorectal cancer (mCRC) and metastatic triple-negative breast\ncancer (mTNBC), today announced that updated clinical and translational data\nfrom its ongoing Phase 2 CLOVER study (ClinicalTrials.gov\nIdentifier: NCT06699836\n(https://www.globenewswire.com/Tracker?data=OzE4dD5wDk9ssMW897Cavv7wlN8AsioJ8hD4dGTIsNjMYvG81O8IMSWLj2v_9TdXhTlXriCdQ4kU-eYUr-OdN3UdpeBQrlPfaNLQqvfHQdC_qWnHRrE5H-Qd2mztygj7))\nevaluating leronlimab in combination with trifluridine and tipiracil (TFD/TPI)\nplus bevacizumab in mCRC were presented at the ESMO Congress 2026, held\nOctober 23–27, 2026, in Madrid, Spain.\n\nThe poster presentation, titled “Leronlimab (LRM) in combination with\ntrifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) in metastatic\ncolorectal cancer (mCRC): The phase 2 CLOVER study,” was presented by\nBenjamin Weinberg, M.D., Associate Professor at Georgetown University on\nSunday, October 25, 2026, from 4:00 – 4:45 a.m. PDT (12:00 - 12:45 p.m.\nCET), as Poster #820P, and included updated safety and biomarker findings from\nthe multicenter study in patients with previously treated mCRC.\n\nCCR5 is implicated in the recruitment of immunosuppressive immune cell\npopulations, including regulatory T cells and myeloid cells, into the tumor\nmicroenvironment and may contribute to immune evasion in colorectal cancer.\nThe CLOVER study is evaluating the safety of adding leronlimab to TFD/TPI plus\nbevacizumab and whether CCR5 inhibition may enhance anti-tumor activity\nthrough immune modulation. The study’s primary efficacy endpoint is\nobjective response rate (“ORR”), defined as the proportion of patients\nachieving a confirmed complete or partial response according to RECIST v1.1.\n\n“These updated findings continue to provide important insight into the\nbiological effects of CCR5 inhibition in metastatic colorectal cancer,\nparticularly through the integration of tissue and blood-based biomarkers,”\nsaid Benjamin Weinberg, M.D., Associate Professor of Medicine at Georgetown\nUniversity. “The consistent CCR5 expression observed across all evaluable\ntumor samples, together with rapid, early reductions in circulating tumor DNA,\nsupports continued investigation of leronlimab in combination with established\ntherapies for patients with refractory disease.”\n\nKey findings from the Phase 2 CLOVER study include:\n* 66 patients were enrolled across seven clinical sites between June 2025 and\nMay 2026. Leronlimab was administered subcutaneously once weekly at either 350\nmg or 700 mg in combination with standard doses of TFD/TPI and bevacizumab.\n* CCR5 expression was detected in 100% of evaluable archival tumor samples\n(91/91) from pre-screened patients, further supporting investigation of CCR5\nas a potential therapeutic target in mCRC.\n* In 28 patients with available baseline and Week 2 ctDNA results, a median\nreduction of 86% in ctDNA was observed at Week 2.\n* Among the 32 patients with currently available safety data, no\nleronlimab-related adverse events led to treatment discontinuation and no\nleronlimab-related adverse events greater than Grade 2 were reported. No\nleronlimab-related dose-limiting toxicities were observed.\n* The TFD/TPI + bevacizumab + leronlimab combination demonstrated deeper ctDNA\nresponses, with significantly greater reductions in molecular residual disease\n(MRD) from baseline versus TFD/TPI + bevacizumab at both 0–4 weeks\n(p=0.0005) and 0–8 weeks (p=0.0006), as well as deeper MRD reductions than\nTFD/TPI alone at both time points.\n“We are encouraged by the consistent CCR5 expression across evaluable tumor\nsamples and the early ctDNA reductions observed in patients with available\ndata,” said Jacob P. Lalezari, M.D., Head of Research and Translational\nSciences at CytoDyn. “These findings give us additional insight into how\nleronlimab may be interacting with the biology of metastatic colorectal cancer\nwhile maintaining a favorable tolerability profile in combination with TFD/TPI\nand bevacizumab. The expanded biomarker data being presented at ESMO will help\nfurther characterize these observations and inform the continued development\nof this program.”