Core Viewpoint - The article emphasizes the importance of identifying and maintaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for sustaining momentum in stocks [1]. Group 1: Recent Price Strength Screen - The "Recent Price Strength" screen is a unique short-term trading strategy that helps investors shortlist stocks with strong fundamentals capable of maintaining an uptrend [2]. - Stocks that pass this screen are typically trading in the upper portion of their 52-week high-low range, indicating bullish sentiment [2]. Group 2: Delcath Systems, Inc. (DCTH) - Delcath Systems, Inc. (DCTH) has shown a solid price increase of 19.2% over the past 12 weeks, indicating investor confidence in its potential upside [3]. - DCTH has experienced a price increase of 34.5% over the last four weeks, suggesting that the upward trend is still intact [4]. - Currently, DCTH is trading at 84.7% of its 52-week high-low range, indicating a potential breakout opportunity [4]. Group 3: 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 [5]. - The Zacks Rank system has a strong track record, with Zacks Rank 1 stocks averaging an annual return of +25% since 1988 [6]. - DCTH also has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [6]. Group 4: Additional Investment Opportunities - Besides DCTH, there are several other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting further investment opportunities [7]. - The article encourages exploring over 45 Zacks Premium Screens tailored to different investing styles to identify potential winning stocks [7].

Company Performance - Delcath Systems, Inc. (DCTH) reported quarterly earnings of $0.03 per share, missing the Zacks Consensus Estimate of $0.10 per share, compared to a loss of $0.43 per share a year ago, representing an earnings surprise of -70% [1] - The company posted revenues of $19.78 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 9.24%, and this is a significant increase from year-ago revenues of $3.14 million [2] - Over the last four quarters, Delcath Systems has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Outlook - The sustainability of Delcath Systems' stock price movement will depend on management's commentary during the earnings call and future earnings expectations [3] - The stock has lost about 3.6% since the beginning of the year, while the S&P 500 has declined by 4.3% [3] - The current consensus EPS estimate for the coming quarter is $0.08 on revenues of $19.75 million, and for the current fiscal year, it is $0.28 on revenues of $82.26 million [7] Industry Context - The Medical - Instruments industry, to which Delcath Systems belongs, is currently in the top 28% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5] - Mesa Labs (MLAB), another company in the same industry, is expected to report quarterly earnings of $2.75 per share, with revenues projected to be $63.1 million, reflecting a year-over-year increase of 7.1% [9]

Financial Data and Key Metrics Changes - The company reported a combined revenue of $19,800,000 for Hebsado and ChemoSATs in Q1 2025, with Hebsado sales in the U.S. contributing $18,000,000 and ChemoSATs in Europe adding $1,800,000, compared to $2,000,000 and $1,100,000 respectively in Q1 2024 [7][16] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [16] - Net income for Q1 2025 was $1,100,000, a significant turnaround from a net loss of $11,100,000 in Q1 2024 [17] - Positive adjusted EBITDA was reported at $7,600,000 compared to an adjusted EBITDA loss of $7,300,000 in Q1 2024 [17] - The company ended the quarter with approximately $59,000,000 in cash and investments and no debt [8][17] Business Line Data and Key Metrics Changes - The U.S. market for Hebsado and ChemoSATs showed strong growth, with a focus on expanding treatment centers, increasing from 17 to 19 active centers [8][9] - The average treatments per center per month were approximately two in Q1, with expectations to remain just under two for the remainder of the year [10][28] Market Data and Key Metrics Changes - The European market for ChemoSATs grew by 29% over the prior quarter to $1,800,000, although it is not expected to be a significant revenue contributor in the short to medium term due to reimbursement pricing challenges [11] - The company is focusing on generating clinical data from European sites, which have over a decade of experience with ChemoSATs [11][44] Company Strategy and Development Direction - The company aims to expand its active treatment centers to 30 by year-end, with a current pace of opening three to five centers per quarter [9][10] - The strategic focus includes leveraging cash from operations to support research and development initiatives for broader patient populations suffering from liver cancer [8][15] - The company is pursuing additional indications for Hepciddo, including metastatic colorectal and breast cancer, with ongoing clinical trials [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a more even distribution of center activations throughout the year, rather than a concentration in the second half [25] - The company anticipates that the ongoing engagement with oncologists and interventional radiologists will drive demand for treatments [15] - Management acknowledged the competitive landscape but emphasized the collaborative nature of information sharing among treatment centers [38] Other Important Information - The company has implemented a patient access program to assist with copay costs and connect patients with treatment centers [10][53] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [44] Q&A Session Summary Question: Update on center activations - Management indicated that the pace of center activations may be more even throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [25][26] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with total operating expenses projected to rise by 60% over 2024, while maintaining positive EBITDA for the year [30][31] Question: Frequency of patient treatments - The average frequency of treatments for patients is expected to remain around 4.1, which is a key driver for overall revenue [36] Question: European market growth and reimbursement - Management noted that while European revenues are increasing, reimbursement challenges remain, and they are focusing on generating clinical data before investing more resources [40][44] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not found suitable opportunities yet [70][72]

