Form 20-F
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Form 40-F
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Exhibit No.
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Description
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Notice of Annual General Meeting
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Directors’ Report and 2021 Irish Statutory Financial Statements
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Annual General Meeting Notice Regarding Agenda
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Annual General Meeting Notice Regarding the Availability of Proxy Materials
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Annual General Meeting Proxy Card (Record Holders)
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Annual General Meeting Proxy Card (Brokers)
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GH Research PLC
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Date: August 11, 2022
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By:
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/s/ Julie Ryan
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Name:
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Julie Ryan
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Title:
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Vice President, Finance
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Florian Schönharting – Co-Founder and Chairman
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Michael Forer, LL.B. – Vice Chairman
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Dermot Hanley – Director
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Duncan Moore, PhD – Director
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1.
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To re-elect, by separate resolutions, the following individuals who retire as directors in accordance with the constitution of the
Company and, being eligible, offer themselves for re-election:
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1.1.
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Florian Schönharting
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1.2.
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Michael Forer, LL.B.
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1.3.
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Dermot Hanley
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1.4.
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Duncan Moore, PhD
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2.
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To review the affairs of the Company and consider the Irish statutory financial statements for the year ended 31 December, 2021,
and the reports of the directors and auditors thereon.
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3.
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To ratify the appointment of PricewaterhouseCoopers Ireland as independent auditors of the Company for the year ending 31
December, 2022, and to authorise the Board to fix the remuneration of the auditors.
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By Order of the Board
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Magnus Halle
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Company Secretary
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Dublin, Ireland
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Dated: 10 August 2022
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1.
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Information and Documentation
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2.
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Who is eligible to vote and how?
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3.
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Attending the AGM - COVID-19 Notice
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4.
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How many votes do you have?
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5.
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Broker Voting
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6.
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Can I change my vote after submitting my proxy?
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You may submit another properly completed proxy with a later date. Your revised proxy must be received no later than 3 hours
before the commencement of the AGM at 2 pm Dublin time on 22 September, 2022, or if the AGM is adjourned, before the commencement of the adjourned meeting;
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You may send a written notice that you are revoking your proxy to the Company Secretary at 28 Baggot Street Lower, Dublin 2,
Ireland. Your notice must be received no later than 3 hours before the commencement of the AGM at 2 pm Dublin time on 22 September, 2022, or if the AGM is adjourned, before the commencement of the adjourned meeting; or
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You may attend the AGM and vote in person.
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What does it mean if I receive more than one set of materials?
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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,
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reduce or eliminate our product discovery and development programs or commercialization efforts;
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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 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 nor the European Union for commercialization;
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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 clinical trials, which to date have only been conducted in the Netherlands, may not satisfy the requirements of the
FDA, EMA or other comparable foreign regulatory authorities;
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Our product candidates 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 following regulatory approval, if obtained;
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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, the United Kingdom 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 potential. This may delay approval and any potential rescheduling process;
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5-MeO-DMT 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 5-MeO-DMT 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 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,
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A pandemic, epidemic or outbreak of an infectious disease in Ireland or worldwide may adversely affect our business;
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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; and
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We have identified material weaknesses in our internal control over financial reporting in connection with the audit of our
financial statements for the years ended December 31, 2020 and 2021, 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.
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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 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;
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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, or any other product candidates that successfully complete clinical development;
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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 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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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
5-MeO-DMT delivery approaches and the medical devices required to deliver these therapies 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 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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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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completing research and technical, nonclinical and clinical development of our product candidates and the medical devices
required to deliver these product candidates; 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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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 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.
