GHRS GH Research PLC

Form 20-F

☒

Form 40-F

Exhibit No.	Description
99.1	Notice of Annual General Meeting
99.2	Directors’ Report and 2023 Irish Statutory Financial Statements
99.3	Annual General Meeting Notice Regarding Agenda
99.4	Annual General Meeting Notice Regarding the Availability of Proxy Materials
99.5	Annual General Meeting Proxy Card (Record Holders)
99.6	Annual General Meeting Proxy Card (Brokers)

	GH Research PLC
Date: May 15, 2024
	By:	/s/ Julie Ryan
	Name:	Julie Ryan
	Title:	Vice President, Finance

Exhibit 99.1

Notice of Annual General Meeting to be held on 27 June 2024

GH Research plc

 

(the Company or GH Research)

 

THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION.

 

If you are in any doubt as to the action to be taken, you should consult with your independent financial adviser who, if you are taking advice in Ireland, is authorised or exempted under the European Communities (Markets in Financial Instruments) Regulations 2017 (as amended) or the Investment Intermediaries Act, 1995 (as amended).

If you have sold or transferred your entire holding of ordinary shares in GH Research, please pass this document, together with the attached proxy form, to the purchaser or transferee, or to the stockbroker, bank or other agent through whom the sale was effected, for transmission to the purchaser or transferee as soon as possible.

15 May 2024 

To: All GH Research shareholders

 

NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS

 

Dear Shareholder

 

The Annual General Meeting of GH Research will be held at 2 pm (Irish Standard Time) on 27 June 2024 at Joshua Dawson House, Dawson Street, Dublin 2, D02 RY95, Ireland (the AGM).

 

The purpose of this letter is to outline the background to and summarise the resolutions to be proposed at the AGM. Please refer to the form of proxy for the AGM (which is separately provided) and the notes on pages 6 to 8 for details on how to vote your shares and return your form of proxy. Your attention is also drawn to the notice of the AGM on pages 4 and 5 which sets out the matters to be considered at the AGM.

In accordance with our Constitution, all members of our board of directors (the Board) must retire from office, and are eligible to stand for re-election, at each AGM.

Accordingly, the following, being all the directors of the Company, will stand for re-election at the AGM:

Each of our directors is a non-executive director and the Board has determined that Michael Forer, Dermot Hanley and Duncan Moore qualify as independent directors under the applicable requirements of Nasdaq and the U.S. Securities Exchange Act of 1934.

 

Each of our directors demonstrate the necessary commitment to the role and provide valuable skills, knowledge and experience and make important contributions to the working of the Board. Further information on the experience, qualifications and industry knowledge of the current directors is available in our Irish statutory financial statements (the 2023 Irish Accounts) and/or our annual report on Form 20-F (the 2023 Form 20-F), in each case for the financial period ended 31 December 2023 and which have been made available at https://investor.ghres.com/corporate-governance/shareholder-meetings. Details of current committee composition is set out on our website at https://investor.ghres.com/corporate-governance/committee-composition.

 

This resolution ratifies the appointment of PricewaterhouseCoopers Ireland as GH Research’s independent auditors and authorises the Board to fix their remuneration.

Shareholders will also be asked to review GH Research's affairs and to receive and consider the 2023 Irish Accounts which have been audited by PricewaterhouseCoopers Ireland, GH Research’s independent auditors. The 2023 Irish Accounts are being made available to shareholders at the same time as this notice on https://investor.ghres.com/corporate-governance/shareholder-meetings.

 

Shareholders may also transact such other business as may properly come before the AGM.

 

 

Resolutions 1.1 to 1.4 and 2 are ordinary resolutions which require approval of a simple majority of the votes cast in person or by proxy. There is no requirement under Irish law that the 2023 Irish Accounts, or the directors' and auditor's reports thereon be approved by the shareholders, and no such approval will be sought at the AGM.

 

Your Board believes that the resolutions to be proposed at the AGM are in the best interests of the Company and its shareholders. Accordingly, your directors unanimously recommend that you vote in favour of all resolutions as they intend to do in respect of the shares held by them.

 

Yours sincerely,

Florian Schönharting

Chairman

 

GH Research plc

Joshua Dawson House

19B Dawson Street

Dublin 2 Ireland

D02 RY95

 

NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS TO BE HELD ON 27 JUNE 2024

 

To: All GH Research shareholders

NOTICE is hereby given that the AGM of the Company will be held at 2 pm (Irish Standard Time) on 27 June 2024 at Joshua Dawson House, Dawson Street, Dublin 2, D02 RY95, Ireland.

 

To consider and act upon the following matters:

 

 

 

 

 

 

 

 

Resolutions 1.1 to 1.4 and 2 are ordinary resolutions which require approval of a simple majority of the votes cast in person or by proxy. There is no requirement under Irish law that the Company's Irish statutory financial statements for the financial year ended 31 December 2023, or the directors' and auditor's reports thereon, be approved by the shareholders, and no such approval will be sought at the AGM.

 

 

NOTES:

 

 

Information regarding the AGM is available on the Company’s website https://www.ghres.com and at www.edocumentview.com/GHRS. If you require a paper copy of the 2023 Irish Accounts and 2023 Form 20-F, please refer to the information on the notice or proxy card you received for the meeting.

 

The record date for the AGM is 3 May, 2024.

 

If your shares are registered in your name, you are a shareholder of record. Shareholders of record who are entered in the register of members of the Company on 3 May, 2024 shall be entitled to attend, speak, ask questions and vote at the AGM, or if relevant, any adjournment thereof. Changes in the register of members of the Company after that time will be disregarded in determining the right of any person to attend and/or vote at the Annual General Meeting.

For those shareholders whose shares are not held in their name, but rather in an account at a brokerage firm, bank, dealer or other similar organisation (i.e. in a “street name”), who in turn hold through The Depository Trust Company (DTC), their entitlement to vote is determined as at 3 May, 2024.

 

Depending on whether your shares are registered in your name or whether your shares are held in a “street name” the arrangements are as follows:

 

Shareholder of Record: Shares Registered in Your Name

 

As a shareholder of record, you may vote in person at the AGM or vote by proxy. In the case of joint holders, the vote of the senior member who tenders a vote, whether in person or by proxy, shall be accepted to the exclusion of the votes of the other shareholder of record and, for this purpose, seniority shall be determined by the order in which the names stand in the register of members of the Company in respect of the joint holding. The appointment of a proxy will not preclude a shareholder of record from attending, speaking, asking questions and voting at the AGM should the shareholder subsequently wish to do so. A proxy need not be a member of the Company. If you wish to appoint more than one proxy or a person not listed on the form of proxy, please contact our Company Secretary at Joshua Dawson House, Dawson Street, Dublin 2, D02 RY95, Ireland.

 

A form of proxy is enclosed with this notice of AGM for shareholders of record. To be effective, the form of proxy duly completed and executed, together with any authority under which it is executed, or a certified copy thereof, must be lodged with the Company Secretary at Joshua Dawson House, Dawson Street, Dublin 2, D02 RY95, Ireland, so as to be received by no later than 3 hours before the AGM on 27 June, 2024, or if the AGM is adjourned, 3 hours before the time appointed for the adjourned meeting or (in the case of a poll taken otherwise than at or on the same day as the AGM or adjourned meeting) the day before the taking of the poll at which it is to be used. Any alteration to the form of proxy must be initialled by the person who signs it.

 

Beneficial Owner: Shares Registered in the Name of a Broker, Bank or Other Agent (i.e. in a "Street Name")

 

If, as at 3 May, 2024, your shares were not held in your name, but rather in an account at a brokerage firm, bank, dealer or other similar organisation, who in turn hold through DTC, then you are the beneficial owner of shares held in “street name” and these proxy materials are being forwarded to you by that organisation, together with instructions as to voting.  You will need to carefully follow the instructions from your broker, bank or other agent or contact your broker, bank or other agent if you have any queries.

 

As a beneficial owner, you have the right to direct your broker or other agent on how to vote the shares in your account as per the instructions enclosed by your broker.

 

Therefore as a beneficial owner of shares registered in the name of your broker, bank or other agent, who in turn hold the shares through DTC, you should have received a voting instruction card and voting instructions with these proxy materials from that organisation rather than from us. Simply follow the instructions on the voting instruction card provided by your broker, bank or other agent to ensure that your vote is counted.

