| • |
continue to develop and conduct clinical trials, including in expanded geographies such as the United States, for our GH001 and GH002 product candidates for our initial indications and any additional indications;
|
| • |
continue both the technical development and expansion of our external manufacturing capabilities for our current product candidates GH001 and GH002, and of the medical devices required to deliver these product candidates, such as our
proprietary aerosol delivery device for GH001;
|
| • |
initiate and continue research and development, including technical, nonclinical, clinical, and discovery efforts for any future product candidates;
|
| • |
seek to identify additional product candidates;
|
| • |
seek regulatory approvals for our product candidates GH001 and GH002 including the medical devices required to deliver these product candidates, such as our proprietary aerosol delivery device for GH001, or any other product candidates
that successfully complete clinical development;
|
| • |
add operational, financial and management information systems and personnel, including personnel to support our product candidate and device development and help us comply with our obligations as a public company;
|
| • |
hire and retain additional personnel, such as clinical, quality control, scientific, commercial, sales, marketing and administrative personnel;
|
| • |
continue to prepare, file, prosecute, maintain, protect and enforce our intellectual property rights and claims;
|
| • |
establish sales, marketing, distribution, manufacturing, supply chain and other commercial infrastructure in the future to commercialize various products for which we may obtain regulatory approval;
|
| • |
comply with ongoing regulatory requirements for products approved for commercial sale, if ever;
|
| • |
adapt to ongoing changes in global economic conditions, including but not limited to continuing inflation, imposition of tariffs and trade barriers, interest rates and foreign currency exchange rates, disruptions in global supply chains
and labor markets and geopolitical risks and global hostilities, including any direct or indirect economic impacts resulting from conflicts in Eastern Europe and the Middle East, tariff and trade wars, or increased tensions between China
and Taiwan;
|
| • |
acquire or in-license other product candidates, medical devices to deliver our product candidates, and other technologies; and
|
| • |
incur increased costs as a result of operating as a public company.
|
|
Three months ended
March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in USD thousands)
|
||||||||||||
|
Operating Expenses:
|
||||||||||||
|
Research and development
|
(12,379
|
)
|
(7,852
|
)
|
(4,527
|
)
|
||||||
|
General and administrative
|
(6,370
|
)
|
(4,880
|
)
|
(1,490
|
)
|
||||||
|
Loss from operations
|
(18,749
|
)
|
(12,732
|
)
|
(6,017
|
)
|
||||||
|
Net finance income1
|
2,111
|
2,562
|
(451
|
)
|
||||||||
|
Foreign exchange loss
|
(2,329
|
)
|
(642
|
)
|
(1,687
|
)
|
||||||
|
Loss for the period
|
(18,967
|
)
|
(10,812
|
)
|
(8,155
|
)
|
||||||
|
Three months ended
March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in USD thousands)
|
||||||||||||
|
External research and development expenses1
|
(8,545
|
)
|
(5,467
|
)
|
(3,078
|
)
|
||||||
|
Employee expenses2
|
(3,834
|
)
|
(2,385
|
)
|
(1,449
|
)
|
||||||
|
Research and development
|
(12,379
|
)
|
(7,852
|
)
|
(4,527
|
)
|
||||||
|
Three months ended
March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in USD thousands)
|
||||||||||||
|
GH001
|
(8,217
|
)
|
(4,940
|
)
|
(3,277
|
)
|
||||||
|
GH002
|
(239
|
)
|
(1,105
|
)
|
866
|
|||||||
|
Related to multiple product candidates and exploratory work for potential future product candidates
|
(3,923
|
)
|
(1,807
|
)
|
(2,116
|
)
|
||||||
|
Research and development
|
(12,379
|
)
|
(7,852
|
)
|
(4,527
|
)
|
||||||
|
Three months ended
March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in USD thousands)
|
||||||||||||
|
External costs1
|
(4,264
|
)
|
(2,939
|
)
|
(1,325
|
)
|
||||||
|
Employee expenses2
|
(2,106
|
)
|
(1,941
|
)
|
(165
|
)
|
||||||
|
General and administrative
|
(6,370
|
)
|
(4,880
|
)
|
(1,490
|
)
|
||||||
|
Three months ended
March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in USD thousands)
|
||||||||||||
|
Net cash flows used in operating activities
|
(10,669
|
)
|
(8,573
|
)
|
(2,096
|
)
|
||||||
|
Net cash flows from investing activities
|
8,637
|
11,838
|
(3,201
|
)
|
||||||||
|
Net cash flows from financing activities
|
2
|
140,858
|
(140,856
|
)
|
||||||||
|
Net (decrease)/increase in cash and cash equivalents
|
(2,030
|
)
|
144,123
|
(146,153
|
)
|
|||||||
| • |
the commencement, timing, progress and results of our research and development programs, nonclinical studies and clinical trials;
|
| • |
the timing, progress and results of developing and conducting clinical trials for our GH001 and GH002 product candidates and the medical devices required to deliver these product candidates, such as our proprietary aerosol delivery
device for GH001, for our initial and any additional indications;
