XPHYF continued its recent upward movement and may be on the verge of a $2.00 push near term.

SmallCapFirm

Complete Thursday Update For Bioscience Accelerator (XPHYF)

June 10th

SCF Readers,

XPHYF continued its recent upward movement and may be on the verge of a $2.00 push near term.

Closing above its final valuation from Tuesday, XPHYF has now strung together 2 straight green days and could be heating up.

Why? Well, as of close Wednesday, this profile was trading above its 5-Day Exponential Moving Average (EMA) and its 13-Day EMA.

As signals go, this could be a very bullish trend emerging as these lines can be viewed as strong potential support.

Furthermore, this comes on the heels of this week's big news announcement: XPhyto Provides Progress Report on Mes-caline Program for Psych-e-delic Therapies

Here's the next two lines to watch: 50-Day Simple Moving Average (SMA) and its 200-Day SMA.

With both of them currently in the $1.90+ range, a breakdown of those levels could lead to a potential squeeze play developing.

Read my initial report below yet? If not, do so now and get XPHYF on your radar.

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What do you know about psych-e-delics?

For many, they have a negative connotation due to a history of illegality associated with them.

But that was then, this is now...

Psych-e-delic compounds have emerged as a new class of dr-ugs with the potential to improve the treatment of mental health related medical conditions such as depression, anxiety, addiction, and trauma-related stress disorder.

Mes-caline is a naturally occurring psych-e-delic compound found in certain cacti, such as pey-ote, and as recently reported in the publication ACS Pharmacology and Translational Science, naturalistic use of mes-caline is associated with self-reported psychiatric improvements and enduring positive life changes.

Of the respondents reporting histories of depression, anxiety, post-traumatic stress disorder (PTSD), and alcohol and dr-ug use disorders (AUD and DUD), most (68-86%) reported subjective improvement following their most memorable mes-caline experience.

These figures are important. Why? Look no further than XPhyto Therapeutics Corp. (XPHYF).

XPhyto Therapeutics Corp. (XPHYF) 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 psych-e-delic compounds and can-na-bin-oids.

The company has a strong pipeline of drugs and diagnostic tests in development.

XPHYF Pipeline

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As you can see above, this company is not messing around and has been hard at work advancing multiple diagnostic products/drugs/treatments towards completion.

And with Tuesday's big press release, they highlight what could be one of their top potential catalysts moving forward.

#1. Potential XPHYF Catalyst - Progress Report On Mes-caline Therapy Program

XPhyto Provides Progress Report on Mes-caline Program for Psych-e-delic Therapies

  • Research and development lab set up, preliminary mes-caline synthesis complete
  • Modified synthesis process developed, mes-caline batches manufactured
  • Development of analytical methods and validation, GMP standard operating procedures and manufacturing scale-up underway

VANCOUVER, BC / ACCESSWIRE / June 8, 2021 /XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) ("XPhyto" or the "Company") is pleased to announce that its GMP mes-caline synthesis program is on schedule with the completion of initial production batches. The industrial scale manufacture of pharmaceutical grade psych-e-delic compounds, including mes-caline and psi-lo-cybin, is an important part of XPhyto's psychedelic medicine program and will provide a foundation for its dr-ug formulation and clinical validation work.

Since launching its mes-caline synthesis program in early 2021, XPhyto is pleased to be on schedule having completed lab set up, preliminary synthesis, modified synthesis, and initial batch production. The Company is currently focused on the scale up of production capability and the development of analytical methods and validation. Development of standard operating procedures (SOP) for GMP certification of the synthesis process is also underway.

"With both its North American GMP mes-caline synthesis program and German-based psi-lo-cybin biotechnology production underway, the first stage of XPhyto's psychedelic medicine program is progressing on schedule. As the manufacturing programs advance, we look forward to focusing our expertise on psych-e-delic dr-ug formulation," said Hugh Rogers, CEO & Director. "We see a significant market opportunity in the production of pharmaceutical grade psychedelics followed by the standardization of dosage formulations with precise, predictable and efficient dr-ug delivery for clinical study and therapeutic use."

[...]

Read the full article here.

