{"success":true,"data":{"pressRelease":{"id":"162848","rtpr_id":"nGNE3gFvJT-20261007","ticker":"VRXA","exchange":"NASDAQ","all_tickers":["VRXA"],"title":"VERAXA Biotech Provides Overview on Implementation of  FDA-Aligned Human-Relevant Models into R&D Strategy","author":"Globe Newswire","published_at":"2026-10-07T11:00:00.078Z","article_body":"Consistent Use of New Approach Methodologies (NAMs) to Potentially Accelerate\nBiTAC® Oncology Pipeline and Significantly Reduce Animal Testing Needs\n\nZURICH, SWITZERLAND, Oct. 07, 2026 (GLOBE NEWSWIRE) -- VERAXA Biotech AG\n(NASDAQ: VRXA; “VERAXA” or the “Company”), a leading developer of\nnext-generation antibody-based cancer therapies, today provided an update on\nits strategy and progress to implement a suite of U.S. Food and Drug\nAdministration (FDA) aligned New Approach Methodologies (NAMs) across its\npreclinical research and development programs, potentially enabling faster\nclinical advancement while significantly reducing animal testing. This\nstrategic implementation positions VERAXA ahead of the FDA’s 2025 roadmap\n(https://www.globenewswire.com/Tracker?data=rzXSP_T6oWFOnoTTRnsuzCrATaD7aXveDJT08pfjVh7Pzv3nSRgLNskniZzpzdmkLNrwRfIY9ry2Hj8AnHBlXNzeKhRlq4dkqdhQg94EytzArK6gsBIxrA79MlMK3WcD_EFXKLDwDCESFrFSJVzuLnsPXarYgQMTgkEqleaoS8ESuAWFFXl0Gbv7ywnIurlHnsPOe1JasYNJDW11qQkkdQ==),\nwhich encourages the phased reduction and ultimate replacement of animal\ntesting in favor of human-relevant, non-animal and non-clinical test methods\nfor developing safe and effective therapies.\n\nNAMs encompass a range of technologies, including cell-based assays,\norgan-on-chip systems, computational modeling and ex vivo tissue models,\ndesigned to more accurately predict human biological responses while reducing\ndependence on animal models. Beyond this regulatory alignment, the shift\ntoward more sustainable and ethical research practices is also expected to\nreduce development costs and timelines, for example, by bypassing certain\nnon-human primate (NHP) toxicology studies traditionally required ahead of\nclinical development.\n\n“We see NAMs as not just a regulatory obligation, but also as a scientific\nopportunity,” said Christoph Erkel, Ph.D., Chief Scientific Officer of\nVERAXA. “We’ve been investing in translational, human-relevant model\nsystems well ahead of the FDA’s 2025 roadmap, and we see this shift as\nbeneficial and a win-win situation for both science and sustainability.\nReducing our reliance on animal studies, particularly NHP toxicology testing,\nallows us to generate more clinically predictive data, move faster, and do so\nmore efficiently and sustainably.”\n\nVERAXA has been building a multi-layered panel of NAMs to characterize and\nde-risk its pipeline of BiTAC (bi-targeted tumor-associated cytotoxicity)\nbased T cell engagers (BiTAC-TCEs), BiTAC-based antibody drug conjugates\n(BiTAC-ADCs) and bispecific antibody-drug conjugates (bsADCs) technologies. At\nthe AACR Annual Meeting 2026, the Company presented initial data on its most\nadvanced BiTAC-TCE program. In those studies, the candidate performed as\nintended in vitro and in vivo, attacking cancer cells that displayed both\ntarget molecules while sparing cells expressing only one of the two, with a\nsafety profile that was superior, and efficacy that matched, a more\ntraditional TCE, pointing to the possibility of a meaningfully improved\ntherapeutic index. The in vitro results came from three-dimensional, cell\nline-derived spheroid models, which recapitulate solid tumor architecture more\nclosely than two-dimensional culture. VERAXA has since generated new spheroid\ndata demonstrating consistent predictivity of T cell engagement specificity\nacross diverse cancer cell lines and validating the model for IND-enabling\nstudies, further reinforcing this model’s translational value ahead of\nclinical development.\n\nVERAXA further evaluated its lead BiTAC-TCE and bsADC candidates in an ex vivo\npanel of ten low-passage patient-derived xenograft models of non-small cell\nlung cancer, models that closely preserve the molecular characteristics,\nheterogeneity, and therapeutic response of the original tumors. Because these\nassays draw on tumor material from a small number of donor mice and can be\nsplit into many parallel patient samples, the panel required only about ten\nmice in total, versus an estimated 200 or more for comparable in vivo efficacy\nstudies.