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 nine months ended September 30, 2025. You should also read this discussion and analysis in conjunction with our audited consolidated financial statements, including the notes thereto, and the section in our annual report on Form 20-F/A for the year ended December 31, 2024, titled “Item 3. Key Information—D. Risk Factors.”

 

Our unaudited condensed consolidated interim financial statements for the three and nine months ended September 30, 2025, 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 lives of patients by developing a practice-changing treatment in depression. Our initial focus is on developing our novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression, or TRD.

 

Our portfolio currently includes GH001, our proprietary inhalable mebufotenin product candidate, and GH002, our proprietary intravenous mebufotenin product candidate. While GH001 is currently delivered via a vaporization device produced by a third party, we are developing a proprietary aerosol delivery device, which is currently in clinical investigation in Europe. We have completed two Phase 1 healthy volunteer clinical trials for GH001 (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, or IDR, with intra-subject dose escalation within a single day. We have also completed a Phase 1/2 clinical trial in patients with TRD (GH001-TRD-102) and have recently completed a randomized, double-blind, placebo-controlled Phase 2b trial in patients with TRD (GH001-TRD-201). Based on observed clinical activity in these clinical trials, we believe that administration of GH001 has the potential to induce ultra-rapid remissions as measured by the Montgomery–Åsberg Depression Rating Scale, or MADRS, in TRD patients.

 

We have incurred losses since inception, including losses of $34.1 million for the nine months ended September 30, 2025, and losses of $39.0 million and $35.6 million for the years ended December 31, 2024 and 2023, respectively. As of September 30, 2025, we had an accumulated deficit of $140.3 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, our expenditures on other research and development activities, and based on foreign currency translation differences. We anticipate that our expenses will increase significantly in connection with our ongoing activities, if and as we:

 

 

 

In addition, as we progress toward marketing approval for any of our product candidates, we also 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.

 

 

Comparison of the Three months ended September 30, 2025 and 2024

 

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

 

1Net finance income for the three months ended September 30, 2025 and 2024, comprises finance income, finance expense and expected credit losses.

 

 

The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:

 

1 Includes a share-based compensation expense of $1.1 million and $0.1 million for the three months ended September 30, 2025 and 2024, respectively. 

 

The following table summarizes our research and development expenses for our product candidates for the three months ended September 30, 2025 and 2024:

 

Research and development expenses increased by $2.2 million to $10.6 million for the three months ended September 30, 2025, from $8.4 million for the three months ended September 30, 2024. The increase is primarily due to increased expenses relating to our technical development activities and employee expenses. These increases have been partly offset by a decrease in clinical development expenses including clinical trial expenses.

 

 

Research and development expenses relating to GH001 increased by $0.9 million in the three months ended September 30, 2025. The increase is primarily due to increased expenses relating to our technical development activities, partly offset by a decrease in clinical development expenses including clinical trial expenses.

 

Research and development expenses relating to multiple product candidates increased by $1.4 million in the three months ended September 30, 2025, primarily due to an increase in employee expenses.

 

 

The following table summarizes our general and administrative expenses for the three months ended September 30, 2025 and 2024:

 

1 Includes a share-based compensation expense of $1.2 million and $0.1 million for the three months ended September 30, 2025 and 2024, respectively. 

 

General and administrative expenses increased by $1.8 million to $6.0 million for the three months ended September 30, 2025, from $4.2 million for the three months ended September 30, 2024. The increase is primarily due to an increase in professional fees and employee expenses in our general and administrative functions to support our growth initiatives.

 

 

Net finance income increased by $0.4 million to $2.8 million for the three months ended September 30, 2025, from $2.4 million for the three months ended September 30, 2024. The increase is primarily due to an increase in finance income relating to return on investments.

 

Foreign Exchange Loss

 

Foreign exchange loss is $0.2 million for the three months ended September 30, 2025, a movement of $1.6 million from a loss of $1.8 million for the three months ended September 30, 2024. This movement is primarily as a result of the translation of our assets and liabilities from their denominated currencies into the functional currency of each entity.

 

Comparison of the Nine months ended September 30, 2025 and 2024

 

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

 

1Net finance income for the nine months ended September 30, 2025 and 2024, comprises finance income, finance expense and expected credit losses.

