{"success":true,"data":{"pressRelease":{"id":"156477","rtpr_id":"nGNX9vDmPB-20260930","ticker":"CNTB","exchange":"NASDAQ","all_tickers":["CNTB"],"title":"Connect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adults with COPD and Type 2 Inflammation","author":"Globe Newswire","published_at":"2026-09-30T11:00:01.715Z","article_body":"– Rademikibart significantly reduced the rate of treatment failure compared\nto placebo through one month by 81% (p=0.0122) –\n\n– Rademikibart significantly reduced the rate of new moderate to severe COPD\nexacerbations through one month by 85% (p=0.030) –\n\n– Rademikibart significantly reduced the rate of hospitalizations or\nemergency department visits for new acute COPD exacerbations by 100%\n(p=0.0137) –\n\n– Rademikibart was well tolerated in COPD patients experiencing an acute\nexacerbation with a lower incidence of adverse events than placebo –\n\n– Connect plans to engage with the U.S. Food and Drug Administration (FDA)\nto gain alignment on a Phase 3 program –\n\n– Company to host a conference call to discuss the data today, September 30\nat 8:00 a.m. ET –\n\nSAN DIEGO, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings\nLimited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a\nclinical-stage biopharmaceutical company focused on transforming care for the\ntreatment of inflammatory diseases, today announced topline results from its\nglobal Phase 2 study evaluating rademikibart, the Company’s next-generation,\npotentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody\nas an add-on treatment for acute exacerbations in adult participants with\nchronic obstructive pulmonary disease (COPD) and type 2 inflammation.\n\n“Topline data from our Seabreeze STAT COPD trial for rademikibart provides\noverwhelming evidence of the potential benefit early treatment with\nrademikibart may provide to COPD patients experiencing an acute\nexacerbation,” said Barry Quart, Pharm.D., CEO and Director of Connect\nBiopharma. “2025 claims data indicate that COPD patients going to the\nemergency department (ED) due to an acute exacerbation generate approximately\n$6 billion in healthcare costs in the following 30 days due to return visits\nto the ED or hospital. This study demonstrated that rademikibart completely\neliminated those return visits while decreasing new moderate to severe COPD\nexacerbations by 85% compared to placebo. These groundbreaking results provide\na unique opportunity to differentiate rademikibart in COPD from all other\napproved biologics. We plan to engage with the FDA as soon as feasible\nregarding a Phase 3 registrational development program for rademikibart as\nadd-on treatment for COPD.”\n\n“Acute exacerbations continue to be a major driver of morbidity in COPD, and\nthere remains a need for therapies that can improve outcomes following these\nevents,” said Surya Bhatt, MD, Director of the University of Alabama at\nBirmingham, UAB Center for Lung Analytics and Imaging Research (CLAIR) in\nBirmingham, Alabama. “The reduction in COPD exacerbations is compelling, and\nthe clinically meaningful increase in pulmonary function provides a very\nimportant improvement over standard-of-care and supports the potential for\nrademikibart to improve outcomes for COPD patients following an acute\nexacerbation and for chronic maintenance.”\n\nMario Castro MD, MPH, Professor of Medicine and Chief of the Division of\nPulmonary, Critical Care and Sleep Medicine at the University of Kansas School\nof Medicine added, “One of the greatest challenges in COPD management is\nhelping patients recover from an acute exacerbation and remain stable once\nthey leave the hospital. The reductions in hospitalizations seen with\nrademikibart address a critical period when patients are at particularly high\nrisk for worsening disease. By helping stabilize patients during the\nvulnerable post-exacerbation period, rademikibart has the potential to provide\nbenefit in both acute and long-term disease management and meaningfully\nimprove patient care.”\n\nThe Phase 2 Seabreeze STAT COPD study (CBP-201-207) is a randomized,\ndouble-blind, placebo-controlled study evaluating the safety and efficacy of\nrademikibart as an adjunct to standard of care for acute exacerbations in\nparticipants with COPD and type 2 inflammation. The study enrolled 159\nparticipants globally with an eosinophil count of ≥300 cells/μL who have\nexperienced an acute COPD exacerbation. Participants were randomized 1:1 to\nreceive either a single dose of rademikibart or placebo, administered\nsubcutaneously in addition to standard of care. The primary endpoint was\ntreatment failure, defined as death due to any cause, (re)admission to a\nhospital for COPD, emergency department (ED) (re)visit or unscheduled medical\nvisit for worsening of COPD symptoms, or the necessity to intensify\npharmacologic treatment within 28 days after randomization. Secondary\nendpoints included post-bronchodilator (post-BD) FEV(1) at Week 1 (key\nsecondary), rate and time to new moderate and severe COPD exacerbations,\nchange-from-baseline in clinical respiratory symptoms of COPD, post-BD FEV(1)\nat other timepoints, and incidence of adverse events for 8 weeks after dosing.