\n\nAcross the panel, the combined BiTAC consistently induced potent T\ncell-mediated killing, while relevant controls, including commercial T cell\nengagers against non-expressed targets, showed only minimal activity,\nproviding strong evidence that VERAXA’s dual-targeting approach extends\nbeyond cell line models into clinically meaningful anti-tumor activity,\nvalidating the need for simultaneous dual-target engagement and reinforcing\nBiTAC as a next-generation approach to T cell redirection. This ex vivo\nplatform demonstrates how VERAXA’s NAM strategy reduces both animal use and\npreclinical cycle time without compromising clinical relevance.\n\nAbout VERAXA Biotech AG (NASDAQ: VRXA)\n\nVERAXA is building a premier engine for the discovery and development of\nnext-generation antibody-based cancer therapeutics, powered by a suite of\ntransformative technologies and guided by rigorous quality-by-design\nprinciples. The company is rapidly advancing its pipeline of conditionally\nactive T cell engagers (BiTAC-TCEs), bispecific antibody-drug conjugates\n(bsADCs), and proprietary BiTAC formats into clinical development. Uniquely,\nVERAXA has implemented FDA-aligned New Approach Methodologies across all\npreclinical programs, enabling faster clinical advancement while reducing\nreliance on animal testing. Founded on scientific breakthroughs from the\nEuropean Molecular Biology Laboratory (EMBL), a world-renowned institution for\npioneering life science research, VERAXA combines innovation with responsible\nresearch practices.\n\nFor regular updates about VERAXA Biotech, visit www.veraxa.com or follow us on\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=22UL6ka4KXeuZZluiDJxCA388Rm7ZkDtnyqY9FUKNdDNQd0-kiaar_1D1aXJeKrzSEx6mkfJNRx-Xw7cftNgVkozyCnnmzFrI7pEOxcG1JC0XhUhSPdfjhhDsiXAe0g-),\nX\n(https://www.globenewswire.com/Tracker?data=A65hVrECUMkcjtGM9lpafpDEc07I-uvr4crrhzJwxWeL6SosWP_wKD1vsuqzMN9dgEMEtMwj__W4oaTZurd2vQ==)\n(formerly known as Twitter) and Bluesky\n(https://www.globenewswire.com/Tracker?data=zLLRQD7Mvz3ffV6jQQjHVL0fwzHuDZo5SiefvbVMRBsS095OK2vkSs7om6ZLesK88AWuMpQGcU3ApigXFQYY6Ojc1vMbwH4ORYTKDKsfytvJJofzpJuYpD9JTKWya-x7).\n\nBiTAC® is a registered trademark of VERAXA Biotech GmbH.\n\nForward-looking Statements\n\nThis press release may contain \"forward-looking statements\" within the meaning\nof the Private Securities Litigation Reform Act of 1995. All statements that\naddress activities, events, or developments that VERAXA Biotech AG (the\n\"Company\") intends, expects, plans, projects, believes, or anticipates will or\nmay occur in the future are forward-looking statements, including the\nCompany’s ability to utilize NAMS across its preclinical research and\ndevelopment programs to enable faster clinical advancement and the ability of\nits technological platform to produce transformative therapeutics. Such\nforward-looking statements are based on current expectations and involve\ninherent risks and uncertainties, including factors that could delay, divert\nor change any of them, and could cause actual outcomes and results to differ\nmaterially from current expectations. No forward-looking statement can be\nguaranteed. Forward-looking statements contained on this press release should\nbe evaluated together with the many uncertainties that affect the Company's\nbusiness, particularly those identified or referenced in the risk factors\nsection of the Company’s most recent Annual Report on Form 20-F and any\nsubsequent reports on Form 6-K. These documents are available from the\nSecurities and Exchange Commission, the Company website or from Company\nInvestor Relations.\n\nIn addition, any information contained in this press release was current as of\nthe date presented and should not be relied upon as representing our estimates\nas of any subsequent date. While we may elect to update forward-looking\nstatements at some point in the future, we specifically disclaim any\nobligation to do so, even if our estimates change, whether as a result of new\ninformation, future events or otherwise. Consequently, the company will not\nupdate the information contained in this press release and investors should\nnot rely upon the information as current or accurate after the presentation\ndate.\n\nAttachment\n*     20261007_VRXA_NAM_Strategy_FINAL\n(https://ml-eu.globenewswire.com/Resource/Download/8eb36ff5-5d7a-4c03-ad10-0a701956f7f4)\n\nContact\nVERAXA Biotech AG – Corporate \n Christoph Antz, Ph.D.