First Quarter 2022 Financial Highlights
Cash position
Cash was
Research and development expenses
R&D expenses were
General and administrative expenses
G&A expenses were
Net loss
Net loss was
Business Updates
GH001 for the treatment of TRD
GH001 is our proprietary inhalable 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate.
We recently announced our 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) in the third quarter of 2022. Preparation of those submissions is ongoing.
On
The data from our previously reported Phase 1/2 clinical trial of GH001 in patients with TRD (GH001-TRD-102) has been recently accepted for oral presentation at the
GH001 for the treatment of BDII and PPD
We recently submitted additional clinical trial applications in further European countries for the planned Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with bipolar II disorder and a current depressive episode (BDII) (GH001-BD-202) and for the planned Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with postpartum depression (PPD) (GH001-PPD-203). Pending regulatory clearance, we expect to initiate these trials in the third quarter of 2022.
About
About GH001
Our lead product candidate, GH001, is formulated for 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. 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 5-MeO-DMT product candidate formulated for administration via a proprietary injectable approach. GH003 is our 5-MeO-DMT product candidate formulated for administration via a proprietary intranasal administration approach. GH002 and GH003 are currently in preclinical development, and we anticipate developing them 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 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, our cash runway, business strategy, product candidates, 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
Condensed Consolidated Interim Statement of Comprehensive Income (Unaudited)
(in thousands, except share and per share amounts)
Three months ended | ||
2022 | 2021 | |
$’000 | $’000 | |
Operating expenses | ||
Research and development | (4,714) | (692) |
General and administration | (3,292) | (448) |
Loss from operations | (8,006) | (1,140) |
Foreign currency translation differences | 2,243 | (9) |
Loss before tax | (5,763) | (1,149) |
Tax charge/(credit) | - | - |
Loss for the period | (5,763) | (1,149) |
Other comprehensive expense | ||
Items that may be reclassified to profit or loss | ||
Currency translation adjustment | (2,261) | (202) |
Total comprehensive loss for the period | (8,024) | (1,351) |
Attributable to owners: | ||
Loss for the period | (5,763) | (1,149) |
Comprehensive loss for the period | (2,261) | (202) |
Loss per share | ||
Basic and diluted loss per share (in USD) | (0.111) | (0.038) |
Condensed Consolidated Interim Balance Sheet (Unaudited)
(in thousands)
At | At | ||
2022 | 2021 | ||
$’000 | $’000 | ||
ASSETS | |||
Current assets | |||
Cash and cash equivalents | 270,750 | 276,776 | |
Other current assets | 2,713 | 3,066 | |
Total current assets | 273,463 | 279,842 | |
Non-current assets | |||
Property, plant and equipment | 81 | 82 | |
Total non-current assets | 81 | 82 | |
Total assets | 273,544 | 279,924 | |
LIABILITIES AND EQUITY | |||
Current liabilities | |||
Trade payables | 1,545 | 883 | |
Other current liabilities | 2,521 | 1,866 | |
Total current liabilities | 4,066 | 2,749 | |
Total liabilities | 4,066 | 2,749 | |
Equity attributable to owners | |||
Share capital | 1,301 | 1,301 | |
Additional paid-in capital | 291,448 | 291,448 | |
Other reserves | 693 | 366 | |
Foreign currency translation reserve | (8,164) | (5,903) | |
Accumulated deficit | (15,800) | (10,037) | |
Total equity | 269,478 | 277,175 | |
Total liabilities and equity | 273,544 | 279,924 | |
Source:
2022 GlobeNewswire, Inc., source