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EUDA Strategically Expands into T-Cell Immunotherapy – Strengthening Its Stem Cell Therapy Portfolio
Globenewswire· 2025-09-04 12:00
Core Insights - EUDA Health Holdings Limited has secured distribution rights for T-cell immunotherapies in Malaysia from Shenzhen Inno Immune Co. Ltd, marking a significant expansion into advanced cell therapy [1][2] - The T-cell immunotherapy package will be priced at USD 8,000 per treatment, significantly lower than traditional costs in the region, making it more accessible [4] - This partnership is part of EUDA's strategy to diversify its healthcare portfolio and focus on regenerative and longevity medicine, addressing the healthcare needs of an aging population in Asia [5][6] Company Overview - EUDA Health Holdings Limited is a leading non-invasive healthcare provider in Asia, focusing on Singapore, Malaysia, and China, with a mission to transform healthcare from reactive treatment to proactive, longevity-focused care [6] - The company aims to address the healthcare needs of over 1.8 billion people in the region, where more than 30% of the population is aging rapidly [6] - EUDA also operates a property management business in Singapore, further diversifying its operations [6] Strategic Partnerships - The agreement with Shenzhen Inno is facilitated by Guangdong Key Lock Health Management Co., Ltd, which has a long-term strategic partnership with both EUDA and Shenzhen Inno [3] - This partnership is expected to enhance EUDA's offerings in immune-enhancing therapies, leveraging Shenzhen Inno's scientific and institutional backing [5][8]
Banner Year for Mesoblast With First FDA Product Approval and Successful Commercial Launch of Ryoncil®
Globenewswire· 2025-08-29 00:24
Core Insights - Mesoblast Limited achieved FDA approval for Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) product in the U.S., and successfully launched it for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients [2][10][34] - The company aims to transform into a commercial biotechnology entity with plans for additional approved indications for Ryoncil and the launch of next-generation platform technologies targeting heart failure and chronic low back pain [2][6] Financial Highlights - Total revenue from cell therapy products reached US$17.2 million, a 191% increase from the previous year, driven by Ryoncil's launch [6][31] - Net operating cash spend was US$50.0 million, a 3% increase year-over-year, reflecting costs associated with the commercial team and product launch [6] - Cash on hand as of June 30, 2025, was US$162 million (A$247 million) [6] Product and Market Opportunities - Ryoncil has a potential annual addressable market of approximately $1 billion for pediatric and adult SR-aGvHD, with additional markets for biologic-refractory inflammatory bowel disease exceeding $5 billion, heart failure with reduced ejection fraction (HFrEF) over $10 billion, and chronic low back pain (CLBP) also exceeding $10 billion [7][35] - The company is developing Ryoncil for additional indications, including adult SR-aGvHD and inflammatory bowel disease, and has a pipeline of therapies targeting unmet medical needs [7][35] Operational Developments - Ryoncil became commercially available on March 28, 2025, shortly after FDA approval [10] - The company has expanded coverage for Ryoncil, with over 250 million U.S. lives insured and federal Medicaid coverage effective July 1, 2025 [11] - Mesoblast has onboarded 32 transplant centers and aims to onboard the top 45 centers that account for 80% of pediatric bone marrow transplants in the U.S. [11] Corporate Governance - The Board of Directors was strengthened with the appointments of Dr. Gregory George and Ms. Lyn Cobley, bringing extensive experience in medical science and financial services [30]
Shineco Unveils World's First On-Chain Cell Asset Tokenization Platform; Strategic Acquisition Expands Global Blockchain-Biotech Network
Prnewswire· 2025-08-20 10:30
Core Viewpoint - Shineco Inc. has entered into a partnership with Plus Me Limited to create a blockchain-based tokenization system for biological cellular assets, aiming to transform the global biological cell industry and enhance the commercial architecture of cell therapy [1][5][6] Group 1: Partnership and Agreement - The partnership involves a "Cellular Asset On-Chaining and Marketing Ecosystem Cooperation Agreement" that facilitates the tokenization of Shineco's mesenchymal stem cells (MSCs) on the Ethereum blockchain [1][2] - Plus Me will provide full lifecycle digital custody of the MSCs, ensuring asset ownership rights through smart contracts and issuing unique non-fungible digital identifiers (NFDIs) for traceability [2][3] Group 2: Tokenization Framework - Plus Me will issue ERC-1400/ERC-20 compliant security tokens named "Cell Infusion Redemption Tokens," which