\nFor more information, please visit clinicaltrials.gov (identifier\nNCT06940154).\n\nKey topline results include:\n* Rademikibart significantly reduced the rate of treatment failure by 81%\nthrough Week 4 compared to placebo (p=0.0122)\n* Rademikibart significantly reduced the rate of new moderate to severe COPD\nexacerbations by 85% through Week 4 compared to placebo (p=0.030)\n* Rademikibart significantly reduced new visits to emergency departments and\nhospital admissions for new exacerbations by 100% through Week 4 compared to\nplacebo (p=0.0137)\n* Rademikibart significantly reduced the use of rescue inhalers from Week 2\nthrough Week 7 and significantly improved COPD symptoms at Week 2 compared to\nplacebo (Total Score, p=0.0197)\n* Clinically meaningful 70 mL greater improvement in FEV(1) at Week 4 with\nrademikibart compared to placebo (p=0.1607)\n* Rademikibart was well tolerated and no new safety signals were observed\nthrough the end of the study. The safety profile was comparable to placebo,\nwith a lower incidence of adverse events and serious adverse events reported\nin the rademikibart arm compared to the placebo arm.\nCompany-Hosted Conference Call and Webcast\n\nConnect will host a conference call and webcast today, September 30, 2026, at\n8:00 a.m. ET. To access the conference call, please pre-register through here\n(https://www.globenewswire.com/Tracker?data=7xmLe67IIbKCXkRsg5RF6WuuEiSERNe4UYgKAd4JmVfoT7AH_tyzOoUckIQFnzK3m5pct3s0u_03fIqQEWKJOC-6pxSme8c_pGAoX80HkwaU67TYpryQ6HLu6RFgrDPi9VIZ84JHByPcvMzHELgkEvETrT6HigHUorXpQTmITQU=)\nto receive dial-in information and a personal PIN to access the live call.\nParticipants may access the live webcast here\n(https://www.globenewswire.com/Tracker?data=7xmLe67IIbKCXkRsg5RF6YHSIsU4DXFtwqez8-M7MXTWdvMarHR8mszks2cuWEHercQv89Zu8aP8vMYK-tJ79BTvf0AvrfEp9uqyJzNGSfM=)\nor from the Investors section of the Connect website at\ninvestors.connectbiopharma.com\n(https://www.globenewswire.com/Tracker?data=_1nvwyJ2ffKmV4Mz0pIfwYVNESz2MdC9FsUqK8M82bCqm1oG4S72xpK3XDDkUMflK9kPOJdaPOx_YHypCf8DunB26ZbGEdGhrNAec0Dx25kIGLeQP4ZX_Rc4T2r1yFvkeGn2AJAGSq0zLUjk9X_3lA==).\nAn archive of the webcast and presentation will be available for approximately\n90 days after the event.\n\nAbout Rademikibart\n\nRademikibart is a fully human monoclonal antibody targeting interleukin-4\nreceptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4)\nand interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα,\nrademikibart can block the functions of IL-4 and IL-13 effectively, thereby\nblocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of\ntreating Th2 related inflammatory diseases such as atopic dermatitis, asthma\nand COPD.\n\nAbout Connect Biopharma\n\nConnect Biopharma is a clinical-stage biopharmaceutical company dedicated to\ntransforming care for asthma and COPD. Headquartered in San Diego, California,\nthe Company is advancing rademikibart, a next-generation, potentially\nbest-in-class antibody designed to target IL-4Rα. The Company is currently\nconducting global clinical studies of rademikibart for the treatment of acute\nexacerbations of asthma and COPD, areas with significant unmet need. Connect\nhas granted an exclusive license to Simcere Pharmaceutical Co., Ltd., for\nrademikibart in Greater China. Under the exclusive license and collaboration\nagreement, Connect is eligible to receive remaining milestone payments up to\nan aggregate amount of approximately $99 million upon the achievement of\ncertain development, regulatory and commercial milestones. Connect is also\neligible to receive royalties at tiered percentage rates up to low\ndouble-digit percentages on net sales in Greater China.\n\nFor more information visit www.connectbiopharma.com.\n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of the Private Securities Litigation Reform Act of 1995, as amended.