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 " ...

Delcath Systems, Inc. (DCTH) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released ...

Core Viewpoint - Delcath Systems' CHEMOSAT Hepatic Delivery System significantly improves melanoma-specific survival in patients with liver metastases from uveal melanoma when used as a first-line therapy, as demonstrated in a recent clinical study [1][4]. Company Overview - Delcath Systems specializes in interventional oncology, focusing on primary and metastatic liver cancers, with key products including HEPZATO KIT and CHEMOSAT Hepatic Delivery System [3]. - The CHEMOSAT device is regulated as a Class III medical device in Europe [3]. Clinical Study Findings - A retrospective study analyzed 167 patients diagnosed between 2005 and 2021, revealing that those receiving liver-directed therapies, including CHEMOSAT, had a median melanoma-specific survival (MSS) of 28 months, compared to 10 months for those on systemic therapies [2][5]. - The MSS improved to 30 months for patients treated between 2016 and 2021, indicating a growing effectiveness of liver-directed therapies [5]. Adoption and Market Trends - The use of CHEMOSAT increased from eight patients between 2005 and 2015 to 30 patients between 2016 and 2021, reflecting its rising preference for treating metastatic uveal melanoma [6]. - The global liver metastases treatment market is estimated to reach $2.66 billion by 2030, growing at a CAGR of 7.3% from an estimated $1.74 billion in 2024, driven by the rising prevalence of liver metastases and advancements in therapeutic options [7][8]. Stock Performance - Delcath Systems' shares have risen 164.4% year to date, outperforming the industry growth of 10% and the S&P 500's rise of 18.4% during the same period [10].

ALIOUI Mohammed Elamine/iStock via Getty Images Snowball Effect Just Getting Started When I wrote my bullish Delcath (NASDAQ:DCTH) article in November 2023 there was a lot of investor angst heading into the HEPZATO KIT launch in Q1 2024. It had received FDA approval in August 2023, but until sales start coming in, medical device stocks can move rapidly in either direction. Medical device stock volatility is the highest prior to approvals. Following approvals, it declines but is still elevated. The next step ...