- Strong financial position and visibility
- Cash position of €11 million
- Financing of activities assured into Q4 2023
- Starting new Phase II clinical trial evaluating temelimab in
patients with “Long‑COVID”
- The personalized medicine trial will evaluate temelimab as a
Disease Modifying Therapy in long-COVID patients suffering from
severe neurological and psychiatric symptoms and who are positive
for the presence of the pathogenic W-ENV protein in their
blood
- New data on the link between HERV-K ENV and ALS
- Two studies on ALS (Amyotrophic Lateral Sclerosis) published in
Annals of Neurology demonstrate the neurotoxic role of human
endogenous retrovirus envelope protein (HERV-K/HML-2 ENV) and the
rationale for targeted therapy with GeNeuro’s new specific
antibody
Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 – GNRO), a
biopharmaceutical company focused on stopping causal factors
driving the progression of neurodegenerative and autoimmune
diseases such as multiple sclerosis (MS), amyotrophic lateral
sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC,
long-COVID or post-COVID), today reported its half-year financial
results for the period ending June 30, 2022 and provided a
corporate update.
Key Financials
On September 29, 2022, the Board of Directors of GeNeuro
reviewed and approved the financial statements for the six-month
period ended June 30, 2022. The auditors have conducted a review of
the condensed consolidated interim financial statements. The
half-year financial report is available in the Investors section on
www.geneuro.com.
“In March 2022, we presented the successful ProTEct-MS Phase II
top-line results, which has met our key objective of showing that
temelimab could bring additional benefits on key markers of
neurodegeneration in a population of MS patients already treated
with a highly effective anti-inflammatory drug. GeNeuro has resumed
discussions with regulatory authorities and with potential partners
to define the best development path combining temelimab and
anti-inflammatory treatments to treat relapses and disability
progression, the key unmet medical need in MS," said Jesús
Martin-Garcia, CEO of GeNeuro. "The successful completion of
the May 2022 capital increase provides GeNeuro with the means to
complete its post-COVID program with temelimab. This trial, which
has now started, will be the first personalized therapeutic
approach in this indication, as the study will only enroll patients
who are positive to the pathogenic W-ENV protein."
“Thanks to the capital increase of May 2022 and a cash balance
of €11 million at the end of the semester, our financial visibility
extends into Q4 2023 taking into account all costs related to the
Long-COVID trial,” said Miguel Payró, Chief Financial Officer at
GeNeuro. “The financial results for the first half of 2022,
which are largely in line with our expectations, reflect the
increase in activity in connection with our long-COVID trial.
Indeed, during the first half of 2022 our gross R&D expenses
increased by 75% compared to the same period of 2021, primarily due
to the launch of a new production of temelimab, our lead drug
candidate, in order to meet the needs of the new GNC-501 Phase 2
clinical trial treating long-COVID patients with severe
neurological and psychiatric symptoms with temelimab. At the same
time, the amount of subsidies and grants more than doubled over the
period, to €1.2 million. As for our general and administrative
expenses, thanks to our continuing cost containment efforts, these
have increased by only 4%, largely thanks to a decrease of 12% in
our administrative payroll expense. Overall, due to the increase in
our clinical activities, the operating loss has increased from
€3.5m to €4.9m in 1H 2022. This loss is in line with our
expectations.”
Cash burn from operating and investing activities in 1H 2022 was
€2.5m, compared to €3.7m in 1H 2021. This is largely due to the
payment during 1Q 2022 of the first instalment from the Swiss
Federal Office for Public Health (FOPH) subsidy for the long-COVID
trial. Taking into account the expected increase in R&D
expenses related to the start of this trial, the cash burn for the
full year is now estimated to be approximately €12.5m on a gross
basis, and €6m when taking into account the FOPH subsidy
instalments and the 2021 French Research Tax Credit, compared to
€6.8m net for 2021.
