Financial Data and Key Metrics Changes - The company reported global revenues of $16.1 million for Q3 2025, marking the second consecutive quarter of record overall quarterly revenue [2] - HIFU revenue reached $7.7 million, a 57% increase compared to Q3 2024 [2] - Total revenue for Q3 2025 was EUR 13.9 million, a 6% increase from EUR 13.1 million in Q3 2024 [11] - Gross profit for Q3 2025 was EUR 6 million, with a gross margin of 43%, up from 39.4% in the same period last year [12][14] - Net loss for Q3 2025 was EUR 5 million, an improvement from a net loss of EUR 6.4 million in Q3 2024 [15] Business Line Data and Key Metrics Changes - HIFU business grew 49% year-over-year, driven by six capital sales in Q3 2025 compared to three in the prior year [11][12] - Focal One placements increased by 167% year-over-year, with eight placements in Q3 2025 [3] - Focal One procedures in the US grew more than 15% year-over-year, indicating a return to double-digit growth [3][4] Market Data and Key Metrics Changes - The company is seeing meaningful progress in reimbursement coverage, particularly among Medicare Advantage providers [4] - The latest hospital and physician payment rules from CMS reinforce the use case of HIFU, providing a clear reimbursement pathway [5] Company Strategy and Development Direction - The company aims to make Focal One the standard of care for localized prostate cancer, focusing on expanding clinical adoption and market access [2][18] - Plans to expand into new clinical indications, including benign prostatic hyperplasia (BPH) and endometriosis, are underway [6][8] - The company maintains financial guidance for 2025, expecting core HIFU business revenue growth of 26%-34% [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, supported by strong clinical evidence and expanding market access [18] - The company is focused on accelerating adoption and utilization across its Focal One install base while maintaining a disciplined investment approach [18] Other Important Information - The company received the first tranche of EUR 11 million from the European Investment Bank, aimed at supporting strategic investments in HIFU [16][22] - The company is monitoring the impact of US tariff policies, estimating a full-year impact of EUR 900,000 [17] Q&A Session Summary Question: Details on the EIB deal and its use - Management indicated that proceeds from the EIB deal will be used for product development, clinical development, and commercial growth, primarily focused on the HIFU core business [22] Question: Coverage of US Focal One procedures and expected growth - Management noted that the procedure mix includes Medicare patients, Medicare Advantage plan patients, and commercial patients, with positive trends in Medicare Advantage coverage expected to drive volume growth [23] Question: Expectations for Q4 given typical seasonal softness - Management reiterated guidance for 2025, confident that Q4 numbers will align with year-end targets of $58 million to $62 million [24]

Core Insights - AIM ImmunoTech Inc. will present significant clinical advancements of its drug Ampligen at the 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care in Warsaw, Poland, focusing on pancreatic cancer and other solid tumors [1][2] - The presentations will include data from the ongoing Phase 2 clinical trial for pancreatic cancer and the positive therapeutic effects of Ampligen on endometriosis, which is linked to ovarian cancer [1][3] Oncology - AIM will showcase data from its pancreatic cancer Early Access Program and the Phase 2 clinical trial at Erasmus Medical Center, highlighting the DURIPANC study that evaluates the combination of Ampligen and AstraZeneca's durvalumab for late-stage metastatic pancreatic cancer [3][4] - Preliminary results from the DURIPANC study indicate that Ampligen is well-tolerated, with promising early signs of improved progression-free survival (PFS) and overall survival (OS) compared to historical data [4][6] - Dr. Kalinski will discuss Ampligen's efficacy in treating various solid tumors, including late-stage recurrent ovarian cancer and triple-negative breast cancer, emphasizing the unmet healthcare needs these therapies address [5] Endometriosis - The upcoming presentation on endometriosis will analyze data from AIM's clinical trials for Chronic Fatigue Syndrome, revealing that approximately 80% of female participants experienced symptom improvement, highlighting Ampligen's potential in treating endometriosis [7][9] - Endometriosis affects around 190 million women globally and is associated with chronic pain and infertility, underscoring the need for new treatment options beyond radical surgeries [8] Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for various cancers, immune disorders, and viral diseases, with Ampligen being a first-in-class investigational drug that acts as a TLR3 agonist [10]