Financial Data and Key Metrics Changes - The company reported a combined revenue of $19.8 million for Q1 2025, with Hebsado sales in the U.S. contributing $18 million and ChemoSAT sales in Europe adding $1.8 million, compared to $2 million and $1.1 million respectively in Q1 2024 [5][15] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [15] - Net income for Q1 2025 was $1.1 million, a significant turnaround from a net loss of $11.1 million in Q1 2024 [16] - Positive adjusted EBITDA for Q1 2025 was $7.6 million, compared to an adjusted EBITDA loss of $7.3 million in Q1 2024 [16] - The company ended the quarter with approximately $59 million in cash and investments, and positive operating cash flow of $2.2 million [16] Business Line Data and Key Metrics Changes - The company activated 19 treatment centers in the U.S. by the end of Q1 2025, with plans to reach 30 active centers by year-end [6][7] - Average treatments per center were approximately two per month in Q1, with expectations to remain just under two for the remainder of the year [8][27] Market Data and Key Metrics Changes - The European market for ChemoSAT experienced a 29% growth over the prior quarter, reaching $1.8 million, although it is not expected to be a significant revenue contributor in the short to medium term [9] - The company is focusing on expanding its presence in the U.S. market while managing reimbursement challenges in Europe [9][40] Company Strategy and Development Direction - The company aims to leverage cash from operations to support research and development initiatives for Hebsado beyond metastatic uveal melanoma patients [6] - The strategy includes expanding treatment centers and enhancing access for patients through the Hepcido KidAccess 360 platform [8] - The company is pursuing additional clinical trials for liver-dominant metastatic colorectal and breast cancer, with FDA clearance received for both trials [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the goal of 30 active centers by year-end, with a balanced approach to center activations throughout the year [22][24] - The company anticipates that the average monthly treatment per site will stabilize just under two for the remainder of the year due to the pace of new center activations [27] - Management highlighted the importance of clinical demand and engagement with oncologists and interventional radiologists in driving revenue growth [13] Other Important Information - The company has no outstanding debt obligations and has successfully raised $16.2 million through the exercise of Series F warrants [16][17] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [43] Q&A Session Summary Question: Update on center activations and expectations for Q2 - Management indicated that center activations may be more evenly distributed throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [20][24] Question: Treatment frequency and center performance - Average treatment frequency is expected to stabilize around 4.1 treatments per patient, with a mix of organic and referred patients contributing to center performance [35][86] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with EBITDA margins projected to remain positive throughout the year despite rising operational costs [29][30] Question: European market growth and reimbursement - Management noted that while the European market is growing, reimbursement challenges remain, and additional resources will be allocated once reimbursement is secured [39][42] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not identified any suitable opportunities at this time [70][72]

