Vistagen selects GATC Health to apply predictive AI across lead clinical-stage drug development programs. Collaboration combines Vistagen's neuroscience expertise and datasets with GATC Health's predictive modeling capabilities to provide additional insights for protocol development and resource allocation. SOUTH SAN FRANCISCO, Calif., Oct. 20, 2026 (GLOBE NEWSWIRE) - Vistagen (Nasdaq: VTGN) a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry, today announced its collaboration with GATC Health, a tech-bio company applying artificial intelligence and multiomics to drug discovery and development. The collaboration brings GATC Health's proprietary Operon(R) platform and Derisq(R) report to Vistagen's lead clinical-stage programs. Through the collaboration, GATC Health uses its Operon(R) platform and Derisq(R) predictive intelligence capabilities to provide strategic insights for Vistagen's potential next Phase 3 study of fasedienol for treatment of social anxiety disorder with the Liebowitz Social Anxiety Scale (LSAS) as the primary efficacy endpoint, as well as potential Phase 2 studies of itruvone for major depressive disorder and refisolone for menopausal hot flashes. Vistagen and GATC Health are now leveraging predictive modeling to complement traditional drug development approaches, providing deeper insights on complex scientific and development questions that impact protocol development, pipeline prioritization, and resource allocation. "GATC Health's predictive, purpose-built AI technology and methods are powerful and designed to model complex biological interactions that impact drug development, including potential efficacy and safety," said Shawn Singh, President and Chief Executive Officer of Vistagen. "We are incorporating key predictive insights from our collaboration with GATC Health into protocol development for our fasedienol program in social anxiety disorder, complementing our experience and existing datasets." "The hardest thing to get in drug development is a true outside read on your own assumptions," said Jayson Uffens, Co-Founder and Chief Technology Officer of GATC Health. "Vistagen knows these programs better than anyone. What we add is that independent perspective. Operon(R) looks at each candidate end-to-end: its chemistry, the biology it acts on, and how it's likely to perform in people. Derisq(R) gives the team a second signal to test their thinking against as they plan the next studies. Their clinical judgment plus our predictive work is how these decisions should be made." About Vistagen Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a new class of rapid-onset neurocircuitry-focused intranasal product candidates called pherines. Vistagen's pherine product candidates are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options, if successfully developed and approved. Vistagen's most advanced intranasal pherine product candidates are fasedienol for the acute treatment of social anxiety disorder, itruvone for treatment of major depressive disorder, and refisolone for treatment of vasomotor symptoms (hot flashes) due to menopause. Connect at www.Vistagen.com About GATC Health GATC Health is a tech-bio company supporting critical decision-making across the life sciences ecosystem. Its proprietary AI platform, Operon(R), unites advanced AI, multiomics, and thousands of models to simulate human biology, prospectively quantifying risk and generating solutions from discovery through development. The company's risk prediction product, the Derisq(R) report, simulates clinical trial outcomes in silico to identify safety, efficacy and off-target outcomes prior to the commitment of development capital. Operon(R) is a purpose-built platform for drug discovery, pipeline prioritization, asset de-risking and optimization, clinical trial design, and reducing financial risk and costly late-stage failures. Forward-looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, whether Vistagen's collaboration with GATC will provide any benefit to the development of product candidates in Vistagen's pipeline or whether future trials of such product candidates will occur. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as "may," "could," "expect," "project," "outlook," "strategy," "intend," "plan," "seek," "anticipate," "believe," "estimate," "predict," "potential," "strive," "goal," "continue," "likely," "will," "would" and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual results or developments may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that any of Vistagen's product candidates, including fasedienol, will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval or be commercially successful. These risks and others are more fully discussed in the section entitled "Risk Factors" in Vistagen's Annual Report on Form 10-K for the period ended March 31, 2026, and Quarterly Report on Form 10-Q for the period ended June 30, 2026, as well as discussions of potential risks, uncertainties, and other important factors in its other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen's SEC filings are available on the SEC's website at www.sec.gov. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing Vistagen's views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. Africa Daily Journal do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