 

 

The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:

 

1 Includes share-based compensation expense of $2.7 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively. 

 

 The following table summarizes our research and development expenses for our product candidates for the nine months ended September 30, 2025 and 2024:

 

Research and development expenses increased by $0.6 million to $27.4 million for the nine months ended September 30, 2025, from $26.8 million for the nine months ended September 30, 2024. The increase is primarily due to an increase in expenses relating to nonclinical activities, technical development activities, as well as employee expenses. These increases have been partly offset by a decrease in clinical development expenses including clinical trial expenses and an increase in the benefit of a research and development tax credit.

 

 

Research and development expenses relating to GH001 decreased by $0.6 million in the nine months ended September 30, 2025, primarily due to a decrease in clinical development expenses including clinical trial expenses, partly offset by an increase in technical development and nonclinical activities.

 

Research and development expenses relating to GH002 increased by $0.3 million in the nine months ended September 30, 2025, primarily due to an increase in nonclinical activities, partly offset by a decrease in technical development expenses and clinical development expenses including clinical trial expenses.

 

Research and development expenses which relate to multiple product candidates increased by $0.9 million in the nine months ended September 30, 2025, primarily due to an increase in employee expenses, partly offset by a decrease in technical development expenses, clinical development expenses and an increase in the benefit of a research and development tax credit.

 

 

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2025, and 2024:

 

1  Includes share-based compensation expense of $3.2 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively.

 

General and administrative expenses increased by $6.1 million to $16.6 million for the nine months ended September 30, 2025, from $10.6 million for the nine months ended September 30, 2024. The increase is primarily due to an increase in professional fees and employee expenses in our general and administrative functions to support our growth initiatives.

 

 

Net finance income increased by $1.0 million to $8.3 million for the nine months ended September 30, 2025, from $7.3 million for the nine months ended September 30, 2024. The increase is primarily due to an increase in finance income relating to return on investments.

 

Foreign Exchange Gain

 

Foreign exchange gain is $1.6 million for the nine months ended September 30, 2025, a movement of $1.7 million from a loss of $0.1 million for the nine months ended September 30, 2024. This movement is primarily as a result of the translation of our assets and liabilities from their denominated currencies into the functional currency of each entity.

 

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. In February 2025, we completed a public offering in which we issued and sold 10,000,000 ordinary shares at $15.00 per share. The net proceeds of the offering are $139.8 million, after deducting underwriting discounts and directly attributable transaction costs of $10.2 million.

 

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $293.9 million, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024.

 

We plan to continue to fund our operating and capital funding needs through sales of additional equity or other forms of financing. We may also consider pursuing strategic partnerships for clinical development and commercialization of our product candidates. The sale of additional equity would result in dilution to our shareholders.

 

Cash Flows

 

The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024:

 

Net Cash Flows Used in Operating Activities

 

Net cash flows used in operating activities decreased by $0.6 million to $31.2 million for the nine months ended September 30, 2025, from $31.8 million for the nine months ended September 30, 2024, due to an increase in loss from operations for the period and movement in working capital.

 

Net Cash Flows From Investing Activities

 

Net cash flows from investing activities decreased by $6.5 million to $37.3 million for the nine months ended September 30, 2025, from $43.8 million for the nine months ended September 30, 2024, due to a decrease in the proceeds from the redemption of marketable securities and a decrease in the proceeds from the sale of other financial assets.

 

Net Cash Flows From/(Used in) Financing Activities

 

Net cash flows from financing activities increased to $139.7 million in the nine months ended September 30, 2025, from net cash flows used in financing activities of $0.2 million in the nine months ended September 30, 2024. The increase is due to the receipt of proceeds from the public offering which took place during the nine months ended September 30, 2025.

 

Funding Requirements

 

We expect our expenses to continue 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. Furthermore, we have incurred and expect to continue to incur additional costs associated with operating as a public company. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of public or private 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 annual report on Form 20-F/A for the year ended December 31, 2024, and this discussion and analysis. We believe that we have sufficient financial resources available to cover our planned cash outflows for at least the next twelve months.

 

Critical Accounting Estimates

 

There have been no material changes to the significant accounting policies and significant judgments and estimates from those referred to in the section in our annual report on Form 20-F/A for the year ended December 31, 2024, titled “Item 5. Operating and Financial Review and Prospects—E. Critical Accounting Estimates.”

