VALBIOTIS SA
Press release
Valbiotis publishes its financial report for the first half of 2023
La Rochelle, September 28, 2023 (5:40 pm CEST) - 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 its results for the first half of 2023 and reviews the progress made since the beginning of the year in terms of clinical development, the structuring of the Company, and Business Development.
TOTUM•63, prediabetes and untreated type 2 diabetes (early stage)
The first half of 2023 was marked by the major success of the Phase II/III REVERSE-IT study. This major clinical milestone positions TOTUM•63 as an unrivaled non-drug innovation in the fight against the type 2 diabetes epidemic, potentially benefiting millions of people currently facing the risks associated with this debilitating chronic disease. Co-designed with Nestlé Health Science as part of its global strategic partnership with Valbiotis, this randomized, placebo-controlled study was conducted in 52 clinical centers and 7 countries on a total population of 636 patients with impaired glucose metabolism, ranging from prediabetes to untreated (early stage) type 2 diabetes. After a final patient visit early in the year (press release of March 13, 2023), REVERSE-IT's results on its primary endpoint were announced in spring 2023 (press release of May 22, 2023), in line with the schedule announced a year ago. The full efficacy results, also remarkable, were published this month (press release of September 11, 2023). REVERSE-IT achieved its primary endpoint of reducing fasting blood glucose levels versus placebo with high statistical significance, after 6 months of supplementation with TOTUM•63 at a daily dose of 5 g, taken 3 times a day. The reduction in fasting blood glucose was also achieved with high statistical significance at a similar dose but taken twice daily, thereby confirming the efficacy of this optimal dosing regimen in real-world conditions. Comprehensive results confirmed TOTUM•63's remarkable efficacy on glucose metabolism. Key results versus placebo after 6 months of TOTUM•63 supplementation at 5 g/day in 2 doses included:
The mode of action clinical study on TOTUM•63 in 19 volunteers at risk of developing type 2 diabetes, conducted by INAF at Université´ Laval in Quebec City in partnership with Nestlé´ Health Science, is on schedule. The results of this study are still expected in the second half of 2023. The scientific publication plan of the data from the TOTUM•63 development program continued in the first half of the year, with a publication in the International Journal of Molecular Sciences in February and, in June 2023, the presentation of the characteristics of the REVERSE-IT study population at baseline, as part of the prestigious scientific sessions of the American Diabetes Association.
TOTUM•070, reduction in LDL hypercholesterolemia ("bad cholesterol")
During the first half of the year, Valbiotis continued to prepare the Phase II/III study on TOTUM•070, which should confirm the very positive results of the Phase II HEART study (June and October 2022). These results demonstrated TOTUM•070's efficacy on blood levels of LDL cholesterol and triglycerides at as early as 3 months (-13.7% and -14.3% respectively per protocol) and at 6 months (-14.3% and -14.4% respectively), with an improvement in the overall lipid profile, in a population with mild to moderate hypercholesterolemia. The final Phase II/III clinical stage on TOTUM•070 will be conducted in parallel with and independently of the product's commercial launch in France, which is scheduled for the first half of 2024. The scientific publication plan for TOTUM•070's development program has also gathered pace, with the first communication of the clinical results of the HEART study and the results of the bioavailability and mode of action study at an international congress, the European Atherosclerosis Society, in May 2023. These results were also published for the first time in a peer-reviewed international scientific journal, Nutrients, in April 2023.
TOTUM•854, reduction in blood pressure
Earlier this year, positive results were published from the TOTUM•854 bioavailability and mode of action clinical study, confirming the potential of this active substance to reduce blood pressure in the early stages (press release of January 30, 2023). This innovative study confirmed the presence of 10 metabolites of interest, mainly polyphenolic compounds, in the serum of volunteers after oral administration of TOTUM•854. In vitro analyses on human cell lines also demonstrated:
On the strength of these promising results for the clinical development of TOTUM•854, Valbiotis continued recruitment in the first half of the year for the Phase II/III INSIGHT and INSIGHT 2 studies, both of which have systolic blood pressure reduction as their primary endpoint. Completion of recruitment is now expected in the second half of 2023 for the INSIGHT study (400 volunteers) and later for the INSIGHT 2 study (press release of July 12, 2023).
TOTUM•448 for the reduction of hepatic steatosis as part of the management of metabolic liver disease, now known as MASLD (Metabolic dysfunction-associated steatotic liver disease)[1] The Company has updated TOTUM•448's clinical development strategy to meet the challenges associated to these emerging pathologies, for which effective preventive and therapeutic strategies have yet to be developed. This strategy and the associated academic partnerships will be announced in the coming months, as announced on July 12, after the half-yearly financial closure (press release of July 12, 2023).
Presenting preclinical data at congresses and updating the clinical strategy Following the significant preclinical results obtained at the end of 2022 with TOTUM•448 (press release of October 27, 2022), Valbiotis carried out a scientific communication plan for these data during the first half of the year, which were presented at the Keystone Symposium dedicated to the pathophysiology of metabolic liver disease (March 2023), then at the annual congress of the European Association for the Study of the Liver (June 2023).
