Business Wire

Valbiotis Reviews Its Activities and Publishes Its Financial Report for the First Half of 2021


Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible) (Paris:ALVAL), a French research and development company committed to scientific innovation for preventing and combating metabolic diseases, publishes its financial report for the first half of 2021 and provides an update on the Company's progress.

Sébastien PELTIER, Chairman of the Board of Directors at Valbiotis, comments: "2020 was a pivotal year for Valbiotis with the conclusion of our strategic global partnership with Nestlé Health Science for TOTUM•63, our flagship product dedicated to the reduction of risk factors for type 2 diabetes. This partnership has decisively strengthened our visibility on an international scale. It has opened up promising marketing prospects for us as we enter the final phase of development of this active substance, which has already been scientifically proven to be effective. And, above all, it has strengthened our resolve to pursue our strategic roadmap. This is what 2021 is all about: redoubling our efforts to reach new milestones with TOTUM•63, as well as with the other products in our portfolio. In the first half of the year, we were on target. In addition to achieving new scientific milestones and strengthening our organization, we also secured our financial resources on a long-term basis. All of these achievements enable us to approach our next challenges with confidence, backed by the commitment of our employees and the crucial support of our shareholders."

Main achievements since the beginning of 2021: start of the year perfectly in line with the roadmap

TOTUM•63, prediabetes

  • Obtaining of Chinese patent

In the area of intellectual property, further progress was made in the first half of the year, with the granting of a patent in China for TOTUM•63. Announced in May 2021 (press release of May 19, 2021), this patent grants broad protection for the composition and use of this substance. It also confers a monopoly on exploitation in this strategic country, one of the most affected by metabolic diseases, where the prevalence of prediabetes in the adult population is estimated at 35%1, i.e. 390 million people, and that of overweight and obesity at 50%2. This is a concrete example of the Society’s global protection strategy, with patents having now been acquired in nearly 50 countries, including across Europe, the United States and China.

  • First publications of scientific articles in three international journals

In line with the strategy developed with Nestlé Health Science, data on TOTUM•63 has been published in three international peer-reviewed journals, highlighting the focus on scientific promotion, which is decisive in preparing for future commercialization. These articles (press release of June 3, 2021) were published in the American Journal of Physiology-Endocrinology and Metabolism, the International Journal of Obesity and Nutrients. They constitute a validation by the scientific community of the work performed and allow the latter to better understand the mechanism of action of this active substance.

On the scientific front, a new study co-designed by Valbiotis teams, INAF experts and Nestlé Health Science experts was also announced. It should provide additional data to support scientific communication and the marketing of this active substance. The launch of the study is planned for the fourth quarter of 2021.

TOTUM•070, reduction of LDL-hypercholesterolemia ("bad cholesterol")

  • Launch of the HEART Phase II clinical study and First Patient First Visit

In February 2021 (press release of February 15, 2021), the company was authorized to launch the HEART Phase II clinical study and subsequently completed the First Patient First Visit (press release of February 22, 2021). The recruitment of the last volunteer in this study was announced at the beginning of September 2021 (press release of September 6, 2021), fully in line with the study's roadmap. Results are expected in the second quarter of 2022.

This study will evaluate the effect of TOTUM•070 on the reduction of LDL-cholesterol, a risk factor for cardiovascular disease, in people with mild to moderate hypercholesterolemia.

With the simultaneous launch of a clinical study to characterize all the metabolites and identify their effects in human cell models, as well as extensive preclinical work to be submitted to the American Heart Association (AHA) annual meeting in November 2021, this program will provide comprehensive data to position TOTUM•070 as a breakthrough innovation in the cardiovascular risk prevention market.

TOTUM•854, reduction of blood pressure
This program is seeing a strong acceleration in its development following the publication of positive preclinical results at the annual congress of the European Society of Hypertension (ESH) and the International Society of Hypertension (ISH) in April 2021 (press release of April 12, 2021).

The Company announced the launch of a Phase II/III international, multicenter, randomized, placebo-controlled study in a population with mild to moderate blood pressure elevation. A second international, multicenter, randomized, placebo-controlled clinical study will be conducted in parallel. This strategy will allow Valbiotis to put together a complete health claim file. Finally, Valbiotis will conduct a third clinical study at the same time to measure the bioavailability of TOTUM•854, characterize its metabolites and explore their mode of action.

