Clearpoint Neuro (CLPT) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0Greetings, and welcome to the ClearPoint Neuro, Inc. Second Quarter twenty twenty five Financial Results Conference Call. As a reminder, this conference is being recorded. Comments made on this call may include statements that are forward looking within the meaning of securities laws. These forward looking statements may include, without limitation, statements related to anticipated industry trends, the company's plans, prospe ...

WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY. Nasdaq: CLPT August 2025 DISCLAIMER T h is p r e se n t at io n an d d is c u ssi o n co n t a in fo r w a rd -l o o k i n g s t at em e n ts w i t h in t h e c o n t ex t o f t h e f ed e r al s ec u r i ti e s la w s, i n c lu d i n g t h e C o m p a n y ' s e x p ec t at i o n f o r r e v e n u es , gr o s s m ar g in , t h e a d eq u ac y o f c as h a n d c as h e q u iv al en t b al an c e s t o su p p o r t o p e r at i o n s an d m e et fu t u r e o b l ig ...

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]

Company Overview - MaxCyte supports 19 clinical and commercial therapies and has 29 SPL customers[9] - The company reported $386 million in 2024 revenue with an 84% Non-GAAP adjusted gross margin[10] - MaxCyte has $190 million in cash and cash equivalents as of December 31, 2024[10] Cell and Gene Therapy Market - There are approximately 1,950 active clinical trials focused on cell and gene therapy as of December 2024[14] - The cell and gene therapy field raised an aggregate of $152 billion in 2024[14] - There are 44 approved cell and gene therapies[14] Strategic Platform Licenses (SPLs) - MaxCyte has 29 SPL customers, with 18 programs currently in clinical development and 1 commercial program[47] - These 18 active clinical programs represent over $220 million of pre-commercial milestone potential[47] - SPL Program-Related revenue accounted for 57% of Core revenue[68] Financial Performance - Total core revenue for the full year 2024 was $325 million, a 9% increase year-over-year[69] - Total revenue for the full year 2024 was $386 million, a 6% decrease year-over-year[69] - Non-GAAP adjusted gross margin was 84% for the full year 2024[69]

WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY. Nasdaq: CLPT May 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 its products and services, and other performance and results. These forward -looking statements are based on management's curren ...

Core Viewpoint - OXB has shown strong commercial momentum and operational progress in 2025, continuing to provide viral vector manufacturing services to a diverse client base, and remains on track to meet its financial outlook for the year ended December 31, 2024 [2][3]. Group 1: Company Performance - OXB has delivered strong operational performance in the first half of 2025, reflecting disciplined execution across global sites and sustained commercial momentum [3]. - The company reiterates its financial guidance and remains focused on supporting clients at all development stages, expressing confidence in its near and medium-term targets [3]. Group 2: Company Background - OXB is a pioneer in cell and gene therapy with 30 years of experience in viral vectors, collaborating with innovative pharmaceutical and biotechnology companies [5]. - The company provides expertise in various viral vector types, including lentivirus, adeno-associated virus (AAV), and adenovirus, supporting capabilities from early-stage development to commercialization [5]. Group 3: Technological Capabilities - OXB offers unique 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 with process enhancers, along with stable producer and packaging cell lines [6]. Group 4: Corporate Information - OXB is headquartered in Oxford, UK, with development and manufacturing facilities in Oxfordshire, UK, Lyon and Strasbourg, France, and Bedford, MA, US [7].

