- A cash position of nearly €22M (excluding potential additional
revenue) at the end of December 2021, securing the execution of the
strategic roadmap through to the first half of 2024;
- 2021: new steps taken on the roadmap;
- 2022: a decisive year with the completion of several clinical
trials in the portfolio's major indications that should pave the
way for future commercialization.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible), a Research
and Development company committed to scientific innovation for
preventing and combating metabolic diseases, announces its results
for the 2021 fiscal year and provides an update on recent
advances.
Key events in 2021: new advances ahead of a decisive fiscal year
2022
TOTUM•63, prediabetes
- Continuation of the last phase of clinical development
This latest Phase II/III clinical study (REVERSE-IT) was
designed with Nestlé Health Science teams and financed by the
partnership. The main objective of this study is to confirm the
positive Phase II results on fasting blood glucose, a
well-established risk factor for type 2 diabetes. REVERSE-IT
continued throughout FY2021. The study is being conducted in more
than 50 clinical centers worldwide. In January 2022, Valbiotis
announced that it expects to complete recruitment in the second
quarter of 2022 with results expected in the fourth quarter of
2022.
- Exploratory clinical mode of action study conducted by the
Institute of Nutrition and Functional Foods (INAF) at Laval
University, Quebec City
This study will be conducted on 20 volunteers and will explore
many mechanistic parameters of the pathophysiology of prediabetes
and type 2 diabetes. It is intended to strengthen the scientific
and commercial value of TOTUM•63.
Announced in May 2021, this patent grants broad protections on
the composition and use of TOTUM•63. It also grants exclusive
commercial rights in this strategic country as one of the most
affected by metabolic diseases, where the prevalence of prediabetes
in the adult population is estimated at 35%, or 390 million people,
and that of overweight and obesity at 50%. This patent, which has
now been acquired in nearly 50 countries including Europe, the
United States and China, is a concrete expression of the Company's
global protection strategy.
Finally, news on TOTUM•63 was also marked by publications in
three international scientific journals (American Journal of
Physiology - Endocrinology and metabolism, International Journal of
Obesity and Nutrients journal), describing its multi-target
mechanism of action. These publications have validated the work
done in the R&D program for the active substance since its
discovery in 2015.
TOTUM•854, blood pressure reduction For TOTUM•854, the positive
preclinical results obtained in hypertension were selected and
presented by the European Society of Hypertension (ESH) and the
International Society of Hypertension (ISH). In vivo results in
predictive models of hypertension in humans have shown that
TOTUM•854 effectively prevents hypertension. This proof of concept
was obtained in partnership with the Cardiovascular Pharm-Ecology
Laboratory (LaPEC) of the University of Avignon as well as within
the Valbiotis R&D platform. Buoyed by these positive
preclinical results, the Company announced in December 2021 that it
had submitted three clinical protocols for TOTUM•854 in blood
pressure reduction to the relevant authorities (the studies have
since been launched):
- The INSIGHT and INSIGHT 2 clinical trials,
international Phase II/III studies with recruitment expected to end
in the first half of 2023; - A clinical bioavailability and mode of
action study to characterize its metabolites and identify their
effects on human cell lines. Results are expected in the fourth
quarter of 2022.
This strategy will allow Valbiotis to build a complete claim
file. This acceleration would allow for commercialization by a
major healthcare player as soon as Phase II/III results are
available, up to 3 years ahead of the initial plan.
As a reminder, the market for mild to moderate hypertension in
the United States and in the primary European countries is
estimated at 1.15 billion euros (study conducted in 2020 by the
firm AEC).
TOTUM•070, reduction of LDL-cholesterol concentration in the
blood For TOTUM•070, 2021 began with the launch of a multicenter,
randomized, placebo-controlled, double-blind, Phase II HEART
clinical trial including 120 people with untreated mild to moderate
high LDL-cholesterol. Its primary endpoint is the reduction of
blood LDL-cholesterol levels, a cardiovascular risk factor.
Recruitment of the final, randomized volunteer was announced in
early September 2021, with results to be reported in the second
quarter of 2022, similar to the results of the clinical
bioavailability and mode of action study.
Meanwhile, in November 2021, TOTUM•070's positive preclinical
results on high cholesterol were selected and presented at the
American Heart Association (AHA) annual meeting. They demonstrated
a 38-47% reduction in "bad" cholesterol (including LDL-cholesterol)
by TOTUM•070, as well as a reduction in total cholesterol and blood
triglycerides, in two in vivo models predictive of human
physiology. These initial data suggest that TOTUM•070 has a
multi-targeted mode of action, with effects revealed on the gut and
liver, involving lipid metabolism and inflammation. All these data
pave the way for promising clinical developments.
TOTUM•448, reduction of hepatic steatosis TOTUM•448 is the
fourth active substance in the Valbiotis portfolio and is being
developed to address unmet needs in the management of metabolic
liver diseases: non-alcoholic fatty liver and non-alcoholic
steatohepatitis (NAFL and NASH).