GATC Health joins Critical Path Institute's New Approach Methodologies Developer Coalition to advance ai-enabled regulatory science. GATC to contribute AI-native, in silico drug discovery and predictive modeling expertise and insights to collaborative effort advancing the validation, qualification and adoption of human-relevant drug development tools C-Path is an independent nonprofit public-private partnership advancing regulatory science and accelerating drug development through collaboration with the FDA, industry, and researchers GATC executives to attend C-Path's 2026 Global Impact Conference September 15-16 in Washington, D.C. IRVINE, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) - GATC Health Corp ("GATC"), a tech-bio company applying artificial intelligence and multiomics to accelerate drug discovery and development, today announced that it has joined the Critical Path Institute's(R)(C-Path) New Approach Methodologies Developer Coalition (NAMs-DC), a precompetitive coalition working to advance the adoption, validation and qualification of new approach methodologies (NAMs) for drug discovery and development. GATC was invited to join NAMs-DC as a contributing member, and as the first AI-native drug discovery and development focused collaborator. GATC brings to the coalition a systems-level approach to in silico modeling of human biology and the prediction of drug safety and efficacy. Through its participation, GATC will work alongside NAM developers, pharmaceutical and biotechnology companies, regulators and other stakeholders to help advance frameworks for evaluating and integrating human-relevant methodologies into drug development. "Today, AI models are already playing a role in determining which drug candidates advance through development, yet there is still no broadly accepted framework for evaluating the quality, reliability, and performance of those models," said Jayson Uffens, Chief Technology Officer and Chairman of GATC Health. "No single company can establish that standard independently. Internal performance metrics are important, but they do not, on their own, create a common benchmark for the field. We joined NAMs-DC to bring the in silico capabilities behind Operon(R) into direct dialogue with technology developers, biopharmaceutical companies and regulators, and to help advance a shared understanding of what meaningful qualification should look like." Launched in 2026, NAMs-DC brings together developers of technologies including complex in vitro systems and computational models to help address a longstanding challenge in drug development: translating promising new methodologies into validated and qualified tools that can be used confidently within defined contexts. The coalition engages developers, biopharma companies and global health authorities to advance common qualification approaches and support broader regulatory adoption of NAMs. GATC's proprietary Operon(R) platform integrates multiomic data, artificial intelligence and predictive modeling to simulate complex human biology and assess how drug candidates may perform before clinical testing. The platform is designed to identify potential efficacy, toxicity, off-target effects and other risk signals earlier in development, providing a human-biology-driven complement to conventional preclinical approaches. "Expanding the range of methodologies represented within NAMs-DC is essential to building qualification approaches that can keep pace with innovation in drug development," said Graham Marsh, Ph.D., Scientific Director at Critical Path Institute and program lead for NAMs-DC. "GATC brings a distinct computational and in silico perspective to the coalition, and we look forward to its contributions as we work across the developer community, industry and regulators to advance human-relevant tools that will positively impact drug development." GATC's addition to NAMs-DC comes ahead of C-Path's 2026 Global Impact Conference, taking place September 15-16 at the Washington Marriott at Metro Center in Washington, D.C. The conference convenes regulators, industry leaders, scientists, clinicians, patient representatives and other stakeholders to address challenges in modern drug development, including discussions on advancing NAMs as drug development tools. Tyrone Lam, Chief Business Officer of GATC Health, and Eric J. Mathur, Chief Innovation Officer of GATC Health, will attend the conference on behalf of the company, participating in discussions around the evolving role of NAMs, computational approaches and artificial intelligence in drug discovery, development and regulatory evaluation. "Whether AI can meaningfully predict how drug candidates may behave in humans is becoming increasingly established. The more important question now is which methods can withstand independent scrutiny, and demonstrate that their outputs can inform real development decisions," added Uffens. "That is the work in front of the field, and we believe it is critical for GATC to contribute directly to shaping those standards rather than observe from the sidelines." About GATC Health GATC Health is a tech-bio company revolutionizing drug discovery and development by simulating complex human biology to predict how drugs will perform in the body, achieving 91% specificity and 86% sensitivity. Trusted by the world's largest insurance marketplace, biopharma, researchers, and investment partners, GATC Health's risk prediction product, the Derisq(TM) AI report, accurately assesses and predicts drug candidate safety, efficacy, and non-obvious side effects prior to the commitment of development capital. GATC Health's AI platform is also generative, creating novel intellectual property, extending pipelines, and optimizing assets. By uniting advanced AI, multiomics, and predictive modeling, GATC Health accelerates breakthroughs and reduces costly late-stage failures to bring safer, more effective therapies to patients worldwide. For more information, visit gatchealth.com. About Critical Path Institute Critical Path Institute(R)(C-Path) is an independent, nonprofit organization established in 2005 as a public-private partnership in response to the U.S. Food and Drug Administration's Critical Path Initiative. C-Path leads collaborative programs bringing together regulatory agencies, industry, academia, patient organizations and other stakeholders to advance tools and approaches that accelerate drug development worldwide. Media Contacts GATC Health Amanda Rice [email protected]