QUEENSBURY, N.Y.--(BUSINESS WIRE)--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 announced preliminary financial results and business updates for the fourth quarter and year-ended December 31, 2025. Preliminary Fourth Quarter and Full-Year 2025 Financial Results (unaudited) Final financial results for the fourth quarter and full year 2025 and a detailed business update will ...

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Core Insights - After-hours trading on Thursday was relatively quiet, with small-cap biotech stocks showing modest movements [1] Company Summaries - **Delcath Systems, Inc. (DCTH)**: The stock rose to $8.52, up 4.02% or $0.33 after announcing a $25 million share repurchase program, reflecting confidence in its long-term outlook [2] - **BioVie Inc. (BIVI)**: The stock climbed to $1.44, a gain of 13.39% or $0.17, despite no specific news, indicating speculative or technical-driven activity [3] - **Cassava Sciences, Inc. (SAVA)**: The stock advanced to $2.87, up 9.17% or $0.24, following a narrower net loss of $10.8 million reported in Q3, compared to $27.9 million a year earlier, with $106.1 million in cash and no debt [4] - **Enlivex Therapeutics Ltd. (ENLV)**: The stock edged higher to $0.95, up 4.24% or $0.04, with no company-specific news released [5]

​Delcath Systems, Inc. (NASDAQ:DCTH) is one of the Fast-Growing Small Cap Stocks to Buy According to Analysts. On November 5, Swayampakula Ramakanth from H.C. Wainwright reiterated a Buy rating on Delcath Systems, Inc. (NASDAQ:DCTH), but lowered the price target from $31 to $30. ​Earlier on November 4, Delcath Systems, Inc. (NASDAQ:DCTH) released results for its fiscal Q3 2025. The company posted a revenue of $20.6 million, up from $11.2 million last year. Moreover, the EPS came in at $0.02, ahead of the ...

Group 1: Company Performance - Delcath (DCTH) reported weak results in the third quarter, leading to significant pressure on the stock [1] - The unexpected sequential revenue decline was attributed to pricing headwinds and seasonality, although the market remains skeptical of this explanation [1] Group 2: Investment Strategy - Narweena, an asset manager led by Richard Durant, focuses on identifying market dislocations due to poor understanding of long-term business prospects [1] - The firm aims to achieve excess risk-adjusted returns by targeting businesses with secular growth opportunities in markets with barriers to entry [1] - Narweena's research emphasizes company and industry fundamentals to uncover unique insights, with a high risk appetite and long-term investment horizon [1] Group 3: Market Trends - An aging population with low growth and stagnating productivity is expected to create a different set of investment opportunities compared to the past [1] - Many industries may face stagnation or secular decline, which could paradoxically improve business performance as competition decreases [1] - The economy is increasingly dominated by asset-light businesses, leading to a declining need for infrastructure investments over time [1] - A large pool of capital is pursuing a limited set of investment opportunities, driving up asset prices and compressing risk premia [1]

Core Points - Stellar AfricaGold Inc. has successfully closed a non-brokered private placement, raising a total of $4 million through the issuance of 22,222,222 units at a price of C$0.18 per unit [1][2] - Each unit consists of one common share and one-half of a transferable common share purchase warrant, with warrants allowing the purchase of additional shares at $0.28 for 36 months [2] - Proceeds from the offering will be used for exploration efforts at the Tichka Est Gold Project in Morocco and the Zuénoula gold property in Ivory Coast, as well as for general corporate purposes [3] Financial Details - The total gross proceeds from the offering amount to $4 million [2] - Finder's fees for the offering included $111,938.40 in cash, 557,725 units, and 64,155 non-transferable Finder's Warrants [5] - Two directors subscribed for a total of 677,545 units, generating gross proceeds of $121,958.10, classified as a related party transaction [6] Regulatory Information - All securities issued are subject to a statutory hold period of four months and one day, expiring on March 1, 2026 [4] - The securities have not been registered under the United States Securities Act of 1933 and cannot be offered or sold in the U.S. without compliance with registration requirements [7] Company Overview - Stellar AfricaGold Inc. is focused on precious metals exploration in North and West Africa, with key projects in Morocco and Côte d'Ivoire [8] - The company is listed on the TSX Venture Exchange, Tradegate Exchange, and Frankfurt Stock Exchange [9] - The head office is located in Vancouver, BC, with a representative office in Casablanca, Morocco [10]

