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 ...

Delcath Systems Inc (NASDAQ:DCTH) Q2 2024 Earnings Conference Call August 5, 2024 4:30 PM ET Company Participants David Hoffman - General Counsel, Corporate Secretary & Chief Compliance Officer Gerard Michel - CEO Sandra Pennell - SVP, Finance Kevin Muir - General Manager, Interventional Oncology Conference Call Participants John Newman - Canaccord Genuity Corp Marie Thibault - BTIG Swayampakula Ramakanth - H.C. Wainwright Sudan Loganathan - Stephens Chase Knickerbocker - Craig-Hallum Capital Group Operator ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _____________________ FORM 10-Q ______________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-16133 ______________________ DELCATH SYSTEMS, INC. ( ...

Exhibit 99.1 Delcath Systems Reports Second Quarter 2024 Results and Business Highlights Company Reports $7.8 million in Quarterly Revenue Conference Call Today at 4:30pm Eastern Time QUEENSBURY, NY – August 5, 2024, Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported financial results and business highlights for the second quarter ended June 30, 2024. Recent Business Hig ...

Core Viewpoint - Delcath Systems, Inc. (DCTH) is identified as a promising momentum stock, currently holding a Zacks Rank of 2 (Buy) and a Momentum Style Score of B, indicating potential for near-term price increases [2][6]. Company Performance - DCTH shares have increased by 65.71% over the past quarter and 63.03% over the last year, significantly outperforming the S&P 500, which has moved 10% and 27.2% respectively during the same periods [4]. - The stock has shown a weekly increase of 1.38%, while the Zacks Medical - Instruments industry has risen by 3.36% in the same timeframe [10]. Earnings Outlook - Over the past two months, one earnings estimate for DCTH has moved higher, while none have moved lower, resulting in an increase in the consensus estimate from -$1.45 to -$1.31 for the full year [14]. - For the next fiscal year, one estimate has also moved upwards with no downward revisions during the same period [14]. Trading Volume - DCTH's average 20-day trading volume is 241,497 shares, which serves as a useful indicator for assessing price movements and market interest [13].

Delcath Systems, Inc. (DCTH) closed the last trading session at $7.05, gaining 26.8% 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 indicates a 197.9% upside potential. The average comprises four short-term price targets ranging from a low of $16 to a high of $25, with a standard deviation of $3.74. While the lowest estimate indicates an increase of 127% from the current price ...

Shares of Delcath Systems, Inc. (DCTH) have gained 48.2% over the past four weeks to close the last trading session at $6.96, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $21 indicates a potential upside of 201.7%. The mean estimate comprises four short-term price targets with a standard deviation of $3.74. While the lowest estimate of $16 indicates a 129.9% increase from the ...

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. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, etc. - ...

Financial Data and Key Metrics Changes - The company reported US revenue of $2 million from HEPZATO and $1.1 million from CHEMOSAT for Q1 2024, compared to $0.6 million for CHEMOSAT in the same period of 2023 [5][38] - Gross margins were 71% in the first quarter, with a non-recurring positive adjustment for standard cost reevaluation; without this adjustment, gross margins would have been approximately 60% [18][31] - Selling, general, and administrative expenses increased to $8.8 million from $4.2 million due to commercial launch preparations [39] Business Line Data and Key Metrics Changes - The company ended Q1 with four active treatment centers, which increased to six by the date of the call, with plans to reach 20 active centers by the end of 2024 [7][10] - The average treatments per center are projected to ramp from approximately one per month to two treatments per month by late Q4 2024 [30] Market Data and Key Metrics Changes - The company has engaged over 30 centers in various stages of becoming treating centers, indicating increased interest from healthcare providers [9] - The establishment of a permanent J-code effective April 1 has simplified the reimbursement process, leading to increased willingness from formulary committees to approve HEPZATO [29][55] Company Strategy and Development Direction - The company aims to build a strong commercial foundation in metastatic uveal melanoma to fund future clinical trials and expand its network of treating centers [33][34] - Plans to initiate clinical trials for HEPZATO in other tumor types within approximately a year [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $10 million in US quarterly revenue by the end of 2024, which would trigger a warrant exercise resulting in $25 million in proceeds [11][48] - The company believes its current financial resources are adequate to fund operations until it becomes cash flow positive [17] Other Important Information - Research and development expenses for Q1 2024 were $3.7 million, down from $4.7 million in Q1 2023, primarily due to decreased clinical trial activities [49] - The company ended Q1 with $27.2 million in cash investments, with cash used in operations approximately $9.6 million [47] Q&A Session Summary Question: What is the realized revenue per KIT sold? - The revenue for Q1 reflects 11 KITs sold, with pricing at $182.5 per KIT [40] Question: Is the growth in EU revenue sustainable? - The company expects continued growth in Germany, which has a consistent reimbursement form, but overall growth may vary [50] Question: What is the expected gross margin at peak revenue? - At peak revenue, gross margins are expected to approach close to 90% [51] Question: How is the patient profile of treated patients? - The company is seeing a mix of first-line and subsequent-line patients, with no trends of patients dropping off early [85][86] Question: What is the status of reimbursement and J-code effectiveness? - The J-code has simplified the reimbursement process, making it more predictable for hospitals [55] Question: How will future R&D be funded? - The company plans to fund R&D through its P&L, aiming to avoid excessive dilution from fundraising [73][74] Question: What is the current status of referrals from general oncologists? - The focus is on opening treatment sites and ensuring oncologists at those sites refer their patients for treatment [81]