Tilray Accelerates U.S. Medical Cannabis Expansion After Landmark Federal Rescheduling: Launches Tilray Medical USA to Lead Nationwide Medical Cannabis Innovation and Growth

NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Tilray Medical, a division of Tilray Brands, Inc. (“Tilray” or the “Company”) (Nasdaq: TLRY; TSX: TLRY) and a global leader in medical cannabis healthcare, today confirmed its planned strategic framework to advance its U.S. medical cannabis operations following federal cannabis rescheduling and related regulatory developments. In conjunction with these regulatory changes, Tilray announced the formation of Tilray Medical USA, Inc., further strengthening its commitment to leading medical cannabis innovation and growth. The Company’s approach is grounded in its proven track record operating at scale in regulated medical cannabis markets globally, supported by established compliance systems, scientific expertise, and disciplined governance. Tilray also issued the following statement in response to President Trump’s decision to reschedule cannabis.

Irwin D. Simon, Chairman and Chief Executive Officer of Tilray Brands, stated, “We support President Trump’s decision to reschedule cannabis as a constructive and necessary evolution of U.S. federal policy. This action aligns regulation with a vast body of scientific and medical data supporting cannabis medical use and safety, economic progress, and a healthcare-focused framework, while creating a more credible foundation for medical cannabis research, clinical development, and regulatory clarity. It also signals a future shaped by innovation, responsible oversight, and evidence-based policy. We believe this landmark decision is a significant catalyst for positive change within the health, wellness, and business communities across the U.S. and a critical, incremental step toward descheduling and comprehensive regulation.”

Mr. Simon continued, “Tilray has dedicated years to developing the necessary infrastructure, scientific knowledge, and regulatory skills to operate responsibly in federally legal medical cannabis markets. As U.S. policies evolve, we’re prepared to engage thoughtfully and in full compliance - just as we have led in over 20 international medical cannabis markets. We believe we are well-positioned to take the lead as we have the experienced team in place and remain committed to supporting the development and growth of a research-focused federal medical cannabis industry in the U.S.”

The direct and indirect impacts of federal cannabis rescheduling have the potential to expand access to medical research and clinical trials, improve standardization, and support the development of evidence-based cannabis therapies - key prerequisites for an integrated state-federal medical cannabis framework within the U.S. healthcare system.

Tilray Medical has built its leadership in federally regulated medical cannabis markets globally by working closely with regulators, physicians, hospitals, and research institutions to uphold the highest standards of quality, compliance, and patient safety. Tilray currently offers more than 200 registered medical cannabis products across international markets for therapeutic use, has served over 500,000 registered patients globally, and has participated in more than 15 medical cannabis studies and clinical trials in partnership with leading hospitals and physicians studying cannabis for various conditions including pediatric epilepsy, cancer-induced nausea, PTSD, pain, anxiety, essential tremors, alcohol use disorder, fibromyalgia, glioblastoma, and cannabinoids and driving performance.

With an established global footprint, mature compliance infrastructure, and deep scientific and regulatory expertise, Tilray Medical plans to adapt swiftly to regulatory developments while maintaining the highest standards of governance, patient safety, and operational integrity. The Company intends to strategically expand collaborations with healthcare operators and medical professionals, ensuring all partnerships are aligned with emerging regulatory medical guidelines. As part of its forward-looking plan, Tilray Medical USA aims to introduce medical-grade cannabis products in targeted therapeutic formats, drawing on real-world data and physician-driven insights accumulated from its international operations.

About Tilray Brands

Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment, elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on Tilray’s brand portfolio, visit and follow @Tilray on all social platforms.

Forward-Looking Statements

Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian and U.S. securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.

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