\n\nA copy of the poster will be made available on CytoDyn’s website under the\nPublications & Posters\n(https://www.globenewswire.com/Tracker?data=sA6mtGy4C2uJB6vuwJZvY7OE2YoHWTVtY2TsXeR7DhmJJFZZJYgGOww4vPhek41qylhI4kLpztVbpyK9_1cuoFiJ1CgFVP073U0VSn3P44pRHlMolYa_qwdhNRPduNkH)\nsection.\n\nAbout the European Society for Medical Oncology (ESMO) Congress 2026\nThe ESMO Congress 2026, taking place October 23–27, 2026, in Madrid, Spain,\nis a leading global oncology meeting bringing together clinicians,\nresearchers, patient advocates, journalists and healthcare industry\nrepresentatives from around the world. The Congress provides a global platform\nfor advances in oncology research, clinical practice and patient care,\nfeaturing new scientific data, educational programming, networking\nopportunities and innovation across the oncology community. For more\ninformation, visit esmo.org\n(https://www.globenewswire.com/Tracker?data=c4pSUBt0hEQ5QmvvnexaG7rCltW7Xgq1zp6X8fxHuLGFz2Xwi5AF5xxXW3Hh8lHqeNz-eqEAR9-Ro_hQDRwBiA==).\n\nAbout CytoDyn\nCytoDyn is a clinical-stage oncology company dedicated to advancing\nleronlimab, a first-in-class humanized monoclonal antibody that targets the\nCCR5 receptor, a key regulator of immune function implicated in cancer,\ninfectious diseases, and autoimmune disorders. Guided by a mission to improve\npatients’ quality of life through therapeutic innovation, CytoDyn is\ncommitted to integrity, responsibility, and service as it works to bring\ntransformative treatments to patients worldwide.\n\nFor more information, please visit www.cytodyn.com and follow us\non LinkedIn\n(https://www.globenewswire.com/Tracker?data=zVudaZZRcnVRM1MozuyHStu-JgvOPMxxWO2Iv4NBt3JhxMeWSlZadhoSNtvcRern6skGKHfUOn0YR5CAb_B-Fz7YdwVrHW93Y31mkqe4UOinkzc9GwFv2MEpL2EkBUzq_Arf2XzpnnBL1VWD1TuqLrD8QAMmfyd0ez_GszBZOEoBl4S2EvT-6kxgwtNcDeCqf_ttuB9TVNI2lhHYbeEC-x-ueHIekL7EGjW9jdGG11jzphol1T9HfROJVOgTEoRMQAKSQLQkiiUNgImrfChF3GZO9E6wcn62Se0cYzhdIQtfdOaR3mQ-b4tO1GU5g4sphibbdLLaamNCX21uQNZTAKahWyocHDI_VKDStp06tksZvtW5Vb8qO1CHJlwvzFw3GNCHvyjcnMZGvnuGirZjMB2eqbCNAqE_DGQfXLNwRF7kmUYpEJ0yHJldq63ymx_3).\n\nNote Regarding Forward-Looking Statements\nThis news release may contain forward-looking statements relating to, among\nother things, the mechanism of action of leronlimab, clinical trial results,\nproduct development, market position, future operating and financial\nperformance, and business strategy. The reader is cautioned not to rely on\nthese statements, which are based on current expectations of future events.\nFor important information about these statements and our Company, including\nthe risks, uncertainties and other factors that could cause actual results to\nvary materially from the assumptions, expectations and projections expressed\nin any forward-looking statements, the reader should review our Annual Report\non Form 10-K for the fiscal year ended May 31, 2026, including the section\ncaptioned “Forward-Looking Statements” and in Item 1A, as well as\nsubsequent reports filed with the Securities and Exchange Commission. CytoDyn\nInc. does not undertake to update any forward-looking statement as a result of\nnew information or future events or developments except as required by\napplicable law.\n\nCorporate Contact\nCytoDyn Inc.\nir@cytodyn.com\n\nMedia Contacts\nDavid Schull or Ignacio Guerrero-Ros, Ph.D.\nRusso Partners, LLC\nCytoDyn@russopartnersllc.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/3b426b4d-6299-4c23-9f95-058174a5b7be)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX9CdYPQ-20261026","title":"CytoDyn Presents Updated Leronlimab Data in Metastatic Colorectal Cancer at ESMO Congress 2026","author":"Globe Newswire","ticker":"CYDY","created":"2026-10-26T12:30:00.631Z","tickers":["CYDY"],"exchange":"OTC","article_body":"* Phase 2 CLOVER study enrolled 66 patients across seven sites in metastatic\ncolorectal cancer\n* Updated data show universal CCR5 expression, early ctDNA reductions and\nfavorable tolerability\nVANCOUVER, Washington, Oct. 26, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB:\nCYDY) (“CytoDyn” or the “Company”), a clinical-stage oncology company\nadvancing leronlimab, a first-in-class humanized monoclonal antibody targeting\nthe CCR5 receptor with therapeutic potential across multiple indications,\nincluding colorectal cancer (mCRC) and metastatic triple-negative breast\ncancer (mTNBC), today announced that updated clinical and translational data\nfrom its ongoing Phase 2 CLOVER study (ClinicalTrials.gov\nIdentifier: NCT06699836\n(https://www.globenewswire.com/Tracker?data=OzE4dD5wDk9ssMW897Cavv7wlN8AsioJ8hD4dGTIsNjMYvG81O8IMSWLj2v_9TdXhTlXriCdQ4kU-eYUr-OdN3UdpeBQrlPfaNLQqvfHQdC_qWnHRrE5H-Qd2mztygj7))\nevaluating leronlimab in combination with trifluridine and tipiracil (TFD/TPI)\nplus bevacizumab in mCRC were presented at the ESMO Congress 2026, held\nOctober 23–27, 2026, in Madrid, Spain.