Phebra Pty Ltd.

BioSenic provides third quarter 2024 Business Update BioSenic is actively seeking one or more new assets through a merger or acquisition process Mont-Saint-Guibert, Belgium, October 28, 2024, 7.00 am CEST – Regulated Information - BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune and inflammatory diseases, as well as cell repair, today provides its business update for the third quarter, ended 30 September 2024. Key highlights In July 2024, BioSenic signed of global licensing, supply and commercialization agreements with Phebra Pty Ltd. related to the adaptation of the License Agreement and the MDA signed earlier in May 2021, when Phebra became a minority shareholder in Medsenic SAS.In July 2024, BioSenic filed of the continuation patent application US 18/763,376 with the United States Patent & Trademark Office (USPTO) to provide protection for the use of arsenic trioxide (ATO) for the prevention and treatment of sepsis syndrome.In July 2024, BioSenic released new in-depth analysis of its positive phase 2 clinical data for optimal administration scheme for its next late-stage trial of arsenic trioxide (ATO) targeting cGvHD.In August 2024, BioSenic announced the granting of a key patent by the Japan Patent Office to expand protection of the arsenic trioxide (ATO) platform.In August 2024, BioSenic announced that the European Patent Office (EPO) has granted an important new EU patent to its subsidiary Medsenic "method for treating relapsing-remitting multiple sclerosis using arsenic trioxide".In September 2024, Véronique Pomi-Schneiter stepped down as BioSenic's Deputy CEO.In September 2024, BioSenic announced (i) the start of the search for new assets through an M&A process (the interests of shareholders of Medsenic SAS will be assessed for this purpose), (ii) a reduction in its costs, (iii) the start of discussions with its creditors with a view to the sale of some of its assets, (iv) a change in the composition of its board of directors and (v) the securing of its financing for the next few months by means of an amendment to the convertible bond contract with GTO 15 allowing it to draw up to a further EUR 1.5 million, including at least two tranches of EUR 0.2 million net without any liquidity conditions.In October 2024, Carole Nicco stepped down from her roles as Chief Scientific and Operations Officer of BioSenic to focus on the subsidiary Medsenic SAS. Financial highlights Net cash at the end of September 2024 amounted to € 0,52 million (1). Upon receipt of the next tranche of €210,000 under the existing convertible bonds program with GTO15, BioSenic anticipates having sufficient cash to carry out its business objectives until the end of the year. BioSenic will continue to require additional financing over 2025 and therefore actively evaluates various options. Outlook for the remainder of 2024 and 2025 Following the homologation judgement of 13 June 2024, BioSenic will take the necessary decisions to implement the approved plan and, notably, to retrocede its rights to the JTA and ALLOB technologies to the Walloon Region and to stop all activities in relation to such technologies.The Medsenic Phase II clinical study with arsenic trioxide in the first-line treatment of cGvHD has been completed and provided positive results. A Phase III study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2024. A Phase IIa clinical trial for systemic lupus erythematosus ("SLE") had previously established safety for the patient and efficacy on the course of the autoimmune disease. Positive preclinical work gives good grounds for a Phase II clinical trial on systemic sclerosis ("SSc"). Phase IIb clinical trials for SLE and SSc are in the planning stage with the protocols for both studies being ready.It will only be possible to start the SLE and SSc Phase 2b clinical trials if the BioSenic Group succeeds in concluding a strong partnership with a biopharmaceutical company or if it manages to successfully out-license some of its technology. The start of SLE and SSc Phase II clinical trials is therefore not envisioned before 2025.Maximum cost reduction and disciplined cash management will remain a key priority, and the situation will be closely and actively monitored.BioSenic will actively initiate the search for new assets through M&A processes.Negotiations with BioSenic's creditors will also be initiated as part of the potential sale of BioSenic's stake in Medsenic and other intellectual property assets held by BioSenic, and with a view to continuing the debt restructuring effort initiated following the court's approval of the plan.Medsenic is preparing a refinancing via an equity raise. (1) Unaudited numbers 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. For further information, please contact: BioSenic SAinvestorrelations@biosenic.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. Attachment BIOS_PR_Q3-2024_EN