\nForward-looking statements are statements that are not of historical fact and\ninclude, without limitation, statements regarding future events, our future\nfinancial and operating results and related expectations, business strategy\nand plans, prospective products (as well as their potential to achieve a\ndifferentiated, competitive, or favorable benefit or profile or trend,\nincluding on safety, tolerability, improvement, maintenance, clinical\nresponse, dosing, efficacy and/or convenience), statements regarding the\ntiming or results of any interim analysis or interim, topline or preliminary\ndata and whether such analysis or data is indicative of safety, efficacy,\nfinal trial results or likelihood of regulatory approval for our product\ncandidates, planned or expected meetings with the FDA or any other regulatory\nauthorities, planned or expected product approval applications or approvals,\nanticipated milestones and milestone payments, expected data readouts and\nenrollments and the timing thereof, research and development plans and costs,\npotential future partnerships, expectations about existing partnerships,\ntiming and likelihood of success, objectives of management for future\noperations, future results of anticipated product development efforts,\nadequacy of existing cash and potential partnership funding to fund operations\nand capital expenditure requirements, anticipated patient populations, market\nopportunities and potential pricing strategies for our prospective products,\nif approved, our plans for rademikibart, including potential indications, as\nwell as statements regarding industry trends. These statements are based on\nmanagement’s current expectations of future events only as of the date of\nthis press release and are inherently subject to a number of risks,\nuncertainties and assumptions, some of which cannot be predicted or quantified\nand some of which are beyond our control, including, among other things: the\nability of our clinical trials to demonstrate safety and efficacy of our\nproduct candidates and other positive results; whether we will need expanded\nor additional trials in order to obtain regulatory approval for our product\ncandidates; the timing and outcome of any meetings with the FDA or other\nregulatory authorities regarding further development of our product\ncandidates, including with respect to a potential Phase 3 program for\nrademikibart; our ability to obtain and maintain regulatory approval of our\nproduct candidates; existing regulations and regulatory developments in the\nU.S., the People’s Republic of China, Europe and other jurisdictions; our\nplans and ability to obtain, maintain, protect and enforce our intellectual\nproperty rights and our proprietary technologies, including extensions of\nexisting patent terms where available; our continued reliance on third parties\nto conduct additional clinical trials of our product candidates, and for the\nmanufacture of our product candidates for preclinical studies and clinical\ntrials; the degree of market acceptance of our product candidates, if\napproved, by physicians, patients, healthcare payors and others in the medical\ncommunity; the impact on our business of adverse global macroeconomic and\ngeopolitical conditions, including high interest rates, the inflationary\nenvironment, recessionary fears, foreign exchange rate volatility, instability\nin financial institutions, government shutdowns, changes in monetary policy,\nchanges in trade policies, including tariffs and other trade restrictions or\nthe threat of such actions, and rising geopolitical instability, including the\nconflicts in the Middle East and the related volatility in the price of oil\nand other commodity prices; as well as the risks and uncertainties described\nin Part I, “Item 1A. Risk Factors” of our Annual Report on Form 10-K for\nthe year ended December 31, 2025, our subsequent Quarterly Reports on Form\n10-Q and our other filings with the SEC .\n\nWords such as “aim,” “anticipate,” “believe,” “commitments,”\n“continue,” “could,” “design,” “estimate,” “expect,”\n“feel,” “goal,” “intend,” “may,” “might,” “objective,”\n“optimistic,” “plan,” “potential,” “predict,” “promising,”\n“seek,” “should,” “target,” “will,” “would,” and similar\nexpressions are intended to identify forward-looking statements, though not\nall forward-looking statements necessarily contain these identifying words.