Field Trip Health & Wellness Ltd.

Reunion reported a net loss from continuing operations of CAD12.5 million, or CAD1.07 per share, for the three months ended December 31, 2022, versus a loss of CAD5.9 million, or CAD0.51 per share, a year earlier. For the nine months ended December 31, 2022, net loss from continuing operations was CAD31.6 million, or CAD2.72 per share, versus CAD11.8 million, or CAD1.02 per share in the prior year. Cash and cash equivalents were CAD32.4 million at December 31, 2022, which management said provides runway through 2023. On the operating-cost side, G&A was CAD4.6 million for the quarter and CAD7.9 million for the nine months, while R&D was CAD3.4 million for the quarter and CAD8.6 million for the nine months. Looking ahead, management said near-term cash burn from Reunion operations is expected to be CAD4 million to CAD6 million per quarter, rising to about CAD7 million to CAD9 million per quarter once Phase 2 is underway; the company also noted a CAD5.3 million reserve related to lease guarantees from the spin-out. Forward guidance centered on a major medical meeting presentation with six cohorts of Phase 1 data later in the second quarter of 2023, continued pre-IND work, and starting the Phase 2 PPD trial later in 2023.

Greg Mayes emphasized that his top priorities since joining were to generate data strong enough to support a U.S. IND for RE104 and to build a team with deep drug-development experience, and he said the company has made significant progress on both. He framed RE104 as a differentiated psychedelic asset because it aims to match psilocybin-like safety/efficacy while offering a much shorter trip time and patent protection through 2041. He also highlighted postpartum depression as a high-unmet-need opportunity and said Reunion intends to broaden the pipeline over time through RE104 expansion and the RE200 series.

Edward Smith walked through the quarter’s financials and reminded listeners that the figures are in Canadian dollars. He reported CAD4.6 million of G&A for the quarter and CAD7.9 million for the nine months, plus CAD3.4 million of R&D for the quarter and CAD8.6 million for the nine months, driven mainly by personnel, manufacturing, and clinical research costs for RE104. He also noted CAD5.7 million and CAD15.3 million in charges tied to lease guarantees and the Field Trip investment, and said cash of CAD32.4 million supports runway through 2023. On capital use, he guided to quarterly burn of CAD4 million to CAD6 million in the near term, moving to CAD7 million to CAD9 million per quarter once Phase 2 is fully underway, excluding potential lease-guarantee cash payments covered by a CAD5.3 million reserve.

Analysts focused on cash burn, the extent of additional Phase 1 dose escalation, timing of the FDA pre-IND meeting, and whether the 40-patient Phase 2 PPD study should use placebo or an active low-dose comparator. Management said the pre-IND process is already underway and does not require the additional cohorts to proceed, though those cohorts will help refine the Phase 2 dose and will be shared later. They also said the placebo-controlled design reflects efforts to maintain blinding and will be reviewed with FDA, and that the full trial design has not yet been disclosed pending that feedback. Other questions probed why management joined the psychedelic space, how RE104 compares qualitatively with psilocybin, and whether there were sex differences or predictors of non-response; management said the experience and adverse-event profile look very similar to psilocybin, no meaningful gender differences have appeared so far, and no predictors of non-response have been identified yet.