BioSenic and its restructuring practitioner (Me Yves Brulard) submit a global restructuring plan covering the years 2024-2030 to the Enterprise Court of Nivelles


PRESS RELEASE - PRIVILEGED INFORMATION

A final circular of the creditors on the basis of XX 83/23 of the Economic Law Code (ELC) will take place before the Court grants authorisation, in accordance with article XX 83/26 of the ELC, to submit the plan to the vote of each class of creditors and to homologation. The creditors will be aware of the plan, which by law contains information that could be privileged.

Mont-Saint-Guibert, Belgium, 11 April 2024, 14:00 CET – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy announces that it has finalised a draft plan with the request referred to in Article XX 83/26 ELC with the Enterprise Court of Nivelles. Creditors will be notified to register their claims in RegSol. They will be able to consult this plan in order to then vote on the proposals made.

The proposed plan provides for differentiated treatment of creditors by class:

  • The plan does not affect the recent financing provided through the convertible bond facilities.
  • Some obligators have been offered to replace their outstanding loans granted to BioSenic for a total principal amount of EUR 7.5 million with new convertible bonds to be issued by BioSenic. The convertible bonds would be unsecured and would have a maturity date of 31 December 2030, which could be further extended by BioSenic for up to 24 months depending on its cash balance. An interest rate of 5% per year, payable annually, with an additional non-compounding interest of 3% per year that would be added to the principal amount upon conversion or repayment of a convertible bond. Under this proposal, which has already been agreed in principle, 200,000 outstanding warrants would be cancelled. The plan, if approved, would remove the conditions precedent previously agreed.
  • The plan provides that an outstanding EUR 8 million principal loan would be replaced by new convertible bonds to be issued by BioSenic. The convertible bonds would be unsecured and would have a maturity date of 31 December 2030, which could be further extended by BioSenic for up to 24 months depending on its cash balance. An interest rate of 5% per year, payable annually, with an additional non-compounding interest of 3% per year that will be added to the principal amount upon conversion or repayment of a convertible bond. If the plan is approved, 800,000 outstanding warrants would also be cancelled.
  • With regard to the ordinary creditors, the plan provides for a payment by BioSenic of 5% of the claim on the last day of the 5th year of the plan.
  • With respect to the lessor, the plan provides for the extraordinary part 100% immediately and the balance in ordinary.
  • Regarding the strategic creditors, the plan provides for 90% over 5 years depending on cash inflows and no later than the last day of the 5th year of the plan.
  • For the accessories employee, the plan provides for 99% immediately.
  • The plan provides, for the very useful creditors, for 50% within 2 years.
  • Regarding the InterCos debts, the plan provides for 5% immediately.
  • Finally, with regard to the shareholders, the plan provides for the allocation of subscription rights, the terms of which will be determined at a later date by BioSenic.

The plan includes a participation clause at the reorganisation value, due on the last day of the 5th year following the homologation of the plan on the basis of the average share price over the preceding 90 days. This participation amount – to be deducted from the company's own financing capacity for projects in the 5th year, with trials to be started or even maintained on new indications – will be due on the last day of the 5th year following the homologation of the plan, and will be assessed on the basis of the average share price over the preceding 90 days: the average share price will have to reach the level observed for the shares of BioSenic in 2017 while a Phase III was ongoing (JTA004). At that time, the share price stood at EUR 10. If this level is reached, the participation of every creditor will be increased by 10% of the debt written off. The increase/participation could reach 20 % of the debt written off if the price reaches EUR 18, 30% if the price reaches EUR 25 and 50% if the price reaches EUR 50, which is highly unlikely for a biotech with no turnover, as indicated in a 2022 MIT study (Singh et al 2022, PloS-ONE, open access article, "The reaction of sponsor stock prices to clinical trial outcomes: An event study analysis").

The plan is based on the non-binding offer of funding from a fund, in particular, to finance a Phase 3 clinical trial on Graft versus Host disease (as announced by BioSenic, via press release, on 8 December 2023). BioSenic will announce, by way of a new press release, the results of the votes of the creditors and after the terms and conditions that will be decided by the Court, as well as the Court's decisions as soon as they are known. This judgement would significantly reduce the debt.

François Rieger, PhD, President of the Board and CEO of the BioSenic Group, said: "An effort to reorganise the assets of BioSenic has now been accompanied by a proposed adjustment to the company's liabilities. This should enable our biotech to regain momentum by focusing its efforts on its most promising projects, in particular a Phase 3 clinical trial for the treatment of chronic Graft versus Host disease. These projects, now at the clinical trial stage, will generate value for all those who have invested financially in the adventure that is now taking shape. We expect decisive results for patients suffering from chronic diseases of the immune system, for which there is currently no medical need.".

About BioSenic

BioSenic is a leading biotech company specializing in the development of clinical assets issued from its Medsenic’s 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 combined the strategic positionings and strengths of Medsenic and Bone Therapeutics. The merger specifically enables Medsenic/Biosenic to develop an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/oral ATO (OATO).

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 the main Medsenic/BioSenic technology platform

The ATO platform provides derived active products with immunomodulatory properties and fundamental effects on the activated cells of the immune system. One direct application is its use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in its chronic, established stage. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Medsenic has been successful in a phase 2 trial with its intravenous formulation, Arscimed®, which has orphan drug designation status by FDA and EMA. The company is heading towards an international phase 3 confirmatory study, with its new, IP-protected, OATO formulation. Another selected target is moderate-to-severe forms of systemic lupus erythematosus (SLE), using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucosae, and the gastrointestinal tract). Systemic sclerosis is now full part of the clinical pipeline of Medsenic/BioSenic. This serious chronic disease badly affects skin, lungs, or vascularization, and has no current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a phase 2 clinical protocol, using new immunomodulatory formulations of APIs recognized to be active on the immune system.

The company is currently focusing its present R&D and clinical activities on a selective, accelerated development of its autoimmune platform.

Note: The allogeneic cell therapy platform-originating from the previous listed company Bone Therapeutics company, may be of renewed interest by using isolated and purified differentiated bone marrow Mesenchymal Stromal Cells (MSCs) as a starting material for further isolation of passive or active biological subcellular elements. Indeed, these cells may provide new subcellular vesicles potentially able to deliver a unique and proprietary approach to organ repair. BioSenic is now involved in determining new patentable approaches in this complex area of cell therapy.

For further information, please contact:

BioSenic SA
François Rieger, PhD, CEO
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com

International Media Enquiries:
IB Communications
Michelle Boxall
Tel: +44 (0)20 8943 4685
michelle@ibcomms.agency

French Investor Enquiries:
Seitosei Actifin
Ghislaine Gasparetto
Tel: +33 (0)1 56 88 11 22
ghislaine.gasparetto@seitosei-actifin.com

Michael Scholze
michael.scholze@seitosei-actifin.com

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.