Phase 2
I’ve written previously about how expensive clinical trials are, and how not many companies are actually cashed enough to run the trials they plan on. Companies need to validate their pre-clinical findings to rationalize moving into Phase 1, which Tryp Therapeutics (TRYP.C) has done successfully, but now a new set of events is on the horizon.
Tryp has 4 upcoming Phase 2 trials. The company currently has around $3 million CAD in the bank and expects another $3 million CAD in December when the warrants from their initial IPO are exercised. Bringing their cash position to roughly $6 million by the end of the year, minus whatever they burn from now until then.
The company’s drug development program centers around psilocybin for neuropsychiatric disorders (PFN), and central nervous system (CNS) pain. Tryp’s drug TRP-8802 is ready to enter into 4 Phase 2 trials. The company hopes to have data from back in Q1 of 2022.
TRP-8802 is a psilocybin derivative sourced from the Usona Group and will be tested in its efficacy in dealing with binge eating, fibromyalgia, phantom limb pain, and complex regional pain syndrome.
TRP-8803 is psilocybin manufactured exclusively by trip. They are also using a novel route of https://e4njohordzs.exactdn.com/wp-content/uploads/2021/10/tnw8sVO3j-2.pngistration which the company thinks will shake up the space. Tryp is anticipating Phase 2 trials starting for TRP-8803 in 2022. Bridging studies are being completed with the University of Michigan and other institutions to prepare TRP-8803 for use in Phase 2b clinical trials and beyond.
Tryp has inked a number of useful partnerships.
Partners
They partnered with the Chronic Pain & Fatigue Research Center at the University of Michigan to advance their studies.
Last year the company announced a research collaboration with Jennifer Miller of the University of Florida. Dr. Miller will be the principal investigator for a Phase 2a clinical trial for eating disorders using Tryp’s psilocybin-based treatments. Dr. Miller is a leading expert in certain eating disorders including binge eating and hyperphagia and brings a wealth of experience in treating these conditions. The trial has commenced and we are still waiting on the results.
In August 2020 Tryp entered into an agreement with AMRI – an R&D/ manufacturing organization for high potency compounds. AMRI will provide research, development, and cGMP manufacturing services for the synthetic psilocybin API that Tryp will use for their PFN program.
Tryp is also developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcoma. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes it is a rare disease and that TRP-1001 should qualify for orphan drug status.
Tryp added three names to its Scientific Advisory Board recently including Robin Carhart-Harris, Ph.D. (Imperial College of London), Joel Castellanos, M.D. (UC San Diego), and William Schmidt, Ph.D.
Cash raise?
Completing all of these Phase 2 studies is going to be costly, and projecting $6 million CAD in cash likely isn’t going to cut it. Their current ratio of 5.4 means their debt is under control and nothing to worry about. The company isn’t heavily diluted at 66 million shares out, but some investors worry that a large capital raise could dilute investors. That said, I don’t really see another option here. I think Tryp’s pipeline makes sense, and they’ve spread the risk out a bit by using both a Usona sourced product, as well as an in-house product.
They are also clearly moving at a fast rate, which is important for any startup, especially ones in the psychedelics space. And who knows, maybe manage has a plan in their back pocket of how and when they will do their future capital raise. For now, Tryp’s investors are excited about the future of this company that seems to just lay low, and keep humming along.
