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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of December 2021.

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Commission File Number: 001-40530

(Exact name of registrant as specified in its charter)

28 Baggot Street Lower

Dublin 2

D02 NX43

Ireland

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

EXHIBIT INDEX

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Exhibit 99.2

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. You should read this discussion and analysis in conjunction with our unaudited condensed consolidated interim financial statements, including the notes thereto, as of and for the three and six months ended September 30, 2021. You should also read this discussion and analysis in conjunction with our audited consolidated financial statements, including the notes thereto, and the section titled “Risk Factors” included in our Registration Statement on Form F-1, as amended (Registration Nos. 333-256796 and 333-257371) (the “Registration Statement”).

Our unaudited condensed consolidated interim financial statements were prepared in accordance with International Accounting Standard 34, Interim Financial Reporting. The terms “dollar,” “USD” or “$” refer to U.S. dollars. We have made rounding adjustments to some of the figures included in this discussion. Accordingly, any numerical discrepancies in any table between totals and sums of the amounts listed are due to rounding.

Unless otherwise indicated or the context otherwise requires, all references in this discussion and analysis to “GH Research” or “GH,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to GH Research PLC and its consolidated subsidiary.

Overview

We are a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. Our initial focus is on developing our novel and proprietary 5-Methoxy-N,N-Dimethyltryptamine, or 5-MeO-DMT, therapies for the treatment of patients with Treatment-Resistant Depression, or TRD. Our portfolio currently includes GH001, our proprietary inhalable 5-MeO-DMT product candidate which is delivered via a vaporization device produced by a third party, and GH002, our proprietary injectable 5-MeO-DMT product candidate, and GH003, our proprietary intranasal 5-MeO-DMT product candidate. We have completed two Phase 1 healthy volunteer clinical trials (GH001-HV-101 and GH001-HV-103), in which administration of GH001 via inhalation was observed to be well tolerated at the investigated single dose levels and in an individualized dosing regimen with intra-subject dose escalation within a single day. We have also recently completed a Phase 1/2 clinical trial in patients with TRD (GH001-TRD-102). Based on observed clinical activity in the Phase 1 part of the clinical trial, we believe that administration of a single dose of GH001 has the potential to induce ultra-rapid remissions as measured by the Montgomery-Åsberg Depression Rating Scale, or MADRS, in certain patients, driven by the ultra-rapid onset of psychoactive effects (commonly within seconds) and an intense and short-lived (commonly five to 30 minutes) initial psychoactive experience. Based on observed clinical activity in the Phase 2 part of the trial, we believe that administration of an individualized dosing regimen with intra-subject dose escalation within a single day can further increase the MADRS remission rate as compared to a single dose of GH001.

We have incurred recurring operating losses since inception, including net losses of $5.1 million, $310 thousand and $446 thousand for the nine months ended September 30, 2021 and the years ended December 31, 2019 and 2020, respectively. As of September 30, 2021, we had an accumulated deficit of $5.9 million. We expect to incur significant expenses and operating losses for the foreseeable future as we expand our research and development activities. In addition, our losses from operations may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:

In addition, as we progress toward marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of one or more of our product candidates or other research and development initiatives, which could have a material adverse effect on our business, results of operations, and financial condition. We will need to generate significant revenue to achieve profitability, and we may never do so.

We are subject to a number of risks comparable to those of other similar companies, including dependence on key individuals; the need to develop product candidates with the required safety and efficacy profile and which support regulatory approval and are commercially viable; competition from other companies, many of which are larger and better capitalized; and the need to obtain adequate additional financing to fund the development of our product candidates.

Business Updates

We announced the successful outcome of the Phase 2 part of our Phase 1/2 clinical trial of GH001 in treatment-resistant depression (TRD), where the primary endpoint was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001).

We plan to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA in the first quarter of 2022 and, pending the outcome of these meetings, we plan to initiate a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD.

