Financial Overview - As of December 31, 2024, the company reported cash and investments totaling $53.2 million[9] - The company anticipates a cash burn of $3.6 million for Q3 2024, with expectations for cash flow positivity in the near future[11] - The company has no outstanding debt obligations, enhancing its financial stability[11] - The company has an expected cash and investments balance of $53.2 million and no outstanding debt obligations[73] Revenue and Market Potential - Preliminary Q4 2024 revenue is expected to be $15.1 million, with gross margins between 80% and 85%[10] - Fourth quarter revenue is expected to be approximately $15 million, with full year total revenue around $37 million, reflecting a 39% increase[73] - Revenue growth is primarily driven by HEPZATO activation, which has shown a 150% increase[73] - The total addressable market (TAM) for metastatic uveal melanoma (mUM) in the US is approximately $600 million[11] - The U.S. incidence of liver-dominant cancers is approximately 50,000 annually, indicating a significant market opportunity[70] Product Development and Clinical Trials - The HEPZATO KIT is the first and only FDA-approved whole-liver directed therapy, targeting unresectable hepatic metastases[10] - The company plans to initiate clinical trials for colorectal cancer (CRC) and basal cell carcinoma (BCC) following the readout of CHOPIN data[11] - The company plans to initiate Phase 2 trials in 2025 targeting liver-dominant metastatic patients[71] - The Phase 1b portion of the Chopin Trial showed an overall response rate (ORR) of 85.7% and a disease control rate (DCR) of 100%[67] - The FOCUS trial reported an ORR of 36.3% and a median overall survival (OS) of 20.53 months[83] Treatment Efficacy and Patient Population - HEPZATO KIT received FDA approval on August 14, 2023, for treating patients with liver-dominant mUM[36] - Approximately 800 patients are potentially eligible for treatment with HEPZATO, which has no HLA genotype restrictions[37] - The one-year overall survival rate for patients with metastatic disease in the liver is only 13%, with median survival ranging from 4 to 15 months[29] - The FOCUS trial reported a median overall survival (OS) of 20.53 months for patients treated with HEPZATO, with a 1-year OS rate of 80%[85] - The median progression-free survival (PFS) for the same group was 9.03 months[85] - 55% of metastatic uveal melanoma (mUM) patients have no approved systemic treatment options, with most treated through multiple lines of therapy[32] Market Strategy and Expansion - The company is focused on expanding its market presence in Europe with the CHEMOSAT device launch[10] - The company aims to have 30 active commercial centers for HEPZATO by the end of 2025, with 22 sites currently accepting referrals[42] - 50% of the target sites for HEPZATO are either PPS exempt or NCI designated Cancer Centers, allowing for favorable reimbursement terms[50] Adverse Events and Safety - Adverse events related to the study treatment included thrombocytopenia (64%), leukopenia (44%), and anemia (33%) among 95 patients[89] - Grade 3 or 4 adverse reactions included leukopenia (34%) and anemia (33%)[89] Overall Objectives - The overall objective is to convert unresectable liver metastases into resectable ones, potentially improving survival rates[59] - The trial results suggest a potential for improved survival outcomes with HEPZATO compared to historical data[85] - The company is exploring further development of HEPZATO based on these promising results[85]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Delcath Systems, Inc. (DCTH) - DCTH currently holds a Momentum Style Score of B, indicating a positive momentum outlook [2] - The company has a Zacks Rank of 2 (Buy), suggesting strong potential for outperformance in the market [3] Performance Metrics - DCTH shares have increased by 4.17% over the past week, contrasting with a 1.24% decline in the Zacks Medical - Instruments industry [5] - Over the past quarter, DCTH shares have surged by 73.06%, and over the last year, they have gained 242.1%, while the S&P 500 has only moved 1.24% and 22.19% respectively [6] Trading Volume - The average 20-day trading volume for DCTH is 496,916 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, one earnings estimate for DCTH has increased, while none have decreased, raising the consensus estimate from -$0.80 to -$0.79 [9] - For the next fiscal year, one estimate has moved upwards with no downward revisions, indicating a positive trend in earnings expectations [9] Conclusion - Considering the positive momentum indicators and earnings outlook, DCTH is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [11]

