Summary of Century Therapeutics Conference Call Company Overview - **Company**: Century Therapeutics - **Ticker**: IPSC (NASDAQ) - **Focus**: Development of next-generation allogeneic cell therapies from programmable induced pluripotent stem cells (iPSCs) for autoimmune diseases and cancer [1][2] Core Technology and Pipeline - **Core Technology**: AlloVision technology, which enables the engineering of iPSC-derived cell therapies [2][5] - **Key Programs**: - **Century 308**: CD19 targeting CD4/CD8 alpha-beta CARiT cell therapy, currently in IND-enabling studies for B-cell-mediated diseases [3][5] - **Century 101**: CAR INK therapy targeting CD19, currently in clinical trials for autoimmune diseases [18][19] Clinical Development and Milestones - **Cash Runway**: Estimated to extend into Q4 2027, covering key clinical milestones [5] - **Clinical Trials**: - **Century 101**: In two Phase I trials for systemic lupus erythematosus (SLE), lupus nephritis, myositis, and systemic sclerosis [18][19] - **Century 308**: Expected to enter the clinic next year [5][18] Market Opportunity - **Autoimmune Disease Market**: Significant unmet medical need with tens of thousands of addressable patients in the U.S. for B-cell-mediated diseases [20][21] - **CAR T Therapy Market**: Current approved CAR T therapies have close to $5 billion in worldwide sales, but access remains a challenge with fewer than 30% of eligible patients receiving treatment [11][20] AlloVision Technology - **Immune Evasion**: AlloVision technology involves genetic edits to enhance the persistence of allogeneic cells and reduce rejection by the immune system [6][7] - **Holistic Protection**: AlloVision 5.0 includes multiple genetic modifications to protect against various immune rejection mechanisms [8][9] Preclinical and Clinical Data - **Century 308**: Demonstrated comparable functionality to primary T cells in preclinical studies, including IL-2 secretion and tumor control in mouse models [13][17] - **Century 101**: Established a safe and well-tolerated dose with effective B-cell depletion observed in clinical trials [22][23] Conclusion - **Future Outlook**: Century Therapeutics aims to leverage its iPSC platform and AlloVision technology to create impactful therapies for patients with severe diseases, with a focus on delivering clinical data throughout 2025 [24]

SINGAPORE, Sept. 04, 2025 (GLOBE NEWSWIRE) -- EUDA Health Holdings Limited (“EUDA” or the “Company”) (NASDAQ: EUDA), a leading Singapore-based non-invasive healthcare provider in Asia with a focus on Singapore, Malaysia, and China, today announced that it has secured distribution rights for T-cell immunotherapies in Malaysia developed by Shenzhen Inno Immune Co. Ltd. (“Shenzhen Inno”), a developer of autologous cellular therapeutic and customized medicines for a wide range of diseases in China. These T-cell ...

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]

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]

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]

FLORHAM PARK, N.J., Aug. 18, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) ("Celularity"), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, announced today that it has completed a major balance sheet restructuring resulting in the retirement of all $32.0 million of the Company's senior secured debt plus $9.6 million in associated unpaid interest. As part of this restructuring, Celularity entered into an Asset Purchase Agreement and a License ...

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]

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]

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]

Appointment aims to reinforce Bonus Biogroup's leadership at a pivotal moment as the company advances toward Phase 3 clinical trials for its two flagship therapies: BonoFill and MesenCure HAIFA, Israel, July 14, 2025 (GLOBE NEWSWIRE) -- Bonus Biogroup (TASE: BONS), a late-stage biotechnology company priming immunomodulatory and regenerative mesenchymal stem cells (MSC) to develop novel tissue engineering and cell therapy solutions, announced the appointment of Professor of Cell Therapy and Pediatric Medicin ...