- Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024
- Phase 2a clinical trial of GH001 in postpartum depression on track for expected completion in Q3 2024
- Successfully completed Phase 1, dose-ranging clinical pharmacology trial of intravenous GH002 in healthy volunteers
- Additional patents granted in
Europe - Cash, cash equivalents, other financial assets and marketable securities of
$222.7 million expected to provide cash runway into 2026
Business Updates
GH001 in Patients with 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 approximately 80 patients with treatment-resistant depression (TRD) (GH001-TRD-201).
We have now initiated approximately 20 sites across seven European countries, and continue to see strong recruitment, supporting the expected completion of the double-blind phase of this trial in the third quarter of 2024, with top-line data expected to be available in the third or the fourth quarter of 2024. In this trial, GH001 is administered using an externally-sourced inhalation device. Consistent with previously completed trials, GH001 is administered on a single initial dosing day, without additional mandated visits for psychotherapy or psychological support before or after dosing.
GH001 in Patients with PPD and BDII
GH001 is also currently being investigated in proof-of-concept clinical trials in patients with postpartum depression (PPD) (GH001-PPD-203) and in patients with bipolar II disorder with a current depressive episode (BDII) (GH001-BD-202).
As announced in
GH002
Our Phase 1, dose-ranging clinical pharmacology trial of GH002 (GH002-HV-105), our proprietary intravenous mebufotenin (5-MeO-DMT) product candidate, in healthy volunteers has been successfully completed in the fourth quarter of 2023. Top-line results demonstrate that GH002 was well-tolerated and produced potent and ultra-rapid psychoactive effects.
This trial enrolled 64 healthy volunteers into a double-blind, placebo-controlled part where 56 subjects received single doses of GH002 or placebo in seven dose groups, and an open-label part where 8 subjects received an individualized dosing regimen (IDR) of up to three escalating doses of GH002 on a single day with a scheduled 1-hour interval between doses. The follow-up period was 7 days. GH002 was administered without additional mandated visits for psychological support before or after dosing. In this trial GH002 was found to be well-tolerated with no severe or serious adverse events. GH002 demonstrated potent pharmacodynamic (PD) effects, as assessed by psychoactive effect intensity, with an ultra-rapid onset and a short duration of the psychoactive experience. The pharmacokinetic (PK) profile of GH002 correlated with the ultra-rapid profile of the psychoactive effects.
Further trial results are described in our corporate presentation, which is available in the investor section on our website. The analyses of the PK/PD relationship and various other secondary endpoints are ongoing and will inform the further clinical development strategy for GH002.
Intellectual Property Updates
As announced in
More recently, the
Update on IND for GH001
As previously announced, our Investigational New Drug Application (IND) for GH001 administered using our proprietary aerosol delivery device has been placed on clinical hold by the
We are working to respond to the FDA’s requests and we have initiated the requested nonclinical studies and are preparing the requested device design verification information. In addition, we have recently requested a meeting with the FDA to discuss certain aspects of the FDA’s feedback.
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 the second quarter of 2024. In parallel, to mitigate a potential delay to the GH001 program, we are also progressing preparations to potentially conduct the Phase 1 healthy volunteer clinical pharmacology trial (GH001-HV-106) in
Full Year 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
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. We have completed a Phase 1 trial of GH002 in healthy volunteers. 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 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 and their effects on our business strategy, 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
Consolidated Statement of Comprehensive Income (Unaudited) (in thousands, except share and per share amounts) | ||
Year ended | ||
2023 | 2022 | |
$’000 | $’000 | |
Operating expenses | ||
Research and development | (29,821) | (20,484) |
General and administration | (11,401) | (10,070) |
Loss from operations | (41,222) | (30,554) |
Finance income | 8,978 | 1,166 |
Finance expense | (723) | (123) |
Movement of expected credit loss | 1 | (121) |
Foreign exchange (loss)/gain | (2,621) | 7,176 |
Total other income | 5,635 | 8,098 |
Loss before tax | (35,587) | (22,456) |
Tax charge/(credit) | — | — |
Loss for the year | (35,587) | (22,456) |
Other comprehensive (expense)/income | ||
Items that may be reclassified to profit or loss | ||
Fair value movement on marketable securities | (95) | 558 |
Currency translation adjustment | 2,528 | (7,132) |
Total comprehensive loss for the year | (33,154) | (29,030) |
Attributable to owners: | ||
Loss for the year | (35,587) | (22,456) |
Total comprehensive loss for the year | (33,154) | (29,030) |
Loss per share | ||
Basic and diluted loss per share (in USD) | (0.68) | (0.43) |
Consolidated Balance Sheet (Unaudited) (in thousands) | ||
At | ||
2023 | 2022 | |
$’000 | $’000 | |
ASSETS | ||
Current assets | ||
Cash and cash equivalents | 78,420 | 165,955 |
Other financial assets | 55,615 | — |
Marketable securities | 27,525 | — |
Other current assets | 2,529 | 2,586 |
Total current assets | 164,089 | 168,541 |
Non-current assets | ||
Marketable securities | 61,142 | 85,724 |
Property, plant and equipment | 1,069 | 97 |
Total non-current assets | 62,211 | 85,821 |
Total assets | 226,300 | 254,362 |
LIABILITIES AND EQUITY | ||
Current liabilities | ||
Trade payables | 3,490 | 1,868 |
Lease liability | 343 | — |
Other current liabilities | 2,868 | 2,678 |
Total current liabilities | 6,701 | 4,546 |
Non-current liabilities | ||
Lease liability | 631 | — |
Total non-current liabilities | 631 | — |
Total liabilities | 7,332 | 4,546 |
Equity attributable to owners | ||
Share capital | 1,301 | 1,301 |
Additional paid-in capital | 291,463 | 291,448 |
Other reserves | 4,651 | 2,595 |
Foreign currency translation reserve | (10,507) | (13,035) |
Accumulated deficit | (67,940) | (32,493) |
Total equity | 218,968 | 249,816 |
Total liabilities and equity | 226,300 | 254,362 |
Source:
2024 GlobeNewswire, Inc., source