- Phase 2 clinical trial of temelimab against neuropsychiatric
syndromes of Post-COVID (GNC-501):
- Recruitment completed in November 2023;
- Topline results planned for end of June 2024.
- Cash position of €2.8m as of December 31, 2023, including
the €1m pre-financing of Research tax Credit received in January
2024
- Financial visibility into the third quarter of 2024 taking
into account the €5m capital increase completed in Q1 2024
Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 – GNRO), a
biopharmaceutical company focused on halting the progression of
neurodegenerative and autoimmune diseases such as multiple
sclerosis (MS), amyotrophic lateral sclerosis (ALS) and the
post-acute sequelae of COVID-19 (PASC, long COVID or post-COVID),
reported today its full-year results for the year ended December
31, 2023, and provided a corporate update.
With the completion in February 2024 of a EUR 5 million capital
increase, GeNeuro’s cash position provides financial visibility
into 3Q 2024 based on its current activities.
“2023 was an important year for GeNeuro, with the completion of
patient recruitment of our GNC-501 Phase 2 trial evaluating
temelimab against post-COVID. GeNeuro is conducting the first
personalized medicine clinical trial against neuropsychiatric
syndromes affecting Post-COVID patients, and we are now looking
forward to the topline results at the end of June 2024. This trial
benefits from an important financial backing from the Swiss and
European authorities who seek potential therapeutic solutions to
address a major public health problem which affects millions of
patients”, said Jesús Martin-Garcia, CEO of GeNeuro. “In our
other main indication, multiple sclerosis, we have continued our
discussions 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.”
PRODUCT DEVELOPMENT HIGHLIGHTS
Multiple Sclerosis (MS)
In MS, GeNeuro is focused on combating neurodegeneration. The
Company has completed three Phase 2 clinical trials, the latest,
which was completed in 2022, in patients with relapsing-remitting
MS under treatment with rituximab, a monoclonal anti-CD20 antibody
that is highly potent and effective against the acute course of the
disease (inflammatory relapses and brain lesion formation). The
results from this study were presented in October 2022 at the
ECTRIMS scientific congress and have shown that 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; in addition, efficacy data, obtained in
these patients already effectively treated against inflammation,
showed that temelimab has a favorable impact on key MRI and liquid
measures of neurodegeneration. Given the high costs of the
international clinical trials necessary to confirm efficacy and
register a product in MS with both the FDA and the EMA, which the
Company estimates to exceed €100 million, continued development in
MS requires a partnership and GeNeuro has continued discussions
with potential partners to define the best development path for
combining existing anti-inflammatory treatments, to treat relapses,
with temelimab to treat neurodegeneration and disability
progression, the key unmet medical need in MS.
Post-COVID
GeNeuro is currently running a Phase 2 clinical trial with
temelimab to treat, during six months, patients suffering from
severe neurological and psychiatric (“neuropsychiatric”) symptoms
post-COVID. GeNeuro has completed the recruitment of 203 patients
in this clinical trial in November 2023, and is expecting its
results for June 2024. This trial, partly financed by the Swiss
Federal Office of Public Health (“FOPH”) through a grant of CHF 6.7
million (€7 million) by the European Investment Bank through a €7
million venture debt financing, results from research conducted
following the COVID-19 pandemic and the emergence of post-COVID,
leading to published results that (1) evidenced the presence of
W-ENV in the serum of patients suffering from acute COVID; (2)
evidenced that SARS-CoV-2 is able to induce the in vitro expression
of W-ENV in human blood cells of approximately 20% of the samples
of healthy volunteers; and (3) have shown that the W-ENV protein is
present in more than 25% of post- COVID patients. This
placebo-controlled double-blind study is the largest one to date in
this indication and the only one based on a precision medicine
approach, as each enrolled patient has been tested positively for
the presence of W-ENV. This study includes numerous clinical
endpoints, including the primary endpoint which is the measure of
fatigue in the patients; as there is today no available
disease-modifying therapy against post-COVID syndromes, positive
results could lead to accelerated processes to make temelimab
rapidly available to the millions of patients affected by severe
post-COVID in Europe and in the USA.
Amyotrophic Lateral Sclerosis
(ALS)
GeNeuro’s pre-clinical program in ALS, developed in partnership
with the NINDS in the United States, has achieved a very strong
preclinical proof of concept, published in major scientific
publications such as Annals of Neurology, and confirmed by
third-party research groups.; The continuation of the Company
program towards IND submission, with a timing target of 18 months
after such fundraising, requires a specific financing estimated at
€7 million.