REGULATED INFORMATIONThe interim financial report is prepared in accordance with article 13 of the Royal Decree on the obligations of issuers of financial instruments admitted to trading on a regulated market and can be accessed on the website of Biosenic in the section ‘Financial reports'. BioSenic publishes its interim financial report in English. A French translation of the report will also be made available. In the event of differences between the English and the French version of the report, the original French version will prevail. Mont-Saint-Guibert, Belgium, 30 September 2024, 7am CEST – BioSenic (Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune and inflammatory diseases and cell repair, today publishes its business update for the first half, ended 30 June 2024, prepared in accordance with IFRS as adopted by the European Union, and the outlook for the remainder of the year. Clinical and corporate highlights of 2024 In January 2024, Dr Carole Nicco has been promoted to Chief Operating Officer (COO) in addition to her position as Chief Scientific Officer (CSO).In January 2024, BioSenic's subsidiary, Medsenic SAS, signed a binding term sheet with Phebra PTY Ltd. related to an adaptation of the License Agreement and the MDA signed in May 2021.In January 2024, BioSenic filed for a U.S. patent for JTA-004, a viscosupplement in late-stage clinical development, following a post hoc analysis showing its efficacy in a recently defined subtype of osteoarthritis (OA).In January 2024, BioSenic has been granted a patent by the Canadian Intellectual Property Office to expand protection of the arsenic trioxide (ATO) platform. The patent, titled “Use of metal ions to potentiate the therapeutic effects of arsenic”, covers the use of ATO platform in combination with metal ions such as copper.In March 2024, BioSenic published an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase II data.In June 2024, BioSenic's board of directors acknowledged the resignation of Mr Yves Sagot as an independent director of the Company, with effect from the Company's 2024 ordinary general meeting.In July 2024, BioSenic signed of global licensing, supply and commercialization agreements with Phebra Pty Ltd. related to the adaptation of the License Agreement and the MDA signed earlier in May 2021, when Phebra became a minority shareholder in Medsenic SAS.In July 2024, BioSenic filed of the continuation patent application US 18/763,376 with the United States Patent & Trademark Office (USPTO) to provide protection for the use of arsenic trioxide (ATO) for the prevention and treatment of sepsis syndrome.In July 2024, BioSenic released new in-depth analysis of its positive phase 2 clinical data for optimal administration scheme for its next late-stage trial of arsenic trioxide (ATO) targeting cGvHD.In August 2024, BioSenic announced the granting of a key patent by the Japan Patent Office to expand protection of the arsenic trioxide (ATO) platform.In August 2024, BioSenic announced that the European Patent Office (EPO) has granted an important new EU patent to its subsidiary Medsenic "method for treating relapsing-remitting multiple sclerosis using arsenic trioxide". In September 2024, Véronique Pomi-Schneiter stands down as BioSenic's Deputy CEO. Financial highlights of 2024 In January 2024, BioSenic signed a new subscription agreement for a maximum EUR 1.2 million convertible bonds facility, arranged by ABO Securities through its affiliated entity Global Tech Opportunities 15.In February 2024, BioSenic raised EUR 500,000 via a private placement.In April 2024, BioSenic filed a debt restructuring plan with the clerk's office of the Walloon Brabant Enterprise Court, with a view to requesting the Court to open private judicial reorganization proceedings by collective agreement and to obtain the agreement of creditors on a plan to reorganize BioSenic's debt. Please refer to the press releases of 11 April 2024,12 April 2024 and 26 April 2024 on this subject for further information.In April 2024, in view of the debt restructuring plan, BioSenic postponed its annual general meeting of the shareholders.In May 2024, BioSenic provided its business update for the first quarter, ended the 31 March 2024. In May 2024, the Walloon Brabant Enterprise Court registered the positive votes of the majority of BioSenic's creditors on the debt restructuring plan.In June 2024, BioSenic announced its business update and full year financial results for the year ending 31 December 2023, prepared in accordance with IFRS. In June 2024, BioSenic received the homologation judgment for the restructuring plan filed with the Enterprise Court of Nivelles, making it binding on all deferred creditors, and the measures provided for therein will continue until June 2029, the end of the five-year period set by law. The restructuring plan can be accessed via the following link: https://biosenic.com/sites/default/files/2024- 04/PRJ_BioSenic_FR.pdfIn June 2024, BioSenic signed a new subscription agreement for a maximum EUR 2.1 million convertible bonds facility, arranged by ABO Securities through its affiliated entity Global Tech Opportunities 15.During the first six months of 2024, total operating income amounted to EUR 2.69 million, compared to EUR 0.37 million in H1 2023.Operating loss for the period amounted to EUR 0.47 million, compared to EUR 3.90 million in H1 2023.BioSenic ended the first six months of 2024 with EUR 0.82 million in cash and cash equivalents. Net cash used for the period amounted to EUR 0.70 million, compared to EUR 1.33 million over the same period of 2023. Outlook for the remainder of 2023 and 2024 Following the homologation judgement of 13 June 2024, BioSenic will take the necessary decisions to implement the approved plan and, notably, to retrocede its rights to the JTA and ALLOB technologies to the Walloon Region and to stop all activities in relation to such technologies. The Medsenic Phase II clinical study with arsenic trioxide