XPhyto Therapeutics Corp. (CSE: XPHY) (FSE: 4XT) (OTC: XPHYF) has been a hot story lately, especially in Germany, due to its recent commercialization of a super-fast PCR test kit for definitively diagnosing COVID-19 infections in point-of-care settings.
The company recently received approval to launch its breakthrough product in Germany, which was soon followed by the announcement of a distribution agreement with a large pharmaceutical wholesaler.
XPhyto also just teamed up with a leading pharmacy to offer point-of-care rapid PCR testing in a pilot project that should set the stage for a Germany’s adoption of portable, fast PCR testing in a diversity of locations. Additionally, XPhyto has announced plans to enter the Israeli and the Middle Eastern marketplaces.
However, all of these bullish developments for XPhyto tend to overshadow the fact that this Canadian-German life sciences start-up acts as a project accelerator for a diversity of cutting-edge biotechnologies, pharmaceuticals, and medical diagnostics.
In investment parlance, this diversified business model is sometimes referred to as a “multiple shots on goal” opportunity. For a biotech innovator, this is a very important distinction, given that the odds of success for most life sciences companies are reliant on just one or two drug candidates or medical products.
In fact, XPhyto benefits from a strong development pipeline, while also offering the potential to provide novel solutions to some of society’s most ubiquitous medical conditions, especially infectious diseases like coronaviruses, as well as seizure disorders and chronic pain.
Company CEO Hugh Rogers explains, “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.”
Rogers describes his company’s strategy as “buy and build”. As previously mentioned, it has created a diverse portfolio of late-stage therapeutic and diagnostic products. This has been achieved through in-house expertise, partnerships, and strategic acquisitions.
These three pillars of this highly-leveraged, high-impact business model – diagnostics, novel drug formulations and delivery systems, and psychedelic drug development – make XPhyto an especially compelling investment opportunity.
Pioneering Drug Formulations and Delivery Systems
XPhyto’s wholly-owned subsidiary, Vektor Pharma TF GmbH, specializes in the innovation of sublingual and transdermal therapeutics – oral strips and patches – to maximize the uptake of various drugs and to ensure the optimized delivery of extremely precise doses. This market is expected to grow to US $29.2 billion by 2024, at a CAGR of 10.5%, according to Market Data Forecast.
In addition to its drug development pipeline, Vektor is developing a portfolio of oral biosensor screening tests for the detection of bacterial and viral infectious diseases. These fast-dissolving thin-film oral solutions include pandemic-focused biosensors.
Earlier this year, the company announced plans to complete human bioavailability studies on its four lead therapeutic products: a transdermal patch for treating Parkinson’s disease, a CBD (cannabinoid) oral strip to treat epilepsy, a THC (psychoactive cannabis) oral strip designed to combat anorexia and nausea, and a blended CBD/THC strip that is designed to address multiple sclerosis.
Four human trials in one year amounts to a major undertaking for an up-and-coming life sciences company. XPhyto says that news regarding these significant milestones is imminent.
Notably, Vektor is a market leader in innovating novel drug delivery systems and has developed new and innovative dosage formulations over the past decade for major drug companies, including the development of generic dosage formulations for commonly prescribed narcotics. So Vektor has plenty of expertise to bring to bear in the development of these prospectively disruptive drug candidates.
Leading the Way with Super-Fast PCR Testing Diagnostics
The company has co-developed with Stuttgart-based joint-venture partner, 3a-Diagnostics GmbH, what is believed to potentially be the world’s fastest and most portable PCR test kit. Known as Covid-ID Lab, it combines the accuracy of PCR testing with the speed of disposable screening tests, which could make it a vital weapon in the global battle against the spread and management of Covid-19.
The technology, named Covid-ID Lab, is now registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test. The news has generated a raft of upbeat coverage in publications on both sides of the Atlantic, while the company now turns its attention to production and distribution in Europe and the Middle East.
XPhyto designed this product to literally be on the frontlines of the battle against COVID-19 by providing super-fast PCR testing capabilities to a diversity of point-of-care settings, such as pharmacies, doctor’s offices, schools, triage centres, pop-up satellite screening sites, etc.
