• Collaboration and license agreement to develop digital therapeutics based on Theraxium and supporting cancer treatment
  • Worldwide scope targeting in particular the US, Japan and Europe, enriching Voluntis’ pipeline and global footprint
  • Strategic investment of Eisai in conjunction with commercial agreement
  • Exploration of collaboration opportunities between Voluntis and Eisai in the field of neurology

Regulatory News:

Voluntis (Euronext Growth Paris, Ticker: ALVTX - ISIN: FR0004183960), a leader in digital therapeutics, today announced a collaboration agreement with Eisai (Headquarters: Tokyo) to design and develop innovative digital therapeutics (DTx) to support patients treated for cancer as well as a strategic investment from Eisai in Voluntis.

Collaboration and license agreement further enriching Voluntis’ commercial pipeline

By leveraging Voluntis’ Theraxium technology platform, the two companies will collaborate on novel DTx specifically designed for patients and healthcare professionals to support cancer treatment.

The partners’ goals are to jointly design and develop new DTx, and evaluate their benefits for patients, caregivers and healthcare professionals. Ultimately, the companies would collaborate on the commercialization of the DTx, once authorized for marketing by regulatory authorities. The new assets will be designed with the intent to be commercialized in the US, Japan and European markets. The initiative supports both partners’ strategy of using digital technology to improve treatment experiences and patient outcomes. The DTx will be based on the Theraxium platform, which powers Voluntis’ portfolio of digital therapeutics, including its first-in-class proprietary oncology solution which received marketing authorization in the US and Europe.

In addition to their partnership in oncology, the partners will explore other opportunities of collaboration to develop, evaluate and commercialize digital therapeutics based on the Theraxium platform in the field of neurology, another area of strategic focus for Eisai notably for Alzheimer’s disease and dementia.

Pierre Leurent, CEO of Voluntis, said: “We are delighted to be starting this alliance with Eisai, a life sciences leader driven by an inspiring human health care philosophy. Our teams are eager to contribute to this mission, bringing complementary skills and capabilities to enable this collaboration. We are honored by the trust Eisai has placed in us and see it as a recognition of Voluntis as a trusted global partner for pharmaceutical companies developing digitally-augmented therapies”.

Following this strategic agreement, Voluntis increases its global footprint with a new opportunity to commercialize its technology in Japan. The collaboration also enriches the company’s portfolio of pharma-partnered DTx, demonstrating once again the strength of its Theraxium platform, a state-of-the-art technology to accelerate and de-risk the strategic DTx initiatives of leading pharmaceutical players.

Main terms of the strategic investment by Eisai

In addition to the payment made upon execution of the collaboration and licensing agreement, Eisai makes a strategic investment in Voluntis. This transaction will strengthen the partnership between the two companies.

The investment will be carried out through the reserved issuance to Eisai of 100,361 ordinary shares without pre-emptive rights for the existing shareholders of the Company. The issue price of the new shares was set at €4.15 per share. Upon settlement-delivery of the new shares, Eisai will hold ca. 1.1% of Voluntis’s share capital and ca. 0.86% of voting rights.

Kazumasa Nagayama, Chief Strategy Officer of Eisai, said: “Eisai is aiming to become a "Medico Societal Innovator" (a company that changes society through creating medicines and providing solutions) in our Medium-Term Business Plan "EWAY 2025". Partnering with Voluntis, a leading DTx company, is one of our key initiatives to realize it. We expect this alliance will help increase the benefits provided to patients and their families”.

Please refer to page 5 for more details about the financial transaction.

About Voluntis

Voluntis creates digital therapeutics that empower people with chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Voluntis’ solutions, combining mobile and web apps, use clinical algorithms to deliver personalized recommendations to patients and their care teams. For example, these recommendations are used to adjust treatment dosage, manage side effects or monitor symptoms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics, especially in oncology and diabetes. Voluntis has long-standing partnerships with leading life science companies. Based in Cambridge, MA, and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance. For more information, please visit: www.voluntis.com

Mnemo: ALVTX - ISIN: FR0004183960

About Eisai

Eisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. We strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.