can be redeemed at Shineco-affiliated Cell Therapy Centers [3] - The tokenization framework aims to address industry challenges such as high user costs and unverifiable product provenance, converting biological assets into tradable digital instruments [3] Group 3: Strategic Acquisitions - Shineco has acquired a controlling 51% stake in Xi'an Dong'ao Health Management Co., Ltd., enhancing its off-chain infrastructure for token redemption [4] - This acquisition, along with the previously acquired Singapore firm Infiniclone, allows Shineco to establish a global storage and infusion network for on-chain and off-chain asset settlement [4] Group 4: Ecosystem Development - The collaboration will create an open-cell industry ecosystem where Plus Me provides tokenization SaaS to third parties, while Shineco offers its physical custody network [5] - Shineco's initiative positions the company as a global infrastructure provider for the cell economy, enabling rapid revenue scalability [5][6] Group 5: Industry Transformation - Shineco's asset tokenization protocol aligns with the industry's shift towards commercial scalability, marking the emergence of a decentralized biotech economy [6] - Token holders will gain governance rights, including future DAO voting, which will enhance the development of the global ecosystem in cell therapy [6]
Legend Biotech Appoints Carlos Santos as Chief Financial Officer
Globenewswire· 2025-08-18 12:00
Core Viewpoint - Legend Biotech Corporation has appointed Carlos Santos as the new Chief Financial Officer, effective immediately, succeeding Jessie Yeung who served as interim CFO since January 2025 [1][2][3] Group 1: Leadership Changes - Carlos Santos brings extensive experience in financial operations across various regions including the US, Latin America, Europe, the Middle East, and Africa [2] - Santos previously held the position of CFO for US Oncology at AstraZeneca and has a decade-long tenure there, along with roles at Alcon and Intel Corporation [3][4] - The CEO of Legend Biotech, Ying Huang, expressed confidence in Santos's financial expertise to drive the success of the company's CAR-T cell therapy franchise, CARVYKTI, and achieve profitability by 2026 [3] Group 2: Company Overview - Legend Biotech is a leading company in cell therapy with over 2,800 employees and is recognized for its innovative CAR-T cell therapy, CARVYKTI, which targets relapsed or refractory multiple myeloma [5] - The company collaborates with Johnson & Johnson for the development and marketing of CARVYKTI and aims to expand patient access and therapeutic potential [5] - Legend Biotech is focused on building a comprehensive cell therapy company and driving future innovations across its pipeline [5]
Celularity Completes Major Balance Sheet Restructuring, Retires All $41.6 Million in Senior Secured Debt
Globenewswire· 2025-08-18 12:00
Core Viewpoint - Celularity Inc. has successfully restructured its balance sheet by retiring all senior secured debt amounting to $32.0 million and associated unpaid interest of $9.6 million through an Asset Purchase Agreement and a License Agreement with Celeniv Pte. Ltd. [1][4] Financial Restructuring - The company sold its intellectual property assets to Celeniv for $33,812,230, which was utilized to pay off a $27 million senior secured loan and a $6.812 million Promissory Note [3][5] - The restructuring has resulted in the complete removal of senior secured debt, which was due for repayment in February 2026, enhancing the company's financial flexibility [4][5] Agreements and Options - Under the License Agreement, Celularity retains exclusive rights to use the intellectual property for an initial term of five years, with options for renewal and repurchase [2][4] - The company has an exclusive five-year option to repurchase the assets from Celeniv, providing additional strategic flexibility [2][4] Internal Restructuring - Celularity has established operating subsidiaries for its four commercial business units: advanced biomaterial products, longevity-focused cellular therapeutics, biobanking services, and contract manufacturing and development services [5][6] - This internal restructuring aims to optimize efficiency and financial performance across its commercial units [5][7] Company Overview - Celularity Inc. focuses on developing, manufacturing, and commercializing advanced biomaterial products and cell therapies derived from postpartum placenta, targeting age-related and degenerative diseases [8]