Given GH001’s mechanism of action, we believe that GH001 may confer beneficial effects in other psychiatric and neurological disorders with unmet medical needs. We have recently initiated the development in two undisclosed psychiatric disorders which are expected to be announced in Q1 2022.

GH002, our 5-MeO-DMT product candidate formulated for administration via a proprietary injectable approach, and GH003, our recently added 5-MeO-DMT product candidate formulated for administration via a proprietary intranasal administration approach, are currently in preclinical development. We anticipate developing them in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders.

COVID-19 Business Update

With the global spread of the ongoing COVID-19 pandemic in 2021, we have followed guidance issued by national and local governments to address and mitigate the impact of the COVID-19 pandemic on our employees and our business, including our nonclinical studies and clinical trials. We are focused on the health and safety of our employees, and have, among other things, implemented a work-from-home policy and eliminated nonessential business travel. While we are experiencing limited financial impacts at this time, the extent of the impact of the COVID-19 pandemic on our business, operations and development timelines and plans remains highly uncertain. The overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic as well as any economic slowdown as a result of the COVID-19 pandemic, could materially and adversely affect our business, financial condition and results of operations. We continue to closely monitor the COVID-19 pandemic as we evolve our business continuity plans, clinical development plans and response strategy.

In addition, our planned clinical trials have been and may continue to be affected by the COVID-19 pandemic, including (i) delays or difficulties in enrolling and retaining patients in our planned clinical trials, including patients that may not be able or willing to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services; (ii) delays or difficulties in clinical site initiation, including difficulties in recruiting and retaining clinical site investigators and clinical site staff as well as closures of trial sites; (iii) diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the COVID-19 pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, and because, who, as healthcare providers, may have heightened exposure to COVID-19 and adversely impact our clinical trial operations; (iv) interruption of our future clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal, state/provincial or municipal governments, employers and others; and (v) limitations in outsourced third-party resources that would otherwise be focused on the conduct of our planned clinical trials, including because of sickness of third-party personnel or their families, or the desire of third-party personnel to avoid contact with large groups of people.

Results of Operations

Comparison of the Three Months Ended September 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended September 30, 2021 and 2020 (in thousands):

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended September 30, 2021 and 2020 (in thousands):

Research and development expenses increased by $2.5 million from $55 thousand for the three months ended September 30, 2020, to $2.6 million for the three months ended September 30, 2021. The increase was primarily due to increased external costs relating to our technical developments and clinical trials and employee expenses relating to the hiring of personnel in our research and development team to support the requirements of increased clinical activities.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the three months ended September 30, 2021 and 2020 (in thousands):

General and administrative expenses increased by $2.1 million from $5 thousand for the three months ended September 30, 2020, to $2.1 million for the three months ended September 30, 2021. The increase was primarily due to costs incurred in preparation for our initial public offering, as well as subsequent higher professional and compliance fees associated with being a public company, and increased employee expenses in our general and administrative functions to support our growth initiatives.

Finance expense

Our financial expense increased to $3 thousand for the three months ended September 30, 2021 from $nil for the three months ended September 30, 2020.

Foreign currency translation differences

Foreign currency translation gains increased to $2.8 million for the three months ended September 30, 2021, from $nil for the three months ended September 30, 2020. This increase was due to the translation of the U.S. dollar cash balance into euro in the accounts of our subsidiary, GH Research Ireland Limited, who’s functional currency is euro. This resulted in a foreign currency translation gain.

Comparison of the Nine Months Ended September 30, 2021 and 2020

The following table summarizes our results of operations for the nine months ended September 30, 2021 and 2020 (in thousands):

Research and Development Expenses

The following table summarizes our research and development expenses for the nine months ended September 30, 2021 and 2020 (in thousands):

Research and development expenses increased by $5.1 million from $105 thousand for the nine months ended September 30, 2020, to $5.2 million for the nine months ended September 30, 2021. The increase was primarily due to increased external costs relating to our technical development and clinical trials and employee expenses relating to the hiring of personnel in our research and development team to support the requirements of increased clinical activities.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2021 and 2020 (in thousands):

General and administrative expenses increased by $3.3 million from $16 thousand for the nine months ended September 30, 2020, to $3.3 million for the nine months ended September 30, 2021. The increase was primarily due to costs incurred in preparation for our initial public offering, as well as subsequent higher professional and compliance fees associated with being a public company, and increased employee expenses in our general and administrative functions to support our growth initiatives.

