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3 Big Biotech Disruptors For 2021



XPhyto (CSE:XPHY / OTC:XPHYF / FSE:4XT) announces European Approval for 25 Minute COVID-19 PCR Test

XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) and its exclusive German diagnostics development partner, 3a-diagnostics GmbH have announced the European approval of its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-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 COVID-19 tests currently approved. With a sample collection to result time of 25 minutes, Covid-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. “Covid-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.”

    • CE Mark received for in vitro diagnostic (IVD) test for the detection of SARS-CoV-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

Biotech investors sensing a soon-to-be blockbuster have begun to watch a quiet North American company.

That’s because the company’s exclusive commercial partner, a German biotech, looks set to win approval for a potential market disrupting diagnostic device.

That diagnostic instrument is poised to become a powerful potential new weapon in the fight to tame the worldwide Covid-19 pandemic.

At the heart of this breakthrough is a huge advance on what’s already considered the gold standard of SARS-CoV-2 diagnostics – the polymerase chain reaction (PCR) test.

The PCR test is based on genetics. It’s why other diagnostic testing methods, like antigen or serology (antibodies), do not provide the same level of accuracy as PCR.

Moreover, non-PCR tests risk increased rates of both false positives and false negatives.

The German biotech re-engineered the gold standard PCR diagnostic exam to make it what could be the world’s fastest and most portable Covid-19 test, with results delivered in as little as 25 minutes.

Moreover, this advance in Covid-19 testing could be ready to deploy immediately, because European regulatory approval may be received any day now, as expected during 2021’s first quarter.[1]

News that the breakthrough’s regulatory approval could happen soon is likely why the company’s shares began to edge up 15% between, mid-November and mid-December.

But there are two important facts to note:

  • The company responsible for developing the advanced Covid-19 test is an exclusive partner of XPhyto Therapeutics (OTC: XPHYF), named 3a-Diagnostics GmbH. And it’s a big part of the reason investors have begun to catch on to XPhyto’s vast potential.
  • While excitement about a 25-minute Covid-19 test seems justifiable, it’s equally important for biotech investors to clearly acknowledge this: that via its partner, 3a, what XPhyto Therapeutics (OTCQB: XPHYF) has developed is in no way to be confused with a vaccine, cure, therapy, treatment, or containment strategy.

Beyond the Gold Standard

Still, there is no denying a rapid version of the PCR test could be a true advance in SARS-CoV-2 testing.

With Covid-19, PCR tests detect RNA – genetic material – that’s specific to the virus. The test is accurate enough to detect the virus within days of infection, even in people who have no symptoms.

And XPhyto’s test is so portable it can be done in a clinic, a hospital, a car – and what may turn out to be the most important settings – the test could be done at nursing homes, convalescent centers, airports, train stations, and office buildings.

That’s because XPhyto Therapeutics (OTCQB: XPHYF) can deliver PCR test results in as little as 25 minutes with minimal testing equipment, significantly less than required by its competitors.

And, that’s a significant improvement on traditional PCR testing that can take from 24 hours to days once sample collection and central laboratory processing is factored in. Worse, when demand is high, results from the non XPhyto tests can take a week or longer.

So if approved, this oral, simplified saliva-based PCR diagnostic system could be a true game-changer.

And, rolling out XPhyto’s rapid Covid-19 test across Europe right now couldn’t happen at a better time.

That’s because Europe and the United Kingdom are suffering a outrageous second and third waves of Covid-19 infections that are even more deadly than the first.

Nearly 105,000 people died of Covid-19 in November in the 31 countries monitored closely by the European Center for Disease Prevention and Control.[2]

Worse, the World Health Organization is warning of a new continent-wide wave as 2021 unfolds.

Adaptable test for a fast-changing world

And, chances are SARS-CoV-2 is not the last the world will see of aggressive viruses.

That’s what led the Infectious Disease Society of America to report that “Despite advances in diagnostic technology, there is an urgent need for tests that are easy to use, identify the microbe causing the infection, determine whether it is drug resistant, and provide results faster than current tests.”