 

 

The total number of issued ordinary shares on the record date, 3 May, 2024, was 52,028,145.  Voting on each of the resolutions will be decided on a poll. This means that every shareholder present in person and every proxy shall have one vote for every share of which he is the holder or proxy. Ordinary resolutions are required to be passed by a simple majority of shareholders voting in person or by proxy. Special resolutions are required to be passed by a majority of 75 per cent of shareholders voting in person or by proxy.

 

If your shares are held by a broker on your behalf (that is, in a “street name”), and you do not instruct the broker as to how to vote these shares, the broker may not exercise discretion to vote for or against any of the proposals. This would be a “broker non-vote” and these shares will not be counted as having been voted on the proposals. Please instruct your bank or broker so your vote can be counted.

 

Shareholder of Record: Shares Registered in Your Name

 

Yes. You can revoke your proxy at any time before the final vote at the AGM. If you are the record holder of your shares, you may revoke your proxy in any one of three ways:

 

 

 

 

Beneficial Owner: Shares Registered in the Name of a Broker, Bank or Other Agent (i.e. in a "Street Name")

 

If your shares are held by your broker, bank or other agent, you should follow the instructions provided by them. Please contact your broker, bank or other agent if you have any queries.

 

6.	What does it mean if I receive more than one set of materials?

 

If you receive more than one set of materials, your shares are registered in more than one name or are registered in different accounts. In order to vote all the shares you own, you must sign and return all of the proxy cards or follow the instructions for any alternative voting procedure on each of the proxy cards you receive.

 

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Directors’ Report	2
Statement of Directors’ Responsibilities	93
Independent auditors’ report to the members of GH Research PLC	94
Consolidated Statement of Comprehensive Income	100
Consolidated Statement of Financial Position	101
Consolidated Statement of Changes in Equity	102
Consolidated Statement of Cash Flows	103
Notes to Consolidated Financial Statements	104
Company Statement of Financial Position	123
Company Statement of Changes in Equity	124
Notes to Company Financial Statements	125

•

We are a clinical-stage biopharmaceutical company and we have incurred significant losses since our inception. We expect that we will continue to incur significant losses for the foreseeable future;

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We will need substantial additional funding, which may not be available on acceptable terms, or at all. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product discovery and development programs or commercialization efforts;

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It may take considerable time and expense to resolve the clinical hold that has been placed by the FDA on the study we proposed in our IND for GH001, and no assurance can be given that the FDA will remove the clinical hold, which could have a material adverse effect on our clinical development efforts or could otherwise harm our business, financial condition, results of operation and prospects;

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Drug and drug-device combination product development is a highly uncertain undertaking and involves a substantial degree of risk;

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GH001, GH002 and GH003 are investigational mebufotenin (5-methoxy-N,N-dimethyltryptamine, or 5-MeO-DMT) therapies based on a novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval. To our knowledge, no such therapies have been approved in the United States or the EU for commercialization;

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Developing our proprietary aerosol delivery device for GH001 is a costly and uncertain process, and any failure of, or delay in, the development or manufacturing of the device may have a material adverse effect on our business and results of operations;

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Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome. The outcome of nonclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our currently completed clinical trials, which to date have only been conducted in the Netherlands, and of our ongoing and future clinical trials, may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities;

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Our product candidates or use of our product candidates through participation in our clinical trials, may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences;

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GH001, GH002 and GH003, and any future product candidates we may develop, are subject to controlled substance laws and regulations in the territories where the product will be marketed, such as the United States, the European Union, EU, the United Kingdom or UK, and the rest of Europe, as well as the UN international drug control treaties, and failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, may adversely affect the results of our business operations, both during clinical development and post-approval, and our financial condition. In addition, during the review process of GH001, GH002 and GH003, and prior to approval, the FDA, EMA and/or other comparable foreign regulatory authorities may require additional data, including with respect to whether GH001, GH002 or GH003 has abuse or misuse potential. This may delay approval and any potential rescheduling process;

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Mebufotenin is currently classified as a Schedule I drug in the United States and any product containing this substance, such as GH001, GH002 and GH003, must be rescheduled to be marketed. There can be no assurance that the Drug Enforcement Administration, or DEA, will make a favorable scheduling decision. Even assuming categorization as a Schedule II or lower controlled substance (i.e., Schedule III, IV or V) at the federal level, such substances would also require scheduling determinations under state laws and regulations;

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The potential reclassification of mebufotenin in the United States could create additional regulatory burdens on our operations and negatively affect our results of operations;

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Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, third-party payors and other members of the medical community;

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We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue;

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Our business and commercialization strategy depends on our ability to identify, qualify, prepare, certify, and support third-party clinics or treatment centers offering any of our product candidates, if approved. If we are unable to do so, our commercialization prospects would be limited and our business, financial condition, and results of operations would be harmed;

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We rely on patents, applications for patents and other intellectual property rights to protect our GH001, GH002 and GH003 product candidates, the prosecution, enforcement, defense and maintenance of which may be challenging and costly. Failure to adequately prosecute, maintain, enforce or protect these rights could harm our ability to compete and impair our business;

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We rely on third parties to assist in conducting our nonclinical studies and clinical trials. If they do not perform satisfactorily, we may not be able to initiate new clinical trials, successfully complete clinical trials, obtain regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed;

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The development and manufacture of our active pharmaceutical ingredients, product candidates and medical devices required to deliver such product candidates is complex, and we may encounter difficulties during further development or in production. We currently rely completely on third parties to develop, formulate and manufacture our nonclinical study and clinical trial supplies. The development and commercialization of any of our active pharmaceutical ingredients, product candidates and medical devices required to deliver such product candidates could be stopped, delayed or made less profitable if those third parties fail to provide us with sufficient quantities of such drug supplies or fail to do so at acceptable quality levels, including in accordance with rigorously enforced regulatory requirements or contractual obligations, and our operations could be harmed as a result;

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We depend heavily on our executive officers, principal consultants and others, and the loss of their services would materially harm our business;

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In relation to our Form 20-F which is filed with the U.S. SEC (“Securities and Exchange Commission), we have identified material weaknesses in our internal control over financial reporting in connection with the preparation and review of our financial statements for the years ended December 31, 2022 and 2023 and we may identify additional material weaknesses. If our remediation of these material weaknesses is not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of internal controls in the future, our ability to accurately or timely report our financial condition or results of operations may be adversely affected; and

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We believe that we were a passive foreign investment company, or a PFIC, for our 2023 taxable year, and we anticipate that we will likely be a PFIC in 2024 and potentially also in future years, which could subject U.S. investors in our ordinary shares to significant adverse U.S. federal income tax consequences.

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continue to develop and conduct clinical trials, including in expanded geographies such as the United States, for our GH001, GH002 and GH003 product candidates for our initial indications and any additional indications;

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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, such as our proprietary aerosol delivery device for GH001;

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initiate and continue research and development, including technical, nonclinical, clinical, and discovery efforts for any future product candidates;

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seek to identify additional product candidates;

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seek regulatory approvals for our product candidates GH001, GH002 and GH003, 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;

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progress any nonclinical programs and any other work that may be required to lift the clinical hold imposed by the FDA on the study we proposed in our IND for GH001;

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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;

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hire and retain additional personnel, such as clinical, quality control, scientific, commercial, sales, marketing and administrative personnel;

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continue to prepare, file, prosecute, maintain, protect and enforce our intellectual property rights and claims;

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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;

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comply with ongoing regulatory requirements for products approved for commercial sale, if ever;

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adapt to ongoing changes in global economic conditions, including but not limited to continuing inflation, 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, or increased tensions between China and Taiwan;

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acquire or in-license other product candidates, medical devices to deliver our product candidates, and other technologies; and

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incur increased costs as a result of operating as a public company.

