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]

Core Insights - Cryoport Inc reported strong third-quarter financial results, with revenue of $44.2 million, surpassing analyst expectations of $41.36 million, and a loss of 18 cents per share, better than the anticipated loss of 21 cents per share [2][3] Financial Performance - Total revenue increased by 15% year-over-year, driven by a 36% rise in Commercial Cell and Gene Therapy revenue [2] - The company achieved a gross margin of 48% in Q3 and showed improvements in adjusted EBITDA [4] Operational Highlights - Cryoport supported 745 global clinical trials as of September 30, with 83 trials currently in Phase 3 [3] - The company ended the quarter with $421.3 million in cash, cash equivalents, and short-term investments [3] Shareholder Actions - Cryoport repurchased 483,397 shares of its common stock at an average price of $7.73 per share, with approximately $65.9 million remaining under its share repurchase program [4] Future Outlook - The company raised its fiscal 2025 revenue guidance to a range of $170 million to $174 million [5] - Cryoport maintains its position as the only pure-play end-to-end temperature-controlled supply chain platform supporting a large portfolio of clinical and commercial Cell & Gene therapies [5]

Core Insights - OXB has been recognized as a Champion in the 'Cell & Gene Therapy' category at the 2025 CDMO Leadership Awards Europe, reflecting its high performance based on feedback from biopharmaceutical professionals [1][2] - This recognition highlights OXB's excellence in quality, innovation, and service, coinciding with strong commercial momentum driven by increased demand for its CDMO services [2][3] Company Overview - OXB is a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapy, with a mission to enable clients to deliver life-changing therapies [4][5] - The company has 30 years of experience in viral vectors, collaborating with innovative pharmaceutical and biotechnology companies to provide expertise in various viral vector types [5][6] - OXB's capabilities range from early-stage development to commercialization, supported by robust quality-assurance systems and regulatory expertise [5][6] Technological Capabilities - OXB offers a wide range of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (TetraVecta™) and a dual-plasmid system for AAV production [6] - The company utilizes advanced processes such as suspension and perfusion processes with process enhancers and stable producer and packaging cell lines [6] Industry Recognition - The CDMO Leadership Awards recognize organizations that excel in quality, capabilities, expertise, reliability, compatibility, and service, based on direct feedback from industry professionals [8]

Core Insights - OXB, a leading CDMO in cell and gene therapy, will participate in several upcoming investor conferences and events, showcasing its commitment to engaging with investors [2][3]. Conferences and Events - OXB will attend the Stifel Healthcare Conference in New York and the Jefferies Global Healthcare Conference in London [3]. - A virtual event, the Jefferies C-Suite "Back to School" Fireside Chat, is scheduled for November 4, 2025, with live webcasts available on OXB's website [3][4]. - Additional financial events can be found on the company's investor calendar [4]. Company Overview - OXB has 30 years of experience in viral vectors, essential for most cell and gene therapies, and collaborates with innovative pharmaceutical and biotechnology companies [7]. - The company offers a range of technologies for viral vector manufacturing, including the TetraVecta™ system for lentiviral vector production and advanced AAV production methods [9]. - OXB is a FTSE250 and FTSE4Good constituent, with facilities in the UK, France, and the US, emphasizing its global presence and capabilities [9].

Core Insights - ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation, and CellReady, has awarded four G-Rex Grants totaling $375,000 to faculty members at Children's National Hospital to support cell and gene therapy initiatives [1][7]. Grant Details - Dr. Patrick Hanley received a $100,000 G-Rex Grant to develop a cost-effective CAR-T cell manufacturing process [2]. - Dr. Michael Keller and Dr. Hanley were awarded a $150,000 G-Rex Grant for optimizing Virus Specific T cell and Tumor Antigen Associate T cell manufacturing processes using G-Rex "M" series bioreactors [3]. - Dr. Amy Hont received a $75,000 G-Rex Grant for developing a closed system G-Rex manufacturing process for ATTACK TAAT cell therapy [4]. - Dr. Conrad Russell Cruz was awarded a $50,000 G-Rex Grant for optimizing CAR-modified TAAT cell manufacturing [4]. Program Impact - ScaleReady's G-Rex Grant Program has surpassed $40 million in no-cost product commitments aimed at advancing cell and gene-modified cell therapy development [7]. - Individual grants can be worth up to $300,000, and recipients gain access to exclusive support from ScaleReady's consortium of partners [7]. New Initiatives - ScaleReady has launched a free program called LEAN Cell & Gene™ in partnership with Hanson Wade to enhance CGT manufacturing efficiency [8]. Industry Context - Children's National Hospital is recognized as a leader in pediatric cell and gene-modified therapies, emphasizing the importance of collaboration in advancing these therapies [5][6]. - The G-Rex manufacturing platform is utilized by over 800 organizations and is involved in approximately 50% of CGT clinical trials [10].

Core Insights - OXB has acquired a state-of-the-art viral vector manufacturing facility in North Carolina from RTP Operating, LLC, enhancing its capabilities in the cell and gene therapy sector [1][8] - The acquisition aligns with OXB's strategic initiatives to expand its US commercial capabilities and meet growing client demand [4][7] Group 1: Acquisition Details - The facility is FDA approved and adds commercial-scale GMP capacity, enabling OXB to support late-stage programs and commercial launches for clients worldwide, particularly in the adeno-associated virus (AAV) field [2][9] - OXB paid $4.5 million (£3.4 million) for the assets, funded by existing cash, with integration planning expected to be operational by Q1 2026 [5][6] Group 2: Operational Enhancements - The North Carolina site includes two operational GMP drug substance suites, a dedicated fill-finish suite, and on-site QC labs, complementing OXB's existing global network [3][11] - The company plans to invest in the new facility, including hiring additional operational staff to enhance US fill-finish capacity and expedite client onboarding [6][8] Group 3: Financial Outlook - The acquisition is expected to support OXB's long-term top-line growth and maintain existing financial guidance, with an anticipated single-digit gain in 2025 [5][7] - OXB aims to achieve EBITDA profitability from FY 2025 and strengthen its competitive position in the global viral vector market [7][9]

