American Psychedelic Biotech Company Emerging as a Leader Brings Complete Package to the Psychedelic Sector
Why Pick The Jockey or The Horse, When TRYP Gives You Both 
Many sports idioms and proverbs easily translate in the investing world. Wayne Gretzky has been quoted ad nauseam for his cliche about skating to where the puck is going to be as a depiction of management’s vision. Mark Cuban famously called business the “ultimate sport” where someone is always trying to beat him. In that lane, investors are constantly faced with decisions on picking a jockey (management) or a horse (product, technology, idea, etc.), but seldom do they get both.

This is particularly true for emerging industries, such as the burgeoning psychedelics space. With the onset of changing regulations encouraging medicinal research for psychoactive compounds like psilocybin found in “magic mushrooms” and lysergic acid diethylamide (LSD) at state and local levels, the marketplace is seeing a resurgence in activity that has been mostly shelved since the 1970s when the Controlled Substances Act was put into law. As such, investors are being inundated with an influx of new companies seeking to capitalize on the nascent opportunity, much like what happened with the legal marijuana boom about a decade ago.

We all know what happened there. All too frequently, companies touted their initiatives as pioneers in the cannabis space, only to fail due to lack of real substance, leadership, or both.

In the psychedelics space, investors should be looking beyond this initial hype and FOMO, to companies that can actually be successful, in what is arguably one of the most difficult businesses to win at. Biotech/pharmaceuticals. Management is critical to success, and one company, Tryp Therapeutics (CSE: TRYP)(OTC: TRYPF), who has been flying relatively under the radar, has quietly put together one of the most experienced and successful drug development teams in the industry. . Tryp has diversified its pipeline to mitigate risk with drug candidates utilizing abbreviated clinical pathways, , focused on indications with large patient populations and a high unmet medical need . This pipeline is being shepherded by a leadership team that has a track record of successfully bringing drugs through the regulatory pathway to commercialization and returning value to their shareholders time and time again.

Tryp is differentiated from the rest of the psychedelic industry in many ways, including being the only pure-play American psychedelic company. While the majority of the psychedelic industry has been built by Canadian companies, or companies accessing the Canadian regulatory market due to eased regulatory hurdles through Health Canada, Tryp Therapeutics is one of the only American public companies that is US based, with a US team going the FDA route to develop their pipeline. Operating from its headquarters in the biotech innovation hub of La Jolla, California, Tryp derives its name from tryptamine, which is the class of compounds that all psychedelics fall under, including psilocybin. The company is working to develop potential therapeutics from a natural compound (psilocybin), targeting orphan diseases where patients suffer the most and first line treatments can be relatively ineffective. They are working through the FDA pathway in clinical trials to develop a potential therapies to help treat patients in the greatest need which certainly brings to mind some similarities to the early stages of another biotech company headquartered up the road in Carlsbad, who took a similar strategy with their drug Epidolex, GW Pharma (NASDAQ: GWPH). Before GW was the massively successful Cannabis Biotech company that we all know of today, they were an upstart startup doing early pre-clinical Phase 1 research in another new and emerging industry, looking at cannabidiol (CBD) and it’s potential therapeutic effects that early research showed some promise in around epilepsy.

Can Tryp become the psychedelic version of GWPH?

A Better Jockey: A Management Play
When it comes to the jockey or horse quandary, most venture capital prefers betting on the jockey. This is especially true in biotech where the onerous roadway to commercialization is littered with potential pitfalls related to safety, IP, MOA, regulatory affairs, CMC manufacturing, and much more where mistakes can cost millions of dollars, years of re-work and jeopardize FDA approval.

Institutional investors want to see professional corporate management at the helm because deftly maneuvering the clinical process and assigning partners requires cross-functional, seasoned veterans with actionable insight to create and unlock value.

To that end, as engaging as the lead drug candidates are, Tryp truly is a management play with a team unheard of in a company with a $40 million market cap. The C-suite, board and advisors have pedigrees steeped in success at all pertinent levels from Big Pharma, to drug development to capital markets.