BioLife Solutions(BLFS) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - In Q2 2025, total revenue increased by 29% year over year to $25.4 million, driven by a 28% increase in cell processing revenue [16][6] - Adjusted EBITDA margin expanded by 400 basis points to 24%, reflecting strong operating leverage [6] - GAAP net loss was $15.8 million or $0.33 per share, compared to a net loss of $5.6 million or $0.12 per share in the prior year [20][16] Business Line Data and Key Metrics Changes - Cell processing revenue reached $23 million, marking a 28% year-over-year increase and a 6% sequential increase [8] - Biopreservation media (BPM) products accounted for approximately 85% of Q2 cell processing revenue, with top 20 customers contributing about 80% of BPM revenue [8][9] - Adjusted operating expenses totaled $16.9 million, up from $14 million in the prior year, largely due to increased stock-based compensation and IPR&D expenses related to the Panthera acquisition [19][16] Market Data and Key Metrics Changes - At the end of Q2, BPM products were embedded in 16 approved therapies and used in over 250 relevant commercially sponsored CGT trials in the U.S., representing over a 70% market share [10] - The company maintains a strong position in late-stage clinical development, with nearly 80% market share in Phase 3 clinical trials [10] Company Strategy and Development Direction - The company is focused on operational execution and disciplined capital allocation, with a sharpened focus on its product portfolio and market share in cell processing [7] - A strategic investment in Pluristics was made to explore product portfolio expansion into relevant adjacencies [12] - The company raised its full-year revenue guidance to $100 million to $103 million, reflecting a growth of 22% to 25% [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating macro uncertainties, citing strong visibility from major customers [26] - The FDA's recent decision to remove the REMS requirement is viewed as a positive development for the CGT landscape, potentially enhancing patient access to therapies [13] - The company expects continued strength in cell processing revenue despite broader market uncertainties [7] Other Important Information - The company reported cash and marketable securities of $100.2 million at the end of Q2 2025 [21] - The acquisition of Panthera is expected to enhance market leadership in biopreservation and introduce new product lines [54] Q&A Session Summary Question: Guidance visibility and commercial ramps - Management indicated good visibility into revenue from top customers and expressed confidence in the second half of the year despite potential lumpiness between Q3 and Q4 [26][27] Question: Cross-selling dynamics - Management noted early traction in cross-selling efforts, with larger accounts showing interest in additional products [31] Question: CryoCase timeline - Management is in discussions with a large customer regarding changes to the CryoCase and has over 30 customers evaluating it [35] Question: Pluristics investment and competition - Management does not view Pluristics as a competitive threat but is interested in their assay development capabilities [40] Question: Panthera updates - The company remains on track to have commercial products from Panthera in the market by the second half of next year [42] Question: Demand trends in early clinical stages - Management noted a slight softness in demand from smaller Phase I and II customers but expects overall growth to continue [49] Question: Distribution channel visibility - Management has not seen any weakness in the distribution channel and remains confident in its strength for the remainder of the year [53] Question: M&A strategy - The company emphasizes a disciplined approach to M&A, focusing on strategic rationale and market leadership [60]
MaxCyte Reports Second Quarter 2025 Financial Results and Updates Full Year 2025 Guidance
Globenewswire· 2025-08-06 20:05
Core Insights - MaxCyte, Inc. reported a total revenue of $8.5 million for Q2 2025, a decrease of 18% compared to $10.4 million in Q2 2024, primarily due to changes in the operating environment and customer inventory management [7][5][3] - Core business revenue increased by 8% to $8.2 million in Q2 2025 from $7.6 million in Q2 2024, driven by sales of instruments and consumables [5][7] - The company has lowered its 2025 guidance, expecting core revenue to be flat to a 10% decline compared to 2024, and SPL Program-related revenue to be approximately $5 million for the year [11][14] Financial Performance - Gross profit for Q2 2025 was $7.0 million, representing an 82% gross margin, down from $8.9 million and 86% gross margin in Q2 2024 [8][7] - Operating expenses increased to $21.2 million in Q2 2025 from $20.9 million in Q2 2024, contributing to a net loss of $12.4 million compared to a net loss of $9.4 million in the same period last year [10][9] - The installed base of instruments grew to 814 units in Q2 2025, up from 723 units in Q2 2024 [6] Strategic Developments - MaxCyte added two new Strategic Platform License (SPL) clients, Adicet Bio and Anocca AB, bringing the total number of SPL agreements to 31 [5][3] - The company remains focused on enhancing operational efficiencies and investing in product improvements, including SeQure Dx, to support its position in the cell and gene therapy industry [3][5] Cash Position - As of June 30, 2025, total cash, cash equivalents, and investments were $165.2 million, reflecting a decrease due to acquisition-related costs [5][11] - The company expects to end 2025 with at least $155 million in total cash, cash equivalents, and investments [11]
