Third 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 in TRD
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). The trial has been approved in seven European countries and is expected to recruit approximately 80 patients across approximately 20 sites. Patient enrollment is on schedule and we continue to expect completion of the double-blind phase of this trial in the third quarter of 2024, with availability of top-line data in the third or the fourth quarter of 2024. In this trial, GH001 is administered using an externally-sourced inhalation device.
Update on IND for GH001
In
We have now received a formal clinical hold letter from the FDA. To remove the hold, they have requested that we provide (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, related to respiratory tract histology findings from a previously completed inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to our investigator brochure. We are working to respond to the FDA’s requests, including by initiating the requested nonclinical studies. We intend to request a meeting with the FDA, expected to take place in the first quarter of 2024, if granted, to discuss the feedback, provide clarifications, and discuss our plan to address their comments. We intend to provide an update regarding the IND response submission and the planned Phase 1 healthy volunteer clinical pharmacology trial (GH001-HV-106) in due course after taking into account the conclusions of that meeting.
GH001 in BD and PPD
GH001 is also currently being investigated in a proof-of-concept clinical trial in patients with bipolar II disorder with a current depressive episode (GH001-BD-202) and in a proof-of-concept clinical trial in patients with postpartum depression (GH001-PPD-203).
Recently, the clinical research organization that manages one of our clinical trial sites informed us that the site will be closed for business reasons. As this is one of two sites activated in each trial, and because both trials have been recruiting slower than previously projected, we expect a delay in the completion of the trials. We are in the process of putting measures in place to support recruitment of both trials, including the addition of further clinical trial sites, and we plan to provide an updated timeline for expected trial completion 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.
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 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 in patients with TRD and in two Phase 2a proof-of-concept trials in patients with bipolar II disorder and a current depressive episode and in patients with postpartum depression.
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, including our plans and expectations for discussions with the FDA and the outcomes and resolution of such discussions related to the clinical hold on the GH001 IND, 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 | Nine Months Ended | ||||
2023 | 2022 | 2023 | 2022 | ||
$’000 | $’000 | $’000 | $’000 | ||
Operating expenses | |||||
Research and development | (7,088) | (4,620) | (21,570) | (13,574) | |
General and administration | (2,631) | (2,006) | (8,493) | (7,808) | |
Loss from operations | (9,719) | (6,626) | (30,063) | (21,382) | |
Finance income | 2,438 | - | 6,049 | - | |
Finance expense | (184) | - | (534) | - | |
Movement of expected credit loss | (17) | - | 1 | - | |
Foreign exchange gain | 1,833 | 6,185 | 232 | 15,512 | |
Total other income | 4,070 | 6,185 | 5,748 | 15,512 | |
Loss before tax | (5,649) | (441) | (24,315) | (5,870) | |
Tax charge/(credit) | - | - | - | - | |
Loss for the period | (5,649) | (441) | (24,315) | (5,870) | |
Other comprehensive expense | |||||
Items that may be reclassified to profit or loss | |||||
Fair value movement on marketable securities | (428) | - | (1,216) | - | |
Currency translation adjustment | (1,780) | (6,464) | (161) | (15,779) | |
Total comprehensive loss for the period | (7,857) | (6,905) | (25,692) | (21,649) | |
Attributable to owners: | |||||
Loss for the period | (5,649) | (441) | (24,315) | (5,870) | |
Total comprehensive loss for the period | (7,857) | (6,905) | (25,692) | (21,649) | |
Loss per share | |||||
Basic and diluted loss per share (in USD) | (0.11) | (0.01) | (0.47) | (0.11) |
Condensed Consolidated Interim Balance Sheet (Unaudited) (in thousands) | |||
At | At | ||
2023 | 2022 | ||
$’000 | $’000 | ||
ASSETS | |||
Current assets | |||
Cash and cash equivalents | 86,439 | 165,955 | |
Other financial assets | 55,494 | - | |
Marketable securities | 19,343 | - | |
Other current assets | 2,765 | 2,586 | |
Total current assets | 164,041 | 168,541 | |
Non-current assets | |||
Marketable securities | 67,449 | 85,724 | |
Property, plant, and equipment | 1,078 | 97 | |
Total non-current assets | 68,527 | 85,821 | |
Total assets | 232,568 | 254,362 | |
LIABILITIES AND EQUITY | |||
Current liabilities | |||
Trade payables | 2,707 | 1,868 | |
Lease liability | 260 | - | |
Other current liabilities | 3,167 | 2,678 | |
Total current liabilities | 6,134 | 4,546 | |
Non-current liabilities | |||
Lease liability | 661 | - | |
Total non-current liabilities | 661 | - | |
Total liabilities | 6,795 | 4,546 | |
Equity attributable to owners | |||
Share capital | 1,301 | 1,301 | |
Additional paid-in capital | 291,448 | 291,448 | |
Other reserves | 2,888 | 2,595 | |
Foreign currency translation reserve | (13,196) | (13,035) | |
Accumulated deficit | (56,668) | (32,493) | |
Total equity | 225,773 | 249,816 | |
Total liabilities and equity | 232,568 | 254,362 | |
Source:
2023 GlobeNewswire, Inc., source