Because of that, investors would be right to assume the market for infectious disease diagnostics is enormous. In fact, the research firm Markets and Markets forecasts that the market will reach $19.35 billion by 2022.[3]

To that end, XPhyto’s advanced testing platforms are ready for the future. Ready to tackle pandemic threats as they arise.

After all, the major reason the Covid-19 vaccine was developed so fast is that much of the research and preclinical animal testing was done in the aftermath of the 2003 SARS pandemic, which is how scientists knew to target the spike protein.

And, as Florian Krammer, a vaccine scientist at Mount Sinai Hospital said, “It’s extremely unlikely that there is something out there that doesn’t belong to one of the known families, that would have been flying under the radar. I wouldn’t be worried about that.”[4]

Not that the current scourge is going anywhere fast.

The U.S. Department of Defense reports that “we have a long path ahead,” with the pandemic continuing to spread through 2021.[5]

And, in fact, the world may need a rapid test for Covid-19 for many years to come.

That’s because scientists doubt Covid-19 can ever be fully eradicated.[6]

If that’s the case, if Covid-19 becomes a chronic reality like the flu, then XPhyto’s test could have a long successful run in front of it pending approval and successful roll-out.

Or as one leading pandemic expert put it… Covid-19 may be something that becomes endemic, and we’ll always have to be careful about it.[7]

Careful means-testing.

And, the only way to invest in the breakthrough rapid Covid-19 test from 3a-Diagnostics is via its exclusive commercial partner –  XPhyto Therapeutics (OTCQB: XPHYF).

XPhyto looks to disrupt GW’s hold on the market

While XPhyto’s breakthrough Covid-19 test is targeting a continentwide rollout in Europe, the company’s scientists could soon be ready with a novel drug for worldwide distribution.

It’s a drug candidate that could challenge GW Pharma (GWPH) for supremacy in the anti-epilepsy drug market.

That potential blockbuster comes from Vektor Pharma, a well-known German drugmaker and a wholly-owned XPhyto Therapeutics (OTCQB: XPHYF) subsidiary.

Here’s what’s going on with that breakthrough.

When GW Pharmaceuticals launched its ground-breaking anti-epileptic drug Epidiolex in late 2018, it was a historic event.  Epidiolex was the first cannabis drug ever to be approved by the FDA.

What’s more, Wall Street analysts predicted it would be a “blockbuster.”

Blockbusters are drugs that generate sales of $1 billion or more per year.  Fewer than 1% of the 20,000+ drugs on the market today have achieved blockbuster status.[1]

They are the holy grail for both pharmaceutical companies and investors, and they can make the fortunes of both.

On its release, JPMorgan forecasted that Epidiolex sales would reach $1 billion by 2023.[2]  BofA went on to predict annual sales would hit $2.5 billion by 2027.[3]

That small biotech with less than $10 million in annual revenue would have the next blockbuster drug – and the drug would be a simple concoction of cannabidiol (CBD), one of the two main active constituents of cannabis – caught the attention of investors across the globe.

The blockbuster forecast was especially surprising since Epidiolex may suffer the same problem that plagues nearly every developer of orally consumed CBD products – poor bioavailability.

Solving CBD’s big bioavailability problem

Bioavailability refers to the amount of an active substance that is absorbed into the system to reach its therapeutic target.  When the active compounds of cannabis, either CBD or THC, are taken orally, only about 15% of those metabolites are absorbed into the bloodstream.[1]

The majority are passed out of the body as waste, meaning that the vast part of every dose never reaches its therapeutic target.  That may even be the case with FDA-approved Epidiolex, which is taken as a liquid that is administered orally via syringe.

With the global cannabis-based pharmaceuticals market expected to reach $50 billion by 2029, bioavailability is a problem in need of an immediate remedy.[2]  And one little-known drug developer XPhyto Therapeutics may have the solution.

XPhyto Therapeutics (CSE: XPHY, OTCQB: XPHYF): Advanced technology to improve bioavailability

XPhyto is a developer of advanced drug delivery technologies, with a focus on off-patent drugs and cannabinoid-based products.

