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, 2023, and provided business
updates.
Third Quarter 2023 Financial
Highlights
Cash position
Cash, cash equivalents, other financial assets
and marketable securities were $228.7 million as of September 30,
2023, compared to cash, cash equivalents and marketable securities
of $251.7 million as of December 31, 2022. Cash equivalents
and other financial assets comprise money market funds. Marketable
securities comprise investment grade bonds. We believe that our
existing cash, cash equivalents, other financial assets and
marketable securities will be sufficient for us to fund our
operating expenses and capital expenditure requirements into
2026.
Research and development
expenses
R&D expenses were $7.1 million for the
quarter ended September 30, 2023, compared to $4.6 million for the
same quarter in 2022. The increase was primarily due to increased
activities relating to our clinical trials and increases in
employee expenses to support these activities.
General and administrative expenses
G&A expenses were $2.6 million for the
quarter ended September 30, 2023, compared to $2.0 million for the
same quarter in 2022. The increase was primarily due to an increase
in professional fees and employee expenses offset by lower
insurance costs.
Net loss
Net loss was $5.6 million, or $0.11 loss per
share, for the quarter ended September 30, 2023, compared to a net
loss of $0.4 million, or $0.01 loss per share, for the same quarter
in 2022.
Business Updates
GH001 in TRD
GH001, our proprietary inhalable mebufotenin
(5-MeO-DMT) product candidate, is currently being investigated in a
multi-center, randomized, double-blind, placebo-controlled Phase 2b
trial in patients with treatment-resistant depression (TRD)
(GH001-TRD-201). The trial has been approved in seven European
countries and is expected to recruit approximately 80 patients
across approximately 20 sites. Patient enrollment is on schedule
and we continue to expect completion of the double-blind phase of
this trial in the third quarter of 2024, with availability of
top-line data in the third or the fourth quarter of 2024. In this
trial, GH001 is administered using an externally-sourced inhalation
device.
Update on IND for GH001
In August 2023, we submitted an Investigational
New Drug Application (IND) for GH001 with the U.S. Food and Drug
Administration (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). The trial is designed to support bridging to the
clinical data generated with the third-party device we currently
use in our clinical trials. As previously announced in September,
the FDA advised that it had placed our IND on clinical hold.
We have now received a formal clinical hold
letter from the FDA. To remove the hold, they have requested 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. We are working to respond to the FDA’s
requests, including by initiating the requested nonclinical
studies. We intend to request a meeting with the FDA, expected to
take place in the first quarter of 2024, if granted, to discuss the
feedback, provide clarifications, and discuss our plan to address
their comments. We intend to provide an update regarding the IND
response submission and the planned Phase 1 healthy volunteer
clinical pharmacology trial (GH001-HV-106) in due course after
taking into account the conclusions of that meeting.
GH001 in BD and PPD
GH001 is also currently being investigated in a
proof-of-concept clinical trial in patients with bipolar II
disorder with a current depressive episode (GH001-BD-202) and in a
proof-of-concept clinical trial in patients with postpartum
depression (GH001-PPD-203).
Recently, the clinical research organization
that manages one of our clinical trial sites informed us that the
site will be closed for business reasons. As this is one of two
sites activated in each trial, and because both trials have been
recruiting slower than previously projected, we expect a delay in
the completion of the trials. We are in the process of putting
measures in place to support recruitment of both trials, including
the addition of further clinical trial sites, and we plan to
provide an updated timeline for expected trial completion in the
first quarter of 2024.
GH002
As previously announced, our randomized,
double-blind, placebo-controlled, dose-ranging clinical
pharmacology trial of GH002, our mebufotenin (5-MeO-DMT) product
candidate formulated for administration via a proprietary
intravenous approach, in healthy volunteers (GH002-HV-105) is
expected to be completed in the fourth quarter of 2023.
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
mebufotenin (5-MeO-DMT) therapies for the treatment of patients
with treatment-resistant depression (TRD).
GH Research PLC's annual report on Form 20-F/A
filed with the U.S. Securities and Exchange Commission for the year
ended December 31, 2022 is available at www.ghres.com and
shareholders may receive a hard copy free of charge upon
request.
About GH001
Our lead product candidate, GH001, is formulated
for mebufotenin (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 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. GH001 is
currently in a multi-center, randomized, double-blind,
placebo-controlled Phase 2b trial in patients with TRD and in two
Phase 2a proof-of-concept trials in patients with bipolar II
disorder and a current depressive episode and in patients with
postpartum depression.
About GH002 and GH003
GH002 is our mebufotenin (5-MeO-DMT) product
candidate formulated for administration via a proprietary
intravenous approach. GH002 is currently in Phase 1 clinical
development. GH003 is our mebufotenin (5-MeO-DMT) product candidate
formulated for administration via a proprietary intranasal
administration approach. GH003 is currently in preclinical
development. We anticipate developing GH002 and GH003 in
subpopulations and confined use scenarios within our focus
area of psychiatric and neurological disorders.
