GH Research Archives - Green Market Report

Debra BorchardtAugust 23, 2022
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5min200

GH Research PLC (Nasdaq: GHRS) reported financial results for the second quarter ended June 30, 2022 and gave updates on its business. The company has no revenue at this time and is focused on developing its DMT drugs for mental health issues. The company also said it does not expect to have revenue for several years. GH Research has $265.4 million in cash as of June 30, 2022, compared to $276.8 million as of December 31, 2021. The company said it believes that has enough capital to fund its operating expenses and capital expenditure requirements into 2025.

GH Research reported a net profit of $0.3 million, or $0.006 earnings per share, for the quarter versus a net loss of $2.1 million, or $0.053 loss per share, for the same quarter in 2021. This was due to the foreign exchange gain in the quarter.

In May 2022, the company announced the positive outcome of its pre-IND meeting with the U.S. Food and Drug Administration (FDA) and said it expects to submit the IND for GH001 in TRD no later than the first quarter of 2023. GH001 is the proprietary inhalable 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate. The planned IND-opening study is a Phase 1 imaging study in patients with TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104).

Expenses

R&D expenses were $4.2 million for the quarter versus $2.0 million for the same quarter in 2021. The increase was primarily due to increased activities relating to the company’s technical development and clinical trials and increases in employee expenses to support these activities. G&A expenses were $2.5 million for the quarter versus $0.7 million for the same quarter in 2021. The increase was primarily due to an increase in insurance costs, as well as increased employee expenses.

Studies

In March 2022, GH Research announced its plan to submit clinical trial applications in several European countries for a multi-center, randomized, controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). “We plan to submit such applications beginning in the third quarter of 2022. When such applications are approved, we expect to recruit approximately 80 patients for this trial. The primary objective will be to determine the efficacy of a single-day individualized-dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) at the end of the 7-day double-blind phase.”
In May 2022, the company announced the positive outcome of its pre-IND meeting with the U.S. Food and Drug Administration (FDA), and expects to submit the IND for GH001 in TRD not later than the first quarter of 2023. The planned IND-opening study is a Phase 1 imaging study in patients with TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104).
“Our recently announced Phase 2a proof-of-concept clinical trials of GH001 for the treatment of patients with bipolar II disorder and a current depressive episode (BDII) (GH001-BD-202) and for the treatment of patients with postpartum depression (PPD) (GH001-PPD-203) have now received regulatory approvals and site startup activities have commenced. The trials have an open-label, single-arm design with 7 days duration and they are expected to recruit approximately 15 patients each. The primary objective of the trials will be to determine the efficacy of a single day IDR of GH001 in improving depressive symptoms as assessed by mean change in MADRS from baseline to day 7.”

 

 


StaffDecember 6, 2021
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3min60

Psychedelic biotech company GH Research PLC (Nasdaq: GHRS) reported financial results for the third quarter ended September 30, 2021, and gave updates on its business. R&D expenses were $2.6 million for the quarter ended September 30, 2021, compared to $55 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to the company’s technical developments and clinical trials and increases in employee expenses to support these activities. the company has no revenue to report at this time.

G&A expenses were $2.1 million for the quarter versus $5 thousand for the same quarter in 2020. GH Research said the increase was primarily due to higher professional and compliance fees associated with being a public company, as well as increased employee expenses. The company also reported a net loss of $1.8 million, or $0.035 loss per share versus $60 thousand, or $0.002 loss per share, for the same quarter in 2020. Cash was $280.7 million as of September 2021 versus $5.9 million as of December 31, 2020.

GH Research lead product is GH001, which is an inhalable 5-MeO-DMT. The company also reported the successful outcome of the Phase 2 part of its Phase 1/2 clinical trial of GH001 in treatment-resistant depression (TRD), where the primary endpoint was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001). According to the FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.

GH Research said it plans to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA in the first quarter of 2022 and, pending the outcome of these meetings, it plans to initiate a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD. The company also stated that it has recently initiated the development in two undisclosed psychiatric disorders which are expected to be announced in the first quarter of 2022.

In addition, the company also reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103). This trial enrolled 46 healthy volunteers with 30-day safety follow-up. The trial investigated three different single doses of GH001 in a double-blind, placebo-controlled design (6 mg (n=8), 12 mg (n=8), 18 mg (n=8), placebo (n=2 in each dose group)) and a proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day in an open-label, non-randomized design in two groups with two different intervals between doses (1 hour (n=8), 2 hours (n=8)).


StaffOctober 28, 2021
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4min90

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.”

DMT

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.


StaffJuly 6, 2021
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3min60

GH Research, a Dublin-based company studying the potential of 5-MeO-DMT for the treatment of psychiatric and neurological disorders, is now listing its stock on the Nasdaq under the symbol “GHRS” after opening for trading on Friday, July 2 at $22.

The company had an IPO of 10 million shares at an initial price of $16 per share for total proceeds of approximately $160 million.

The company said that its initial focus is on developing the novel and proprietary 5-Methoxy-N, N-Dimethyltryptamine, or 5-MeO-DMT, therapies for the treatment of patients with Treatment-Resistant Depression, or TRD. The portfolio currently includes GH001, our proprietary inhalable 5-MeO-DMT product candidate, and GH002, our proprietary injectable 5-MeO-DMT product candidate. It has completed a Phase 1 healthy volunteer clinical trial, in which administration of GH001 via inhalation was observed to be well tolerated at the investigated single dose levels and in an individualized dosing regimen with intra-subject dose escalation.

GH001 is currently being investigated in the Phase 2 part of an ongoing Phase 1/2 clinical trial in patients with TRD. Based on observed clinical activity, The company said it believes 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 of the trial 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 GH001 dose.

GH Research closed a series B financing round for $125 million in April, which allowed it to move to a Phase 1/2 clinical trial testing the product in patients with treatment-resistant depression. The financing was co-led by RA Capital and RTW Investments, LP, U.S.-based biopharmaceutical investment firms, alongside existing investor BVF Partners. Other new investors in the Series B round included Acuta Capital Partners, Boxer Capital, Cormorant Asset Management, Deerfield Management Company, Logos Capital, Surveyor Capital (a Citadel company), Venrock Healthcare Capital Partners, and Verition Fund Management.

 


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