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the scope, progress, results and costs of researching and developing our GH001, GH002 and GH003 product candidates, additional mebufotenin (5-methoxy-N,N-dimethyltryptamine, or 5-MeO-DMT) delivery approaches and the medical devices required to deliver these therapies, such as our proprietary aerosol delivery device for GH001, for our initial and any additional indications as well as other product candidates we may develop;

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the timing and uncertainty of, and the costs involved in, obtaining marketing approvals for our GH001, GH002 and GH003 product candidates including the medical devices required to deliver these therapies for our initial and any additional indications, and other product candidates we may develop and pursue;

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the duration of the clinical hold imposed by the FDA on the study we proposed in our IND for GH001, including the progression of, and associated costs from, any nonclinical programs and any other work necessary to lift the clinical hold, as well as discussions with the FDA and the outcomes and resolution of such discussions;

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the number of future product candidates that we may pursue and their development requirements;

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the number of jurisdictions in which we plan to seek regulatory approvals;

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if approved, the costs of commercialization activities for GH001, GH002 and GH003 for any approved indications, or any other product candidate that receives regulatory approval to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution, and manufacturing capabilities;

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subject to receipt of regulatory approval, revenue, if any, received from commercial sales of GH001, GH002 and GH003 and the respective medical devices for any approved indications or any other product candidates;

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if approved, the establishment and maintenance of coverage and adequate reimbursement from third-party payors for GH001, GH002, GH003, or any other product candidates;

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the extent to which we may in-license or acquire rights to other products, product candidates, medical devices or technologies;

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our headcount growth and associated costs as we expand our research and development, increase our office space, and establish a commercial infrastructure;

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the costs of preparing, filing and prosecuting patent applications and maintaining and protecting our intellectual property rights, including enforcing and defending intellectual property-related claims;

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the effect of competing product and market developments; and

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the ongoing costs of operating as a public company.

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devaluation in U.S. government bond investments held by the Company;

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inability to access capital markets, or increased difficulty in doing so; or

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government shutdown, or reduced operation, of agencies such as the FDA, which could impede our ability to progress our planned IND and/or other U.S. operations.

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completing research and technical, nonclinical and clinical development of our product candidates and the medical devices required to deliver these product candidates, such as our proprietary aerosol delivery device for GH001;

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obtaining regulatory approvals and marketing authorizations for product candidates, including the medical devices required to deliver these product candidates for which we successfully complete clinical development and clinical trials;

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progressing 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;

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developing a sustainable and scalable manufacturing process for our product candidates and the medical devices required to deliver these product candidates, as well as establishing and maintaining commercially viable supply relationships with third parties that can provide adequate products and services to support clinical activities and commercial demand of our product candidates and medical devices;

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identifying, assessing, acquiring and/or developing new product candidates;

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negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;

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successfully getting our product candidates rescheduled under the federal Comprehensive Drug Abuse Prevention and Control Act of 1970, also known as the Controlled Substances Act, or CSA, and comparable state laws by the DEA and other applicable regulatory agencies inside and outside the United States;

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launching and successfully commercializing product candidates and the medical devices required to deliver these product candidates for which we obtain regulatory approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure;

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obtaining and maintaining an adequate price for our product candidates and devices in the countries where our products are commercialized;

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obtaining coverage and adequate reimbursement for our product candidates and medical devices from payors;

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obtaining market acceptance of our product candidates as viable treatment options;

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addressing any competing technological and market developments;

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receiving milestone and other payments under any future collaboration arrangements;

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maintaining, protecting, expanding and enforcing our portfolio of intellectual property rights, including patents, trade secrets and know-how;

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attracting, hiring and retaining qualified personnel; and

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complying with laws and regulations, including laws applicable to controlled substances, data privacy and pre-commercial activities.

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delay or failure in establishing acceptable performance characteristics, quality manufacturing standards and manufacturing capabilities for our product candidates or for the medical devices required to deliver our product candidates;

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negative or inconclusive results from our nonclinical studies or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional nonclinical testing or clinical trials or abandon a program;

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product or device-related side effects experienced by subjects in our clinical trials or by individuals using drugs or therapeutics similar to our product candidates;

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delays in submitting INDs (or IDEs, if applicable) in the United States or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators or institutional review boards, or IRBs, to commence a clinical trial, including Schedule I research protocols required by the DEA, or a suspension or termination of a clinical trial once commenced;

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if the FDA, EMA or other comparable foreign regulatory authorities do not find the earlier technical, nonclinical and clinical trial work sufficient, then we may need to conduct additional technical development work or nonclinical or clinical trials beyond what we had previously planned. For example, our previously completed nonclinical data and device design verification information submitted with our GH001 IND was deemed by the FDA to contain insufficient information to assess risks to human subjects, and the FDA therefore requested additional nonclinical toxicology studies and other work (including acceptable device design verification information) before the FDA may lift the clinical hold and allow us to initiate clinical studies in the United States, such as the study we proposed in our IND for GH001. Any significant technical development, nonclinical or clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our drug candidates and medical devices or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our drug candidates and medical devices and may harm our business and results of operations;

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conditions imposed by the FDA, EMA or other comparable foreign regulatory authorities regarding the scope or design of our clinical trials;

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the FDA, EMA or other comparable foreign regulatory authorities may disagree with our clinical trial design, including with respect to dosing levels administered in our planned clinical trials, or the medical devices used to deliver our product candidates in the clinical trials, which may delay or prevent us from initiating our clinical trials with our originally intended trial design and the originally planned medical devices;

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delays in contracting with clinical trial sites or enrolling subjects in clinical trials, the inability to identify clinical trial sites willing to host our clinical trials and the required scheduled drug DEA researcher registration and Schedule I research protocol in the United States and similar licenses in other jurisdictions to be obtained and maintained by our clinical investigators;

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delays or interruptions in the supply of materials necessary for the conduct of our clinical trials;

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regulators, IRBs or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

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the FDA has in relation to our clinical hold required, and it or the EMA or other comparable foreign regulatory authorities may in the future require us to submit additional data such as long-term toxicology studies, additional device design verification information or additional data for our product candidates or the medical devices required to deliver our product candidates;

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delays in reaching, or failure to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

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the number of subjects required for clinical trials of any product candidates may be larger than we anticipate, or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate;

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our third-party contractors for nonclinical studies or clinical trials may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or take actions that could cause clinical trial sites or clinical investigators to drop out of the trial, which may require that we add new clinical trial sites or investigators;

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due to the impact of a pandemic, such as the COVID-19 pandemic, epidemic, outbreak of an infectious disease or a similar event, we may experience some delays and interruptions to our technical development efforts, nonclinical studies, clinical trials and/or regulatory approvals, we may experience delays or interruptions to our manufacturing supply chain, or we could suffer delays in reaching, or we may fail to reach, agreement on acceptable terms with third-party service providers on whom we rely;

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greater-than-anticipated clinical trial costs, including as a result of delays or interruptions that could increase the overall costs to finish our clinical trials as our fixed costs are not substantially reduced during delays;

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we may elect to, or regulators, IRBs, Data Safety Monitoring Boards, or DSMBs, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including non-compliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

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we may not have the financial resources available to begin and complete the planned trials, or the cost of clinical trials of any product candidates may be greater than we anticipate;

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the supply or quality of our product candidates, medical devices required to deliver our product candidates, or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate to initiate or complete a given clinical trial;

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inability to compete with other therapies;

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poor efficacy of our product candidates during clinical trials;

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failure to demonstrate an acceptable benefit/risk profile for our product candidates;

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inability to provide sufficient design, testing, manufacturing and quality information for the medical devices required to deliver our product candidates, including information to support their use and compatibility with the drug constituent of our product candidates;

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unfavorable FDA, EMA or other comparable foreign regulatory authority inspection and review of clinical trial sites or manufacturing facilities;

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if the DEA, or any state or other jurisdiction, delays rescheduling or fails to reschedule mebufotenin (5-methoxy-N,N-dimethyltryptamine, or 5-MeO-DMT) to Schedule II, III, IV or V, or delays classifying or fails to classify our product candidates to Schedule II, III, IV or V;

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unfavorable product labeling associated with any product approvals and any requirements for a Risk Evaluation and Mitigation Strategy, or REMS, that may be required by the FDA or comparable requirements in other jurisdictions to ensure the benefits of an individual product outweigh its risks;

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unfavorable acceptance of our product candidates or clinical trial data by the patient or medical communities or third-party payors;

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failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;

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delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular; or

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varying interpretations of data by the FDA, EMA or other comparable foreign regulatory authorities.