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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 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 currently have planned, before we can initiate further clinical studies. Any significant technical
development, nonclinical or clinical trial delays also could 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 sites or enrolling subjects in clinical trials, including, due to the COVID-19 pandemic,
the inability to identify clinical 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 or institutional review boards, or 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, the EMA or other comparable foreign regulatory authorities may require us to submit additional data such as long-term
toxicology studies 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 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 the COVID-19 pandemic, we may experience some delays and interruptions to our technical development
efforts, nonclinical studies and clinical trials, 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 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 related to the impact or the spread of COVID-19 or other pandemics, including the impact of COVID-19 on the FDA’s, EMA’s
or other comparable foreign regulatory authority’s ability to continue its normal operations;
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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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the impacts of the COVID-19 pandemic on clinical trial sites, personnel and patient travel;
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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, 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
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Clinical trials. Because our GH001, GH002 and GH003 product candidates contain
5-MeO-DMT, 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 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., 5-MeO-DMT) 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 files an application for 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 5-MeO-DMT, 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 classification or
voluntarily, we were to conduct manufacturing or repackaging/relabeling in the United States for commercial purposes, our contract manufacturers would be subject to the DEA’s annual 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 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 United Kingdom. If GH001, GH002 or GH003 is
scheduled as Schedule II, III or IV, 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 or IV distribution registrations. This limitation in the ability to distribute GH001, GH002 or GH003 more broadly may limit commercial uptake and could
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•
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restrictions on the manufacturing of our products, the approved manufacturers or the manufacturing process;
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•
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withdrawal of the product from the market or voluntary product recalls;
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•
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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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•
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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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•
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suspensions of any of our ongoing clinical trials;
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•
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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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•
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product seizure or detention or refusal to permit the import or export of products; and
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•
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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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•
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the ability to offer our products, if approved, for sale at competitive prices;
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•
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relative convenience and ease of administration compared to alternative treatments;
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•
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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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•
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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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•
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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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•
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the strength of sales, marketing and distribution support;
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•
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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; 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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•
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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
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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) and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members. Effective January 1, 2022, these reporting
obligations now extend to include transfers of value made in the previous year to certain non-physician providers including physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified
registered nurse anesthetists and certified nurse midwives;
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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
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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 European Union; 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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•
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for the period beginning on January 31, 2022 and ending on January 31, 2023, all clinical trial applications can 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 are required to be submitted under the CTR alone;
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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, no new national clinical trial applications can be submitted under the Clinical Trials Directive 2001/20/EC after January 31, 2023. Consequently, if the sponsor
has chosen to submit the clinical trial application under the Clinical Trials Directive during the one-year transition period ending 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; and
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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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•
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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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•
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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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•
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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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•
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changes in a specific country’s or region’s political or economic environment;
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•
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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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•
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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 European Economic Area;
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•
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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 health epidemics such as COVID-19; and
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•
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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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•
|
The price of the securities of publicly traded emerging pharmaceutical and drug discovery and development companies has been
highly volatile and is likely to remain highly volatile in the future. The market price of our ordinary shares may fluctuate significantly due to a variety of factors, including the following:
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•
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positive or negative results of testing and clinical trials by us, strategic partners or competitors;
|
•
|
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;
|
•
|
entry into strategic relationships on terms that are not deemed to be favorable to us;
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•
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technological innovations or commercial therapeutic introductions by competitors;
|
•
|
changes in government regulations and healthcare payment systems;
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•
|
developments concerning proprietary rights, including patent and litigation matters;
|
•
|
public concern relating to the commercial value or safety of any of our GH001, GH002 and GH003 product candidates or any future
product candidates;
|
•
|
negative publicity or public perception of the use of 5-MeO-DMT as a medical treatment;
|
•
|
financing or other corporate transactions, or the failure to obtain financing or enter into other corporate transactions;
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•
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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);
|
•
|
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;
|
•
|
general economic, political, and market conditions and overall market volatility in the United States, the United Kingdom or
the European Union as a result of the COVID-19 pandemic or other pandemics or similar events; and
|
•
|
other events and factors, many of which are beyond our control.
|
•
|
the majority independent director requirement under Nasdaq listing rules;
|
•
|
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 percent 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;
|
•
|
that it was not the appropriate forum for such proceedings;
|
•
|
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
|
•
|
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.
|
•
|
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
|
•
|
the judgment must be final and conclusive and the decree must be final and unalterable in the court which pronounces it.
|
•
|
the judgment is not for a definite sum of money;
|
•
|
the judgment was obtained by fraud;
|
•
|
the enforcement of the judgment in Ireland would be contrary to natural or constitutional justice;
|
•
|
the judgment is contrary to Irish public policy or involves certain U.S. laws which will not be enforced in Ireland; or
|
•
|
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
|
•
|
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.
|
Name
|
| |
Position
|
Florian Schönharting(2)(3)
|
| |
Chairman and Director
|
Michael Forer(1)(2)(3)
|
| |
Director (Appointed May 27, 2021)
|
Dermot Hanley(1)
|
| |
Director (Appointed September 24, 2021)
|
Duncan Moore(1)
|
| |
Director (Appointed September 24, 2021)
|
Spike Loy(2)(3)
|
| |
Director (Appointed May 27, 2021)
|
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(1)
|
| |
15,070,179
|
| |
29.0%
|
(1)
|
Florian Schönharting, the Chairman of the board of directors, held no shares in the Company on
January 1, 2021, as it was incorporated on March 29, 2021. At January 1, 2021, Mr. Schönharting held 36,786,750 ordinary shares of €0.01 each and 686,000 Series A preferred shares of €0.01 each in the Subsidiary.
|
•
|
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 (as defined in section 225(3)(a)), is being drawn up that will set out the Company’s policies to
ensure compliance with the Company’s relevant obligations;
|
•
|
Appropriate arrangements and structures that are, in the directors’ opinion, designed to secure material compliance with the
relevant obligations are being put in place; and
|
•
|
A review of those arrangements or structures will be carried out.
|
|
| |
|
| |
|
Dermot Hanley
|
| |
Duncan Moore
|
| |
|
Director
|
| |
Director
|
| |
|
•
|
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 Company;
|
•
|
enable, at any time, the assets, liabilities, financial position and profit and loss of the 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.
|
|
| |
|
| |
|
Dermot Hanley
Director |
| |
Duncan Moore
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 2021 and of the group’s loss and cash flows for the year then ended;
|
•
|
the group 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 2021;
|
•
|
the Company statement of financial position as at 31 December 2021;
|
•
|
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 period from incorporation on 29 March 2021 to 31 December 2021; and
|
•
|
the notes to the financial statements, which include a description of the significant accounting policies.
|
|
|
| |
Materiality
• $142,000 - Consolidated financial statements
• Based on 1% of total expenses.