Summary of Sana Biotechnology (SANA) FY Conference Call - June 10, 2025 Company Overview - **Company**: Sana Biotechnology (SANA) - **Industry**: Biotechnology - **Focus**: Development of cell-based therapies, particularly for type one diabetes and CAR T cell therapies Key Points and Arguments Portfolio Strategy and Pipeline - The company is focused on using cells as medicines, specifically through two technologies: hypoimmune technology and in vivo gene modification [3][4] - The majority of capital is allocated towards the hypoimmune platform, which aims to hide cells from immune system recognition, particularly in type one diabetes [5][12] - Type one diabetes affects approximately 9 million people globally, with about 2 million in the U.S., and has seen little meaningful progress in treatment over the past century [6][7] - The goal is to provide a single treatment that results in normal blood sugar levels for life without the need for insulin or immunosuppression [8][12] Type One Diabetes Program - The lead program, SC451, is a hypoimmune iPSC-derived islet cell therapy expected to file an IND in 2026 [15] - Investigator-sponsored trials have shown promising results, including a patient making insulin without immunosuppression for over 35 years [21][22] - The therapy aims to be scalable and consistent, addressing the limitations of current treatments that require lifelong immunosuppression [24][53] Risks and Challenges - Major risks identified include capital and time constraints, safety concerns, and the need for scalable manufacturing [56][57] - The company is focused on ensuring product purity to avoid tumor emergence, which is critical for long-term patient safety [56] CAR T Cell Programs - The company is also developing allogeneic CAR T therapies for oncology and autoimmune diseases, facing competition and investor fatigue in the CAR T space [9][10][11] - The allogeneic CAR T program aims to provide off-the-shelf therapies that do not require patient-specific modifications [61][64] - The company is optimistic about achieving deep B cell depletion in autoimmune settings based on oncology data [62][64] Competitive Landscape - The company differentiates itself by eliminating the need for immunosuppression in its therapies, which is a significant advantage over competitors [52][53] - The market for type one diabetes treatments is vast, with potential for significant revenue if successful [51] Financial Strategy and Partnerships - The company acknowledges the need for additional funding to support its various programs and is exploring partnerships as a non-dilutive option [74][75] - There is a strong commitment to protect the type one diabetes franchise while seeking capital for other programs [75][76] Upcoming Data and Expectations - The company plans to present updated data at the American Diabetes Association meeting, with expectations for stable C peptide levels and glucose-sensitive insulin secretion [35][36] - The focus remains on ensuring that the therapy meets safety and efficacy standards before moving forward with broader applications [66][67] Additional Important Content - The company has made significant progress in developing a master iPSC cell bank, which is crucial for scaling production [41][49] - The challenges of scaling production to meet the needs of millions of patients are acknowledged, with ongoing efforts to ensure genomic stability [46][47] This summary encapsulates the key points discussed during the conference call, highlighting Sana Biotechnology's strategic focus, challenges, and future expectations in the biotechnology sector.

Summary of Abeona Therapeutics (ABEO) Conference Call Company Overview - Abeona Therapeutics is a commercial stage cell and gene therapy company that recently received approval for ZivaSkin, a therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB) [5][70] - The company has a market cap of approximately $300 million and anticipates becoming profitable in the early half of 2026 [6][71] Key Developments - ZivaSkin was approved just over a month ago, and the company has entered into a sale agreement for a Priority Review Voucher (PRV) for $155 million [5][70] - Abeona is funded for eight quarters of operations without accounting for revenue generation [6][71] Launch Metrics and Treatment Centers - Lurie Children's Hospital has been activated as the first qualified treatment center for ZivaSkin [7][72] - The company is tracking patient throughput and referral volume from other centers of excellence [7][72] - The timeline to fully activate all five treatment centers is by the end of 2025 [9][74] Patient Demand and Treatment Capacity - There are currently an upper double-digit number of patients eligible for treatment across the five centers [11][73] - The company expects to treat 10 to 14 patients this year, with the capacity to ramp up to 10 patients per month by the first half of 2026 [18][37] - The treatment window runs from August to November, with minimal disruption expected due to a planned December manufacturing shutdown [20][21] Pricing and Payer Engagement - ZivaSkin is priced at $3.1 million, which is considered reasonable compared to the standard of care costs [28][30] - The company has not faced pushback from payers and has entered agreements covering over 100 million commercially insured lives [31][36] Financial Outlook - Abeona expects to achieve cash flow positivity in 2026 with a target of treating 36 patients [37][39] - The company is confident in exceeding this target, potentially treating up to 50 patients [38][39] Future Plans and Market Expansion - Abeona is exploring regulatory submissions outside the U.S. and assessing reimbursement scenarios in major markets like Western Europe and Japan [46][47] - The company has identified approximately 750 patients in the U.S. with RDEB, with a significant opportunity for repeat treatments [49][51] Competitive Landscape - ZivaSkin differentiates itself by providing long-lasting wound coverage with a single application, addressing both wound healing and quality of life improvements [53][54] Partner Programs - Abeona is eligible for royalties and milestones from partnered programs with Ultragenyx and Atacea, which are not factored into current projections [55][58] Key Milestones Ahead - The company aims to achieve its treatment goals for ZivaSkin and activate additional qualified treatment centers, with several PDUFA action dates for partnered programs expected in 2025 [66][67]