\nThe inclusion of forward-looking statements should not be regarded as a\nrepresentation by Connect Biopharma that any of its expectations, projections\nor plans will be achieved. Actual results or outcomes, or the timing of such\nresults or outcomes, may differ materially from those expressed or implied in\nour forward-looking statements due to the risks and uncertainties described\nabove. These forward-looking statements should not be taken as forecasts or\npromises nor should they be taken as implying any indication, assurance or\nguarantee that the assumptions on which such forward-looking statements have\nbeen made are correct or exhaustive or, in the case of the assumptions, fully\nstated herein. Drug development and commercialization involve a high degree of\nrisk, and only a small number of research and development programs result in\ncommercialization of a product. Results in early-stage clinical trials may not\nbe indicative of full results or results from later stage or larger scale\nclinical trials and do not ensure regulatory approval. You are cautioned not\nto place undue reliance on the scientific data presented or these\nforward-looking statements, which speak only as of the date hereof. Except as\nrequired by law, Connect Biopharma undertakes no obligation to publicly update\nany forward-looking statements, whether because of new information, future\nevents or otherwise.\n\nThis press release discusses our product candidate, rademikibart, which is\nunder clinical investigation and has not yet been approved for marketing by\nthe FDA, the National Medical Products Administration, or by any other\nregulatory agency. No representation is made as to the safety or effectiveness\nof rademikibart for the uses for which it is being studied. The trademarks\nincluded herein are the property of the owners thereof and are used for\nreference purposes only.\n\nInvestor Relations Contact:\n\nAlex Lobo \nPrecision AQ \nAlex.lobo@precisionaq.com \n(212) 698-8802\n\nMedia Contact:\n\nIgnacio Guerrero-Ros, Ph.D., or David Schull\nRusso Partners, LLC\nIgnacio.guerrero-ros@russopartnersllc.com \nDavid.schull@russopartnersllc.com \n(858) 717-2310 or (646) 942-5604\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/831dcc2a-691d-4cad-813e-855f9fa2bd69)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX9vDmPB-20260930","title":"Connect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adults with COPD and Type 2 Inflammation","author":"Globe Newswire","ticker":"CNTB","created":"2026-09-30T11:00:01.715Z","tickers":["CNTB"],"exchange":"NASDAQ","article_body":"– Rademikibart significantly reduced the rate of treatment failure compared\nto placebo through one month by 81% (p=0.0122) –\n\n– Rademikibart significantly reduced the rate of new moderate to severe COPD\nexacerbations through one month by 85% (p=0.030) –\n\n– Rademikibart significantly reduced the rate of hospitalizations or\nemergency department visits for new acute COPD exacerbations by 100%\n(p=0.0137) –\n\n– Rademikibart was well tolerated in COPD patients experiencing an acute\nexacerbation with a lower incidence of adverse events than placebo –\n\n– Connect plans to engage with the U.S. Food and Drug Administration (FDA)\nto gain alignment on a Phase 3 program –\n\n– Company to host a conference call to discuss the data today, September 30\nat 8:00 a.m. ET –\n\nSAN DIEGO, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings\nLimited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a\nclinical-stage biopharmaceutical company focused on transforming care for the\ntreatment of inflammatory diseases, today announced topline results from its\nglobal Phase 2 study evaluating rademikibart, the Company’s next-generation,\npotentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody\nas an add-on treatment for acute exacerbations in adult participants with\nchronic obstructive pulmonary disease (COPD) and type 2 inflammation.\n\n“Topline data from our Seabreeze STAT COPD trial for rademikibart provides\noverwhelming evidence of the potential benefit early treatment with\nrademikibart may provide to COPD patients experiencing an acute\nexacerbation,” said Barry Quart, Pharm.D., CEO and Director of Connect\nBiopharma. “2025 claims data indicate that COPD patients going to the\nemergency department (ED) due to an acute exacerbation generate approximately\n$6 billion in healthcare costs in the following 30 days due to return visits\nto the ED or hospital. This study demonstrated that rademikibart completely\neliminated those return visits while decreasing new moderate to severe COPD\nexacerbations by 85% compared to placebo. These groundbreaking results provide\na unique opportunity to differentiate rademikibart in COPD from all other\napproved biologics. We plan to engage with the FDA as soon as feasible\nregarding a Phase 3 registrational development program for rademikibart as\nadd-on treatment for COPD.”\n\n“Acute exacerbations continue to be a major driver of morbidity in COPD, and\nthere remains a need for therapies that can improve outcomes following these\nevents,” said Surya Bhatt, MD, Director of the University of Alabama at\nBirmingham, UAB Center for Lung Analytics and Imaging Research (CLAIR) in\nBirmingham, Alabama. “The reduction in COPD exacerbations is compelling, and\nthe clinically meaningful increase in pulmonary function provides a very\nimportant improvement over standard-of-care and supports the potential for\nrademikibart to improve outcomes for COPD patients following an acute\nexacerbation and for chronic maintenance.”