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nonclinical studies or clinical trials may show the product candidates to be ineffective or less effective than expected (e.g., a clinical trial could fail to meet its primary endpoint(s)) or to have unacceptable side effects or toxicities;

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failure to reflect similarly efficacious activity in subsequent clinical trials with larger patient populations;

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failure to use clinical endpoints that applicable regulatory authorities would consider clinically meaningful;

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manufacturing issues or formulation issues with the product candidate or device that cannot be resolved;

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failure to receive the necessary regulatory approvals;

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manufacturing issues, formulation issues, pricing or reimbursement issues or other factors that make a product candidate or device uneconomical; and

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intellectual property and proprietary rights of others and their competing products and technologies that may prevent one of our product candidates from being commercialized.

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regulatory authorities may withdraw or limit their approval of such product candidates or medical devices;

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regulatory authorities may require the addition of labeling statements, such as a “Boxed Warning” or contraindications;

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we may be required to change the way such product candidates are distributed or administered, or change the labeling of the product candidates or medical devices;

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the FDA may require a REMS to mitigate risks, which could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools, and regulatory authorities in other jurisdictions may require comparable risk mitigation plans;

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we may be subject to regulatory investigations and government enforcement actions;

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the FDA, EMA or a comparable foreign regulatory authority may require us to conduct additional technical development work or clinical trials or costly post-marketing testing and surveillance to establish and monitor the safety and efficacy of the product;

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we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates or operating our medical devices; and

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our reputation may suffer.

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the patient eligibility criteria defined in the protocol;

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the size of the patient population required for analysis of the trial’s primary endpoints;

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in the case of clinical trials focused on rare disease, the small size of the patient population and the potential of a patient being undiagnosed or misdiagnosed;

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the proximity of patients to trial sites;

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the design of the trial;

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our ability to recruit clinical trial investigators with the appropriate competencies and experience;

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competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications that we are investigating;

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reluctance of physicians to encourage patient participation in clinical trials;

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our ability to obtain and maintain patient consents; and

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the risk that patients enrolled in clinical trials will drop out of the trials before completion.

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our inability to design such product candidates with the pharmacological or pharmacokinetic properties that we desire; or

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potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be medicines that will receive marketing approval and achieve market acceptance.

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decreased demand for any of our future approved products;

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injury to our reputation;

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initiation of investigations by regulators;

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withdrawal of clinical trial participants;

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termination of clinical trial sites or entire trial programs;

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significant litigation costs;

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substantial monetary awards to, or costly settlements with, patients or other claimants;

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product recalls or a change in the indications for which any approved drug products may be used;

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loss of revenue;

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diversion of management and scientific resources from our business operations; and

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the inability to commercialize our product candidates.

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greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization of products;

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more extensive experience in nonclinical studies, conducting clinical trials, obtaining regulatory approvals, and in manufacturing, marketing and selling drug products;

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more developed intellectual property portfolios;

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products that have been approved or are in late stages of development; and

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collaborative arrangements in our target markets with leading companies and research institutions.

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DEA registration and inspection of facilities. Facilities conducting research, manufacturing, distributing, importing or exporting, or dispensing controlled substances must be registered (licensed) to perform these activities and have the security, control, record keeping, reporting and inventory mechanisms required by the DEA to prevent drug loss and diversion. All these facilities must renew their registrations annually, except dispensing facilities (e.g. pharmacies), which must renew every three years. The DEA conducts periodic inspections of certain registered establishments that handle controlled substances. Failure to obtain or maintain the necessary registrations may result in delay of the importation, manufacturing or distribution of GH001, GH002 or GH003. Furthermore, importation of controlled substances is subject to additional permits or approvals, which must be obtained prior to each importation. Failure to comply with the CSA, particularly non-compliance resulting in theft, loss or diversion, can result in regulatory action that would have a material adverse effect on our business, financial condition and results of operations. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to restrict, suspend or revoke those registrations. In certain circumstances, violations could lead to criminal proceedings.

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State-controlled substances laws. Individual U.S. states have also established controlled substance laws and regulations. Though state-controlled substances laws often mirror federal law, because the states are separate jurisdictions, they will need to separately reschedule GH001, GH002 or GH003. While some states automatically schedule or reschedule a drug based on federal action, other states schedule drugs through rule making or a legislative action. State scheduling may delay commercial sale of any product for which we obtain federal regulatory approval and adverse scheduling would have a material adverse effect on the commercial attractiveness of such product. We or our partners must also obtain separate state registrations, permits or licenses in order to be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.

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Clinical trials. Because our GH001, GH002 and GH003 product candidates contain mebufotenin, to conduct clinical trials with GH001, GH002 and GH003 in the United States prior to approval, each of our research sites must submit a research protocol to the DEA and obtain and maintain a DEA Schedule I researcher registration that will allow those sites to handle and dispense GH001, GH002 and GH003 and to obtain the product from our importer. If the DEA delays or denies the grant of a researcher registration or approval of the research protocol to one or more research sites, the clinical trial could be significantly delayed, and we could lose clinical trial sites. The importer for the clinical trials must also obtain a Schedule I importer registration and an import permit for each import. We do not currently conduct any manufacturing or repackaging/relabeling of either GH001, GH002 or their active ingredients (i.e., mebufotenin) in the United States.

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Post-Approval Importation. If GH001, GH002 or GH003 is approved and classified as a Schedule II, III or IV substance, an importer can import it for commercial purposes if it obtains an importer registration and applies for and receives an import permit (Schedule II) or files an import declaration (Schedule III or IV) for each import shipment. The DEA provides annual assessments/estimates to the UN International Narcotics Control Board, which guides the DEA in the amounts of controlled substances that the DEA authorizes to be imported. The failure to identify an importer or obtain the necessary import authority, including specific quantities, could affect the availability of GH001, GH002 or GH003 and have a material adverse effect on our business, results of operations and financial condition. In addition, an application for a Schedule II importer registration must be published in the Federal Register, and there is a notice and comment period to receive public comments. It is always possible that adverse comments may delay the grant of an importer registration. If GH001, GH002 or GH003 is approved and classified as a Schedule II controlled substance, federal law may prohibit the import of the substance for commercial purposes. If GH001, GH002 or GH003 is listed as a Schedule II substance, we will not be allowed to import the drug for commercial purposes unless the DEA determines that domestic supplies are inadequate or there is inadequate domestic competition among domestic manufacturers for the substance as defined by the DEA. Moreover, Schedule I controlled substances, including mebufotenin, have never been registered with the DEA for importation for commercial purposes, only for scientific and research needs. Therefore, if neither GH001, GH002 or GH003, nor its drug substance could be imported, GH001, GH002 and GH003 would have to be wholly manufactured in the United States, and we would need to secure a manufacturer that would be required to obtain and maintain a separate DEA registration for that activity.

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Manufacture in the United States. If, because of a Schedule II (and possibly Schedule III) classification or voluntarily, we were to conduct manufacturing or repackaging/relabeling in the United States for commercial purposes, mebufotenin will be subject to an annual aggregate production quote established by the DEA and our contract manufacturers would be subject to the DEA’s annual and quarterly manufacturing and procurement quota requirements. Additionally, regardless of the scheduling of GH001, GH002 or GH003, the active ingredient in the final dosage form is currently a Schedule I controlled substance and would be subject to such quotas as this substance could remain listed on Schedule I during the clinical trials. The annual and quarterly quota allocated to us or our contract manufacturers for the active ingredient in GH001, GH002 or GH003 may not be sufficient to complete clinical trials or meet commercial demand. Consequently, any delay or refusal by the DEA in establishing our, or our contract manufacturers’, procurement and/or production quota for controlled substances could delay or stop our clinical trials or product launches, which would have a material adverse effect on our business, financial position and results of operations.