Core Insights - Delcath Systems, Inc. (DCTH) reported quarterly earnings of $0.02 per share, matching the Zacks Consensus Estimate, and showing improvement from a loss of $0.03 per share a year ago [1] - The company achieved revenues of $20.56 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 0.41% and significantly up from $11.2 million year-over-year [2] - Delcath Systems shares have underperformed, losing about 20.9% since the beginning of the year, while the S&P 500 has gained 16.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.02 on revenues of $19.51 million, and for the current fiscal year, it is $0.13 on revenues of $83.93 million [7] - The estimate revisions trend for Delcath Systems was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Instruments industry, to which Delcath Systems belongs, is currently ranked in the top 38% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Revenue from HEPZATO sales was $19.3 million in Q3 2025, compared to $10 million in Q3 2024, while CHEMOSAT revenue was $1.3 million, up from $1.2 million in the same period last year [18] - Gross margins improved to 87% in Q3 2025 from 85% in Q3 2024 [18] - Research and development expenses increased to $8.0 million from $3.9 million year-over-year, while selling, general, and administrative expenses rose to $10.3 million from $7.0 million [18] - Net income for Q3 2025 was $0.8 million, down from $1.9 million in Q3 2024 [18] - Positive adjusted EBITDA for Q3 2025 was $5.3 million, compared to $1.0 million in Q3 2024 [18] - The company ended the quarter with approximately $89 million in cash and investments, with a quarterly positive operating cash flow of $4.8 million [19] Business Line Data and Key Metrics Changes - The average revenue per kit sold decreased by approximately 13% due to 340B pricing related to NDRA participation [5] - The total HEPZATO treatment volume in 2025 is projected to increase by nearly 150% compared to 2024 [19] Market Data and Key Metrics Changes - There was a slowdown in the pace of site activation from June to August, but the company activated four new sites in the past two months, bringing the total to 25 REMS-certified treatment sites [6][9] - The company plans to expand to 26-28 active treating centers by the end of 2025 and 40 centers by the end of 2026 [6] Company Strategy and Development Direction - The company aims to build referral networks to treatment locations, particularly as many targeted clinical sites have few metastatic uveal melanoma patients [6] - Delcath is committed to advancing research and development for HEPZATO, with ongoing trials in liver-dominant metastatic colorectal cancer and liver-dominant metastatic breast cancer [15][16] - The company is exploring additional tumor types and indications for HEPZATO, including intrahepatic cholangiocarcinoma, cutaneous metastatic melanoma, and non-small cell lung cancer [16] Management's Comments on Operating Environment and Future Outlook - Management adjusted the 2025 annual guidance to $83-$85 million due to changes in the rate of new patient starts and competitive clinical trial activity [10] - The results from the Chopin trial are expected to lessen competitive impacts as data is disseminated and physicians observe durable patient responses [10] - Management acknowledged the challenges posed by seasonality and competition for clinical trials, particularly during holiday periods [9][10] Other Important Information - The company has no outstanding debt obligations and no outstanding warrants [19] - Forecasts for 2025 gross margins are expected to be between 85%-87% [19] Q&A Session Summary Question: What are the Q4 expectations regarding competitive clinical trial activity and seasonality? - Management expects a modest amount of seasonality in Q4 and has factored in the same level of clinical trial competition seen mid-year [22] Question: How will site additions roll out into 2026? - Management anticipates that site additions will accelerate in the latter half of the year as the company expands to nine regions [26] Question: What steps are being taken to improve utilization at lower volume accounts? - The company is building referral networks and expanding the medical affairs team to address lower utilization sites [28] Question: How does the NDRA program influence profitability and revenue growth? - Management indicated that the NDRA will result in a one-time step down in revenue, but they do not anticipate a dramatic change in average revenue per kit [37] Question: What is the status of the Scandium III trial? - The Scandium III trial is recruiting slowly, and no timeline is available for when data might be reported [43]