Core Viewpoint - Delcath Systems, Inc. (DCTH) has seen a significant stock price increase of 35.2% over the past four weeks, closing at $16.30, with analysts suggesting a potential upside to a mean price target of $21.80, indicating a further increase of 33.7% [1] Group 1: Price Targets and Analyst Consensus - The mean price target is based on five short-term estimates with a standard deviation of $1.92, where the lowest estimate of $20 suggests a 22.7% increase, and the highest estimate of $25 indicates a potential surge of 53.4% [2] - A low standard deviation among price targets reflects a strong agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [7] - Despite the consensus price target being a popular tool among investors, its reliability has been questioned, as empirical research shows that price targets often mislead rather than guide investors [5][6] Group 2: Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about DCTH's earnings prospects, as evidenced by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has risen by 3.5% over the past month, with no negative revisions, indicating positive sentiment [10] - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting a strong potential upside [11]

Core Viewpoint - The article emphasizes the importance of confirming the sustainability of stock trends for successful short-term investing, highlighting the use of a specific screening strategy to identify stocks with strong fundamentals and positive price momentum [1][2]. Group 1: Stock Screening Strategy - The "Recent Price Strength" screen is designed to identify stocks with sufficient fundamental strength to maintain their recent uptrend, focusing on those trading in the upper portion of their 52-week high-low range, indicating bullishness [3]. - Delcath Systems, Inc. (DCTH) is highlighted as a strong candidate for trend investing, having increased by 43.1% over the past 12 weeks, reflecting investor confidence [4]. - A price increase of 30% over the last four weeks further confirms that the upward trend for DCTH is intact, with the stock currently trading at 93.8% of its 52-week high-low range, suggesting a potential breakout [5]. Group 2: Fundamental Strength - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, which are critical for near-term price movements [6]. - The Zacks Rank system has a proven track record, with Zacks Rank 1 stocks averaging an annual return of +25% since 1988, indicating the effectiveness of this ranking in identifying strong investment opportunities [7]. - The Average Broker Recommendation for DCTH is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding the stock's near-term performance [7]. Group 3: Additional Investment Opportunities - Besides DCTH, there are several other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting a broader range of investment opportunities for investors [8]. - The article encourages investors to explore over 45 Zacks Premium Screens tailored to different investing styles, which can help in identifying potential winning stocks [8].

Core Viewpoint - The article emphasizes the importance of confirming the sustainability of stock trends for successful short-term investing, highlighting the use of a specific screening strategy to identify stocks with strong fundamentals and positive price momentum. Group 1: Stock Screening Strategy - The "Recent Price Strength" screen is designed to identify stocks with sufficient fundamental strength to maintain their recent uptrend, focusing on those trading in the upper portion of their 52-week high-low range, indicating bullishness [3][4]. - Delcath Systems, Inc. (DCTH) is highlighted as a strong candidate for trend investing, having increased by 15.8% over the past 12 weeks, reflecting investor confidence [4]. - DCTH has also shown a price increase of 4.7% over the last four weeks, indicating that the upward trend is still intact [5]. Group 2: Fundamental Strength - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, which are critical for near-term price movements [6]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), suggesting high optimism from the brokerage community regarding its near-term price performance [7]. Group 3: Market Insights - The article suggests that the price trend for DCTH is unlikely to reverse soon, and encourages investors to consider other stocks that meet the criteria of the "Recent Price Strength" screen [8]. - The Zacks Rank stock-rating system has a proven track record, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988, indicating the effectiveness of this rating system in identifying potential winners [7].