\n\nThe poster presentation, titled “Leronlimab (LRM) in combination with\ntrifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) in metastatic\ncolorectal cancer (mCRC): The phase 2 CLOVER study,” was presented by\nBenjamin Weinberg, M.D., Associate Professor at Georgetown University on\nSunday, October 25, 2026, from 4:00 – 4:45 a.m. PDT (12:00 - 12:45 p.m.\nCET), as Poster #820P, and included updated safety and biomarker findings from\nthe multicenter study in patients with previously treated mCRC.\n\nCCR5 is implicated in the recruitment of immunosuppressive immune cell\npopulations, including regulatory T cells and myeloid cells, into the tumor\nmicroenvironment and may contribute to immune evasion in colorectal cancer.\nThe CLOVER study is evaluating the safety of adding leronlimab to TFD/TPI plus\nbevacizumab and whether CCR5 inhibition may enhance anti-tumor activity\nthrough immune modulation. The study’s primary efficacy endpoint is\nobjective response rate (“ORR”), defined as the proportion of patients\nachieving a confirmed complete or partial response according to RECIST v1.1.\n\n“These updated findings continue to provide important insight into the\nbiological effects of CCR5 inhibition in metastatic colorectal cancer,\nparticularly through the integration of tissue and blood-based biomarkers,”\nsaid Benjamin Weinberg, M.D., Associate Professor of Medicine at Georgetown\nUniversity. “The consistent CCR5 expression observed across all evaluable\ntumor samples, together with rapid, early reductions in circulating tumor DNA,\nsupports continued investigation of leronlimab in combination with established\ntherapies for patients with refractory disease.”\n\nKey findings from the Phase 2 CLOVER study include:\n* 66 patients were enrolled across seven clinical sites between June 2025 and\nMay 2026. Leronlimab was administered subcutaneously once weekly at either 350\nmg or 700 mg in combination with standard doses of TFD/TPI and bevacizumab.\n* CCR5 expression was detected in 100% of evaluable archival tumor samples\n(91/91) from pre-screened patients, further supporting investigation of CCR5\nas a potential therapeutic target in mCRC.\n* In 28 patients with available baseline and Week 2 ctDNA results, a median\nreduction of 86% in ctDNA was observed at Week 2.\n* Among the 32 patients with currently available safety data, no\nleronlimab-related adverse events led to treatment discontinuation and no\nleronlimab-related adverse events greater than Grade 2 were reported. No\nleronlimab-related dose-limiting toxicities were observed.\n* The TFD/TPI + bevacizumab + leronlimab combination demonstrated deeper ctDNA\nresponses, with significantly greater reductions in molecular residual disease\n(MRD) from baseline versus TFD/TPI + bevacizumab at both 0–4 weeks\n(p=0.0005) and 0–8 weeks (p=0.0006), as well as deeper MRD reductions than\nTFD/TPI alone at both time points.\n“We are encouraged by the consistent CCR5 expression across evaluable tumor\nsamples and the early ctDNA reductions observed in patients with available\ndata,” said Jacob P. Lalezari, M.D., Head of Research and Translational\nSciences at CytoDyn. “These findings give us additional insight into how\nleronlimab may be interacting with the biology of metastatic colorectal cancer\nwhile maintaining a favorable tolerability profile in combination with TFD/TPI\nand bevacizumab. The expanded biomarker data being presented at ESMO will help\nfurther characterize these observations and inform the continued development\nof this program.”\n\nA copy of the poster will be made available on CytoDyn’s website under the\nPublications & Posters\n(https://www.globenewswire.com/Tracker?data=sA6mtGy4C2uJB6vuwJZvY7OE2YoHWTVtY2TsXeR7DhmJJFZZJYgGOww4vPhek41qylhI4kLpztVbpyK9_1cuoFiJ1CgFVP073U0VSn3P44pRHlMolYa_qwdhNRPduNkH)\nsection.