|
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Form 20-F
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☒
|
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Form 40-F
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☐ |
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Exhibit No.
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Description
|
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Unaudited Condensed Consolidated Interim Financial Statements for the three and six months ended June 30, 2025
|
|
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
|
Press release dated August 7, 2025
|
|
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101.INS
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Inline XBRL Instance Document
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101.SCH
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Inline XBRL Taxonomy Extension Schema Document
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101.CAL
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Inline XBRL Taxonomy Extension Calculation Linkbase Document
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101.DEF
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Inline XBRL Taxonomy Extension Definition Linkbase Document
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101.LAB
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Inline XBRL Taxonomy Extension Label Linkbase Document
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101.PRE
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Inline XBRL Taxonomy Extension Presentation Linkbase Document
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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GH Research PLC
|
||
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Date: August 7, 2025
|
||
|
|
By:
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/s/ Julie Ryan
|
|
|
Name:
|
Julie Ryan
|
|
Title:
|
Vice President, Finance
|
|
|
|
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| GH RESEARCH PLC |
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||||||
|
2025
|
2024
|
2025 | 2024 | |||||||||||||||||
| Note | $’000 | $’000 | $’000 | $’000 | ||||||||||||||||
|
Operating expenses
|
||||||||||||||||||||
|
Research and development
|
3
|
(8,958
|
)
|
(9,755
|
)
|
(16,810 | ) | (18,413 | ) | |||||||||||
|
General and administration
|
3
|
(5,746
|
)
|
(3,464
|
)
|
(10,626 | ) | (6,334 | ) | |||||||||||
|
Loss from operations
|
(14,704
|
)
|
(13,219
|
)
|
(27,436 | ) | (24,747 | ) | ||||||||||||
|
Finance income
|
4
|
3,074
|
2,555
|
5,833 | 5,225 | |||||||||||||||
|
Finance expense
|
4
|
(174
|
)
|
(178
|
)
|
(352 | ) | (357 | ) | |||||||||||
|
Movement of expected credit loss
|
13
|
(3
|
)
|
(6 | ) | 47 | ||||||||||||||
|
Foreign exchange gain
|
2,502
|
466
|
1,860 | 1,787 | ||||||||||||||||
|
Total other income
|
5,415
|
2,840
|
7,335 | 6,702 | ||||||||||||||||
|
Loss before tax
|
(9,289
|
)
|
(10,379
|
)
|
(20,101 | ) | (18,045 | ) | ||||||||||||
|
Tax charge/(credit)
|
-
|
-
|
- | - | ||||||||||||||||
|
Loss for the period
|
(9,289
|
)
|
(10,379
|
)
|
(20,101 | ) | (18,045 | ) | ||||||||||||
| Other comprehensive (expense)/income | ||||||||||||||||||||
|
Items that may be reclassified to profit or loss
|
||||||||||||||||||||