Core Viewpoint - Delcath Systems, Inc. preannounced Q3 sales results, reporting $10 million in the US and $1.2 million in Europe, indicating a significant performance in the US market [1] Group 1: Sales Performance - Q3 sales in the US reached $10 million, showcasing strong market demand [1] - European sales amounted to $1.2 million, contributing to the overall revenue [1]

Group 1 - The article discusses Delcath Systems (NASDAQ: DCTH) and its progress towards submitting a New Drug Application (NDA) for its melphalan drug/device kit, highlighting the company's efforts over the past three years [1] - The author emphasizes their long position in DCTH shares, indicating a personal investment interest in the company's future performance [2] - The article is part of a broader investment research service called Compounding Healthcare, which focuses on innovative healthcare companies and potential investment opportunities [1]

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was reported at $11.2 million, with $10 million from HEPZATO in the US and $1.2 million from CHEMOSAT in Europe, marking a significant increase compared to previous periods [8][33] - Revenue from HEPZATO grew significantly, while CHEMOSAT revenue increased over 100% year-on-year, indicating strong growth momentum [15][33] - Gross margins were reported at 85% for the third quarter [33] Business Line Data and Key Metrics Changes - HEPZATO revenue was $10 million, while CHEMOSAT revenue was $1.2 million for the three months ended September 30, 2024, compared to $0.4 million for CHEMOSAT during the same period in 2023 [33] - The average treatment rate post-activation was just under two treatments per month in Q3, with expectations for this rate to remain flat as new centers are added [13][15] Market Data and Key Metrics Changes - The company activated 11 centers by the end of Q3, with an additional center activated in October, bringing the total to 12, and aims to reach 15 treating centers by year-end [10][12] - The goal for 2025 is to have 30 centers operational by the end of the year [12] Company Strategy and Development Direction - The company is focusing on expanding its center activations and treatment rates, with a strategic goal of increasing the number of treating centers significantly [12][31] - Plans to initiate two phase II randomized clinical trials for liver dominant metastatic colorectal cancer and metastatic breast cancer were announced, indicating a strategic expansion into new indications [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, citing a strong balance sheet and expected revenue growth, with a cash burn of only $3.6 million in Q3 [31][32] - The company is on the cusp of being cash flow break-even, with adequate resources to fund further expansion of both commercial and clinical development activities [31][32] Other Important Information - The company has no outstanding debt obligations as of the end of Q3, following the maturity of loans [36][37] - The company is actively engaging with medical oncologists to integrate HEPZATO into treatment algorithms for metastatic uveal melanoma and other cancers [25][28] Q&A Session Summary Question: Will the holiday season affect treatment days? - Management indicated that there may be fewer treatment days due to the holiday season, but this is expected to be a temporary shift rather than lost business [40][42] Question: What is the expected increase in R&D spend for upcoming trials? - R&D expenses are expected to remain flat in Q4, with a projected range of $35 million to $40 million for the full year, including new indications [43][89] Question: How is the company approaching medical oncologists for referrals? - The company is actively engaging medical oncologists and has seen a fair number of referrals, although it acknowledges the need for further development in this area [66][70] Question: What data is expected from the CHOPIN trial? - The CHOPIN trial is fully enrolled, and data readouts are expected mid-next year, with results to be presented in the second half of the year [63][64]

Core Insights - Delcath Systems, Inc. (DCTH) reported a quarterly loss of $0.03 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.13, and an improvement from a loss of $0.61 per share a year ago, indicating a 76.92% earnings surprise [1] - The company achieved revenues of $11.2 million for the quarter ended September 2024, aligning with the Zacks Consensus Estimate and showing a substantial increase from $0.43 million in the same quarter last year [2] - Delcath Systems shares have increased approximately 163% year-to-date, outperforming the S&P 500's gain of 25.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.16 on projected revenues of $11.35 million, while for the current fiscal year, the estimate is -$1.64 on revenues of $33.45 million [7] - The estimate revisions trend for Delcath Systems is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Instruments industry, to which Delcath Systems belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, Stereotaxis Inc. (STXS), is expected to report a quarterly loss of $0.05 per share, reflecting a year-over-year change of +28.6%, with revenues anticipated to be $6.8 million, down 12.8% from the previous year [9][10]

