- TOTUM-63, prediabetes: - Signature of a global strategic
partnership with Nestlé Health Science; - Launch of REVERSE-IT, the
last phase of clinical development, and inclusion of the first
patient; - Cumulative payments since the signature of the
partnership: CHF 8M.
- TOTUM-070, reduction of LDL hypercholesterolemia ("bad
cholesterol"): - Launch of the Phase II clinical study in the
second half of 2020; - American and European patent obtained.
- TOTUM-854, blood pressure reduction, and TOTUM-448, liver
steatosis reduction: - Clinical development program currently being
designed.
- A solid financial position: - A cash position of €10.9M at June
30, 2020, not including the financing obtained since this date,
i.e. nearly €8M (CHF 3M milestone payment from Nestlé Health
Science, €3M from the French State-guaranteed loan (PGE) and the
proceeds of the capital increase carried out with AMIRAL GESTION
for an amount of €2M) providing financial visibility until S1 2022,
not including potential additional revenue.
Regulatory News:
VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / eligible for the
PEA/SME), a Research & Development company committed to
scientific innovation for preventing and combating metabolic
diseases, announces its results for the first half of 2020 and
provides an update on developments since the beginning of the
year.
Sébastien PELTIER, CEO of VALBIOTIS, commented: "Events in the
first half of 2020 have transformed our outlook and helped further
boost our international recognition. With the signature of the
development and marketing partnership for TOTUM-63 and the launch
of the final clinical phase for this Nutrition Healthcare product,
entirely financed by Nestlé Health Science, we have demonstrated
the soundness of our development model. We are now moving
confidently towards marketing and claim submission for TOTUM-63
and, thanks to a solid financial position, we are also working to
apply this same model to the rest of our Nutrition Healthcare
portfolio. At the head of the pipeline is TOTUM-070, which has just
obtained U.S. and European patents, required to establish a
commercial partnership in the future. We still have work to do with
this product and our other ongoing developments, but the road ahead
is now clear!"
Key achievements since the beginning of 2020
TOTUM-63, prediabetes
- Signature of a global strategic partnership with Nestlé Health
Science
At the beginning of fiscal year 2020, VALBIOTIS announced the
signature of a global strategic partnership with Nestlé Health
Science for the development and marketing of TOTUM-63, a
plant-based active substance clinically proven to have metabolic
benefits in prediabetics just six months earlier (press release of
February 5, 2020).
This strategic partnership guarantees the financing of
TOTUM-63's late-stage clinical development until the health claims
are obtained from the American and European authorities. In
addition to milestone payments and royalties expected from
marketing, this agreement also includes an additional source of
revenue: the supply of TOTUM-63 by VALBIOTIS to Nestlé Health
Science.
- Launch of REVERSE-IT, the last phase of clinical development,
and inclusion of the first patient
Following the conclusion of this agreement and with the
favorable opinion of the CPP (French Committee for the Protection
of Persons) and the authorization of the ANSM (French National
Agency for the Safety of Medicines and Health Products), VALBIOTIS
announced the launch of REVERSE-IT, the last phase of clinical
development for TOTUM-63 (press release of July 8, 2020).
REVERSE-IT, fully funded by Nestlé Health Science, will include
600 people recruited in more than 30 international clinical
centers. The main objective of the study is to confirm the positive
Phase II results already obtained with TOTUM-63 on fasting blood
glucose, a risk factor for type 2 diabetes.
The COVID-19 public health and economic crisis has not impacted
VALBIOTIS' business plan, which had anticipated the production of
clinical batches for REVERSE-IT. As a result, the first visit of
the first patient in the REVERSE-IT clinical study was carried out
as announced in mid-2020 (press release of July 15, 2020). The
results of this study are expected in the first half of 2022 and
will allow, in the event of positive results, the filing of a
health claim application with the American and European
authorities.
- Cumulative payments since the signature of the partnership: CHF
8M
With this major agreement, in April VALBIOTIS received a first
payment (upfront) from Nestlé Health Science for an amount of CHF
5M. The partnership also includes milestone payments (up to CHF
66M), such as the CHF 3M payment validated by Nestlé Health Science
for the inclusion of the first patient in July, received in
September 2020.
As a reminder, TOTUM-63 may be marketed before health claims are
obtained. The negotiated agreement also includes progressive
royalties on net sales.
