ZYUS Life Sciences Receives United States Patent No. 11,963,943 Covering Pain Management

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ZYUS Receives Patent from United States Patent and Trademark Office ("USPTO") Supporting ZYUS’ Lead Drug Candidate

SASKATOON, Saskatchewan, April 23, 2024--(BUSINESS WIRE)--ZYUS Life Sciences Corporation (the "Company") (TSX-V: ZYUS), a Canadian-based life sciences company focused on the development and commercialization of novel cannabinoid-based pharmaceutical drug candidates for pain management, announced today that the USPTO issued U.S. Patent No. 11,963,943, entitled FORMULATION FOR PAIN MANAGEMENT on today’s date. The patent, held by ZYUS’ wholly owned subsidiary, ZYUS Life Sciences Inc., is based on International Patent Application No. PCT/CA2020/050588 with claims pertaining to ZYUS’ lead drug candidate, Trichomylin? softgel capsules. This marks the seventh issuance of a patent in this patent family, joining other jurisdictions such as Canada, Australia, Israel, India, Korea and South Africa. The issuance of this patent by the USPTO underscores ZYUS’ commitment to innovation and dedication to improving patient outcomes through the development of non-opioid-based pharmaceutical solutions as a viable alternative for managing pain.

Intellectual Property Portfolio

ZYUS’ intellectual property portfolio contains multiple patent families related to fixed-dose cannabinoid-based formulations for the treatment of pain and a variety of other clinically unmet needs. Including the U.S. patent issued covering its lead drug candidate, Trichomylin? softgel capsules, ZYUS’ intellectual property portfolio, with a focus on novel therapies, currently contains seven issued patents, eleven nonprovisional patent applications that have been filed internationally, four continuation-in-part applications filed in the U.S. and one provisional patent application directed to formulations and treatments.

Trichomylin? Softgel Capsules Phase 2 Clinical Trial

Trichomylin? softgel capsules have been formulated with a proprietary fixed-dose combination, specifically designed for the management of chronic pain by delivering a balanced ratio of three cannabinoids – cannabichromene ("CBC"), cannabidiol ("CBD") and delta-9-tetrahydrocannabinol ("THC"). ZYUS’ previously announced Phase 2 Clinical Trial will assess the preliminary efficacy, safety and tolerability of Trichomylin? softgel capsules in patients with advanced cancer and moderate to severe cancer-related pain.

"Receiving this patent for the treatment of pain using our non-opioid-based formulation validates our ongoing commitment to innovation and investment in research, marking a pivotal step towards the development of this urgently needed medicine. To our knowledge, this is the first time a U.S. patent has been awarded for a cannabinoid-based fixed-dosed formulation containing CBC, CBD and THC," said Brent Zettl, President and CEO of ZYUS. "Our clinical development program for the Trichomylin? formulation is well-positioned for success given both the new patent issuance and recently announced Phase 2 Clinical Trial, which aims to demonstrate preliminary efficacy, safety and tolerability of this novel drug candidate. We intend to use the data from our extensive pre-clinical and non-clinical studies, completed Phase 1 Clinical Trial and proposed Phase 2 Clinical Trial to form the basis of an Investigational New Drug application with the U.S. FDA."