Psychedelic biopharmaceutical company GH Research PLC (NASDAQ: GHRS) saw its shares pop over 15% in trading after the company was named in a hedge fund purchase. Mark Lampert’s Biotechnology Value Fund initiated $200 million worth of brand new positions in depression drug-focused GH Research, making it the largest stock holding of the fund’s 13F portfolio.
Last month, the company noted that it has $292 million in cash and the net loss was $2.1 million, or $0.053 loss per share. Its R&D expenses were $2 million for the quarter versus just $39 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to its technical developments and clinical trials and increases in employee expenses to support these activities. The stock was rising 17% at one point in trading, but was lately selling at $19.47. GH Research went public in June pricing shares at $16.
GH Research reported that its inhalable 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT) product candidate also called GH001, is currently being investigated in the Phase 2 part of an ongoing open-label, single-arm Phase 1/2 clinical trial in patients with Treatment-Resistant Depression (TRD). “Based on the observed clinical activity in the Phase 1 part of the trial, we believe that administration of a single dose of GH001 has the potential to induce ultra-rapid remissions as measured by the Montgomery–Åsberg Depression Rating Scale, or MADRS, in certain patients. The goal of the ongoing Phase 2 part, which we expect to complete in the fourth quarter of 2021, is to assess whether an individualized dosing regimen with intra-subject dose escalation within a single day can further increase the MADRS remission rate as compared to a single dose of GH001.”
We have previously announced the plan to conduct a clinical pharmacology trial in healthy volunteers to further elucidate the pharmacokinetic profile of GH001. This trial has been initiated and is expected to be completed in the fourth quarter of 2021.
GH Research said that once these studies are completed, it plans to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA and plan to initiate a multi-center, randomized, controlled Phase 2b trial in TRD. “Given GH001’s mechanism of action, we believe that GH001 may confer beneficial effects as an earlier line of treatment in MDD, including the potential to serve as a front-line treatment, as well as in other psychiatric and neurological disorders with unmet medical needs. We plan to initiate proof-of-concept Phase 2a trials in two such disorders.”
The 5-MeO-DMT is analogous to the N,N-DMT, one of the main active ingredients of Ayahuasca, a millenarian decoction used as a sacrament by South American indigenous tribes, known to induce powerful hallucinogenic states when administered. Itn addition to being found in plants, it is also secreted by the glands of at least one toad species, the Sonoran Desert toad.