- Preclinical data show that SLS009 lowers the apoptotic threshold in AML cells by suppressing critical survival pathways -NEW YORK, March 17, 2026 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that preclinical data on SLS009 (tambiciclib), a potent, selective CDK9 inhibitor, will be presented in a poster ses ...

Core Insights - SELLAS Life Sciences Group has initiated a Phase 2 trial for SLS009 (tambiciclib), a CDK9 inhibitor, targeting newly diagnosed acute myeloid leukemia (AML) patients [1][2] - The trial aims to enroll approximately 80 patients, focusing on two cohorts with high unmet medical needs [2] - Topline data from the trial is expected in Q4 2026 [1] Group 1: Trial Details - The trial, designated NCT04588922, includes a predictive biomarker cohort and an early resistance cohort [4] - The predictive biomarker cohort targets newly diagnosed patients unlikely to benefit from standard venetoclax/azacitidine therapy based on molecular profiling [4] - The early resistance cohort includes patients who show no response after two cycles of aza/ven treatment [4] Group 2: Previous Results and Efficacy - In a completed Phase 2 trial for relapsed/refractory (r/r) AML, SLS009 combined with aza/ven met all endpoints, achieving an overall response rate (ORR) of 33% across all evaluable patients [3][5] - The ORR was 40% for the recommended 30mg BIW dose level, with specific subgroups showing even higher response rates: 44% in AML patients with myelodysplasia-related changes and 50% in ASXL1-mutated AML patients [5] - Median overall survival (mOS) for patients treated with the 30mg BIW dose was reported at 8.8 months, significantly higher than the 2.4 months with the best available therapy [5] Group 3: Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [3] - The company's lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [3] - SLS009 is positioned as a potentially first and best-in-class CDK9 inhibitor, aiming to offer reduced toxicity and increased potency compared to existing options [3]

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Financial Data and Key Metrics Changes - The reported revenue for Q4 2025 was $29.5 million, a 19% increase from $24.7 million in Q4 2024 [10] - Gross profit for Q4 2025 was $18.7 million, up 20% from $15.5 million in Q4 2024, with gross margins increasing to 63.2% from 62.7% [11] - The operating loss for Q4 2025 increased by 14% to $5.3 million compared to $4.6 million in Q4 2024 [11] - Net loss rose 31% to $8.9 million from $6.8 million in the prior year, driven by increased financial expenses [12] - Adjusted EBITDA for Q4 was -$2.1 million, compared to -$1.4 million in Q4 2024 [12] - Cash and cash equivalents as of December 31, 2025, were $29 million [12] Business Line Data and Key Metrics Changes - Total billable volume in Q4 was approximately 38,000 tests, with tissue-based tests decreasing by 5% and liquid-based tests increasing by 128% year-over-year [10] - The acquisition of ExoDx contributed to the growth in liquid-based tests, which include Select mdx, Resolve mdx, and ExoDx [10][34] Market Data and Key Metrics Changes - The company aims to balance revenue contributions from tissue and liquid tests, which previously saw tissue tests accounting for 85% of revenue [34] - The integration of ExoDx is expected to enhance the customer base and drive growth in both segments [34] Company Strategy and Development Direction - MDxHealth's strategy focuses on menu expansion, operational discipline, and customer experience, which are expected to drive sustained top-line growth [4][6] - The company is committed to integrating ExoDx and enhancing its sales organization to capitalize on the combined customer base [34] - The goal for 2026 is to achieve revenue guidance of $137 million to $140 million, reflecting a 28% year-over-year growth [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver growth and profitability, emphasizing the importance of operational discipline and customer experience [3][14] - The integration of ExoDx is seen as a significant growth opportunity, with expectations for improved operational efficiencies and market leadership in prostate cancer diagnostics [6][16] Other Important Information - The company amended its earn-out payment to Exact Sciences, reducing the upcoming payment by nearly $20 million, providing additional financial flexibility [8] - The collaboration with the University of Oxford is expected to enhance the utility of the GPS test in clinical guidelines, further solidifying MDxHealth's market position [16] Q&A Session Summary Question: Tissue ASP decline and mix shift - Management confirmed that the decline in tissue ASP was due to a mix shift towards Confirm and noted that ASPs reflect Medicare rates [19] Question: EBITDA performance and cash flow - Management acknowledged the lower EBITDA and higher cash burn, attributing it to the integration of ExoDx and expressed confidence in achieving a 10% EBITDA margin by year-end [20][21] Question: 2026 revenue guidance assumptions - Management indicated that the guidance reflects balanced growth from both tissue and liquid segments, with significant contributions expected from the ExoDx acquisition [32][34] Question: Operating leverage and gross margin expectations - Management stated that they expect to maintain flat OpEx while achieving growth and indicated that gross margins are expected to remain in the low 60s, with aspirations for improvement [44][46]