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Distribution in the United States and the UK. If GH001, GH002 or GH003 is scheduled as Schedule II, III, IV or V, we would also need to identify wholesale distributors with the appropriate DEA registrations and authority to distribute GH001, GH002, GH003 and any future product candidates. These distributors would need to maintain Schedule II, III, IV or V distribution registrations. This limitation in the ability to distribute GH001, GH002 or GH003 more broadly may limit commercial uptake and could negatively impact our prospects. The failure to obtain, or delay in obtaining, or the loss of any of those registrations could result in increased costs to us. If GH001, GH002 or GH003 is classified as a Schedule II drug, participants in our supply chain may have to maintain enhanced security including specially constructed vaults at manufacturing and distribution facilities. This additional security may also discourage some pharmacies from carrying the product. In addition, GH001, GH002 and/or GH003 could be required to be administered at our trial sites or other certified healthcare settings, which could limit commercial uptake. Furthermore, state and federal enforcement actions, regulatory requirements, and legislation intended to reduce prescription drug abuse, such as the tracking of prescribing and dispensing of controlled substances through a state prescription drug monitoring program, may make physicians less willing to prescribe, and pharmacies to dispense, certain controlled substances, especially Schedule II products. Similarly, the Medicines and Healthcare products Regulatory Agency, or MHRA, considers that all Schedule 1 drugs under the UK’s Misuse of Drugs Regulations 2001 (which Schedule includes mebufotenin) have no therapeutic benefit, and can only be imported, exported, produced, supplied, possessed and the like under a license issued by the UK government’s Home Office. Mebufotenin may never be rescheduled under the Misuse of Drugs Regulations 2001, or reclassified under the UK’s Misuse of Drugs Act 1971 (under which it is a Class A controlled substance).

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restrictions on the manufacturing of our products, the approved manufacturers or the manufacturing process;

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withdrawal of the product from the market or voluntary product recalls;

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requirements to conduct post-marketing studies or clinical trials;

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fines, restitution or disgorgement of profits or revenues;

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warning or untitled letters from the FDA or comparable notice of violations from comparable foreign regulatory authorities;

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suspensions of any of our ongoing clinical trials;

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refusal by the FDA or other comparable foreign regulatory authorities to approve pending applications or supplements to approved applications filed by us or suspension or withdrawal of marketing approvals;

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product seizure or detention or refusal to permit the import or export of products; and

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consent decrees, injunctions or the imposition of civil or criminal penalties.

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efficacy and potential advantages compared to alternative treatments;

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the ability to offer our products, if approved, for sale at competitive prices;

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relative convenience and ease of administration compared to alternative treatments;

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perceptions by the medical community, physicians, and patients, regarding the safety and effectiveness of our products and the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

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the size of the market for such product candidate, based on the size of the patient subsets that we are targeting, in the territories for which we gain regulatory approval;

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the recommendations with respect to our product candidates in guidelines published by various scientific organizations applicable to us and our product candidates;

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the strength of sales, marketing and distribution support;

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the timing of any such marketing approval in relation to other product approvals;

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any restrictions on concomitant use of other medications;

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support from patient advocacy groups;

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media coverage regarding psychedelic substances;

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the ability to obtain sufficient third-party coverage and adequate reimbursement from government and third-party payors; and

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the prevalence and severity of any side effects.

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a covered benefit under its health plan;

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safe, effective and medically necessary;

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appropriate for the specific patient;

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cost-effective; and

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neither experimental nor investigational.

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in the EU, member states can restrict the range of medicinal products for which their national health insurance systems provide reimbursement and, in most EU countries, the prices of medicinal products for human use must be approved by national health authorities, before they may be supplied;

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a common criterion relied upon by almost all EU Member States for pricing decisions is international reference pricing (the methodology and weight to be attached varies between countries), whereas in the UK, international reference pricing is not a criterion relied upon formally for pricing decisions;

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in the UK and many EU member states, prices of branded medicines must be notified or approved prior to product launch;

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reimbursement decisions in EU/European Economic Area, or EEA, and the UK are typically based on various forms of health technology assessment, including cost effectiveness determinations. From 2025, the EU’s Health Technology Assessment Regulation (Regulation (EU) 2021/2282), or HTA Regulation, will start to come into effect providing for a common assessment of clinical effectiveness to be taken into account by national reimbursement authorities across EU/EEA. This will not have direct effect in the UK, but may in practice be influential; and

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additionally public procurement tenders are widely used for purchasing of medicinal products by hospitals.

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the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual, or the purchase, lease, order, arrangement or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. The term remuneration has been interpreted broadly to include anything of value. Further, courts have found that if “one purpose” of remuneration is to induce referrals, the federal Anti-Kickback Statute is violated. Violations are subject to significant civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment and exclusion from government healthcare programs. In addition, a claim submitted for payment to any federal healthcare program that includes items or services that were made as a result of a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims act, or the FCA. The Anti-Kickback Statute has been interpreted to apply to arrangements between biopharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers, among others, on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but they are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor;

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the federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using or causing to be made or used, a false record or statement material to a false, fictitious or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. A claim that includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the FCA. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery or settlement. When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA fraud provisions without actual knowledge of the statute or specific intent to violate it;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose, among other things, certain requirements relating to the privacy, security and transmission of individually identifiable health information on certain covered healthcare providers, health plans and healthcare clearinghouses, known as covered entities, as well as their respective “business associates,” those independent contractors or agents of covered entities that create, receive, maintain, transmit or obtain protected health information in connection with providing a service on behalf of a covered entity as well as their covered subcontractors. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, there may be additional federal, state and non-U.S. laws which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

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the federal Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or, collectively, the ACA, and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician providers, including physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives, and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members;

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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and

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analogous U.S. state, local and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers, and may be broader in scope than their federal equivalents; state and foreign laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and other relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing; state and local laws that require the registration of biopharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health and other personal information, some of which may be more stringent than those in the United States (such as the EU’s General Data Protection Regulation (Regulation (EU) 2016/679), or GDPR, which became effective in May 2018, or the UK’s General Data Protection Regulation, or UK GDPR) in certain circumstances, and may differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

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strengthens the rules on placing medical devices on the market and reinforce surveillance once they are available;

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establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of medical devices placed on the market;

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improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

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sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and

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strengthens rules for the assessment of certain high-risk medical devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

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2026 for class III custom made devices;

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2027 for class III and class IIb implantable devices;

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2028 for other class IIb, class IIa and class Is, Im devices; and

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2028 for class I up classified devices.

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for the period beginning on January 31, 2022 and ending on January 31, 2023, all clinical trial applications could be made either under the Clinical Trials Directive or under the CTR;

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from January 31, 2023, all initial clinical trial applications must be submitted under the CTR alone; and

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from January 31, 2023 to January 31, 2025, ongoing clinical trials authorized under the Clinical Trials Directive can remain under the Clinical Trials Directive or can transition to the CTR. However, as of January 31, 2023, no new national clinical trial applications can be submitted under the Clinical Trials Directive 2001/20/EC. Consequently, if the sponsor chose to submit the clinical trial application under the Clinical Trials Directive during the one-year transition period which ended on January 31, 2023, a new EU member state can only be added to the clinical trial after January 31, 2023 once the entire clinical trial has been transferred to CTIS. Further, substantial amendments to trials authorized under the Clinical Trials Directive are permitted until January 31, 2025; and by January 31, 2025, all ongoing clinical trials will be required to have transitioned to the CTR.

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others may be able to make compositions that are the same as or similar to GH001, GH002, GH003, and any future product candidate compositions, or may be able to make medical devices to deliver such compositions, that are not covered by the claims of the patents that we own or license;

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the patents of third parties may have an adverse effect on our business;

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we or our licensors or collaboration partners might not have been the first to conceive or reduce to practice the inventions covered by the issued patent or pending patent application that we own or license;

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we or our licensors or collaboration partners might not have been the first to file patent applications covering certain of our or their inventions;

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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing, misappropriating or otherwise violating our intellectual property rights;

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it is possible that current and future pending patent applications we own or in-license will not lead to issued patents;

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issued patents that we own or in-license may not provide us with any competitive advantage, or may be held invalid or unenforceable as a result of legal challenges by third parties;

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issued patents that we own or in-license may not have sufficient term or geographic scope to provide meaningful protection;

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our competitors might conduct research and development activities in countries that provide a safe harbor from patent infringement claims for certain research and development activities or in countries where we do not have patent rights and then use the information learned from such activities to develop competitive therapies for sale in our major commercial markets;

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third parties performing manufacturing or testing for us using our therapies or technologies could use the intellectual property of others without obtaining a proper license;

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we may not develop additional technologies that are patentable; and

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we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property, or otherwise develop similar know-how.

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the scope of rights granted under the agreement and other interpretation-related issues;

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whether and the extent to which our technology and processes infringe, misappropriate or otherwise violate intellectual property of the licensor or collaboration partner that is not subject to the agreement;

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the sublicensing of patents and other rights under any current or future collaboration relationships;

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our diligence obligations under the agreement and what activities satisfy those diligence obligations;

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our rights to transfer or assign the agreement;

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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaboration partners; and

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the priority of invention of patented technology.

