Second Quarter 2023 Financial Highlights
Cash position
Cash, cash equivalents, other financial assets 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
Business Updates
GH001
GH001, our proprietary inhalable mebufotenin (5-MeO-DMT) product candidate, is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial in patients with treatment-resistant depression (TRD) (GH001-TRD-201). Patient enrollment for this trial is underway, with expected recruitment of approximately 80 patients across several European countries. The primary objective is 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 is 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 corporate presentation, which is available in the investor section on our website.
As previously announced, we expect to submit an IND with the
Our Phase 2a proof-of-concept clinical trial of GH001 in postpartum depression (GH001-PPD-203) is ongoing and, as previously announced, is expected to be completed in the fourth quarter of 2023. Our Phase 2a proof-of-concept clinical trial of GH001 in bipolar II disorder with a current depressive episode (GH001-BD-202) is recruiting slower than previously projected and we now expect this trial to be completed in the first quarter of 2024.
GH002
As previously announced, our randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002, our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach, in healthy volunteers (GH002-HV-105) is expected to be completed in the fourth quarter of 2023.
Expansion of Executive Management Team
We are pleased to announce the recent expansion of our Executive Management Team, with the appointment of
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 TRD.
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, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, cash runway, 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
Condensed Consolidated Interim Statement of Comprehensive Income (Unaudited) (in thousands, except share and per share amounts) | |||||
Three months ended | Six months ended | ||||
2023 | 2022 | 2023 | 2022 | ||
$’000 | $’000 | $’000 | $’000 | ||
Operating expenses | |||||
Research and development | (7,176) | (4,240) | (14,482) | (8,954) | |
General and administration | (2,749) | (2,510) | (5,862) | (5,802) | |
Loss from operations | (9,925) | (6,750) | (20,344) | (14,756) | |
Finance income | 2,122 | - | 3,611 | - | |
Finance expense | (179) | - | (350) | - | |
Movement of expected credit loss | 217 | - | 18 | - | |
Foreign exchange gain/(loss) | 36 | 7,084 | (1,601) | 9,327 | |
Total other income | 2,196 | 7,084 | 1,678 | 9,327 | |
(Loss)/profit before tax | (7,729) | 334 | (18,666) | (5,429) | |
Tax charge/(credit) | - | - | - | - | |
(Loss)/profit for the period | (7,729) | 334 | (18,666) | (5,429) | |
Other comprehensive (expense)/income | |||||
Items that may be reclassified to profit or loss | |||||
Fair value movement on marketable securities | (1,512) | - | (788) | - | |
Currency translation adjustment | (57) | (7,054) | 1,619 | (9,315) | |
Total comprehensive loss for the period | (9,298) | (6,720) | (17,835) | (14,744) | |
Attributable to owners: | |||||
(Loss)/profit for the period | (7,729) | 334 | (18,666) | (5,429) | |
Total comprehensive loss for the period | (9,298) | (6,720) | (17,835) | (14,744) | |
(Loss)/earnings per share | |||||
Basic and diluted (loss)/earnings per share (in USD) | (0.15) | 0.01 | (0.36) | (0.10) | |
Condensed Consolidated Interim Balance Sheet (Unaudited) (in thousands) | |||
At | At | ||
2023 | 2022 | ||
$’000 | $’000 | ||
ASSETS | |||
Current assets | |||
Cash and cash equivalents | 96,895 | 165,955 | |
Other financial assets | 54,728 | - | |
Marketable securities | 13,761 | - | |
Other current assets | 1,015 | 2,586 | |
Total current assets | 166,399 | 168,541 | |
Non-current assets | |||
Marketable securities | 72,697 | 85,724 | |
Property, plant, and equipment | 1,176 | 97 | |
Total non-current assets | 73,873 | 85,821 | |
Total assets | 240,272 | 254,362 | |
LIABILITIES AND EQUITY | |||
Current liabilities | |||
Trade payables | 2,912 | 1,868 | |
Lease liability | 267 | - | |
Other current liabilities | 3,378 | 2,678 | |
Total current liabilities | 6,557 | 4,546 | |
Non-current liabilities | |||
Lease liability | 732 | - | |
Total non-current liabilities | 732 | - | |
Total liabilities | 7,289 | 4,546 | |
Equity attributable to owners | |||
Share capital | 1,301 | 1,301 | |
Additional paid-in capital | 291,448 | 291,448 | |
Other reserves | 2,809 | 2,595 | |
Foreign currency translation reserve | (11,416) | (13,035) | |
Accumulated deficit | (51,159) | (32,493) | |
Total equity | 232,983 | 249,816 | |
Total liabilities and equity | 240,272 | 254,362 | |
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