Revenues at the upper end of guidance and pivot to EBITDA profitability - expectations for 2026 unchanged and guidance reiterated Revenues expected to increase c.30% as OXB continues to execute its strategy, FY 2025 revenues expected to be £166-169 million (£168 - 171 million CC1), at the upper end of guidance of £160-170 million (CC) (FY 2024: £128.8 million)FY 2025 Operating EBITDA2 profitability expected to be mid-to-high single-digit £ million (CC) including a larger than expected non-recurring gain fro ...

Core Insights - Senti Biosciences, Inc. is advancing its proprietary Gene Circuit platform for next-generation cell and gene therapies, participating in a Cell & Gene Live virtual event to discuss innovative cell therapy technologies [1][2][3] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing cell and gene therapies for incurable diseases, utilizing synthetic biology to engineer Gene Circuits that enhance precision and control in targeting cancer cells while sparing healthy cells [6] Product Development - SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy designed to target CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS), while protecting healthy bone marrow cells [4] - The therapy includes an OR GATE for targeting cancer cells, a NOT GATE to protect healthy cells, and calibrated-release IL-15 to enhance cell persistence and activity [4] - Currently, Senti Bio is enrolling adult patients with relapsed/refractory CD33 and/or FLT3 expressing hematologic malignancies in a Phase 1 clinical trial for SENTI-202, which may become a first-in-class allogeneic treatment for AML/MDS patients [4] Regulatory Designations - The FDA has granted Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202 for treating relapsed/refractory hematologic malignancies, including AML [5]

Core Viewpoint - BioLife Solutions, Inc. is set to release its fourth quarter and full year 2025 financial results on February 26, 2026, along with a business update [1] Company Overview - BioLife Solutions is a leading developer and supplier of bioproduction products and services specifically for the cell and gene therapy (CGT) market [1] - The company provides solutions that maintain the health and function of biologic materials during various stages including collection, development, storage, and distribution [1] Financial Reporting - The financial results will be discussed in a conference call and live webcast scheduled for 4:30 PM ET (1:30 PM PT) on the release date [1] - Access to the webcast will be available through the Investor Relations page of the BioLife Solutions website [1] Contact Information - The Chief Financial Officer, Troy Wichterman, can be contacted for media and investor relations inquiries [1]

Investment Rating - The report does not explicitly state an investment rating for the industry Core Insights - Australia is recognized for its mature R&D ecosystem, established regulatory pathways, and cost-effective clinical trial environment for Cell and Gene Therapy (CAGT) products [4][5][6] - The country has over 160 ongoing industry CAGT trials, with a focus on oncology, autoimmune diseases, and cardiovascular conditions [9][12] - IQVIA is highlighted as a leading Contract Research Organization (CRO) in Australia, providing comprehensive support for CAGT products from pre-clinical to post-marketing stages [24][29] Summary by Sections Why Australia for CAGT Trials? - Australia offers a cost-effective and mature clinical research infrastructure, with high-quality data accepted by global regulators [5][6] - The regulatory framework allows for rapid trial initiation and approvals, with minimal documentation required [7][11] - The favorable AUD exchange rate and R&D tax incentives contribute to lower trial costs compared to the U.S. [7] Mature R&D Ecosystem - Australia hosts over 160 ongoing CAGT trials, with a robust clinical research infrastructure and experienced investigators [9][11] - The country has established treatment centers for complex therapies, including CAR-T, and offers end-to-end support from CDMO partners [10][11] Established and Favorable Regulatory Pathway - The Clinical Trial Notification (CTN) process allows for a fast regulatory start-up, typically taking around 7 to 10 days [14][17] - The Therapeutic Goods Administration (TGA) does not evaluate clinical trial data under the CTN scheme, focusing instead on product safety [18] IQVIA, the Leading CRO in Australia - IQVIA provides a local presence with global capabilities, supporting CAGT trials through a network of sites and a dedicated study management team [26][28] - The organization has participated in the clinical development of 17 approved CAGT products, showcasing its expertise in the field [33] Global Reach and Local Impact - IQVIA's capabilities allow for seamless integration of new countries into multi-regional development plans for CAGT products [26][30] - The company offers a comprehensive strategy for commercialization, policy shaping, and stakeholder engagement [29]