\n Chief Executive Officer, Co-Founder\n investors@veraxa.com\n \nFor Media and Investors – U.S.\n Brandon Weiner\n ICR Healthcare\n VERAXA@icrhealthcare.com\n \nFor Media and Investors – EU\n Mario Brkulj\n investors@veraxa.com","article_body_html":"","raw_payload":{"data":{"id":"nGNE3gFvJT-20261007","title":"VERAXA Biotech Provides Overview on Implementation of  FDA-Aligned Human-Relevant Models into R&D Strategy","author":"Globe Newswire","ticker":"VRXA","created":"2026-10-07T11:00:00.078Z","tickers":["VRXA"],"exchange":"NASDAQ","article_body":"Consistent Use of New Approach Methodologies (NAMs) to Potentially Accelerate\nBiTAC® Oncology Pipeline and Significantly Reduce Animal Testing Needs\n\nZURICH, SWITZERLAND, Oct. 07, 2026 (GLOBE NEWSWIRE) -- VERAXA Biotech AG\n(NASDAQ: VRXA; “VERAXA” or the “Company”), a leading developer of\nnext-generation antibody-based cancer therapies, today provided an update on\nits strategy and progress to implement a suite of U.S. Food and Drug\nAdministration (FDA) aligned New Approach Methodologies (NAMs) across its\npreclinical research and development programs, potentially enabling faster\nclinical advancement while significantly reducing animal testing. This\nstrategic implementation positions VERAXA ahead of the FDA’s 2025 roadmap\n(https://www.globenewswire.com/Tracker?data=rzXSP_T6oWFOnoTTRnsuzCrATaD7aXveDJT08pfjVh7Pzv3nSRgLNskniZzpzdmkLNrwRfIY9ry2Hj8AnHBlXNzeKhRlq4dkqdhQg94EytzArK6gsBIxrA79MlMK3WcD_EFXKLDwDCESFrFSJVzuLnsPXarYgQMTgkEqleaoS8ESuAWFFXl0Gbv7ywnIurlHnsPOe1JasYNJDW11qQkkdQ==),\nwhich encourages the phased reduction and ultimate replacement of animal\ntesting in favor of human-relevant, non-animal and non-clinical test methods\nfor developing safe and effective therapies.\n\nNAMs encompass a range of technologies, including cell-based assays,\norgan-on-chip systems, computational modeling and ex vivo tissue models,\ndesigned to more accurately predict human biological responses while reducing\ndependence on animal models. Beyond this regulatory alignment, the shift\ntoward more sustainable and ethical research practices is also expected to\nreduce development costs and timelines, for example, by bypassing certain\nnon-human primate (NHP) toxicology studies traditionally required ahead of\nclinical development.\n\n“We see NAMs as not just a regulatory obligation, but also as a scientific\nopportunity,” said Christoph Erkel, Ph.D., Chief Scientific Officer of\nVERAXA. “We’ve been investing in translational, human-relevant model\nsystems well ahead of the FDA’s 2025 roadmap, and we see this shift as\nbeneficial and a win-win situation for both science and sustainability.\nReducing our reliance on animal studies, particularly NHP toxicology testing,\nallows us to generate more clinically predictive data, move faster, and do so\nmore efficiently and sustainably.”\n\nVERAXA has been building a multi-layered panel of NAMs to characterize and\nde-risk its pipeline of BiTAC (bi-targeted tumor-associated cytotoxicity)\nbased T cell engagers (BiTAC-TCEs), BiTAC-based antibody drug conjugates\n(BiTAC-ADCs) and bispecific antibody-drug conjugates (bsADCs) technologies. At\nthe AACR Annual Meeting 2026, the Company presented initial data on its most\nadvanced BiTAC-TCE program. In those studies, the candidate performed as\nintended in vitro and in vivo, attacking cancer cells that displayed both\ntarget molecules while sparing cells expressing only one of the two, with a\nsafety profile that was superior, and efficacy that matched, a more\ntraditional TCE, pointing to the possibility of a meaningfully improved\ntherapeutic index. The in vitro results came from three-dimensional, cell\nline-derived spheroid models, which recapitulate solid tumor architecture more\nclosely than two-dimensional culture. VERAXA has since generated new spheroid\ndata demonstrating consistent predictivity of T cell engagement specificity\nacross diverse cancer cell lines and validating the model for IND-enabling\nstudies, further reinforcing this model’s translational value ahead of\nclinical development.\n\nVERAXA further evaluated its lead BiTAC-TCE and bsADC candidates in an ex vivo\npanel of ten low-passage patient-derived xenograft models of non-small cell\nlung cancer, models that closely preserve the molecular characteristics,\nheterogeneity, and therapeutic response of the original tumors. Because these\nassays draw on tumor material from a small number of donor mice and can be\nsplit into many parallel patient samples, the panel required only about ten\nmice in total, versus an estimated 200 or more for comparable in vivo efficacy\nstudies.