ZYUS Life Sciences Finalizing Site Initiation for Phase 2A Clinical Trial Advancing Novel Non-Opioid Pain Drug

Paving the way for evidence-based solutions in cancer pain management with its lead drug product, Trichomylin^® softgel capsules

ZYUS Life Sciences Corporation (the “Company”) (TSXV: ZYUS), a Canadian-based life sciences company focused on the development and commercialization of novel cannabinoid-based pharmaceutical drug candidates for pain management, is pleased to announce it is in the process of finalizing site initiation for the initial locations to be used in its Phase 2 UTOPIA (Unique Treatment of Oncology Pain in Advanced Cancer) clinical trial.

The Phase 2 UTOPIA clinical trial will consist of Phase 2A (“UTOPIA-1”) and Phase 2B (“UTOPIA-2). UTOPIA-1 is a single-arm proof-of-concept study to investigate the safety and preliminary analgesic efficacy of Trichomylin^® softgel capsules in humans with advanced cancer and moderate to severe cancer-related pain. Insights gained from UTOPIA-1 will guide the strategy for UTOPIA-2, which will be a randomized, placebo-controlled trial that will further assess safety and efficacy in a larger patient population.

Patient enrollment for UTOPIA-1 is expected to begin in early June 2025, across multiple sites in Canada, with interim data from UTOPIA-1 anticipated mid-summer 2025.

ZYUS’ announcement comes at a time of growing global recognition of the untapped potential of cannabinoids in oncology. A meta-analysis of medial cannabis outcomes and associations with cancer published in Frontiers in Oncology on April 14, 2025, analyzed over 10,000 peer-reviewed studies encompassing 39,767 data points. The findings revealed a “strong consensus” supporting cannabinoids for managing cancer-related symptoms. While researchers highlight the need for further research to assess the full therapeutic potential of cannabinoids, the findings signal a critical shift in the scientific conversation. This emerging body of evidence reinforces the importance of rigorous clinical research, product purity and consistency, and reinforces ZYUS’ commitment to advancing evidence-based cannabinoid therapies.

“As we finalize site initiation for UTOPIA-1, we are proud to advance clinical development of Trichomylin^® softgel capsules,” said Brent Zettl, President and CEO of ZYUS. “Our research aims to bridge the gap between conventional treatments like opioids and NSAIDs, and deliver an alternative, evidence-based pharmaceutical option for cancer pain. This trial is a pivotal step in our journey to improve patient outcomes and quality of life.”

About ZYUS Life Sciences Corporation

ZYUS (TSXV: ZYUS) is a life sciences company focused on the development and commercialization of novel cannabinoid-based pharmaceutical drug candidates for pain management. Through rigorous scientific exploration and clinical research, ZYUS aims to secure intellectual property protection, safeguarding its innovative therapies and bolstering shareholder value. ZYUS’ unwavering commitment extends to obtaining regulatory approval of non-opioid-based pharmaceutical solutions, in pursuit of transformational impact on patients’ lives. For additional information, visit www.zyus.com or follow us on X @ZYUSCorp.

Cautionary Note Regarding Forward-Looking Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the Company’s business, the Company’s ability to advance clinical research activities, obtain regulatory approval of cannabinoid-based pharmaceutical drug candidates and introduce products that act as alternatives to current pain management therapies such as opioids, use UTOPIA-1 to guide the strategy for UTOPIA-2, begin patient enrollment in June 2025 and obtain interim data respecting UTOPIA-1 by mid-summer 2025. Any such forward-looking statements may be identified by words such as “expects”, “anticipates”, “intends”, “contemplates”, “believes”, “projects”, “plans”, “will” and similar expressions. Readers are cautioned not to place undue reliance on forward-looking statements. Statements about, among other things, the Company’s business, the Company’s ability to advance clinical research activities, obtain regulatory approval of cannabinoid-based pharmaceutical drug candidates, introduce products that act as alternatives to current pain management therapies such as opioids, use UTOPIA-1 to guide the strategy for UTOPIA-2 begin patient enrollment in June 2025 and obtain interim data respecting UTOPIA-1 by mid-summer 2025 are all forward-looking information. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance that the Company will be able to achieve these results. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances or actual results unless required by applicable law.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250522640382/en/

"Our research aims to bridge the gap between conventional treatments like opioids and NSAIDs, and deliver an alternative, evidence-based pharmaceutical option for cancer pain."