Financial Performance - Total revenues for the three months ended September 30, 2024, were $11.2 million, compared to $434,000 for the same period in 2023, representing a significant increase due to the commercial launch of the HEPZATO KIT in the U.S.[125] - Gross profit for the three months ended September 30, 2024, was $9.56 million, compared to $301,000 for the same period in 2023, indicating improved profitability following the product launch[125] - The net income for the three months ended September 30, 2024, was $1.86 million, a significant improvement from a net loss of $20.34 million in the same period in 2023[125] - The company reported a total operating loss of $1.26 million for the three months ended September 30, 2024, compared to a loss of $10.56 million in the same period in 2023, indicating improved operational efficiency[125] - During the quarter ending September 30, 2024, the company recorded at least $10.0 million in quarterly U.S. revenue due to the commercialization of the HEPZATO KIT[147] Expenses - Research and development expenses for the three months ended September 30, 2024, were $3.87 million, a decrease from $4.66 million in the same period in 2023, primarily due to lower costs associated with NDA submission[128] - Selling, general and administrative expenses increased to $6.95 million for the three months ended September 30, 2024, compared to $6.20 million in the same period in 2023, driven by commercial launch activities[129] Cash and Capital Management - As of September 30, 2024, the company had cash and cash equivalents totaling $8.3 million, down from $12.7 million at December 31, 2023, reflecting cash used for operating activities[131] - The company anticipates needing to raise additional capital due to potential delays in site activation for HEPZATO and lower-than-expected revenue from HEPZATO and CHEMOSAT, which raises substantial doubt about its ability to continue as a going concern[134] - Capital commitments over the next twelve months include $6.8 million for accounts payable and $2.0 million for convertible note principal payments[135] - The company filed a universal shelf registration statement allowing it to offer up to $150 million in various securities, including common and preferred stock, debt securities, and warrants[136] - The company expects to raise additional capital if revenue from HEPZATO and CHEMOSAT is less than anticipated, which may involve unfavorable terms[134] Product Development and Market Expansion - The overall response rate (ORR) from the Phase 3 FOCUS Trial was reported at 36.35%, significantly higher than the historical control group's ORR of 5.5%, supporting the clinical adoption of CHEMOSAT[123] - The company plans to initiate studies for the HEPZATO KIT to treat other liver cancers in late 2024 or early 2025, targeting significant unmet medical needs[123] - The commercial expansion of CHEMOSAT in Europe has contributed to increased demand, further enhancing revenue growth[126] - As of October 31, 2024, 12 facilities have treated at least one patient with the HEPZATO KIT, indicating early adoption in clinical settings[123] - The company expects to continue its commercialization efforts for HEPZATO and CHEMOSAT, with a focus on obtaining additional regulatory approvals and building a commercial infrastructure[134] Securities and Financing - As of September 30, 2024, 58,924 shares of Series F Preferred Stock were converted into 15,005,211 shares of common stock[148] - The exercise of all Preferred and Common Warrants from the March 2023 Private Placement could generate approximately $60.0 million in proceeds[145] - The March 2024 Private Placement closed with gross proceeds of approximately $7.0 million before deducting offering expenses[149] - As of September 30, 2024, 1,758,843 Series E and Series E-1 Warrants remain outstanding, with no warrants exercised during the three and nine months ended September 30, 2024[141] - As of September 30, 2024, 1,851,900 Series F Warrants remain outstanding, with no warrants exercised during the three and nine months ended September 30, 2024[142] - The Avenue Loan had an interest rate of 16.20% as of September 30, 2024, and the company made its final payment on the loan on August 1, 2024[139][140]