MaxCyte Signs Platform License Agreement with Adicet Bio
GlobeNewswire News Room· 2025-08-04 12:05
Core Insights - MaxCyte has signed a strategic platform license agreement with Adicet Bio to utilize its Flow Electroporation® technology and ExPERT™ platform for developing gamma delta T cell therapies [1][2] - Adicet Bio aims to enhance its manufacturing capabilities for allogeneic gamma delta T cell therapies, which are designed for cancer and autoimmune diseases [3][4] Company Overview - MaxCyte is a leading cell-engineering company focused on advancing cell-based therapeutics through its Flow Electroporation® technology and ExPERT™ platform [5] - The company has over 25 years of experience in cell engineering, providing tools and services that support the development of safe and effective treatments [5] Agreement Details - The agreement grants Adicet Bio non-exclusive rights for research, clinical, and commercial use of MaxCyte's technologies, while MaxCyte will receive licensing fees and program-related revenue [2] - MaxCyte's ExPERT™ platform is noted for its high transfection efficiency, cell viability, and scalability, which are essential for developing next-generation cell therapies [4]
Bonus Biogroup Appoints Renowned Cell Therapy Leader, Professor Edwin M. Horwitz, MD, PhD, to its Advisory Board
Globenewswire· 2025-07-14 11:00
Core Insights - Bonus Biogroup has appointed Professor Edwin M. Horwitz to its Advisory Board to strengthen its scientific leadership as it progresses toward Phase 3 clinical trials for its therapies BonoFill and MesenCure [1][2][3] Company Overview - Bonus Biogroup is a late-stage biotechnology company focused on immunomodulatory and regenerative mesenchymal stem cells (MSC) to develop innovative tissue engineering and cell therapy solutions [1][7] - The company aims to create effective and safe therapies for common and severe conditions with limited treatment options, ensuring broad accessibility through cost-effective solutions [7] Key Products BonoFill - BonoFill is an autologous tissue-engineered live human bone graft designed for treating large or nonhealing bone defects, with a 90% success rate in Phase 2 trials [4] - The company plans to initiate a Phase 3 study for BonoFill in 2026, targeting a total addressable market (TAM) of approximately $25.0 billion in the U.S. by 2030 [4] MesenCure - MesenCure is an allogeneic cell therapy aimed at treating inflammation and tissue damage, with a Phase 2 trial showing a 68% reduction in mortality for COVID-19 pneumonia patients [6] - The FDA has cleared an IND application for MesenCure, allowing the company to proceed with a Phase 3 clinical trial, with a market potential of approximately $9.4 billion in the U.S. by 2030 [6] Leadership and Expertise - Professor Horwitz brings over three decades of experience in cell therapy, clinical hematology, and oncology, enhancing the company's commitment to scientific excellence and innovation [2][3] - He has authored over 210 scientific publications, significantly influencing global research and therapeutic development in cell therapy [3] Intellectual Property - Bonus Biogroup holds a strong intellectual property portfolio with six patent families, including 71 granted patents and 10 pending applications across multiple countries [8]
Genscript Biotech (01548) Earnings Call Presentation
2025-07-02 07:40
Financial Performance - GenScript Life Science revenue increased by 26.4% year-over-year[20] - Biologics CDMO revenue increased by 33.6% year-over-year, achieving historical breakeven financial goal[20] - Cell Therapy revenue increased by 101.5% year-over-year, with backlog up 108.4% year-over-year[21] - In FY21, external revenue reached $424.7 million, a 30.8% year-over-year increase[23] - Adjusted net loss of Cell Therapy was $(354.6) million in 2021 compared to $(213.3) million in 2020[23] - Adjusted net profit of Non-Cell Therapy was $50.2 million in 2021, an 18.1% year-over-year increase[23] Investments - R&D expenses for Non-Cell Therapy were $36.3 million and for Cell Therapy were $49.9 million in 2021[25], representing a 36.1% year-over-year increase in total R&D investment[24] - Capital expenditure for Cell Therapy was $47.1 million, for Biologics CDMO was $34.5 million, and for Life Science & Other was $55.8 million in 2021[28] Business Segments - Legend Biotech, a cell therapy company, received an upfront payment of $350 million and $300 million in milestone payments from Janssen[61]