\n\nMario Castro MD, MPH, Professor of Medicine and Chief of the Division of\nPulmonary, Critical Care and Sleep Medicine at the University of Kansas School\nof Medicine added, “One of the greatest challenges in COPD management is\nhelping patients recover from an acute exacerbation and remain stable once\nthey leave the hospital. The reductions in hospitalizations seen with\nrademikibart address a critical period when patients are at particularly high\nrisk for worsening disease. By helping stabilize patients during the\nvulnerable post-exacerbation period, rademikibart has the potential to provide\nbenefit in both acute and long-term disease management and meaningfully\nimprove patient care.”\n\nThe Phase 2 Seabreeze STAT COPD study (CBP-201-207) is a randomized,\ndouble-blind, placebo-controlled study evaluating the safety and efficacy of\nrademikibart as an adjunct to standard of care for acute exacerbations in\nparticipants with COPD and type 2 inflammation. The study enrolled 159\nparticipants globally with an eosinophil count of ≥300 cells/μL who have\nexperienced an acute COPD exacerbation. Participants were randomized 1:1 to\nreceive either a single dose of rademikibart or placebo, administered\nsubcutaneously in addition to standard of care. The primary endpoint was\ntreatment failure, defined as death due to any cause, (re)admission to a\nhospital for COPD, emergency department (ED) (re)visit or unscheduled medical\nvisit for worsening of COPD symptoms, or the necessity to intensify\npharmacologic treatment within 28 days after randomization. Secondary\nendpoints included post-bronchodilator (post-BD) FEV(1) at Week 1 (key\nsecondary), rate and time to new moderate and severe COPD exacerbations,\nchange-from-baseline in clinical respiratory symptoms of COPD, post-BD FEV(1)\nat other timepoints, and incidence of adverse events for 8 weeks after dosing.\nFor more information, please visit clinicaltrials.gov (identifier\nNCT06940154).\n\nKey topline results include:\n* Rademikibart significantly reduced the rate of treatment failure by 81%\nthrough Week 4 compared to placebo (p=0.0122)\n* Rademikibart significantly reduced the rate of new moderate to severe COPD\nexacerbations by 85% through Week 4 compared to placebo (p=0.030)\n* Rademikibart significantly reduced new visits to emergency departments and\nhospital admissions for new exacerbations by 100% through Week 4 compared to\nplacebo (p=0.0137)\n* Rademikibart significantly reduced the use of rescue inhalers from Week 2\nthrough Week 7 and significantly improved COPD symptoms at Week 2 compared to\nplacebo (Total Score, p=0.0197)\n* Clinically meaningful 70 mL greater improvement in FEV(1) at Week 4 with\nrademikibart compared to placebo (p=0.1607)\n* Rademikibart was well tolerated and no new safety signals were observed\nthrough the end of the study. The safety profile was comparable to placebo,\nwith a lower incidence of adverse events and serious adverse events reported\nin the rademikibart arm compared to the placebo arm.\nCompany-Hosted Conference Call and Webcast\n\nConnect will host a conference call and webcast today, September 30, 2026, at\n8:00 a.m. ET. To access the conference call, please pre-register through here\n(https://www.globenewswire.com/Tracker?data=7xmLe67IIbKCXkRsg5RF6WuuEiSERNe4UYgKAd4JmVfoT7AH_tyzOoUckIQFnzK3m5pct3s0u_03fIqQEWKJOC-6pxSme8c_pGAoX80HkwaU67TYpryQ6HLu6RFgrDPi9VIZ84JHByPcvMzHELgkEvETrT6HigHUorXpQTmITQU=)\nto receive dial-in information and a personal PIN to access the live call.\nParticipants may access the live webcast here\n(https://www.globenewswire.com/Tracker?data=7xmLe67IIbKCXkRsg5RF6YHSIsU4DXFtwqez8-M7MXTWdvMarHR8mszks2cuWEHercQv89Zu8aP8vMYK-tJ79BTvf0AvrfEp9uqyJzNGSfM=)\nor from the Investors section of the Connect website at\ninvestors.connectbiopharma.com\n(https://www.globenewswire.com/Tracker?data=_1nvwyJ2ffKmV4Mz0pIfwYVNESz2MdC9FsUqK8M82bCqm1oG4S72xpK3XDDkUMflK9kPOJdaPOx_YHypCf8DunB26ZbGEdGhrNAec0Dx25kIGLeQP4ZX_Rc4T2r1yFvkeGn2AJAGSq0zLUjk9X_3lA==).\nAn archive of the webcast and presentation will be available for approximately\n90 days after the event.\n\nAbout Rademikibart\n\nRademikibart is a fully human monoclonal antibody targeting interleukin-4\nreceptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4)\nand interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα,\nrademikibart can block the functions of IL-4 and IL-13 effectively, thereby\nblocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of\ntreating Th2 related inflammatory diseases such as atopic dermatitis, asthma\nand COPD.