Core Insights - ClearPoint Neuro (CLPT) has developed a proprietary Robotic Neuro-Navigation System, enhancing its role in robotics, neurosurgery, and advanced drug delivery [1] - The integration of neuro-navigation software with the FDA-cleared KUKA LBR Med robotic arm aims to improve precision and flexibility in minimally invasive cranial procedures [1] Strategic Fit for Cell and Gene Therapy Launches - The new platform addresses the need for biopharma partners in the commercialization of cell and gene therapies, which require complex delivery into the brain [2] - ClearPoint's approach combines MRI and iCT-guided techniques with robotic assistance, providing standardized execution paths through a single planning module [2] - This hybrid model ensures flexibility for surgeons and uniformity across procedures, which is critical for regulatory approval and large-scale adoption [2] Likely Share Price Movement - ClearPoint's shares have increased by 78% this year, contrasting with a 6.8% decline in the industry and a 15.2% gain in the S&P 500 Index [3] Investor Sentiment and Long-term Growth - The unveiling of the robotic drug delivery system is expected to generate positive investor sentiment, reflecting strategic positioning in the growing cell and gene therapy market [4] - While near-term gains may be modest pending regulatory approvals, the innovation strengthens long-term growth prospects, potentially supporting sustained upward momentum in share price [4] Leveraging Partnerships to Reduce Risk - ClearPoint's strategy involves leveraging KUKA's proven robotic arm while focusing on neuro-navigation software, reducing development risk and accelerating timelines [8] - Collaborations and software focus are aimed at reducing risk and positioning ClearPoint for long-term growth [7] Market Potential and Commercial Readiness - ClearPoint is embedded in the neuro-therapeutics ecosystem through global collaborations with academic centers, biopharma firms, and CROs [9] - The addition of robotic navigation expands its portfolio at a critical moment, as treatment centers are being established for upcoming commercial launches [9] - The initiative underscores ClearPoint's intent to be the preferred partner for cell and gene therapy delivery, potentially driving significant long-term revenue growth [9] Recent Developments - ClearPoint has secured FDA 510(k) clearance to expand its Prism Neuro Laser Therapy System for use with 1.5T MRI scanners, broadening its addressable market [10] - This clearance enables access to hospitals lacking 3T MRI capability, potentially accelerating the adoption of its minimally invasive laser therapy [11] - Prism procedures create a training foundation for future cell and gene therapy applications, viewed as a long-term value driver for ClearPoint [11]

Core Insights - Ernexa Therapeutics is set to present at the Cell & Gene Meeting on the Mesa, highlighting its advancements in cell therapies for cancer and autoimmune diseases [1][2] - The company aims to showcase its scalable iMSC therapies, particularly focusing on ERNA-101 for ovarian cancer and ERNA-201 for autoimmune diseases [3][6] Company Overview - Ernexa Therapeutics specializes in innovative cell therapies targeting advanced cancer and autoimmune diseases, utilizing proprietary synthetic, allogeneic induced mesenchymal stem cell (iMSC) technology [6] - The lead product, ERNA-101, is designed to stimulate the immune system against cancer cells, while ERNA-201 targets inflammation in autoimmune diseases [7] Upcoming Presentation Details - The presentation will take place on October 7, 2025, at 2:45 p.m. in Phoenix, Arizona, and will also be available via virtual livestream [8] - Ernexa previously shared insights on iPSC developments at the Annual iPSC Drug Development Summit and presented new data on ERNA-101 at the AACR Special Conference [4] Industry Context - The Cell & Gene Meeting on the Mesa serves as a significant platform for discussing commercialization challenges in the cell and gene therapy sector, featuring expert panels and industry leaders [5]

Core Insights - Protara Therapeutics is a clinical-stage biotech company focused on developing treatments for cancer and rare diseases, with its lead program TARA-002 targeting non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][8] - TARA-002 utilizes a novel approach derived from a genetically distinct cell bank, functioning through dual mechanisms of directly killing tumor cells and stimulating an immune response [1][8] - The company is also advancing IV Choline Chloride for patients requiring parenteral nutrition, addressing a significant unmet need [10] TARA-002 Development - TARA-002 is currently being evaluated in a mid-stage study called ADVANCED-2 for NMIBC, showing promising early results with a 67% complete remission rate in BCG-unresponsive patients at six months [8][12] - In the Phase 2 STARBORN-1 trial for lymphatic malformations, two out of three pediatric patients achieved complete response after one injection, indicating a favorable safety profile [9][12] - Protara plans to deliver interim results for both trials in 1Q26 and 4Q25, respectively [8][9] Market Potential and Analyst Sentiment - Analysts project TARA-002 represents a potential market opportunity exceeding $500 million, with a strong buy consensus rating and a price target suggesting an 840% upside [12][13] - The average price target from analysts for TARA shares is $24.20, indicating a potential upside of approximately 659% [13] Financial Performance of Alpha Teknova - Alpha Teknova reported $10.3 million in revenue for 2Q25, a 7.3% year-over-year increase, with a reaffirmed full-year revenue guidance of $39-42 million [17] - The company is positioned to benefit from growth in the bioprocessing market, with expectations of over 20% revenue growth and 30%+ adjusted EBITDA margins in the long term [19][20] Analyst Ratings for Alpha Teknova - Alpha Teknova holds a strong buy consensus rating, with a price target of $12 indicating a potential one-year upside of approximately 159% [20]