• $2,900,000 - Company financial statements
• Based on 1% of total assets.
|
| |||
|
|
| |
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 calculated 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 judgments, and accounting policies” and note 17 “Share Based Compensation”.
|
| |
We examined the “GH Research PLC Share Option Plan”, remuneration committee meeting minutes and
individual award letters to understand the contractual arrangements applicable to the respective awards granted.
|
|
|
|
| |
|
|
|
As set out in note 17, the Company approved and implemented a share option plan (“GH Research
plc Share Option Plan”) and issued a number of shares options in the year. The amount of expense for all awards recognized for services received during the year amounted to $366 thousand.
|
| |
We evaluated the appropriateness of the peer companies used to determine the expected volatility of
the Company’s share price assisted by PwC professionals with specialized skills and knowledge.
|
|
|
Key audit matter
|
| |
How our audit addressed the key audit matter
|
|
|
The fair value of the share options granted were determined on the date of grant using a
Black-Scholes option-pricing model. A key assumption used in this model is the expected volatility of the Company’s share price. This was estimated using the share price volatility of identified peer companies due to the lack of
historical data for the Company’s share price.
|
| |
We recalculated the fair value of all awards via the Black-Scholes model and assessed the
reasonableness of all inputs to the calculation by reference to employee grant documentation, available market data and the Company’s future plans.
|
|
|
|
| |
|
|
|
We determined this to be a key audit matter due to the significant judgment that was exercised
in selecting the peer companies used.
|
| |
We recalculated the corresponding expense attributable to the share-based awards for the financial
year ending 31 December 2021.
|
|
|
|
| |
Consolidated financial statements
|
| |
Company financial statements
|
|
|
Overall materiality
|
| |
$142,000
|
| |
$2,900,000
|
|
|
How we determined it
|
| |
1% of total expenses.
|
| |
1% of total assets.
|
|
|
Rationale for benchmark applied
|
| |
We have considered total expenses as the most relevant key performance indicator for the group
given the nature of the Company as a clinical-stage biopharmaceutical Company.
|
| |
We considered total assets to be the most relevant benchmark as the Company is primarily an
investment holding Company for the group. The Company holds the investment in the operating subsidiary entity, as well as cash and cash equivalents.
We have used the lower overall group materiality on any balances and transactions that do not
eliminate consolidation.
|
|
>
|
Obtaining management’s going concern assessment for the going concern period of twelve months from the date on which the
financial statements are authorized 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 2021 is consistent with the financial statements and has been prepared in accordance with applicable legal requirements.
|
•
|
Based on our knowledge and understanding of the Company and its environment obtained in the course of the audit, we have not
identified any material misstatements in the Directors’ Report.
|
•
|
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 statement of financial position is in agreement with the accounting records.
|
•
|
The maintenance and integrity of the GH Research plc website is the responsibility of the directors; the work carried out by
the auditors does not involve consideration of these matters and, accordingly, the auditors accept no responsibility for any changes that may have occurred to the financial statements since they were initially presented on the website.
|
•
|
Legislation in the Republic of Ireland governing the preparation and dissemination of financial statements may differ from
legislation in other jurisdictions.
