Bukwang Pharmaceutical Co., Ltd.

July 16, 2024 Biodexa Announces Phase 2a Study of Tolimidone in Type 1 Diabetes Approved by Health Canada Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs announces progress on initiation of a Phase 2a study of tolimidone in Type 1 diabetes (“T1D”). Health Canada has approved a Phase 2a dose confirmation study of tolimidone in T1D. The study will be an Investigator Initiated Trial (IIT) to be conducted by the University of Alberta. The study will measure C-peptide levels (a marker for insulin) and HbA1c (a marker for blood glucose) after three months compared with baseline and the number of hyperglycemic events initially in 12 patients across three dose groups. The study may be expanded in due course. It is expected the first patient will be enrolled in the current quarter. Commenting, Stephen Stamp, CEO and CFO of Biodexa said: ”We are excited to initiate our clinical program in Type 1 diabetes with the University of Alberta and build on the extensive tolimidone data package put together by Pfizer, Melior and Bukwang ”. About Tolimidone Tolimidone was originally discovered by Pfizer Inc. (“Pfizer”) and was developed through Phase II for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug due to lack of efficacy for that indication in a Phase II clinical trial. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signalling cascade initiated by the binding of insulin to its receptor. Biodexa plans to develop tolimidone for the treatment of T1D. Tolimidone’s potential utility in T1D has been demonstrated by a number of preclinical studies conducted at the University of Alberta, where Lyn kinase was identified as a key factor for beta cell survival and proliferation in in vitro and in vivo models. Most importantly, tolimidone was able to induce proliferation in beta cells isolated from human cadavers. For more information, please contact: Biodexa Pharmaceuticals PLCStephen Stamp, CEO, CFOTel: +44 (0)29 20480 180www.biodexapharma.com About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa™, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer; tolimidone, under development for the treatment of Type 1 diabetes and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.

DUBLIN, March 29, 2024 /PRNewswire/ -- The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023" report has been added to ResearchAndMarkets.com's offering. MSCs appear to be an exceptionally promising tool for cell therapy, because of their unusual advantages, which include availability, expandability, transplantability, and ethical implications. Interest in therapeutic applications of human MSCs arises from their diverse ability to impact human health, as well as their ability to migrate to sites of tissue injury/inflammation or tumor growth. MSCs are essential raw materials for many regenerative medicine products, including cell-based therapies, engineered tissues, exosome products, cosmeceuticals, and cultured meat production. MSCs are also well-suited for use in the exponential growth field of 3D printing and numerous companies are working on manufacturing technologies to support the commercial-scale production of MSCs. Today, numerous market competitors are also exploring commercialization strategies for MSC-derived extracellular vesicles (EVs) and exosomes, because these extracellular "packages" represent a novel strategy for accessing the therapeutic effects of MSCs without the risks of administering whole cells to patients. Gene editing of MSCs for overexpressing antitumor genes or therapeutic factors is broadening their application as well. Despite the challenges associated with commercializing MSC-based therapeutics, there are more than 100,000 scientific publications published about MSCs and over 1,100 MSC-based clinical trials underway worldwide. Clinical trials involving MSC therapeutics have risen in recent years, in part due to trials related to COVID-19. Current "hotspots" for MSC clinical trials include the U.S., E.U., China, Middle East, and South Korea. While many early-stage MSC trials have demonstrated safety and efficacy, only a small number of MSC products have reached commercialization, indicating that the therapeutic market for MSCs remains early-stage. The first MSC-based cell therapy product was approved in 2010 in South Korea. To date, ten MSC-based cell therapy products have gained approval, as well as 19 MSC-based bone matrices. While therapeutic success has been challenging, the demand for MSC-based research products has surged in recent years, with most large research product suppliers now offering a variety of MSC-based products, services, kits, and manufacturing tools. Major players involved in the market for MSC-based research products include Lonza, Thermo Fisher Scientific, Sigma Aldrich, VWR, Sartorius, ATCC, EMD Millipore, and others. Smaller and mid-sized players are also competing in this promising market, including but not limited to Axol Bioscience, StemBioSys, PromoCell, and iXCell Biotechnologies. To date, the company to establish itself with the greatest domain knowledge in the area of MSC-based products and manufacturing technologies is RoosterBio, headquartered in Frederick, Maryland, USA. Cynata