Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash, cash equivalents, short-term investments, and restricted cash of $84.5 million, down from $98.1 million as of December 31, 2024, before accounting for the proceeds from the Priority Review Voucher (PRV) sale [17] - Research and development expenses increased to $9.9 million for Q1 2025 from $7.2 million in Q1 2024, primarily due to increased headcount for manufacturing scale-up [18] - General and administrative expenses rose to $9.8 million for Q1 2025 from $7.1 million in Q1 2024, also due to increased headcount related to the ZivaSkin launch [18] - The net loss for Q1 2025 was $12 million, or $0.24 loss per share, compared to a net loss of $31.6 million, or $1.16 loss per share, in Q1 2024 [19] Business Line Data and Key Metrics Changes - The company launched ZivaSkin, the first autologous cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), following FDA approval [4][5] - The first Qualified Treatment Center (QTC) activated was Lurie Children's Hospital of Chicago, which is expected to treat the first patient in Q3 2025 [6][8] Market Data and Key Metrics Changes - The company has received inquiries from approximately 30 patients and families across the country since ZivaSkin's approval, indicating strong demand [10] - The company is actively engaging with commercial payers and state Medicaid programs to expand access to ZivaSkin [16] Company Strategy and Development Direction - The company aims to treat 10 to 14 patients with ZivaSkin in 2025 and anticipates a robust start to 2026 [13] - The company has entered into an agreement to sell the PRV for $155 million, which will strengthen its balance sheet and fund operations for over two years [9][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial launch of ZivaSkin and the positive response from patients and physicians [10][13] - The company is focused on ensuring that the value of ZivaSkin is recognized by payers and that patients have timely access to the therapy [16] Other Important Information - The company expects to achieve profitability driven by ZivaSkin revenues in early 2026 [17] - The company is on track to activate additional QTCs by the end of 2025, with ongoing discussions with recognized institutions [12] Q&A Session Summary Question: What does site activation mean? - Site activation means that staff and surgeons are trained and ready to identify patients for ZivaSkin treatment [22][25] Question: How many RDEB patients are eligible at Lurie Children's Hospital? - There are at least a couple of dozen patients treated at Lurie, with potential for more referrals from the local community [26] Question: What factors affect patient access to treatment? - Commercially insured patients are expected to have faster access compared to Medicaid patients, which may take longer [29] Question: What is the expected patient throughput at QTCs? - Initial throughput is expected to be two patients per month per site, with potential to ramp up to four patients per month at some centers [39] Question: What are the anticipated net proceeds from the PRV sale? - The net proceeds from the PRV sale are expected to be about $152 million [54] Question: How will billing and reimbursement work? - Revenue recognition will occur after patient treatment, with discussions already in place with insurance companies to ensure reimbursement [72][75]

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 [10] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [11] 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 [8] - Neurosurgery Navigation revenue surged 70% to $3.3 million, attributed to higher sales of new product offerings [9] - Capital Equipment and Software revenue fell 63% to $500,000 due to fewer new placements of navigation and laser units [10] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, which were both capital placements [51] - The introduction of the three point zero navigation software has allowed expansion into operating rooms, enhancing market reach [14] 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 focus on fast, simple, and predictable workflows to increase hospital efficiency [5] - The company is pursuing global scale by expanding its installed base and generating more access to its ecosystem [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 [16] - The recent partnership with Overland Capital provides the company with the necessary funding to execute its strategy [6] - Management anticipates that operational cash burn will continue to increase but expects to generate meaningful cash flow as new drugs come online [31] Other Important Information - The company has implemented a Pathfinder subscription program to smooth capital revenue recognition over time [22] - The three point zero navigation software has been well received, with positive feedback from surgeons regarding efficiency and accuracy [18] Q&A Session Questions and Answers Question: Are there initiatives that can be prioritized now with access to incremental capital? - Management confirmed that there are opportunities to accelerate hiring and expand preclinical resources in response to partner requests [29] Question: How does the new capital runway relate to achieving sustained breakeven? - Management believes the new debt facility can support the company towards cash breakeven, especially with the flexibility of an interest-only period [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, with potential upside from new product launches [34] Question: What is the expected mix of MRI versus OR procedures in the future? - Management indicated that while MRI procedures currently dominate, there is potential for OR procedures to grow faster as new therapies are introduced [40] Question: What is the status of GLP certification and customer interest? - Management confirmed that they are on track for GLP certification by the end of the year and noted strong interest from pharma partners for studies once certified [42][46]