\n\nAbout Connect Biopharma\n\nConnect Biopharma is a clinical-stage biopharmaceutical company dedicated to\ntransforming care for asthma and COPD. Headquartered in San Diego, California,\nthe Company is advancing rademikibart, a next-generation, potentially\nbest-in-class antibody designed to target IL-4Rα. The Company is currently\nconducting global clinical studies of rademikibart for the treatment of acute\nexacerbations of asthma and COPD, areas with significant unmet need. Connect\nhas granted an exclusive license to Simcere Pharmaceutical Co., Ltd., for\nrademikibart in Greater China. Under the exclusive license and collaboration\nagreement, Connect is eligible to receive remaining milestone payments up to\nan aggregate amount of approximately $99 million upon the achievement of\ncertain development, regulatory and commercial milestones. Connect is also\neligible to receive royalties at tiered percentage rates up to low\ndouble-digit percentages on net sales in Greater China.\n\nFor more information visit www.connectbiopharma.com.\n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of the Private Securities Litigation Reform Act of 1995, as amended.\nForward-looking statements are statements that are not of historical fact and\ninclude, without limitation, statements regarding future events, our future\nfinancial and operating results and related expectations, business strategy\nand plans, prospective products (as well as their potential to achieve a\ndifferentiated, competitive, or favorable benefit or profile or trend,\nincluding on safety, tolerability, improvement, maintenance, clinical\nresponse, dosing, efficacy and/or convenience), statements regarding the\ntiming or results of any interim analysis or interim, topline or preliminary\ndata and whether such analysis or data is indicative of safety, efficacy,\nfinal trial results or likelihood of regulatory approval for our product\ncandidates, planned or expected meetings with the FDA or any other regulatory\nauthorities, planned or expected product approval applications or approvals,\nanticipated milestones and milestone payments, expected data readouts and\nenrollments and the timing thereof, research and development plans and costs,\npotential future partnerships, expectations about existing partnerships,\ntiming and likelihood of success, objectives of management for future\noperations, future results of anticipated product development efforts,\nadequacy of existing cash and potential partnership funding to fund operations\nand capital expenditure requirements, anticipated patient populations, market\nopportunities and potential pricing strategies for our prospective products,\nif approved, our plans for rademikibart, including potential indications, as\nwell as statements regarding industry trends. These statements are based on\nmanagement’s current expectations of future events only as of the date of\nthis press release and are inherently subject to a number of risks,\nuncertainties and assumptions, some of which cannot be predicted or quantified\nand some of which are beyond our control, including, among other things: the\nability of our clinical trials to demonstrate safety and efficacy of our\nproduct candidates and other positive results; whether we will need expanded\nor additional trials in order to obtain regulatory approval for our product\ncandidates; the timing and outcome of any meetings with the FDA or other\nregulatory authorities regarding further development of our product\ncandidates, including with respect to a potential Phase 3 program for\nrademikibart; our ability to obtain and maintain regulatory approval of our\nproduct candidates; existing regulations and regulatory developments in the\nU.S., the People’s Republic of China, Europe and other jurisdictions; our\nplans and ability to obtain, maintain, protect and enforce our intellectual\nproperty rights and our proprietary technologies, including extensions of\nexisting patent terms where available; our continued reliance on third parties\nto conduct additional clinical trials of our product candidates, and for the\nmanufacture of our product candidates for preclinical studies and clinical\ntrials; the degree of market acceptance of our product candidates, if\napproved, by physicians, patients, healthcare payors and others in the medical\ncommunity; the impact on our business of adverse global macroeconomic and\ngeopolitical conditions, including high interest rates, the inflationary\nenvironment, recessionary fears, foreign exchange rate volatility, instability\nin financial institutions, government shutdowns, changes in monetary policy,\nchanges in trade policies, including tariffs and other trade restrictions or\nthe threat of such actions, and rising geopolitical instability, including the\nconflicts in the Middle East and the related volatility in the price of oil\nand other commodity prices; as well as the risks and uncertainties described\nin Part I, “Item 1A. Risk Factors” of our Annual Report on Form 10-K for\nthe year ended December 31, 2025, our subsequent Quarterly Reports on Form\n10-Q and our other filings with the SEC .