Form 20-F
|
☒
|
Form 40-F
|
GH Research PLC
|
||
Date: May 18, 2022
|
||
By:
|
/s/ Julie Ryan
|
|
Name:
|
Julie Ryan
|
|
Title:
|
Vice President, Finance
|
Exhibit No.
|
Description
|
Unaudited Condensed Consolidated Interim Financial Statements for the three months ended March 31, 2022
|
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
Press release dated May 18, 2022
|
|
99.4 | Corporate Presentation for May 2022 |
|
Three months ended
March 31,
|
|||||||
2022
|
2021
|
||||||
|
Note |
$’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)
|
10
|
(0.111
|
)
|
(0.038
|
)
|
|
At March 31,
|
At December 31,
|
||||||||
2022
|
2021
|
||||||||
Note
|
$’000
|
$’000
|
|||||||
ASSETS
|
|||||||||
Current assets
|
|||||||||
Cash and cash equivalents
|
270,750
|
276,776
|
|||||||
Other current assets
|
4
|
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
|
5
|
1,545
|
883
|
||||||
Other current liabilities
|
6
|
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
|
|
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, 2021
|
871
|
5,430
|
-
|
200
|
(835
|
)
|
5,666
|
|||||||||||
Loss for the period
|
-
|
-
|
-
|
-
|
(1,149
|
)
|
(1,149
|
)
|
||||||||||
Translation adjustment
|
-
|
-
|
-
|
(202
|
)
|
-
|
(202
|
)
|
||||||||||
Total comprehensive loss for the period
|
-
|
-
|
-
|
(202
|
)
|
(1,149
|
)
|
(1,351
|
)
|
|||||||||
At March 31, 2021
|
871
|
5,430
|
-
|
(2
|
)
|
(1,984
|
)
|
4,315
|
||||||||||
At January 1, 2022
|
1,301
|
291,448
|
366
|
(5,903
|
)
|
(10,037
|
)
|
277,175
|
||||||||||
Loss for the period
|
-
|
-
|
-
|
-
|
(5,763
|
)
|
(5,763
|
)
|
||||||||||
Translation adjustment
|
-
|
-
|
-
|
(2,261
|
)
|
-
|
(2,261
|
)
|
||||||||||
Total comprehensive loss for the period
|
-
|
-
|
-
|
(2,261
|
)
|
(5,763
|
)
|
(8,024
|
)
|
|||||||||
Share-based compensation expense
|
-
|
-
|
327
|
-
|
-
|
327
|
||||||||||||
Total transactions with owners
|
-
|
-
|
327
|
-
|
-
|
327
|
||||||||||||
At March 31, 2022
|
1,301
|
291,448
|
693
|
(8,164
|
)
|
(15,800
|
)
|
269,478
|
|
Three months ended
March 31,
|
||||||
2022
|
2021
|
|||||
$’000
|
$’000
|
|||||
Cash flows from operating activities
|
||||||
Loss for the period
|
(5,763
|
)
|
(1,149
|
)
|
||
Depreciation
|
11
|
1
|
||||
Share-based compensation expense
|
327
|
-
|
||||
Foreign exchange translation differences
|
(2,243
|
)
|
-
|
|||
Movement in working capital
|
1,667
|
61
|
||||
Cash flows used in operating activities
|
(6,001
|
)
|
(1,087
|
)
|
||
Finance expense paid
|
-
|
-
|
||||
Net cash used in operating activities
|
(6,001
|
)
|
(1,087
|
)
|
||
Cash flows used in investing activities
|
||||||
Purchase of property, plant and equipment
|
(10
|
)
|
(21
|
)
|
||
Net decrease in cash
|
(6,011
|
)
|
(1,108
|
)
|
||
Cash at the beginning of the period
|
276,776
|
5,895
|
||||
Impact of foreign exchange on cash
|
(15
|
)
|
(211
|
)
|
||
Cash at the end of the period
|
270,750
|
4,576
|
|
1. |
Corporate information
|
2. |
Basis of preparation, significant judgments, and accounting policies
|
|
|
Estimated Useful Life
|
||
IT equipment
|
3 years
|
|
Office equipment
|
3 years
|
|
Medical equipment
|
2 years
|
|
3. |
Expenses by nature
|
Three months ended
March 31,
|
||||||||
2022
|
2021
|
|||||||
$’000
|
$’000
|
|||||||
External costs1
|
3,916
|
588
|
||||||
Employee expenses2
|
798
|
104
|
||||||
Total research and development expenses
|
4,714
|
692
|
External costs1
|
2,752
|
343
|
||||||
Employee expenses2
|
540
|
105
|
||||||
Total general and administrative expenses
|
3,292
|
448
|
||||||
Total operating expenses
|
8,006
|
1,140
|
4. |
Other current assets
|
5. |
Trade payables
|
6. |
Other current liabilities
|
7. |
Contingent liabilities
|
8. |
Share based compensation
|
|
Average exercise
price per share
in
USD
|
Number of awards
|
Weighted
average
remaining
life
in years
|
||||||||||
At December 31, 2021
|
15.80
|
157,187
|
7.62
|
|||||||||
Granted
|
20.26
|
73,372
|
7.80
|
|||||||||
At March 31, 2022
|
18.50
|
230,559
|
7.51
|
|
Three months ended
March 31, 2022
|
||||
Share price, in USD
|
15.71-18.32
|
|||
Strike price, in USD (weighted average)
|
20.26
|
|||
Expected volatility
|
89% - 90%
|
|
||
Award life (weighted average)
|
6
|
|||
Risk-free interest rate
|
1.74% - 1.87%
|
|
9. |
Related party disclosures
|
10. |
Loss per share
|
Three months ended
March 31,
|
||||||||
2022
|
2021
|
|||||||
Loss attributable to shareholders (in $’000)
|
(5,763
|
)
|
(1,149
|
)
|
||||
Weighted average number of shares in issue(1)
|
52,020,849
|
30,369,232
|
||||||
Basic and diluted loss per share (in USD) (2)
|
(0.111
|
)
|
(0.038
|
)
|
11. |
Events after the reporting date
|
• |
continue to develop and conduct clinical trials, including in expanded geographies such as the United States, for GH001, our inhalable 5-MeO-DMT product candidate, GH002, our injectable 5-MeO-DMT product candidate, and GH003, our