in the first-line treatment of cGvHD has been completed and provided positive results. A Phase III study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2024. A Phase IIa clinical trial for systemic lupus erythematosus ("SLE") had previously established safety for the patient and efficacy on the course of the autoimmune disease. Positive preclinical work gives good grounds for a Phase II clinical trial on systemic sclerosis ("SSc"). Phase IIb clinical trials for SLE and SSc are in the planning stage with the protocols for both studies being ready. It will only be possible to start the SLE and SSc Phase 2b clinical trials if the BioSenic Group succeeds in concluding a strong partnership with a biopharmaceutical company or if it manages to successfully out-license some of its technology. The start of SLE and SSc Phase II clinical trials is therefore not envisioned before 2025.Maximum cost reduction and disciplined cash management will remain a key priority, and the situation will be closely and actively monitored. The Company will actively initiate the search for new assets through M&A processes. Negotiations with BioSenic's creditors will also be initiated as part of the potential sale of BioSenic's stake in Medsenic and other intellectual property assets held by BioSenic, and with a view to continuing the debt restructuring effort initiated following the court's approval of the plan.The Company has also invited Medsenic's representatives to urgently carry out a refinancing of Medsenic in which BioSenic will not participate.Financing for the next few months has been secured by means of an amendment to the convertible bond contract with GTO 15, allowing up to EUR 1.5 million to be drawn down, including at least two tranches of EUR 0.2 million net without any liquidity conditions. Unaudited Interim Condensed Consolidated Statement of Comprehensive Income (in thousands of euros) For the six-months period ended30/06/202430/06/2023Revenues 00Other operating income2,694365Total revenues and operating income2,694365Research and development expenses(1,628)(2,452)General and administrative expenses(1,532)(1,813)Other operating expenses(1)(1)Operating profit/(loss)(467)(3,900)Financial Income1,57935Interest income2430Impairment expenses0(16,094)Financial expenses(787)(1,136)Exchange gains/(losses)11 Result Profit/(loss) before taxes349(21,063)Income taxes0(24)Result Profit/(loss) for the Period349(21,087)Thereof attributable to: Owners of the Company495(20,843) Non-controlling interests(146)(244) Other comprehensive income00 TOTAL COMPREHENSIVE INCOME/(LOSS) OF THE PERIOD349(21,087)Thereof attributable to: Owners of the Company495(20,843) Non-controlling interests(146)(244) Basic and diluted loss per share (in euros)0.003(0.17) Unaudited Interim Condensed Consolidated Statement of Financial Position Consolidated Assets IFRS per: (in thousands of euros) 30/06/2024 31/12/2023 Non-current assets6,8087,713Intangible assets2,9842,989Property, plant and equipment591698Finance lease receivable322398Investments in associates1212Other non-current assets53135R&D Tax Credits2,8453,480 Current assets2,5401,846Trade and other receivables1,1871,315Other current assets437272Finance lease receivable148141Cash and cash equivalents816117 TOTAL ASSETS9,3969,559Consolidated Equity & Liabilities IFRS per: (in thousands of euros) 30/06/2024 31/12/2023 Equity attributable to owners of the parent(20,465)(22,912)Share capital8,1756,275Share premium5,8395,720Accumulated losses and other reserves(34,396)(34,887) Other reserves(82)(20) Non-controlling interests61207Total Equity(20,403)(22,705) Non-current liabilities23,31316,420Interest bearing borrowings23,23316,340Other non-current liabilities8080 Current liabilities7,43415,844Interest bearing borrowings3,56111,821Trade and other payables2,8313,871Current tax liabilities05Other current liabilities94147 Total liabilities29,79932,264TOTAL EQUITY AND LIABILITIES9,3969,559 Unaudited Interim Condensed Consolidated Statement of Cash Flows Consolidated Statement of Cash Flows(in thousands of euros) For the six-month period ended 30 June20242023 CASH FLOW FROM OPERATING ACTIVITIES Operating profit/(loss)(467) (3,900)Adjustments for: Depreciation and Amortisation106101Share-based compensation(63)0Grants income related to tax credit(48)(115)Grants income related to withholding tax(5)(47)Other(141)(68) Movements in working capital: (Increase)/Decrease in Trade and other receivables (excluding government grants)(125)(34)Increase/(Decrease) in Trade and other Payables(827)492 Cash used by operations(1,569)(3,570)Cash received from license agreement0940Cash received from grants related to tax credit735700Net cash used in operating activities(834)(1,930) CASH FLOW FROM INVESTING ACTIVITIES Disposal of intangible assets017Disposal of property, plant and equipment03Purchases of property, plant and equipment0(12)Purchases of intangible assets0(1)Net cash generated from investing activities07 CASH FLOW FROM FINANCING ACTIVITIES Repayment of borrowings(122)(150)Proceeds from borrowings2100Proceeds from convertible borrowings1,200550Repayment of lease liabilities(9)(84)Repayment of other financial liabilities(125)(75)Interests paid(12)(13)Transaction costs(109)(81)Proceeds from issue of equity instruments500450 Net cash generated from financing activities1,533596 NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS699(1,327)CASH AND CASH EQUIVALENTS at beginning