Regulatory Approvals and Clinical Trials - The HEPZATO KIT was approved by the FDA on August 14, 2023, for liver-directed treatment of adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver[110]. - The first commercial use of the HEPZATO KIT occurred in January 2024[110]. - The CHOPIN clinical trial showed a one-year progression-free survival rate of 54.7% in the combination group versus 15.8% in the PHP group[114]. - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic colorectal cancer (mCRC) is expected to enroll approximately 90 patients, with results anticipated by the end of 2027[119]. - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic breast cancer (mBC) is expected to enroll approximately 90 patients, with results anticipated by the end of 2028[120]. - The Phase 2 clinical trial for HEPZATO in combination with standard care for mCRC and mBC is expected to progress, with significant investments in clinical team expansion[127]. - The company expects to enroll approximately 90 patients in the Phase 2 clinical trial for liver-dominant metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC), with trials expected to take place at over 20 sites across the U.S. and Europe[119][120]. - The Phase 2 trial for HEPZATO in liver-dominant mBC is expected to read out its primary endpoint by the end of 2028[120]. Market and Patient Data - The total addressable market for liver-dominant mCRC receiving third-line treatment is estimated to be between 6,000 and 10,000 patients annually in the United States[119]. - Approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases[121]. - The number of facilities treating patients with HEPZATO increased to 22 in the nine months ended September 30, 2025, from 11 facilities in the same period of 2024[125]. Financial Performance - Total revenues for the three months ended September 30, 2025, increased to $20,563,000, up from $11,200,000 in the same period of 2024, representing an 83.5% growth[124]. - For the nine months ended September 30, 2025, total revenues reached $64,503,000, compared to $22,105,000 in 2024, marking a 192.5% increase[124]. - Gross profit for the three months ended September 30, 2025, was $17,939,000, compared to $9,560,000 in 2024, reflecting a 87.8% increase[124]. - Gross profit for the nine months ended September 30, 2025, was $55,716,000, up from $18,043,000 in 2024, indicating a significant increase in profitability[124]. - Net income for the three months ended September 30, 2025, was $830,000, compared to a net loss of $1,864,000 in the same period of 2024[124]. - Cash and cash equivalents totaled $41.8 million as of September 30, 2025, compared to $8.3 million at the same date in 2024[132]. - The company has capital commitments of $8.0 million over the next twelve months for accounts payable and accrued expenses[134]. Expenses and Investments - Research and development expenses are expected to increase due to costs associated with completing Phase 2 clinical trials[122]. - Research and development expenses rose to $7,986,000 for the three months ended September 30, 2025, up from $3,866,000 in 2024, a 106.0% increase[127]. - Selling, general and administrative expenses increased to $10,341,000 for the three months ended September 30, 2025, compared to $6,953,000 in 2024, a 48.5% rise[128]. - The company anticipates that research and development expenses will continue to rise as it completes ongoing clinical trials[122]. - Selling, general and administrative expenses increased to $10.341 million for the three months ended September 30, 2025, from $6.953 million in 2024, driven by commercial expansion activities[128]. Supply Chain and Product Management - The company has sufficient raw materials for the HEPZATO KIT to meet anticipated demand and plans to manage supply chain risks[112]. - CHEMOSAT received Medical Device Regulation certification in Europe on February 28, 2022, and the company has assumed direct responsibility for its sales and marketing in Europe[113].

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