KEY FINANCIALS 2023
The Board of Directors of GeNeuro reviewed and approved the
financial statements for the year ended December 31, 2023. The
Statutory Auditors have conducted a review of the annual
consolidated financial statements.
GeNeuro Consolidated Income
Statement
(in thousands of EUR)
31/12/2023 12 months
Audited
31/12/2022 12 months
Audited
Income
-
-
Research and development expenses
Research and development expenses
(12,492.1
)
(9,833.2
)
Subsidies
1,143.4
1,825.8
General and administrative expenses
(3,008.6
)
(3,221.8
)
Operating loss
(14,357.3
)
(11,229.2
)
Net loss for the period
(14,757.0
)
(12,199.8
)
31/12/2023
31/12/2022
Basic losses per share
(EUR/share)
(0.59
)
(0.51
)
Diluted losses per share
(EUR/share)
(0.59
)
(0.51
)
Due to its development stage, the Company generated no income in
2023 or 2022.
Research & Development expenses increased by €2.7
million in 2023 compared to 2022, due to the expenses incurred in
connection with the Post-COVID program, which led to an increase of
€2.6 million in studies and research in connection with the GNC-501
clinical trial. R&D payroll expense increased by €0.1 million
and other costs remained broadly in line with the levels observed
in 2022. Despite the higher level of studies and research expenses,
subsidies (under the form of research tax credits linked to R&D
activities) decreased by €0.8 million in 2023 over 2022 as the bulk
of the Company’s GNC-501 Phase 2 clinical trial activities are
conducted out of the Swiss parent and are therefore not eligible
for French Research Tax Credit; other subsidies increased from K€
509 to K€ 588; these other subsidies include K€ 140 of debt
cancellation from Bpifrance in connection with the K€ 200
reimbursable advance that had been granted to GeNeuro Innovation
SAS in 2011, K€ 182 from the European Union HERVCOV grant and K€
265 of subsidies accounted for in connection with the Swiss FOPH
grant. As a result, net R&D expenses increased by 42%, or €3.3
million in 2022 compared to 2021.
General and administrative expenses decreased by €0.2
million in 2023, as GeNeuro replaced the cash bonuses for staff and
management by stock options, resulting in a reduction of payroll
expense by €0.2 million in 2023 compared to 2022.
Cash and cash equivalents amounted to €1.8 million at
December 31, 2023, compared to €5.6 million at December 31, 2022.
In addition, in January 2024 2024 the Company implemented a €1
million bank non-recourse pre-financing for the 2022 Research Tax
Credit and completed in February 2024 a €5 million capital
increase. The Company’s reported cash consumption (i.e., cash
outflow from operating activities, given the low level of capital
expenditures and investment in intangible assets) was €10.1 million
in 2023 compared to €13.1 million in 2022; this €3.0 million
decrease was due primarily to the positive €3.9 million impact from
the change in working capital in 2023 compared to a negative impact
of €1.9 million in 2022, as a result of higher trade payables and
accrued liabilities and the reduction of other current assets. With
the GNC-501 clinical trial ending in June 2024, cash consumption is
expected to decrease significantly during 2024.
BUSINESS OUTLOOK
GeNeuro’s priorities for 2024 are focused on the completion of
the GNC-501 trial, with topline results planned for end of June
2024 and, subject to positive results, the preparation of a Phase 3
and/or of the temporary marketing authorization. In MS, GeNeuro
will continue discussions with potential partners to define the
best development path combining temelimab and
anti-neuroinflammatory treatments to bring the synergistic benefits
of temelimab to MS patients. As for ALS, GeNeuro continues to seek
specific funding for this program, which would allow to bring this
project to an IND within 18 months.
2024 FIRST-QUARTER FINANCIAL INFORMATION
On March 31, 2024, the Company had a cash position of €2.9
million. This includes the net proceeds of € 5 million capital
increase and the cash consumption for the quarter. The available
cash resources provide GeNeuro with good visibility into mid
Q3-2024.
For Q1 2024, the cash consumption related to GeNeuro’s operating
and investing activities was €2.9 million, compared to €3.0 million
for the same period of 2023. The Q1 2024 cash consumption included
the reduction of working capital in connection with trade payables
for the Phase 2 clinical trial in Post-COVID. The Company expects
its quarterly cash consumption to decrease during 2024 as the
post-COVID clinical trial will be completed in June 2024.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240430799385/en/
GeNeuro Jesús Martin-Garcia Chairman and CEO +41 22 552
4800 investors@geneuro.com
NewCap (France) Mathilde Bohin / Louis-Victor Delouvrier
(investors) +33 1 44 71 98 52 Arthur Rouillé (media) +33 1 44 71 94
98 geneuro@newcap.eu
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