As the protocols are expected to be filed in the fourth quarter for results scheduled for the second half of 2023, acceleration of the program should allow commercialization as soon as Phase II/III results are available, up to 3 years ahead of the initial plan.

TOTUM•448, reduction of hepatic steatosis
The development strategy is being finalized. It will address the reduction of non-alcoholic hepatic steatosis, a condition that puts individuals at risk of developing NASH (“fatty liver disease”). A Phase II study should be initiated in the second half of the year.

Structuring of Marketing and Commercial Operations
During the first part of the year, strengthening the organization was also a priority. This was demonstrated in particular by the appointment of Sébastien BESSY as Chief Operating Marketing and Business Officer, responsible for the global deployment and coordination of the international strategy related to Valbiotis’ marketing and commercial development (press release of June 7, 2021). Former Vice President Global Strategic Operations Consumer Healthcare at Ipsen, Sébastien BESSY brings his international expertise in Consumer Healthcare at a key time for the Company. He has more than 20 years of experience in international marketing strategy, commercial strategy, portfolio strategy and business development. Upon his appointment, Sébastien BESSY became a member of the Company's Board of Directors.

Obtaining of ISO-9001:2015 certification
The strengthening of the organization was also highlighted by the awarding of ISO-9001:2015 certification, issued by AFNOR, for all activities relating to "Design, development and production control of solutions for preventing and combating metabolic and cardiovascular diseases" (press release of March 22, 2021). This certification guarantees expertise in all Discovery, Preclinical Research, Clinical Research, Production and Product Quality Management activities. Once again, this recognition constitutes a decisive asset in the pursuit of the strategy and the prospect of future market launches.

Financial information for the first half of 2021: a secure long-term financial position
The Company's half-yearly financial statements, prepared in accordance with IFRS, were approved by the Board of Directors on September 27, 2021. They have been subject to a limited review by the Statutory Auditor and are available on the Valbiotis website: (investors section).

IFRS in €K, at June 30 (1)

First half of 2021

First half of 2020

Operating income


- Turnover

- Grants

- Research Tax Credit





R&D expenditure

(2 355)

(1 939)

Sales and Marketing expenditure



Overhead expenditure



Share-based payment expenditure



Operating profit for the period

(3 386)

(2 557)

Operating profit

(3 386)

(2 557)

Earnings before tax

(3 469)

(2 830)

Net profit

(3 469)

(2 931)

IFRS in €K (1)

First half of 2021

First half of 2020

Cash flow from operating activities

(3 706)

3 323

Cash flow from investing activities



Cash flow from financing activities

14 865


Net cash flow

11 235

2 881

Cash flow

25 820

10 914

For the first half of 2021, Valbiotis generated €748K of operating income, consisting mainly of the Research Tax Credit and revenue from the recognition of the share for the first half of 2021 of the upfront payment of CHF 5 million received under the partnership signed with Nestlé Health Science in February 2020.

Research and Development expenses increased by €416K, mainly due to the continuation of the Phase II/III REVERSE-IT clinical study on TOTUM•63 and the launch of the Phase II clinical study on TOTUM•070. The company also continued its preclinical research work at its technical platform in Riom.

Commercial and marketing expenditure remained stable at €542K and overhead expenditure decreased by €89K to €549K. This decrease is explained in particular by the finalization of the implementation of a new ERP system at the end of 2020.

During the first half of the year, cash flow from operating activities amounted to €3 706K reflecting the continuation and intensification of R&D activities. Cash flow from investing activities was positive at €76K, mainly due to the refinancing by the banking partner (lease back) of technical equipment for the Riom platform acquired during the second half of 2020 and the first half of 2021. Cash flow from financing activities was positive at €14 865K, mainly related to the capital increase by private placement in April 2021, for a gross amount of €15 million (press release of April 15, 2021), as well as to two loans obtained from Bpifrance for an amount of €1.3 million (press release of May 26, 2021).

At June 30, 2021, Valbiotis had a cash position of €25 820K, up nearly 77% compared to December 31, 2020.

To date, and taking into account in particular:

- Its available cash on June 30, 2021 amounting to €25 820K;
- Its operating expenses related to its current development plan;
- The maturity of its current financial debt;
- The upcoming receipt of the Research Tax Credit for the 2020 fiscal year in the amount of €1 257K (amount received in August 2021).