|
Fair value movement on marketable securities
|
(82
|
)
|
(107
|
)
|
(22 | ) | (650 | ) | ||||||||||||
|
Currency translation adjustment
|
457
|
(446
|
)
|
989 | (1,735 | ) | ||||||||||||||
|
Total comprehensive loss for the period
|
(8,914
|
)
|
(10,932
|
)
|
(19,134 | ) | (20,430 | ) | ||||||||||||
|
Attributable to owners:
|
||||||||||||||||||||
|
Loss for the period
|
(9,289
|
)
|
(10,379
|
)
|
(20,101 | ) | (18,045 | ) | ||||||||||||
|
Total comprehensive loss for the period
|
(8,914
|
)
|
(10,932
|
)
|
(19,134 | ) | (20,430 | ) | ||||||||||||
|
Loss per share
|
||||||||||||||||||||
|
Basic and diluted loss per share (in USD)
|
15
|
(0.15
|
)
|
(0.20
|
)
|
(0.33 | ) | (0.35 | ) | |||||||||||
|
|
|
| GH RESEARCH PLC |
|
|
|
At June 30,
|
At December 31,
|
||||||||||
|
2025
|
2024
|
|||||||||||
| Note |
$’000
|
$’000
|
||||||||||
|
ASSETS
|
||||||||||||
|
Current assets
|
||||||||||||
|
Cash and cash equivalents
|
5
|
253,873
|
100,791
|
|||||||||
|
Other financial assets
|
5 |
-
|
19,387
|
|||||||||
|
Marketable securities
|
6
|
37,662
|
29,146
|
|||||||||
|
Other current assets
|
7
|
2,345
|
4,901
|
|||||||||
|
Total current assets
|
293,880
|
154,225
|
||||||||||
|
Non-current assets
|
||||||||||||
|
Marketable securities
|
6
|
17,151
|
33,300
|
|||||||||
|
Property, plant and equipment
|
739
|
748
|
||||||||||
|
Other non-current assets
|
8 |
1,658 | - | |||||||||
|
Total non-current assets
|
19,548
|
34,048
|
||||||||||
|
Total assets
|
313,428
|
188,273
|
||||||||||
|
LIABILITIES AND EQUITY
|
||||||||||||
|
Current liabilities
|
||||||||||||
|
Trade payables
|
9
|
3,447
|
3,741
|
|||||||||
|
Lease liability
|
364
|
255
|
||||||||||
|
Other current liabilities
|
10 |
6,155
|
4,957
|
|||||||||
|
Total current liabilities
|
9,966
|
8,953
|
||||||||||
|
Non-current liabilities
|
||||||||||||
|
Lease liability
|
283
|
369
|
||||||||||
|
Total non-current liabilities
|
283
|
369
|
||||||||||
|
Total liabilities
|
10,249
|
9,322
|
||||||||||
|
Equity attributable to owners
|
||||||||||||
|
Share capital
|
1,551
|
1,301
|
||||||||||
|
Additional paid-in capital
|
431,061
|
291,463
|
||||||||||
|
Other reserves
|
8,407
|
5,194
|
||||||||||
|
Foreign currency translation reserve
|
(11,572
|
)
|
(12,561
|
)
|
||||||||
|
Accumulated deficit
|
(126,268
|
)
|
(106,446
|
)
|
||||||||
|
Total equity
|
303,179
|
178,951
|
||||||||||
|
Total liabilities and equity
|
313,428
|
188,273
|
||||||||||
|
|
|
| GH RESEARCH PLC |
|
|
|
Attributable to owners
|
|||||||||||||||||||||||
|
|
Share capital
|
Additional
paid-in
capital
|
Other
reserves
|
Foreign
currency
translation
reserve
|
Accumulated
deficit |
Total
|
||||||||||||||||||
|
$’000
|
$’000
|
$’000
|
$’000
|
$’000
|
$’000
|
|||||||||||||||||||
|
At January 1, 2024
|
1,301
|
291,463
|
4,651
|
(10,507
|
)
|
(67,940
|
)
|
218,968
|
||||||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
-
|
(18,045
|
)
|
(18,045
|
)
|
||||||||||||||||
|
Other comprehensive expense
|
-
|
-
|
(650
|
)
|
(1,735
|
)
|
-
|
(2,385
|
)
|
|||||||||||||||
|
Total comprehensive loss for the period
|
-
|
-
|
(650
|
)
|
(1,735
|
)
|
(18,045
|
)
|
(20,430
|
)
|
||||||||||||||
|
Share-based compensation expense
|
-
|
-
|
139
|
-
|
-
|
139
|
||||||||||||||||||
|
Transfer of share options
|
- | - | (427 | ) | - | 427 | - | |||||||||||||||||