Further structuring of the company and business development activities At the same time as progress is being made in R&D, Valbiotis teams are engaged in structuring the Company with two objectives in sight. Firstly, preparing for direct commercial launch in France, with the first milestone being TOTUM•070 for hypercholesterolemia (first half of 2024). Secondly, supporting partnerships - the global agreement with Nestlé Health Science on TOTUM•63, as well as future partnerships (outside France) on the three other products (TOTUM•070 [hypercholesterolemia], TOTUM•854 [arterial hypertension], TOTUM•448 [MASLD, Metabolic dysfunction-associated steatotic liver disease]). On the marketing front in France, digital projects, including the e-commerce platform, are now well advanced, thanks to the Digital Director, who was appointed at the end of 2022. The company has also begun drawing up the operational launch plan, including trade names, claims and benefits, finalizing eco-friendly packaging and product packaging graphics, and producing the first marketing tools for healthcare professionals. Regarding the structuring of logistics, sales administration and information systems, a senior external project manager was appointed in early 2023 to support the Company in its IT transformation project. A first decision was quickly made, confirming that the historical ERP would remain the cornerstone of the future IT structure. From an industrial standpoint, operations are piloted by a dedicated, experienced in-house team, strengthened by the recruitment of a project manager in January 2023. This in-house team has already selected a number of industrial partners, all of whom are highly certified and subject to regular audits and visits. These partners have been chosen for their reliability and experience in the field. For the production of the 4 main active substances, the company has confirmed the transposition of these processes to industrial scale with its partners, using stability studies and appropriate analytical data. To support the structuring of the Company and its transition to a new commercial scale, Charlotte JEZEQUEL joined Valbiotis as Director of Human Relations last March, before joining the Executive Committee (press release of July 3, 2023). With a career spanning over 20 years in major international groups, Charlotte JEZEQUEL's role will be to define an HR policy that supports growth, the attainment of strategic ambitions, talent management and CSR. Finally, in recent months, the company has continued pursuing its business development activities with the support of AEC Partners, Valbiotis' long-standing partner and the firm behind the TOTUM•63 agreement with Nestlé Health Science. With a view to marketing TOTUM•070 internationally, discussions are underway with several global and regional players in the nutrition and health sectors.
Half-year financial statements: cash position of nearly €14 million The company's interim financial statements, prepared in accordance with IFRS, were approved by the Board of Directors on September 15, 2022. They have been subject to a limited review by the Statutory Auditors and are available on the Valbiotis website: www.valbiotis.com (investors section).
In the first half of 2023, operating income more than tripled to €5,236,000, in line with the sharp rise in turnover, which reached €4,241,000 compared with €635,000 a year earlier.
This turnover includes two revenue streams from the partnership with Nestlé Health Science:
Other operating income includes €816,000 in research tax credit, a slight increase on the €778,000 figure for the first half of 2022. Research and Development expenses came to €5,006,000, up 23.5% in view of the sustained level of clinical trials carried out over the period. They reflect the finalization of the Phase II/III REVERSE-IT study (TOTUM•63), the continuation of the two clinical studies INSIGHT and INSIGHT 2 (TOTUM•854) and the mode of action study on TOTUM•63, as well as the finalization of the Phase II HEART study (TOTUM•070). Sales and marketing expenses were relatively stable (-4.2%) at €873,000, while overheads rose to €923,000 from €768,000 a year earlier, mainly as a result of higher personnel costs linked to structuring efforts.
Cash flow from operating activities amounted to €(6,389,000) in the first half of 2023, compared with €(5,745,000) for the same period in 2022. This reflects the increase in WCR linked to the level of receivables, notably the milestone payment from Nestlé Health Science relating to the success of REVERSE-IT (to be collected in the second half of 2023) and the tax credits due in respect of 2022 - and not yet collected. Cash flow from financing activities amounted to €(599,000), consisting mainly of loan repayments and advances.
As of June 30, 2023, Valbiotis had cash and cash equivalents of €13,744,000, close to its level of €15,441,000 a year earlier. These amounts enable the Company to finance its operating expenses and meet its financial debt repayment schedule, with an estimated end-of-cash horizon set for Q4 2024. It should be noted that this horizon:
The half-yearly financial report to June 30 has been made available to the public and filed with the AMF. This document is available on the following website: www.valbiotis.com/en/investors.
Valbiotis confirms that it complies with the PEA-PME eligibility criteria specified in Article D.221-113-5 of implementing decree no. 2014-283 of March 4, 2014, namely:
As a result, Valbiotis shares continue to be included in PEA-PME accounts, which benefit from the same tax advantages as the traditional PEA share savings plan.
The company's corporate profile is available at: www.valbiotis.com.
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 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 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
Name: Valbiotis 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.
[1]Metabolic diseases of the liver related to metabolic dysfunction, new international denomination adopted in June 2023, replacing the appellation NAFLD (Non-alcoholic fatty liver diseases): Rinella ME et al. A multi-society Delphi consensus statement on new fatty liver disease nomenclature, Hepatology, 2023. Regulatory filing PDF file File: Valbiotis publishes its financial report for the first half of 2023 and confirms its strategic roadmap | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Language: | English |
| Company: | VALBIOTIS SA |
| 12F, Rue Paul Vatine | |
| 17180 Périgny | |
| France | |
| Phone: | 0546286258 |
| E-mail: | contact@valbiotis.com |
| Internet: | www.valbiotis.com |
| ISIN: | FR0013254851 |
| Euronext Ticker: | ALVAL |
| AMF Category: | Inside information / News release on accounts, results |
| EQS News ID: | 1737149 |
| End of Announcement | EQS News Service |
1737149 28-Sep-2023 CET/CEST