 

Emerging Growth Company Status

 

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) was enacted. As an emerging growth company, or EGC, we rely on exemptions and reduced reporting requirements under the JOBS Act including exemptions from (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 $1.235 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 that are mandatory for the financial year beginning on January 1, 2025, that are relevant to, and have had any material impact on, our unaudited condensed consolidated interim financial statements. The review of the impact of new standards on our unaudited condensed consolidated interim financial statements, including IFRS 18 “Presentation and Disclosure in Financial Statements”, which is not yet effective, and which has not been early adopted by us, is ongoing.

 

Risk Factors

 

The information presented below updates, and should be read in conjunction with, the risk factors and information disclosed in our Annual Report on Form 20-F/A for the year ended December 31, 2024. Except as presented below, there have been no material changes in our risk factors since those reported in our Annual Report for the year ended December 31, 2024.

 

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

 

On September 29, 2023, we announced that we were notified by the FDA that the study we proposed in our IND for GH001 has been placed on clinical hold. In October 2023, we received the formal clinical hold letter from the FDA, requesting that we provide (i) an inhalation toxicology study in a non-rodent species, and an additional inhalation toxicology study in rats, related to respiratory tract histology findings from a previously completed inhalation toxicology study in rats, (ii) additional device design verification information, and (iii) updates to our investigator brochure. On January 10, 2025, we announced the completion of the requested inhalation toxicology studies. On June 20, 2025, we announced that we submitted our complete response to the previously announced clinical hold. In July 2025, we received a response from the FDA following our submission stating that it was maintaining its clinical hold at this time and requesting additional information. We are working to respond to the FDA’s requests, but there are no assurances that the FDA will accept the results of nonclinical studies or other responses (including device design verification information) we may provide, and the FDA may require us to conduct additional nonclinical studies or other work, or have additional questions. While we do not believe the respiratory tract histology findings from our completed inhalation toxicology studies in rats to be necessarily predictive of respiratory tract toxicology in other species or humans, we may see similar findings in nonclinical studies completed in other species, if conducted, or even in humans. If the FDA does not accept the results of our nonclinical studies or our conclusions from those studies, disagrees with other responses we may provide, requires us to conduct additional trials or studies and/or finds the device design verification information we provide to be unsatisfactory, it may take a further considerable period of time, the length of which is not certain at this time, and expense for us to fully address the FDA’s concerns. Any such delays and/or increases in expense caused by the additional nonclinical studies or device design verification information we intend to submit could be exacerbated by a need to find, or develop, an alternative device to deliver GH001. Further, comparable foreign regulatory authorities may also have questions or requests or may initiate the equivalent of a clinical hold, in each case prompted by the clinical hold by the FDA or by the nonclinical studies or any other work we may initiate, which may similarly take considerable time and expense for us to address. Even if we are able to fully respond to the FDA’s current concerns, the FDA may subsequently make additional requests that we would need to fulfill prior to the lifting of the clinical hold. It is possible that we will be unable to fully address the FDA’s concerns and, as a result, the clinical hold may never be lifted, and we may never be able to initiate clinical trials for GH001 in the United States. It is also possible that the clinical hold may be lifted as to the clinical trial of GH001 we proposed in our IND, but that future clinical trials of GH001 or clinical trials of GH002 or other product candidates we propose in future INDs are placed on clinical hold by the FDA. These matters could have a material adverse effect on our clinical development efforts or could otherwise harm our business, financial condition, results of operation and prospects.

 

We may not be able to submit INDs or IND amendments, or comparable foreign applications, to commence additional clinical trials on the timelines we expect, and even if we are able to do so, the FDA, EMA or comparable foreign regulatory authorities may not permit us to proceed.

 