Core Insights - Bio-Techne's GMP reagents, including proteins and small molecules, are essential for its cell therapy offerings, with acquisitions playing a significant role in expanding its portfolio and entering adjacent markets [1] - The company is pursuing clinical diagnostic opportunities with its Ella platform, despite facing macroeconomic challenges that may impact operations [1][10] Financial Performance - Over the past year, Bio-Techne's shares have declined by 38.1%, underperforming the industry’s 15.3% decline, while the S&P 500 composite grew by 13.1% [2] - The company has a market capitalization of $7.63 billion, with earnings surpassing estimates in three of the last four quarters, averaging a surprise of 6.7% [2] Growth Drivers - The Cell and Gene Therapy segment is a major growth area, with the GMP reagents business experiencing high single-digit revenue growth in Q3 of fiscal 2025 and over 500 customers engaged in cell therapy development [3] - The GMP reagents business grew by just over 13% on a trailing 12-month basis, influenced by large, infrequent orders from late-stage clinical trials [3] - In China, the cell and gene therapy solutions are resilient despite funding challenges, with increasing adoption of organoid solutions expected to drive demand for GMP reagents [4] Strategic Initiatives - Bio-Techne has made several strategic acquisitions, including Lunaphore in fiscal 2024 and a 19.9% investment in Wilson Wolf, with plans to acquire the remaining ownership by the end of 2027 [5] - The launch of ProPak GMP Cytokines optimized for the Wilson WolfG-Rex bioreactor and an investment in Spear Bio for ultra-sensitive immunoassays highlight the company's focus on innovation [6] Market Opportunities - The Ella platform has received ISO 13485 certification and is being positioned for clinical diagnostics, with a partnership with Novomol-Dx to launch the BMP kit in India [7][9] - Ella is gaining traction among cell and gene therapy customers for viral titer and release testing, as well as among CROs for its high sensitivity and reproducibility [9] Challenges - The macroeconomic environment is causing increased raw material and labor costs, with a 2.8% rise in cost of sales and a 35.2% increase in selling, general, and administrative expenses year over year [10] - Funding challenges, particularly in China, are leading to extended sales cycles and production-related hazards, compounded by potential NIH funding cuts [11] Earnings Estimates - The Zacks Consensus Estimate for fiscal 2025 earnings has decreased by a cent to $1.88, while revenue estimates are pegged at $1.22 billion, indicating a 5.2% increase from the previous year [12]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [9] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [10] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [7][8] - Neurosurgery Navigation revenue grew 70% to $3.3 million, attributed to higher sales of new product offerings [8] - Capital Equipment and Software revenue decreased 63% to $500,000 due to fewer new placements of navigation and laser units [9] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, expanding its installed base [51] - The single-use consumables business saw a growth rate of 104%, driven by increased orders from biopharma partners [13] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to enhance hospital efficiency and throughput [5] - The company is focused on expanding its global installed base and generating scale for novel treatments [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain approvals in the next two years [15] - The recent partnership with Overland Capital provides the company with foundational funding to execute its strategy [6][12] - Management anticipates that revenue growth will outpace expense growth for the full year [11][57] Other Important Information - The company has implemented a new subscription program called Pathfinder, allowing hospitals to access technology through annual fees [21] - The company expects to achieve GLP certification by the end of the year, which will enable larger studies and increased demand [42][47] Q&A Session Summary Question: What initiatives can be prioritized now that capital is available? - Management indicated opportunities to accelerate hiring for field support and preclinical resources to meet partner demands [29] Question: How does the new capital runway relate to achieving sustained breakeven? - Management believes the new debt facility can support cash breakeven, with expectations of generating meaningful cash flow in the coming years [31] Question: How is the neuro franchise tracking relative to expectations? - Management stated that the neuro franchise is on plan and expects significant growth throughout the year [34] Question: What is the expected mix of MRI versus OR procedures in the future? - Management anticipates a shift towards more OR procedures, but expects MRI procedures to remain crucial for drug delivery therapies [40][41] Question: What is the status of GLP certification and customer interest? - Management confirmed that they are on track for GLP certification and have received interest from pharma partners for studies once certified [42][46] Question: How are the new sites placed in terms of sales agreements? - Management clarified that the two new sites activated were capital placements, with additional systems placed under the Pathfinder agreements [51][52]