Condensed Consolidated Income
Statement
(in thousands of EUR)
subject to a limited review
June 30, 2022
6 months
June 30, 2021
6 months
Income
-
-
Research & Development
expenses
(3,402
)
(2,080
)
R&D expenses
(4,651
)
(2,664
)
Subsidies
1,249
584
General & administrative
expenses
(1,487
)
(1,426
)
Operating loss
(4,889
)
(3,506
)
Net loss for the period
(5,675
)
(3,403
)
Basic loss per share (EUR)
(0.25
)
(0.17
)
Diluted loss per share (EUR)
(0.25
)
(0.17
)
Cash outflow from operations
(2,519
)
(3,703
)
Cash at period end
10,999
2,961
As in the prior year and as expected, no Income was
recognized during 1H 2022.
Research & Development expenses increased by 75% on a
gross (before subsidies) basis, compared to the first half of 2021,
due to expenses related to the preparation of the long-COVID trial
and the completion of the ProTEct-MS study of temelimab in MS at
the Karolinska Institutet in Stockholm. Costs for studies and
research more than doubled from €1,555K to €3,236K (+108%), whereas
other research and development costs showed either decreases or
much slower increases; in particular, personnel costs increased
from €783K to €1,023K due to the build-up in clinical staff for the
long-COVID trial. Reflecting the increase in R&D activities,
subsidies also increased from €584K to €1,249K, with net R&D
costs increasing by 64%.
General and administrative expenses increased by 4% in 1H
2022, following a 17% decrease in 1H 2021. Among the key expense
categories to increase were travel expenses (+€89K), as
COVID-related restrictions were lifted; and professional fees
(+€64K). The Company continued to control its administrative staff
costs, which decreased by €97K (-12%) due to lower variable
compensation. Share-based payments recorded an expense of €75K
compared to €54K in 1H 2021.
Financial expenses increased from €103K in 1H 2021 to
€787K in 1H 2022, which includes €589K of share-based expense
related to the May 2022 capital increase having been realized
through a private placement at a 7% discount to the market
price.
As a result, the Company recorded a net loss of €5,675K in 1H
2022, compared to a net loss of €3.4m in 1H 2021, in line with
management's expectations.
Cash and cash equivalents amounted to €11m at 30 June
2022, compared to €5.5m at 31 December 2021. This reflects the €3m
first instalment payment from the Swiss FOPH subsidy contract for
the Long-COVID trial as well as the €7.7m capital increase
completed in May 2022 through a private placement reserved for
institutional investors. In addition, the Company entered into an
unsecured 3-year €1m bank loan with a major French bank. Cash burn
in 1H 2022 was €2.5m, compared to €3.7m in 1H 2021; taking into
account all the costs of the long-COVID clinical trial, cash burn
for the full year is now estimated to be approximately €12.5m on a
gross basis, and €6m when taking into account the FOPH subsidy
instalments and the 2021 French Research Tax Credit (received in
September 2022), compared to €6.8m net for 2021.
Business and Financial Outlook
Multiple Sclerosis (MS): on March 21, 2022, GeNeuro
presented the top-line results from its ProTEct-MS temelimab Phase
2 MS trial performed at the Karolinska Institutet’s Academic
Specialist Center in Stockholm.
The primary endpoint of the ProTEct-MS study was met, with
results confirming the excellent safety profile and tolerability of
higher doses of temelimab administered concomitantly with a
high-efficacy anti-inflammatory drug.
Efficacy data, obtained in this patient group already
effectively treated against inflammation, showed that temelimab has
a favorable impact on key MRI parameters measuring
neurodegeneration; the observed effect sizes in this new patient
population were consistent with the ones shown in the previous
CHANGE-MS and ANGEL-MS studies.
By targeting fundamental underlying mechanisms of
neurodegeneration in MS, i.e. neutralizing microglial-mediated
damage, as well as restoring OPC1 remyelination capacity, temelimab
may address progression independent of relapses, the critical unmet
need in MS.
Long-COVID: the expression of the pathogenic W-ENV
protein triggered by the SARS-CoV-2 infection, continuing long
after the acute COVID-19 phase has been resolved, is suspected to
have a major role in the persistence of inflammation in many
long-COVID patients, and may explain many of the nervous system
disorders that patients experience, such as cognitive losses and
fatigue. GeNeuro has started a 6-month multicentre personalized
medicine trial, co-financed by the Swiss FOPH, to evaluate
temelimab as a Disease Modifying Therapy in long-COVID patients
suffering from severe neurological and psychiatric symptoms. The
study will recruit 200 patients who are positive for the presence
of the pathogenic W-ENV protein in their blood.