In November 2022, we announced that we submitted clinical trial applications in several European countries for a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in TRD (GH001-TRD-201), and in August 2023, we submitted an IND for GH001 with the FDA, with the purpose to initiate a Phase 1 healthy volunteer clinical pharmacology trial, where GH001 is administered using our proprietary aerosol delivery device (GH001-HV-106). We also expect to submit an IND for GH002 with the FDA. However, we may not be able to submit INDs or comparable foreign applications for GH001, GH002, or for our other product candidates, on the timelines we expect. For example, we may experience delays with IND-enabling studies. Moreover, we cannot be sure that submission of an IND or a comparable foreign application will result in the FDA, the European Medicines Agency, or the EMA, or a comparable foreign regulatory authority allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials. For example, we announced in September 2023 that the FDA placed our IND for GH001 on clinical hold and in July 2025 we received a response from the FDA stating that it was maintaining its clinical hold at this time and requesting additional information. See “—It may take considerable time and expense to resolve the clinical hold that has been placed by the FDA on the study we proposed in our IND for GH001, and no assurance can be given that the FDA will remove the clinical hold, which could have a material adverse effect on our clinical development efforts or could otherwise harm our business, financial condition, results of operation and prospects” above for further information on certain of the risks associated with this clinical hold. Additionally, even if such regulatory authorities ultimately agree with the design and implementation of the clinical trials set forth in an IND or in a comparable foreign application, we cannot guarantee that such regulatory authorities will not change their requirements in the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs or to a new IND, or to comparable existing or new foreign applications. Any failure to submit INDs or comparable foreign applications on the timelines we expect, or to obtain permission for our trials to proceed, may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.

 

Cautionary Statement Regarding Forward-Looking Statements

 

This discussion contains statements that are, or may be deemed to be, forward-looking. All statements other than statements of historical fact included in this discussion, including statements regarding the clinical hold on GH001, including plans and expectations for progressing any nonclinical programs and any other work needed to lift the continuing clinical hold and the timing required for the FDA to lift such clinical hold; our plans and expectations with respect to progressing development of GH002 and the likelihood of IND submission; our targets regarding the initiation of our first global pivotal program; our business strategy, product candidates, medical devices required to deliver these product candidates, ongoing and currently planned nonclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy; our expectations related to commencing trials in the United States, research and development costs, cash runway, 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 titled “—Risk Factors” herein and the section in our annual report on Form 20-F/A for the year ended December 31, 2024, titled “Item 3. Key Information—D. 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 titled “—Risk Factors” herein and the sections in our annual report on Form 20-F/A for the year ended December 31, 2024, titled “Item 3. Key Information—D. Risk Factors” and “Item 5. Operating and Financial Review and Prospects” and elsewhere in our annual report and 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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GH Research Reports Third Quarter 2025 Financial Results and Provides Business Updates

 

November 6, 2025

•

Engagement with FDA on GH001 IND complete response ongoing

•

Full dataset from the Phase 2b clinical trial of GH001 in TRD reported in July 2025

•

Long-term clinical data on safety and efficacy from Open-Label Extension presented at ECNP in October 2025

•

Cash, cash equivalents and marketable securities of $293.9 million as of September 30, 2025

 

DUBLIN, November 6, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the quarter ended September 30, 2025, and provided updates on its business.

 

 

 

 

 

 

 

 

 

 

Third Quarter 2025 Financial Highlights

 

Cash position

 

Cash, cash equivalents and marketable securities were $293.9 million as of September 30, 2025, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024. Other financial assets are comprised of money market funds, and marketable securities are comprised of investment grade bonds.

 

Research and development expenses

 

R&D expenses were $10.6 million for the quarter ended September 30, 2025, compared to $8.4 million for the same quarter in 2024. The increase is primarily due to increased expenses relating to technical development activities and employee expenses, partly offset by a decrease in clinical development expenses.

 

General and administrative expenses

 

G&A expenses were $6.0 million for the quarter ended September 30, 2025, compared to $4.2 million for the same quarter in 2024. The increase is primarily due to an increase in professional fees and employee expenses.

 

Net loss

 

Net loss was $14.0 million, or $0.23 loss per share, for the quarter ended September 30, 2025, compared to $12.1 million, or $0.23 loss per share, for the same quarter in 2024.

 

About GH Research PLC

 

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD). Based on the observed clinical activity in our Phase 2b trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that our mebufotenin product candidates have the potential to change the way TRD is treated today.

 

About GH001

 

Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today.

 

About GH002

 

GH002 is our mebufotenin product candidate formulated for administration via a proprietary intravenous approach. We have completed a Phase 1 trial of GH002 in healthy volunteers.

 

Forward-Looking Statements

 

Investor Relations:

 

Julie Ryan

 

 

Condensed Consolidated Interim Statement of Comprehensive Loss (Unaudited)

 

(in thousands, except share and per share amounts)

 

 

Condensed Consolidated Interim Balance Sheet (Unaudited)

 

(in thousands)