Therapeutics is also working diligently on technologies to enable large-scale production of MSC-based therapeutics, although it is exclusively focused on MSC-based therapeutics and is using its CymerusT platform technology to produce nearly infinite numbers of iPSC-derived MSCs. It is concurrently pursuing several clinical trials worldwide. In the coming years, an increasing number of research products and therapeutic products will continue to be developed around MSCs and their differentiated cell types. Within this rapidly changing landscape, having a thorough understanding of the competition is essential. Therefore, this global strategic report details the activities of 113 leading MSC companies, including their core technologies and products under development. It presents detailed market size figures for the global MSC market, segmented by Geography and Business Segment, and accompanied by future forecasts through 2030. This global strategic report includes: Market size determination for the global MSC market, segmented by Geography and Business Segment Future forecasts for the Global MSC Market through 2030 Major diseases addressed by MSCs in the ongoing clinical trials Cost of manufacturing autologous and allogeneic MSCs Rates, quantities, geographic locations, and types of MSC clinical trials Types and sources of MSC industry funding Detailed MSC patent analysis, including rates and geographic breakdown of MSC patents The top owners, inventors, and sponsors of MSC patents Recent business developments related to MSCs, including strategic collaborations and partnerships MSC-based products with marketing approval and the companies commercializing them Currently marketed MSC-based bone matrices Pricing comparison of MSC-based products with marketing approval The pipeline for MSC-based therapeutics Emerging applications for MSCs, including genetic modification, 3D bioprinting, clean meat production, and cosmeceuticals Company profiles for MSC market competitors, including their products, services, and technologies under development Dozens of charts, figures, and tables And so much more In summary, this global strategic report presents market size figures with forecasts through 2030, as well as rates of MSC clinical trials, scientific publications, patents, funding events, and strategic collaborations. It also presents the pipeline for MSC-based therapeutics, identifies leading market competitors, and explores future directions for the industry at large. With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities. Key Topics Covered: 1. REPORT OVERVIEW 2. MESENCHYMAL STEM CELLS (MSCS): AN OVERVIEW 3. PUBLISHED SCIENTIFIC PAPERS ON MSCS 4. STEM CELLS PATENT LANDSCAPE: AN OVERVIEW 4.1 Geographical Distribution of Stem Cell Patent Filing 4.2 MSC Patents 5. MSCS: CLINICAL TRIAL LANDSCAPE 5.1 Analysis of Data from ClinicalTrials.gov 5.2 Administration of MSCs in Clinical Trials 5.3 MSC Clinical Trials by Disease Category 6. BIOENGINEERING SOLUTIONS TO BOOST MSC'S FUNCTIONS 6.1 Small-Molecule Priming 6.2 Particle Engineering 6.3 Genetic Engineering 6.4 Bioengineering Approaches to Improve MSC Administration 7. MANUFACTURING OF MSCS 7.1 Autologous and Allogeneic MSCs 7.2 Methods of Isolation of MSCs 7.3 Cell Expansion: Conventional Cultures to Bioreactors 7.4 Bioreactors in Current Use 7.5 Main Features of Commercial Bioreactors 7.6 Number of Cells per Batch by Technologies 7.7 Microcarriers for the Expansion of MSCs 7.8 Downstream Processing of MSCs 7.9 Autologous & Allogeneic MSC Manufacturing: A Comparison 7.10 Cost Breakdown in MSC Manufacturing 8. SMALL SCALE PROCESSING OF MSCS 8.1 Model Design 8.2 Culture Media 9. LARGE-SCALE MANUFACTURING OF MSCS 9.1 The Four Common Bioprocessing Strategies for Large-Scale Expansion of MSCs 9.2 Commonly Used Sources of MSCs for Large-Scale Expansion 9.3 Commonly used Culture Media for Large-Scale Expansion of MSCs 9.3.1 Expansion Ratios Achieved with Different Culture Media 9.4 Comparison between the Four Large-Scale MSC Expansion Strategies 10. CONTRACT MANUFACTURING FOR CELL & GENE THERAPIES 10.1 The Need for Staff with Expertise 10.2 Capacity Constraints 10.3 CDMO Platforms Showing Greatest Growth Potential 10.4 Outsourcing Trends for Cell & Gene Therapies (CGT) 10.5 CMOs/CDMOs 10.6 Global Bioprocessing Capacity 10.7 Top Global CDMOs in 2022 10.8 U.K.'s Domination in European Cell & Gene Therapy Contract Manufacturing 11. MAJOR DISEASES ADDRESSED BY MSCS 12. CURRENT STATUS OF MESENCHYMAL STEM CELL INDUSTRY 12.1 Brief Account of Modified MSCs 12.2 MSC-Based Products with Marketing Approval 12.3 Currently Marketed MSC-Based Bone Matrices 13. RECENT COLLABORATIONS IN MSC SECTOR 14. MARKET ANALYSIS 14.1 Price Tags of MSC-Based CT Treatment 14.2 Price Tags of MSC-Based Matrices 14.3 Market Size of MSC-Based Therapies 14.4 Global Market for MSC-Based Therapeutics 14.5 Global Demand for Mesenchymal Stem Cells (MSCs) 15. COMPANY PROFILES 101 Bio AGC Biologics AMS Biotechnology AQ Skin Solutions AbbVie Abzena Adipomics Advancells Advent Bio Aegle Therapeutics Aethlon Medical AgeX Therapeutics AlloSource Ambulero American CryoStem Corporation American Type Culture Collection (ATCC) Andelyn