|
Total transactions with owners
|
-
|
-
|
(288
|
)
|
-
|
427
|
139
|
|||||||||||||||||
|
At June 30, 2024
|
1,301
|
291,463
|
3,713
|
(12,242
|
)
|
(85,558
|
)
|
198,677
|
||||||||||||||||
|
At January 1, 2025
|
1,301
|
291,463
|
5,194
|
(12,561
|
)
|
(106,446
|
)
|
178,951
|
||||||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
-
|
(20,101
|
)
|
(20,101
|
)
|
||||||||||||||||
|
Other comprehensive (expense)/income
|
-
|
-
|
(22
|
)
|
989
|
-
|
967
|
|||||||||||||||||
|
Total comprehensive loss for the period
|
-
|
-
|
(22
|
)
|
989
|
(20,101
|
)
|
(19,134
|
)
|
|||||||||||||||
|
Share-based compensation expense
|
-
|
-
|
3,514
|
-
|
-
|
3,514
|
||||||||||||||||||
|
Transfer of share options
|
- | - | (269 | ) | - | 269 | - | |||||||||||||||||
|
Share option exercises
|
- | - | (10 | ) | - | 10 | - | |||||||||||||||||
|
Issue of share capital
|
250 | 139,598 | - | - | - | 139,848 | ||||||||||||||||||
|
Total transactions with owners
|
250
|
139,598
|
3,235
|
-
|
279
|
143,362
|
||||||||||||||||||
|
At June 30, 2025
|
1,551
|
431,061
|
8,407
|
(11,572
|
)
|
(126,268
|
)
|
303,179
|
||||||||||||||||
|
|
|
| GH RESEARCH PLC |
|
|
Six months ended
June 30,
|
||||||||
|
2025
|
2024
|
|||||||
|
$’000
|
$’000
|
|||||||
|
Cash flows from operating activities
|
||||||||
|
Loss for the period
|
(20,101
|
)
|
(18,045
|
)
|
||||
|
Depreciation
|
158
|
158
|
||||||
|
Share-based compensation expense
|
3,514
|
139
|
||||||
|
Finance income
|
(5,833
|
)
|
(5,225
|
)
|
||||
|
Finance expense
|
352
|
357
|
||||||
|
Movement of expected credit loss
|
6
|
(47
|
)
|
|||||
|
Foreign exchange gain
|
(1,860
|
)
|
(1,787
|
)
|
||||
|
Movement in working capital
|
1,369
|
2,237
|
||||||
|
Cash flows used in operating activities
|
(22,395
|
)
|
(22,213
|
)
|
||||
|
Finance expense paid
|
(360
|
)
|
(366
|
)
|
||||
|
Finance income received
|
5,215
|
3,047
|
||||||
|
Net cash used in operating activities
|
(17,540
|
)
|
(19,532
|
)
|
||||
|
Cash flows from investing activities
|
||||||||
|
Purchase of property, plant and equipment
|
(63
|
)
|
(20
|
)
|
||||
|
Proceeds from sale of other financial assets
|
19,585 | 15,000 | ||||||
|
Proceeds from redemptions and disposals of marketable securities
|
8,026 | 13,540 | ||||||
|
Cash flows from investing activities
|
27,548
|
28,520
|
||||||
|
Cash flows from financing activities
|
||||||||
|
Payment of lease liability
|
(63
|
)
|
(185
|
)
|
||||
|
Proceeds from equity public offering
|
150,000 | - | ||||||
|
Transaction costs from equity public offering
|
(10,152 | ) | - | |||||
| Net cash flows from/(used in) financing activities |
139,785 | (185 | ) | |||||
|
Net increase in cash and cash equivalents
|
149,793
|
8,803
|
||||||
|
Cash and cash equivalents at the beginning of the period
|
100,791
|
78,420
|
||||||
|
Impact of foreign exchange on cash and cash equivalents
|
3,289
|
(92
|
)
|
|||||
|
Cash and cash equivalents at the end of the period
|
253,873
|
87,131
|
||||||
|
|
|
GH RESEARCH PLC
|
|
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
|
| 1. |
Corporate information
|
| 2. |
Basis of preparation, significant judgments, and accounting policies
|
|
|
|
GH RESEARCH PLC
|
|
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (continued)
|
|
|
|
GH RESEARCH PLC
|
|