|
|
| |
|
| |
Year ended
December 31,
|
|||
|
| |
Note
|
| |
2021
$’000
|
| |
2020
$’000
|
Operating expenses
|
| |
|
| |
|
| |
|
Research and development
|
| |
4
|
| |
(8,553)
|
| |
(338)
|
General and administration
|
| |
4
|
| |
(6,547)
|
| |
(108)
|
Loss from operations
|
| |
|
| |
(15,100)
|
| |
(446)
|
|
| |
|
| |
|
| |
|
Finance expense
|
| |
|
| |
(9)
|
| |
—
|
Foreign currency translation differences
|
| |
|
| |
5,907
|
| |
—
|
Loss before tax
|
| |
|
| |
(9,202)
|
| |
(446)
|
Tax charge/(credit)
|
| |
8
|
| |
—
|
| |
—
|
Loss for the year
|
| |
|
| |
(9,202)
|
| |
(446)
|
|
| |
|
| |
|
| |
|
Other comprehensive income/(expense)
|
| |
|
| |
|
| |
|
Items that may be reclassified to profit or loss
|
| |
|
| |
|
| |
|
Currency translation adjustment
|
| |
|
| |
(6,103)
|
| |
212
|
Total comprehensive loss for the year
|
| |
|
| |
(15,305)
|
| |
(234)
|
|
| |
|
| |
|
| |
|
Attributable to owners:
|
| |
|
| |
|
| |
|
Loss for the year
|
| |
|
| |
(9,202)
|
| |
(446)
|
Comprehensive loss for the year
|
| |
|
| |
(15,305)
|
| |
(234)
|
|
| |
|
| |
|
| |
|
|
| |
|
| |
|
| |
|
Loss per share
|
| |
|
| |
|
| |
|
Basic and diluted loss per share (in USD)
|
| |
19
|
| |
(0.211)
|
| |
(0.016)
|
|
| |
|
| |
|
Dermot Hanley
Director |
| |
Duncan Moore
Director
|
| |
|
|
| |
|
| |
At December 31,
|
|||
|
| |
Note
|
| |
2021
$’000
|
| |
2020
$’000
|
ASSETS
|
| |
|
| |
|
| |
|
Non-current assets
|
| |
|
| |
|
| |
|
Property, plant and equipment
|
| |
12
|
| |
82
|
| |
—
|
Total non-current assets
|
| |
|
| |
82
|
| |
—
|
|
| |
|
| |
|
| |
|
Current assets
|
| |
|
| |
|
| |
|
Cash and cash equivalents
|
| |
10
|
| |
276,776
|
| |
5,895
|
Other current assets
|
| |
11
|
| |
3,066
|
| |
17
|
Total current assets
|
| |
|
| |
279,842
|
| |
5,912
|
Total assets
|
| |
|
| |
279,924
|
| |
5,912
|
|
| |
|
| |
|
| |
|
LIABILITIES AND EQUITY
|
| |
|
| |
|
| |
|
Current liabilities
|
| |
|
| |
|
| |
|
Trade payables
|
| |
13
|
| |
883
|
| |
1
|
Other current liabilities
|
| |
14
|
| |
1,866
|
| |
245
|
Total current liabilities
|
| |
|
| |
2,749
|
| |
246
|
Total liabilities
|
| |
|
| |
2,749
|
| |
246
|
|
| |
|
| |
|
| |
|
Equity attributable to owners
|
| |
|
| |
|
| |
|
Share capital
|
| |
15
|
| |
1,301
|
| |
871
|
Share Premium
|
| |
15
|
| |
304,411
|
| |
5,430
|
Other reserves
|
| |
15
|
| |
(12,963)
|
| |
—
|
Share-based compensation reserve
|
| |
17
|
| |
366
|
| |
—
|
Foreign currency translation reserve
|
| |
15
|
| |
(5,903)
|
| |
200
|
Accumulated deficit
|
| |
|
| |
(10,037)
|
| |
(835)
|
Total equity
|
| |
|
| |
277,175
|
| |
5,666
|
Total liabilities and equity
|
| |
|
| |
279,924
|
| |
5,912
|
|
| |
|
| |
|
Dermot Hanley
Director |
| |
Duncan Moore
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 15
|
| |
Note 15
|
| |
Note 15
|
| |
Note 17
|
| |
Note 15
|
| |
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
At January 1, 2020
|
| |
801
|
| |
—
|
| |
—
|
| |
—
|
| |
(12)
|
| |
(389)
|
| |
400
|
Loss for the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(446)
|
| |
(446)
|
Translation adjustment
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
212
|
| |
—
|
| |
212
|
Total comprehensive loss for the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
212
|
| |
(446)
|
| |
(234)
|
Issue of share capital
|
| |
70
|
| |
5,430
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
5,500
|
Total transactions with owners
|
| |
70
|
| |
5,430
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
5,500
|
At December 31, 2020
|
| |
871
|
| |
5,430
|
| |
—
|
| |
—
|
| |
200
|
| |
(835)
|
| |
5,666
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
At January 1, 2021
|
| |
871
|
| |
5,430
|
| |
—
|
| |
—
|
| |
200
|
| |
(835)
|
| |
5,666
|
Loss for the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(9,202)
|
| |
(9,202)
|
Translation adjustment
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(6,103)
|
| |
—
|
| |
(6,103)
|
Total comprehensive loss for the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(6,103)
|
| |
