BioSenic SA: Transparency notification received from ABO Infinium Americas OpCo LTD.

BioSenic SA: Transparency notification received from ABO Infinium Americas OpCo LTD.

BioSenic SA: Transparency notification received from ABO Infinium Americas OpCo LTD.

REGULATED INFORMATION

Article 14 of the law of May 2, 2007, concerning the disclosure of significant shareholdings

Mont-Saint-Guibert, Belgium, August 19, 2024, at 7:00 a.m. CEST –BIOSENIC (Euronext Brussels and Paris: BIOS), a company that specializes in clinical trials for serious autoimmune and inflammatory diseases as well as cell therapy, today announced the receipt of a transparency notification from ABO Infinium Americas OpCo LTD. Details of the transparency notification are outlined below, and the full text can be found on BioSenic’s website under the section “Major shareholders and transparency notices.”

The transparency notification indicates that the voting rights attached to BioSenic shares held by ABO Infinium Americas OpCo LTD. have dropped below the 5% threshold due to the sale of BioSenic shares by the latter.

The statement received from ABO Infinium Americas OpCo LTD., dated August 16, 2024, contains the following information:

  • Reason for notification: Acquisition or transfer of securities conferring voting rights or voting rights

  • Notification by: A parent company or controlling entity

  • Person required to notify:

    • ABO Infinium Americas OpCo LTD.
    • ABO Securities

    • Omega Financial Corporation

    • Mr. Pierre Vannineuse

  • Threshold crossing date: August 14, 2024

  • Threshold crossed: 5%

  • Denominator: 251,312,817

  • Complete chain of controlled companies through which the interest is held: ABO Infinium Americas OpCo LTD. (303 Shriley Street, Nassau, Bahamas) is entirely owned by ABO Securities (71 Fort Street, Georges Town, Grand Cayman, Cayman Islands). ABO Securities is wholly owned by Omega Financial Corporation (71 Fort Street, Georges Town, Grand Cayman, Cayman Islands). Omega Financial Corporation is fully owned by Pierre Vannineuse.

About BioSenic

BioSenic is a biotechnology firm focused on the clinical development of therapies for autoimmune diseases.

BioSenic is a leading biotechnology company dedicated to developing clinical assets from its Medsenic arsenic trioxide (ATO) platform. Key target indications for the autoimmune platform include graft-versus-host disease (GvHD), systemic lupus erythematosus (SLE), and now systemic sclerosis (SSc).

Following the merger in October 2022, BioSenic has integrated the strategic positions and strengths of Medsenic and Bone Therapeutics. This merger allows Medsenic/BioSenic to develop an entirely new range of various anti-inflammatory and anti-autoimmune formulations utilizing the immunomodulatory properties of oral ATO (OATO).

BioSenic is headquartered in the Louvain-la-Neuve science park in Mont-Saint-Guibert, Belgium. More information can be found at:http://www.biosenic.com.

About Medsenic/BioSenic’s core technologies

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

Medsenic has successfully completed a Phase 2 clinical trial with BioSenic’s intravenous formulation of ATO,Arscimed®, which has received orphan drug designation from the FDA and EMA, demonstrating good safety and substantial clinical efficacy in the skin, mucosa, and gastrointestinal tract. The company is preparing for a global confirmatory Phase 3 study with its novel oral formulation of ATO (OATO), which will also target moderate to severe forms of SLE. BioSenic is also developing a novel formulation of OATO, protected by intellectual property, for the treatment of SSc, a serious chronic disease affecting the skin, lungs, or vasculature, for which there is currently no effective treatment. Preclinical studies in relevant animal models support the initiation of a Phase 2 clinical trial using new immunomodulatory formulations of active pharmaceutical ingredients known to influence the immune system.

The company is currently concentrating its R&D and clinical efforts on the selective and accelerated development of its autoimmune platform.

Note: The allogeneic cell therapy platform, originating from the previously listed company Bone Therapeutics, may regain interest by utilizing isolated and purified bone marrow-derived mesenchymal stromal cells (MSCs) as the initial material for the subsequent isolation of passive or active biological subcellular elements. These cells may provide novel subcellular vesicles that could offer a unique and exclusive approach to organ repair. BioSenic is currently working on identifying new patentable strategies in this complex field of cell therapy.