Financial Performance - Total revenues for the three months ended March 31, 2025, increased to $19.784 million, compared to $3.139 million in the same period of 2024, reflecting a significant growth due to the commercial expansion of HEPZATO and CHEMOSAT[115] - Gross profit for the three months ended March 31, 2025, was $16.939 million, compared to $2.236 million in the same period of 2024, showcasing improved profitability[115] - The company reported a net income of $1.069 million for the three months ended March 31, 2025, compared to a net loss of $11.111 million in the same period of 2024[115] - During the three months ended March 31, 2025, $2.2 million of cash was provided by operating activities, compared to $9.6 million used in the same period in 2024[121] Research and Development - Research and development expenses rose to $5.007 million for the three months ended March 31, 2025, up from $3.700 million in 2024, primarily due to costs associated with expanding the clinical team and initiating a Phase 2 clinical trial[118] - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic colorectal cancer is expected to enroll approximately 90 patients, with patient enrollment anticipated to begin in the second half of 2025[110] - The Phase 2 clinical trial for HEPZATO in liver-dominant metastatic colorectal cancer is expected to enroll approximately 90 patients, with results anticipated by the end of 2027[110] - The company expects research and development expenses to increase in the foreseeable future due to ongoing clinical trials and related activities[113] Market and Product Expansion - The number of facilities treating patients with HEPZATO increased from 4 in Q1 2024 to 17 by March 31, 2025, indicating a strong demand for the product[116] - The total addressable market for liver-dominant metastatic colorectal cancer receiving third-line treatment is estimated to be between 6,000 and 10,000 patients annually in the United States[110] - HEPZATO received FDA approval on August 14, 2023, for the treatment of adult patients with uveal melanoma with unresectable hepatic metastases[103] - The overall response rate (ORR) in the Phase 3 FOCUS Trial for HEPZATO was reported at 36.35%, significantly higher than the historical control group's ORR of 5.5%[107] Expenses and Financial Position - Selling, general and administrative expenses increased to $11.290 million in Q1 2025 from $8.814 million in Q1 2024, driven by marketing-related expenses and additional personnel[119] - Research and development expenses increased due to costs associated with expanding the clinical team and initiating the Phase 2 clinical trial for HEPZATO[118] - As of March 31, 2025, the company had cash and cash equivalents totaling $12.8 million and short-term investments of $46.1 million, compared to $32.4 million and $20.8 million respectively at December 31, 2024[121] - The company believes current cash and investments will support operations for at least 12 months from the issuance of the financial statements[122] - Capital commitments over the next twelve months include $5.3 million for accounts payable, accrued expenses, and current lease liabilities[123] Securities and Registrations - The company has filed a universal shelf registration statement allowing for the potential offering of up to $150 million in various securities[124] - A universal shelf registration statement was filed on June 28, 2024, allowing the company to offer up to $150 million in various securities[124] - 238,500 Series F Warrants were exercised during the three months ended March 31, 2025, with an additional 1,377,275 exercised after the quarter[125] Accounting and Estimates - There were no material changes to critical accounting estimates or policies as reported in the Annual Report[126][127]

Core Viewpoint - Delcath Systems, Inc. (DCTH) shows potential for significant upside, with a mean price target of $22.60 indicating a 58.5% increase from the current price of $14.26 [1] Price Targets and Analyst Consensus - The average price target for DCTH ranges from a low of $21 to a high of $25, with a standard deviation of $1.82, suggesting a relatively tight clustering of estimates [2] - The lowest estimate indicates a potential increase of 47.3%, while the highest suggests a 75.3% upside [2] - Analysts' price targets should be approached with caution, as they may not reliably predict actual stock price movements [3][7] Earnings Estimates and Analyst Agreement - Strong agreement among analysts regarding DCTH's ability to report better earnings than previously predicted supports the view of potential upside [4] - A positive trend in earnings estimate revisions has been shown to correlate with stock price movements, indicating a potential for growth [11] - Over the last 30 days, one earnings estimate for DCTH has increased, leading to a Zacks Consensus Estimate rise of 134.2% [12] Zacks Rank and Investment Potential - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors [13] - The strong externally-audited track record of DCTH further supports its potential for near-term upside [13]