#2. Potential XPHYF Catalyst - European Approval News

XPhyto announces European Approval for 25 Minute CV19 PCR Test

  • CE Mark received for in vitro diagnostic (IVD) test for the detection of SA-RS-Co-V-2
  • Rapid results with ease of use - single 20-minute PCR cycle plus 5-minute detection process
  • High sensitivity - 104.73 c/PCR limit of detection with 95% confidence interval
  • High specificity - zero cross-reactivity on 19x respiratory infectious disease panel
  • High robustness - no impact on results from minor changes in process parameters
  • 100% repeatability and laboratory precision observed
  • Sales launch in Europe planned for April 2021

VANCOUVER, BC / ACCESSWIRE / March 18, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF)(FSE:4XT) ("XPhyto" or the "Company"), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH ("3a"), are pleased to announce the European approval of its point-of-care SA-RS-Co-V-2 (CV-19) RT-PCR test system ("CV-ID Lab"). CV-ID Lab is now registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.

"Our test is one of the fastest PCR-based CV19 tests currently approved. With a sample collection to result time of 25 minutes, CV-ID Lab combines the speed of a rapid screening test with the accuracy of a PCR diagnostic," said Hugh Rogers, CEO and Director of XPhyto. "CV-ID Lab is designed for point-of-care testing, particularly in satellite and small-scale labs, such as transportation hubs, borders, care facilities, schools, pharmacies, and hospitality settings."

[...]

During validation of the assay, the limit of detection for SA-RS-Co-V-2 RNA was determined to be 104.73 c/PCR within a 95% confidence interval. Specificity of 100% against 19 other pathogens of serious respiratory infections was demonstrated on a respiratory verification panel. Precision was determined through evaluation of variance of the analysis results due to random deviations, a repeatability/intra-assay precision evaluation (same lab, user, equipment, etc.), and a laboratory precision evaluation (different lab, user, equipment, etc.). Robustness was measured by evaluation of the impact of minor changes on process parameters (transport medium, PCR cycler model, ramp rate, template volume, hybridization mixing ratio, etc.). The validation studies were carried out accordingly to ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology and VQ-015 Validation of Methods, European Medicines Agency. The quality management system was in accordance with EN ISO 13485: 2016 and EN ISO 9001: 2015.

XPhyto is currently in discussions with various potential distribution and wholesale partners as well as potential licensees. The sales launch in Europe is targeted for April 2021. The company will provide further information and updates in due course.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the CV19 pandemic.

Read the full article here.

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BREAKING: As millions are struggling with Parkinson’s Disease, health professionals fear we could be on the cusp of an epidemic...

That’s according to Dr. Ray Dorsey, a neurologist at the University of Rochester Medical Center, as reported by The Guardian.(2)

Parkinson’s is already the fastest-growing neurological disorder in the world; in the US, the number of people with Parkinson’s has increased 35% the last 10 years," says Dorsey, and “We think over the next 25 years it will double again.”(2)

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Unfortunately, there is no cure – at least not yet. However, there may be help on the way.

In fact, XPhyto Therapeutics’ subsidiary, Vektor Pharma’s transdermal form of dopamine treatment – Rotigotine — could help ease motor symptoms of Parkinson’s, and potentially help with several non-motor symptoms.(3)

After all, according to a report from CNS Drugs:

Motor and non-motor symptoms (NMS) have a substantial effect on the health-related quality of life (QoL) of patients with Parkinson’s disease (PD). Transdermal therapy has emerged as a time-tested practical treatment option, and the rotigotine patch has been used worldwide as an alternative to conventional oral treatment for PD.

That's why this recent news about a successful human pilot study could be major news for XPHYF in the short term. Check it out:

#3. Potential XPHYF Catalyst - Drug Formulation And Development Business Update

XPhyto Provides Update on Drug Formulation and Development Business

  • Rotigotine transdermal human pilot study successfully completed; program advancing to pivotal study
  • Land purchased for construction of commercial drug manufacturing facility in Germany

VANCOUVER, BC & BIBERACH, GERMANY / ACCESSWIRE / May 13, 2021 /XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) ("XPhyto" or the "Company") is pleased to announce that its 2021 drug formulation programs are advancing on schedule and continue to expand in scope. XPhyto is a bioscience accelerator at the leading-edge of the life science industry. The Company's drug formulation and development business is conducted primarily by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor").