\n\nAcross the panel, the combined BiTAC consistently induced potent T\ncell-mediated killing, while relevant controls, including commercial T cell\nengagers against non-expressed targets, showed only minimal activity,\nproviding strong evidence that VERAXA’s dual-targeting approach extends\nbeyond cell line models into clinically meaningful anti-tumor activity,\nvalidating the need for simultaneous dual-target engagement and reinforcing\nBiTAC as a next-generation approach to T cell redirection. This ex vivo\nplatform demonstrates how VERAXA’s NAM strategy reduces both animal use and\npreclinical cycle time without compromising clinical relevance.\n\nAbout VERAXA Biotech AG (NASDAQ: VRXA)\n\nVERAXA is building a premier engine for the discovery and development of\nnext-generation antibody-based cancer therapeutics, powered by a suite of\ntransformative technologies and guided by rigorous quality-by-design\nprinciples. The company is rapidly advancing its pipeline of conditionally\nactive T cell engagers (BiTAC-TCEs), bispecific antibody-drug conjugates\n(bsADCs), and proprietary BiTAC formats into clinical development. Uniquely,\nVERAXA has implemented FDA-aligned New Approach Methodologies across all\npreclinical programs, enabling faster clinical advancement while reducing\nreliance on animal testing. Founded on scientific breakthroughs from the\nEuropean Molecular Biology Laboratory (EMBL), a world-renowned institution for\npioneering life science research, VERAXA combines innovation with responsible\nresearch practices.\n\nFor regular updates about VERAXA Biotech, visit www.veraxa.com or follow us on\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=22UL6ka4KXeuZZluiDJxCA388Rm7ZkDtnyqY9FUKNdDNQd0-kiaar_1D1aXJeKrzSEx6mkfJNRx-Xw7cftNgVkozyCnnmzFrI7pEOxcG1JC0XhUhSPdfjhhDsiXAe0g-),\nX\n(https://www.globenewswire.com/Tracker?data=A65hVrECUMkcjtGM9lpafpDEc07I-uvr4crrhzJwxWeL6SosWP_wKD1vsuqzMN9dgEMEtMwj__W4oaTZurd2vQ==)\n(formerly known as Twitter) and Bluesky\n(https://www.globenewswire.com/Tracker?data=zLLRQD7Mvz3ffV6jQQjHVL0fwzHuDZo5SiefvbVMRBsS095OK2vkSs7om6ZLesK88AWuMpQGcU3ApigXFQYY6Ojc1vMbwH4ORYTKDKsfytvJJofzpJuYpD9JTKWya-x7).\n\nBiTAC® is a registered trademark of VERAXA Biotech GmbH.\n\nForward-looking Statements\n\nThis press release may contain \"forward-looking statements\" within the meaning\nof the Private Securities Litigation Reform Act of 1995. All statements that\naddress activities, events, or developments that VERAXA Biotech AG (the\n\"Company\") intends, expects, plans, projects, believes, or anticipates will or\nmay occur in the future are forward-looking statements, including the\nCompany’s ability to utilize NAMS across its preclinical research and\ndevelopment programs to enable faster clinical advancement and the ability of\nits technological platform to produce transformative therapeutics. Such\nforward-looking statements are based on current expectations and involve\ninherent risks and uncertainties, including factors that could delay, divert\nor change any of them, and could cause actual outcomes and results to differ\nmaterially from current expectations. No forward-looking statement can be\nguaranteed. Forward-looking statements contained on this press release should\nbe evaluated together with the many uncertainties that affect the Company's\nbusiness, particularly those identified or referenced in the risk factors\nsection of the Company’s most recent Annual Report on Form 20-F and any\nsubsequent reports on Form 6-K. These documents are available from the\nSecurities and Exchange Commission, the Company website or from Company\nInvestor Relations.\n\nIn addition, any information contained in this press release was current as of\nthe date presented and should not be relied upon as representing our estimates\nas of any subsequent date. While we may elect to update forward-looking\nstatements at some point in the future, we specifically disclaim any\nobligation to do so, even if our estimates change, whether as a result of new\ninformation, future events or otherwise. Consequently, the company will not\nupdate the information contained in this press release and investors should\nnot rely upon the information as current or accurate after the presentation\ndate.