Amyotrophic lateral sclerosis: as previously reported,
two joint publications in the leading scientific journal "Annals of
Neurology" presented the results of the collaboration between
GeNeuro and the US National Institute of Neurological Disorders and
Stroke (NINDS), which is part of the National Institutes of Health
(NIH) of the United States. The two publications describe the novel
pathogenic mechanism of HERV-K in sporadic ALS and confirm the
rationale for the therapeutic relevance of GeNeuro's antibody to
neutralize this neurotoxic protein. GeNeuro's preclinical
development program has confirmed the ability to detect HERV-K ENV
in sporadic ALS patients and has enabled its anti-HERV-K ENV
antibody to be humanized and ready to enter GMP production. The
published findings now open the way for precision medicine with a
biomarker-based clinical approach, administering GeNeuro’s
neutralizing antibody only to sporadic ALS patients who are
positive to the HERV-K ENV protein. As previously mentioned,
GeNeuro continues to actively discuss paths with potential partners
for the clinical development of GNK301.
Financial visibility until end 2023: thanks to the
capital increase completed in May 2022, the Company’s cash provides
financial visibility into Q4 2023, including the completion of the
long-COVID clinical trial.
Other highlights and post-closing events
On August 30, 2022, the Company announced the joint publications
in the leading scientific journal "Annals of Neurology" of the
results of the collaboration between GeNeuro and the National
Institute of Neurological Disorders and Stroke (NINDS).
Next events
Investor Access Event: October 6-7, 2022 – Paris ECTRIMS: oral
presentation of ProTEct-MS results, October 27, 2022 -
Amsterdam
About GeNeuro
GeNeuro‘s mission is to develop safe and effective treatments
against neurological disorders and autoimmune diseases, such as
multiple sclerosis, by neutralizing causal factors encoded by
HERVs, which represent 8% of human DNA.
GeNeuro is based in Geneva, Switzerland and has R&D
facilities in Lyon, France. It has rights to 17 patent families
protecting its technology.
For more information, visit: www.geneuro.com.
Disclaimer
This press release contains certain forward - looking statements
and estimates concerning GeNeuro’s financial condition, operating
results, strategy, projects and future performance and the markets
in which it operates. Such forward-looking statements and estimates
may be identified by words such as “anticipate,” “believe,” “can,”
“could,” “estimate,” “expect,” “intend,” “is designed to,” “may,”
“might,” “plan,” “potential,” “predict,” “objective,” “should,” or
the negative of these and similar expressions. They incorporate all
topics that are not historical facts. Forward looking statements,
forecasts and estimates are based on management’s current
assumptions and assessment of risks, uncertainties and other
factors, known and unknown, which were deemed to be reasonable at
the time they were made but which may turn out to be incorrect.
Events and outcomes are difficult to predict and depend on factors
beyond the Company’s control. Consequently, the actual results,
financial condition, performances and/or achievements of GeNeuro or
of the industry may turn out to differ materially from the future
results, performances or achievements expressed or implied by these
statements, forecasts and estimates. Owing to these uncertainties,
no representation is made as to the correctness or fairness of
these forward-looking statements, forecasts and estimates.
Furthermore, forward-looking statements, forecasts and estimates
speak only as of the date on which they are made, and GeNeuro
undertakes no obligation to update or revise any of them, whether
as a result of new information, future events or otherwise, except
as required by law.
_________________________ 1 Oligodendrocyte precursor cell
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GeNeuro
Jesús Martin-Garcia
Chairman and CEO +41 22 552 4800 investors@geneuro.com
NewCap (France)
Louis-Victor Delouvrier / Mathilde Bohin (investors)
+33 1 44 71 98 52 Arthur Rouillé (media) +33 1 44 71 94 98
geneuro@newcap.eu
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