Vektor is focused on the development of generic and hybrid-generic drug formulations for neurological conditions through its transdermal and oral dissolvable drug delivery platforms. Products in the development pipeline are targeting large and growing markets with the potential for meaningful patient outcomes.

As announced, January 28, 2021, the Company's drug development trial schedule for Q1 2021 was focused on a human bioavailability pilot study of its Rotigotine transdermal patch for Parkinson's disease. The Company is pleased to announce the Rotigotine study was completed successfully in March 2021. Based on the encouraging study results the Rotigotine development program will be advanced to a pivotal human trial. Further details will be released in due course.

Further to XPhyto's press release on January 28, 2021, and in anticipation of Vektor's drug product commercialization schedule, the Company has signed a purchase and sale agreement for a property in the district of Biberach, Germany, for the construction of a new commercial drug manufacturing facility. The estimated maximum capacity of laboratory and manufacturing space permitted on the property is 3,000 m2 (32,000 ft2). The Company is reviewing scalable construction options to synchronize its manufacturing capacity with demand from in-house and contract manufacturing opportunities. Further details will be released in due course.

"Vektor continues to build shareholder value by advancing its product development pipeline. Its lead program is now progressing to a pivotal human study in Europe, which is the final major milestone on the path to commercial regulatory approval," said Hugh Rogers, XPhyto CEO & Director. "The addition of in-house, scalable commercial drug manufacturing capability is expected to add further value and optionality to XPhyto's drug formulation and manufacturing businesses."

Vektor is a German drug manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions.

Read the full article here.

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#4. Potential XPHYF Catalyst - Test Offered For Sale In Germany

XPhyto Rapid Point-of-Care CV-19 PCR Test Offered for Sale in Germany

  • Rapid 25-minute point-of-care CV19 PCR test available for purchase in Germany commencing May 25, 2021
  • Volume based pricing competitive with other CV19 PCR test products on the market
  • Initial manufacturing capacity secured, additional capacity to increase based on demand

VANCOUVER, BC and MEMMINGEN, GERMANY / ACCESSWIRE / May 20, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF)(FSE:4XT) ("XPhyto" or the "Company") is pleased to announce that its distribution, storage and logistics partner, Max Pharma GmbH ("Max Pharma"), will launch the sale of its 25-minute SA-RS-C-oV-2 (C19) RT-PCR test system ("CV-ID Lab") in Germany next week. CV-ID Lab is registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.

CV-ID Lab is a rapid RT-PCR test for the qualitative detection of SA-RS-Co-V-2 based on the reverse transcriptase polymerase chain reaction (RT-PCR) method. CV-ID Lab requires only a 20-minute PCR run time without prior RNA extraction. Following the RT-PCR process, the SA-RS-C-oV-2 virus is detected on a test chip and the results can be read visually within 5 minutes, combining the speed of an antigen test with the accuracy of a PCR test.

"CV-ID Lab provides diagnostic level accuracy in minutes at the point-of-care. It is a specialized product that is designed to fill the market gap between disposable antigen tests and centralized automated PCR systems," says Wolfgang Probst, COO and director of XPhyto. "Examples of target customers are airports, cruise lines, pharmacies, medical clinics, and any industrial or education site that requires rapid, definitive results."

CV-ID Lab will be available for purchase and delivery in Germany from Max Pharma commencing May 25, 2021, at volume dependent pricing within the range of commonly available C-19 PCR test products currently on the market. Initial German manufacturing capacity has been secured with additional manufacturing capacity available based on demand.

Max Pharma is a full-range German pharmaceutical wholesaler in accordance with Section 52a of the German Medicines Act (AMG). Max Pharma supplies pharmacies and clinics throughout Germany with pharmaceuticals, narcotics, and medical products. As announced April 21, 2021, Max Pharma is a licensed distribution, storage and delivery provider for CV-ID Lab in Germany in addition to fulfilling certain regulatory reporting, notification and logistics obligations.

[...]

