Tryp Therapeuatics (TRYPF) Coverage Report

INTELLECTUAL PROPERTY AND OTHER MARKET EXCLUSIVITIES Tryp Therapeutics’ primary patent protection is focused on its development of a novel drug delivery technology of psilocybin, TRP-8803. Currently, Tryp is testing a non-proprietary, 25mg oral capsule of psilocybin, TRP-8802, for its Phase 2 proof-of-concept studies. TRP- 8803’s formulation patent is under development and later patent filings are expected to cover TRP-8803’s manufacturing. TRP-8803’s formulation is being developed by Alcami. On March 15, 2021, Tryp filed a provisional patent, 63/161,070, with the USPTO. According to Tryp’s March 18, 2021 press release on the patent, “Improved methods for the use of psychedelics”, it includes innovative methods for the formulation, delivery, and dosing of psychedelics to decrease the probability of abuse and addiction. It also includes novel methods to manufacture the active pharmaceutical ingredient, methods to improve the safety of the medication, and methods to reduce side effects such as, addiction and abuse. The patent is set to become non-provisional in September 2022, at which time its description is to become public. Some information on the formulation (sublingual, or intra- nasal, or topical, or inhaled, etc.), plus any diagnostic-related components will become public once the company begins a clinical trial with TRP-8803, expected in 2H’22. Tryp may also benefit from Orphan Drug designation should the company successfully develop TRP-8803 in conditions with estimated patient populations <200,000 in the U.S., or <250,000 in Europe, providing marketing exclusivity for seven and ten years in each market, respectively. TRP-8803 would also have to be the first psilocybin-based product to be approved in the relatively small indication. We believe the most likely indication would be hypothalamic obesity, which we view as Ultra-rare condition with ~1,500 patients in the U.S., and likely a similar number in Europe. It is possible Tryp is able to file new drug applications following Phase 2b data in 2H’24, considering the lack of available treatments and the agency’s precedent in ultra-rare filings to skip Phase 3 evidence. If this develops, the earliest TRP-8803 would expire is 2032 (assuming Priority Review and approval in 2025), or 2035 should the company decide to conduct a smaller Phase 2b and the agency requests a Phase 3. Michael Higgins 212.409.2074 Tryp Therapeutics, Inc. (TRYPF) Page 34