(9,202)
|
| |
(15,305)
|
Share-based compensation expense
|
| |
—
|
| |
—
|
| |
—
|
| |
366
|
| |
—
|
| |
—
|
| |
366
|
Issue of share capital – Series B
|
| |
302
|
| |
124,897
|
| |
(6,379)
|
| |
—
|
| |
—
|
| |
—
|
| |
118,820
|
Corporate reorganization
|
| |
(160)
|
| |
(9,629)
|
| |
9,789
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Issue of share capital - IPO
|
| |
288
|
| |
183,713
|
| |
(16,373)
|
| |
—
|
| |
—
|
| |
—
|
| |
167,628
|
Total transactions with owners
|
| |
430
|
| |
298,981
|
| |
(12,963)
|
| |
366
|
| |
—
|
| |
—
|
| |
286,814
|
At December 31, 2021
|
| |
1,301
|
| |
304,411
|
| |
(12,963)
|
| |
366
|
| |
(5,903)
|
| |
(10,037)
|
| |
277,175
|
|
| |
|
| |
Year ended December 31,
|
|||
|
| |
Note
|
| |
2021
$’000
|
| |
2020
$’000
|
Cash flows from operating activities
|
| |
|
| |
|
| |
|
Loss for the year
|
| |
|
| |
(9,202)
|
| |
(446)
|
Depreciation
|
| |
12
|
| |
19
|
| |
—
|
Share-based compensation expense
|
| |
17
|
| |
366
|
| |
—
|
Finance expense
|
| |
|
| |
9
|
| |
—
|
Foreign exchange translation differences
|
| |
4
|
| |
(5,907)
|
| |
—
|
Movement in working capital
|
| |
|
| |
(559)
|
| |
116
|
Cash flows used in operating activities
|
| |
|
| |
(15,274)
|
| |
(330)
|
Finance expense paid
|
| |
|
| |
(9)
|
| |
—
|
Net cash used in operating activities
|
| |
|
| |
(15,283)
|
| |
(330)
|
|
| |
|
| |
|
| |
|
Cash flows used in investing activities
|
| |
|
| |
|
| |
|
Purchase of property, plant and equipment
|
| |
12
|
| |
(104)
|
| |
—
|
|
| |
|
| |
|
| |
|
Cash flows from financing activities
|
| |
|
| |
|
| |
|
Proceeds from capital contributions
|
| |
15
|
| |
309,200
|
| |
5,500
|
Transaction costs from capital contributions
|
| |
15
|
| |
(22,753)
|
| |
—
|
Net cash flows from financing activities
|
| |
|
| |
286,447
|
| |
5,500
|
|
| |
|
| |
|
| |
|
Net increase in cash and cash equivalents
|
| |
|
| |
271,060
|
| |
5,170
|
Cash at the beginning of the year
|
| |
|
| |
5,895
|
| |
498
|
Impact of foreign exchange on cash
|
| |
|
| |
(179)
|
| |
227
|
Cash and cash equivalents at the end of the year
|
| |
|
| |
276,776
|
| |
5,895
|
Corporate information
|
2.
|
Basis of preparation, significant judgments, and accounting policies
|
|
| |
Estimated Useful Life
|
IT equipment
|
| |
3 years
|
Office equipment
|
| |
3 years
|
Medical equipment
|
| |
2 years
|
3.
|
Financial risk management
|
•
|
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.
|
|
| |
2021
Local Currency
’000
|
| |
2021
$’000
|
| |
2020
Local Currency
’000
|
| |
2020
$’000
|
In USD
|
| |
276,447
|
| |
276,447
|
| |
—
|
| |
—
|
In Euro
|
| |
290
|
| |
329
|
| |
4,826
|
| |
5,895
|
|
| |
|
| |
276,776
|
| |
|
| |
5,895
|
—
|
Cash and cash equivalents
|
—
|
Other current assets
|
—
|
Trade payables and other current liabilities
|
4.
|
Expenses by nature
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Research and development
|
| |
|
| |
|
External costs(1)
|
| |
7,134
|
| |
338
|
Employee expenses(2)
|
| |
1,419
|
| |
—
|
Total research and development expenses
|
| |
8,553
|
| |
338
|
|
| |
|
| |
|
General and administrative
|
| |
|
| |
|
External costs(1)
|
| |
5,623
|
| |
103
|
Employee expenses(2)
|
| |
924
|
| |
5
|
Total general and administrative expenses
|
| |
6,547
|
| |
108
|
Total operating expenses
|
| |
15,100
|
| |
446
|
(1)
|
Includes depreciation expense (see note 12, “Property, plant and equipment”).
|
(2)
|
Includes share-based compensation expense (see note 17, “Share-based compensation”).
|
5.
|
Auditors’ remuneration
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Audit fees(1)(2)
|
| |
193
|
| |
—
|
Other assurance services(3)
|
| |
1,128
|
| |
—
|
Tax advisory services(4)
|
| |
29
|
| |
—
|
Total
|
| |
1,350
|
| |
—
|
(1)
|
Audit fees include annual audit fees for GH Research PLC. All audit fees are billed or billable by
PricewaterhouseCoopers, Ireland.
|
(2)
|
Includes audit fees billed or billable by PricewaterhouseCoopers, Ireland of $11 thousand with
respect to audit fees for the Company.
