BOSTON, April 02, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the Company will present at the Stifel 2025 Virtual Targeted Oncology Forum taking place April 8-9, 2025. Presentation Details Date: Tuesday, April 8, 2025 Time: 3:00 PM EDTWebcast Link: https://wsw.com/webcast/stifel99/cmpx/2119000 Virtual/Replay availabilit ...

Core Insights - Compass Therapeutics announced statistically significant top-line data from the COMPANION-002 trial, indicating the efficacy of tovecimig in combination with paclitaxel for patients with advanced biliary tract cancer (BTC) [1][2][6] Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology [12] - The company aims to address critical biological pathways involved in tumor growth and angiogenesis [12] Clinical Trial Details - The COMPANION-002 trial is a Phase 2/3 randomized study involving 168 adult patients with unresectable advanced BTC, comparing tovecimig plus paclitaxel to paclitaxel alone [4][6] - Patients in the trial were randomized in a 2:1 ratio, with 111 receiving the combination therapy and 57 receiving paclitaxel alone [4] Efficacy Results - The primary endpoint of the trial, overall response rate (ORR), was 17.1% for the combination therapy compared to 5.3% for paclitaxel alone, demonstrating a statistically significant difference (p=0.031) [5][6][7] - The combination therapy also showed a lower progressive disease (PD) rate of 16.2% compared to 42.1% for paclitaxel alone [6][8] Patient Population and Need - Biliary tract cancer affects approximately 23,000 patients annually in the U.S., with 85% of patients lacking FDA-approved second-line treatment options [3] - Current second-line therapies have an ORR of ~5% or less, with a median overall survival of about six months [3] Future Expectations - The company plans to report additional data, including key secondary endpoints, in Q4 2025 [5][13] - Safety data will also be reported alongside the secondary endpoint analyses, with an independent Data Monitoring Committee recommending the continuation of the study without modifications [13]

Core Insights - Compass Therapeutics, Inc. is set to host a webcast on April 1, 2025, to discuss top-line clinical data from its Phase 2/3 COMPANION-002 trial, which evaluates tovecimig in combination with paclitaxel for advanced biliary tract cancer [1][2] Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics for various diseases [3] - The company's research emphasizes the interplay between angiogenesis, the immune system, and tumor growth, aiming to create therapies that target critical biological pathways for effective anti-tumor responses [3] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics is advancing its product candidates through clinical development as standalone therapies and in combination with other proprietary antibodies [3]