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (continued)
|
| 3. |
Expenses by nature
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
|
2025
|
2024
|
2025 | 2024 | |||||||||||||
|
$’000
|
$’000
|
$’000 | $’000 | |||||||||||||
|
External research and development expenses
|
6,085
|
7,876
|
11,507 | 14,923 | ||||||||||||
|
Employee expenses1, 3
|
2,857
|
1,810
|
5,242 | 3,358 | ||||||||||||
|
Depreciation
|
7
|
5
|
13 | 11 | ||||||||||||
|
Other expenses
|
9
|
64
|
48 | 121 | ||||||||||||
|
Total research and development expenses
|
8,958
|
9,755
|
16,810 | 18,413 | ||||||||||||
|
External costs
|
3,694
|
2,322
|
6,563 | 4,237 | ||||||||||||
|
Employee expenses2, 3
|
1,977
|
1,069
|
3,918 | 1,950 | ||||||||||||
|
Depreciation
|
75
|
73
|
145 | 147 | ||||||||||||
|
Total general and administrative expenses
|
5,746
|
3,464
|
10,626 | 6,334 | ||||||||||||
|
Total operating expenses
|
14,704
|
13,219
|
27,436 | 24,747 | ||||||||||||
|
|
|
GH RESEARCH PLC
|
|
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (continued)
|
| 4. |
Finance income and expense
|
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
||||||||||||||
|
|
2025
|
2024
|
2025 | 2024 | ||||||||||||
|
|
$’000
|
$’000
|
$’000 |
$’000 |
||||||||||||
|
Finance income
|
||||||||||||||||
| Finance income on cash, cash equivalents and other financial
assets |
596 | 522 | 1,888 | 1,080 | ||||||||||||
|
Gain on cash equivalents and other financial assets at fair value through profit and loss (“FVTPL”)
|
1,819
|
1,081
|
2,564 | 2,138 | ||||||||||||
|
Interest income under effective interest rate method at fair value through other comprehensive income (“FVOCI”)
|
659
|
952
|
1,381 | 2,007 | ||||||||||||
|
Finance income
|
3,074
|
2,555
|
5,833 | 5,225 | ||||||||||||
|
|
||||||||||||||||
|
Finance expense
|
||||||||||||||||
|
Finance expense on investments
|
(165
|
)
|
(165
|
)
|
(333 | ) | (331 | ) | ||||||||
|
Finance expense on lease liability
|
(9
|
)
|
(13
|
)
|
(19 | ) | (26 | ) | ||||||||
|
Finance expense
|
(174
|
)
|
(178
|
)
|
(352 | ) | (357 | ) | ||||||||
| 5. |
Cash and cash equivalents
|
| June 30, |
December 31,
|
|||||||
| 2025 |
2024 |
|||||||
| $’000 | $’000 |
|||||||
|
Cash at bank and in hand
|
31,673 |
28,577
|
||||||
|
Cash equivalents
|
222,200 |
72,214
|
||||||
| 253,873 |
100,791
|
|||||||
| 6. |
Marketable securities
|
|
|
Marketable
securities
|
|||
|
$’000
|
||||
|
Fair value
|
||||
|
At January 1, 2025
|
62,446
|
|||
|
Accrued interest
|
1,381
|
|||
|
Interest received
|
(346
|
)
|
||
|
Redemptions and disposals of marketable securities
|
(8,640 | ) | ||
|
Revaluation adjustment
|
(28
|
)
|
||
|
At June 30, 2025
|
54,813
|
|||
|
|
|
GH RESEARCH PLC
|
|
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (continued)
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
| 2025 | 2024 | 2025 |
2024 |
|||||||||||||
|
$’000
|
$’000
|
$’000
|
$’000
|
|||||||||||||
|
Revaluation adjustments
|
(69 | ) | (110 | ) | (28 | ) | (603 | ) | ||||||||
|
Movement of expected credit losses on assets measured at FVOCI
|
(13 | ) | 3 | 6 | (47 | ) | ||||||||||
|
Movement on marketable securities through OCI
|
(82 | ) | (107 | ) | (22 | ) | (650 | ) | ||||||||
| 7. |
Other current assets
|
| 8. |
Other non-current assets
|
| 9. |
Trade payables
|
| 10. |
Other current liabilities
|
|
11.