For more information about Eisai, please visit www.eisai.com (for global), us.eisai.com (for U.S.) or www.eisai.eu (for Europe, Middle East, Africa), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S.).

Disclaimer

This press release contains certain forward-looking statements concerning Voluntis group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Voluntis considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2019 annual financial report and the 2020 half-year financial report published by Voluntis respectively on April 30, 2020 and September 29, 2020 (a copy of which is available on www.voluntis.com) and to the development of economic conditions, financial markets and the markets in which Voluntis operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Voluntis or not currently considered material by Voluntis. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Voluntis to be materially different from such forward-looking statements. Voluntis expressly declines any obligation to update such forward-looking statements.

Details of the financial transaction

Voluntis’ Board of directors of April 26, 2021, using the delegation granted by the Company's general meeting of June 29, 2020 under its 26th resolution, decided to issue a total number of 100,361 new ordinary shares, with a nominal value of €0.10 each, and reserved the subscription for Eisai (falling within the category of persons defined in the 26th resolution1).

The capital increase, representing approximately 1.1% of the Company's share capital, on a non-diluted basis, prior to the completion of the offering, was carried without shareholders' preferential subscription rights, on the basis of article L. 225-138 of the French Commercial Code.

The issue price of the new shares was set at €4.15 per share. This price corresponds to the average of the volume-weighted average prices of the last 3 trading sessions prior to its setting, in accordance with the 26th resolution of the Company's combined shareholders' meeting of June 29, 2020. The gross proceeds of the issue for Voluntis are €416,498.15 (issue premium included).

Impact of the issue on the distribution of capital

As an indication, the participation of a shareholder holding 1% of the Company's share capital prior to the capital increase will become approximately 0.99% after the operation.

 

Before issuance

 

After issuance

 

# of

% of

% of

 

# of

% of

% of

 

shares

share capital

voting rights

 

shares

share capital

voting rights

Management & employees

405,161

4.5%

6.8%

 

405,161

4.5%

6.7%

Bpifrance Participations

1,890,974

21.1%

16.3%

 

1,890,974

20.9%

16.2%

SHAM Innovation Santé

975,218

10.9%

16.8%

 

975,218

10.8%

16.7%

LBO France

609,839

6.8%

10.5%

 

609,839

6.7%

10.4%

Vesalius Biocapital

544,282

6.1%

9.4%

 

544,282

6.0%

9.3%

Debiopharm Innovation Fund

885,778

9.9%

7.6%

 

885,778

9.8%

7.6%

Indigo

491,782

5.5%

4.2%

 

491,782

5.4%

4.2%

Eisai

 

 

 

 

100,361

1.1%

0.9%

Others

3,144,234

35.1%

28.3%

 

3,144,234

34.8%

28.1%

TOTAL

8,947,268

100.00%

100.00%

 

9,047,629

100.00%

100.00%

Settlement-delivery and listing of new shares

The settlement and delivery of the new shares and their admission to trading on the market of Euronext Growth in Paris are planned for May 3rd, 2021, subject to customary conditions. The new ordinary shares will be admitted to trading on the market of Euronext Growth Paris on the same trading line as the existing ordinary shares of Voluntis already listed under the same ISIN code FR0004183960 - ALVTX. The new ordinary shares will be immediately fungible with the existing ordinary shares of Voluntis.

The offering was not subject to a prospectus to be approved by the French financial markets authority (Autorité des marchés financiers – the “AMF”).

______________________ 1 i.e. "natural or legal persons (including companies), trusts or investment funds, or other investment vehicles, regardless of their form (including, without limitation, any investment fund or venture capital company, in particular any FPCI, FCPI or FIP), governed by French or foreign law, whether or not shareholders of the Company, that invest on a regular basis in the technology industry".

ACTUS Media Relations Vivien Ferran vferran@actus.fr +33 (0)1 53 67 36 34

ACTUS Investor Relations Jérôme Fabreguettes-Leib voluntis@actus.fr +33 (0)1 53 67 36 78

Voluntis Chief Financial Officer Guillaume Floch investisseurs@voluntis.com +33 (0)1 41 38 39 20