\n\nWords such as “aim,” “anticipate,” “believe,” “commitments,”\n“continue,” “could,” “design,” “estimate,” “expect,”\n“feel,” “goal,” “intend,” “may,” “might,” “objective,”\n“optimistic,” “plan,” “potential,” “predict,” “promising,”\n“seek,” “should,” “target,” “will,” “would,” and similar\nexpressions are intended to identify forward-looking statements, though not\nall forward-looking statements necessarily contain these identifying words.\nThe inclusion of forward-looking statements should not be regarded as a\nrepresentation by Connect Biopharma that any of its expectations, projections\nor plans will be achieved. Actual results or outcomes, or the timing of such\nresults or outcomes, may differ materially from those expressed or implied in\nour forward-looking statements due to the risks and uncertainties described\nabove. These forward-looking statements should not be taken as forecasts or\npromises nor should they be taken as implying any indication, assurance or\nguarantee that the assumptions on which such forward-looking statements have\nbeen made are correct or exhaustive or, in the case of the assumptions, fully\nstated herein. Drug development and commercialization involve a high degree of\nrisk, and only a small number of research and development programs result in\ncommercialization of a product. Results in early-stage clinical trials may not\nbe indicative of full results or results from later stage or larger scale\nclinical trials and do not ensure regulatory approval. You are cautioned not\nto place undue reliance on the scientific data presented or these\nforward-looking statements, which speak only as of the date hereof. Except as\nrequired by law, Connect Biopharma undertakes no obligation to publicly update\nany forward-looking statements, whether because of new information, future\nevents or otherwise.\n\nThis press release discusses our product candidate, rademikibart, which is\nunder clinical investigation and has not yet been approved for marketing by\nthe FDA, the National Medical Products Administration, or by any other\nregulatory agency. No representation is made as to the safety or effectiveness\nof rademikibart for the uses for which it is being studied. The trademarks\nincluded herein are the property of the owners thereof and are used for\nreference purposes only.\n\nInvestor Relations Contact:\n\nAlex Lobo \nPrecision AQ \nAlex.lobo@precisionaq.com \n(212) 698-8802\n\nMedia Contact:\n\nIgnacio Guerrero-Ros, Ph.D., or David Schull\nRusso Partners, LLC\nIgnacio.guerrero-ros@russopartnersllc.com \nDavid.schull@russopartnersllc.com \n(858) 717-2310 or (646) 942-5604\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/831dcc2a-691d-4cad-813e-855f9fa2bd69)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-30T11:00:02.968025565Z","server_sent_at_ms":1790766002968},"received_at":"2026-09-30T11:00:03.018Z","source_url":null},"analysis":{"id":"145169","press_release_id":"156477","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Key secondary FEV(1) endpoint at Week 4 not statistically significant (p=0.1607)","Phase 2 data are preliminary and may not predict Phase 3 or regulatory outcomes; company not yet FDA-aligned on Phase 3 design"],"eventType":"clinical_trial","narrative":"Connect Biopharma announced positive topline data from its global Phase 2 Seabreeze STAT COPD trial of rademikibart as add-on treatment for acute exacerbations in adults with COPD and type 2 inflammation.\n\nRademikibart reduced treatment failure by 81% (p=0.0122), new moderate-to-severe exacerbations by 85% (p=0.030), and hospitalizations or ED visits by 100% (p=0.0137) through Week 4, with a safety profile comparable to placebo. The 159-participant trial also showed a 70 mL greater improvement in FEV(1) at Week 4 that missed statistical significance (p=0.1607).\n\nThe company plans to engage with the FDA to align on a Phase 3 registrational program, and remains eligible for up to approximately $99 million in remaining milestones from its Simcere partnership in Greater China.