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collaborators generally have significant discretion in determining the amount and timing of efforts and resources that they will apply to these collaborations;

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collaborators may not properly obtain, maintain, enforce or defend intellectual property or proprietary rights relating to our product candidates or research programs, or may use our proprietary information in such a way as to expose us to potential litigation or other intellectual property-related proceedings, including proceedings challenging the scope, ownership, validity and enforceability of our intellectual property;

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collaborators may own or co-own intellectual property covering our product candidates or research programs that results from our collaboration with them, and in such cases, we may not have the exclusive right to commercialize such intellectual property or such product candidates or research programs;

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we may need the cooperation of our collaborators to enforce or defend any intellectual property we contribute to or that arises out of our collaborations, which may not be provided to us;

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collaborators may control certain interactions with regulatory authorities, which may impact our ability to obtain and maintain regulatory approval of our product candidates;

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disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or research programs or that result in costly litigation or arbitration that diverts management attention and resources;

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collaborators may decide to not pursue development and commercialization of any product candidates we develop or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities;

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collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates or research programs if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

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collaborators may restrict us from researching, developing or commercializing certain products or technologies without their involvement;

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collaborators with marketing and distribution rights to one or more product candidates may not commit sufficient resources to the marketing and distribution of such product candidates;

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we may lose certain valuable rights under circumstances identified in our collaborations, including if we undergo a change of control;

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collaborators may grant sublicenses to our technology or product candidates or undergo a change of control and the sublicensees or new owners may decide to take the collaboration in a direction which is not in our best interest;

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collaborators may become bankrupt, which may significantly delay our research or development programs, or may cause us to lose access to valuable technology, know-how or intellectual property of the collaborator relating to our products, product candidates or research programs;

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key personnel at our collaborators may leave, which could negatively impact our ability to productively work with our collaborators;

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collaborations may require us to incur short and long-term expenditures, issue securities that dilute our shareholders or disrupt our management and business;

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if our collaborators do not satisfy their obligations under our agreements with them, or if they terminate our collaborations with them, we may not be able to develop or commercialize product candidates as planned;

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collaborations may require us to share in development and commercialization costs pursuant to budgets that we do not fully control and our failure to share in such costs could have a detrimental impact on the collaboration or our ability to share in revenue generated under the collaboration;

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collaborations may be terminated in their entirety or with respect to certain product candidates or technologies and, if so terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates or technologies; and

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collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If a present or future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our development or commercialization program under such collaboration could be delayed, diminished or terminated.

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regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities;

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manufacturing standards;

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federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable foreign regulatory authorities; and

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laws that require the accurate reporting of financial information or data.

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economic weakness, including inflation, or political instability in particular in foreign economies and markets;

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differing and changing regulatory requirements, price controls and reimbursement regimes;

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potentially reduced protection for our intellectual property rights;

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difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations;

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changes in regulations and customs, tariffs and trade barriers;

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changes in currency exchange rates and currency controls;

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changes in a specific country’s or region’s political or economic environment;

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trade protection measures, import or export licensing requirements or other restrictive actions by governments;

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negative consequences from changes in, including the interpretation of, tax laws;

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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

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workforce uncertainty in countries where labor unrest is more common than in the United States and the EEA;

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difficulties associated with staffing and managing international operations, including differing labor relations;

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business interruptions resulting from geo-political actions, including war and terrorism, natural disasters including earthquakes, typhoons, floods and fires, or pandemics such as the COVID-19 pandemic, epidemics, outbreaks of an infectious disease or similar events; and

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cyber-attacks, which are growing in frequency, sophistication and intensity, and are becoming increasingly difficult to detect.

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positive or negative results of testing and clinical trials by us, strategic partners or competitors;

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a failure to lift, or significant delay in lifting, the clinical hold on the study we proposed in our IND for GH001, or other adverse developments related to regulatory approvals of our product candidates;

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delays in entering into strategic relationships with respect to development or commercialization of our GH001, GH002 and GH003 product candidates or any future product candidates;

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entry into strategic relationships on terms that are not deemed to be favorable to us;

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technological innovations or commercial therapeutic introductions by competitors;

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changes in government regulations and healthcare payment systems;

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developments concerning proprietary rights, including patent and litigation matters;

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public concern relating to the commercial value or safety of any of our GH001, GH002 and GH003 product candidates or any future product candidates;

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negative publicity or public perception of the use of mebufotenin (5-methoxy-N,N-dimethyltryptamine, or 5-MeO-DMT) as a medical treatment;

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financing or other corporate transactions, or the failure to obtain financing or enter into other corporate transactions;

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publication of research reports or comments by securities or industry analysts;

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the trading volume of our ordinary shares on the Nasdaq Global Market (referred to herein as Nasdaq);

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sales of our ordinary shares by us, members of our senior management and directors or our shareholders or the anticipation that such sales may occur in the future;

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general market conditions in the pharmaceutical industry or in the economy as a whole;

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general economic, political, and market conditions and overall market volatility in the United States, the UK or the EU as a result of pandemics or similar events; and

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other events and factors, many of which are beyond our control.

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the majority independent director requirement under Nasdaq listing rules;

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the requirement under Nasdaq listing rules that a compensation committee composed solely of independent directors governed by a compensation committee charter oversee executive compensation;

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the requirement under Nasdaq listing rules that director nominees be selected or recommended for selection by either a majority of the independent directors or a nominations committee composed solely of independent directors;

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the requirement under Nasdaq listing rules that a quorum must consist of at least 331/3% of the outstanding shares of a listed company’s common voting stock; and

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the requirement under Nasdaq listing rules that the independent directors have regularly scheduled meetings with only the independent directors present.

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that it did not have jurisdiction;

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that it was not the appropriate forum for such proceedings;

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that, applying Irish conflict of law rules, U.S. law (including U.S. securities laws) did not apply to the relationship between you and us or our directors and officers; or

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that the U.S. securities laws were of a penal nature and violated Irish public policy and should not be enforced by the Irish court.

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U.S. courts must have had jurisdiction in relation to the particular defendant according to Irish conflict of law rules (the submission to jurisdiction by the defendant would satisfy this rule); and

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the judgment must be final and conclusive and the decree must be final and unalterable in the court which pronounces it.

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the judgment is not for a definite sum of money;

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the judgment was obtained by fraud;

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the enforcement of the judgment in Ireland would be contrary to natural or constitutional justice;

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the judgment is contrary to Irish public policy or involves certain U.S. laws which will not be enforced in Ireland; or

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jurisdiction cannot be obtained by the Irish courts over the judgment debtors in the enforcement proceedings by personal service in Ireland or outside Ireland under Order 11 of the Irish Superior Courts Rules.

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impose advance notice requirements for shareholder proposals and director nominations to be considered at annual shareholder meetings; and

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require the approval of 75% of the voting power of our shares entitled to vote at a general meeting of shareholders to amend or repeal any provisions of our Constitution.

•

design and maintain formal accounting policies, procedures and controls over the fair presentation of our financial statements; and

•

design and maintain controls over the preparation and review of account reconciliations, journal entries and financial statements, including maintaining appropriate segregation of duties and controls over information technology systems.

	Name	Position
	Florian Schönharting (2)(3)	Chairman and Director
	Michael Forer (1)(2)(3)	Vice Chairman and Director
	Dermot Hanley (1)	Director
	Duncan Moore (1)	Director
	Magnus Halle	Company Secretary

(1)

Member of Audit Committee

(2)

Member of Remuneration Committee

(3)

Member of Nominating and Corporate Governance Committee

	Name	Number of Ordinary Shares Beneficially Owned		Percentage of Ordinary Shares Beneficially Owned
	Florian Schönharting	14,824,419		28.5%

•

So far as the director is aware, there is no relevant audit information of which the Company’s statutory auditor is unaware; and

•

The directors have taken all steps that ought to have been taken as a director in order to be aware of any relevant audit information and to establish that the Company’s statutory auditor is aware of that information.

•

A compliance policy statement has been drawn up setting out the Group’s policies that in their opinion are appropriate with regard to such compliance;

•

Appropriate arrangements and structures have been put in place that, in their opinion, are designed to provide reasonable assurance of compliance in all material respects with those relevant obligations; and

•

A review had been conducted, during the financial year, of those arrangements and structures.