Financial Data and Key Metrics Changes - The reported revenue for Q4 2025 was $29.5 million, a 19% increase from $24.7 million in Q4 2024 [17] - Gross profit for Q4 2025 was $18.7 million, up 20% from $15.5 million in Q4 2024, with gross margins increasing to 63.2% from 62.7% [18] - The operating loss for Q4 2025 increased by 14% to $5.3 million compared to $4.6 million in Q4 2024 [18] - The net loss for Q4 2025 rose by 31% to $8.9 million from $6.8 million in the prior year [19] - Adjusted EBITDA for Q4 was -$2.1 million, compared to -$1.4 million in Q4 2024 [19] - Cash and cash equivalents as of December 31, 2025, were $29 million [19] Business Line Data and Key Metrics Changes - Total billable volume in Q4 was approximately 38,000 tests, with tissue-based tests at 11,000 and liquid-based tests at 27,000, representing a total unit growth of 62% year-over-year [16] - Tissue-based test volumes decreased by 5% year-over-year, while liquid-based test volumes increased by 128% [17] Market Data and Key Metrics Changes - The acquisition of ExoDx is expected to significantly contribute to revenue growth, with an anticipated contribution of $20 million or more in 2026 [45] - The company aims to balance revenue growth between tissue and liquid tests, which previously saw tissue tests account for 85% of revenue [45] Company Strategy and Development Direction - MDxHealth is focused on three core operating principles: focus, execution, and growth, which have positioned the company as a leader in precision diagnostics in urology [4][9] - The company is committed to improving the customer experience, achieving a turnaround time of five days or less for critical tissue-based patient samples [8] - The integration of the ExoDx business is expected to enhance operational efficiencies and drive growth [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustained top-line growth while advancing operating profitability, with a target of reaching a 10% EBITDA margin by the end of 2026 [14][20] - The company anticipates some operational challenges in Q4 and Q1 due to the integration of the ExoDx acquisition but expects significant growth opportunities thereafter [32] Other Important Information - The company amended the Exact Sciences earn-out from the GPS acquisition, reducing the upcoming payment by nearly $20 million and deferring the full earn-out amount by an additional year [13] - The collaboration with the University of Oxford is expected to enhance the utility of the GPS test in clinical guidelines, positioning MDxHealth as a leader in risk stratification for prostate cancer [24][25] Q&A Session Summary Question: Tissue ASP decline - The decline in tissue ASP was attributed to a mix shift towards Confirm tests, with no significant issues related to denial rates [30] Question: EBITDA and cash flow concerns - Management acknowledged the lower-than-expected EBITDA and higher cash burn, attributing it to the integration of ExoDx and expressed confidence in future cash flow improvements [31][32] Question: 2026 revenue guidance assumptions - The guidance for 2026 implies 28% growth, driven by core volume growth and contributions from ExoDx, with a focus on balancing growth across tissue and liquid tests [43][45] Question: Operating leverage and gross margin - Management indicated confidence in maintaining flat OpEx while achieving growth, with gross margins expected to remain in the low 60s, aiming for improvements over time [56][60]

Financial Data and Key Metrics Changes - The reported revenue for Q4 2025 was $29.5 million, a 19% increase from $24.7 million in Q4 2024 [11] - Gross profit for Q4 2025 was $18.7 million, up 20% from $15.5 million in Q4 2024, with gross margins increasing to 63.2% from 62.7% [12] - The operating loss for Q4 2025 increased by 14% to $5.3 million compared to $4.6 million in Q4 2024 [12] - The net loss for Q4 2025 rose 31% to $8.9 million from $6.8 million in the prior year [13] - Adjusted EBITDA for Q4 was -$2.1 million, compared to -$1.4 million in Q4 2024 [13] - Cash and cash equivalents as of December 31, 2025, were $29 million [13] Business Line Data and Key Metrics Changes - Total billable volume in Q4 was approximately 38,000 tests, with tissue-based tests decreasing by 5% and liquid-based tests increasing by 128% year-over-year [11] - The acquisition of ExoDx contributed to the growth in liquid-based tests, which include Select mdx, Resolve mdx, and ExoDx [11][36] Market Data and Key Metrics Changes - The company is focused on the urology market, aiming to balance growth between tissue and liquid biopsy products [4][34] - The integration of ExoDx is expected to enhance the company's market position and customer base [36] Company Strategy and Development Direction - MDxHealth's strategy emphasizes focus, execution, and growth, with a commitment to operational discipline and customer experience [3][14] - The company aims to achieve sustained top-line growth while advancing operating profitability, targeting a 10% EBITDA margin by the end of 2026 [9][14] - The integration of ExoDx is a key part of the growth strategy, aimed at enhancing the product offering and customer base [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver growth, citing a disciplined approach to capital allocation and a commitment to patient and customer experience [14][18] - The company anticipates continued growth driven by the integration of ExoDx and the expansion of its diagnostic menu [36][40] Other Important Information - The company amended the Exact Sciences earn-out, reducing the upcoming payment by nearly $20 million and deferring the full amount by an additional year [9] - The collaboration with the University of Oxford is expected to enhance the company's reputation and position in the market [17] Q&A Session Summary Question: Tissue ASP decline and mix shift - Management confirmed that the decline in tissue ASP was due to a mix shift towards Confirm, with ASPs reflecting Medicare rates [20] Question: EBITDA and cash flow concerns - Management acknowledged the lower EBITDA and higher cash flow use, attributing it to the integration of ExoDx and expressed confidence in achieving a 10% EBITDA margin [21][24] Question: 2026 revenue guidance assumptions - Management indicated that the 2026 revenue guidance reflects balanced growth across tissue and liquid products, with expectations of $20 million contribution from ExoDx [35][36] Question: Operating leverage and gross margin expectations - Management stated that they expect to maintain flat OpEx while achieving growth, with gross margins anticipated to remain in the low 60s [44][48]