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Potential best-in-class anti-IL-4Rα shows near-uniform elimination of post-exacerbation hospitalizations in COPD -- FDA Phase 3 alignment is the next catalyst."},"keyFigures":{"drugName":"rademikibart","phaseOfTrial":"Phase 2","customDimensions":{"enrolled_participants":159,"new_exacerbation_reduction":"85% (p=0.030)","fev1_improvement_vs_placebo":"70 mL at Week 4 (p=0.1607)","treatment_failure_reduction":"81% (p=0.0122)","simcere_milestones_remaining":"$99 million","hospitalization_ed_visit_reduction":"100% (p=0.0137)"}},"quotedText":"These groundbreaking results provide a unique opportunity to differentiate rademikibart in COPD from all other approved biologics.","namedEntities":{"people":[{"name":"Barry Quart, Pharm.D.","role":"CEO and Director"},{"name":"Surya Bhatt, MD","role":"Director, UAB Center for Lung Analytics and Imaging Research"},{"name":"Mario Castro MD, MPH","role":"Professor of Medicine, University of Kansas School of Medicine"}],"products":["rademikibart","CBP-201"],"companies":[{"name":"Connect Biopharma Holdings Limited","ticker":"CNTB","relationship":"filer"},{"name":"Simcere Pharmaceutical Co., Ltd.","relationship":"licensing partner (Greater China rights to rademikibart)"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[{"amount":"$6 billion","context":"approximate 30-day healthcare costs from COPD ED visits per 2025 claims data"},{"amount":"$99 million","context":"remaining milestone payments eligible from Simcere collaboration"}]},"materialImpact":{"score":4,"reasoning":"Positive Phase 2 topline for the company's lead asset rademikibart in COPD with striking efficacy signals (81% reduction in treatment failure, 100% reduction in hospitalizations/ED visits) and plans to engage FDA on a Phase 3 program. A value-inflecting readout for a clinical-stage biotech, though not an approval event."},"tickerRelevance":{"others":[],"primary":"CNTB"},"globalImportance":45,"audienceRelevance":35,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap clinical-stage biotech","eventGravity":"positive Phase 2 topline on lead asset","sectorWeight":"biotech binary-catalyst sector","retailFavoriteBoost":"moderate -- biotech trial readouts attract retail flow"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Connect Biopharma announced positive topline data from its global Phase 2 Seabreeze STAT COPD trial of rademikibart as add-on treatment for acute exacerbations in adults with COPD and type 2 inflammation.\n\nRademikibart reduced treatment failure by 81% (p=0.0122), new moderate-to-severe exacerbations by 85% (p=0.030), and hospitalizations or ED visits by 100% (p=0.0137) through Week 4, with a safety profile comparable to placebo. The 159-participant trial also showed a 70 mL greater improvement in FEV(1) at Week 4 that missed statistical significance (p=0.1607).\n\nThe company plans to engage with the FDA to align on a Phase 3 registrational program, and remains eligible for up to approximately $99 million in remaining milestones from its Simcere partnership in Greater China.","key_figures":{"drugName":"rademikibart","phaseOfTrial":"Phase 2","customDimensions":{"enrolled_participants":159,"new_exacerbation_reduction":"85% (p=0.030)","fev1_improvement_vs_placebo":"70 mL at Week 4 (p=0.1607)","treatment_failure_reduction":"81% (p=0.0122)","simcere_milestones_remaining":"$99 million","hospitalization_ed_visit_reduction":"100% (p=0.0137)"}},"named_entities":{"people":[{"name":"Barry Quart, Pharm.D.","role":"CEO and Director"},{"name":"Surya Bhatt, MD","role":"Director, UAB Center for Lung Analytics and Imaging Research"},{"name":"Mario Castro MD, MPH","role":"Professor of Medicine, University of Kansas School of Medicine"}],"products":["rademikibart","CBP-201"],"companies":[{"name":"Connect Biopharma Holdings Limited","ticker":"CNTB","relationship":"filer"},{"name":"Simcere Pharmaceutical Co., Ltd.","relationship":"licensing partner (Greater China rights to rademikibart)"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[{"amount":"$6 billion","context":"approximate 30-day healthcare costs from COPD ED visits per 2025 claims data"},{"amount":"$99 million","context":"remaining milestone payments eligible from Simcere collaboration"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-30T11:00:23.950Z","global_importance":45,"audience_relevance":35,"importance_components":{"tickerTier":"small-cap clinical-stage biotech","eventGravity":"positive Phase 2 topline on lead asset","sectorWeight":"biotech binary-catalyst sector","retailFavoriteBoost":"moderate -- biotech trial readouts attract retail flow"}},"durationMs":7335,"modelName":"glm-5.3-flashx"}}