For further information, please contact:

BioSenic SA

Prof. François Rieger, PhD, Managing Director

Tel: +33 (0)671 73 31 59
[email protected]

Certain statements, beliefs, and opinions contained in this press release are forward-looking in nature and reflect the current expectations and projections of the Company or, as applicable, the Company’s directors regarding 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, may cause actual events, performance, or results to differ materially from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be interpreted as a representation that such trends or activities will continue in the future. Accordingly, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements contained in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which any such forward-looking statements are based. Neither the Company nor its advisors or representatives, nor any of its subsidiaries, nor any of these persons’ directors or employees guarantee that the assumptions underlying such forward-looking statements are free from errors and accept no responsibility for the future accuracy of the forward-looking statements contained in this press release or for the actual realization of the anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

BioSenic SA: Transparency Notification Received from ABO Infinium Americas OpCo LTD

INFORMATION REGLEMENTEE

Article 14 of the law of 2 May 2007 relating to the disclosure of significant shareholdings

Mont-Saint-Guibert, Belgium, August 19, 2024 at 7:00 a.m. CEST – BioSenic,
(Euronext Brussels and Paris: BIOS), a company specializing in clinical trials related to serious
autoimmune and inflammatory diseases and cell therapy, has announced the receipt of a transparency
notification from ABO Infinium Americas OpCo LTD. The details are outlined below; the full text can
be accessed on BioSenic’s website under the heading “Major shareholders and transparency notices“.

The transparency notification indicates that the voting rights linked to BioSenic shares held by
ABO Infinium Americas OpCo LTD. have fallen below the 5% participation threshold
following their sale of BioSenic shares.

The statement received from ABO Infinium Americas OpCo LTD. dated August 16, 2024, includes the
following information:

  • Reason for notification: Acquisition or transfer of securities conferring voting rights or voting rights
  • Notification by: A parent company or controlling person
  • Person required to notify:

    • ABO Infinium Americas OpCo LTD.
    • ABO Securities
    • Omega Financial Corporation
    • Mr. Pierre Vannineuse
  • Threshold crossing date: August 14, 2024
  • Threshold crossed: 5%
  • Denominator: 251,312,817
  • Complete chain of controlled companies:
    ABO Infinium Americas OpCo LTD. (303 Shriley Street, Nassau, Bahamas) is 100% owned by
    ABO Securities (71 Fort Street, Georges Town, Grand Cayman, Cayman Island).
    ABO Securities is 100% owned by Omega Financial Corporation (71 Fort Street, Georges Town,
    Grand Cayman, Cayman Island). Omega Financial Corporation is 100% owned by
    Pierre Vannineuse.

About BioSenic

BioSenic is a biotechnology company specializing in the clinical development of therapies for
autoimmune diseases, focusing on innovative treatments that target chronic conditions.

BioSenic operates through its Medsenic arsenic trioxide (ATO) platform, developing therapies
for significant indications including graft-versus-host disease (GvHD), systemic lupus erythematosus
(SLE), and systemic sclerosis (SSc).

After merging with Bone Therapeutics in October 2022, BioSenic has strengthened its position
in the biotech arena, allowing it to leverage synergies between two pioneering platforms. This
merger has enabled the development of a variety of anti-inflammatory and anti-autoimmune formulations
using the immunomodulatory effects of oral ATO formulations (OATO).

Core Technologies and Innovations

ATO Platform – The ATO platform boasts immunomodulatory properties, significantly
influencing the actions of activated immune cells. Its primary application targets the treatment of
chronic autoimmunity, particularly effective for managing GvHD as a complication of allogeneic
hematopoietic stem cell transplantation (allo-HSCT).

Following the successful completion of a Phase 2 clinical trial, BioSenic’s intravenous ATO product,
Arscimed®, has acquired orphan drug status from the FDA and EMA. It demonstrated favorable safety
profiles along with significant clinical efficacy, particularly in skin, mucosal, and gastrointestinal
manifestations.

Currently, BioSenic is gearing up for a global confirmatory Phase 3 study involving its innovative
OATO product, which also aims to address moderate to severe SLE cases. Furthermore, BioSenic is
advancing a novel OATO formulation with intellectual property protection, aimed at treating SSc.

Preclinical investigations conducted on pertinent animal models substantiate the initiation of a
Phase 2 clinical trial, focusing on novel immunomodulatory formulations that are known to impact
immune responses significantly.

Research & Development Focus

BioSenic is channeling its R&D efforts towards the selective and expedited development of its
autoimmune therapy platform, seeking breakthroughs that can transform patient outcomes in chronic
disease scenarios.

Cell Therapy Platform – The allogeneic cell therapy sector, deriving from Bone Therapeutics,
recognizes renewed interest as BioSenic explores the utility of isolated and purified mesenchymal
stromal cells (MSCs) derived from bone marrow. These cells have shown promise in offering unique
approaches to organ repair via subcellular vesicles.

BioSenic is actively researching new methodologies in this complex domain of cell therapy,
aiming to introduce novel patentable approaches that could lead to significant advancements in
treatment options.

Key Company Information

Company Details:
BioSenic SA
Prof. François Rieger, PhD, Managing Director
Contact: +33 (0)671 73 31 59
Email: [email protected]

Note: Forward-looking statements contained herein entail uncertainties and assumptions that may
cause actual results to differ materially from those projected. These may include supply and demand
changes and competitive dynamics, thus emphasizing caution for stakeholders relying on projected
outcomes.

Leave a Replay