VALBIOTIS Will Present the Results of the International Phase IIA Clinical Study of VALEDIA® before 31 July 2019

• The results of this study will evaluate the efficacy of VALEDIA^®
in prediabetic subjects for the first time

• Predicted to be the catalyst for concluding a commercial partnership
with a major player in the healthcare sector

• Beyond prediabetes, additional results are expected to shed light on
the potential development of other applications of VALEDIA^®

LA ROCHELLE, France–(BUSINESS WIRE)–Regulatory News:

VALBIOTIS (FR0013254851 – ALVAL / PEA/SME eligible) (Paris:ALVAL), a
French Research & Development company committed to scientific innovation
for preventing and combating metabolic diseases, announces the
completion of the international Phase IIA clinical study evaluating
VALEDIA^® in prediabetic subjects, after the final follow-up
visit was conducted with the last patient. VALBIOTIS will present the
results of this study before 31 July 2019.

“Announcing the results of the Phase IIA clinical trial
represents a major development for VALBIOTIS. We would like to thank all
those who participated in the study as well as our academic and
scientific partners for their valuable contributions. We are confident
in the results, which will evaluate the efficacy of VALEDIA^®
on the target population of prediabetics for the first time,”
comments Murielle CAZAUBIEL, Head of Development and Medical Affairs at
VALBIOTIS.

The international Phase IIA, multicentric study was randomized,
double-blind placebo-controlled, and included 66 prediabetic subjects¹.
The study evaluates the efficacy of TOTUM-63, the active ingredient of
VALEDIA^®, in reducing one or more of the 3 risk factors for
type 2 diabetes, from the 3 criteria chosen by the Food and Drug
Administration² to obtain a healthclaim: insulin resistance,
moderate fasting hyperglycemia and glucose intolerance.

In addition to these prediabetes results, the study will evaluate other
physiological parameters, including, for example, triglyceride
regulation or intestinal microbiota composition. This additional data
will help confirm the potential of VALEDIA^® for other
applications.

About TOTUM-63, the active substance of VALEDIA^®
Prediabetes
is a growing public health issue worldwide that has been acknowledged by
international organizations. Without appropriate management, 70% to 90%
of prediabetic subjects will develop type 2 diabetes.
VALEDIA^®
intend to be be the first natural and clinically proven solution
specifically designed for prediabetics. VALEDIA^® contains the
active substance TOTUM-63, a unique and patented combination of 5 plant
extracts, with high potential to target the physiopathological
mechanisms of type 2 diabetes.
The launch of VALEDIA^® is
planned for 2021, with a health claim for reducing the risk of type 2
diabetes.
TOTUM-63 has already been proven safe and effective in
healthy human volunteers during a Phase I/II clinical study.

ABOUT VALBIOTIS
VALBIOTIS is a French Research & Development
company committed to scientific innovation for preventing and combating
metabolic diseases. Its products are made for major players in the
health care sector. VALBIOTIS particularly focuses on solutions to
prevent type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity
and cardiovascular diseases.
VALBIOTIS was founded in La Rochelle
in early 2014 and has formed numerous partnerships with top academic
centers in France and abroad, including La Rochelle University, the CNRS
and Clermont Auvergne University located in Clermont-Ferrand. These
partnerships have enabled VALBIOTIS to benefit from strong financial
leverage, particularly thanks to experts and technical partners who
support its projects. The Company has established three sites in France
– Périgny, La Rochelle (17) and Riom (63) – and an American office in
Boston (MA).
VALBIOTIS is a member of the “BPI Excellence” network
and received the “Innovative Company” status accorded 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 by obtaining support from 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. VALBIOTIS considers that these projections
are 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 can be
reconsidered based on changes in economic conditions and financial
markets, as well as a certain number of risks and doubts, including
those described in the VALBIOTIS core document, filed with the French
Financial Markets Regulator (AMF) on 5 April 2017 (application number
I.17-012), as well as in the 2017 annual financial report, filed with
AMF on 3 April 2018. These documents are available on the Company’s
website (www.valbiotis.com).
VALBIOTIS does not accept any liability regarding the update or revision
of these forward-looking statements. 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 Divided into two arms, for a period of 6 months. The
subjects who were randomized to the supplemented arm received a 5g dose
of VALEDIA® each day.
² Guidance for Industry:
Evidence-Based Review System for the Scientific Evaluation of Health
Claims, FDA, 2009, www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm073332.htm

Contacts

VALBIOTIS
CORPORATE COMMUNICATION
Carole Rocher /
Marc
Delaunay
+33 5 46 28 62 58
[email protected]

FINANCIAL COMMUNICATION
ACTIFIN
Stéphane Ruiz
+33 1 56 88
11 14
[email protected]

MEDIA RELATIONS
MADIS PHILEO
Guillaume De Chamisso
+33 6
85 91 32 56
[email protected]

UNITED STATES
SOLEBURY TROUT
Rebecca John / Patrick Till
+1
646 378 2935
[email protected]
[email protected]