Core Insights - MDxHealth reported a fourth quarter revenue growth of 19% to $29.5 million and a full-year revenue growth of 20% to $107.9 million, indicating strong commercial execution and operational discipline [1][2][6] - The company anticipates further acceleration in growth for 2026, projecting revenue between $137 million and $140 million, representing a growth rate of 27% to 30% [3][12] Financial Performance - Fourth quarter revenue increased by 19% to $29.5 million compared to $24.7 million in the prior year, with tissue-based tests contributing 59% of total revenue [5][6] - Gross profit for the fourth quarter rose 20% to $18.7 million, with gross margins improving to 63.2% from 62.7% year-over-year [5][9] - Operating expenses increased by 19% to $23.9 million, primarily due to headcount increases and costs related to the ExoDx acquisition [7][10] - The net loss for the fourth quarter was $8.9 million, a 31% increase from $6.8 million in the previous year [7][10] - Adjusted EBITDA for the fourth quarter was ($2.1) million, reflecting a 53% increase compared to ($1.4) million in the same period last year [8][11] Year-End Summary - For the full year 2025, revenue reached $107.9 million, a 20% increase from $90.0 million in 2024, with tissue-based tests accounting for 76% of total revenue [8][10] - Gross profit for the year increased by 26% to $69.6 million, with gross margins improving to 64.5% from 61.2% [9][10] - The net loss for the year decreased by 12% to $33.5 million compared to $38.1 million in 2024, driven by a significant increase in gross profit [10][11] Outlook - The company maintains its 2026 revenue guidance of $137-140 million and aims for an adjusted EBITDA margin of 10% by the end of 2026 [3][12]

Company Overview - Garmin Ltd. (NYSE:GRMN) was founded in 1989 and is headquartered in Olathe, Kansas, specializing in wearable technology, GPS, and communication devices across consumer, aviation, marine, and fitness markets through connected IoT-enabled products [3]. Financial Performance - For the full year 2025, Garmin reported consolidated revenue of $7.246 billion, marking a 15% year-over-year increase and setting a new annual record. The fourth-quarter revenue reached $2.125 billion, up 17% year-over-year, surpassing $2.0 billion for the first time in a single quarter [2]. - The pro forma EPS for 2025 was $8.56, reflecting a 16% year-over-year increase, with fourth-quarter pro forma EPS also at $2.79, up 16% [2]. - Garmin ended 2025 with approximately $4.1 billion in cash and marketable securities and generated around $1.4 billion in free cash flow [2]. Dividend and Share Repurchase - The company proposed an annual dividend of $4.20 per share, representing a 17% increase, and approved a $500 million share repurchase program [2]. Future Guidance - For 2026, Garmin management guided consolidated revenue to approximately $7.9 billion, with a gross margin of about 58.5%, operating margin near 25.5%, and operating income expected to exceed $2.0 billion for the first time. Pro forma EPS is projected at approximately $9.35 [2]. - The guidance incorporates anticipated memory cost pressures and tariff impacts, which are expected to be offset by a favorable product mix and supply chain initiatives [2]. Analyst Upgrade - On February 19, Morgan Stanley upgraded Garmin to Equal Weight from Underweight and raised its price target to $252 from $195, citing stronger-than-expected 2026 revenue and margin guidance as a catalyst for improved sentiment [1].

Core Viewpoint - Trimble Navigation (TRMB) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, making it a valuable tool for investors [2][4]. - Institutional investors often rely on earnings estimates to determine a stock's fair value, leading to buying or selling actions that affect stock prices [4]. Business Improvement Indicators - The upgrade reflects an improvement in Trimble's underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. - The Zacks Consensus Estimate for Trimble indicates expected earnings of $3.53 per share for the fiscal year ending December 2026, with a 4.7% increase in estimates over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Trimble's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting strong potential for market-beating returns in the near term [10].

Core Insights - The GPS and wearables maker has provided a forecast for 2026 earnings and revenue that exceeds analysts' expectations [1] Group 1 - The company anticipates strong financial performance in 2026, indicating confidence in its growth trajectory [1]