The development plan has been updated to meet the challenges
imposed by these emerging pathologies, for which effective
preventive and therapeutic strategies have yet to be developed.
This plan will be based on an innovative study design, in ‘real
life’, in healthcare centers and in direct connection with patient
care. Combined with clinical mode of action studies, this work on
the ground positions TOTUM•448 very well on the management of NAFL
and NASH.
New R&D area: microalgae Finally, the latest advances in
Research and Development, Valbiotis has integrated the exploration
of microalgae produced in New Caledonia into its portfolio, through
an exclusive agreement with ADECAL-Technopole and IFREMER. This
program should make it possible to develop a bank of high-potential
strains selected by ADECAL-Technopole and IFREMER in New Caledonia
since 2013 as part of the joint research project "AMICAL".
In addition to the progress made in the field of Research and
Development, this year, Valbiotis obtained ISO 9001 certification
awarded by AFNOR. This certification guarantees all of the
Company's partners control over all Discovery, Preclinical
Research, Clinical Research, Production, as well as product quality
management.
Valbiotis has also strengthened its management structure by
appointing Sébastien Bessy, international expert in Consumer
Healthcare, as Director of Marketing and Sales Operations.
Previously Vice President of Global Strategic Operations Consumer
Healthcare at Ipsen, Sébastien Bessy has more than 20 years of
experience in international marketing strategy, sales strategy,
portfolio strategy and business development. This appointment comes
at a key time in the acceleration of the Company's growth, with
four active substances now in clinical phase.
On the financial front, Valbiotis successfully completed a €15
million private placement capital increase in April 2021 with the
issuance of 1,930,000 new shares at a unit price of €7.80.
Financing needs are assured until the first half of 2024. The
financial situation is therefore secure in the long term. In
addition, Valbiotis has received €1.25M in innovation support from
Bpifrance (€750,000 Research and Development Innovation Loan and
€500,000 Investment Seed Loan).
As at December 31, 2021, Valbiotis had a cash position of
€21,819,000, up nearly 50% compared to December 31, 2020. At this
time, the cash flow horizon is estimated to be the first half of
2024 and does not take into account additional milestone payments
and potential royalties that could be received from Nestlé Health
Science or additional revenue that could be generated from new
strategic partnerships on other products in the portfolio.
2021 annual results: a perfectly controlled financial situation
that is well positioned for future developments The Company’s 2021
financial statements prepared in accordance with IFRS standards
were approved by the Executive Board on March 9, 2022. They have
been audited by the Statutory Auditor and are available on the
Valbiotis website: www.valbiotis.com/investors.
Income statement - IFRS in €K, as at
December 31
2021
2020
Operating income including
2,693
5,099
Turnover
298
3,092
Grants
645
750
Research Tax Credit
1,750
1,258
R&D expenditure
-7,028
-5,411
Sales & Marketing expenditure
-1,509
-1,031
Overhead expenditure
-1,115
-1,387
Operating profit for the period
-8,475
-3,407
Operating profit
-8,475
-3,407
Earnings before tax
-8,681
-3,829
Net income
-8,681
-3,829
IFRS in €K
2021
2020
Cash flow from operating activities
-7,156
2,693
Cash flow from investing activities
-7
-332
Cash flow from financing activities
14,398
4,191
Change in cash position
7,235
6,552
Closing cash position
21,819
14,585
In 2021, Valbiotis generated a turnover of €298,000, in light of
the 5 million Swiss franc (€4,679,000) upfront payment spread over
the duration of the licensing agreement under the partnership with
Nestlé Health Science.
In addition to turnover, operating income (€2,693,000) consists
mainly of the Research Tax Credit acquired during the period
(€1,750,000) and grants (€645,000), which remained stable during
the year.
Research and Development expenses increased by 30% to €7,028,000
(compared to €5,411,000 in 2020). This anticipated increase
includes the continuation of the Phase II/III clinical trial,
REVERSE-IT, on TOTUM•63, the launch of the Phase II clinical trial
on TOTUM•070 and the continuation of preclinical research work on
the Riom technical platform.
Sales and marketing expenses were up 46% to €1,509,000 (compared
to €1,031,000 in 2020). This increase, again expected, reflects the
intensification of marketing and sales efforts to prepare for
future opportunities. The increase in personnel costs illustrates
the need to strengthen the Group’s management structure in order to
secure the execution of the business plan for the various
indications in the portfolio.
Cash flow from operating activities amounted to (€7,156,000) in
2021, reflecting the intensification of research and development
work. Cash flows from investing activities were negative by €7,000.
Cash flows from financing activities were positive by €14,398,000,
mainly due to the private placement capital increase in April 2021,
for a gross amount of €15M, as well as to two loans obtained from
Bpifrance for an amount of €1.3M.
As at December 31, 2021, Valbiotis had a cash position of
€21,819,000, up 49% compared to the available liquid assets at the
end of December 2020 (€14,595,000).
To date, taking into account in particular:
- its €21,819,000 in available liquid assets
on December 31, 2021, - its operating expenses related to its
current development plan, - the maturity of its current financial
debt.
