Valbiotis SA

The REVERSE-IT study has met its primary endpoint: TOTUM•63 reduced fasting blood glucose at 6 months versus placebo, on both a 3-intake/day and a 2-intake/day regimen, the optimal regimen for marketing and real-life patient compliance ( press release, May 22 ). Detailed results today demonstrate TOTUM•63's impressive efficacy on glucose metabolism, including plasma glycated hemoglobin (HbA1c), a biomarker established for microvascular risk, used for monitoring type 2 diabetes, with results comparable to some anti-diabetic drugs in a similar population. Among the main results, TOTUM•63 supplementation at 5 g/day, in 2 intakes, after 6 months: significantly reduces fasting blood glucose (-8.1 mg/dl), 2-hour blood glucose (-21.9 mg/dl), glycated hemoglobin (-0.18%) and the HOMA-IR insulin resistance score (-1.04 pts), the main markers assessed in clinical practice, compared with placebo; significantly reduces progression towards type 2 diabetes, with a 40% relative reduction in new cases of type 2 diabetes at the end of the study versus placebo; significantly reduces low-grade inflammation (-13% of patients above the threshold) involved in the pathogenesis of type 2 diabetes ; demonstrates its efficacy on fasting blood glucose and glycated hemoglobin in early-stage untreated type 2 diabetics. The study confirms TOTUM•63's excellent safety profile, with no risk of hypoglycemia, very good tolerability, notably digestive, and a compliance exceeding 97%. With such data, the REVERSE-IT study positions TOTUM•63 as an unparalleled non-drug innovation in the fight against the type 2 diabetes epidemic, benefiting the millions of people today facing the risks associated with this disabling chronic disease. LA ROCHELLE, FRANCE / ACCESSWIRE / September 11, 2023 / Valbiotis (FR0013254851 - ALVAL, PEA/SME eligible), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the results of the international Phase II/III REVERSE-IT study, demonstrating TOTUM•63's impressive efficacy on key markers of glucose metabolism, with efficacy results comparable to those of some leading anti-diabetic drugs, in a similar population. With REVERSE-IT, TOTUM•63 now has unrivaled proof of efficacy for a non-drug health product against prediabetes and the untreated early stages of type 2 diabetes. This new, natural, clinically proven product will benefit people affected by the risks associated with diabetes and support them in the fight against the progression of this disease, alongside their physician. "With the data announced today, the REVERSE-IT study is a breakthrough for the prevention of type 2 diabetes: TOTUM•63, a non-drug, plant-based active substance reduces glycated hemoglobin and fasting blood glucose with results at least comparable to some drugs, such as metformin, in a similar population. We also demonstrated a 40% reduction in the number of new diagnoses of type 2 diabetes among prediabetics. The objective we set ourselves with our partner Nestlé Health Science has been achieved: to demonstrate with unequivocal clinical evidence that we can act successfully at a very early stage, for the benefit of patients. I would like to underline the great joint success of our partnership with Nestlé Health Science, with whom we have an exclusive and global licence agreement on TOTUM•63. For Valbiotis, it is a tremendous achievement, and one that will lead to further successes in the future. But above all, it is a real breakthrough for the patients and people at risk who will benefit from this global innovation," explains Sébastien PELTIER, co-founder and Chairman of the Valbiotis Executive Committee. Diabetes: a global public health challenge Around 537 million adults (aged 20-79) live with diabetes worldwide, 90% of whom have type 2 diabetes, according to the International Diabetes Federation1. In addition to this growing number, there are almost 900 million people affected by prediabetes, including 128 million in the United States and the five main European countries2. TOTUM•63 responds to an essential need that has been neglected until now: early intervention in the metabolic impairments associated with type 2 diabetes, particularly in prediabetes. No other non-drug health product currently boasts a level of efficacy as clearly demonstrated as TOTUM•63. With the completion of its clinical development, TOTUM•63 opens up new prospects both for people facing the risks associated with diabetes and for doctors, who currently lack reliable solutions dedicated to prevention. TOTUM•63: a worldwide innovation in health nutrition for prediabetic and type 2 diabetic patients In the