Core Insights - The "China Nansha Cell and Gene Industry Innovation Development Conference" was held in Guangzhou, focusing on cutting-edge technologies and industrial development in the cell and gene sector, attracting over a thousand enterprises [1] - The establishment of several key centers during the conference aims to promote the standardization and regulation of the cell and gene industry, addressing technical and management challenges [1][5] Industry Overview - Cell and gene therapy (CGT) is a rapidly developing frontier technology in biomedicine, with China's CGT market projected to exceed 8 billion RMB in 2024, primarily driven by CAR-T therapy, and expected to surpass 28.9 billion RMB by 2030 [2] - Global CGT market is forecasted to reach 76 billion USD by 2030, indicating significant growth potential [2] Regional Development - Guangzhou Nansha is positioned as a key area for the development of the biomedicine and health sector, leveraging its geographical, policy, and talent advantages [3] - The "Nansha Plan" includes tax incentives and regulatory reforms to support the growth of cell and gene therapy enterprises, creating a conducive environment for industry development [3] Ecosystem Building - Nansha has over 400 biomedicine enterprises, with more than 40 focused on cell and gene therapy, fostering collaboration among various entities to build a comprehensive industry ecosystem [3] - The release of the Nansha biomedicine and health industry map aims to facilitate project matching and address common challenges faced by enterprises [3] Regulatory Challenges - The safety, efficacy, compliance, and industrialization of cell and gene therapy remain areas requiring further exploration, with challenges including unclear responsibility, outdated regulations, and conflicts between safety and economic interests [4] - Experts suggest adopting established drug regulatory processes for cell and gene therapy to ensure safety and effectiveness, advocating for a balanced regulatory approach [4] Recent Developments - The launch of the Greater Bay Area Cell and Gene Therapy Industry Public Service Center and other key initiatives during the conference is expected to enhance the standardization and development of the industry [5] - Significant projects in gene therapy, immunotherapy, and stem cell pharmaceuticals were signed, with a total investment of approximately 500 million RMB and an expected annual output value of 1 billion RMB [6]

Financial Data and Key Metrics Changes - Total revenue for the second quarter of 2025 was $8,500,000, an 18% decline from $10,400,000 in 2024 [28] - Core revenue increased to $8,200,000, representing an 8% year-over-year growth compared to $7,600,000 in the prior year [28] - Gross margin was 82% in 2025, down from 86% in the previous year [30] Business Line Data and Key Metrics Changes - Instrument revenue grew 22% year-over-year to $2,100,000, up from $1,800,000 in 2024 [28][12] - License revenue remained flat at $2,600,000 compared to the same quarter in 2024 [28] - Processing Assembly (PA) revenue increased to $3,100,000, up from $3,000,000 in 2024 [28] Market Data and Key Metrics Changes - 42% of core revenue was derived from SPL customers in 2025, down from 51% in the prior year [30] - SPL program-related revenue was $300,000 in 2025, significantly lower than $2,900,000 in 2024 [30] Company Strategy and Development Direction - The company is focusing on disciplined investments while aiming for profitability with existing capital [6] - MaxSight is integrating SecurDx, which is seen as a substantial long-term opportunity [6] - The company plans to return to growth in 2026, driven by new platform launches and increasing clinical programs [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged short-term external headwinds impacting growth expectations for the second half of 2025 [7] - The company is lowering its core revenue guidance for 2025 to flat to down 10% compared to 2024 [8] - Despite current challenges, management remains confident in the long-term value proposition of MaxSight within the cell and gene therapy industry [25] Other Important Information - The company officially delisted from the AIM markets on June 26, 2025, and is now solely listed on NASDAQ [26] - MaxSight expects to end 2025 with approximately $155,000,000 in cash equivalents and investments [34] Q&A Session Summary Question: Impact of manufacturing operations reorganization by the largest customer - Management confirmed that the reorganization is a short-term consolidation and will not impact future licensing revenue [36][37] Question: Opportunities for additional efficiencies within the organization - Management is focused on achieving profitability and is continuously looking for efficiencies across the organization [42][43] Question: Quarterly cadence expectations from Q3 to Q4 - Slight weight towards Q4 is expected, but not materially significant [46][47] Question: Performance expectations for instrumentation sales - Instrument sales are expected to continue performing well, with a focus on lower-priced systems [49][50] Question: SPL partnerships and program prioritization - There is a shift towards allogeneic therapies among partners, which is favorable for the company's systems [56][57] Question: PA revenue benefits and future expectations - PA revenue benefited from a single order, but this is not expected to have a material impact on future guidance [62][63] Question: Impact of macro headwinds on SPL pipeline - No significant impact on the SPL pipeline is observed, with continued confidence in signing new SPLs [65][66]