For the sake of brevity, it’s impossible to detail the C.V.’s of the complete Tryp team. A sampling lends plenty of evidence as to the quality. The company is founded by two highly successful pharma & biotech executives, Bill Gardner M.D. & James Kuo M.D. Bill Gardner has extensive director and executive management experience and is the Founder of Race Oncology (ASX:RAC) and Isla Pharmaceuticals after spending a long tenure at Hoffmann LaRoche’s oncology division. Jim Kuo, M.D. was previously CEO of BioMicro Systems and Discovery Laboratories (NASDAQ: DSCO), Head of Business Development at Myriad Genetics (NASDAQ: MYGN), and was Associate Director at Pfizer (NYSE: PFE) where he licensed the cholesterol drug Lipitor, still to this day the best-selling drug of all time. 

Leading Tryp Therapeutics as Chairman & CEO, is Greg McKee. An equally impressive biotech executive with over 20 years building and leading biotech and life sciences companies and was chairman, president and chief executive officer publicly traded Nventa Biopharmacueticals which successfully merged with Akela Pharma. Additionally, he has held senior management roles at Genzyme Corporation, which was acquired by Sanofi for $22 billion.

President and CSO Dr. James Gilligan has spent over 35 years in the life science industry, including time at Roche (OTC: RHHBY) and co-founding many successful companies, including the life science consulting firm The Bracken Group, Unigene Labs and Tarsa Therapeutics, which sold the rights to calcitonin for postmenopausal osteoporosis to international pharma R-Pharm JSC in 2019.

COO Tom D’Orazio previously spearheaded in-licensing two cancer drugs and taking them through Health Canada approval. He also managed a $250 million/year portfolio at Pfizer and a $500 million/year partnership with Novartis (NYSE: NVS) while at QLT.

VP of Drug Development Dr. Peter Guzzo specializes in poorly treated diseases and is named as an inventor of 43 patents. Manufacturing VP Larry Norder’s resume as a chemistry and pharma software expert including work integral to the development of the blockbuster Naproxen is a testament to the breadth of experience this team has at all levels.

Luke Hayes recently came on board as Chief Financial Officer, bringing decades of experience gained while working with companies like Dow Chemical (NYSE: DOW) where his responsibilities included pharmaceutical partners like Eli Lilly (NYSE: LLY) and AbbVie (NYSE: ABBV).
 The TRYP board of directors and scientific advisory board are equally impressive, comprised of successful doctors and businessmen with highly relevant experience specific to the corporate mission.

Quickly Making Up Ground on Leaders
TRYP has made some major advancements over the last couple of months, most notably officially launching into clinical trials with a Phase 2a study around eating disorders with the University of Florida. Again, while peers are focused on work outside the U.S., TRYP is going the FDA route, a pathway that should command more value for the validation it lends and the opportunity it presents in the U.S. markets should and FDA approval one day be earned.

The Phase 2a clinical trial is being designed as an open-label study in patients suffering from rare and orphan over-eating disorders.
TRYP is partnered with the University of Florida and Dr. Jennifer Miller, a renowned expert in the field of eating disorders, has agreed to serve as the trial’s Principal Investigator. Dr. Miller’s expertise is rare diseases like Prader-Willi syndrome speak to the opportunity to meet vast areas of unmet medical need with an innovative new treatment for over-eating disorders..

"There are currently no approved drugs and only limited options to treat patients with rare over-eating disorders. I'm excited to work with the Tryp team to explore the use of psilocybin as a new paradigm to treat symptoms associated with this devastating medical disease."
- Dr. Jennifer Miller, Professor Pediatric Endocrinology division, University of Florida

TRYP is now one of only 4 companies in the Psychedelic sector who are in a Phase 2 trials: 
Compass Pathways ($1.5B Market Cap)
MindMed ($910M Market Cap)
Cybin ($185M Market Cap)
Mydecine ($70M Market Cap)

Comparatively, it is clear to see that TRYP is massively undervalued next to this peer group, particularly with consideration for the U.S. factor. Other positive developments from TRYP recently include the addition of world renowned Psychedelic researcher, Dr. Robin Carhart-Harris (the most published researcher in the world on psychedelic compounds) and Dr. Joel Castellanos, another published author and noted chronic pain physician at UC San Diego Medical Center, to the company's Scientific Advisory Board. Life sciences veteran Greg McKee has been appointed to the position of Executive Chairman.

