Click to Download
Wednesday, 6 December 2023
BioSenic on its way to find the necessary funds to perform its key clinical trial on chronic Graft-versus-Host Disease
Biosenic signs term sheet with SPRIM Global Investments (TrialCap fund) for up to USD 8 million debt financing and USD 800,000 equity investment as a first decisive, financing step towards a Phase 3 clinical trial for its ground-breaking auto-immune medication, a first-in-class drug oral arsenic salt
Mont-Saint-Guibert, Belgium, December 6, 2023 – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, and its subsidiary Medsenic SAS, today announces that it has signed a term sheet with Singapore based fund TrialCap Pte. Ltd. (the "Term Sheet") and/or other lenders (the "Lender") for a proposed debt and equity financing. BioSenic is seeking the funds to continue its clinical development, backed by previous highly promising Phase 2 and pre-clinical results of arsenic trioxide (ATO). Previous results show that ATO is a very valuable medication for correcting dysregulations of the immune system.
In accordance with the Term Sheet, the Lender will provide two term loan facilities of each up to USD 4,000,000. The facilities will be structured as a loan note facility agreement, with each loan to be advanced in cash directly to the relevant trial service provided or to BioSenic for relevant expenditures under the Phase 3 clinical study with oral arsenic trioxide (OATO) in first-line treatment of chronic Graft-versus-Host Disease (cGvHD). The loan facilities will allow BioSenic to finance between 25 percent and 37 percent of the trial expenses eligible for an R&D tax credit in France and Australia, respectively. The loan facilities have a maturity date of 7 years from the first utilization date, an interest rate of SOFR plus 9.5 percent per annum and an upfront fee of an amount equal to 1.0 percent of the facility amount, payable on each drawdown.
In addition, under the Term Sheet, the Lender intends to make an equity investment of USD 800,000 in new shares of BioSenic. BioSenic will also issue warrants equal to 20 percent of the total amounts drawn under the loan facilities. These warrants become exercisable when 20 percent of the two loan facilities have been drawn and the exercise price is equal to the subscription price of the equity investment.
Completion of the transactions set out in the Term Sheet is subject to the following conditions: (i) the satisfactory completion of due diligence by the Lender, (ii) the signing of the definitive agreements for the debt and equity financing, (iii) the signing with a Clinical Research Organization (CRO) and (iv) an equity raise by BioSenic of an amount to be further determined. BioSenic expects such conditions to be satisfied in Q1 2024.
François Rieger, PhD, Chairman and Chief Executive Officer of BioSenic said: "We are very pleased to announce that we have found ways to set up a decisive financing for our lead project, an international Phase 3 clinical trial in chronic Graft versus Host disease, to confirm the remarkable therapeutic effects of our medication ArsciCor, soon available for clinical trials as an oral medication. This is a major step forward in harnessing the unique therapeutic properties of arsenic trioxide to correct immune dysregulation as seen in various autoimmune diseases. The success of the present project should lead BioSenic to progress other important therapeutic approaches related to abnormalities of the immune system, with chronic detrimental characteristics affecting the innate, trained and/or adaptative system, in chronic, serious diseases, and with unmet medical needs. The involvement of Singapore SPRIM Global Investment Company, through its dedicated TrialCap Fund, is greatly appreciated by the all BioSenic team, for the benefit of the patients.”
BioSenic is a biotech company specializing in the development of clinical assets issued from: (i) the arsenic trioxide (ATO) platform (with key target indications including Graft-versus-Host Disease (GvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the development of innovative products to meet unmet needs in immune and autoimmune diseases. Following a reverse merger in October 2022, BioSenic combined its strategic positioning and key strengths to develop, separately and in combination, an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/oral ATO (OATO) with its innovative cell therapy platform and strong IP for tissue repair protection.
About BioSenic technology platforms
1) The ATO platform has immunomodulatory properties with 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). BioSenic has been successful in a phase 2 trial with its intravenous formulation, 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) in an early phase 2a study. Systemic sclerosis is also part of the clinical pipeline of 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.
2) ALLOB, 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 stromal cells from healthy donors into bone-forming cells on the site of injury. After phase 2 clinical results with contradictory conclusions, BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (between early or late treatment).
The company is currently focusing its present R&D and clinical activities on a selective, accelerated development of its autoimmune (ATO/OATO) platform.
About SPRIM Global Investments:
SPRIM Global Investments (SGI) invests principally in companies that provide R&D capabilities to bring life science, biotech and medtech innovations to patients around the world. SPRIM portfolio of R&D Service/CRO and digital technology companies are addressing many of the main points across the different clinical stages of drug and device development. Additionally, SGI leverages its unique vantage point in clinical stages to invest in Biotech and in Medtech. Further information is available at https://sprim.net.
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.