\n\nAbout the European Society for Medical Oncology (ESMO) Congress 2026\nThe ESMO Congress 2026, taking place October 23–27, 2026, in Madrid, Spain,\nis a leading global oncology meeting bringing together clinicians,\nresearchers, patient advocates, journalists and healthcare industry\nrepresentatives from around the world. The Congress provides a global platform\nfor advances in oncology research, clinical practice and patient care,\nfeaturing new scientific data, educational programming, networking\nopportunities and innovation across the oncology community. For more\ninformation, visit esmo.org\n(https://www.globenewswire.com/Tracker?data=c4pSUBt0hEQ5QmvvnexaG7rCltW7Xgq1zp6X8fxHuLGFz2Xwi5AF5xxXW3Hh8lHqeNz-eqEAR9-Ro_hQDRwBiA==).\n\nAbout CytoDyn\nCytoDyn is a clinical-stage oncology company dedicated to advancing\nleronlimab, a first-in-class humanized monoclonal antibody that targets the\nCCR5 receptor, a key regulator of immune function implicated in cancer,\ninfectious diseases, and autoimmune disorders. Guided by a mission to improve\npatients’ quality of life through therapeutic innovation, CytoDyn is\ncommitted to integrity, responsibility, and service as it works to bring\ntransformative treatments to patients worldwide.\n\nFor more information, please visit www.cytodyn.com and follow us\non LinkedIn\n(https://www.globenewswire.com/Tracker?data=zVudaZZRcnVRM1MozuyHStu-JgvOPMxxWO2Iv4NBt3JhxMeWSlZadhoSNtvcRern6skGKHfUOn0YR5CAb_B-Fz7YdwVrHW93Y31mkqe4UOinkzc9GwFv2MEpL2EkBUzq_Arf2XzpnnBL1VWD1TuqLrD8QAMmfyd0ez_GszBZOEoBl4S2EvT-6kxgwtNcDeCqf_ttuB9TVNI2lhHYbeEC-x-ueHIekL7EGjW9jdGG11jzphol1T9HfROJVOgTEoRMQAKSQLQkiiUNgImrfChF3GZO9E6wcn62Se0cYzhdIQtfdOaR3mQ-b4tO1GU5g4sphibbdLLaamNCX21uQNZTAKahWyocHDI_VKDStp06tksZvtW5Vb8qO1CHJlwvzFw3GNCHvyjcnMZGvnuGirZjMB2eqbCNAqE_DGQfXLNwRF7kmUYpEJ0yHJldq63ymx_3).\n\nNote Regarding Forward-Looking Statements\nThis news release may contain forward-looking statements relating to, among\nother things, the mechanism of action of leronlimab, clinical trial results,\nproduct development, market position, future operating and financial\nperformance, and business strategy. The reader is cautioned not to rely on\nthese statements, which are based on current expectations of future events.\nFor important information about these statements and our Company, including\nthe risks, uncertainties and other factors that could cause actual results to\nvary materially from the assumptions, expectations and projections expressed\nin any forward-looking statements, the reader should review our Annual Report\non Form 10-K for the fiscal year ended May 31, 2026, including the section\ncaptioned “Forward-Looking Statements” and in Item 1A, as well as\nsubsequent reports filed with the Securities and Exchange Commission. CytoDyn\nInc. does not undertake to update any forward-looking statement as a result of\nnew information or future events or developments except as required by\napplicable law.\n\nCorporate Contact\nCytoDyn Inc.\nir@cytodyn.com\n\nMedia Contacts\nDavid Schull or Ignacio Guerrero-Ros, Ph.D.\nRusso Partners, LLC\nCytoDyn@russopartnersllc.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/3b426b4d-6299-4c23-9f95-058174a5b7be)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-26T12:30:00.678259747Z","server_sent_at_ms":1793017800678},"received_at":"2026-10-26T12:30:00.744Z","source_url":null},"analysis":{"id":"167526","press_release_id":"179643","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["No efficacy (ORR) data reported yet -- signals are biomarker-based only","Safety dataset covers only 32 of 66 enrolled patients","Clinical-stage OTCQB issuer with binary dependency on leronlimab development"],"eventType":"clinical_trial","narrative":"CytoDyn presented updated Phase 2 CLOVER study data for leronlimab in metastatic colorectal cancer at the ESMO Congress 2026 in Madrid.\n\nThe 66-patient study showed CCR5 expression in 100% of evaluable tumor samples, a median 86% ctDNA reduction at Week 2, and no leronlimab-related adverse events above Grade 2 or treatment discontinuations.\n\nThe combination with TFD/TPI plus bevacizumab showed significantly deeper molecular residual disease reductions versus control arms (p=0.0005 and p=0.0006). These are biomarker and safety signals only -- the study's primary ORR efficacy endpoint has not yet been reported.