Field Trip Health Ltd.

Greetings and welcome to Field Trip Second Quarter 2022 Earnings Results Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the former presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Kathleen Heaney, KCSA moderator. Please proceed.

Good morning, everyone, and welcome to FieldTrips Fiscal Second Quarter 2022 Financial Results Conference Call. Before I begin the call, I'm obligated to remind everyone that during the course of this conference call, management may be making some forward-looking statements that are based on current expectations and are subject to a number of risks and uncertainties that may cause actual results to differ materially from expectations. These results are outlined in the risk section of the filings and our disclosure materials. Any forward-looking statements should be considered in light of these factors. Please also note that Safe Harbor, any outlook we present is as of today, and management does not undertake any obligation to revise any forward-looking statements in the future. Presenting today will be Joseph Del Moral, co-founder and chief executive officer, Ronan Levy, co-founder and executive chairman, and Donna Wong, chief financial officer. I will now turn the call over to Joseph to provide an update on Fieldtrip's drug development pipeline.

Thank you, Kathleen, and welcome to everyone joining us this morning. I'm very proud of the progress the company has made in a short period of time in building two successful interrelated but distinct businesses, Fieldtrip Discovery and Fieldtrip Health. This is a testament to the hard work of our teams and the strategic vision of our board and management team to achieve this. I will discuss Fieldtrip Discovery and then turn the call over to Ronan to discuss Fieldtrip Health and our announcement with respect to reviewing our corporate structure. During the quarter, we further progressed the development of our lead novel psychedelic compound, FT-104, with a September announcement that the lead indications for FT-104 will be treatment resistant depression, or TRD, and postpartum depression, or PPD. Both represent areas of large unmet need It is estimated that approximately 100 million people meet the diagnostic criteria for TRD, while PPD affects about 10 to 15% of all mothers of newborns, with an estimated 400,000 diagnosed patients in the U.S. for a year. There are a few effective treatment options available for people suffering with TRD, and those who are diagnosed have typically failed first and second line therapies. For PPD, the only currently approved therapy requires a significant time commitment away from family and newborn, about two to three days, while off-label serotonin reuptake inhibitors can take weeks for onset and only show limited efficacy. The strategy of pursuing both indications enables us to achieve expected marketing approval more quickly for PPD, along with a larger potential total market with TRD subsequently. FG104 is progressing through preclinical studies with the in vivo portion completed and final results from safety pharmacology and GLP toxicology being available in calendar Q4 2021. To date, GLP toxicology, cardiovascular, pulmonary, and neurological safety pharmacology studies, as well as genotoxicity potential, all continue to be encouraging and in line with expectations. In addition, final investigational drug product manufacturing and key clinical startup activities will be completed in calendar Q1 2022, positioning the company for trial initiation in the first half of 2022. In parallel to the Phase 1 study, the company will prepare a detailed regulatory strategy that integrates developments in both PPD and TRD, which will define next steps in clinical development. While in completion of Phase 1 in calendar 2022, the company anticipates opening an IND in the U.S. with the intent to begin Phase 2A studies in the two indications. Lastly, on FT-104, USPTO and PCT patents are pending on FT-104's structure, formulation, and use in treating a variety of central nervous system disorders. We announced yesterday that we are expanding the scope of our development pipeline with a new group of molecules termed the FT-200 group. This discovery effort is aimed at developing novel molecules with a structure of classical psychedelics, similar in potency at the target serotonin 2A receptor, the 5-HT2A, as FT-104 and psilocybin, but with reduced or the absence of activity at the off-target 5-HT2B receptor, which has been associated with the risk of cardiovascular toxicity. The first molecule in the FT-200 group was developed internally by our Chief Science Officer, Dr. Nathan Bryce. Based on in vivo assay details, the first molecule in the group meets the above criteria and has, in addition, demonstrated improved selectivity for the 5-HT2A receptor versus off-target serotonin, 5-HT1A, 5-HT2B, and 5-HT2C receptors. The aim of the work is that by reducing or eliminating 5-HT2B activity, it may allow molecules like those in the FT200 group to be administered more frequently. such as more chronic or chronic intermittent administration or microdosing strategies. We continue to explore structural analogs within the FT200 group to better define and optimize this new family of substances, understand their properties better, and work towards identifying a lead candidate. This is a very exciting time for FieldTrip as we further strengthen our position in the development of the next generation of psychedelic molecules. I will now hand the call over to Ronan to provide an update on the clinic's business and FieldTrip's strategic outlook.