Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Focus**: Development of CTX-009 for advanced biliary tract cancer (BTC) Key Points CTX-009 and COMPANION-002 Trial - **Trial Overview**: COMPANION-002 is a randomized trial comparing CTX-009 plus paclitaxel versus paclitaxel alone for patients with advanced biliary tract cancer who have received one prior line of therapy [2][3] - **Patient Enrollment**: 168 patients enrolled, with the last patient enrolled in August 2024 [3] - **Survival Data**: Historical data suggests median overall survival for this patient population is approximately six months; however, the trial is showing fewer deaths than expected, indicating potential efficacy of CTX-009 [4][5] - **Follow-Up**: Top-line data expected in late Q1 2026, with nearly two years of median follow-up for the majority of patients [2][4] Market Opportunity - **Epidemiology**: Approximately 25,000 patients diagnosed with biliary tract cancer annually in the U.S., with 15-20% eligible for targeted therapy [28][29] - **Addressable Market**: Estimated at around 15,000 patients annually for second-line BTC treatment, representing a market opportunity exceeding one billion USD annually [30][32] Safety and Efficacy - **Safety Monitoring**: Data Safety Monitoring Committee has not raised any concerns regarding safety [23] - **Patient Outcomes**: 70% of patients appear to derive some benefit from CTX-009, with a low follow-up loss rate of about 5% [4][14] Future Plans - **Breakthrough Therapy Designation**: Plans to pursue this designation once analyses are completed [27] - **Frontline Trials**: Interest in initiating frontline trials post-002 data disclosure, with ongoing studies at MD Anderson [33] Pipeline Developments - **CTX-8371**: A PD-1/PD-L1 bispecific antibody showing promising early results, with plans for cohort expansions in triple-negative breast cancer and non-small cell lung cancer [42][46] - **CTX-10726**: A new drug candidate with superior PD-1 blockade compared to existing therapies, targeting gastric, hepatocellular, renal cell, and endometrial cancers [51][52] Financial Position - **Cash Reserves**: Approximately $220 million in cash as of Q3, providing runway into 2028 for executing clinical programs [55] Additional Insights - **Commercialization Strategy**: Plans to launch CTX-009 independently in the second-line BTC market, focusing on academic medical centers where the patient population is concentrated [32][34] - **Potential for Business Development**: Ongoing conversations regarding partnerships or acquisitions to enhance the value of their drug candidates [53] This summary encapsulates the critical insights from the Compass Therapeutics conference call, highlighting the company's strategic direction, clinical trial progress, market potential, and financial health.

Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Location**: Boston - **Focus**: Monoclonal antibody discovery and development in oncology - **Pipeline**: Three drugs currently in clinical trials, including a DLL4 VEGFA bispecific antibody for advanced biliary tract cancer [2][3] Key Points on Clinical Programs Tuvesimig and Biliary Tract Cancer (BTC) - **Market Opportunity**: Approximately 25,000 new BTC cases diagnosed annually in the U.S. Only 15%-20% of patients have actionable mutations for targeted therapy. The remaining 80%-85% lack approved second-line therapies, presenting a significant commercial opportunity exceeding $1 billion annually in the U.S. [4][5] - **COMPANION-002 Study**: - Focuses on Tuvesimig (DLL4 VEGFA bispecific) combined with paclitaxel versus paclitaxel alone in second-line BTC patients. - Achieved a statistically significant increase in overall response rate (p-value of 0.031) and a notable reduction in progressive disease rates at week eight (42.1% in control vs. 16.2% in combination arm) [6][7]. - Safety data monitored by a data safety monitoring committee showed no new safety signals [8]. - Future readouts for progression-free survival (PFS) and overall survival (OS) expected in late Q1 2026 [9][10]. Regulatory Considerations - The FDA required paclitaxel as the control arm for the study, despite FOLFOX being in NCCN guidelines [14]. - Historical precedent from the Tibsovo study suggests that positive PFS results could support regulatory filings even without significant OS improvements [10][11]. Other Pipeline Developments PD-1, PD-L1 Bispecific Antibody (8371) - **Mechanism**: Acts as a next-generation checkpoint inhibitor, converting PD-1 positive T cells to PD-1 negative T cells, enhancing T cell engagement [17][18]. - **Phase One Data**: No dose-limiting toxicities observed across 15 patients, with three responses noted in post-checkpoint inhibitor patients [19][20]. - **Cohort Expansion**: Plans to expand cohorts in triple negative breast cancer and non-small cell lung cancer [21]. CD137 Agonist (471) - **Phase One Study**: Enrolled 60 patients across 17 tumor types, with five responses observed. A complete response was noted in a small cell lung cancer patient [25][26]. - **Future Plans**: An NCAM-positive basket study is set to begin in Q1 2026, with multiple clinical readouts anticipated in 2026 [26]. Financial and Operational Outlook - Compass Therapeutics is funded through 2028 to support ongoing clinical programs and development efforts [26]. Conclusion - Compass Therapeutics is positioned to capitalize on significant market opportunities in oncology, particularly in biliary tract cancer, with promising clinical data supporting its lead programs. The company is actively preparing for future regulatory submissions and expanding its clinical pipeline.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ 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: 001-39696 COMPASS THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) D ...