Core Insights - Sidra Medicine has been awarded a $100,000 G-Rex® Grant to develop a CAR-T cell production platform focused on pediatric oncology [1][2] - The grant will facilitate the preclinical development of a CD19 CAR-T cell therapy product and support the implementation of a fully closed system, semi-automated G-Rex production compliant with current Good Manufacturing Practices (cGMPs) [2][3] - ScaleReady's G-Rex Grant Program has committed over $40 million to advance cell and gene-modified cell therapy (CGT) development and manufacturing [5] Company Developments - Sidra Medicine aims to enhance treatment protocols for pediatric diseases, leveraging the G-Rex® method for efficient T cell manufacturing [3][4] - The G-Rex manufacturing platform is utilized by over 800 organizations and is involved in approximately 50% of CGT clinical trials [8] - ScaleReady has introduced a new program, LEAN Cell & Gene™, to help CGT entities improve operational efficiency and product quality [6] Industry Context - The G-Rex centric manufacturing process offers significant technical and economic advantages for CAR-T manufacturing in Qatar and the Middle East [4] - The G-Rex Grant recipients gain access to exclusive support from ScaleReady's consortium, enhancing their capabilities in cGMP manufacturing and regulatory affairs [5][9] - Bio-Techne Corporation collaborates with Wilson Wolf to provide tailored products for G-Rex® Bioreactors, supporting high throughput closed-system manufacturing [11]

Core Insights - BioLife Solutions, Inc. has invested $2 million in convertible notes of Pluristyx, Inc., a Seattle-based developer of iPSC-based products for cell therapy [1] - This investment is part of a larger financing round and includes a board observer seat and rights related to potential future acquisitions of Pluristyx [1] Company Overview - BioLife Solutions specializes in bioproduction products and services for the cell and gene therapy market, facilitating the commercialization of new therapies [4] - Pluristyx focuses on developing next-generation cell-based tools and therapies, offering products like PluriKit™, PluriForm™ Organoids, and PluriBank™ stem cells [3] Strategic Rationale - The investment aligns with BioLife's strategy to explore biological assays as a product portfolio adjacency, following similar investments in other companies [2] - Pluristyx's recent development of an iPSC-based biological assay for organoid manufacturing complements BioLife's interests [2]

Core Viewpoint - OXB will participate in the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) from May 13 to May 17, 2025, showcasing its expertise in viral vector development and manufacturing [1][2]. Group 1: Event Participation - OXB will exhibit at Booth 1611, allowing delegates to meet its team of viral vector experts and explore its capabilities in lentiviral, AAV, and other viral vector types [2]. - The company will contribute to the scientific program with an industry-sponsored symposium, five poster presentations, and two oral presentations [2]. Group 2: Presentations and Topics - The industry-sponsored symposium is titled "Accelerate Time to Clinic: A Process and Analytics Platform Approach" [3]. - Poster presentations will cover various topics, including: - "The 3 Rs of Replication-Competent Lentivirus (RCL) Formation Risk: Real, Rare, or Artificial?" - "Enhancing Titers of Therapeutic Lentiviral Vectors using PKC Agonists" - "Optimising the Production of the 4th Generation Lentiviral Vector (LV) TetraVecta™ System: Towards Plug-and-Play LV Manufacturing" - "The Impact of Individual Helper Genes on AAV Productivity" [4]. Group 3: Oral Presentations - Oral presentations will include: - "Enhancing Upstream Processes for High-Yield, High-Quality AAV Vector Production Using a Novel In-House Cell Line" - "Diving Deeper: Using a SYBR Gold Capsid Ejection Assay as an Orthogonal Method of Measuring Potency and VP1 Deamidation in AAV9 Drug Product Samples" [6]. Group 4: Company Background - OXB is a global quality and innovation-led contract development and manufacturing organization (CDMO) specializing in cell and gene therapy, with 30 years of experience in viral vectors [9][10]. - The company collaborates with leading pharmaceutical and biotechnology firms, providing expertise in various viral vector types, including lentivirus and AAV [9]. - OXB's capabilities range from early-stage development to commercialization, supported by robust quality-assurance systems and regulatory expertise [9].