|
Share capital
|
|
Number of
outstanding
shares
|
||||
|
At December 31, 2024
|
52,028,145
|
|||
|
Share issue from public offering
|
10,000,000
|
|||
| Share option exercise |
1,250 | |||
|
At June 30, 2025
|
62,029,395
|
|||
| 12. |
Contingencies
|
| 13. |
Share based compensation
|
|
|
|
GH RESEARCH PLC
|
|
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (continued)
|
|
Average exercise
price per share
in
USD
|
Number of
awards
|
Weighted
average remaining
life
in years
|
||||||||||
|
At December 31, 2024
|
3.95
|
1,869,547
|
6.56
|
|||||||||
|
Granted
|
2.42
|
637,000
|
7.07
|
|||||||||
|
Forfeited
|
11.92
|
(34,634
|
)
|
5.17
|
||||||||
| Exercised |
0.03 | (1,250 | ) | 4.83 | ||||||||
|
At June 30, 20251
|
3.44
|
2,470,663
|
6.33
|
|||||||||
|
Three months ended
June 30, 2025 |
Six months ended
June 30, 2025 |
|||||||
|
Share price, in USD
|
10.16 - 12.72
|
7.91 - 12.72
|
||||||
|
Strike price, in USD (weighted average)
|
1.82
|
2.42
|
||||||
|
Expected volatility
|
91% - 92%
|
|
83% - 92%
|
|
||||
|
Award life (weighted average)
|
5.6
|
5.6
|
||||||
|
Expected dividends
|
-
|
-
|
||||||
|
Risk-free interest rate
|
3.90% - 4.19%
|
|
3.90% - 4.47%
|
|
||||
|
|
|
GH RESEARCH PLC
|
|
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (continued)
|
| 14. |
Related party disclosures
|
| 15. |
Loss per share
|
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
||||||||||||||
|
2025
|
2024 | 2025 |
2024 |
|||||||||||||
|
Loss attributable to shareholders (in $’000)
|
(9,289
|
)
|
(10,379
|
)
|
(20,101 | ) | (18,045 | ) | ||||||||
|
Weighted average number of shares in issue
|
62,028,736 |
52,028,145
|
60,039,492 | 52,028,145 | ||||||||||||
|
Basic and diluted loss per share (in USD)
|
(0.15
|
)
|
(0.20
|
)
|
(0.33 | ) | (0.35 | ) | ||||||||
| 16. |
Events after the reporting date
|
|
|
• |
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;
|
|
|
• |
progress any nonclinical programs and any other work that may be required to lift the clinical hold on the study we proposed in our IND for GH001;
|
|
|
• |
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;
|
|
|
• |
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.
|
|
|
• |
We have established a steering committee with key opinion leaders (KOLs) to review Phase 2b results and assist with design of pivotal program;
|
|
|
• |
CRO and site selection process is ongoing and we are scaling our team for efficient execution; and
|
|
|
• |
We are in the process of getting regulatory input on phase 3 requirements and preparation for end-of-phase 2 meeting is underway.