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Early ctDNA and safety signals for leronlimab in mCRC at ESMO -- watch for the ORR readout as the real catalyst."},"keyFigures":{"drugName":"leronlimab","phaseOfTrial":"Phase 2","customDimensions":{"clinical_sites":7,"patients_enrolled":66,"ccr5_expression_rate":"100% (91/91 evaluable archival tumor samples)","safety_data_patients":32,"mrd_reduction_p_values":"0.0005 (0-4 weeks) vs TFD/TPI+BEV, 0.0006 (0-8 weeks)","median_ctdna_reduction_week2":"86% (n=28)"}},"quotedText":"The consistent CCR5 expression observed across all evaluable tumor samples, together with rapid, early reductions in circulating tumor DNA, supports continued investigation of leronlimab in combination with established therapies for patients with refractory disease.","namedEntities":{"people":[{"name":"Benjamin Weinberg","role":"Associate Professor of Medicine, Georgetown University; study presenter"},{"name":"Jacob P. Lalezari","role":"Head of Research and Translational Sciences at CytoDyn"},{"name":"David Schull","role":"Media contact, Russo Partners"},{"name":"Ignacio Guerrero-Ros","role":"Media contact, Russo Partners"}],"products":["leronlimab","TFD/TPI (trifluridine/tipiracil, TAS-102)","bevacizumab"],"companies":[{"name":"CytoDyn Inc.","ticker":"CYDY","relationship":"filer"},{"name":"Georgetown University","relationship":"academic research partner"},{"name":"European Society for Medical Oncology (ESMO)","relationship":"conference host"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Early Phase 2 data presentation at ESMO showing favorable biomarker (ctDNA) signals and tolerability for leronlimab in mCRC, but no efficacy readout (ORR data not reported) and no regulatory or commercial milestone."},"tickerRelevance":{"others":[],"primary":"CYDY"},"globalImportance":28,"audienceRelevance":22,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap OTCQB","eventGravity":"early Phase 2 biomarker data at major congress","retailFavoriteBoost":"moderate -- CYDY has a retail following","efficacyReadoutAvailable":false}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"CytoDyn presented updated Phase 2 CLOVER study data for leronlimab in metastatic colorectal cancer at the ESMO Congress 2026 in Madrid.\n\nThe 66-patient study showed CCR5 expression in 100% of evaluable tumor samples, a median 86% ctDNA reduction at Week 2, and no leronlimab-related adverse events above Grade 2 or treatment discontinuations.\n\nThe combination with TFD/TPI plus bevacizumab showed significantly deeper molecular residual disease reductions versus control arms (p=0.0005 and p=0.0006). These are biomarker and safety signals only -- the study's primary ORR efficacy endpoint has not yet been reported.","key_figures":{"drugName":"leronlimab","phaseOfTrial":"Phase 2","customDimensions":{"clinical_sites":7,"patients_enrolled":66,"ccr5_expression_rate":"100% (91/91 evaluable archival tumor samples)","safety_data_patients":32,"mrd_reduction_p_values":"0.0005 (0-4 weeks) vs TFD/TPI+BEV, 0.0006 (0-8 weeks)","median_ctdna_reduction_week2":"86% (n=28)"}},"named_entities":{"people":[{"name":"Benjamin Weinberg","role":"Associate Professor of Medicine, Georgetown University; study presenter"},{"name":"Jacob P. Lalezari","role":"Head of Research and Translational Sciences at CytoDyn"},{"name":"David Schull","role":"Media contact, Russo Partners"},{"name":"Ignacio Guerrero-Ros","role":"Media contact, Russo Partners"}],"products":["leronlimab","TFD/TPI (trifluridine/tipiracil, TAS-102)","bevacizumab"],"companies":[{"name":"CytoDyn Inc.","ticker":"CYDY","relationship":"filer"},{"name":"Georgetown University","relationship":"academic research partner"},{"name":"European Society for Medical Oncology (ESMO)","relationship":"conference host"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-26T12:30:12.794Z","global_importance":28,"audience_relevance":22,"importance_components":{"tickerTier":"micro-cap OTCQB","eventGravity":"early Phase 2 biomarker data at major congress","retailFavoriteBoost":"moderate -- CYDY has a retail following","efficacyReadoutAvailable":false}},"durationMs":6687,"modelName":"glm-5.3-flashx"}}