Financial Data and Key Metrics Changes - Cryoport reported $41 million in revenue from continuing operations for Q1 2025, representing a 10% year-over-year growth and contributing to significant adjusted EBITDA improvement [10] - The company confirmed its revenue guidance for fiscal year 2025 in the range of $165 million to $172 million, indicating a 7.5% growth compared to fiscal year 2024 [13] Business Line Data and Key Metrics Changes - Life sciences services revenue increased by 17% year-over-year, driven by a 33% growth in support for commercial cell and gene therapies [10] - Life sciences services now account for 56% of total revenue, reflecting the increasing development and commercialization of cell and gene therapies [10] - The life sciences products business showed a 2% year-over-year growth, indicating demand stabilization [12] Market Data and Key Metrics Changes - Cryoport supported 19 commercial therapies and 711 clinical trials as of March 31, representing approximately 70% of cell and gene therapy trials [11] - The company anticipates up to 17 additional application filings and four therapy approvals for the remainder of 2025, indicating a robust pipeline [11] Company Strategy and Development Direction - The strategic partnership with DHL, involving the sale of Cryo PDP for an enterprise value of $195 million, is expected to enhance Cryoport's positioning in Asia Pacific and EMEA [12][13] - The partnership aims to leverage DHL's global scale and capabilities, allowing Cryoport to sharpen its focus on core life sciences service offerings in the regenerative medicine space [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth forecast despite potential tariff impacts, stating that they have taken steps to diversify the supply chain [14][15] - The company does not expect tariffs to significantly impact core support for clinical trials or commercial therapies [15] - Management remains optimistic about the commercial revenue ramp-up and the maturation of commercial therapies [44] Other Important Information - The company reported a significant increase in service gross margins year-over-year, with expectations for continued margin improvements [34] - The onboarding process for EntegraCell is progressing smoothly, with multiple commercial contracts already in place [65] Q&A Session Summary Question: Update on the launch of Entegrisel and client adoption - Management sees the market positively, with commercial revenue continuing to ramp and growth in clinical trials [20] Question: Contingent consideration impact on adjusted EBITDA - Management clarified that contingent consideration was backed out, and adjusted EBITDA improved significantly compared to Q1 of the previous year [29] Question: Response to potential tariffs and macro environment - Management indicated no significant tariff impact on cell and gene therapy, with continued commercial revenue growth [41][42] Question: Supply chain initiatives and margin improvements - Management stated that while they cannot quantify the impact of supply chain initiatives on margins, they expect strong gross margins to continue [54] Question: Impact of the new FDA director on therapy modalities - Management expressed optimism about the new FDA director's qualifications and the continued interest in cell and gene therapy [56] Question: Demand for new product launches - Management reported positive reception and ongoing adoption for new products, with expectations for substantial contributions in the future [62]

Financial Data and Key Metrics Changes - Cryoport reported $41 million in revenue from continuing operations for Q1 2025, representing a 10% year-over-year growth, contributing to significant adjusted EBITDA improvement [8] - The company confirmed its revenue guidance for fiscal year 2025 in the range of $165 million to $172 million, indicating a 7.5% growth relative to fiscal year 2024 [12][14] Business Line Data and Key Metrics Changes - Life sciences services revenue increased by 17% year-over-year, driven by a 33% growth in support for commercial cell and gene therapies [9][87] - Life sciences services now account for 56% of total revenue, reflecting the increasing development and commercialization of cell and gene therapies [9] Market Data and Key Metrics Changes - Cryoport supported 19 commercial therapies and 711 clinical trials as of March 31, representing approximately 70% of cell and gene therapy trials [10] - The company anticipates up to 17 additional application filings and four therapy approvals for the remainder of 2025, indicating a robust pipeline [11] Company Strategy and Development Direction - The strategic partnership with DHL, involving the sale of Cryo PDP for an enterprise value of $195 million, is expected to enhance Cryoport's positioning in Asia Pacific and EMEA [12] - The partnership aims to leverage DHL's global scale and capabilities, allowing Cryoport to sharpen its focus on core life sciences service offerings in the regenerative medicine space [12][84] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth forecast despite potential tariff