Finance expense

Our financial expense increased to $9 thousand for the nine months ended September 30, 2021 from $nil    for the nine months ended September 30, 2020.

Foreign currency translation differences

Foreign currency translation gains increased to $3.4 million for the nine months ended September 30, 2021, from $nil for the nine months ended September 30, 2020. This increase was due to the translation of the U.S. dollar cash balance into euro in the accounts of our subsidiary, GH Research Ireland Limited, who’s functional currency is euro. This resulted in a foreign currency translation gain.

Liquidity and Capital Resources

Sources of Liquidity

We have incurred operating losses since inception, and we have not generated any revenue from any product sales or any other sources. We have not yet commercialized any of our product candidates, which are in various phases of technical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. We have funded our operations to date primarily through equity financings, including our initial public offering. As of September 30, 2021, we had cash of $280.7 million.

In June 2021, we completed our initial public offering, in which we issued and sold an aggregate of 11,499,999 ordinary shares, including those issued and sold pursuant to the exercise in full of the underwriters’ option to purchase additional ordinary shares. The net proceeds of the offering were $167.7 million, after deducting underwriting discounts and offering expenses payable by us.

In April 2021, we issued 25,379,047 Series B preferred shares (which were redesignated into 10,151,618 ordinary shares prior to the closing of the initial public offering). The net proceeds of this issuance were $118.8 million, after deducting estimated directly attributable transaction costs payable by us.

We plan to continue to fund our operating and capital funding needs through the net proceeds of our public offerings, additional equity financings and/or other forms of financing. We may also consider pursuing strategic partnerships for clinical development and commercialization of our product candidates.

Cash Flows

The following table provides information regarding our cash flows for the nine months ended September 30, 2021 and 2020, as well as for the years ended December 31, 2020 and 2019 (in thousands):

Net Cash Flows Used in Operating Activities

Net cash flows used in operating activities increased to $11.5 million for the nine months ended September 30, 2021 from $181 thousand for the nine months ended September 30, 2020, an increase of $11.3 million. The increase was primarily due to a $5 million increase in loss for the period, a $3.4 million foreign exchange gain and $3.1 million related to changes in the components in working capital, including a $4.8 million increase in other current assets which primarily related to prepaid insurance costs, offset by a $1.7 million increase in trade payables and other current liabilities primarily related to an increase in clinical trial costs, technical development costs and legal and professional fees, primarily related to expenses associated with operating as a public company and other corporate activities as we continue to grow our business.

Net Cash Flows Used in Investing Activities

Net cash flows used in investing activities increased to $85 thousand for the nine months ended September 30, 2021 from $nil for the nine months ended September 30, 2020. The increase was due to purchase of property, plant and equipment.

Net Cash Flows from Financing Activities

Net cash flows from financing activities increased to $286.6 million for the nine months ended September 30, 2021 from $nil for the nine months ended September 30, 2020. The increase was due to the proceeds from the issuance of Series B preferred shares and our initial public offering.

Funding Requirements

We expect our expenses to increase substantially in connection with our ongoing research and development activities, particularly as we advance the technical development work, nonclinical studies and clinical trials of our product candidates and the medical devices required to deliver such product candidates. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. Accordingly, we expect to finance our cash needs through a combination of equity offerings, debt financings, convertible debt financings, strategic collaborations and licensing arrangements. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Our future capital requirements will depend on many factors, which are outlined in our Registration Statement and this discussion and analysis.