Financial Performance and Projections - The company has incurred significant net losses totaling $365 million as of December 31, 2024, and expects to continue incurring substantial losses for the foreseeable future [230]. - The company anticipates that its cash resources of $126.7 million will fund operating expenses into the first quarter of 2027, based on current research and development plans [238]. - The company has never generated revenue from product sales and does not expect to do so for several years, if ever [234]. - The company has a history of significant losses and may never achieve or maintain profitability, impacting its ability to raise capital [233]. - The company’s future capital requirements depend on various factors, including the costs of clinical trials and the timing of obtaining marketing approvals [238]. Clinical Development and Regulatory Risks - The company plans to continue advancing preclinical and clinical development of existing product candidates, which will significantly increase expenses [232]. - The company faces risks related to the lengthy and expensive clinical development process, which may lead to delays or inability to commercialize product candidates [247]. - The company must successfully complete preclinical studies and clinical trials to advance its product candidates, which is essential for generating future revenues [245]. - The company faces significant risks in clinical trials, including potential delays due to regulatory requirements and the need for additional data, which could impact the timeline for product development [248]. - The regulatory approval process for the company's bispecific and monoclonal antibody product candidates is uncertain and may take longer and be more expensive than anticipated [261]. - The company has not demonstrated that its current product candidates are safe in humans, and there is uncertainty regarding the outcomes of ongoing or future clinical trials [267]. - The regulatory approval process for product candidates is lengthy and unpredictable, with no current approvals obtained [283]. - The FDA or comparable foreign regulatory authorities may delay or deny approval of product candidates due to various reasons, including safety and efficacy concerns [293]. - Clinical trials must adhere to regulatory requirements, and any deficiencies could lead to suspension or termination of trials, affecting product development timelines [297]. Market and Commercialization Challenges - Market acceptance of approved product candidates is uncertain, and failure to achieve sufficient acceptance could hinder revenue generation and profitability [311]. - The company may initially seek approval for product candidates as second- or third-line therapies, with no guarantee of first-line therapy approval even if benefits are demonstrated [316]. - The potentially addressable patient population for current or future product candidates may be lower than expected, impacting profitability without additional marketing approvals [317]. - Establishing marketing, sales, and distribution capabilities is crucial for commercial success, but the company currently lacks this infrastructure [321]. - The ability to obtain adequate reimbursement from third-party payors is essential for the commercialization of product candidates [326]. Intellectual Property and Patent Risks - Patent protection is critical for the company's product candidates, and failure to secure robust patents could allow competitors to commercialize similar products [347]. - The patent prosecution process is expensive and complex, and the company may not be able to maintain necessary patent protections in a timely manner [352]. - The company faces challenges in enforcing intellectual property rights globally, particularly in jurisdictions with less favorable legal systems [360]. - If patents are challenged in court, they could be found invalid or unenforceable, leading to a loss of protection for product candidates [374]. - The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding intellectual property rights, which could adversely affect commercialization efforts [380]. Competition and Industry Landscape - The biotechnology industry is highly competitive, with significant competition from major pharmaceutical companies and research institutions [425]. - Competitors may obtain FDA or other regulatory approvals more rapidly, potentially limiting the company's ability to develop or commercialize its product candidates [427]. - Numerous companies are developing treatments for cancer, including well-capitalized firms with significant clinical experience [428]. - Established pharmaceutical companies may invest heavily in novel compound discovery, potentially making the company's product candidates obsolete [425]. - The presence of numerous compounds in clinical development for cancer treatment intensifies competition in the market [428]. Compliance and Regulatory Environment - Compliance with healthcare laws and regulations is critical, as violations could lead to significant penalties and operational restrictions [339]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the cost-effectiveness of its products to secure coverage and reimbursement [330]. - Legislative and regulatory changes may increase the difficulty and cost of commercializing product candidates, impacting pricing and demand [333]. - The rapidly changing legislative environment regarding data privacy could lead to increased litigation risks and compliance costs for the company [399]. Manufacturing and Supply Chain Risks - The company relies on third-party CDMOs for manufacturing product candidates, which poses risks related to regulatory compliance and supply quality [341]. - Manufacturing processes are subject to various regulatory requirements, and any failure to comply could significantly impact the company's ability to develop and market its products [342]. - Changes in manufacturing methods or formulations during development could lead to increased costs, delays, and the need for additional testing or regulatory approvals [344]. - The complexity of manufacturing antibody therapeutics involves risks such as product loss due to contamination or equipment failure, which could disrupt supply chains [345].

Core Insights - Compass Therapeutics, Inc. reported a strong foundation in 2024, anticipating a transformational year ahead with significant clinical developments and financial stability [2][4]. Financial Performance - The net loss for the year ended December 31, 2024, was $49.4 million, or $0.36 per common share, compared to a net loss of $42.5 million, or $0.33 per common share for 2023 [12]. - Research and Development (R&D) expenses increased to $42.3 million in 2024 from $38.1 million in 2023, primarily due to additional spending on tovecimig and CTX-471 [13]. - General and Administrative (G&A) expenses rose to $15.1 million in 2024 from $12.2 million in 2023, marking a 24% increase [14]. - As of December 31, 2024, the company had $127 million in cash and marketable securities, down from $152 million in 2023, providing a cash runway into 2027 [15]. Clinical Developments - Enrollment for the COMPANION-002 study of tovecimig in patients with advanced biliary tract cancer (BTC) was completed, with top-line data expected by the end of Q1 2025 [6][7]. - An Investigator Sponsored Study (IST) for tovecimig in the first-line setting for BTC is set to begin patient dosing in Q1 2025 [6][7]. - The company advanced CTX-10726, a PD-1 x VEGF-A bispecific antibody, through preclinical development, with an IND filing expected by the end of 2025 and clinical data anticipated in 2026 [3][6]. - A Phase 2 clinical trial for CTX-471, a CD137 agonist antibody, is expected to begin in mid-2025, utilizing a new potential biomarker, NCAM (CD56) [4][10]. - The Phase 1 study of CTX-8371, a PD-1 x PD-L1 bispecific antibody, has completed dosing of the first three cohorts with no dose-limiting toxicities observed [4][11]. Pipeline Updates - The company plans to initiate two Phase 2 clinical trials in mid-2025: one for tovecimig in DLL4-positive colorectal cancer (CRC) in combination with chemotherapy, and another for CTX-471 in NCAM/CD56 expressing tumors [6][8]. - The company aims to report preclinical data for CTX-10726 in 2025, differentiating its product profile from other antibodies in the class [3].

