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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of each classTrading symbol(s)Name of each exchange on which registered Common Stock, $.01 par value DCTH The Nasdaq Capital Market FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 17, 2024 DELCATH SYSTEMS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-16133 06-1245881 (State or other jurisdiction of inc ...

Delcath Systems, Inc. (DCTH) closed the last trading session at $10.77, gaining 26.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $21.20 indicates a 96.8% upside potential.The mean estimate comprises five short-term price targets with a standard deviation of $2.59. While the lowest estimate of $18 indicates a 67.1% increase from the current price level, the most optimistic anal ...

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it.The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive.Our " ...