VALBIOTIS SA: Valbiotis sets out its commercial and clinical roadmap for 2024

DJ Valbiotis sets out its commercial and clinical roadmap for 2024

VALBIOTIS SA 
Valbiotis sets out its commercial and clinical roadmap for 2024 
16-Jan-2024 / 17:40 CET/CEST 
Dissemination of a French Regulatory News, transmitted by EQS Group. 
The issuer is solely responsible for the content of this announcement. 
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Press release 
 
Valbiotis sets out its commercial 
and clinical roadmap for 2024 
 
   -- A new phase of development is opening up for the Company, with at least one product due for launch this 
  year. 
 
   -- French market launch of TOTUM.070 (hypercholesterolemia) confirmed for the first half of 2024. 
 
   -- Structuring of industrial activities soon to be finalized with a view to Nestlé Health Science's first 
  order for TOTUM.63 (prediabetes / type 2 diabetes), followed by future worldwide or regional licensing and/or 
  distribution partnerships for other TOTUM products. 
 
   -- In terms of clinical development, Valbiotis announces the launch of the HEART 2 study on TOTUM.070 
  (hypercholesterolemia) and the end of recruitment for the INSIGHT study on TOTUM.854 (arterial hypertension). 
 
 
   -- Continued clinical development of the Company's portfolio to consolidate its scientific value. 
 
La Rochelle, January 16, 2024 (5:40 p.m. CET) - Valbiotis (FR0013254851 - ALVAL, PEA / SME eligible), a commercially 
oriented Research and Development company, specializing in dietary supplements, committed to scientific innovation for 
preventing and combating metabolic and cardiovascular diseases, sets out its roadmap for 2024. This year will be marked 
by several major strategic milestones, with the launch of TOTUM.070 for hypercholesterolemia in the first half of the 
year, and Nestlé Health Science's first order for TOTUM.63. While the Company plans to finalize a new licensing and/or 
distribution agreement over the course of the year, and to pursue the clinical development of its portfolio, this new 
development phase, focused on generating sales, should enable Valbiotis to rapidly establish itself as one of Europe's 
leaders in 100% plant-based dietary supplements. 
 
 
A strategic roadmap built around marketing challenges 
The Company enters this new year rich in strategic ambitions and in a stronger financial position thanks to the 
resounding success of the capital increase finalized last December, for a net amount of 13 million euros (press release 
of December 22, 2023). 
 
These new resources will enable Valbiotis to achieve several major milestones, starting with the preparation of the 
commercialization of TOTUM.63 alongside Nestlé Health Science, Valbiotis' global strategic partner since February 2020 
in prediabetes and the early stages of type 2 diabetes. Commercialization is the next step for TOTUM.63, which has an 
exemplary clinical track record, culminating recently in the positive full results of the Phase II/III REVERSE-IT study 
(press release of September 11, 2023) followed by the success of the mode of action study (press release of November 7, 
2023). 
 
Under this partnership with Nestlé Health Science, which includes an exclusive supply agreement, Valbiotis expects to 
receive its first TOTUM.63 order in the first half of 2024. In order to be able to deliver on this order and secure the 
TOTUM.63 production chain over the long term, industrial activities are already up and running, with the production of 
the first strategic stocks, the qualification of industrial partners with high-level, controlled certifications, and 
the validation of processes on an industrial scale. 
 
These structuring efforts will be stepped up in 2024 to support future licensing and/or distribution partnerships for 
the international marketing - outside France - of other dietary supplements: TOTUM.070 (hypercholesterolemia), 
TOTUM.854 (arterial hypertension) and TOTUM.448 (metabolic liver disease). For these three products, the objective 
remains the signature of one or more global or regional agreements. Business Development activities are also continuing 
at this early stage of the year. Among the 68 prospects identified, discussions are underway with several major players 
in the nutrition and healthcare sectors. 
 
Valbiotis' latest strategic milestone is the direct marketing of its products in France (excluding TOTUM.63), which 
will begin in the first half of 2024 with the launch of TOTUM.070. Preparations for this launch are already well 
advanced, in terms of industrial processes, IT infrastructure (ERP expansion, e-commerce platform project) and sales 
and marketing policy. The latter will be supported by a dedicated team of Medical Promotion Officers (MPOs), whose 
recruitment has already begun, targeting prescribers and key pharmacies, and will be complemented by a direct approach 
to patients via an adapted digital strategy. 
 