Core Viewpoint - Compass Therapeutics, Inc. (CMPX) has received an upgrade to a Zacks Rank 2 (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 is effective for individual investors as it focuses on earnings estimate revisions, which are strongly correlated with near-term stock price movements [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Company Performance Indicators - The upgrade for Compass Therapeutics reflects an improvement in the company's underlying business, suggesting that investor sentiment may drive the stock price higher [5]. - The Zacks Consensus Estimate for Compass Therapeutics has increased by 11% over the past three months, although the expected earnings per share for the fiscal year ending December 2024 is projected at -$0.35, representing a year-over-year decline of 6.1% [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Only the top 20% of Zacks-covered stocks receive a 'Strong Buy' or 'Buy' rating, indicating superior earnings estimate revisions and potential for market-beating returns [9][10].

Core Insights - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology and other diseases [1][3] - The company will present at the Guggenheim Securities SMID Cap Biotech Conference in New York City on February 5-6, 2025 [1][2] Company Overview - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics specializes in the relationship between angiogenesis, the immune system, and tumor growth [3] - The company's pipeline includes novel product candidates targeting critical biological pathways for effective anti-tumor responses, including angiogenesis modulation and immune response induction [3] - Compass plans to advance its product candidates through clinical development as standalone therapies and in combination with proprietary pipeline antibodies [3]

Financial Position - Estimated cash, cash equivalents, and marketable securities were approximately $127 million as of December 31, 2024[6] - The financial data is unaudited and preliminary, subject to completion of financial closing procedures[6] Product Development - The company announced the advancement of a new drug candidate[5]

Core Insights - Compass Therapeutics, Inc. is approaching a significant milestone with the upcoming top-line data readout for its Phase 2/3 study of tovecimig in patients with advanced biliary tract cancer (BTC) expected at the end of Q1 2025 [2][6] - The company has introduced a new drug candidate, CTX-10726, a PD-1 x VEGF-A bispecific antibody, with an IND submission anticipated by the end of 2025 and initial clinical data expected in 2026 [2][6][12] - Compass is progressing with two new Phase 2 biomarker studies, one for tovecimig and another for CTX-471, both expected to start in mid-2025 [2][6] Development Pipeline Updates - Tovecimig (CTX-009) is a DLL4 x VEGF-A bispecific antibody with a top-line data readout scheduled for the end of Q1 2025 in patients with BTC [3][6] - CTX-471 is a CD137 agonist antibody, with a Phase 2 trial initiation expected in mid-2025 targeting tumors expressing NCAM/CD56 [4][6] - CTX-8371 is a PD-1 x PD-L1 bispecific antibody, with the third dosing cohort of its Phase 1 study fully enrolled and preliminary data expected in the second half of 2025 [5][6][12] Financial Position - As of December 31, 2024, Compass Therapeutics reported an estimated $127 million in cash and marketable securities, which is projected to sustain operations into Q1 2027 [9][6]

Core Viewpoint - Compars Therapeutics, Inc. (CMPX) has experienced a significant decline of 23.5% in its stock price over the past four weeks, but it is now in oversold territory, suggesting a potential for a turnaround as analysts expect better earnings than previously predicted [1]. Group 1: Stock Performance and Technical Indicators - CMPX's stock is currently showing signs of being oversold, with a Relative Strength Index (RSI) reading of 28.08, indicating that the heavy selling pressure may be exhausting itself [5]. - The RSI is a momentum oscillator that helps identify whether a stock is oversold, typically when the reading falls below 30 [2]. - The stock's price movements suggest it could soon revert to its previous equilibrium of supply and demand [5]. Group 2: Earnings Estimates and Analyst Sentiment - There has been a strong consensus among sell-side analysts to raise earnings estimates for CMPX, resulting in a 15.4% increase in the consensus EPS estimate over the last 30 days [7]. - An upward trend in earnings estimate revisions is generally associated with price appreciation in the near term [7]. - CMPX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate trends and EPS surprises, indicating a strong potential for a turnaround [8].