It’s a unique business model that allows the company to rapidly bring essential drugs onto market is significantly more efficient dosage forms without the burdensome time and expense of full clinical trials. The FDA currently lists more than 300 off-patent drugs for which there is no approved generic version.

XPhyto has several promising pharmaceutical and cannabinoid solutions in its development pipeline, including chronic pain, infectious disease detection, appetite regulation, inflammatory dermatology, and sleep disorders.

The company has developed and several novel drug delivery technologies, including sublingual (under the tongue) and transdermal (on the skin) thin films.  Thin films are emerging as the future of drug delivery because of their many advantages, including superior bioavailability and ease of administration.

Analysis from Market Data Forecast reports that the global thin-film market will grow at 9% CAGR to reach $29.2 billion by 2025, an increase of more than $10 billion over today.  The report states that “the growing demand for efficient drug delivery systems has amplified the uptake of thin-film drugs due to their efficiency and effectiveness.”

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Up to 10 times more CBD bioavailability

With the massive expected growth of the pharmaceutical cannabis market and the sad state of current cannabis bioavailability, XPhyto saw a timely opportunity.

To that end, they have developed a sublingual thin film cannabinoid dosage form that the company reports “may yield as much as a 10-fold increase in bioavailability of CBD over existing oil delivery methods.”

A therapeutic CBD product with that magnitude of efficiency is well beyond even what other sublingual thin-film technologies have been able to achieve.

Placed under the tongue, XPhyto’s thin films allow its CBD formulation to enter the circulatory system directly by absorption through the mucus membranes.  This means they bypass the harsh conditions of the stomach and deliver a significantly larger proportion of active compound per dose than swallowed CBD, whether it’s in pill, liquid, or edible form.

The International Journal of Pharmacy and Pharmaceutical Sciences says, “Absorption of the drug through the sublingual route is 3 to 10 times greater than oral route and is only surpassed by hypodermic injection.”

XPhyto’s development pipeline includes several cannabis-derived formulations, but the one receiving the most attention is an oral thin film CBD-based sublingual epilepsy product.

In other words…

XPhyto Therapeutics (CSE: XPHY, OTCQB: XPHYF) may give Epidiolex a run for its money

XPhyto’s proprietary thin-film technology may provide a distinct and instant advantage over GW Pharmaceuticals’ Epidiolex.

Like Epidiolex, XPhyto’s developmental solution is targeted for refractory epilepsy, defined as hard-to-treat forms of the disease.  Specifically, both target Dravet syndrome and Lennox-Gastaut syndrome.  About a third of all those who suffer from epilepsy do not respond to treatment. Which is why the refractory epilepsy market is expected to reach $2.94 billion by 2023.

That’s also why Wall Street expects Epidiolex to be a billion-dollar blockbuster, being a far more effective treatment than any others currently on the market.  But Epidiolex is not a highly secret, proprietary formula. As the company admits, the active ingredient is “nearly 100% cannabidiol.”

Though GW Pharmaceuticals does not publish the bioavailability of Epidiolex, orally swallowed cannabidiol (CBD) is on average about 6.5 times less bioavailable than sublingual delivery.

What’s more, Epidiolex may suffer from another drawback. The drug is administered as a liquid taken via oral syringe, making it prone to dosing errors.  One randomized, controlled study published in the journal Pediatrics asked 2,110 parents to administer a liquid compound to their children via syringe.  The results of the study showed that fully 24% of the parents made dosing errors.

Later, the Journal of the American Medical Association sounded the alarm on the frequency of unintentional drug overdoses among children given oral liquid medications.

Thin films like XPhyto’s are also easier to administer, especially for people who have trouble swallowing, which is estimated to be around 37% of the population.  In fact, a review in the journal Current Drug Delivery says, “Statistics have shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosage forms.”

Which is why, the review notes, “Many pharmaceutical companies are switching their products from tablets to fast dissolving oral thin films

XPhyto’s thin-film epilepsy solution rapidly advancing to clinical studies

XPhyto is currently in the final stages of product development and testing.

Over the first three months of 2020, XPhyto completed the initial stage of product development through the company’s wholly-owned subsidiary, Germany-based Vektor Pharma TF GmbH.