Valbiotis considers that it does not face a liquidity risk with
an estimated cash flow horizon of the first half of 2024. This cash
flow horizon does not take into account additional milestone
payments that may be made to Nestlé Health Science, nor additional
revenue that may be generated from new strategic partnerships.
2022: a decisive year with the completion of several clinical
trials on the portfolio's major indications
After 2021, a year of background work, which enabled us to reach
new milestones in the clinical plans of the portfolio's main active
substances, 2022 will be a pivotal year with major clinical results
expected in three key indications: prediabetes, high cholesterol
and blood pressure:
- TOTUM•63 (prediabetes): end of recruitment
planned for the second quarter with results expected in the fourth
quarter of 2022 for the pivotal Phase II/III REVERSE-IT study and
completion of the mode of action clinical study by INAF; -
TOTUM•070 (high cholesterol): results of the Phase II HEART
clinical efficacy study and the clinical bioavailability and mode
of action study (second quarter 2022); - TOTUM•854 (blood
pressure): results of the bioavailability and mode of action
clinical study (fourth quarter 2022) and launch of the two Phase
II/III clinical studies INSIGHT and INSIGHT 2. In February 2022,
these two randomized, placebo-controlled studies were authorized,
paving the way for the recruitment of 800 volunteers, which should
be completed in the first half of 2023. Their results are essential
for a health claim application and will follow the protocols
validated by the competent authorities.
Sébastien Peltier, CEO, Chairman of the Board of Valbiotis,
states: "We closed 2021 with a strong financial position that will
allow us to continue to execute our business plan across our entire
product portfolio with confidence. 2022 thus promises to be a key
year with major clinical results expected on our primary active
substances. Thanks to these results, we intend to demonstrate the
efficacy of our innovations for patients and impose our innovative
model in the prevention of metabolic and cardiovascular diseases.
They should also enable us to prepare for future commercialization,
particularly in prediabetes, alongside our partner Nestlé Health
Science. We are therefore looking forward to the coming months with
even greater mobilization and enthusiasm to achieve our position as
an innovative player in health nutrition."
Valbiotis' annual financial report on December 31, 2021, has
been made available to the public and filed with the AMF. This
document is available on the website:
www.valbiotis.com/investors.
Valbiotis confirms that it complies with the PEA-SME eligibility
criteria specified in Article D.221-113-5 of the regulatory decree
no. 2014-283 of March 4, 2014, namely:
- A total workforce of fewer than 5,000
employees; - A total turnover of less than 1.5 billion euros or
total assets of less than 2 billion euros.
As a result, Valbiotis shares continue to be included in PEA-SME
accounts, which benefit from the same tax advantages as the
traditional equity savings plan (PEA).
About Valbiotis
Valbiotis is a Research & Development company committed to
scientific innovation for preventing and combating metabolic
diseases in response to unmet medical needs. Valbiotis has adopted
an innovative approach, aiming to revolutionize healthcare by
developing a new class of health nutrition products designed to
reduce the risk of major metabolic diseases, relying on a
multi-target strategy enabled by the use of plant-based terrestrial
and marine resources. Its products are intended to be licensed to
players in the health sector. Created at the beginning of 2014 in
La Rochelle, the Company has forged numerous partnerships with
leading academic centers. The Company has established three sites
in France – Périgny, La Rochelle (17) and Riom (63) – and a
subsidiary in Quebec City (Canada). Valbiotis is a member of the
"BPI Excellence" network and has been recognized as an "Innovative
Company" by the BPI label. Valbiotis has also been awarded "Young
Innovative Company" status and has received major financial support
from the European Union for its research programs via the European
Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible
company. For more information about Valbiotis, please visit
www.valbiotis.com
Name: Valbiotis ISIN Code: FR0013254851
Mnemonic code: ALVAL EnterNext© PEA-PME 150
This press release contains forward-looking statements about
Valbiotis’ objectives. Valbiotis considers that these projections
are based on rational hypotheses and the information available to
Valbiotis at the present time. However, in no way does this
constitute a guarantee of future performance, and these projections
may be affected by changes in economic conditions and financial
markets, as well as certain risks and uncertainties, including
those described in the Valbiotis Universal Registration Document
approved by the French Financial Markets Regulator (AMF) on July
27, 2021 (application number R 21-039). This document is available
on the Company’s website (www.valbiotis.com). This press release
and the information it contains do not constitute an offer to sell
or subscribe, or a solicitation to purchase or subscribe to
Valbiotis’ shares or financial securities in any country.
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version on businesswire.com: https://www.businesswire.com/news/home/20220315005696/en/
Corporate communication / Valbiotis Carole ROCHER / Marc
DELAUNAY +33 5 46 28 62 58 media@valbiotis.com
Medias relations / PrPa Damien MAILLARD +33 6 80 28 47 70
damien.maillard@prpa.fr
Financial communication / Actifin Stéphane RUIZ +33 1 56 88 11
14 sruiz@actifin.fr
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