Transparency notification received from SRIW SA and Sofipôle SA

Transparency notification received from SRIW SA and Sofipôle SA
Bone therapy SA

Bone therapy SA

REGULATORY INFORMATION

Article 14 of the Law of May 2, 2007 on the advertising of significant holdings

Mont-Saint-Guibert, Belgium, November 4, 2022, 7 a.m. CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the innovative company addressing unmet medical needs in the areas of innate immunity, inflammation, and organ/function repair, announces today that it has received a transparency notice from SRIW SA (Société Régionale d ‘Investissement de Wallonie) dated October 27, 2022. The transparency notice indicates that the combined holdings of SRIW and its subsidiary, Sofipôle SA (Société Wallonne pour le Financement des Infrastructures des Pôles de Competitivité), have passively crossed below the threshold 5% as a result of the issuance of new BioSenic shares to Medsenic shareholders on October 24, 2022.

The notification dated October 27, 2022 contains the following information:

  • Reason for notification:

  • Notification by: A parent company or a controlling person

  • Persons subject to notification requirement: SRIW SA & Sofipôle SA

  • Transaction date: 24 October twenty22

  • Threshold crossed: 5%

  • Denominator: 115,132,015

Right to vote

Previous notification

after the transaction

Voting rights holders

# of right to vote

# of right to vote

% of right to vote

SRIW SA

344,530

344,530

0.30%

SOFIPOLE SA

862,027

862,027

0.75%

Total voting rights

1,206,557

1,206,557

1.05%

The notification can be consulted on the BioSenic website, under the heading “Shareholder Information”.

Acombat BioSenic

BioSenic is a leading biotechnology company that specializes in the development of clinical assets issued from: (Yo), the ALLOB allogeneic cell therapy platform and (ii) the Arsenic trioxide (ATO) platform. Key target indications for the platforms include graft-versus-host disease (GVHD), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and high-risk tibial fractures.

Following the merger in October 2022, BioSenic combines the strategic positioning and strengths of Medsenic and Bone Therapy. The merger also allows Biosenic to add to its innovative cell therapy platform and strong intellectual property for tissue repair protection an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations utilizing the immunomodulatory properties of ATO/OATO.

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

On BioSenic technology platforms

BioSenic The technology is based on:

1) The allogeneic cell and gene therapy platform, developed by Bone Therapeutics with differentiated mesenchymal stromal cells (MSCs) of bone marrow origin that can be stored at the point of use in hospitals. Its current investigational drug, ALLOB, represents a unique, patented approach to organ repair and specifically bone regeneration, by converting undifferentiated stromal cells from healthy donors into bone-forming cells at the site of injury. These cells are produced through a proprietary BioSenic scalable manufacturing process. Following approval of the CTA by regulatory authorities in Europe, the company has begun patient recruitment for the phase IIb clinical trial of ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications, including spinal fusion, osteotomy, maxillofacial, and dental, and should be of value in new indications when cells will be further adapted or transformed with additional targeting properties.

two) arsenic trioxide (ATO) platform developed by Medsenic. The immunomodulatory properties of ATO have demonstrated a dual basic effect on cells of the immune system. The first effect is increased cellular oxidative stress on activated B, T or other cells of the innate/adaptive immune system to the point that they will enter a cell death (apoptosis) program and be eliminated. The second effect is the potent immunomodulatory properties of various proinflammatory cytokines involved in inflammatory or autoimmune cellular pathways. A direct application is its use in oncoimmunology to treat GVHD (graft versus host disease) in its established chronic stage. GvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation.hello-SCT). GvHD is primarily mediated by the transplanted immune system which can cause severe multi-organ damage. Medsenic had been successful in a phase II trial with its intravenous formulation, allowing the FDA and EMA to grant arsenic trioxide orphan drug designation status and is heading towards an international Phase III confirmation study, with a new IP-protected oral formulation (OATO).

Moderate to severe forms of systemic lupus erythematosus (SLE)° are another selected target, using the same oral formulation. ATO has shown good safety and significant clinical efficacy in various target organs (skin, mucous membranes and the gastrointestinal tract) in a phase IIa to study.
Systemic Sclerosis is also part of the clinical pipeline of BioSenic. Preclinical studies in relevant animal models are positive. This gives a good basis to launch a Phase II clinical protocol for this serious disease that severely affects the skin, lungs or vascularization, and no real current effective treatment.

For more information contact:

BioSenic SA
francois riegerPhD, Executive Director
Telephone: +33 (0)671 73 31 59
Investorrelations@biosenic.com

For inquiries from Belgian investors and media:
Bepublic
Bert Bouserie
Telephone: +32 (0)488 40 44 77
bert.bouserie@bepublicgroup.be

International media inquiries:
IB Communications
Neil Hunter / Michelle Boxall
Telephone: +44 (0)20 8943 4685
neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French media and investor inquiries:
NewCap Investor relations and financial communications
Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouillé
Telephone: +33 (0)1 44 71 94 94
bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking and reflect the Company’s or, as applicable, the Company’s directors’ current expectations and projections about future events. By their nature, forward-looking statements imply a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by forward-looking statements. These risks, uncertainties and assumptions could adversely affect the results and financial effects of the plans and events described in this document. A multitude of factors including, but not limited to, changes in demand, competition and technology, may cause actual events, performance or results to differ materially from any anticipated developments. 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 publish any update or revision of any forward-looking statement 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 subsidiaries nor the officers or employees of any such person warrant that the assumptions underlying any such forward-looking statements are free from error or accept any responsibility for the future accuracy of any forward-looking statements. statements contained in this press release or the actual occurrence of anticipated developments. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this press release.

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