XPhyto Therapeutics Corp. (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT)

XPhyto Therapeutics Corp. (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT) is a bioscience accelerator focused on next-generation drug delivery, diagnostic and new active pharmaceutical ingredient investment opportunities. This includes products that are being readied for commercialization within the coming weeks, such as a rapid COVID-19 PCR test kit that reduces turnaround times to less than 30 minutes.

The company has research and development operations in North America and Europe and an operational focus in Germany. Its regulatory approval and commercialization focus is currently on products for the European market.

XPhyto was founded in 2017 and is headquartered in Vancouver, British Columbia.

Business Strategy & Milestones for 2021

On January 18, 2021, XPhyto issued a news release detailing its business strategy for the coming year. The company noted that it is “on the cusp of transformational change as product development programs advance from the laboratory to the clinic.” In addition to continuing to leverage its scientific expertise and operations in North America and Europe for product development and optimization, XPhyto intends to pursue growth through the commercialization of existing products and adherence to a focused investment strategy targeting impact-driven innovation with “the potential for extreme value creation.”

In particular, XPhyto is well positioned to execute on opportunities across its current business divisions, including:

• Commercialization of infectious disease diagnostics
• Clinical validation of transdermal and sublingual drug formulations
• Continued investment and development in psychedelic medicine

“2020 was a very productive year for XPhyto. We made significant progress in all areas of our business,” Hugh Rogers, CEO & Director of XPhyto, stated in the update. “We have ambitious milestones for 2021 with multiple product launches on the horizon, multiple clinical drug programs underway, and an aggressive commitment to psychedelic medicine. I am extremely confident that our team can execute on the company’s business plan for 2021.”

Infectious Disease Diagnostics

XPhyto’s lead diagnostic product, secured through an exclusive global commercialization agreement with 3a-diagnostics GmbH (“3a”), is a rapid and highly portable PCR diagnostic test. Notably, PCR testing “has emerged as the only internationally recognized standard for COVID-19 testing” and is expected to play a key role in facilitating the recovery of the domestic and international travel industries, among others.

Successful validation of the PCR system was achieved in Q4 2020, and XPhyto has expressed confidence that it will achieve European commercial (CE-IVD) approval in Q1 2021. In preparation for this milestone and an anticipated Q1 product launch, the company is currently in discussion with manufacturing and distribution partners in Europe and the Middle East.

In addition to COVID-19 products, XPhyto and partner 3a are developing and commercializing a portfolio of low-cost oral biosensors. The company’s lead biosensor product is an oral health screening test for the detection of peri-implantitis for which XPhyto is targeting a late 2021 European commercial approval.

XPhyto does not make any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.

Drug Formulation & Delivery

In 2020, XPhyto’s German subsidiary, Vektor Pharma TF GmbH (“Vektor”), reported significant advancement in four therapeutic programs targeting neurological indications with significant market demand. Vektor also successfully developed a sublingual drug formulation on contract for a major generic drug manufacturer and distributor.

XPhyto will look to build on this progress in 2021, with plans to complete human pilot studies evaluating its four lead therapeutic products:

• Rotigotine transdermal patch for Parkinson’s disease
• CBD oral/sublingual strip for treatment resistant epilepsy
• THC oral/sublingual strip for anorexia/nausea
• CBD:THC (1:1) oral/sublingual strip for multiple sclerosis associated spasticity

Per its 2021 business update, the company is currently in “ongoing discussions with multiple potential commercial partners, licensors and distributors and will be reviewing monetization opportunities on a continued basis.”

Psychedelic Medicine

Psychedelic compounds are a highly promising new class of active pharmaceutical ingredient (“API”) demonstrating strong potential for a variety of mental health conditions. XPhyto is positioned to capitalize on this promise through two strategic initiatives:

• An agreement for the development of industrial scale biotechnology processes for the production of psilocybin
• An agreement for R&D related to multiple psychedelic compounds, including psilocybin, mescaline, LSD, MDMA and DMT, among others

XPhyto intends to advance and expand its programs focused on the industrial scale production of psychedelic API in 2021. The company also plans to launch new programs for the development of psychedelic drug formulations, with a focus on sublingual and transdermal therapeutics and the integration of these products into established clinical programs relating to mental health indications.

Management Team

Hugh Rogers is the CEO and Director of XPhyto Therapeutics Corp. He is an entrepreneur and lawyer with private and public start-up company experience in various industries and operational roles. His recent advisory work has focused on public listings and corporate restructuring. This restructuring has occurred in the life science (cell therapy and medical device) and natural resources (natural gas co-gen and conventional oil) industries. Mr. Rogers holds a bachelor’s degree in Cellular Biology and Genetics and a law degree. He is a member in good standing of the Law Society of British Colombia.

Christopher Ross is the CFO of XPhyto. He is a professional accountant with broad financial experience across numerous industries, including forestry, distribution, construction, mining and multi-family real estate. He has provided advisory services to private and public companies in the areas of financial accounting, strategic analysis, audit and taxation. Mr. Ross holds a bachelor’s degree in commerce. He is a member in good standing with the Chartered Professional Accountants Association of British Columbia.

Wolfgang Probst serves as Director of XPhyto and Managing Director of BUNKER Pflanzenextrakte GmbH. He is a seasoned management and financial consultant based in Bavaria, Germany. He has consulting experience as branch head working with private clients and corporations of high net worth. In 2017, Mr. Probst assumed the CFO role of BUNKER and continues to play a key role in its operational and financial development.

Professor Dr. Raimar Löbenberg serves as Director of XPhyto. He holds a Bachelor of Science in pharmacy from Johannes Gutenberg-University and a Ph.D. in pharmaceutics from the Johann Wolfgang Goethe-University. He is the co-founder of RS Therapeutics Inc., which concentrates on foam-based topical drug delivery systems.

Professor Dr. Thomas Beckert is the Founder and Managing Director of Vektor Pharma TF GmbH. His expertise includes the formulation and machine development of transdermal therapeutic systems and ODFs. Professor Beckert holds a Bachelor of Science in pharmacy from the University of Freiburg and a Ph.D. in pharmacy and economics from the University of Tubingen.

Investment Considerations

• XPhyto Therapeutics Corp. is a bioscience accelerator focused on next-generation drug delivery, diagnostic and new active pharmaceutical ingredient investment opportunities.
• The company has research and development operations in North America and Europe and an operational focus in Germany.
• XPhyto’s operations are concentrated into three core divisions: infectious disease diagnostics, clinical development of transdermal and sublingual drug formulations, and psychedelic medicine.
• The company’s lead diagnostic product is an accurate, rapid and highly portable PCR diagnostic test system being evaluated in Europe for the detection of COVID-19.
• XPhyto’s German subsidiary, Vektor Pharma TF GmbH, is advancing four therapeutic programs targeting neurological indications; the company intends to complete human pilot studies evaluating these products in 2021.
• The company has two agreements in place focused on psychedelic compounds, a promising new class of API with strong potential for the treatment of mental health conditions.