Company Overview - Precigen Therapeutics is a biotech company focused on cell and gene therapy for various indications, including rare diseases and oncology [3] - The company is based in Maryland and aims to utilize differentiated technology and platforms tailored to specific indications with a clear regulatory strategy [3] Product Development - Precigen has successfully developed its first drug, PAPZIMEOS, which received approval in a rapid timeframe of four years from discovery to development [3]

Core Insights - BioLife Solutions, Inc. has opened the Aby J. Mathew Center for Biopreservation Excellence to enhance biopreservation and cell processing innovation [1][2] - The center is named after Dr. Aby J. Mathew, a founding team member and key contributor to the company's biopreservation media platform [2] - The facility will serve as a research and training hub, showcasing the company's product portfolio and fostering collaboration with customers and industry partners [2][3] Company Overview - BioLife Solutions is a leading developer and supplier of bioproduction products and services for the cell and gene therapy (CGT) market [4] - The company focuses on maintaining the health and function of biologic materials during collection, development, storage, and distribution [4] Facility Details - The center features 4,500 square feet of advanced conference and laboratory space [2] - Initial activities will focus on optimizing biopreservation processes, customized training programs, and conducting internal research [2] - The center aims to build industry best practices and train specialists in biopreservation and cell processing [3]

Financial Data and Key Metrics Changes - Total revenue for the third quarter of 2025 was $6.8 million, down from $8.2 million in the same quarter of 2024, with core revenue at $6.4 million compared to $8.1 million in the prior year [18][19] - Gross margin improved to 77% in Q3 2025 from 76% in Q3 2024, while non-GAAP adjusted gross margin decreased to 81% from 85% [21][22] - Total operating expenses were $19.4 million, a decrease from $20.3 million in Q3 2024, including $3.1 million in restructuring charges [22][23] Business Line Data and Key Metrics Changes - Instrument revenue was $1.4 million in Q3 2025, down from $1.8 million in Q3 2024, while license revenue fell to $1.8 million from $2.5 million [19] - Processing assembly (PA) revenue decreased to $2.6 million from $3.4 million in the same period [19] - Program-related revenue from SPLs was $0.4 million in Q3 2025 [19] Market Data and Key Metrics Changes - 53% of core revenue in Q3 2025 was derived from SPL customers, consistent with the prior year [19] - The company reported a total of 165 patients globally who have completed cell collection, with 39 patients receiving infusions of CASGEVY [20] Company Strategy and Development Direction - The company is focused on transforming into an end-to-end platform for cell and gene therapy, with plans for organic and inorganic growth [16][17] - A restructuring initiative was implemented, resulting in a 34% reduction in workforce, aimed at maximizing cash for investments and aligning operating expenses with the current environment [10][12] - The company anticipates annualized savings of $17 million to $19 million from the restructuring, with a focus on maintaining innovation through its Field Application Scientist team [12][13] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a challenging operating environment but expressed optimism about stabilization in biotech funding and customer confidence [28][31] - The company expects to see a ramp-up in SecureDX services and a new product launch in early 2026, which could contribute to future growth [36][37] - Management remains confident in the long-term potential of cell and gene therapy and the role of the company in this space [16][17] Other Important Information - The company reiterated its guidance for 2025, expecting core revenue to be flat to a 10% decline compared to 2024 [24] - The company ended Q3 2025 with $158 million in cash equivalents and investments, with no debt [23] Q&A Session Summary Question: What is the current operating environment for the company and its customers? - Management noted that while the environment has been challenging, there are signs of stabilization in biotech funding and customer confidence [28][31] Question: How does the recent FDA leadership change affect customer confidence? - Management indicated that there have been no reported delays in customer programs due to FDA changes, and the focus on curative therapies aligns with the company's offerings [32][43] Question: What are the expectations for SecureDX and the new product launch? - Management expressed optimism about the ramp-up of SecureDX services and the potential impact of the new product launch in early 2026 [36][37] Question: Can you provide insights on M&A activities? - The company is actively looking for M&A opportunities that align with its end-to-end platform strategy, focusing on best-in-class assets that do not impact financial health [51][52] Question: What is the outlook for CASGEVY and its contribution to revenue? - Management is encouraged by the recent acceleration in patient cell collections and expects corresponding royalty contributions to grow as more SPL partners advance their programs [56][57]