Enhancing the clinical value of the portfolio: launch of the HEART 2 study (TOTUM.070, hypercholesterolemia) and 
completion of recruitment for INSIGHT (TOTUM.854, arterial hypertension) 
In 2024, Valbiotis will also continue its R&D efforts to consolidate the high level of scientific proof of its 
portfolio in the prevention of metabolic and cardiovascular diseases, and to prepare tomorrow's pipeline. Following the 
successful completion of TOTUM.63, the Company's goal remains to complete the clinical processes for the other three 
products and to obtain health claims - these steps not necessarily representing a prerequisite for their 
commercialization. On this scientific front, several key milestones are also expected in 2024. 
 
TOTUM.070 is now entering its final clinical phase: after obtaining the necessary approvals, the 
Phase II/III HEART 2 study is underway. Carried out in three centers in Germany, this randomized, 
placebo-controlled study is being conducted in two arms on a total population of 180 people with mild to moderate 
hypercholesterolemia (72 subjects recruited to date), with 3 months of TOTUM.070 supplementation. The aim is to confirm 
the positive results obtained in 2022 by the Phase II HEART study, which demonstrated TOTUM.070's efficacy, from three 
months, on blood LDL cholesterol and triglyceride levels (-13.7% and -14.3% respectively on target population). HEART 2 
should pave the way for TOTUM.070 to be granted a health claim. 
 
Regarding TOTUM.854, enrollment in the Phase II/III INSIGHT study has just been completed, with the inclusion of the 
last of the 411 participating volunteers. This international, multicenter, randomized, placebo-controlled study is 
being conducted in a population with mild to moderate arterial hypertension. Its primary objective is to reduce 
systolic blood pressure between the TOTUM.854 group (dose of 3.7 g/day) and the placebo group, after 3 months of 
supplementation. Results from the INSIGHT study are expected in the second half of 2024. 
With regard to the INSIGHT 2 study, which is also underway, recruitment is now scheduled to end in time for the 
marketing of TOTUM.854 in France, still scheduled for 2025. Designed with a different dose (2.6 g/day), this 
international, multicenter, placebo-controlled Phase II/III study (400 volunteers) will bolster TOTUM.854's health 
claim files. 
 
Finally, Valbiotis plans to announce the clinical strategy for TOTUM.448 and associated academic partnerships in the 
non-drug treatment of metabolic liver disease (MASLD, formerly NAFLD) shortly. 
 
 
Sébastien PELTIER, Chairman of the Board, and co-founder of Valbiotis, concludes: "After a landmark year 2023 in 
scientific terms, featuring the very good results of TOTUM.63 in its latest clinical phase, 2024 opens a new chapter in 
the history of Valbiotis with the launch of marketing, which will be conducted both alongside international partners 
and directly in France. With 100% natural plant-based dietary supplements backed by a high level of scientific proof, 
our value proposition is unique and will enable us to meet the immediate preventive needs of millions of patients. The 
potential markets are growing fast and are already significant: today, 30% of the adult population is affected by 
prediabetes, almost 40% by "bad cholesterol", 25% by arterial hypertension and 18% by metabolic liver disease - all 
public health challenges targeted by our innovations." 
 
 
About Valbiotis 

Valbiotis is a commercially oriented Research & Development company, specializing in dietary supplements, committed to 
scientific innovation for preventing and combating metabolic and cardiovascular 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. 

Internationally, its products are intended to be the subject of licensing or distribution agreements with global and 
regional health and nutrition players. In France, Valbiotis will be responsible for marketing its own products. 
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 
 
 
Contacts 
Corporate communication / Valbiotis 
[phone] 
 [e-mail] 
 
Media relations / Monet Agency 
Victoire BEAU 
Alexandra DUNANT 
Mélanie DA RUI PONS 
[phone] 
[e-mail] 
 

January 16, 2024 11:40 ET (16:40 GMT)