- Strong financial situation and visibility:
- Net cash position of €5.9 million
- Company’s operations funded until Q2-2023
Regulatory News:
GeNeuro (Paris:GNRO) (Euronext Paris: CH0308403085 - GNRO), a
biopharmaceutical company developing treatments for
neurodegenerative and autoimmune diseases, such as multiple
sclerosis (MS), amyotrophic lateral sclerosis (ALS) and the severe
neuropsychiatric consequences of COVID-19 (post-COVID), today
reported on its 2022 first quarter cash position.
2022 First-quarter financial information
At March 31, 2022, GeNeuro had €5.9 million in cash. This
includes the first instalment of €3.0 million from the Swiss
Federal Office for Public Health (FOPH) grant for its post-COVID
program, which was received in January 2022. The available cash
resources provide GeNeuro with good visibility until Q2-2023 in
terms of financing its current activities.
The cash consumption related to GeNeuro’s operating and
investing activities in Q1 2022 was €2.5 million, compared to €2.1
million for the same period of 2021. The increase is due to
expenses related to the preparation of the Phase 2 clinical trial
in post-COVID, primarily for the manufacturing of a new batch of
the company’s leading drug candidate, temelimab, which will be used
in the clinical trial. Accordingly, Q1 2022 cash consumption was in
line with the Company’s expectations and also included the payment
of outstanding invoices from suppliers and accruals at end December
2021. With the Company’s ProTEct-MS clinical trial at the
Karolinska Institutet in Stockholm having been completed during Q1
2022, with the topline results announced on March 21, 2022, the
Company expects its cash consumption to continue decreasing during
2022, excluding the effect of the post-COVID clinical trial.
Other product development highlights since January 1,
2022
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
under the leadership of Prof. Fredrik Piehl. 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
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.
In the earlier trials, temelimab was used as a monotherapy in an
active relapsing remitting MS population. However, today the
majority of patients in developed countries receive an effective
therapy against inflammation. As existing therapies against
inflammation and relapses only have a modest impact on long-term
disability progression, the therapeutic opportunity for temelimab
is to be used in combination as a treatment against
neurodegeneration, in order to tackle both inflammation and
neurodegeneration. The ProTEct-MS results have now confirmed that
temelimab’s effect remain visible and coherent with previous
results, when administered in combination with a potent
anti-inflammatory drug and in a population whose disability
progresses despite an effective treatment against relapses.
In September 2021, GeNeuro had announced it had opened an
extension to ProTEct-MS in order to provide patients having
completed their one-year treatment duration the possibility of
continued treatment with temelimab. However, the current lot of
temelimab used for this extension will expire at the end of April
2022. Due to the worldwide shortage in the supply of culture media
for antibody manufacturing during the COVID-19 pandemic, delivery
of the new batch of temelimab has been delayed until the summer. As
a result, GeNeuro has decided to close at the end of April 2022
this extension study, which was not designed to generate additional
MRI data.
Post-COVID
In January 2022, GeNeuro received the first instalment of €3.0
million from the Swiss Federal Office for Public Health (FOPH)
grant for its post-COVID program.
On April 13, 2022, GeNeuro announced the first results of its
collaboration with FondaMental Foundation for the development of
diagnostic and therapeutic options for patients with post-COVID
neuropsychiatric syndromes. The study showed a strong correlation
between SARS-CoV-2 infection, W-ENV protein and markers of innate
immunity, in patients with psychiatric disorders, confirming the
interest of treating post-COVID neuropsychiatric syndromes by
neutralizing the W-ENV protein with the temelimab antibody. GeNeuro
is preparing to launch a phase 2 clinical trial in 200 patients
with post-COVID syndromes and positive for W-ENV.
Next financial report:
Second-quarter 2022 cash position: July 15, 2022.
Forthcoming investor and industry events:
May 31, 2022 Annual general meeting of shareholders
June 28, 2022 Gilbert Dupont Midcaps Forum
About GeNeuro
GeNeuro‘s mission is to leverage HERV biology to develop safe
and effective treatments for the benefit of patients, by
neutralizing causal factors encoded by HERVs that 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
https://twitter.com/GeneuroO
https://www.youtube.com/channel/UCODwH_v0z6wwnlVhGzmw0pA
https://www.linkedin.com/company/geneuro-sa/
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/20220414005590/en/
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
GeNeuro (EU:GNRO)
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