intranasal 5-MeO-DMT product candidate 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, GH002 and GH003 and of the medical devices required to deliver these product candidates;
|
• |
initiate and continue research and development, including nonclinical, clinical, and discovery efforts for any future product candidates;
|
• |
seek to identify additional product candidates;
|
• |
seek regulatory approvals for our product candidates GH001, GH002 and GH003 including the medical devices required to deliver these product candidates, 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;
|
• |
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
|
Change
|
||||||||||
|
2022
|
2021
|
||||||||||
Operating Expenses:
|
||||||||||||
Research and development
|
$
|
(4,714
|
)
|
$
|
(692
|
)
|
$
|
(4,022
|
)
|
|||
General and administrative
|
(3,292
|
)
|
(448
|
)
|
(2,844
|
)
|
||||||
Loss from operations
|
(8,006
|
)
|
(1,140
|
)
|
(6,866
|
)
|
||||||
Foreign currency translation differences
|
2,243
|
(9
|
)
|
2,252
|
||||||||
Loss for the period
|
$
|
(5,763
|
)
|
$
|
(1,149
|
)
|
$
|
(4,614
|
)
|
|
Three Months Ended
March 31
|
Change
|
||||||||||
|
2022
|
2021
|
||||||||||
External costs1
|
$
|
(3,916
|
)
|
$
|
(588
|
)
|
$
|
(3,328
|
)
|
|||
Employee expenses2
|
(798
|
)
|
(104
|
)
|
(694
|
)
|
||||||
Research and development
|
$
|
(4,714
|
)
|
$
|
(692
|
)
|
$
|
(4,022
|
)
|
Three Months Ended
March 31
|
Change | |||||||||||
|
2022
|
2021
|
||||||||||
External costs1
|
$
|
(2,752
|
)
|
$
|
(343
|
)
|
$
|
(2,409
|
)
|
|||
Employee expenses2
|
(540
|
)
|
(105
|
)
|
(435
|
)
|
||||||
General and administrative
|
$
|
(3,292
|
)
|
$
|
(448
|
)
|
$
|
(2,844
|
)
|
Three Months Ended
March 31
|
Change
|
|||||||||||
2022
|
2021
|
|||||||||||
Net cash flows used in operating activities
|
$
|
(6,001
|
)
|
$
|
(1,087
|
)
|
$
|
(4,914
|
)
|
|||
Net cash flows used in investing activities
|
(10
|
)
|
(21
|
)
|
11
|
|||||||
Net decrease in cash
|
$
|
(6,011
|
)
|
$
|
(1,108
|
)
|
$
|
(4,903
|
)
|
• |
the commencement, timing, progress and results of our research and development programs, preclinical studies and clinical trials;
|
• |
the timing, progress and results of developing and conducting clinical trials for our GH001, GH002 and GH003 product candidates and the medical devices required to deliver these product candidates 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, GH002 and GH003 product candidates as well as the medical devices required to deliver these product candidates;
|
• |
our reliance on the success of our GH001, GH002 and GH003 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, GH002
and GH003 product candidates and our initial and any additional indications;
|
• |
our expectations regarding the size of the eligible patient populations for our GH001, GH002 and GH003 product candidates, if approved for commercial use;
|
• |
our ability to identify third-party clinical sites to conduct trials and our ability to identify and train appropriately qualified therapists to administer our investigational therapy;
|
• |
the effect of the COVID-19 pandemic on aspects of our business or operations, including delays in the regulatory approval process, contracting with clinical sites and engaging in clinical trials;
|
• |
our ability to implement our business model and our strategic plans for our business and GH001, GH002 and GH003 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, GH002 and GH003 product candidates;
|
• |
our commercialization and marketing capabilities and strategy;
|
• |
the effects of undesirable clinical trial outcomes and potential adverse public perception regarding the use of 5-MeO-DMT and psychedelics generally on the regulatory approval process and future development of our product;
|
• |
the pricing, coverage and reimbursement of our GH001, GH002 and GH003 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, GH002 and GH003 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, GH002 and GH003 product candidates and our approach generally;
|
• |
our expectations around regulatory development paths and with respect to Controlled Substances Act 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, GH002 and GH003 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;
|
• |
developments and projections relating to our competitors and our industry;
|
• |
our ability to remediate our material weaknesses in our internal control over financial reporting;
|
• |
the amount of time that our existing cash 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; and
|
• |
the future trading price of the ordinary shares and impact of securities analysts’ reports on these prices.
|
Three months ended
March 31,
|
||||||||
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
|
)
|
At March 31,
|
At December 31,
|
|||||||
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
|
Seeking
Ultra-Rapid, Durable Remissions
in Depression