|
|
|
Three months ended
June 30
|
|||||||||||
|
|
2025
|
|
2024
|
|
Change
|
|||||||
|
(in USD thousands)
|
||||||||||||
|
Operating Expenses:
|
|
|
||||||||||
|
Research and development
|
(8,958
|
)
|
|
(9,755
|
)
|
|
797
|
|||||
|
General and administrative
|
(5,746
|
)
|
|
(3,464
|
)
|
|
(2,282
|
)
|
||||
|
Loss from operations
|
(14,704
|
)
|
|
(13,219
|
)
|
|
(1,485
|
)
|
||||
|
Net finance income1
|
2,913
|
2,374
|
539
|
|||||||||
|
Foreign exchange gain
|
2,502
|
|
466
|
|
2,036
|
|||||||
|
Loss for the period
|
(9,289
|
)
|
|
(10,379
|
)
|
|
1,090
|
|||||
|
|
Three months ended
June 30
|
|||||||||||
|
|
2025
|
|
2024
|
|
Change
|
|||||||
|
(in USD thousands)
|
||||||||||||
|
External research and development expenses
|
(6,085
|
)
|
|
(7,876
|
)
|
|
1,791
|
|||||
|
Employee expenses1
|
(2,857
|
)
|
|
(1,810
|
)
|
|
(1,047
|
)
|
||||
|
Depreciation
|
(7
|
)
|
(5
|
)
|
(2
|
)
|
||||||
|
Other expenses
|
(9
|
)
|
(64
|
)
|
55
|
|||||||
|
Research and development
|
(8,958
|
)
|
|
(9,755
|
)
|
|
797
|
|||||
|
|
Three months ended
June 30
|
|||||||||||
|
|
2025
|
|
2024
|
Change
|
||||||||
|
|
(in USD thousands)
|
|||||||||||
|
GH001
|
(5,897
|
)
|
|
(6,295
|
)
|
398
|
||||||
|
GH002
|
(400
|
)
|
|
(570
|
)
|
170
|
||||||
|
Related to multiple product candidates and exploratory work for potential future product candidates
|
(2,661
|
)
|
|
(2,890
|
)
|
229
|
||||||
|
Research and development
|
(8,958
|
)
|
|
(9,755
|
)
|
797
|
||||||
|
|
Three months ended
June 30
|
|||||||||||
|
|
2025
|
2024
|
Change
|
|||||||||
|
(in USD thousands)
|
||||||||||||
|
External costs
|
(3,694
|
) |
(2,322
|
) |
(1,372
|
) |
||||||
|
Employee expenses1
|
(1,977
|
)
|
(1,069
|
)
|
(908
|
)
|
||||||
|
Depreciation
|
(75
|
)
|
(73
|
)
|
(2
|
)
|
||||||
|
General and administrative
|
(5,746
|
)
|
(3,464
|
)
|
(2,282
|
)
|
||||||
|
|
Six months ended
June 30
|
|||||||||||
|
|
2025
|
|
2024
|
Change
|
||||||||
|
(in USD thousands)
|
||||||||||||
|
Operating Expenses:
|
|
|||||||||||
|
Research and development
|
(16,810
|
)
|
|
(18,413
|
)
|
1,603
|
||||||
|
General and administrative
|
(10,626
|
)
|
|
(6,334
|
)
|
(4,292
|
)
|
|||||
|
Loss from operations
|
(27,436
|
)
|
|
(24,747
|
)
|
(2,689
|
)
|
|||||
|
Net finance income1
|
5,475
|
|
4,915
|
560
|
||||||||
|
Foreign exchange gain
|
1,860
|
|
1,787
|
73
|
||||||||
|
Loss for the period
|
(20,101
|
)
|
|
(18,045
|
)
|
(2,056
|
)
|
|||||
|
|
Six months ended
June 30
|
|||||||||||
|
|
2025
|
2024
|
Change
|
|||||||||
|
(in USD thousands)
|
||||||||||||
|
External research and development expenses
|
(11,507
|
)
|
(14,923
|
)
|
3,416
|
|||||||
|
Employee expenses1
|
(5,242
|
)
|
(3,358
|
)
|
(1,884
|
)
|
||||||
|
Depreciation
|
(13
|
)
|
(11
|
)
|
(2
|
)
|
||||||
|
Other expenses
|
(48
|
)
|
(121
|
)
|
73
|
|||||||
|
Research and development
|
(16,810
|
)
|
(18,413
|
)
|
1,603
|
|||||||
|
|
Six months ended
June 30
|
|||||||||||
|
|
2025
|
2024
|
Change
|
|||||||||
|
|
(in USD thousands)
|
|||||||||||
|
GH001
|
(10,837
|
)
|
(12,316
|
)
|
1,479
|
|||||||
|
GH002
|
(1,505
|
)
|
(1,156
|
)
|
(349
|
)
|
||||||
|
GH003
|
-
|
(18
|
)
|
18
|
||||||||
|
Related to multiple product candidates and exploratory work for potential future product candidates
|
(4,468
|
)
|