|
(3)
|
Includes other assurance services billed or billable by PricewaterhouseCoopers, Ireland, of $350
thousand.
|
(4)
|
All tax advisory services are billed or billable by PricewaterhouseCoopers, Ireland.
|
6.
|
Employee expenses
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Salary and related expenses
|
| |
1,862
|
| |
4
|
Social security costs
|
| |
115
|
| |
1
|
Share-based compensation expense
|
| |
366
|
| |
—
|
Total employee expenses
|
| |
2,343
|
| |
5
|
7.
|
Leases
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Lease expenses for short-term leases
|
| |
76
|
| |
5
|
8.
|
Income tax
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Loss before tax
|
| |
(9,202)
|
| |
(446)
|
Tax credit calculated at the domestic tax rate 12.5%
|
| |
(1,150)
|
| |
(56)
|
Tax effects of:
|
| |
|
| |
|
Losses for which no deferred tax asset was recognized
|
| |
1,150
|
| |
56
|
Tax charge/(credit)
|
| |
—
|
| |
—
|
9.
|
Deferred income taxes
|
10.
|
Cash and cash equivalents
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Cash
|
| |
276,776
|
| |
5,895
|
11.
|
Other current assets
|
|
| |
Year ended
December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Prepaid expenses
|
| |
3,008
|
| |
6
|
VAT receivable
|
| |
48
|
| |
6
|
Other
|
| |
10
|
| |
5
|
|
| |
3,066
|
| |
17
|
12.
|
Property, plant and equipment
|
|
| |
Computer
Equipment
$’000
|
| |
Office
Equipment
$’000
|
| |
Medical
Devices
$’000
|
| |
Total
$’000
|
Cost
|
| |
|
| |
|
| |
|
| |
|
At January 1, 2021
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Additions
|
| |
57
|
| |
8
|
| |
39
|
| |
104
|
Exchange difference
|
| |
(2)
|
| |
—
|
| |
(1)
|
| |
(3)
|
At December 31, 2021
|
| |
55
|
| |
8
|
| |
38
|
| |
101
|
|
| |
|
| |
|
| |
|
| |
|
Accumulated Depreciation
|
| |
|
| |
|
| |
|
| |
|
At January 1, 2021
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Additions
|
| |
10
|
| |
1
|
| |
9
|
| |
20
|
Exchange difference
|
| |
(1)
|
| |
—
|
| |
—
|
| |
(1)
|
At December 31, 2021
|
| |
9
|
| |
1
|
| |
9
|
| |
19
|
|
| |
|
| |
|
| |
|
| |
|
Net Book Amount
|
| |
|
| |
|
| |
|
| |
|
At December 31, 2021
|
| |
46
|
| |
7
|
| |
29
|
| |
82
|
13.
|
Trade payables
|
14.
|
Other current liabilities
|
|
| |
Year ended
December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Accruals
|
| |
1,698
|
| |
242
|
Social security payable
|
| |
96
|
| |
3
|
Other
|
| |
72
|
| |
—
|
|
| |
1,866
|
| |
245
|
15.
|
Share capital and reserves
|
Issued and fully paid shares:
|
| |
Number of
outstanding
shares
|
| |
Share
capital
$’000
|
| |
Share
Premium
$’000
|
| |
Other
reserves
$’000
|
At January 1, 2020(1)(2)
|
| |
70,000,000
|
| |
801
|
| |
—
|
| |
—
|
Issuance of share capital - Series A preferred shares (i)
|
| |
5,923,079
|
| |
70
|
| |
5,430
|
| |
—
|
At December 31, 2020(2)
|
| |
75,923,079
|
| |
871
|
| |
5,430
|
| |
—
|
Issuance of share capital - A Ordinary Shares (ii)
|
| |
25,000
|
| |
—
|
| |
—
|
| |
—
|
Issuance of share capital - Series B preferred shares (iii)
|
| |
25,379,047
|
| |
302
|
| |
124,897
|
| |
(6,379)
|
Share exchange (iv)
|
| |
—
|
| |
(160)
|
| |
(9,629)
|
| |
9,789
|
Redemption of A Ordinary Shares (v)
|
| |
(25,000)
|
| |
—
|
| |
—
|
| |
—
|
Share consolidation (vi)
|
| |
(60,781,276)
|
| |
—
|
| |
—
|
| |
—
|
Issue of share capital (vii)
|
| |
11,499,999
|
| |
288
|
| |
183,713
|
| |
(16,373)
|
At December 31, 2021
|
| |
52,020,849
|
| |
1,301
|
| |
304,411
|
| |
(12,963)
|
(1)
|
In 2018, GH Research Ireland Limited issued 70,000,000 ordinary shares with a nominal value of €0.01.
|
(2)
|
Share information presented as of December 31, 2020, and for the financial year then ended, is
prior to the incorporation of GH Research PLC and relates solely to GH Ireland Research Limited and does not give effect to the 2.50-for-one share consolidation described below.
