Financial Data and Key Metrics Changes - The company reported a combined revenue of $19,800,000 for Hebsado and ChemoSATs in Q1 2025, with Hebsado sales in the U.S. contributing $18,000,000 and ChemoSATs in Europe adding $1,800,000, compared to $2,000,000 and $1,100,000 respectively in Q1 2024 [7][16] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [16] - Net income for Q1 2025 was $1,100,000, a significant turnaround from a net loss of $11,100,000 in Q1 2024 [17] - Positive adjusted EBITDA was reported at $7,600,000 compared to an adjusted EBITDA loss of $7,300,000 in Q1 2024 [17] - The company ended the quarter with approximately $59,000,000 in cash and investments and no debt [8][17] Business Line Data and Key Metrics Changes - The U.S. market for Hebsado and ChemoSATs showed strong growth, with a focus on expanding treatment centers, increasing from 17 to 19 active centers [8][9] - The average treatments per center per month were approximately two in Q1, with expectations to remain just under two for the remainder of the year [10][28] Market Data and Key Metrics Changes - The European market for ChemoSATs grew by 29% over the prior quarter to $1,800,000, although it is not expected to be a significant revenue contributor in the short to medium term due to reimbursement pricing challenges [11] - The company is focusing on generating clinical data from European sites, which have over a decade of experience with ChemoSATs [11][44] Company Strategy and Development Direction - The company aims to expand its active treatment centers to 30 by year-end, with a current pace of opening three to five centers per quarter [9][10] - The strategic focus includes leveraging cash from operations to support research and development initiatives for broader patient populations suffering from liver cancer [8][15] - The company is pursuing additional indications for Hepciddo, including metastatic colorectal and breast cancer, with ongoing clinical trials [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a more even distribution of center activations throughout the year, rather than a concentration in the second half [25] - The company anticipates that the ongoing engagement with oncologists and interventional radiologists will drive demand for treatments [15] - Management acknowledged the competitive landscape but emphasized the collaborative nature of information sharing among treatment centers [38] Other Important Information - The company has implemented a patient access program to assist with copay costs and connect patients with treatment centers [10][53] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [44] Q&A Session Summary Question: Update on center activations - Management indicated that the pace of center activations may be more even throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [25][26] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with total operating expenses projected to rise by 60% over 2024, while maintaining positive EBITDA for the year [30][31] Question: Frequency of patient treatments - The average frequency of treatments for patients is expected to remain around 4.1, which is a key driver for overall revenue [36] Question: European market growth and reimbursement - Management noted that while European revenues are increasing, reimbursement challenges remain, and they are focusing on generating clinical data before investing more resources [40][44] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not found suitable opportunities yet [70][72]

Financial Data and Key Metrics Changes - The company reported a combined revenue of $19.8 million for Q1 2025, with Hebsado sales in the U.S. contributing $18 million and ChemoSAT sales in Europe adding $1.8 million, compared to $2 million and $1.1 million respectively in Q1 2024 [5][15] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [15] - Net income for Q1 2025 was $1.1 million, a significant turnaround from a net loss of $11.1 million in Q1 2024 [16] - Positive adjusted EBITDA for Q1 2025 was $7.6 million, compared to an adjusted EBITDA loss of $7.3 million in Q1 2024 [16] - The company ended the quarter with approximately $59 million in cash and investments, and positive operating cash flow of $2.2 million [16] Business Line Data and Key Metrics Changes - The company activated 19 treatment centers in the U.S. by the end of Q1 2025, with plans to reach 30 active centers by year-end [6][7] - Average treatments per center were approximately two per month in Q1, with expectations to remain just under two for the remainder of the year [8][27] Market Data and Key Metrics Changes - The European market for ChemoSAT experienced a 29% growth over the prior quarter, reaching $1.8 million, although it is not expected to be a significant revenue contributor in the short to medium term [9] - The company is focusing on expanding its presence in the U.S. market while managing reimbursement challenges in Europe [9][40] Company Strategy and Development Direction - The company aims to leverage cash from operations to support research and development initiatives for Hebsado beyond metastatic uveal melanoma patients [6] - The strategy includes expanding treatment centers and enhancing access for patients through the Hepcido KidAccess 360 platform [8] - The company is pursuing additional clinical trials for liver-dominant metastatic colorectal and breast cancer, with FDA clearance received for both trials [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the goal of 30 active centers by year-end, with a balanced approach to center activations throughout the year [22][24] - The company anticipates that the average monthly treatment per site will stabilize just under two for the remainder of the year due to the pace of new center activations [27] - Management highlighted the importance of clinical demand and engagement with oncologists and interventional radiologists in driving revenue growth [13] Other Important Information - The company has no outstanding debt obligations and has successfully raised $16.2 million through the exercise of Series F warrants [16][17] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [43] Q&A Session Summary Question: Update on center activations and expectations for Q2 - Management indicated that center activations may be more evenly distributed throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [20][24] Question: Treatment frequency and center performance - Average treatment frequency is expected to stabilize around 4.1 treatments per patient, with a mix of organic and referred patients contributing to center performance [35][86] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with EBITDA margins projected to remain positive throughout the year despite rising operational costs [29][30] Question: European market growth and reimbursement - Management noted that while the European market is growing, reimbursement challenges remain, and additional resources will be allocated once reimbursement is secured [39][42] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not identified any suitable opportunities at this time [70][72]