TOTUM-070, reduction of LDL hypercholesterolemia ("bad
cholesterol")
- Launch of the Phase II clinical study in the second half of
2020
On the strength of this major success, VALBIOTIS confirmed the
continuation of its well-established development strategy. As a
consequence, the Company announced the development of three
innovative Nutrition Healthcare active substances from its
proprietary R&D platform, also targeting the early stages of
chronic metabolic and cardiovascular diseases with unmet medical
needs.
The first active substance being developed is TOTUM-070 for the
reduction of blood LDL cholesterol levels, a risk factor for
cardiovascular disease (press release of April 16, 2020). A Phase
II clinical study is planned to start in the second half of 2020
and will evaluate the effect of TOTUM-070 on the reduction of
LDL-cholesterol in individuals with mild to moderate
hypercholesterolemia. The results of this study are expected by the
end of fiscal year 2021/early 2022. This research program is
supported by a €500K grant awarded by the European Regional
Development Fund (ERDF) of the Nouvelle Aquitaine region.
VALBIOTIS plans to obtain, notably in Europe and North America,
the first proprietary health claim relating to the reduction of LDL
cholesterol, a risk factor for cardiovascular disease, for a
product containing neither phytosterols nor red rice yeast.
- Obtaining an American and European patent
VALBIOTIS has taken a key step in the development of its active
substance TOTUM-070 with the granting of its US and European patent
(press release of September 14, 2020). This protects the
composition of TOTUM-070 for food and pharmaceutical applications
in strategic international markets.
It is estimated that in 2020, more than 174 million adults in
the United States and Europe will be living with
hypercholesterolemia, and the market for non-prescription products
is estimated at €1.2 billion in these regions1.
TOTUM-854, blood pressure reduction, and TOTUM-448, liver
steatosis reduction: clinical development programs in progress
In line with its roadmap, VALBIOTIS has also made progress on
two other Nutrition Healthcare development programs (press release
of April 16, 2020). These two active substances are now ready to
enter Phase II of clinical development with:
- The initiation of a Phase II clinical study
in the first quarter of 2021 evaluating the effect of TOTUM-854 on
the reduction of blood pressure, a risk factor for cardiovascular
disease, in patients with mild to moderate hypertension, and; - The
launch of a Phase II clinical study in the second half of 2021
evaluating the effect of TOTUM-448 on the reduction of liver
steatosis, a condition that increases the risk of developing NASH,
in patients with non-alcoholic fatty liver (NAFL).
Major scientific recognition
During fiscal year 2020, VALBIOTIS has intensified its
scientific promotion strategy for its clinical results.
VALBIOTIS was selected by the American Diabetes Association
(ADA) to present Phase II clinical results for TOTUM-63
demonstrating the metabolic benefits of its Nutrition Healthcare
active substance in prediabetic subjects (press release of June 12,
2020). This fourth publication at the world's largest diabetes
congress is a sign of strong recognition by the scientific
community.
A few months later, VALBIOTIS was selected for the third
consecutive year by the European Association for the Study of
Diabetes (EASD) to present its results on TOTUM-63 (press release
of September 21, 2020). This new selection by the leading European
diabetes congress is further testimony to the value of these
clinical results.
These publications at the two largest world diabetes congresses
highlights the quality of VALBIOTIS' research programs and its
innovative approach, to the main scientific and industrial players
in the field of Nutrition Healthcare.
Financial information for the first half of 2020: a solid
financial situation
The Company's interim financial statements, prepared in
accordance with IFRS, were approved by the Executive Board on
September 24, 2020. They have been subject to a limited review by
the Statutory Auditors and are available on the VALBIOTIS website:
www.valbiotis.com
IFRS in €K(1) , at June 30
S1 2020
S1 2019
Operating revenue, of which
714
1,023
Turnover
121*
46
Grants
156
372
Research tax credit
437
605
R&D expenses
(1,939)
(2,105)
Sales and Marketing expenses
(545)
(823)
Overheads
(638)
(641)
Current operating result
(2,557)
(2,639)
Operating result
(2,557)
(2,639)
Pre-tax profit or loss
(2,830)
(2,724)
Net result
(2,931)
(2,724)
IFRS in €K(1)
S1 2020
S1 2019
Cash flow generated by activity
3,323
(3,139)
Cash flow linked to investments
(101)
(54)
Cash flow linked to financing
activities
(341)
(330)
Net cash flow
2,881
(3,523)
Balance
10,914
3,897
*For the first half of 2020, VALBIOTIS generated turnover of
€121K, resulting from recognition of the initial payment of CHF 5M
received by the Company in April 2020. This initial payment,
acquired from the date of signature, is considered to be part of
the service price and is therefore spread over the duration of the
contract, i.e. until October 2035.