Additionally, the company announced another injection of $2,000,000 from strategic investor, Marc Lustig. Mark is one of Canada's most active and respected businessmen. Formerly a life sciences investment banker, Marc most recently is well known for being the founder of Origin House which was acquired by Cresco Labs in 2020 for nearly $1 billion.

The company is also shoring up its patent estate, most recently filing a provisional patent (US 63/161,070) to improve how psychedelics are administered across a broad range of indications.

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A Better Horse: A Differentiated Pipeline
Tryp is no “me too” company like so many others jumping into the psychedelics space. For starters, the company has two active development programs: The company’s Psychedelic program, Psilocybin for Neuropsychiatric Disorders (dubbed its “PFN™ Program”) and Rozoxane , an Oncology drug being developed to treat soft tissue sarcomas (STS).

The lead drug in the PFN™ Program is TRP-8802, which is initially indicated for fibromyalgia. Tryp is clearly differentiated by targeting fibromyalgia, a chronic neurosensory disorder affecting 10 million Americans annually characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. Unattended by peers, Tryp stands alone in addressing a fibromyalgia treatment market forecast to reach $3.6 billion by 2026.

The vast majority of companies developing psychedelic-assisted therapies – albeit psilocybin, MDMA, LSD, DMT, etc. – are targeting the same handful of indications, with depression, addiction and anxiety often the common threads. Indeed, these could be targets for Tryp also (along with eating and other neuropsychiatric disorders), but the decision to focus first on fibromyalgia could garner attention from big pharma. This dovetails with the company’s mission to seek licensing, acquisition and/or partnering deals after successful Phase 2 efficacy.

There is no known cause and no cure for fibromyalgia. Currently treatments for the disease, including opioids, painkillers, muscle relaxants, cognitive therapy and more, are sub-par at best, not to mention having abuse potential and frequently unpleasant side effects.

Apropos, it is probably safe to assume that a major like Pfizer (NYSE: PFE) is looking for ways to replenish sales after a nosedive in revenue from its neuroscience drugs, including the now off-patent anti-epileptic Lyrica that is also prescribed for fibromyalgia. Remember the hype surrounding Daiichi Sankyo (OTC: DSNKY), Japan’s second biggest drugmaker ($59 billion MC) in 2017 when the company had bet big on mirogabalin as more effective version of Lyrica (a $600 million cash cow for Pfizer) that was going to be the next big thing in fibromyalgia, but failed in a PH3 clinical trial.

Against the backdrop of the opioid epidemic, the high risk of overdose/addiction and little evidence proving opioids are effective, about 30% of all fibromyalgia patients take chronic opioids. Moreover, research shows that the proportion of people who achieve satisfactory pain reduction (defined as “at least a 50% reduction in pain intensity”) is generally only 10% - 25% more than with placebo.

In short, fibromyalgia is the poster child for an area of great unmet medical need in a multi-billion-dollar market. Investors and the pharma space will, without question, stand up and take notice of a new, safe and effective drug for fibromyalgia.

Tryp is judiciously evaluating TRP-8802 as an orally delivered formulation based on the development of Tryp’s synthetic psilocybin. Leveraging known safety and toxicity profiles collected from lab and dozens of other clinical trials on psilocybin in the past, it is hypothesized that TRP-8802 will have distinct advantages over both approved drugs for fibromyalgia and those in development, including, but not limited to, increased efficacy, natural penetration of the blood/brain barrier and decreased abuse and addiction risks.

As it positions for clinical research, Tryp has entered into an agreement with New York-based Albany Molecular Research (AMRI) for R&D and cGMP manufacturing of their synthetic psilocybin for the PFN™ Program. Synthetic compounds are necessary to ensure a safe and consistent manufacturing supply chain, and AMRI is one of the world’s leading manufacturing organizations. They were most recently selected by AstraZeneca (NASDAQ: AZN) to manufacture the COVID-19 vaccine and have an exclusive partnership with Tryp for the manufacturing of psilocybin.

AMRI has begun the process of manufacturing the 200g non-GMP demonstration batch of psilocybin. This production step is one of a series of steps in the project plan to manufacture batches of Tryp's proprietary formulation of cGMP psilocybin to support the company's clinical development and for Tryp’s upcoming clinical trials.