Core Insights - ClearPoint Neuro, Inc. reported a quarterly revenue of $8.9 million, reflecting a 9% year-over-year increase compared to Q3 2024 [1] - The company narrowed its full-year revenue forecast for 2025 to a range between $36.0 million and $38.0 million [1] - ClearPoint Neuro continues to support over 60 active biopharma partners, with nine partner programs accepted for FDA expedited review [1] Financial Performance - Quarterly revenue reached $8.9 million, marking a 9% increase year-over-year [1] - Cash and cash equivalents totaled $38.2 million as of September 30, 2025 [1] Strategic Developments - The company completed the transition to its new Pre-clinical CRO Facility, ClearPoint Advanced Laboratories, which became operational in Q4 2025 [1] - ClearPoint Neuro announced the development of a prototype Robotic Neuro-Navigation System to enhance minimally invasive cranial surgical procedures [1] - The company received FDA 510(k) clearance for the ClearPoint PRISM Laser Therapy System, expanding its compatibility with 1.5T MRI guidance [1] Regulatory and Market Expansion - ClearPoint Neuro achieved several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan, totaling 34 countries worldwide [1] - An agreement was signed for the acquisition of IRRAS Holdings, Inc., which will enhance the company's presence in the neurocritical care space [1] - Five new global customers were activated in the third quarter [1]

WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY. Nasdaq: CLPT November 2025 DISCLAIMER This presentation and discussion contain forward - looking statements within the context of the federal securities laws, including the Company's expectation for revenues, gross margin, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of the Company's products and services, the Company's belief about the outcome of regulatory interactions with respect to its ...

Financial Data and Key Metrics Changes - Revenue from continuing operations is projected to be in the range of $170-$174 million for fiscal year 2025, reflecting an 8%-11% growth over the prior year [12] - Adjusted EBITDA loss in Q3 was $600,000, showing significant improvement with a positive cash flow from operating activities of approximately $2.2 million for the quarter [31][32] Business Line Data and Key Metrics Changes - Revenue from Life Sciences Services increased by 16% year-over-year, accounting for 55% of total revenue, with biostorage bioservices revenue up by 21% [6][12] - Revenue from commercial cell and gene therapy support grew 36% year-over-year to $8.3 million, driven by the global adoption of these therapies [5][12] - Life Sciences Products revenue grew 15% year-over-year, supported by improved demand for cryogenic systems [6][12] Market Data and Key Metrics Changes - The company supports the largest portfolio of clinical and commercial gene therapies globally, with 745 global clinical trials, including 83 in phase three [11] - Despite macroeconomic challenges, the regenerative therapies market remains resilient, indicating strong future growth potential [5][10] Company Strategy and Development Direction - The company is focused on expanding its product portfolio and enhancing its service offerings, including the launch of new cryogenic shippers and condition monitoring solutions [7][8] - A strategic partnership with DHL Group aims to enhance the company's positioning in the APAC and EMEA regions, leveraging DHL's global scale [10] - The company is advancing its Global Supply Chain Centers in Paris and California to optimize operations and client support [9] Management's Comments on Operating Environment and Future Outlook - Management acknowledges macro uncertainties, including the government shutdown and tariff landscape, but remains optimistic about long-term growth in the cell and gene therapy market [17][18] - The company anticipates continued growth in commercial therapies and clinical trials, with expectations for additional application filings and therapy approvals [11][18] Other Important Information - The company has received ISO certification for handling cell therapy-based materials, reinforcing its position as a best-in-class provider [66][68] - The company is not expecting growth in China for 2026 but is working on strategies for future growth in that region [72] Q&A Session Summary Question: Concerns about sequential revenue decline despite positive momentum - Management explained that guidance reflects macro uncertainties, balancing growth momentum with cautious outlook due to government shutdown and tariffs [17][18] Question: Impact of recent FDA draft guidance on clinical trials - Management noted that new FDA guidance could drive more activity in biologics approvals, positively impacting the company [22][24] Question: EBITDA guidance and profitability expectations - Management indicated strong progress towards positive adjusted EBITDA, with expectations to reach it by year-end [31][33] Question: Trends in gene therapy and cell therapy markets - Management highlighted ongoing investment in gene therapy despite some financing challenges, with strong activity in cell therapy [26][45] Question: Impact of government shutdown on operations - Management stated that the shutdown has caused delays in filing activities but has not significantly impacted service demand [50][51] Question: Updates on IntegriCell and revenue generation - Management confirmed that revenue is being generated from IntegriCell facilities, with expectations for significant growth post-2026 [90]