of the period1171,846CASH AND CASH EQUIVALENTS at end of the period816519 Unaudited Interim Condensed Consolidated Statement of Changes in Shareholders' Equity Attributable to owners of the parent Non-controlling interests TOTAL EQUITY (in thousands of euros)Share capitalShare premiumAccumulated Losses & other reservesOther elements of comprehensive income BALANCE AT 1 JANUARY 20234,7744,517(5,723) (42) (402)3,124Total comprehensive income of the period00(20,843) 0 (244)(21,087)Issue of share capital450158000609Transaction costs for equity issue0(81)000(81)Other00 (85)(6)0(91)BALANCE AT 30 JUNE 20235,2244,594(26,652) (48) (646)(17,528) BALANCE AT 1 JANUARY 20246,2755,720(34,887)(20)207(22,705)Total comprehensive income of the period004950(146)349Issue of share capital1,9002280002,128Transaction costs for equity issue0(109)000(109Share-based payment000(63)0(63)Other00(4)00(4)BALANCE AT 30 JUNE 20248,1755,839(34,396)(82)61(20,405) 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. For further information, please contact: BioSenic SAFinsys Management SRL, represented by its permanent representative Jean-Luc Vandebroek, managing-director ad interimTel : +32 478 27 68 42 investorrelations@biosenic.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.

The adapted supply and commercialization conditions to better achieve the development of the first oral formulation of arsenic trioxide for the treatment of cGvHD should provide the best chances for final market access. July 2, 2024, 7.00am CEST – 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 announce the signature of global licensing, supply and commercialization agreements with Phebra Pty Ltd. related to the adaptation of the License Agreement and the MDA signed earlier in May 2021, when Phebra became a minority shareholder in Medsenic SAS. The improved terms will make it more attractive for investors to participate in the financing of the upcoming Phase 3 trial of oral arsenic trioxide (OATO/ ArsciCor). This new licensing agreements between Medsenic SAS and Phebra Pty Ltd should facilitate the final steps of manufacturing, clinical confirmation of efficacy and subsequent commercialization of our oral arsenic drug in the field of chronic Graft versus Host Disease (cGvHD). The existing License Agreement has been updated and provides a balanced set of terms best suited for the optimal drug manufacturing, clinical development and future commercialization of our oral arsenic trioxide medication (OATO/ArsciCor), all adapted to the sole indication of cGvHD. The license provides for a royalty on worldwide sales to Phebra, which simplifies and facilitates the terms and conditions for possible sublicensing to future external partners. In addition, under the license agreement, Phebra Pty Ltd. agrees that Medsenic SAS will have exclusive worldwide territorial rights for the use of OATO in GvHD. Commercial arrangements for other indications in the initial Licence Agreement remain unchanged. With respect to the Supply and Commercialization Agreements, Phebra Pty Ltd. remains responsible for maintaining and updating the drug substance file to comply with the regulation of all active territories; of controlling the compliance with various regulatory authorities on ongoing supplier approval and compliance with Good Manufacturing Practices (GMP) requirements; of updating the drug master file of OATO; of managing the Contract Manufacturing Organization (CMO) and supply chain of the active pharmaceutical ingredient for the clinical release of the product; and of covering the regulatory and quality and GMP expenses. In addition, Medsenic will have the right to establish an Australian entity to use the OATO patents for the cGvHD indication. The Australian entity will not commercially compete with Phebra Pty Ltd., particularly in the field of APL (acute promyelocytic leukemia) cancer treatment, by producing Medsenic's GvHD treatment in indication-specific packaging. Prof. François Rieger, President of the Board and CEO of the BioSenic Group, said: ”Our collaboration and partnership with Phebra Pty Ltd. – a long term minority shareholder in our group – now leads us to an optimal set of agreements for our licensing and commercialization of the oral formulation of the API arsenic trioxide, OATO/ ArsciCor, which is believed to be favorable for of a smooth development and increased interest from new investors to help make our cGvHD project a success. Our goal is to provide patients with Graft versus Host Disease with a safe, effective and convenient therapeutic solution to treat and control, if not cure, this unmet medical need that occurs after the transplantation of a foreign, functional immune system following the elimination of cancer blood cells. The present radical improvement in the commercial agreement between Phebra Pty Ltd. and Medsenic should facilitate our task of implementing all the necessary funding for the few years of the cGvHD Phase 3 trial. It has already been stated that BioSenic needs a successful cGvHD lead development program: this is key to the company's success, although parallel efforts to develop new indications/therapeutic applications for innovative formulations of ATO can add very significant value.” 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). 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. The content above comes from the network. if any infringement, please contact us to modify.