"AMRI is proud to support Tryp Therapeutics in their mission to address diseases with highly unmet needs through the rapid development and scale-up of a novel process to advance Psilocybin into human clinical trials."
- Christopher Conway, President, Albany Molecular Research.

A De-Risked Drug Portfolio
While the fibromyalgia opportunity could be a “company maker” on its own, Tryp is experienced enough to know that to mitigate risk, having multiple shots on goal is important and they are building added value with multiple assets. Namely, the company is developing TRP-1001, an oral formulation of razoxane, for STS (Soft Tissue Sarcomas). Selecting razoxane aligns with management’s strategy to seek expedited development pathways for diseases with a high unmet medical need.

STS are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. It is estimated that there are more than 100 different subtypes of STS. Only a small number of drugs have earned FDA approval in recent years, including trabectedin (Yondelis®), a product of Johnson & Johnson (NYSE: JNJ) and Spain's Zeltia, in 2015, Eli Lilly’s (NYSE: LLY) Lartruvo in 2016, which was withdrawn from the market in 2019, and Epizyme’s (NASDAQ: EPZM) tazemetostat (Tazverik®) in 2020.
All three of these drugs received some type of FDA accelerated approval.

Compelling results from multiple Phase 2 clinical studies of razoxane for the treatment of STS have been published, including those that indicate TRP-1001 may be effective as evidenced through 6 complete remissions, 2 partial remissions and 1 minor remission achieved along with an 89% major response rate in one study.

As the image below shows, a small study of razoxane combined with Videsine supported by radiotherapy and occasionally by surgery in advanced STS demonstrated impressive improvements in progression-free survival.

All three of these drugs received some type of FDA accelerated approval.

Compelling results from multiple Phase 2 clinical studies of razoxane for the treatment of STS have been published, including those that indicate TRP-1001 may be effective as evidenced through 6 complete remissions, 2 partial remissions and 1 minor remission achieved along with an 89% major response rate in one study.

As the image below shows, a small study of razoxane combined with Videsine supported by radiotherapy and occasionally by surgery in advanced STS demonstrated impressive improvements in progression-free survival.

Additional clinical research is required by Tryp, but to lend a little color consider that when Yondelis got the FDA nod in 2015, it did so by extending progression-free survival to just 4.2 months compared to 1.5 months for dacarbazine, an older chemotherapy drug.

There aren’t many drugs that have demonstrated effectiveness and safety against STS, which puts Tryp in an enviable position. It is not without good reason that PharmaMar continues to study trabectedin for STS; there is big revenue potential owing to a large gap in therapeutics.

Tryp will employ the razoxane data to apply for FDA 505(b)(2) and other accelerated regulatory pathways to save time and development costs. Using this strategy, the company is optimistic it can forego extensive pre-clinical work and Phase 1 safety studies to jump right into Phase 2 clinical trials. In laymen’s terms, if things play out like they look like they could, Tryp could vault right into the thick of the STS race.

The company is building an intellectual IP estate around these flagship drug candidates. Patent applications for the use of psilocybin for the treatment of fibromyalgia and razoxane for the treatment of soft tissue sarcomas, along with other future indications, are currently awaiting decisions from the U.S. PTO.

The Gate is Opening, the Bell is Ringing
Only public since December, Tryp is still flying relatively under the radar in the retail markets, but as they’re about to get their OTCQB listing in the U.S., this well kept secret won’t be so “under the radar” for much longer. . Many institutions aren’t allowed to invest in pink sheet stocks, and many U.S. retailers won’t trade them either. That will change now that Tryp has graduated. With the pedigree of the team, the FDA pathway and advancements of the pipeline, it won’t be long until the company is recognised for their pedigree, as it becomes recognised as one of the psychedelic industry’s leading companies.

Tryp is now capitalized for 2021 to begin the regulatory process and is a company that has all the boxes checked. In particular, the company has checked off the most important box: Differentiation. Tryp is differentiated in all areas, from indications to leadership to assets, and that is critical to building value.

Tryp is in the psilocybin market that is starting to heat up, driven by FOMO that has its grip on investors of all sizes. Furthermore, the company is backstopped by a cancer drug candidate that is one of the more promising experimental drugs in development for STS today. Factor in the seasoned management and the potential to expand indications in both the psychedelic and oncology markets and the real value of Tryp begins to show through.

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