Vektor is a well-established narcotics research and development firm founded in 2009.  As a recognized leader in thin-film drug delivery technologies, including for Fentanyl, Buprenorphine, Hydromorphone, Oxycodone, and cannabis, they hold a number of patents as well as licenses for import, handling, and manufacture of narcotics and vaccines.

In a March 2020 news release, the company stated that “based on recent positive product development results, XPhyto will be advancing the [epilepsy] program to clinical studies immediately.”[1]

XPhyto CEO Hugh Rogers says, “An efficient and well-defined dosage form is the future of cannabis-based medicine. High bioavailability with controlled and reproducible delivery is critical. Our initial results suggest significant potential timing and efficiency advantages over conventional delivery methods.”[2]

Advancing the program is one of the company’s priority drug-development initiatives for 2021.

Ultimately, XPhyto Therapeutics (OTCQB: XPHYF) has the real potential to bring powerful one-two punches in the fight to defeat two significant global diseases.

Psychedelic drugs – the future of mental health therapy

Finally, while many American investors might blanch at the idea, XPhyto has begun to explore how its sublingual thin film technology can be used in a bourgeoning field of psychotherapy.

That new field is treating deep-seated emotional and phycological conditions with psychedelic compounds, such as mescaline, psilocybin, and LSD.

This is currently a limited field of research.

But, in small study of adults with major depression, done at the prestigious Johns Hopkins School of Medicine, researchers reported that two doses of the psychedelic substance psilocybin, given with supportive psychotherapy, produced rapid and large reductions in depressive symptoms.[1]Voters in Oregon took that study to heart and as part of the Nov. 3 election voted to legalize psilocybin mushrooms for use in therapy. Moreover, the magic mushrooms have been decriminalized in Ann Arbor, Denver, Oakland, Santa Cruz, and Washington D.C.

So the trend is moving toward legalization.

The study is likely part of what led to a global phenomenon called microdosing. That’s when people take a tiny bit of illegal LSD or hallucinatory mushroom because they believe it helps open their minds to new ideas.

The trend took off in Silicon Valley and spread through the entrepreneur ranks. So there is snob appeal and significant money behind a drive to legalize psilocybin mushrooms.

And Mescaline, a naturally occurring psychedelic, similar to psilocybin and LSD, has been used in spiritual ceremonies in the Americas for thousands of years.

Of course, there’s an obvious problem with microdosing, that is “the dose” is just a guess. It could be a fleck off of a mushroom or tiny slice from a blotter of LSD, but its potency is a crap shoot.

So, you can see the advantages of sublingual thin film loaded with an exact dose.

But, again, this is blue sky thinking.

But, when thinking about XPhyto Therapeutics (OTCQB: XPHYF), investors might do well to keep in the back of their minds this thought:

Canada has legalized marijuana nationwide. It could quickly legalize mescaline and psilocybin mushrooms.

That’s because Health Canada, the national health regulator, just okayed the right to research standardize extraction of psilocybin from mushrooms.

Mescaline is already permitted for use in certain native American ceremonies in Canada and the United States.

There is one company in particular that is working on a solution to the standardized dosing problem. It is XPhyto Therapeutics (OTCQB: XPHYF).

“Lab in a tab” for rapid infectious disease detection

As COVID-19 raged across the planet in early 2020, testing for the infectious disease became a top priority in most countries.

Efforts to ramp up testing were often met with problems, ranging from a shortage of the swabs necessary to perform nasal screenings, to a lack of enough trained personnel or labs to perform the tests and interpret the results. That entire process eats up valuable days while the disease progresses in those who are infected.

In late April several points of care (POC) tests were deployed that offered results within minutes, which allowed tests to be conducted anywhere, including airports and schools.

Unfortunately, “these tests are performing terribly,” as Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, testified to a Project on Government Oversight panel.

XPhyto Therapeutics’ biosensor-enabled oral thin film infectious disease rapid detection test may offer a much better solution.

The test is based on the relatively new development of biosensors, which are powerful and innovative sensors that convert a biological response into an electrical signal.