EXHIBIT 99.1 Compass Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update BOSTON, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical- stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, today reported third quarter 2025 financial results and provided a business update. "We have made strong progress across our clinical pipeline this quarter and based on a continuing trend of lower mortali ...

Core Insights - Compass Therapeutics reported strong progress in its clinical pipeline, particularly with tovecimig for advanced biliary tract cancer (BTC), expecting to release overall survival (OS) and progression-free survival (PFS) data in late Q1 2026, which may support a Biologics License Application (BLA) filing in the second half of 2026 [2][4][5] - The company has observed promising responses in CTX-8371, with no dose-limiting toxicities, and plans to expand cohorts in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC) [2][4][12] - Compass Therapeutics has a strong cash position of $220 million as of September 30, 2025, which is expected to fund operations through 2028 [14] Clinical Pipeline Updates - Tovecimig is in the Phase 2/3 COMPANION-002 study for advanced BTC, with analyses of OS and PFS expected in late Q1 2026 [4][5] - CTX-8371 has shown new responses in a third indication, with cohort expansions planned for NSCLC and TNBC based on previous results [2][12] - CTX-10726 is on track for an Investigational New Drug (IND) filing in Q4 2025, with initial Phase 1 clinical data anticipated in H2 2026 [4][12] Financial Performance - For Q3 2025, the net loss was $14.3 million, compared to $10.5 million in Q3 2024, with a net loss of $50.8 million for the nine months ended September 30, 2025, compared to $34.3 million for the same period in 2024 [9][19] - Research and development (R&D) expenses increased to $12.8 million for Q3 2025, up 49% from $8.6 million in Q3 2024, primarily due to manufacturing and IND-enabling costs for CTX-10726 [10][19] - General and administrative (G&A) expenses decreased to $3.0 million for Q3 2025, down 18% from $3.6 million in Q3 2024, attributed to a credit from unvested employee equity [13][19] Cash Position - As of September 30, 2025, Compass Therapeutics had $220 million in cash and marketable securities, a significant increase from $127 million at the end of 2024, providing a cash runway into 2028 [14][21]

Core Insights - Compass Therapeutics, Inc. is presenting its preclinical development of CTX-10726, a bispecific antibody targeting PD-1 and VEGF-A, at the 40th Society for Immunotherapy of Cancer Annual Meeting [1][3] Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics to treat various human diseases [4][7] - The company emphasizes the interplay between angiogenesis, the immune system, and tumor growth, aiming to create a robust pipeline of product candidates targeting critical biological pathways for effective anti-tumor responses [4][7] Product Development - CTX-10726 is designed for patients with metastatic or locally advanced tumors, enhancing anti-tumor responses by targeting both immune checkpoints and tumor vasculature [3][5] - The bispecific antibody has shown potent anti-tumor activity in preclinical mouse models, outperforming competitive antibodies like ivonescimab in controlling tumor growth [5][6] - IND submission for CTX-10726 is on track for Q4 2025 [5] Preclinical Data Highlights - In vitro, CTX-10726 demonstrated high-affinity binding to VEGF-A and PD-1, effectively blocking their interactions in a dose-dependent manner [6] - In vivo studies showed superior anti-tumor efficacy in various cancer models, including human lung and colon cancer, with significant tumor size reduction compared to other treatments [6]

BOSTON, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (“Compass”) (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 participate in the following investor events during the month of November. Details are as follows: Guggenheim 2nd Annual Healthcare Innovation ConferenceLocation: Boston, MADate: Monday, November 10, 2025 Time: 3:30 PM ETWebcast L ...

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgency to invest in AI technologies now [1][13] - The energy demands of AI technologies are highlighted as a critical concern, with predictions that AI will significantly strain global power grids and increase electricity prices [2][3] Investment Opportunity - A specific company is presented as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for supporting the anticipated surge in energy demand from AI data centers [3][7] - This company is characterized as a "toll booth" operator in the AI energy boom, benefiting from the increasing need for energy as AI technologies expand [4][5] Market Position - The company is noted for its unique position in the market, being debt-free and holding a significant cash reserve, which is approximately one-third of its market capitalization [8] - It also has a substantial equity stake in another AI-related company, providing investors with indirect exposure to multiple growth opportunities in the AI sector [9][10] Industry Trends - The article discusses the broader context of the AI infrastructure supercycle, the onshoring boom driven by tariffs, and the surge in U.S. LNG exports, all of which are interconnected with the company's operations [14] - The company is described as capable of executing large-scale engineering, procurement, and construction projects across various energy sectors, positioning it strategically within the evolving energy landscape [7][8] Future Outlook - The influx of talent into the AI sector is expected to drive continuous innovation and advancements, reinforcing the notion that investing in AI is a way to back the future [12] - The potential for significant returns is emphasized, with projections of over 100% return within 12 to 24 months for investors who act promptly [15]