|
(i)
|
Share issuance – Series A preferred shares
|
(ii)
|
Incorporation of GH Research PLC
|
(iii)
|
Share issuance – Series B preferred shares
|
(iv)
|
Share exchange
|
—
|
70,000,000 ordinary shares, nominal value $0.01 each;
|
—
|
5,923,079 Series A preferred shares, nominal value $0.01 each; and
|
—
|
25,379,047 Series B preferred shares, nominal value $0.01 each.
|
(v)
|
Redemption of A Ordinary Shares
|
(vi)
|
Conversion and share consolidation
|
(vii)
|
Share issuance – IPO
|
•
|
the difference to the share premium previously carried in GH Research Ireland Limited and the nominal value of the shares
issued in GH Research PLC as part of the corporate reorganization that took place on May 27, 2021, as explained above, of $9.8 million; and
|
•
|
transaction costs totaling $22.8 million incurred as part of the issuance of the Series B preferred shares and the IPO.
|
16.
|
Contingencies
|
17.
|
Share-based compensation
|
|
| |
Average
exercise
price per share
in USD
|
| |
Number of
awards
|
| |
Weighted
average
remaining life
in years
|
At December 31, 2020
|
| |
—
|
| |
—
|
| |
—
|
Granted
|
| |
15.80
|
| |
157,187
|
| |
7.62
|
At December 31, 2021
|
| |
15.80
|
| |
157,187
|
| |
7.62
|
|
| |
Year ended
December 31, 2021
|
Share price, in USD
|
| |
15.00 - 23.74
|
Strike price, in USD – employees (weighted average)
|
| |
18.45
|
Strike price, in USD – non-executive directors
|
| |
2.05
|
Expected volatility
|
| |
90% - 95%
|
Award life (weighted average)
|
| |
5.95
|
Expected dividends
|
| |
—
|
Risk-free interest rate
|
| |
0.97% - 1.25%
|
18.
|
Related party disclosures
|
|
| |
Year ended
December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Salary and related expenses
|
| |
687
|
| |
5
|
Share-based compensation expense
|
| |
163
|
| |
—
|
|
| |
850
|
| |
5
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
$’000
|
| |
2020
$’000
|
Directors’ emoluments(1)
|
| |
33
|
| |
—
|
(1)
|
Aside from director emoluments disclosed above, there was no other directors’ remuneration
requiring disclosure under Section 305 of the Companies Act, 2014.
|
19.
|
Loss per share
|
|
| |
Year ended December 31,
|
|||
|
| |
2021
|
| |
2020
|
Loss attributable to shareholders (in $’000)
|
| |
(9,202)
|
| |
(446)
|
Weighted average number of shares in issue(1)(2)
|
| |
43,683,296
|
| |
28,359,368
|
Basic and diluted loss per share (in USD)
|
| |
(0.211)
|
| |
(0.016)
|
(1)
|
Share data for the years ended December 31, 2020, has been revised to give effect to the share
consolidation as explained in note 15, “Share capital and reserves”.
|
(2)
|
Ordinary and preferred shares as of December 31, 2020 have been treated as a single class for the
purpose of calculating loss per share as they contractually shared equally in the profits and losses of the entity.
|
20.
|
Subsidiary undertaking
|
21.
|
Events after the reporting date
|
|
| |
|
| |
At December 31,
|
|
| |
|
| |
2021
|
|
| |
Note
|
| |
$’000
|
ASSETS
|
| |
|
| |
|
Non-current assets
|
| |
|
| |
|
Investment in subsidiary
|
| |
3
|
| |
122,077
|
Total non-current assets
|
| |
|
| |
122,077
|
Current assets
|
| |
|
| |
|
Cash and cash equivalents
|
| |
4
|
| |
163,100
|
Other current assets
|
| |
5
|
| |
2,934
|
Total current assets
|
| |
|
| |
166,034
|
Total assets
|
| |
|
| |
288,111
|
|
| |
|
| |
|
LIABILITIES AND EQUITY
|
| |
|
| |
|
Current liabilities
|
| |
|
| |
|
Trade payables
|
| |
|
| |
399
|
Other current liabilities
|
| |
6
|
| |
2,983
|
Total current liabilities
|
| |
|
| |
3,382
|
Total liabilities
|
| |
|
| |
3,382
|
|
| |
|
| |
|
Equity
|
| |
|
| |
|
Share capital
|
| |
7
|
| |
1,301
|
Share Premium
|
| |
7
|
| |
304,411
|
Other reserves
|
| |
7
|
| |
(16,373)
|
Share-based compensation reserve
|
| |
7
|
| |
366
|
Accumulated deficit
|
| |
|
| |
(4,976)
|
Total equity
|
| |
|
| |
284,729
|
Total liabilities and equity
|
| |
|
| |
288,111
|
|
| |
|
| |
|
Dermot Hanley
Director |
| |
Duncan Moore
Director
|
| |
|
|
| |
Share
capital
|
| |
Share
Premium
|
| |
Other
reserves
|
| |
Share-based
compensation
reserve
|
| |
Accumulated
deficit
|
| |
Total
|
|
| |
$’000
|
| |
$’000
|
| |
$’000
|
| |
$’000
|
| |
$’000
|
| |
$’000
|
|
| |
Note 7
|
| |
Note 7
|
| |
Note 7
|
| |
Note 7
|
| |
|
| |
|
At January 1, 2021
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Loss for the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(4,976)
|
| |
(4,976)
|
Total comprehensive loss for the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(4,976)
|
| |
(4,976)
|
Share-based compensation expense
|
| |
—
|
| |
—
|
| |
—
|
| |
366
|
| |
—
|
| |
366
|
Issue of share capital
|
| |
1,301
|
| |
304,411
|
| |
(16,373)
|
| |
—
|
| |
—
|
| |
289,339
|
Total transactions with owners
|
| |
1,301
|
| |
304,411
|
| |
(16,373)
|
| |
366
|
| |
—
|
| |
289,705
|
At December 31, 2021
|
| |
1,301
|
| |
304,411
|
| |
(16,373)
|
| |
366
|
| |
(4,976)
|
| |
284,729
|
Corporate information
|
2.