Operating income therefore amounted to €714K, mainly consisting
of research tax credits, turnover and state subsidies.
In the first half of the year, Research and Development expenses
decreased by 8% compared to the same period last year, to €1,939K.
This evolution is mainly due to the absence of clinical studies
carried out during the period, which was focused on the preparation
of the launch of REVERSE-IT and the continuation of preclinical
research work on the technical platform in Riom. Sales and
Marketing expenses were also down 34% compared to the first half of
2019, at €545K. This decrease in business development efforts
follows the effective signature of the contract with Nestlé Health
Science. Finally, overheads expenses remained stable at €638K in S1
2020 compared to €642K in S1 2019. Overall, VALBIOTIS recorded a
net loss of €2,931K.
For the first half of the year, cash flow generated by activity
was positive at €3,323K, driven by the CHF 5M upfront payment from
Nestlé Health Science. Cash flow linked to investments was negative
by €101K, mainly related to activities aimed at extending
VALBIOTIS' intellectual property rights with the registration of
trademarks and patents internationally. Finally, cash flow linked
to financing activities was negative by €341K, largely due to the
restatement of lease contracts in the context of the implementation
of IFRS 16.
At June 30, 2020, VALBIOTIS had a cash position of €10,914K, up
36% compared to December 31, 2019.
To date, and taking into account in particular:
- €10,914K of available cash as at June 30,
2020 - Operating expenses related to the current development plan;
- The maturity schedule of the current financial debt; - Receipt in
the second half of 2020 of the CHF 3M milestone payment resulting
from the partnership signed with Nestlé Health Science; - The
capital increase of €2M carried out in July 2020; - Receipt in the
summer of 2020 of €3M from the French State-guaranteed loan (PGE)
obtained from the banking consortium made up of Bpifrance, Société
Générale and BNP Paribas;
The Company has carried out a specific review of its liquidity
and considers that it does not face any short-term risk. As of
today, the end of cash flow is estimated to be in the first half of
2022.
On the basis of the current development plan, this timeframe
could be extended if additional revenues are generated to
complement the milestone payments already scheduled with Nestlé
Health Science. This scenario may arise in particular in the event
that TOTUM-63 is marketed before the health claim is obtained,
which would result in the early payment of progressive royalties on
net sales. The communicated cash horizon also does not include
revenues from new strategic partnerships that may be entered into
for other products in the current portfolio.
VALBIOTIS' half-year financial report at June 30, 2020 has been
made available to the public and filed with the French financial
markets regulator (AMF). This document can be consulted on the
website: valbiotis.com ("Investors" section).
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 nutritional
health solutions designed to reduce the risk of major metabolic
diseases, based on a multi-target approach and made possible by the
use of plant-based ingredients.
Its products are intended to be licensed to players in the
health world.
VALBIOTIS was founded in La Rochelle in early 2014 and has
formed numerous partnerships with top academic centers. The Company
has established three sites in France – Périgny, La Rochelle (17)
and Riom (63).
VALBIOTIS is a member of the “BPI Excellence” network and
received “Innovative Company“ status awarded by BPI France.
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.
Find out more about VALBIOTIS: www.valbiotis.com
Name: VALBIOTIS ISIN code: FR0013254851
Mnemonic code: ALVAL
DISCLAIMER
This press release contains forward-looking statements about
VALBIOTIS’ objectives, based on rational hypotheses and the
information available to the company 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 a certain number of
risks and uncertainties, including those described in the VALBIOTIS
registration document, filed with the French Financial Markets
Regulator (AMF) on 31 July 2020 (application number R 120--018).
This document is available on the Company’s website
(www.valbiotis.com).
This press release, as well as the information contained herein,
does not constitute an offer to sell or subscribe to, or a
solicitation to purchase or subscribe to, VALBIOTIS’ shares or
securities in any country.
1 AEC Partners data for the United States and VALBIOTIS' 5
priority European countries (Germany, Spain, France, Italy and the
United Kingdom), 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200930005626/en/
VALBIOTIS / CORPORATE COMMUNICATION Carole Rocher / Marc
Delaunay +33 5 46 28 62 58 media@valbiotis.com
ACTIFIN / FINANCIAL COMMUNICATION Stéphane Ruiz +33 1 56 88 11
14 sruiz@actifin.fr
Grafico Azioni Valbiotis (EU:ALVAL)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Valbiotis (EU:ALVAL)
Storico
Da Apr 2023 a Apr 2024