Havn Life Sciences announced that, on August 31, 2020, its wholly-owned subsidiary, HAVN Research Inc., was granted a Section 56 exemption by Health Canada, meaning it now has the ability to possess certain amounts of pure psilocybin for scientific purposes, specifically for the research and development of quality control methods.
Havn Life said it plans to immediately begin work on experiments with the objective of developing a set of methods for the safe, standardized, quality-controlled production of medical compounds extracted from the Psilocybe spp. mushroom.
“We are thrilled to be among the first to receive permission from the Canadian government to begin work with psilocybin”, stated Tim Moore, Co-CEO of Havn Life. “This important milestone will enable Havn to begin working toward creating method-validation and analytical chemistry to standardize methods for quality control and testing of these substances.”
“Having access to compounds is essential in order to further research in the medical field. This is the start of our journey into developing standardized protocols to ensure that as this industry grows, we understand efficient new methodology”, stated Susan Chapelle, Havn Life Co-CEO, noting the advent of new technology and variables in extraction have changed significantly in the last decade.
Havn recently began trading on the Canadian Securities Exchange using the ticker symbol “HAVN”. Havn Life said it is focused on the standardized, quality-controlled extraction of psychoactive compounds from plants and fungi to develop products for use in research. Havn Life is also developing natural healthcare products designed to unlock human potential, containing novel and natural psychoactive compounds. The company has no revenue as of yet.
“Listing on the Canadian Securities Exchange is an important step in Havn Life’s growth within the emerging global psychedelic space,” says Tim Moore, Havn Life Co-CEO. “There is a tremendous opportunity to transform and enhance the healthcare and wellness space with psychedelic medicine, and the time is now to lay the foundations for what is likely to be a significant industry. Our multidisciplinary team is focused on laying the groundwork by developing quality controls and methodology for research and the medical supply chain.”
Moore was the only employee of Havn when the prospectus was published. Havn Research has a staff of seven, comprising seven consultants and no fulltime employees. Havn Research said it has the qualified personnel required to operate its facility and to develop research protocols and formulate drug compounds
According to the company’s prospectus
, Havn Research plans to undertake research to develop the research protocols to cover the production of Psilocybe spp. mushrooms in sterile conditions, the extraction and purification of psilocybin, psilocin, baeocystin, and other compounds found in the genus, and quality control and testing necessary for safety and formulation protocols with Psilocybe spp. and/or constituents. Havn Research said it plans to develop a compound library designed to support the science of safe, quality-controlled psychoactive compounds for the formulation to supply researchers with compounds for clinical trials.
Havn Research said it expects that it will take one year to complete the development of research protocols, after which
approximately an additional four months will be required for the protocols to be published. Havn Research’s research is expected to be split into two 17-week phases and one 18-week phase. The company said it plans to build a dedicated lab facility for its research, formulation, extraction, and pilot-scale manufacturing purposes.
The phase 1 lab build-out is anticipated to cost $300,000 and to be completed by the beginning of the third quarter of 2020. Phase 1 will be designed to meet the requirements to operate under the Health Canada section 56 research exemption. The Corporation also plans to complete a phase 2 lab build-out designed to satisfy the requirements necessary for a Dealer’s License, which it aims to complete by the first quarter of 2021. The phase 2 lab build-out is anticipated to cost $500,000. Havn said it expects it will take an additional four months for the protocol to be published.
HAVN Research aims to have natural health products (NHP) ready for the market in early 2021. HAVN Research said it expects to market its proprietary NHP products under the HAVN brand through a direct to consumer market model and through third party point of sale locations of NHP products.
“We are currently working on a variety of projects including product formulation of effective microdosing of novel psychoactive compounds as well as the development of a state-of-the-art mycology lab for extraction,” said Susan Chapelle, Co-CEO of Havn Life.