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the C19 pandemic.

Read the full article here.

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#5. Potential XPHYF Catalyst - Pursuing Market Access In Israel

XPhyto Pursues Market Access in Israel for its CV19 PCR Rapid Test

  • XPhyto delivered 2,000 of its 25-minute PCR tests to Israeli distributor for clinical evaluation and regulatory approval
  • Potential customers include government institutions, private healthcare providers and neighboring countries

VANCOUVER, BC / ACCESSWIRE / April 28, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) ("XPhyto" or the "Company") is pleased to announce that it has delivered 2,000 of its rapid 25-minute PCR tests ("CV-ID Lab") to an established medical distributor in Israel for clinical evaluation of CV-ID Lab for the purpose of commercial regulatory approval and potential product distribution.

Based on the European CE-IVD approval of CV-ID Lab, announced by the Company on March 18, 2021, CV-ID Lab will be evaluated by the Medical Device Division of the Israeli Ministry of Health (AMAR) for the purpose of securing Israeli regulatory approval. Israel recognizes several international medical device certifications including the European CE-IVD mark. The clinical evaluation process is expected to be complete in less than 90 days and will form the basis for commercial approval of CV-ID Lab in Israel.

The Israeli distributor markets and distributes a range of medical products, including diagnostics, in Israel and surrounding Middle Eastern countries. Its customers include government and private institutions such as hospitals, pharmacies and a broad range of health care providers.

"We are excited by the opportunity to expand potential distribution beyond Germany. We are building strong partnerships around the world and Israel is a leading nation for CV-19 management and research," said Hugh Rogers, CEO and Director of XPhyto. "We expect that rapid and accurate diagnostic testing will remain a primary tool for pandemic management and monitoring for many years to come."

[...]

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the CV-19 pandemic.

Read the full article here.

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#6. Potential XPHYF Catalyst - Signing Of German Distribution, Storage And Logistics Agreement

XPhyto Signs German Distribution, Storage and Logistics Agreement for 25-Minute CV19 PCR Test

VANCOUVER, BC / ACCESSWIRE / April 21, 2021 /XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) ("XPhyto" or the "Company") is pleased to announce that it has entered into an agreement (the "Agreement") with an established German pharmaceutical wholesaler and service provider (the "Distributor") for the distribution, storage and logistics of XPhyto's diagnostic products in Germany. The Agreement secures XPhyto a full-service distribution partner for its 25-minute SA-RS-Co-V-2 (CV-19) RT-PCR test system ("CV-ID Lab"). CV-ID Lab is registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.

Pursuant to the Agreement, the Distributor will distribute, store and deliver CV-ID Lab test kits according to the product specifications and all applicable regulations to XPhyto's customers. In addition, the Distributor will provide the documentation and fulfillment of storage obligations, the fulfillment of reporting and notification obligations, and the processing of any returned products. The obligations and services to be rendered under the Agreement satisfy all of the logistical and regulatory requirements for the commercial sale of CV-ID Lab in Germany.

"With this agreement, we have secured a strong partner with an established medical distribution network throughout Germany. This is an exciting and critical step towards commercial sales of CV-ID Lab," said Hugh Rogers, CEO and Director of XPhyto. "The Company's commercialization strategy is focused on the German market for initial product launch and the creation of robust and sustainable sales."

[...]

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the CV-19 pandemic.

Read the full article here.

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XPhyto Therapeutics Corp. World-class Management Team

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Recap: Top 6 Potential XPHYF Catalysts

1. Progress Report On Mes-caline Therapy Program

2. European Approval

3. Drug Formulation And Development Business Update

4. Test Offered For Sale In Germany

5. Pursuing Market Access In Israel

6. Signing Of German Distribution, Storage And Logistics Agreement

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Coverage is officially initiated on XPHYF. Also, while you have time now, do this:

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If there are any more updates today, I'll get them out to you quickly.

Sincerely,

Axel Adams

Editor, SCF


Remember that the best source for full disclosure about the company is the company itself, SEDAR or CSE profile pages for regulatory filings and news releases.


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(Always Remember The Stock Prices Could Be Significantly Lower Now From The Dates I Provided.)​

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