Biosciences Anemocyte Anterogen Arranta Bio Aruna Bio Avid Bioservices Bacthera Baylx, Inc. Bio-Techne BioCardia BioCentriq BioEden, Inc. BioRestorative Therapies Bioinova Bioscience Institute Blue Horizon International Boehringer Ingelheim BioXcellence Bonus Biogroup, Ltd. BrainStorm Cell Therapeutics CCRM CardioCell, LLC Caregen Nordic Catalent Pharma Solutions CellResearch Cellipont Bioservices Celltex Therapeutics Cellular Biomedicine Group Celprogen, Inc. Charles River Laboratories International, Inc. Citius Pharmaceuticals, Inc. Corestem, Inc. Creative Bioarray Cynata Therapeutics, Ltd. Cytovance Biologics Dendreon Direct Biologics EXOSOMEplus ElevateBio Exothera FUJIFILM Cellular Dynamics Fujifilm Diosynth Biotechnologies Future Cell Japan Co., Ltd. Genezen Hope Biosciences Invitrx Therapeutics JCR Pharmaceuticals Just-Evotec Biologics Kimera Labs LifeCell Longeveron Lonza Group, Ltd. Lorem Cytori USA, Inc. Lykan Bioscience Matica Biotechnology, Inc. Medipost, Co., Ltd. Mesoblast, Ltd. MilliporeSigma NecstGen Novus Biologicals NuVasive Orthofix Medical Personal Cell Sciences Personalized Stem Cells Pluristem Therapeutics Porton Advanced PromoCell Regeneus Reliance Life Sciences Rentschler Biopharma Resilience Richter-HELM RoosterBio, Inc. RoslinCT STEMCELL Technologies, Inc. Samsung Biologics Sentien Biotechnologies, Inc. Smith & Nephew plc Stemedica Cell Technologies, Inc. Stemmatters Stempeutics Research Pvt. Ltd. Symbiosis Pharmaceutical Syngene International Ltd. TaiwanBio Therapeutics Takeda Pharmaceutical Tempo Bioscience Thermo Fisher Scientific TranstoxBio VIVEbiotech Viralgen Waisman Biomanufacturing WuXi Biologics Yapan Bio Yposkesi Zimmer Biomet Holdings For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Biodexa Pharmaceuticals PLC Biodexa Announces Allowance of U.S. Patent Covering Tolimidone Biodexa plans to initiate a Phase 2 clinical program of tolimidone in Type 1 diabetes, following several preclinical studies demonstrating its role in beta cell survival Safety profile established in prior human studies of more than 700 patients CARDIFF, United Kingdom, February 7, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”)(Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes (“T1D”) and rare/orphan brain cancers, today announced that the U.S. Patent and Trademark Office allowed U.S. patent application No. 16/546,595 titled “Prevention of Pancreatic Cell Degeneration” which was exclusively licensed to Biodexa by Melior Pharmaceuticals, Inc., along with other patents, in a transaction which closed in December 2023. Stephen Stamp, CEO and CFO of Biodexa, commented “This soon-to-be-issued patent is expected to provide market exclusivity for tolimidone in the U.S. and underpins our investment thesis in ongoing preclinical studies and an upcoming Phase 2 program in Type 1 diabetes patients which we expect to start in next quarter.” About tolimidoneTolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signalling cascade initiated by the binding of insulin to its receptor. Tolimidone’s potential utility in the treatment of T1D has been demonstrated in several preclinical studies in which Lyn kinase was identified as a key factor for beta cell survival in in vitro and in vivo models. As a first step in the continuing clinical development of tolimidone, Biodexa plans to initiate an open-label Phase 2a dose confirmation study in 2Q24 to establish the preferred dose of tolimidone in patients with T1D. This will be followed by a double-blind, placebo-controlled Phase 2b study. End points of both studies will include C-peptide levels, HbA1c and the number of hyperglycemic events. Tolimidone was discovered by Pfizer Inc. (“Pfizer”) which developed it through Phase 2 for the treatment of gastric ulcers. Pfizer undertook a broad preclinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Melior, together with Bukwang Pharmaceutical Co Ltd, subsequently conducted two Phase 2 studies in Type 2 diabetes. The two Phase 2 studies together with Pfizer’s earlier work exposed more than 700 patients to tolimidone, creating an extensive safety data package. For more information, please contact: Biodexa Pharmaceuticals PLCStephen Stamp, CEO, CFOTel: +44 (0)29 20480 180www.biodexapharma.comEdison Group (US Investor Relations)Laine YonkerTel: +1 (610) 716 2868Email: lyonker@edisongroup.com About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programmes include tolimidone, under development as a novel agent for the treatment of type 1 diabetes and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumour, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Examples of forward-looking statements include, among others, statements we make regarding our pre-clinical data and clinical trials. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that the Company shall file from time to time or announcements that may be made by the Company in accordance with the rules and regulations promulgated by the United States Securities and Exchange Commission, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning the Company are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, the Company does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.