(4,923
|
)
|
455
|
|||||||
|
Research and development
|
(16,810
|
)
|
(18,413
|
)
|
1,603
|
|||||||
|
|
Six months ended
June 30
|
|||||||||||
|
|
2025
|
2024
|
Change
|
|||||||||
|
(in USD thousands)
|
||||||||||||
|
External costs
|
(6,563
|
)
|
(4,237
|
)
|
(2,326
|
)
|
||||||
|
Employee expenses1
|
(3,918
|
)
|
(1,950
|
)
|
(1,968
|
)
|
||||||
|
Depreciation
|
(145
|
)
|
(147
|
)
|
2
|
|||||||
|
General and administrative
|
(10,626
|
)
|
(6,334
|
)
|
(4,292
|
)
|
||||||
|
|
Six months ended
June 30
|
|||||||||||
|
|
2025
|
2024
|
Change
|
|||||||||
|
(in USD thousands)
|
||||||||||||
|
Net cash flows used in operating activities
|
(17,540
|
)
|
(19,532
|
)
|
1,992
|
|||||||
|
Net cash flows from investing activities
|
27,548
|
28,520
|
(972
|
)
|
||||||||
|
Net cash flows from/(used in) financing activities
|
139,785
|
(185
|
)
|
139,970
|
||||||||
|
Net increase in cash and cash equivalents
|
149,793
|
8,803
|
140,990
|
|||||||||
|
|
• |
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 the European Union;
|
|
|
• |
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 U.S. Food and Drug Administration, or the FDA, the European Medicines Agency, or the EMA, or other comparable foreign regulatory authorities, for our GH001
and GH002 product candidates and our initial and any additional indications;
|
|
|
• |
our expectations related to the clinical hold imposed by the FDA on the study we proposed in our IND for GH001, including our plans and expectations for progressing any nonclinical programs and any other work to lift the clinical
hold, the timing required to lift such clinical hold and for discussions with the FDA and the outcomes and resolution of such discussions;
|
|
|
• |
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, 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 Russia’s invasion of Ukraine, the ongoing military conflict between Israel and Hamas and any resulting conflicts in the region, 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, other financial assets 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 and as a foreign private issuer;
|
|
|
• |
the future trading price of the ordinary shares and impact of securities analysts’ reports on these prices; 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/A for the year ended December 31, 2024.
|
|
|
|
|
• |
Global pivotal program initiation on track for 2026
|
|
|
• |
Engagement with FDA on GH001 IND complete response ongoing
|
|
|
• |
The fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months with infrequent treatment visits and no psychotherapy
|
|
|
• |
Treatment was well tolerated and no treatment related serious adverse events were reported. There was no evidence of treatment-emergent suicidal ideation or behavior
|
|
|
• |
Cash, cash equivalents and marketable securities of $308.7 million as of June 30, 2025
|
|
|
• |
We have established a steering committee with KOLs to review Phase 2b results and assist with design of pivotal program;
|
|
|
• |
CRO and site selection process is ongoing and we are scaling our team for efficient excution; and
|
|
|
• |
We are in the process of getting regulatory input on phase 3 requirements and preparation for end-of-phase 2 meeting is underway.