impacts, stating that they have taken steps to diversify the supply chain [13] - The overall market for cell and gene therapies is viewed positively, with expectations of continued commercial revenue growth and a robust pipeline of therapies [19][20] Other Important Information - The company reported a significant increase in service gross margins, with expectations for continued expansion throughout 2025 [33] - Management noted that the new FDA director's conservative views are not expected to negatively impact the cell and gene therapy sector, emphasizing the importance of data in regulatory decisions [57][60] Q&A Session Summary Question: Update on Entegrisel launch and CGP trial growth - Management sees a positive market outlook with continued growth in commercial therapies and clinical trials, indicating a robust pipeline [19][20] Question: Contingent consideration impact on adjusted EBITDA - Management clarified that contingent consideration was backed out, and adjusted EBITDA improved significantly compared to Q1 of the previous year [28] Question: Steps to bolster shareholder value post-divestiture - Management plans to be prudent and opportunistic with cash allocation, considering stock buybacks due to undervaluation [29][30] Question: Service gross margins expansion - Management confirmed a significant increase in service gross margins and expects continued leverage from core services [33] Question: Performance of small vs. large pharma - Management reported balanced contributions from both biotech and large pharma, with a robust pipeline and continued interest in promising therapies [37] Question: Response to macroeconomic pressures and tariffs - Management indicated minimal impact from tariffs on cell and gene therapy, with ongoing commercial revenue growth [41][42] Question: Supply chain initiatives and margin improvement - Management emphasized that supply chain initiatives aim to protect margins rather than quantify specific improvements [55] Question: Impact of new FDA director on therapy approvals - Management expressed optimism regarding the new FDA director's qualifications and the continued progress of cell and gene therapies [57][60] Question: Demand for new product launches - Management reported positive reception and ongoing adoption of new products, with expectations for meaningful revenue contributions in the future [67]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 was $10.4 million, down 8% from $11.3 million in the first quarter of 2024 [20][21] - Core revenue remained stable at $8.2 million, reflecting a slight increase of 1% year-over-year [21] - Gross margin decreased to 86% from 88% year-over-year, while non-GAAP adjusted gross margin remained stable at 83% [23] Business Line Data and Key Metrics Changes - Instrument revenue was $1.4 million, down from $1.9 million in the first quarter of 2024, impacted by cautious capital spending from customers [21][22] - License revenue was stable at $2.5 million, while processing assembly (PA) revenue increased to $3.9 million from $3.4 million year-over-year [21] - SPL program-related revenue was $2.1 million, down from $3.2 million in the first quarter of 2024 [22] Market Data and Key Metrics Changes - 57% of core revenue was derived from SPL customers, up from 53% in the first quarter of 2024, indicating a healthy balance of early-stage to clinical-stage customers [22] - The company noted a cautious environment for capital equipment purchasing decisions among customers, leading to some hesitance in capital expenditures [10][42] Company Strategy and Development Direction - The company is focused on executing its growth plan for 2025 and beyond, despite macro uncertainties [8][10] - MaxSite is committed to enhancing operational efficiency and making targeted investments to drive long-term returns [23][24] - The integration of SecureDx is progressing smoothly, allowing the company to expand its offerings in the cell and gene therapy space [12][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term health of the business, despite recent regulatory changes at the FDA [31][34] - The company anticipates continued strong demand in the cell and gene therapy market, with a focus on safety assessments [12][34] - Management reiterated guidance for core revenue growth of 8% to 15% for 2025, including at least $2 million from SecureDx [24][25] Other Important Information - The company is seeking shareholder approval to delist from AIM and maintain a single listing on NASDAQ [19] - MaxSite ended the first quarter with $174.7 million in cash equivalents and investments, with no debt [24] Q&A Session Summary Question: Regulatory changes and their impact - Management indicated that it is too early to assess the impact of recent FDA leadership changes, but they do not foresee any regulatory risks affecting their business [30][34] Question: Cost savings from operational review - The company expects to save approximately $100,000 annually from delisting, and has begun realizing savings from personnel reductions [35][36] Question: Changes in customer funding strategies - Management noted some constraints on capital expenditures but remains confident in their guidance for the year [42][43] Question: SecureDx acquisition integration - The integration is going well, with opportunities to expand into in vivo customers and complementary delivery systems [51][52] Question: SPL revenue performance - SPL revenue of $2.1 million exceeded expectations, with confidence in achieving the full-year guidance of $5 million [55][56] Question: Future product launches - The company has a robust product pipeline and plans to launch meaningful products this year [64][65] Question: Pipeline and portfolio management - Management noted a status quo in program rationalization among customers, with no significant expansion observed [71][73] Question: Revenue cadence for the year - Management is comfortable modeling incremental growth, particularly in the latter half of the year, based on identified opportunities [76][77]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 was $10.4 million, an 8% decline from $11.3 million in the first quarter of 2024 [20] - Core revenue remained stable at $8.2 million, showing a slight increase of approximately 1% year-over-year [21] - Gross margin decreased to 86% in Q1 2025 from 88% in Q1 2024, while non-GAAP adjusted gross margin remained stable at 83% [23] Business Line Data and Key Metrics Changes - Instrument revenue was $1.4 million, down from $1.9 million in Q1 2024, impacted by cautious capital spending from customers [21][22] - License revenue was stable at $2.5 million compared to $2.6 million in the prior year [21] - Processing assembly (PA) revenue increased to $3.9 million from $3.4 million year-over-year, indicating strong performance [21] Market Data and Key Metrics Changes - 57% of core revenue was derived from SPL customers in Q1 2025, up from 53% in Q1 2024, reflecting a healthy balance of early-stage to clinical-stage customers [22] - SPL program-related revenue was $2.1 million in Q1 2025, down from $3.2 million in Q1 2024, indicating variability in milestone revenue [22] Company Strategy and Development Direction - The company is focused on executing its growth plan for 2025 and beyond, adapting to macro uncertainties while maintaining operational focus [8][12] - MaxSite is committed to enhancing its product offerings and capital allocation initiatives, aiming for profitability with its existing balance sheet [10][18] - The integration of SecureDx is progressing smoothly, with expectations to deliver at least $2 million in revenue for the year [12][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of the cell and gene therapy market, despite current market challenges [12][20] - The company is closely monitoring customer spending and expects cautious capital expenditure decisions to continue [11][44] - Management reiterated guidance for core revenue growth of 8% to 15% for 2025, assuming no significant changes in the operating environment [24][25] Other Important Information - The company announced plans to seek shareholder approval for delisting from AIM and maintaining a single listing on NASDAQ [19] - MaxSite finished Q1 2025 with total cash equivalents and investments of $174.7 million and no debt [24] Q&A Session Summary Question: Regulatory changes and their impact - Management indicated that recent FDA leadership changes have not raised concerns among customers regarding regulatory hurdles, maintaining confidence in the cell and gene therapy market [30][36] Question: Cost savings from operational review - The company expects to save approximately $100,000 annually from delisting and has begun realizing savings from personnel reductions [37][38] Question: Changes in customer funding strategies - Management noted some constraints on capital expenditure but remains confident in achieving annual guidance despite these challenges [42][44] Question: SecureDx acquisition integration - The integration of SecureDx is progressing well, with opportunities to expand into in vivo customer segments [50][52] Question: SPL revenue performance - SPL revenue of $2.1 million exceeded expectations, with management confident in achieving the full-year guidance of $5 million [55][56] Question: Future product launches - The company has a robust product pipeline and plans to launch new products this year, enhancing its total addressable market [63][65] Question: Pipeline and portfolio management - Management observed a status quo in program rationalization among customers, with no significant expansion noted [69][72] Question: Revenue cadence for the year - Management is comfortable modeling incremental growth in revenue, particularly in the latter half of the year, based on identified opportunities [73][75]

Stevenage, UK, and Boca Raton, Florida, US, April 14, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:INMB) a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system has partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms. CGT Catapult is an independent technology and innovation organization specializing in the advancement of the cell and gene therapy indu ...