Company Overview - Atyr Pharma (ATYR) is part of the Medical sector, which includes 1012 individual stocks and currently holds a Zacks Sector Rank of 4, indicating its relative strength within the sector [2] - Atyr Pharma belongs to the Medical - Biomedical and Genetics industry, which consists of 510 individual stocks and is currently ranked 73 in the Zacks Industry Rank [6] Performance Metrics - Atyr Pharma has returned 6.9% year-to-date, outperforming the Medical sector's average return of 4.8% [4] - The Zacks Consensus Estimate for Atyr Pharma's full-year earnings has increased by 19.4% over the past quarter, reflecting stronger analyst sentiment and an improving earnings outlook [4] - The Medical - Biomedical and Genetics industry has gained an average of 6.3% year-to-date, indicating that Atyr Pharma is performing better than its industry peers [6] Comparative Analysis - Delcath Systems, Inc. (DCTH), another Medical stock, has outperformed the sector with a year-to-date return of 11.6% and a significant increase of 132.9% in its consensus EPS estimate over the past three months [5] - Delcath Systems operates in the Medical - Instruments industry, which has seen a decline of 3.5% year-to-date and is currently ranked 129 [7]

Corporate Presentation 2 NASDAQ: DCTH March 2025 Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potenti ...

Financial Data and Key Metrics Changes - In 2024, the company generated $32.3 million in HEPZATO revenue in the U.S., including $13.7 million in Q4 from 14 active treatment centers [9][24] - The company achieved a positive adjusted EBITDA of $4.6 million in Q4, marking the first time the company reached this milestone [11][26] - The company ended the year with $53.2 million in cash and investments, with no debt [11][23] Business Line Data and Key Metrics Changes - HEPZATO sales for Q4 were $13.7 million, while CHEMOSAT sales were $1.4 million, up from $0.5 million in Q4 2023 [24] - Full year 2024 revenue for HEPZATO was $32.3 million, and CHEMOSAT was $4.9 million, compared to $2.1 million for CHEMOSAT in 2023 [24] - Gross margins were reported at 86% for Q4 and 83% for the full year [25] Market Data and Key Metrics Changes - CHEMOSAT volumes in Europe grew 137% in 2024, with Germany up 75% and other markets like the UK and Turkey doubling year-over-year [16] - The company activated three new U.S. treatment centers in Q4 and has plans to reach 30 active centers by year-end 2025 [12][14] Company Strategy and Development Direction - The company aims to expand its R&D capabilities to maximize the hepatic delivery system's potential for treating other liver-dominant cancers [11][21] - The strategic value of the European presence lies in supporting clinical trials and generating publications, with plans to expand into France, Italy, and Spain in 2025 [17] - The company is increasing its commercial team and expanding from four to six regions to enhance operational efficiency [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, stating that the first year of HEPZATO's U.S. launch has been a success and has brought the company close to cash flow break-even [22][23] - The company plans to continue investing in high-impact R&D initiatives while maintaining a focus on revenue growth [23] Other Important Information - The company received over $41 million in proceeds from the exercise of warrants during the year [11] - The SCANDIUM 3 trial in Sweden began screening patients, and the CHOPIN trial in the Netherlands completed enrollment with 76 patients [18][19] Q&A Session Summary Question: Changes in treatment cycles with new sites for HEPZATO - Management noted that the average treatment rate per site is expected to remain steady at around 4.1 treatments, similar to the FOCUS trial [31][32] Question: SG&A ramp with expansion plans - SG&A expenses are expected to increase by 30% to 40% in 2025, with most expenses starting in the second quarter [39] Question: R&D expenses and cash flow - Management indicated that while they expect to be cash flow positive, they will prioritize R&D opportunities over maintaining positive cash flow [47][48] Question: Price increase for HEPZATO - A price increase of approximately 2.74% was implemented, with future increases dependent on inflation rates [49][50] Question: Referral network effectiveness - The referral network is functioning well, with community centers referring patients to larger academic centers [56] Question: Expansion of treatment indications - Management confirmed that no device modifications are necessary for new indications, and they are focusing on engaging existing treatment sites [41] Question: Expectations for European market growth - Management anticipates modest growth in Europe, contingent on reimbursement developments [76][78] Question: Timeline for activating new treatment centers - More centers are expected to come online in the second half of the year, with a goal of reaching 30 active centers by year-end [88] Question: Competitive landscape for HEPZATO - Management believes that HEPZATO will complement systemic therapies, emphasizing the need for liver-directed treatments [94][96]