Critical Accounting Policies and Significant Judgments and Estimates

There have been no material changes to the significant accounting policies and significant judgments and estimates from those described in the section in the Registration Statement titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” with the exception of the accounting for the share-based compensation expense as described in note 2, “Basis of preparation, significant judgments, and accounting policies” in the notes to our unaudited condensed consolidated interim financial statements.

Emerging Growth Company Status

On April 5, 2012, the JOBS Act was enacted. As an emerging growth company, or EGC, under the JOBS Act, we can take advantage of an extended transition period for complying with new or revised accounting standards applicable to public companies. This provision allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. This transition period is only applicable under U.S. GAAP. As a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required or permitted by the International Accounting Standards Board.

We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we intend to continue to rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis.

We will remain classified as an EGC until the earlier of (1) the last day of the fiscal year (i) in which we have total annual gross revenue of $1.07 billion; (ii) following the fifth anniversary of the completion of our initial public offering; or (iii) in which we are deemed to be a “large accelerated filer,” which requires the market value of our ordinary shares that is held by non-affiliates to exceed $700 million as of the prior June 30th, and (2) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three-year period.

Recently Issued Accounting Pronouncements

As disclosed in note 2 to our unaudited condensed consolidated interim financial statements, there are no standards issued but not yet adopted which will have an impact on our unaudited condensed consolidated interim financial statements.

Cautionary Statement Regarding Forward-Looking Statements

This discussion contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this discussion, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this discussion can be identified by the use of forward-looking words such as ‘‘may,’’ ‘‘anticipate,’’ ‘‘believe,’’ ‘‘could,’’ ‘‘expect,’’ ‘‘should,’’ ‘‘plan,’’ ‘‘intend,’’ ‘‘estimate,’’ ‘‘will,’’ ‘‘potential’’ and ‘‘ongoing,’’ among others.

Forward-looking statements appear in a number of places in this discussion and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section in the Registration Statement titled ‘‘Risk Factors’’. These risks and uncertainties include, among others, factors relating to:

These forward-looking statements speak only as of the date of this discussion and are subject to a number of risks, uncertainties and assumptions described under the section in the Registration Statement titled ‘‘Risk Factors’’ and elsewhere in this discussion. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

In addition, statements that ‘‘we believe’’ and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this discussion, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

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Exhibit 99.3

GH Research Reports Third Quarter 2021 Financial Results and Provides Business Updates

Dublin, Ireland, December 6, 2021 – GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the third quarter ended September 30, 2021 and gave updates on its business.

Third Quarter 2021 Financial Results

Cash position

Cash was $280.7 million as of September 30, 2021, compared to $5.9 million as of December 31, 2020.

Research and development expenses

R&D expenses were $2.6 million for the quarter ended September 30, 2021, compared to $55 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to our technical developments and clinical trials and increases in employee expenses to support these activities.

General and administrative expenses

G&A expenses were $2.1 million for the quarter ended September 30, 2021, compared to $5 thousand for the same quarter in 2020. The increase was primarily due to higher professional and compliance fees associated with being a public company, as well as increased employee expenses.

Net loss

Net loss was $1.8 million, or $0.035 loss per share, for the quarter ended September 30, 2021, compared to $60 thousand, or $0.002 loss per share, for the same quarter in 2020.

Business Updates

We announced today, in a separate press release, the successful outcome of the Phase 2 part of our Phase 1/2 clinical trial of GH001 in treatment-resistant depression (TRD), where the primary endpoint was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001).

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC’s initial focus is on developing its novel and proprietary 5-MeO-DMT therapies for the treatment of patients with treatment-resistant depression (TRD).

About GH001

Our lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. Across the GH001 program, no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen.

Forward-Looking Statements

This press release contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations:

Julie Ryan

GH Research PLC

investors@ghres.com

 

GH RESEARCH PLC

Condensed Consolidated Interim Statement of Comprehensive Income (Unaudited)

(in thousands, except share and per share amounts)

GH RESEARCH PLC

Condensed Consolidated Interim Statement of Financial Position

(in thousands)

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