|
Basis of preparation, significant judgments, and accounting policies
|
i.
|
Exemption from the requirements of Section 7 of FRS 102 and FRS 102 paragraph 3.17(d) to present statement of cash flows.
|
Exemption from the financial instrument disclosure requirements of Section 11 paragraphs 11.39 to 11.48A and Section 12
paragraphs 12.26 to 12.29A 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.
|
3.
|
Investment in subsidiary
|
|
| |
2021
$’000
|
Balance at start of period
|
| |
—
|
Additions(1)
|
| |
121,711
|
Increase in investment(2)
|
| |
366
|
Balance at end of period
|
| |
122,077
|
(1)
|
The Company was incorporated on March 29, 2021. Pursuant to the terms of a share for share exchange agreement dated May 27,
2021, all shareholders of GH Research Ireland Limited exchanged each of the shares held by them for ordinary shares of GH Research PLC of the same share classes with the same shareholder rights as the shares held by them in GH Research
Ireland Limited and, as a result, GH Research Ireland Limited became a wholly owned subsidiary of GH Research PLC.
|
(2)
|
Share-based compensation.
|
4.
|
Cash and cash equivalents
|
|
| |
2021
$’000
|
Cash
|
| |
163,100
|
5.
|
Other current assets
|
|
| |
2021
$’000
|
Prepaid expenses
|
| |
2,900
|
Other
|
| |
34
|
|
| |
2,934
|
6.
|
Other current liabilities
|
|
| |
2021
$’000
|
Amounts owed to subsidiary undertaking
|
| |
2,054
|
Social security payable
|
| |
3
|
Other accruals
|
| |
926
|
|
| |
2,983
|
7.
|
Share capital and reserves
|
Issued and fully paid shares:
|
| |
Number of
outstanding
shares
|
| |
Share
capital
$’000
|
| |
Share
Premium
$’000
|
| |
Other
reserves
$’000
|
At January 1, 2021
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Issuance of share capital - A
Ordinary Shares (i)
|
| |
25,000
|
| |
—
|
| |
—
|
| |
—
|
Share exchange (ii)
|
| |
101,302,126
|
| |
1,013
|
| |
120,698
|
| |
—
|
Redemption of A Ordinary Shares (iii)
|
| |
(25,000)
|
| |
—
|
| |
—
|
| |
—
|
Share consolidation (iv)
|
| |
(60,781,276)
|
| |
—
|
| |
—
|
| |
—
|
Issue of share capital (v)
|
| |
11,499,999
|
| |
288
|
| |
183,713
|
| |
(16,373)
|
At December 31, 2021
|
| |
52,020,849
|
| |
1,301
|
| |
304,411
|
| |
(16,373)
|
(i)
|
Incorporation of GH Research PLC
|
(ii)
|
Share exchange
|
-
|
70,000,000 ordinary shares, nominal value $0.01 each;
|
-
|
5,923,079 Series A preferred shares, nominal value $0.01 each; and
|
-
|
25,379,047 Series B preferred shares, nominal value $0.01 each.
|
(iii)
|
Redemption of A Ordinary Shares
|
(iv)
|
Conversion and share consolidation
|
(v)
|
Share issuance – IPO
|
8.
|
Related party transactions
|
9.
|
Auditors’ remuneration
|
10.
|
Employee particulars
|
11.
|
Contingencies
|
12.
|
Events after the reporting date
|
13.
|
Approval of financial statements
|