The Company has conducted a specific review of its liquidity risk and considers that it does not face any short-term risk. The cash flow horizon is therefore estimated at the first half of 2024 and does not take into account additional milestone payments that may be made by Nestlé Health Science or additional revenues that could come from new strategic partners.

Update on post-closing events
The month of September opened with the recruitment of the last volunteer in the Phase II HEART study conducted with TOTUM•070 for hypercholesterolemia (press release of September 6, 2021). The completion of this recruitment confirms the announced schedule of the HEART clinical study, the results of which will be available in the second quarter of 2022. The HEART study is a key step in the development of TOTUM•070 and in the commercialization strategy for the non-drug hypercholesterolemia market, which is estimated at €1.2 billion in Europe and the United States3.

In addition, Valbiotis announced the consolidation of its development of innovative natural health solutions, by integrating the exploration of microalgae produced in New Caledonia, through an exclusive agreement with ADECAL-Technopole and IFREMER (press release of September 29, 2021). This program should allow to develop a bank of high-potential strains selected by ADECAL-Technopole and IFREMER since 2013 in New Caledonia as part of the "AMICAL" joint research project.

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, using a multi-target approach enabled by the use of terrestrial and marine plant-based 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 (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:

Name: Valbiotis
ISIN code: FR0013254851
Ticker symbol: 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 (
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.

1Limin Wang et al. JAMA. 2017; 317(24):2515-2523
2Chinese national nutrition and chronic disease report 2020, National Health Commission (published on April 21, 2021)
3AEC Partners Data, 2019, for Valbiotis

To view this piece of content from, please give your consent at the top of this page.

Contact information

Corporate communication / Valbiotis
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58

Financial communication / Actifin
Stéphane Ruiz
+33 1 56 88 11 14

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

FourKites Expands its Market-Leading Ocean Visibility Platform with Industry-First Dynamic ETA ® for Ocean Shipping and New Tools to Manage Demurrage and Detention20.10.2021 08:30:00 CEST | Press release

FourKites®, the world’s leading real-time supply chain visibility platform, today introduced Dynamic ETA® for Ocean, a new AI-powered innovation as part of its Dynamic OceanSM offering. The new enhancement provides shippers, carriers and 3PLs with the market’s most accurate estimated times of arrival (ETAs) for 100% of their ocean shipments across all lanes worldwide. In addition, the company has rolled out new capabilities for monitoring and mitigating demurrage and detention risks. With these new enhancements, FourKites now provides the most advanced and robust solution on the market for real-time and predictive ocean visibility, exception management and cost controls. This press release features multimedia. View the full release here: FourKites Expands its Market-Leading Ocean Visibility Platform with Industry-First Dynamic ETA® for Ocean Shipping and New Tools to Manage Demurrage and Detention (Photo: Business Wire) These po

Evasc Neurovascular Announces the New eCLIPs Bifurcation Flow Diverter20.10.2021 07:00:00 CEST | Press release

Evasc Neurovascular is proud to announce the third generation of its eCLIPs™ device, the eCLIPs Bifurcation Flow Diverter. This press release features multimedia. View the full release here: The third generation of Evasc's eCLIPs™ device, the eCLIPs Bifurcation Flow Diverter. The new device is classified as a flow diverter, with a leaf density of 35%, which is 60% higher than the existing eCLIPs devices. As a result, the new eCLIPs Bifurcation Flow Diverter does not require coiling and provides for the same unique neck bridging delivery. The new eCLIPs Bifurcation Flow Diverter can cover up to a 6mm neck length. The eCLIPs Bifurcation Flow Diverter also simplifies deployment with greatly reduced delivery times. “We’re excited to see the latest innovation in Evasc Neurovascular’s eCLIPs devices, which will lead to better outcomes for patients and remarkable device delivery time—usually within 10 minutes,” said Leif Sorensen, Neur

Breaking the Silence in Osteoporosis20.10.2021 07:00:00 CEST | Press release

A new international survey of 1,008 women with osteoporosis from six countries, launched on World Osteoporosis Day, reveals that while more than two-thirds (67%) of women over the age of 55 mostly understand what osteoporosis is and the potential negative impact of future fractures, 19% felt poorly informed at the time of the diagnosis.1 This press release features multimedia. View the full release here: The survey initiated by Theramex in cooperation with the International Osteoporosis Foundation (IOF), was conducted in Germany, France, Italy, Spain, Australia, and Brazil. It included 316 postmenopausal women over the age of 55 years and 315 premenopausal women (40-55 years) with osteoporosis (altogether 62% of the surveyed women). Of these women, osteoporosis was only diagnosed after a fracture in almost 60% of the cases. This survey highlights a gap in osteoporosis awareness, as one-fourth of the patients aged 55 years and ov

