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
second quarter ended June 30, 2023 and provided business updates.
Second Quarter 2023 Financial
Highlights
Cash position
Cash, cash equivalents, other financial assets
and marketable securities were $238.1 million as of June 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 $7.2 million for the
quarter ended June 30, 2023, compared to $4.2 million for the same
quarter in 2022. The increase was primarily due to increased
activities relating to our technical development and clinical
trials and increases in employee expenses to support these
activities.
General and administrative expenses
G&A expenses were $2.7 million for the
quarter ended June 30, 2023, compared to $2.5 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 $7.7 million, or $0.15 loss per
share, for the quarter ended June 30, 2023, compared to a net
profit of $0.3 million, or $0.01 earnings per share, for the same
quarter in 2022. The net profit in the prior year quarter was due
to a foreign exchange gain which was not repeated in 2023.
Business Updates
GH001
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). Patient enrollment for this trial is underway,
with expected recruitment of approximately 80 patients across
several European countries. The primary objective is to determine
the efficacy of our single-day individualized dosing regimen (IDR)
of GH001 compared with placebo in improving depressive symptoms as
assessed by the mean change from baseline in Montgomery-Åsberg
Depression Rating Scale (MADRS) at the end of the 7-day
double-blind phase. The double-blind phase is followed by a 6-month
open-label extension phase where all patients can receive treatment
with the GH001 IDR as-needed, based on the patient’s clinical
status. Further trial design details are described in our corporate
presentation, which is available in the investor section on our
website.
As previously announced, we expect to submit an
IND with the U.S. FDA for GH001 in TRD, delivered with our
proprietary aerosol delivery device, in the third quarter of 2023.
Pending clearance by the FDA, we expect to initiate a Phase 1
clinical pharmacology trial of GH001 delivered with our proprietary
aerosol delivery device in healthy volunteers (GH001-HV-106) in the
fourth quarter of 2023. The trial is designed to support bridging
to the clinical data generated with the third-party device we
currently use in our clinical trials.
Our Phase 2a proof-of-concept clinical trial of
GH001 in postpartum depression (GH001-PPD-203) is ongoing and, as
previously announced, is expected to be completed in the fourth
quarter of 2023. Our Phase 2a proof-of-concept clinical trial of
GH001 in bipolar II disorder with a current depressive episode
(GH001-BD-202) is recruiting slower than previously projected and
we now expect this trial to be completed 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.
Expansion of Executive Management Team
We are pleased to announce the recent expansion
of our Executive Management Team, with the appointment of Velichka
(Villy) Valcheva, MD, MSc as VP Clinical Research and Medical
Affairs. Villy has more than 20 years’ experience in various
leadership roles, with global exposure in pharmaceutical and
biotech companies, including Global Senior Medical Director
positions at Ipsen and Sanofi. Villy joins us from Albireo, where,
in her position as VP and Head of Medical Affairs International,
she was responsible for all international medical activities,
played a pivotal role in gaining market access across multiple
countries, was deeply involved in driving the company’s strategic
decisions, and significantly contributed to the recent acquisition
of Albireo by Ipsen.
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 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. GH001 is currently in a multi-center, randomized,
double-blind, placebo-controlled Phase 2b trial of GH001 in
TRD.
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, 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 endedJune 30, |
|
Six months endedJune 30, |
|
2023 |
2022 |
|
2023 |
2022 |
|
$’000 |
$’000 |
|
$’000 |
$’000 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
Research and development |
(7,176) |
(4,240) |
|
(14,482) |
(8,954) |
General and administration |
(2,749) |
(2,510) |
|
(5,862) |
(5,802) |
Loss from
operations |
(9,925) |
(6,750) |
|
(20,344) |
(14,756) |
|
|
|
|
|
|
Finance income |
2,122 |
- |
|
3,611 |
- |
Finance expense |
(179) |
- |
|
(350) |
- |
Movement of expected credit loss |
217 |
- |
|
18 |
- |
Foreign exchange gain/(loss) |
36 |
7,084 |
|
(1,601) |
9,327 |
Total other
income |
2,196 |
7,084 |
|
1,678 |
9,327 |
|
|
|
|
|
|
(Loss)/profit before
tax |
(7,729) |
334 |
|
(18,666) |
(5,429) |
Tax charge/(credit) |
- |
- |
|
- |
- |
(Loss)/profit for the
period |
(7,729) |
334 |
|
(18,666) |
(5,429) |
|
|
|
|
|
|
Other comprehensive
(expense)/income |
|
|
|
|
|
Items that may be
reclassified to profit or loss |
|
|
|
|
|
Fair value movement on marketable securities |
(1,512) |
- |
|
(788) |
- |
Currency translation adjustment |
(57) |
(7,054) |
|
1,619 |
(9,315) |
Total comprehensive
loss for the period |
(9,298) |
(6,720) |
|
(17,835) |
(14,744) |
|
|
|
|
|
|
Attributable to
owners: |
|
|
|
|
|
(Loss)/profit for the period |
(7,729) |
334 |
|
(18,666) |
(5,429) |
Total comprehensive loss for the period |
(9,298) |
(6,720) |
|
(17,835) |
(14,744) |
|
|
|
|
|
|
(Loss)/earnings per
share |
|
|
|
|
|
Basic and diluted (loss)/earnings per share (in USD) |
(0.15) |
0.01 |
|
(0.36) |
(0.10) |
|
GH RESEARCH PLCCondensed Consolidated
Interim Balance Sheet (Unaudited)(in thousands) |
|
|
|
At June 30, |
At December 31, |
|
|
2023 |
2022 |
|
|
$’000 |
$’000 |
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
|
96,895 |
165,955 |
Other financial assets |
|
54,728 |
- |
Marketable securities |
|
13,761 |
- |
Other current assets |
|
1,015 |
2,586 |
Total current
assets |
|
166,399 |
168,541 |
Non-current
assets |
|
|
|
Marketable securities |
|
72,697 |
85,724 |
Property, plant, and equipment |
|
1,176 |
97 |
Total non-current
assets |
|
73,873 |
85,821 |
Total
assets |
|
240,272 |
254,362 |
|
|
|
|
LIABILITIES AND
EQUITY |
|
|
|
Current
liabilities |
|
|
|
Trade payables |
|
2,912 |
1,868 |
Lease liability |
|
267 |
- |
Other current liabilities |
|
3,378 |
2,678 |
Total current
liabilities |
|
6,557 |
4,546 |
Non-current
liabilities |
|
|
|
Lease liability |
|
732 |
- |
Total non-current
liabilities |
|
732 |
- |
Total
liabilities |
|
7,289 |
4,546 |
|
|
|
|
Equity attributable to
owners |
|
|
|
Share capital |
|
1,301 |
1,301 |
Additional paid-in capital |
|
291,448 |
291,448 |
Other reserves |
|
2,809 |
2,595 |
Foreign currency translation reserve |
|
(11,416) |
(13,035) |
Accumulated deficit |
|
(51,159) |
(32,493) |
Total
equity |
|
232,983 |
249,816 |
Total liabilities and
equity |
|
240,272 |
254,362 |
|
|
|
|
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