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XPhyto $XPHY.ca Announces Business Strategy and Milestones For 2021 Innovation to Impact $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 7:41 AM on Monday, January 18th, 2021
  • 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.

Diagnostics

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.

Psychedelics

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.

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CLIENT FEATURE: Xphyto Therapeutics $XPHY.ca Providing Investor Access to Leading Edge Bioscience Opportunities $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 12:37 PM on Thursday, January 7th, 2021

(CSE:XPHY / OTC:XPHYF / FSE:4XT)

  • Completed Successful SARS-CoV-2 RT-PCR Diagnostic Test Kit Validation
  • Secured Exclusive Psychedelic Drug Development Agreement
  • Appointed European Healthcare Executive to Board of Director
  • Engaged German Partner for Development of Psilocybin API Production
  • Announced Update on Contract Drug Delivery Program
  • Announced Update on Oral Thin Film Drug Delivery Program
  • Provided Update on Parkinson’s Transdermal Patch

Three Xphyto Divisions:

1. Vektor Pharma TF: World-class thin film drug delivery platforms for transdermal and oral dissolvable dosage forms

2. 3a-Diagnostics: Rapid, low-cost screening tests for pandemic and dental health applications

3. Xphyto Laboratories Inc.: Development of industrial production processes for emerging active pharmaceutical ingredients, including psychedelics and cannabinoid isolates

1. Vektor Pharma TF GmbH – Drug Delivery

100% owned XPhyto subsidiary

Global leader in design, testing and manufacture of therapeutic film drug delivery systems

  • Major pharma clients – past, present and future
  • Focused and nimble team – rapid turnaround on new opportunities

Versatile platform technology

  • Transdermal patches (TDS) – slow and steady release
  • Oral dissolvable film (ODF) sublingual strips – instant bioavailability

EU GMP facilities in Baden-Württemberg, Germany

Holder of numerous German narcotics import and manufacturing licences

XPhyto Drug Development Pipeline – Stage 1 & 2

  • Platform technology
  • Scalable product development pipeline
  • High-growth and new API opportunities
  • Neurological indications
  • Generic and hybrid-generic drug formulations

2. 3a-Diagnostics GmbH – Rapid Testing

XPhyto has an exclusive development, technology purchase and licence agreement

Specializing in the development, production, and marketing of low-cost point-of-care screening test systems:

  • COVID-19 rapid PCR Kit
  • COVID-19 disposable ultra-rapid test
  • Oral biosensors for the instant detection of bacterial and viral pathogens
  • Influenza A, H1N1 (swine flu), H5N1 (avian flu), Strep A, stomatitis, periimplantitis and periodontitis
  • Biosensor screening platform for high-throughput for identification of new biosensor targets for new biosensor products

Development partially funded by grants from the German Federal Ministry of Education and Research (BMBF)

Lead Products:

COVID-19 rapid PCR Kit

  • Diagnostic level accuracy, rapid results (<25 minutes), minimal lab equipment
  • European commercial approval and product launch planned for Q1 2021

Periimplantitis oral biosensor

  • For the early detection of infection associated with dental implants
  • Biosensor releases an extremely bitter compound when exposed to the causative pathogenic bacteria
  • European commercial approval and product launch planned for Q4 2021 

3. XPhyto Laboratories Inc. & Vektor Pharma TF GmbH – Psychedelics

100% owned XPhyto subsidiaries

Exclusive agreements with leading German and Canadian universities

Germany:

  • Development of psychedelic drug formulations – sublingual and transdermal
  • Development of biotechnology process for industrial scale production of psilocybin API
  • 12-month development program commenced Q3 2020

Canada:

  • Certified analytical testing for cannabis and psychedelics
  • Development programs for industrial scale and EU GMP production of mescaline, MDMA, DMT, and cannabinoid isolates
  • Novel psychedelic drug formulations

Clinical validation planned for Germany and Canada

Hub On AGORACOM / Corporate Profile