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
|||||||||||||
|
|
$’000
|
|
$’000
|
|
$’000
|
|
$’000
|
|||||||||
|
Operating expenses
|
||||||||||||||||
|
Research and development
|
(8,958
|
)
|
(9,755
|
)
|
(16,810
|
)
|
(18,413
|
)
|
||||||||
|
General and administration
|
(5,746
|
)
|
(3,464
|
)
|
(10,626
|
)
|
(6,334
|
)
|
||||||||
|
Loss from operations
|
(14,704
|
)
|
(13,219
|
)
|
(27,436
|
)
|
(24,747
|
)
|
||||||||
|
Finance income
|
3,074
|
2,555
|
5,833
|
5,225
|
||||||||||||
|
Finance expense
|
(174
|
)
|
(178
|
)
|
(352
|
)
|
(357
|
)
|
||||||||
|
Movement of expected credit loss
|
13
|
(3
|
)
|
(6
|
)
|
47
|
||||||||||
|
Foreign exchange gain
|
2,502
|
466
|
1,860
|
1,787
|
||||||||||||
|
Total other income
|
5,415
|
2,840
|
7,335
|
6,702
|
||||||||||||
|
Loss before tax
|
(9,289
|
)
|
(10,379
|
)
|
(20,101
|
)
|
(18,045
|
)
|
||||||||
|
Tax charge/(credit)
|
-
|
-
|
-
|
-
|
||||||||||||
|
Loss for the period
|
(9,289
|
)
|
(10,379
|
)
|
(20,101
|
)
|
(18,045
|
)
|
||||||||
|
Other comprehensive (expense)/income
|
||||||||||||||||
|
Items that may be reclassified to profit or loss
|
||||||||||||||||
|
Fair value movement on marketable securities
|
(82
|
)
|
(107
|
)
|
(22
|
)
|
(650
|
)
|
||||||||
|
Currency translation adjustment
|
457
|
(446
|
)
|
989
|
(1,735
|
)
|
||||||||||
|
Total comprehensive loss for the period
|
(8,914
|
)
|
(10,932
|
)
|
(19,134
|
)
|
(20,430
|
)
|
||||||||
|
Attributable to owners:
|
||||||||||||||||
|
Loss for the period
|
(9,289
|
)
|
(10,379
|
)
|
(20,101
|
)
|
(18,045
|
)
|
||||||||
|
Total comprehensive loss for the period
|
(8,914
|
)
|
(10,932
|
)
|
(19,134
|
)
|
(20,430
|
)
|
||||||||
|
Loss per share
|
||||||||||||||||
|
Basic and diluted loss per share (in USD)
|
(0.15
|
)
|
(0.20
|
)
|
(0.33
|
)
|
(0.35
|
)
|
||||||||
|
At June 30,
|
At December 31,
|
|||||||
|
2025
|
2024
|
|||||||
|
|
|
$’000
|
|
$’000
|
||||
|
ASSETS
|
||||||||
|
Current assets
|
||||||||
|
Cash and cash equivalents
|
253,873
|
100,791
|
||||||
|
Other financial assets
|
-
|
19,387
|
||||||
|
Marketable securities
|
37,662
|
29,146
|
||||||
|
Other current assets
|
2,345
|
4,901
|
||||||
|
Total current assets
|
293,880
|
154,225
|
||||||
|
Non-current assets
|
||||||||
|
Marketable securities
|
17,151
|
33,300
|
||||||
|
Property, plant and equipment
|
739
|
748
|
||||||
|
Other non-current assets
|
1,658
|
-
|
||||||
|
Total non-current assets
|
19,548
|
34,048
|
||||||
|
Total assets
|
313,428
|
188,273
|
||||||
|
LIABILITIES AND EQUITY
|
||||||||
|
Current liabilities
|
||||||||
|
Trade payables
|
3,447
|
3,741
|
||||||
|
Lease liability
|
364
|
255
|
||||||
|
Other current liabilities
|
6,155
|
4,957
|
||||||
|
Total current liabilities
|
9,966
|
8,953
|
||||||
|
Non-current liabilities
|
||||||||
|
Lease liability
|
283
|
369
|
||||||
|
Total non-current liabilities
|
283
|
369
|
||||||
|
Total liabilities
|
10,249
|
9,322
|
||||||
|
Equity attributable to owners
|
||||||||
|
Share capital
|
1,551
|
1,301
|
||||||
|
Additional paid-in capital
|
431,061
|
291,463
|
||||||
|
Other reserves
|
8,407
|
5,194
|
||||||
|
Foreign currency translation reserve
|
(11,572
|
)
|
(12,561
|
)
|
||||
|
Accumulated deficit
|
(126,268
|
)
|
(106,446
|
)
|
||||
|
Total equity
|
303,179
|
178,951
|
||||||
|
Total liabilities and equity
|
313,428
|
188,273
|
||||||