On Behalf of the Board
Dermot Hanley		Duncan Moore
Director		Director
Date: May 6, 2024

•

select suitable accounting policies and then apply them consistently;

•

make judgments and estimates that are reasonable and prudent;

•

state whether the financial statements have been prepared in accordance with applicable accounting standards and identify the standards in question, subject to any material departures from those standards being disclosed and explained in the notes to the financial statements; and

•

prepare the financial statements on the going concern basis unless it is inappropriate to presume that the Company will continue in business.

•

correctly record and explain the transactions of the Group and Company;

•

enable, at any time, the assets, liabilities, financial position and profit and loss of the Group and Company to be determined with reasonable accuracy; and

•

enable the directors to ensure that the financial statements comply with the Companies Act and enable those financial statements to be audited.

On behalf of the Board
Dermot Hanley	Duncan Moore
Director	Director

∙

GH Research PLC’s consolidated financial statements and company financial statements (the “financial statements”) give a true and fair view of the group’s and the company’s assets, liabilities and financial position as at 31 December 2023 and of the group’s loss and cash flows for the year then ended;

∙

the consolidated financial statements have been properly prepared in accordance with International Financial Reporting Standards (“IFRSs”) as adopted by the European Union;

∙

the company financial statements have been properly prepared in accordance with Generally Accepted Accounting Practice in Ireland (accounting standards issued by the Financial Reporting Council of the UK, including Financial Reporting Standard 102 “The Financial Reporting Standard applicable in the UK and Republic of Ireland” and Irish law); and

∙

the financial statements have been properly prepared in accordance with the requirements of the Companies Act 2014.

∙

the Consolidated Statement of Financial Position as at 31 December 2023;

∙

the Company Statement of Financial Position as at 31 December 2023;

∙

the Consolidated Statement of Comprehensive Income for the year then ended;

∙

the Consolidated Statement of Cash Flows for the year then ended;

∙

the Consolidated Statement of Changes in Equity for the year then ended;

∙

the Company Statement of Changes in Equity for the year then ended; and

∙

the notes to the financial statements, which include a description of the accounting policies.

Overall materiality ∙          c. $400,000 (2022: $280,000) - Consolidated financial statements ∙          Based on c. 1% of total expenses. ∙          $2,800,000 (2022: $2,800,000) - Company financial statements ∙          Based on c. 1% of total assets. Performance materiality ∙          $260,000 (2022: $182,000) - Consolidated financial statements. ∙          $1,820,000 (2022: $1,820,000) - Company financial statements. ∙

		Audit scope ∙          The consolidated financial statements are a consolidation of the operating subsidiary and the Company. We performed a full scope audit of the Group inclusive of the Company and the subsidiary based on our materiality levels.
		Key audit matter ∙          Share-based compensation awards.

	Key audit matter		How our audit addressed the key audit matter
	Share-based compensation awards Refer to note 2 “Basis of preparation, significant judgements, and accounting policies - Use of estimates and judgements, - Share-based compensation expense” and note 18 “Share-based compensation”.   Share option charge for the financial year ended 31 December 2023 was $2.3 million. The fair value is determined on the date of the grant by using a Black-Scholes pricing model based on verifiable market data (i.e. grant date price), contractual inputs (i.e. exercise price) as well as using assumptions to determine the risk-free rate and expected volatility, which is determined by median values observed among other comparable public companies.   Share options are subject to service conditions and are expensed over the relevant service period for each vesting tranche.   The awards approved by the Remuneration Committee include  bespoke terms in relation to service conditions and the Remuneration Committee has discretion in setting the exercise price within the terms of the Company’s Share Option Plan.   We determined shared-based compensation awards to be a key audit matter due to the variability of both observable and unobservable model inputs required to estimate the fair value of the awards resulting from multiple bespoke conditions in awards granted.		We read the underlying Share Option Plan, all Remuneration Committee meeting minutes from 1 January 2023 through the date of our report, and all 2023 granted award letters to understand the contractual arrangements applicable to the respective awards granted.   We recalculated the fair value of all 2023 awards using a  Black-Scholes model and agreed the model inputs to market data and award letters, which detail all specific terms associated with each grant. In assessing the appropriateness of the risk-free rate and  volatility assumptions, we involved PwC professionals with specialised skills and knowledge in valuation practices. We recalculated the expense attributable to the share based awards for the financial year ending 31 December 2023. Our recalculation was tailored for the specific terms detailed in the award letters.   Based on the procedures set out above, no material exceptions were noted.   We also assessed the appropriateness of the related disclosures in the financial statements.

			Consolidated financial statements		Company financial statements
	Overall materiality		$400,000 (2022: $280,000).		$2,800,000 (2022: $2,800,000).
	How we determined it		c. 1% of total expenses.		c. 1% of total assets.
	Rationale for benchmark applied		The Company does not earn any revenues and is currently loss making. Total expenses is considered to be the most suitable benchmark given the user focus on overall spend.		Total assets is considered as the primary measure used by the shareholders in assessing the performance of the entity. We have used the lower overall group audit materiality on balances and transactions that do not eliminate on consolidation.

∙

Obtaining management’s going concern assessment for the going concern period of  at least twelve months from the date on which the financial statements are authorised for issue;

∙

Understanding the process undertaken by management in performing the going concern assessment;

∙

Assessing the key assumptions underpinning the group’s cash flow forecasts;

∙

Assessing the current liquidity position and financial condition of the group by reference to the level of cash and cash equivalents as further explained in note 2 to the consolidated financial statements.

∙

In our opinion, based on the work undertaken in the course of the audit, the information given in the Directors’ Report for the year ended 31 December 2023 is consistent with the financial statements and has been prepared in accordance with the applicable legal requirements.

∙

Based on our knowledge and understanding of the group and company and their environment obtained in the course of the audit, we have not identified any material misstatements in the Directors’ Report.

∙

Inquiries with the Audit Committee, internal audit, and senior management, including consideration of known or suspected instances of non-compliance with laws and regulations and fraud;

∙

Reading the meeting minutes of the Board of Directors, the Audit Committee, and the Remuneration Committee;

∙

Evaluating whether there was evidence of management bias in accounting estimates that represents a risk of material misstatement due to fraud;

∙

Identifying and testing journal entries based on our risk assessment

∙

Designing audit procedures to incorporate elements of unpredictability.

∙

We have obtained all the information and explanations which we consider necessary for the purposes of our audit.

∙

In our opinion the accounting records of the company were sufficient to permit the company financial statements to be readily and properly audited.

∙

The Company Statement of Financial Position is in agreement with the accounting records.

						Year ended December 31,
							2023				2022
		Note					$’000				$’000
Operating expenses
Research and development			3				(29,821	)			(20,484	)
General and administration			3				(11,401	)			(10,070	)
Loss from operations							(41,222	)			(30,554	)
Finance income			6				8,978				1,166
Finance expense			6				(723	)			(123	)
Movement of expected credit loss			11				1				(121	)
Foreign exchange (loss)/gain			19				(2,621	)			7,176
Total other income							5,635				8,098
Loss before tax							(35,587	)			(22,456	)
Tax charge/(credit)			7				-				-
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			11				(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)			21				(0.68	)			(0.43	)

On behalf of the Board
Dermot Hanley	Duncan Moore
Director	Director

						At December 31,
							2023				2022
		Note					$’000				$’000
ASSETS
Non-current assets
Marketable securities			11				61,142				85,724
Property, plant and equipment			12				1,069				97
Total non-current assets							62,211				85,821
Current assets
Cash and cash equivalents			9				78,420				165,955
Other financial assets			9				55,615				-
Marketable securities			11				27,525				-
Other current assets			10				2,529				2,586
Total current assets							164,089				168,541
Total assets							226,300				254,362
LIABILITIES AND EQUITY
Non-current liabilities
Lease liability			15				631				-
Total non-current liabilities							631				-
Current liabilities
Trade payables			13				3,490				1,868
Lease liability			15				343				-
Other current liabilities			14				2,868				2,678
Total current liabilities							6,701				4,546
Total liabilities							7,332				4,546
Equity attributable to owners
Share capital			16				1,301				1,301
Share premium			16				304,426				304,411
Other reserves			16				(12,500	)			(12,405	)
Share-based compensation reserve			16				4,188				2,037
Foreign currency translation reserve			16				(10,507	)			(13,035	)
Accumulated deficit			16				(67,940	)			(32,493	)
Total equity							218,968				249,816
Total liabilities and equity							226,300				254,362