field of prediabetes and untreated type 2 diabetes, the REVERSE-IT study surpasses studies carried out to date using nutritional approaches, both in terms of its scale (636 volunteers) and the number of centers involved internationally (52 centers in 7 countries). In terms of methodology, the REVERSE-IT study complies with the recommendations of international learned societies, in particular those of the American Diabetes Association, the world's leading learned society for diabetes. Design of the Phase II/III REVERSE-IT study REVERSE-IT studied the overall efficacy of TOTUM•63, a plant-based active substance, on key markers of glucose metabolism in a randomized, placebo-controlled trial. It included 636 people: 501 prediabetics and 135 early-stage, untreated type 2 diabetics. Patients were divided into three arms, each with over 200 participants: A blind arm supplemented with TOTUM•63 (5 g/day) in 3 intakes per day, An open arm supplemented with TOTUM•63 (5 g/day) in 2 intakes per day, A placebo arm. The duration of supplementation was 6 months. All participants received identical dietary and physical activity advice, with no significant difference between groups at the end of the study. Widely demonstrated efficacy in prediabetic and early-stage untreated type 2 diabetic patients The primary endpoint of the study, a reduction in fasting blood glucose levels after 6 months of TOTUM•63 supplementation at 3 intakes per day versus placebo, was achieved (-5.8 mg/dl, p=0.015), as it was with TOTUM•63 at 2 intakes per day (-8.1 mg/dl, p<0.001). No statistically significant differences were observed between the 3 and 2 intakes per day groups. The main markers of glucose metabolism - 2-hour blood glucose (-21.9 mg/dl), glycated hemoglobin (HbA1c, -0.18%) and insulin resistance (HOMA-IR, -1.04 points) - were also significantly reduced by TOTUM•63 taken twice daily versus placebo. Figure: TOTUM•63 efficacy results on key glycemic parameters after 6 months compared with placebo. These results demonstrate the overall efficacy of TOTUM•63 on key markers of glucose metabolism in both prediabetic and early-stage untreated type 2 diabetic patients. Moreover, in prediabetic patients, TOTUM•63 reduced disease progression and the number of new cases of type 2 diabetes by 40% after 6 months, compared with placebo, with two intakes per day. The results also showed a benefit on low-grade inflammation, with a 13% reduction in the number of volunteers above the inflammation threshold (hsCRP). These chronic low-grade inflammatory processes are directly involved in the pathogenesis of type 2 diabetes. With efficacy values comparable to those of certain anti-diabetic drugs such as metformin, in a similar population, particularly in terms of fasting blood glucose and glycated hemoglobin3, TOTUM•63 can easily find its place in strategies for both the prevention in prediabetics and early stages of type 2 diabetes. Samy HADJADJ, Professor of Endocrinology, Diabetology and Metabolic Diseases, Hospital Practitioner at Nantes University Hospital and Scientific Advisor to the REVERSE-IT study, comments:"The complete data from the REVERSE-IT study are remarkable: they show TOTUM•63's efficacy on glucose homeostasis, even reducing plasma glycated hemoglobin levels, a biomarker established for microvascular risk, used for monitoring type 2 diabetes. Achieving such results in a population at a very early stage is a clinical challenge. It is very beneficial to have an active substance that is both clinically proven and widely usable in a preventive or early-stage setting, to limit the incidence of type 2 diabetes, a chronic disease with often severe long-term complications and a major impact on patients' quality of life." Jean-Marie BARD, Emeritus Professor of Biochemistry and Hospital Pharmacy Practitioner, Scientific Advisor to the REVERSE-IT study, adds: "In addition to its efficacy on blood glucose parameters, the results of the REVERSE-IT study show a positive impact of TOTUM•63 on the pathogenesis of the disease, with a clear reduction in insulin resistance and a significant benefit in terms of inflammation. This is an important factor demonstrating the ability of this active substance to slow disease progression. In clinical terms, TOTUM•63's safety and very good tolerability, particularly at the gastrointestinal level, are also a major advantage for patients over existing drug approaches, in a preventive context." Following these excellent results, the next scientific steps will include the submission of clinical data from the REVERSE-IT study to international congresses and publication