Forward-Looking Statements
This press release contains statements that are,
or may be 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, medical devices required to deliver these product
candidates, research pipeline, ongoing and currently planned
preclinical studies and clinical trials, regulatory submissions and
approvals, including our plans and expectations for discussions
with the FDA and the outcomes and resolution of such discussions
related to the clinical hold on the GH001 IND, research and
development costs, cash runway, 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 press release
speak only as of the date hereof. 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 RyanGH Research
PLCinvestors@ghres.com
GH RESEARCH PLCCondensed Consolidated
Interim Statement of Comprehensive Income (Unaudited)(in
thousands, except share and per share amounts) |
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2023 |
2022 |
|
2023 |
2022 |
|
$’000 |
$’000 |
|
$’000 |
$’000 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
Research and development |
(7,088) |
(4,620) |
|
(21,570) |
(13,574) |
General and administration |
(2,631) |
(2,006) |
|
(8,493) |
(7,808) |
Loss from
operations |
(9,719) |
(6,626) |
|
(30,063) |
(21,382) |
|
|
|
|
|
|
Finance income |
2,438 |
- |
|
6,049 |
- |
Finance expense |
(184) |
- |
|
(534) |
- |
Movement of expected credit loss |
(17) |
- |
|
1 |
- |
Foreign exchange gain |
1,833 |
6,185 |
|
232 |
15,512 |
Total other
income |
4,070 |
6,185 |
|
5,748 |
15,512 |
|
|
|
|
|
|
Loss before
tax |
(5,649) |
(441) |
|
(24,315) |
(5,870) |
Tax charge/(credit) |
- |
- |
|
- |
- |
Loss for the
period |
(5,649) |
(441) |
|
(24,315) |
(5,870) |
|
|
|
|
|
|
Other comprehensive
expense |
|
|
|
|
|
Items that may be reclassified to
profit or loss |
|
|
|
|
|
Fair value movement on marketable securities |
(428) |
- |
|
(1,216) |
- |
Currency translation adjustment |
(1,780) |
(6,464) |
|
(161) |
(15,779) |
Total comprehensive loss
for the period |
(7,857) |
(6,905) |
|
(25,692) |
(21,649) |
|
|
|
|
|
|
Attributable to
owners: |
|
|
|
|
|
Loss for the period |
(5,649) |
(441) |
|
(24,315) |
(5,870) |
Total comprehensive loss for the period |
(7,857) |
(6,905) |
|
(25,692) |
(21,649) |
|
|
|
|
|
|
Loss per
share |
|
|
|
|
|
Basic and diluted loss per share (in USD) |
(0.11) |
(0.01) |
|
(0.47) |
(0.11) |
GH RESEARCH PLCCondensed Consolidated
Interim Balance Sheet (Unaudited)(in thousands) |
|
|
At September 30, |
At December 31, |
|
|
2023 |
2022 |
|
|
$’000 |
$’000 |
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
|
86,439 |
165,955 |
Other financial assets |
|
55,494 |
- |
Marketable securities |
|
19,343 |
- |
Other current assets |
|
2,765 |
2,586 |
Total current
assets |
|
164,041 |
168,541 |
Non-current
assets |
|
|
|
Marketable securities |
|
67,449 |
85,724 |
Property, plant, and equipment |
|
1,078 |
97 |
Total non-current
assets |
|
68,527 |
85,821 |
Total
assets |
|
232,568 |
254,362 |
|
|
|
|
LIABILITIES AND
EQUITY |
|
|
|
Current
liabilities |
|
|
|
Trade payables |
|
2,707 |
1,868 |
Lease liability |
|
260 |
- |
Other current liabilities |
|
3,167 |
2,678 |
Total current
liabilities |
|
6,134 |
4,546 |
Non-current
liabilities |
|
|
|
Lease liability |
|
661 |
- |
Total non-current
liabilities |
|
661 |
- |
Total
liabilities |
|
6,795 |
4,546 |
|
|
|
|
Equity attributable to
owners |
|
|
|
Share capital |
|
1,301 |
1,301 |
Additional paid-in capital |
|
291,448 |
291,448 |
Other reserves |
|
2,888 |
2,595 |
Foreign currency translation reserve |
|
(13,196) |
(13,035) |
Accumulated deficit |
|
(56,668) |
(32,493) |
Total
equity |
|
225,773 |
249,816 |
Total liabilities and
equity |
|
232,568 |
254,362 |
|
|
|
|
GH Research (NASDAQ:GHRS)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
GH Research (NASDAQ:GHRS)
Gráfica de Acción Histórica
De May 2023 a May 2024