Rossum raises record $100 million Series A from General Catalyst to reinvent B2B document communication20.10.2021 06:00:00 CEST | Press release

Rossum, the artificial intelligence company that is re-inventing the way businesses send documents to each other, has raised $100m from one of the US’s best known funds, General Catalyst in what is Eastern Europe’s largest ever Series A. Previous investors, including LocalGlobe, Seedcamp, Miton and Elad Gil are participating, as Rossum looks to capitalise on surging corporate demand for automation in business processes. Having rapidly secured market leadership in document AI technology and become the go-to software for many of Europe’s biggest companies, Rossum is creating a universal document gateway designed to help the corporate world move faster and complete transactions in minutes not weeks. Rossum’s founders, three PhD students who dropped out of university to start the business, are automating the whole business communication stack with a view to making bureaucratic, costly and time-consuming document communication frictionless and paperless. Rossum has seen year-on-year growth

Deenova Keeps Trouncing its competitors in France’s Unit Dose Pharmacy Automation Market20.10.2021 06:00:00 CEST | Press release

Deenova announced today it continues its record-breaking market momentum started during Covid-19, by winning 2 mechatronic competitive public tenders this Summer for a total of 4 ACCED robotic medication solutions to be operated around the clock at Centre Hospitalier Sainte-Marie Rodez in Occitanie, and Hospital of St Die-des-Vosges near Strasburg. Loïc Bessin, Managing Director of Deenova in France stated: “When I joined Deenova 3 years ago, the company was a small unit dose specialty business only present in 2 of the Top 5 European markets, having had customers only in France and Italy. I am extremely proud that over the last year alone, we have grown to become the dominant force in the GDP Top 5 healthcare European mechatronics markets for unit-dose, by establishing close partnership with key customers.” Christophe Jaffuel, Deenova Chief Commercial Officer, stated: “After Deenova multi-million and multi-year recent entries into the two largest European GDP healthcare markets in Germ

Amedeo and AURA AERO Announce a Strategic Partnership Agreement and a Letter of Intent to Purchase 200 Electric Regional Aircraft (“ERA”)19.10.2021 19:21:00 CEST | Press release

AURA AERO has created a clean sheet design while integrating new technologies, as well as existing technologies such as fly by wire, and is driving digital efficiencies to build revolutionary momentum in creating an electrical aircraft. With its current prototype aircraft, INTEGRAL, AURA AERO is achieving design and production maturity at a fraction of the cost and will carry that to the commercially sized 19- seater, Electric Regional Aircraft named ‘ERA’. This press release features multimedia. View the full release here: “Amedeo are delighted to have signed an LOI for 200 Electric Regional Aircraft ‘ERA,’ that draws the commercial aviation industry closer to achieving its goal of net-zero by 2050. We are very pleased to be partnered with AURA AERO in leading such an important climate supporting initiative for the future. For Amedeo, sustainable aviation is more than aspirational and we are committed and focused on partnership

JAB and BNP Paribas Cardif Announce Strategic Pet Healthcare Alliance19.10.2021 18:37:00 CEST | Press release

JAB and insurer BNP Paribas Cardif today announced a strategic alliance to deliver a range of pet insurance services throughout the UK, EMEA and Latin America, with a vision to offer additional pet healthcare services over time. As part of the agreement, JAB will hold a majority stake in a new holding company to which BNP Paribas Cardif will contribute Cardif Pinnacle, its subsidiary focused on the rapidly growing pet insurance sector. BNP Paribas Cardif will remain significantly involved in the pet healthcare activity, supporting the development of this alliance through a continued stake in the business. The transaction is expected to close in Q2 2022, subject to customary closing conditions, including applicable regulatory approvals. Cardif Pinnacle has built a leading pet insurance business providing solutions to partners and pet owners based on innovation and a scalable platform. The Company’s business proposition leverages digital services, artificial intelligence and continuous i