in international peer-reviewed journals. In addition, the results of the mode-of-action clinical study on TOTUM•63 conducted by INAF in Quebec City are expected in the second half of 2023. About TOTUM•63 TOTUM•63 is a unique and patented combination of 5 plant extracts which targets the pathophysiological mechanisms of type 2 diabetes, and benefits from an unrivaled clinical demonstration of efficacy for a non-drug active substance. This innovation, both natural and clinically proven, offers new perspectives to the millions of people confronted with the risks of type 2 diabetes, as well as to all doctors and healthcare professionals currently lacking reliable, targeted preventive solutions. TOTUM•63 benefits from intellectual property validated by patents in the world's major markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand, Singapore, Saudi Arabia, Australia, Algeria, Ukraine, Malaysia, Chile, India, South Korea, and national phases are still underway in Brazil, Argentina, Canada, Thailand, Qatar and the United Arab Emirates. TOTUM•63's industrial production capacity, in line with North American and European standards, has been validated. TOTUM•63 already has marketing authorizations linked to its status in Europe. In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Health Nutrition provides for the marketing of TOTUM•63 by Nestlé Health Science worldwide, possibly before obtaining a health claim depending on the area. It will also finance the final stages of TOTUM•63's development. About Valbiotis Valbiotis is a commercially oriented Research & Development company, 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 and cardiovascular 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 and/or distribution agreements with global or 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 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: . Contacts Corporate communication / Valbiotis Carole Rocher Communication and Public Affairs Director +33 6 77 82 56 88 Marc Delaunay Communication Manager media@valbiotis.com Financial communication / Seitosei Actifin Marianne PY Senior consultant +33 1 80 48 25 31 mpy@actifin.fr Jennifer JULLIA DE BELLABRE Press relations +33 1 56 88 11 19 jjullia@actifin.fr Relations médias / Agence Monet Victoire BEAU Mélanie DA RUI-PONS +33 1 45 63 12 43 valbiotis@monet-rp.com 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 filed to the French Financial Markets Regulator (AMF) on April 26, 2023. 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. 1The IDF Diabetes Atlas (2021) 2AEC Partners data on Valbiotis' key markets, 2019 3Knowler et al., Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin, NEJM, 2002. SOURCE: VALBIOTIS SA View source version on accesswire.com:

LA ROCHELLE, France--( BUSINESS WIRE )--Regulatory News: Valbiotis (FR0013254851 – ALVAL, PEA/PME eligible) (Paris:ALVAL), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the large success of the REVERSE-IT Phase II/III clinical study on TOTUM•63. Conducted in 636 prediabetic and untreated type 2 diabetic patients (early stage), this international, multicentric, randomized and placebo-controlled study confirms the efficacy of TOTUM•63 in reducing fasting blood glucose at 2 and 3 intakes per day. These positive results trigger a lump sum payment of CHF 4 million from Nestlé Health Science as part of the global strategic partnership. Sébastien PELTIER, co-founder and Chairman of the Valbiotis Executive Committee, comments: "I am extremely proud of the results of the REVERSE-IT study on TOTUM•63, which represent a major breakthrough in the fight against diabetes and its complications for people with prediabetes and untreated type 2 diabetes (early stage). We have provided unequivocal clinical evidence that TOTUM•63 is a promising solution for millions of people worldwide, helping to prevent the progression to type 2 diabetes. This is a groundbreaking and exciting moment for our company, and I would like to extend my warmest thanks to our employees, our partners including Nestlé Health Science, and especially to the patients who participated in this study. Together, we have accomplished something truly remarkable, and we are determined to continue our mission to develop innovative solutions to improve the health of people around the world. Beyond this great achievement, which opens up a new path, it is also a personal satisfaction, after almost 10 years of hard work." Hans-Juergen WOERLE, Chief Scientific and Chief Medical Officer at Nestlé Health Science , comments: "We are thrilled with the completion of this large clinical