Core Insights - The article highlights stocks reaching new 52-week highs, indicating market recognition of strong fundamentals and potential catalysts for growth [1][2]. Company Summaries Cogent Biosciences Inc. (COGT) - Cogent Biosciences plans to file its first New Drug Application for Bezuclastinib by the end of 2025, targeting non-advanced systemic mastocytosis [3]. - A phase III trial comparing Bezuclastinib with Sutent is ongoing, with results expected in the second half of 2025 [4]. - The stock reached a 52-week high of $16.99, up from $7.25 when last featured [5]. Assembly Biosciences Inc. (ASMB) - Assembly Biosciences is advancing four key development programs, with ABI-5366 expected to enter phase 2 studies in mid-2026 [6]. - Interim data for ABI-1179 is anticipated this fall, while ABI-6250 is in a phase 1a trial [7]. - The stock hit a 52-week high of $28, up from $14.53 when last featured [8]. Compass Therapeutics Inc. (CMPX) - Compass Therapeutics is conducting a phase 2/3 study of Tovecimig for advanced biliary tract cancer, with analyses of secondary endpoints expected in Q1 2026 [9][10]. - The stock reached a 52-week high of $4.39, up from $2.91 when last featured [11]. NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam Pharma is developing Obicetrapib as a cholesterol-lowering therapy, with positive data from the BROADWAY trial [12][13]. - The company has completed two additional phase III trials and submitted marketing applications to the EMA [16]. - The stock reached a 52-week high of $39.76, up from $21.56 when last featured [17]. Mineralys Therapeutics Inc. (MLYS) - Mineralys is developing Lorundrostat for uncontrolled hypertension, with a pivotal phase III trial achieving its primary endpoint [19]. - A phase II trial for overweight participants with OSA is ongoing, with topline results expected in 1H 2026 [20]. - The stock hit a 52-week high of $43.88, up from $10.34 when last featured [20]. Kymera Therapeutics Inc. (KYMR) - Kymera is set to report data from its phase I trial of KT-621 this quarter, with phase 2b studies planned for late 2025 and early 2026 [21][22]. - The stock reached a 52-week high of $60, up from $40 when last featured [22]. Insmed Inc. (INSM) - Insmed has two approved drugs and is conducting a phase 3 trial of Arikayce, with topline results expected in 1H 2026 [24][25]. - The stock hit a high of $166.54, up from $76.54 when last featured [26]. Adaptive Biotechnologies Corp. (ADPT) - Adaptive Biotechnologies expects MRD revenue between $190 million and $200 million for 2025, up from $145.5 million in 2024 [28][29]. - The stock reached a 52-week high of $15.94, up from $9.80 when last featured [29]. BridgeBio Pharma Inc. (BBIO) - BridgeBio has upcoming topline results from the FORTIFY and CALIBRATE studies expected in Fall 2025 [30]. - The stock reached a 3-year high of $56.24, up from $25.10 when last featured [31]. Tarsus Pharmaceuticals Inc. (TARS) - Tarsus reported strong sales for Xdemvy, with Q2 2025 sales of $102.7 million, compared to $40.8 million in Q2 2024 [32]. - The stock hit an all-time high of $70.15, up from $25.01 when last featured [34]. Palvella Therapeutics Inc. (PVLA) - Palvella's QTORIN is under development for various skin diseases, with a phase 2 trial expected to report data in mid-December 2025 [35][36]. - The stock reached a 52-week high of $76.76, up from $25 when last featured [36]. Merus N.V. (MRUS) - Merus agreed to be acquired by Genmab for $97 per share, with the deal expected to close in early Q1 2026 [37]. - The stock was at $39.71 when last featured [39]. Nephros Inc. (NEPH) - Nephros reported net revenue of $4.4 million for Q2 2025, marking its third consecutive quarter of profitability [40][41]. - The stock hit a 52-week high of $5.98, up from $2.93 when last featured [42].

Group 1 - Compass Therapeutics Inc. (NASDAQ:CMPX) is identified as a promising multibagger stock, with its lead program CTX-009 targeting advanced solid tumors, particularly biliary tract cancer (BTC), which presents a market opportunity exceeding $1 billion [1] - Approximately 85% of BTC patients who fail first-line therapy currently lack approved and effective treatment options, highlighting a significant unmet medical need [1] - Analyst Michael Schmidt from Guggenheim raised the price target for Compass Therapeutics to $12 from $10, maintaining a Buy rating following positive Q2 results and pipeline updates [2] Group 2 - The management updated the timeline for the COMPANION-002 Phase 2/3 trial of tovecimig in biliary tract cancer, with final progression-free survival and overall survival data now expected in early 2026, slightly delayed from the previous estimate of Q4 2025 [3] - Despite the delay, the trial is still considered a key near-term catalyst for the company [3] - Schmidt's report reflects increased confidence in the company's pipeline, particularly in tovecimig and CTX-8371, which are seen as having clinical and commercial potential [4][5]