\n\nAttachment\n*     20261007_VRXA_NAM_Strategy_FINAL\n(https://ml-eu.globenewswire.com/Resource/Download/8eb36ff5-5d7a-4c03-ad10-0a701956f7f4)\n\nContact\nVERAXA Biotech AG – Corporate \n Christoph Antz, Ph.D.\n Chief Executive Officer, Co-Founder\n investors@veraxa.com\n \nFor Media and Investors – U.S.\n Brandon Weiner\n ICR Healthcare\n VERAXA@icrhealthcare.com\n \nFor Media and Investors – EU\n Mario Brkulj\n investors@veraxa.com"},"type":"article","timestamp":"2026-10-07T11:00:00.1843385Z","server_sent_at_ms":1791370800184},"received_at":"2026-10-07T11:00:00.345Z","source_url":null},"analysis":{"id":"151325","press_release_id":"162848","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"operations_update","narrative":"VERAXA Biotech announced it has implemented FDA-aligned New Approach Methodologies (NAMs) across all preclinical programs, positioning itself ahead of the FDA's 2025 roadmap to phase out animal testing.\n\nNew ex vivo data in ten patient-derived xenograft models of non-small cell lung cancer showed the lead BiTAC-TCE potently killed dual-target cancer cells while sparing single-target cells, using roughly ten mice versus an estimated 200 for comparable in vivo studies.\n\nThe strategy could shorten preclinical timelines and cut costs by bypassing certain non-human primate toxicology studies, supporting faster IND-enabling advancement of the BiTAC oncology pipeline.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"FDA-aligned NAM strategy cuts animal use ~20x in ex vivo testing and may accelerate BiTAC pipeline toward IND."},"keyFigures":{"customDimensions":{"mice_used":10,"exvivo_xenograft_models":10,"mice_estimated_traditional":200}},"quotedText":"We see NAMs as not just a regulatory obligation, but also as a scientific opportunity","namedEntities":{"people":[{"name":"Christoph Erkel","role":"Chief Scientific Officer"},{"name":"Christoph Antz","role":"Chief Executive Officer, Co-Founder"}],"products":["BiTAC","BiTAC-TCE","BiTAC-ADC","bsADC"],"companies":[{"name":"VERAXA Biotech AG","ticker":"VRXA","relationship":"filer"},{"name":"European Molecular Biology Laboratory (EMBL)","relationship":"founding institution"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"A strategy update on FDA-aligned non-animal preclinical methods with supportive ex vivo data for the lead BiTAC-TCE program, but no new clinical, regulatory, or financial milestones. Incremental de-risking news, not market-moving."},"tickerRelevance":{"others":[],"primary":"VRXA"},"globalImportance":20,"audienceRelevance":15,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"micro-cap biotech","eventGravity":"preclinical strategy update, no clinical or financial milestone","issuerAuthored":true,"retailFavoriteBoost":false}},"event_type":"operations_update","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":2,"narrative":"VERAXA Biotech announced it has implemented FDA-aligned New Approach Methodologies (NAMs) across all preclinical programs, positioning itself ahead of the FDA's 2025 roadmap to phase out animal testing.\n\nNew ex vivo data in ten patient-derived xenograft models of non-small cell lung cancer showed the lead BiTAC-TCE potently killed dual-target cancer cells while sparing single-target cells, using roughly ten mice versus an estimated 200 for comparable in vivo studies.\n\nThe strategy could shorten preclinical timelines and cut costs by bypassing certain non-human primate toxicology studies, supporting faster IND-enabling advancement of the BiTAC oncology pipeline.","key_figures":{"customDimensions":{"mice_used":10,"exvivo_xenograft_models":10,"mice_estimated_traditional":200}},"named_entities":{"people":[{"name":"Christoph Erkel","role":"Chief Scientific Officer"},{"name":"Christoph Antz","role":"Chief Executive Officer, Co-Founder"}],"products":["BiTAC","BiTAC-TCE","BiTAC-ADC","bsADC"],"companies":[{"name":"VERAXA Biotech AG","ticker":"VRXA","relationship":"filer"},{"name":"European Molecular Biology Laboratory (EMBL)","relationship":"founding institution"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-07T11:00:05.592Z","global_importance":20,"audience_relevance":15,"importance_components":{"tickerTier":"micro-cap biotech","eventGravity":"preclinical strategy update, no clinical or financial milestone","issuerAuthored":true,"retailFavoriteBoost":false}},"durationMs":5173,"modelName":"glm-5.3-flashx"}}