study, gathering more than 600 patients, designed to rigorously evaluate TOTUM•63. This non-drug, plant-based active substance has the potential to significantly impact the management of early impairments of glucose metabolism." Jean-Marie BARD, emeritus professor of biochemistry and hospital practitioner in pharmacy, scientific advisor of the REVERSE-IT study, President of the French Nutrition Society Scientific Committee, specifies: "With more than 600 patients included in more than 50 centers internationally, REVERSE-IT is one of the largest and most ambitious studies in the world with non-drug approaches to early dysglycemia, from prediabetes to the early stages of type 2 diabetes. The results of this study represent a significant breakthrough for these people with glycemic impairment and confirm the data already obtained in 2019 with the Phase II study, published in the journal Diabetes, Obesity and Metabolism in 2022. I am delighted to have participated in the clinical validation of this new approach. Many healthcare professionals will be able to provide a solution for their patients and change their clinical practices, which until now have been limited to lifestyle recommendations alone." The REVERSE-IT study was co-designed with Nestlé Health Science's medical teams as part of the global strategic partnership between Valbiotis and Nestlé Health Science signed in February 2020. Under this agreement, positive results of the REVERSE-IT study on the primary endpoint trigger a lump sum payment of CHF 4 million from Nestlé Health Science to Valbiotis. This milestone payment from Nestlé Health Science will occur upon submission of the full study report during the summer. The REVERSE-IT study and its results on its primary endpoint The randomized and placebo-controlled REVERSE-IT Phase II/III study included 636 people with impaired glucose metabolism, ranging from prediabetes to untreated type 2 diabetes (early stage). The volunteers were divided into three equally balanced arms, each with more than 200 participants. In the intervention arm, participants were supplemented with TOTUM•63 at a dose of 5 g/day in three daily intakes. To complete the study, a second open-label arm evaluated a similar dose of 5 g of TOTUM•63 in two daily intakes. The REVERSE-IT study met its two objectives on its primary endpoint, fasting blood glucose, with a high statistical significance on the data obtained in ITT (Intention To Treat): the reduction in fasting blood glucose with TOTUM•63 after 6 months of supplementation with a 5g/day dose in three daily intakes, compared to placebo (p=0.015); the reduction in fasting blood glucose with TOTUM•63 after 6 months of supplementation with a 5g/day dose in two daily intakes, compared to placebo. The statistical analysis conducted in the per protocol population also confirms the statistical significance of these two results. At the end of all the analyses, the comprehensive results of the study will be communicated in a subsequent press release, on the secondary endpoints and exploratory analysis, and submitted for presentation at international congresses and publication in international peer-reviewed journals. About TOTUM•63 TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes. TOTUM•63 benefits from intellectual property validated by patents in the world's leading markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand, Singapore, Saudi Arabia, Australia, Algeria, Ukraine, Malaysia, Chile, India, South Korea and national phases are currently ongoing in Brazil, Argentina, Canada, Thailand, Qatar and the United Arab Emirates Production capacity for TOTUM•63 has been validated in accordance with North American and European standards. TOTUM•63 already has marketing authorizations related to its status in Europe. In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM•63 by Nestlé Health Science on a global scale, possibly before obtaining a medical clearance depending on the area. They will also fund the final stages of development of TOTUM•63. About Valbiotis Valbiotis is a commercially oriented Research & Development company, committed to scientific innovation forpreventing 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 and cardiovascular 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 and/or distribution agreements with global or 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 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 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 filed to the French Financial Markets Regulator (AMF) on April 26, 2023. 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.