These sensors are so small that they can be applied to a thin film platform that is then dissolved as a small tab under the tongue, where it can detect the presence of pathogens in the saliva.

No lab is necessary to process the test, and no technicians are necessary to administer it. Rather, it is a “lab in a tab” that should be inexpensive, portable, provides near-instantaneous results, and can be self-administered anywhere. XPhyto plans to brings its first biosensor product to market in late 2021.

From COVID-19 to annual flu outbreaks

As we are witnessing today, global pandemics of infectious disease continue to periodically threaten the survival of entire populations.

In the first five months of 2020 more than five million people were infected by the COVID-19 coronavirus, resulting in a third of a million deaths.

And it’s far from over. The U.S. Department of Defense reports that “we have a long path ahead,” with the pandemic continuing to spread through 2021.

The U.S. Centers for Disease Control reports that even in a normal year, 15 million people die of infectious disease globally.

All of which makes the need for new diagnostic testing platforms critical.

The Infectious Disease Society of America states that “Despite advances in diagnostic technology, there is an urgent need for tests that are easy to use, identify the microbe causing the infection, determine whether it is drug-resistant, and provide results faster than current tests.”

The market for infectious disease diagnostics is enormous, with research firm Markets and Markets forecasting that it will reach $19.35 billion by 2022.

XPhyto’s thin-film biosensor-enabled rapid detection test is currently being designed for the detection of a range of infectious diseases.  The company has adapted the tests for several oral health conditions. And down the road, XPhyto (OTCQB: XPHYF) foresees commercializing the testing platform for even more infectious diseases.

In order to rapidly progress the development of the test, XPhyto is partnering with German biotech 3a-Diagnostics, a leader in biosensor development and diagnostics.

3a-Diagnostics is providing XPhyto with its pathogen-specific peptide biosensors for use with XPhyto’s thin films. Peptides are most commonly used as probes in biosensors because of their versatility in forming various tertiary structures that interact with numerous molecules.

Top 7 reasons to watch XPhyto Therapeutics (CSE: XPHY, OTCQB: XPHYF) now

1. The moment it wins European regulatory approval – likely any day now —  XPhyto is ready to roll out its breakthrough rapid Covid-19 test across Europe. It’s a PCR breakthrough to facilitate rapid point-of-care pandemic testing. The market for infectious disease detection is projected to reach $19.35 billion by 2022.

 2. XPhyto is solving CBD’s bioavailability problem with a unique, proprietary sublingual thin film technology that may yield as much as a 10 fold or greater increase in CBD absorption.

3. The product is in final formula testing before proceeding to pilot studies and final commercialization trials, expected to be announced any day. With the global cannabis-based pharmaceuticals market expected to reach $50 billion by 2029, there is an enormous opportunity for XPhyto’s thin film platform.

4. XPhyto’s epilepsy drug in the final stages of development and appears very similar to FDA-approved Epidiolex, but with a potential 10 times more bioavailability than Epidiolex because of the company’s thin film delivery technology. The market for refractory epilepsy treatment is expected to reach $2.94 billion by 2023.

5. XPhyto’s business model includes applying its thin film platform to off-patent drugs previously approved by the FDA, thus creating better, more bioavailable versions while bypassing large and costly clinical trials before commercialization.

6. The day when mescaline and psilocybin mushrooms become legal could be fast approaching. Canada seems on the fast track to legalize. Data Bridge Market Research sees a legal psychedelic market of about $7 billion by 2027. XPhyto’s experience with novel drug development and thin film technology could make it a market leader if executed correctly.

7. XPhyto might be an attractive buyout target in an exploding industry that is being eyed hungrily by food, tobacco, and pharmaceutical companies. With XPhyto’s thin film technology delivering vastly higher bioavailability, their epilepsy and infectious disease products already in final stages of development, and their access to the German and European markets, XPhyto may gain the interest of major players both inside and outside the cannabis industry.

Ask your broker about XPhyto Therapeutics (CSE: XPHY, OTCQB: XPHYF) today. All investments involve risk. Remember to always do your own due diligence and consider the risks, including potential failure to secure regulatory approval for any product in development, before buying any stock. 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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XPhyto does not make any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.