BioSenic raises €500,000 in private placement of new shares with established new investors

PRESS RELEASE – REGULATED INFORMATION

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO.

Mont-Saint-Guibert, Belgium, 2 February 2024, 17:30 CET – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces that it raised €500,000 in gross proceeds through a private placement of 12,195,120 new shares at an issue price of €0,041 per share with institutional investors, Gestys Santé Biotech and Friedland Gestion.

BioSenic intends to use the net proceeds of the placement, together with other sources, to prepare for an IND application with FDA for the Phase 3 clinical study with oral arsenic trioxide (OATO) in the first-line treatment of chronic graft-versus-host disease (cGvHD). They will also cover general business expenses, mainly related to clinical regulatory requirements and BioSenic corporate activities.

In line with its financing strategy, the private placement will allow BioSenic to continue exploring more funding options in the coming months to further strengthen its balance sheet and cash position. The payment and delivery of the new shares are expected to take place on or about 6 February 2024. At the same time, an application will be made to admit the new shares to trading on the regulated markets of Euronext Brussels and Euronext Paris, and a listing prospectus will be published by the company.

The new shares to be issued will have the same rights and benefits as, and rank pari passu in all respects with, the existing and outstanding shares of BioSenic at the moment of their issuance. A copy of the report prepared by the board of directors of BioSenic in accordance with the Belgian Code on Companies and Associations further describing, among others, the capital increase, the consequences thereof and the justification of the issue price is made available in the Investors section (under Regulated financial information – Share and Bond Issues) on BioSenic's website.

The aggregate dilution for the existing shareholders resulting from the issuance of the new shares amounts to 6.95% and upon effective issuance of the new shares, the total number of shares of BioSenic will amount to 175,376,594.

François Rieger, President of the Board and CEO of BioSenic Group, declares: "BioSenic is grateful for the trust in its development projects and capacity to reach significant milestones, expressed by the shareholding participations of two well-known funds, Gestys and Friedland Gestion. The financial conditions of this placement are quite favorable to BioSenic’s shareholders, as no discount is involved in the present deal as compared to the last closing price of the company's shares. Since other funding options are being explored to cover the necessary long-term budget needs, we needed only a modest amount of funds at this stage. Our objective this year is to start patient recruitment for this study, our lead project, as soon as possible. We expect to confirm and extend the good results obtained in a recent Phase 2 study for the use of arsenic trioxide using a patent-protected new oral formulation, OATO, for the treatment of cGvHD."

Banque Delubac & Cie acted as placement agent for the private placement.

About BioSenic

BioSenic is a biotech company specializing in the clinical development of autoimmune disease therapies. Following a reverse merger in October 2022, BioSenic combined its strategic positioning, key strengths and strong IP to develop products along two tracks, separately and in combination. The first platform leverages immunomodulatory properties of arsenic trioxide (ATO) for an entirely new arsenal of formulations, including oral delivery (OATO), for anti-inflammatory and anti-autoimmune indications such as chronic graft-versus-host disease (cGvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). In parallel, BioSenic develops innovative products through a second platform that includes cell therapies and strong IP protection for tissue repair technologies.

BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com.

About BioSenic's technology platforms

The ATO platform has immunomodulatory properties with fundamental effects on the activated cells of the immune system. One direct application is its use in autoimmunity to treat in its chronic, established stage. Chronic GvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT), a curative treatment for patients with serious blood diseases, including cancers.

BioSenic’s intravenous ATO formulation, Arscimed®, has orphan drug designation status by FDA and EMA, and it has shown good safety and significant clinical efficacy for skin, mucosae, and the gastrointestinal tract in an early Phase 2a study. The company is planning a confirmatory international Phase 3 study with its oral ATO (OATO) formulation. OATO will also target moderate-to-severe forms of SLE. BioSenic is also developing a new IP-protected OATO formulation for the treatment of SSc, a serious chronic disease that affects skin, lungs or vascularization, and has no current effective treatment. Preclinical studies on pertinent animal models support the launch of a Phase 2 clinical trial.

ALLOB is an allogeneic cell therapy platform made of differentiated, bone marrow-sourced mesenchymal stromal cells (MSCs), which can be stored at the point-of-use in hospitals. ALLOB represents a unique and proprietary approach to organ repair, and specifically to bone regeneration, by turning undifferentiated MSCs from healthy donors into bone-forming cells at the site of injury. BioSenic is studying the results of a Phase 2 trial to optimise the efficacy of ALLOB by determining the best timing for therapeutic intervention and seeking partners to continue the development of the promising underlying therapy strategies.

The company is also exploring partnerships at all levels for its JTA-004 viscosupplement for a severe inflammatory subtype of osteoarthritis, following a positive post hoc analysis of Phase 3 data demonstrating safety and efficacy in support of this licensing.

For further information, please contact:

BioSenic SA
François Rieger, PhD, CEO
Tel: [phone]
[e-mail]

International Media Enquiries:
IB Communications
Michelle Boxall
Tel: [phone]
[e-mail]

French Investor Enquiries:
Seitosei Actifin
Ghislaine Gasparetto
Tel: [phone]
[e-mail]

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the company or, as appropriate, the company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.