The last patient included in the study has completed the final protocol follow-up visit. The first results of the study will be released before the end of the first half of 2023, after the database is frozen and the statistical analysis work is completed. This international, multicenter Phase II/III study evaluates the efficacy of TOTUM•63, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). Its primary objective is to reduce fasting blood glucose levels after 24 weeks of supplementation with a daily dose of 5 g of TOTUM•63, in 3 intakes, compared with placebo. The REVERSE-IT study was co-designed by Nestlé Health Science and Valbiotis as part of the overall strategic partnership between the two companies on TOTUM•63; as such, the results of the study are associated with milestone payments from Nestlé Health Science. LA ROCHELLE, France--(BUSINESS WIRE)-- Regulatory News: Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible) (Paris:ALVAL), a commercially oriented Research and Development company, committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the last visit of the last patient enrolled in the Phase II/III REVERSE-IT study on the active substance TOTUM•63. This international, multi-center, randomized, placebo-controlled study on 600 untreated prediabetic and type 2 diabetic patients (early stage) is designed to confirm the efficacy of TOTUM•63 on impaired glucose metabolism. The first results will be available and communicated before the end of the first half of 2023, in accordance with the schedule announced on September 15, 2022. TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes. It has been developed to address a large unmet need: to act on metabolic impairments in the early stages of type 2 diabetes, in particular prediabetes. Prediabetes currently affects nearly 900 million people worldwide, including 128 million in the United States and the five main European1 countries, for whom no non-drug health product yet has solid proof of efficacy. Nestlé Health Science has the exclusive and global commercial rights to use TOTUM•63 in the prediabetes and type 2 diabetes market. Murielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs, member of the Valbiotis Executive Committee, comments: "The development of TOTUM•63, our first innovative active substance, is nearing completion. The conclusion of the REVERSE-IT study is an unprecedented achievement for Valbiotis: with 600 patients enrolled in more than 50 centers worldwide, REVERSE-IT is one of the largest and most ambitious studies conducted globally with non-drug approaches in early dysglycemia, from prediabetes to early type 2 diabetes. We would like to pay tribute to the long-term work carried out by all the teams involved, without whom this challenge could not have been met. We also thank the Nestlé Health Science teams for their guidance and support as part of our strategic partnership on TOTUM•63. The demanding work of analyzing the database will now begin, with the hope that it will confirm the potential of TOTUM•63 for people affected by the risk of diabetes and its early stages and pave the way for the commercialization of this breakthrough active substance." Hans-Juergen WOERLE, Chief Scientific and Chief Medical Officer at Nestlé Health Science, adds: "We co-designed the REVERSE-IT study with Valbiotis to provide a large clinical dataset on TOTUM•63 for the benefit of people with early dysglycemia. An increasing number of people around the world are at risk of type 2 diabetes. We welcome the completion of this highly ambitious study and look forward to the initial results for the management of this early deterioration in glucose metabolism." The Phase II/III REVERSE-IT randomized, double-blind, placebo-controlled study includes 600 people with impaired glucose metabolism, ranging from prediabetes to untreated type 2 diabetes (early stage). Its primary objective will be to confirm the reduction of fasting blood glucose levels by TOTUM•63 taken three times daily for a total daily dose of 5 g over 24 weeks. The protocol will also evaluate the effect of the same daily dose of TOTUM•63 on fasting blood glucose levels but taken twice daily. Finally, REVERSE-IT will evaluate the effects of TOTUM•63 on other metabolic parameters of interest. Following the collection and monitoring of data from the last follow-up medical visits planned in the protocol, the clinical database will be frozen for statistical analysis. At the end of this process in accordance with Good Clinical Practices, Valbiotis confirms that the first results of the REVERSE-IT study will be available and communicated before the end of the first half of 2023, as announced in the schedule published on September 15, 2022 (September 15, 2022, press release). About TOTUM•63 TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes. TOTUM•63 has already been shown to be safe and effective in healthy patients in a Phase I/II clinical study. Results from a randomized, placebo-controlled, international Phase II study showed that when compared to the placebo, TOTUM•63 reduced fasting blood glucose and 2-hour blood glucose levels, two risk factors for type 2 diabetes. In these subjects, who were also abdominally obese, TOTUM•63 also significantly reduced body weight and waist circumference. TOTUM•63 benefits from intellectual property validated by patents in the world's leading markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand, Singapore, Saudi Arabia, Australia, Algeria, Ukraine, Malaysia, Chili, India, South Korea and national phases are still underway in Brazil, Argentina, Canada, Thailand, Qatar, United Arab Emirates. Production capacity for TOTUM•63 has been validated in accordance with North American and European standards. TOTUM•63 already has marketing authorizations related to its status in Europe. In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM•63 by Nestlé Health Science on a worldwide scale, possibly before obtaining a medical clearance depending on the area. They will also fund the final stages of development of TOTUM•63. About Valbiotis Valbiotis is a commercially oriented Research & Development company, 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 and/or distribution agreements with global or 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 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 filed to the French Financial Markets Regulator (AMF) on May 19, 2022 and completed by an amendment on November 8, 2022. 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. 1AEC Partners data on Valbiotis' key markets, 2019