Tryp will look to partner / monetize programs with Phase 2 clinical data

1. Tryp intends to seek approval from FDA to proceed directly into a Phase 2 clinical trial based on existing preclinical and clinical data for the active pharmaceutical ingredients in TRP-8802 and TRP-1001.
2. A number of eating disorders are under evaluation.
3. Multiple Phase 2 clinical trials of razoxane for the treatment of STS have been conducted by clinicians unaffiliated with Tryp.

TRYP's Psilocybin-for-Neuropsychiatric Disorders (PFN™ ) Program

Tryp Therapeutics is focused on identifying compounds with well characterized safety and activity profiles that have potential utility in orphan diseases and other diseases with high unmet medical needs. Tryp currently has two active development programs:

• Psilocybin-for-Neuropsychiatric Disorders, which we call our PFN™ Program.
  • Our lead PFN™ Program candidate is TRP-8802.
  • Our initial indication for TRP-8802 is fibromyalgia.
• Razoxane (TRP-1001) for soft tissue sarcomas.

Develop: Tryp intends to combine FDA’s 505b2 regulatory pathway with available third-party preclinical and clinical data to shorten the timelines and lower the cost of its development programs.

Protect: Tryp will utilize regulatory exclusivity, patents, trade secrets, and proprietary know-how to protect the commercial lifespan of its drug candidates.

Monetize: Tryp intends to seek out licensing, acquisition, and co-development opportunities for its drug candidates during and around their Phase 2 stage of development.

Through our PFN™ program, we are focused on developing orally-delivered drug therapies for certain neuropsychiatric disorders that have distinct advantages over other drugs that are currently in the market or are in development. These advantages include:

• Increased efficacy;
• Natural blood-brain barrier penetration;
• Enhanced safety and toxicity profiles;
• Reduced risk of abuse; and
• Reduced risk of addiction.

The lead candidate in our PFN™ Program is TRP-8802, an orally-delivered formulation base on the development of Tryp's synthetic psilocybin. 

Overview

Chronic and debilitating CNS / neurobiological disorder characterized by:

• Chronic widespread pain
• Fatigue
• Non-restorative / disrupted sleep
• Depressions
• Diminished cognition ¹

Believed to be a neurosensory disorder characterized in part by abnormalities in pain processing by the central nervous system.

Causes significant impairment in all areas of life ²

• Lower levels of health-related quality of life – reduced daily functioning
• Interference with work (loss of productivity, disability)

The three drugs with FDA approval for the treatment of fibromyalgia are Pregabalin (Lyrica®), Duloxetine (Cymbalta®*) and Milnacipran (Savella®)

Currently-approved medications may have side effects that limit long-term use ³ are only effective for some symptoms, but do not cover the full burden of the disease

Substantial off-label use of narcotic painkillers and prescription sleep aids ⁴

1. Phillips K & Clauw DJ, Best PractRes Clin Rheumatol 2011; 25:141
2. Schaefer et al., Pain Pract, 2015
3. Nueschet al, Ann Rheum Dis 2013;72:955-62
4. Patient Trends: Fibromyalgia”, Decision Resources, 2011

Market Opportunity

Fewer than half of those treated for fibromyalgia receive complete relief from the three FDA-approved drugs

The disease inflicts substantial strain on the healthcare system:

• Average patient has 20 PHYSICIAN OFFICE VISITS PER YEAR ¹
• Annual direct medical costs are TWICE those of non-fibromyalgia individuals ²

High rates of discontinuation, switching and augmentation:

• Attempts to treat multiple symptoms and/or avoid intolerable side effects
• Average of 2-3 MEDICATIONS USED SIMULTANEOUSLY ³
• Typical patient has tried SIX DIFFERENT MEDICATIONS ⁴
• Medication-related side effects may be similar to fibromyalgia symptoms

Overview

Sarcomas are rare tumors derived from connective tissues in the body ¹

Sarcomas can occur anywhere in the body and have widely variable clinical courses ranging from indolent to highly aggressive ¹

In most cases, it is not clear what causes sarcoma, but family history and radiation exposure may increase risk ²

In 2018, estimated 13,000 new cases of soft tissue sarcoma and over 5,000 deaths in the US alone ³

Surgery is still the most common treatment as it remains the only means of curing the disease ⁴ radiation and chemotherapy also part of treatment paradigm

Development Path: Re-establish Phase 2 activity in soft tissue sarcomas after which will endeavor to monetize the asset.

Multicenter Phase 2 clinical study conducted in Austria by the Austrian Society of Radio-Oncology in 2009

• Two additional Phase 2 clinical trails completed. Results published in medical journals in 2006 and 2008
• 13 evaluable patients – 10 angiosarcomas and 3 hemangiopericytomas
• Drug was well tolerated
• Six complete remissions, 2 partial remissions and 1 minor remission were achieved for A major response rate of 89%

When used in conjunction with radiation therapy or other agents the  combination tended to work well together and inhibit metastatic tumor activities (the recurrence of additional tumors elsewhere in the body)

Tryp believes that existing clinical data regarding razoxane may allow TRP-1001 to be studied in a Phase 2 trial without the need for extensive preclinical or Phase 1 trials. 

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6221061/
2. https://www.mdanderson.org/cancer-types/soft-tissue-sarcoma.html
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6221061/
4. https://www.cancertherapyadvisor.com/home/cancer-topics/sarcoma/lartruvo-  olaratumab-offers-new-promise-for-patients-with-soft-tissue-sarcoma/

Market Opportunity

Oncology is the leading therapeutic category and represented 25% of all drug sales in 2018 - approximately US $151 billion, estimated to grow to 30% of all drug sales in 2024 - approximately US $200 billion¹

Oncology is one of the most active therapeutic areas in terms of licensing and M&A transactions 2 and 2019 saw several high-profile deals:

• BMS acquisition of Celgene for US $74 billion
• Astra Zeneca co-development and commercialization deal with Daiichi Sankyo for trastuzumab deruxtecan for breast cancer and other cancers for total possible value of US $6.9 billion
• Two additional Phase 2 clinical trails completed. Results published in medical journals in 2006 and 2008

1. Cowen Therapeutic Categories Outlook, September 2019
2. Biopharma dealmakers, December 2019