Business Updates
We are pleased to report that we have recently initiated our multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). GH001 is our proprietary inhalable mebufotenin (5-MeO-DMT) product candidate.
We expect to recruit approximately 80 patients for this trial across several European countries. The primary objective will be to determine the efficacy of our 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. The double-blind phase will be followed by a 6-month open-label extension phase where all patients can receive treatment with the GH001 IDR as-needed, based on the patient’s clinical status. Further trial design details are described in our updated corporate presentation, which is available in the investor section on our website.
Recent Business Highlights
In
We also reported, in
Furthermore, we reported the recent expansion of our patent portfolio, to include 11 patent families that relate to various aspects of mebufotenin (5-MeO-DMT) use in a therapeutic context, including but not limited to the use of mebufotenin (5-MeO-DMT) for treatment of various disorders when administered by inhalation, or by nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes.
We also announced the selection of mebufotenin as the International Nonproprietary Name (INN) for 5-MeO-DMT by the
Full Year 2022 Financial Highlights
Cash position
Cash, cash equivalents and marketable securities were
Research and development expenses
R&D expenses were
General and administrative expenses
G&A expenses were
Net loss
Net loss was
About
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin (5-MeO-DMT) administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. GH001 is currently in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD). Across the GH001 program, no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen.
About GH002 and GH003
GH002 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach. GH002 is currently in Phase 1 clinical development. GH003 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intranasal administration approach. GH003 is currently in preclinical development. We anticipate developing GH002 and GH003 in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders.
Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, cash runway, business strategy, product candidates, proprietary medical devices, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the
Investor Relations:
investors@ghres.com
Consolidated Statement of Comprehensive Income (Unaudited)
(in thousands, except share and per share amounts)
Year ended | |||
2022 | 2021 | ||
$’000 | $’000 | ||
Operating expenses | |||
Research and development | (20,484) | (8,553) | |
General and administration | (10,070) | (6,547) | |
Loss from operations | (30,554) | (15,100) | |
Net finance income/(expense) | 922 | (9) | |
Foreign exchange gain | 7,176 | 5,907 | |
Total finance income | 8,098 | 5,898 | |
Loss before tax | (22,456) | (9,202) | |
Tax charge/(credit) | — | — | |
Loss for the year | (22,456) | (9,202) | |
Other comprehensive income/(expense) | |||
Items that may be reclassified to profit or loss | |||
Fair value movement on marketable securities | 558 | — | |
Currency translation adjustment | (7,132) | (6,103) | |
Total comprehensive loss for the year | (29,030) | (15,305) | |
Attributable to owners: | |||
Loss for the year | (22,456) | (9,202) | |
Comprehensive loss for the year | (29,030) | (15,305) | |
Loss per share | |||
Basic and diluted loss per share (in USD) | (0.432) | (0.211) |
Consolidated Balance Sheet (Unaudited)
(in thousands)
At | |||
2022 | 2021 | ||
$’000 | $’000 | ||
ASSETS | |||
Current assets | |||
Cash and cash equivalents | 165,955 | 276,776 | |
Other current assets | 2,586 | 3,066 | |
Total current assets | 168,541 | 279,842 | |
Non-current assets | |||
Marketable securities | 85,724 | — | |
Property, plant and equipment | 97 | 82 | |
Total non-current assets | 85,821 | 82 | |
Total assets | 254,362 | 279,924 | |
LIABILITIES AND EQUITY | |||
Current liabilities | |||
Trade payables | 1,868 | 883 | |
Other current liabilities | 2,678 | 1,866 | |
Total current liabilities | 4,546 | 2,749 | |
Total liabilities | 4,546 | 2,749 | |
Equity attributable to owners | |||
Share capital | 1,301 | 1,301 | |
Additional paid-in capital | 291,448 | 291,448 | |
Other reserves | 2,595 | 366 | |
Foreign currency translation reserve | (13,035) | (5,903) | |
Accumulated deficit | (32,493) | (10,037) | |
Total equity | 249,816 | 277,175 | |
Total liabilities and equity | 254,362 | 279,924 |
Source:
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