Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].

Summary of Delcath Systems FY Conference Call - September 10, 2025 Company Overview - **Company**: Delcath Systems (NasdaqCM:DCTH) - **Industry**: Oncology, specifically focused on liver cancers - **Lead Product**: HEPZATO KIT, a minimally invasive percutaneous perfusion technology launched in January 2024 for treating primary and secondary liver tumors [2][4] Core Business Strategy - **Initial Focus**: Targeting metastatic uveal melanoma, an ultra-orphan indication where the liver is often the life-limiting organ [4][5] - **Market Potential**: Over 100,000 patients annually in the U.S. have liver as a life-limiting organ due to cancer [4] - **Expansion Plans**: Revenue from the initial indication will fund expansion into other cancers, including metastatic colorectal cancer (40,000 patients annually), breast cancer, and pancreatic cancer [5][6] Competitive Advantages of HEPZATO KIT - **Unique Treatment Method**: Unlike other liver-directed therapies (Y-90, microwave ablation, TACE), HEPZATO KIT perfuses the entire liver with chemotherapy, allowing for treatment of multiple small metastases that are not visible on imaging [6][7][8] - **Liver Function Preservation**: High doses of melphalan can be administered without losing liver function, unlike other methods that can compromise liver health [8] Commercial Growth and Center Activation - **Current Status**: 22 active commercial centers in the U.S. with plans to grow to 40 centers next year [9][10] - **Revenue Guidance**: Revised guidance for the year is $93 million to $96 million, with growth linked to the number of active centers [9][10] - **Procedure Volume**: Average of two procedures per center per month, with potential for growth through referrals and operational improvements [10][14] Training and Operational Challenges - **Team Composition**: Each treatment team consists of an Interventional Radiologist, Anesthesiologist, and Perfusionist, which requires coordination and training [18][19] - **Training Complexity**: Training involves didactic learning and proctoring, which can be logistically challenging [18][19] Medicaid National Drug Rebate Agreement (NDRA) - **Impact on Revenue**: NDRA participation results in a 11% to 13% decrease in revenue per kit, affecting Q3 financials but potentially increasing patient access [20][23] - **Reimbursement Changes**: New guidelines have expanded the number of customers under NDRA, which may help in patient access despite the revenue decrease [21][24] Clinical Development and Future Indications - **Current Trials**: Ongoing trials for metastatic colorectal cancer and breast cancer, with interim data expected in 1997-1998 [25][26] - **Future Studies**: Potential for additional studies based on the safety and efficacy of combining HEPZATO with immuno-oncology agents [27] Financial Health - **Cash Position**: Company is cash positive with no debt, indicating a strong financial position for future growth [29][30][32] Conclusion - **Outlook**: Delcath Systems is positioned for growth with a unique product offering in the oncology space, a solid commercial strategy, and a focus on expanding treatment indications while maintaining a strong financial position [29][30]

Company Overview - Delcath is focused on liver-dominant cancers with a high unmet medical need[16, 22] - The company's lead product is the HEPZATO KIT, a liver-directed treatment for metastatic uveal melanoma (mUM)[38] - Delcath has an experienced management team with expertise in commercializing high-value, specialty products[10, 14, 100] - The company has a strong financial position with $58.9 million in cash and investments as of March 31, 2025, and no outstanding debt obligations[15] HEPZATO KIT Commercialization - HEPZATO KIT received FDA approval in August 2023 for mUM[17] - In Q1 2025, total revenue was $19.8 million with gross margins of 86%[14] - Full-year revenue guidance for 2025 is $94 to $98 million[14] - The company is expanding its commercial presence, with 19 active centers as of May 8, 2025, and 29 sites accepting referrals[65] - The US mUM total addressable market (TAM) is approximately $500 million[15] Clinical Development and Pipeline - Delcath has IND approval for Phase 2 trials in metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC)[14] - Phase 2 trials for mCRC and mBC are planned to initiate enrollment in Q3/Q4 2025 and Q4 2025, respectively[17] - The company is evaluating HEPZATO in combination with SOC (trifluridine-tipiracil and bevacizumab) in liver-dominant mCRC, enrolling approximately 90 patients[17] - The company is also evaluating HEPZATO in combination with SOC (eribulin, vinorelbine or capecitabine) in liver-dominant HER2-negative mBC, enrolling approximately 90 patients[18] Financial Performance - Q1 2025 net income was $1.1 million, and adjusted EBITDA was $7.6 million (Non-GAAP)[15] - Q1 2025 operating cash flow was $2.2 million[15] - The company received approximately $16 million from warrant exercises through May 5th at a $10 strike price[15]