Financial Data and Key Metrics Changes - In 2024, Delcath Systems generated $32.3 million in HEPZATO revenue in the U.S., including $13.7 million in Q4 from 14 active treatment centers [9][24] - The company achieved a positive adjusted EBITDA of $4.6 million in Q4, marking a first for the company, and ended the year with $53.2 million in cash and investments, with no debt [11][27] - The net loss for Q4 was $3.4 million, compared to a loss of $11.1 million in the same period in 2023 [26] Business Line Data and Key Metrics Changes - Revenue from HEPZATO sales was $13.7 million in Q4 and $32.3 million for the full year, while CHEMOSAT revenue was $1.4 million in Q4 and $4.9 million for the full year, compared to $0.5 million and $2.1 million respectively in 2023 [24][26] - Gross margins were reported at 86% for Q4 and 83% for the full year [25] Market Data and Key Metrics Changes - In Europe, CHEMOSAT volumes grew by 137% in 2024, with Germany up 75% and other markets like the UK and Turkey doubling year-over-year [10][16] - The company plans to expand into France, Italy, and Spain in 2025, complementing its presence in the UK, Germany, and The Netherlands [17] Company Strategy and Development Direction - The company aims to activate 30 treatment centers by year-end 2025, having activated three new centers in Q4 and two more in 2025, bringing the total to 16 [12][14] - Delcath is increasing its commercial team from four to six regions to support the expansion of HEPZATO and CHEMOSAT [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, stating that 2024 was a transformative year and that the company is well-positioned for growth while investing in R&D initiatives [23] - The management highlighted the importance of reimbursement in driving future growth, particularly in Europe [78] Other Important Information - The company received over $41 million in proceeds from the exercise of warrants during the year [11] - The SCANDIUM 3 trial in Sweden began screening patients, and the CHOPIN trial in the Netherlands completed enrollment with 76 patients [18][19] Q&A Session Summary Question: Changes in treatment cycles with new sites for HEPZATO - Management noted that the average treatment rate is expected to remain steady at around 4.1 treatments per patient, similar to the FOCUS trial results [31][32] Question: SG&A ramp with expansion plans - SG&A expenses are expected to increase by 30% to 40% in 2025, with most expenses starting in the second quarter [39] Question: R&D expenses and cash flow - Management indicated that while they expect to be cash flow positive, they will invest in R&D opportunities as they arise [48] Question: Price increase for HEPZATO - A price increase of approximately 2.74% was implemented, with future increases dependent on inflation [49][50] Question: Referral network effectiveness - The referral network is functioning well, with community referrals to larger academic centers increasing [56] Question: Expansion of treatment indications - Management confirmed that no device modifications are necessary for new indications, and they are focusing on engaging new doctors for upcoming trials [41][42] Question: Gross margin expectations - The company expects gross margins to continue at 86% and potentially reach 90% by the end of 2025 [119] Question: Geographic expansion plans - Management indicated that while modest growth is expected in Europe, strategic value lies in supporting clinical trials and generating publications [78][132]