Company COO Wolfgang Probst elaborates: “It is conceivable that we could equip vehicles with small mobile laboratories and they could then stop off at schools, public authorities or large industrial sites and offer on-site tests as mass screening or as confirmation of antigen test results. We already have plenty of inquiries. We see a huge market for the use of these mobile PCR systems.”
Probst cautions, “The pandemic is likely to be with us for some time. That's why testing will likely remain an important tool. The market is huge. According to estimates by Allied Market Research, it is likely to grow by almost 9 percent a year by 2023, swelling to $39.1 billion.”
Tackling Europe’s Mental Health Crisis
XPhyto is also at the forefront of the fight against depression, anxiety, and addiction – disorders cost the global economy up to US $1 trillion each year in lost productivity. Accordingly, the global mental health treatment market is worth an estimated US $70 billion a year, according to Bloomberg.
Psychedelics are known to modulate neurotransmitters such as serotonin and dopamine, which regulate cognition, perception, and mood. This makes them well suited to treating a variety of mental conditions.
With this in mind, XPhyto is also a pioneer in working on developing novel psychedelic pharmaceutical drugs to alleviate the crippling symptoms of mental illness. The company is developing pharmaceutical grade production of psilocybin and mescaline at an industrial scale, while also working on R&D related to precise and effcient drug formulations and delivery methods.
In Canada, this R&D work is headed up by Professor Raimar Löbenberg, the founder of the Drug Development and Innovation Centre at the University of Alberta and the former president of the Canadian Society for Pharmaceutical Sciences
Professor Löbenberg explains, "Our initial focus is to develop standardized drug formulations with precise, predictable and efficient delivery of their active pharmaceutical ingredients for clinical study and therapeutic use. We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganization.”
“XPhyto intends to first produce psychedelic active pharmaceutical ingredients, which can then be incorporated into our novel sublingual and transdermal delivery systems,” he says. “This is our competitive advantage, from production of API to drug formulation to clinical validation.”
Investment Summary
2021 is shaping up to be a breakthrough year for XPhyto, with the realization of major developmental milestones on several fronts, from diagnostics to drug development and psychedelic medicine. This includes the commercialization of the company’s Covid-ID Lab test kit – an impressive and timely technological achievement that has already earned extensive media coverage. Now the opportunity to become a major player in the COVID-19 diagnostics markets beckons. Accordingly, XPhyto has lately been on a recruitment drive, adding commercial expertise in the fields of manufacturing, distribution, marketing and sales.
Rogers now believes he has assembled a strong team of skilled professionals from across the life sciences, pharmaceutical and business sectors. And he is “extremely confident” that XPhyto can achieve its lofty goals in 2021.
They include securing major supply deals for its Covid-19 test kits, earning clinical validation of its drug formulations, and making significant breakthroughs within the field of psychedelics medicine.
In the near-term, XPhyto seems poised to become a significant player in the rapidly expanding Covid-19 diagnostics market in Europe. Indeed, the company believes that the probable commercial success of its Covid-19 test kit can help super-charge its future growth – which is all good news for its diverse pipeline of novel drug candidates and delivery platforms.
All told, the company has plenty of reasons to be a stellar performer in 2021 – and beyond. The advent of the near-term commercial success of Covid-ID Lab should set as very positive precedent going forward.
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.
ABOUT THE AUTHOR: Marc Davis has a deep background in the capital markets spanning 30 years, having mostly worked as an analyst and stock market commentator. He is also a longstanding financial journalist. Over the years, his articles have appeared in dozens of digital publications worldwide. They include USA Today, CBS Money Watch, The Times (UK), Investors’ Business Daily, the Financial Post, Reuters, National Post, Google News, Barron’s, China Daily, Huffington Post, AOL, City A.M. (London), Bloomberg, WallStreetOnline.de (Germany) and the Independent (UK). He has also appeared in business interviews on the BBC, CBC, and SKY TV.
Marc is also an enthusiastic investor in XPhyto Therapeutics and his commentary is not intended to be a solicitation for other investors to purchase this stock. Investors are always advised to consult a professional investment advisor before making investment decisions.
Business writer Martin Green also contributed to this article.
FULL DISCLOSURE: XPhyto Therapeutics Corp. is a client of Stockhouse Publishing.