|
| • |
our efforts to expand into other jurisdictions such as the United States and in Europe;
|
| • |
our expectations related to the technical development and expansion of our external manufacturing capabilities for our GH001 and GH002 product candidates as well as the medical devices required to deliver these product candidates, such
as our proprietary aerosol delivery device for GH001;
|
| • |
our reliance on the success of our GH001 and GH002 product candidates;
|
| • |
the timing, scope or likelihood of regulatory filings and approvals by the FDA, the EMA, or other comparable foreign regulatory authorities, for our GH001 and GH002 product candidates and our initial and any additional indications;
|
| • |
our expectations regarding the size of the eligible patient populations for our GH001 and GH002 product candidates, if approved for commercial use;
|
| • |
our ability to identify third-party clinical trial sites to conduct trials and our ability to identify and train appropriately qualified therapists to administer our investigational therapy;
|
| • |
the effect of pandemics, such as the COVID-19 pandemic, epidemics, outbreaks of an infectious disease or similar events on aspects of our business or operations, including delays in the regulatory approval process, contracting with
clinical trial sites and engaging in clinical trials;
|
| • |
our ability to implement our business model and our strategic plans for our business and GH001 and GH002 product candidates;
|
| • |
our ability to identify, develop or acquire and obtain approval by the FDA, EMA or other comparable foreign regulatory authorities of medical devices required to deliver our GH001 and GH002 product candidates, such as our proprietary
aerosol delivery device for GH001;
|
| • |
our commercialization and marketing capabilities and strategy;
|
| • |
the effects of undesirable clinical trial outcomes and potential adverse public perception regarding the use of mebufotenin and psychedelics generally on the regulatory approval process and future development of our product;
|
| • |
the pricing, coverage and reimbursement of our GH001 and GH002 product candidates, if approved;
|
| • |
the scalability and commercial viability of our manufacturing methods and processes;
|
| • |
the rate and degree of market acceptance and clinical utility of our GH001 and GH002 product candidates;
|
| • |
our reliance on third-party suppliers for our nonclinical study and clinical trial drug substance and product candidate supplies, as well as key raw materials used in our manufacturing processes;
|
| • |
our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;
|
| • |
our expectations regarding potential benefits of our GH001 and GH002 product candidates and our approach generally;
|
| • |
our expectations around regulatory development paths and with respect to Controlled Substances Act, or CSA, classification;
|
| • |
the scope of protection we and any current or future licensors or collaboration partners are able to establish and maintain for intellectual property rights covering our GH001 and GH002 product candidates;
|
| • |
our ability to operate our business without infringing, misappropriating, or otherwise violating the intellectual property rights and proprietary technology of third parties;
|
| • |
our ability to protect our intellectual property rights, including enforcing and defending intellectual property-related claims;
|
| • |
regulatory developments in the United States, under the laws and regulations of the European Union and other jurisdictions;
|
| • |
continuing inflation, imposition of tariffs and trade barriers, interest rates and foreign currency exchange rates, disruptions in global supply chains and labor markets, and geopolitical risks and global hostilities, including any
direct or indirect economic impacts resulting from conflict in Eastern Europe and the Middle East, tariff and trade wars, or increased tensions between China and Taiwan;
|
| • |
developments and projections relating to our competitors and our industry;
|
| • |
our ability to maintain an effective system of internal control over financial reporting;
|
| • |
the amount of time that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations and capital expenditures;
|
| • |
our estimates regarding expenses, capital requirements and needs for additional financing;
|
| • |
our ability to effectively manage our anticipated growth;
|
| • |
our ability to attract and retain qualified employees and key personnel;
|
| • |
whether we are classified as a passive foreign investment company for current and future periods;
|
| • |
our expectations regarding the time during which we will be an EGC under the JOBS Act or the time during which we will be a foreign private issuer;
|
| • |
the future trading price of the ordinary shares and impact of securities analysts’ reports on this price; and
|
| • |
other risks and uncertainties, including those listed under “—Risk Factors” herein and “Item 3. Key Information—D. Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2025.
|