XPhyto Announces Business Strategy and Milestones For 2021 Innovation to Impact
January 18, 2021 (Source) —
- Commercialization of rapid COVID-19 PCR test
- Clinical validation of transdermal and sublingual drug formulations
- Psychedelic API production, drug formulation and clinical integration
XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company“) is pleased to announce its business strategy and milestones for 2021. The Company is on the cusp of transformational change as product development programs advance from the laboratory to the clinic. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto will target growth through commercialization of existing products and focused investment in impact driven innovation with the potential for extreme value creation.
The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. Following a successful business year 2020, XPhyto is well positioned to execute on important core milestones in all business divisions, which include the commercialization of infectious disease diagnostics, the clinical validation of transdermal and sublingual drug formulations and continued investment and development in psychedelic medicine.
XPhyto’s lead diagnostic product is an accurate, rapid and highly portable PCR diagnostic test system which is secured under an exclusive global commercialization agreement from its German development partner, 3a-diagnostics GmbH (“3a”). PCR testing has emerged as the only internationally recognized standard for COVID-19 testing, which is expected to play a critical role in expediting the revitalization of many industries, particularly domestic and international travel. Successful validation of the PCR system was achieved in Q4 2020 and the Company is confident that European commercial (CE-IVD) approval will be achieved in Q1 2021. XPhyto is in discussions to secure manufacturing and distribution partners in Europe and the Middle East in anticipation of pending commercial approval and product launch in Q1 2021.
In addition to COVID-19 products, XPhyto and its 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. There is a significant clinical need for the early detection of infection associated with dental implants prior to the onset of irreversible tissue and bone damage. The company is targeting late 2021 for European commercial approval and product launch for several biosensor screening tests.
Drug Formulations and Delivery
XPhyto’s drug formulation business is focused on neurological indications with significant market demand and the potential for meaningful patient impact. In 2020, XPhyto’s German subsidiary, Vektor Pharma TF GmbH (“Vektor”), a leader in the development of transdermal and sublingual drug formulations reported significant advancements in four therapeutic development programs. Vektor also successfully developed a sublingual drug formulation on contract for a major generic drug manufacturer and distributor.
In 2021, the Company plans to complete human pilot studies on its four lead therapeutic products: 1) Rotigotine transdermal patch for Parkinson’s disease; 2) CBD oral/sublingual strip for treatment resistant Epilepsy; 3) THC oral/sublingual strip for anorexia/nausea; and 4) CBD:THC (1:1) oral/sublingual strip for Multiple Sclerosis associated spasticity. 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 compounds are a highly promising new class of active pharmaceutical ingredient (“API”) with strong potential for the treatment of mental health related medical conditions such as depression, anxiety, addiction, and trauma-related stress disorder. Psychedelics could provide a major improvement over currently available therapeutics for a global market with unmet medical need.
XPhyto has entered into two psychedelic agreements: first, for the development of industrial scale biotechnology processes for the production of psilocybin, and second, for research and development related to multiple psychedelic compounds, including psilocybin, mescaline, LSD, MDMA, DMT, among others.
In 2021, XPhyto will continue to advance and expand its programs focused on the industrial scale production of psychedelic API, in addition to launching new programs for the development of psychedelic drug formulations, particularly sublingual and transdermal therapeutics, as well as the integration of these therapeutic products into established clinical care programs for mental health related indications.
“2020 was a very productive year for XPhyto. We made significant progress in all areas of our business,” said Hugh Rogers, CEO & Director of XPhyto. “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.”
The Company will provide more detailed plans for each of its diagnostics, drug formulation, and psychedelic businesses in the coming weeks as well as specific updates as they arise.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.
About XPhyto Therapeutics Corp.
XPhyto Therapeutics Corp. is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization of emerging active pharmaceutical ingredients for neurological applications, including psychedelic compounds and cannabinoids. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.
XPhyto Therapeutics Corp.:
Hugh Rogers, CEO and Director
Mr. Knox Henderson
MC Services AG
Julia Hofmann, Andreas Jungfer
T: +49 89 210 228 0
Forward looking statements
This news release includes statements containing forward-looking information within the meaning of applicable Canadian securities law (“forward-looking statements”). Forward-looking statements are frequently characterized by words such as “develop”, “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “potential”, “propose” and other similar words, or statements that certain events or conditions “may” or “will” occur, and in this release include the statement regarding the Company’s goal of building a successful diagnostic, drug delivery, and medical cannabis company. Forward-looking statements are only predictions based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements, including: that the Company may not succeed in developing a commercial product; that the sale of products may not be a viable business; that the Company may be unable to scale its business; product liability risks; product regulatory risk; general economic conditions; adverse industry events; future legislative and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; currency risks; competition; international risks; and other risks beyond the Company’s control. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.
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