On behalf of the Board
Dermot Hanley	Duncan Moore
Director	Director

		Share capital				Share Premium				Other reserves				Share-based compensation reserve				Foreign currency translation reserve				Accumulated deficit				Total
			$’000				$’000				$’000				$’000				$’000				$’000				$’000
		Note 16				Note 16				Note 16				Note 18				Note 16
At January 1, 2022			1,301				304,411				(12,963	)			366				(5,903	)			(10,037	)			277,175
Loss for the year			-				-				-				-				-				(22,456	)			(22,456	)
Other comprehensive income/(loss)			-				-				558				-				(7,132	)			-				(6,574	)
Total comprehensive income/(loss) for the year			-				-				558				-				(7,132	)			(22,456	)			(29,030	)
Share-based compensation expense			-				-				-				1,671				-				-				1,671
Total transactions with owners			-				-				-				1,671				-				-				1,671
At December 31, 2022			1,301				304,411				(12,405	)			2,037				(13,035	)			(32,493	)			249,816
At January 1, 2023			1,301				304,411				(12,405	)			2,037				(13,035	)			(32,493	)			249,816
Loss for the year			-				-				-				-				-				(35,587	)			(35,587	)
Other comprehensive (loss)/income			-				-				(95	)			-				2,528				-				2,433
Total comprehensive (loss)/income for the year			-				-				(95	)			-				2,528				(35,587	)			(33,154	)
Share-based compensation expense			-				-				-				2,291				-				-				2,291
Share option exercises			-				15				-				(140	)			-				140				15
Total transactions with owners			-				15				-				2,151				-				140				2,306
At December 31, 2023			1,301				304,426				(12,500	)			4,188				(10,507	)			(67,940	)			218,968

						Year ended December 31,
		Note					2023				2022
							$’000				$’000
Cash flows from operating activities
Loss for the year							(35,587	)			(22,456	)
Depreciation			12				315				47
Share-based compensation expense			18				2,291				1,671
Finance income			6				(8,978	)			(1,166	)
Finance expense			6				723				123
Movement of expected credit loss			11				(1	)			121
Foreign exchange loss/(gain)			19				2,621				(7,176	)
Movement in working capital							1,645				2,159
Cash flows used in operating activities							(36,971	)			(26,677	)
Finance expense paid							(648	)			(22	)
Finance income received							4,283				500
Net cash used in operating activities							(33,336	)			(26,199	)
Cash flows used in investing activities
Purchase of property, plant and equipment			12				(100	)			(67	)
Purchase of marketable securities			11				-				(84,621	)
Purchase of other financial assets			9				(54,000	)			-
Cash flows used in investing activities							(54,100	)			(84,688	)
Cash flows used in financing activities
Payment of lease liability			15				(219	)			-
Proceeds from share issuances			16				15				-
Net cash flows used in financing activities							(204	)			-
Net decrease in cash and cash equivalents							(87,640	)			(110,887	)
Cash and cash equivalents at the beginning of the year							165,955				276,776
Impact of foreign exchange on cash and cash equivalents							105				66
Cash and cash equivalents at the end of the year							78,420				165,955

•

The asset has contractual terms that give rise to cash flows on specified dates that are solely payments of principal and interest on the principal outstanding; and

•

The asset is held within a business model whose objective is achieved by both collecting contractual cash flows and selling those assets.

•

Interest income on cash and cash equivalents, other financial assets and marketable securities;

•

Interest expense; and

•

Net gain or loss on financial assets classified at FVTPL.

•

the difference to the share premium previously carried in GH Research Ireland Ltd. and the nominal value of the shares issued in GH Research PLC as part of the corporate reorganization of $9.8 million (2022: $9.8 million). As part of the corporate reorganization which took place on May 27, 2021, shareholders in GH Research Ireland Ltd exchanged each of the shares held by them in GH Research Ireland Ltd, which had a nominal value of €0.01, for shares of GH Research PLC of the same share classes and with the same shareholder rights as the shares held by them in GH Research Ireland Ltd. This share exchange resulted in a share premium balance of $120.7 million, a difference of $9.8 million to the share premium previously carried in GH Research Ireland Ltd, and was recorded under Other reserves.

•

transaction costs totaling $22.8 million (2022: $22.8 million) incurred as part of the issuance of the Series B preferred shares and the IPO; and

•

the difference between the fair value and the amortized cost of marketable securities measured at FVOCI of $0.5 million as at 31 December 2023 (2022: $0.6 million).

•

forecast expenses denominated in a currency other than the entity’s functional currency; and

•

recognized assets and liabilities denominated in a currency other than the entity’s functional currency.

•

Cash

•

Other current assets

•

Trade payables and other current liabilities

						At December 31,
							2023				2022
		Note					$’000				$’000
ASSETS
Non-current assets
Investment in subsidiary			3				125,874				123,659
Marketable securities			4				61,142				85,724
Total non-current assets							187,016				209,383
Current assets
Cash and cash equivalents			5				68,469				70,882
Marketable securities			4				27,525				-
Other current assets			6				1,389				1,643
Total current assets							97,383				72,525
Total assets							284,399				281,908
LIABILITIES AND EQUITY
Current liabilities
Trade payables							31				96
Other current liabilities			7				713				600
Total current liabilities							744				696
Total liabilities							744				696
Equity
Share capital			8				1,301				1,301
Share premium			8				304,426				304,411
Other reserves			8				(15,910	)			(15,815	)
Share-based compensation reserve			8				4,188				2,037
Accumulated deficit							(10,350	)			(10,722	)
Total equity							283,655				281,212
Total liabilities and equity							284,399				281,908

On behalf of the Board
Dermot Hanley	Duncan Moore
Director	Director

Company Statement of Changes in Equity

		Share capital				Share Premium				Other reserves				Share-based compensation reserve				Accumulated deficit				Total
			$’000				$’000				$’000				$’000				$’000				$’000
		Note 8				Note 8				Note 8				Note 8
At January 1, 2022			1,301				304,411				(16,373	)			366				(4,976	)			284,729
Loss for the year			-				-				-				-				(5,746	)			(5,746	)
Other comprehensive income			-				-				558				-				-				558
Total comprehensive loss for the year			-				-				558				-				(5,746	)			(5,188	)
Share-based compensation expense			-				-				-				1,671				-				1,671
Total transactions with owners			-				-				-				1,671				-				1,671
At December 31, 2022			1,301				304,411				(15,815	)			2,037				(10,722	)			281,212

i.

Exemption from the requirements of Section 7 of FRS 102 and FRS 102 paragraph 3.17(d) to present statement of cash flows.

ii.

Exemption from the financial instrument disclosure requirements of Section 11 paragraphs 11.42 to 11.48A of FRS 102 as the equivalent disclosures are included in the consolidated financial statements of the Company in which the entity is consolidated.

iii.

Exemption from certain disclosure requirements of Section 26 of FRS 102 (paragraphs 26.18(b), 26.19 to 26.21 and 26.23), in respect of share-based compensation as the share-based compensation concerns its own equity instruments its separate financial statements are presented alongside the consolidated financial statements of the Company; and the equivalent disclosures are included in the consolidated financial statements of the Company in which the entity is consolidated.

iv.

Exemption from the requirement of FRS 102 paragraph 33.7 to disclose key management personnel compensation in total.

v.

The Company has not disclosed related party transactions between the Company and its subsidiary, having availed of the exemption under Schedule 3(67), paragraph 3 of the Companies Act 2014. This provides an exemption from the disclosures of transactions entered into between two or more members of a group, provided that any subsidiary undertaking which is a party to the transaction is wholly owned by a member of the Group.

•

The asset has contractual terms that give rise to cash flows on specified dates that are solely payments of principal and interest on the principal outstanding; and

•

The asset is held within a business model whose objective is achieved by both collecting contractual cash flows and selling those assets.

•

transactions costs of $16.4 million incurred as part of the IPO share issuance which occurred on June 29, 2021, when GH Research PLC closed its IPO of 11,499,999 ordinary shares on the Nasdaq Global Market at $16.00 per share; and

•

the difference between the fair value and the amortized cost of marketable securities measured at fair value through OCI of $0.5 million as at 31 December 2023 (2022: $0.6 million).